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Background: In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking., Objectives: The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems., Methods: Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562)., Conclusions: In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome., Competing Interests: Funding Support and Author Disclosures Dr Iliadis has received travel support from Abbott; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Hausleiter has received research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr Möllmann has received speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Rudolph has received research grants and consulting honoraria from Edwards Lifesciences. Dr von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Edwards Lifesciences, NeoChord, and Medtronic. Dr Nef has received speaker and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr Luedike has received consulting and lecture honoraria from Edwards Lifesciences. Drs Pfister and Baldus have received consulting honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Mitral regurgitation (MR) is common in patients with heart failure and constitutes an independent risk factor for adverse prognosis besides NYHA-class. The predictive value of dyspnea reduction after transcatheter mitral valve repair (TMVr) on outcome has not been investigated up to now., Methods and Results: We enrolled 627 consecutive patients (47.0% female, 57.4% functional MR; median follow-up 486 days[IQR 157/961]; survival status available in 96.8%; symptoms assessed in n = 556 at baseline / n = 406 at 1 month) treated with isolated percutaneous mitral valve edge-to-edge repair in our center from 06/2010-03/2018 (exclusion of combined forms of TMVr) in a monocentric retrospective analysis. Survival was 97.6% at discharge, 73.9% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7-years. Before TMVr, NYHA-classes III/IV were found in 89.0%. Of these, 74.7% reported symptomatic relief (reduction in NYHA-class) one month after procedure (NYHA class recorded in 406 patients at 30 days). NYHA-classes III/IV were documented in 37.2% (p < 0.001) at 30 days and in 36.6% (p < 0.001) at 1 year without significant changes between the follow-ups. Dyspnea reduction was accompanied by significantly improved long-term survival (1 year, 89.1 vs 71.2%, p = 0.001, 2 years: 75.5 vs 58.7%, p = 0.039) and was identified as an independent predictor for lower mortality (1-year HR for increased mortality by missing symptomatic improvement 2.94 [95%CI 1.53-5.65], p = 0.001; long-term HR 1.95 [95%CI 1.29-2.94], p = 0.001) independently in both etiologies of MR., Conclusion: TMVr by edge-to-edge therapy enables early and sustainable symptomatic improvement in nearly 75% of the symptomatic patients. The simple assessment of postinterventional changes in NYHA-class might serve as an independent predictor for mid- and long-term prognosis in both FMR and DMR., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI., Methods: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively., Results: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively., Conclusions: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess 30-day outcomes of transcatheter edge-to-edge repair with the MitraClip XTR for significant tricuspid regurgitation (TR), relative to baseline coaptation gap sizes (CGS)., Background: Transcatheter edge-to-edge repair using the MitraClip NT for patients with significant TR is safe and efficacious; the utility of the MitraClip XTR is unknown., Methods: Patients with significant, symptomatic TR treated at a single site between April 2018 and December 2019, with consent and with complete data, were included (n = 50). Baseline and 30-day echocardiograms were assessed by an echocardiography core laboratory. Patients were divided into 3 subgroups on the basis of site-assessed CGS: subgroup I (< 7 mm), subgroup II (7 to 10 mm), and subgroup III (>10 mm)., Results: Technical success of the MitraClip XTR implantation was 100% (88% in the septal-anterior position) using a median of 2 clips (interquartile range: 1 to 2). At 30 days, single-leaflet detachment was noted in 3 patients (6%), with no instances of device embolization. TR was reduced by 1 grade in subgroup I and by 2 grades in subgroups II and III. New York Heart Association functional class was reduced by 1 class in all 3 subgroups. The 6-min walk distance increased in subgroup I (+115 m; p = 0.014) and subgroup II (+31.5 m; p = 0.028) but not subgroup III (+50 m; p = 0.999). A CGS of ≤8.4 mm was predictive of a reduction to moderate or less TR., Conclusions: MitraClip XTR implantation is a safe, effective treatment for a wider range of CGS in patients with symptomatic, significant TR than prior device iterations. All patients showed improvement in New York Heart Association functional class, and those with CGS <10 mm also experienced improved functional capacity., Competing Interests: Funding Support and Author Disclosures The core laboratory was funded by Abbott Laboratories. Dr. Hahn has received speaker fees from Edwards Lifesciences; is a consultant for Abbott Vascular, Boston Scientific, Gore & Associates, and Medtronic; holds equity in Navigate; and is the chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. von Bardeleben is a consultant, advisory board member, TRILUMINATE trial eligibility committee member, and speaker for Abbott Vascular, and Edwards Lifesciences. Drs. Kreidel and Ruf have received speaker honoraria from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes., Background: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population., Methods: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up., Results: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis., Conclusions: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr. Fam has received speaker honoraria from Abbott Vascular; and is a consultant to Edwards Lifesciences. Dr. von Bardeleben received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Ye is a consultant to Edwards Lifesciences, JC Medical, and CryoLife. Dr. Moss is a consultant to Edwards Lifesciences. Dr. Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences; and is a consultant to Abbott Vascular and Edwards Lifesciences. Dr. George is consultant to VDyne, CardioMech, Atricure, MitreMedical, Neptune Medical, and W.L. Gore. Dr. Nabauer has received speaker honoraria from Abbott Vascular. Dr. Mack is co–principal investigator of the PARTNER (Placement of Aortic Transcatheter Valves) 3 trial for Edwards Lifesciences; is co–principal investigator of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial for Abbott; and is study chair of the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial for Medtronic (all uncompensated). Dr. Hahn has received speaker fees from Edwards Lifesciences; is a consultant for Abbott Vascular, Boston Scientific, Gore & Associates, and Medtronic; holds equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Becton Dickinson, and ViVitro Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system., Background: The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture., Methods: Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%)., Conclusions: Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status., Competing Interests: Author Disclosures Drs. Pfister and Baldus have received honoraria for consulting from Edwards Lifesciences. Dr. Luedike has received honoraria for consulting and lectures from Edwards Lifesciences. Dr. Rudolph has received research grants and honoraria for consulting from Edwards Lifesciences. Dr. Hausleiter has received research grants and speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr. Nef has received speaking and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Möllmann has received speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Cardiac Dimensions, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI)., Background: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR., Methods: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year., Results: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048)., Conclusions: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background and Aim: The number of percutaneous edge-to-edge mitral regurgitation (MR) valve repairs with MitraClip® implantations increased exponentially in recent years. Studies have suggested an obesity survival paradox in patients with cardiovascular diseases. We investigated the influence of obesity on adverse in-hospital outcomes in patients with MitraClip® implantation., Methods and Results: We analyzed data on characteristics of patients and in-hospital outcomes for all percutaneous mitral valve repairs using the edge-to-edge MitraClip®-technique in Germany 2011-2015 stratified for obesity vs. normal-weight/over-weight. The nationwide inpatient sample comprised 13,563 inpatients undergoing MitraClip® implantations. Among them, 1017 (7.5%) patients were coded with obesity. Obese patients were younger (75 vs.77 years,P < 0.001), more often female (45.4% vs.39.5%,P < 0.001), had more often heart failure (87.1% vs.79.2%,P < 0.001) and renal insufficiency (67.0% vs.56.4%,P < 0.001). Obese and non-obese patients were comparable regarding major adverse cardiac and cerebrovascular events (MACCE) and in-hospital death. The combined endpoint of cardio-pulmonary resuscitation (CPR), mechanical ventilation and death was more often reached in non-obese than in obese patients with a trend towards significance (20.6%vs.18.2%,P = 0.066). Obesity was an independent predictor of reduced events regarding the combined endpoint of CPR, mechanical ventilation and death (OR 0.75, 95%CI 0.64-0.89,P < 0.001), but not for reduced in-hospital mortality (P = 0.355) or reduced MACCE rate (P = 0.108). Obesity class III was associated with an elevated risk for pulmonary embolism (OR 5.66, 95%CI 1.35-23.77,P = 0.018)., Conclusions: We observed an obesity paradox regarding the combined endpoint of CPR, mechanical ventilation and in-hospital death in patients undergoing MitraClip® implantation, but our results failed to confirm an impact of obesity on in-hospital survival or MACCE., Competing Interests: Declaration of Competing Interest KK, MG, MAO, CJL, TM report no conflict of interest. LH reports having received lecture honoraria from MSD. FK reports having received consultancy and lecture honoraria from Abbott, Cardiac Implants, Edwards Lifesciences. M.L. reports having received consultancy and lecture honoraria from Actelion, Bayer, Daiichi-Sankyo, MSD, Pfizer – Bristol-Myers Squibb and research funding from BRAHMS – Thermo Fisher scientific. S.K. reports having received consultancy and lecture honoraria from Bayer, Boehringer Ingelheim, Daiichi-Sankyo, MSD and Pfizer – Bristol-Myers Squibb; and institutional grants from Actelion, Bayer, Boehringer Ingelheim, Daiichi-Sankyo and Pfizer – Bristol-Myers Squibb. RSB reports having received consultancy and lecture honoraria from Abbott Structural Heart, Boehringer Ingelheim, Cardiac Dimensions, Edwards Lifesciences, GE Health Systems and Philips Healthcare., (Copyright © 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Objectives: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear., Background: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis., Methods: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed., Results: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm 2 vs. 0.6 ± 0.3 cm 2 ; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30)., Conclusions: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Background: Many candidates with ischaemic functional mitral regurgitation (FMR) have previously undergone coronary artery bypass grafting (CABG), in which transcatheter mitral valve repair can be reasonable for ameliorating the deteriorated hemodynamic and heart failure symptoms. We sought to elucidate the outcomes of MitraClip (MC) implantation in patients with symptomatic ischaemic FMR after CABG., Methods: We investigated clinical characteristics, outcomes and predictive impact of previous CABG on mortality in ischaemic FMR patients who underwent MC implantation from two high-volume centres in Germany., Results: We enrolled 159 patients who previously underwent CABG. Compared with a reference group that did not previously undergo CABG (n = 182), the cohort consisted of more elderly patients (75.0, standard deviation [SD] 7.7 versus 72.9, SD 9.6 years, p = 0.028), more men (84% vs. 69%, p < 0.001), and reduced tricuspid annular plane systolic excursion (14.0, SD 4.0, vs. 16.6, SD 4.6 mm, p < 0.0001). The CABG group showed similar outcomes regarding procedural success (91% vs. 94%, p = 0.24) and 30-day mortality (5.0% vs. 6.0%, p = 0.68), but worse survival after MC implantation (log-rank p = 0.019, hazard ratio 1.56 [95% confidence interval (CI) 1.08-2.26]). After propensity score matching (n = 224), the hazard ratio was 1.18 [95%CI 0.76-1.84] without statistical significance (p = 0.46)., Conclusions: Transcatheter mitral valve repair using the MC is a viable treatment option for patients with symptomatic ischaemic FMR after CABG. Although the baseline characteristics seemed to point to sick patients, CABG itself had only a modest impact on survival., (Copyright © 2019 Elsevier B.V. All rights reserved.)

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 2 ). 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., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives: This study sought to develop a large, international registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results., Background: Several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation (TR), generally a high-risk surgical population., Methods: The TriValve (Transcatheter Tricuspid Valve Therapies) registry included 106 high-risk patients (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II 7.6 ± 5.7%) from 11 cardiac centers, with severe TR., Results: A total of 35% of the patients had prior left heart valve intervention (surgical in 29 of 106 and transcatheter in 8 of 106 patients). Right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion <17 mm) was present in 56.3% of the patients; 95% of the patients were in New York Heart Association functional class III to IV. The etiology of TR was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm. In 76.9% of the patients, the main location of the regurgitant jet was central; pre-procedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg; and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm). Implanted devices included MitraClip (n = 58), Trialign (n = 17), TriCinch (n = 15), FORMA (n = 7), Cardioband (n = 5), and caval valve implantation (n = 3). One case had combined Trialign + MitraClip. Patients treated with the different techniques were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of RV dysfunction. In 68% of the cases the tricuspid intervention was performed as an isolated procedure. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%; 58% of the patients were New York Heart Association functional class I or II at 30 days., Conclusions: Patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired RV function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment., Background: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device., Methods: Thirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled., Results: Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was 5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 ± 0.5 cm at baseline to 2.5 ± 0.4 cm after 1 month and to 2.4 ± 0.4 cm after 6 months, respectively (p < 0.001). Percentage of patients with FMR ≥3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p < 0.001); exercise capacity as assessed by 6-min walking test increased from 250 ± 107 m to 332 ± 118 m (p < 0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001)., Conclusions: In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the feasibility and safety of using a filter-based cerebral protection system (CPS) during MitraClip implantation and to report on the histopathologic analysis of the captured debris., Background: Stroke is one of the serious adverse events associated with MitraClip therapy., Methods: Between July 2014 and March 2015, 14 surgical high-risk patients (age 75 ± 7 years; 7 men; median logistic EuroSCORE 21%) underwent MitraClip implantation employing cerebral protection with a dual embolic filter system. All patients had severe mitral regurgitation of predominantly functional origin., Results: All procedures were successfully completed for both CPS deployment/retrieval and MitraClip implantation. A total of 28 filters (2 from each patient) were analyzed. Microscopically, debris was identified in all 14 patients. The most common tissue types were acute thrombus and small fragments of foreign material, which were found in 12 patients (85.7%) each. Organizing thrombus was present in 4 patients (28.6%), valve tissue and/or superficial atrial wall tissue in 9 patients (64.3%), and fragments of myocardium in 2 patients (14.3%). No transient ischemic attacks, strokes, or deaths occurred peri-procedurally or during a median follow-up interval of 8.4 months., Conclusions: In this small study of patients undergoing MitraClip treatment with cerebral protection, embolic debris potentially conducive to cerebrovascular events was found in all patients. Debris was composed most often of acute thrombus, foreign material likely originating from the hydrophilic device coating, and valve/atrial wall tissue. Further studies are warranted to assess the impact of cerebral protection on the incidence of cerebrovascular events after MitraClip therapy., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The goal of this study was to assess procedural details and outcomes of repeat MitraClip therapy., Background: MitraClip implantation is a safe and efficacious percutaneous approach to treat significant mitral regurgitation (MR)., Methods: Of 410 inoperable or high surgical risk patients treated with the MitraClip at our institution, 17 (4.1%) patients, as well as 4 patients initially treated at external institutions, underwent repeat MitraClip procedures. Mean age of the 21 patients (14 men [67%]) was 77 years; 15 patients (71%) had functional MR., Results: Repeat procedures performed at a median of 6.3 months (range 0.7 to 34 months) after the index intervention were successful (discharge MR grade ≤2+) in 13 patients (62%), with a pronounced difference in success rate observed between the 13 patients with adequate leaflet insertion at the time of the repeat intervention and the 8 patients in whom loss of leaflet insertion (LLI) (leaflet tear/perforation or partial clip detachment) was present (11 of 13 [85%] vs. 2 of 8 [25%], respectively). The 21 patients were followed for a median of 8.5 (interquartile range: 2.3 to 18.6) months; 13 patients (62%), 8 with adequate leaflet insertion and 5 with LLI, died during follow-up., Conclusions: Repeat MitraClip intervention for significant recurrent MR appears to be a viable therapeutic approach in patients in whom leaflet insertion into the MitraClip is not compromised. LLI is strongly associated with repeat procedural failure., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Intramyocardial dissecting hemorrhage is a very rare and potentially lethal complication of myocardial infarction. The diagnosis is typically made by echocardiography, by cardiac magnetic resonance imaging, at operation, or during postmortem examination. Medical treatment is most often associated with high mortality, and surgical treatment is required. We report a 53-year old man admitted to the urology department with a large left-sided kidney infarction. A subacute myocardial infarction by electrocardiogram, elevated troponin T level, and typical clinical signs of an acute coronary syndrome 5 days and 2 weeks before admission were also evident. Intramyocardial dissecting hemorrhage with an adjacent thrombotic formation was suspected by echocardiography and cardiac computed tomography and confirmed by magnetic resonance imaging. The patient underwent successful surgical correction and was discharged in good clinical condition., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Papillary muscle rupture is a rare but potentially lethal complication of acute myocardial infarction. We report a 77-year-old man who presented to the emergency department with dyspnea and nausea and acute onset of severe back pain 3 days earlier. Owing to rapid deterioration of his hemodynamic and respiratory situation, the patient was immediately transferred to the intensive care unit. Intubation and catecholamine support became necessary to stabilize hemodynamics. Echocardiography revealed severe mitral regurgitation due to a complete rupture of the posterior papillary muscle. Despite treatment extension to intraaortic balloon counterpulsation, the patient continued to be in cardiogenic shock. Because the patient was rejected for surgical intervention, he underwent successful emergency MitraClip (Abbott Vascular, Santa Clara, CA) implantation and was discharged from hospital in good clinical condition. This report suggests that MitraClip implantation is a safe and effective alternative treatment option in this devastating disorder., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Valve-in-valve implantation for degenerated surgical bioprosthetic valves is becoming an increasingly accepted approach in selected high-risk patients. In the past, valve-in-valve implantations have been mainly performed in aortic position and only rarely in mitral position. We describe the case of an 81-year-old female patient with severe mitral regurgitation of a degenerated Carpentier-Edwards biological prosthesis treated by transfemoral and transseptal implantation of a SAPIEN-XT valve., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices., Background: Transaxillary TAVI is gaining increasing acceptance as an alternative to the transfemoral route; however, the access has always been done via surgical cutdown so far., Methods: Between August 2010 and September 2011, a total of 24 high-risk patients with severe aortic valvular stenosis underwent a percutaneous TAVI procedure by direct puncture of the axillary artery without surgical cutdown. For safety reasons and as a target for the puncture, a wire was advanced via the ipsilateral brachial artery. Moreover, a balloon was placed into the subclavian artery via the femoral artery for temporary vessel blockade before percutaneous vessel closure. Vascular closure was performed using either the ProStar XL system (Abbott Vascular Devices, Redwood City, California) or 2 ProGlide systems (Abbott Vascular Devices)., Results: The true percutaneous approach was successfully completed in all patients (14 left and 8 right axillary artery cases). Overall mortality at 30 days was 8.3%. Acute vascular closure device success was achieved in 17 patients (71%). Vascular closure device success rate was 100% for the ProGlide device and 37% for the ProStar device, respectively. Seven patients (29%) with failing closure devices were treated by endovascular stent graft implantation without the need for surgical repair. For the last 12 treated patients, direct closure was achieved in 11 patients., Conclusions: Direct puncture of the axillary artery for TAVI is feasible and safe if a wire is placed into the subclavian artery via the ipsilateral brachial artery., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)