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Suture-mediated closure device and Figure-of-Eight suture are commonly used to achieve hemostasis after use of large bore venous access. Although both methods of closure are commonly used in clinical practice, a head-to-head comparison in a controlled setting has not been performed. Patients presenting to a single center for elective left atrial appendage occlusion or transcatheter edge-to-edge mitral valve repair were randomized to large bore venous closure using the Perclose ProGlide suture-based closure or a Figure-of-Eight suture closure. The patients were followed for 1 month after the procedure. Primary outcome, a composite of access site large ecchymosis, hematoma, infection, pain, need for unscheduled venous ultrasound and need for transfusion, was compared between the 2 arms. A total of 40 patients were randomized in a 1:1 fashion to the 2 venous closure strategies. Baseline characteristics were similar between the 2 groups. Perclose ProGlide arm required use of more devices for hemostasis (1.5 ± 0.5 vs 1 ± 0 respectively, p <0.0001), and there was a significant difference in the cost of closure device ($367.00 ± 122.00 vs $1.00 ± 0 respectively, p <0.001). At 1 month post-procedure, the primary outcome occurred in 4 patients (20%) in the Perclose arm and 7 (35%) patients in the Figure-of-Eight arm, a difference that was not statistically significant (p = 0.48). Time to hemostasis between Figure-of-Eight and Perclose arms did not reach statistical significance (2.5 ± 2.1 vs 3.7 ± 2.3, p = 0.09). In conclusion, both Perclose ProGlide suture-based device and Figure-of-Eight closure are equally feasible and safe for patients who underwent large bore venous access. Figure-of-Eight-based closure is more cost effective., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023. Published by Elsevier Inc.)

Atrial fibrillation is a major risk factor for stroke. Left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for patients with high risk of bleeding. Diabetes mellitus (DM) is associated with adverse events after cardiac procedures. We sought to compare procedural and hospital outcomes in patients who underwent LAAC with and without DM. The Nationwide Inpatient Database was queried for patients with atrial fibrillation who underwent LAAC between January 1, 2016, and December 31, 2019. The primary outcome was all adverse events that included in-hospital death, acute myocardial infarction, cardiac arrest, stroke, pericardial effusion, pericardial tamponade, pericardiocentesis, pericardial window, and postprocedural hemorrhage requiring blood transfusion. Analysis included 62,220 patients who underwent LAAC from 2016 to 2019; 34.9% of patients had DM. There was a slight increase in the percentage of patients who underwent LAAC who had DM during the study period, from 29.92% to 34.93%. In unadjusted and adjusted analysis, there was no significant difference in all adverse events between patients with and without DM who underwent LAAC (9.18% vs 8.77%, respectively, adjusted p = 0.63), and no difference in length of stay. Patients with DM have higher risk of acute kidney injury (3.75 vs 1.96%, p <0.001). This nationwide retrospective study demonstrates that DM is not associated with an increase in adverse event rates in patients who underwent LAAC., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR)-related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies., Objectives: This study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis., Methods: Preprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort., Results: Sixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm 3 ) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right., Conclusions: A novel computed tomography-based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis., Competing Interests: Funding Support and Author Disclosures This work was supported by a research grant from Medtronic to MedStar Cardiovascular Research Network and MedStar Health. Dr Kamioka has served as a proctor for Edwards Lifesciences. Dr Ludwig has received grant support from the German Heart Foundation; and received travel compensation from Edwards Lifesciences. Dr. Sinning has received speaker honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences; and served as a proctor for Medtronic and Boston Scientific. Dr Fuku has served as a proctor for Edwards Lifesciences and Medtronic. Dr Iyer has served as a proctor for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Rodriguez has served as a speaker for Medtronic, Abbott, and Edwards Lifesciences. Dr Montorfano has served as a proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr Ancona has received consulting fees from Abbott and Abiomed. Dr Ahmad has served as a proctor for Edwards Lifesciences. Dr Ruggiero has served as a proctor for Abbott and Edwards Lifesciences; served as a consultant for Abbott, Edwards Lifesciences, and RegenX-Bio; and received research support from Ancora Heart and Bard. Dr Weissman has served as the director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Dr Waksman has served on the advisory board for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; has served as a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; has received institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and is an investor in MedAlliance and Transmural Systems Inc. Dr Rogers has served as a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; has served on the advisory board for Medtronic; and holds equity interest in Transmural Systems Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. All rights reserved.)

Background: Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m 2 are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post-transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality., Objectives: The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF., Methods: In a multicenter retrospective registry of patients undergoing TAVR, Cox models with regression splines explored the relationship between invasive and echocardiographic gradients post-TAVR with 2-year mortality. An invasive gradient <5 mm Hg was considered low, between ≥5 and <10 mm Hg was considered intermediate, and ≥10 mm Hg was considered high. An echocardiographic gradient <10 mm Hg was considered low, ≥10 and <20 mm Hg was considered intermediate, and ≥20 mm Hg was considered high., Results: Higher mortality occurred in low echocardiographic gradients at discharge relative to intermediate gradients (P < 0.001), and low gradient was associated with lower EF and echocardiographic SVi (P < 0.001 and P < 0.008, respectively). Lower mortality occurred in low invasive gradients relative to intermediate gradients (P = 0.012) with no difference in EF and echocardiographic SVi between groups (P = 0.089 and P = 0.947, respectively). There were insufficient observations to determine the impact of high echocardiographic and invasive gradients on mortality., Conclusions: In this large retrospective analysis, the impact of transaortic gradients on mortality after TAVR was not linear and complex, showing opposite results among echocardiographic and invasive measurements in low-gradient patients., Competing Interests: Funding Support and Author Disclosures Dr Khalili has received a research grant from Edwards Lifesciences; and speaker fees from Abbott Vascular. Dr Pibarot has received research grants and consulting fees from Edwards Lifesciences; and has received grants from Medtronic. Dr Hahn has received speaker fees from Boston Scientific, Edwards Lifesciences, and Medtronic; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Gore & Associates, Medtronic, and Philips Healthcare. Dr Elmariah has received research grants and consulting fees from Edwards Lifesciences; and has received research grants from Medtronic. Dr Pilgrim has received grants from Boston Scientific; has received speaker fees from Biotronik; is a consultant for HighLife SAS; and is a proctor for Boston Scientific and Medtronic. Dr Okuno has received speaker fees from Abbott. Dr Mack has received research grants and consulting fees from Edwards Lifesciences. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF., Objective: The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort., Methods: At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days., Results: A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%)., Conclusions: Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Despite more than 80% of interventional operators reporting one or more orthopedic injuries attributed to the X-ray laboratory, there has been limited adoption of various strategies and equipment to minimize these injuries. A comprehensive review of these methods to reduce musculoskeletal strain is lacking in the current literature, and is essential in order to ensure a long, healthy, and productive interventional career., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Transesophageal echocardiogram (TEE) is the preferred imaging modality to guide transcatheter left atrial appendage closure (LAAC). Intracardiac echocardiography (ICE) has evolved as a less invasive alternative to TEE. Several observational studies have shown similar success rates and perioperative complications between TEE and ICE for LAAC., Objectives: We sought to examine the temporal trends and patient characteristics of TEE versus ICE use in LAAC using a national database. We also evaluated hospital outcomes including periprocedural complications, mortality, and length of hospital stay., Methods: This is a retrospective analysis of data from the National Readmission Database, collected from 2016 to 2018. The primary outcome was major adverse events (MAE) defined as in-hospital mortality, cardiac arrest, pericardial effusion with or without tamponade, pericardiocentesis or window pericardiocentesis and pericardial window, pericardial effusion and tamponade, and hemorrhage requiring transfusion., Results: Trend analysis showed that TEE-guided LAAC increased from 96.6% in 2016 to 98.4% in 2018 (relative increase, 1.9%), while ICE-guided LAAC decreased from 3.4% to 1.6% during the same period (relative decrease, 53%, p for trend = 0.08). In the unmatched cohorts, the MAE was significantly lower in TEE-guided LAAC compared to ICE-guided LAAC (6.5% vs. 9.3%, p = 0.022). In the propensity score matching analysis, MAE remained significant (5.6% vs. 9.4%, p < 0.001). The incidence of pericardial effusion with or without tamponade remained significantly lower in the TEE group (2.3% vs. 5.8%, p < 0.001). Length of stay (3.4 vs. 1.9 days, p < 0.001) and hospitalization cost ($34,826 vs. $20,563, p < 0.001) remained significantly lower for TEE-guided LAAC., Conclusions: Compared to ICE, the incidence of MAE was significantly lower for TEE-guided LAAC, driven mainly by less pericardial effusion events. Large-scale randomized trials are needed to confirm the findings of the current and previous studies., (© 2022 Wiley Periodicals LLC.)

Background: The modes of failure of coronary polymer-jacketed guidewires have received limited study., Methods: We queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports., Results: The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection)., Conclusions: The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires., Competing Interests: Declaration of competing interest Khaldoon Alaswad: consulting/speaker honoraria from Boston Scientific, Cardiovascular Systems Inc., Abbott Vascular, Teleflex. Mir Basir: Consulting/Speaker Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Zoll. Emmanouil Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens; owner, Hippocrates LLC; shareholder: MHI Ventures, Cleerly Health. H Khalili: Abbott vascular speaker bureau. All other authors have nothing to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs)., Methods: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA)., Results: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX., Conclusions: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications., (© 2021 Wiley Periodicals LLC.)

Background: MitraClip is approved for treatment of both degenerative and functional mitral regurgitation (MR). The landmark trials for this device included only patients with A2P2 location of MR. Initial commercial experience showed A2P2 location was associated with higher technical success as compared with non-A2P2 location. We intended to compare technical success of A2P2 vs non-A2P2 MitraClip procedures in terms of residual MR and transmitral gradient (TMG) in the contemporary setting as the operator experience has increased. A total of 159 patients with complete data were included in the study. A total of 129 patients were in the A2P2 MitraClip group and 30 patients were in the non-A2P2 MitraClip group. Post implantation, there was a significant increase in TMG in both A2P2 and non-A2P2 groups (0.73 ± 1.42 and 0.94 ± 1.85, respectively; both P<.01). However, postimplantation TMG was not different between the 2 groups (3.6 ± 1.9 A2P2 vs 3.7 ± 1.7 non-A2P2; P=.56) and there was no difference in residual MR (P=.40). At 1-month follow-up of 82 patients (64 A2P2 and 18 non-A2P2), the results were similar; TMG (3.7 ± 1.6 A2P2 vs 3.7 ± 2.1 non-A2P2; P=.96) and residual MR (P=.41). Our data showed similar technical success of MitraClip procedures in both types of MR.

Background: There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles., Objectives: To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States., Methods: We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure., Results: The final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG)., Conclusions: Needle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training., (© 2021 Wiley Periodicals LLC.)

Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device., Methods: Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points., Results: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=-0.14 [95% CI, -3.42 to 3.13]; P <0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, -1.55 to 1.55]; P <0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=-2.12 [95% CI, -4.45 to 0.21]; P <0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=-0.71 [95% CI, -3.72 to 2.31]; P =0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41-3.66]; P <0.001 for noninferiority; P =0.003 for superiority)., Conclusions: The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.

The authors describe a patient with hypertrophic cardiomyopathy with concomitant left ventricular outflow tract obstruction and aortic stenosis. Detailed haemodynamic assessment of the serial lesions was performed. Alcohol septal ablation resulted in a significant reduction of gradients across the left ventricular outflow tract., Competing Interests: Disclosure: The authors have no conflicts of interest to declare, (Copyright © 2021, Radcliffe Cardiology.)

The cardiovascular and renal systems share an intimate physiological relationship, wherein a perturbance in one system may have an adverse effect on the other. Since the burden of renal disease increases with age, there is a considerable interest in the pathophysiology of kidney disease in the geriatric patient population. This review will explore the physiological dynamics behind the increased susceptibility to kidney disease in this population. A better understanding of these pathophysiological changes may lead to improved prevention and management strategies., (© 2020 The American Geriatrics Society.)

Background: Post-operative atrial fibrillation (POAF) is common after aortic valve replacement (AVR) and is associated with worse outcomes. We performed a meta-analysis of randomized controlled trials comparing Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) for incidence of POAF at 30 days., Methods: We searched databases from 1/1/1990 to 1/1/2020 for randomized studies comparing TAVR and SAVR. POAF was defined as either worsening or new-onset atrial fibrillation. Random effects model was used to estimate the risk of POAF with TAVR vs SAVR in all trials, and in subgroups (low, intermediate, high risk, and in self-expandable vs balloon expandable valves). Sensitivity analysis was performed including only studies reporting new-onset atrial fibrillation., Results: Seven RCTs were identified that enrolled 7,934 patients (3,999 to TAVR and 3,935 to SAVR). The overall incidence of POAF was 9.7% after TAVR and 33.3% after SAVR. TAVR was associated with a lower risk of POAF compared with SAVR (OR 0.21 [0.18-0.24]; P < 0.0001). Compared with SAVR, TAVR was associated with a significantly lower risk of POAF in the high-risk cohort (OR 0.37 [0.27-0.49]; P < 0.0001), in the intermediate-risk cohort (OR 0.23 [0.19-0.28]; P < 0.0001), low-risk cohort (OR 0.13 [0.10-0.16]; P < 0.0001). Sensitivity analysis of 4 trials including only new-onset POAF showed similar summary estimates (OR 0.21, 95% CI [0.18-0.25]; P< 0.0001)., Conclusions: TAVR is associated with a significantly lower risk of post-operative atrial fibrillation compared with SAVR in all strata. Further studies are needed to identify the contribution of post-operative atrial fibrillation to the differences in clinical outcomes after TAVR and SAVR.

Background: Transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) is an increasingly prevalent treatment in patients who are intermediate or high risk for surgical intervention. In nonagenarian patients undergoing TAVR, symptomatic relief and quality of life (QoL) outcomes have not been well established. This study explores these outcomes in this patient population that has been underrepresented in landmark clinical trials., Methods: All patients who underwent TAVR between January 1, 2015 and December 31, 2018 at Delray Medical Center were included. The 12-item Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score was used to assess QoL prior to and 30 days following TAVR in two patient groups: the nonagenarian group (patients ≥90 years old) and the younger group (patients <90 years old). KCCQ-OS scores were compared between these two groups. Frailty assessment included grip strength, gait speed, and activities of daily living. Unadjusted and adjusted analyses (baseline KCCQ-OS score, frailty, and Society of Thoracic Surgery perioperative risk of mortality [STS-PROM] score) were performed to assess the impact of age on QoL outcomes in both groups., Results: Of the total 223 patients included in this study, a total of 46 (20.6%) were nonagenarians and 118 (52.7%) were men. KCCQ-OS scores were lower at baseline and 30-day follow-up in nonagenarians compared with the younger group (P=.70). Age was a significant predictor of 30- day KCCQ-OS in unadjusted and adjusted analyses (adjusted for baseline KCCQ-OS, frailty, and STS-PROM score). Nonagenarians had an average 6.45 points lower 30-day KCCQ-OS scores than the younger patients in adjusted analysis. However, there was a significant clinical improvement in the 30-day KCCQ-OS score in both groups (P<.001)., Conclusions: Our data suggest that with appropriate patient selection, a significant clinical improvement may be expected with TAVR in nonagenarians.

Background: Autopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes., Objectives: The purpose of this study was to evaluate the association between LRP detected by near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents., Methods: In this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI 4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion-related, nonculprit (untreated) lesion-related, or indeterminate., Results: Among 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion-related, 10.7% were nonculprit lesion-related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion-related MACE was not significantly associated with maxLCBI 4mm (hazard ratio of maxLCBI 4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors., Conclusions: Following PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Fluoroscopy and transesophageal echocardiography (TEE) are used to guide transcatheter left atrial appendage (LAA) closure in patients with atrial fibrillation to prevent thromboembolic events. This study examines whether real-time three-dimensional volume ICE guidance (4D volume ICE) can be used as an alternative to TEE during LAA closure (LAAC)., Methods and Results: Fifteen patients with atrial fibrillation (AF), who had high risk for stroke and contraindication for long-term warfarin therapy, were enrolled in the study. The WATCHMAN device was used for transcatheter LAAC under fluoroscopy. LAA and device sizing was performed using TEE and volume ICE guidance from the right heart. Intraprocedural ICE measurements were consistent with TEE; LAA maximal width and depth, and maximal diameter of the implanted device were moderately correlated (Pearson's coefficient: 0.63, 0.65, and 0.71 respectively; p<0.05) with good agreement (bias: -0.03 cm, -0.07 cm, and 0.003 cm respectively). The average imaging success rate, defined by the number of patients with all the required intraprocedural measurements, was 67% for ICE and 100% for TEE. The WATCHMAN device was successfully implanted in all patients with a device to patient ratio of 1.33., Conclusions: 4D volume ICE can be used as an intraprocedural sizing and guidance tool for transcatheter LAAC with measurements comparable to TEE. Challenging patient characteristics significantly degrade the diagnostic image quality when imaging from the right heart. Standardized workflow with proper patient selection and optimal preprocedural planning may improve the diagnostic quality of volume ICE guidance for transcatheter LAAC procedure.

Contrast-induced acute kidney injury (CI-AKI) is an important consideration in patients undergoing cardiac catheterization. There has been a continuous strive to decrease morbidity and improve procedural safety. This review will address the pathophysiology, predictors, and clinical management of CI-AKI with a concise overview of the pathophysiology and a suggested association with left atrial appendage closure. Minimizing contrast administration and intravenous fluid hydration are the cornerstones of an effective preventive strategy. A few adjunctive pharmacotherapies hold promise, but there are no consensus recommendations on prophylactic therapies., Competing Interests: Declaration of conflicting interests:The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2019.)

The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS 2 score ≥2 or a CHA 2 DS 2 -VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Periprocedural imaging assessment for percutaneous Left Atrial Appendage (LAA) transcatheter occlusion can be obtained by utilizing different imaging modalities including fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), and ultrasound imaging. Given the complex and variable morphology of the left atrial appendage, it is crucial to obtain the most accurate LAA dimensions to prevent intra-procedural device changes, recapture maneuvers, and prolonged procedure time. We therefore sought to examine the accuracy of the most commonly utilized imaging modalities in LAA occlusion. Institutional Review Board (IRB) approval was waived as we only reviewed published data. By utilizing PUBMED which is an integrated online website to list the published literature based on its relevance, we retrieved thirty-two articles on the accuracy of most commonly used imaging modalities for pre-procedural assessment of the left atrial appendage morphology, namely, two-dimensional transesophageal echocardiography, three-dimensional transesophageal echocardiography, computed tomography, and three-dimensional printing. There is strong evidence that real-time three-dimensional transesophageal echocardiography is more accurate than two-dimensional transesophageal echocardiography. Three-dimensional computed tomography has recently emerged as an imaging modality and it showed exceptional accuracy when merged with three-dimensional printing technology. However, real time three-dimensional transesophageal echocardiography may be considered the preferred imaging modality as it can provide accurate measurements without requiring radiation exposure or contrast administration. We will present the most common imaging modality used for LAA assessment and will provide an algorithmic approach including preprocedural, periprocedural, intraprocedural, and postprocedural.

Patients with prior coronary artery bypass grafting (CABG) represent a high-risk cohort given associated medical conditions and worse outcome of saphenous vein graft compared with native vessel percutaneous coronary intervention (PCI). The goal of the current analysis was to compare clinical outcomes in 591 patients with and without prior CABG and multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function underwent Impella supported PCI from the PROTECT II randomized trial and the cVAD Registry. Patients with prior CABG surgery (n = 201) were compared with those without prior CABG surgery (n = 390). The primary end point of this analysis was overall mortality at 30 days. Patients with prior CABG surgery had greater Society of Thoracic Surgery mortality score compared with patients without prior CABG surgery, 7.6 ± 6.4 versus 5.1 ± 5.5, respectively, p <0.001. Saphenous vein graft PCI was performed in 17% of patients with prior CABG surgery. Number of vessels treated was lower in patients with prior CABG surgery compared with patients without prior CABG surgery, 1.66 ± 0.56 versus 1.89 ± 0.64, respectively, p <0.001. Achievement of TIMI 3 flow post PCI and overall PCI success was similar in the two groups. Overall mortality at 30 days was similar in patients with prior CABG surgery compared with patients without prior CABG surgery, 6.75% versus 6.61%, respectively, p = 1.0. In conclusion, in this high-risk cohort of patients underwent hemodynamically supported PCI, prior CABG surgery was not associated with worse outcome. The use of hemodynamic support appears to mitigate the increased risk of PCI associated with prior CABG., (Copyright © 2018. Published by Elsevier Inc.)

Background: In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation., Methods: We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA 2 DS 2 -VASC and HAS-BLED scores., Results: Of 1739 patients who received an implant (7159 patient-years follow-up; CHA 2 DS 2 -VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90-5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26-4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19-4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08-3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01-1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94-0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT., Conclusions: After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism.

Background: The Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices., Methods and Results: From January 2009 to December 2016, 46,949 patients from 1010US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0-100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P<.0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P<.001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P<.0001). Overall institutional Impella volume was related to survival (56% survival at sites with >7/year vs. 51% at sites with ≤1; P<.001)., Conclusions: In this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study., Methods: The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline., Results: There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year., Conclusions: Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory support devices, there is a need for continued surveillance of outcomes. Three factors underline the importance of a registry for these populations. First, large randomized trials of hemodynamic support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide "real-world" experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical support treatment of cardiogenic shock. The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices. Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance. This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide., Condensed Abstract: The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood., Objectives: This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura., Methods: The PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura., Results: Of 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (-3.4 vs. -2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01)., Conclusions: PFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To assess post-procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention (PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS)., Background: Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized., Methods: Thirty-six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study., Results: The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre-PCI group (n = 20) and Post-PCI group (n = 16). Non-ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre-PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan-Meier 30-day survival analysis showed very poor survival in Post-PCI group (48.1% vs 12.5%, Log-Rank P = 0.004)., Conclusions: Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days., (© 2017, Wiley Periodicals, Inc.)

Background: End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined., Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year., Results: Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm 2 , mean gradient 9.33 mm Hg) CONCLUSIONS: Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk., Methods: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement., Results: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group., Conclusions: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) are not well understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device; 287 consecutive unselected patients enrolled in the catheter-based ventricular assist device registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66 ± 12.5 years, 76% were men, and mean left ventricular ejection fraction was 25 ± 12%. Before receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump; 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis, early implantation of a MCS device before PCI (p = 0.04) and before requiring inotropes and vasopressors (p = 0.05) was associated with increased survival. Survival was 66% when MCS was initiated <1.25 hours from shock onset, 37% when initiated within 1.25 to 4.25 hours, and 26% when initiated after 4.25 hours (p = 0.017). Survival was 68%, 46%, 35%, 35%, and 26% for patients requiring 0, 1, 2, 3, and ≥4 inotropes before MCS support, respectively (p <0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and before PCI, is independently associated with improved survival in patients presenting with AMICS., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk., Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR., Design, Setting, and Participants: The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors., Interventions: Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR., Main Outcomes and Measures: We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less., Results: The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P < .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28)., Conclusions and Relevance: Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk., Trial Registration: Clinicaltrials.gov Identifier: NCT01240902.

Background: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread., Methods and Results: Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke., Conclusions: Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR., Clinical Trial Registrations: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374., (© 2016 American Heart Association, Inc.)

Background: Multidetector computed tomography is useful for determining the appropriate transcatheter heart valve (THV) size in patients with severe aortic stenosis who are suboptimal surgical candidates. The relationship between adherence to the recommended CoreValve sizing algorithm and clinical outcomes is not known., Methods and Results: We evaluated 1023 patients with severe aortic stenosis deemed high or extreme risk for surgery treated with the CoreValve THV. All patients underwent preprocedural multidetector computed tomography, and the scans were reviewed at a central analysis center using standardized software. Compliance to a recommended sizing algorithm was used to identify patients with below-range, in-range, and above-range THV sizing. A device annular sizing ratio (DAR) was also calculated based on the native annulus perimeter and perimeter of the selected THV. Clinical end points included the presence of paravalvular aortic regurgitation evaluated by an independent echocardiographic laboratory. Adherence to the sizing algorithm was highest with a 31-mm THV (92.6%) and lowest with the 23-mm THV (38.5%). Below-range sizing was associated with a higher rate of moderate or severe paravalvular aortic regurgitation (15.3%) than in-range (6.5%) or above-range (10.0%; P<0.001) sizing. Higher DARs were associated with lower rates of moderate or severe paravalvular aortic regurgitation: DAR ≤10%, 17.6%; DAR 10% to 15%, 9.9%; DAR 15% to 20%, 6.3%; and DAR >20%, 4.9%; P<0.001. There was no increase in clinical events associated with higher DARs., Conclusions: Adherence to a sizing algorithm guided by multidetector computed tomography resulted in lower rates of paravalvular aortic regurgitation after self-expanding transcatheter valve replacement without an increase in complications., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902., (© 2016 American Heart Association, Inc.)

Background: In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery., Objectives: This study sought to determine whether this clinical benefit was sustained over time., Methods: Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure., Results: A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group., Conclusions: Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve(®) System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis., Objectives: Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained., Methods: Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients., Results: A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01)., Conclusions: In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

As interventional procedures in structural heart diseases are coming of age, there is a significant lag in the periinterventional imaging development for these procedures to become safe, expedient, accurate, and well tolerated by this patient population. Currently, transesophageal echocardiography (TEE), including real-time three-dimensional (RT-3D), has been used for monitoring and guidance for these procedures. Accurate identification of the pathology, its anatomy, and its relationship with the adjoining structures along with spatial resolution is of paramount importance for wire and catheter placement, device deployment, evaluation of the results, and any potential complications. Two-dimensional intracardiac echocardiography (ICE) has been used extensively for a variety of interventional procedures that undergo conscious sedation of monitored anesthesia. RT-3D ICE has recently become available; we describe our initial experience with this new imaging technology.

Objectives: The CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access., Methods: The present study included 150 patients with prohibitive iliofemoral anatomy who were treated with the CoreValve transcatheter heart valve delivered by way of the subclavian artery (n = 70) or a direct aortic approach (n = 80). The echocardiograms were read by an independent core laboratory. The primary endpoint was all-cause mortality or major stroke at 12 months., Results: The preoperative aortic valve area was 0.72 ± 0.27 cm(2) and mean aortic valve gradient was 49.5 ± 17.0 mm Hg. After the transcatheter aortic valve replacement, the effective aortic valve area was 1.82 ± 0.64 cm(2) at 1 month and 1.85 ± 0.51 cm(2) at 12 months. The mean aortic valve gradient was 9.7 ± 5.8 mm Hg at 30 days and 9.5 ± 5.7 mm Hg at 12 months. The death or major stroke rate was 15.3% at 30 days and 39.4% at 12 months. The individual rate of all-cause mortality and major stroke was 11.3% and 7.5% at 30 days and 36.0% and 9.1% at 12 months., Conclusions: These data demonstrate that the CoreValve transcatheter heart valve delivered by an alternative access provides a suitable alternative for treatment of extreme risk patients with symptomatic severe aortic stenosis, who have prohibitive iliofemoral anatomy and no surgical options., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

This article systematically appraises the findings and conclusions derived from six recent studies of the economic impact and relative value of using percutaneous ventricular assist devices to render short-term hemodynamic support to high-risk patients with particular attention to the settings of cardiogenic shock and percutaneous coronary interventions. Although the extant body of literature is still growing, these studies offer evidence and insight regarding the health economics of traditional and emerging technologies in this treatment domain, and generally find the latter to be cost-effective in the long term. As the incidence of heart disease rises and the attendant economic burden of healthcare climbs, technologies for mitigating cardiovascular illness will be the target for more robust empirical evidence to justify the comparative value of minimally invasive hemodynamic support interventions in the armamentarium of treatment options available to physicians.

Background: We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery., Methods: We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing., Results: A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke., Conclusions: In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).

Unlabelled: This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives., Background: Previous research has demonstrated the cost-effectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS)., Methods: National utilization and outcome data from the 2010-2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n = 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n = 305)., Results: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, P < 0.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, P = 0.055) and a significantly lower cost of the index admission ($90,929 and $144,257, respectively, P < 0.001). Cost-effectiveness analysis based on the national data demonstrated that pVAD achieved improved outcomes at lower cost. Data were also collected for similar patients who underwent protocol-guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (n = 30). At this site, the survival rate increased to 60%, length of hospitalization was shortened to 6 days, and admission costs were lowered to $53,850 relative to the surgical alternatives strategy., Conclusions: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost, and a survival benefit when compared with traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI)., Background: Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized., Methods: Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients' hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality., Results: Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17-0.79, P = 0.01) in multivariate analysis. The incidence of in-hospital complications included in the secondary end-point was similar between the 2 groups., Conclusions: The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI., (© 2013 The Authors. Journal of Interventional Cardiology published by Wiley Periodicals, Inc.)

Background: Coronary revascularization is associated with no-reflow phenomenon and elevation of cardiac biomarkers. This may occur due to plaque modification. We used near-infrared spectroscopy (NIRS) to evaluate lipid core plaque (LCP) modification with coronary revascularization and its correlation with periprocedural myocardial infarction., Methods: Patients presenting to the cardiac catheterization laboratory who underwent NIRS, NIRS/intravascular ultrasound (IVUS) were reviewed and their lipid core burden index (LCBI) was assessed. Using fuzzy c-means clustering algorithm, the coronary was divided into three zones and the lipid burden was recalculated. Its correlation to postprocedure troponin elevation and outcomes with a mean follow-up of 42 months were studied., Results: A total of 77 coronaries were evaluated. There was an overall decrease in the LCBI after percutaneous revascularization (P<.0001). Using fuzzy c-means clustering algorithm, there was always a decrease in the lipid burden at the site of the percutaneous revascularization (P<.0001). Postprocedure troponin elevation was only noted in patients with an axial shifting of the LCP. There was no difference in long-term outcomes due to the degree of reduction of lipid burden or its axial., Conclusions: Plaque modification may be performed successfully using interventional methods and can be evaluated with NIRS. Axial plaque shifting is an acute prognostic marker for postprocedure myocardial infarction.