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The aim of this study was to investigate the prevalence and prognostic impact of tricuspid annular dilatation (TAD) measured in multislice computed tomography datasets in patients undergoing transfemoral transcatheter aortic valve replacement for severe aortic stenosis.TAD is an increasingly recognized entity associated with poor outcomes in patients with valvular heart disease.The maximal septolateral diameter of the tricuspid annulus was measured in consecutive patients with 3-dimensional multidetector row computed tomographic datasets undergoing transfemoral transcatheter aortic valve replacement. Receiver-operating curve characteristic analysis was performed to obtain an ideal, body surface area-normalized cutoff for TAD. Ethical approval was obtained from the institutional ethics board.The study included 1,137 patients, of whom 299 died within a mean follow-up period of 1.8 ± 1.0 years. TAD was identified in 446 patients (39.2%) on the basis of a receiver-operating characteristic cutoff of 23 mm/mTAD is an independent predictor of all-cause mortality in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Background To investigate the impact of left ventricular outflow tract (LVOT) calcification on the incidence of device failure and mortality in patients undergoing transcatheter aortic valve implantation (TAVI). Methods Of 690 consecutive patients undergoing transfemoral TAVI in our center from January 2013 to December 2015, 600 presented with non-severe (NSCALVOT) and 90 (13.0%) with severe (SCALVOT) LVOT calcification. Primary outcome of interest was device failure defined as a composite of procedural death, prosthesis dislocation, annulus rupture or significant para-valvular leakage (PVL). Secondary outcome of interest was 30-day and one-year all-cause mortality. Results Mean age of the population was 80.8 ± 7.2 years, mean STS score was 5.7 ± 4.6% and 50.6% of the patients were women. Patients with SCALVOT more frequently experienced device failure (10.0% vs. 3.8%, p = 0.009) and were at higher risk of 30 day (10.0% vs. 2.8%, p Conclusion Presence of severe LVOT calcification in patients undergoing transfemoral TAVI is associated with a higher risk of device failure and short-term mortality.

Background The outcome of patients with low-flow low-gradient (LFLG) aortic stenosis after transcatheter aortic valve replacement (TAVR) is not well evaluated. Long-term clinical success is thought to be less pronounced in LFLG patients compared to patients with high gradient (HG) aortic stenosis. Purpose The purpose of this study was to characterise different LFLG groups and determine their outcome after TAVR. We hypothesised that there would be relevant differences in baseline characteristics and patient survival after TAVR. Methods All patients undergoing TAVR for severe aortic stenosis at our centre between 2013 and 2019 were included in the study. Patients have been split into groups according preinterventional echocardiography data according to mean pressure gradient (dPmean), ejection fraction (EF), and stroke volume index (SVi). Patients with a dPmean Results 1,772 patients were analysed (mean follow-up 2.2 years, median age 81.7 [77.5–85.7] years) and split into groups: HG, 953 patients (54.3%), cLFLG, 446 patients (25.2%), and pLFLG 373 patients (21.1%). Baseline characteristics showed significant differences (p Rates of periprocedural complications including death, device failure, pericardial effusion, stroke or myocardial infarction were comparable between groups. Mortality rate (figure 1) was highest for cLFLG patients (43.4% [95% confidence interval, 37.3–48.6%]) compared to HG (25.1% [21.6–28.5%]) or pLFLG (32.9% [26.9–38.4%]), Log-rank test, Conclusion In this all-comer analysis, almost half of the patients belong toLFLG groups with considerable differences in patient characteristics. While equally safe during the procedure, patients with LFLG aortic stenosis show increased 3-year mortality rates compared to patients with HG aortic stenosis. Further studies evaluating this are needed. Funding Acknowledgement Type of funding sources: None. Figure 1. 3-year mortalityFigure 2. STS score-adjusted mortality

Objectives The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR). Background Non–vitamin K oral anticoagulants (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated. Methods The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. Results Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR: 0.97; 95% CI: 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR: 1.36; 95% CI: 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively. Conclusions Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.

Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear.This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation.Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32];In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.

Background: Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. Methods: This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. Results: Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63–1.32]; P =0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62–1.32), P =0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44–1.73), P =0.70, respectively. Conclusions: In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02548611.

Beyond thromboembolic events, peri-procedural bleeding remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). The majority of TAVI patients receive a dual anti-platelet treatment (DAPT) regimen. This analysis from the EVERY-TAVI register database aimed to analyse whether the level of on-treatment adenosine diphosphate-induced platelet reactivity predicts early outcomes at 30 days after TAVI. A total of 146 consecutive TAVI patients on DAPT who underwent platelet function testing with the Multiplate analyser were included here. Definition of bleeding events was done according to the Valve Academic Research Consortium-2 (VARC-2) classification. In our cohort, a status of low platelet reactivity (LPR, ≤ 18 units) was observed in 79 patients (54%), while high platelet reactivity (HPR, ≥ 46 units) was present in 18 patients (12%). At 30-day follow-up, the incidence of VARC-2 bleeds was 45.6% (n = 36) in LPR patients and 23.9% (n = 16) in patients without LPR (hazard ratio [HR] 2.10, 95% confidence interval [CI], 1.17–3.79; p = 0.01). In age-adjusted multivariate analysis, a status of LPR was independently associated with VARC-2 bleeding events (HRadj, 2.06, 95% CI, 1.14–3.71; p = 0.02). HPR was not associated with the 30-day risk of death, stroke, or myocardial infarction (p ≥ 0.43). In summary, presence of LPR was associated with bleeding events in patients undergoing TAVI while presence of HPR was not associated with ischaemic outcomes at 30 days. The value of platelet function testing for bleeding risk prediction and for a possible guidance of anti-thrombotic treatment in the elderly TAVI population warrants further investigation.

Background According to current recommendations, transcatheter aortic valve implantation (TAVI) should only be performed among patients with a life expectancy of at least one year. However, many deaths occur within the first year after TAVI. Purpose To assess the causes of death within one year after TAVI. Methods Data was taken between November 2007 and December 2017 from the EVERY-TAVI registry. Patients who died during TAVI or experienced mechanical complications requiring surgery were excluded from the analysis. We assessed the causes of death over 3 periods post-TAVI: within the first 30 days, between 30 and 90 days, and between 90 and 365 days. Results Overall, 2389 patients underwent TAVI without mechanical complications. Among them, 320 (1.3%) died within one year. Age was the main cause of death, accounting for 73 deaths (22.8%), followed by heart failure (20.6%) and infections (18.7%). During the first month, cardiogenic shock was the main cause of death (25.4%), followed by infections (22.2%) and terminal heart failure (20.6%), while age was responsible of only one death (1.6%). During the two following months, heart failure was the main cause of death (33.3%), followed by infections (21.2%), and the percentage of deaths due to age increased to 18.2%. After 3 months, age was the main cause of death (31.4%), followed by infection (16.8%) and heart failure (16.2%). Causes of death within one year of TAVI Cause of death All (n=320) 90 days (n=191) Older age, n (%) 73 (22.8) 1 (1.6) 12 (18.2) 60 (31.4) Terminal heart failure, n (%) 66 (20.6) 13 (20.6) 22 (33.3) 31 (16.2) Infection, n (%) 60 (18.7) 14 (22.2) 14 (21.2) 32 (16.8) Terminal renal failure, n (%) 26 (8.1) 4 (6.3) 5 (7.6) 17 (8.9) Cardiogenic shock, n (%) 26 (8.1) 16 (25.4) 4 (6.1) 6 (3.1) Malignancies, n (%) 18 (5.6) 0 (0.0) 2 (3.0) 16 (8.4) Sudden death, n (%) 17 (5.3) 6 (9.5) 2 (3.0) 9 (4.7) Stroke, n (%) 12 (3.7) 4 (6.3) 2 (3.0) 6 (3.1) Accident, n (%) 7 (2.2) 2 (3.2) 0 (0.0) 5 (2.6) Myocardial infarction, n (%) 7 (2.2) 2 (3.2) 2 (3.0) 3 (1.6) Non-cardiac surgery, n (%) 5 (1.6) 1 (1.6) 1 (1.5) 3 (1.6) Pulmonary embolism, n (%) 3 (0.9) 0 (0.0) 0 (0.0) 3 (1.6) Conclusion Cardiogenic shock is the main cause within the first month after TAVI, while older age is the main cause overall and after the initial months, highlighting the need to more carefully selection of patients undergoing TAVI.

Aims: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. Methods and results: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p

Background Several clinical and procedural factors determine outcomes after transcatheter aortic valve replacement (TAVR), but data are scarce on the impact of post-TAVR discharge disposition on long-term outcomes. We sought to analyse whether discharge location after TAVR is associated with 1-year outcomes in women undergoing contemporary TAVR. Methods The Women’s INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry is the first all-female TAVR registry to study the safety and performance of contemporary TAVR in women (n = 1019). Information on discharge location was available in 817 patients (80.2%). We compared women discharged home vs those discharged to another location (nursing home, rehabilitation, or other hospital). One-year outcomes were adjusted using multivariable Cox regression methods with discharge home as the reference group. Results Of the study subjects, 75.2% (n = 614) were discharged home and 24.8% (n = 203) to another location. Women discharged to other locations were older with a greater prevalence of severe lung disease requiring home oxygen and renal failure on dialysis but were less frequently considered frail or at high surgical risk compared with women discharged home. After multivariable adjustment, non-home discharge was associated with greater hazard for 1-year Valve Academic Research Consortium 2 efficacy (21.3% vs 10.8%, hazards ratio [HR] 1.9, 95% confidence interval [CI] 1.2-2.9) and safety endpoints (31.5% vs 15.2%, HR 2.1, 95% CI 1.5-3.0), cardiovascular death (12.7% vs 5.5%, HR 2.0, 95% CI 1.1-3.6), and stroke (6.5% vs 0.8%, HR 8.5, 95% CI 2.9-25.6). Conclusions In women undergoing contemporary TAVR, discharge disposition significantly affects 1-year risk of outcomes even after adjustment for recorded baseline differences. This might suggest the necessity of considering additional factors beyond comorbidities in the TAVR decision-making process.

Presence of moderate or severe left ventricular outflow tract (LVOT) calcification (SCALVOT) in patients undergoing transcatheter aortic valve replacement (TAVR) has been linked to adverse outcomes [(1,2)][1]. However, calcium quantification in contrast-enhanced computed tomography (CTA) scans

Background Clinical relevant cerebrovascular events (CVE) following transcatheter aortic valve implantation (TAVI) still remain a devastating complication associated with mortality and severe impairments. Therefore, identification of particularly modifiable predictors of this complication is clinically relevant and an important step for planning preventive strategies. Methods A total of 985 patients who underwent trans-femoral TAVI for aortic valve stenosis in our institution from February 2008 to January 2015 were considered. The influence of demographics, clinical and procedural data on the occurrence of CVE was assessed with a competing risk model with death as competing event. Clinical events were defined according to VARC-2 criteria. Results At a median follow-up of 838days, 95% CI 807–892, 59 patients experienced any CVE (5.9%) and the overall cumulative mortality rate was 46.1%. CVEs mainly occur later than 30days after TAVI (47.5%), 88.1% of them were of ischemic origin and 52.5% were disabling events. Independent predictors of CVEs were age (hazard ratio 1.05; 95% CI 1.01 to 1.09), history of CVE (hazard ratio 2.54; 95% CI 1.39 to 4.63) and use of balloon post-dilation (hazard ratio 1.85; 95% CI 1.08 to 3.18). Conclusion In patients undergoing TAVI incidence of clinically relevant CVEs is frequent with half of the events occurring after the first 30days post-TAVI. Identification of balloon post-dilation as the only modifiable predictor of CVE risk at mid-term, urges its cautious performance after prosthesis implantation. ClinicalTrials.gov identifier NCT02289339.

AIMS Our aim was to assess the incidence of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the second (SXT) versus third-generation (S3) balloon-expandable SAPIEN prosthesis in patients with symptomatic aortic stenosis (AS). METHODS AND RESULTS Of 634 patients undergoing TAVI in our centre from May 2010 to July 2014, 354 were treated with the SXT and 100 with the S3 prosthesis. The primary outcome was the incidence of more-than-mild post-TAVI AR at discharge. Secondary outcomes were 30-day incidence of all-cause death, any bleeding complications and need for new pacemaker. The incidence of the primary outcome was 2.0% vs. 8.8%, p

To determine access site related bleeds and vascular complications after access site closure using either the Proglide (PG) or Prostar (PS) suture mediated closure device after transfemoral aortic valve implantation (TAVI). In this large multicenter registry we analyzed a total of 1001 patients