Effectiveness of Transcatheter Reduction of Significant Mitral Regurgitation in High Surgical Risk Patients with Mitraclip: Final 5 Year Results of the Everest II High Risk Registry (original) (raw)
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Journal of the American College of Cardiology, 2014
BACKGROUND Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported. OBJECTIVES This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR. METHODS A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. RESULTS A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 AE 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 AE 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR #1þ or MR 2þ. At 1 year, the majority of surviving patients (82.9%) remained MR #2þ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 AE 40.1 ml to 108.5 AE 37.9 ml; p < 0.0001 [n ¼ 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced. CONCLUSIONS TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year.
2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study
JACC: Cardiovascular Interventions, 2021
OBJECTIVES The study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS Patients had clinically significant MR 3þasevaluatedbytheechocardiographiccorelaboratoryandweredeemedcandidatesfortranscatheterrepairbytheheartteam.Assessmentswereperformedbyclinicaleventscommitteeto1year(site−reportedthereafter)andcorelaboratoryto2years.RESULTSAtotalof124patients(693þ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR 3þasevaluatedbytheechocardiographiccorelaboratoryandweredeemedcandidatesfortranscatheterrepairbytheheartteam.Assessmentswereperformedbyclinicaleventscommitteeto1year(site−reportedthereafter)andcorelaboratoryto2years.RESULTSAtotalof124patients(693þ. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR #1þ was achieved in 78% of patients (84% FMR, 71% DMR) and MR #2þ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.
JACC: Cardiovascular Imaging, 2021
OBJECTIVES This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the Mitraclip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial. BACKGROUND It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials. METHODS In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months. RESULTS We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO 30mm2,RVOL30 mm 2 , RVOL 30mm2,RVOL45 ml or RF 5050%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/enddiastolic volume ratio 50 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. CONCLUSIONS In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the Mitraclip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).
Journal of the American College of Cardiology, 2019
BACKGROUND In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) led to reduced heart failure (HF) hospitalizations and improved survival in patients with symptomatic HF and 3þ to 4þ secondary mitral regurgitation (MR) on maximally-tolerated medical therapy. Given the advanced age and comorbidities of these patients, improvement in health status is also an important treatment goal. OBJECTIVES The purpose of this study was to understand the health status outcomes of patients with HF and 3þ to 4þ secondary MR treated with TMVr versus standard care. METHODS The COAPT trial randomized patients with HF and 3þ to 4þ secondary MR to TMVr (n ¼ 302) or standard care (n ¼ 312). Health status was assessed at baseline and at 1, 6, 12, and 24 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey. The primary health status endpoint was the KCCQ overall summary score (KCCQ-OS; range 0 to 100; higher ¼ better; minimum clinically important difference ¼ 5 points). RESULTS At baseline, patients had substantially impaired health status (mean KCCQ-OS 52.4 AE 23.0). While health status was unchanged over time in the standard care arm, patients randomized to TMVr demonstrated substantial improvement in the KCCQ-OS at 1 month (mean between-group difference 15.9 points; 95% confidence interval [CI]: 12.3 to 19.5 points), with only slight attenuation of this benefit through 24 months (mean between-group difference 12.8 points; 95% CI: 7.5 to 18.2 points). At 24 months, 36.4% of TMVr patients were alive with a moderately large ($10-point) improvement versus 16.6% of standard care patients (p < 0.001), for a number needed to treat of 5.1 patients (95% CI: 3.6 to 8.7 patients). TMVr patients also reported better generic health status at each timepoint (24-month mean difference in SF-36 summary scores: physical 3.6 points; 95% CI: 1.4 to 5.8 points; mental 3.6 points; 95% CI: 0.8 to 6.4 points). CONCLUSIONS Among patients with symptomatic HF and 3þ to 4þ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079)
Mini-invasive Surgery , 2020
A growing body of evidence shows that transcatheter mitral valve edge-to-edge repair (TMVr) for mitral regurgitation (MR) improves symptoms and prognosis of patients with heart failure. Still, as recently shown by two large randomized controlled trials (COAPT and MITRA-FR), there is differing information on which patients have the largest benefit. We aimed to summarize the current knowledge of clinical and anatomic predictors for acute procedural failure and long-term all-cause mortality after TMVr. TMVr is an effective treatment option for patients with symptomatic MR fulfilling certain echocardiographic and clinical criteria or being ineligible for surgery despite optimal medical therapy. Acute procedural failure is influenced by anatomic features of the mitral valve, among those are increased tenting and mitral valve leaflet configuration, leaflet-to-annulus index, as well as the mitral valve opening area. In contrast, anatomy of the mitral valve plays a minor role in predicting all-cause mortality after TMVr. This endpoint is associated with patient comorbidities (e.g., renal failure and chronic lung disease), severe heart failure as expressed by New York Hear Association functional class (NYHA) IV, left and right heart dysfunction, laboratory parameters (NT-proBNP), clinical scoring systems (STS and EuroScore), and procedural MR reduction. In patients undergoing TMVr for severe MR, careful preprocedural evaluation of relevant comorbidities, mitral valve anatomy, as well as left and right heart function can provide detailed prognostic value regarding acute procedural success and long-term survival.
Annals of Translational Medicine, 2020
Background: Functional mitral regurgitation (FMR) is a bad prognosis condition despite optimal medical treatment. Nowadays there is an open debate about the surgical versus percutaneous treatment. The main objective of this study is to evaluate the mid-term follow up clinical outcomes of patients with FMR treated with MitraClip ® system, according to their left ventricular ejection fraction (LVEF). Methods: Data was obtained from two experienced centers in transcatheter mitral valve repair (TMVR). All consecutive cases of severe FMR undergoing TMVR in both centers with the same inclusion criteria were included prospectively in this study and followed-up. Periodical follow-ups with clinical and echocardiographic evaluation were scheduled from the baseline procedure, at 3 months and then yearly. Results: From October 2015 to October 2019, a total of 119 patients with FMR at 2 centers in Spain underwent TMVR with the MitraClip ® procedure and were included in this study. The mean age was 73.8±8.9 years old and 32 patients (26.9%) were female. A 39.5% of cases [47] had a LVEF ≤30% (group 1) and 60.5% (72 cases) had a LVEF >30% (group 2). There was a similar distribution in cardiovascular risk factors, age and other diseases. All MitraClip ® implantations were elective and procedural success was achieved in 110 patients (92.4%) with a similar distribution between the groups. There were no differences in procedural time and the number of implanted clips. The median follow-up was 22.6 months (IQR, 11.43-34.98 months). The primary combined endpoint occurred in the 41.6% of the global cohort, 57.5% in group 1 and 30.99% in group 2 (P=0.036). LVEF was associated to the main event in the multivariate analysis (HR 2.09, 95% CI: 1.12-3.89; P=0.02). Conclusions: The MitraClip edge-to-edge technique is a safe and effective procedure for the treatment of FMR. In this study, patients with LVEF >30% treated with Mitraclip presented better clinical cardiovascular outcomes than those with a LVEF ≤30%. Regardless clinical outcomes, at the end of the follow-up, there was a sustained reduction in MR grades and an important improvement in NYHA functional class.