TAVI Outcome According to Endpoint Definitions by the VARC
TAVI Outcome According to Endpoint Definitions by the VARC
Background. Transcatheter aortic valve implantation (TAVI) has become an accepted treatment option for severe aortic stenosis (AS) in high-risk individuals. Yet, current results are difficult to compare given the lack of standardized definitions.
Methods and Results. TAVI was performed in 130 high-risk individuals. The Edwards SAPIEN (n = 50) and the Medtronic CoreValve (n = 80) prostheses were implanted by transfemoral (75%) or transapical (25%) access. Outcomes at 30 days and 1 year are reported according to the newly established Valve Academic Research Consortium (VARC) criteria. Median follow-up was 235 days (range, 44–490 days). Thirty-day device success was high (91.5%). Combined safety endpoint at 30 days was 20.8%, with an all-cause mortality of 11.5%. Major vascular complications (11.5%), life-threatening or disabling bleeding (8.5%), and acute kidney injury (6.2%) were further major adverse events. At 1-year follow-up, valve performance was accurate in 94.7% of patients. However, prosthetic-valve associated complications, such as new left bundle branch block (20.0%) or permanent pacemaker implantation (34.7%), were common; cumulative prosthetic-valve associated complications were significantly more frequent in patients treated with a Medtronic CoreValve prosthesis (p = 0.0012). Overall 1-year survival was 80%, with the VARC combined efficacy endpoint (composite of survival, freedom from therapy failure, and accurate valve performance) met in 70.2%. In particular, at 1 year, 68.5% of the patients were living independently at home.
Conclusion. The newly established VARC standardized definitions are useful for TAVI outcome reporting.
Degenerative aortic stenosis (AS) is the most common isolated valve disease in Western communities. The current prevalence in individuals aged more than 75 years is 4.8%, and the incidence is steadily increasing as a result of the ageing population. Once symptoms develop, the disease rapidly progresses; without treatment, patients usually die within 2–3 years. Surgical aortic valve replacement (SAVR) is considered the standard treatment for symptomatic AS. However, due to significant comorbidities, elderly patients often are at high operative risk, and hence, are not suitable candidates for surgery. Indeed, about 30% of patients with symptomatic severe AS are thus not referred to surgery. Since the first-in-man procedure by Alain Cribier in 2002, transcatheter aortic valve implantation (TAVI) has become a valuable less invasive treatment option for these high-risk individuals.
Comprehensive clinical testing and outcome assessment is a key issue in interventional cardiology and the basis for evidence-based medicine in the field. TAVI — particularly given this new technology's explosive growth — should follow the same rules. Yet, the lack of uniform outcome measures for this entirely different catheter-based therapy did not allow for meaningful comparisons. Most recently, the Valve Academic Research Consortium (VARC) proposed standardized consensus definitions for clinical endpoints, including device success, safety, and efficacy at defined points in time. Although primarily intended for application in clinical trials, the VARC standardized definitions may generally improve the outcome reporting of TAVI, and thus also facilitate future comparisons among the numerous ongoing studies and registries.
Recently, two centers revisited their TAVI outcomes according to the VARC criteria. Both registries included one prosthesis type only and outcome was limited to 30 days. In this study, single-center 30-day and 1-year TAVI outcomes of both currently available prosthesis types, the Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) and the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California), are reported according to the recently defined VARC definitions.
Abstract and Introduction
Abstract
Background. Transcatheter aortic valve implantation (TAVI) has become an accepted treatment option for severe aortic stenosis (AS) in high-risk individuals. Yet, current results are difficult to compare given the lack of standardized definitions.
Methods and Results. TAVI was performed in 130 high-risk individuals. The Edwards SAPIEN (n = 50) and the Medtronic CoreValve (n = 80) prostheses were implanted by transfemoral (75%) or transapical (25%) access. Outcomes at 30 days and 1 year are reported according to the newly established Valve Academic Research Consortium (VARC) criteria. Median follow-up was 235 days (range, 44–490 days). Thirty-day device success was high (91.5%). Combined safety endpoint at 30 days was 20.8%, with an all-cause mortality of 11.5%. Major vascular complications (11.5%), life-threatening or disabling bleeding (8.5%), and acute kidney injury (6.2%) were further major adverse events. At 1-year follow-up, valve performance was accurate in 94.7% of patients. However, prosthetic-valve associated complications, such as new left bundle branch block (20.0%) or permanent pacemaker implantation (34.7%), were common; cumulative prosthetic-valve associated complications were significantly more frequent in patients treated with a Medtronic CoreValve prosthesis (p = 0.0012). Overall 1-year survival was 80%, with the VARC combined efficacy endpoint (composite of survival, freedom from therapy failure, and accurate valve performance) met in 70.2%. In particular, at 1 year, 68.5% of the patients were living independently at home.
Conclusion. The newly established VARC standardized definitions are useful for TAVI outcome reporting.
Introduction
Degenerative aortic stenosis (AS) is the most common isolated valve disease in Western communities. The current prevalence in individuals aged more than 75 years is 4.8%, and the incidence is steadily increasing as a result of the ageing population. Once symptoms develop, the disease rapidly progresses; without treatment, patients usually die within 2–3 years. Surgical aortic valve replacement (SAVR) is considered the standard treatment for symptomatic AS. However, due to significant comorbidities, elderly patients often are at high operative risk, and hence, are not suitable candidates for surgery. Indeed, about 30% of patients with symptomatic severe AS are thus not referred to surgery. Since the first-in-man procedure by Alain Cribier in 2002, transcatheter aortic valve implantation (TAVI) has become a valuable less invasive treatment option for these high-risk individuals.
Comprehensive clinical testing and outcome assessment is a key issue in interventional cardiology and the basis for evidence-based medicine in the field. TAVI — particularly given this new technology's explosive growth — should follow the same rules. Yet, the lack of uniform outcome measures for this entirely different catheter-based therapy did not allow for meaningful comparisons. Most recently, the Valve Academic Research Consortium (VARC) proposed standardized consensus definitions for clinical endpoints, including device success, safety, and efficacy at defined points in time. Although primarily intended for application in clinical trials, the VARC standardized definitions may generally improve the outcome reporting of TAVI, and thus also facilitate future comparisons among the numerous ongoing studies and registries.
Recently, two centers revisited their TAVI outcomes according to the VARC criteria. Both registries included one prosthesis type only and outcome was limited to 30 days. In this study, single-center 30-day and 1-year TAVI outcomes of both currently available prosthesis types, the Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) and the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California), are reported according to the recently defined VARC definitions.
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