RESUMEN
Background: Transcatheter mitral valve replacement (TMVR) represents a novel treatment option for patients with mitral regurgitation (MR), but little is known about the hemodynamic impact of MR elimination following TMVR. We sought to investigate the hemodynamic impact of TMVR on left ventricular (LV) and right ventricular (RV) function using noninvasive pressure-volume loops. Methods: All consecutive patients undergoing TMVR with dedicated devices between May 2016 and August 2022 were enrolled. The end-diastolic and end-systolic pressure-volume relationships were estimated from 26 patients using single-beat echocardiographic measurements at baseline and after TMVR at discharge. RV function was assessed by RV-pulmonary artery (PA) coupling and RV fractional area change. One-year follow-up was available for 19 patients. The prognostic impact of calculated end-diastolic volume at an end-diastolic pressure of 20 mmHg (VPed20) reduction was assessed by Cox regression. Results: A total of 26 patients (77.0 years [interquartile range 73.9-80.1], N = 17 [65.4%] male) with successful TMVR were included (secondary MR [N = 21, 80.8%]; median LV ejection fraction was 37.0% [interquartile range 30.7-50.7]). At discharge, a decrease in VPed20 (p < 0.001) indicating leftward shift of end-diastolic pressure-volume relationship, and an increase of the end-systolic elastance slope (p = 0.007) were observed after TMVR. No changes were observed for RV-PA coupling (p = 0.19) and RV fractional area change (p = 0.22). At 1-year follow-up, LV contractility (end-systolic elastance) and RV-PA coupling remained stable. Vped20 reduction at discharge was significantly associated with 1-year all-cause mortality or heart failure hospitalization (hazard ratio 0.16, 95% CI 0.04-0.71, p = 0.016). Conclusions: Noninvasive assessment of pressure-volume loops demonstrated early LV reverse remodeling and improved LV contractility, while RV performance was preserved. These results indicate the potential prognostic impact of complete MR elimination after TMVR.
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BACKGROUND: The impact of intraprocedural results following transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation (MR) is controversial. OBJECTIVES: This study sought to investigate the prognostic impact of intraprocedural residual mitral regurgitation (rMR) and mean mitral valve gradient (MPG) in patients with primary MR undergoing TEER. METHODS: The PRIME-MR (Outcomes of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation) registry included consecutive patients with primary MR undergoing TEER from 2008 to 2022 at 27 international sites. Clinical outcomes were assessed according to intraprocedural rMR and mean MPG. Patients were categorized according to rMR (optimal result: ≤1+, suboptimal result: ≥2+) and MPG (low gradient: ≤5 mm Hg, high gradient: > 5 mm Hg). The prognostic impact of rMR and MPG was evaluated in a Cox regression analysis. The primary endpoint was 2-year all-cause mortality or heart failure hospitalization. RESULTS: Intraprocedural rMR and mean MPG were available in 1,509 patients (median age = 82 years [Q1-Q3: 76.0-86.0 years], 55.1% male). Kaplan-Meier analysis according to rMR severity showed significant differences for the primary endpoint between rMR ≤1+ (29.1%), 2+ (41.7%), and ≥3+ (58.0%; P < 0.001), whereas there was no difference between patients with a low (32.4%) and high gradient (42.1%; P = 0.12). An optimal result/low gradient was achieved in most patients (n = 1,039). The worst outcomes were observed in patients with a suboptimal result/high gradient. After adjustment, rMR ≥2+ was independently linked to the primary endpoint (HR: 1.87; 95% CI: 1.32-2.65; P < 0.001), whereas MPG >5 mm Hg was not (HR: 0.78; 95% CI: 0.47-1.31; P = 0.35). CONCLUSIONS: Intraprocedural rMR but not MPG independently predicted clinical outcomes following TEER for primary MR. When performing TEER in primary MR, optimal MR reduction seems to outweigh the impact of high transvalvular gradients.
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Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Hemodinámica , Insuficiencia de la Válvula Mitral , Válvula Mitral , Recuperación de la Función , Sistema de Registros , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Masculino , Femenino , Anciano , Resultado del Tratamiento , Válvula Mitral/cirugía , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Factores de Riesgo , Factores de Tiempo , Anciano de 80 o más Años , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/etiología , Medición de RiesgoRESUMEN
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.
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Cateterismo Cardíaco , Fármacos Cardiovasculares , Adhesión a Directriz , Insuficiencia de la Válvula Mitral , Guías de Práctica Clínica como Asunto , Sistema de Registros , Disfunción Ventricular Derecha , Función Ventricular Derecha , Humanos , Femenino , Masculino , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Anciano , Resultado del Tratamiento , Factores de Tiempo , Disfunción Ventricular Derecha/fisiopatología , Disfunción Ventricular Derecha/mortalidad , Disfunción Ventricular Derecha/etiología , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/terapia , Factores de Riesgo , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Fármacos Cardiovasculares/uso terapéutico , Fármacos Cardiovasculares/efectos adversos , Europa (Continente) , Anciano de 80 o más Años , Medición de Riesgo , Ecocardiografía Transesofágica , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Persona de Mediana Edad , Recuperación de la FunciónAsunto(s)
Cateterismo Cardíaco , Anuloplastia de la Válvula Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Válvula Tricúspide , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/efectos adversos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/lesiones , Vasos Coronarios/cirugía , Lesiones Cardíacas/etiología , Lesiones Cardíacas/diagnóstico por imagen , Lesiones Cardíacas/terapia , Lesiones Cardíacas/cirugía , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/etiología , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/cirugíaRESUMEN
AIMS: Data on the prognostic impact of residual tricuspid regurgitation (TR) after tricuspid transcatheter edge-to-edge repair (T-TEER) are scarce. The aim of this analysis was to evaluate 2-year survival and symptomatic outcomes of patients in relation to residual TR after T-TEER. METHODS AND RESULTS: Using the large European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR registry) we investigated the impact of residual TR on 2-year all-cause mortality and New York Heart Association (NYHA) functional class at follow-up. The study further identified predictors for residual TR ≥3+ using a logistic regression model. The study included a total of 1286 T-TEER patients (mean age 78.0 ± 8.9 years, 53.6% female). TR was successfully reduced to ≤1+ in 42.4%, 2+ in 40.0% and 3+ in 14.9% of patients at discharge, while 2.8% remained with TR ≥4+ after the procedure. Residual TR ≥3+ was an independent multivariable predictor of 2-year all-cause mortality (hazard ratio 2.06, 95% confidence interval 1.30-3.26, p = 0.002). The prevalence of residual TR ≥3+ was four times higher in patients with higher baseline TR (vena contracta >11.1 mm) and more severe tricuspid valve tenting (tenting area >1.92 cm2). Of note, no survival difference was observed in patients with residual TR ≤1+ versus 2+ (76.2% vs. 73.1%, p = 0.461). The rate of NYHA functional class ≥III at follow-up was significantly higher in patients with residual TR ≥3+ (52.4% vs. 40.5%, p < 0.001). Of note, the degree of TR reduction significantly correlated with the extent of symptomatic improvement (p = 0.012). CONCLUSIONS: T-TEER effectively reduced TR severity in the majority of patients. While residual TR ≥3+ was associated with worse outcomes, no differences were observed for residual TR 1+ versus 2+. Symptomatic improvement correlated with the degree of TR reduction.
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Cateterismo Cardíaco , Sistema de Registros , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/epidemiología , Femenino , Masculino , Anciano , Cateterismo Cardíaco/métodos , Válvula Tricúspide/cirugía , Europa (Continente)/epidemiología , Pronóstico , Resultado del Tratamiento , Anciano de 80 o más Años , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Tasa de Supervivencia/tendenciasRESUMEN
BACKGROUND: According to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion. OBJECTIVES: The aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients. METHODS: Clinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance. RESULTS: Of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤2+ at discharge, 82% vs 85%; survival, 85% vs 75%; HFH, 14% vs 22% for eligible vs ineligible patients). CONCLUSIONS: The observed differences in survival and HFH outcomes suggest a limited generalizability of TRILUMINATE to real-world conditions and indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.
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Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Insuficiencia de la Válvula Tricúspide , Humanos , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Calidad de Vida , Resultado del Tratamiento , Determinación de la Elegibilidad , Insuficiencia Cardíaca/terapia , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Cateterismo Cardíaco/efectos adversosRESUMEN
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.
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Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Volumen Sistólico , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/complicacionesRESUMEN
BACKGROUND: Leaflet morphology has been associated with treatment success in edge-to-edge repair of tricuspid regurgitation (TR), but the impact on annuloplasty is unclear. OBJECTIVES: The authors sought to examine the association of leaflet morphology with efficacy and safety of direct annuloplasty in TR. METHODS: The authors analyzed patients who underwent catheter-based direct annuloplasty with the Cardioband at 3 centers. Leaflet morphology was assessed according to number and location of leaflets by echocardiography. Patients with simple morphology (2 or 3 leaflets) were compared with complex morphology (>3 leaflets). RESULTS: The study included 120 patients (median age 80 years) with ≥severe TR. A total of 48.3% of patients had a 3-leaflet morphology, 5% a 2-leaflet morphology, and 46.7% had >3 tricuspid leaflets. Baseline characteristics did not differ relevantly between groups except for a higher incidence of torrential TR grade (50 vs 26.6%) in complex morphologies. Postprocedural improvement of 1 (90.6% vs 92.9%) and 2 (71.9% vs 67.9%) TR grades was not significantly different between groups, but patients with complex morphology had more often residual TR ≥3 at discharge (48.2 vs 26.6%; P = 0.014). This difference did not remain significant (P = 0.112) after adjusting for baseline TR severity, coaptation gap, and nonanterior jet localization. Safety endpoints including complications of the right coronary artery, and technical success did not show significant differences. CONCLUSIONS: Efficacy and safety of transcatheter direct annuloplasty using Cardioband are not affected by leaflet morphology. Assessment of leaflet morphology should be part of procedural planning in patients with TR and might help to individually tailor repair techniques to patient anatomy.
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Insuficiencia de la Válvula Tricúspide , Humanos , Anciano de 80 o más Años , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/etiología , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Válvula Mitral/cirugía , Ecocardiografía/efectos adversosRESUMEN
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.
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Fibrilación Atrial , Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/etiología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Resultado del Tratamiento , Volumen SistólicoRESUMEN
AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.
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Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Masculino , Humanos , Femenino , Válvula Tricúspide/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Resultado del Tratamiento , Sistema de Registros , Insuficiencia Cardíaca/complicacionesAsunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Función del Atrio Izquierdo , Cateterismo Cardíaco/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
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.
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Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
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.
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Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Hipertensión Pulmonar , Insuficiencia de la Válvula Mitral , Atrios Cardíacos/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Hipertensión Pulmonar/etiología , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to investigate the adverse impact of elevated postprocedural mitral valve pressure gradient (MPG) on outcome in a real-world population of patients with severe mitral regurgitation (MR) who underwent transcatheter mitral valve edge-to-edge repair (TEER). BACKGROUND: TEER has become a routine treatment alternative for patients with severe MR at high surgical risk. The consequences of elevated MPG after TEER have been subject to controversial debates. METHODS: All consecutive patients undergoing TEER for either severe degenerative MR (DMR) or functional MR (FMR) at a high-volume center between September 2008 and January 2020 were prospectively included and followed periodically. Postprocedural MPG by discharge transthoracic echocardiography was considered elevated at ≥5 mm Hg. The primary combined endpoint was death or heart failure rehospitalization after 5 years. RESULTS: A total of 713 patients undergoing TEER (DMR, n = 265; FMR, n = 445) were included. Elevated postprocedural MPG was present in 37.0% of those with DMR (n = 98) and 22.0% of those with FMR (n = 98). In contrast to patients with FMR, 6-minute walk distance did not improve in patients with DMR with elevated MPG. Kaplan-Meier analyses did not demonstrate significant differences for the primary endpoint in patients with DMR (low vs elevated MPG, 67.3% vs 74.4%; P = 0.06) and those with FMR (78.6% vs 74.8%; P = 0.54). After adjustment, elevated MPG was an independent predictor of the primary endpoint in patients with DMR (HR: 1.59; 95% CI: 1.03-2.45; P = 0.034) but not in those with FMR (HR: 0.87; 95% CI: 0.63-1.22; P = 0.43). CONCLUSIONS: Elevated postprocedural MPG is an independent predictor of adverse clinical and functional outcomes in patients with DMR but not in those with FMR.
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Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Ecocardiografía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter mitral valve implantation (TMVI) represents a novel treatment alternative for patients with severe mitral regurgitation (MR) considered ineligible for standard therapies. Data on the management of patients after TMVI screening are scarce. AIMS: We aimed to investigate outcomes of patients with severe MR undergoing TMVI evaluation treated with either TMVI, bailout-transcatheter edge-to-edge repair (bailout-TEER) or medical therapy (MT). METHODS: Between May 2016 and February 2021, 121 patients with MR considered ineligible for standard therapy were screened for TMVI. Outcomes were assessed for the subgroups of patients treated with TMVI, bailout-TEER and MT. The primary composite endpoint was all-cause death or heart failure hospitalisation after one year. RESULTS: The subgroups of TMVI (N=38), bailout-TEER (N=28) and MT (N=44) differed significantly with regard to MR aetiology (secondary MR: TMVI 68.4%, bailout-TEER 39.3%, MT 38.6%, p=0.014) and left ventricular ejection fraction (TMVI 37.0% [31.4-51.2], bailout-TEER 48.0% [35.3-58.3], MT 54.5% [40.8-60.0], p<0.001). At discharge and after one year, MR was reduced to ≤mild residual MR in all patients undergoing TMVI, while ≥moderate residual MR was present in 25.9% and 20.0% of patients, respectively, after bailout-TEER, and in 100.0% of patients on MT at one year. The primary endpoint occurred in 72.2% of patients remaining on MT, in 51.6% of patients undergoing TMVI and in 40.2% of those receiving bailout-TEER. CONCLUSIONS: In MR patients considered ineligible for standard therapy, TMVI provided acceptable clinical outcomes and MR elimination in the majority of patients. In screen-failed patients, bailout-TEER represented a reasonable alternative while MT was associated with poor outcomes.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
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.
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Adaptación Fisiológica , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Evaluación de Resultado en la Atención de Salud/métodos , Sistema de Registros , Anciano , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/fisiopatología , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia/tendenciasRESUMEN
Mitral regurgitation (MR) is the most common valvular disease. With a rising incidence in older age, the prevalence of relevant comorbidities inevitably increases. Considering the constantly aging population with high surgical risk, transcatheter therapy of MR is gaining increasing importance. Interventional therapy of either primary or secondary MR represents an alternative to pure drug or surgical therapy. With mitral valve transcatheter edge-to-edge repair, a well-established treatment has evolved in the past two decades. In addition, direct or indirect annuloplasty and ultimately transcatheter mitral valve implantation further expand the armamentarium. The current broad spectrum of interventional therapy options allows for patient-oriented therapy individually targeting different MR pathologies. This review discusses the current landscape of transcatheter therapies for relevant MR.
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Implantación de Prótesis de Válvulas Cardíacas , Anuloplastia de la Válvula Mitral , Insuficiencia de la Válvula Mitral , Anciano , Válvula Aórtica , Cateterismo Cardíaco , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVES: Due to high rates of transcatheter mitral valve replacement (TMVR) screening failure, a substantial proportion of patients with severe mitral regurgitation (MR) remains on optimal medical treatment (OMT) only. Data on outcomes of these patients ineligible for mitral interventions are scarce. This study aimed to assess characteristics and outcomes of severe MR patients treated medically following TMVR screening failure. METHODS: From 2016-2020, a total of 111 patients with severe MR underwent screening for TMVR. Screening failure occurred in 66 cases. Among these, 30 patients were treated with OMT only. Characteristics of these patients were analyzed, Kaplan-Meier estimates calculated, and univariate regression analysis performed. Median follow-up time was 2.26 years (95% confidence interval, 1.24-3.25). RESULTS: Anatomical reasons for screening failure in the study cohort (n = 30) were left ventricular (LV) restraints, risk of LV outflow tract obstruction, mitral annulus calcification, and sizing issues. Median ejection fraction was 56.0% (interquartile range, 38.8%-60.0%). Concomitant tricuspid regurgitation and severe pulmonary hypertension were present in 36.7% and 46.2%, respectively. Intercommissural diameters ranged from 22.5-52.0 mm. Mortality was 23.6% after 6 months and 35.7% after 1 year. Factors associated with mortality were female sex, MR severity, ischemic MR, high N-terminal pro-brain natriuretic peptide levels, and small annulus diameters. CONCLUSIONS: Despite growing experience with TMVR, the subset of MR patients anatomically eligible for TMVR is small and many patients are treated medically. Mortality in these patients remains high, underlining an unmet need for adequate therapeutic alternatives. TMVR devices adapting to broader annular size ranges with smaller ventricular profiles might fill this gap.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
AIMS: The aim of this study was to assess the prognostic value of the H2 FPEF score in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF). METHODS AND RESULTS: In this multicentre study, a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H2 FPEF score. Patients were dichotomized according to low (0-5 points; n = 570) and high (6-9 points; n = 262) H2 FPEF scores. Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H2 FPEF score. We observed a decrease in stroke volume index (-2.04 mL/m2 /point) and mean transvalvular gradients (-1.14 mmHg/point) with increasing H2 FPEF score translating into a higher prevalence of paradoxical low-flow, low-gradient AS among patients with high H2 FPEF score. One year after TAVI, the rates of all-cause (low vs. high H2 FPEF score: 8.0% vs. 19.4%, P < 0.0001) and cardiovascular (CV) mortality (1.9% vs. 9.0%, P < 0.0001) as well as the rate of CV mortality or rehospitalization for congestive heart failure (6.4% vs. 23.2%, P < 0.0001) were higher in patients with high H2 FPEF score compared with those with low H2 FPEF score. After multivariable analysis, a high H2 FPEF score remained independently predictive of all-cause mortality [hazard ratio 1.59 (1.28-2.35), P = 0.018] and CV mortality or rehospitalization for congestive heart failure [hazard ratio 2.92 (1.65-5.15), P < 0.001]. Among the H2 FPEF score variables, atrial fibrillation, pulmonary hypertension, and elevated left ventricular filling pressure were the strongest outcome predictors. CONCLUSIONS: The H2 FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H2 FPEF score is associated with the presence of paradoxical low-flow, low-gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H2 FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI.
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Estenosis de la Válvula Aórtica , Insuficiencia Cardíaca , Reemplazo de la Válvula Aórtica Transcatéter , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Insuficiencia Cardíaca/epidemiología , Humanos , Pronóstico , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
Protocols for "Enhanced recovery after surgery (ERAS)" are on the rise in different surgical disciplines and represent one of the most important recent advancements in perioperative medical care. In cardiac surgery, only few ERAS protocols have been described in the past. At University Heart Center Hamburg, Germany, we invented an ERAS protocol for patients undergoing minimally invasive cardiac valve surgery. In this retrospective single center study, we aimed to describe the implementation of our ERAS program and to evaluate the results of the first 50 consecutive patients. Our ERAS protocol was developed according to a modified Kern cycle by an expert group, literature search, protocol creation and pilot implementation in the clinical practice. Data of the first 50 consecutive patients undergoing minimally invasive cardiac valve surgery were analysed retrospectively. The key features of our multidisciplinary ERAS protocol are physiotherapeutic prehabilitation, minimally invasive valve surgery techniques, modified cardiopulmonary bypass management, fast-track anaesthesia with on- table extubation and early mobilisation. A total of 50 consecutive patients (mean age of 51.9±11.9 years, mean STS score of 0.6±0.3) underwent minimally-invasive mitral or aortic valve surgery. The adherence to the ERAS protocol was high and neither protocol related complications nor in-hospital mortality occurred. 12% of the patients developed postoperative atrial fibrillation, postoperative delirium emerged in two patients and reintubation was required in one patient. Intensive care unit stay was 14.0±7.4 hours and total hospital stay 6.2±2.9 days. Our ERAS protocol is feasible and safe in minimally-invasive cardiac surgery setting and has a clear potential to improve patients outcome.