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Introduction and Objectives: In patients undergoing percutaneous coronary intervention (PCI) in the workup pre-transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup., Methods: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated., Results: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiac death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.31; 95%CI, 1.01-1.71; P=.042)., Conclusions: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population., Methods: Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding., Results: Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively)., Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes., Competing Interests: Dr Ternacle is a consultant for Abbott. Dr Modine is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Asmarats has received speaker fees from Edwards Lifesciences. Dr Capodanno has received payments to the institution from Medtronic and personal fees from Sanofi, Novo Nordisk, and Terumo. Dr Morice served as a shareholder and chief executive officer (CEO) of Cardiovascular European Research Center (CERC) and minor shareholder of Electroducer. Dr Garot has received proctor/advisory fees from Abbott, Biosensors, Boston Scientific, Cordis, General Electric HealthCare, and Terumo. He served as co-medical director and shareholder of CERC Contract Research Organization (CRO), organizing the Valve Academic Research Consortium for High Bleeding Risk initiative (nonprofit initiative, as per Academic Research Consortium [ARC] Charter). Dr Rodés-Cabau has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Conduction disturbances (CDs) are common after transcatheter aortic valve replacement. Continuous improvements in preprocedural planification, implant techniques, and device design have markedly reduced periprocedural complications. However, CDs rate remains in the double-digit range. Because CDs after TAVR are associated with poorer outcomes, seeking a reduction in their occurrence is paramount. Several nonmodifiable and modifiable factors are associated with an increased risk of CDs. Previous right bundle branch block has been shown to have a strong association with pacemaker implant after TAVR. Among the modifiable factors, a lower implantation depth seems to be associated with a higher risk of CDs, and several implant strategies aiming to obtain a higher implant depth have shown promising results. This literature review provides a detailed description of updated evidence about the epidemiology, impact, and preventive and management strategies of CDs after TAVR. Also, based on these updated data, a fast-track protocol CDs management is proposed., Competing Interests: Funding Support and Author Disclosures Dr Nuche is a recipient of a grant from the Fundación Alfonso Martín Escudero. Dr Mittal has received consultant fees from Medtronic. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University); and has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. Dr Philippon has received consultant and research grants from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: In low-risk patients with severe aortic stenosis (AS), sutureless surgical aortic valve replacement (SU-SAVR) may be an alternative to transcatheter aortic valve implantation (TAVI). The risk of heart failure hospitalization (HFH) after aortic valve replacement (AVR) in this population is incompletely characterized. This study aims to investigate the incidence, predictors, and outcomes of HFH in patients undergoing SU-SAVR versus TAVI., Methods and Results: Patients referred for AVR between 2013 and 2020 at two centres were consecutively included. The decision for SU-SAVR or TAVI was determined by a multidisciplinary Heart Team. Cox regression and competing risk analysis were conducted to assess adverse events. Of 594 patients (mean age 77.5 ± 6.4, 59.8% male), 424 underwent SU-SAVR, while 170 underwent TAVI. Following a mean follow-up of 34.1 ± 23.1 months, HFH occurred in 112 (27.8%) SU-SAVR patients and in 8 (4.8%) TAVI patients (P < 0.001). The SU-SAVR cohort exhibited higher all-cause mortality (138 [32.5%] patients compared with 30 [17.6%] in the TAVI cohort [P < 0.001]). These differences remained significant after sensitivity analyses with 1:1 propensity score matching for baseline variables. SU-SAVR with HFH was associated with increased all-cause mortality (61.6% vs. 23.1%, P < 0.001). Independent associates of HFH in SU-SAVR patients included diabetes, atrial fibrillation, chronic obstructive pulmonary disease, lower glomerular filtration rate and lower left ventricular ejection fraction. SU-SAVR patients with HFH had a 12-month LVEF of 59.4 ± 12.7., Conclusions: In low-risk AS, SU-SAVR is associated with a higher risk of HFH and all-cause mortality compared to TAVI. In patients with severe AS candidate to SU-SAVR or TAVI, TAVI may be the preferred intervention., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

More than mild paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI) is associated with a twofold increase in all-cause mortality, heart failure hospitalizations, and the need for reintervention. Successfully addressing PVL in TAVIs is more challenging than in surgical valves. The arterial-arterial (A-A) rail technique emerges as a valuable strategy for post-TAVI PVL closure, enhancing success rates by enabling the effective use of lower-profile vascular plug devices. When standard approach is ineffective, generating an A-A loop for post-TAVI PVL closure is probably the most recommended strategy to ensure procedural success., (© 2024 Wiley Periodicals LLC.)

Background: Obesity paradox in cardiovascular risk prediction has gained increasing attention in recent years. We aimed to investigate the impact of BMI on mortality following transcatheter aortic valve replacement (TAVR)., Methods: We performed a multi-center retrospective analysis of patients with severe aortic stenosis undergoing TAVR. Patients were categorized into: Underweight (BMI < 18.5), normal weight (18.5 ≤ BMI < 25), overweight (25 ≤ BMI < 30) and obese (BMI ≥ 30). Multivariate cox-proportional hazard model was used to compare all-cause mortality., Results: Total of 6688 patients included (175 underweight, 2252 normal weight, 2368 overweight and 1893 with obesity). Mean age of patients was 81 ± 8 years with 55% males. Patients with obesity had higher prevalence of comorbidities but a lower overall STS score. Mortality at 30-days post-TAVR was lower in the obese population compared to underweight, normal weight, and overweight patients (1.6% vs. 6.9%, 3.6%, and 2.8%, respectively, p < 0.001). Similarly, 3-year mortality was lowest in patients with obesity (17.1% vs. 28.9%, 24.5% and 18.6%, respectively, p < 0.001). On multivariate analysis, long term all-cause mortality at 3-years remained significantly lower in patients with obesity compared to underweight (HR 1.74, 95% CI: 1.30-2.40, p < 0.001) and normal weight (HR: 1.41, 95% CI:1.21-1.63, p < 0.001) but not in overweight patients (HR: 1.10, 95% CI:0.94-1.28, p = 0.240)., Conclusion: In conclusion, patients with obesity have improved short and long term mortality following TAVR with an observed progressive increase in mortality with lower BMI ranges., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The Valve Academic Research Consortium (VARC)-3 definition for neurologic events after transcatheter aortic valve replacement (TAVR) lacks clinical validation., Objectives: This study sought to determine the incidence, predictors, and clinical impact of neurologic events following TAVR as defined by VARC-3 criteria., Methods: This was a multicenter study including 2,924 patients with severe aortic stenosis undergoing TAVR. Based on Neurologic Academic Research Consortium (NeuroARC) classification, neurologic events were classified as NeuroARC type 1 (stroke), NeuroARC type 2 (covert central nervous system injury), and NeuroARC type 3 (transient ischemic attack and delirium). Baseline, procedural, and follow-up data were prospectively collected in a dedicated database., Results: After a median follow-up of 13 (7-37) months, neurologic events occurred in 471 patients (16.1%), NeuroARC type 1, 2, and 3 in 37.4%, 4.7%, and 58.0% of cases, respectively, and the majority (58.6%) were periprocedural. Advanced age, chronic kidney disease, atrial fibrillation, major vascular complications, and in-hospital bleeding determined an increased risk of periprocedural events (P < 0.03 for all). Neurologic events occurring during the periprocedural time frame were independently associated with a substantial increase in mortality at 1 year after the intervention (HR: 1.91; 95% CI: 1.23-2.97; P = 0.004). However, although NeuroARC type 1 was associated with an increased mortality risk (IRR: 3.38; 95% CI: 2.30-5.56; P < 0.001 and IRR: 21.7; 95% CI: 9.63-49.1; P < 0.001 for ischemic and hemorrhagic stroke, respectively), the occurrence of NeuroARC type 3 events had no impact on mortality., Conclusions: Neurologic events after TAVR were associated with poorer short- and long-term survival. This correlation was related to the type of NeuroARC event defined by the VARC-3 criteria. Given the negative impact on clinical outcomes, every attempt should be made to reduce the risk of neurologic complications after TAVR., Competing Interests: Funding Support and Author Disclosures Dr Cepas-Guillén has received a grant from the Fundación Alfonso Martín Escudero. Dr Rodés-Cabau has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic, and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Interventions (Laval University). All other authors have reported that they have no relationships relevant to the contents of this paper., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems., Methods: This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status., Results: Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg)., Conclusions: Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Objectives: Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value., Methods: We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL., Results: The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976)., Conclusions: In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.

Background: Little is known about the occurrence of subclinical new-onset atrial fibrillation (NOAF) after transcatheter aortic valve implantation (TAVI)., Aims: We aimed to evaluate the incidence, predictors, and clinical impact of subclinical NOAF after TAVI., Methods: This was a multicentre study, including patients with aortic stenosis (AS) and no previous atrial fibrillation undergoing TAVI, with continuous ambulatory electrocardiogram (AECG) monitoring after TAVI., Results: A total of 700 patients (79±8 years, 49% female, Society of Thoracic Surgeons score 2.9% [1.9-4.0]) undergoing transarterial TAVI were included (85% balloon-expandable valves). AECG was started 1 (0-1) day after TAVI (monitoring time: 14121314 days). NOAF was detected in 49 patients (7%), with a median duration of 185 (43-421) minutes (atrial fibrillation burden of 0.7% [0.3-2.8]). Anticoagulation was started in 25 NOAF patients (51%). No differences were found in baseline or procedural characteristics, except for a higher AS severity in the NOAF group (peak gradient: no NOAF: 71.9±23.5 mmHg vs NOAF: 85.2±23.8 mmHg; p=0.024; mean gradient: no NOAF: 44.4±14.7 mmHg vs NOAF: 53.8±16.8 mmHg; p=0.004). In the multivariable analysis, the baseline mean transaortic gradient was associated with a higher risk of NOAF after TAVI (odds ratio 1.04, 95% confidence interval: 1.01-1.06 for each mmHg; p=0.006). There were no differences between groups in all-cause mortality (no NOAF: 4.7% vs NOAF: 0%; p=0.122), stroke (no NOAF: 1.4% vs NOAF: 2.0%; p=0.723), or bleeding (no NOAF: 1.9% vs NOAF: 4.1%; p=0.288) from the 30-day to 1-year follow-up., Conclusions: NOAF detected with AECG occurred in 7% of TAVI recipients and was associated with a higher AS severity. NOAF detection determined the start of anticoagulation therapy in about half of the patients, and it was not associated with an increased risk of clinical events at 1-year follow-up.

Introduction and Objectives: There are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR., Methods: This multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis., Results: The mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up., Conclusions: Up to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed., (Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA., Methods: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes., Results: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P =0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P =1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P =0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P =0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P =0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P =0.80)., Conclusions: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445., Competing Interests: Disclosures Dr Rodés-Cabau has received institutional research grants from and is consultant for Edwards Lifesciences and Medtronic. Dr Ribeiro has received fees as a proctor from Medtronic, Edwards Lifesciences and Boston Scientific and research grant from Medtronic. Dr Al-Atassi has received honoraria/fees as a proctor from Edwards. Dr Nombela-Franco has received consulting fees from Edwards Lifesciences. Dr Conradi is a member of the Advisory Board of Medtronic, Abbott, and JenaValve; and has received consulting fees from Edwards Lifesciences, Boston Scientific, MicroPort, Venus Medtech, and PiCardia. Dr Moris received fees as a proctor from Medtronic and Boston Scientific. Dr Pibarot has received institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Novartis. The other authors report no conflicts.

Transcatheter aortic valve replacement (TAVR) has emerged as a successful treatment option for severe aortic stenosis. However, the long-term outcomes of TAVR in nonagenarians is lacking. We aimed to examine the long-term mortality and quality of life in nonagenarians after TAVR. This is a multicenter, retrospective analysis on patients with severe aortic stenosis who underwent TAVR. Patients were divided into 2 groups: nonagenarians (age ≥90 years) and age <90 years. The Kansas City cardiomyopathy questionnaire (KCCQ) and New York Heart Association (NYHA) scores were compared before and after TAVR. All-cause mortality was compared between both groups at 30 days, 1 year, and 5 years after TAVR using the Cox proportional hazard model. A total of 6,896 patients were included, of whom 591 were nonagenarians. Nonagenarians had a higher Society of Thoracic Surgeons perioperative risk of mortality (8.1 ± 4.6% vs 5.4 ± 4.2%, p <0.001) before TAVR. Both groups were similar in KCCQ and NYHA scores at baseline. At 1 year after TAVR, there was no significant difference in improvement in the KCCQ overall score between those aged <90 years and nonagenarians (-4.76, 95% confidence interval [CI] -11.4 to 1.9, p = 0.161). Similarly, there was no statistically significant difference in improvement in NYHA class between the 2 groups at 1 year (odds ratio 1.07, 95% CI 0.85 to 1.25), p = 0.526). The unadjusted 30-day (3.2% vs 2.7%, hazard ratio 1.11, 95% CI 0.70 to 1.80, p = 0.667) and 5-year (28.0% vs 26.6%, hazard ratio 1.05, 95% CI 0.89 to 1.24, p = 0.60) all-cause mortality were similar between the 2 groups. In conclusion, this study demonstrates an excellent long-term mortality rate at 5 years after TAVR in nonagenarians, comparable to patients younger than 90 years. There is a significant and enduring improvement in functional status in nonagenarians, observed up to 1 year after TAVR., Competing Interests: Declaration of competing interest Amr Abbas, Philippe Pibarot, and Sammy Elmariah have received research grants and consulting fees from Edwards life Sciences. Philippe Pibarot and Sammy Elmariah have received research grants from Medtronic. Thomas Pilgrim received grants from Boston Scientific and Pilgrim, received speaker fees from Biotronik, consultancy fees from HighLife SAS, and proctor fees from Boston Scientific and Medtronic. Taishi Okuno reports speaker fees from Abbott. The remaining authors have no competing interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The growing number of candidates for transcatheter aortic valve replacement (TAVR) has increased the interest in the concomitant presence of coronary artery disease (CAD) and severe aortic stenosis (AS), prompting the need to define the appropriate revascularization strategy for each case. The reported prevalence of concurrent AS and CAD has varied over the years on the basis of the CAD definition and the population evaluated. Revascularization for treating CAD in patients with severe AS involves additional interventions that could impact outcomes. The addition of coronary artery bypass grafting (CABG) to surgical aortic valve replacement (SAVR) has demonstrated favourable effects on long-term prognosis, while the impact of adding percutaneous coronary intervention (PCI) to TAVR may depend on the CAD complexity and the feasibility of achieving complete or reasonably incomplete revascularization. Furthermore, the comparison between SAVR+CABG and TAVR+PCI in low-intermediate surgical risk and low-intermediate complex CAD patients did not reveal differences in all-cause mortality or stroke between the groups. However, there is some evidence showing a lower incidence of major cardiovascular events with the SAVR+CABG strategy for patients with complex CAD. Thus, SAVR+CABG seems to be the best option for patients with low-intermediate surgical risk and complex CAD, and TAVR+PCI for high surgical risk patients seeking complete and/or reasonable incomplete revascularization. After deciding between TAVR+PCI or SAVR+CABG, factors such as timing for PCI, low ejection fraction, coronary reaccess, and valve durability must be considered. Finally, alternative methods for assessing CAD severity are currently under evaluation to ascertain their real value for guiding revascularization in patients with severe AS with CAD., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population., Methods: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure., Results: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires., Conclusions: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies., Objectives: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR., Methods: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR., Results: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found., Conclusions: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr Nuche is supported by a grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University). Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Nombela-Franco holds a research grant (INT19/00040 and CM21/00091) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III); and has received consulting fees from Edwards Lifesciences. Dr Conradi is a member of the advisory board of Medtronic, Abbott, JenaValve, and Neovase; and has received consulting fees from Edwards Lifesciences, Boston Scientific, New Valve Technology, and MicroInterventions. Dr Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Dr Rodés-Cabau has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring., Objectives: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures., Methods: This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire., Results: A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported., Conclusions: The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by Opsens Medical. Dr Regueiro is a consultant from Abbott, Meril Life, and Opsens Medical. Dr Picard-Deland is an employee of Opsens Medical. Dr Rodés-Cabau is a consultant for and has received institutional research grants and consulting fees from Opsens Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: To evaluate the prevalence, clinical characteristics, and outcomes of patients with angina undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis., Methods: A total of 1687 consecutive patients with severe aortic stenosis undergoing TAVR at our center were included and classified according to patient-reported angina symptoms prior to the TAVR procedure. Baseline, procedural and follow-up data were collected in a dedicated database., Results: A total of 497 patients (29%) had angina prior to the TAVR procedure. Patients with angina at baseline showed a worse New York Heart Association (NYHA) functional class (NYHA class> II: 69% vs 63%; P=.017), a higher rate of coronary artery disease (74% vs 56%; P <.001), and a lower rate of complete revascularization (70% vs 79%; P <.001). Angina at baseline had no impact on all-cause mortality (HR, 1.02; 95%CI, 0.71-1.48; P=.898) and cardiovascular mortality (HR, 1.2; 95%CI, 0.69-2.11; P=.517) at 1 year. However, persistent angina at 30 days post-TAVR was associated with increased all-cause mortality (HR, 4.86; 95%CI, 1.71-13.8; P=.003) and cardiovascular mortality (HR, 20.7; 95%CI, 3.50-122.6; P=.001) at 1-year follow-up., Conclusions: More than one-fourth of patients with severe aortic stenosis undergoing TAVR had angina prior to the procedure. Angina at baseline did not appear to be a sign of a more advanced valvular disease and had no prognostic impact; however, persistent angina at 30 days post-TAVR was associated with worse clinical outcomes., (Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation., Objectives: The aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria., Methods: A total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected., Results: Bleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001)., Conclusions: Bleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis., Competing Interests: Funding Support and Author Disclosures Dr Real is supported by the Fundacion Interhospitalaria Para la Investigación Cardiovascular (Madrid, Spain). Dr Nuche is a recipient of a grant from Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Rodés-Cabau has received institutional research grants and speaker and consultant fees from Edwards Lifesciences and Medtronic, and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University, Quebec City, Canada). 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. Published by Elsevier Inc. All rights reserved.)

Background: The burden of cardiac death after transcatheter aortic valve replacement (TAVR), particularly from advanced heart failure (HF) and sudden cardiac death (SCD), remains largely unknown., Objectives: This study sought to evaluate the incidence and predictors of SCD and HF-related death in TAVR recipients treated with newer-generation devices., Methods: This study included a total of 5,421 consecutive patients who underwent TAVR with newer-generation devices using balloon (75.7%) or self-expandable (24.3%) valves., Results: After a median follow-up of 2 (IQR: 1-3) years, 976 (18.0%) patients had died, 50.8% from cardiovascular causes. Advanced HF and SCD accounted for 11.6% and 7.5% of deaths, respectively. Independent predictors of HF-related death were atrial fibrillation (HR: 2.17; 95% CI: 1.47-3.22; P < 0.001), prior pacemaker (HR: 1.79; 95% CI: 1.10-2.92; P = 0.01), reduced left ventricular ejection fraction (HR: 1.08 per 5% decrease; 95% CI: 1.01-1.14; P = 0.02), transthoracic approach (HR: 2.50; 95% CI: 1.37-4.55; P = 0.003), and new-onset persistent left bundle branch block (HR: 1.85; 95% CI: 1.14-3.02; P = 0.01). Two baseline characteristics (diabetes, HR: 1.81; 95% CI: 1.13-2.89; P = 0.01; and chronic kidney disease, HR: 1.72; 95% CI: 1.02-2.90; P = 0.04) and 3 procedural findings (valve in valve, HR: 2.17; 95% CI: 1.01-4.64; P = 0.04; transarterial nontransfemoral approach, HR: 2.23; 95% CI: 1.23-4.48; P = 0.01; and periprocedural ventricular arrhythmia, HR: 7.19; 95% CI: 2.61-19.76; P < 0.001) were associated with an increased risk of SCD after TAVR., Conclusions: Advanced HF and SCD accounted for a fifth of deaths after TAVR in contemporary practice. Potentially treatable factors leading to increased risk of HF deaths and SCD were identified, such as arrhythmia/dyssynchrony factors for HF and valve-in-valve TAVR or periprocedural ventricular arrhythmias for SCD., Competing Interests: Funding Support and Author Disclosures Dr Mesnier was supported by a research grant from Fédération Française de Cardiologie. Dr Belahnech was supported by a research grant from Aula Vall d’Hebron. Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions; and has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. Dr Ternacle has served as a consultant for Abbott. Dr Modine has served as a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Nombela-Franco has served as a proctor for Abbott and Edwards Lifesciences. Dr Reguiero has served as a proctor for Abbott. Dr Himbert has served as a proctor for Abbott and Edwards Lifesciences. Dr Asmarats has received speaker fees from Edwards Lifesciences. 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. Published by Elsevier Inc. All rights reserved.)

Background: In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown., Objectives: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR., Methods: This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria., Results: LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020)., Conclusions: In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients., Competing Interests: Funding Support and Author Disclosures Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University); and has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce., Aims: This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure., Methods: All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included., Results: Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%)., Conclusions: Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.

Background: A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce., Aims: The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA., Methods: A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm 2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV)., Results: A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up., Conclusions: TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.

Introduction: Small aortic annulus (SAA) poses a challenge in the management of patients with severe aortic stenosis requiring aortic valve replacement - both surgical and transcatheter - since it has been associated with worse clinical outcomes., Areas Covered: This review aims to comprehensively summarize the available evidence regarding the management of aortic stenosis in patients with SAA and discuss the current controversies as well as future perspectives in this field., Expert Opinion: It is paramount to agree in a common definition for diagnosing and properly treating SAA patients, and for that purpose, multidetector computer tomography is essential. The results of recent trials led to the expansion of transcatheter aortic valve replacement among patients of all the surgical-risk spectrum, and the choice of treatment (transcatheter, surgical) should be based on patient comorbidities, anatomical characteristics, and patient preferences.

Background: No data exist on the clinical and prognostic significance of syncope in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis., Methods: A total of 1705 consecutive patients with severe aortic stenosis undergoing TAVR in a tertiary university centre between 2007 and 2021 were included and classified according to the presence of syncope before the TAVR procedure. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database., Results: A total of 115 patients (7%) presented with syncope before the TAVR procedure. Of these, 15 patients (13%) showed arrhythmic episodes as the probable cause of the syncope, and all of them had pacemakers implanted at a median of 13 (6 to 53) days before the TAVR procedure. Patients with syncope were older (82 ± 8 years vs 80 ± 8 years, P = 0.001) and had a higher rate of pacemaker implantation before the TAVR procedure (27% vs 14%, P < 0.001), with no differences between groups regarding the severity of aortic stenosis (transvalvular gradient, valve area). There were no differences between groups in 30-day (adjusted hazard ratio [HR], 1.28; 95% confidence interval [CI], 0.46-3.60) and 1-year (adjusted HR, 0.71; 95% CI, 0.0.35-1.45) mortality following TAVR., Conclusions: Syncope was not associated with a more advanced valvular disease and had no significant prognostic impact on patients undergoing TAVR. However, arrhythmias and conduction-system disturbances were more common in patients with previous syncope and might play a relevant role in the pathogenesis of syncope in patients with aortic stenosis., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: The Valve Academic Research Consortium (VARC)-3 definition for myocardial injury after transcatheter aortic valve replacement (TAVR) lacks of clinical validation., Objectives: This study sought to determine the incidence, predictors, and clinical impact of periprocedural myocardial injury (PPMI) following TAVR as defined by recent VARC-3 criteria., Methods: We included 1,394 consecutive patients who underwent TAVR with a new-generation transcatheter heart valve. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs ≥15 times according to the VARC-2 definition). Baseline, procedural, and follow-up data were prospectively collected., Results: PPMI was diagnosed in 193 (14.0%) patients. Female sex and peripheral artery disease were independent predictors of PPMI (P < 0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.69, 95% CI: 1.50-4.82; P = 0.001) and 1-year (for all-cause mortality, HR: 1.54; 95% CI: 1.04-2.27; P = 0.032; for cardiovascular mortality, HR: 3.04; 95% CI: 1.68-5.50; P < 0.001) follow-up. PPMI according to VARC-2 criteria had no impact on mortality., Conclusions: About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria, and baseline factors like female sex and peripheral artery disease determined an increased risk. PPMI had a negative impact on early and late survival. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted., Competing Interests: Funding Support and Author Disclosures Dr Real was funded by the Fundación Interhospitalaria para la Investigación Cardiovascular. Dr Nuche was the recipient of a grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Rodés-Cabau has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Echocardiography is the primary imaging modality for diagnosis of infective endocarditis (IE) in prosthetic valve endocarditis (PVE) including IE after transcatheter aortic valve implantation (TAVI). This study aimed to evaluate the characteristics and clinical outcomes of patients with absent compared with evident echocardiographic signs of TAVI-IE., Methods: Patients with definite TAVI-IE derived from the Infectious Endocarditis after TAVI International Registry were investigated comparing those with absent and evident echocardiographic signs of IE defined as vegetation, abscess, pseudo-aneurysm, intracardiac fistula, or valvular perforation or aneurysm., Results: Among 578 patients, 87 (15.1%) and 491 (84.9%) had absent (IE-neg) and evident (IE-pos) echocardiographic signs of IE, respectively. IE-neg were more often treated via a transfemoral access with a self-expanding device and had higher rates of peri-interventional complications (eg, stroke, major vascular complications) during the TAVI procedure (P < .05 for all). IE-neg had higher rates of IE caused by Staphylococcus aureus (33.7% vs 23.2%; P = .038) and enterococci (37.2% vs 23.8%; P = .009) but lower rates of coagulase-negative staphylococci (4.7% vs 20.0%, P = .001). IE-neg was associated with the same dismal prognosis for in-hospital mortality in a multivariate binary regression analysis (odds ratio: 1.51; 95% confidence interval [CI]: .55-4.12) as well as a for 1-year mortality in Cox regression analysis (hazard ratio: 1.10; 95% CI: .67-1.80)., Conclusions: Even with negative echocardiographic imaging, patients who have undergone TAVI and presenting with positive blood cultures and symptoms of infection are a high-risk patient group having a reasonable suspicion of IE and the need for an early treatment initiation., Competing Interests: Potential conflicts of interest. N. M. reports personal fees from Edwards Lifesciences (payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events), Medtronic (payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events), Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott (payment or honoraria for lectures, presentations, speaker's bureaus, manuscript writing, or educational events), Abiomed, and Boston Scientific (consulting and payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events), outside the submitted work. J. R.-C. has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. V. P. received research grants from Boston Scientific, Medtronic, and Microport. A. L. reports personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer, outside the submitted work. H. C. H. has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and consulting fees from Edwards Lifesciences and Medtronic. H. L. B. reports lecture fees from Edwards Lifesciences, outside the submitted work. J.-M. S. reports speaker’s honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and research grants from Boston Scientific, Edwards Lifesciences, and Medtronic, outside the submitted work. W.-K. K. reports proctor/speaker’s fees/advisory board participation from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and ShockWave Medical, outside the submitted work. L. S. has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. O. H. reports personal fees from Boston Scientific and payments from Abbott. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation., Objectives: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves., Methods: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT., Results: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI., Conclusions: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048)., Competing Interests: Funding Support and Author Disclosures This study was funded by Medtronic. Dr Grubb is a proctor, principal investigator, and on the advisory board for Medtronic; and serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, Gore, BioVentrix, and Edwards Lifesciences. Dr Gada has served as a consultant to Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mittal has received honoraria/consultant fees from Abbott, Boston Scientific, and Medtronic. Dr Nazif is consultant for and has received institutional grants from Edwards LifeSciences, Medtronic, and Boston Scientific. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Fraser is a proctor for Medtronic; and receives speaker fees from Edwards and Medtronic. Dr Rovin is a physician proctor with Medtronic and Abbott; and is a consultant for Medtronic and Abbott. Dr Sultan receives institutional research support from Abbott, Atrivion, Boston Scientific, Edwards Lifesciences, and Medtronic; and is a consultant for Medtronic Vascular. Dr Gardner has received research support from Abbott; and is on the advisory board, is a consultant, and has received research support from Medtronic. Dr Chetcuti has received grant support and fees for proctoring from Medtronic; and is a consultant for Jena valve. Dr Patel is a speaker for Medtronic and Penumbra; and is on the advisory board of St. Jude Medical. Dr Harvey has served as a consultant; and is on the advisory board for Boston Scientific. Dr Mahoney is a proctor and consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Schwartz is an investigator for Medtronic. Dr Jafar is an investigator for Medtronic. Dr Wang is a speaker and consultant for Boston Scientific; is a consultant for Cordis; and is a consultant for Edwards Lifesciences. Dr Potluri has received honoraria from Boston Scientific, Medtronic, Edwards Lifesciences, Zoll, Gore, Abbott, and Cardinal. Dr Vora serves as a consultant for Medtronic. Dr Sanchez is a consultant for Edwards Lifesciences and Medtronic. Ms Corrigan is an employee and shareholder of Medtronic. Dr Li is an employee and shareholder of Medtronic. Dr Yakubov has received institutional research grants from Medtronic; and serves on an advisory board for Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The potential benefit of using larger or smaller transcatheter heart valves (THV) in patients with borderline aortic annulus measurement (BAM) remains uncertain. The objective of this study was to evaluate the clinical outcomes associated with the selection of larger or smaller THV in the context of BAM., Methods: This was a multicenter observational study including patients who underwent transcatheter aortic valve replacement with the SAPIEN 3 or SAPIEN 3 Ultra-valve systems (Edwards Lifesciences, Irvine, CA) from April 2014 to June 2021. BAM was defined according to the manufacturer sizing chart and included the following annulus areas: 314 to 346, 400 to 430, 500 to 546 mm 2 . A 1:1 propensity score matching was used to compare outcomes of patients with larger or smaller THV., Results: From a total of 2467 patients, BAM was identified in 852 patients (34.5%). A larger and smaller THV was selected in 338 (39.7%) and 514 patients (60.3%) patients, respectively. The choice of a larger THV was associated (before and after propensity matching) with a higher risk of new-onset left bundle branch block (HR, 2.25 [95% CI, 1.39-3.65; P =0.001) and permanent pacemaker implantation (HR, 1.86 [95% CI, 1.11-3.09]; P =0.016) without any impact on gradients or the risk of moderate or severe paravalvular regurgitation at discharge (HR, 0.78 [95% CI, 0.41-1.45]; P =0.427). The risk of periprocedural complications such as aortic rupture and tamponade was low (<1%) and similar between groups., Conclusions: In patient with BAM, selecting a larger SAPIEN 3/Ultra THV increased the risk of conduction disturbances without any benefit on valve hemodynamics and clinical outcomes.

Objectives: The effectiveness of a multidisciplinary heart team in the management of patients with severe symptomatic aortic stenosis is unknown. This study evaluated the impact of a heart team on the outcomes of surgical aortic valve replacement in octogenarians., Methods: Between May 2007 and January 2016, 528 patients aged 80 years or more were referred to our institutional heart team for a transcatheter aortic valve replacement. Among these, 101 were redirected to surgical aortic valve replacement (heart team group). These patients were compared with a surgical aortic valve replacement cohort (n = 506) without prior heart team screening (non-heart team group), taken from the same time period. Propensity score matching with bootstrap analysis was performed; 76 heart team patients were matched to 76 non-heart team patients. Early and late outcomes including survival and readmission for cardiovascular causes were compared., Results: Matched subgroups were largely comparable; congestive heart failure and echocardiographic pulmonary hypertension were more prevalent in the heart team group. In-hospital mortality was significantly lower in the matched heart team group (0% vs 6.0%, bootstrap mean difference 6.0%, 95% confidence interval, 2.2-9.8). The risk of stroke, low cardiac output state, reexploration for bleeding, pneumonia, and prolonged ventilation was also significantly lower in the heart team group. There was no significant between-group difference regarding late survival (hazard ratio, 0.86, 95% confidence interval, 0.55-1.33, P = .49) or readmission for cardiovascular reasons (hazard ratio, 0.70, 95% confidence interval, 0.41-1.20, P = .19)., Conclusions: Preoperative multidisciplinary assessment of octogenarians by a heart team was associated with lower in-hospital mortality and adverse events after surgical aortic valve replacement., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has gained over time a major reduction in procedural complications. Despite this, clinically relevant bleeding still occurs in a non-negligible proportion of patients and adversely affects prognosis. Patients with severe aortic stenosis are at heightened risk for spontaneous bleeding due to advanced age and a high comorbidity burden. Also, procedural factors and antithrombotic management contribute to define individual bleeding susceptibility. Bleeding prevention represents an emerging area for improving patient care. Because of the tight hemorrhagic/ischemic balance, a tailored approach based on individual bleeding-risk profile, such as a less invasive antithrombotic regimen or appropriate diagnostic preprocedural evaluation, should be pursued to avoid bleeding events. This review aims to provide an in-depth overview of bleeding events in the TAVR field, including definitions, timing and the extent of risk, and clinical impact, as well as updates on antithrombotic management and its potential influence on bleeding complications., Competing Interests: Funding Support and Author Disclosures Dr Nuche has received a research grant from the “Fundación Alfonso Martín Escudero” (Madrid, Spain). Dr Rodés-Cabau has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic. Dr Rodés-Cabau holds the research chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Interventions. 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. Published by Elsevier Inc. All rights reserved.)

Infective endocarditis (IE) is a rare but serious complication following transcatheter aortic valve replacement (TAVR). Despite substantial improvements in the TAVR procedure (less invasive) and its expansion to younger and healthier patients, the incidence of IE after TAVR remains stable, with incidence rates similar to those reported after surgical aortic valve replacement. Although IE after TAVR is recognized as a subtype of prosthetic valve endocarditis, this condition represents a particularly challenging scenario given its unique clinical and microbiological profile, the high incidence of IE-related complications, the uncertain role of cardiac surgery, and the dismal prognosis in most patients with TAVR-IE. The number of TAVR procedures is expected to grow exponentially in the coming years, increasing the number of patients at risk of developing this life-threatening complication. Therefore, a detailed understanding of this disease and its complications will be essential to improve clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr del Val was supported by a grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Panagides has received research grants from Medtronic, Boston Scientific, and Microport. Dr Miró has received consulting honoraria and/or research grants from AbbVie, Angelini, Contrafect, Cubist, Genentech, Gilead Sciences, Janssen, Medtronic, Merck Sharp & Dohme, Novartis, Pfizer, and ViiV Healthcare; and has received a personal 80:20 research grant from Institut d’Investigacions Biomèdiques August Pi i Sunyer during the 2017-2023 period. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University). 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. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the incidence, predictive factors and prognostic value of new-onset persistent left bundle branch block (NOP-LBBB) in patients undergoing sutureless surgical aortic valve replacement (SU-SAVR)., Methods: A total of 329 consecutive patients without baseline conduction disturbances or previous permanent pacemaker implantation (PPI) who underwent SU-SAVR with the Perceval valve (LivaNova Group, Saluggia, Italy) in two centres from 2013 to 2019 were included. Patients were on continuous ECG monitoring during hospitalisation and 12-lead ECG was performed after the procedure and at hospital discharge. NOP-LBBB was defined as a new postprocedural LBBB that persisted at hospital discharge. Baseline, procedural and follow-up clinical and echocardiography data were collected in a dedicated database., Results: New-onset LBBB was observed in 115 (34.9%) patients, and in 76 (23.1%) persisted at hospital discharge. There were no differences in baseline and procedural characteristics between patients with (n=76) and without (n=253) NOP-LBBB. After a median follow-up of 3.3 years (2.3-4.4 years), patients with NOP-LBBB had a higher incidence of PPI (14.5% vs 6.3%, p=0.016), but exhibited similar rates of all-cause mortality (19.4% vs 19.2%, p=0.428), cardiac mortality (8.1% vs 9.4%, p=0.805) and heart failure readmission (21.0% vs 23.2%, p=0.648), compared with the no/transient LBBB group. NOP-LBBB was associated with a decrease in left ventricular ejection fraction (LVEF) at 1-year follow-up (delta: -5.7 vs +0.2, p<0.001)., Conclusions: NOP-LBBB occurred in approximately a quarter of patients without prior conduction disturbances who underwent SU-SAVR and was associated with a threefold increased risk of PPI along with a negative impact on LVEF at follow-up., Competing Interests: Competing interests: JR-C is consultant for and has received institutional research grants from Edwards Lifesciences, Medtronic and Boston Scientific., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: High (≥20 mmHg) postprocedural mean transvalvular gradients are relatively common among valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) recipients, but its clinical impact remains controversial., Methods: Observational study including 190 consecutive ViV-TAVR recipients. Patients were classified according to the presence of high (≥20 mmHg) or low (<20 mmHg) residual mean transvalvular gradient on post-procedural echocardiography. Functional status (NYHA class, DASI), exercise capacity (6MWT), and quality of life (KCCQ) were evaluated at baseline and at 1-year follow-up., Results: 73 (38.4%) and 117 (61.6%) patients exhibited high (HG) and low (LG) postprocedural gradients, respectively. Baseline characteristics were well balanced between groups except for a lower rate of large (>23 mm) surgical valves, atrial fibrillation, and aortic regurgitation as mechanism of valve failure in the HG group (p < 0.05 for all). After a median follow-up of 3 (1-5) years, there were no differences between HG and LG groups in HF hospitalization (HRadj: 1.38, 95%CI 0.44-4.22, p = 0.57), cardiac death (HRadj: 0.50; 95%CI 0.11-2.41, p = 0.39), all-cause mortality (HRajd: 0.71; 95%CI 0.35-1.46, p = 0.36), or the composite endpoint of heart failure/all-cause mortality (HRadj:1.00; 95%CI 0.52-1.94, p = 0.98). At 1-year follow-up, functional status (ΔDASI score, HG: 9.9 ± 10.9, LG: 9.9 ± 12.5, padj = 0.41), exercise capacity (Δ6MWT, HG: 111 ± 67 m, LG: 103 ± 124 m, padj = 0.14), and quality of life parameters (ΔKCCQ, HG: 27 ± 18, LG: 17 ± 21, padj = 0.12) improved similarly in both groups., Conclusions: HG as evaluated by echocardiography following ViV-TAVR were not associated with a negative effect on clinical outcomes including major adverse events, functional status, exercise capacity and quality of life parameters., Competing Interests: Declaration of Competing Interest Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences and Medtronic. The rest of authors do not disclose any conflict of interest with respect to the content of this article., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is well established for treating severe symptomatic aortic stenosis. Whereas broad information on the epidemiology, clinical implications, and management of bradyarrhythmias after TAVR is available, data about tachyarrhythmic events remain scarce. Despite the progressively lower risk profile of TAVR patients and the improvement in device characteristics and operator skills, approximately 10% of patients develop new-onset atrial fibrillation (NOAF) after TAVR. The proportion of patients in whom NOAF actually corresponds to previously undiagnosed silent atrial fibrillation (AF) has not been properly determined. The transapical approach, the need for pre- or post- balloon dilation, and the presence of periprocedural complications have been associated with a higher risk of NOAF. Older age, left atrial volume, or worse functional class are patient-derived risk factors shared with preprocedural AF. NOAF after TAVR has been associated with poorer survival and a higher incidence of cerebrovascular events. However, patient management differs markedly among different centers, especially with regard to anticoagulation in patients with short-duration AF episodes detected in the periprocedural setting and in cases of silent NOAF detected during continuous electrocardiographic (ECG) monitoring. Evidence about ventricular arrhythmias is even more scarce than for AF. Some case reports of sudden cardiac death after TAVR in patients with a pacemaker have identified ventricular tachycardia or ventricular fibrillation in device interrogation. TAVR has been shown to reduce the arrhythmic burden, but a significant proportion of patients (16%) present with complex premature ventricular complex arrhythmias within the year after TAVR. Whether these events are related to poorer outcomes is unknown. Continuous ECG monitoring after TAVR may help describe the frequency, risk factors, and prognostic implications of tachyarrhythmias in this population., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Scarce data exist about early infective endocarditis (IE) after trans-catheter aortic valve replacement (TAVR)., Objective: The objective was to evaluate the characteristics, management, and outcomes of very early (VE) IE (≤ 30 days) after TAVR., Methods: This multicenter study included a total of 579 patients from the Infectious Endocarditis after TAVR International Registry who had the diagnosis of definite IE following TAVR., Results: Ninety-one patients (15.7%) had VE-IE. Factors associated with VE-IE (vs. delayed IE (D-IE)) were female gender (p = 0.047), the use of self-expanding valves (p < 0.001), stroke (p = 0.019), and sepsis (p < 0.001) after TAVR. Staphylococcus aureus was the main pathogen among VE-IE patients (35.2% vs. 22.7% in the D-IE group, p = 0.012), and 31.2% of Staphylococcus aureus infections in the VE-IE group were methicillin-resistant (vs. 14.3% in the D-IE group, p = 0.001). The second-most common germ was enterococci (34.1% vs. 24.4% in D-IE cases, p = 0.05). VE-IE was associated with very high in-hospital (44%) and 1-year (54%) mortality rates. Acute renal failure following TAVR (p = 0.001) and the presence of a non-enterococci pathogen (p < 0.001) were associated with an increased risk of death., Conclusion: A significant proportion of IE episodes following TAVR occurs within a few weeks following the procedure and are associated with dismal outcomes. Some baseline and TAVR procedural factors were associated with VE-IE, and Staphylococcus aureus and enterococci were the main causative pathogens. These results may help to select the more appropriate antibiotic prophylaxis in TAVR procedures and guide the initial antibiotic therapy in those cases with a clinical suspicion of IE. Very early infective endocarditis after trans-catheter aortic valve replacement. VE-IE indicates very early infective endocarditis (≤30 days post TAVR). D-IE indicates delayed infective endocarditis., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases)., Methods: Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation., Results: Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV., Conclusions: This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objectives: With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses., Methods: Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described., Results: Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%., Conclusions: Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted., (© 2022 Wiley Periodicals LLC.)

Background: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients., Methods: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula., Results: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all)., Conclusions: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes., Competing Interests: Potential conflicts of interest. J. R.-C. has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. V. P. has received institutional research grants from Medtronic, Boston Scientific, and Microport. D. T. has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. H. C. H. has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and consulting fees from Edwards Lifesciences and Medtronic. J. G. W. has received consulting fees from Edwards Lifesciences and St. Jude Medical. R. M. has received research grants from Edwards Lifesciences, Medtronic, Abbott, Capricor, and St. Jude Medical; has served as a proctor for Edwards Lifesciences; and has received consulting fees from Medtronic. F. S. de B. has received honoraria from Medtronic and Edwards Lifesciences for symposium speeches and proctoring cases. S. L. has received consulting fees from Edwards Lifesciences. H. Le B. has received lecture fees from Edwards Lifesciences outside the submitted work. J. M. S. has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and research grants from Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. K. W.-K. has received personal fees from Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, and Meril outside the submitted work. S. S. reports grants to their institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and has received personal fees from Boston Scientific, BTG, and Teleflex outside the submitted work. O. H. has received personal fees from Boston Scientific and payments from Abbott. N. M. has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, and Bayer outside the submitted work. All remaining authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Outcomes after transcatheter aortic valve replacement (TAVR) and infectious diseases may vary according to sex., Methods: This multicentre study aimed to determine the sex differences in clinical characteristics, management, and outcomes of infective endocarditis (IE) after TAVR. A total of 579 patients (217 women, 37.5%) who had the diagnosis of definite IE following TAVR were included retrospectively from the Infectious Endocarditis After TAVR International Registry., Results: Women were older (80 ± 8 vs 78 ± 8 years; P = 0.001) and exhibited a lower comorbidity burden. Clinical characteristics and microbiological profiles were similar between men and women, but culture-negative IE was more frequent in women (9.9% vs 4.3%; P = 0.009). A high proportion of patients had a clinical indication for surgery (54.4% in both groups; P = 0.99), but a surgical intervention was performed in a minority of patients (women 15.2%, men 20.3%; P = 0.13). The mortality rate at index IE hospitalisation was similar in both groups (women 35.4%, men 31.7%; P = 0.37), but women exhibited a higher mortality rate at 2-year follow-up (63% vs 52.1%; P = 0.021). Female sex remained an independent risk factor for cumulative mortality in the multivariable analysis (adjusted HR 1.28, 95% CI 1.02-1.62; P = 0.035). After adjustment for in-hospital events, surgery was not associated with better outcomes in women., Conclusions: There were no significant sex-related differences in the clinical characteristics and management of IE after TAVR. However, female sex was associated with increased 2-year mortality risk., (Copyright © 2022 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies., Objectives: The purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR., Methods: Patients with a failed small (≤23 mm) surgical valve were randomized to receive a BEV or an SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients, severe prosthesis patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days as evaluated by Doppler echocardiography., Results: A total of 102 patients were randomized, and of these, 98 patients finally underwent a ViV-TAVR procedure (BEV: n = 46, SEV: n = 52). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15 ± 8 mm Hg vs 23 ± 8 mm Hg; P ˂ 0.001; 28 ± 16 mm Hg vs 40 ± 13 mm Hg, P ˂ 0.001), and a tendency toward a lower rate of severe PPM (44% vs 64%; P = 0.07). There were no cases of moderate-severe aortic regurgitation. In total, 55 consecutive patients (SEV: n = 27; BEV: n = 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups (P = 0.41 and P = 0.70, respectively)., Conclusions: In patients with small failed aortic bioprostheses, ViV-TAVR with an SEV was associated with improved valve hemodynamics as evaluated by echocardiography. There were no differences between groups in intraprocedural invasive valve hemodynamics and 30-day clinical outcomes (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses. The 'LYTEN' Trial; NCT03520101)., Competing Interests: Funding Support and Author Disclosures Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University); and has received institutional research grants from and is consultant for Edwards Lifesciences and Medtronic. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Nombela-Franco holds a research grant (INT19/00040 and CM21/00091) from the Spanish Ministry of Science and Inovation (Instituto de Salud Carlos III); and has received consulting fees from Edwards Lifesciences. Dr Conradi is a member of the Advisory Board of Medtronic, Abbott, JenaValve, and Neovase; and has received consulting fees from Edwards Lifesciences, Boston Scientific, New Valve Technology, and MicroInterventions. Dr Pibarot has received research grants from Edwards Lifesciences and Medtronic; and has received 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: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome., Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV., Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91])., Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm 2 vs 1.3 ± 0.8 cm 2 ; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176)., Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR., Competing Interests: Funding Support and Author Disclosures Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr Kim is a proctor for and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Abdel-Wahab has received speaker honoraria and/or consultancy fees to the hospital on his behalf from Boston Scientific and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr Søndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr Redwood is a proctor for and has received lecture fees from Edwards Lifesciences. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Sathananthan is a consultant to Edwards Lifesciences. Dr Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr Castriota is a proctor for Medtronic and Boston Scientific. Dr Nazif is a consultant for or has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and is a consultant for and holds equity in Venus Medtech. Dr Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr Latib has received institutional research and grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr Hildick-Smith is a proctor and adviser for Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Background: Morbidly obese (MO) patients are increasingly undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS). However, the best therapeutic strategy for these patients remains a matter for debate., Aims: Our aim was to compare the periprocedural and mid-term outcomes in MO patients undergoing TAVR versus SAVR., Methods: A multicentre retrospective study including consecutive MO patients (body mass index ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity-related comorbidities) from 18 centres undergoing either TAVR (n=860) or biological SAVR (n=696) for severe AS was performed. Propensity score matching resulted in 362 pairs., Results: After matching, periprocedural complications, including blood transfusion (14.1% versus 48.1%; p<0.001), stage 2-3 acute kidney injury (3.99% versus 10.1%; p=0.002), hospital-acquired pneumonia (1.7% versus 5.8%; p=0.005) and access site infection (1.5% versus 5.5%; p=0.013), were more common in the SAVR group, as was moderate to severe patient-prosthesis mismatch (PPM; 9.9% versus 39.4%; p<0.001). TAVR patients more frequently required permanent pacemaker implantation (14.4% versus 5.6%; p<0.001) and had higher rates of ≥moderate residual aortic regurgitation (3.3% versus 0%; p=0.001). SAVR was an independent predictor of moderate to severe PPM (hazard ratio [HR] 1.80, 95% confidence interval [CI]: 1.25-2.59; p=0.002), while TAVR was not. In-hospital mortality was not different between groups (3.9% for TAVR versus 6.1% for SAVR; p=0.171). Two-year outcomes (including all-cause and cardiovascular mortality, and readmissions) were similar in both groups (log-rank p>0.05 for all comparisons). Predictors of all-cause 2-year mortality differed between the groups; moderate to severe PPM was a predictor following SAVR (HR 1.78, 95% CI: 1.10-2.88; p=0.018) but not following TAVR (p=0.737)., Conclusions: SAVR and TAVR offer similar mid-term outcomes in MO patients with severe AS, however, TAVR offers some advantages in terms of periprocedural morbidity.

Bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) may be caused by structural or nonstructural valve dysfunction. Both surgical and transcatheter bioprosthetic valves have limited durability because of structural valve deterioration. The main objective of this summary of experts participating in a virtual workshop was to propose standardized definitions for nonstructural and structural BVD and BVF following aortic or mitral biological valve replacement with the goal of facilitating research reporting and implementation of these terms in clinical practice. Definitions of structural BVF, based on valve reintervention or death, underestimate the true incidence of BVF. However, definitions solely based on the presence of high transprosthetic gradient at a given echocardiogram during follow-up overestimate the incidence of structural BVD and BVF. Definitions of aortic or mitral structural BVD must therefore include the confirmation by imaging of permanent structural changes to the leaflets alongside evidence of deterioration in valve hemodynamic function at echocardiography follow-up., Competing Interests: Funding Support and Author Disclosures Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; has received consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and has equity in Holistick Medical and Microinterventional Devices. Dr Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic and Novartis; and has equity in Navigate. Dr Abbas has received research grants and consulting fees from Edwards Lifesciences. Dr Dweck has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Leipsic has served as a consultant for Circle CVI and MVRX; and has received institutional funding for CT core laboratory analyses from Edwards Lifesciences, Neovasc, Abbott, Medtronic, Boston Scientific, PI Cardia, and Conformal. Dr Rogers has served as a consultant and physician proctor for Edwards Lifesciences and Medtronic; has served as an advisory board member for Medtronic; and holds equity interest in Transmural Systems. Dr Sathananthan has served as a consultant to Edwards Lifesciences and Medtronic; has received research funding from Edwards Lifesciences and Medtronic; and has received speaking fees from NVT. Dr Guerrero has received institutional research grant support from Edwards Lifesciences. Dr Ternacle has served as a consultant for Philips Healthcare and Abbott Medical. Dr Barbanti has served as a consultant for Edwards Lifesciences and Boston Scientific. Dr Généreux has served as a consultant and advisor for and received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, and Medtronic; has served as a consultant for Boston Scientific, GE Healthcare, iRhythm Technologies, Opsens, Siemens, and Teleflex; has served as a consultant, PI Eclipse Trial, for Cardiovascular System Inc; has served as a consultant, advisor, and proctor for and received speaker fees and research grant from Edwards LifeSciences for the PI EARLY-TAVR and PI PROGRESS trials; has served as a consultant for and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; has served as a consultant for and received speaker fees from Shockwave; and has served as a consultant for the PI Feasibility study for 4C Medical. Dr Kaneko has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Structural. Dr Wood has served as a consultant to and his institution (CCI-CIC) receives grant support from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Gillam has served as a consultant to Philips and Bracco; is an advisory board member for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences, Medtronic, and Abbott for which she receives no direct compensation. Dr Reardon has served as a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical; all fees for such are to his department. Dr Rodes-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Thourani has performed consulting/research for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, Medtronic, and Shockwave. Dr Bax’s institution (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Mack has served as a co-principal investigator for clinical trials for Abbott and Edwards Lifesciences; and has served as study chair for a trial for Medtronic; all roles were uncompensated. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)