Outcomes After TAVI in Patients With Severe Aortic Stenosis
Outcomes After TAVI in Patients With Severe Aortic Stenosis
Objectives The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term.
Background Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients.
Methods The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010.
Results Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model.
Conclusions Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.
Symptomatic severe aortic stenosis carries a poor prognosis. Surgical aortic valve replacement (AVR) has, until recently, been the only effective treatment in adults with severe symptomatic aortic stenosis. For patients who are selected for isolated surgical aortic valve replacement the overall perioperative risk is low. However, the operative risk is increased for elderly patients, for patients with concomitant coronary artery disease or severely reduced left ventricular (LV) function and also for patients with comorbid conditions such as cerebral and peripheral vascular disease, renal failure, and respiratory dysfunction.
Transcatheter aortic valve implantation (TAVI) was developed as an alternative to AVR in this high-risk patient population. The first implant in man was performed by Cribier in 2002, using a balloon expandable frame and equine valve. Currently, 2 devices are under post-marketing surveillance in Europe: the balloon-expandable Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) and the self-expandable CoreValve revalving prosthesis (Medtronic, Minneapolis, Minnesota). A substantial body of data now exists in relation to the early clinical outcomes after TAVI but there are few data on outcome beyond 1 year in any notable number of patients. A number of observational clinical studies demonstrated the feasibility of TAVI leading its use as an alternative treatment in these patients. There are a number of reports that have emanated from post-marketing device specific and national registries. In general, these have been limited to selected centers, largely focused on 1 or another technology and usually have been dependent of industry funding. To date, none of these registries has reported significant numbers of patients with long-term follow-up.
Cohort B of the PARTNER (Placement of Aortic Transcatheter Valve) trial compared the outcome after TAVI compared with medical therapy in a very high risk patient population considered unsuitable for surgery. One-year survival and cardiac symptoms were significantly and markedly better in the TAVI arm, with only 5 patients needing to be treated to prevent 1 death at 12 months. There was, however, a higher incidence of stroke and major vascular complications. Cohort A of the PARTNER trial compared TAVI to AVR in a high-risk population in whom both therapies were considered clinically acceptable. This study showed noninferiority of TAVI to AVR for the primary endpoint of all cause 1-year mortality but an increased risk of stroke at 30 days and 1 year in the TAVI arm. This trial took place in tightly defined and highly selected patients in highly selected centers with a single technology (Edwards SAPIEN).
In 2007, as the first patients in the United Kingdom were being considered for TAVI, a national program was established to coordinate and monitor the practice and dissemination of TAVI. The purpose of this project was to define the characteristics and clinical outcomes of the patient population treated with TAVI (regardless of technology or access route) in every (i.e., nonselected) center undertaking TAVI. In this paper, we report the outcomes (survival status as of December 12, 2010) of all TAVI procedures undertaken in England and Wales between the first implant in January 2007 until the end of December 2009.
Abstract and Introduction
Abstract
Objectives The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term.
Background Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients.
Methods The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010.
Results Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model.
Conclusions Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.
Introduction
Symptomatic severe aortic stenosis carries a poor prognosis. Surgical aortic valve replacement (AVR) has, until recently, been the only effective treatment in adults with severe symptomatic aortic stenosis. For patients who are selected for isolated surgical aortic valve replacement the overall perioperative risk is low. However, the operative risk is increased for elderly patients, for patients with concomitant coronary artery disease or severely reduced left ventricular (LV) function and also for patients with comorbid conditions such as cerebral and peripheral vascular disease, renal failure, and respiratory dysfunction.
Transcatheter aortic valve implantation (TAVI) was developed as an alternative to AVR in this high-risk patient population. The first implant in man was performed by Cribier in 2002, using a balloon expandable frame and equine valve. Currently, 2 devices are under post-marketing surveillance in Europe: the balloon-expandable Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) and the self-expandable CoreValve revalving prosthesis (Medtronic, Minneapolis, Minnesota). A substantial body of data now exists in relation to the early clinical outcomes after TAVI but there are few data on outcome beyond 1 year in any notable number of patients. A number of observational clinical studies demonstrated the feasibility of TAVI leading its use as an alternative treatment in these patients. There are a number of reports that have emanated from post-marketing device specific and national registries. In general, these have been limited to selected centers, largely focused on 1 or another technology and usually have been dependent of industry funding. To date, none of these registries has reported significant numbers of patients with long-term follow-up.
Cohort B of the PARTNER (Placement of Aortic Transcatheter Valve) trial compared the outcome after TAVI compared with medical therapy in a very high risk patient population considered unsuitable for surgery. One-year survival and cardiac symptoms were significantly and markedly better in the TAVI arm, with only 5 patients needing to be treated to prevent 1 death at 12 months. There was, however, a higher incidence of stroke and major vascular complications. Cohort A of the PARTNER trial compared TAVI to AVR in a high-risk population in whom both therapies were considered clinically acceptable. This study showed noninferiority of TAVI to AVR for the primary endpoint of all cause 1-year mortality but an increased risk of stroke at 30 days and 1 year in the TAVI arm. This trial took place in tightly defined and highly selected patients in highly selected centers with a single technology (Edwards SAPIEN).
In 2007, as the first patients in the United Kingdom were being considered for TAVI, a national program was established to coordinate and monitor the practice and dissemination of TAVI. The purpose of this project was to define the characteristics and clinical outcomes of the patient population treated with TAVI (regardless of technology or access route) in every (i.e., nonselected) center undertaking TAVI. In this paper, we report the outcomes (survival status as of December 12, 2010) of all TAVI procedures undertaken in England and Wales between the first implant in January 2007 until the end of December 2009.
