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Previous studies have investigated a 1 to 6-month short dual antiplatelet therapy (S-DAPT) after percutaneous coronary intervention (PCI) with modern drug eluting-stents to reduce bleeding events. To investigate cardiovascular outcomes in patients at high bleeding risk (HBR) according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria after PCI with the Synergy bioresorbable-polymer everolimus-eluting stents (EES). We applied ARC-HBR criteria in the population of the prospective, single-arm, multicenter POEM (Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy Stent in Patients at HBR Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy) trial. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 12 months. The original POEM cohort included 356 patients (80.4 %) fulfilling ARC-HBR criteria. Oral anticoagulant (OAC) usage and age ≥75 years were the most frequent major and minor ARC-HBR criteria, respectively. The ARC-HBR group was mainly represented by men (71.1 %), with 74.4 ± 9.3 years and a high burden of cardiovascular risk factors. DAPT was prescribed in 79.3 %, and single antiplatelet (SAPT) with OAC in 18.7 %. 12-month follow-up was completed in 96.2 %. The primary endpoint occurred in 5.2 % (95 % CI 3.29–8.10) of patients, whereas bleeding Academic Research Consortium type 3–5 occurred in 2.7 % (95 % CI, 1.39 %–5.05 %). Previous results of the POEM trial showed positive outcomes regarding ischemic and bleeding events with an S-DAPT regimen after Synergy EES. These results are also confirmed in sub-group analysis when ARC-HBR criteria are applied. • High Bleeding Risk patients represent 40 % of coronary angioplasty population. • Short-DAPT could be safely use in PCI performed with several stent platform. • Clinical trials usually apply heterogeneous different bleeding definitions. • ARC-HBR criteria better discern clinical features of high bleeding risk patients. [ABSTRACT FROM AUTHOR]

Preprocedural right ventricular–to–pulmonary artery (RV-PA) coupling is a major predictor of outcome in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (M-TEER). However, clinical significance of changes in RV-PA coupling after M-TEER is unknown. The aim of this study was to evaluate changes in RV-PA coupling after M-TEER, their prognostic value, and predictors of improvement. This was a retrospective observational study, including patients undergoing successful M-TEER (residual mitral regurgitation ≤2+ at discharge) for SMR at 13 European centers and with complete echocardiographic data at baseline and short-term follow-up (30-180 days). RV-PA coupling was assessed with the use of echocardiography as the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP). All-cause death was assessed at the longest available follow-up starting from the time of the echocardiographic reassessment. Among 501 patients included, 331 (66%) improved their TAPSE/PASP after M-TEER (responders) at short-term follow-up (median: 89 days; IQR: 43-159 days), whereas 170 (34%) did not (nonresponders). Lack of previous cardiac surgery, low postprocedural mitral mean gradient, low baseline TAPSE, high baseline PASP, and baseline tricuspid regurgitation were independently associated with TAPSE/PASP improvement after M-TEER. Compared with nonresponders, responders had lower New York Heart Association functional class and less heart failure hospitalizations at short-term follow-up. Improvement in TAPSE/PASP was independently associated with reduced risk of mortality at long-term follow-up (584 days; IQR: 191-1,243 days) (HR: 0.65 [95% CI: 0.42-0.92]; P = 0.017). In patients with SMR, improvement in TAPSE/PASP after successful M-TEER is predicted by baseline clinical and echocardiographic variables and postprocedural mitral gradient, and is associated with a better outcome. [Display omitted] [ABSTRACT FROM AUTHOR]

Over the last two decades there has been a significant shift towards the use of bioprostheses in the context of surgical aortic valve replacement, despite the well-known process of structural valve deterioration (SVD). This process has been extensively evaluated even though with many different definitions and methods, thus, the true long-term durability of surgical bioprostheses is not yet fully elucidated. Following the increasing implementation of the transcatheter aortic valve implantation (TAVI) technology, a better understanding of the long-term durability of transcatheter bioprostheses has become increasingly important as well, despite the limited availability of such data compared to the surgical experience. This lack of knowledge is a major barrier to the use of TAVI platforms to treat relatively younger patients. We thus aimed at providing an overview on long-term actual data concerning the durability of bioprostheses focusing on definition, incidence, and subsequent management of SVD of both surgical and transcatheter bioprosthetic aortic valves. [ABSTRACT FROM AUTHOR]

A-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR). The study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes. After reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371–21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057–16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up. MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients. The MITRA-TUNE registry: A-FMR characteristics and changes in MR and NYHA class during the follow-up after MitraClip (A) Compared to baseline (34.5% MR 3+ and 65.5% MR 4+), a statistically significant improvement was observed at discharge (70% MR 1+, 28% MR 2+, 2% MR ≥3+, p ≤ 0.001) and at the follow-up (43% MR 1+, 46% MR 2+, 11% MR 3+, p ≤ 0.001). Median echocardiographic follow-up was 371 days [IQR 158–1067 days]. (B) Compared to baseline (17% NYHA II, 71% NYHA III and 12% NYHA IV), a statistically significant improvement was observed at the follow-up (4% NYHA I, 75% NYHA II, 18% NYHA III, 3% NYHA IV, p ≤ 0.001). Median clinical follow-up was 489 days [IQR 242–1033 days]. LVEF = left ventricle ejection fraction; LVEDD = left ventricle end-diastolic diameter; LV = left ventricle; MR = mitral regurgitation; FMR = functional mitral regurgitation; TMVr = transcatheter mitral valve repair; A-FMR = atrial functional mitral regurgitation; MVARC = Mitral Valve Academic Research Consortium; NYHA = New York Heart Association. [Display omitted] • Up to 1135 patients with FMR treated in Italy with the MitraClip, 87 (7.6%) fulfilled criteria for A-FMR • The MitraClip in A-FMR presented a technical success of 97%, 30-day device success of 83% and procedural success of 80%. • Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%. • Positive reverse remodeling of LA and mitral annular dimensions occurred after the MitraClip during the follow-up. [ABSTRACT FROM AUTHOR]

Objectives This study is the first report of 2 cases of HighLife (HighLife, Paris, France) implantation in humans. Background Transcatheter mitral valve implantation represents a promising approach to treating mitral regurgitation in patients at increased risk of perioperative mortality. The HighLife transcatheter mitral valve is a 2-component system. The valve is implanted in the mitral position and is anchored by interacting and then reaching an equilibrium position with a previously positioned subannular implant. Methods The procedures were successfully performed in a 69-year-old man and a 65-year-old woman with severe functional mitral regurgitation. Both patients were in New York Heart Association functional class IV heart failure with depressed left ventricular ejection fraction and additional comorbidities. Results The valve was implanted uneventfully in both patients. General anesthesia was used. The subannular implant was deployed through the transfemoral access, whereas the transcatheter mitral valve was released using the transapical access. Patients maintained hemodynamically stable. There were no intraoperative complications. Acutely, post-procedural echocardiograms demonstrated excellent prosthetic valve function with a low transvalvular gradient and no paravalvular leak and left ventricular outflow tract obstruction. Both patients had mild intraprosthetic regurgitation. Patient #1 survived at 5-months follow-up in New York Heart Association functional class II with excellent prosthesis performance. Patient #2 expired 4 days after a technically successful procedure, because the left ventricle did not tolerate the reduction of mitral regurgitation and despite a high dose of inotropic agents the left ventricular function rapidly deteriorated. Conclusions Transcatheter mitral valve implantation using the 2-component HighLife system is technically feasible and can be performed safely. Early hemodynamic performance of the prosthesis was excellent. [ABSTRACT FROM AUTHOR]

TAVR is an established treatment for patients with severe symptomatic aortic stenosis. Different THV platforms are nowadays available, each of them with its inherent limitations and others are under development aiming at overcoming such limitations. We thus sought to investigate the performance and 1-year clinical outcome of a new generation, balloon expandable, THV: the Myval™ (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India). This registry included the first 100 consecutive patients (mean age 80.7 ± 7.7; STS 4.3 ± 3.3 %), who underwent transcatheter aortic valve implantation for severe stenosis of the native aortic valve from May 2020 to December 2020, in two Italian Centers. Clinical and procedural outcomes were defined according to VARC-3 criteria. Transfemoral Myval THV was successfully implanted in all patients, with no intra-hospital mortality (technical success 100 %): vascular access complications were all "minor" (16 %), and managed by compression/balloon inflation; no cases of annular rupture or coronary obstruction occurred; 5 % of patients required an in-hospital pacemaker implantation (PM). Device success was 99 %. Overall and cardiovascular mortality were 6 % (CI 5 %–7 %) and 4 % (CI 2 %–5 %) at 1- year, while 12 % (CI 9 %–14 %) and 7 % (6–9 %) at 2 years. A total of 9 % of the patients required a PM within 12 months, and no further PM implantation occurred afterwards. No cerebrovascular events, renal failure and myocardial infarction occurred between discharge and 2-year follow-up. No events of structural valve deterioration but a sustained improvement of echocardiographic parameters were observed. The Myval THV has a promising safety/efficacy profile at 2 year follow up. This performance should be further evaluated in the context of randomized trials to better elucidate its potential. • A new generation of TAVR platforms is currently under evaluation aiming at improving the results of previous generation • The MyvalTM THV is a balloon-expandable TAVR system made by a nickel-cobalt alloy frame composed of hexagons cells. • The present manuscript reports a high success rate as well as a very low rate of vascular complication and PM implantation • The 2 year follow up showed no cases of structural valve deterioration • Large RCTs against the current generation are needed to place this new platform into the cardiovascular arena [ABSTRACT FROM AUTHOR]

Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan–Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF. [ABSTRACT FROM AUTHOR]