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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 (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. Methods: Multicenter study including 10,449 patients undergoing TAVR. Based on consensus, twenty-one 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 VARC-HBR definition. The primary endpoint was the rate of BARC type 3 or 5 bleeding at 1 year, defined as the composite of peri-procedural (within 30 days) or late (after 30 days) bleeding. Results: Patients with at least one VARC-HBR criterion (n=9,267, 88.7%) had a higher risk of BARC 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 ROC 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 (HR: 1.33, 95% CI: 1.04-1.70; and HR: 1.97, 95% CI: 1.53-2.53, respectively). Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in TAVR. The results of the present study would support the predictive validity of the newly definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.

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.)

Background: Intravascular lithotripsy (IVL) combined with rotational atherectomy (RA), known as Rotatripsy, is used to treat severe coronary artery calcification (CAC), though data on efficacy, midterm safety and use sequence is limited. We aimed to identify indicators for Rotatripsy use and to assess its safety and success rates, both acutely and at 1-year follow-up., Methods: Patients undergoing Rotatripsy for severe CAC across six centers from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success [composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised Rotatripsy-related complications and MACE at 1-year follow-up., Results: A total of 114 patients (75 ± 9 years, 78% male) underwent Rotatripsy for 120 lesions. In the majority of procedures RA was followed by IVL, mostly electively (n = 68, 57%) but also for balloon underexpansion (n = 37, 31%) and stent crossing failure (n = 1, 1%). Diverse and complex target lesions were addressed with an average SYNTAX score of 24.6 ± 13.0. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications included two (2%) coronary perforations, one (1%) coronary dissection and one (1%) burr entrapment. At 1-year follow-up(present in 77(67%) patients), MACE occurred in 7(9%) cases., Conclusions: Over a 1-year follow-up period, Rotatripsy was safe and effective, predominantly using RA electively before IVL., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Aims: The objective of this study was to perform a cost-benefit analysis of the CardioMEMS HF System (Abbott Laboratories, Abbott Park, IL, USA) in a heart failure (HF) clinic in Spain by evaluating the real-time remote monitoring of pulmonary artery pressures, which has been shown to reduce HF-related hospitalizations and improve the quality of life for selected HF patients. Particularly, the study aimed to determine the value of CardioMEMS in Southern Europe, where healthcare costs are significantly lower and its effectiveness remains uncertain., Methods and Results: This single-centre study enrolled all consecutive HF patients (N = 43) who had been implanted with a pulmonary artery pressure sensor (CardioMEMS HF System); 48.8% were females, aged 75.5 ± 7.0 years, with both reduced and preserved left ventricular ejection fraction; 67.4% of them were in New York Heart Association Class III. The number of HF hospitalizations in the year before and the year after the sensor implantation was compared. Quality-adjusted life years gained based on a literature review of previous studies were calculated. The rate of HF hospitalizations was significantly lower at 1 year compared with the year before CardioMEMS implantation (0.25 vs. 1.10 events/patient-year, hazard ratio 0.22, P = 0.001). At the end of the first year, the usual management outperformed the CardioMEMS HF System. By the end of the second year, the CardioMEMS system is estimated to reduce costs compared with usual management (net benefits of €346)., Conclusions: Based on the results, we suggest that remote monitoring of pulmonary artery pressure with the CardioMEMS HF System represents a midterm and long-term efficient strategy in a healthcare setting in Southern Europe., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

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: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients., Aims: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness., Methods: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations., Results: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year., Conclusion: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL., (© 2024 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

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: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease., Objectives: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting., Methods: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients., Results: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073])., Conclusions: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307)., Competing Interests: Funding Support and Author Disclosures The study sponsor, Fundación EPIC, has received an institutional research grant from Shockwave Medical (Santa Clara, California, USA) to cover the design and maintenance costs of the electronic case report form. Shockwave Medical has had no influence on the study design or protocol in any respect. Shockwave Medical was not involved in the conduct of the study, including inclusion, follow-up, data collection, analysis, interpretation of results, drafting, and final approval of the protocol, nor in the genesis of this paper. Dr Rodriguez-Leor has received speaker honoraria and consulting fees from Medtronic and World Medica. Dr Pérez de Prado has received speaker honoraria and consulting fees from iVascular, Boston Scientific, Terumo, B. Braun, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The 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.

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.)

Competing Interests: Conflict of interest: V.D. receives speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Philips, GE healthcare, Novartis. Consultancy from Novo Nordisk, Edwards Lifesciences. The remaining authors declares no conflict of interest.

Competing Interests: Conflict of interest: V.D. received speaker fees from Edwards Lifesciences, Medtronic, Novartis, and Philips and consulting fees from Edwards Lifesciences and Novo Nordisk. The rest of the authors have nothing to disclose.

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.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Cardiogenic shock (CGS) occurs in 10% of patients presenting with acute myocardial infarction (MI), with in-hospital mortality rates of 40-50% despite revascularisation., Aims: The EURO SHOCK trial aimed to determine if early use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) could improve outcomes in patients with persistent CGS following primary percutaneous coronary intervention (PPCI)., Methods: This multicentre, pan-European trial randomised patients with persistent CGS 30 minutes after PPCI of the culprit lesion to receive either VA-ECMO or continue with standard therapy. The primary outcome measure was 30-day all-cause mortality in an intention-to-treat analysis. Secondary endpoints included 12-month all-cause mortality and 12-month composite of all-cause mortality or rehospitalisation due to heart failure., Results: Due to the impact of the COVID-19 pandemic, the trial was stopped before completion of recruitment, after randomisation of 35 patients (standard therapy n=18, VA-ECMO n=17). Thirty-day all-cause mortality occurred in 43.8% of patients randomised to VA-ECMO and in 61.1% of patients randomised to standard therapy (hazard ratio [HR] 0.56, 95% confidence interval [CI]: 0.21-1.45; p=0.22). One-year all-cause mortality was 51.8% in the VA-ECMO group and 81.5% in the standard therapy arm (HR 0.52, 95% CI: 0.21-1.26; p=0.14). Vascular and bleeding complications occurred more often in the VA-ECMO arm (21.4% vs 0% and 35.7% vs 5.6%, respectively)., Conclusions: Due to the limited number of patients recruited to the trial, no definite conclusions could be drawn from the available data. Our study demonstrates the feasibility of randomising patients with CGS complicating acute MI but also illustrates the challenges. We hope these data will inspire and inform the design of future large-scale trials.

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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.

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: 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: 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.)

Objectives: Sutureless aortic valve replacement (SU-SAVR) has been associated with higher rates of permanent pacemaker (PPM) compared with conventionally implanted aortic bioprostheses. The purpose of this study was to determine the incidence, predictors and mid-term prognostic impact of PPM after Perceval (Livanova, London, UK) SU-SAVR in low-risk patients., Methods: A total of 400 consecutive low-risk (EuroSCORE II < 4%) patients without prior pacemaker who underwent surgical aortic valve replacement with the Perceval prosthesis from 2013 to 2019 in 2 centres were included. Baseline, clinical and electrocardiographic parameters, procedural characteristics and follow-up data were collected., Results: PPM was required in 36 (9%) patients after SU-SAVR, with a median time between the procedure and PPM implantation of 7.5 (4.5-10.5) days. Older age and prior right bundle branch block (RBBB) were associated with an increased risk of PPM (P < 0.05 for all), but only baseline RBBB was found to be an independent predictor of new PPM requirement (odds ratio: 2.60, 95% confidence interval: 1.15-5.81; P = 0.022). At a median follow-up of 3.4 (2.3-4.5) years, there were no differences between groups in mortality (PPM: 36%, no PPM: 22%, P = 0.105) or heart failure rehospitalization (PPM: 25%, no PPM: 21%, P = 0.839)., Conclusions: About 1 out of 10 low-risk patients with aortic stenosis undergoing SU-SAVR with the Perceval prosthesis required PPM implantation. Prior RBBB determined an increased risk (close to 3-fold) of PPM following the procedure. PPM was not associated with a higher risk of clinical events at 3-year follow-up., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up., (Copyright © 2022 Elsevier Inc. All rights reserved.)

We systematically categorized the longer-term (≥3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 ± 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised in-segment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p <0.03 for all) were each independently associated with abnormal BVS endothelium-dependent vasomotor function. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction., Competing Interests: Disclosures Dr. Amat-Santos has received a nonconditional grant from Abbott. Dr. Latib is a consultant for Abbott, Boston Scientific, Medtronic, and Philips. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain., Objectives: The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB)., Methods: Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry., Results: Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HR unadj : 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HR unadj : 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HR adj : 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HR adj : 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock., Conclusions: In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications., Competing Interests: Funding Support and Author Disclosures Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific, outside the submitted work. Dr del Val was supported by a research grant from the Fundación Alfonso Martin Escudero (Madrid, Spain). Dr Tchetche has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Herrmann has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. Dr Webb has received consulting fees from Edwards Lifesciences and St. Jude Medical. Dr Makkar 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. Dr de Brito has received honoraria from Medtronic and Edwards Lifesciences for symposium speeches and proctoring cases. Dr Lerakis has received consulting fees from Edwards Lifesciences. Dr Le Breton has received lecture fees from Edwards Lifesciences, outside the submitted work. Dr Sinning has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic, outside the submitted work. Dr Kim has received proctor/speaker fees/served on the advisory board for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and Shockwave Medical, outside the submitted work. Dr Stortecky has received grants to the institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received personal fees from Boston Scientific, BTG, and Teleflex, outside the submitted work. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Dr Husser has received personal fees from Boston Scientific; and payments from Abbott. Dr Linke has received personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer outside the submitted work. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. 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: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR)., Methods: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE., Results: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038)., Conclusions: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR., Methods: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014)., Results: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all)., Conclusions: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time., (© 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.)

Objectives: The aim of this study was to compare, in a cohort of patients with complex coronary artery disease (CAD) and severe aortic stenosis (AS), the clinical outcomes associated with transfemoral transcatheter aortic valve replacement (TAVR) (plus percutaneous coronary intervention [PCI]) versus surgical aortic valve replacement (SAVR) (plus coronary artery bypass grafting [CABG])., Background: Patients with complex CAD were excluded from the main randomized trials comparing TAVR with SAVR, and no data exist comparing TAVR + PCI vs SAVR + CABG in such patients., Methods: A multicenter study was conducted including consecutive patients with severe AS and complex CAD (SYNTAX [Synergy Between PCI with Taxus and Cardiac Surgery] score >22 or unprotected left main disease). A 1:1 propensity-matched analysis was performed to account for unbalanced covariates. The rates of major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, nonprocedural myocardial infarction, need for new coronary revascularization, and stroke, were evaluated., Results: A total of 800 patients (598 undergoing SAVR + CABG and 202 undergoing transfemoral TAVR + PCI) were included, and after propensity matching, a total of 156 pairs of patients were generated. After a median follow-up period of 3 years (interquartile range: 1-6 years), there were no significant differences between groups for MACCE (HR for transfemoral TAVR vs SAVR: 1.33; 95% CI: 0.89-1.98), all-cause mortality (HR: 1.25; 95% CI: 0.81-1.94), myocardial infarction (HR: 1.16; 95% CI: 0.41-3.27), and stroke (HR: 0.42; 95% CI: 0.13-1.32), but there was a higher rate of new coronary revascularization in the TAVR + PCI group (HR: 5.38; 95% CI: 1.73-16.7)., Conclusions: In patients with severe AS and complex CAD, TAVR + PCI and SAVR + CABG were associated with similar rates of MACCE after a median follow-up period of 3 years, but TAVR + PCI recipients exhibited a higher risk for repeat coronary revascularization. Future trials are warranted., Competing Interests: Funding Support and Author Disclosures Dr Alperi was supported by a research grant from the Martín Escudero Foundation. 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 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 © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Sutureless-surgical aortic valve replacement (SU-SAVR) has been proposed as a surgical alternative for treating aortic stenosis, which facilitates a minimally invasive approach. While some studies have compared the early outcomes of SU-SAVR versus transcatheter aortic valve replacement (TAVR), most data were obtained in high-risk patients and/or limited to in-hospital outcomes. This study aimed to compare in-hospital and midterm clinical outcomes following SU-SAVR and TAVR in low-risk patients with aortic stenosis., Methods: A total of 806 consecutive low-risk (EuroSCORE II <4%) patients underwent TAVR or SU-SAVR between 2011 and 2020 in 2 centers. A 1:1 propensity score matching was performed and identified 171 pairs with similar characteristics that were included in the analysis. Baseline characteristics, in-hospital and follow-up events (defined according to Valve Academic Research Consortium-2) were collected., Results: Baseline characteristics were well balanced between groups, with a median EuroSCORE II of 1.9% (1.3%-2.5%) in both SU-SAVR and TAVR groups ( P =0.85). There were no statistically significant differences regarding in-hospital mortality (SU-SAVR: 4.1%, TAVR: 1.8%, P =0.199) and stroke (SU-SAVR: 2.3%, TAVR: 2.9%, P =0.736), but SU-SAVR recipients exhibited higher rates of bleeding and new-onset atrial fibrillation, higher residual transvalvular gradients ( P <0.001), and a lower rate of pacemaker implantation ( P =0.011). After a median follow-up of 2 (1-3) years, there were no differences between groups in all-cause mortality (hazard ratio, 0.97 [95% CI, 0.52-1.82], P =0.936) and stroke (hazard ratio, 0.83 [95% CI, 0.32-2.15], P =0.708), but SU-SAVR was associated with a higher risk of heart failure hospitalization (hazard ratio, 5.38 [95% CI, 1.88-15.38], P =0.002)., Conclusions: In low-risk patients with aortic stenosis, TAVR was associated with improved in-hospital outcomes (except for conduction disturbances) and valve hemodynamics, compared with SU-SAVR. Although similar mortality and stroke rates were observed at 2-year follow-up, the risk of heart failure hospitalization was higher among SU-SAVR patients. These results may contribute to reinforce TAVR over SU-SAVR for the majority of such patients. Graphic Abstract: A graphic abstract is available for this article.

Background: The arrhythmic burden after discharge in patients with new-onset left bundle branch block (LBBB) undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 (S3) valve remains largely unknown., Objective: The purpose of this study was to determine the incidence of late arrhythmias in patients with new-onset LBBB undergoing TAVR with the balloon-expandable S3 valve., Methods: This was a multicenter, prospective study that included 104 consecutive TAVR patients with new-onset persistent LBBB following TAVR with the S3 valve. An implantable cardiac monitor (Reveal XT, Reveal LINQ) was implanted before discharge. The primary endpoint was the incidence of high-degree atrioventricular block or complete heart block (HAVB/CHB)., Results: A total of 40 patients (38.5%) had at least 1 significant arrhythmic event, leading to a treatment change in 17 (42.5%). Significant bradyarrhythmias occurred in 20 of 104 patients (19.2%) (34 HAVB/CHB episodes, 252 severe bradycardia episodes), with 10 of 20 patients (50%) exhibiting at least 1 episode of HAVB/CHB. Most HAVB/CHB episodes (60%) occurred within 4 weeks after discharge. Nine patients (8.7%) underwent permanent pacemaker implantation at 12 months based on the Reveal findings (6 HAVB/CHB, 3 severe bradycardia)., Conclusion: S3 valve recipients with new-onset LBBB have a high arrhythmic burden, with more than one-third of patients exhibiting at least 1 significant arrhythmic episode within 12 months (HAVB/CHB in 10% of patients). About one-half of bradyarrhythmic events occurred within 4 weeks after discharge. These results should inform future strategies on the use of continuous electrocardiographic monitoring in TAVR S3 patients with new conduction disturbances following the procedure., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Stroke is one of the most common and potentially disabling complications of infective endocarditis (IE). However, scarce data exist about stroke complicating IE after transcatheter aortic valve replacement (TAVR)., Objectives: The purpose of this study was to determine the incidence, risk factors, clinical characteristics, management, and outcomes of patients with definite IE after TAVR complicated by stroke during index IE hospitalization., Methods: Data from the Infectious Endocarditis after TAVR International Registry (including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries) was analyzed. Patients were divided into two groups according to stroke occurrence during IE admission (stroke [S-IE] vs. no stroke [NS-IE])., Results: A total of 57 (10%) patients had a stroke during IE hospitalization, with no differences in causative microorganism between groups. S-IE patients exhibited higher rates of acute renal failure, systemic embolization, and persistent bacteremia (p < 0.05 for all). Previous stroke before IE, residual aortic regurgitation ≥moderate after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size >8 mm were associated with a higher risk of stroke during the index IE hospitalization (p < 0.05 for all). Stroke rate in patients with no risk factors was 3.1% and increased up to 60% in the presence of >3 risk factors. S-IE patients had higher rates of in-hospital mortality (54.4% vs. 28.7%; p < 0.001) and overall mortality at 1 year (66.3% vs. 45.6%; p < 0.001). Surgical treatment was not associated with improved outcomes in S-IE patients (in-hospital mortality: 46.2% in surgical vs. 58.1% in no surgical treatment; p = 0.47)., Conclusions: Stroke occurred in 1 of 10 patients with IE post-TAVR. A history of stroke, short time between TAVR and IE, vegetation size, valve prosthesis type, and residual aortic regurgitation determined an increased risk. The occurrence of stroke was associated with increased in-hospital and 1-year mortality rates, and surgical treatment failed to improve clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr. del Val was supported by a research grant from the Fundación Alfonso Martin Escudero (Madrid, Spain). Dr. Mangner has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, and Bayer, outside of the submitted work. Dr. Husser has received personal fees from Boston Scientific; and has received payments from Abbott. Dr. Sinning has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic, outside of the submitted work. Dr. Won-Keun has received personal fees from Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, and Meril, outside of the submitted work. Dr. Herrmann has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. Dr. Stortecky has received grants to the institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received personal fees from Boston Scientific, BTG, and Teleflex, outside of the submitted work. Dr. Tchetche has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Webb has received consulting fees from Edwards Lifesciences and St. Jude Medical. Dr. Makkar 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. Dr. Lerakis has received consulting fees from Edwards Lifesciences. Dr. de Brito Jr. has received honoraria from Medtronic and Edwards Lifesciences for symposium speeches and proctoring cases. Dr. Le Breton has received lecture fees from Edwards Lifesciences, outside of the submitted work. Dr. Linke has received personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer, outside the submitted work. 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 from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre-transcatheter aortic valve replacement (TAVR): 1) the clinical and peri-procedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features., Background: A PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown., Methods: Multicenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF)., Results: One-half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population)., Conclusions: Patients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR., Competing Interests: Author Relationship With Industry Dr. Faroux has received fellowship support from Institut Servier and the Association Régionale de Cardiologie de Champagne-Ardenne; and has received research grant support from Biotronik, Edwards Lifesciences, and Medtronic. Dr.Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Few and controversial data exist on the outcomes of patients with paradoxical low-flow, low-gradient aortic stenosis (PLFLG-AS) following transcatheter aortic valve replacement (TAVR). This study aims to better characterize clinical outcomes and predictors of treatment futility in PLFLG-AS patients undergoing TAVR., Methods: In this multicenter study, 318 patients with PLFLG-AS undergoing TAVR were categorized according to treatment futility, defined as all-cause mortality, poor functional status (NYHA class III-IV) or deterioration in functional class at 1-year follow-up. Clinical outcomes and the factors associated with treatment futility were assessed., Results: The mean age of the patients was 81.0 ± 8.3 years and 50.3% were women. At 1-year follow-up, 17.6% died and 12.9% had heart failure hospitalization. Residual impaired functional capacity (NYHA ≥ II) was present in 54.4% of patients who were alive at 1-year, and 9.8% remained in NYHA III/IV. The primary endpoint was observed in 103 (32.4%) patients, of which 54% died and 46% had a poor or worsening functional class. Factors independently associated with treatment futility were the presence of atrial fibrillation (AF) (OR:1.79, 95%CI, 1.04-3.10), chronic obstructive pulmonary disease (COPD) (OR:2.66, 95%CI, 1.50-4.74) and a lower SVi (OR per each decrease in 10 ml/m 2 :1.89, 95%CI, 1.06-3.45). The risk of treatment futility of patients with AF, COPD and a SVi < 30 ml/m 2 was 66.38% (95%CI, 54.29%-78.48%)., Conclusion: Close to one-third of patients with PLFLG-AS failed to derive a benefit from TAVR. The presence of AF, COPD and a low SVi were predictors of treatment futility. Being able to identify patients less likely to improve after the procedure may help to guide management and improve outcomes in patients with PLFLG-AS., Competing Interests: Declaration of competing interest Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciencies, Medtronic and Boston Scientific. Dr. Pibarot reports having Core Lab contracts with Edwards Lifesciences for which he receives no direct compensation, and receiving grants from Edwards Lifesciences and Medtronic during the conduct of the study. The rest of authors do not report any potential conflict of interest with respect to the content of this study., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: The crossover balloon occlusion technique (CBOT) facilitates primary access hemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The CBOT is usually performed through the contralateral femoral artery. The aim of this study was to evaluate, in patients undergoing TAVR, the safety and feasibility of transradial CBOT using the new Oceanus balloon dilatation catheter (iVascular)., Methods: This multicenter study included 104 patients (mean age, 81 ± 7 years; 43% women) undergoing transfemoral TAVR. A modified CBOT through the radial artery was performed in all patients with the Oceanus balloon catheter. Data regarding transradial CBOT, balloon performance, vascular complications, and 30-day clinical events were recorded., Results: Up to 21% of patients had a height >170 cm and 17% presented with severe aortic/iliofemoral tortuosity. The transradial CBOT (left radial 74%, right radial 26%) was performed using either the 140 cm Oceanus (37.5%) or the 200 cm Oceanus (62.5%) balloon catheter. The balloon reached the femoral artery in all patients, and balloon inflation achieved an appropriate vessel closure in 98%. There were no complications related to the balloon catheter, and only 1 patient (1.0%) suffered a minor vascular complication related to the secondary radial access. The 30-day rates of primary access major vascular complications and death were 3.8% and 1.9%, respectively., Conclusion: In patients undergoing transfemoral TAVR, transradial CBOT with the Oceanus balloon dilatation catheter was feasible and safe. A balloon length up to 200 cm allowed the use of this technique (from right or left radial access) in all patients regardless of patient height or the presence of a challenging vascular anatomy.

Background: Scarce data exist on coronary events following transcatheter aortic valve replacement (TAVR), and no study has determined the factors associated with poorer outcomes in this setting. This study sought to determine the clinical characteristics, outcomes, and prognostic factors of acute coronary syndrome (ACS) events following TAVR., Methods: Multicenter cohort study including a total of 270 patients presenting an ACS after a median time of 12 (interquartile range, 5-17) months post-TAVR. Post-ACS death, myocardial infarction, stroke, and overall major adverse cardiovascular or cerebrovascular events were recorded., Results: The ACS clinical presentation consisted of non-ST-segment-elevation myocardial infarction (STEMI) type 2 (31.9%), non-STEMI type 1 (31.5%), unstable angina (28.5%), and STEMI (8.1%). An invasive strategy was used in 163 patients (60.4%), and a percutaneous coronary intervention was performed in 97 patients (35.9%). Coronary access issues were observed in 2.5% and 2.1% of coronary angiography and percutaneous coronary intervention procedures, respectively. The in-hospital mortality rate was 10.0%, and at a median follow-up of 17 (interquartile range, 5-32) months, the rates of death, stroke, myocardial infarction, and major adverse cardiovascular or cerebrovascular events were 43.0%, 4.1%, 15.2%, and 52.6%, respectively. By multivariable analysis, revascularization at ACS time was associated with a reduction of the risk of all-cause death (hazard ratio, 0.54 [95% CI, 0.36-0.81] P =0.003), whereas STEMI increased the risk of all-cause death (hazard ratio, 2.06 [95% CI, 1.05-4.03] P =0.036) and major adverse cardiovascular or cerebrovascular events (hazard ratio, 1.97 [95% CI, 1.08-3.57] P =0.026)., Conclusions: ACS events in TAVR recipients exhibited specific characteristics (ACS presentation, low use of invasive procedures, coronary access issues) and were associated with a poor prognosis, with a very high in-hospital and late death rate. STEMI and the lack of coronary revascularization determined an increased risk. These results should inform future studies to improve both the prevention and management of ACS post-TAVR.

Objectives: To report on the feasibility and technical differences between coronary procedures performed before and after TAVR with the balloon-expandable Edwards-SAPIEN or the SAPIEN XT valves., Background: Coronary artery disease (CAD) and aortic stenosis often coexist. Transcatheter aortic valve replacement (TAVR) is emerging as a treatment for younger and lower surgical risk patients who might not present with clinically evident CAD before TAVR. The demand for performing post-TAVR coronary angiograms (CAs) and percutaneous coronary interventions (PCIs) will thus increase, posing new technical challenges., Methods: Over 1000 TAVRs were performed at the Quebec Heart and Lung Institute, of which 616 with the abovementioned valves. Of these, 28 patients had an analyzable pre- and post-TAVR CAs and 13 patients had pre- and post-TAVR PCIs performed. Procedural characteristics were gathered from all coronary procedures and subsequently compared amongst the same type of procedure performed at these two distinct time periods., Results: Neither CAs-nor PCIs-performed after valve implantation revealed significant differences regarding arterial access site, catheter diameter, number of diagnostic or guiding catheters used, procedural duration, fluoroscopy time, or achievement of selective coronary injection. Lesion location and classification, as well as the preference of using a drug-eluting stent, remained unchanged. During post-TAVR CA, the amount of contrast delivered and the radiation dose area product were significantly lower compared with pre-TAVR CA values., Conclusions: Performance of CA and PCI after TAVR with a balloon-expandable valve appears unaffected by its presence., Competing Interests: Dr. Josep Rodés-Cabau has received research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. The other authors do not report any potential conflicts of interest., (Copyright © 2019 Alfredo Nunes Ferreira-Neto et al.)

Background: The use of cocaine as a recreational drug has increased over recent years. In this study, we aimed to analyze the prevalence, and in-hospital and long-term outcomes of acute coronary syndrome (ACS) associated with cocaine consumption (ACS-ACC)., Methods: A prospective observational registry of young patients hospitalised with ACS from 2001 through 2015, we analysed ACS-ACC temporal trends, clinical characteristics, and major adverse cardiovascular events (MACE) during long-term follow-up., Results: There were 8153 admissions with ACS, of whom 864 patients were ≤50-years-old; 59 patients (6.8%) presented with ACS-ACC. The prevalence of patients with a history of cocaine consumption increased to maximum of 18% in 2008 with no variations thereafter (r = 0.74, p < 0.001). The ACS-ACC incidence increased over time from 5% to 9% (r = 0.25, p = 0.07). Compared to patients with ACS not associated with cocaine consumption, the ACS-ACC exhibited a higher incidence of in-hospital ventricular tachycardia (16.9% vs 4.7%, p < 0.001) and trends to in-hospital mortality (3.4% vs 1.0%, p = 0.097); during a median follow-up of 5.6 years, ACS-ACC had higher risk of MACE (HR 1.83; 95% CI 1.04-3.25, p = 0.038), higher risk of myocardial infarction (HR 2.39, 95% CI 1.02-5.60, p = 0.045), and higher risk of cardiovascular mortality (HR 6.26; 95% CI 1.67-23.43, p = 0.006)., Conclusion: Young patients with ACS-ACC carry a high risk of short and long-term major adverse cardiovascular events. Over the 15-year study period, we observed an increasing prevalence of this entity. This trend and its outcomes underscore the need for increased awareness and improved management strategies., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Introduction: Patients with femur fracture benefit from early surgery. Recent reports suggest that regional anesthesia may be superior to general anesthesia in these patients. Early surgery under spinal anesthesia could be performed safely by determining platelet function in patients receiving antiplatelet agents., Methods: Multicenter, randomized, open-label, parallel clinical trial expected to include 156 patients ≥ 18 years of age under chronic treatment with antiplatelet agents who develop a proximal femur fracture., Exclusion Criteria: presence of multiple or pathological fractures, current treatment with vitamin K antagonists or new oral anticoagulants, and congenital or acquired coagulopathy.Patients will be randomized to eitherThe primary endpoint is time (hours) from admission to surgery. Secondary endpoints include: platelet function; postoperative bleeding; medical-surgical complications; perioperative and 1-year mortality; quality of life; length of hospital stay; cost-effectiveness; and cost-utility. Follow-up assessments will be performed during hospital admission and at 1, 6, and 12 months after surgery., Potential Impact of the Study: The determination of platelet function at admission to the emergency department in patients with femoral fracture receiving antiplatelet therapy may permit earlier surgery under spinal anesthesia, thus shortening the hospital stay and reducing the risk of complications. These advantages associated with early surgery could positively impact patient well-being and also reduce treatment-related healthcare costs., Ethics and Dissemination: The study has been approved by the ethics committees at all participating centers. Their results will be disseminated in congresses and published in peer reviewed journals.

Objectives: The authors sought to assess the incidence, predictors, management, and prognosis of acute coronary syndrome (ACS) following TAVR., Background: About one-half of the patients undergoing transcatheter aortic valve replacement (TAVR) have concurrent coronary artery disease (CAD). However, the occurrence and clinical impact of coronary events following TAVR remain largely unknown., Methods: Consecutive patients undergoing TAVR in our institution between May 2007 and November 2017 were included. Patients were followed at 1, 6, and 12 months, and yearly thereafter. ACS was diagnosed and classified according to the Third Universal Definition of Myocardial Infarction., Results: A total of 779 patients (mean age 79 ± 9 years, 52% male, mean STS: 6.8 ± 5.1%) were included, 68% of which had a history of CAD. At a median follow-up of 25 (interquartile range: 10 to 44) months, 78 patients (10%) presented at least 1 episode of ACS, with one-half of the events occurring within the year following TAVR. Clinical presentation was type 2 non-ST-segment elevation myocardial infarction (35.9%), unstable angina (34.6%), type 1 non-ST-segment elevation myocardial infarction (28.2%), and ST-segment elevation myocardial infarction (1.3%). Male sex (hazard ratio [HR]: 2.19; 95% confidence interval [CI]: 1.36 to 3.54; p = 0.001), prior CAD (HR: 2.78; 95% CI: 1.50 to 5.18; p = 0.001), and nontransfemoral approach (HR: 1.71; 95% CI: 1.04 to 2.75; p = 0.035) were independently associated with ACS. Coronary angiography was performed in 53 (67.9%) patients with ACS, and 30 of them (56.6%) underwent percutaneous coronary intervention. In-hospital death rate at the time of the ACS episode was 3.8%. At a median follow-up of 21 (interquartile range: 8 to 34) months post-ACS, all-cause and cardiovascular death rates were 37.3% and 25.3%, respectively., Conclusions: Approximately one-tenth of patients undergoing TAVR were readmitted for an ACS after a median follow-up of 25 months. Male sex, prior CAD, and nontransfemoral approach were independent predictors of ACS. ACS was associated with high midterm mortality., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The preferred management of a cardiac mass remains controversial, but it often includes open-chest surgical excision to obtain an adequate tissue sample for histological workup. We herein report a less invasive approach in which an accurate and timely cytological diagnosis of pericardial angiosarcoma was reached by studying a CT-guided fine-needle aspiration cell block. The cell block showed proliferation of atypical cells with occasional mitotic figures, vasoformative features, and immunoreactivity to WT1, vimentin, CD31, CD34, ERG, and Ki67. Recourse to fine-needle aspiration and cell block study is a valuable diagnostic approach to be considered when a cardiac mass is percutaneously accessible., (Copyright © 2016 Elsevier Inc. All rights reserved.)