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Background: Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear., Objectives: This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort., Methods: The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality., Results: The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality., Conclusions: PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics., Competing Interests: Funding Support and Author Disclosures This work was supported by the Deutsche Forschungsgemeinschaft (397484323) to Drs Guthoff, Matti Adam and Stephan Baldus, and Mauri; PA 2409/5-2 to Drs Thurow and Pauly; the Dean’s Office, Faculty of Medicine, University of Cologne (clinician scientist position) to Dr Guthoff; and the Center for Molecular Medicine Cologne (Baldus B-02) to Dr Stephan Baldus. Dr Abdel-Wahab’s institution has received speaker honoraria and/or consultancy fees from Abbott, Boston Scientific, and Medtronic. Dr Kim has received proctor and personal fees from Abbott, Boston Scientific, Meril Life Sciences, and Shockwave Med; is a member of the advisory boards for Abbott, Boston Scientific, and HID Imaging; and Dr Kim’s institution has received fees from Boston Scientific. Dr Nombela-Franco has served as proctor for Abbott and Edwards Lifesciences. Dr Matjaz Bunc served as proctor for TAVR procedures with Edwards Lifesciences, Medtronic, Meril, and Abbott. Matjaz Bunc is a member of the advisory boards for Medtronic and Edwards Lifesciences. Dr Veulemans has received speaker and/or study honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Tanja Rudolph has received lecture fees from Abbott, SIS Medical and Translumina. Dr Zeus has received speaker and/or study honoraria 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 © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The need for permanent pacemaker (PPM) implantation is a common complication after transcatheter aortic valve replacement (TAVR). Deep implantation position is a risk factor for PPM implantation. Thus, in the field of self-expandable (SE) transcatheter heart valves (THV) cusp overlap projection (COP) technique was implemented to reduce parallax, allowing a more precise guidance of implantation depth., Aims: This meta-analysis aims to report the outcome of patients undergoing TAVR with SE THV using COP versus conventional implantation technique (CIT)., Methods: Systematical search in MEDLINE and EMBASE yielded five observational controlled studies comparing both implantation techniques for the SE Evolut prosthesis (Medtronic Intern. Ltd., CA, USA) and fulfilling the inclusion criteria for meta-analysis., Results: Totally, 1227 patients were included, comprising 641 who underwent COP and 586 CIT TAVR. Incidence of post-procedural need for PPM implantation was significantly lower in COP group (9.8% vs 20.6%; OR = 0.43; p < 0.00001). This was accompanied by significantly higher implantation position in COP group (mean difference distance from distal end of the intraventricular portion of the THV to the non-coronary cusp (NCC): - 1.03 mm; p = 0.00001). Incidence of new-onset left bundle branch block did not differ. Regarding procedural and 30-day mortality, technical success, post-procedural aortic regurgitation, and rates of multiple device implantation, no difference between COP and CIT was found., Conclusion: COP is an effective and safe implantation technique to reduce the need for a permanent pacemaker implantation during TAVR with SE Evolut prosthesis., (© 2023. The Author(s).)

Objective: Periinterventional stroke is one of the most feared potential complication, among patients treated with transcatheter aortic valve implantation (TAVI). The purpose of this review was to investigate the incidence of cerebrovascular events and the influence of postinterventional neurologic check-up in patients undergoing TAVI., Methods: A systematic review and meta-analysis were conducted according to the PRISMA guideline. Three separate electronic searches of the public domains Medline and Clinicaltrials.gov were performed to identify the 30-day incidence of stroke within randomized controlled trials (RCTs) and registries for patients undergoing a TAVI procedure. A meta-analysis was conducted to evaluate the 30-day incidence of stroke within RCTs. Furthermore, we pooled the RCTs in which a scheduled neurological check-up was conducted or not to investigate the effect of this intervention., Results: Twenty-three studies including 399,491 TAVI patients were included, 6370 from RCTs, 833 from cerebral-embolic protection device RCTs and 392,288 were adopted from registries. The mean 30-day incidence of stroke among all reviewed studies was 2.33%. In RCTs evaluating TAVI the pooled stroke incidence was 3.86%, among RCTs focused CEP the incidence was 6.36% and in registries the incidence was 2.29%. Ten RCTs conducted scheduled neurological check-ups, the incidence in these was 4.03% and among the remaining RCTs it was 2.47%. In the meta-analysis, the pooled 30-day stroke incidence was 3.61% (95% CI 2.57-4.79%)., Conclusion: This systematic review demonstrates that the stroke incidences following TAVI differ strongly according to the study design and neurological follow-up. Intense neurological testing increases the incidence of a stroke after TAVI., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and heart failure with severely reduced ejection fraction, prediction of postprocedural left ventricular ejection fraction (LVEF) improvement is challenging. Decision-making and timing for implantable cardioverter defibrillator (ICD) treatment are difficult and benefit is still unclear in this patient population., Objective: Aims of the study were to analyse long-term overall mortality in TAVI-patients with a preprocedural LVEF ≤ 35% regarding LVEF improvement and effect of ICD therapy., Methods and Results: Retrospective analysis of a high-risk TAVI-population suffering from severe AS and heart failure with a LVEF ≤ 35%. Out of 1485 TAVI-patients treated at this center between January 2013 and April 2018, 120 patients revealed a preprocedural LVEF ≤ 35% and had sufficient follow-up. 36.7% (44/120) of the patients suffered from persistent reduced LVEF without a postprocedural increase above 35% within 1 year after TAVI or before death, respectively. Overall mortality was neither significantly reduced by LVEF recovery above 35% (p = 0.31) nor by additional ICD treatment in patients with persistent LVEF ≤ 35% (p = 0.33)., Conclusion: In high-risk TAVI-patients suffering from heart failure with LVEF ≤ 35%, LVEF improvement to more than 35% did not reduce overall mortality. Patients with postprocedural persistent LVEF reduction did not seem to benefit from ICD treatment. Effects of LVEF improvement and ICD treatment on mortality are masked by the competing risk of death from relevant comorbidities., (© 2021. The Author(s).)

Background: A small aortic annulus is associated with increased risk of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI). Whether specific transcatheter heart valve (THV) designs yield superior hemodynamic performance in these small anatomies remains unclear., Methods: Data from 8411 consecutive patients treated with TAVI from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as multidetector computed tomography-derived annulus area < 400 mm 2 . TAVI was performed with a balloon-expanding intra-annular (Sapien-3, n = 288), self-expanding intra-annular (Portico, n = 110), self-expanding supra-annular (Evolut, n = 179 and Acurate-Neo, n = 428) and mechanically expanding infra-annular (Lotus, n = 64) THV according to local practice. PPM was defined as indexed effective orifice area ≤ 0.85cm 2 /m 2 ., Results: A small annulus was found in 1069 (12.7%) patients. PPM was detected in 38.3% overall with a higher prevalence after implantation of a balloon-expanding intra-annular or mechanically expanding infra-annular THV compared to self-expanding intra- and supra-annular THV. Multivariable analysis linked self-expanding THV (Evolut: Odds ratio [OR] 0.341, Acurate-Neo: OR 0.436, Portico: OR 0.291), postdilatation (OR 0.648) and age (OR 0.968) to lower rates of PPM, while aortic valve calcification was associated with an increased risk (OR 1.001). Paravalvular regurgitation > mild was more frequent after TAVI with self-expanding THV (p = 0.04)., Conclusion: In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy were left with PPM after TAVI. Self-expanding supra- and intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation., (© 2021. The Author(s).)

Background:  Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo /TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort., Methods:  A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes., Results:  Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p  = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p  = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p  = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p  = 0.752). However, higher numbers of PVL (mild-PER = 0.0% vs. NEO = 55.9%, p  = 0.001; moderate or higher-PER = 0.0% vs. NEO = 6.8%, p  = 0.119) after TAVI with NEO were observed., Conclusion:  Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: In recent studies, a 5-stage cardiac damage classification in severe aortic stenosis (AS) based on echocardiographic parameters has shown to provide predictive value regarding clinical outcome. The objective of this study was to investigate the prognostic impact of a cardiac damage classification based on invasive hemodynamics in patients with AS undergoing transcatheter aortic valve replacement (TAVR)., Methods: A total of 1400 patients with symptomatic AS and full invasive hemodynamic assessment before TAVR were included. Patients were categorized according to their cardiac damage stage into five groups that are defined as: stage 0, no cardiac damage; stage 1, left ventricular damage; stage 2, left atrial and/or mitral valve damage; stage 3, pulmonary vasculature and/or tricuspid valve damage; stage 4, right ventricular damage., Results: 9.9% patients were classified as stage 0, 23.6% as stage 1, the majority of patients as stage 2 (33.5%), 23.1% as stage 3 and 10% as stage 4. One- and 4-year mortality were 10.1%/29.5% in stage 0, 16.1%/60.6% in stage 1, 17.3%/39.4% in stage 2, 22%/54.6% in stage 3, 27.1%/62.2% in stage 4 (p = 0.001/p < 0.001). The extent of cardiac damage was independently associated with increased mortality after TAVR (HR 1.16 per each increment in stage, 95% confidence interval 1.03-1.18; p = 0.018)., Conclusions: Cardiac damage staging in severe AS patients based on invasive hemodynamics appears to show strong association between the extent of cardiac damage and post-TAVR mortality. This staging classification provides predictive value and may improve risk stratification, therapy management and decision-making in patients with AS. Invasive Staging Classification of Cardiac Damage in Severe Symptomatic Aortic Stenosis has an Impact on Outcome after TAVR. (Top) Invasive staging criteria for cardiac damage in five stages using left ventricular end-diastolic pressure (LVEDP) for stage 1 (red), post-capillary wedge pressure (PCWP) for stage 2 (green), systolic pulmonary artery pressure (SPAP) for stage 3 (purple) and right atrial pressure (RAP) for stage 4 (yellow). The cake chart shows the distribution of the different stage in the whole cohort. (Bottom) Survival Analyses According to Stage of Cardiac Damage after Transcatheter Aortic Valve Replacement using Invasive Criteria. Kaplan-Meier plots comparing overall (left) and cardiovascular (right) 4-year survival showing with the more advancing stage a higher mortality rate.

Background During the past decade, the use of transcatheter aortic valve replacement (TAVR) was extended beyond treatment-naïve patients and implemented for treatment of degenerated surgical bioprosthetic valves. Selection criteria for either valve-in-valve (viv) TAVR or redo surgical aortic valve replacement are not well established, and decision making on the operative approach still remains challenging for the interdisciplinary heart team. Methods and Results This review was intended to analyze all studies on viv-TAVR focusing on short- and mid-term stroke and mortality rates compared with redo surgical aortic valve replacement or native TAVR procedures. A structured literature search and review process led to 1667 potentially relevant studies on July 1, 2020. Finally, 23 studies fulfilled the inclusion criteria for qualitative analysis. All references were case series either with or without propensity score matching and registry analyses. Quantitative synthesis of data from 8509 patients revealed that viv-TAVR is associated with mean 30-day stroke and mortality rates of 2.2% and 4.2%, respectively. Pooled data analysis showed no significant differences in 30-day stroke rate, 30-day mortality, and 1-year mortality between viv-TAVR and comparator treatment (native TAVR [n=11 804 patients] or redo surgical aortic valve replacement [n=498 patients]). Conclusions This review is the first one comparing the risk for stroke and mortality rates in viv-TAVR procedures with native TAVR approach and contributes substantial data for the clinical routine. Moreover, this systematic review is the most comprehensive analysis on ischemic cerebrovascular events and early mortality in patients undergoing viv-TAVR. In this era with increasing numbers of bioprosthetic valves used in younger patients, viv-TAVR is a suitable option for the treatment of degenerated bioprostheses.

Objective: The objective of this study was to assess imaging predictors of mitral regurgitation (MR) improvement and to evaluate the impact of MR regression on long-term outcome in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Concomitant MR is a frequent finding in patients with severe aortic stenosis but usually left untreated at the time of TAVR., Methods: Mitral regurgitation was graded by transthoracic echocardiography before and after TAVR in 677 consecutive patients with severe aortic stenosis. 2-year mortality was related to the degree of baseline and discharge MR. Morphological echo analysis was performed to determine predictors of MR improvement., Results: 15.2% of patients presented with baseline MR ≥ 3 +, which was associated with a significantly decreased 2-year survival (57.7% vs. 74.4%, P < 0.001). MR improved in 50% of patients following TAVR, with 44% regressing to MR ≤ 2 +. MR improvement to ≤ 2 + was associated with significantly better survival compared to patients with persistent MR ≥ 3 +. Baseline parameters including non-severe baseline MR, the extent of mitral annular calcification and large annular dimension (≥ 32 mm) predicted the likelihood of an improvement to MR ≤ 2 +. A score based on these parameters selected groups with differing probability of MR ≤ 2 + post TAVR ranging from 10.5 to 94.4% (AUC 0.816; P < 0.001), and was predictive for 2-year mortality., Conclusion: Unresolved severe MR is a critical determinant of long term mortality following TAVR. Persistence of severe MR following TAVR can be predicted using selected parameters derived from TTE-imaging. These data call for close follow up and additional mitral valve treatment in this subgroup. Factors associated with MR persistence or regression after TAVR.

Objectives: The aim of this study was to investigate reliability and accuracy of noninvasive measurement method by echocardiography compared to invasive measurement of systolic pulmonary artery pressure (SPAP) in a large cohort of aortic stenosis (AS) patients., Background: Pulmonary hypertension (PH) is common in patients with cardiac disease, especially in left heart disease like severe AS. Invasive measurement by right heart catheterization (RHC) is the gold standard to assess pulmonary pressures. Nevertheless, echocardiography is widely used in everyday practice for estimation of pulmonary pressures and diagnosing PH., Methods: A total of 1400 patients with AS and full invasive hemodynamic assessment by RHC and noninvasive measurements by Doppler echocardiography were included., Results: Mean patient age was 81.5 ± 6.8 years, and 46.3% were males. SPAP was 44.7 ± 15.1 mm Hg by echocardiography and 45.3 ± 15.2 mm Hg by RHC. Pearson's correlation coefficient was r = .820 (P < .0001). Bland-Altman analysis showed a bias of -0.56 mm Hg (95% limits of agreement -18.38 to + 17.26 mm Hg) and 80.6% measurement accuracy. Pulmonary hypertension defined by RHC as a mean PAP ≥25 mm Hg was reliably diagnosed via an echocardiographically measured SPAP of >40 mm Hg (82.2% sensitivity, 80.2% specificity, 83.1% positive predictive value, 79.2% negative predictive value)., Conclusions: In a large cohort of patients with severe aortic stenosis, we could demonstrate a very good correlation of SPAP between Doppler echocardiography and invasive RHC measurement. Pulmonary hypertension could be diagnosed by echocardiography with high sensitivity and specificity., (© 2020 Wiley Periodicals, Inc.)

Aims: Approximately 40% of severe aortic stenosis (AS) patients have a low-gradient (<40 mmHg) AS (LG-AS). The aim of this study was to investigate the invasively measured haemodynamic changes and long-term outcome after transcatheter aortic valve replacement (TAVR) in the subgroups of LG-AS., Methods and Results: A total of 600 LG-AS patients with haemodynamic assessment by left and right heart catheterisation were divided into three groups: normal-flow (NFLG-AS; n=296), paradoxical low-flow (PLFLG-AS; n=153), and classic low-flow (CLFLG-AS; n=151). Post TAVR, PLFLG-AS and CLFLG-AS showed a significant reduction in global afterload (p<0.005), as well as a significant elevation of stroke volume index (SVI), and left and right ventricular stroke work index (p<0.001). NFLG-AS was associated with an elevation of global afterload and a decrease of SVI (p<0.05). Overall survival was highest in NFLG-AS, followed by PLFLG-AS and CLFLG-AS. All subgroups experienced similar symptomatic improvement., Conclusions: NFLG-AS was the most prevalent form of LG severe AS and was associated with adequate left ventricular compensation and good prognosis. On the other hand, CLFLG-AS represents the heart failure with reduced ejection fraction (HFrEF) form of AS and was associated with the worst prognosis, whereas PLFLG-AS represents the heart failure with preserved ejection fraction (HFpEF) form of AS with intermediate prognosis. Both groups showed early haemodynamic reverse response after TAVR.

Objectives: The purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality., Methods: Patients who were enrolled in 'The German Aortic Valve Registry' undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality., Results: Twenty thousand eight hundred and seventy-two patients who underwent TAVR and 17 750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18-1.41; P < 0.001]. This association persisted after adjustment for confounding factors (HR 1.29, CI 1.16-1.43; P < 0.001). In the SAVR group, NPMI significantly increased 1-year mortality in univariable analysis as well (HR 1.55, CI 1.08-2.22; P = 0.02), whereas after multivariable adjustment, NPMI did not emerge as an independent risk factor (HR 1.29, 0.88-1.89; P = 0.19). NPMI was not associated with 30-day mortality in both procedure groups., Conclusions: The rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim of this study was to investigate the prognostic impact and development of pulmonary hypertension (PH) in the different hemodynamic subtypes of PH in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR)., Background: PH is a frequent finding in patients with severe AS and predicts outcome after TAVR. Nevertheless, outcomes among PH subtypes and the impact of residual PH after TAVR are controversial., Methods: A total of 1,400 patients with symptomatic AS and full invasive hemodynamic assessment before and after TAVR were included. Patients were stratified into 4 groups: no PH (n = 658); isolated pre-capillary PH (n = 139), isolated post-capillary PH (Ipc-PH; n = 534), and combined post-capillary and pre-capillary PH (n = 69)., Results: The mean overall patient age was 81.5 ± 6.8 years, and 46.3% were men. Acute device success was achieved in 94.9%. Patients without PH showed significantly lower mortality rates compared with patients with PH (1 year, 13.8% vs. 22.4% [p < 0.001]; 4 years, 37.2% vs. 51.5% [p < 0.001]). Patients with pre-capillary PH showed 1.9-fold increased 1-year mortality and those with Ipc-PH showed 1.5-fold increased 1-year mortality compared with patients without pH (p = 0.001). No differences regarding survival were found among the subgroups. Only in patients with Ipc-PH, residual PH was associated with 2.1-fold increased mortality (p = 0.010). All patients benefited in terms of functional capacity after TAVR., Conclusions: Patients with pre-capillary PH and those with Ipc-PH showed significantly higher risk for death after TAVR compared with those without PH. Reversible PH had no benefit for survival except in patients with Ipc-PH. Hemodynamic stratification of PH is helpful for risk and response prediction in patients with AS undergoing TAVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The VIVALL study aims to investigate the technical feasibility, safety and performance of the ALLEGRA transcatheter heart valve (THV) for the treatment of failing surgical aortic valves (SAV)., Methods and Results: Thirty patients with failing SAV were investigated. An independent combined Data Safety Monitoring-Clinical Events Committee (DSM-CEC) and core lab adjudicated adverse events, patient safety and echocardiograms, respectively. Primary endpoints were invasive post-procedure mean pressure gradient (performance) and 30-day survival (safety). Of the treated patients (78.6±6.0 years, 50% female, STS score 4.5±2.1% and EuroSCORE II 9.2±4.3%), the majority (90%) had a small SAV (true inner diameter ≤22 mm). Implantation was successful in all but one patient (96.7%). Overall, the invasively assessed preoperative mean pressure gradient was significantly reduced from 37.1±13.3 mmHg to 11.6±3.7 mmHg. At 30 days, all-cause mortality and new pacemaker implantation were both 0% and the effective orifice area increased from 1.18±0.58 cm2 at baseline to 1.4±0.52 cm2. Paravalvular regurgitation was "none or trace" in 100% of the cases., Conclusions: Transfemoral implantation of the ALLEGRA THV is feasible and safe in patients with failing SAV. Haemodynamic outcomes and a 100% survival rate after 30 days suggest that the ALLEGRA THV might be a valid option for valve-in-valve treatment.

Aims: We sought to assess the impact of different manifestations of heart failure (HF) at baseline on the short- and long-term outcomes of transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS)., Methods and Results: Of 361 patients undergoing TAVI between May 2013 and April 2015, 185 (51%) showed clinical signs of HF at the time of admission. HF was diagnosed as isolated left ventricular (LV) and biventricular in 63 (34%) and 122 patients (66%), respectively. Acute device success (VARC-2) was achieved in 97% of patients without HF, in all patients with LV HF, and in 97% of patients with biventricular HF. Follow-up for a median of 427 days revealed significantly poorer survival in patients with biventricular HF (1-year estimate, 72.1% [95% confidence interval, 64.0-80.2%]) than in patients with LV HF (84.5% [75.2-93.8%]; p = 0.0203) or no HF (94.3% [90.7-97.9%]; p < 0.0001). Survival in the latter two patient subgroups was statistically not different. A diagnosis of biventricular HF was associated with a hazard ratio of 2.62 (p = 0.0089) vs. no HF in the likelihood of death; NT-proBNP and the logistic EuroSCORE were not significantly associated with survival. Half of all deaths in patients with biventricular HF occurred within 42 days of TAVI., Conclusion: Biventricular HF is a strong predictor of mortality following TAVI for severe AS. AS in patients with LV HF should be treated without delay to avoid progression to biventricular HF. Patients with AS and biventricular HF should be monitored closely after TAVI to possibly prevent early death.

Purpose of Review: The goal of this paper is to describe the treatment challenges in patients with aortic stenosis in combination with a reduced left ventricular function., Recent Findings: Since the risk of mortality is increased in this patient population, transcatheter aortic valve implantation emerged as an important treatment option. Concomitant factors such as mitral regurgitation or coronary artery disease are important co-factors that need to be evaluated and taken into account for treatment decision. Treatment of the severe aortic stenosis is key in this complex setting. Since several co-factors may exist in addition to aortic stenosis, treatment needs to be decided by a Heart Team.

Objectives: This study investigated differences between transcatheter heart valve (THV) types and regarding debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, California)., Background: Differences of THV types and cerebral injury after transcatheter aortic valve replacement (TAVR) are not well understood., Methods: A total of 246 patients pooled from 2 prospective studies (SENTINEL [Cerebral Protection in Transcatheter Aortic Valve Replacement] trial, N = 100; SENTINEL-H [Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement] trial, N = 146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150, ≥500, and ≥1,000 μm), particle count, total particle area, and maximum of largest dimension. Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT)., Results: Particles were captured in 99% of patients. There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared with S3 patients; 53% of all patients irrespective of valve type had at least 1 particle ≥1 mm. Larger particles (≥500 and ≥1,000 μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1,000 μm were significantly more frequent than in S3 patients. Particle count, total particle area, and maximum of largest dimension were significantly higher in both Lotus and EvR patients compared with S3 and XT., Conclusions: Debris was captured in 99% of patients, of whom 53% had at least 1 particle of debris >1 mm. The number and size of particles captured during a procedure in which EvR or Lotus THV was used were higher and larger than with a Sapien THV. Regardless, embolic debris, including large particles, is universal across valve types and provides mechanistic support for the potential benefit of using cerebral embolic protection in all TAVR procedures., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS)., Objectives: This study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry., Methods: Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria., Results: Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28)., Conclusions: Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) diabetes mellitus (DM) is a common comorbidity. It is known to increase the risk of arteriosclerosis and adversely affect morbidity, mortality for all types of cardiovascular disease, and post-procedural outcome after percutaneous and surgical procedures. Moreover, DM is known to facilitate the genesis of renal failure (RF). Pre-existing RF seems to increase the rate of acute kidney injury (AKI), which is a powerful short- and midterm predictor of mortality in patients undergoing TAVR. Therefore, the aim of the present study was to investigate the impact of DM on AKI, short- and midterm prognosis after TAVR, especially in patients with pre-existing RF., Methods and Results: In 337(30%) of 1109 patients DM was documented. The incidence of RF at baseline (GFR <60mL/min) was statistically similar in both patient groups (no DM vs. DM: 54% vs. 61%; p=0.057). Also, the incidence of AKI stage 3 was similar in all patients (no DM vs. DM: 1.6% vs. 1.8%; p=0.799). There were no significant differences regarding the procedure-related complications according to VARC-2 and mortality between patients neither with nor without DM. Even after differentiating patients according to baseline renal function, similar incidence of AKI and midterm mortality were documented., Conclusion: In patients undergoing TAVR, neither in case of preserved nor impaired renal function, we couldn't find any evidence for influence of DM on overall acute and midterm prognosis nor the incidence of AKI., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Histopathological analyses of debris captured by a cerebral protection system during transcatheter aortic valve replacement have been reported, but the origin of the captured debris was not determined and risk factors were not defined., Methods and Results: Embolic debris was analyzed from 322 filters used in a dual-cerebral-filter protection system implemented during transcatheter aortic valve replacement for 161 patients (mean age 81 years, 82 male [51%], logistic EuroSCORE 19% [interquartile range 12-31%]). The debris capture rate was high, with debris from 97% of all patients (156 of 161). No differences by filter location were found (brachiocephalic trunk 86% [139 of 161], left carotid artery 91% [147 of 161]; adjusted P=0.999). Five prevalent types of debris were identified: thrombus (91%), arterial wall tissue (68%), valve tissue (53%), calcification (46%), and foreign material (30%). Female sex (P=0.0287, odds ratio 1.364, 95% CI 1.032-1.812) and diabetes mellitus (P=0.0116, odds ratio 1.474, 95% CI 1.089-2.001) were significant risk factors for embolic debris. Additional analysis showed significantly more valve tissue in patients with predilation (P=0.0294). Stroke and transient ischemic attack rates were 0.6% each (1 of 161)., Conclusion: This study showed a high rate of embolic debris consisting of typical anatomic structures known to be altered in patients with aortic stenosis undergoing transcatheter aortic valve replacement. Female patients with diabetes mellitus have increased risk of embolic debris and should be protected by a cerebral protection system during transcatheter aortic valve replacement. Because valve tissue embolizes more often in patients with predilation, procedural planning should consider this finding. Both cerebral arteries (brachiocephalic trunk, left carotid artery) should be protected in the same way., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Objective: Histological analyses of debris captured by a cerebral protection system (CPS) during transcatheter valve-in-valve (VIV) procedures have not been reported., Methods: Fifteen consecutive patients with stenotic aortic (n=13) or mitral (n=2) surgical or transcatheter bioprostheses were treated with implantation of a transcatheter heart valve (THV) in the presence of a dual-filter CPS. Mean patient age was 75 years; mean logistic EuroSCORE was 31%. Filters were collected and histological assessment of debris was performed. Patients were followed clinically until discharge., Results: Debris captured by either or both filters was detected in all patients. Acute thrombus was the most common type of debris, found in all patients, followed in frequency by arterial wall tissue (n=12 patients (80%)), calcification (n=11 (73%)) and valve tissue (n=9 (60%)). Less frequently found were organised thrombus (n=5 (30%)), foreign material (n=4 (27%)) and myocardium (n=2 (13%)). A median of 123 debris particles per patient was detected, with a trend towards a greater median number of particles collected in proximal filters (78 vs 39, p=0.065). The average maximum particle diameter was 88 (range 56-175) µm, with a median of 20 particles ≥150 µm. No stroke or transient ischaemic attack (TIA) had occurred by the time of discharge (mean 8 days)., Conclusions: Transcatheter VIV procedures were associated with the release of particulate debris into the cerebral circulation in all patients. The type of debris suggests that debris originates predominantly from arterial and valvular passage of the THV., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Aims: To assess outcomes of TAVR as a rescue therapy in patients with cardiogenic shock due to acutely decompensated aortic stenosis., Methods and Results: Of 771 high-risk patients who underwent TAVR, 27 (3.5%; 78±9 years; 12 men) were treated emergently due to acutely decompensated aortic stenosis with cardiogenic shock. SAPIEN and CoreValve prostheses were implanted in 11 and 16 patients, respectively: the transfemoral access route was used in 25. Three patients died within 72 hours of successful valve deployment, and a further six died within a month, giving a 30-day mortality of 33.3%, which was significantly higher than in electively treated patients (7.7%, p<0.0001). Univariate predictors of 30-day mortality in cardiogenic-shock patients were baseline cardiac output <3.0 l/min, reduced cardiac power index, impaired renal function, and mechanical ventilation, as well as severe acute kidney injury after TAVR. Estimated one-year survival was 59.3% in emergently and 82.7% in electively treated patients (p=0.0009). However, 30-day landmark analysis showed no difference in cumulative survival between TAVR modalities. In cardiogenic-shock patients without concomitant reduced cardiac output and impaired renal function at baseline (n=22), estimated one-year survival was 72.7%., Conclusions: TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.

Background: We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population., Methods: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria., Results: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%)., Conclusion: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.

Aims Conduction abnormalities (CA), in particular complete atrioventricular block (CAVB), requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS). However, the potential mechanisms are still incompletely understood. The objective of this retrospective study was to determine further predictors of CAVB after TAVI in patients without the known predictors. Methods and results This study included patients without prior CA/PPM who underwent TAVI of a balloon-expandable valve (Sapien or Sapien XT or Sapien 3). Of 563 patients (81.2 ± 6.9 years, 245 men [43.5%], logistic EuroSCORE 22.2 ± 14.1%, STS PROM 5.9 [3.4–8.0]) who were treated by TAVI at our institution between July 2008 and January 2016, 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18–3.55; p = 0.010) was identified as an independent predictor for new CAVB after TAVI. Moreover, patients with more pronounced TR presented with increased left and right ventricular overload (left ventricular (LV) end-diastolic diameter, LV end-diastolic pressure), pulmonary pressures, NT-proBNP, and prevalence of mitral regurgitation ≥II, whereas LV ejection fraction, TAPSE and cardiac output were decreased. Conclusions PPM implantation is a frequent complication in patients undergoing TAVI. Increasing severity of TR seems to be a consequence of left and right ventricular overload caused by severe AS and is a significant predictor of new CAVB after TAVI. Condensed abstract Conduction abnormalities (CA) requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI). This study included patients without prior CA/PPM who underwent TAVI. Of 563 patients 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18–3.55; p = 0.010) was identified as an independent predictor for new CAVB. Therefore, in patients with moderate/severe TR utmost care should be taken to avoid procedural factors conducive to mechanical irritation of the conduction system, resulting in pacemaker dependency. [ABSTRACT FROM AUTHOR]