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BACKGROUND Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI). METHODS We pooled individual participant data from 5 randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model. RESULTS At a median duration of follow-up of 739 days (interquartile range 365-1,806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, P = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P���=���.73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P���=���.061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P���=���.61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events. CONCLUSIONS In this patient-level meta-analysis of 5 randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI. STUDY REGISTRATION PROSPERO registry (CRD42018109098).

BACKGROUND Mitral annular calcification (MAC) has been associated with mitral valve (MV) disease and cardiovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to investigate the incidence and impact of mitral calcium volume (MCV) quantified by multidetector computed tomography (MDCT) on MV function and clinical outcomes after TAVI. METHODS Consecutive patients with exploitable echocardiography and MDCT performed during TAVI screening were enrolled in this retrospective analysis. Mitral calcium was assessed visually and measured using a semi-automatic tool developed for the aortic valve in an off-label fashion. RESULTS MCV >0 mm3 was found in 65% of the 875 included patients. Patients with calcification were older (82 ± 6 versus 81 ± 7; P = 0.002) and had high prevalence of renal dysfunction (69% versus 61%; P = 0.017) and mitral stenosis (25% versus 4%, P

OBJECTIVES A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. BACKGROUND TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). METHODS The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4TECH, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (caval implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. RESULTS A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. CONCLUSIONS TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.

OBJECTIVES This study sought to determine the impact of left ventricular (LV) diastolic dysfunction (LVDD) on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND LV hypertrophy in response to afterload increase promotes the development of LVDD and represents an early stage in the progression to valvular heart failure. METHODS In a consecutive cohort of 777 aortic stenosis patients undergoing TAVR, LVDD was categorized according to the latest guidelines. The primary endpoint was 1-year all-cause mortality. RESULTS There were 545 (70.1%) patients with LVDD. Ninety-eight (18.0%), 198 (36.3%), and 104 (19.1%) patients were classified as LVDD grades I, II, and III, respectively. In 145 (26.6%) patients, LVDD grade could not be determined because of only 1 or 2 discrepant variables. One-year all-cause mortality was higher in patients with LVDD grades I (16.3%; HR: 2.32; 95% CI: 1.15 to 4.66), II (17.9%; HR: 2.58; 95% CI: 1.43 to 4.67), and III (27.6%; HR: 4.21; 95% CI: 2.25 to 7.86) than in those with normal diastolic function (6.9%). The difference in clinical outcome emerged within 30 days, was driven by cardiovascular death, and maintained in a sensitivity analysis of patients with normal systolic LV function. Furthermore, LVDD grades I (HR: 2.36; 95% CI: 1.17 to 4.74), II (HR: 2.58; 95% CI: 1.42 to 4.66), and III (HR: 4.41; 95% CI: 2.37 to 8.20) were independent predictors of 1-year mortality. CONCLUSIONS Advancing stages of LVDD are associated with an incremental risk of all-cause mortality after TAVR, driven by cardiovascular death and taking effect as early as 30 days after the intervention.

BACKGROUND The impact of baseline renal dysfunction on early and late clinical outcomes after transcatheter aortic valve implantation (TAVI) remains to be defined. METHODS 927 patients included in the prospective Bern TAVI registry were classified on the basis of the baseline estimated glomerular filtration rate (eGFR), as having none or mild (eGFR ≥60mL/min/1.73m2, n=284, 30.6%), moderate (eGFR between 30 and 59mL/min/1.73m2, n=535, 57.7%) and severe (eGFR

Background The prognostic role of concomitant coronary artery disease (CAD) among patients undergoing transcatheter aortic valve implantation (TAVI) is still uncertain. Methods Data from the Bern TAVI Registry and the Bern PCI Registry were analyzed. Patients with concomitant CAD undergoing TAVI (TAVI+CAD) were age- and gender-matched to the following two cohorts: patients without CAD undergoing TAVI (TAVI-noCAD) and patients with stable CAD undergoing percutaneous coronary intervention (CAD-noAS). Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite of cardiovascular death, myocardial infarction, or cerebrovascular events, represented the primary endpoint at 1-year. Results Out of 9478 procedures performed between 2007 and 2013 (807 TAVI; 8671 PCI), three cohorts, each including 248 subjects, were derived. At 1-year, MACCE were significantly increased among TAVI+CAD compared with TAVI-noCAD (16.8% vs. 9.8%, hazard ratio, HR, 1.75, 95% confidence intervals, CI, 1.06–2.89, p=0.030) and CAD-noAS patients (16.8% vs. 9.5%, HR 1.85, 95%CI 1.11–3.09, p=0.018) whereas no difference was found between TAVI-noCAD and CAD-noAS patients. The higher rate of MACCE among TAVI+CAD patients was mainly driven by an increased risk of cardiovascular mortality compared with the TAVI-noCAD (HR 1.86, 95%CI 1.03–3.36, p=0.040) and CAD-noAS cohorts (HR 2.29, 95%CI 1.22–4.30, p=0.010). The 1-year rate of MACCE was similar between TAVI-noCAD and CAD-noAS patients (9.8% vs. 9.5%, HR 1.05, 95%CI 0.59–1.87, p=0.86). Conclusions Concomitant CAD in the setting of TAVI conveyed an increased risk of ischemic events and cardiovascular mortality at 1-year follow-up.

This study aimed to systematically assess the importance of left ventricular outflow tract (LVOT) calcification on procedural outcomes and device performances with contemporary transcatheter heart valve (THV) systems.LVOT calcification has been associated with adverse clinical outcomes after transcatheter aortic valve replacement (TAVR). However, the available evidence is limited to observational data with modest numbers and incomplete assessment of the effect of the different THV systems.In a retrospective analysis of a prospective single-center registry, LVOT calcification was assessed in a semiquantitative fashion. Moderate or severe LVOT calcification was documented in the presence of 2 nodules of calcification, or 1 extending5 mm in any direction, or covering10 % of the perimeter of the LVOT.Among 1,635 patients undergoing TAVR between 2007 and 2018, moderate or severe LVOT calcification was found in 407 (24.9%). Patients with moderate or severe LVOT calcification had significantly higher incidences of annular rupture (2.3% vs. 0.2%; p 0.001), bailout valve-in-valve implantation (2.9% vs. 0.8%; p = 0.004), and residual aortic regurgitation (11.1% vs. 6.3%; p = 0.002). Balloon-expandable valves conferred a higher risk of annular rupture in the presence of moderate or severe LVOT calcification (4.0% vs. 0.4%; p = 0.002) as compared with the other valve designs. There was no significant interaction of valve design or generation and LVOT calcification with regard to the occurrence of bailout valve-in-valve implantation and residual aortic regurgitation.Moderate or severe LVOT calcification confers increased risks of annular rupture, residual aortic regurgitation, and implantation of a second valve. The risk of residual aortic regurgitation is consistent across valve designs and generations. (SWISS TAVI Registry; NCT01368250).