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BACKGROUND: Type 2 diabetes (T2D) is a frequent comorbidity encountered in patients with severe aortic stenosis (AS), leading to an adverse left ventricular (LV) remodeling and dysfunction. Metabolic alterations have been suggested as contributors of the deleterious effect of T2D on LV remodeling and function in patients with severe AS, but so far, the underlying mechanisms remain unclear. Mitochondria play a central role in the regulation of cardiac energy metabolism. OBJECTIVES: We aimed to explore the mitochondrial alterations associated with the deleterious effect of T2D on LV remodeling and function in patients with AS, preserved ejection fraction, and no additional heart disease. METHODS: We combined an in-depth clinical, biological and echocardiography phenotype of patients with severe AS, with (n = 34) or without (n = 50) T2D, referred for a valve replacement, with transcriptomic and histological analyses of an intra-operative myocardial LV biopsy. RESULTS: T2D patients had similar AS severity but displayed worse cardiac remodeling, systolic and diastolic function than non-diabetics. RNAseq analysis identified 1029 significantly differentially expressed genes. Functional enrichment analysis revealed several T2D-specific upregulated pathways despite comorbidity adjustment, gathering regulation of inflammation, extracellular matrix organization, endothelial function/angiogenesis, and adaptation to cardiac hypertrophy. Downregulated gene sets independently associated with T2D were related to mitochondrial respiratory chain organization/function and mitochondrial organization. Generation of causal networks suggested a reduced Ca2+ signaling up to the mitochondria, with the measured gene remodeling of the mitochondrial Ca2+ uniporter in favor of enhanced uptake. Histological analyses supported a greater cardiomyocyte hypertrophy and a decreased proximity between the mitochondrial VDAC porin and the reticular IP3-receptor in T2D. CONCLUSIONS: Our data support a crucial role for mitochondrial Ca2+ signaling in T2D-induced cardiac dysfunction in severe AS patients, from a structural reticulum-mitochondria Ca2+ uncoupling to a mitochondrial gene remodeling. Thus, our findings open a new therapeutic avenue to be tested in animal models and further human cardiac biopsies in order to propose new treatments for T2D patients suffering from AS. TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov ; Unique Identifier: NCT01862237.
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Estenosis de la Válvula Aórtica , Señalización del Calcio , Diabetes Mellitus Tipo 2 , Perfilación de la Expresión Génica , Mitocondrias Cardíacas , Índice de Severidad de la Enfermedad , Transcriptoma , Función Ventricular Izquierda , Remodelación Ventricular , Humanos , Estenosis de la Válvula Aórtica/metabolismo , Estenosis de la Válvula Aórtica/genética , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/patología , Masculino , Mitocondrias Cardíacas/metabolismo , Mitocondrias Cardíacas/patología , Femenino , Anciano , Diabetes Mellitus Tipo 2/genética , Diabetes Mellitus Tipo 2/metabolismo , Diabetes Mellitus Tipo 2/complicaciones , Persona de Mediana Edad , Anciano de 80 o más Años , Disfunción Ventricular Izquierda/fisiopatología , Disfunción Ventricular Izquierda/genética , Disfunción Ventricular Izquierda/metabolismo , Disfunción Ventricular Izquierda/diagnóstico por imagenRESUMEN
OBJECTIVES: Left atrial appendage occlusion during cardiac surgery is a therapeutic option for stroke prevention in patients with atrial fibrillation. The effectiveness and safety of left atrial appendage occlusion have been evaluated in several studies, including the LAAOS-III trial. While these studies have demonstrated efficacy and safety, the long-term economic impact of this surgical technique has not yet been assessed. Here, we aimed to evaluate the cost-effectiveness and cost-utility of left atrial appendage occlusion during cardiac surgery over a long-term time horizon. METHODS: Our study was based on a model representing an hypothetical cohort with the same characteristics as LAAOS-III trial patients. We modelled the incidence of ischemic strokes and systemic embolisms in each intervention arm: "occlusion" and "no-occlusion," using a one-month cycle length with a 20-year time horizon. Regarding occlusion devices, sutures, staples, or an approved surgical occlusion device (AtriClip™-AtriCure, Ohio, USA) could be used. RESULTS: Our model generated an average cost savings of 607 euros per patient and an incremental gain of 0.062 quality-adjusted life years (QALYs), resulting an incremental cost-utility ratio (ICUR) of -9,775/QALY. The scenario analysis in which occlusion was systematically performed using the AtriClip™ device generated an ICUR of 3,952/QALY gained. CONCLUSIONS: In the base-case analysis, the strategy proved to be more effective and less costly, confirming left atrial appendage occlusion during cardiac surgery as an economically dominant strategy. The scenario analysis also appeared cost-effective, although it did not result in cost savings. This study provides a new perspective on the assessment of the cost-effectiveness of these techniques.
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Apéndice Atrial , Fibrilación Atrial , Procedimientos Quirúrgicos Cardíacos , Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , Humanos , Apéndice Atrial/cirugía , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/economía , Procedimientos Quirúrgicos Cardíacos/métodos , Fibrilación Atrial/cirugía , Fibrilación Atrial/economía , Francia , Masculino , Femenino , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/economía , Accidente Cerebrovascular/etiología , AncianoRESUMEN
BACKGROUND AND AIMS: Mechanical complications (MCs) are rare but potentially fatal sequelae of acute myocardial infarction (AMI). Surgery, though challenging, is considered the treatment of choice. The authors sought to study early and long-term results of patients undergoing surgical treatment for post-AMI MCs. METHODS: Patients undergone surgical treatment for post-infarction MCs between 2001 through 2019 in 27 centers worldwide were retrieved from the database of CAUTION study. In-hospital and long-term mortality were the primary outcomes. Cox proportional hazards regression models were used to determine independent factors associated with overall mortality. RESULTS: The study included 720 patients. The median age was 70.0 [62.0-77.0] years, with a male predominance (64.6%). The most common MC encountered was ventricular septal rupture (VSR) (59.4%). Cardiogenic shock was seen on presentation in 56.1% of patients. In-hospital mortality rate was 37.4%; in more than 50% of cases, the cause of death was low cardiac output syndrome (LCOS). Late mortality occurred in 133 patients, with a median follow-up of 4.4 [1.0-8.6] years. Overall survival at 1, 5 and 10 years was 54.0%, 48.1% and 41.0%, respectively. Older age (p < 0.001) and postoperative LCOS (p < 0.001) were independent predictors of overall mortality. For hospital survivors, 10-year survival was 65.7% and was significant higher for patients with VSR than those with papillary muscle rupture (long-rank P = 0.022). CONCLUSIONS: Contemporary data from a multicenter cohort study show that surgical treatment for post-AMI MCs continues to be associated with high in-hospital mortality rates. However, long-term survival in patients surviving the immediate postoperative period is encouraging.Trial registration number: NCT03848429.
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BACKGROUND: Type A aortic dissection (TAAD) surgical management is still under debate. The purpose of this study was to demonstrate the feasibility and safety of the aortic valve-sparing root reconstruction (AVSR) procedure in 92 consecutive patients operated for TAAD, even when preoperative condition was severe (malperfusion, shock or both). METHODS: Our hospital database was reviewed to identify all patients who underwent an AVSR procedure for TAAD over 14 years. From May 2000 to June 2014, 92 consecutive patients were studied regarding to their preoperative condition. RESULTS: Age (61±13 years) and logistic Euroscore (23.4±15.3%) as well as cross-clamping (113±39 min), cardiopulmonary bypass (142±49 min) and circulatory arrest (22±13 min) times were collected. Hospital mortality was 16.3%. Mean follow-up was complete for a mean period of 27.6 months. One patient had early reoperation for aortic insufficiency. Actuarial survival at 1 year was 82.5%. The analysis of each group showed comparable mortality and morbidity in between patients. CONCLUSIONS: Based upon our experience in the management of TAAD, a reimplantation procedure could be performed regardless preoperative malperfusion or shock, with an acceptable postoperative over mortality or morbidity. A word of caution should be brought to patients over 70 years old.
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Aneurisma de la Aorta , Disección Aórtica , Insuficiencia de la Válvula Aórtica , Azidas , Desoxiglucosa/análogos & derivados , Humanos , Persona de Mediana Edad , Anciano , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/cirugía , Resultado del Tratamiento , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/cirugía , Reoperación , Reimplantación/efectos adversos , Contraindicaciones , Estudios RetrospectivosRESUMEN
BACKGROUND AND AIMS: Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563-0.832; P = .0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238-1.971; P = .0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835-1.118; P = .65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction. CONCLUSIONS: Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER.
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Fibrilación Atrial , Endocarditis , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Accidente Cerebrovascular , Humanos , Insuficiencia de la Válvula Mitral/epidemiología , Insuficiencia de la Válvula Mitral/cirugía , Accidente Cerebrovascular/epidemiología , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Bases de Datos Factuales , Resultado del TratamientoRESUMEN
BACKGROUND AND AIMS: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE. METHODS: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years. RESULTS: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively). CONCLUSIONS: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category.
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Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Resultado del Tratamiento , Cateterismo CardíacoRESUMEN
OBJECTIVES: Relevant paravalvular leakage (PVL) due to prosthesis dislodgement is a rare but potentially severe complication after transcatheter mitral valve implantation (TMVI). Due to the epicardial anchoring mechanism of the Tendyne® TMVI system, repositioning of the valve stent may be possible by retensioning of the tether. This multicentre study aimed to investigate the procedural and short-term safety as well as efficacy of retensioning manoeuvres. METHODS: From 2017 to 2021, N = 18 patients who underwent secondary tether retensioning were identified. Baseline, procedural and follow-up data were available from N = 11 patients and analysed according to the Mitral Valve Research Consortium definitions. Continuous variables are shown as median with interquartile range. RESULTS: All patients [age 75 years (73.5, 85.0), 64% male (N = 7), EuroSCORE II 6.2% (5.8, 11.6)] presented with post-procedural PVL [63.6% (N = 7) with PVL ≥3+]. Of these, 54% (N = 6) showed signs of haemolysis. The majority were severely symptomatic [New York Heart Association ≥III (91%, N = 10)]. Procedural outcomes revealed no acute complications and no mortality. At discharge, PVL was completely eliminated in 91% (N = 10) of patients with 1 case of remaining moderate PVL. At 30 days, Mitral Valve Research Consortium device success was achieved in 82% (N = 9) of patients. Two patients required open surgical mitral valve replacement due to persistent and recurrent PVL. In 89% (N = 8) of patients with successful retensioning procedure, New York Heart Association class was I/II. There was no 30-day mortality. CONCLUSIONS: This multicentre study demonstrates technical feasibility, procedural safety and acute efficacy of retensioning procedures in the majority of patients. The potential to retension the tether in transapical TMVI may provide additional management advantages in populations at high surgical risk.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Masculino , Anciano , Femenino , Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/cirugía , Resultado del Tratamiento , New York , Cateterismo Cardíaco/métodosRESUMEN
OBJECTIVES: Post-acute myocardial infarction mechanical complications (post-AMI MCs) represent rare but life-threatening conditions, including free-wall rupture, ventricular septal rupture and papillary muscle rupture. During the coronavirus disease-19 (COVID-19) pandemic, an overwhelming pressure on healthcare systems led to delayed and potentially suboptimal treatments for time-dependent conditions. As AMI-related hospitalizations decreased, limited information is available whether higher rates of post-AMI MCs and related deaths occurred in this setting. This study was aimed to assess how COVID-19 in Europe has impacted the incidence, treatment and outcome of MCs. METHODS: The CAUTION-COVID19 study is a multicentre retrospective study collecting 175 patients with post-AMI MCs in 18 centres from 6 European countries, aimed to compare the incidence of such events, related patients' characteristics, and outcomes, between the first year of pandemic and the 2 previous years. RESULTS: A non-significant increase in MCs was observed [odds ratio (OR) = 1.15, 95% confidence interval (CI) 0.85-1.57; P = 0.364], with stronger growth in ventricular septal rupture diagnoses (OR = 1.43, 95% CI 0.95-2.18; P = 0.090). No significant differences in treatment types and mortality were found between the 2 periods. In-hospital mortality was 50.9% and was higher for conservatively managed cases (90.9%) and lower for surgical patients (44.0%). Patients admitted during COVID-19 more frequently had late-presenting infarction (OR = 2.47, 95% CI 1.24-4.92; P = 0.010), more stable conditions (OR = 2.61, 95% CI 1.27-5.35; P = 0.009) and higher EuroSCORE II (OR = 1.04, 95% CI 1.01-1.06; P = 0.006). CONCLUSIONS: A non-significant increase in MCs incidence occurred during the first year of COVID-19, characterized by a significantly higher rate of late-presenting infarction, stable conditions and EuroSCORE-II if compared to pre-pandemic data, without affecting treatment and mortality.
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Aims: Many historical and recent reports showed that post-infarction ventricular septal rupture (VSR) represents a life-threatening condition and the strategy to optimally manage it remains undefined. Therefore, disparate treatment policies among different centres with variable results are often described. We analysed data from European centres to capture the current clinical practice in VSR management. Methods and results: Thirty-nine centres belonging to eight European countries participated in a survey, filling a digital form of 38 questions from April to October 2022, to collect information about all the aspects of VSR treatment. Most centres encounter 1-5 VSR cases/year. Surgery remains the treatment of choice over percutaneous closure (71.8% vs. 28.2%). A delayed repair represents the preferred approach (87.2%). Haemodynamic conditions influence the management in almost all centres, although some try to achieve patients stabilization and delayed surgery even in cardiogenic shock. Although 33.3% of centres do not perform coronarography in unstable patients, revascularization approaches are widely variable. Most centres adopt mechanical circulatory support (MCS), mostly extracorporeal membrane oxygenation, especially pre-operatively to stabilize patients and achieve delayed repair. Post-operatively, such MCS are more often adopted in patients with ventricular dysfunction. Conclusion: In real-life, delayed surgery, regardless of the haemodynamic conditions, is the preferred strategy for VSR management in Europe. Extracorporeal membrane oxygenation is becoming the most frequently adopted MCS as bridge-to-operation. This survey provides a useful background to develop dedicated, prospective studies to strengthen the current evidence on VSR treatment and to help improving its currently unsatisfactory outcomes.
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OBJECTIVES: To analyze the incidence, clinical impact on survival, and risk factors of lower limb ischemia (LLI) of surgical peripheral femoral venoarterial extracorporeal membrane oxygenation (VA ECMO) in the current era. DESIGN: A retrospective analysis of the authors' institutional database of VA ECMO was performed. Patients were divided into 2 groups according to the occurrence of LLI. The primary endpoint was survival to hospital discharge. Risk factors of LLI were searched with multivariate analyses. SETTING: University hospital. PARTICIPANTS: Adult patients receiving peripheral VA ECMO for refractory cardiogenic shock and cardiac arrest. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: From January 2018 to December 2021, 188 patients (mean age: 52.0 ± 14.1 years; 63.8% male, 36.2% female) received peripheral VA ECMO. Male sex was more prevalent in the group without LLI (65.9% v 33.3%; p = 0.031). Twelve (6.4%) patients developed LLI during VA ECMO support (n = 6) or after VA ECMO removal (n = 6). Survival to hospital discharge was not statistically different between patients with and without LLI (50.0% v 48.3%; p = 0.571). Female sex patients were at increased risk for LLI (odds ratio 4.38, 95% CI 1.21-15.81; p = 0.024). CONCLUSIONS: Peripheral femoral VA ECMO through a surgical approach is associated with a low LLI rate, which does not increase the risk of in-hospital mortality. The female sex is an independent risk factor for LLI.
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Oxigenación por Membrana Extracorpórea , Enfermedades Vasculares Periféricas , Adulto , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Oxigenación por Membrana Extracorpórea/efectos adversos , Estudios Retrospectivos , Choque Cardiogénico/cirugía , Factores de Riesgo , Isquemia/etiología , Isquemia/cirugíaRESUMEN
BACKGROUND: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). AIMS: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. METHODS: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality. RESULTS: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality. CONCLUSIONS: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Masculino , Anciano , Femenino , Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cateterismo Cardíaco/métodos , Resultado del Tratamiento , Factores de Riesgo , Sistema de RegistrosRESUMEN
BACKGROUND: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. METHODS: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. RESULTS: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P<0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P=0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P=0.03) and at 2 years (77.8% versus 53.2%; P=0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P=0.98). CONCLUSIONS: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT).
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Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Femenino , Humanos , Masculino , Cateterismo Cardíaco/efectos adversos , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/terapia , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Puntaje de Propensión , Resultado del TratamientoRESUMEN
OBJECTIVE: To review the survival modelling used in cost-effectiveness studies evaluating an interventional procedure and to discuss implications for decision-makers. DESIGN: A case study of three economic evaluations that each used immature data from the EVEREST II High Surgical Risk (HSR) Study of transcatheter edge-to-edge repair (TEER) for patients with severe mitral regurgitation (MR) who were at high risk of surgery. SETTING: Estimation of patient survival in cost-effectiveness studies. PARTICIPANTS: The EVEREST II HSR Study included 78 patients who had TEER of the mitral valve using the MitraClip device and a retrospectively identified control group of 36 patients who received medical management and were followed up for 12 months. Observed survival (TEER arm only) was updated at 5 years. RESULTS: Two studies used 12-month observed mortality from EVEREST II HSR to model survival over lifetime horizons. Observed and modelled survival were associated with considerable uncertainty due to short follow-up and small numbers of participants. Modelling control patients' survival required an approximate 10-fold extrapolation based on 12-month observation of only 38 patients. Observed 5-year survival in the TEER group differed from that less mature follow-up suggesting that survival modelling based on shorter follow-up was unsatisfactory. No public domain data for the control group are available beyond 12-month follow-up so meaningful estimates using mature data for both arms are currently not possible. A third study developed survival models using incompletely reported transitions between MR grades in EVEREST II HSR and mortality rates observed for different MR grades derived from a study in an unrelated population. CONCLUSIONS: Modelling survival in such small samples followed up for only 12 months is associated with great uncertainty, and cost-effectiveness results based on these analyses should be viewed as premature and used cautiously in reimbursement decisions.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Análisis Costo-Beneficio , Estudios Retrospectivos , Válvula Mitral/cirugía , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cateterismo CardíacoRESUMEN
BACKGROUND: We aimed to analyze the impact of timing of implantation (strategy-outcome relationship) and volume of procedures (volume-outcome relationship) on survival of veno-arterial extracorporeal membrane oxygenation (VA ECMO) for cardiogenic shock complicating acute myocardial infarction (AMI). METHODS: We conducted an observational retrospective study through two propensity score-based analyses using a nationwide database between January 2013 and December 2019. We classified patients into early implantation (VA ECMO on the day of primary percutaneous coronary intervention [PCI]) and delayed implantation (VA ECMO beyond the day of PCI) groups. We classified patients into low- or high-volume groups based on the median hospital volume. RESULTS: During the study period 649 VA ECMO were implanted across 20 French hospitals. Mean age was 57.1 ± 10.4 years, 80% were male. Overall, 90-day mortality was 64.3%. Patients in the early implantation group (n = 479, 73.8%) did not show a statistical difference in 90-day mortality than in the delayed group (n = 170, 26.2%) (HR: 1.18; 95% CI 0.94-1.48; p = 0.153). The mean number of VA ECMO implanted during the study period by low-volume centers was 21.3 ± 5.4 as compared to 43.6 ± 11.8 in high-volume centers. There was no significant difference in 90-day mortality between high-volume and low-volume centers (HR: 1.00; 95% CI: 0.82-1.23; p = 0.995). CONCLUSIONS: In this real-world nationwide study, we did not find a significant association between early VA ECMO implantation as well as high-volume centers and lower mortality in AMI-related refractory cardiogenic shock.
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Oxigenación por Membrana Extracorpórea , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/epidemiología , Choque Cardiogénico/etiología , Oxigenación por Membrana Extracorpórea/métodos , Estudios Retrospectivos , Intervención Coronaria Percutánea/efectos adversos , Infarto del Miocardio/complicaciones , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/terapia , Mortalidad HospitalariaRESUMEN
OBJECTIVES: The TRI-SCORE reliably predicts in-hospital mortality after isolated tricuspid valve surgery (ITVS) on native valve but has not been tested in the setting of redo interventions. We aimed to evaluate the predictive value of the TRI-SCORE for in-hospital mortality in patients with redo ITVS and to compare its accuracy with conventional surgical risk scores. METHODS: Using a mandatory administrative database, we identified all consecutive adult patients who underwent a redo ITVS at 12 French tertiary centres between 2007 and 2017. Baseline characteristics and outcomes were collected from chart review and surgical scores were calculated. RESULTS: We identified 70 patients who underwent a redo ITVS (54±15 years, 63% female). Prior intervention was a tricuspid valve repair in 51% and a replacement in 49%, and was combined with another surgery in 41%. A tricuspid valve replacement was performed in all patients for the redo surgery. Overall, in-hospital mortality and major postoperative complication rates were 10% and 34%, respectively. The TRI-SCORE was the only surgical risk score associated with in-hospital mortality (p=0.005). The area under the receiver operating characteristic curve for the TRI-SCORE was 0.83, much higher than for the logistic EuroSCORE (0.58) or EuroSCORE II (0.61). The TRI-SCORE was also associated with major postoperative complication rates and survival free of readmissions for heart failure. CONCLUSION: Redo ITVS was rarely performed and was associated with an overall high in-hospital mortality and morbidity, but hiding important individual disparities. The TRI-SCORE accurately predicted in-hospital mortality after redo ITVS and may guide clinical decision-making process (www.tri-score.com).
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Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Adulto , Humanos , Femenino , Masculino , Válvula Tricúspide/cirugía , Mortalidad Hospitalaria , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Factores de Riesgo , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous mitral repair (PR) for secondary mitral regurgitation. We updated our previous three-state time-varying Markov model to assess the cost-effectiveness of PR + guideline directed medical treatment (GDMT) versus GDMT alone. Key clinical inputs (overall survival (OS) and heart failure hospitalisations (HFH)) were obtained using the 3-year trial findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) RCT. We calculated incremental cost-effectiveness ratios (ICER) and report how these differ between analyses based on early (2-year) and updated (3-year) evidence. Updated trial data showed an increase in mortality in the intervention arm between two and three years follow-up that was not seen in the control arm. Deterministic and multivariate cost-effectiveness modelling yielded incremental cost effectiveness ratios ICERs of 38,123 and 31,227 /QALY. Compared to our 2-year based estimate (21,918 / QALY) these results imply an approximate 1.5-fold increase in ICER. The availability of updated survival analyses from the COAPT pivotal trial suggests previous estimates based on 2-year trial findings were over optimistic for the intervention.
Asunto(s)
Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Humanos , Análisis Costo-Beneficio , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia Cardíaca/terapia , Evaluación de Resultado en la Atención de Salud , Resultado del TratamientoRESUMEN
BACKGROUND: Differences in procedural success rates have been proposed to explain the divergent results between the MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). AIM: To examine whether MITRA-FR patients who had successful clip implantation achieved a better outcome than the control group. METHODS: Based on the per protocol population of MITRA-FR, we compared the outcome in 71 patients in whom optimal clip implantation was achieved (group 1: mitral regurgitation grade ≤ 1 + at discharge) with that in 23 patients with non-optimal clip implantation (group 2: mitral regurgitation grade ≥ 2 + at discharge) and that in 137 patients in the control group (group 3). The primary endpoint was all-cause death or unplanned hospitalization for heart failure at 24 months. RESULTS: Event-free survival was not different across the groups (42±6% in group 1, 30±10% in group 2 and 31±4% in group 3; log-rank P=0.32). In multivariable analyses, after adjustment for age, sex, rhythm, aetiology, left ventricular ejection fraction and mitral regurgitation severity, group was not associated with variations in outcome: using Group 3 as reference, hazard ratio 0.86, 95% confidence interval 0.58-1.27 (P=0.43) in group 1; and hazard ratio 0.98 95% confidence interval 0.54-1.76 (P=0.94) in group 2. CONCLUSIONS: The clinical outcome of patients in whom optimal procedural result was achieved at discharge was not different compared with the control group. Our results do not support the hypothesis that the differences in rates of residual mitral regurgitation at discharge between MITRA-FR and COAPT explain the divergent results between the two trials.
Asunto(s)
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 de la Válvula Mitral/etiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Volumen Sistólico , Función Ventricular Izquierda , Resultado del Tratamiento , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/complicacionesRESUMEN
Introduction: De novo anti-HLA donor specific antibodies (DSA) have been inconsistently associated with cardiac allograft vasculopathy (CAV) and long-term mortality. We tested whether C3d-binding de novo DSA were associated with CAV or long-term-survival. Methods: We included 282 consecutive patients without preformed DSA on coronary angiography between 2010 and 2012. Angiographies were classified according to CAV ISHLT grading. The primary outcome was a composite criterion of severe CAV or mortality. As the impact of de novo antibodies should be assessed only after appearance, we used a Cox regression with time-dependent covariables. Results: Of the 282 patients, 51(18%) developed de novo DSA during follow-up, 29 patients had DSA with C3d-binding ability (DSA+C3d+), and 22 were without C3d-binding ability (DSA+C3d-). Compared with patients without DSA, DSA+C3d+ patients had an increased risk for the primary outcome of severe CAV or mortality (adjusted HR = 4.31 (2.40−7.74) p < 0.001) and long-term mortality (adjusted HR = 3.48 (1.97−6.15) p < 0.001) whereas DSA+C3d- did not (adjusted HR = 1.04 (0.43−2.47) p = 0.937 for primary outcome and HR = 1.08 (0.45−2.61) p = 0.866 for mortality). Conclusion: According to this large monocentric study in heart transplant patients, donor specific antibodies were associated with worse clinical outcome when binding complement. DSA and their complement-binding ability should thus be screened for to optimize heart transplant patient follow-up.
RESUMEN
BACKGROUND: In the MITRA-FR trial, transcatheter mitral valve repair (TMVR) was not associated with a 2-year clinical benefit in patients with secondary mitral regurgitation (SMR). AIMS: This landmark analysis aimed at investigating a potential reduction of the hospitalisation rate for heart failure (HF) between 12 and 24 months after inclusion in the MITRA-FR trial in patients randomised to the intervention group (TMVR with the MitraClip device), as compared with patients randomised to the control group (guideline-directed medical therapy [GDMT]). METHODS: The MITRA-FR trial randomised 307 patients with SMR for TMVR on top of GDMT (TMVR group; n=152) or for GDMT alone (control group; n=155). We conducted a 12-month landmark analysis in surviving patients who were not hospitalised for HF within the first 12 months of follow-up. The primary endpoint was the 1-year cumulative number of HF hospitalisations. RESULTS: A total of 140 patients (TMVR group: 67; GDMT group: 73) were selected for this landmark analysis with similar characteristics at inclusion in the trial. The primary endpoint was 28 events per 100 patient-years in the TMVR group, as compared with 60 events per 100 patient-years in the GDMT group (hazard ratio [HR] 0.46, 95% confidence interval [CI]: 0.20-1.02; p=0.057). CONCLUSIONS: In this landmark analysis of the MITRA-FR trial, the cumulative rate of HF hospitalisation between 12 and 24 months among patients treated with TMVR on top of GDMT was approximately half as many as those of patients treated with GDMT alone, a difference which did not reach statistical significance in the setting of a low number of events.