369 Mono-orifice mitral valve after transcatehter repair with mitraclip system

A 70 years old male with non-ischaemic dilated cardiomyopathy (left ventricular end-diastolic volume, LVEDV, 200 mL), reduced left ventricular ejection fraction (LVEF, 30%) and worsening dyspnoea was screened for transcatheter repair of severe mitral regurgitation (MR). Baseline echocardiogram showed marked symmetrical bi-leaflet tethering with a symmetrical central jet. Etiology was predominantly functional with organic features including partial flail scallop (A1) and a ruptured second order chorda (Figure 1A). Pre-operative strategy was to deploy a single MitraClip NT in the central position. After correct deployment of the first clip, we observed a remarkable reduction of regurgitant jets in the lateral position accompanied by a complete holosystolic lack of leaflet coaptation in the medial orifice which caused significant residual regurgitation. (Figure 1B) MitraClip deployment in the commissural position is associated with technical challenges, including limited maneuvering, risk of chordae rupture and inability to retrieve the device if entangled. (1) Therefore, after careful crossing of the medial neo-orifice and rapid positioning a second MitraClip NT was implanted medial to the first device in the commissural position (Figure 2). As a result, the medial orifice was obliterated resulting in an atypical mono-orifice morphology which resembles a commissural edge-to-edge plasty. Anterograde flow was normal (G med 2.5 mmHg) and the trivial residual jet of MR was lateral to the two clips implanted. At 1-year follow-up the patient was asymptomatic (NYHA functional class I) with a stable mild MR and no change in anterograde gradients; positive remodelling of the left ventricle (LVEDP: −48 ml) and increased LVEF (+8%) were observed. 369 Figure 1.

Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P <0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67–0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46–0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68–0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Percutaneous edge-to-edge mitral repair in the presence of mitral annulus calcification

Background Mitral annular calcification (MAC) is commonly found in patients affected with mitral regurgitation (MR) and it's associated with high morbidity, mortality and worse cardiac surgical outcomes. Transcatheter edge-to-edge mitral valve repair with the MitraClip system has been stablished as a valid alternative to surgery in high risk patients with severe MR. However, its efficacy in patients affected with MAC remains uncertain as this population has been excluded from trials. Objectives To analyze the safety, efficacy and mid-term durability of the treatment of MR with the MitraClip system in patients affected with moderate or severe MAC. Methods Data was obtained from a multicenter spanish registry that prospectively included consecutive patients with MR grade ≥3 undergoing transcatheter mitral valve repair with the MitraClip system. Sixty-one patients with moderate or severe MAC were included in the “MAC” group and 791 with no-or-mild MAC were allocated in the “NoMAC” group. Results Procedural success was similar in both groups (91.8% vs 95.06%, p=0.268, in MAC and NoMAC respectively) with a very low rate of complications beside a higher residual mean gradient in the MAC group (3.0 vs 3.6mmHg, p=0.001). At one-year follow-up, 79.5% of NoMAC and 90.6% of MAC patients had MR grade ≤2 (p=0.129). Only 9 patients (1,14%), all in NoMAC group, required reintervention during follow up. Eighty percent of patients in both groups remained in NYHA functional class ≤II and a significant reduction in readmissions for heart failure was also observed (65% vs 78% respectively, p=0.145). One-year mortality was slightly higher in MAC patients (19.67% vs 11.25%, p=0.050) with no difference in cardiovascular mortality (15.25% vs 9.21%, p=0.129). Conclusions Transcatheter edge-to-edge repair with the MitraClip system in selected patients with moderate or severe MAC is safe and feasible with a mid-term durability similar to those without MAC. These patients also benefit clinically from this treatment with a sustained mid-term subjective clinical improvement and no increase in cardiovascular mortality as compared to NoMAC patients. FUNDunding Acknowledgement Type of funding sources: None.

Clinical outcome after MitraClip procedure: role of right ventricle

Background MitraClip system is a device for percutaneous edge-to-edge repair of the mitral valve in symptomatic patients with severe mitral regurgitation (MR) not eligible for surgery, but frequently heart failure symptoms remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in heart failure but little is known about its prognostic role in patients after MitraClip implantation. Purpose To identify echocardiographic predictors of clinical outcome after MitraClip procedure, with a particular focus on RV-PA coupling. Methods We retrospectively analyzed the data of patients with severe MR who underwent MitraClip implantation between April 2015 and October 2019 at our Institution. Echocardiographic data were assessed at baseline, 3 and 12 months after the procedure; RV to PA coupling was assessed using the ratio between tricuspid annular plane systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). Functional class was assessed at 12 months of follow-up. Significance level was set to 0.05 and SPSS was used for statistical analysis. Results 41 patients were included (age 77.1±7.3, 71% male, BMI 25.8±5.5). MR was primary, functional and mixed in 22, 76 and 2% of patients, respectively. 1/2/3 mitraclips were implanted in 39/56/5% of patients, respectively. Echocardiographic data at baseline, at 3 and 12 months follow-up are shown in Table. NYHA class at 12 months significantly correlated with TAPSE and PASP at 3 months follow-up echocardiogram (beta coefficient −0.83 and 0.78 respectively). On the contrary, NYHA class did not show a correlation with left ventricular ejection fraction (LVEF) or residual MR grade. At 12 months 44% of patients showed an improvement in NYHA class; these patients had a better TAPSE (22.7±1.3 vs 19.4±4.6 mm), a lower PASP (37.9±10.2 vs 48.5±12.9 mmHg) and a better TAPSE/PASP (0.61±0.2 vs 0.42±0.2) compared to patients who did not improve their functional class, while LVEF and residual MR did not differ. Conclusion In this sample of significant MR undergoing repair with MitraClip System, patients with functional class improvement at 12 months follow-up showed a better RV-coupling without difference in LV function and residual MR. FUNDunding Acknowledgement Type of funding sources: None. Table 1

Cost-effectiveness study of the MitraClip system for mitral regurgitation treatment in inoperable patients

The study aims to estimate the MitraClip system’s cost-effectiveness compared with optimal medical therapy in adult patients with inoperable mitral regurgitation and assess its impact on the budget of the Russian Federation health system.Materials and methods. The cost-effectiveness analysis of the MitraClip system was carried out using the Markov model. The time horizon was three & five years. The budget impact analysis (BIA) model compared the costs of treating patients distributed across different management practices. Standard management practice included only optimal medical therapy. Expected management practice included different patient allocation between the MitraClip system and optimal medical therapy. The time horizon for the budget impact analysis was five years. Results. The incremental cost-effectiveness ratio (ICER) per additional quality-adjusted life-year (QALY) gained of the MitraClip system in comparison with optimal medical therapy was 6,271,657 rubles in three years and 3,451,342 rubles in five years. Based on the BIA results of the MitraClip system, its use would lead to an increase in costs by 12.6 billion rubles (+6.09%, minimal scenario), by 37.8 billion rubles (+18.28%, optimal scenario) or by 63 billion rubles (+30.47%, maximum scenario).Conclusion. As a result of the analysis performed, it was found that economic efficiency is noted with an increasing time horizon of up to five years. The obtained ICER values are comparable with the average values obtained in other foreign cost-effectiveness studies. The use of this technology will lead to an increase in direct medical costs by 6.09% over five years compared to the current management practice. In more comprehensive MitraClip system implementation (maximum scenario), direct medical costs will increase by 30.47% compared to the current management practice.

Complications Following MitraClip Implantation

Purpose of Review To provide a detailed overview of complications associated with MitraClip therapy and its development over time with the aim to alert physicians for early recognition of complications and to offer treatment strategies for each complication, if possible. Recent Findings The MitraClip system (MC) is the leading transcatheter technique to treat mitral regurgitation (MR) and has been established as a safe procedure with very low adverse event rates compared to mitral surgery at intermediate to high risk or in secondary MR. Lately, the fourth MC generation has been launched with novel technical features to facilitate device handling, decrease complication rates, and allow the treatment of even complex lesions. Summary Although the complication rate is low, adverse events are associated with increased morbidity and mortality. The most common complications are bleeding, acute kidney failure, procedure-induced mitral stenosis, and an iatrogenic atrial septal defect with unknown clinical impact.