Percutaneous Mitral Valve Repair Research Articles

Vision-language foundation model for echocardiogram interpretation.

The development of robust artificial intelligence models for echocardiography has been limited by the availability of annotated clinical data. Here, to address this challenge and improve the performance of cardiac imaging models, we developed EchoCLIP, a vision-language foundation model for echocardiography, that learns the relationship between cardiac ultrasound images and the interpretations of expert cardiologists across a wide range of patients and indications for imaging. After training on 1,032,975 cardiac ultrasound videos and corresponding expert text, EchoCLIP performs well on a diverse range of benchmarks for cardiac image interpretation, despite not having been explicitly trained for individual interpretation tasks. EchoCLIP can assess cardiac function (mean absolute error of 7.1% when predicting left ventricular ejection fraction in an external validation dataset) and identify implanted intracardiac devices (area under the curve (AUC) of 0.84, 0.92 and 0.97 for pacemakers, percutaneous mitral valve repair and artificial aortic valves, respectively). We also developed a long-context variant (EchoCLIP-R) using a custom tokenizer based on common echocardiography concepts. EchoCLIP-R accurately identified unique patients across multiple videos (AUC of 0.86), identified clinical transitions such as heart transplants (AUC of 0.79) and cardiac surgery (AUC 0.77) and enabled robust image-to-text search (mean cross-modal retrieval rank in the top 1% of candidate text reports). These capabilities represent a substantial step toward understanding and applying foundation models in cardiovascular imaging for preliminary interpretation of echocardiographic findings.

Frailty, periinterventional complications and outcome in patients undergoing percutaneous mitral and tricuspid valve repair.

Frailty is common in elderly and multimorbid patients and associated with increased vulnerability to stressors. In a single centre study frailty according to Fried criteria was assessed in consecutive patients before transcatheter mitral and tricuspid valve repair. Postprocedural infections, blood transfusion and bleeding and renal failure were retrospectively assessed from records. Median follow-up time for survival was 560 days (IQR: 363 to 730 days). 90% of 626 patients underwent mitral valve repair, 5% tricuspid valve repair, and 5% simultaneous mitral and tricuspid valve repair. 47% were classified as frail. Frailty was associated with a significantly increased frequency of bleeding (16 vs 10%; p = 0.016), blood transfusions (9 vs 3%; p = < 0.001) and infections (18 vs 10%; p = 0.006), but not with acute kidney injury (20 vs 20%; p = 1.00). Bleeding and infections were associated with longer hospital stays, with a more pronounced effect in frail patients (interaction test p < 0.05, additional 3.2 and 4.1 days in frail patients, respectively). Adjustment for the occurrence of complications did not attenuate the increased risk of mortality associated with frailty (HR 2.24 [95% CI 1.62-3.10]; p < 0.001). Bleeding complications and infections were more frequent in frail patients undergoing transcatheter mitral and tricuspid valve repair and partly explained the longer hospital stay. Albeit some of the complications were associated with higher long-term mortality, this did not explain the strong association between frailty and mortality. Further research is warranted to explore interventions targeting periprocedural complications to improve outcomes in this vulnerable population.

Guideline-directed medical therapy assessment in heart failure patients undergoing percutaneous mitral valve repair.

Achieving optimized guideline-directed medical therapy (GDMT) is recommended prior to transcatheter mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). We aimed to propose and validate an easy-to-use score for assessing the quality of GDMT in patients with heart failure with reduced ejection fraction (HFrEF) undergoing M-TEER. Among the 1641 EuroSMR patients enrolled in the EuroSMR Registry who underwent M-TEER, a total of 1072 patients [median age 74, interquartile range (IQR) 67-79years, 29% female] had complete data on GDMT and a left ventricular ejection fraction≤40% and were included in the current study. We proposed a GDMT score that considers the dosage levels of three medication classes (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists), with a maximum score of 12 points indicating optimal GDMT. The primary outcome was all-cause mortality. The median GDMT score was 4 points (IQR 3-6). All three domains of the scoring system were associated with all-cause mortality (P<0.05 for all). The overall GDMT score was associated with all-cause mortality (hazard ratio 0.90, 95% confidence interval 0.86-0.95 for each 1-point increase in the GDMT score). This association remained significant after adjusting for renal function and co-morbidities. This study demonstrates the utility of a simple GDMT scoring system for assessing the adequacy of GDMT in HFrEF patients with relevant SMR undergoing M-TEER. The GDMT score has potential applications in guiding the design of future clinical trials and aiding clinical decision-making processes.

The Results of Urgent and Emergent Transcatheter Mitral Valve Repair (MitraClip®): A Comparison with Standard Elective Repair

Background: Mitral regurgitation (MR) is the most common valvular disease worldwide. MR has been managed surgically, with either a mitral valve replacement or repair. Percutaneous transcatheter mitral valve repair (TMVr) with MitraClip® insertion has gained wide popularity and success over medical and surgical therapy for MR. Some patients with acute MR or decompensated heart failure could benefit from urgent TMVr. This meta-analysis aims to compare clinical outcomes of urgent versus elective TMVr. Methods: We performed a study-level meta-analysis to compare the clinical outcomes of urgent versus elective TMVr using the MitraClip system. The primary endpoint outcome was all-cause mortality. Additional outcomes included procedural success, postoperative acute kidney injury (AKI), stroke, and length of in-hospital stay. Results: Overall, 30-day mortality was significantly higher in the urgent group (odds ratio [OR]: 2.74; 95% confidence interval [CI] [2.17, 3.48]; P &lt; 0.00001; I² =0%). However, subgroup analysis of matched cohorts showed no significant difference between both groups (OR: 1.80; 95% CI [0.94, 3.46]; P = 0.08; I² =0%). One-year mortality was similar between both groups (and: 1.67; 95% CI [0.96, 2.90]; P = 0.07; I² =0%). Procedural success was similar between both groups (89.4% vs. 89.8%; P = 0.43). Postoperative AKI was significantly higher in the urgent group (OR: 4.12; 95% CI [2.87, 5.91]; P &lt; 0.00001; I² =0%). Conclusion: Urgent TMVr should be indicated in select populations as it is considered therapeutic with acceptable outcomes therein.

Percutaneous Mitral Valve Repair in Pediatric Patients.

Rigorous clinical trials have demonstrated the safety and efficacy of Transcatheter Edge-to-Edge Repair to treat severe secondary mitral regurgitation (MR) in adults with primary cardiomyopathy who have failed guideline-directed medical therapy, as well as those with primary MR at high surgical risk. To date, there are only three case reports describing this procedure in the pediatric population. We report a case series of four pediatric patients, including the youngest and smallest reported, who underwent this procedure.

Contemporary Echocardiographic Evaluation of Mitral Regurgitation and Guidance for Percutaneous Mitral Valve Repair.

Mitral valve regurgitation (MR) is a multifaceted valvular heart disease. Echocardiography plays a central role in etiology assessment, severity quantification, treatment candidacy, outcome evaluation, and patient follow-up. In this review, we describe the comprehensive echocardiographic assessment of MR, including transthoracic (TTE) and transesophageal (TEE) approaches, 2D and 3D modalities, strain imaging, stress echocardiography, and artificial intelligence (AI) applications. Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a key therapy for patients with severe, symptomatic MR and high surgical risk. TEER is performed under TEE guidance. We outline a practical overview of echocardiographic guidance on TEER.

Impact of sacubitril valsartan initiation in patients with HFrEF and severe mitral regurgitation referred for percutaneous mitral repair

Abstract Background In patients with heart failure with reduced ejection fraction (HFrEF), the severity of functional mitral regurgitation (MR) is a major predictor of worsened symptoms and poor outcomes. Percutaneous MR repair has been shown to improve outcomes in HFrEF with MR. However, because MR is related to abnormal myocardial function and adverse remodeling, the optimization of guideline-directed medical therapy (GDMT) could improve loading conditions, reversal remodelling and left ventricle function and also may reduce MR severity. We sought to evaluated whether the left ventricle reverse remodeling induced by the addition of sacubitril/valsartan may reduce MR severity sufficiently to avoid need for percutaneous MR repair approach. Methods We performed a single-center, prospective assessor-blinded study to determine the reverse remodeling response of sacubitril/valsartan therapy in HFrEF patients (NYHA class II-IV) with MR evaluated for percutaneous MR repair. Echocardiographic images were assessed offline by 2 investigators blinded to both the clinical data and timing of echocardiograms. Doses of sacubitril/valsartan were optimized to individual tolerance. A clinical and echocardiographic 1 year follow-up was performed. Results Thirty-nine HFrEF patients with MR grade 3-4 were included (mean age 63 years old, 69,2% male). Optimal dose of sacubitril/valsartan was reached in 63,2% of patients. After 1-year follow-up, only 1 patient died and, as we show in Table 1, a significant improvement on NYHA functional class and NT-ProBNP values were present. Left ventricle ejection fraction improved (29.7 ± 6.7% vs 41.3 ± 13.2%; P &amp;lt; 0.001) and left ventricular end-diastolic and end-systolic volume indexed to body surface area decreased (123.4 ± 35.7 mL/m2 vs 98.4 ± 39.7 mL/m2; P &amp;lt; 0.001 and 87.7 ± 30.0 mL/m2 vs 61.9 ± 35.3 mL/m2; P &amp;lt; 0.001, respectively). Volumetric remodeling was associated with a reduction in the degree of mitral regurgitation (64.1% grade 3 and 35.9% grade 4 at the beginning to 28.9% grade 1, 36.8% grade 2, 21.5% grade 3 and 13.2% grade 4 after one year of follow-up; [scale from 0-4]). Conclusion The optimization of GDMT with sacubitril/valsartan induced an improvement on functional class and a beneficial reverse cardiac remodelling, with enhancement of left ventricle function and reducing MR severity, enough in 24 patients to avoid need for percutaneous MR repair. In HFrEF patients with grade 3-4 mitral regurgitation, our results reinforce importance of ensuring optimal GDMT before a percutaneous mitral valve repair approach.Table 1.Changes during follow-up.

Pulmonary venous flow changes after Mitraclip implantation is predictor of mid-term right ventricular function improvement

Abstract Background Percutaneous mitral valve repair with Mitraclip has become an effective therapeutic alternative to mitral valve surgery in high-risk surgical patients with severe mitral regurgitation. Pulmonary venous flow assessment by pulsed Doppler is widely used to determine the severity of mitral regurgitation and apparently is the best method to evaluate mitral regurgitation after the procedure because device artifacts do not affect it. The main objective of this study was to assess the impact of pulmonary venous flow changes after Mitraclip implantation in right ventricular function in the follow up at 6 months after the procedure. Methods This single-center, retrospective study included all consecutive patients with mitral regurgitation ≥ III/IV undergoing percutaneous mitral valve repair with the MitraClip device at our institution between 2010 and 2023. We analyzed the changes in the systolic/diastolic flow velocity time integral ratio in pulmonary veins pre and postprocedure. The tricuspid annular plane systolic excursion (TAPSE) was the method used to assess the right ventricular function in the follow up. Results A total of 158 consecutive patients that underwent Mitraclip implantation at our institution were included. Men age was 77 years ±10.3, and 82 patients (52.5%) were women. The etiology of mitral regurgitation was degenerative in 70 patients (44.3%), functional in 60 patients (37.9%) and mixed in 28 patients (17.7%). Preprocedurally, tridimensional effective regurgitant orifice was 0.63 ±0.33cm2, left ventricular end-diastolic volume 145.19 ± 66.14 ml (indexed 80.33 ± 59.59 ml/m2), left ventricular ejection fraction 45.90 ± 15.99%, pulmonary artery systolic pressure (PASP) 48.79 ± 18.12 mmHg and TAPSE 18.59 ± 4.43mm. The change in the pulmonary venous flow assessed by the systolic/diastolic flow velocity time integral ratio, was predictor of a right ventricular function improvement at 6 months (y = -2.7169 + 3.0171 x, r= 0.45, p= 0,006 see figure 1). Conclusions Pulmonary venous flow changes after Mitraclip implantation assessed by the systolic/diastolic flow velocity time integral ratio is predictor of mid-term right ventricular function improvement.Figure 1

Temporal trends in characteristics and outcomes in patients undergoing percutaneous mitral valve repair for secondary mitral regurgitation

Abstract Background and purpose Several studies have investigated the procedural and clinical outcomes of patients with secondary mitral regurgitation (MR) who underwent percutaneous mitral valve repair. However, temporal trend of patients’ characteristics and outcomes has not been studied in comparison with landmark studies. Thus, this systematic review investigated the temporal trend in patient characteristics and outcomes from observational studies over years in comparison with landmark studies in secondary MR. Methods The identified observational studies were grouped into two 5-year periods. The first 5-year period included 36 studies that started recruiting patients at any year between 2008 and 2012, whereas 25 studies in the second 5-year period started recruitment between 2012 and 2018. Pooled data of two every 5-year period were compared with the landmark studies. Multicenter studies with potential overlap in term of recruitment periods were excluded. Variables from observational studies were compared with those of landmark trials using a random-effects model for each variable. R software was used for non-comparative pooling of variables, and the RevMan software was used for the comparative meta-analysis. Results EVEREST versus observational studies: In first 5-year period, patients in EVERST program were more likely to have non-ischemic MR aetiology and less likely to be symptomatic at presentation (i.e., NYHA III/IV) or getting implanted cardiac device. They were less likely to have MR grade ≤2+ (OR 0.58, 95% CI:0.44-0.78) post procedure but maintained NYHA class I/II at 12-month follow-up (OR 1.74, 95% CI: 1.38-2.19) with no difference in mortality. In the subsequent 5-year period, there was no change from the former comparisons. COAPT versus observational studies: In the first period, COAPT patients were more likely to have renal insufficiency and receive beta-blockers and implanted device. They were less likely to present with severe heart failure symptoms or severe MR. There was no difference in post procedure outcomes, but they were more likely to maintain MR grade ≤2+ at follow-up (OR 3.98, 95% CI: 2.15-7.37). In the following period, COAPT patients were more likely to present with MR grade 3+ without a difference in procedural or clinical outcomes except for more chance to maintain procedural success at 12-mont follow-up (i.e., MR grade ≤2+; OR 2.41, 95% CI: 1.27-4.58). MITRA-FR versus observational studies: In the first period, MITRA-FR patients were less likely to have atrial fibrillation, renal insufficiency, or NYHA class III/IV. They were more likely receive beta-blockers and implanted device. However, there was no difference in post procedure and clinical outcomes. In the second period, there was no major change from the previous comparisons. Conclusion Although patients from landmark studies, namely COAPT and MITRA-FR, may have favourable characteristics, this did not translate into better outcome over time.

Abstract 13012: Impact of End-Stage Renal Disease on Short-Term Outcomes Among Adults Undergoing Percutaneous Mitral Valve Repair

Introduction: Patients with end-stage renal disease (ESRD) are predisposed to multiple complications following invasive and non-invasive procedures. With the recent introduction of percutaneous mitral valve repair (PMVR), there needs to be more data on ESRD patients' outcomes following such procedures. Our analysis aims to bridge data via national hospitalization records. Methods: We used de-identified data of adults(ages 18 and more) undergoing PMVR between 2016-2020 via the National Inpatient Sample. Patients were separated into two groups based on the presence of a diagnosis of ESRD. We excluded all other forms of Chronic kidney disease classifications from our control group. Differences in outcomes were studied via logistic regression models. Results: Between 2016-2020, a total of 24680 procedures of PMVR were performed in the United States that met our selection criteria. Among them, 1655 (6.7%) patients were reported with a diagnosis of ESRD, while 23025 (93.3%) were without any diagnosis of CKD or ESRD. Patients with ESRD consisted of a younger cohort (mean age 68.68 years) compared to the non-ESRD group (mean age 77.39 years, p&lt;0.01). Furthermore, the ESRD group showed a higher mean Charlson Comorbidity Index Score (CCI) score (6.47) compared to the non-ESRD group (score of 2.20). Most procedures were conducted in Urban teaching centers (90.4% of non-ESRD patients and 93.4% of ESRD patients). ESRD patients recorded higher odds of sepsis (aOR 1.747, 95% CI 1.191-2.560, p&lt;0.01), major bleeding (aOR 8.316, 95% CI 7.336-9.426, p&lt;0.01), postprocedural respiratory failure (aOR 2.531, 95% CI 1.441-4.445, p&lt;0.01), and mortality (aOR 2.109, 95% CI 1.513-2.940, p&lt;0.01). The two groups showed no differences in acute myocardial infarction events (aOR 1.235, 95% CI 0.899-1.697, p=0.193) during their hospitalization for the procedure. Conclusions: Patients with ESRD experienced poorer outcomes following PMVR as they had higher odds of mortality, postprocedural respiratory failure, major bleeding, and sepsis. Thus, physicians must adequately address the potential complications with and without the procedure and closely monitor the post-operative progress.

The CINCH-FMR postmarket registry: Real-world long-term outcomes with percutaneous mitral valve repair with the Carillon Mitral Contour System®

BackgroundThe Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it has been found to reduce mitral regurgitation, reduce left ventricular and atrial volumes, and be associated with improvements in clinical parameters. AimsThe CINCH post-market registry is designed to evaluate immediate, mid-term and long-term outcomes from a post-approval study of the Carillon® device evaluated in real-world practice. MethodsThe CINCH post-market registry is a single-arm study of percutaneous mitral annuloplasty with the Carillon device in patients with functional (secondary) mitral regurgitation and symptomatic congestive heart failure when utilized in real-world conditions. Patient selection, echocardiographic hemodynamic measurements, and patient follow-up requirements were performed per standard of care at each institution. ResultsA total of 101 patients treated with the Carillon device at 13 sites in Germany were enrolled in the CINCH registry. The mean age was 75 ± 9 years, 57 % were male, and patient presentation included primarily NYHA class III (69 %) with MR grade 3 (68 %). Over 5 years of follow-up, all-cause mortality was 40.1 %, the incidence of HFH was 53.9 %, and the composite outcome of HFH or death was 66.4 %. At each follow-up interval through 5 years, statistically significant reductions in NYHA class (p < 0.05) and MR grade (p < 0.01) were reported. ConclusionsIn this “real world” registry of the Carillon Mitral Contour System, procedural safety and medium-term follow-up outcomes is similar to the outcomes seen in the prospective, controlled clinical trials, despite being used in populations of patients that extend outside of those studied in the trials. The use of this therapy in patients with atrial functional mitral regurgitation, and heart failure with preserved ejection fraction, was notable, since these types of patients were excluded from the prospective, controlled trials. This supports possible additional patient populations who might benefit from this type of mechanical therapy. The safety profile of this therapy in this registry and in the earlier trials may support a potential role in earlier forms of secondary mitral regurgitation.

Transcatheter Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation: COAPT Post-Approval Study

BackgroundReal-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT) has been debated because of careful patient selection and the contrasting results of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT. ObjectivesThe COAPT-PAS (COAPT Post-Approval Study) was initiated to assess the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR). MethodsCOAPT-PAS is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 U.S. centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019 to 2020. The 1-year outcomes from the COAPT-PAS full cohort and the COAPT-like and MITRA-FR–like subgroups who met RCT inclusion/exclusion criteria are reported. ResultsPatients in the COAPT-PAS had more comorbidities, more severe HF and functional limitations, and less guideline-directed medical therapy than those in the COAPT or MITRA-FR RCTs. Patients in the COAPT-PAS full cohort and the COAPT-like (n = 991) and MITRA-FR–like (n = 917) subgroups achieved a 97.7% MitraClip implant rate, a similar and durable reduction of mitral regurgitation to ≤2+ at 1 year (90.7%, 89.7%, and 86.6%, respectively), a large improvement in quality of life at 1 year (Kansas City Cardiomyopathy Questionnaire +29 COAPT-PAS, +27 COAPT-like, and +33 MITRA-FR–like), faster procedure times, similar or lower clinical event rates compared with the RCTs’ MitraClip arms, and lower clinical event rates than the RCTs’ guideline-directed medical therapy only arms. One-year heart failure hospitalizations was 18.9% in COAPT-PAS, 19.7% in COAPT-like compared with 24.9% in COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR–like compared with 47.4% in MITRA-FR-RCT. ConclusionsThis large, contemporary, real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR RCT inclusion/exclusion criteria and patients excluded from the RCTs.

One-year real-world outcomes for patients undergoing transcatheter mitral valve repair: the Gulf MTEER registry (GULF Mitral Transcatheter Edge to Edge Repair)

BackgroundSevere mitral regurgitation (MR) with left ventricular dysfunction portends worse outcomes. Over the course of the last two decades, transcatheter repair of the mitral valve offered an alternative therapeutic modality...

Impact of Percutaneous Mitral Valve Repair on Left Atrial Strain and Atrial Fibrillation Progression.

Transcatheter edge-to-edge repair (TEER) currently represents a valuable therapeutic option for patients with severe mitral regurgitation (MR) considered at high surgical risk. Besides symptoms and left ventricular (LV) echocardiographic improvements upon TEER, it has been postulated that left atrial (LA) function plays a prognostic role. The aims of our study were to evaluate LA changes after TEER, measured by two-dimensional speckle-tracking echocardiography analysis (2D-STE), their association with atrial fibrillation (AF) occurrence, and relative arrhythmic burden. We considered in a single-center study 109 patients affected by symptomatic severe MR undergoing TEER from February 2015 to April 2022. By 2D-STE, LA reservoir (R_s), conduct (D_s), and contractile (C_s) strains were assessed along with four-chamber emptying fraction (LAEF-4CH) before, 1, 6, and 12 months following TEER. Statistical analysis for comparison among baseline, and follow-ups after TEER was carried out by ANOVA, MANOVA, and linear regression. Successful TEER significantly improved LV dimensions and LA performances, as indicated by all strain components, and LAEF-4CH after 1 year. Strikingly, a significant reduction in arrhythmic burden was observed, since only one case of subclinical AF detected by a previously implanted cardiac electronic device was found in the cohort of sinus rhythm patients (n = 48) undergone TEER; in addition, ventricular rate was reduced in the AF cohort (n = 61) compared to baseline, together with few episodes of nonsustained ventricular tachycardias (5/61, 8.2%) after MR improvement. Overall, TEER was associated with improved cardiac performance, LA function amelioration, and reduced arrhythmic burden.

A novel useful 3D multiplanar reconstruction algorithm to detect the optimal transseptal puncture positioning in percutaneous mitral valve repair

Abstract Funding Acknowledgements Type of funding sources: None. Background in transcatheter edge to edge mitral repair (TEER), the use of transesophageal echocardiography (TEE) guidance is mandatory in every procedural step. The transseptal puncture (TPS) height is measured by TEE using a four chamber view (4CV) in mid-upper esophagus between the catheter tenting in fossa ovalis and the coaptation of the mitral valve (MV) and its correct positioning influence procedural outcome. However, TSP can represents a tricky step, because of poor images, challenging interatrial septa or a malalignment of TEE probe, catheter and mitral coaptation. Aim In this abstract we describe an alternative TEE 3D technique to measure TSP height. Methods Between August 2022 and December 2022 we performed 18 cases of TEER. In all cases we obtained a measure of the height of tenting (HT) with two different techniques: the 2D view (2DV) in 4CV and the 3D reconstruction algorithm (3DA) (fig.1). This 3DA starts with a real-time single-beat 3D volume acquisition from a mid esophagus at 0 degrees view. The 3D dataset should include IAS, aortic valve, and MV. In multiplanar reconstruction (MPR), three 2D planes are reconstructed from the 3D dataset. These MPR planes must be positioned in a predefined manner with the cursors correctly aligned on the catheter tip at the level of the fossa ovalis. The first plan (P1) is an off axis 4CV oriented perpendicular to the IAS exactly on the height of the catheter tip and serves as the orientation plane. This plane allows the exact location of the tenting point and the positioning of the other two MPR planes. The crossing of the axes should be positioned in all planes at the center of the left atrium. The second plane (P2) and the third plane (P3) are oriented perpendicular to the previous one (fig.1) and each other. Rotating and moving those two planes in a stepwise manner a 4CV, including the plane passing by catheter tip and MV coaptation is obtained in P1. In order to identify the exact plane of the coaptation, while in P1 the axis passing through the MV is positioned at the center of the MV, in P2 the axis is adjusted at the point of leaflet coaptation (fig.1). The HT is then measured in P1 thus avoiding the possible foreshortening affecting a simple 2DV. Results In all cases the 3D measure was accomplished but in 3 of 18 cases the 2DV was difficult to obtain because of loss of contact between the esophagus and the probe in retroflection, in those cases the HT was measured in a 0 degrees off axis view from the tenting of the fossa to a very anterior part of the coaptation line or to anterior leaflet. In all those cases the height of tenting was underestimated (fig.2). Conclusion The 3DA described can be useful in obtaining a more precise and reliable measure of the HT even in anatomical challenging patients. A comparative study that consents to investigate the correlation between the two methods and the inter and intra observer agreement is mandatory and planned at our institution.

Prognostic impact of precipitated cardiac decompensation in symptomatic heart failure with reduced ejection fraction and severe secondary mitral regurgitation

Our aim was to assess the distribution of primary (with no trigger) and secondary (with a decompensation trigger) heart failure events in a severe heart failure population and their association with 2-year all-cause mortality in the Mitra.Fr study. We included 304 patients with symptomatic heart failure, and severe mitral regurgitation and guideline directed medical therapy randomized to medical therapy alone or medical therapy with percutaneous mitral valve repair. According to the follow-up, we defined 3 categories of events: follow-up without any heart failure event, at least 1 decompensation starting with a primary heart failure decompensation or starting with a precipitated secondary heart failure event. The primary outcome was 2-years all-cause mortality. A total of 179 patients (59 %) had at least 1 heart failure decompensation within 24-months of follow-up. 129 heart failure decompensations (72%) were a first primary heart failure and 50 (28%) were a first secondary decompensation. Finally, 30 patients had both types of decompensations but these were not taken into account for the comparison of primary and secondary decompensations. Primary decompensations were 3-times more frequent than secondary decompensations, but the mean number of heart failure decompensations was similar in the "Primary heart failure group" compared to the "Secondary heart failure group": (1.94 ± 1.39 vs 1.80 ± 1.07 respectively; P=.480). Compared to patients without heart failure decompensation, patients with "Only primary decompensation" or with "Only secondary decompensation" had a significantly increased risk of death (HR=4.87, 95% CI [2.86, 8.32] and 2.68 95%CI [1.64, 4.37] respectively). All-cause mortality, was not significantly different between these 2 type of decompensations (HR=1.82, 95% CI [0.93, 3.58]; P=.082), but each additional heart failure recurrence was associated with a significant increase in mortality risk (HR = 1.27, 95% CI [1.08; 1.50]; P=.005). In heart failure with reduced ejection fraction and severe secondary mitral regurgitation patients, primary heart failure decompensations were 3-times more frequent compared to precipitated decompensations with a nonsignificant trend in increased risk of all-cause mortality. Our results fail to support the differentiation between primary and secondary decompensations as they seem to portend the same outcome impact.

Disentangling Heart Failure and Physical Frailty: Prospective Study of Patients Undergoing Percutaneous Mitral Valve Repair

BackgroundFrailty and heart failure share pathophysiology and clinical characteristics. ObjectivesThe aim of this study was to analyze the contribution of heart failure to the physical frailty phenotype by examining patients with heart failure before and after percutaneous mitral valve repair (PMVR). MethodsFrailty according to the Fried criteria (weight loss, weakness, exhaustion, slowness, and low activity) was assessed in consecutive patients before and 6 weeks after PMVR. ResultsA total of 118 of 258 patients (45.7%) (mean age: 78 ± 9 years, 42% female, 55% with secondary mitral regurgitation) were frail at baseline, which significantly decreased to 74 patients (28.7 %) at follow-up (P < 0.001). The frequency of frailty domains slowness, exhaustion, and inactivity significantly decreased, whereas weakness remained unchanged. Baseline frailty was significantly associated with comorbidities, N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels, and functional capacity, whereas frailty after PMVR was not associated with NT-proBNP levels. Predictors of postprocedural reversibility of frailty were NYHA functional class <IV, absence of weakness, and lower frailty score. In comparison with patients who were persistently nonfrail (reference group HR: 1.00), the risk of mortality continuously increased for patients who experienced new frailty (HR: 1.41 [95% CI: 0.41-4.86]), those who had reversal of frailty (HR: 2.17 [95% CI: 1.03-4.57]), and those who were persistently frail (HR: 3.26 [95%: CI 1.62-6.57]; P = 0.006 for trend). ConclusionsTreatment of mitral regurgitation in patients with heart failure is associated with almost a halved burden of physical frailty, particularly in patients with a less advanced phenotype. Considering the prognostic relevance of frailty dynamics, this data warrants further evaluation of the concept of frailty as a primary treatment target.

P358 FATAL CONSPIRACY: MIDVENTRICULAR OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY COMPLICATED BY GIANT APICAL ANEURYSM AND SEVERE MITRAL REGURGITATION

Abstract This case refers to a 69–year–old woman with a history of hypertrophic cardiomyopathy (HCM) with severe mid–ventricular obstruction complicated by apical aneurysm and restrictive phenotype. This patient had no left ventricular outflow tract obstruction and previous examinations showed moderate mitral regurgitation (MR) with suboptimal echocardiographic follow–up. ICD was previously implanted for primary prevention. Disease progression was complicated by episodes of acute heart failure (HF) caused by atrial fibrillation/tachycardia (AF or AT) with rapid ventricular response despite pharmacological therapy and a transcatheter ablation attempt. The patient was admitted to our Cardiac Intensive Care Unit with acute pulmonary oedema and extreme general frailty. EKG showed normal sinus rhythm alternating with AT with high ventricular rate. Transthoracic (TTE) and transesophageal (TEE) echocardiograms gave evidence of severe hypertrophy of left ventricular (LV) mid–cavity segments (mid IVS = 26 mm) with mid–ventricular systolic obliteration (with no more evidence of significant gradient) and a large apical aneurysm (37x35 mm) resulting in an “hourglass” shaped LV cavity (Figure 1). In addition the examinations highlighted systolic dysfunction with severe stroke volume reduction and severe MR caused by annulus dilatation with anterior jet direction due to leaflets abnormal coaptation (Figure 2). HF was multifactorial, caused not only by MR and atrial tachyarrhythmias but also due to the abnormal large apical aneurysm and the small left ventricular chamber with low compliance. The anatomical features obtained from TEE and cardiac CT (Figure 3) were analyzed by the Heart Team. Surgery with aneurysmectomy and mitral valve repair or replacement was excluded due to patient‘s frailty. Despite the suboptimal valve and LV chamber anatomy, percutaneous mitral valve repair with MitraClip was considered but also deferred owing to the unstable hemodynamic conditions. Further hemodynamic deterioration led to the patient’s exitus. Discussion HCM with mid–ventricular obstruction may be complicated by apical aneurysm. Large apical aneurysms can reduce LV contractile efficiency and the combination with severe MR can cause further loss of anterograde cardiac output leading to a progressive and fatal deterioration. A better outcome can only be achieved through careful follow–up and early detection and management of disease complications.

PO-04-016 FIRST REPORT OF LEADLESS PACEMAKER IMPLANTATION IN A PATIENT WITH BOTH A TRANSCATHETER TRICUPID VALVE REPAIR (TRICLIP) AND SURGICAL TRICUSPID VALVE ANNULOPLASTY

An increasing number of patients with valvular heart disease are undergoing novel structural valve interventions with subsequent need for pacemaker implantation. Leadless cardiac pacemakers (LCP) may be particularly suitable in patients with prior tricuspid valve interventions. However, the process of navigating previously repaired tricuspid valves (surgical or percutaneous) can be challenging. To our knowledge, implantation of an LCP in a patient with both surgical TV repair (annuloplasty) and transcatheter TV repair (TriClip, TTVr) has not been reported. In this case, intracardiac echocardiography (ICE) was used to navigate the LCP to its final implant position. To describe the feasibility of implanting an LCP in a patient with surgical and percutaneous tricuspid valve repairs, and the utility of ICE-guided implantation. N/A A 69 year old female with prior inferior vena cava (IVC) filter, percutaneous mitral valve repair (MitraClip) and transcatheter tricuspid valve repair (TriClip) underwent a BioBentall procedure with tricuspid valve repair (annuloplasty band). The existing clips were not removed at the time of surgery. She ultimately developed an indication for back-up ventricular pacing (intermittent high-degree AV block) and an LCP was recommended (Micra, Medtronic Inc., Minneapolis, MN). Under fluoroscopic guidance, the LCP introducer sheath (27 French outer diameter) was first traversed through the IVC filter into the right atrium. Then, using ICE to visualize the tricuspid valve and taking note of the clip position, the deflectable delivery system was maneuvered through the residual tricuspid valve orifice into the right ventricle while avoiding the clips via a superior and anterior approach. Positioning of the delivery system in the apical right ventricular septum in respect to the annuloplasty band and clips was confirmed on ICE imaging and fluoroscopy before and after deployment. LCP sensing, pacing threshold and impedance values were within normal limits. The severity of pre-existing moderate residual tricuspid regurgitation remained unchanged on follow up transthoracic echocardiography. Implantation of a leadless pacemaker after both transcatheter tricuspid valve repair and surgical tricuspid valve annuloplasty band is feasible. Steering through an anatomically challenging tricuspid valve neo-orifices can be performed safely and effectively under intracardiac echocardiography guidance.

Improved mid-term stability of MR reduction with an increased number of clips after percutaneous mitral valve repair in functional MR.

Percutaneous mitral valve repair (PMVR) has evolved to be a standard procedure in suitable patients with mitral regurgitation (MR) not accessible for open surgery. Here, we analyzed the influence of the number and positioning of the clips implanted during the procedure on MR reduction analyzing also sub-collectives of functional and degenerative MR (DMR). We included 410 patients with severe MR undergoing PMVR using the MitraClip® System. MR and reduction of MR were analyzed by TEE at the beginning and at the end of the PMVR procedure. To specify the clip localization, we sub-divided segment 2 into 3 sub-segments using the segmental classification of the mitral valve. We found an enhanced reduction of MR predominantly in DMR patients who received more than one clip. Implantation of only one clip led to a higher MR reduction in patients with functional MR (FMR) in comparison to patients with DMR. No significant differences concerning pressure gradients could be observed in degenerative MR patients regardless of the number of clips implanted. A deterioration of half a grade of the achieved MR reduction was observed 6months post-PMVR independent of the number of implanted clips with a better stability in FMR patients, who got 3 clips compared to patients with only one clip. In patients with FMR, after 6months the reduction of MR was more stable with an increased number of implanted clips, which suggests that this specific patient collective may benefit from a higher number of clips.