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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.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life., Methods: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time., Results: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning ( P =0.008) and role limitations due to emotional problems ( P =0.001) than patients without a shock, but this effect did not differ between treatment arms., Conclusions: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022., Competing Interests: Dr Knops reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical, Inc. Dr El Chami reports consultancy fees from Boston Scientific and Medtronic. Dr Mittal reports consultancy fees from Boston Scientific and Medtronic. K.M. Kooiman reports consultancy fees from Boston Scientific. Dr Lambiase reports educational and research grants from and is in the research board of Boston Scientific, and reports research grants from Abbott. Dr Vernooy reports consultancy fees from Medtronic and Abbott. M.C. Burke is a consultant and receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. Dr Wright has consultancy arrangements with Boston Scientific and Medtronic and iRhythm and a research grant from Boston Scientific. Dr Nordbeck reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. Dr Miller reports consultancy fees from Boston Scientific. Dr Whinnett is an advisor for Boston Scientific and is on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts.

Background: Mitral annular calcification with valve dysfunction remains a challenging syndrome. Operative risk is high, and available transcatheter therapies are limited., Methods: This study describes our initial experience with a novel procedure to address large mitral annuli when no surgical or trial-based transcatheter mitral valve replacement device is available. The rationale was to shorten the intercommissural distance using commissural mitral transcatheter edge-to-edge repair (TEER) followed by valve-in-mitral annular calcification transcatheter mitral valve replacement with a balloon-expandable aortic valve platform. Patients with long intercommissural distances and large mitral annulus areas were selected based on a high perceived risk of transcatheter valve embolization. Patients underwent mitral TEER with MitraClip in a commissural position, followed immediately by transseptal transcatheter mitral valve replacement with a 29 mm SAPIEN 3 valve., Results: Thirteen patients were included. Median intercommissural distance and annular area were 39.1 mm and 930 mm 2 , respectively. Commissural mitral TEER was successful in all patients with no instances of single leaflet detachment. In 10 of 13 instances, an NTW device size was used. In 12 of 13 patients, valve implantation was successful, including 1 case that required a second valve for atrial positioning of the first valve. In 1 case, frank valve embolization into the left atrium occurred. Among the 12 successful cases, paravalvular leak was 1+ or less, and there were no instances of paravalvular leak adjacent to the TEER device., Conclusions: In patients with large annuli and sufficient annular calcium, a hybrid mitral TEER and valve replacement with the SAPIEN platform can be successfully used to facilitate transcatheter mitral valve replacement., Competing Interests: Dr McCabe receives honoraria from Abbott Vascular and Edwards LifeSciences. The other authors report no conflicts.

Background: Stent underexpansion is a significant challenge in percutaneous coronary intervention, critically impacting patient outcomes. While excimer laser coronary angioplasty (ELCA) and intravascular lithotripsy (IVL) are increasingly used to address this issue, their full impact on the integrity of drug-eluting stents remains unclear, raising concerns about their safety and efficacy., Methods: This in vitro study assessed the effects of ELCA and IVL on the structural integrity of drug-eluting stents using scanning electron microscopy. Nine stents, 5 Onyx Frontier (with durable circumferential polymer coating) and 4 Cre8 (polymer-free), were implanted in a 3-dimensional coronary artery simulator following standardized protocols. After implantation, treatments with saline-ELCA, contrast-ELCA, IVL, and high-pressure balloon dilatation were applied. A comprehensive evaluation of the stent surface was performed at 60-fold magnification., Results: Scanning electron microscopy analysis revealed significant differences in polymer damage between the techniques. High-pressure balloon dilatation and contrast-ELCA exhibited substantial polymer fragmentation and detachment compared with IVL, saline-ELCA, and conventional dilatation. High-pressure balloon dilatation demonstrated the highest incidence of polymer shaving and overcoating. No significant alterations were observed in polymer-free stents, regardless of the technique used., Conclusions: IVL and saline-ELCA applied immediately after stent implantation produce minimal polymer damage, whereas high-pressure balloon dilatation and contrast-ELCA cause significant damage to the polymer coating. The integrity of polymer-free drug-eluting stent appears stable regardless of the technique used. Further research is needed to validate these findings and explore their clinical implications., Competing Interests: Dr Rivero-Santana is a Rio Hortega Researcher at the Carlos III Health Institute (CM23/00121). Dr Jurado-Roman received speaker fees from Shockwave, Philips, Abbott, Boston Scientific, and Biotronik. In addition, Dr Jurado-Roman has served as a proctor for Philips, Abbott, Boston Scientific, and World Medica. The other authors report no conflicts.

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery., Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years., Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery ( P =0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients ( P <0.001) and lower rates of severe prosthesis-patient mismatch ( P <0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation., Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR., Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283., Competing Interests: Dr Modine is a consultant and Senior Advisory Board member for Medtronic. Dr Tchétché is a consultant for Medtronic. Dr Van Mieghem receives grants from Medtronic during the conduct of the trial and grants from Abbott Vascular, Edwards Lifesciences, Boston Scientific, Abiomed, PulseCath BV, and Daiichi Sankyo outside the submitted work. Dr Chetcuti receives personal fees from Medtronic; grants from Edwards, Boston Scientific, and Jena (paid to institution) during conduct of trial; and on an advisory board for Biotrace and Jena valve without remuneration. Dr Yakubov receives grants from Boston Scientific and Medtronic (paid to institution) and personal fees from Medtronic during the conduct of the trial. Dr Sorajja is a consultant to Boston Scientific and Medtronic. Dr Gada receives personal fees from Medtronic, Abbott Vascular, Becton Dickenson, and Boston Scientific outside the submitted work. Dr Mumtaz is a consultant and has received honoraria and research grants from Medtronic, Edwards, Atricure, Teleflex, Foldax, Japanese Organization for Medical Device Development, and Abbott. Dr Ramlawi receives grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Bajwa is a consultant for Medtronic. Dr Teirstein receives research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic, and serves on an advisory board for Boston Scientific and Medtronic. Dr Kleiman receives clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the trial. Dr Bagur serves as a consultant for Medtronic. Dr Chu receives Speakers’ honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic and Artivion. Dr Huang is an employee and shareholder of Medtronic, plc. Dr Popma is a full-time employee and shareholder for Medtronic. Dr Forrest receives grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon receives grants from Medtronic (paid to institution) during conduct of trial, and consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. The other authors report no conflicts.

Purpose of Review: Stress urinary incontinence is a growing issue in ageing men, often following treatment for prostate cancer or bladder outflow obstruction. While implantable urological devices offer relief, infections are a significant concern. These infections can lead to device removal, negating the benefits and impacting patient outcomes. This review explores the risks and factors contributing to these infections and existing strategies to minimize them. These strategies encompass a multifaceted approach that considers patient-specific issues, environmental issues, device design and surgical techniques. However, despite these interventions, there is still a pressing need for further advancements in device infection prevention., Recent Findings: Faster diagnostics, such as Raman spectroscopy, could enable early detection of infections. Additionally, biocompatible adjuncts like ultrasound-responsive microbubbles hold promise for enhanced drug delivery and biofilm disruption, particularly important as antibiotic resistance rises worldwide., Summary: By combining advancements in diagnostics, device design, and patient-specific surgical techniques, we can create a future where implantable urological devices offer men a significant improvement in quality of life with minimal infection risk., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The difficulty in obtaining long-term data with the use of breast implants is well known. The majority of available data are from multicenter studies with different surgical techniques, and different implants., Methods: The authors provide retrospective 10-year study data (2001 to 2011) with Mentor Contour Profile Gel implants after a mean of 13 years of follow-up, in the first single-center study of such size and length. This study included 835 patients with 1674 Mentor implants across 6 surgery types, all of them performed with a consistent surgical technique developed by the senior author (J.L.M.Y.). Long-term complication rates were analyzed. For the safety analysis, Kaplan-Meier risk rates were calculated., Results: A total of 85% of the patients had long-term follow-up data (at least 7 years). The overall complication rate was 13.2%. The reoperation rate was 12.3%, being just 6.2% caused by complications. The 21-year Kaplan Meier cumulative incidence rate was 1.7% for capsular contracture and 5.1% for implant rupture. The periareolar approach and having a previous capsular contracture were found to be risk factors to develop a new capsular contracture. Low-height, high-projected implants had a significant higher risk of implant rotation. No breast implant-associated anaplastic large cell lymphoma or breast implant illness cases were found; 89.2% of the patients reported being satisfied or very satisfied with the surgery and the implant., Conclusion: With a consistent surgical technique, these 21-year follow-up data of the Mentor Contour Profile Gel implants reaffirm the very strong safety profile of these implants, and continued patient satisfaction with them., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Purpose of Review: The AMS 800 has dominated the treatment of postprostatectomy urinary incontinence (PPUI) due to intrinsic sphincter deficiency (ISD) for five decades. A narrative review from June 2022 to June 2024 was conducted using 'artificial urinary sphincter' (AUS) MeSH terms in Embase. We extracted information on innovative AUS, randomized controlled trials (RCTs) or prospective studies, and systematic reviews. We evaluated the latest guidelines and consensus and analyzed current trends to discuss options for advancing AUS practices., Recent Findings: Of 465 papers identified, 320 were excluded (irrelevant, duplicates, non-AUS devices, non-English, veterinary), and 145 were reviewed, with 24 selected: seven on novel AUS in development, 7 with higher-level evidence (1 RCT, 1 prospective, 4 systematic reviews, 1 nonsystematic review), and 9 retrospective relevant studies [pressure regulating balloon (PRB), revision strategies, radiotherapy history, manual dexterity/cognition, transscrotal vs. transperineal approach]. The final paper summarized current guidelines from Asia & Pacific on AUS., Summary: In the past 2 years, six novel AUS have emerged, two female RCTs are ongoing, the SATURN study published its 1-year outcomes, and four systematic reviews on female AUS were conducted. These findings enhance evidence levels and position novel AUS to challenge the Gold Standard., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Sequential intermediate kissing balloon dilation (sIKBD) is crucial for crush stenting, but it require appropriate procedure remains unclear for crush stenting. This study aims to investigate whether sIKBD is necessary and how it can be properly performed during crush stenting. Mini-crush stenting (mini-CS) and sIKBD for mini-crush stenting (sIKBD-mini-CS) using metal drug-eluting stents/polymer bioresorbable vessel scaffolds (mDES/pBVS) were emulated in bifurcation models considering the branch diameter difference, and sIKBD was added to mini-CS for pretreating side-branch (SB) stent before main-branch (MB) stenting (second figure), respectively. Micro-computed tomography was used to assess the morphological parameters of bifurcated stents including length of overlapping stent segment, residual ostial stenosis of the SB, and neocarina length using quantitative methods. Further, optical coherence tomography was to analyze the incidence of stent malapposition. Quantitative analysis demonstrated that in mDES/pBVS phantom, the neocarina length (mDES: 0.45 ± 0.10 mm vs 0.30 ± 0.09 mm, P = .005; pBVS: 0.47 ± 0.11 mm vs 0.29 ± 0.09 mm, P = .001), residual ostial stenosis at the SB (mDES: 19.37 ± 8.21% vs 12.47 ± 2.05%, P = .001; pBVS: 21.89 ± 8.54% vs 9.98 ± 3.35%, P = .035), and stent malapposition in the overlapping segment (mDES: 10.29 ± 3.31% vs 3.83 ± 0.97%, P = .001; pBVS: 12.05 ± 3.87% vs 6.40 ± 1.59%, P = .003) were lower in the sIKBD-mini-CS group than those in the mini-CS group (P < .05 for all). The results of factorial analysis showed that mDES platform tended to have better morphological indicators than the pBVS platform. Adding the sIKBD to mini-CS showed better morphologic characteristics of mDES/pBVS phantoms when compared with mini-CS. Therefore, it should be considered as a critical and proper technique for crush stenting., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms., Methods: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events., Results: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years., Conclusions: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis., Competing Interests: The following authors declare conflicts of interest regarding consulting, research grants, advisory boards and/or any compensation fees from the mentioned companies. N. Tsilimparis (Proctor fees, speaking fees and institutional research support), D.J. Adam (speaking, research and proctor fees), L. Mendes Pedro (speaking and proctor fees), L. Bertoglio (speaking and proctor fees), T. Kölbel (speaking and proctor fees, institutional research support, royalties and consulting), and G. Panuccio (proctor and speaking fees) are supported by Cook Medical. R. Gouveia e Melo is supported by Cook Medical (speaking fees), Cordis (speaking fees), and Abbott Laboratories (travel and accommodation for congress). S. Scali is supported by Medtronic Inc, Boston Scientific Corporation, and Cook Medical (food and beverage). B. Mendes is supported by WL Gore & Associates Inc, Cook Medical (consulting, speaker and research fees, all proceeds towards Mayo Clinic), Medtronic Inc (aortic advisory board); and Bolton Medical Inc (food and beverage). S. Han is supported by WL Gore & Associates Inc, Cook Medical, Bolton Medical Inc (research support and consulting with all proceeds towards University of San Diego); Medtronic Inc (travel and lodging); Artivion Inc (food and beverage), Guard Medical Inc (consulting fees), Bolton Medical Inc (food and beverage), Endologix LLC (food and beverage), Silk Road Medical Inc (food and beverage), and Viz.ai Inc(food and beverage). M. Schermerhorn is supported by WL Gore & Associates Inc, Silk Road Medical Inc (travel and lodging), Shape Memory Medical Inc and Medtronic Inc (food and beverage). M. Farber is supported by Cook Medical (research support, honoraria and clinical trial support), Centerline Biomedical Inc, WL Gore & Associates Inc and Merck Sharp & Dohme LLC (consulting), Medtronic Inc and Getinge USA Sales LLC (food and beverage). B. Starnes is supported by Bolton Medical Inc, Terumo Aortic (consulting and travel and lodging), Surmodics Inc, Abbott Laboratories and Medtronic Inc and Cook Medical(food and beverage). D. Branzan is supported by Artivion, Bentley InnoMed, Cook Medical, Endologix, Getinge, and Medtronic (consulting and research support).C. Timaran is supported by Cook Medical, WL Gore & Associates Inc, and Philips Healthcare (research support and consulting). F. Verzini is supported by Cook Medical, WL Gore & Associates Inc, and Medtronic (proctor and speaking fees). A.W. Beck is supported by Artivion, Cook Medical, Medtronic, Philips Healthcare, Terumo, and WL Gore & Associates (research and consulting fees with all proceeds towards the University of Alabama). J. Chait is supported by WL Gore & Associates, Bard Peripheral Vascular, and Medtronic Inc (food and beverage). A. Pyun is supported by Silk Road Medical Inc (food and beverage) and Medtronic Inc (education). G. Magee is supported by Silk Road Medical Inc (consulting, travel and lodging, food and beverage), Medtronic Inc (consulting fees, travel and lodging), WL Gore & Associates (consulting fees, food and beverage), ShockWave Medical Inc (travel and lodging and food and beverage), Penumbra Inc, Boston Scientific Inc and Bolton Medical Inc (food and beverage). N. Swerdlow is supported by Silk Road Medical Inc and Shape Memory Medical Inc (food and beverage). M. Juszczak is supported by Cook Medical (research support) and Terumo (research grant). A. Barleben is supported by Cook Medical (consulting; travel and lodging fees), Endologix LLC (consulting; food and beverage), WL Gore & Associates (food and beverage), Silk Road Medical Inc (food and beverage), Penumbra Inc (consulting; travel and lodging), Musculoskeletal Transplant Foundation Inc (food and beverage), Abbott Laboratories (food and beverage), Surmodics Inc (food and beverage), and Cagent Vascular Inc (food and beverage). R. Patel is supported by Silk Road Medical Inc (food and beverage). M.P. Sweet is supported by Artivion Inc and Bolton Medical Inc (food and beverage). S.L. Zettervall is supported by WL Gore & Associates Inc, Bolton Medical Inc, Cook Medical, and Terumo Aortic (consulting and research support), Silk Road Medical Inc and Artivion Inc (food and beverage). G.S. Oderich is supported by Cook Medical (consulting, travel and lodging, speaking fees), WL Gore & Associates (consulting, travel and lodging, education, food and beverage), GE HealthCare (speaking fees, food and beverage), Centerline Biomedical Inc (consulting), Atrium Medical Corporation, Silk Road Medical Inc, Bard Peripheral Vascular Inc, Medtronic Inc (food and beverage). The remaining authors have no conflict of interest to declare.

Background: Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events., Methods: Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events., Results: A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; P =0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; P noninferiority =0.07)., Conclusions: In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501., Competing Interests: Dr Byrne reports research or educational funding to the institution of current employment from Abbott Vascular, Biosensors, Boston Scientific, and Translumina. Dr Maeng is supported by a grant from the Novo Nordisk Foundation (grant number NNF22OC0074083), has received lecture and advisory board fees from Astra-Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Novo Nordisk, has received research grants from Philips, Bayer, and Novo Nordisk, has ongoing research contracts with Novo Nordisk and Philips, and is a minor shareholder in Eli Lilly and Novo Nordisk. Dr Brunner is a previous employee of CeloNova. Dr Urban reports personal consulting fees from and is a shareholder of MedAlliance, Nyon, Switzerland, outside of the submitted work. Dr Cutlip reports contracted research support paid to institution of current employment from Celonova. Dr Kirtane reports Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CathWorks, Cardiovascular Systems Inc, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, and Shockwave Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content. Personal: Travel Expenses/Meals from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Edwards, Cardiovascular Systems Inc, Novartis, Philips, Abiomed, ReCor Medical, Chiesi, Zoll, Shockwave, and Regeneron. The other authors report no conflicts.

Background: No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting., Methods: In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha., Results: Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; P =0.02 for noninferiority at a 0.025 significance level and P =0.55 for 2-sided superiority at a 0.05 significance level)., Conclusions: Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912., Competing Interests: Dr Smits reports personal fees from Terumo and Abiomed, institutional grants and personal fees from Abbott Vascular and Microport, and institutional grants from SMT. Dr Hofma reports an institutional grant from Terumo. Dr Oemrawsingh reports speaker fees from Abbott Vascular and Philips. Dr Paradies reports speaker fees from Boston Scientific and Abbott Vascular and institutional grants from Abbott Vascular. The other authors report no conflicts.

Objective: The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms., Methods: Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion., Results: Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%., Conclusions: PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available., Competing Interests: B.W.S.: Terumo Aortic (consulting). The remaining authors report no conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Summary: Innovations in prosthetic devices and neuroprosthetic control strategies have opened new frontiers for the treatment and rehabilitation of individuals undergoing amputation. Commercial prosthetic devices are now available with sophisticated electrical and mechanical components that can closely replicate the functions of the human musculoskeletal system. However, to truly recognize the potential of such prosthetic devices and develop the next generation of bionic limbs, a highly reliable prosthetic device control strategy is required. In the past few years, refined surgical techniques have enabled neuroprosthetic control strategies to record efferent motor and stimulate afferent sensory action potentials from a residual limb with extraordinary specificity, signal quality, and long-term stability. As a result, such control strategies are now capable of facilitating intuitive, real-time, and naturalistic prosthetic experiences for patients with amputations. This article summarizes the current state of upper extremity neuroprosthetic devices and discusses the leading control strategies that are critical to the ongoing advancement of prosthetic development and implementation., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Purpose: We determined the effects of shorter affected side (AS) crank arm lengths and cycling with two different prostheses on joint and crank power, asymmetry, and net efficiency., Methods: Twelve participants with a TTA rode at 1.5 W·kg -1 with equal (175 mm) and shorter AS crank arms (160, 165, 170 mm) using a daily-use prosthesis and CSP. We used statistical parametric mapping to determine differences in instantaneous joint and crank power between prostheses and linear mixed-effects models to compare average joint and crank power, asymmetry, and net efficiency., Results: Shorter AS crank arm lengths reduced the magnitude of peak positive ( P ≤ 0.001) and negative ( P < 0.001) crank power on the AS. Use of a CSP increased the magnitude of peak positive knee power ( P < 0.001) and decreased the magnitude of peak negative crank power ( P < 0.001) on the AS compared with a daily-use prosthesis. Shorter AS crank arm lengths while using a CSP reduced average hip joint ( P = 0.014) and hip transfer ( P = 0.025) power asymmetry from 35% to 20% and 118% to 62%, respectively. However, we found no significant differences in AS average joint or crank power, knee joint or crank power asymmetry, or net efficiency., Conclusions: Cycling at 1.5 W·kg -1 with unequal crank arm lengths and CSP improves hip joint power and hip transfer power asymmetry but does not alter crank asymmetry or net efficiency for recreational cyclists with a TTA., (Copyright © 2024 by the American College of Sports Medicine.)

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 breast augmentation surgery, selection of the appropriate breast implant size is a crucial step that can greatly affect patient satisfaction and the outcome of the procedure. However, this decision is often based on the subjective judgment of the surgeon and the patient, which can lead to suboptimal results. The authors aimed to develop a machine-learning approach that can accurately predict the size of breast implants selected for breast augmentation surgery., Methods: The authors collected data on patient demographic characteristics, medical history, and surgeon preferences from a sample of 1000 consecutive patients who underwent breast augmentation. This information was used to train and test a supervised machine-learning model to predict the size of breast implant needed., Results: The study demonstrated the effectiveness of the algorithm in predicting breast implant size, achieving a Pearson correlation coefficient of 0.9335 ( P < 0.001). The model generated accurate predictions in 86% of instances, with a mean absolute error of 27.10 mL. Its effectiveness was confirmed in the reoperation group, in which 36 of 57 patients (63%) would have received a more suitable implant size if the model's suggestion had been followed, potentially avoiding reoperation., Conclusions: The findings show that machine learning can accurately predict the needed size of breast implants in augmentation surgery. By integrating the artificial intelligence model into a decision support system for breast augmentation surgery, essential guidance can be provided to surgeons and patients. This approach not only streamlines the implant selection process but also facilitates enhanced communication and decision-making, ultimately leading to more reliable outcomes and improved patient satisfaction., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting., Methods: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up., Results: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P =0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P =0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P =0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P =0.329), target vessel revascularization (14.0% versus 13.1%; P =0.822), myocardial infarction (7.2% versus 4.5%; P =0.186), all-cause death (5.7% versus 4.2%; P =0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P =0.242) between DES and SCB treatment., Conclusions: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years., Competing Interests: None.

Objective: To determine differences in failure rate and hearing outcomes of a completely encircling heat-activated crimping prosthesis (SMart 360°) compared to partially encircling prosthesis (SMart)., Study Design: Retrospective chart review., Setting: Private neurotology tertiary referral center., Patients: Patients who underwent stapedotomies performed by the senior authors from 2008 to 2019 using the SMart prosthesis and SMart 360° prothesis., Interventions: Stapedotomy operations with placement of a SMart or SMart 360° prosthesis., Main Outcome Measures: Incidence of early failure requiring revision surgery. Differences in preoperative air-bone gap (ABG) compared to postoperative ABG at 3 months, 1 year, and 2 years after surgery., Results: A total of 228 stapedotomies were performed (SMart n = 48 and SMart 360° n = 180). Mean preoperative ABG for SMart and SMart 360° were 26.15 and 29 dB, respectively. The mean difference in ABG for the SMart at 3 months, 1 year, and 2 years were 17, 18, and 11 dB, respectively. The mean difference in ABG for the SMart 360° at 3 months, 1 year, and 2 years were 20, 20, and 19 dB. ABG differences at 3 months (p = 0.10) and 1 year (p = 0.36) were not statistically different. The failure rate for the SMart prosthesis was 12.5% and for the SMart 360° 2.2% (p = 0.002)., Conclusions: There were no statistically significant differences in ABG changes for SMart compared to SMart 360°. The Smart 360 corrects the problem with early failure seen with the Smart prosthesis., Professional Practice Gap and Educational Need: Determination of most efficacious stapes prosthesis., Learning Objective: Which stapes prosthesis produces better hearing results with fewer failures., Desired Result: To disseminate information necessary to choose the best stapes prosthesis for patients., Level of Evidence: Level III., Indicate Irb or Iacuc: 2022-029-agh., Competing Interests: Conflicts of interest: The authors disclose no conflicts of interest., (Copyright © 2024, Otology & Neurotology, Inc.)

Purpose of Review: To discuss available premium intraocular lenses (IOLs), patient selection, and important considerations for each premium IOL., Recent Findings: We review important topics and considerations for premium IOL selection: specifically, toric, extended depth of focus (EDOF), multifocal/trifocal, light adjustable lenses (LALs), and small aperture IOLs. Toric lenses are an excellent option for patients with astigmatism. However, to achieve optimal patient satisfaction, it is critical to account for the ATR astigmatism contribution from the posterior cornea and high angle alphas. Additionally, examining the ocular surface prior to placement of EDOF/multifocal IOLs is important, yet the significance of HOAs on outcomes after implantation still must be elucidated more. Finally, recent studies reveal that the small aperture lens is a good alternative for those with corneal irregularities, and second generation LALs are a great option to achieve target refractions in those with less predictable refractive outcomes, such as in Fuchs' dystrophy or in eyes with previous refractive surgery., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The Neovasc Coronary Sinus Reducer Stent (CSRS) was developed for the treatment of patients who continue to suffer from disabling symptoms despite optimal medical therapy. This patient population with refractory angina symptoms is expected to grow, since life expectancy of individuals with atherosclerotic coronary artery disease is increasing. In this paper, we discussed the development of a novel device the CSRS and the upside-down strategy to rebuild a retrograde coronary pressure that was attenuated by the atherosclerotic disease., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Summary: In transumbilical breast augmentation (TUBA) with prefilled silicone implants, technical challenges remain to accommodate more implant options and dissection planes. The authors aimed to demonstrate the feasibility of TUBA using various types of prefilled silicone implants (TUSBA) and its applicability for subglandular, subfascial, dual-plane implantation. In the early stage, TUSBA was primarily performed using endoscope-assisted blunt dissection, and later converted to full endoscopy dissection to achieve better results. An endoscope was used to confirm the pocket and check bleeding for both groups. For the endoscope-assisted group, surgical techniques were modified from conventional TUBA. In full endoscopy TUSBA, the entire dissection process was performed under endoscopic monitoring. Preliminary data of patients undergoing TUSBA from June of 2016 to April of 2021 were retrospectively reviewed. Breast implants with smooth, textured, or nanotextured surface properties and round or anatomic shapes were used, with sizes up to 500 mL. Seventy-four patients with a mean age of 36.4 years (range, 21 to 55 years) were enrolled in this study. Follow-up ranged from 1 month to 4.5 years (mean, 15.6 months). No excessive postoperative pain in breast or abdomen was reported. Surgery outcomes were aesthetically pleasing in both groups. In the endoscope-assisted group, 3 patients (4.6%) required major revisional procedures. No revision was required in the full-endoscopy group. TUSBA with various types of silicone implants is feasible and accommodable to all dissection planes. The full-endoscopy technique is helpful in reducing the higher complication rate., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Textured implants were developed with the goal of reducing rates of capsular contracture and preventing implant malposition (eg, malrotation). Recent evidence has questioned whether textured implants are as resistant to malrotation as previously reported., Methods: Women presenting to a single health care system for removal of textured implants were prospectively enrolled in the study from September of 2019 to July of 2022. Patients who underwent removal of an anatomical, textured implant in the operating room were included in the study; whereas those who did not undergo implant removal, or were found to have a smooth implant, or a round, textured implant, were excluded. The degree of implant rotation on removal of the implant was measured intraoperatively. Information regarding implant-specific factors, patient demographics, clinical factors, and operative characteristics, was collected., Results: A total of 51 patients (80 implants) were included in the study; 45% of implants were malrotated (rotated >30 degrees), and the median degree of rotation was 30 degrees. Having more than one previous revision of the breast pocket was predictive of implant rotation (42 degrees) on multivariate linear regression analysis. Patients who presented with a complaint of "aesthetic dissatisfaction" had 2.89 increased odds of having an implant rotated greater than 30 degrees., Conclusion: The authors' study found a high rate of malrotation of textured shaped implants on explantation., Clinical Question/level of Evidence: Risk, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Study Design: A biomechanical in vitro investigation.Objective: To evaluate the function and stability of self-designed biomimetic artificial atlanto-odontoid joint (BAAOJ) replacement on the atlantoaxial joint.Summary Of Background Data: Upper cervical fusion surgery is a common treatment for various atlantoaxial disorders, and favorable clinical outcome has been achieved. However, the fusion surgery results in loss of atlantoaxial motion as well as adjacent segments degeneration, reducing the quality of life of patients and might produce severe neurological symptoms. Non-fusion technology is expected to solve the above problems, but various designed devices have certain defects and are still in the exploratory phase.Materials and Methods: Biomechanical tests were conducted on 10 fresh human cadaveric craniocervical specimens in the following sequence: 1) intact condition, 2) after the BAAOJ arthroplasty, 3) after BAAOJ fatigue test, 4) after odontoidect-omy, and 5) after anterior rigid plate fixation. Three-dimensional movements of the C1-C2 segment were evaluated to investigate the function and stability of BAAOJ arthroplasty compared with the intact condition after the BAAOJ fatigue test, odontoidect-omy, and rigid plate fixation.Results: Comparing the BAAOJ implantation to the intact state, the range of motion and neutral zone were slightly reduced in all directions (P > 0.05). Compared with the rigid plate fixation, the BAAOJ implantation significantly increased the range of motion and neutral zone in all directions, especially in the axial rotation (P < 0.05).Conclusion: We designed a BAAOJ for correcting atlantoaxial disorders arising from atlantoaxial instability. As a non-fusion device, the most critical feature of BAAOJ replacement is the retention of flexion-extension, lateral bending, and axial rotation range of motion similar to the normal state. It can also stabilize the atlantoaxial complex, and the BAAOJ itself has a good initial stability.Level of Evidence: 4. [ABSTRACT FROM AUTHOR]

Background: Surgery or fibrinolysis is the currently available evidence-based treatment for obstructive mechanical valve thrombus. We reported the feasibility and short-term outcomes of percutaneous transcatheter therapy with cerebral embolic protection. Mid- and long-term outcomes remain unknown., Methods: From 2020 to 2023, 24 patients underwent percutaneous transcatheter release of stuck leaflets with cerebral embolic protection for obstructive mitral mechanical valve thrombus. The indications for the transcatheter therapy were failed fibrinolysis, contraindications for fibrinolysis, not willing for fibrinolysis, or high risk for surgery. The study participants were followed up for a median period of 344.50 (65.00-953.75) days., Results: Technical success was achieved in 91.67% (n=22) of procedures. During the follow-up, 12.50% (n=3) all-cause death, 4.17% (n=1) stroke, and 16.67% (n=4) recurrence were seen. The mean survival time free from death was 1101.48 (95% CI, 929.49-1273.47) days, stroke was 1211.38 (95% CI, 1110.40-1312.35) days, and recurrence was 907.71 (95% CI, 760.20-1055.21) days., Conclusions: Transcatheter release of the stuck mitral mechanical valve with cerebral embolic protection is an alternative therapy with promising mid-term outcomes where surgery or fibrinolysis is not possible or in failed fibrinolysis subsets., Competing Interests: None.

Background: SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing., Methods: CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area., Results: Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P <0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P <0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP., Conclusions: CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary., Competing Interests: Dr Bapat has received consulting fees from Abbott Structural, Medtronic, Boston Scientific, Edwards Lifesciences. Dr Cavalcante has received consulting fees from 4C, Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, HighLife, Medtronic, VDyne, WL Gore, Xylocor; has received research grant support from Abbott Northwestern Hospital Foundation; Dr Sorajja has received consulting fees from 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GE Medical, Laza, Medtronic, Phillips, WL Gore, vDyne, xDot; has received institutional research grant support from Abbott Structural, Edwards Lifesciences, Medtronic and Boston Scientific. The other authors report no conflicts.

Background: The number of patients undergoing exchange of textured implants for smooth devices has greatly increased because of concern over breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The authors examined long-term patient- and surgeon-reported outcomes in terms of aesthetics, comfort, and complications., Methods: Patients who underwent reconstruction with shaped, textured implants replaced with round, smooth implants between 1994 and 2022 and who had a minimum follow-up of 1 year were included. Patient-reported outcomes were collected using the BREAST-Q Reconstruction module and a survey evaluating aesthetics and comfort. Surgeon-reported outcomes included evaluation of aesthetics and capsular contracture., Results: A total of 530 patients were reviewed, and 307 patients were included. Pairwise comparison of BREAST-Q data demonstrated that psychosocial well-being (72.68 to 76.45; P = 0.0075) and physical well-being (78.79 to 81.88; P = 0.0078) increased significantly. Overall breast satisfaction (61.94 to 67.27; P = 0.0082) and sexual well-being (53.89 to 57.98; P = 0.0002) were also significantly higher in parallel with a clinically meaningful increase in BREAST-Q score of 5.33 and 4.09 points, respectively. Most patients felt they appeared better (56.4%) or similar (27.3%) and were more comfortable (54.4%) or similar (39.4%) after the exchange procedure. The senior surgeon (P.G.C.) rated 40.1% of patients as having a better aesthetic grade after replacement and 50.3% as the same; 36.8% of patients were rated as having a decrease in Baker capsular contracture grade; 2.9% of patients experienced a perioperative complication; and there were no reconstructive failures., Conclusion: Exchange of textured to smooth implants is safe, does not sacrifice aesthetic outcome, and provides a more comfortable and satisfactory outcome for patients with minimal complications., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

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.

Competing Interests: Dr Reed performed consulting for Boston Scientific, Edwards Lifesiences. The other authors report no conflicts.

For pediatric patients with refractory temporomandibular joint (TMJ) ankylosis, reconstruction with autologous techniques such as costochondral grafts or distraction osteogenesis has long been considered the gold standard. Many surgeons believed the use of alloplastic joint replacement to be contraindicated in pediatric patients due to concerns for growth restriction and the limited lifespan of the implants. However, recent data has supported TMJ prostheses in skeletally immature patients. This study aims to present a case series of pediatric patients undergoing bilateral TMJ reconstruction with custom-made implants and evaluate their postoperative results. A retrospective chart review was performed of all consecutive pediatric patients undergoing bilateral alloplastic TMJ reconstruction for refractory ankylosis. All patients underwent bilateral TMJ release and total joint replacement with custom-made implants. Preoperative and postoperative cephalometric and volumetric airway data was obtained using cone-beam computed tomography. Three patients, aged 8 to 17, underwent bilateral TMJ replacement with custom-made implants. There were no postoperative complications, and no implants required explantation or replacement. Postoperatively, all patients had increases in maximal interincisal opening, which was stable over months/years of follow-up. The patients also subjectively reported improved speech and mastication; 1 patient had significant improvements in sleep apnea symptoms. Volumetric airway analysis revealed an average airway size increase of 25.6%. Alloplastic TMJ reconstruction is a safe, effective solution for refractory ankylosis in pediatric patients and represents a promising new frontier in craniofacial surgery. Continued long-term evaluation will provide further evidence of the utility of this procedure., Competing Interests: Conflicts of Interest: The authors declare no conflicts of interest., (Copyright © 2024 by Mutaz B. Habal, MD.)

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.

Bioprosthetic aortic valve thrombosis is frequently detected after transcatheter and surgical aortic valve replacement due to advances in cardiac computed tomography angiography technology and standardized surveillance protocols in low-surgical-risk transcatheter aortic valve replacement trials. However, evidence is limited concerning whether subclinical leaflet thrombosis leads to clinical adverse events or premature structural valve deterioration. Furthermore, there may be net harm in the form of bleeding from aggressive antithrombotic treatment in patients with subclinical leaflet thrombosis. This review will discuss the incidence, mechanisms, diagnosis, and optimal management of bioprosthetic aortic valve thrombosis after transcatheter aortic valve replacement and bioprosthetic surgical aortic valve replacement., Competing Interests: Dr Chitturi is a consultant for Glass Health. Dr Case is a speaker for Asahi Intecc USA, Inc, and Zoll Medical. Dr Waksman reports participation on the advisory boards for Abbott Vascular, Philips Image-Guided Therapy, and Pi-Cardia Ltd; consulting for Abbott Vascular, Apend Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips Image-Guided Therapy, Pi-Cardia Ltd, Swiss Interventional Systems Medical AG, and Transmural Systems Inc; institutional grant support from Biotronik, Medtronic, Philips Image-Guided Therapy; and equity in Transmural Systems, Inc. Dr Rogers reports participation on the advisory boards for Medtronic and Boston Scientific; consulting for Edwards Lifesciences, Medtronic, and Boston Scientific; equity in Transmural Systems, Inc; and is a coinventor of patents assigned to the National Institutes of Health. The other authors report no conflicts.

Background: Textured implants have been linked to breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). Patients who undergo explantation have options for reconstruction, but data on safety and patient-reported outcomes (PROs) are limited. The purpose of this study was to classify complications and PROs in patients opting for surgical management of textured implants., Methods: Complication rates and BREAST-Q scores were compared between (1) asymptomatic patients who underwent conversion from textured to smooth implants ( n = 224), (2) symptomatic patients who underwent conversion from textured to smooth implants ( n = 83), (3) patients who underwent explantation without replacement ( n = 44), and (4) patients who underwent replacement with autologous reconstruction ( n = 33). Linear regression examined PROs controlling for clinical and surgical variables., Results: Overall complication rates in 384 patients (637 implants) differed across groups ( P = 0.034), with the highest rate (25%) in patients who underwent explantation without replacement. These patients were specifically more impacted by minor complications, notably seroma. Capsulectomy extent did not significantly impact complications. Asymptomatic and symptomatic smooth implant patients had improvements in Satisfaction with Breasts ( P < 0.05). Autologous reconstruction patients had significant improvements in Satisfaction with Breasts sustained after 3 months postoperatively ( P < 0.01) and Sexual Well-being sustained after 6-months postoperatively ( P < 0.05). Patients who underwent removal without replacement had lower Physical Well-being of the Chest scores at 1 year or more than the other groups., Conclusions: Replacement of textured implants with smooth implants or flaps is safe and is associated with improved satisfaction with breasts and quality of life. The degree of capsulectomy does not appear to impact the incidence of perioperative complications., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

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: The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES., Methods: The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months., Results: The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P =0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P =0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P =0.34) were comparable between the 2 groups., Conclusions: In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157., Competing Interests: Dr Han reports grants from ChongKunDang and HanMi outside the submitted work. Dr K.W. Park reports speaker fees from Daiichi Sankyo, AstraZeneca, Sanofi, Bristol-Myers Squibb, Bayer, and Pfizer outside the submitted work. Dr H.-S. Kim reports grants or speaker fees from Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, Dio, Medtronic, Abbott Vascular, Edwards Life Science, Amgen, and Behringer Ingelheim outside of the submitted work. The other authors report no conflicts.

Competing Interests: Dr Chhatriwalla: consultant fees/honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc; research grant from Boston Scientific. Dr Allen: general disclosures are Abbott, Medtronic, and Edwards; institutional research support, proctoring, and speakers bureau with all payments to the institution and none personally. Dr Saxon: Proctor and consulting support for Edwards Lifesciences and Medtronic, Inc. Dr Huded: consulting at Boston Scientific and Medtronic. Dr Makkar: research grants from Abbott, Edwards Lifesciences, and Boston Scientific; consultant at Cordis and Medtronic; employee at Cedars-Sinai Medical Center. Dr Jilaihawi: grant/research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Inc, and Pi-Cardia; consultant fees/honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc. Dr Greenbaum: honoraria from Edwards Lifesciences and Medtronic. Dr Babaliaros: equity in Transmural Systems; consultant at Edwards Lifesciences. Dr Whisenant: consultant at Edwards Lifesciences and Medtronic. Dr Yakubov: proctor at Medtronic, Inc; advisory board at Medtronic, Inc, and Boston Scientific. The other authors report no conflicts.

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.

Purpose: To review the literature focusing on the clinical outcomes of KeraKlear (KK) (KeraMed), a foldable intrastromal keratoprosthesis., Methods: We searched 6 databases using 4 keywords: KeraKlear, Foldable Keratoprosthesis, Intrastromal Keratoprosthesis, and Non-penetrating Keratoprosthesis. Included studies had to be conducted in vivo on humans, published until January 3, 2023, and had to investigate the implantation of the KK. Eyes were considered at high risk of keratoprosthesis retention failure whenever there was an active inflammatory ocular surface disorder or in case of previous KK failure. We aimed at recording the postoperative complications, rate of prosthesis retention, and mean improvements in visual acuity., Results: We identified 144 publications, 6 of which (38 eyes) met the inclusion criteria. No randomized controlled trials were found, and some studies had significant limitations regarding sample size and follow-up duration. With a mean follow-up of 28 ± 18.8 months, postoperative complications of any kind occurred between 0% and 50% and 24% had an implant extrusion/needed a reoperation. The mean postoperative visual acuity improvement on the last follow-up was -0.83 ± 0.27 LogMAR, that is, -0.57 ± 0.3 for high-risk and -1.03 ± 0.25 for low-risk eyes, whereas 1 year after implantation, 50% of the prostheses were retained in the former and 81% in the latter group. None of the eyes developed glaucoma, endophthalmitis, or expulsive hemorrhages; none had to be eviscerated/enucleated., Conclusions: Despite the limited quality and quantity of evidence, the available literature seems to suggest the KK to be a valuable tool in the treatment of complicated corneal disorders. Because in many parts of the world, the access to corneal transplantation is limited, this prosthesis could represent a valid alternative., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, 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.

Left ventricular assist devices (LVADs), which were introduced as a bridge to heart transplantation, are now an established alternative to heart transplantation (HT) for patients with advanced heart failure. These devices have undergone significant technological advancements over the years, and contemporary LVADs prolong life substantially in patients dependent on inotropic therapy or in those with severe ambulatory advanced heart failure with a median survival that exceeds 5 y, and most patients benefit from a doubling in functional capacity, even among those intended as destination therapy because of ineligibility for transplantation. Other intended goals for LVAD implantation consist of (1) bridge to remission or recovery and (2) bridge to transplant or candidacy for transplant. In the former situation, few selected patients underwent LVAD implantation, facilitating myocardial remission to recovery that allowed explantation. Among those bridged to transplantation, survival in the intended goal was excellent, with 80% success at 5 y (with a 50% rate of transplantation). In this review, we provide a brief historical background on the evolution of LVADs and discuss outcomes with contemporary pumps, immunological and infection-related impact of such devices, impact of bridging in HT, and use of devices for facilitating myocardial recovery and remission. Furthermore, we discuss implications of HT allocation policies, with a specific focus within the United States, and outline future perspectives and novel device in development., Competing Interests: M.R.M. reports payment made to institution from Abbott for consulting, consulting fees from Mesoblast, Janssen, Moderna, Paragonix, and Baim Institute for Clinical Research, and advisory board member for Transmedics, NuPulseCV, Leviticus, and FineHeart. The other authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To report the long-term clinical outcomes of transscleral four-point fixation of Akreos intraocular lens using a closed continuous-loop suture technique., Methods: This was a retrospective, multicenter, interventional case series. Primary outcome measures were best-corrected visual acuity, intraocular pressure, corneal endothelial cell density, and complications with a minimum of 1-year follow-up., Results: One hundred and ninety-two eyes of 177 patients from two surgical hospital sites were identified. The mean best-corrected visual acuity improved from 0.88 ± 0.74 logarithm of the minimum angle of resolution (Snellen 20/152) preoperatively to 0.42 ± 0.52 logarithm of the minimum angle of resolution (Snellen 20/53) postoperatively ( P < 0.001). The mean preoperative intraocular pressure was 17.51 ± 8.67 mmHg, and the mean postoperative intraocular pressure at final follow-up was 15.08 ± 4.18 mmHg ( P = 0.001). The mean corneal endothelial cell density significantly reduced from 2,259 ± 729 cells/mm 2 to 2077 ± 659 cells/mm 2 , representing a cell loss of 5.73% ( P < 0.001). The intraocular lens was fixed well during follow-up. There were no intraoperative complications noted. Postoperative complications included transient ocular hypertension in 15 eyes (7.81%), hypotony in two eyes (1.04%), retinal detachment in one eye (0.52%), and macular edema in one eye (0.52%)., Conclusion: The transscleral four-point fixation Akreos intraocular lens using the closed continuous-loop suture technique was effective and safe with satisfactory visual acuity with a minimum of 1-year follow-up.

Objective: The objective of this study is to examine the influence of electrode array design on the position of the basal-most electrode in cochlear implant (CI) surgery and therefore the stimulability of the basal cochlea. Specifically, we evaluated the angular insertion depth of the basal-most electrode in perimodiolar and straight electrode arrays in relation to postoperative speech perception., Materials and Methods: We conducted a retrospective analysis of 495 patients between 2013 and 2018 using the Cochlear™ Contour Advance® (CA), Cochlear™ Slim Straight® (SSA), or Cochlear™ Slim Modiolar® (SMA) electrode arrays, as well as the MED-EL Flex24 (F24), MED-EL Flex28 (F28), and MED-EL FlexSoft (F31.5) electrode arrays. Cochlear size and the position of the basal-most electrode were measured using rotational tomography or cone beam computed tomography, and the results were compared with postoperative speech perception in monosyllables and numbers., Results: The straight electrode arrays, specifically the F31.5 (31.5 mm length) and the F28 (28 mm length), exhibited a significantly greater angular insertion depth of the basal-most electrode. No significant correlation was found between cochlear morphology measurements and the position of the basal-most electrode artifact. Cochleostomy-inserted electrode arrays showed a significantly higher insertion depth of the basal-most electrode. Nevertheless, the position of the basal-most electrode did not have a significant impact on postoperative speech perception., Conclusion: Straight electrode arrays with longer lengths achieved deeper angular insertion depths of the basal-most electrode. Cochlear morphology does not have a substantial influence on the position of basal-most electrode. The study confirms that the basal area of the cochlea, responsible for high-frequency range during acoustic stimulation, is not the primary region for speech understanding via electrical stimulation with CI., Competing Interests: Conflict of interest: M.C.K. received travelling expenses and financial support for research from Cochlear Ltd, Australia and financial support for research expenses from Oticon Inc. A.A. received travelling expenses and financial support for research from Cochlear Ltd, Australia; financial support for research and travelling expenses from Med-El, Innsbruck, Austria; financial support for research and travelling expenses from Oticon Inc., Somerset, NJ; financial support for research and travelling expenses from Advanced Bionics, Valencia, CA. S.A. received financial support for research and travelling expenses from Cochlear Ltd, Australia; financial support for research and travelling expenses from Med-El, Innsbruck, Austria travelling expenses from Advanced Bionics, Valencia, CA. The authors R.B. and T.H. declare no conflict of interest. This study is not sponsored by industry., (Copyright © 2024, Otology & Neurotology, Inc.)

Blood vessels are subjected to complex biomechanical loads, primarily from pressure-driven blood flow. Abnormal loading associated with vascular grafts, arising from altered hemodynamics or wall mechanics, can cause acute and progressive vascular failure and end-organ dysfunction. Perturbations to mechanobiological stimuli experienced by vascular cells contribute to remodeling of the vascular wall via activation of mechanosensitive signaling pathways and subsequent changes in gene expression and associated turnover of cells and extracellular matrix. In this review, we outline experimental and computational tools used to quantify metrics of biomechanical loading in vascular grafts and highlight those that show potential in predicting graft failure for diverse disease contexts. We include metrics derived from both fluid and solid mechanics that drive feedback loops between mechanobiological processes and changes in the biomechanical state that govern the natural history of vascular grafts. As illustrative examples, we consider application-specific coronary artery bypass grafts, peripheral vascular grafts, and tissue-engineered vascular grafts for congenital heart surgery as each of these involves unique circulatory environments, loading magnitudes, and graft materials., Competing Interests: Disclosures None.

Background: Anatomic selection for Harmony valve implant is determined with the aid of a screening report and perimeter plot (PP) that depicts the perimeter-derived radius along the right ventricular outflow tract (RVOT) and projects device oversizing. The PP provides an estimation of suitability for implant, but its sensitivity as a screening method is unknown. This study was performed to describe anatomic features and outcomes in patients who underwent Harmony TPV25 implant despite a PP that predicted inadequate oversizing., Methods: We reviewed RVOT anatomic features and measurements in patients who underwent transcatheter pulmonary valve replacement with the Harmony TPV25 device despite a PP that predicted inadequate oversizing., Results: This study included 22 patients. There were no unsuccessful implants or adverse valve-related events. Anatomic features varied, but all patients fit into 1 of 3 anatomic types characterized by differences in RVOT dimensions. Type 1 patients (n=9) had a long RVOT with a choke point and a wide main pulmonary artery. Type 2 patients (n=6) had a short RVOT that was pyramidal in shape, with no choke point, and extensive main pulmonary artery lengthening/expansion during systole. Type 3 patients (n=7) had a short, bulbous main pulmonary artery with a choke point and an open pulmonary artery bifurcation., Conclusions: Transcatheter pulmonary valve replacement with the Harmony valve is feasible in some patients whose PP fit analysis predicts inadequate oversizing. All cases in this series fit into 1 of 3 anatomic patterns, which are not identified in the screening report. Implanters must review cases individually to assess the feasibility of the implant., Competing Interests: Disclosures Drs McElhinney and Aboulhosn worked as Proctor and consultant for Medtronic and Edwards. Dr Gillespie is a consultant and proctor for Medtronic and W.L. Gore and Associates. Dr Cabalka is a Consultant for Medtronic, Edwards, and B. Braun. Dr Morray worked as Proctor and consultant for Medtronic and Abbott. Dr Balzer worked as Proctor and consultant for Medtronic, Edwards, and Abbott. Dr Qureshi worked as proctor and consultant for Medtronic, W.L. Gore and Associates, and B. Braun. Dr Goldstein worked as consultant and Proctor for Medtronic and W.L. Gore & Associates, Consultant for Edwards, Consultant and Advisory Board Member for PECA Labs and Mezzion Pharmaceuticals.

Background: The prognostic impact of left atrial appendage (LAA) patency, including those with and without visible peri-device leak (PDL), post-LAA closure in patients with atrial fibrillation, remains elusive., Methods: Patients with atrial fibrillation implanted with the WATCHMAN 2.5 device were prospectively enrolled. The device surveillance by cardiac computed tomography angiography was performed at 3 months post-procedure. Adverse events, including stroke/transient ischemic attack (TIA), major bleeding, cardiovascular death, all-cause death, and the combined major adverse events (MAEs), were compared between patients with complete closure and LAA patency., Results: Among 519 patients with cardiac computed tomography angiography surveillance at 3 months post-LAA closure, 271 (52.2%) showed complete closure, and LAA patency was detected in 248 (47.8%) patients, including 196 (37.8%) with visible PDL and 52 (10.0%) without visible PDL. During a median of 1193 (787-1543) days follow-up, the presence of LAA patency was associated with increased risks of stroke/TIA (adjusted hazard ratio for baseline differences, 3.22 [95% CI, 1.17-8.83]; P =0.023) and MAEs (adjusted hazard ratio, 1.12 [95% CI, 1.06-1.17]; P =0.003). Specifically, LAA patency with visible PDL was associated with increased risks of stroke/TIA (hazard ratio, 3.66 [95% CI, 1.29-10.42]; P =0.015) and MAEs (hazard ratio, 3.71 [95% CI, 1.71-8.07]; P =0.001), although LAA patency without visible PDL showed higher risks of MAEs (hazard ratio, 3.59 [95% CI, 1.28-10.09]; P =0.015). Incidences of stroke/TIA (2.8% versus 3.0% versus 6.7% versus 22.2%; P =0.010), cardiovascular death (0.9% versus 0% versus 1.7% versus 11.1%; P =0.005), and MAEs (4.6% versus 9.0% versus 11.7% versus 22.2%; P =0.017) increased with larger PDL (0, >0 to ≤3, >3 to ≤5, or >5 mm). Older age and discontinuing antiplatelet therapy at 6 months were independent predictors of stroke/TIA and MAEs in patients with LAA patency., Conclusions: LAA patency detected by cardiac computed tomography angiography at 3 months post-LAA closure is associated with unfavorable prognosis in patients with atrial fibrillation implanted with WATCHMAN 2.5 device., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03788941., Competing Interests: Disclosures None.