There is little known about the long-term results of the CoreValve prosthesis. The aim of this study was to assess the 3-year clinical and hemodynamic outcomes of the CoreValve prosthesis. One hundred fifty consecutive patients with severe aortic stenosis successfully underwent transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. The primary study end point was death from any cause after TAVI. The secondary end points were defined as (1) cardiovascular death and (2) prosthesis-related mortality and morbidity. At 1 to 3 years, all-cause mortality rates were 25%, 32%, and 41%, respectively, and cardiovascular mortality rates were 14%, 21%, and 27%, respectively. Before TAVI, 95% of patients were in New York Heart Association class III or IV. Of the surviving patients, rates of New York Heart Association class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively. There was an annual decrease of the valve area of approximately 0.1 cm². Aortic restenosis occurred in 2 patients. Moderate or severe aortic regurgitation (AR) occurred in 15% of patients immediately after TAVI. Twenty patients (13%) had a slight worsening of AR within 3 years. New severe AR did not occur. The incidence of prosthesis-related endocarditis was 0.66% per year. Overall, 7 patients (incidence of 1.5% per year) had a clinically relevant problem of the prosthesis. In conclusion, TAVI with the CoreValve prosthesis had favorable effects on symptoms and outcomes even after 3 years. These results are clouded by side effects, such as AR and prosthesis-related mortality and morbidity.
In the last few years, transcatheter aortic valve implantation (TAVI) has become a routine procedure in patients with severe aortic stenosis (AS) and high risk for surgical aortic valve replacement. Worldwide, the most widely used transcatheter valves were the Edwards SAPIEN valve (Edwards Lifescience, Irvine, California) and the CoreValve ReValving system (Medtronic, Minneapolis, Minnesota). Several studies have shown favorable acute and medium-term clinical and hemodynamic results. However, relatively little is known about the long-term results of transcatheter valves. Recently, long-term outcomes beyond 2 years (up to 5 years) were described in patients who underwent TAVI with the Edwards SAPIEN prosthesis. However, few data exist on the long-term outcomes of patients who underwent TAVI with the CoreValve prosthesis. Therefore, the aim of this study was to assess the 3-year clinical and hemodynamic outcomes of the CoreValve prosthesis.
Methods
In this prospective monocenter study, patients with symptomatic severe AS (aortic valve area ≤1.0 cm²) and high risk for surgical aortic valve replacement were screened for transfemoral or transaxillary TAVI. The risk of surgical aortic valve replacement was estimated with the logistic EuroSCORE. Indications, contraindications, and anatomic requirements for TAVI were described previously.
From March 2008 to September 2010, all patients who successfully underwent TAVI with the CoreValve prosthesis in our department were included in the present study.
During the procedure, 2 patients died (rupture of the eccentric calcified aortic base, n = 1; fatal vascular access–related complications, n = 1). These patients who died before prosthesis was implanted were excluded. All patients gave informed consent before participation. The protocol was approved by the local ethics committee.
The aortic valve prosthesis (18Fr generation, Medtronic CoreValve Percutaneous System; Medtronic, Minneapolis, Minnesota) was inserted retrograde without hemodynamic support using a femoral arterial approach or using a subclavian arterial approach.
The primary study end point was death from any cause after TAVI. Secondary end points were defined as (1) cardiovascular death and (2) prosthesis-related mortality and morbidity. Cardiovascular death included death due to myocardial infarction, stroke, sudden cardiac death, heart failure, fatal prosthesis failure with conversion to heart surgery, and death of unknown cause. Study end points were defined according to the recommendations of the Valve Academic Research Consortium.
Prosthesis-related mortality and morbidity was defined as early prosthesis endocarditis (within the first year after TAVI), late prosthesis endocarditis (beyond 1 year after TAVI), prosthesis-related mitral endocarditis, prosthesis failure with conversion to surgery, late valve-in-valve implantation (>7 days after TAVI), late valve embolization (>7 days after TAVI), valve thrombosis, valve restenosis (aortic valve area ≤1 cm²), worsening of transvalvular aortic regurgitation (AR; within the first 3 years after TAVI), and worsening of paravalvular AR (within the first 3 years after TAVI).
Examinations of study patients were performed within 7 days before TAVI and annually after implantation. Follow-up information was obtained during routine ambulatory visits and comprised New York Heart Association (NYHA) functional class and echocardiography. For deceased patients, medical records were examined to determine the cause of death. A “death of unknown cause” was assumed if the cause of death was not clear to determine.
Echocardiographic examinations of patients were performed within 7 days before TAVI, within 5 days after TAVI, at 12 months, and annually thereafter. Transthoracic echocardiography was performed according to the guidelines of the American Society of Echocardiography using a digital ultrasound scanner (Vivid 7; General Electrics, Horton, Norway). Before and after TAVI, effective aortic valve area was measured by means of the continuity equation. After TAVI, prosthetic valve performance was evaluated according to the recommendations of the Valve Academic Research Consortium. Prosthetic aortic valve regurgitation was graded by means of echocardiography into mild, moderate, and severe. Diagnosing endocarditis was done using the current guidelines.
Numerical values are expressed as mean ± SD. Continuous variables were compared between groups using an unpaired t test (for normally distributed variables) or the Mann-Whitney U test (for non-normally distributed variables). Continuous variables were compared between patients using the paired Student t test (for normally distributed variables) or the Wilcoxon test (for non-normally distributed variables). Postprocedural (transvalvular and paravalvular) AR was evaluated for all-cause mortality in univariate regression analysis. Results are presented as hazard ratio with 95% confidence interval. For the outcome analysis, Kaplan-Meier survival curves were generated. Differences between all-cause mortality were assessed using the log-rank test. All reported probability values are 2-tailed, and p <0.05 was considered statistically significant. Analyses were performed with the SPSS statistical software package (version 19.0) (SPSS, Inc., Chicago, Illinois).
Results
A total of 150 consecutive patients with AS who underwent successfully transfemoral (n = 145) or transaxillary (n = 5) TAVI with the CoreValve prosthesis were enrolled. Baseline characteristics of patients are provided in Table 1 .
| Variable | |
|---|---|
| Age (years) | 79 ± 6 |
| Women | 76 (50%) |
| Logistic EuroScore (%) | 23 ± 17 |
| NYHA functional class III/IV | 142 (95%) |
| Body mass index (kg/m²) | 27 ± 5 |
| Coronary artery disease | 77 (51%) |
| Previous myocardial infarction | 32 (21%) |
| Previous coronary artery bypass grafting | 25 (17%) |
| Atrial fibrillation | 48 (32%) |
| Severe mitral regurgitation | 25 (17%) |
| Chronic obstructive pulmonary disease | 47 (31%) |
| Creatinine (mg/dl) | 1.2 ± 0.6 |
| Aortic valve area (cm²) | 0.7 ± 0.1 |
| Aortic mean gradient (mm Hg) | 46 ± 13 |
| Left ventricular end-diastolic diameter (mm) | 49 ± 7 |
| Left ventricular end-systolic diameter (mm) | 34 ± 8 |
| Left ventricular ejection fraction | 53 ± 13 |
| Valve-in-valve implantation | 5 (3%) |
Within the first 30 days after TAVI, 15 patients died (10%). All-cause mortality rates at 1 to 3 years were 25%, 32%, and 41%, respectively. Cardiovascular mortality rates at 1 to 3 years were 14%, 21%, and 27%, respectively ( Figure 1 ). A total of 62 patients died within 3 years. Causes of death are given in Table 2 .
| Variable | Patients (n) |
|---|---|
| Cardiovascular death | |
| Heart failure | 20 |
| Myocardial infarction | 5 |
| Sudden cardiac death | 5 |
| Prosthesis endocarditis | 2 |
| Prosthesis related mitral endocarditis | 1 |
| Fatal prosthesis failure with conversion to surgery | 1 |
| Intracranial bleeding | 1 |
| Fatal vascular bleeding | 1 |
| Death of unknown cause | 6 |
| Death of other cause | |
| Respiratory failure | 7 |
| Sepsis | 5 |
| Renal failure | 4 |
| Malignant tumor | 4 |
| Gastrointestinal bleeding | 1 |
Before TAVI, 95% of patients were in NYHA functional class III or IV. Of the surviving patients, rates of NYHA functional class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively (NYHA functional class III or IV before TAVI vs at 1, 2, or 3 years, p <0.001; Figure 2 ).
Aortic valve area significantly increased after TAVI (0.7 ± 0.1 cm² before TAVI vs 1.8 ± 0.2 cm² immediately after TAVI, p <0.001). Within the 3 years, aortic valve area decreased slightly but significantly (immediately after TAVI 1.8 ± 0.2 cm² vs 3 years after TAVI 1.5 ± 0.4 cm², p <0.001; Figure 3 ). In 2 patients, an aortic restenosis occurred (one patient within the second year and the other within the third year after TAVI). Both patients lived 3 years after TAVI but were in NYHA functional class III. No cases of stent fracture, leaflet disruption, or retraction were observed.
At echocardiographic examination immediately after TAVI, any prosthetic valve regurgitation occurred in 88 of 150 patients (59%). Of them, 85 patients had paravalvular regurgitation and 3 patients presented with transvalvular regurgitation. Overall, mild AR occurred in 66 patients (44%), moderate AR in 19 patients (13%), and severe AR in 3 patients (2%; Figure 4 ).
Because of severe AR after implantation, 1 patient was converted to surgery and died (fatal prosthesis failure with conversion to surgery). Because of moderate AR after TAVI, late valve-in-valve implantation was performed in 1 patient ( Table 3 ).
| Variable | Patients (n) |
|---|---|
| Early prosthesis endocarditis | 0 |
| Late prosthesis endocarditis | 2 |
| Prosthesis related mitral endocarditis | 1 |
| Fatal prosthesis failure with conversion to surgery | 1 |
| Late valve-in-valve implantation | 1 |
| Late valve embolization | 0 |
| Valve thrombosis | 0 |
| Valve restenosis | 2 |
| Paravalvular aortic regurgitation—worsening | |
| From mild AR to moderate AR | 5 |
| From none AR to mild AR | 15 |
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