Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically ...searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% 75% to 83%) were in class New York Heart Association I/II and 57 (11% 8% to 14%) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% 20% to 31%) of the patients and 78 (15% 1% to 17%) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation.
Summary The assessment and management of tricuspid valve disease have evolved substantially during the past several years. Whereas tricuspid stenosis is uncommon, tricuspid regurgitation is ...frequently encountered and is most often secondary in nature and caused by annular dilatation and leaflet tethering from adverse right ventricular remodelling in response to any of several disease processes. Non-invasive assessment of tricuspid regurgitation must define its cause and severity; advanced three-dimensional echocardiography, MRI, and CT are gaining in clinical application. The indications for tricuspid valve surgery to treat tricuspid regurgitation are related to the cause of the disorder, the context in which it is encountered, its severity, and its effects on right ventricular function. Most operations for tricuspid regurgitation are done at the time of left-sided heart valve surgery. The threshold for restrictive ring annuloplasty repair of secondary tricuspid regurgitation at the time of left-sided valve surgery has decreased over time with recognition of the risk of progressive tricuspid regurgitation and right heart failure in patients with moderate or lesser degrees of tricuspid regurgitation and tricuspid annular dilatation, as well as with appreciation of the high risks of reoperative surgery for severe tricuspid regurgitation late after left-sided valve surgery. However, many patients with unoperated severe tricuspid regurgitation are also deemed at very high or prohibitive surgical risk. Novel transcatheter therapies have begun to emerge for the treatment of tricuspid regurgitation in such patients. Experience with such therapies is preliminary and further studies are needed to determine their role in the management of this disorder.
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.
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.
Objective To assess the very long-term clinical and echocardiographic results of the edge-to-edge repair for mitral regurgitation (MR) due to isolated prolapse or flail of the anterior leaflet. ...Methods From 1991 to 2004, 139 patients (age, 54 ± 14.4 years; left ventricular ejection fraction 56% ± 7.8%, New York Heart Association class I-II in 68.9%, atrial fibrillation in 20.1%) with severe degenerative MR due to isolated segmental prolapse or flail of the anterior leaflet were treated with the EE technique combined with annuloplasty. MR had resulted from prolapse or flail of the central scallop of the anterior leaflet (A2) in 105 patients (75.5%) and scallops A1 or A3 in 34 (24.4%). Results No hospital deaths occurred. At hospital discharge, MR was absent or mild in 130 patients (93.5%) and moderate (2+/4+) in 9 (6.4%). The clinical and echocardiographic follow-up data were 97.1% complete (mean length, 11.5 ± 3.73 years; median, 11; longest duration, 21.5). At 17 years, the actuarial survival was 72.4% ± 7.89%, freedom from cardiac death was 90.8% ± 4.77%, and freedom from reoperation was 89.6% ± 2.74%. At the last echocardiographic examination, recurrence of MR grade ≥3+ was documented in 17 patients (17 of 135, 12.5%). Freedom from MR grade ≥3+ at 17 years was 80.2% ± 5.86%. At multivariate analysis, the predictors of MR recurrence grade ≥3+ were residual MR greater than mild at hospital discharge (hazard ratio, 7.4; 95% confidence interval, 2.5-21.2; P = .0001) and the use of posterior pericardial rather than prosthetic ring annuloplasty, which was very close to statistical significance (hazard ratio, 2.8; 95% confidence interval, 0.9-8.7; P = .06). Conclusions In patients with MR due to segmental anterior leaflet prolapse, the very long-term results of the edge-to-edge repair combined with annuloplasty were excellent.
Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the ...incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.
Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one ...consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n = 447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7 ± 7.1 vs 79.8 ± 7.4 years, p = 0.06) and with a larger aortic annulus (25.0 ± 1.8 vs 23.6 ± 2.1 mm, p = 0.01). Device success (85.7% vs 94.4%, p = 0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p = 0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p = 0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p = 0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment.
Objective The very long-term results of the double-orifice mitral valve repair are unknown. The aim of this study was to assess the late clinical and echocardiographic outcomes of this technique in ...patients with degenerative mitral regurgitation. Methods From 1993 to 2000, 174 patients with severe degenerative mitral regurgitation were treated with the double-orifice technique combined with ring annuloplasty. Mean age of patients was 52 ± 12.8 years, New York Heart Association class I or II was present in 71% of the patients, atrial fibrillation in 17.2%, and preoperative left ventricular ejection fraction was 59.5% ± 7.5%. Mitral regurgitation was due to anterior leaflet prolapse in 36 patients (20.6%), bileaflet prolapse in 128 (73.5%), and posterior leaflet prolapse in 10 patients (5.7%). Results There were no hospital deaths. At hospital discharge, mitral regurgitation was absent or mild in 169 patients (97.1%) and moderate (2+/4+) in 5 patients (2.8%). Mitral stenosis requiring reoperation was detected in 1 patient (0.6%). Clinical and echocardiographic follow-up was 97.1% complete (mean length, 11.5 ± 2.53 years; median, 11.6 years; longest duration, 17.6 years). At 14 years, actuarial survival was 86.9% ± 3.37%, freedom from cardiac death was 95.8% ± 1.54%, and freedom from reoperation was 89.6 ± 2.51%. At the last echocardiographic examination, recurrence of mitral regurgitation ≥3+ was documented in 23 patients (23/169, 13.6%). Freedom from mitral regurgitation ≥3+ at 14 years was 83.8% ± 3.39%. The only predictor of recurrence of mitral regurgitation ≥3+ was residual mitral regurgitation greater than mild at hospital discharge (hazard ratio, 5.7; 95% confidence interval, 1.6-20.6; P = .007). Conclusions The double-orifice repair combined with ring annuloplasty provides very satisfactory long-term results in patients with degenerative mitral regurgitation in the setting of bileaflet and anterior leaflet prolapse.
Objectives Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a ...stepwise fashion. Background Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis. Methods We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach. Results A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events. Conclusions Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.
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