Guideline-Directed Medical Therapy and Survival After TEER for Secondary Mitral Regurgitation With Right Ventricular Impairment.

BACKGROUND: Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients. OBJECTIVES: The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort. METHODS: Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular-to-pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMTtit) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years. RESULTS: Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMTtit showed a significantly higher long-term survival vs the 729 patients not on GDMTtit (61.8% vs 36.0%; P < 0.00001). Propensity score-matched analysis confirmed a significant association between GDMTtit and higher survival (61.0% vs 43.1%; P = 0.018). GDMTtit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMTtit vs those not on GDMTtit). Its association with better outcomes was confirmed among all subgroups analyzed. CONCLUSIONS: In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities.

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

AIMS: 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. METHODS AND RESULTS: 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) 67-79 years, 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. CONCLUSIONS: 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.

A report on a survey among Portuguese Association of Interventional Cardiology associates regarding ionizing radiation protection practices in national interventional cath-labs.

INTRODUCTION AND OBJECTIVES: Concerns surrounding the consequences of ionizing radiation (IR) have increased in interventional cardiology (IC). Despite this, the ever-growing complexity of diseases as well as procedures can lead to greater exposure to radiation. The aim of this survey, led by Portuguese Association of Interventional Cardiology (APIC), was to evaluate the level of awareness and current practices on IR protection among its members. METHODS: An online survey was emailed to all APIC members, between August and November 2021. The questionnaire consisted of 50 questions focusing on knowledge and measures of IR protection in the catheterization laboratory. Results were analyzed using descriptive statistics. RESULTS: From a response rate of 46.9%, the study obtained a total sample of 159 responses (156 selected for analysis). Most survey respondents (66.0%) were unaware of the radiation exposure category, and only 60.4% reported systematically using a dosimeter. A large majority (90.4%) employed techniques to minimize exposure to radiation. All participants used personal protective equipment, despite eyewear protection only being used frequently by 49.2% of main operators. Ceiling suspended shields and table protectors were often used. Only two-thirds were familiar with the legally established limit on radiation doses for workers or the dose that should trigger patient follow-up. Most of the survey respondents had a non-certified training in IR procedures and only 32.0% had attended their yearly occupational health consultation. CONCLUSIONS: Safety methods and protective equipment are largely adopted among interventional cardiologists, who have shown some IR awareness. Despite this, there is room for improvement, especially concerning the use of eyewear protection, monitoring, and certification.

Interventional cardiology in cancer patients: A position paper from the Portuguese Cardiovascular Intervention Association and the Portuguese Cardio-Oncology Study Group of the Portuguese Society of Cardiology.

The field of Cardio-Oncology has grown significantly, especially during the last decade. While awareness of cardiotoxicity due to cancer disease and/or therapies has greatly increased, much of the attention has focused on myocardial systolic disfunction and heart failure. However, coronary and structural heart disease are also a common issue in cancer patients and encompass the full spectrum of cardiotoxicity. While invasive percutaneous or surgical intervention, either is often needed or considered in cancer patients, limited evidence or guidelines are available for dealing with coronary or structural heart disease. The Society for Cardiovascular Angiography and Interventions consensus document published in 2016 is the most comprehensive document regarding this particular issue, but relevant evidence has emerged since, which render some of its considerations outdated. In addition to that, the recent 2022 ESC Guidelines on Cardio-Oncology only briefly discuss this topic. As a result, the Portuguese Association of Cardiovascular Intervention and the Cardio-Oncology Study Group of the Portuguese Society of Cardiology have partnered to produce a position paper to address the issue of cardiac intervention in cancer patients, focusing on percutaneous techniques. A brief review of available evidence is provided, followed by practical considerations. These are based both on the literature as well as accumulated experience with these types of patients, as the authors are either interventional cardiologists, cardiologists with experience in the field of Cardio-Oncology, or both.

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration.

BACKGROUND: Guideline-directed medical therapy (GDMT) optimization is mandatory before transcatheter edge-to-edge mitral valve repair (M-TEER) in patients with secondary mitral regurgitation (SMR) and heart failure (HF) with reduced ejection fraction (HFrEF). However, the effect of M-TEER on GDMT is unknown. OBJECTIVES: The authors sought to evaluate frequency, prognostic implications and predictors of GDMT uptitration after M-TEER in patients with SMR and HFrEF. METHODS: This is a retrospective analysis of prospectively collected data from the EuroSMR Registry. The primary events were all-cause death and the composite of all-cause death or HF hospitalization. RESULTS: Among the 1,641 EuroSMR patients, 810 had full datasets regarding GDMT and were included in this study. GDMT uptitration occurred in 307 patients (38%) after M-TEER. Proportion of patients receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists was 78%, 89%, and 62% before M-TEER and 84%, 91%, and 66% 6 months after M-TEER (all P < 0.001). Patients with GDMT uptitration had a lower risk of all-cause death (adjusted HR: 0.62; 95% CI: 0.41-0.93; P = 0.020) and of all-cause death or HF hospitalization (adjusted HR: 0.54; 95% CI: 0.38-0.76; P < 0.001) compared with those without. Degree of MR reduction between baseline and 6-month follow-up was an independent predictor of GDMT uptitration after M-TEER (adjusted OR: 1.71; 95% CI: 1.08-2.71; P = 0.022). CONCLUSIONS: GDMT uptitration after M-TEER occurred in a considerable proportion of patients with SMR and HFrEF and is independently associated with lower rates for mortality and HF hospitalizations. A greater decrease in MR was associated with increased likelihood for GDMT uptitration.

Transcatheter mitral valve replacement or repair for secondary mitral regurgitation: a propensity score-matched analysis.

AIMS: This study aimed to compare outcomes after transcatheter mitral valve replacement (TMVR) and mitral valve transcatheter edge-to-edge repair (M-TEER) for the treatment of secondary mitral regurgitation (SMR). METHODS AND RESULTS: The CHOICE-MI registry included 262 patients with SMR treated with TMVR between 2014 and 2022. The EuroSMR registry included 1065 patients with SMR treated with M-TEER between 2014 and 2019. Propensity score (PS) matching was performed for 12 demographic, clinical and echocardiographic parameters. Echocardiographic, functional and clinical outcomes out to 1 year were compared in the matched cohorts. After PS matching, 235 TMVR patients (75.5 years [70.0, 80.0], 60.2% male, EuroSCORE II 6.3% [interquartile range 3.8, 12.4]) were compared to 411 M-TEER patients (76.7 years [70.1, 80.5], 59.0% male, EuroSCORE II 6.7% [3.9, 12.4]). All-cause mortality was 6.8% after TMVR and 3.8% after M-TEER at 30 days (p = 0.11), and 25.8% after TMVR and 18.9% after M-TEER at 1 year (p = 0.056). No differences in mortality after 1 year were found between both groups in a 30-day landmark analysis (TMVR: 20.4%, M-TEER: 15.8%, p = 0.21). Compared to M-TEER, TMVR resulted in more effective mitral regurgitation (MR) reduction (residual MR ≤1+ at discharge for TMVR vs. M-TEER: 95.8% vs. 68.8%, p < 0.001), and superior symptomatic improvement (New York Heart Association class ≤II at 1 year: 77.8% vs. 64.3%, p = 0.015). CONCLUSION: In this PS-matched comparison between TMVR and M-TEER in patients with severe SMR, TMVR was associated with superior reduction of MR and superior symptomatic improvement. While post-procedural mortality tended to be higher after TMVR, no significant differences in mortality were found beyond 30 days.

Impact of the use of cusp-overlap projection on the incidence of permanent pacemaker implantation post-transcatheter aortic valve implantation with self-expanding valves.

INTRODUCTION: Current rates of permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) range between 3.4% and 25.9%. PPMI is associated with a worse prognosis. A lower valve implantation depth is associated with an increased risk of conduction disturbances. Theoretically, cusp-overlap projection (COP) has the potential to enable higher valve deployment. OBJECTIVE: To compare the 30-day PPMI incidence post-TAVI using self-expanding valves according to the fluoroscopic guidance technique. METHODS: This retrospective single-center study assessed consecutive patients undergoing TAVI with CoreValve™ valves between April 2019 and November 2021, grouped according to the fluoroscopic guidance technique (COP vs. coplanar implantation technique [CIT]). RESULTS: A total of 122 patients were included, predominantly women (52.5%), with a mean age of 81.6±5.5 years. COP was used in 49.2% of the sample. The CIT group had a significantly higher prevalence of previous beta-blocker use (p<0.01), lower baseline left ventricular ejection fraction (p=0.04) and a higher EuroSCORE II (p=0.02). The 30-day PPMI rate was 27.9% (n=34), with no significant difference between the COP and CIT groups (26.7% vs. 29.0%, p=0.77). Complete atrioventricular block was the main cause (38.5%). Likewise, mean fluoroscopy time (p=0.14) and contrast volume (p=0.35) used were similar between the two groups. Radiation dose was lower in the COP group (p=0.02). There was no significant difference between post-TAVI grades III and IV aortic valve regurgitation (p=0.27) and there were no cases of periprocedural acute coronary occlusion. CONCLUSIONS: This study shows that the COP technique, although safe and not associated with increased complexity, did not significantly reduce the 30-day PPMI rate compared to the traditional CIT view.

Coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement: Feasibility in clinical practice.

INTRODUCTION AND OBJECTIVE: Coronary artery disease is highly prevalent among patients with severe aortic stenosis who undergo transcatheter aortic valve replacement (TAVR). As indications for TAVR are now expanding to younger and lower-risk patients, the need for coronary angiography (CA) and percutaneous coronary intervention (PCI) during their lifetime is expected to increase. The objective of our study was to assess the need for CA and the feasibility of re-engaging the coronary ostia after TAVR. METHODS: We performed a retrospective analysis of 853 consecutive patients undergoing TAVR between August 2007 and December 2020. Patients who needed CA after TAVR were selected. The primary endpoint was the rate of successful coronary ostia cannulation after TAVR. RESULTS: Of a total of 31 CAs in 28 patients (3.5% of 810 patients analyzed: 57% male, age 77.8±7.0 years) performed after TAVR, 28 (90%) met the primary endpoint and in three cannulation was semi-selective. All failed selective coronary ostia cannulations occurred in patients with a self-expanding valve. Sixteen (52%) also had indication for PCI, which was successfully performed in all. The main indication for CA was non-ST-elevation acute coronary syndrome (35%, n=11). Two cases of primary PCI occurred without delay. There were no complications reported during or after the procedure. CONCLUSION: Although CA was rarely needed in patients after TAVR, selective diagnostic CA was possible in the overwhelming majority of patients. PCI was performed successfully in all cases, without complications.

Staging Heart Failure Patients With Secondary Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair.

BACKGROUND: Secondary mitral regurgitation (SMR) is a progressive disease with characteristic pathophysiological changes that may influence prognosis. Although the staging of SMR patients suffering from heart failure with reduced ejection fraction (HFrEF) according to extramitral cardiac involvement has prognostic value in medically treated patients, such data are so far lacking for edge-to-edge mitral valve repair (M-TEER). OBJECTIVES: This study sought to classify M-TEER patients into disease stages based on the phenotype of extramitral cardiac involvement and to assess its impact on symptomatic and survival outcomes. METHODS: Based on echocardiographic and clinical assessment, patients were assigned to 1 of the following HFrEF-SMR groups: left ventricular involvement (Stage 1), left atrial involvement (Stage 2), right ventricular volume/pressure overload (Stage 3), or biventricular failure (Stage 4). A Cox regression model was implemented to investigate the impact of HFrEF-SMR stages on 2-year all-cause mortality. The symptomatic outcome was assessed with New York Heart Association functional class at follow-up. RESULTS: Among a total of 849 eligible patients who underwent M-TEER for relevant SMR from 2008 until 2019, 9.5% (n = 81) presented with left ventricular involvement, 46% (n = 393) with left atrial involvement, 15% (n = 129) with right ventricular pressure/volume overload, and 29% (n = 246) with biventricular failure. An increase in HFrEF-SMR stage was associated with increased 2-year all-cause mortality after M-TEER (HR: 1.39; CI: 1.23-1.58; P < 0.01). Furthermore, higher HFrEF-SMR stages were associated with significantly less symptomatic improvement at follow-up. CONCLUSIONS: The classification of M-TEER patients into HFrEF-SMR stages according to extramitral cardiac involvement provides prognostic value in terms of postinterventional survival and symptomatic improvement.

Experiencia ibérica con PASCAL para la reparación percutánea borde a borde en insuficiencia mitral / Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation

Introducción y objetivos: PASCAL es un dispositivo novedoso de terapia mitral transcatéter basada en la reparación borde a borde. Algunas características únicas podrían tener un impacto relevante en sus resultados. Hay pocos datos sobre los resultados clínicos en registros de la vida real. El objetivo de este estudio es publicar la experiencia ibérica precoz (centros de España y Portugal) del sistema PASCAL. Métodos: Se incluyó prospectivamente a los pacientes tratados consecutivamente de insuficiencia mitral (IM) grave sintomática en 10 centros. El objetivo primario de eficacia fue el éxito técnico y el grado de regurgitación al alta. El objetivo primario de seguridad fueron los eventos adversos mayores (MAE) a 30 días. Resultados: Se incluyó a 68 pacientes (75 [68-81] años, 38% mujeres, EuroSCORE II 4,5%). La IM fue degenerativa en el 25% de los casos, funcional en el 65%, y mixta en el 10%. El 71% de pacientes estaban en clase funcional New York Heart Association (NYHA)≥III. El éxito técnico fue del 96% y la captura independiente se usó en el 73% de los procedimientos. Toda la población tratada obtuvo una IM al alta≤2+ (100%) y no hubo muertes intrahospitalarias. A los 30 días, los MAE fueron del 5,9%, la mortalidad global del 1,6%, el 98% estuvieron en clase NYHA≤II y el 95% tuvieron IM≤2+ (p <0,001). Conclusiones: El sistema PASCAL de terapia transcatéter mitral fue efectivo y seguro, con elevado éxito técnico y baja tasa de MAE. A los 30 días la IM se redujo significativamente, y hubo una mejoría en la clase funcional.(AU)

Introduction and objectives: The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Methods: Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. Results: We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). Conclusions: Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.(AU)

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation.

INTRODUCTION AND OBJECTIVES: The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. METHODS: Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. RESULTS: We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). CONCLUSIONS: Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.

Sex-specific impact of anthropometric parameters on outcomes after transcatheter edge-to-edge repair for secondary mitral regurgitation.

BACKGROUND: Body surface area (BSA) has been reported to be the stronger predictor for prognosis than body mass index in heart failure (HF) patients. The sex-specific association of BSA with mortality has been unclear. METHODS: EuroSMR, a European multicenter registry, included patients who underwent edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR). The outcome was two-year all-cause mortality. RESULTS: The present cohort included 1594 HF patients (age, 74 ± 10 years; male, 66%). Association of calculated BSA with two-year all-cause mortality was evaluated. Patients were classified into three BSA groups: the lowest 10% (S), the highest 10% (L), and intermediate between S and L (M). Mean BSA was 1.87 ± 0.21 m2 (male, 1.94 ± 0.18 m2; female, 1.73 ± 0.18 m2). The association of BSA with the endpoint in females showed a U-shaped curve, indicating worse prognosis for both S and L. The association in males followed a linear regression, demonstrating better prognosis for L. Hazard ratio (HR) of L to S in males was 0.43 (95% confidence interval [CI], 0.25-0.74; p = 0.002), whereas HR of L to M in females was 1.76 (95% CI, 1.11-2.78; p = 0.016) (p for interaction = 0.003). CONCLUSIONS: Sex-specific association patterns demonstrate the complex influence of anthropomorphic factors in HF patients scheduled for TEER. Further investigation beyond simple evaluation of weight and height is needed for better comprehension of the obesity paradox and better prediction of the results of transcatheter therapy in HF patients.

Rescue percutaneous repair of ischemic acute severe mitral regurgitation.

Acute severe mitral regurgitation (MR) because of secondary left ventricular impaired regional contractility can present with severe acute heart failure, associated with a high risk for rapid decompensation, pulmonary edema and cardiogenic shock. Frequently, in these highly unstable patients, surgical risk can be prohibitive. Evidence for percutaneous repair of acute MR is scarce, but a few case series show that this approach could be safe and effective for bailing out hemodynamically unstable patients. We report a case of an 84-year-old man with acute ischemic severe MR post-acute myocardial infarction (MI), who remained hemodynamically unstable despite coronary revascularization, positive pressure non-invasive ventilation, vasodilator therapy and intra-aortic balloon pump (IABP) support. In heart team discussions, he was considered a high risk surgical candidate. We decided on rescue off-label percutaneous mitral valve repair with a MitraClip device (Abbott Vascular, Santa Clara, California), with good clinical result, allowing weaning from the supports and discharge seven days after the procedure. At one-year follow-up, the patient maintained a MV repair results and had a good functional status. In unstable patients with acute ischemic MR, percutaneous MV repair could be a rescue therapeutic option to consider, allowing hemodynamic compensation with potential persistent MR improvement up to one-year follow-up.

Guideline-directed medical therapy in patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation.

AIMS: Guideline-directed medical therapy (GDMT), based on the combination of beta-blockers (BB), renin-angiotensin system inhibitors (RASI), and mineralocorticoid receptor antagonists (MRA), is known to have a major impact on the outcome of patients with heart failure with reduced ejection fraction (HFrEF). Although GDMT is recommended prior to mitral valve transcatheter edge-to-edge repair (M-TEER), not all patients tolerate it. We studied the association of GDMT prescription with survival in HFrEF patients undergoing M-TEER for secondary mitral regurgitation (SMR). METHODS AND RESULTS: EuroSMR, a European multicentre registry, included SMR patients with left ventricular ejection fraction <50%. The outcome was 2-year all-cause mortality. Of 1344 patients, BB, RASI, and MRA were prescribed in 1169 (87%), 1012 (75%), and 765 (57%) patients at the time of M-TEER, respectively. Triple GDMT prescription was associated with a lower 2-year all-cause mortality compared to non-triple GDMT (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.60-0.91). The association persisted in patients with glomerular filtration rate <30 ml/min, ischaemic aetiology, or right ventricular dysfunction. Further, a positive impact of triple GDMT prescription on survival was observed in patients with residual mitral regurgitation of ≥2+ (HR 0.62; 95% CI 0.44-0.86), but not in patients with residual mitral regurgitation of ≤1+ (HR 0.83; 95% CI 0.64-1.08). CONCLUSION: Triple GDMT prescription is associated with higher 2-year survival after M-TEER in HFrEF patients with SMR. This association was consistent also in patients with major comorbidities or non-optimal results after M-TEER.

Transcatheter Mitral Valve Repair in Patients With Atrial Functional Mitral Regurgitation.

BACKGROUND: Among patients with severe functional mitral regurgitation (FMR), atrial functional mitral regurgitation (aFMR) represents an underrecognized entity. Data regarding outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) in aFMR remain scarce. OBJECTIVES: The objective of this study was to analyze the outcome of aFMR patients undergoing M-TEER. METHODS: Using patients from the international EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry undergoing M-TEER for FMR, the authors analyzed baseline characteristics and 2-year outcomes in aFMR in comparison to non-aFMR and ventricular FMR. Additionally, the impact of right ventricular dysfunction (RVD) (defined as right ventricular to pulmonary artery uncoupling) on outcome after M-TEER was assessed. RESULTS: Among 1,608 FMR patients treated by M-TEER, 126 (7.8%) were categorized as aFMR. All 126 aFMR patients had preserved left ventricular function without regional wall motion abnormalities, left arterial dilatation and Carpentier leaflet motion type I. Procedural success (defined as mitral regurgitation ≤2+ at discharge) was 87.2% (P < 0.001) and New York Heart Association (NYHA) functional class significantly improved during follow-up (NYHA functional class III/IV: 86.5% at baseline to 36.6% at follow-up; P < 0.001). The estimated 2-year survival rate in aFMR patients was 70.4%. Two-year survival did not differ significantly between aFMR, non-aFMR, and ventricular FMR. Besides NYHA functional class IV, RVD was identified as a strong independent predictor for 2-year survival (HR: 2.82 [95% CI: 1.24-6.45]; P = 0.014). CONCLUSIONS: aFMR is a frequent cause of FMR and can be effectively treated with M-TEER to improve symptoms at follow-up. Advanced heart failure symptoms and RVD were identified as important risk factors for survival in aFMR patients.

Left atrial volume index and outcome after transcatheter edge-to-edge valve repair for secondary mitral regurgitation.

AIMS: To investigate the role of left atrial volume index (LAVi) in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (TEER). METHODS AND RESULTS: Outcomes were evaluated in SMR patients of a European multicentre registry according to baseline LAVi. Main analysis was performed for all-cause mortality; residual mitral regurgitation (MR) and New York Heart Association (NYHA) class improvement were analysed for patients available. A total of 1074 patients were included with a median LAVi (interquartile range) of 58 ml/m2 (46-73). Postprocedural reduction of MR grade to ≤2+ was similar across LAVi quintiles, ranging 91%-96% (p = 0.26). Symptomatic benefit (≥1 NYHA class improvement) also did not differ by LAVi quintiles (61%-68% of patients) (p = 0.66). The risk of mortality increased by 23%-42% in the four upper quintiles compared to the bottom quintile (LAVi <42 ml/m2 ). The hazard ratio (HR) of mortality was 1.35 (95% confidence interval [CI] 1.02-1.78, p = 0.035) associated with a LAVi >42 ml/m2 , which was attenuated after multivariable adjustment (HR 1.18, 95% CI 0.83-1.67, p = 0.36). A significant interaction was found for MR severity and pulmonary hypertension, with an increased risk of death associated with enlarged LAVi in patients with inframedian effective regurgitant orifice area (HR 1.99, 95% CI 1.06-3.74, p = 0.032) and in patients with systolic pulmonary pressure ≤50 mmHg (HR 1.67, 95% CI 1.02-2.75, p = 0.042) in multivariable analysis. CONCLUSION: Procedural success and symptomatic benefit were high throughout the whole range of LAVi. The prognostic impact of left atrial enlargement was relevant in patients with less severe SMR and without pulmonary hypertension, reinforcing the need to identify patients in the early course of backward congestion to achieve good long-term outcome after TEER.

Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair.

BACKGROUND: Although mitral valve transcatheter edge-to-edge repair (M-TEER) achieves symptomatic benefit for a broad spectrum of patients with relevant secondary mitral regurgitation, conflicting data exist on its prognostic impact. OBJECTIVES: Adapted enrollment criteria approaching those used in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and MITRA-FR (Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation) trials were retrospectively applied to a European real-world registry to evaluate the influence of the respective criteria on outcomes. METHODS: A total of 1,022 patients included in the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry and treated with M-TEER (November 2008 to September 2019) were stratified into COAPT-eligible (n = 353 [34.5%]) and COAPT-ineligible (n = 669 [65.5%]) as well as MITRA-FR-eligible (n = 408 [48.3%]) and MITRA-FR-ineligible (n = 437 [51.7%]) groups. RESULTS: Although the stratification of patients according to adapted MITRA-FR criteria led to comparable outcomes regarding all-cause mortality (P = 0.19), the application of adapted COAPT enrollment criteria demonstrated lower mortality rates in COAPT-eligible compared with COAPT-ineligible patients (P < 0.001). Multivariable Cox regression analysis identified New York Heart Association functional class IV (hazard ratio [HR]: 2.29; 95% confidence interval [CI]: 1.53-3.42; P < 0.001), logarithmic N-terminal pro-brain natriuretic peptide (HR: 1.47; 95% CI: 1.24-1.75; P < 0.001), and right ventricular-to-pulmonary arterial coupling (HR: 0.10; 95% CI: 0.02-0.57; P = 0.009) as independent predictors of outcome. Yet improvement of functional outcome was demonstrated in a subset of patients irrespective of COAPT eligibility status. CONCLUSIONS: In this real-world cohort of patients with secondary mitral regurgitation undergoing M-TEER, the retrospective application of adapted COAPT enrollment criteria successfully identified a specific phenotype demonstrating lower mortality rates. On the contrary, stratification according to adapted MITRA-FR criteria resulted in comparable outcomes.