Search

Background: Silicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants., Objectives: The authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts., Methods: The Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submitted to the FDA on adverse events, reoperations, patient and physician satisfaction, connective tissue diseases, and quality of life validated instruments. A subset of the patients underwent annual magnetic resonance imaging (MRI) at years 1, 2, and 3 to screen for implant rupture., Results: A total of 451 patients were implanted in the primary augmentation cohort and 109 patients in the revisional augmentation cohort. There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort (92.4% follow-up) and 25.8% in the revisional augmentation cohort (88.7% follow-up)., Discussion: Motiva implants were first introduced in 2010. The 3-year Motiva data suggests that the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change., Conclusions: Three-year data from the primary augmentation and revisional augmentation cohorts submitted to the FDA demonstrate the safety and efficacy of the Motiva implants. There were low complication rates for implant-related complications and high surgeon and patient satisfaction., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement., Methods: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications., Results: A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year ( P <0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital ( P =0.0005), 30-day ( P =0.004), and 1-year mortality rates ( P =0.01)., Conclusions: This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates., Competing Interests: Dr Goel has served as a consultant and proctor for Edwards Lifesciences and Abbott Vascular; and has received research support for clinical trials from Medtronic, Innovalve, Trisol and Teleflex. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as national principal investigator for Portico (Abbott) and Acurate (Boston Scientific) US investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, and Abbott Vascular and has equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, and Admedus. Dr Barker has received institutional research support from Edwards Lifesciences and Abbott. Dr Dhoble has served as a consultant and proctor for Edwards Lifesciences and Abbott Vascular; and has received research support for clinical trials from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Medtronic. Dr Yadav has served as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Shockwave Medical. Dr Rihal has received research grants from Edwards Lifesciences. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Guerrero has received research grant support from Abbott Structural Heart and Edwards Lifesciences. Dr Whisenant has served as a consultant for Edwards Lifesciences. The other authors report no conflicts.

Objectives: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy., Methods: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol., Results: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts., Conclusions: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device., Competing Interests: Conflict of Interest Statement Dr Gosev reports consulting for Abbott. Dr Pham reports consulting for Abbott, Abiomed, and Medtronic. Dr Itoh reports speaker honoraria from Abbott and Abiomed. Dr Kotkar is a speaker (nonfinancial) for Abiomed and 3M. Dr Naka reports consulting for Abbott, Biomet-Zimmer, Cryolife, and receiving speaker’s fees for Nipro Co. Dr Peltz reports research support from Bridge to Life Ltd and Paragonix Inc. Dr Silvestry reports consulting for Abbott, Abiomed, Medtronic, and data and safety monitoring board participation for Carmat. Dr Leacche reports consulting for Abbott and advisory board participation for Abiomed. Dr Rao reports consulting for Abbott, Medtronic, and Gore. Dr Sun reports consulting for Abbott. Dr Tedford reports consulting for Abbott, Medtronic, Aria CV Inc, Alleviant, Acorai, Acceleron, Cytokinetics, Itamar, Edwards LifeSciences, Eidos Therapeutics, Lexicon Pharmaceuticals, Gradient, and United Therapeutics. He is the national co-principal investigator for the RIGHT-FLOW clinical trial (Edwards), serves on steering committees for Merck, and a research advisory board for Abiomed. He also does hemodynamic core lab work for Merck. Dr Mokadam reports consulting for Abbott, Medtronic, SynCardia, Carmat, and Xylocor. Drs McNutt and Crandall are employees of Abbott. Dr Mehra reports payment made to institution from Abbott for consulting; consulting fees from Mesoblast, Janssen, Moderna, and Paragonix, and Baim Institute for clinical research; he is an advisory board member for Transmedics, NuPulseCV, Leviticus, and FineHeart. Dr Salerno reports consulting for Abbott. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article reported no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective cohort study of anatomic predictors of adverse iliac events (AIEs) in aortoiliac aneurysms treated with iliac branch devices (IBDs)., Methods: Patients with pre-IBD and post-IBD computed tomography imaging were included. We measured arterial diameters, stenosis, calcification, bifurcation angles, and tortuosity indices using a standardized, validated protocol. A composite of ipsilateral AIE was defined, a priori, as occlusion, type I or III endoleak, device constriction, or clinical event requiring reintervention. Paired t-test compared tortuosity indices and splay angles pretreatment and post-treatment for all IBDs and by device material (stainless steel and nitinol). Two-sample t-test compared anatomical changes from pretreatment to post-treatment by device material. Logistic regression assessed associations between AIE and anatomic measurements. Analysis was performed by IBD., Results: We analyzed 297 patients (286 males, 11 females) with 331 IBDs (227 stainless steel, 104 nitinol). Median clinical follow-up was 3.8 years. Iliac anatomy was significantly straightened with all IBD treatment, though stainless steel IBDs had a greater reduction in total iliac artery tortuosity index and aortic splay angle compared to nitinol IBDs (absolute reduction -0.20 [-0.22 to -0.18] vs. -0.09 [-0.12 to -0.06], P < 0.0001 and -19.6° [-22.4° to -16.9°] vs. -11.2° [-15.3° to -7.0°], P = 0.001, respectively). There were 54 AIEs in 44 IBDs in 42 patients (AIE in 13.3% of IBD systems), requiring 35 reinterventions (median time to event 41 days; median time to reintervention 153 days). There were 18 endoleaks, 29 occlusions, and 5 device constrictions. There were no strong associations between anatomic measurements and AIE overall, though internal iliac diameter was inversely associated with AIE in nitinol devices (n AIE, nitinol  = 8)., Conclusions: Purpose-built IBDs effectively treat aortoiliac disease, including that with tortuous anatomy, with a high patency rate (91.5%) and low reintervention rate (9.1%) at 4 years. Anatomic predictors of AIE are limited., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device., Objective: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study., Methods: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported., Results: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group., Conclusion: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair., Methods: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines., Results: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m 2 . Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor., Conclusions: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure., Competing Interests: Disclosures M.F. is a consultant for W. L. Gore & Associates, Cook Medical, Getinge, and ViTAA; and has received research support from Cook Medical, clinical trial support from Centerline Biomedical, W. L. Gore Associates, Cook Medical, and ViTAA; an has stock options in Centerline Biomedical. J.M. has received a research grant from W. L. Gore Associates (granted to University of Colorado). S.H. is a consultant for Cook Medical, Terumo Aortic, and W. L. Gore & Associates (all honoraria paid to USC, no personal income); is on the scientific advisory board for Cook Medical, Terumo Aortic, W. L. Gore & Associates, and Vestek; and has received educational grants from W. L. Gore & Associates and Terumo Aortic, M.M. is on the advisory board of W. L. Gore & Associates. B.S. is a consultant for W. L. Gore & Associates, Cook Medical, Endologix, and Astute Imaging. C.T. has received consulting fees and research support from Cook Medical, W. L. Gore & Associates, and Philips Healthcare. B.M. reports payments to Mayo Clinic, with no personal income, for work on the advisory boards of Cook Medical and Medtronic; as a consultant for Cook Medical and W. L. Gore Associates; and research grants from W. L. Gore Associates and Cook Medical. G.O. reports a consulting agreement with Cook Medical, W. L. Gore Associates, GE Healthcare, and Centerline biomedical; and a research grant from GE Healthcare., (Published by Elsevier Inc.)

Background: A dilated native right ventricular outflow tract (RVOT) presents unique challenges for transcatheter management using balloon-expandable valves. The Alterra Adaptive Prestent was designed to expand transcatheter therapy to treat patients with dilated RVOTs., Objectives: The aim of this study was to report 2-year outcomes of the main cohort of the ALTERRA (Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent) pivotal trial using the prestent with transcatheter pulmonary valve replacement., Methods: The prestent device used with the 29 mm SAPIEN 3 transcatheter heart valve (THV) was evaluated for the management of patients with moderate or greater pulmonary valve regurgitation (PR). The primary endpoint was THV dysfunction at 6 months, defined as a nonhierarchical composite of RVOT/pulmonary valve reintervention, moderate or greater total PR on transthoracic echocardiography, and mean RVOT/pulmonary valve gradient 35 mm Hg or greater on transthoracic echocardiography. The primary endpoint and outcomes through 2 years are presented in this analysis., Results: Of 97 patients screened, 60 underwent prestent and THV implantation. There was 1 staged procedure. No patients had THV dysfunction at 6 months. At 2 years, the majority of patients (92.5%) had mild or less PR, with no reports of coronary compression, stent fractures warranting reintervention, or endocarditis. Of the 21 patients (34.4%) who experienced early (days 0-1) arrhythmias, 12 had episodes of nonsustained ventricular tachycardia that resolved with medication. One patient underwent reintervention secondary to an iatrogenic RVOT obstruction; there were no deaths or explantations through 2 years., Conclusions: The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort., Competing Interests: Funding Support and Author Disclosures Edwards Lifesciences sponsored this study. Dr Dimas is a proctor and consultant for Edwards Lifesciences, Medtronic, and B. Braun; and is a consultant for Abbott. Dr Babaliaros is a consultant for Edwards Lifesciences and Abbott Vascular; and holds stock options in TransMural Systems. Dr Kim is a consultant for Edwards Lifesciences. Dr Lim has received research grants to his institution on his behalf from Abbott, atHeart, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, V-Wave, and W.L. Gore; and has received personal consulting fees from LagunaTech, Philips, Valgen, and Venus. Dr Morgan is a consultant and proctor for Edwards Lifesciences. Dr Jones is a consultant for Edwards Lifesciences and atHeart Medical; and is a consultant and proctor for Medtronic, Abbott, and W.L. Gore. Dr Armstrong is a consultant for Abbott, Medtronic, Edwards Lifesciences, and Starlight Cardiovascular. Dr Berman is a consultant and proctor for Abbott, B. Braun, Edwards Lifesciences, and Medtronic. Dr Aboulhosn is a consultant and proctor for Edwards Lifesciences and Medtronic. Dr Mahadevan is principal investigator for clinical trials sponsored by Abbott, and RECOR Medical; and is a proctor for Edwards Lifesciences. Dr Gillespie is a consultant and proctor for Abbott, Medtronic, and W.L. Gore. Dr Balzer is a consultant and proctor for Abbott, Edwards Lifesciences, and Medtronic. Dr Yu is an employee of Edwards Lifesciences. Dr Shirali has received institutional grant funding from Edwards Lifesciences. Dr Parthiban has received grant funding to the institution from Edwards Lifesciences. Dr Leipsic has institutional computed tomography core laboratory contracts with Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr Blanke is a consultant for Edwards Lifesciences and LARALAB. Dr Zahn is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Shahanavaz is a consultant for Edwards Lifesciences and Medtronic. Dr Zellers has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure., Objectives: This study sought to report the combined pivotal and continued access cohorts of the ASSURED (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs) trial results through 36 months., Methods: This prospective, multicenter, single-arm trial evaluated procedural and clinical outcomes of ASD closure with the GCA. The primary endpoints were 6-month closure success following device implantation and composite clinical success (deployment/retention of device, safety, and closure). Technical and procedure success, safety, clinically significant new arrhythmia (CSNA) secondary endpoints, and wire frame fracture (WFF, with fluoroscopy) at 6 and 36 months were evaluated., Results: Of 569 patients (median age of 10.4 years and median weight of 35.0 kg) who underwent attempted secundum ASD closure, 526 were technical successes. The mean stop-flow ASD diameter was 17.6 ± 5.3 mm. All 478 patients with 6-month imaging achieved closure success. Composite clinical success at 6 and 36 months was achieved in 87.6% (468/534) and 84.0% (351/418) of patients, respectively. Technical failure occurred in 8.1% (43/548), 30-day device- or procedure-related serious adverse event in 3.9% (21/534), and 6-month device events in 2.8% (15/534) of patients. At 30 days, 21 of 569 patients (3.7%) had CSNA. At 6 months, 138 of 436 (31.7%) patients had WFFs and 105 of 185 (56.8%) at 36 months (without sequelae)., Conclusions: In this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae. The unique features, size range, and safety profile expand the options for secundum ASD closure. (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs [ASSURED]; NCT02985684)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by W. L. Gore & Associates. Dr Qureshi is a consultant for W. L. Gore & Associates, Medtronic, and B. Braun. Dr Sommer has received institutional funding from W. L. Gore & Associates for working on their national PFO and ASD trials; and serves on the Advisory Board for Conformal Medical. Dr Morgan is a consultant/proctor for W. L. Gore & Associates. Dr Paolillo is a consultant, proctor, and preceptor for W. L. Gore & Associates. Dr Goldstein is a consultant for Medtronic, W. L. Gore & Associates, Edwards Lifesciences, and Mezzion Pharmaceuticals. Dr Sugeng serves on the Speakers Bureau for Philips Healthcare; and is a consultant for Siemens Healthineers and Yale Echo Corelab YCRG. Dr Gillespie is a consultant for W. L. Gore & Associates and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Food and Drug Administration (FDA) blood pump is an open-source benchmark cardiovascular device introduced for validating computational and experimental performance analysis tools. The time-resolved velocity field for the whole impeller has not been established, as is undertaken in this particle image velocimetry (PIV) study. The level of instantaneous velocity fluctuations is important, to assess the flow-induced rotor vibrations which may contribute to the total blood damage., Methods: To document these factors, time-resolved two-dimensional PIV experiments were performed that were precisely phase-locked with the impeller rotation angle. The velocity fields in the impeller and in the volute conformed with the previous single blade passage experiments of literature., Results: Depending on the impeller orientation, present experiments showed that volute outlet nozzle flow can fluctuate up to 34% during impeller rotation, with a maximum standard experimental uncertainty of 2.2%. Likewise, the flow fields in each impeller passage also altered in average 33.5%. Considerably different vortex patterns were observed for different blade passages, with the largest vortical structures reaching an average core radii of 7 mm. The constant volute area employed in the FDA pump design contributes to the observed velocity imbalance, as illustrated in our velocity measurements., Conclusions: By introducing the impeller orientation parameter for the nozzle flow, this study considers the possible uncertainties influencing pump flow. Expanding the available literature data, analysis of inter-blade relative velocity fields is provided here for the first-time to the best of our knowledge. Consequently, our research fills a critical knowledge gap in the understanding of the flow dynamics of an important benchmark cardiovascular device. This study prompts the need for improved hydrodynamic designs and optimized devices to be used as benchmark test devices, to build more confidence and safety in future ventricular assist device performance assessment studies., (© 2024 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Objectives: Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for severe blunt thoracic aortic injuries (BTAI). Successful outcomes rely on accurate endograft sizing, but initial imaging may underestimate aortic diameters. This study examines the impact of intravascular ultrasound (IVUS) on endograft sizing and clinical outcomes in BTAI patients., Methods: A prospectively collected multi-institutional dataset from the Aortic Trauma Foundation was analyzed. Patients with BTAI undergoing TEVAR with IVUS were compared to patients who underwent TEVAR alone. Demographics and operative variables were compared, focusing on IVUS effects on endograft sizing by examining maximal proximal and distal aortic diameter on initial CT imaging compared to the graft diameters used during TEVAR., Results: 293 patients underwent TEVAR for BTAI with IVUS utilized in 124 cases (42.3%). The average graft size in the IVUS and non-IVUS groups were similar proximally (26.91 ± 4.3 mm IVUS vs 27.77 ± 4.7 mm non-IVUS, P = 0.116) and distally (25.96 ± 4.7 mm IVUS vs 26.51 ± 4.7 mm non-IVUS). IVUS did not impact the difference between graft size and initial CT measurements proximally (4.32 ± 4.8 mm IVUS vs 4.23 ± 3.9 mm non-IVUS, P = 0.859) or distally (4.17 ± 5.9 mm IVUS vs 4.50 ± 4.3 mm non-IVUS, P = 0.606). Although delayed hemorrhagic and ischemic stroke occurred less frequently in IVUS patients (0.8% IVUS vs 7.1% non- IVUS, P = 0.024), in-hospital mortality was similar between groups (5.6% IVUS vs 7.7% non-IVUS, P = 0.581)., Conclusions: IVUS is not associated with significant changes in endograft sizing compared to sizing based on CT scan alone in BTAI patients. IVUS was not associated with differences in mortality but was associated with a decrease in delayed hemorrhagic and ischemic stroke. Routine IVUS in BTAI patients may not be necessary for accurate sizing, but there may be a relationship between IVUS and stroke., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life., Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR., Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory., Results: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001)., Conclusions: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757)., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott Structural Heart. Dr Nickenig has received research funding and honoraria from Abbott, Edwards Lifesciences, and Medtronic; and has participated in clinical trials with Abbott, Edwards Lifesciences, and Medtronic. Dr Lurz has served as a consultant for Abbott Structural Heart, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, and xDot; and has received personal fees from Abbott Vascular (outside the submitted work). Dr von Bardeleben has received institutional research grants and speaker honorarium from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Sitges has served as a consultant for Abbott, Edwards Lifesciences, Metronic, and General Electric; has received speaker honoraria from Abbott, Edwards Lifesciences, Medtronic, and General Electric; and has received speaker honoraria and travel and grant support from Abbott. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr Trochu has received speaker honoraria, travel support, and grant support from Abbott and Novartis; has received honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr Näbauer has received speaker honoraria from Abbott. Dr Heitkemper is an employee of Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV)., Objectives: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes., Methods: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality., Results: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF)., Conclusions: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes., Competing Interests: Funding Support and Author Disclosures Dr Eng is a clinical proctor for Medtronic and Edwards Lifesciences. Dr Khalili has received a research grant from Edwards Lifesciences; and has received speaker fees from Abbott Vascular. Dr Vavalle is a consultant for Edwards Lifesciences. Dr Southard has received personal fees from Edwards Lifesciences and Boston Scientific. Dr Hahn has received speaker fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; has received consulting fees from Abbott Structural, Edwards Lifesciences, Gore Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity with Navigate; and is chief scientific officer of the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Materialise. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the TVT Registry., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States., Methods: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year., Results: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients., Conclusions: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice., Competing Interests: Dr R.W. Yeh is a consultant and has research grants with Boston Scientific Corporation. Dr J.P. Piccini is a consultant and has research grants with Abbott, Boston Scientific Corporation and Bayer. Drs T. Christen and D.J. Allocco are full time employees and stockholders in Boston Scientific Corporation. The other authors report no conflicts.

Background: In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup., Methods: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes., Results: From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm²., Conclusion: The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety., (© 2024 Wiley Periodicals LLC.)

Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting., Competing Interests: Declarations of Competing Interest Kalyan R. Chitturi – Consultant: Glass Health. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. All other authors – None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The Impella 5.0 and 5.5 pumps (Abiomed, Danvers, MA) are large-bore transvalvular micro-axial assist devices used in cardiogenic shock (CS) for patients requiring high-capacity flow. Despite their increasing use, real-world data regarding indications, rates of utilization and clinical outcomes with this therapy are limited. The objective of our study was to examine clinical profiles and outcomes of patients in a contemporary, real-world CS registry of patients who received an Impella 5.0/5.5 alone or in combination with other temporary mechanical circulatory support (tMCS) devices., Methods: The CS Working Group (CSWG) Registry includes patients from 34 US hospitals. For this analysis, data from patients who received an Impella 5.0/5.5 between 2020-2023 were analyzed. Use of Impella 5.0/5.5 with or without additional tMCS therapies, duration of support, adverse events and outcomes at hospital discharge were studied. Adverse events including stroke, limb ischemia, bleeding and hemolysis were not standardized by the registry but reported per individual CSWG Primary Investigator discretion. For those who survived, rates of native heart recovery (NHR) or heart replacement therapy (HRT) including heart transplant (HT), or durable ventricular assist device (VAD) were recorded. We also assessed outcomes based on shock etiology (acute myocardial infarction or MI-CS vs. heart failure-related CS or HF-CS)., Results: Among 6,205 patients, 754 received an Impella 5.0/5.5 (12.1%), including 210 MI-CS (27.8%) and 484 HF-CS (64.1%) patients. Impella 5.0/5.5 was used as the sole tMCS device in 32% of patients, while 68% of patients received a combination of tMCS devices. Impella cannulation sites were available for 524/754 (69.4%) of patients, with 93.5% axillary configuration. Survival to hospital discharge for those supported with an Impella 5.0/5.5 was 67%, with 20.4% NHR and 45.5% HRT. Compared to HF-CS, patients with MI-CS supported on Impella 5.0/5.5 had higher in-hospital mortality (45.2% vs 26.2%, p < 0.001) and were less likely to receive HRT (22.4% vs 56.6%, p < 0.001. For patients receiving a combination of tMCS during hospitalization, this was associated with higher rates of limb ischemia (9% vs. 3%, p < 0.01), bleeding (52% vs 33%, p < 0.01), and mortality (38% vs 25%; p < 0.001) compared to Impella 5.0/5.5 alone. Among Impella 5.0/5.5 recipients, the median duration of pump support was 12.9 days (IQR: 6.8-22.9) and longer in patients bridged to HRT (14 days; IQR: 7.7-28.4)., Conclusions: In this multi-center cohort of patients with CS, use of Impella 5.0/5.5 was associated with an overall survival of 67.1% and high rates of HRT. Lower adverse event rates were observed when Impella 5.0/5.5 was the sole support device used. Further study is required to determine whether a strategy of early Impella 5.0/5.5 use for CS improves survival., Condensed Abstract: High capacity Impella heart pumps are capable of provide up to 5.5 liter/min of flow while upper body surgical placement allows for ambulation. Patients with advanced cardiogenic shock from acute myocardial infarction or heart failure requiring temporary mechanical circulatory support may benefit from upfront use of Impella 5.5 to improve overall survival, including native heart recovery or successful bridge to durable left ventricular assist device surgery or heart transplantation., (Copyright © 2024. Published by Elsevier Inc.)

Background: Transcatheter tricuspid valve-in-valve (ViV) replacement has yielded good hemodynamic outcomes in the treatment of dysfunctional bioprosthetic valves (BPVs). Intentional fracture of certain rigid BPV frames, if feasible, allows a larger implanted valve when compared with implant into an unfractured BPV. There remains limited data on the feasibility of tricuspid valve frame fracture., Aims: Evaluate the feasibility of transcatheter tricuspid ViV replacement with fracture of the underlying BPV ring., Methods: An international multicenter registry of tricuspid ViV replacement with intentional tricuspid valve frame fracture was created. Demographic data along with procedural characteristics, outcomes, and follow-up data were collected. Comparison was made to the pre- and post-ViV replacement with fracture of the tricuspid valve frame conditions., Results: Ten patients from six centers were included with a median age and weight of 29 years and 67.3 kg respectively. Tricuspid valve frame fracture was performed using a median balloon diameter 3 mm (IQR 3-5) larger than the true inner diameter (ID). The final ID was a mean of 1.5 mm (95% CI: 0.35, 2.64: p < 0.05), and median 1.1 mm (0.5, 2.1) larger than the reported true ID of the surgical BPV after ViV replacement. The mean tricuspid inflow gradient by echocardiogram decreased by 6.65 mmHg (95% CI: 4.14, 9.15: p < 0.001). All procedures were without complication, specifically there was no heart block, pericardial effusion, or right coronary disruption., Conclusion: Intentional tricuspid valve frame fracture with tricuspid ViV replacement is feasible and can increase the valve orifice potentially reducing the risk of ViV patient prosthesis mismatch and is not associated with significant complications., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received Food and Drug Administration (FDA) approval to begin marketing the WavelinQ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ EndoAVF System was of "substantial equivalence" to the WavelinQ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they were significantly different from the predicate device its 510(k) approval was based on., Methods: FDA database Manufacturer and User Facility Device Experience was queried for all adverse report events for the WavelinQ EndoAVF System and WavelinQ 4F EndoAVF System. Data were collected on patient issues and device issues. Fisher's exact test was used., Results: There were a total of 125 reports for the WavelinQ 4F EndoAVF System and 78 for the WavelinQ EndoAVF System. There was a significant increase in patient problem "hypertension" (0% vs. 5.1%; P = 0.02) for the WavelinQ EndoAVF System but a statistically significant decrease in device issue "failure to align" for the WavelinQ EndoAVF System (24.8% vs. 10.3%; P ≤ 0.01)., Conclusions: There were changes in device and patient outcomes between the WavelinQ EndoAVF System and WavelinQ 4F EndoAVF System. While we noted a decrease in device problem "failure to align", there was an overall increase in patients' "hypertension" rates. This highlights the importance of the FDA Manufacturer and User Facility Device Experience reporting in ensuring that device safety is maintained when devices are approved for marketing through the 510(k) process., (Published by Elsevier Inc.)

Objective: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury., Methods: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality., Results: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up., Conclusions: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury., Competing Interests: Disclosures All authors were principal investigators in the study and as such received research grants to conduct the study. B.S. has been paid a consulting fee by Terumo Corporation for an unrelated project., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking., Objectives: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality., Methods: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement., Results: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001)., Conclusions: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions., Competing Interests: Funding Support and Author Disclosures Statistical analyses were supported by Edwards Lifesciences. Dr Zahr has received research and educational grants and consultation honoraria from Edwards Lifesciences, Medtronic, and Philips. Dr Elmariah is a consultant for Edwards Lifesciences and Medtronic; and has received institutional research support from Edwards Lifesciences and Medtronic. Dr Vemulapalli has received grants or contracts from the American College of Cardiology, the STS, Cytokinetics, Abbott Vascular, the National Institutes of Health (R01 and SBIR), and Boston Scientific; and has performed consultation work for and holds advisory board status with Janssen, the American College of Physicians, HeartFlow, and Edwards Lifesciences. Dr Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, and Abbott Vascular; and holds equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; holds institutional consultation contracts with no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; holds stock options with Navigate; and is the chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Davidson has received research grant support from and performed unpaid consultation for Edwards Lifesciences. Dr O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Bethea has received consultation fees from Abbott Vascular. Dr Thourani has been an advisor for Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave Medical. Dr Chakravarty is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Gupta is a consultant for Boston Scientific and Shockwave Medical; and holds equity in Heartbeat Health and iCardio.ai. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has received personal proctoring funds from Edwards Lifesciences; has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific; and serves as national principal investigator for the Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study., Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year., Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients., Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801., Competing Interests: Dr Malaisrie reports institutional research grants from Edwards Lifesciences, Medtronic, and Terumo Medical Corporation and consulting/speaker fees from Edwards Lifesciences, Terumo Medical Corporation, and Artivion; Dr Guerrero reports institutional research grants from Edwards Lifesciences; Dr Davidson reports institutional research grants from Edwards Lifesciences and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Williams reports institutional research grants from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific and consulting/speaker fees from Medtronic; Dr de Brito is a proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; Dr Shah reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Kaneko reports consulting/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Vascular; Dr Poon reports institutional research grants from Edwards Lifesciences and consulting/speaker fees from Edwards Lifesciences and Anteris; Dr Yu is an employee of Edwards Lifesciences; Dr Pibarot reports institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation; Dr Blanke reports consulting/speaker fees from Edwards Lifesciences and LARALAB; Dr Leon reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; Dr Mack has served as trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and has served as a study chair for Medtronic; Dr Zajarias reports consulting/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Objective: To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes., Methods: Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 definition for bioprosthetic valve failure was applied., Results: A Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2% were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3% (range, 2.1%-6.2%), and 33.4% had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9% vs 1.9% for small and 55.1% vs 19.5% for medium; P < .001). The mean aortic valve gradients decreased significantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient-prosthesis mismatch (with an effective orifice area/m 2 of >0.8). Significant LV mass regression was documented regardless valve sizes, plateaued at -9.1% at 5 years. Freedom from SVD and reintervention were 95.2% and 96.3%, respectively, at 5 years and were independent of implanted valve size (P = .22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8% at 5 years., Conclusions: The Perceval valve demonstrated low and stable mean gradients, significant LV mass regression, and low SVD and reintervention rates across all valve sizes., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Periprosthetic femur fracture is a known complication after THA. The associated risk of cementless femoral component design for periprosthetic femur fracture in a registry population of patients older than 65 years has yet to be clearly identified., Questions/purposes: (1) Is femoral stem geometry associated with the risk of periprosthetic femur fracture after cementless THA? (2) Is the presence or absence of a collar on cementless femoral implant designs associated with the risk of periprosthetic femur fracture after THA?, Methods: We analyzed American Joint Replacement Registry data from 2012 to March 2020. Unique to this registry is the high use of cementless femoral stems in patients 65 years and older. We identified 266,040 primary cementless THAs during the study period in patients with a diagnosis of osteoarthritis and surgeries linked to supplemental Centers for Medicare and Medicaid data where available. Patient demographics, procedure dates, and reoperation for periprosthetic femur fracture with revision or open reduction and internal fixation were recorded. The main analysis was performed comparing the Kheir and Chen classification: 42% (112,231 of 266,040) were single-wedge, 22% (57,758 of 266,040) were double-wedge, and 24% (62,983 of 266,040) were gradual taper/metadiaphyseal-filling cementless femoral components, which yielded a total of 232,972 primary cementless THAs. An additional analysis compared cementless stems with collars (20% [47,376 of 232,972]) with those with collarless designs (80% [185,596 of 232,972]). A Cox proportional hazard regression analysis with the competing risk of death was used to evaluate the association of design and fracture risk while adjusting for potential confounders., Results: After controlling for the potentially confounding variables of age, sex, geographic region, osteoporosis or osteopenia diagnosis, hospital volume, and the competing risk of death, we found that compared with gradual taper/metadiaphyseal-filling stems, single-wedge designs were associated with a greater risk of periprosthetic femur fracture (HR 2.9 [95% confidence interval (CI) 2.2 to 3.9]; p < 0. 001). Compared with gradual taper/metadiaphyseal-filling stems, double-wedge designs showed an increased risk of periprosthetic femur fracture (HR 3.0 [95% CI 2.2 to 4.0]; p < 0. 001). Collarless stems showed an increased risk of periprosthetic fracture compared with collared stems (HR 7.8 [95% CI 4.1 to 15]; p < 0. 001)., Conclusion: If cementless femoral fixation is used for THA in patients 65 years or older, surgeons should consider using gradual taper/metadiaphyseal-filling and collared stem designs because they are associated with a lower risk of periprosthetic femur fracture. Future investigations should compare gradual taper/metadiaphyseal-filling and collared cementless designs with cemented fixation in this population., Level of Evidence: Level III, therapeutic study., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 by the Association of Bone and Joint Surgeons.)

Objectives: The TOBA (Tack Optimized Balloon Angioplasty) II trial is a prospective, single-arm, multicenter study that investigated Tack treatment for patients with dissection after angioplasty in the superficial femoral artery and/or proximal popliteal artery. The Tack device is a nitinol-based, short (6 mm), stent-like implant with low outward force that can be deployed in a targeted fashion to treat vascular dissection. TOBA II primary results through 12 months have been published previously. This report provides follow-up safety and efficacy results through 24 months (RC)., Methods: The TOBA II trial enrolled 213 patients with Rutherford classification 2 to 4 and a de novo or non-stented restenotic lesion in the superficial femoral artery and/or proximal popliteal artery who developed a dissection of any grade after treatment with plain balloon or drug-coated balloon (DCB) angioplasty. Participants were followed for 30 days, 6 months, 12 months, 24 months, and 36 months following the procedure. Evaluations included clinically driven target lesion revascularization (CD-TLR), ankle-brachial index, Rutherford classification, peripheral artery questionnaire, quality of life assessed by the EQ-5D-3L, and the Walking Impairment Questionnaire., Results: At enrollment, mean age was 68.2 ± 9.1 years, 70.9% were male, and 95.8% of patients were categorized as RC 2 or 3. The distribution of balloon types in the study were standard balloons: 42.3%; and drug-coated balloons: 57.7%. At 24-month follow-up, 167 patients (78.4%) had available data. The overall survival rate at 24 months was 95.4% and there were no major amputations during this time. After 24 months of follow-up, the Kaplan-Meier freedom from CD-TLR was 77.7%. Rutherford classification, ankle-brachial index, and quality of life were significantly improved compared with baseline through 24 months., Conclusions: The TOBA II 24-month data demonstrate durable intermediate-term outcomes with the use of the Tack Endovascular System. Tack deployment was a safe and effective therapeutic option for dissection repair following angioplasty., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Marianne Brodmann is a consultant for Philips, Medtronic, Boston Scientific, Cagent, Biotronik, Cook Medical, MedAlliance, Surmodics, BD Bard, and Shockwave. Martin Werner has no conflicts of interest to declare. Ami Sood is an employee of Philips North America, LLC. William A. Gray is a consultant for Philips.

Background: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited., Objectives: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study., Methods: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S., Centers: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints., Results: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR., Conclusions: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance., Competing Interests: Funding Support and Author Disclosures Medtronic funded the Low Risk study. Dr Zahr has received grant support/research support from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria from Edwards Lifesciences and Medtronic. Dr Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, LivaNova, and AtriCure. Dr Reardon has received grants from Medtronic (paid to institution) during the conduct of the study; and has received consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. Dr Deeb has received grants from Medtronic (paid to institution) during the conduct of the trial; and has received personal fees from Medtronic outside the submitted work. Dr Yakubov has received grants from Boston Scientific and Medtronic (paid to institution); and has received personal fees from Medtronic during the conduct of the study. Dr Song has received grant support/research contracts from Medtronic; and has received consultant fees from Medtronic. Dr Kleiman has received clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the study. Dr Chetcuti serves on the Advisory Board for Medtronic; and serves as a consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Gada has received personal fees from Medtronic, Abbott, Becton Dickinson, and Boston Scientific outside the submitted work. Dr Mumtaz has received grants and personal fees from Medtronic, Edwards Lifesciences, AtriCure, Japanese Organization for Medical Device Development, and Z Medical outside the submitted work. Dr Rovin serves as a consultant, proctor, and speaker for Abbott and Medtronic. Dr Kauten serves as a consultant for Boston Scientific and Medtronic. Dr Huang is an employee and shareholder of Medtronic. Dr Forrest has received grant support/research contracts from Edwards Lifesciences and Medtronic; and has received consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transverse aortic arch obstruction is a challenging lesion for which stent implantation provides a potentially important alternate therapy. The objectives were to evaluate the technical, procedural, and medium-to-long-term clinical outcomes of percutaneous stent implantation of transverse aortic arch obstruction., Methods: This is a retrospective, multicenter study of transverse aortic arch stent implantation. Univariable and multivariable analyses were performed., Results: Index catheterization included 187 stent implants in 146 patients. The median age is 14.3 years (interquartile range, 9.3-19), weight is 53 kg (30-69), and follow-up is 53 months (12-120). The most common stent design was open cell (n=90, 48%). Stents overlapped 142 arch vessels (37 carotid arteries) in 118 (81%) cases. Technical and procedural success rates were 100% and 88%, respectively. Lower weight ( P =0.018), body surface area ( P =0.013), and minimum-to-descending aortic diameter ratio ( P <0.001) were associated with higher baseline aortic gradient. The residual gradient was inversely associated with implant and final dilation diameters ( P <0.001). The combined incidence of aortic injury and stent-related complications was 14%. There were no reports of abnormal brain scans or stroke. Blood pressure cuff gradient, echocardiographic arch velocity, and hypertension rates improved within 1-year follow-up with increased antihypertensive medication use. Reintervention was reported in 60 (41%) patients at a median of 84 (22-148) months to first reintervention. On multivariable logistic regression, residual aortic gradient >10 mm Hg was associated with increased odds of reintervention at all time points when controlling for each final dilation diameter, weight, and minimum-to-descending aortic diameter ratio., Conclusions: Transverse aortic arch stent implantation has high rates of technical, procedural, and medium-to-long-term clinical success. Aortic gradient >10 mm Hg is associated with increased odds of reintervention at 1-year and most recent follow-ups. Open cell stent design was frequently used for its advantages in conformability, perfusion of arch vessels, low fracture rate, and the ability to perform effective angioplasty of side cells., Competing Interests: Dr Armstrong is a consultant for Abbott, Medtronic, Edwards Lifesciences, Cook Medical, Starlight Cardiovascular, and B. Braun Interventional Systems and received research support from Edwards Lifesciences, Renata Medical, and atHeart Medical. Dr Boe is a consultant at Abbott and Medtronic. Dr Cheatham is a consultant, a proctor, and a principal investigator at Medtronic; a consultant at NuMED; a consultant and a proctor at Beijing Med-Zenith Medical Technology Co; a data monitoring committee at Autus Valve Technologies; on the data safety monitoring board at Xeltis; and received research support from Xeltis and Med-Zenith Medical Technology Co. Dr Jones is an investigator, a consultant, and a proctor at Medtronic; an investigator and a consultant at Edwards; an investigator, a consultant, and a proctor at Abbott; and an investigator, a consultant, and a proctor at W. L. Gore. Dr Morray is a proctor at Medtronic and Abbott. Dr Steinberg is a proctor and a consultant at Medtronic, Gore Medical, Abbott, and B. Braun. Dr Berman is a proctor and a consultant at Abbott, B. Braun, Medtronic, and Edwards Lifesciences. The other authors report no conflicts.

Background: The anatomic substrate of bicuspid valves may lead to suboptimal TAVR stent expansion and geometry., Aim: We evaluated determinants of stent geometry in bicuspid valves treated with Sapien transcatheter aortic valve replacement (TAVR) valves., Methods: A multicenter retrospective registry of patients (February 2019 to August 2022) who underwent post-TAVR computed tomography to determine stent area (vs. nominal valve area) and stent ellipticity (maximum diameter/minimum diameter). Predictors of relative stent expansion (minimum area/average of inflow + outflow area) and stent ellipticity were evaluated in a multivariable regression model, including valve calcium volume (indexed by annular area), presence of raphe calcium, sinus diameters indexed by area-derived annular diameter, and performance of pre-dilation and post-dilation., Results: The registry enrolled 101 patients from four centers. The minimum stent area (vs. nominal area) was 88.1%, and the maximum ellipticity was 1.10, with both observed near the midframe of the valve in all cases. Relative stent expansion ≥90% was observed in 64/101 patients. The only significant predictor of relative stent expansion ≥90% was the performance of post-dilation (OR: 4.79, p = 0.018). Relative stent expansion ≥90% was seen in 86% of patients with post-dilation compared to 57% without (p < 0.001). The stent ellipticity ≥1.1 was observed in 47/101 patients. The significant predictors of stent ellipticity ≥1.1 were the indexed maximum sinus diameter (OR: 0.582, p = 0.021) and indexed intercommisural diameter at 4 mm (OR: 2.42, p = 0.001). Stent expansion has a weak negative correlation with post-TAVR mean gradient (r = -0.324, p < 0.001)., Conclusion: Relative stent expansion ≥90% was associated with the performance of post-dilation, and stent ellipticity ≥1.1 was associated with indexed intercommisural diameter and indexed maximum sinus diameter. Further studies to determine optimal deployment strategies in bicuspid valves are needed., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Introduction: The traditional sutured venous anastomosis used during arteriovenous graft implantation is associated with a high incidence of subsequent stenosis that is attributed to neointimal hyperplasia. Hyperplasia results from multiple factors, including hemodynamic abnormalities and vessel trauma during implantation. A novel anastomotic connector device was designed to provide an alternative, less traumatic, endovascular venous anastomosis that may ameliorate the clinical challenges associated with a sutured anastomosis. A prospective single-arm multicenter study was performed to evaluate safety and effectiveness of graft implantation using the study device., Methods: Patients requiring graft creation and who met the study criteria were enrolled between February 2018 and July 2021 and observed for 6 months. Collected data included baseline characteristics, graft patency and use for hemodialysis, graft interventions, and adverse events. The primary study endpoint was cumulative graft patency, compared to a pre-specified Performance Goal of 75%. Secondary endpoints included primary unassisted patency and serious adverse events, defined as the occurrence of death, graft infection, emergent surgery, significant bleeding, and pseudoaneurysm., Results: A total of 158 patients were enrolled from 10 study sites, among which 144 subjects were evaluable at 6 months and 14 were censored with partial follow-up observation. Three patients died and the graft was abandoned in 12. The primary endpoint was met ( p -value < 0.001). By Kaplan Meier survival analysis, cumulative patency was 92.08% with a lower 95% Confidence Bound of 86.98%. Primary unassisted patency was 60.21% with a lower 95% Confidence Bound of 50.84%. Graft infections occurred in six patients, all unrelated to the study device. There were no reports of emergent surgery, significant bleeding or pseudoaneurysm., Conclusion: These results demonstrate that the study device can be used for successful endovascular anastomosis of a vein to a graft for hemodialysis, with acceptable cumulative patency and safety profile at 6 months., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02532621., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JSB and JR have served as consultants to Phraxis, Inc. AY and CS are employees of Phraxis, Inc. and have stock agreements. All other authors have no competing interests.

Background: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation., Methods: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion., Results: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up., Conclusions: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. postapproval study. The authors present results from the first 6 years of this study., Methods: An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients undergoing breast augmentation, reconstruction, and revision in the postmarket environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015 (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022)., Results: Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1% (3.9% with submuscular placement and 6.75%with subglandular placement), the risk of reoperation was 11.6%, and the risk of implant removal was 7.8% (5.9% with implant replacement and 2.0% without replacement). The primary reason (>50%) for reoperation was aesthetic (eg, style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8%. Overall, 82.6% of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported., Conclusion: Six-year results of the postapproval study were consistent with the 10-year core study and provide additional evidence in a large data set supporting the comprehensive safety and effectiveness profile of the Sientra implants., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons.)

Background: Elevated aortic valve gradients are common after transcatheter aortic valve implantation for degenerated surgical aortic valve replacement bioprostheses, but their clinical impact is uncertain., Methods: A total of 12 122 patients who underwent transcatheter aortic valve implantation-in-surgical aortic valve replacement from November 2011 to December 2019 in the Society of Thoracic Surgery/American College of Cardiology Transvalvular Therapeutics Registry were included. The primary outcome was a composite of 1-year all-cause mortality, stroke, myocardial infarction, or valve reintervention. Secondary outcomes included 1-year all-cause mortality, readmission, and change from baseline 12-question self-administered Kansas City Cardiomyopathy Questionnaire-Overall Summary Score. Due to nonlinearity observed with restricted cubic splines analysis, a Cox regression analysis with aortic valve mean gradient modeled as a spline-continuous variable (with 20 mm Hg as a cutoff) was used to study the 1-year composite outcome and mortality., Results: The composite outcome occurred most frequently in patients with aortic valve mean gradient ≥30 and <10 mm Hg, as compared with those with 10 to 20 and 20 to 30 mm Hg ranges (unadjusted rates, 13.9%, 12.1%, 7.5%, and 6.5%, respectively; P =0.002). When the mean aortic valve gradient was ≥20 mm Hg, higher gradients were associated with greater risk of the 1-year composite outcome (adjusted hazard ratio, 1.02 [1.02-1.03] per mm Hg; P <0.001) and 1-year mortality (adjusted hazard ratio, 1.02 [1.00-1.03] per mm Hg; P =0.007). Whereas when the mean aortic valve gradient was <20 mm Hg, higher gradients were not significantly associated with the composite outcome (adjusted hazard ratio, 0.99 [0.98-1.003] per mm Hg; P =0.12) but were associated with lower 1-year mortality (adjusted hazard ratio, 0.98 [0.97-0.99] per mm Hg; P =0.007)., Conclusions: The relationship between postprocedural aortic valve mean gradient after transcatheter aortic valve implantation-in-surgical aortic valve replacement and clinical outcomes is complex and nonlinear, with relatively greater adverse events occurring at low and high gradient extremes. Further study of factors mediating the relationship between postprocedural gradients and clinical outcomes, including low-flow states, is necessary., Competing Interests: Dr Kleiman served as investigator and part of steering and screening committees for Medtronic, Abbott, Edwards, and Boston Scientific. Will be serving on the Transvalvular Steering Therapeutic Steering committee beginning 2023. Dr Vemulapalli received grants from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (RO1 and SBIR), Cytokinetics, Abbott Vascular, Food and Drug Administration. He has received consulting fees or honorariums from Medtronic, Edwards Lifesciences, and the American College of Physicians. Dr Kapadia received stock options for Anteris and Navigate.

Objective: To quantify the incremental downstream revenue generated from subsequent treatment of men who received an inflatable penile prosthesis (IPP) to treat erectile dysfunction (ED), compared to men without ED., Methods: The 100% Medicare Standard Analytic Files were used to conduct a retrospective claims analysis of the 5-year revenue generated by patients receiving IPP to treat their ED, compared to a propensity-matched cohort of men without ED. Men aged 65 years or older with ED who underwent IPP implantation (Current Procedural Terminology 54405) in a hospital outpatient setting between January 1, 2016 and December 31, 2021, and who had continuous Medicare Parts A and B enrollment for 12 months pre-index IPP and 5 years post-index IPP discharge date were included in the study. Men without ED but with comparable characteristics were identified and used as a comparator group. Revenue received by hospitals from Medicare was defined as the sum of payments for patient services, other payor-paid amounts, patient deductibles, copayments, and coinsurance. Revenue was inflated to 2022 US dollars. The mean values and their corresponding standard deviations (SD) are reported., Results: After matching, there were 2905 men with ED who received an IPP and 7462 men without ED. The IPP cohort showed a significantly higher 5-year cumulative revenue (mean=$34,571 [SD=$50,234]) compared to the men without ED (mean=$3189 [SD=$11,527]). When stratified by diagnosis type, the differences in revenue were $10,258 for circulatory disease, $2646 for diabetes, $2013 for urology, and $1043 for prostate cancer. Significantly more IPP patients had at least 1 health encounter for these conditions over the 5-year follow-up period than their matched controls (55.0% vs 7.8% for circulatory, 46.7% vs 16.8% for urology, 19.3% vs 3.6% for diabetes, and 19.0% vs 3.0% for prostate cancer)., Conclusion: Men with ED who received IPP generated substantially higher revenue for the healthcare system over a 5-year period, nearly 10 times as much, compared to men without ED, excluding the initial cost of the IPP procedure. The presence of ED, coupled with IPP usage, is associated with significantly increased healthcare revenue across a range of medical conditions compared to men without ED. These findings emphasize the financial implications for advanced ED programs to improve access to necessary care for these patients. Healthcare facilities may leverage these insights to effectively allocate resources to deliver critical healthcare to men with ED., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Abimbola O. Williams, Sirikan Rojanasarot, Alysha M. McGovern, Liesl M. Hargens, Gregory Moore, and Erin Turner are employees of and own stock in Boston Scientific. Paurush Babbar is a Physician at The Urology Group, Cincinnati, Ohio. Andrew Sun is a physician at Urology Partners of North Texas, Arlington, Texas. Dr. Andrew Sun and Dr. Paurush Babbar were not compensated for their participation in this study., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI)., Methods: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization)., Results: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m 2 , 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m 2 or on dialysis., Conclusions: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m 2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392., Competing Interests: Dr Bharadwaj reports consulting and speaker fees from Abiomed, Shockwave Medical, and Cardiovascular Systems, Inc. Dr Batchelor reports consulting for Abbott, Medtronic, and Boston Scientific. Dr Grines reports participation on the advisory boards for Philips and Abiomed. Dr Baron reports receiving institutional research support from Boston Scientific Corporation, Acarix, and Abiomed; speaker fees from Medtronic, Edwards Lifesciences, Shockwave, and Zoll Medical; and consulting fees/advisory board membership from Medtronic, Boston Scientific Corporation, Zoll Medical, and Abiomed. Dr Redfors reports consultant fees from Pfizer and Boehringer Ingelheim. Dr Lansky received speaker fees from Abiomed. M.B. Basir has been a consultant/speaker for Abiomed, Boston Scientific, Chiesi, Saranas, and Zoll. Dr O’Neill reports grant/research support from St. Jude Medical, Edwards Life Sciences, and Biomed; consulting fees/honoraria from Medtronic and Abiomed; and major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitral Align. The other authors report no conflicts.

Objective: To determine if lower limb prosthesis (LLP) sophistication is associated with patient-reported mobility and/or mobility satisfaction, and if these associations differ by amputation level., Design: Cohort study that identified participants through a large national database and prospectively collected self-reported patient outcomes., Setting: The Veterans Administration (VA) Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls., Participants: 347 Veterans who underwent an incident transtibial (TT) or transfemoral (TF) amputation due to diabetes and/or peripheral artery disease and received a qualifying LLP between March 1, 2018, and November 30, 2020., Interventions: Basic, intermediate, and advanced prosthesis sophistication was measured by the accurate and reliable PROClass system., Main Outcome Measure: Patient-reported mobility using the advanced mobility subscale of the Locomotor Capabilities Index-5; mobility satisfaction using a 0-10-point Likert scale., Results: Lower limb amputees who received intermediate or advanced prostheses were more likely to achieve advanced mobility than those who received basic prostheses, with intermediate nearing statistical significance at nearly twice the odds (adjusted odds ratio (aOR)=1.8, 95% confidence interval (CI), .98-3.3; P=.06). The association was strongest in TF amputees with over 10 times the odds (aOR=10.2, 95% CI, 1.1-96.8; P=.04). The use of an intermediate sophistication prosthesis relative to a basic prosthesis was significantly associated with mobility satisfaction (adjusted β coefficient (aβ)=.77, 95% CI, .11-1.4; P=.02). A statistically significant association was only observed in those who underwent a TT amputation (aβ=.79, 95% CI, .09-1.5; P=.03)., Conclusions: Prosthesis sophistication was not associated with achieving advanced mobility in TT amputees but was associated with greater mobility satisfaction. In contrast, prosthesis sophistication was associated with achieving advanced mobility in TF amputees but was not associated with an increase in mobility satisfaction., (Published by Elsevier Inc.)

Background: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV)., Objectives: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV., Methods: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR., Results: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02)., Conclusions: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth., Competing Interests: Funding Support and Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Dr R.T. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic and Philips Healthcare, Siemens Healthineers; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. P Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Dr George has received consulting fees from Edwards Lifesciences. Dr Zhao is an employee of Edwards Lifesciences. Dr Blanke has institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, PI Cardia, and Conformal; he is a Consultant for Edwards Lifesciences and Laralab Imaging. Dr Babaliaros has received consulting fees from Abbott and Edwards Lifesciences. Dr Szeto has received grant support from Edwards Lifesciences and Medtronic; and is a consultant for MicroInterventional Devices. Dr Makkar has received research support from Edwards Lifesciences and Abbott; and consultant fees/honoraria from Abbott, Cordis Corporation, and Medtronic. Dr Thourani serves on advisory boards for Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Webb is a consultant for Edwards Lifesciences. Michael Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (unpaid); has received institutional research grants from Abbott, Boston Scientific, and Medtronic; has been an unpaid advisor for Abbott, Boston Scientific, Sinomed, and Medtronic; and holds equity in Medinol. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Nazif has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Purpose: To report 3-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction., Materials and Methods: The VIVO study included patients with symptomatic obstruction of 1 iliofemoral venous segment (ie, 1 limb), characterized by a Clinical, Etiological, Anatomic, Pathophysiology (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) for pain of ≥2. Patients were retrospectively grouped based on baseline clinical presentation as postthrombotic syndrome (PTS), nonthrombotic iliac vein (NIVL) obstruction, or acute deep vein thrombosis (aDVT). Clinical improvement was assessed by change in VCSS, Venous Disability Score, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) scores, and CEAP C classification. Stent performance was evaluated by rates of patency by ultrasound (US), freedom from clinically driven reintervention, and freedom from stent fracture., Results: The 3-year results for the 243 patients in the VIVO cohort included a 90.3% rate of patency by US and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rates of patency by US for the NIVL, aDVT, and PTS groups were 100%, 84.0%, and 86.1%, respectively. Sustained clinical improvement through 3 years was demonstrated by changes in VCSS, Venous Disability Score, CIVIQ-20, and CEAP C classification. No stent fractures were observed., Conclusions: The VIVO study demonstrated sustained high rates of patency and freedom from clinically driven reintervention and improvements in venous clinical symptoms through 3 years. Each patient group (NIVL, aDVT, and PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (eg, only the NIVL group had a 100% patency rate)., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

Background: This study evaluates trends of cemented versus press-fit total knee arthroplasty (TKA). We hypothesized that press-fit TKA is more common in younger and obese patients. There may also be racial, geographic, and institutional variation., Methods: The American Joint Replacement Registry was used to conduct a retrospective review of primary TKA procedures for osteoarthritis in the United States between January 2019 and March 2022. The objective was to identify differences in incidence, demographics, body mass index (BMI), Charlson Comorbidity Index (CCI), and institutional teaching status (teaching vs. non-teaching) between press-fit and cemented TKAs., Results: Two hundred ninety-seven thousand four hundred two patients (61% female, average age 68 years, 88.3% White) underwent cemented TKA versus 50,880 patients (52% female, average age 65 years, 89% White) underwent press-fit TKA. Overall, 20.8% of press-fit versus 19.9% of cemented TKA had a BMI of 35 to 39.9 and 15.2% of press-fit versus 12.5% of cemented TKA had BMI >40 ( P < 0.001). Patients undergoing press-fit TKA were less likely Black (OR = 0.727; P < 0.0001), Asian (OR = 0.651, P < 0.0001), and Native Hawaiian/other Pacific Islander (OR = 0.705, P < 0.02) with White as the reference group. Northeastern and Southern United States were more likely to use press-fit TKA than the Midwest (OR = 1.89 and OR = 1.87, P < 0.0001) and West (OR = 1.67; and OR = 1.65; P < 0.0001). Press-fit TKA incidence in 2019 was 9.9% versus 20.6% in 2022 ( P < 0.001)., Conclusion: Press-fit TKA is increasingly more common in Northeastern and Southern United States, and patients are older than expected. Patients with BMI >35 had a slightly higher rate of undergoing press-fit than cemented TKA. Notable racial differences also exist. Additional research addressing racial disparities and evaluating longevity of press-fit designs is needed., (Copyright © 2024 by the American Academy of Orthopaedic Surgeons.)

Introduction: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is., Methods: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends., Results: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher., Conclusions: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant., Methods: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure., Results: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient., Conclusion: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497)., (Copyright © 2024 International Society for the Heart and Lung Transplantation. All rights reserved.)

Background: Next-day discharge (NDD) outcomes following uncomplicated self-expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non-NDD transcatheter aortic valve replacement with Evolut., Methods and Results: Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self-expanding supra-annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non-NDD). Propensity score matching was used to compare risk adjusted 30-day readmission rates and 1-year outcomes in NDD versus non-NDD, and multivariable regression to determine predictors of NDD and readmission. Between the first and last calendar quarter, the rate of NDD increased from 45.4% to 62.1% and median length of stay decreased from 2 days to 1. Propensity score matching produced relatively well-matched NDD and non-NDD cohorts (n=10 549 each). After matching, NDD was associated with lower 30-day readmission rates (6.3% versus 8.4%; P <0.001) and 1-year adverse outcomes (death, 7.0% versus 9.3%; life threatening/major bleeding, 1.6% versus 3.4%; new permanent pacemaker implantation/implantable cardioverter-defibrillator, 3.6 versus 11.0%; [all P <0.001]). Predictors of NDD included non-Hispanic ethnicity, preexisting permanent pacemaker implantation/implantable cardioverter-defibrillator, and previous surgical aortic valve replacement., Conclusions: Most patients undergoing uncomplicated self-expanding Evolut transcatheter aortic valve replacement are discharged the next day. This study found that NDD can be predicted from baseline patient characteristics and was associated with favorable 30-day and 1-year outcomes, including low rates of permanent pacemaker implantation and readmission.

Background: Dual mobility acetabular cups (DMC) were designed to increase the effective femoral head size and improve stability with the goal of reducing revision risk at the potential cost of polyethylene thickness. We sought to evaluate revision risk following primary elective total hip arthroplasty with DMC compared to highly cross-linked polyethylene (XLPE)., Methods: A cohort study was conducted using data from a Kaiser Permanente's total joint arthroplasty registry. Patients ≥18 years who underwent primary elective total hip arthroplasty using DMC, unipolar Metal-on-XLPE (MoXLPE), or unipolar Ceramic-on-XLPE (CoXLPE) were identified (2010 to 2021). The final sample comprised 2,219 DMC, 48,251 MoXLPE, and 57,058 CoXLPE. Multiple Cox proportional hazard regressions were used to evaluate aseptic revision and any dislocation regardless of revision within 6 years follow-up., Results: In adjusted analyses, no differences in aseptic revision risk were observed for MoXLPE (hazard ratio [HR] = 1.04, 95% confidence interval [CI] = 0.72 to 1.51) or CoXLPE (HR = 0.98, 95% CI = 0.69 to 1.40) compared to DMC. No differences in dislocation risk were observed for MoXLPE (HR = 1.42, 95% CI = 0.93 to 2.15) or CoXLPE (HR = 1.25, 95% CI = 0.84 to 1.87) compared to DMC., Conclusions: In a US-based cohort, 6-year aseptic revision risk of DMC was similar to metal or ceramic femoral head unipolar constructs. Furthermore, no difference in dislocation risk was observed. Continued longer-term follow-up may reveal if there is a reduced risk of dislocation that comes at the cost of increased late revision., Level of Evidence: Level III., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The clinical benefits of transcatheter edge to edge mitral valve repair have been well established in patients with heart failure and severe mitral regurgitation (MR) who have prohibitive surgical risk. In March of 2019, the FDA approved the MitraClip for treatment of selected patients with HF and severe secondary MR. However, the relative outcomes of patients with HFrEF and HFpEF treated with MitraClip are largely unknown. We therefore sought to investigate the incidence and characteristics of in-hospital mortality in patients with HFpEF and HFrEF following MitraClip., Methods: The study sample analyzed was originated from the National Inpatient Sample (NIS) registry which includes data from hospitalized patients in the United States (US) between January 1, 2012 and December 31, 2020. Data were extracted from the entire NIS registry using ICD-9 codes. Patients with the primary or secondary diagnosis of MitraClip were identified. Hospitalizations for HFpEF and HFrEF were identified based on ICD-9-CM and ICD-10-CM codes. Demographics, conventional risk factors, and in-hospital outcomes were evaluated., Results: 23,260 hospitalizations for MitraClip implantation between 2016 and 2020 were analyzed. The HFrEF group had higher absolute rates of complications as well as a higher observed in-hospital mortality (2.4 % vs 1.7 %; OR 0.75 95 % CI 0.44-1.26; p 0.28) which did not meet statistical significance. Absolute rates of acute myocardial infarction (AMI), acute kidney injury (AKI) and respiratory failure necessitating invasive mechanical ventilation were observed to be higher among HFrEF patients. Post-procedural shock was significantly more common in patients with HFrEF (9.0 % vs 2.8 %: OR 0.34 95 % CI 0.25-0.48 p < 0.001). Significantly longer hospitalizations were observed in the HFrEF cohort (5.3 ± 11.2 days vs 4.2 ± 7.3 days; p < 0.001) as well as a higher total hospitalization cost (61,723 ± 56,728 USD vs 57,278 ± 46,143)., Conclusions: In the present study of US patients, those with HFrEF were observed to have statistically higher risk of in-hospital post-procedural shock and longer hospitalization length of stay when compared with patients with HFpEF who underwent MitraClip implantation. Additionally, patients with HFrEF undergoing MitraClip procedure were observed to have higher absolute rates of certain post-procedural complications, however these observations did not reach statistical significance. Understanding of the aforementioned differences after MitraClip implantation may be useful in-patient selection, prognostic guidance, and hypothesis generation to propel future large clinical studies., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Stone has the following personal disclosures: Speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, Boehringer Ingelheim; consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, Apollo Therapeutics, TherOx, HeartFlow, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife; equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, Xenter. Institutional disclosures: Dr. Stone's employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc., Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, V-wave. Dr. Krittanawong discloses the following relationships – Member of the American College of Cardiology Solution Set Oversight Committee, the American Heart Association Committee of the Council on Genomic and Precision Medicine, the American College of Cardiology/American Heart Association (ACC/AHA) Joint Committee on Clinical Data Standards, and the ACC/AHA Task Force on Performance Measures, The Lancet Digital Health (Advisory Board), European Heart Journal Digital Health (Editorial board), Journal of the American Heart Association (Editorial board), JACC: Asia (Section Editor), The Journal of Scientific Innovation in Medicine (Associate Editor), and Frontiers in Cardiovascular Medicine (Associate Editor). Other authors have no disclosure., (Copyright © 2023. Published by Elsevier Inc.)

Background: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported., Objectives: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR)., Methods: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes., Results: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm 2 vs 1.9 ± 0.6 cm 2 ; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001)., Conclusions: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms., Competing Interests: Funding Support and Author Disclosures Dr Stinis has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Shockwave Medical; and serves on an advisory board for Boston Scientific. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Teirstein has received research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic; and serves on advisory boards for Boston Scientific and Medtronic. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St. Jude Medical; and has received consultant fees/honoraria and served on the Speakers Bureaus of Abbott Vascular, Cordis Corporation, and Medtronic. Dr Généreux has been a consultant for Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, CARANX, Cardiovascular Systems Inc (for the PI Eclipse Trial), Edwards Lifesciences, GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Siemens, Soundbite Medical Inc, Teleflex, and 4C Medical (for the PI Feasibility study). Dr Huang has received speaker honoraria from Abbott Vascular; and has received consulting fees from Edwards Lifesciences. Dr Aragon received has consultant fees from Edwards Lifesciences. Dr McCabe has received fees from Edwards Lifesciences, Boston Scientific, and Teleflex outside the submitted work. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), or the STS/ACC TVT Registry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In recent years, self-expanding technology to treat pulmonary regurgitation in the native right ventricular outflow tract became Food and Drug Administration approved in the United States and is now routinely used. The current practice for selection of patients who are candidates for these devices includes screening for "anatomic fit," performed by each of the manufacturing companies. Our study aims to validate the use of virtual reality (VR) as a tool for local physician-led screening of patients., Methods and Results: This retrospective study from Children's Hospital Colorado included patients who underwent pulmonary valve replacement and had screening for a Harmony TPV or Alterra Prestent performed between September 2020 and January 2022. The data from the commercial companies' dedicated analysis for self-expanding transcatheter pulmonary valve frames evaluation with perimeter analysis were collected. VR simulation was performed blinded by 2 congenital interventional cardiologists using Elucis VR software and an Oculus Quest 2 headset. Among the 27 evaluated cases, the use of a self-expandable valve was recommended by companies' dedicated analysis in 23 cases (85.2%), by VR assessment in 26 cases (96.3), and finally implanted in 25 cases (92.6%). Regarding the level of agreement, both modalities (manufacturer and VR) were good at screening-in patients who received a self-expanding valve (100% versus 96.1%). When it came to screening-out the patients, VR presented good capacity to accurately classify nonsuitable patients (50% versus 100%)., Conclusions: Our institutional experience with VR transcatheter pulmonary valve implantation planning accurately predicted clinical outcomes. This paves the way for routine use of VR in patient selection for self-expanding valve technologies.

Background: Femoral neck retaining prostheses have gained popularity in Europe, but the United States has not seen the same trends occurring. Previous reports demonstrate high survivorship for these implants, but to our knowledge, there are no reports examining US data., Methods: After institutional review board approval, 824 primary total hip arthroplasties utilizing a femoral neck-retaining prosthesis were examined for femoral component survivorship rates. European studies were systematically reviewed to determine survivorship rates. The data were used to formulate a Kaplan-Meier survivorship curve and compare US data to that of the European studies., Results: European studies demonstrated survivorship rates for all causes of 97.7 and 99.0% for aseptic loosening at an average of 6 years (range, 4.5 to 10). The current study demonstrated an all-cause 94% Kaplan-Meier survivorship estimate at 5 years and when aseptic loosening only was considered, survivorship increased to 99.4% at 5 years and 98.4% at 11 years., Conclusion: This femoral neck-retaining prosthesis demonstrated excellent survivorship that is comparable to the rates seen in European studies as well as the rates of standard and mid-stem prostheses in the United States., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: The role of different femoral head materials for total hip arthroplasty (THA) has been widely studied in the context of wear properties and corrosion. Cobalt chrome (CoCr) femoral heads are commonly used as a standard of comparison to other materials such as ceramic and oxidized zirconium (OxZi). This study aims to evaluate the impact of femoral head material on clinical outcomes in elective primary THA patients., Methods: Retrospective analysis of THA patients within the Medicare claims database between October 2017 and September 2020 using diagnosis-related group codes was conducted. Information collected included sex, age, Charlson Comorbidity Index, and femoral head type. Patients with CoCr femoral heads were compared against patients with either OxZi or ceramic femoral heads using 1:1 propensity score matching. Z-testing and Chi-square analysis were used to determine between-group significance., Results: In total, 112,960 elective THA patients were included, with 56,480 in OxZi or ceramic and 56,480 in CoCr. Readmission rates were lower in patients that received OxZi or ceramic femoral heads at 30-day (p < 0.0001), 60-day (p < 0.0001), and 90-day postoperatively (p < 0.0001) compared to CoCr. Mortality rates were also lower in patients that received OxZi or ceramic femoral heads at 30-day (p = 0.004), 60-day (p = 0.018), and 90-day postoperatively (p = 0.009) compared to CoCr., Conclusion: CoCr femoral heads had higher rates of readmissions and mortality compared to OxZi or ceramic. Further analysis of bearing surface combinations and sub-group analyses to determine significance between-group differences is needed., Level Iii Evidence: Retrospective analysis., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Complex endovascular juxta-, para- and suprarenal abdominal aortic aneurysm repair (comEVAR) is frequently accomplished with commercially available fenestrated (FEVAR) devices or off-label use of aortoiliac devices with parallel branch stents (chEVAR). We sought to evaluate the implantable vascular device costs incurred with these procedures as compared with standard Medicare reimbursement to determine the financial viability of comEVAR in the modern era., Methods: Five geographically distinct institutions with high-volume, complex aortic centers were included. Implantable aortoiliac and branch stent device cost data from 25 consecutive, recent, comEVAR in the treatment of juxta-, para-, and suprarenal aortic aneurysms at each center were analyzed. Cases of rupture, thoracic aneurysms, reinterventions, and physician-modified EVAR were excluded, as were ancillary costs from nonimplantable equipment. Data from all institutions were combined and stratified into an overall cost group and two, individual cost groups: FEVAR or chEVAR. These groups were compared, and each respective group was then compared with weighted Medicare reimbursement for Diagnosis-Related Group codes 268/269. Median device costs were obtained from an independent purchasing consortium of >3000 medical centers, yielding true median cost-to-institution data rather than speculative, administrative projections or estimates., Results: A total of 125 cases were analyzed: 70 FEVAR and 53 chEVAR. Two cases of combined FEVAR/chEVAR were included in total cost analysis, but excluded from direct FEVAR vs chEVAR comparison. Median Medicare reimbursement was calculated as $35,755 per case. Combined average implantable device cost for all analyzed cases was $28,470 per case, or 80% of the median reimbursement ($28,470/$35,755). Average FEVAR device cost per case ($26,499) was significantly lower than average chEVAR cost per case ($32,122; P < .002). Device cost was 74% ($26,499/$35,755) of total reimbursement for FEVAR and 90% ($32,122/$35,755) for chEVAR., Conclusions: Results from this multi-institutional analysis show that implantable device cost alone represents the vast majority of weighted total Medicare reimbursement per case with comEVAR, and that chEVAR is significantly more costly than FEVAR. Inadequate Medicare reimbursement for these cases puts high-volume, high-complexity aortic centers at a distinct financial disadvantage. In the interest of optimizing patient care, these data suggest a reconsideration of previously established, outdated, Diagnosis-Related Group coding and Medicare reimbursement for comEVAR., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aortic endograft evolution has altered our approach to treating patients with both standard and complex aortic disease. In particular, fenestrated and branched aortic endografts have allowed for the expansion of therapy to include those patients with extensive thoracoabdominal aortic aneurysms (TAAAs). The fenestrations and branches allow for the aortic endografts to achieve a seal in the proximal and distal aspects of the aorto-iliac tree, to exclude the aneurysm, while maintaining perfusion to the renal and visceral vessels. Historically, many of the grafts used for this purpose are custom made devices designed for a specific patient based on their preoperative computed tomography imaging. One downside to this approach is the time it takes to construct these grafts. Given this, much effort has been directed towards developing "off-the-shelf" grafts which may be applicable to many patients in an immediate-need bases. The Zenith T-Branch device offers an off-the-shelf graft with four directional branches. Its utilization is not applicable to all patients, but can be applied to many patients with TAAAs. Large reported series on outcomes for these devices is limited to centers in Europe as well as within the United States Aortic Research Consortium. While early outcomes appear excellent, long-term outcomes related to aneurysm exclusion, branch patency, and freedom from reintervention are needed and will be forthcoming.

Objective: To report mid-term outcomes of renal-mesenteric target arteries (TAs) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal and thoracoabdominal aortic aneurysm., Background: TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR., Methods: Data from consecutive patients enrolled in 9 prospective nonrandomized physician-sponsored investigational device exemption studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability., Results: A total of 1681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%), and 194 scallops (3%). Mean follow was 23 ± 21 months. At 5 years, TAs incorporated by fenestrations had higher primary (95 ± 1% vs 91 ± 1%, P < 0.001) and secondary patency (98 ± 1% vs 94 ± 1%, P < 0.001), and higher freedom from TAI (87 ± 2% vs 84 ± 2%, P = 0.002) compared with TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts had significantly lower freedom from TAI (78 ± 4% vs 88 ± 1%, P = 0.006), TA endoleak (87 ± 3% vs 97 ± 1%, P < 0.001), and TA reintervention (83 ± 4% vs 95 ± 1%, P < 0.001) compared with those targeted by self-expandable stent-grafts., Conclusions: Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for self-expandable stent grafts as compared with balloon-expandable stent grafts., Competing Interests: G.S.O has received consulting fees and research grant support from Centerline Biomedical, Cook Medical, G.E. Healthcare, and W.L. Gore. G.S.O has a Global Principal Investigator agreement with Cook Medical; B.C.M. receives consulting fees and research support from Cook Medical and W.L. Gore and is a regional aortic advisor for Medtronic with all fees paid to Mayo Clinic; A.S. receives consulting and research grants from Cook; M.A.F. receives consulting and research grants from Cook, W. L. Gore, and Endologix and consulting and stock options from Centerline Biomedica; D.B.S. receives consulting and research grants from Cook, W. L. Gore, Endologix, and Medtronic. C.H.T. receives research support and consulting from Cook Medical Inc, W. L. Gore and Associates, and Philips Healthcare. The remaining authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Cobalt chromium (CoCr) is the most commonly used material in TKA; however, the use of oxidized zirconium (OxZr) implants has increased. The advantages to this material demonstrated in basic science studies have not been borne out in clinical studies to date., Question/purpose: In the setting of the American Joint Replacement Registry (AJRR), how do revision rates differ between CoCr and OxZr after primary TKA?, Methods: The AJRR was accessed for all primary TKAs performed between 2012 and 2020 for osteoarthritis, resulting in 441,605 procedures (68,506 with OxZr and 373,099 with CoCr). The AJRR is the largest joint replacement registry worldwide and collects procedure-specific details, making it ideal for large-scale comparisons of implant materials in the United States. Competing risk survival analyses were used to evaluate the all-cause revision rates of primary TKAs, comparing CoCr and OxZr implants. Data from the Centers for Medicare and Medicaid Services claims from 2012 to 2017 were also cross-referenced to capture additional revisions from other institutions. Revision rates were tabulated and subclassified by indication. Multivariate Cox regression was used to account for confounding variables such as age, gender, region, and hospital size., Results: After controlling for confounding variables, there were no differences between the OxZr and CoCr groups in terms of the rate of all-cause revision at a mean follow-up of 46 ± 23 months and 44 ± 24 months for CoCr and OxZr implants, respectively (hazard ratio 1.055 [95% confidence interval 0.979 to 1.137]; p = 0.16) The univariate analysis demonstrated increased rates of revisions for pain and instability in the OxZr group (p = 0.003 and p < 0.001, respectively)., Conclusion: These findings suggest there is no difference in all-cause revision between OxZr and CoCr implants in the short-term to mid-term. However, further long-term in vivo studies are needed to monitor the safety and all-cause revision rate of OxZr implants compared with those of CoCr implants. OxZr implants may be favorable in patients who have sensitivity to metal. Despite similar short-term to mid-term all-cause revision rates to CoCr implants, because of the limitations of this study, definitive recommendations for or against the use of OxZr cannot be made., Level of Evidence: Level III, therapeutic study., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2023 by the Association of Bone and Joint Surgeons.)