Transcatheter Edge-to-edge Mitral Valve Repair Research Articles

Abstract 4125729: Elevated Pre-Procedural Serum Natriuretic Peptide Levels Are Associated with All-Cause Mortality in Patients Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair: A Systematic Review and Meta-Analysis

Background: Transcatheter edge-to-edge mitral valve repair (TEER) is an established procedure in patients with severe mitral regurgitation (MR) and elevated surgical risk on optimal medical therapy. However, there remains considerable mortality in this patient population. Some studies have shown that serum brain natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) predict all-cause mortality after TEER, whereas other studies have shown mortality to be independent of these markers. To address this gap in knowledge, we sought to examine the existing literature to determine whether there is an association between pre-procedural serum natriuretic peptides and mortality after TEER. Hypothesis: Among patients undergoing TEER, elevated pre-procedural BNP and NT-proBNP are associated with increased all-cause mortality. Methods: Databases including MEDLINE, Embase, and Cochrane Library were searched from inception through September 2023 for studies assessing pre-procedural serum natriuretic peptide levels and mortality among patients undergoing TEER. Pooled hazard ratios (HR) and standardized mean differences (SMD) were calculated using a random-effects model estimated by restricted maximum likelihood with the Hartung-Knapp modification. Results: A total of 30 studies comprising 10259 patients undergoing TEER met inclusion criteria. 25 studies measured NT-proBNP and 5 studies measured BNP. Elevated pre-procedural NT-proBNP (>5000 or >10000 pg/mL) was associated with increased all-cause mortality in both adjusted (HR = 2.94; 95% CI = 1.75 - 4.95; I2 = 46.8%) and unadjusted (HR = 5.16; 95% CI = 1.85 - 14.40; I2 = 0.0%) analyses (Figures 1 and 2). Pre-procedural BNP and NT-proBNP were also significantly lower among survivors at 12 months compared to non-survivors (SMD = 0.82; 95% CI = 0.37 - 1.27; I2 = 78.3%) (Figure 3). This association was demonstrated in patients with primary or secondary MR. Conclusions: Pre-procedural BNP and NT-proBNP levels are significant predictors of all-cause mortality in patients undergoing TEER for primary or secondary MR. This supports the inclusion of BNP or NT-proBNP in pre-procedural assessments to help inform patient discussions and guide post-procedural follow-up and monitoring.

Technical and Clinical Outcomes After Transcatheter Edge-to-Edge Repair of Mitral Regurgitation in Male and Female Patients: Is Equality Achieved?

Currently, no clear impact of sex on short- and long-term survival following transcatheter edge-to-edge mitral valve repair (TEER) is evident, although no data are available on postprocedural life expectancy. Our aim was to assess sex-specific differences in outcomes of patients with mitral regurgitation (MR) treated by TEER. Short-term and 5-year outcomes in men and women undergoing TEER between 2011 and 2018 who were included in the large, multicenter, real-world MitraSwiss registry were analyzed. Outcomes were compared stratified by sex and according to MR cause (primary versus secondary). The impact of TEER on postprocedural life expectancy was estimated by relative survival analysis. Among 1142 patients aged 60 to 89 years, 39.8% were women. They were older, with fewer cardiovascular risk factors and lower functional capacity compared with men. Thirty-day mortality was higher in men than in women (3.3% versus 1.1%; odds ratio, 3.16 [95% CI, 1.16-10.7]; P=0.020). Five-year survival was comparable in both sexes (adjusted hazard ratio for 5-year mortality in men, 1.14 [95% CI, 0.90-1.44], P=0.275). Both men and women with either primary or secondary MR showed similar clinical efficacy over time. TEER provided high relative survival estimates among all groups, and fully restored predicted life expectancy in women with primary MR (5-year relative survival estimate, 97.4% [95% CI, 85.5-107.0]). TEER is not associated with increased short-term mortality in women, whereas 5-year outcomes are comparable between sexes. Moreover, TEER completely restored normal life expectancy in women with primary MR. A residual excess mortality persists in secondary MR, independently of sex.

Transcatheter edge-to-edge mitral valve repair in patients with acute decompensated heart failure due to severe mitral regurgitation.

Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a therapy for severe symptomatic mitral regurgitation (MR) in stable patients, and it has recently emerged as a reasonable option for acutely ill patients. The aim of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure (ADHF) and severe MR that was deemed to play a major role in their deterioration. We included 31 patients who underwent emergent TEER for MR ≥ 3+ from 2012 to 2022 at Sheba Medical Center. Outcomes included procedural safety, procedural success, all-cause mortality, heart failure readmission, and functional improvement. Outcomes were evaluated at 3 months and at 1 year. Data were obtained retrospectively by chart review. Implantation of a TEER device was achieved in 97% of patients, and reduction in MR severity of at least two grades and final MR ≤ 2+ at discharge was achieved in 74%. No intra-procedural mortality or life-threatening complications were noted. Mortality at 30 days was 23%. No excess mortality occurred beyond 6 months, with a total mortality of 41%. At 1 year all survivors had MR ≤ 2+, all were free of heart failure hospitalizations, and 88% were at New York Heart Association class ≤ II. Mitral valve TEER for patients with ADHF and significant MR is safe, feasible, and achieves substantial reduction in MR severity. Despite high early mortality, procedural success is associated with good long-term clinical outcomes for patients surviving longer than 6 months.

Transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.

Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting. We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68±14years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1+was achieved in 13 patients (57%), to 2+in 7 patients (30%), P<0.01. V-Wave was reduced from 49±8mmHg to 26±10mmHg post-procedure, P<0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1year was documented. TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population.

Predictive Factors of Cardiac Mortality Following TEER in Patients with Secondary Mitral Regurgitation

Background: Transcatheter edge-to-edge mitral valve repair (TEER) has emerged as a viable approach to addressing substantial secondary mitral regurgitation. In the contemporary landscape where ultimate heart failure-specific therapies, such as cardiac replacement modalities, are available, prognosticating a high-risk cohort susceptible to early cardiac mortality post-TEER is pivotal for formulating an effective therapeutic regimen. Methods: Our study encompassed individuals with secondary mitral regurgitation and chronic heart failure enlisted in the multi-center (Optimized CathEter vAlvular iNtervention (OCEAN)-Mitral registry. We conducted an assessment of baseline variables associated with cardiac death within one year following TEER. Results: Amongst the 1517 patients (median age: 78 years, 899 males), 101 experienced cardiac mortality during the 1-year observation period after undergoing TEER. Notably, a history of heart failure-related admissions within the preceding year, utilization of intravenous inotropes, and elevated plasma B-type natriuretic peptide levels emerged as independent prognosticators for the primary outcome (p &lt; 0.05 for all). Subsequently, we devised a novel risk-scoring system encompassing these variables, which significantly stratified the cumulative incidence of the 1-year primary outcome (16%, 8%, and 4%, p &lt; 0.001). Conclusions: Our study culminated in the development of a new risk-scoring system aimed at predicting 1-year cardiac mortality post-TEER.

Left ventricular assist device and transcatheter edge-to-edge mitral valve repair in advanced heart failure: allies or enemies?

The implantation of left ventricular assist devices (LVADs) has been increasing, with good long-term results, in parallel with a growing population with advanced heart failure (HF). However, in some European countries, LVADs are still underused, with one of the main issues being the patient's late referral. On the contrary, the use of transcatheter edge-to-edge mitral valve repair (TEER) has exponentially increased over the past decade, expanding its potential use even in patients on the heart transplantation waiting list. Even though the study populations of the main trials that investigated the prognostic impact of LVAD and TEER are different, in clinical practice a clear distinction might not be so clear. Therefore, patients with refractory HF symptoms and significant mitral regurgitation should be thoroughly evaluated through a multidisciplinary Heart Team meeting with both an advanced HF specialist and interventional cardiologist, to avoid futile procedures and to define the optimal timing for advanced HF therapies, when they are indicated. We analyzed the main available studies and registries on both TEERs and LVADs and we compared their populations and outcomes, to provide the current evidence on the use of LVAD and TEER in the HF population, especially in the light of the recently released 5-year follow-up results, giving some insights on the Italian situation, and finally to stress the importance of a solid HF network between hospitals, aiming for advanced HF patients' timely referral for LVAD or heart transplants.

Transcatheter edge-to-edge mitral valve repair for mitral regurgitation in patients with cardiogenic shock: A systematic review and meta-analysis.

There is currently little evidence for transcatheter edge-to-edge mitral valve repair (TEER) for mitral regurgitation (MR) in patients with cardiogenic shock (CS). Therefore, this study investigated the characteristics and outcomes of CS patients who underwent TEER for MR. PubMed, EMBASE were searched in July 2023. Case series and observational studies reporting clinical characteristics and outcomes in CS patients with MR who underwent TEER were included. We performed a one-group meta-analysis using a random effects model. A total of 4060 patients from 7 case series and 5 observational studies were included. The mean age was 68.2 (95% confidence interval [CI]: 64.1-72.2) years, and 41.4% of patients (95% CI: 39.1%-43.7%) were female. Pre-TEER, severe MR was present in 85.3% (95% CI: 76.1%-91.3%) of patients. Mean left ventricular ejection fraction was 36.7% (95% CI: 29.2%-44.2%), and 54.6% (95% CI: 36.9%-71.2%) of patients received mechanical circulatory support. The severity of MR post-TEER was less than 2+ in 88% (95% CI: 87%-89%) of patients. In-hospital mortality was 11% (95% CI: 10%-13%), whereas 30-day and 1-year mortality rates were 15% (95% CI: 13%-16%), and 36% (95% CI: 21%-54%), respectively. This systematic review and meta-analysis assessed the clinical characteristics and outcomes of TEER in CS patients with MR. TEER for MR in patients with CS has been successful in reducing MR in most of the patients, but with a high mortality rate. Randomized controlled trials of TEER for MR and CS are needed.

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Mitral valve leaflet stiffness predicts residual mitral regurgitation after transcatheter edge-to-edge mitral valve repair.

Residual regurgitation after transcatheter edge-to-edge mitral valve repair (TMVR) is a predictor of poor prognosis in patients with functional mitral regurgitation (FMR). This study sought to identify the mitral valve (MV) parameters measured by three-dimensional transesophageal echocardiography (3D-TEE) and MV leaflet features that predict residual mitral regurgitation (MR) after TMVR in patients with FMR. Consecutive patients with FMR who underwent TMVR were classified into two groups based on the degree of residual MR just after TMVR:<2+ in the optimal MR reduction group and ≥ 2+ in the suboptimal MR reduction group. The two groups were compared with respect to 3D-TEE parameters and the MV leaflet features, including the following parameters: stiffness, defined as a leaflet that remains at a fixed angle even during diastole, and thickness, measured in both clear and rough zones. Thirty-four of 46 patients (74%) were classified as the optimal MR reduction group. Multivariable analysis showed that anterior mitral leaflet + posterior mitral leaflet length/anteroposterior annulus diameter (p=.044) and MV leaflet stiffness (p=.007) were independent predictors of residual MR. MV leaflet stiffness and the ratio of MV leaflet lengths to the annulus diameter may be good predictors of residual MR after TMVR in patients with FMR.

Influence of device generations on alternations of mitral annulus after transcatheter edge-to-edge repair: a real-time three-dimensional transesophageal echocardiography study

Abstract Background Alternation of the mitral annulus (MA) after transcatheter edge-to-edge mitral valve repair (TEER) is reported to be associated with a reduction of mitral regurgitation (MR). However, the influence of the new device system with 4 device size options (MitraClip G4) on MA geometry compared to the conventional device (G2) remains unknown. Methods and results A total of 129 patients (mean age 79±10 years, male 66%) including 38 primary MR and 91 secondary MR who underwent TEER guided with three-dimensional (3D) transesophageal echocardiography (TEE) were included. MA area, anterior-posterior (AP) diameter, inter-commissure (CC) diameter, and MA ellipticity before and after MitraClip implantation were measured using 3D TEE images assessed by dedicated software. MitraClip G4 was used in 54 cases (42%). In patients with secondary MR, greater changes in MA area, AP diameter, and MA ellipticity were observed in patients treated with G4 compared to G2 (P=0.001, 0.003, and 0.39, respectively). In contrast, patients with primary MR had no differences in the change of MA parameters between G2 and G4. Patients with significant residual MR had less increase of MA ellipticity after device implantation in secondary MR (P=0.014), but not in primary MR (P=0.062). Conclusion In patients with secondary MR, MitraClip G4 made greater changes in MAA, AP diameter, and MA ellipticity compared to MitraClip G2, but not in CC diameter. The change of ellipticity was associated with a reduction of MR after device implantation in secondary MR. These findings indicated that MitraClip G4 may lead favorable MA alternation than G2, especially in secondary MR.

Outcome of transcatheter mitral valve repair in heart failure patients with reduced ejection fraction and severe left ventricular dilatation

Abstract Introduction The COAPT trial demonstrated the benefit of transcatheter edge­to­edge mitral valve repair (TEER) for heart failure patients who had reduced ejection fraction (HFrEF) with symptomatic secondary mitral regurgitation (MR). However, patients with severe left ventricular (LV) dilatation were not included in the COAPT trial. Furthermore, disproportionate LV dilatation was suggested as a possible explanation for the lack of benefit in the MITRA­FR trial. Purpose The purpose of this study was to assess the safety and efficacy of TEER in HFrEF patients with severe LV dilatation. Methods We studied 75 HFrEF patients who underwent mitral valve repair between 2018-2021. Reduced LV ejection fraction (LVEF) was defined as LVEF of 40% or less. These patients were categorized with and without severe LV dilatation based on left ventricular end-diastolic volume index (LVEDVI) using a median cut­off value of &amp;gt;139ml/m2 in men and &amp;gt;128cm/m2 in women. Results There were 37 patients with severe LV dilatation (D) and 38 without (ND). Median LVEDVI was 172 [149-190] ml/m2 in the D group vs 120 [105-127] ml/m2 in the ND group. Compared to the ND patients, patients with severe LV dilatation were more treated with SGLT2-inhibitor (rate 24% vs 3%), had lower LVEF (30 [25-31] % vs 32 [30-36] %), and higher BNP (1160 [683-2586] vs 619 [396-1253] pg/ml). There was no significant difference in MR grade (4 [3-4] vs 4 [3-4]), EROA (0.32 [0.22-0.66] vs 0.34 [0.24-0.48] cm2), NYHA class (3 [2-4] vs 3 [2-3]) and mean systolic pulmonary pressure (31 [20-43] vs 34 [25-41] mmHg). Peri­procedural adverse events were rare in both groups. 1 patient had pseudoaneurysm in the ND group, and 1 patient had cardiogenic shock and 1 patient had stroke after the procedure in the D group. At discharge, there was marked improvement in MR grade (1 [1-2] vs 1 [1-2] for both). D group had a tendency of higher reduction in LVEDVI (-12 [-24--1] vs -5[-13-4] ml/m2) than ND group. BNP level of the D group had a significantly higher degree of decline before discharge (-458 [-141--1566] to -102 [+51--306] pg/ml) than that of ND group. No differences were noted in mortality between two groups (Figure). Conclusion TEER in HFrEF patients with severe LV dilatation seems to provide similar outcomes compared to patients with less severe dilatation. Further studies are needed to clarify the indication and establish the effectiveness of TEER in these patients.

Abstract 16372: Prognostic Value of Baseline Right Ventricular Dysfunction Using TAPSE and TAPSE to PASP Ratio in Patients Undergoing Mitra-Clip: Systematic Review and Meta-Analysis

Introduction: Transcatheter edge-to-edge mitral valve repair (TEER) using Mitra-clip is an established therapy for high-risk surgical candidates who are refractory to optimal medical treatment. Several reports have shown that right ventricular dysfunction (RVD) is associated with increased morbidity and mortality in heart failure (HF) patients. Emerging data on the relationship between baseline RVD and post-TEER mortality has been published. Objective: Our main goal is to assess the prognostic impact of baseline RV function markers; tricuspid annular plane excursion (TAPSE) and TAPSE/PASP (pulmonary arterial systolic pressure) ratio, as an expression of the right ventricle-pulmonary artery coupling following Mitra-Clip. Methods: MEDLINE and EMBASE were searched for studies discussing outcomes of Mitra-Clip in patients with and without RV dysfunction as expressed by TAPSE or TAPSE:PASP ratio. Two reviewers independently screened the studies and extracted the pertinent survival data. Odds ratios (OR) with 95% confidence interval were calculated using a random-effects model. Results: Twelve reports enrolling 3515 patients (1443 with and 2072 without pre-existing RVD) were included. Patients with RVD had OS reduction after Mitra-Clip by 55% at 6 months, 60% at one year, and 63% at two years [OR: 0.45 (0.35-0.58), 0.40 (0.33-0.48), 0.37 (0.31-0.45) respectively; P &lt; .001] compared to normal RV group. Likewise, HR readmission free survival was minimized among RVD patients by 53% at 6 months, 56% at one year, and 59% at two years compared to normal RV group [OR: 0.47 (0.35-0.65), 0.44 (0.35-0.55), 0.41 (0.30-0.56) respectively; P &lt; .00001]. TAPSE:PASP ≤ 0.30-0.37 was associated with lower OS and HF re-admission free survival at 6 months (OR: 0.37, 0.44; P &lt; .00001) and 1 year (OR: 0.35, 0.41; P &lt; .00001) after Mitra-Clip. Furthermore, TAPSE ≤ 15-16 negatively impacted the OS at 6 months (OR: 0.40 P &lt; .00001) and 1 year (OR: 0.50; P &lt; .00001) after Mitra-Clip. Conclusions: Pre-existing RV dysfunction as expressed by TAPSE ≤15-16 or TAPSE:PASP ratio ≤ 0.30-0.37 decreased the overall survival and HF readmission free survival after Mitra-Clip therapy. Further research is warranted to guide interventional timing based on the degree of RV dysfunction.

Residual or recurrent mitral regurgitation predicts mortality following transcatheter edge-to-edge mitral valve repair

ObjectiveAlthough regurgitant mitral valves can be repaired through surgical or transcatheter approaches, contemporary comparative outcomes are limited with the impact of residual and recurrent mitral regurgitation (MR) on clinical outcomes being poorly defined. We hypothesized that moderate (2+) or greater residual or recurrent (RR) MR—regardless of type of repair—predicts worse clinical outcomes. MethodsOur institutional experience of 660 consecutive patients undergoing mitral valve repair (2015-2021) consisting of 393 surgical mitral valve repair (SMVr) and 267 transcatheter edge-to-edge mitral valve repair (TEER) was studied. The echocardiographic impact of RRMR (2+) following both SMVr and TEER on death and reintervention was evaluated. ResultsPatients averaged 67.8 ± 14.2 years (SMVr = 63.8 ± 13.3 vs 73.6 ± 13.6, P < .0001) and 62.1% were male. Baseline clinical and demographic data were vastly different between the 2 groups. Residual or recurrent 2+ or greater MR developed in 25% (n = 68) of patients who received TEER compared with 6% (n = 25) of SMVr (P < .0001). Reintervention (9.3% vs 2.4%, P = .002) and death (37.9% vs 10.4%, P < .0001) rates at 3-years were greater among the TEER group versus SMVr group. Given the heterogeneity in baseline characteristics and difference in survival, each cohort was analyzed separately, stratified by RRMR, using multivariable modeling to identify predictors of repeat reintervention and death. There were too few events of RRMR in the SMVr cohort for evaluation. For the TEER subgroups, we observed greater long-term mortality, but not reintervention among those with RRMR., Hypertension was the strongest predictor of death and obesity was for reintervention. ConclusionsPatients undergoing SMVr and TEER are vastly different with respect to baseline patient characteristics and clinical outcomes, with patients who undergo TEER being much greater risk with poorer prognosis. Moderate or greater RRMR predicted worse long-term survival but not reintervention among patients who received TEER. Given the difference in survival among patients with RRMR following TEER, care must be taken to ensure that patients entering clinical trials and receiving TEER should have a high probability of achieving mild or less MR as seen in contemporary surgical results.

Dobutamine stress echocardiography during transcatheter edge-to-edge mitral valve repair predicts residual mitral regurgitation.

The current study sought to determine whether low-dose dobutamine stress echocardiography (DSE) during transcatheter edge-to-edge mitral valve repair (TMVR) can predict residual mitral regurgitation (MR) at discharge. In most patients, TMVR can successfully reduce MR from severe to mild or moderate. However, general anesthesia during the intervention affects hemodynamics and MR assessment. At discharge transthoracic echocardiogram residual MR (>moderate) is present in 10%-30% of patients which is associated with worse clinical outcome. In consecutive patients the severity of MR was determined at baseline, immediately after TMVR clip implantation and subsequently during low-dose DSE (both under general anesthesia) and at discharge. A total of 39 patients were included (mean age 76.1 ± 8.1 years, 39% male, 56% functional MR, 41% left ventricular ejection fraction < 45%). An increase of MR during DSE was seen in 11 patients, of whom 6 (55%) showed >moderate MR at discharge. None of the 28 patients without an increase of MR during DSE showed >moderate MR at discharge. The diagnostic performance of the test could be established at a sensitivity of 100% and a specificity of 85% in unselected patients. DSE during TMVR is a useful tool to predict residual MR at discharge. It could support procedural decision making, including implantation of additional clips and thus potentially improve clinical outcome.

Successful bailout clipping for rare complication of anterior mitral leaflet dissection during transcatheter edge-to-edge mitral valve repair

A 91-year-old woman underwent transcatheter edge-to-edge mitral valve repair (TEER) due to severe mitral regurgitation (MR) with the central posterior mitral leaflet (PML) prolapse (Figure 1A; Supplementary data online, Movie S1). The XTW size of MitraClip G4 (Abbott Vascular, USA) was chosen considering the larger length of PML. Before inserting the MitraClip into left ventricle, a newly developed membranous structure was suddenly detected on the central anterior mitral leaflet (AML) by transoesophageal echocardiography (TEE) (Figure 1B). The structure appeared to spread widely from the tip of the central AML toward lateral side (Figure 1C; Supplementary data online, Movie S2) and colour jet flow of TEE penetrated in-between the AML and mobile layered structure (Figure 1D; Supplementary data online, Movie S3). Based on the TEE findings, we suspected AML dissection caused by the proximal edge of MitraClip during one of the procedural steps. The dissection area was localized in the central to lateral side of AML but did not advance further. Therefore, the bailout-TEER was performed to stabilize for both the PML prolapse and iatrogenic AML dissection. The clip was placed under the mitral valve and the clippers grasped both the leaflets (Figure 1E). After successful TEER, the part of AML dissection was minimized (Figure 1F; Supplementary data online, Movie S4). The abnormal colour jet disappeared and trivial amount of MR was present after the procedure (Figure 1G and H). Postprocedural enhanced computed tomography also confirmed absence of abnormal findings in the left atrium around mitral valve. Although extremely rare complication, caution against the occurrence of mitral leaflet dissection during TEER should be exercised.

Deceleration capacity of heart rate predicts 1-year mortality in patients undergoing transcatheter edge-to-edge mitral valve repair.

Risk stratification for transcatheter procedures in patients with severe mitral regurgitation is challenging. Deceleration capacity (DC) has already proven to be a reliable risk predictor in patients undergoing transcatheter aortic valve implantation. We hypothesized, that DC provides prognostic value in patients undergoing transcatheter edge-to-edge mitral valve repair (TEER). We retrospectively analyzed electrocardiogram signals from 106 patients undergoing TEER at the University Hospital of Tübingen. All patients received continuous heart-rate monitoring to assess DC following the procedure. One-year all-cause mortality was defined as the primary end point. Sixteen patients (15.1%) died within 1 year. The DC in nonsurvivors was significantly reduced compared to survivors (5.1 ± 3.0 vs. 3.0 ± 1.6 ms, p = 0.002). A higher EuroSCORE II and impaired left ventricular function were furthermore associated with poor outcome. In Cox regression analyses, a DC < 4.5 ms was found a strong predictor of 1-year mortality (hazard ratio: 0.10, 95% confidence interval: 0.13-0.79, p = 0.029). Finally, a significant negative correlation was found between DC and residual mitral regurgitation after TEER (r = -0.41, p < 0.001). In patients with severe mitral regurgitation undergoing TEER, DC may serve as a new predictor of follow-up mortality.

Percutaneous closure of the iatrogenic atrial septal defect following the transcatheter edge-to-edge mitral valve repair with MitraClip system led to instant improvement of hypoxemia — case report

Transcatheter edge-to-edge mitral valve repair (TEER) is an established alternative for patients with severe, symptomatic mitral regurgitation (MR) at high surgical risk. The TEER procedure requires transseptal access, therefore might lead to the development of persistent iatrogenic atrial septal defect (iASD). The clinical significance of iASD and optimal management particularly from a long-term perspective is not clear. Herein, we described a case report of a 76-year-old female with prior left atrial appendage occlusion and severe MR that underwent a TEER procedure using MitraClip® (MC) system. After the MC implantation, she developed acute hypoxemia due to interatrial right-to-left shunt and required immediate iASD closure.

Peri-procedural management of transcatheter mitral valve replacement in patients with heart failure.

Over the past decade, transcatheter mitral valve replacement (TMVR) technologies have evolved with the objective of improving outcomes for patients with severe mitral regurgitation (MR) deemed unsuitable for conventional mitral valve surgery. Although the safety and efficacy of transcatheter edge-to-edge mitral valve repair (TEER) is well-established, there is a sense amongst innovators that a major advantage of TMVR may be to offer a more complete solution for the correction of MR in patients whose complex anatomy means that the likelihood of achieving grade 0 or 1 MR with TEER is low. However, abrupt correction of MR in a poorly prepared left ventricle poses a number of unique haemodynamic challenges, particularly when sudden elimination of regurgitant flow causes a relative increase in left ventricular (LV) afterload. Rapid reduction in LV cavity size following MR elimination may itself result in relative LV outflow tract obstruction (LVOTO), irrespective of the intrinsic risk of LVOTO associated with TMVR. Nevertheless, TMVR on a beating heart affords the opportunity to study real-time invasive cardiac indices in high-risk patients with acute reversal of severe MR.

Outcomes of transcatheter edge-to-edge mitral valve repair with percutaneous coronary intervention vs. surgical mitral valve repair with coronary artery bypass grafting.

Patients with severe ischemic mitral regurgitation (IMR) may receive concurrent coronary artery bypass graft (CABG) with surgical mitral valve repair (SMVr) or percutaneous coronary stent implantation (PCI) with transcatheter edge-to-edge mitral valve repair (TMVr). However, there is no consensus on the management of severe IMR in this setting. We aimed to compare the outcomes of combined SMVr with CABG to concurrent TMVr with PCI among patients with IMR in the National Inpatient Sample (NIS) database. The National Inpatient Sample was queried for all patients diagnosed with IMR who underwent SMVr with CABG or TMVr with PCI during the years 2016-2018. Study outcomes included all-cause in-hospital mortality, periprocedural complications, and resources used. A total of 1,360 potentially eligible patients were included in the study. After 1:5 propensity score matching, 133 patients were classified in the SMVr + CABG group and 29 patients in the TMVr + PCI group. Adjusted mortality was higher in the TMVr + PCI group compared with the SMVr + CABG group (13.8% vs. 4.5%, P = 0.034). Perioperative complications were higher among patients who underwent SMVr + CABG including blood transfusions (29.3% vs. 6.9%, P = 0.01) and post-procedural cardiogenic shock (11.3% vs. 0%, P = 0.044). The cost of care was higher (USD$783548.80 vs. USD$331846.523, P = 0.001) and the length of stay was longer (17.9 vs. 15.44 days, P < 0.001) in the TMVr + PCI group. On multivariable analysis, age (OR, 1.039 [95% CI, 1.006-1.072]; P = 0.032), renal failure (OR, 3.465 [95% CI, 1.867-6.433]; P < 0.001), and liver disease (OR, 5.012 [95% CI, 2.578-9.686]; P < 0.001) were associated with in-hospital mortality. TMVr + PCI was associated with higher resource use and in-hospital mortality but with improved perioperative complications compared with SMVr + CABG.

Impact of transcatheter edge-to-edge mitral valve repair on central sleep apnoea

AimsSleep-disordered breathing (SDB) and its subtype central sleep apnoea (CSA) are highly prevalent in patients with heart failure and associated with worse prognosis. Whereas pharmacological therapy of heart failure has been shown to ameliorate CSA, results from previous studies on the effect of mitral regurgitation therapy on SDB are contradicting. The aim of this study was to assess the impact of transcatheter edge-to-edge mitral valve repair (TEER) on prevalence and severity of CSA.Methods and resultsWe enrolled 47 patients undergoing TEER for symptomatic mitral regurgitation in a prospective study. Secondary mitral regurgitation and left ventricular ejection fraction < 50% were present in 79% and 68% of patients, respectively. Respiratory polygraphy was performed before TEER in a compensated condition and four weeks after the procedure. 34 patients completed the follow-up. At baseline, 19 (56%) patients showed moderate-to-severe SDB, of whom 13 (68%) were classified as CSA. Both apnoea-hypopnoea index and percentage of recorded time spent in Cheyne-Stokes respiration strongly decreased from baseline to follow-up (median [IQR] 16 [7–30] vs. 7 [4–15] /h, p = 0.007; 6 [0–34] vs. 0 [0–8] %, p = 0.008). Median relative reduction of central apnoea index was 75% (p = 0.023), while obstructive apnoea index did not change significantly. Increase in stroke volume after TEER and high systolic pulmonary artery pressure at baseline predicted a > 50% reduction of both Apnoea-hypopnoea index and Cheyne-Stokes respiration.ConclusionTEER is associated with a significant short-term reduction of CSA and Cheyne-Stokes respiration in high-risk patients, strengthening its value as an effective treatment option for advanced heart failure.Graphical abstract