Costo-Efectividad de Reemplazo Valvular Aórtico Percutáneo vs Terapia Conservadora en la Estenosis Aórtica de muy alto riesgo en un centro terciario chileno

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Abstract

Introducción: El objetivo fue evaluar la costo-efectividad del reemplazo valvular aórtico percutáneo (RVAP) contra terapia conservadora (TC) en pacientes con estenosis aórtica (EA) severa de muy alto riesgo, en un centro de derivación. Métodos: Los pacientes derivados entre Enero 2013 y Septiembre 2014, considerados de muy alto riesgo y candidatos a RVAP fueron incluidos. El costo de los recursos usados, de las readmisiones y la sobrevida fueron obtenidos para determinar el tiempo de vida ganado y la relación incremental de costo-efectividad (RICE) del RVAP Resultados: El grupo estudiado quedó compuesto por 39 pacientes, con edad promedio 82±7 años, más frecuentemente mujeres (74.4%), con elevado perfil de riesgo (STS score 11.4±5.6). Diecisiete pacientes (43.6%) fueron sometidos a RVAP y 22 (56.4%) a TC. Durante el seguimiento se registraron 25 rehospitalizaciones en el grupo de TC, a un costo promedio de $4.195.073 por paciente (7,027 dólares). Todos los pacientes sometidos a RAVP recibieron con éxito una prótesis Sapien XT y fueron egresados vivos. El costo promedio estimado del RVAP fue $20.000.000 (33,500 dólares). La sobrevida media fue de 54.5% (10 eventos) en grupo TC contra 94.1% (una muerte) en el grupo RVAP [285±204 días/seguimiento] (p<0.001). Así se pudo estimar que RVAP se asoció a un incremento de vida de al menos un año, lo cual resultó en una RICE de 26,470 dólares/año de vida ganado. Conclusión: El RAVP resultó costo-efectivo comparado con la TC en pacientes portadores de EA severa de muy alto riego tratados en la realidad de un centro de derivación nacional.

Translated abstract

Aim: to evaluate cost-effectiveness of Transcatheter Aortic Valve Replacement (TAVR) compared to conservative treatment in patients with very high risk severe aortic stenosis (AS) referred to a tertiary center in Santiago, Chile Methods: Patients with high surgical risk and severe AS referred between January 2013 and September 2014 were included. Cost of resources, readdmissions, life-years gained and incremental cost-effectiveness of TAVI were calculated Results: Thirty-nine patients were finally included. Mean age was 82±7 years old, more commonly women (74%) with a mean STS score of 11.4±5.6 that confirmed their high-risk. Seventeen patients (43.6%) had TAVR and 22 (56.4%) underwent conventional medical therapy. All patients in the TAVR group - treated with Sapien XT® device - survived the procedure and were discharged alive. Mean cost of the procedure was approximately US$33,500. After a mean follow-up period of 285±204 days, mean survival rate in the control group was 54.5% (10 deaths) as compared to 94.1% in the TAVR group (1 death, p<0.001). Therefore, a gain of al least one year was obtained with TAVR resulting in an incremental cost effectiveness of US$ 26.470 per year of life gained. Conclusion: TAVR resulted costly-effective compared to conventional therapy in patients with severe AS and high surgical risk in a Chilean referral center.

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Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

Martin Leon, Craig R Smith, Michael E Mack … (2010)

Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

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Transcatheter versus surgical aortic-valve replacement in high-risk patients.

Craig R Smith, Martin Leon, Michael J Mack … (2011)

The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).

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Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium.

Marie-Pierre Morel, Stephan Windecker, Jeffrey J. Popma … (2011)

To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the U.S. Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included: 1) respect for the historical legacy of surgical valve guidelines; 2) identification of pathophysiological mechanisms associated with clinical events; 3) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes. Copyright Â© 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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Journal

Journal ID (publisher-id): rchcardiol

Title: Revista chilena de cardiología

Abbreviated Title: Rev Chil Cardiol

Publisher: Sociedad Chilena de Cardiología y Cirugía Cardiovascular (Santiago, , Chile )

ISSN (Electronic): 0718-8560

Publication date (Print and electronic): April 2015

Volume: 34

Issue: 1

Pages: 11-17

Affiliations

[01] Santiago orgnameUniversidad de Chile orgdiv1Faculta de Medicina orgdiv2Hospital Clínico San Borja Arriarán Chile

Article

Publisher ID: S0718-85602015000100001 Publisher ID: S0718-8560(15)03400100001

DOI: 10.4067/S0718-85602015000100001

SO-VID: 5e4bc09c-953b-41d8-943d-2317a5f3b0a0

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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Date accepted : 04 March 2015

Date received : 03 January 2015

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Figures: 0, Tables: 0, Equations: 0, References: 11, Pages: 7

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Most cited references 16

Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

Transcatheter versus surgical aortic-valve replacement in high-risk patients.

Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium.

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