Cost-effectiveness of Transcatheter Mitral Valve Leaflet Repair for the Treatment of Mitral Regurgitation in Heart Failure

Contexte: La régurgitation mitrale (RM) est une maladie valvulaire nécessitant une intervention dans les cas les plus grave. Une réparation percutanée de la valve mitrale avec le dispositif MitraClip est un traitement sécuritaire et efficace pour les patients à haut risque chirurgical. Nous voulons évaluer les résultats cliniques et l'impact économique de cette thérapie par rapport à la gestion médicale des patients en insuffisance cardiaque avec insuffisance mitrale symptomatique. Méthodes: L'étude a été composée de deux phases; une étude d'observation de patients souffrant d'insuffisance cardiaque et de régurgitation mitrale traitée avec une thérapie médicale ou le MitraClip, et un modèle économique. Les résultats de l'étude observationnelle ont été utilisés pour estimer les paramètres du modèle de décision, qui a estimé les coûts et les avantages d'une cohorte hypothétique de patients atteints d'insuffisance cardiaque et insuffisance mitrale sévère traitée avec soit un traitement médical standard ou MitraClip. Résultats: La cohorte de patients traités avec le système MitraClip était appariée par score de propension à une population de patients atteints d'insuffisance cardiaque, et leurs résultats ont été comparés. Avec un suivi moyen de 22 mois, la mortalité était de 21% dans la cohorte MitraClip et de 42% dans la cohorte de gestion médicale (p = 0,007). Le modèle de décision a démontré que MitraClip augmente l'espérance de vie de 1,87 à 3,60 années et des années de vie pondérées par la qualité (QALY) de 1,13 à 2,76 ans. Le coût marginal était 52.500 $dollars canadiens, correspondant à un rapport coût-efficacité différentiel (RCED) de 32,300.00$ par QALY gagné. Les résultats étaient sensibles à l'avantage de survie. Conclusion: Dans cette cohorte de patients atteints d'insuffisance cardiaque symptomatique et d insuffisance mitrale significative, la thérapie avec le MitraClip est associée à une survie supérieure et est rentable par rapport au traitement médical.Background: Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral valve leaflet repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. We sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart failure patients with symptomatic MR. Methods: The study was comprised of two phases; an observational study of patients with heart failure and MR treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate to severe MR treated with either standard medical therapy or MitraClip. Results: The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p=0.007). The decision model demonstrated that MitraClip increased life expectancy from 1.87 to 3.60 years and quality-adjusted life years (QALY) from 1.13 to 2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of$32,300.00 per QALY gained. Results were sensitive to the survival benefit. Conclusion: In this cohort of heart failure patients with symptomatic moderate-severe MR, therapy with the MitraClip was associated with superior survival and is cost-effective compared to medical therapy

Redo-Transcatheter Aortic Valve Replacement: Strategies When the First Transcatheter Aortic Valve Replacement Fails

Transcatheter aortic valve replacement (TAVR) is the standard of care for patients with symptomatic severe aortic stenosis at high or prohibitive surgical risk. The 2020 valvular heart disease guidelines from the American College of Cardiology and American Heart Association now include TAVR as a class I indication for patients aged 65–80 years and not at high or prohibitive risk. The longer life expectancy of this patient population raises the issue of TAVR valve durability and the management of bioprosthetic valve failure of TAVR valves. In this review, the authors discuss bioprosthetic valve dysfunction and summarize existing data regarding redo-TAVR and surgery for failed TAVR. Finally, they propose an approach to evaluate patients with failed TAVR and plan for a second TAVR procedure as indicated

The Benefits Conferred by Radial Access for Cardiac Catheterization Are Offset by a Paradoxical Increase in the Rate of Vascular Access Site Complications With Femoral Access The Campeau Radial Paradox

AbstractObjectivesThe purpose of this study was to assess whether the benefits conferred by radial access (RA) at an individual level are offset by a proportionally greater incidence of vascular access site complications (VASC) at a population level when femoral access (FA) is performed.BackgroundThe recent widespread adoption of RA for cardiac catheterization has been associated with increased rates of VASCs when FA is attempted.MethodsLogistic regression was used to calculate the adjusted VASC rate in a contemporary cohort of consecutive patients (2006 to 2008) where both RA and FA were used, and compared it with the adjusted VASC rate observed in a historical control cohort (1996 to 1998) where only FA was used. We calculated the adjusted attributable risk to estimate the proportion of VASC attributable to the introduction of RA in FA patients of the contemporary cohort.ResultsA total of 17,059 patients were included. At a population level, the VASC rate was higher in the overall contemporary cohort compared with the historical cohort (adjusted rates: 2.91% vs. 1.98%; odds ratio [OR]: 1.48, 95% confidence interval [CI]: 1.17 to 1.89; p = 0.001). In the contemporary cohort, RA patients experienced fewer VASC than FA patients (adjusted rates: 1.44% vs. 4.19%; OR: 0.33, 95% CI: 0.23 to 0.48; p < 0.001). We observed a higher VASC rate in FA patients in the contemporary cohort compared with the historical cohort (adjusted rates: 4.19% vs. 1.98%; OR: 2.16, 95% CI: 1.67 to 2.81; p < 0.001). This finding was consistent for both diagnostic and therapeutic catheterizations separately. The proportion of VASCs attributable to RA in the contemporary FA patients was estimated at 52.7%.ConclusionsIn a contemporary population where both RA and FA were used, the safety benefit associated with RA is offset by a paradoxical increase in VASCs among FA patients. The existence of this radial paradox should be taken into consideration, especially among trainees and default radial operators

Invasive Hemodynamics of Valvular Heart Disease

In the current era, diagnosis and follow-up of valvular heart disease is performed noninvasively using echocardiography. In some cases, the results of echocardiographic evaluation are inconclusive or discrepant with the patient's clinical symptoms. In such cases, a well-planned and executed cardiac catheterization is invaluable to clarify the clinical dilemma and assist in planning further management. This article reviews the indications, technique, and interpretation of cardiac catheterization in the setting of valvular stenosis and regurgitation

Left Ventricular Outflow Tract Obstruction: A Potential Obstacle for Transcatheter Mitral Valve Therapy

Transcatheter mitral valve replacement is the focus of much enthusiasm as the future of therapy for mitral valve disease. Despite technological advances, left ventricular outflow tract (LVOT) obstruction from the valve prosthesis remains an important issue. In this review the authors discuss the pathophysiology of LVOT obstruction in both the surgical and transcatheter experience, imaging evaluation preprocedure, outcomes to date, and therapeutic options

Sex-related factors in valvular heart disease : JACC Focus Seminar 5/7

Numerous sex-based differences are observed across the spectrum of valvular heart disease, starting with pathophysiology and progression of disease, moving on to compensation and comorbidities (both cardiovascular such as coronary artery disease and noncardiovascular such as frailty), assessment of severity and hemodynamics including timing of intervention, and procedural risks/benefits and outcomes. The aortic valve is perhaps best understood with sex differences in both pathologic changes and response to volume and pressure overload, yet large gaps in our understanding still exist. Studies of other valve diseases have focused on differences in prevalence, presentation, and outcomes for surgical or transcatheter therapies. Defining sex-specific responses to valvular heart disease may improve disease recognition, define treatment strategies, and improve outcomes

Cost consequence analysis of use of a balloon expandable vascular access system and standard vascular sheath for transcatheter aortic valve implantation

Background: Vascular complications are an important complication of transcatheter aortic valve implantation and are associated with increased morbidity and mortality as well as cost. The Solopath device is an expandable vascular access system that has previously been shown to be associated with lower rates of vascular complications. This study sought to evaluate the impact of the use of this system on vascular complications and costs in a decision model analysis. Methods: A cost-consequence analysis was undertaken utilizing event rate data from the PARTNER trials and a published retrospective analysis of the Solopath device. The decision model estimated costs and benefits in a hypothetical cohort of patients with aortic stenosis undergoing TAVI using either a standard sheath or Solopath. The modeled analysis compared the occurrence of vascular complications and mortality at 30 days and 1 year using TreeAge Pro. Results: The decision model demonstrated that use of the Solopath sheath resulted in 36 fewer major vascular complications, three fewer deaths at 30 days, and five fewer deaths at 1 year, resulting in a discounted cost savings of $846 CDN. Results were sensitive to decreasing rates of vascular complications with newer generation devices, however maintained modest cost-savings. Conclusions: Reduction in vascular complications is an important part of improving care for TAVI patients. The Solopath vascular access device offers an alternative to standard sheaths with a potential reduction in complications and cost-savings