Abstract Tricuspid valve (TV) disease has been relatively neglected, despite the known association between severe tricuspid regurgitation (TR) and mortality. Few patients undergo isolated tricuspid ...surgery, which remains associated with high in-hospital mortality rates, particularly in patients with prior left-sided valve surgery. Patients with severe TR are often managed medically for years before TV repair or replacement. Current guidelines recommend TV repair in the presence of a dilated tricuspid annulus at the time of a left-sided valve surgical intervention, even if regurgitation is mild. This proposed algorithm aims to prevent the inevitable progression to severe TR and the need for a second surgical intervention. Recently, novel transcatheter treatment options were developed for treating patients with severe TR and right heart failure with prohibitive surgical risk. Here we describe currently available transcatheter treatment options for severe TR implanted at different levels: the junction between vena cavae and right atrium; the tricuspid annulus; or between TV leaflets, improving coaptation.
Functional or secondary tricuspid regurgitation (STR) is the most frequent etiology of tricuspid valve pathology in Western countries. Surgical tricuspid repair has been avoided for years, because of ...the misconception that tricuspid regurgitation should disappear once the primary left-sided problem is treated; this results in a large number of untreated patients with STR. Over the past few years, many investigators have reported evidence in favor of a more aggressive surgical approach to STR. Consequently, interest has been growing in the physiopathology and treatment of STR. The purpose of this review is to explore the anatomical basis, pathophysiology, therapeutic approach, and future perspectives with regard to the management of STR.
Abstract
Aims
The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of ...consecutive patients who underwent the Cardioband procedure between 2013 and 2016.
Methods and results
Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guideline-recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year but worsened by at least one grade in 11 patients (22%). Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (−19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01).
Conclusion
In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.
Abstract
The right ventricular (RV)-pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile ...response to increased afterload.
This study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR).
The study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up.
Among 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio >0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio >0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio OR: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs <1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling.
RV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR.
Approximately 4% of subjects aged 75 years or more have clinically relevant tricuspid regurgitation (TR). Primary TR results from anatomical abnormality of the tricuspid valve apparatus and is ...observed in only 8-10% of the patients with tricuspid valve disease. Secondary TR is more common and arises as a result of annular dilation caused by right ventricular enlargement and dysfunction as a consequence of pulmonary hypertension, often caused by left-sided heart disease or atrial fibrillation. Irrespective of its aetiology, TR leads to volume overload and increased wall stress, both of which negatively contribute to detrimental remodelling and worsening TR. This vicious circle translates into impaired survival and increased heart failure symptoms in patients with and without reduced left ventricular ejection fraction. Interventions to correct TR are underutilised in daily clinical practice owing to increased surgical risk and late patient presentation. The recently introduced transcatheter tricuspid valve interventions aim to address this unmet need. Dedicated expertise and an interdisciplinary Heart Team evaluation are essential to integrate these new techniques successfully and select patients. The present article proposes a standardised approach to evaluate patients with TR who may be candidates for transcatheter interventions. In addition, a state-of-the-art review of the available transcatheter therapies, the main criteria for patient and device selection, and information concerning the remaining uncertainties are provided.
Objectives The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European ...prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California). Background MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes. Methods A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%. Results The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points. Conclusions In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events.
Moderate-to-severe tricuspid regurgitation (TR) affects ∼1.6 million patients in the USA, of whom only 8000 undergo tricuspid surgery annually; this results in an extremely large number of untreated ...patients with significant TR. Therefore, there is a large unmet clinical need for patients with severe TR who are not referred for conventional surgery, mainly due to expected high surgical risk. Percutaneous procedures are an attractive alternative to surgery for patients deemed to be high-risk surgical candidates. Whereas over the past few years, the development and clinical use of percutaneous approaches to the aortic valve and mitral valve have been widespread, few data are available about the feasibility and the efficacy of the percutaneous tricuspid valve treatment. This review will explore the available technologies, which are today under evaluation and the preliminary clinical results.
Objectives This study evaluated the safety, efficacy, and effect of MitraClip treatment on symptoms and left ventricular (LV) remodeling in nonresponders to cardiac resynchronization therapy (CRT). ...Background Moderate to severe functional mitral regurgitation (FMR) frequently persists after CRT, contributing to reduced or no response to CRT. Percutaneous repair with the MitraClip has been proposed as an additional therapeutic option in select patients with significant FMR. Methods Fifty-one severely symptomatic CRT nonresponders with significant FMR (grade ≥2, 100%) underwent MitraClip treatment. Changes in New York Heart Association functional class, degree of FMR, LV ejection fraction (EF), and LV end-diastolic/end-systolic volumes (EDV/ESV) before and after (3, 6, and 12 months) MitraClip implantation were recorded. Mortality data, including cause of death, were collected. Results MC treatment was feasible in all patients (49% 1 clip, 46% 2 clips). There were 2 periprocedural deaths. Median follow-up was 14 months (25th to 75th percentile: 8 to 17 months). New York Heart Association functional class improved acutely at discharge (73%) and continued to improve progressively during follow-up (regression model, p < 0.001). The proportion of patients with significant residual FMR (grade ≥2) progressively decreased during follow-up (regression model, p < 0.001). Reverse LV remodeling and improved LVEF were detected at 6 months, with further improvement at 12 months (regression model, p = 0.001, p = 0.008, and p = 0.031 for ESV, EDV, and LVEF, respectively). Overall 30-day mortality was 4.2%. Overall mortality during follow-up was 19.9 per 100 person-years (95% confidence interval: 10.3 to 38.3). Nonsurvivors had more compromised clinical baseline conditions, longer QRS duration, and a more dilated heart. Conclusions FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients.
Objectives The aim of this study is to report the long-term outcomes (median follow-up time, 7 years; range, 1 month to 14 years) of patients who underwent surgery for paravalvular leak in our ...single-center experience. Methods From October 2000 to November 2007, 122 consecutive patients underwent surgery for symptomatic paravalvular leak (40 patients with aortic paravalvular leak; 82 with mitral paravalvular leak). In 7 patients (5.7%, all mitral), surgery was performed on the beating heart through a right thoracotomy. In 35% of patients, multiple paravalvular leaks were present. Results The mean age of patients was 62 ± 11 years, and European System for Cardiac Operative Risk Evaluation II was 7.2% ± 6%. Most of the patients were in New York Heart Association functional class III or IV (60%). Symptomatic hemolysis was present in 31% of the patients, and 41% of the patients had more than 1 previous cardiac operation. Paravalvular leak repair was feasible in 79 patients (65%), whereas in 43 patients (35%) prosthesis re-replacement was required. Thirty-day mortality was 10.7% (13/122 patients; 5% for aortic paravalvular leak and 13% for mitral paravalvular leak; P = .1); 2 patients (1.6%) with residual severe mitral paravalvular leak underwent successful redo surgery before discharge. Median length of stay was 7 days. Overall actuarial survival was 39% ± 6% at 12 years; freedom from cardiac death was 54% ± 7% at 12 years. Only 1 patient underwent redo surgery during follow-up. Multivariable analysis identified preoperative chronic renal failure (hazard ratio, 2.6; 95% confidence interval, 1.4-4.9; P = .03) and more than 1 previous cardiac reoperation (hazard ratio, 2.3; 95% confidence interval, 1.3-4; P = .03) as independent predictors of death at follow-up. Conclusions The operative mortality of surgical treatment of paravalvular leak is still high. Long-term outcomes remain suboptimal in these challenging patients, especially in the presence of multiple previous cardiac operations and associated co-pathologies. These results support the importance of alternative therapeutic options.
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