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Aortic valve replacement improves and prolongs lives of patients with aortic valve disease, but requires significant healthcare resources, which are mainly determined by the length of associated hospital stays. Therefore, this study aims to identify risk factors for extended length of stay after surgical aortic valve replacement. Between 2018 and 2023, 458 consecutive patients underwent isolated surgical aortic valve replacement at our center and were included in our analysis. To identify independent predictors for hospital and intensive care unit stay, multivariable linear regression analysis using backward elimination process was performed. Upon multivariable linear regression, endocarditis [regression coefficient (β) 2.98; 95% confidence interval (CI) 1.51, 4.45; p<0.001)] and prior aortic valve surgery (β 1.72; 95% CI 0.18, 3.26; p=0.029) were associated with prolonged hospital stay. Prior aortic valve surgery was associated with prolonged intensive care unit stay (β 0.99; 95% CI 0.39, 1.59; p=0.001) as well as chronic obstructive pulmonary disease (β 1.61; 95% CI 0.66, 2.55; p=0.001), smaller prosthetic valve sizes (β -0.18; 95% CI -0.30, -0.06; p=0.003), preoperative atrial fibrillation (β 1.06; 95% CI 0.32, 1.79; p=0.005), and reduced left ventricular ejection fraction (β -0.03; 95% CI -0.05, -0.01; p=0.006). Pending further validation, structured programs aiming to accelerate intensive care unit and hospital discharge after surgical aortic valve replacement should focus on patients with prior cardiac surgery, atrial fibrillation, and chronic obstructive pulmonary disease. Surgeons should aim to implant large-diameter valves. Furthermore, the identified predictors should be used to discuss surgical versus transcatheter procedures in the interdisciplinary heart team., Competing Interests: CONFLICT OF INTEREST: AS received lecture fees/travel support from Abbott, Boston Scientific, and Edwards Lifesciences. AS is a proctor for Abbott. FUNDING: Till Demal was funded by the Clinician Scientist Programme of the German Center for Cardiovascular Research (Grant number DZHK; FKZ 81X3710109)., (Thieme. All rights reserved.)

Prosthesis-patient mismatch (PPM) is a common phenomenon after transcatheter aortic valve implantation (TAVI), especially in patients with small aortic annuli. Whether factors during implantation, such as the implantation depth, have an impact on the occurrence of PPM is currently unclear. The objectives of our study were to (1) investigate the influence of procedure planning- and implantation-related factors on the occurrence of PPM and (2) evaluate the impact of PPM on long-term mortality after TAVI. Data from 315 patients with small aortic annuli, defined as multidetector computed tomography-derived annulus area <400 mm 2 , treated with transfemoral TAVI between 2014 and 2021 were retrospectively analyzed. TAVI was performed with ballon-expandable valves (BEVs) in 113 and self-expanding valves (SEVs) in 202 cases. PPM was defined according to Valve Academic Research Consortium 3 and follow-up was obtained within 5 years after TAVI. Overall, PPM occurred in 121 patients (38.4%) and was significantly more frequent in patients treated with BEVs (54.9%) than with SEVs (29.2%, p <0.001). Evaluation of planning- and implantation-related factors found that deeper implantation of BEVs significantly increased the risk of PPM (p = 0.014), whereas no association was observed in SEVs. The overall mortality rates at 3 and 5 years were 25.5% and 43.1%, respectively, without significant differences between patients with and without PPM. In conclusion, PPM occurred frequently, especially after BEV implantation. In these patients, implantation depth was identified as a predictor of PPM, whereas no association was found for SEV implantation. In addition, there was no difference in longer-term mortality between patients with and without PPM., Competing Interests: Declaration of competing interest Dr. Voigtlaender-Buschmann reports a relation with German Center for Cardiovascular Research that includes funding grants. Dr. Schofer reports a relation with Edwards Lifesciences and St Jude Medical that includes travel reimbursement; and Boston Scientific that includes: speaking and lecture fees and travel reimbursement. Dr. Conradi reports a relation with Abbott, Medtronic, and JenaValve that includes board membership; Edwards Lifesciences, Boston Scientific, VenusMedtech, MicroPort, PiCardia, MicroInterventions, Neovasc, and Smartcanula Sarl that includes consulting or advisory. Dr. Seiffert reports a relation with JenaValve and Boston Scientific that includes: consulting or advisory; Edwards Lifesciences, JenaValve Technology Inc., Boston Scientific, and Biotronik that includes travel reimbursement; and Medtronic that includes speaking and lecture fees. The remaining authors have no competing interests to declare., (Copyright © 2024. Published by Elsevier Inc.)

Background and Aims: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE., Methods: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD)., Results: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16)., Conclusions: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background:  Systemic inflammation due to cardiogenic shock is associated with vasoplegia leading to organ hypoperfusion, right heart failure, and poor clinical outcome. Extracorporeal cytokine hemoadsorption emerged to attenuate excessive levels of inflammatory cytokines, potentially improving patient outcomes. Nevertheless, its prognostic impact during high-risk left ventricular assist device (LVAD) implantation remains unknown., Methods:  In total, 40 consecutive patients with advanced heart failure underwent continuous-flow LVAD implantation at our institution between 2018 and 2020. Out of 25 high-risk patients in cardiogenic shock (Interagency Registry for Mechanically Assisted Circulatory Support profile 1 and 2), 9 patients ( CytoSorb group ) underwent LVAD implantation with and 16 patients ( control group ) without simultaneous cytokine hemoadsorption during cardiopulmonary bypass. Besides preoperative patient characteristics, postoperative lactate clearance, vasopressor administration and mean arterial pressure, perioperative complication, and 30-day mortality rates were retrospectively analyzed., Results:  Apart from an increased rate of reoperations within the CytoSorb group, baseline characteristics including the severity of ventricular dysfunction and consecutive signs of end-organ failure were similar in both groups. Preoperative short-term mechanical circulatory support bridging was comparable (66.7 vs. 75%; p  = 0.66) prior to LVAD implantation. Procedural characteristics including intraoperative volume management and postoperative vasopressor administration were similar in both groups. There was no difference regarding postoperative lactate clearance, although postoperative mean arterial pressure was significantly higher in the control group (71.3 vs. 57.4 mm Hg; p  < 0.01). Furthermore, the 30-day mortality rate was significantly higher in the CytoSorb group (33.3 vs. 0.0%; p  = 0.01)., Conclusion:  Extracorporeal cytokine hemoadsorption during high-risk LVAD implantation was not associated with a decrease of postoperative vasopressor support, improved hemodynamics, or an accelerated lactate clearance., Competing Interests: A.M.B declared personal fees from Abbott, Abiomed, AstraZeneca, BerlinHeart, and Medtronic. H.R. declared travel grants from Abbott and Medtronic. Additionally, here are no further disclosures., (Thieme. All rights reserved.)

Background: Previous reports suggest septal hypertrophy with an interventricular septum depth (IVSD) ≥ 14 mm may adversely affect outcomes after transcatheter aortic valve implantation (TAVI) due to suboptimal valve placement, valve migration, or residual increased LVOT pressure gradients., Aims: This analysis investigates the impact of interventricular septal hypertrophy on acute outcomes after TAVI., Methods: Between 2009 and 2021, 1033 consecutive patients (55.8% male, 80.5 ± 6.7 years, EuroSCORE II 6.3 ± 6.5%) with documented IVSD underwent TAVI at our center and were included for analysis. Baseline, periprocedural, and 30-day outcome parameters of patients with normal IVSD (< 14 mm; group 1) and increased IVSD (≥ 14 mm; group 2) were compared. Data were retrospectively analyzed according to updated Valve Academic Research Consortium-3 (VARC-3) definitions. Comparison of outcome parameters was adjusted for baseline differences between groups using logistic and linear regression analyses., Results: Of 1033 patients, 585 and 448 patients were allocated to groups 1 and 2, respectively. There was no significant difference between groups regarding transfemoral access rate (82.6% (n = 478) vs. 86.0% (n = 381), p = 0.157). Postprocedural mean transvalvular pressure gradient was significantly increased in group 2 (group 1, 7.8 ± 4.1 mmHg, vs. group 2, 8.9 ± 4.9 mmHg, p = 0.046). Despite this finding, there was no significant difference between groups regarding the rates of VARC-3 adjudicated composite endpoint device success (90.0% (n = 522) vs. 87.6% (n = 388), p = 0.538) or technical success (92.6% (n = 542) vs. 92.6% (n = 415), p = 0.639). Moreover, the groups showed no significant differences regarding the rates of paravalvular leakage ≥ moderate (3.1% (n = 14) vs. 2.6% (n = 9), p = 0.993), postprocedural permanent pacemaker implantation (13.4% (n = 77) vs. 13.8% (n = 61), p = 0.778), or 30-day mortality (5.1% (n = 30) vs. 4.5% (n = 20), p = 0.758)., Conclusion: Although transvalvular mean pressure gradients were significantly higher in patients with increased IVSD after TAVI, acute outcomes were comparable between groups suggesting no early impact of adverse hemodynamics due to elevated IVSD. However, how these differences in hemodynamic findings may affect mid- and long-term outcomes, especially in terms of valve durability, needs to be evaluated in further investigations., (© 2024. The Author(s).)

Background: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI., Aims: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV)., Methods: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions., Results: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation., Conclusions: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Objectives: Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients., Methods: Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions., Results: Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented., Conclusion: Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³., (© 2023 Wiley Periodicals LLC.)

Introduction: Despite increasing use of transcatheter approaches, endoscopic mitral valve surgery (MVS) remains an established option for treatment of mitral regurgitation (MR). Nevertheless, as perioperative risk increases with age, outcome of endoscopic MVS in elderly patients is uncertain., Methods: We retrospectively analyzed 756 consecutive patients with MR ≥2, who underwent minimally-invasive MVS at our institution between 2016 and 2022. Patients were stratified by age ≥75 (elderly-group; n  = 91) or <75 years (control-group; n  = 665). All patients received endoscopic MVS via right anterolateral minithoracotomy with non-rib spreading soft tissue retraction and 3D-camera visualization., Results: Overall surgical risk was increased in the elderly-group (median age of 77 (76-80) years vs. 58 (51-67) years, p  < 0.001) with STS-PROM Scores of 1.9% vs. 0.4% ( p  < 0.001) and increased prevalence of hypertension, diabetes, coronary artery disease and atrial fibrillation (AFib). Elderly patients were also more symptomatic ( N YHA class III 45.7% vs. 29.8%; p  = 0.002). Axillo-femoral perfusion was more frequently used in the elderly-group (27.5% vs. 4.2%; p  < 0.001). Cross-clamp and cardiopulmonary bypass times were similar. Rate of MV repair was 85.7% vs. 93.8% ( p  = 0.005). Closure of the left atrial appendage was more frequently performed in the elderly-group (45.1% vs. 23.9%; p  < 0.001), whereas rate of concomitant tricuspid valve repair was similar (11.0% vs. 8.9%; p  = 0.511). Postoperative complications including perioperative hemodialysis (3.3% vs. 2.9%; p  = 0.739), low cardiac output (5.3% vs. 3.8%; p  = 0.393), perioperative stroke (1.1% vs. 0.15%; p  = 0.224) and myocardial infarction (0% vs. 0.15%) were favorably low in both groups. Acute mortality at 30 days was 2.2% vs. 0.4% ( p  = 0.112)., Conclusion: Despite increased prevalence of outcome-relevant comorbidities and surgical risk, perioperative outcome of patients aged ≥75 years undergoing endoscopic MVS is favorable. Therefore, endoscopic MVS is a valuable therapeutic option for selected elderly patients and should be taken in consideration during routine heart-team discussion., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor [PD] declared a past co-authorship with the author(s) [ODB, HR, LC]., (© 2023 Pausch, Bhadra, Hua, Stolfa, Kuhlmann, Voß, Girdauskas, Reichenspurner and Conradi.)

Background: Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention., Aim: We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures., Materials and Methods: Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions., Results: At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients., Conclusion: The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment., Competing Interests: AS received speaker honoraria from Abbott. LC is an advisory board member for Abbott, Medtronic, JenaValve, and MicroPort and has received honoraria from Edwards Lifesciences, Boston Scientific, Neovasc, Highlife, PiCardia, and MicroInterventions. MS received speaker honoraria from Abbott Vascular, Abiomed, Amgen, AstraZeneca, Boston Scientific, BMS/Pfizer, Daiichi Sankyo, Edwards Lifesciences, Inari, Medtronic, Philips, Shockwave Medical, and Siemens. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Schaefer, Demal, Bhadra, Grundmann, Voigtläender, Waldschmidt, Schirmer, Pecha, Schneeberger, Schofer, Sörensen, Blankenberg, Reichenspurner, Seiffert and Conradi.)

Transcatheter aortic valve replacement (TAVR) is an established therapy for severe, symptomatic aortic valve stenosis even in patients with impaired left ventricular systolic function. However, there is uncertainty on the clinical effectiveness of the currently available TAVR devices in patients with reduced left ventricular ejection fraction (LVEF). The LOSTAVI (Low Systolic function and Transcatheter Aortic Valve Implantation) registry is a retrospective observational study using baseline, procedural, discharge, and long-term follow-up details. A total of 3 groups of interest were distinguished: extremely reduced LVEF (<25%), severely reduced LVEF (25% to 30%), and reduced LVEF (31% to 35%). Unadjusted and adjusted analyses were carried out for in-hospital and follow-up outcomes. A total of 923 patients were included from 12 centers, with 146 patients (16%) with LVEF <25%, 425 (46%) with LVEF 25% to 30%, and 352 (38%) with LVEF 31% to 35%. Several baseline and procedural features were different across groups, including age, risk, functional class, and prevalence of bicuspid disease (all p <0.05). In-hospital mortality was similar in the 3 groups (7 [4.8%], 18 [4.2%], and 7 [2.0%], respectively, p = 0.661), but major adverse events were more common in those with extremely reduced and severely reduced LVEF (19 [13%], 53 [13%], and 25 [7.1%], respectively, p = 0.024). The 12-month follow-up confirmed the significant detrimental impact of reduced LVEF on both death (21 [14%], 49 [12%], and 25 [7.1%], respectively, p = 0.024) and major adverse events (37 [25%], 89 [21%], and 53 [15%], respectively, p = 0.016). The adjusted analysis confirmed the significant prognostic role of LVEF on both outcomes, whereas TAVR device type was not associated with death or major adverse events (all p >0.05). In conclusion, TAVR yields favorable early and 1-year results in patients with reduced LVEF, including those with extremely depressed systolic dysfunction. However, reduced LVEF still represents a major adverse prognostic factor for both short- and mid-term outcomes., Competing Interests: Declaration of Competing Interest Dr. Biondi-Zoccai has consulted for Amarin, Balmed, Cardionovum, Crannmedical, Endocore Lab, Eukon, Innovheart, Guidotti, Meditrial, MicroPort, Opsens Medical, Terumo, and Translumina. Lars Sondergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Dr. Schaefer has received speaker honoraria from Abbott. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: There are several surgical approaches for explanting a left ventricular assist device (LVAD) after recovery of cardiac function. Thus, remaining ventricular assist device components may bear significant risks of infection or thrombosis. We hereby report our technique and two-center experience with explantation of LVADs using a new double-patch technique., Methods: From March 2019 to April 2021, five patients underwent LVAD explantation after myocardial recovery (HVAD, n = 2; HeartMate 3, n = 3). The mean patient age was 50.3 years (100% male); the mean time on the LVAD was 23.1 ± 20.8 months. The aetiology of the primary heart failure was dilated cardiomyopathy (n = 4) and myocarditis (n = 1).LVAD explantation was performed using a median sternotomy and cardiopulmonary bypass. The LVAD was stopped, and the outflow graft was clamped. The outflow graft was ligated and sutured close to the aortic anastomosis. The driveline was clipped and removed. Under induced fibrillation, the attachment of the LVAD was released from the apical cuff and the LVAD was removed. A round pericardial patch was fixed from the inner of the ventricle. This step sealed the apex of the heart. An additional Gore-Tex patch was continuously sutured epicardially over the suture ring., Results: The 5 cases showed technically uncomplicated explantation of the LVADs. During the follow-up of a mean of 16.4 ± 16.9 months, we observed 100% survival. There were no bleeding complications or thromboembolic events during the follow-up period., Conclusions: LVAD explantation with the double-patch technique is feasible and safe. This technique allows discontinuation of anticoagulation. The 30-day survival was 100%. Further studies are needed to provide better evidence for LVAD explantation and long-term follow-up., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Objectives: Implantation of implantable cardioverter defibrillators (ICD) reduces the risk of all-cause mortality in symptomatic heart failure (HF) patients with severe left ventricular (LV) dysfunction. Nevertheless, the prognostic impact of ICD therapy in continuous flow left ventricular assist device (LVAD) recipients remains controversial., Methods: 162 consecutive HF patients, who underwent LVAD implantation at our institution between 2010 and 2019, were categorized according to the presence ( n  = 94, ICD-group ) or absence ( n  = 68, Control-group) of ICDs. Apart from clinical baseline and follow-up parameters, adverse events (AEs) related to ICD therapy and overall survival rates were retrospectively analyzed., Results: Out of 162 consecutive LVAD recipients 79 patients (48.8%) were preoperatively categorized as Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile ≤2. The prevalence of severe HF symptoms and preoperative use of short-term circulatory support devices (54.4% vs. 13.8%, p  < 0.001) was higher within the Control-group, although baseline severity of LV and RV dysfunction was similar. Apart from an increased prevalence of perioperative right heart failure (RHF) within the Control-group (45.6% vs. 17.0%; p  < 0.001), procedural characteristics and perioperative outcome were similar. Overall-survival during a median follow-up of 14 (3.0-36.5) months was similar within both groups ( p  = 0.46). During the first 2 years after LVAD implantation 53 ICD-related AEs occurred within the ICD-group. Thereof, lead-dysfunction occurred in 19 patients and unplanned ICD-reintervention in 11 patients. Furthermore, in 18 patients appropriate shocks without loss of consciousness occurred, whereas inappropriate shocks occurred in 5 patients., Conclusion: ICD therapy in LVAD recipients was not associated with a survival benefit or reduced morbidity after LVAD implantation. Conservative ICD-programming seems to be justified to avoid ICD-related complications and "awake shocks" after LVAD implantation., Competing Interests: TT declared consulting activity for Medtronic and Boston Scientific, as well as speaker honorarium from Medtronic. YY and SP declared consulting activity for Medtronic and Philips Medical. HR declared travel grants and speaker honoraria from Abbott and Abiomed. AB declared consulting activity for Abiomed, as well as travel grants and speaker honoraria from Abbott and Abiomed., (© 2023 Pausch, Mersmann, Bhadra, Barten, Tönnis, Yildirim, Pecha, Reichenspurner and Bernhardt.)

Background: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown., Objectives: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology., Methods: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery., Results: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years., Conclusions: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes., Competing Interests: Funding Support and Author Disclosures Dr Bhadra has received travel compensation from Edwards Lifesciences. Dr Tagliari has received research support from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. Dr Leurent has been a consultant and physician proctor for and has received speaker honoraria from Abbott. Dr Asgar has been a consultant for Medtronic, Abbott, Edwards Lifesciences, and W. L. Gore & Associates; and has received research grants from Abbott. Dr Leroux has been a physician proctor for Medtronic and Abbott; and a consultant for Edwards Lifesciences. Dr Dumonteil has received speaker honoraria and travel reimbursement by Edwards Lifesciences; and has been a physician proctor and consultant for Edwards Lifesciences. Dr Geirsson has been a member of the Medtronic Strategic Surgical Advisory Board. Dr Wyler von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Reardon has been a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Nazif has equity in Venus Medtech; and has received consulting fees or honoraria from Keystone Heart, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Kaneko has been a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and has been a consultant for 4C Medical. Dr Modine has been a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has been a consultant for InnovHeart. Dr Tang has been a physician proctor for Medtronic; a consultant for Medtronic, Abbott, and NeoChord; and a physician advisory board member for Abbott, Boston Scientific and JenaValve; and has received speaker honoraria from Siemens Healthineers and East End Medical. 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: Ejection time (ET), acceleration time (AT) and time between left ventricular and aortic systolic pressure peaks (T-LVAo) might be of diagnostic and prognostic use in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI)., Aim: We aimed to assess the diagnostic value and prognostic impact of invasively measured ET, AT, and T-LVAo in patients undergoing TAVI., Methods: A total of 1274 patients received invasive measurement of ET, AT and T-LVAo prior to TAVI. Anatomic AS severity was assessed by CT-derived aortic valve calcification density (AVC d ). Impact on all-cause mortality was retrospectively analyzed., Results: In multivariable linear regression, T-LVAo showed the strongest correlation with AVC d . No prognostic impact of T-LVAo was found according to uni- and multivariable analyses. In contrast, using an individual C-statistic derived cutoff (C D ), patients with ET or AT ≥ C D showed lower mortality rates compared to patients with ET or AT < C D (1-year mortality: ET ≥ vs. < C D : 15.01vs. 33.1%, AT ≥ vs < C D 16.3 vs. 26.5%, p < 0.001). Moreover, multivariable analysis identified ET ≥ C D (HR 0.61 [95% CI 0.43-0.87; p < 0.007]) to be associated with beneficial outcome after TAVI, independent from clinical risk factors and echocardiography-derived parameters., Conclusion: Among the studied hemodynamic parameters T-LVAo provides the highest diagnostic value, whereas ET is an outcome predictor beyond clinical risk factors and echocardiographic parameters in AS patients following TAVI. These parameters could be of considerable use in diagnostic evaluation and risk assessment of patients scheduled for TAVI. T-LVAo (yellow): defined as time between left ventricular and aortic systolic pressure peaks. ET (green): Ejection Time defined as time from the start to flow end. AT (orange): Acceleration time defined as time from the start to the peak flow. AOP: aortic pressure, AVC: aortic valve calcification, CI: confidence interval, HGAS: high-gradient aortic stenosis, LGAS: low-gradient aortic stenosis, LVP: left ventricular pressure, SD: standard deviation., (© 2023. The Author(s).)

Background: Beneficial results of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients at all risk strata have led to substantial changes in guideline recommendations for valvular heart disease., Aim: To examine influence of these guideline changes on a real-world TAVI cohort, we evaluated how risk profiles and outcomes of TAVI patients developed in our single-center patient cohort over a period of 12 years., Methods: Baseline, procedural and 30-day outcome parameters of TAVI patients were retrospectively compared between three time periods (period 1: 2008-2012, period 2: 2013-2017, period 3: 2018-2020)., Results: Between 03/2008 and 12/2020, a total of 3678 patients underwent TAVI at our center. The median age was 81.1 years (25th, 75th percentile: 76.7, 84.9) with no significant change over time. The EuroSCORE II showed a continuous and significant decline from 5.3% (3.3, 8.6) in period 1 to 2.8% (1.7, 5.0) in period 3 (p < 0.001). Furthermore, rates of permanent pacemaker implantation, acute kidney injury, and paravalvular leakage ≥ moderate continuously declined over time. Accordingly, the 30-day mortality fell from 9.3% in period 1 to 4.3% in period 3 (p < 0.001)., Conclusion: Despite substantial guideline alterations, median patient age remained largely unchanged in our TAVI cohort over the past 12 years. Therefore, increased age still appears to be the main reason to choose TAVI over SAVR. However, risk profiles declined substantially. Significant improvements in early outcomes suggest favorable influence of less invasive access routes, improved device platforms and growing user experience., (© 2023. The Author(s).)

Background: Patients with chronic hemodialysis due to end-stage renal disease (ESRD) or severely impaired kidney function (CKD) constitute a relevant share of patients undergoing trans-catheter aortic valve implantation (TAVI). However, data on specific challenges and outcomes remain limited., Aim: We aimed to characterize this patient population, evaluate clinical results and assess the significance of calcification patterns., Methods: This retrospective single-center analysis evaluated 2,712 TAVI procedures (2012-2019) according to baseline renal function: GFR < 30 ml/min/1.73m 2 (CKD; n = 210), chronic hemodialysis (ESRD; n = 119) and control (CTRL; n = 2383). Valvular and vascular calcification patterns were assessed from contrast-enhanced multi-detector computed tomography. Outcomes were evaluated in accordance with the VARC-2 definitions., Results: Operative risk was higher in ESRD and CKD vs. CTRL (STS-score 8.4% and 7.6% vs. 3.9%, p < 0.001) and patients with ESRD had more severe vascular calcifications (49.1% vs. 33.9% and 29.0%, p < 0.01). Immediate procedural results were similar but non-procedure-related major/life-threatening bleeding was higher in ESRD and CKD (5.0% and 5.3% vs. 1.6%, p < 0.01). 3-year survival was impaired in patients with ESRD and CKD (33.3% and 35.3% vs. 65.4%, p < 0.001). Multivariable analysis identified ESRD (HR 1.60), CKD (HR 1.79) and vascular calcifications (HR 1.29) as predictors for 3-year and vascular calcifications (HR 1.51) for 30-day mortality., Conclusion: Patients with ESRD and CKD constitute a vulnerable patient group with extensive vascular calcifications. Immediate procedural results were largely unaffected by renal impairment, yielding TAVI a particularly valuable treatment option in these high-risk operative patients. Mid-term survival was determined by underlying renal disease, cardiovascular comorbidities, and vascular calcifications as a novel risk marker., (© 2021. The Author(s).)

Background: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs. surgical axillary approaches for TAVI., Methods: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses., Results: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs. 4.2%, P<0.001), leading to more common use of covered stent implantation (13.2% vs. 3.7%, P<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], P=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], P=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], P=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], P=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], P=0.038)., Conclusions: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.

Objectives: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota)., Background: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting., Methods: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes., Results: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157)., Conclusions: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objective: Subannular mitral valve (MV) repair techniques have been developed to address increased rates of recurrent mitral regurgitation (MR) in patients with secondary MR (SMR) type IIIb. Endoscopic papillary muscle relocation (PMR) is feasible via minithoracotomy. Nevertheless, the periprocedural outcome of patients with severe left ventricular (LV) dysfunction remains unknown. Methods: A total of 98 consecutive patients with SMR type IIIb underwent PMR at our institution. Due to concomitant coronary artery bypass grafting, 62 patients underwent sternotomy and were excluded from the current analysis, whereas 36 patients were treated by a minimally invasive technique using 3-dimensional endoscopy. Of these, 18 patients had severely depressed LV ejection fraction (LVEF) ≤35% (study group) and were compared to the remaining 18 patients with LVEF >35% (control group). Periprocedural outcome was retrospectively analyzed. Results: Although LVEF was significantly worse in the study group (30% ± 4% vs 43% ± 6%, P  < 0.001), the severity of SMR and the degree of MV leaflet tethering were similar. The prevalence of concomitant procedures and the duration of surgery, cardiopulmonary bypass, and aortic cross-clamp were comparable. Periprocedural low cardiac output syndrome was favorably low in both groups (16.7% vs 5.6%, P  = 0.29). Postoperative ventilation time (5.7 h [4.2 to 8.7 h] vs 6.0 h [4.6 to 9.8 h], P  = 0.43) and duration of intensive care unit stay (2 days [1 to 3 days] vs 2 days [1 to 3 days], P  = 0.22) were similar. There was no 30-day mortality in either group. Conclusions: Standardized endoscopic PMR resulted in favorable periprocedural outcomes in patients with severe LV dysfunction, suggesting that minimally invasive surgery can safely be extended to this patient population.

Objectives: The major drawback of isolated annuloplasty for treatment of secondary mitral regurgitation (SMR) with restricted leaflet motion during systole (type IIIb) is the recurrence of SMR, leading to adverse clinical outcome. Additional papillary muscle relocation (PMR) specifically addresses leaflet tethering to restore mitral valve geometry. We aimed to compare the 2-year outcome of annuloplasty with additional PMR vs isolated annuloplasty., Methods: A total of 105 consecutive type IIIb SMR patients with preoperative left ventricular (LV) ejection faction <45%, left ventricular end-diastolic diameter >55 mm and a tenting height >10 mm reached 2-year postoperative follow-up after mitral valve repair and were included in the current analysis. A total of 51 patients underwent annuloplasty and additional PMR (study group). A total of 54 patients underwent isolated annuloplasty (control group). Primary composite study end point comprised death or recurrence of mitral regurgitation ≥2 at 2 years postoperatively., Results: Echocardiographic baseline variables indicating the severity of LV dysfunction and mitral leaflet tethering were similar. Procedural and periprocedural outcome was comparable in both groups. The primary composite end point was significantly improved in the study group (19.6% [10/51]) in comparison to the control group (44.4% [24/54]; P = 0.009). Two-year all-cause mortality was 7.8% [4/51] in the study group vs 18.5% [10/54] in the control group (P = 0.098). After 2 years, a significant improvement in New York Heart Association functional class as compared to the baseline values was observed in the study group., Conclusions: Additional PMR to treat SMR type IIIb resulted in an improved 2-year outcome in comparison to isolated annuloplasty. PMR specifically addressing mitral leaflet tethering represents a valid therapeutic option for heart failure patients with SMR type IIIb., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

As valve-in-valve (ViV) transcatheter aortic valve implantation is still an evolving method, we evaluated the development of early and midterm outcomes after ViV and conventional redo-surgical aortic valve replacement (SAVR) over the past 2 decades. In-hospital databases were retrospectively screened for patients ≥60 years treated for failing bioprosthetic aortic valves at our center. Clinical and follow-up characteristics were compared between patients who underwent ViV or redo-SAVR according to valve academic research consortium-2 (VARC-2) definitions. The comparison of outcome parameters was adjusted for baseline differences between groups. Between June 2002 and April 2020, 209 patients with ViV and 65 redo-SAVR patients met inclusion criteria. No significant differences were found in 30 days (ViV 3.8%, SAVR 3.1%, p = 0.778) or 6-month mortality (ViV 14.0%, SAVR 7.5%, p = 0.283). As patients with ViV less frequently experienced acute kidney injury (stage II or III) and life-threatening bleeding, they more frequently reached the 30-day VARC-2 combined safety end point (79.2% vs 61.5%, odds ratio [OR] 2.540, p = 0.023). Patients with ViV less frequently reached clinical efficacy (68.3% vs 84.6%, OR 0.408, p = 0.041) and device success (79.9% vs 92.3%, OR 0.311, p = 0.040) end points, because of higher frequency of postprocedural transvalvular gradients >20 mm Hg. However, over the past decade, VARC-2 clinical efficacy and device success rates continuously increased in ViV cases. In conclusion, ViV and SAVR were associated with similar acute mortality and different beneficial and adverse outcome profiles in this single-center cohort. Results after ViV procedures have continuously improved over the past years., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Despite continuous improvements in transcatheter aortic valve implantation (TAVI), periprocedural strokes remain a devastating complication. Randomized controlled trials failed to demonstrate a reduction in clinically apparent strokes or mortality after TAVI due to cerebral embolic protection (CEP). To identify potential targets of CEP strategies during TAVI, we evaluated affected brain regions, and temporal patterns of stroke onset in a routine clinical sample., Methods and Results: A total of 3,164 consecutive patients treated with TAVI from 2008 to 2019 at a single center were screened for cerebrovascular events. Affected cerebral regions were determined according to clinical symptoms and brain imaging. Rates of disabling stroke and non-disabling stroke at 30 days were 2.2% and 1.4%, respectively. The frequency of all strokes decreased from 5.0% to 3.0% over time (P = .012). Patients with impaired left-ventricular function (OR 2.19), increased CHA2DS2-VASc (OR 1.39) and moderate/severe spontaneous echo contrast (OR 3.60) had a higher stroke risk. Acute symptom onset occurred during TAVI (19.4%), within 24 hours (40.3%) or later (25.0%); 98.3% of strokes were of ischemic origin. In intraprocedural strokes, 53.2% of lesions were found in locations considered protected by current CEP devices, and 37.5% of patients with intraprocedural strokes were exclusively affected in these areas. Baseline or procedural parameters were not associated with embolic distribution patterns., Conclusions: Most strokes occurred early after TAVI - but not necessarily during the procedure - and affected multiple brain regions only partially protected by current CEP devices. Efficient prevention of cerebrovascular events may require strategies beyond the TAVI procedure to minimize stroke risk and additional randomized controlled trials will be required to clarify the role of CEP in efficient stroke prevention during TAVI., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: Transcatheter aortic valve implantation (TAVI) is routinely performed in patients with severe aortic stenosis (AS). For patients with pure non-calcified aortic regurgitation (AR) who are not suitable for open heart surgery no clear recommendations exist and use of TAVI has been largely off-label. We herein report a series of patients treated with the self-expandable AcurateNeo and Neo2 (Boston Scientific Co., Marlborough, MS, USA) transcatheter heart valve (THV) for pure AR. Methods: Between 05/2017 and 03/2021, 9 patients (88.8% female, 74.4 ± 7.1 years, logEuroSCORE II 5.5 ± 3.6%, STS PROM 6.2 ± 3.0%) received transfemoral (TF) TAVI for pure non-calcified AR following an adjusted valve sizing algorithm. Data were retrospectively analyzed according to updated Valve Academic Research Consortium (VARC-2) definitions. Results: Device success was 100%. Early safety was 77.7% (7/10), due to two (22.2%) cases of acute kidney injury. Thirty-day mortality was 0%, in seven (77.7%) patients no or trace paravalvular leakage (PVL) was seen and mild PVL in two (22.2%) patients at 30-day follow-up. No permanent pacemaker (PPM) was required during 30-day follow-up. Conclusion: In this series of selected patients using the Acurate neo THV for pure non-calcified AR, safety and efficacy were demonstrated. Thirty-day mortality as well as PPM implantation and PVL rates showed excellent results in this high-risk patient cohort. These results will have to be confirmed in larger patient cohorts., Competing Interests: MS reports lecture fees and travel expenses from Boston Scientific. LC is advisory board member for Boston Scientific. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Schneeberger, Seiffert, Schaefer, Bhadra, Schofer, Pecha, Westermann, Blankenberg, Reichenspurner and Conradi.)

Objectives: This study aimed to assess the clinical outcome of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (BASILICA) technique in a single-center patient cohort considered at high or prohibitive risk of transcatheter aortic valve implantation (TAVI)-induced coronary obstruction., Methods: Between October 2019 and January 2021, a total of 15 consecutive patients (age 81.0 [78.1, 84.4] years; 53.3% female; EuroSCORE II 10.6 [6.3, 14.8] %) underwent BASILICA procedure prior to TAVI at our institution. Indications for TAVI were degeneration of stented (n = 12, 80.0%) or stentless (n = 1, 6.7%) bioprosthetic aortic valves, or calcific stenosis of native aortic valves (n = 2, 13.3%), respectively. Individual risk of TAVI-induced coronary obstruction was assessed by pre-procedural computed tomography analysis. Procedural and 30-day outcomes were documented in accordance with Valve Academic Research Consortium (VARC)-2 criteria., Results: BASILICA was attempted for single left coronary cusp in 12 patients (80.0%), for single right coronary cusp in 2 patients (13.3%), and for both cusps in 1 patient (6.7%), respectively. The procedure was feasible in 13 patients (86.7%) resulting in effective prevention of coronary obstruction, whilst TAVI was performed without prior successful bioprosthetic leaflet laceration in two patients (13.3%). In one of these patients (6.7%), additional chimney stenting immediately after TAVI was performed. No all-cause deaths or strokes were documented after 30 days., Conclusion: The BASILICA technique appears to be a feasible, safe and effective concept to avoid iatrogenic coronary artery obstruction during TAVI in both native and bioprosthetic valves of patients at high or prohibitive risk. ClinicalTrials.gov Identifier: NCT04227002 (Hamburg AoRtic Valve cOhoRt)., (© 2021. The Author(s).)

Background: Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. The outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF., Aims: The aim of this study was to evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF., Methods: In total, 81 cases of BVF VIV-TAVI (BVF group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control group)., Results: VARC-2-defined device success was 93% in the BVF group and 68.4% in the control group (p<0.001). The mean transvalvular gradient decreased from 37±13 mmHg to 10.8±5.9 mmHg (p<0.001) in the BVF group and from 35±16 mmHg to 15.8±6.8 mmHg (p<0.001) in the control group with a significantly higher final gradient in the control group (p<0.001). The transvalvular gradients did not change significantly over time. In-hospital major adverse events occurred in 3.7% in the BVF group and 7.6% in the control group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors of lower transvalvular gradients., Conclusions: Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors of lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.

Objectives: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR)., Background: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing., Methods: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers., Results: Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients., Conclusions: BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients., (© 2021 Wiley Periodicals LLC.)

[Figure: see text].

Background: Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated., Methods: This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored., Results: For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p < 0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p < 0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p < 0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed., Conclusions: We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes., Methods and Results: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge., Conclusions: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality., (© 2020 Wiley Periodicals LLC.)

Aims: The aim of this study was to assess the prognostic value of the H 2 FPEF score in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF)., Methods and Results: In this multicentre study, a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H 2 FPEF score. Patients were dichotomized according to low (0-5 points; n = 570) and high (6-9 points; n = 262) H 2 FPEF scores. Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H 2 FPEF score. We observed a decrease in stroke volume index (-2.04 mL/m 2 /point) and mean transvalvular gradients (-1.14 mmHg/point) with increasing H 2 FPEF score translating into a higher prevalence of paradoxical low-flow, low-gradient AS among patients with high H 2 FPEF score. One year after TAVI, the rates of all-cause (low vs. high H 2 FPEF score: 8.0% vs. 19.4%, P < 0.0001) and cardiovascular (CV) mortality (1.9% vs. 9.0%, P < 0.0001) as well as the rate of CV mortality or rehospitalization for congestive heart failure (6.4% vs. 23.2%, P < 0.0001) were higher in patients with high H 2 FPEF score compared with those with low H 2 FPEF score. After multivariable analysis, a high H 2 FPEF score remained independently predictive of all-cause mortality [hazard ratio 1.59 (1.28-2.35), P = 0.018] and CV mortality or rehospitalization for congestive heart failure [hazard ratio 2.92 (1.65-5.15), P < 0.001]. Among the H 2 FPEF score variables, atrial fibrillation, pulmonary hypertension, and elevated left ventricular filling pressure were the strongest outcome predictors., Conclusions: The H 2 FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H 2 FPEF score is associated with the presence of paradoxical low-flow, low-gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H 2 FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: The relevance of spontaneous echo contrast (SEC) and left atrial appendage thrombus (LAAT) in patients undergoing transcatheter aortic valve implantation (TAVI) remains unclear. In this study, we aimed to assess the prevalence of SEC and LAAT and evaluate the impact on periprocedural outcome after TAVI., Methods and Results: A total of 2,549 consecutive patients underwent TAVI between 2008 and 2017. After exclusion of cases with insufficient imaging, concomitant procedures or severe intraprocedural complications, 1,558 cases were analysed. Three groups were defined according to (pre)thrombotic formations - moderate or severe SEC (n=89), LAAT (n=53), and reference (n=1,416). The primary outcome was disabling ischaemic stroke within 24 hours. The prevalence was 4.4% for LAAT and 5.4% for moderate/severe SEC. The primary outcome occurred more frequently in patients with moderate/severe SEC (6.8%) compared to the reference (2.1%) and LAAT (1.9%) groups (p=0.020). SEC was identified as an independent risk factor for the primary outcome (OR 3.54 [95% CI: 1.30-9.61], p=0.013). LAAT was associated with an impaired unadjusted one-year survival (43.4%) compared to the SEC (27.3%) and reference groups (18.7%, p<0.001)., Conclusions: SEC and LAAT were detected in a relevant number of patients undergoing TAVI. SEC may represent an important risk factor for intraprocedural stroke; increased mortality was observed in patients with LAAT.

Background: Compared to high gradient aortic stenosis (AS), patients with low-flow, low-gradient AS have higher mortality after transcatheter aortic valve replacement (TAVR), but distinct outcome predictors in this patient subset are yet to be determined. The present study investigated the prognostic impact of aortic valve calcification (AVC) in patients with low-flow, low-gradient AS undergoing TAVR., Methods: This retrospective single-center analysis includes all patients undergoing TAVR for severe low-flow, low-gradient AS (n = 526), ie, low EF low gradient AS (LEF-LG AS; n = 290) and paradoxical low-flow, low-gradient AS (PLF-LG AS; n = 236), in whom AVC was quantified from contrast-enhanced multislice computed tomography images. AVC density was defined as calcium volume per annulus area. Patients were trichotomized according to sex-specific AVC density tertiles in both subgroups. All-cause mortality was assessed by Kaplan-Meier analyses and independent outcome predictors were determined by multivariable analyses., Results: In both subgroups, patients with high AVC density had higher mean transvalvular gradients at baseline and higher rates of PVL after TAVR. High AVC density was associated with lowest 1- and 3-year mortality after TAVR in the LEF-LG AS but not in the PLF-LG AS group. According to multivariable analysis AVC density was independently associated with better survival in LEF-LG AS patients (HR 0.73 [0.60-0.88], P = .0011), but not in those with PLF-LG AS (HR 0.91 [0.73-1.14], P = .42)., Conclusions: Quantification of AVC may not only be of diagnostic but also of prognostic value, as it facilitates the selection of LEF-LG AS patients with higher probability of beneficial outcome after TAVR., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices., Background: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR., Methods: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles., Results: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation., Conclusions: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices., (Copyright © 2019. Published by Elsevier Inc.)

Objective: Hepatitis delta virus (HDV) was shown to persist for weeks in the absence of HBV and for months after liver transplantation, demonstrating the ability of HDV to persevere in quiescent hepatocytes. The aim of the study was to evaluate the impact of cell proliferation on HDV persistence in vitro and in vivo., Design: Genetically labelled human sodium taurocholate cotransporting polypeptide (hNTCP)-transduced human hepatoma(HepG2) cells were infected with HBV/HDV and passaged every 7 days for 100 days in the presence of the entry inhibitor Myrcludex-B. In vivo, cell proliferation was triggered by transplanting primary human hepatocytes (PHHs) isolated from HBV/HDV-infected humanised mice into naïve recipients. Virological parameters were measured by quantitative real time polymerase chain reaction (qRT-PCR). Hepatitis delta antigen (HDAg), hepatitis B core antigen (HBcAg) and cell proliferation were determined by immunofluorescence., Results: Despite 15 in vitro cell passages and block of viral spreading by Myrcludex-B, clonal cell expansion permitted amplification of HDV infection. In vivo, expansion of PHHs isolated from HBV/HDV-infected humanised mice was confirmed 3 days, 2, 4 and 8 weeks after transplantation. While HBV markers rapidly dropped in proliferating PHHs, HDAg-positive hepatocytes were observed among dividing cells at all time points. Notably, HDAg-positive cells appeared in clusters, indicating that HDV was transmitted to daughter cells during liver regeneration even in the absence of de novo infection., Conclusion: This study demonstrates that HDV persists during liver regeneration by transmitting HDV RNA to dividing cells even in the absence of HBV coinfection. The strong persistence capacities of HDV may also explain why HDV clearance is difficult to achieve in HBV/HDV chronically infected patients., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Unlabelled: Chronic hepatitis B virus (HBV) infection has been associated with alterations in lipid metabolism. Moreover, the Na+-taurocholate cotransporting polypeptide (NTCP), responsible for bile acid (BA) uptake into hepatocytes, was identified as the functional cellular receptor mediating HBV entry. The aim of the study was to determine whether HBV alters the liver metabolic profile by employing HBV-infected and uninfected human liver chimeric mice. Humanized urokinase plasminogen activator/severe combined immunodeficiency mice were used to establish chronic HBV infection. Gene expression profiles were determined by real-time polymerase chain reaction using primers specifically recognizing transcripts of either human or murine origin. Liver biopsy samples obtained from HBV-chronic individuals were used to validate changes determined in mice. Besides modest changes in lipid metabolism, HBV-infected mice displayed a significant enhancement of human cholesterol 7α-hydroxylase (human [h]CYP7A1; median 12-fold induction; P<0.0001), the rate-limiting enzyme promoting the conversion of cholesterol to BAs, and of genes involved in transcriptional regulation, biosynthesis, and uptake of cholesterol (human sterol-regulatory element-binding protein 2, human 3-hydroxy-3-methylglutaryl-coenzyme A reductase, and human low-density lipoprotein receptor), compared to uninfected controls. Significant hCYP7A1 induction and reduction of human small heterodimer partner, the corepressor of hCYP7A1 transcription, was also confirmed in liver biopsies from HBV-infected patients. Notably, administration of Myrcludex-B, an entry inhibitor derived from the pre-S1 domain of the HBV envelope, provoked a comparable murine CYP7A1 induction in uninfected mice, thus designating the pre-S1 domain as the viral component triggering such metabolic alterations., Conclusion: Binding of HBV to NTCP limits its function, thus promoting compensatory BA synthesis and cholesterol provision. The intimate link determined between HBV and liver metabolism underlines the importance to exploit further metabolic pathways, as well as possible NTCP-related viral-drug interactions., (© 2014 by the American Association for the Study of Liver Diseases.)