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Background: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice., Methods: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year., Results: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively., Conclusions: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.)., (Copyright © 2024 Massachusetts Medical Society.)

Competing Interests: Funding Support and Author Disclosures Dr Mangner has received personal fees from Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, B. Braun, and Boston Scientific outside the submitted work. Dr Fassl has received speaker fees from CSL Behring and Edwards Lifesciences outside the submitted work. Dr Haussig has received speaker honoraria and consulting fees from Edwards Lifesciences, Abbott, and Boston Scientific outside the submitted work. Dr Linke has received grants from Novartis; personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer; and personal fees from Picardia, Transverse Medical, and Claret Medical outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: "valve-in-valve" TAVR (VIV-TAVR) is established and provides good initial clinical and hemodynamic outcomes. Lacking long-term durability data baffle the expand to lower risk patients. For those purposes, the present study adds a hemodynamic 3-years follow-up., Methods: A total of 77 patients underwent VIV-TAVR for failing aortic bioprosthesis during a 7-years period. Predominant mode of failure was stenosis in 87.0%. Patients had a mean age of 79.4 ± 5.8 years and a logistic EuroSCORE of 30.8 ± 15.7%. The Society of Thoracic Surgeons-PROM averaged 5.79 ± 2.63%. Clinical results and hemodynamic outcomes are reported for 30-days, 1-, 2-, and 3-years. Completeness of follow-up was 100% with 44 patients at risk after 3-years. Follow-up ranged up to 7.1 years., Results: Majority of the surgical valves were stented (94.8%) with a mean labeled size of 23.1 ± 2.3 mm and true-ID of 20.4 ± 2.6 mm. A true-ID ≤21 mm had 58.4% of the patients. Self-expanding valves were implanted in 68.8% (mean labeled size 24.1 ± 1.8 mm) and balloon-expanded in 31.2% (mean size 24.1 ± 1.8 mm). No patient died intraoperatively. Hospital mortality was 1.3% and three-years survival 57.1%. All patients experienced an initial significant dPmean-reduction to 16.8 ± 7.1 mmHg. After 3-years mean dPmean raised to 26.0 ± 12.2 mmHg. This observation was independent from true-ID or type of transcatheter aortic valve replacement (TAVR)-prosthesis. Patients with a true-ID ≤21 mm had a higher initial (18.3 ± 5.3 vs. 14.9 ± 7.1 mmHg; p = .005) and dPmean after 1-year (29.2 ± 8.2 vs. 13.0 ± 6.7 mmHg; p = .004). There were no significant differences in survival., Conclusions: VIV-TAVR is safe and effective in the early period. In surgical valves with a true-ID ≤21 mm inferior hemodynamic and survival outcomes must be expected. Nonetheless, also patients with larger true-IDs showed steadily increasing transvalvular gradients. This raises concern about durability., (© 2022 The Authors. Journal of Cardiac Surgery published by 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.)

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.)

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.)

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 Linke has received grants from Novartis; has received personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer; and has stock options from Picardia, Transverse Medical, and Claret Medical, outside the submitted work. Dr Kappert has reported that he has no relationships relevant to the contents of this paper to disclose.

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: 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.)

Objective:  The purpose of this study was to evaluate the impact of chronic obstructive pulmonary disease (COPD) on clinical outcomes in patients referred for transfemoral (TF) as well as transapical (TA) aortic valve implantation and furthermore to delineate possible advantages of the TF access., Methods:  One thousand eight hundred forty-two patients undergoing transcatheter aortic valve implantation (TAVI) at two study centers were included in the present analysis. The outcome was measured and classified according to Valve Academic Research Consortium-II criteria. Kaplan-Meier estimate was used to assess long-term survival., Results:  The present analysis suggests that COPD has limited influence on post-procedural outcome after TAVI. Comparing the TF to TA approach, no significant difference on the impact of COPD on clinical outcomes has been found, except for longer post-procedural ventilation times in COPD patients treated via TA access ( p  < 0.001)., Conclusions:  COPD in patients referred for TAVI procedure was associated with poorer overall long-term survival, thus characterizing a high-risk population for futile treatment; however, the selection of access did not result in a significant difference in most Valve Academic Research Consortium-II-defined clinical outcomes in COPD patients., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions., Background: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far., Methods: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure., Results: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm 2 , mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients., Conclusions: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR)., Background: Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism., Methods: The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled., Results: Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up., Conclusions: The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication., (© 2017 Wiley Periodicals, Inc.)

Aims: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population., Methods and Results: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak., Conclusions: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

Background The ideal approach for transfemoral transcatheter aortic valve implantation is still widely debated. The objective of this study was to compare access and bleeding complications of complete percutaneous versus the surgical cut-down approach for transfemoral transcatheter aortic valve implantation. Methods The study included 667 consecutive patients from November 2008 to December 2016, 466 in the percutaneous group and 201 in the cut-down group. There were no significant differences in baseline characteristics between the 2 groups. Primary study endpoints were vascular access site and bleeding complications according to the Valve Academic Research Consortium II criteria. Results Mean procedure time was shorter in the cut-down group: 93.5 ± 22.0 (percutaneous) vs. 69 ± 19 min (cut-down), p < 0.001. The rate of access complications was higher in the percutaneous group: 20.4% (95/466) vs. 8.5% (17/201), p = 0.037; with predominantly minor complications in the percutaneous cohort: 14.4% (67/466) vs. 2.5% (5/201), p = 0.04. Bleeding complications were more frequent in the percutaneous group: 21.9% (102/466) vs. 4.5% (9/201), p = 0.01. Hospital mortality was 5.2% in the percutaneous group and 1.9% in the cut-down group ( p = 0.075). Conclusions Surgical cut-down provided controlled access and resulted in fewer access site and bleeding complications. Nonetheless, major access complications were not significantly different between the two cohorts. The two approaches must be seen as complementary techniques. A portfolio containing both techniques is the only way to provide a tailor-made and patient-orientated approach ensuring the safest access based on the individual vessel condition.

Objectives: Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR., Methods: The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions., Results: The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation., Conclusions: In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The presence of concomitant mitral (MR) or tricuspid regurgitation (TR) is a common issue in patients undergoing transcatheter aortic valve implantation (TAVI). The objective was (i) to analyse the outcomes of patients with concomitant moderate or more severe MR, (ii) to compare the outcomes with those of TAVI patients without concomitant MR and (iii) to evaluate the impact of TAVI on grade of concomitant MR., Methods: For creating a homogeneous study group, the study was restricted to transapical (TA)-TAVI patients. Since 2008, 615 patients have undergone TAVI at our institution, 386 of these using the TA approach with the Edwards SAPIEN™ bioprosthesis. Out of these, 116 (30.1%) presented with concomitant moderate or more severe MR. Mean logistic European System for Cardiac Operative Risk (EuroSCORE) was 18.1 ± 11.5%, EuroSCORE II 5.4 ± 0.7%. Intra- and post-hospital course, change in grade of MR, TR, right ventricular systolic pressure (RVSP) and tricuspid annular plane systolic excursion (TAPSE) were particularly analysed. Outcomes were compared with those of the remaining TA-TAVI patients (n = 270). Mean follow-up time was 471 ± 391 days, giving a total of 135 patient-years., Results: Three patients (2.6%) died during primary hospital stay. Estimated 1-, 2-, 3- and 4-year survival rates were 76.7, 75.6, 68.3 and 50.6% for study and 78.1, 77.8, 61.1 and 55.0% for control groups, respectively. Postoperative morbidity and mortality did not differ significantly from those of the control group. Postoperatively, a significant reduction in MR (2.1 ± 0.2 to 1.5 ± 0.7; P < 0.01) and TR (1.9 ± 0.5 to 1.5 ± 0.7; P < 0.01) was observed. Likewise, RVSP decreased significantly from 46 ± 16 to 39 ± 15 mmHg (P < 0.01) and TAPSE non-significantly (21.9 ± 7.3 to 19.5 ± 5.5 mm; P = 0.07). After 3-6 months, 68.9% of the patients were at New York Heart Association (NYHA) Class I or II, 25% at Class III and 6.0% downgraded to Class IV. A reason for remaining in NYHA Class III or downgrading to NYHA Class IV could not be detected, and particularly, there was no impact of grade of MR/TR, left ventricular ejection fraction, TAPSE or right ventricular endsystolic pressure (RVESP) on outcomes or NYHA class., Conclusion: TA-TAVI in patients with concomitant moderate or more severe MR provides results comparable with those of TA-TAVI in general. Concomitant MR had no significant impact on the short- and mid-term outcomes. A significant reduction in MR, TR and pulmonary hypertension was observed after TA-TAVI during short-term follow-up. Nonetheless, a relevant number of patients did not experience an improvement in NYHA class., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)