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Background: The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time., Aims: This study aimed to examine whether these changes impacted clinical outcomes., Methods: EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+ SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared., Results: Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43)., Conclusion: During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV., (© 2024 Wiley Periodicals LLC.)

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/purpose: The cusp overlap technique has standardized implantation for self-expanding valves with the goal of achieving more consistent implantation depths and lowering permanent pacemaker (PPM) implantation rates. We retrospectively compared short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve implanted using the cusp overlap technique vs. the traditional coplanar technique in a large tertiary referral center., Methods: We conducted a retrospective study among PPM-naïve patients who underwent TAVR using the CoreValve Evolut PRO/PRO+. We compared in-hospital PPM rates in patients who underwent TAVR using the cusp overlap technique vs. the coplanar technique. Additional outcomes included in-hospital all-cause mortality, stroke, major vascular complications, annular rupture, and >mild paravalvular leak. Furthermore, we compared outcomes over time to see whether there was evidence of a learning curve., Results: Of the 528 patients included, 270 underwent TAVR using the coplanar technique and 258 underwent TAVR using the cusp overlap technique. The rate of new PPM implantation did not differ between cohorts (17.0 % vs. 16.7 %; p = 0.910). Additionally, rates of in-hospital all-cause mortality (0.0 % vs. 0.4 %; p = 0.328), stroke (3.7 % vs. 1.6 %; p = 0.124), major vascular complications (0.7 % vs. 1.2 %; p = 0.617), annular rupture (0.4 % vs. 0.0 %; p = 0.328) and >mild paravalvular leak (0.0 % vs. 0.4 %; p = 0.444) were similar. Our secondary analysis did not identify any evidence of a learning curve., Conclusions: The cusp overlap technique may not yield a reduction in PPM rates when compared with the coplanar technique. Other confounders should be explored to further minimize in-hospital PPM rates., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Consultant: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott; Advisory board: Medtronic, Boston Scientific; Equity: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, and Transmural Systems Inc.; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no conflicts of interest to declare., (Copyright © 2023. Published by Elsevier Inc.)

Subclinical leaflet thrombosis occurs with transcatheter heart valves (THVs) and could be associated with structural valve deterioration. The current guidelines recommend the use of antiplatelet agents after transcatheter aortic valve replacement (TAVR) but not the routine use of oral anticoagulation. Our study examines the effects of short-term warfarin therapy on THV hemodynamics at 24 months after TAVR in low-risk patients. Low-risk patients who underwent TAVR were randomly allocated 1:1 to receive low-dose aspirin (n = 50) or low-dose aspirin plus warfarin (n = 44). After 30 days of treatment, ongoing medication regimens, including anticoagulation, were at the physicians' discretion. Follow-up after a period of 24 months was available for clinical and echocardiographic outcomes. At the 24-month mark, follow-up echocardiography of the randomly allocated patients revealed just 1 additional case of new structural valve deterioration in the aspirin group (compared with the occurrence within 30 days), based on the Valve Academic Research Consortium 3 definitions. There were also no differences in mean pressure gradients (11.5 ± 0.5 mm Hg vs 11.05 ± 4.0 mm Hg, p = 0.6) or peak velocity (2.2 ± 0.5 m/s vs 2.1 ± 0.4 m/s, p = 0.7) between the groups. A composite end point (mortality, stroke, and myocardial infarction) did not show any difference between the groups at long-term follow-up (p = 0.07). In conclusion, in low-risk patients who underwent TAVR, short-term anticoagulation with warfarin did not impact clinical outcomes or THV hemodynamics by echocardiography at 24 months., Competing Interests: Declaration of Competing Interest Dr. Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; on the advisory board for Medtronic and Boston Scientific; has equity in Transmural Systems; owns intellectual property as a co-inventor on patents, assigned to the NIH. Dr. Weissman is a director of an academic cardiac CT core laboratory with institutional contracts with Ancora Heart and LivaNova. Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, and Transmural Systems Inc., receiving institutional grant support from Amgen, Biotronik, Boston Scientific, and Philips IGT; and being an investor in MedAlliance and Transmural Systems. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being 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; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no conflicts of interest to declare.

Surgical aortic valve replacement (SAVR) remains the standard of care for patients with chronic severe aortic regurgitation (AR). The introduction of a dedicated transcatheter heart valve for AR has fueled interest in using transcatheter aortic valve replacement to treat patients with isolated AR. We aimed to characterize the profile and outcomes of patients with symptomatic severe AR who underwent isolated SAVR. We conducted a retrospective, observational study of patients who underwent isolated SAVR for symptomatic severe AR at our institution. The primary outcome was in-hospital all-cause mortality. Patients were followed up with 30-day clinical and echocardiographic assessment. A total of 979 patients who underwent SAVR for severe AR between January 2015 and June 2021 were screened for eligibility, of whom 112 patients (11.4%) underwent isolated SAVR for symptomatic severe AR and were included in this analysis. Approximately 25% of patients were deemed to be at intermediate or high risk (n = 26 of 112). The primary outcome occurred in 2.7% of patients (n = 3 of 112). In-hospital stroke occurred in 2.7% of patients (n = 3 of 112), and new-onset atrial fibrillation occurred in 32.1% (n = 36 of 112). At 30-day follow-up, all-cause mortality occurred in 3.6% of patients (n = 4 of 112), and 0.8% (1 of 112) had >mild AR. In conclusion, in a tertiary referral center, the number of patients who underwent isolated SAVR for pure AR represented a small fraction of the overall SAVR patients. The vast majority were low risk and younger when compared with patients with severe aortic stenosis. SAVR yielded excellent short-term mortality and echocardiographic improvements., Competing Interests: Disclosures Dr. Rogers reports being a proctor and consultant for Medtronic and Edwards Lifesciences; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc. Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being 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; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in Med Alliance and Transmural Systems Inc. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: Evaluate transcatheter heart valve (THV) geometry according to left ventricular outflow tract (LVOT) calcium degree and its impact on hemodynamics and outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a contemporary self-expanding THV., Background: LVOT calcium remains challenging for contemporary THVs. LVOT calcium location and degree may affect THV deployment and impact flow patterns and shear stress, accelerating THV degeneration., Methods: EPROMPT (CoreValve Evolut Pro Prospective Registry; NCT03423459) is a prospective, investigator-initiated, multicenter registry of patients undergoing TAVR using CoreValve Evolut PRO/PRO + THVs. A total of 107 patients were enrolled in EPROMPT's computed tomography (CT) cohort between January 2018 and October 2021. These patients underwent follow-up CT scan 30 days post-TAVR. We analyzed THV geometry and its interaction with the aortic root following deployment using 30-day post-TAVR CT in patients with none/mild versus moderate/severe LVOT calcium., Results: Thirty-day THV inflows were less eccentric in the short axis in patients with none/mild versus moderate/severe LVOT calcium (1.16 ± 0.09 vs. 1.21 ± 0.12; p = 0.007). THV became more circular and was similar between both cohorts at the THV waist (1.08 ± 0.06 vs. 1.09 ± 0.11; p = 0.551), leaflet tips (1.03 ± 0.04 vs. 1.05 ± 0.09; p = 0.299), and THV outflow (1.04 ± 2.2 vs. 1.03 ± 2.7; p = 0.143). Thirty-day > mild paravalvular leak was low in both cohorts (1.5% vs. 2.4%; p = 0.724); mean gradients were similar (7.7 ± 3.6 vs. 7.7 ± 3.4 mmHg; p = 0.955)., Conclusions: Despite inflow deformities observed in patients with moderate/severe LVOT calcium, Evolut PRO/PRO + conforms to elliptical aortic annuli, maintaining circularity and proper function at the leaflets and outflow, even in patients with moderate/severe LVOT calcium., (© 2022 Wiley Periodicals LLC.)

Background: Given enough time, transcatheter heart valves (THVs) will degenerate and may require reintervention. Redo transcatheter aortic valve implantation (TAVI) is an attractive strategy but carries a risk of coronary obstruction., Aims: We sought to predict how many TAVIs patients could undergo in their lifetime using computed tomography (CT) simulation., Methods: We analysed paired CT scans (baseline and 30 days post-TAVI) from patients in the LRT trial and EPROMPT registry. We implanted virtual THVs on baseline CTs, comparing predicted valve-to-coronary (VTC) distances to 30-day CT VTC distances to evaluate the accuracy of CT simulation. We then simulated implantation of a second virtual THV within the first to estimate the risk of coronary obstruction due to sinus sequestration and the need for leaflet modification., Results: We included 213 patients with evaluable paired CTs. There was good agreement between virtual (baseline) and actual (30 days) CT measurements. CT simulation of TAVI followed by redo TAVI predicted low coronary obstruction risk in 25.4% of patients and high risk, likely necessitating leaflet modification, in 27.7%, regardless of THV type. The remaining 46.9% could undergo redo TAVI so long as the first THV was balloon-expandable but would likely require leaflet modification if the first THV was self-expanding., Conclusions: Using cardiac CT simulation, it is possible to predict whether a patient can undergo multiple TAVI procedures in their lifetime. Those who cannot may prefer to undergo surgery first. CT simulation could provide a personalised lifetime management strategy for younger patients with symptomatic severe aortic stenosis and inform decision-making., Clinicaltrials: gov: NCT02628899; ClinicalTrials.gov: NCT03557242; ClinicalTrials.gov: NCT03423459.

New-onset left bundle branch block (NLBBB) is the most common complication after transcatheter aortic valve implantation (TAVI). Expert consensus recommends temporary transvenous pacemaker (TTVP) support for 24 hours in these patients. To date, no study has examined TTVP use during the index hospitalization in detail. Therefore, we aimed to assess TTVP use in patients with TAVI who developed NLBBB. In this prospective observational study, we performed a detailed analysis of 24-hour telemetry in patients who developed NLBBB during TAVI. Baseline characteristics and procedural and postprocedural data were recorded. The primary outcome was pacing by the TTVP. We evaluated inappropriate TTVP use, electrophysiology study findings, permanent pacemaker (PPM) implantation, and NLBBB resolution. A total of 83 patients (74.4 ± 8.7 years, 41% female) developed NLBBB during TAVI. During index hospitalization, 1 patient (1%) required TTVP because of complete heart block and received a PPM. Five of the 83 (6%) patients were inappropriately paced, and 1 patient (1%) had ventricular fibrillation, likely secondary to TTVP. A total of 34 patients (41%) underwent electrophysiology study during hospitalization, with 4 of 83 (5%) subsequently receiving a PPM. One (1%) patient died during hospitalization, and 9 patients were lost to follow-up because of the COVID-19 pandemic. Of the remaining 73 patients with a 30-day follow-up, NLBBB had resolved in 36 (49%) at 30 days, and 2 (3%) were readmitted with complete heart block and received PPM. In conclusion, in patients with TAVI who develop NLBBB, temporary pacing is rarely necessary, may carry additional risks to the patient, and prolong hospitalization time., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Studies have reported worse outcomes after transcatheter aortic valve implantation (TAVI) in women receiving early generation transcatheter heart valves (THVs). They have smaller aortic annuli, which could result in higher gradients and more patient-prosthesis mismatch (PPM) after TAVI. We investigated the interactions between contemporary THV hemodynamics and outcomes in women who underwent TAVI. We conducted a retrospective, observational study of patients who underwent contemporary TAVI from 2015 to 2020. We compared baseline characteristics, in-hospital outcomes, and hemodynamics according to sex. We then dichotomized women according to aortic annular area (<430 or ≥430 mm 2 ). Included were 869 patients who underwent TAVI with the SAPIEN 3 or CoreValve Evolut PRO/PRO+. Most patients with small annuli were female (82.5%). They had nonsignificantly higher mortality (30-day: 1.5% vs 0.6%, p = 0.313; 1-year: 4.1% vs 2.7%, p = 0.265). Those who received self-expanding THVs had lower gradients (8.0 mm Hg vs 13.8 mm Hg, p <0.001), resulting in less moderate PPM (21.2% vs 73.6%, p <0.001), similar severe PPM (19.5% vs 15.3%, p = 0.454), and higher rates of pacemaker implantation (14.4% vs 4.2%, p = 0.009). Women with small annuli who received a balloon-expandable THV had nonsignificantly higher mortality (30-day: 2.1% vs 0.8%, p = 0.631; 1-year: 6.3% vs 1.7%, p = 0.118). In conclusion, women who underwent contemporary TAVI had nonsignificantly higher mortality, which could be due to higher PPM rates. These findings were more pronounced in the subset of women with small annuli, in whom those who received self-expanding THVs demonstrated superior hemodynamics at the cost of increased rates of pacemaker implantation., Competing Interests: Disclosures Dr. Rogers is a proctor and consultant at Medtronic and Edwards Lifesciences; is a member of the advisory board of Medtronic; and has equity interest in Transmural Systems. Dr. Waksman is a member of the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; is a consultant to Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receives grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; is a member of the speakers bureau of AstraZeneca; and is an investor in MedAlliance and Transmural Systems Inc. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Despite advances in transcatheter aortic valve replacement (TAVR) technology, periprocedural stroke remains a complication of TAVR procedures. The TriGUARD 3 device is designed to be positioned in the aortic arch to deflect debris away from the brachiocephalic, left common carotid, and left subclavian arteries during TAVR. The United States Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel to review safety and effectiveness data for the TriGUARD 3 device. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we summarize the data presented by both the sponsor and FDA, as well as the panel discussion., (© 2022 Wiley Periodicals LLC.)

Left ventricular outflow tract (LVOT) calcium remains a challenge for transcatheter aortic valve implantation (TAVI) and is associated with an increased risk of debris embolization, permanent pacemaker requirement, and annular rupture. We report the results of the (EPROMPT) CoreValve Evolut PRO Prospective Registry, which sought to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter heart valve (THV) according to computed tomography-defined extent of LVOT calcium. The prospective, investigator-initiated, multicenter registry includes patients who underwent TAVI using the CoreValve Evolut PRO/PRO+ THV system. Analyzed patients were dichotomized on the basis of the severity of their LVOT calcium at baseline (none/mild vs moderate/severe). Patients were followed with 30-day clinical assessment and echocardiography. Of the 277 patients included, 177 had computed tomography-defined none/mild LVOT calcium (63.9%), and 100 had moderate/severe LVOT calcium (36.1%). Device success was similar in both cohorts (97.7% vs 95.0%; p = 0.217). Stroke rates were numerically higher in the moderate/severe LVOT calcium cohort (in-hospital and 30 day: 1.7% vs 4.0%; p = 0.240). Patients with none/mild LVOT calcium had higher rates of permanent pacemaker implantation (in-hospital: 21.5% vs 9.0%; p = 0.008 and 30-day: 22.0% vs 12.0%; p = 0.027). At 30 days, there were numerically higher rates of >mild paravalvular leak in patients with moderate/severe LVOT calcium (1.7% vs 4.0%; p = 0.240). Thirty-day mean gradients were similar (7.5 vs 7.6 mm Hg; p = 0.782). In conclusion, patients in the EPROMPT registry receiving the contemporary self-expanding CoreValve Evolut PRO/PRO+ THV demonstrated similar short-term outcomes and hemodynamics across the entire spectrum of LVOT calcium., Competing Interests: Disclosures Dr. Rogers declares the following positions: proctor and consultant for Medtronic, Edwards Lifesciences; advisory board for Medtronic; and equity interest for Transmural Systems. Dr. Wang declares the following positions: consultant for Edwards Lifesciences; speaker and consultant for Boston Scientific; and consultant for Cordis. Dr. Weissman has no personal disclosure and declares the following position: director of an academic cardiac CT core lab with institutional contracts with Boston Scientific, Abbott, Medtronic, Ancora Heart, LivaNova, and Neovasc. Dr. Waksman declares the following positions: advisory board for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; 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; speakers bureau for AstraZeneca; and investor in MedAlliance and Transmural Systems Inc. Dr. Waksman also receives grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT. The remaining authors have no conflicts of interest to declare., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients., Background: PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking., Methods: We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee., Results: We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care., Conclusions: PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR., (© 2021 Wiley Periodicals LLC.)

Background: We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses., Materials/methods: We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable., Results: We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99-1.02)., Conclusions: TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR., (Copyright © 2021. Published by Elsevier Inc.)

Background: Most pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials., Methods: We selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model., Results: Included were 3 Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials that enrolled a total of 1810 low-risk patients with symptomatic severe AS for TAVR. We compared 380 bicuspid patients with 1430 tricuspid patients. Event rates at 30 days overall were low, with similar mortality (odds ratio [OR], 0.38; 95% credible interval [CrI]: 0.08, 1.78; I 2 , 0%), non-disabling stroke (OR, 0.45; 95% CrI: 0.15, 1.07; I 2 , 9%), and permanent pacemaker implantation (OR, 0.86; 95% CrI: 0.41, 1.47; I 2 , 59%). There were statistically significant differences in disabling stroke (OR, 0.16; 95% CrI: 0.01, 0.90; I 2 , NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days., Conclusions: Preliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Background: Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS)., Methods: The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS., Results: A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year., Conclusion: Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies., Trial Registry: NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. Puja Parikh – Consultant: Medtronic, Inc. Federico Asch – No personal disclosures. Director of the MedStar Health Academic Echocardiography Core Laboratory which has institutional contracts with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Biotronik and LivaNova. Gaby Weissman – No personal disclosures. Director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

All bioprosthetic valves, both surgical and transcatheter, have a finite lifespan before their leaflets inevitably degenerate, leading to stenosis or regurgitation. As younger, low-risk patients receive a transcatheter aortic valve, it is expected that they will most likely outlive their bioprosthetic valve. The heterogeneity of studies regarding surgical valve durability makes the interpretation of the data challenging. Leaflet thickening is seen in transcatheter heart valves but currently there is no evidence that it leads to premature valve deterioration or clinical events. Standardized definitions of structural valve deterioration should allow for comparisons between future clinical trials to assess the durability of different transcatheter heart valves., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR)., Background: The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse., Methods: This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality., Results: We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications., Conclusions: In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations., (© 2021 Wiley Periodicals LLC.)

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

The rationale for dual antiplatelet therapy (DAPT) after transcatheter aortic valve implantation (TAVI) is to facilitate endothelialization of metallic struts of the transcatheter heart valve and to prevent thrombosis that could lead to thromboembolic events. Based on expert consensus, current societal guidelines recommend DAPT for 1 to 6 months after TAVI with weak evidence. Although the pivotal TAVI trials mandated this regimen, the evidence for the efficacy of DAPT to prevent transcatheter heart valve thrombosis is limited to 3 small trials and a handful of observational studies. Multiple coronary trials have demonstrated that DAPT is associated with increased bleeding in comparison with single antiplatelet therapy, especially in elderly patients. TAVI patients are predominantly elderly and frequently have risk factors that predispose them to bleeding. Herein, we summarize the evidence for antiplatelet therapy after TAVI and explore the theoretical benefit of DAPT to prevent thromboembolic events versus the risk of increased bleeding., Competing Interests: Disclosures Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance.; Gary S. Mintz – Honoraria from Boston Scientific, Philips, Terumo, and Medtronic; Toby Rogers – Consultant and proctor: Medtronic, Edwards Lifesciences; Advisory board: Medtronic. Equity interest: Transmural Systems. All other authors – None., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to investigate whether the degree of aortic angulation (AA) affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation transcatheter heart valves (THVs)., Background: AA ≥48° has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with early generation self-expanding (SE) THVs., Methods: A retrospective observational study was conducted among 841 patients across all risk strata who underwent transfemoral TAVR using the balloon-expandable (BE) SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020. The previously published cutoff of 48° was used to analyze procedural success and in-hospital outcomes according to THV type. Receiver-operating characteristic analysis was performed to investigate the impact of AA on an in-hospital composite outcome (need for >1 THV, more than mild PVL, new permanent pacemaker implantation, stroke, and death)., Results: AA ≥48° did not influence outcomes in patients with BE THVs. Additionally, AA ≥48° did not influence procedural success (99.1% vs. 99.1%; p = 0.980), number of THVs used (1.02 vs. 1.04; p = 0.484), rates of more than mild PVL (0.4% vs. 0%; p = 0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p = 0.178), in-hospital stroke (3.9% vs. 1.8%; p = 0.298), or in-hospital death (0.4% vs. 0.9%; p = 0.980) in patients with SE THVs. Receiver-operating characteristic analysis demonstrated similar outcomes irrespective of AA, with areas under the curve of 0.5525 for SE THVs and 0.5115 for BE THVs., Conclusions: AA no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice. AA ≥48° did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection., Competing Interests: Funding Support and Author Disclosures Dr. Rogers is a proctor and consultant for Medtronic and Edwards Lifesciences; is an advisory board member for Medtronic; and holds equity interest in Transmural Systems. Dr. Waksman is an advisory board member for Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; is a consultant for Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, Pi-Cardia, and Transmural Systems; has received grant support from AstraZeneca, Biotronik, Boston Scientific, and Chiesi; is a Speakers Bureau member for AstraZeneca and Chiesi; and is an investor in MedAlliance and Transmural Systems. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (<65 years), low-risk patients. Unanswered questions remain, including the safety and effectiveness of TAVR in patients with bicuspid aortic valves; future coronary access; durability of transcatheter heart valves; technical considerations for surgical transcatheter heart valve explantation; management of concomitant conditions such as aortopathy, mitral valve disease, and coronary artery disease; and the safety and feasibility of future TAVR-in-TAVR. The authors predict that balancing these questions with patients' clear preference for less invasive treatment will become common. In this paper, the authors consider each of these questions and discuss risks and benefits of theoretical treatment strategies in the lifetime management of young patients with severe aortic stenosis., Competing Interests: Funding Support and Author Disclosures Dr. Waksman is an advisory board member for Amgen, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; is a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; has received grant support from AstraZeneca, Biotronik, Boston Scientific, and Chiesi; is on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in MedAlliance. Dr. Rogers is an advisory board member for Medtronic; is a consultant and proctor for Edwards Lifesciences and Medtronic; and holds equity interest in Transmural Systems. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background/purpose: Despite the high prevalence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS), the optimal management of concomitant CAD, including revascularization before transcatheter aortic valve replacement (TAVR), remains controversial. Contemporary, real-world practice patterns have not yet been described. We aimed to characterize the burden of CAD in contemporary TAVR patients and evaluate revascularization practices at a high-volume center., Methods/materials: We retrospectively analyzed all adult patients referred for TAVR at our center between January 2019 and January 2020. Presence of significant CAD and subsequent management were recorded. Presenting symptoms, use of non-invasive and invasive ischemia testing, and pre-TAVR computed tomography (CT) imaging were analyzed., Results: A total of 394 patients with severe AS were referred for TAVR. Thirty-nine patients (9.9%) instead underwent surgery, of whom only 5 (1.3%) received coronary artery bypass grafting. Of the remaining 355 patients, 218 patients (61.4%) had insignificant CAD. Of the 137 patients (38.6%) with significant CAD, only 30 (8.5%) underwent percutaneous coronary intervention (PCI). Of these, less than half had anginal symptoms, a third had CAD in proximal segments, and a third underwent ischemia testing before PCI. Pre-TAVR CT accurately identified significant CAD in 28/30 patients (93.3%) who underwent PCI., Conclusions: Only 1 in 25 contemporary TAVR patients had significant CAD and angina requiring intervention, calling into question the utility of routine invasive coronary angiography before TAVR. A Heart Team approach integrating anginal symptoms, ischemia testing and possibly pre-TAVR CT is needed to guide the need, timing, and strategy of revascularization., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. All other authors – None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has evolved toward a minimalist approach, resulting in shorter hospital stays. Real-world trends of next-day discharge (NDD) TAVR are unknown. This study aimed to evaluate underlying trends and readmissions of NDD TAVR., Methods: This study was derived from the Nationwide Readmissions Database from 2012 to 2016. International Classification of Diseases, Ninth and Tenth Revisions, codes were used to identify patients. Any discharge within 1 day of admission was identified as NDD. NDD TAVR trends over the years were analyzed, and any admissions within 30 days were considered readmissions. A hierarchical logistic regression model was used to identify predictors of readmission., Results: Of 49,742 TAVR procedures, 3,104 were NDD. The percentage of NDD TAVR increased from 1.5% (46/3,051) in 2012 to 12.2% (2,393/19,613) in 2016. However, the 30-day readmission rate remained the same over the years (8.6%). The patients' mean age was 80.3 ± 8.4 years. Major readmission causes were heart-failure exacerbation (16%), infections (9%), and procedural complications (8%). In 2016, there were significantly higher late conduction disorder and gastrointestinal bleeding readmission rates than in 2012-2015. Significant predictors of readmission were anemia, baseline conduction disease, cardiac arrhythmias, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, neoplastic disorders, and discharge to facility., Conclusions: The percentage of NDD TAVR increased over the years; however, readmission rates remained the same, with a higher rate of conduction abnormality-related hospitalizations in 2016. Careful discharge planning that includes identification of baseline factors that predict readmission and knowledge of etiologies may further prevent 30-day readmissions., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The supra-annular leaflet position and tall stent frame of the self-expanding Evolut PRO or Evolut PRO+ transcatheter heart valves (THVs) may cause coronary occlusion during transcatheter aortic valve replacement (TAVR)-in-TAVR and present challenges for future coronary access. We sought to evaluate the risk of TAVR-in-TAVR with Evolut PRO or Evolut PRO+ THVs and the feasibility of future coronary access., Methods: The CoreValve Evolut PRO Prospective Registry (EPROMPT; NCT03423459) prospectively enrolled patients with symptomatic severe aortic stenosis to undergo TAVR using a commercially available latest generation self-expanding THV at 2 centers in the United States. Computed tomography was performed 30 days after TAVR, which we used to simulate TAVR-in-TAVR with a second Evolut PRO or Evolut PRO+ THV and evaluate for risk of coronary obstruction and feasibility of future coronary access., Results: Eighty-one patients enrolled with interpretable computed tomography are reported herein. Computed tomography simulation predicted sinus of Valsalva sequestration and resultant coronary obstruction during future TAVR-in-TAVR in up to 23% of patients. Computed tomography simulation predicted that the position of the pinned THV leaflets would hinder future coronary access in up to 78% of patients after TAVR-in-TAVR., Conclusions: Further THV design improvements and leaflet modification strategies are needed to mitigate the risk of coronary obstruction during TAVR-in-TAVR with self-expanding THVs and to facilitate future coronary access. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03423459.

Background/purpose: The Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture and remove embolic material during transcatheter aortic valve procedures and was approved by the US Food and Drug Administration (FDA) in 2017. Robust data on the most commonly reported complications and modes of failure associated with the Sentinel device are limited., Methods/materials: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports., Results: Of the 43 reports of major complications involving Sentinel devices, 23 involved either death (3) or injury (20) related to the device. The 3 deaths were due to stroke, while 18 of the 20 injuries were reported as stroke. The other 20 reports were related to device modes of failure. Modes of failure were due to damaged device (5), difficulty retrieving/resheathing the device (5); package contamination (4), difficulty deploying the device (3), and, finally, complications with preparation (3)., Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, the Sentinel Cerebral Protection System may be associated with complications, including death, stroke, vascular injury, and difficulties with the device itself. The MAUDE database serves as an important tool for both physicians and manufacturers to optimize performance and clinical outcomes., Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Toby Rogers – Consultant and Proctor Medtronic; Proctor: Edwards Lifesciences. Jaffar M. Khan – Proctor: Medtronic; Proctor: Edwards Lifesciences. All other authors: None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background/purpose: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania).Methods/materials: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports.Results: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1).Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD. [ABSTRACT FROM AUTHOR]

• ACC Scientific Sessions 2020 shared the latest research in cardiology. • We highlight results from 14 late-breaking trials. • Areas covered include TAVR, coronary, and peripheral artery disease. [ABSTRACT FROM AUTHOR]

• CRT 2024 shared the latest research in interventional cardiology. • We highlight results from the late-breaking clinical trials. • Areas covered include structural heart disease, coronary and intervention. • Other areas are RDN, peripheral vascular disease, and AI and machine learning. [ABSTRACT FROM AUTHOR]