MitraClip Repair Research Articles

Abstract 14791: Mitral Annular Calcification is Not Associated With Survival After Percutaneous Edge-to-Edge Repair of Mitral Regurgitation

Introduction: Mitral annular calcification (MAC) has been associated with age, hemodialysis (HD) status, coronary disease, and mortality. While MAC is seen frequently in pts undergoing percutaneous edge-to-edge repair of mitral regurgitation (MR) its impact on survival is unknown. Hypothesis: MAC is not associated with mortality after percutaneous MR repair. Methods: Pts who underwent MitraClip repair of MR between Apr 2009 and May 2014 were included. Kaplan-Meier survival was plotted between pts with no MAC and pts with MAC. A multivariate Cox regression of all-cause mortality was performed simultaneously adjusting for MAC, age, HD status, and prior myocardial infarction (MI). Results: 173 pts were included. Mean age at percutaneous repair was 76.9 ± 12.6 yrs and 40.8% were females. MAC was present in 86/173 (49.7%) of pts, and was mild in 61/86 (70.9%) cases and moderate or severe in the remaining cases. In pts with MAC prevalence of prior MI was higher 28/86 (32.6%) vs. 16/87 (18.4%) p=0.037 but ejection fraction was similar 51.8 ± 17.1 vs. 50.4 ± 18.6 % p=0.603. Age was increased in pts with MAC 79.9 ± 10.1 vs. 74.3 ± 14.0 yrs p=0.003. MR was moderate-to-severe in 35/173 (20.2%) of pts and severe in 138/173 (79.8%) of pts. MR improved by 2 grades or more in 165/173 (95.4%) of pts after repair. Survival was decreased in pts with MAC as compared to pts with no MAC by Log Rank p=0.049 (Figure 1A). However, in a multivariate Cox regression model of all-cause mortality, MAC, after adjusting for age, HD status, and prior MI, was not associated with mortality with a hazard ratio of 1.166 (95% CI 0.707 - 1.922) p=0.548 (Figure 1B). In this model age and prior MI were associated with mortality with hazard ratios of 1.048 (95% CI 1.021 - 1.077) p=0.001 and 1.798 (95% CI 1.052 - 3.075) p=0.032, respectively. Conclusions: The presence of MAC was not associated with mortality after adjusting for age, HD status, and prior MI and should not preclude the MitraClip procedure. Procedural success was equally high.

What is a “good” result after transcatheter mitral repair? Impact of 2+ residual mitral regurgitation

ObjectiveThe study objective was to assess the impact on follow-up outcomes of residual mitral regurgitation 2+ in comparison with ≤1+ after MitraClip (Abbott Vascular Inc, Santa Clara, Calif) repair. MethodsWe compared the outcomes of mitral regurgitation 2+ and mitral regurgitation ≤1+ groups among a population of 223 consecutive patients with acute residual mitral regurgitation ≤2+ who underwent MitraClip implantation at San Raffaele Scientific Institute (Milan, Italy) between October 2008 and December 2014. ResultsResidual mitral regurgitation 2+ was found in 64 patients (28.7%). Overall actuarial survival was 63.1% ± 4.4% at 48 months. Cumulative incidence functions of cardiac death in patients with mitral regurgitation 2+ was significantly higher (Gray test P < .001) compared with the mitral regurgitation ≤1+ group. The adjusted hazard ratio was 5.28 (95% confidence interval, 2.41-11.56, P < .001). Cumulative incidence function of mitral regurgitation ≥3+ recurrence in patients with residual mitral regurgitation ≤1+ and mitral regurgitation 2+ at 48 months was 13.3% ± 3.8% and 45.2% ± 6.8%, respectively (Gray test P < .001). Multivariate model showed that mitral regurgitation 2+ was the only factor associated with the development of mitral regurgitation ≥3+ at follow-up (adjusted hazard ratio, 6.71; 95% confidence interval, 3.48-12.90; P < .001). Mitral regurgitation cause was not associated with cardiac death and recurrence of mitral regurgitation ≥3+ at follow-up. No relationship between New York Heart Association class and follow-up time after MitraClip implant was found (odds ratio, 1.07; 95% confidence interval, 0.98-1.15; P = .11), and factors related to postoperative New York Heart Association also included residual mitral regurgitation 2+ (P = .07). ConclusionsResidual 2+ mitral regurgitation after MitraClip implantation was associated with worse follow-up outcomes compared with ≤1+ mitral regurgitation, including survival, symptom relief, and mitral regurgitation recurrence. Better efficacy should be pursued by transcatheter mitral repair technologies.

TCT-711 Moderately Elevated Mean Mitral Gradient after MitraClip Repair of Mitral Regurgitation Is Not Associated with Increased Mortality

TCT-711 Moderately Elevated Mean Mitral Gradient after MitraClip Repair of Mitral Regurgitation Is Not Associated with Increased Mortality

Quantitation of mitral regurgitation after percutaneous MitraClip repair: comparison of Doppler echocardiography and cardiac magnetic resonance imaging.

Percutaneous valve intervention for severe mitral regurgitation (MR) using the MitraClip is a novel technology. Quantitative assessment of residual MR by transthoracic echocardiography (TTE) is challenging, with multiple eccentric jets and artifact from the clips. Cardiovascular magnetic resonance (CMR) is the reference standard for left and right ventricular volumetric assessment. CMR phase-contrast flow imaging has superior reproducibility for quantitation of MR compared to echocardiography. The objective of this study was to establish the feasibility and reproducibility of CMR in quantitating residual MR after MitraClip insertion in a prospective study. Twenty-five patients underwent successful MitraClip insertion. Nine were excluded due to non-magnetic resonance imaging (MRI) compatible implants or arrhythmia, leaving 16 who underwent a comprehensive CMR examination at 1.5 T (Siemens Aera) with multiplanar steady state free precession (SSFP) cine imaging (cine CMR), and phase-contrast flow acquisitions (flow CMR) at the mitral annulus atrial to the MitraClip, and the proximal aorta. Same-day echocardiography was performed with two-dimensional (2D) visualization and Doppler. CMR and echocardiographic data were independently and blindly analyzed by expert readers. Inter-rater comparison was made by concordance correlation coefficient (CCC) with 95% confidence intervals (CIs), and Bland-Altman (BA) methods. Mean age was 79 years, and mean LVEF was 44%±11% by CMR and 54%±16% by echocardiography. Inter-observer reproducibility of echocardiographic visual categorical grading by expert readers was poor, with a CCC of 0.475 (-0.7, 0.74). Echocardiographic Doppler regurgitant fraction reproducibility was modest (CCC 0.59, 0.15-0.84; BA mean difference -3.7%, -38% to 31%). CMR regurgitant fraction reproducibility was excellent (CCC 0.95, 0.86-0.98; BA mean difference -2.4%, -11.9 to 7.0), with a lower mean difference and narrower limits of agreement compared to echocardiography. Categorical severity grading by CMR using published ranges had good inter-observer agreement (CCC 0.86, 0.62-0.95). CMR performs very well in the quantitation of MR after MitraClip insertion, with excellent reproducibility compared to echocardiographic methods. CMR is a useful technique for the comprehensive evaluation of residual regurgitation in patients after MitraClip. Technical limitations exist for both techniques, and quantitation remains a challenge in some patients.

IMPROVEMENT IN QUALITY OF LIFE IN PATIENTS WITH DEGENERATIVE MITRAL REGURGITATION ST PROHIBITIVE SURGICAL RISK FOLLOWING TRANSCATHETER MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM

Improvement in quality of life in patients with degenerative mitral regurgitation at prohibitive surgical risk following transcatheter mitral valve repair with the MitraClip system. MitraClip repair was performed in 42 prohibitive risk DMR patients with 4+ MR after a multi-disciplinary heart team

Evaluation of renal function before and after percutaneous mitral valve repair.

Chronic kidney disease (CKD) is strongly related to outcome in cardiovascular diseases. The relationship between treatment of mitral regurgitation (MR) and renal function is not well described. We sought to evaluate renal function before and after mitral valve repair by the MitraClip device. Patients with moderate-to-severe or severe (3+ or 4+, respectively) MR by core laboratory determination who underwent transcatheter mitral valve repair with the MitraClip device in multicenter, investigational trials were included in this study. Estimated glomerular filtration rate (eGFR) was evaluated before and at hospital discharge, 30 days, 6 months, and 1 year after mitral valve repair. Eight hundred fifty-four patients with baseline mean eGFR 61.5 ± 23.1 mL/min/1.73 m(2) were studied, including 438 (51.3%) with eGFR ≥ 60 mL/min/1.73 m(2) (CKD stage 1 or 2), 371 (42.6%) with eGFR 30 to 59 mL/min/1.73 m(2) (CKD stage 3), and 52 (6.1%) with eGFR < 30 mL/min/1.73 m(2) (CKD stage 4 or 5). Baseline renal dysfunction was more prevalent in older patients with a history of heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, hypertension, and atrial fibrillation. Baseline eGFR was associated with 1-year survival (P < 0.001) after MitraClip repair. At 1-year follow-up, the mean change in eGFR for the overall cohort was -1.0 ± 15.1 mL/min/1.73 m(2); for patients with CKD stage 1 or 2, stage 3, or stage 4 or 5, mean change was -4.1 ± 16.6, +2.6 ± 12.4, and +4.8 ± 9.5 mL/min/1.73 m(2), respectively. Linear mixed effect modeling demonstrated a strong association between MR and eGFR, and a statistically significant improvement in eGFR in patients with CKD stage 4 or 5 associated with MR reduction to ≤ 2+ (P = 0.007). Renal dysfunction is associated with lower survival in patients with severe MR even after percutaneous mitral valve repair. Reduction in MR severity by the MitraClip device is associated with improvement in renal function at 1 year in patients with baseline renal dysfunction. http://www.clinicaltrials.gov. Unique identifiers: NCT00209274, NCT01931956, NCT01940120.

Comparison of Outcomes of Percutaneous MitraClip Versus Surgical Repair or Replacement for Degenerative Mitral Regurgitation in Octogenarians

Octogenarians affected by mitral regurgitation (MR) are an increasing high-risk population. MitraClip repair is emerging as a promising option for this kind of patients. In this retrospective study, the outcomes of patients aged ≥80 years, affected by isolated degenerative MR, who underwent isolated transcatheter (n = 25) or surgical (n = 35, 29 repairs and 6 replacements) mitral intervention from September 2008 to February 2014 were compared. MitraClip patients had higher mean age (84.5 ± 3.2 vs 81.9 ± 2.0 years, p <0.01), median Logistic Euroscore 19.4 (11.1 to 29.0) versus 8.4 (7.0 to 10.1) (p <0.01), median Society of Thoracic Surgeons predicted mortality 5.3 (3.5 to 6.6) versus 2.7 (2.3 to 3.9) (p <0.01), and more advanced New York Heart Association class (III to IV in 68% vs 37%, p = 0.02). At 30 days, 1 death occurred in the MitraClip group (p = 0.2). MitraClip was associated with significantly less complications (p <0.05) but more residual MR >2 (p <0.01). Two-year actuarial survival rate was 90% for MitraClip versus 97% for surgery (p <0.01). Higher Society of Thoracic Surgeons mortality was associated with reduced follow-up survival rate (p = 0.01). Two-year actuarial freedom from MR >2 was 70% versus 100%, respectively (p <0.01). New York Heart Association class and quality of life improved after MitraClip and were similar to surgical patients. Recurrent MR >2 was not significantly associated with follow-up mortality in this elderly setting. After the introduction of MitraClip, octogenarian patients with isolated degenerative MR receiving mitral treatment significantly increased (p <0.01). In conclusion, MitraClip patients, despite being older, more symptomatic, and affected by more co-morbidities showed significantly reduced postoperative complications. Two-year mortality was higher in the MitraClip group likely because of co-morbidities. Transcatheter mitral repair resulted in more octogenarians being treated compared with the past.

Abstract 13699: A True World Picture - Surgical Revision After Percutaneous Mitral Valve Repair With the Mitraclip Device

Background: Transcatheter mitral valve (MV) repair is of increasing interest facing however questionable mid term results. We herein report MV reference center experience of 18 patients who underwent MV surgery after failed percutaneous MV repair with MitraClip device (Evalve, Menlo Park, CA). Methods: Between June 2010 and October 2013, a total of 141 patients with severe mitral regurgitation (MR) underwent MitraClip procedure at Heart Center Leipzig. 11 patients (7.8%) needed surgical treatment for failed MV repair with the MitraClip device. For the same reasons we admitted 7 patients who underwent MitraClip procedure in other cardiac surgery centers. Mean EuroScore II of the patients was 23,51 (5,17-60,14). Results: From the group of 18 patients undergoing surgical treatment after MitraClip repair, 14 patients (77.7%) received one or more clip-implants and 4 patients (22.2%) suffered from failed MitraClip implantation. All patient were symptomatic (n=9, 50% - NYHA III; n=9, 50% - NYHA IV). The primary indications for surgery were: partial clip detachment (n=11, 61.1%), failed MitraClip implantation (n=4, 22.2%), recurrent MR greater than moderate (2+) (n=3, 16.6%), acute mitral valve endocarditis (n=1, 5.5%), mitral ring and clip detachment (n=1, 5.5%). 13 patients (72.2%) underwent MV replacement, 3 patients (16.6%) received left-ventricular assist device (LVAD), 2 patients (11.1%) underwent MV repair. One-month mortality reached 27,8% (n=5), and the overall mortality reached 50% (n=9). Conclusions: MV repair was feasible in only 2 cases (11.1%). Despite the high operative risk, surgical treatment after percutaneous MV repair failure with the MitraClip device is an option to be considered.

Annulus Remodeling and Double Orifice Repair Using a Multiple Clip Approach in Complex Mitral Valve Anatomy

Transcatheter repair of mitral regurgitation (MR) with the MitraClip System (Abbott Vascular, Abbott Park, Illinois) requires specific echocardiographic criteria [(1,2)][1]. Suboptimal results after standard MitraClip repair have been associated with a coaptation length <2 mm, coaptation depth ≥11

Hemodynamic patterns of residual interatrial communication after transcatheter MitraClip repair

We sought to assess the hemodynamic sequel and the therapy adopted in patients treated with MitraClip system, who experienced a persistent interatrial communication (IAC) after the procedure. From January 2012 to March 2013, 28 consecutive patients (mean age 74 +/- 8 years) underwent transcatheter MitraClip repair, as part of an ongoing prospective study to assess the IAC. Acute procedural success was 100% and a 30-days survival of 97% was reported. Immediately after the procedure, a residual IAC was present in all patients with an average diameter of 0.51 +/- 0.39 cm. At 30 days, IAC was detected in 81% of patients with a diameter of 0.45 +/- 0.31 cm (P = 0.53). To date, three patients developed different hemodynamic impairment secondary to the residual IAC, requiring percutaneous closure of the defect. Anatomic and hemodynamic criteria for early recognition of harmful residual IAC have to be identified, in order to select those patients who are benefited the most from atrial septal defect closure.

Transcatheter Mitral Leaflet Repair for High Risk Patients With Mitral Regurgitation: Follow Up Echocardiographic Outcomes

Transcatheter mitral leaflet repair using the MitraClip (Abbott Vascular) is an alternative to surgery for high-risk patients with significant mitral regurgitation (MR). Acute results of this technique have demonstrated adequate reductions in mitral regurgitation in the initial clinical Canadian experience however longer term echocardiographic follow up has been lacking in this cohort. We sought to determine the follow up echocardiographic outcomes in a prospective cohort of patients undergoing MitraClip repair at the Institut de Cardiologie de Montréal.

Prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter‐based mitral valve repair with the mitraclip system

Review the prevalence, echocardiographic features and potential predictors of iatrogenic ASD (iASD) created with the MitraClip guiding catheter. Catheter-based repair of mitral regurgitation (MR) with the MitraClip device (Abbott Vascular, Menlo Park, CA), is performed through a 22-French transseptal guiding catheter. The echocardiographic prevalence of iASDs after the MitraClip procedure has not been reported. Thirty subjects undergoing MitraClip repair during the roll-in phase of the EVEREST II randomized trial who had baseline, 30 day, 6 and 12 month transthoracic echocardiograms (TTEs) available for review were included. Patients who underwent surgery for MR within the first 12 months were excluded. Residual iASD size, right ventricular (RV) size, left atrial (LA) volume, and tricuspid/MR grade were quantified. iASDs were found at 12 months in 8 patients (27%) with a mean diameter of 6.6 ± 3.1 mm. Subjects with iASD at 12 months had more residual MR, increased TR and a trend toward larger LA volumes than non-iASD patients. 83% of non-ASD patients were free from MR > 2+ at 12 mos. vs. 38% of those with iASD (p=0.016). There were no other significant associations between clinical and echocardiographic variables and the persistence of iASD. After MitraClip repair, persistent iASDs occur at a rate comparable to reports after other transseptal interventional procedures and do not appear hemodynamically significant. Patients with persistent iASDs had less MR reduction at 12-months and a trend toward larger LA volumes, suggesting that increased LA pressure may be a mechanism for persistent iASD.

TCT-98: Residual Mitral Regurgitation Grade at 12 Months is Correlated with Persistence of Iatrogenic Atrial Septal Defect after MitraClip Repair

TCT-98: Residual Mitral Regurgitation Grade at 12 Months is Correlated with Persistence of Iatrogenic Atrial Septal Defect after MitraClip Repair