The German Aortic Valve Registry (GARY)
The following analysis is based on 13,860 consecutive patients who underwent aortic valve interventions from January 1 to 31 December 2011 covering ~55% of all aortic interventions in Germany during this period. The data are derived from 78 sites (out of 96 in Germany), of which 62 sites contributed data from the beginning of the year. Since several centres joined only in the course of the year 2011, the number of patients analysed in this manuscript does not match with the number of all aortic procedures performed in Germany. Here, we summarize the results of 6537 conventional aortic valve replacements without and 3464 with concomitant coronary bypass surgery. The transcatheter data set includes 2695 TV and 1181 TA interventions.
The decision for a transcatheter AVI was made in most cases by a Heart Team (TV 86.1, TA 90.4%), but in some patients either a cardiologist (TV 8.7. TA 0.7%) or a cardiac surgeon (TV 5.2. TA 8.9%) decided alone.
Reasons for choosing a transcatheter valve implantation over a conventional AVR were high patient age (TV 69, TA 72%), frailty (TV 44, TA 48%), overall high-operative risk defined as log. EuroScore > 20% or STS-score > 10% (TV 64, TA 65%), porcelain aorta (TV 5, TA 11%), or concomitant diseases limiting life expectancy (TV 8, TA 11%). The patients' wish played a minor role as an additional factor (TV 29, TA 15%).
Patients undergoing either conventional AVR or transcatheter AVI differed markedly in baseline characteristics and risk profile. Most transcatheter aortic valve intervention (TAVI) patients (TV 86.3, TA 84.0%) were older than 75 years, whereas this was only the case for a minority of patients undergoing conventional AVR (33.3% without CABG/44.9% with CABG, Figure 1). The mean logistic EUROScore was significantly higher in the TAVI groups (TV 25.9; TA 24.5%) in comparison with patients who underwent conventional AVR without (8.8%) or with concomitant CABG (11.0%). This is concordant with the fact that the TAVI cohort had more cardiovascular risk factors ( Table 1 ).
(Enlarge Image)
Figure 1.
Age (A) and risk (B) distribution.
The comparison between the TV and TA TAVI patients revealed a significantly higher rate of pulmonary hypertension in the TV group and more patients with pre-operative acute and chronic renal failure with dialysis. The TA patients more often suffered from both peripheral artery disease (28.4 vs. 16.4%) and carotid disease (17.7 vs. 11.2%). In the TV group a considerable number of patients was treated <48 h after or still in cardiogenic shock (3.9 vs. 1.9% TA-AVI) and/or still under inotropic support (5.9 vs. 1.5% TA-AVI).
No difference among all groups was found regarding mean and maximum aortic valve gradients. However, the valve area was somewhat lower in both TAVI groups ( Table 2 ). Likewise, the rate of mild-to-moderate concomitant mitral valve regurgitation was higher in the TAVI-treated patients.
The procedure times were significantly longer for conventional operations (AVR: 183 ± 69 min, AVR + CABG: 242 ± 79 min) as opposed to the TAVI (TV: 92 ± 51 min, TA: 100 ± 65 min). Following the trend of the past years a biological prosthesis was implanted in most patients undergoing conventional valve replacement (83.8% in patients without concomitant CABG, 92.2% in patients with CABG). In the TV group the CoreValve revalving system (Medtronic, Minneapolis, MN, USA) was used in >60% of the cases, whereas the Sapien valve (Edwards Lifesciences, Irvine USA) was almost exclusively used for the TA route.
Overall, TAVI patients were treated with prostheses from Edwards Lifesciences (n = 2061) or Medtronic CoreValve (n = 1614). Only a minority was treated with second generation prostheses from Symetis SA (n = 53) or JenaValve (n = 53). The remaining patients (n = 94) received either devices under clinical evaluation or no device due to different reasons.
In the majority of patients, the native aortic valve was treated. Within the TAVI group, however, 81 patients (2.1%) received a valve-in-valve due to deterioration of a previously implanted surgical bioprosthesis.
Most TA patients (95%) were operated under general anaesthesia, whereas this was only the case in 44% of the TV patients. A small proportion of TAVI patients underwent the procedure electively with under support of a heart lung machine (0.5%).
A true 'Heart team approach' with at least one cardiologist and one cardiac surgeon performing the procedure together was present in 40.3% of the TV and 69.4% of the TA cases. The mean fluoroscopy time was lower in the TA (9 ± 19 min) than in the TV group (18 ± 11 min).
The intra-operative complication rates were low. Conversion to sternotomy was necessary in 2.0% of the TA and 1.4% of the TV cases. Unplanned cardiopulmonary bypass was necessary in 2.1% of the TA cases and 0.7% of the TV cases.
Vascular complications (intra- and post-operative) were expectedly highest in the TV AVI patients (15.9%). Other complication rates are listed in Table 3 .
The different pre-operative risk profiles led to differences in the unadjusted post-operative outcome parameters. In-hospital mortality for all patients (including emergent procedures, endocarditis, and similar high-risk patients) was 2.1% in the surgical group for AVR alone and 4.5% for patients with AVR plus CABG. In the TV group, the in-hospital mortality was 5.1% (CoreValve 4.3%, Sapien 5.8%, n.s.) and in-patients who underwent TA AVI 7.7% (Figure 2). The in-hospital stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV TAVI), and 2.3% (TA TAVI). More outcome data are given in Table 4 .
(Enlarge Image)
Figure 2.
In-hospital outcome.
The incidence of post-interventional atrioventriclar block requiring pacemaker implantation was highest in TV-treated patients (25.0%) when compared with the TA group (11.3%) and conventionally treated patients (5.2% without; 4.5% with CABG).
Catheter-based valve implantations may be associated with residual aortic regurgitation. The GARY registry found very good results in both catheter-treated groups with either no regurgitation (TV 37.2, TA 57.3%) or non-valve academic research consortium-relevant regurgitation grade I (TV 55.5, TA 38.6%). Grade II-regurgitation occurred more often in the TV group (7.3%) when compared with the TA group (4.0%; Table 4 ). The duration of post-intervention mechanical ventilation was shorter in the TV group in comparison with TA (29 ± 108 vs. 37 ± 124 h) (Figure 3).
(Enlarge Image)
Figure 3.
Residual aortic regurgitation.
The EuroScore grossly overestimated the real mortality in the GARY registry for all groups (each EuroScore vs. observed mortality: conventional surgery without CABG 8.8 vs. 2.1%; conventional surgery with CABG 11.0 vs. 4.5%; TV-AVI 25.9 vs. 5.1%; TA-AVI 24.5 vs. 7.7%).
The German AV-Score demonstrated reliable risk discrimination for the low-to-intermediate risk patients in all groups. In the TV-AVI group and in conventionally operated patients without bypass surgery, the observed mortality for high-risk patients was significantly lower than expected from the German AV-Score (Figure 4).
(Enlarge Image)
Figure 4.
Observed (bars) vs. predicted (lines) in-hospital mortality by the German AV-Score. Low-risk groups showed a good correlation. The risk was lower in the high-risk groups undergoing aortic valve replacement without CABG and transvascular TAVI.
Results
Centre Participation and Implantation Numbers
The following analysis is based on 13,860 consecutive patients who underwent aortic valve interventions from January 1 to 31 December 2011 covering ~55% of all aortic interventions in Germany during this period. The data are derived from 78 sites (out of 96 in Germany), of which 62 sites contributed data from the beginning of the year. Since several centres joined only in the course of the year 2011, the number of patients analysed in this manuscript does not match with the number of all aortic procedures performed in Germany. Here, we summarize the results of 6537 conventional aortic valve replacements without and 3464 with concomitant coronary bypass surgery. The transcatheter data set includes 2695 TV and 1181 TA interventions.
Patient Selection
The decision for a transcatheter AVI was made in most cases by a Heart Team (TV 86.1, TA 90.4%), but in some patients either a cardiologist (TV 8.7. TA 0.7%) or a cardiac surgeon (TV 5.2. TA 8.9%) decided alone.
Reasons for choosing a transcatheter valve implantation over a conventional AVR were high patient age (TV 69, TA 72%), frailty (TV 44, TA 48%), overall high-operative risk defined as log. EuroScore > 20% or STS-score > 10% (TV 64, TA 65%), porcelain aorta (TV 5, TA 11%), or concomitant diseases limiting life expectancy (TV 8, TA 11%). The patients' wish played a minor role as an additional factor (TV 29, TA 15%).
Patient Characteristics and Risk Profile
Patients undergoing either conventional AVR or transcatheter AVI differed markedly in baseline characteristics and risk profile. Most transcatheter aortic valve intervention (TAVI) patients (TV 86.3, TA 84.0%) were older than 75 years, whereas this was only the case for a minority of patients undergoing conventional AVR (33.3% without CABG/44.9% with CABG, Figure 1). The mean logistic EUROScore was significantly higher in the TAVI groups (TV 25.9; TA 24.5%) in comparison with patients who underwent conventional AVR without (8.8%) or with concomitant CABG (11.0%). This is concordant with the fact that the TAVI cohort had more cardiovascular risk factors ( Table 1 ).
(Enlarge Image)
Figure 1.
Age (A) and risk (B) distribution.
The comparison between the TV and TA TAVI patients revealed a significantly higher rate of pulmonary hypertension in the TV group and more patients with pre-operative acute and chronic renal failure with dialysis. The TA patients more often suffered from both peripheral artery disease (28.4 vs. 16.4%) and carotid disease (17.7 vs. 11.2%). In the TV group a considerable number of patients was treated <48 h after or still in cardiogenic shock (3.9 vs. 1.9% TA-AVI) and/or still under inotropic support (5.9 vs. 1.5% TA-AVI).
No difference among all groups was found regarding mean and maximum aortic valve gradients. However, the valve area was somewhat lower in both TAVI groups ( Table 2 ). Likewise, the rate of mild-to-moderate concomitant mitral valve regurgitation was higher in the TAVI-treated patients.
Intra-operative Parameters
The procedure times were significantly longer for conventional operations (AVR: 183 ± 69 min, AVR + CABG: 242 ± 79 min) as opposed to the TAVI (TV: 92 ± 51 min, TA: 100 ± 65 min). Following the trend of the past years a biological prosthesis was implanted in most patients undergoing conventional valve replacement (83.8% in patients without concomitant CABG, 92.2% in patients with CABG). In the TV group the CoreValve revalving system (Medtronic, Minneapolis, MN, USA) was used in >60% of the cases, whereas the Sapien valve (Edwards Lifesciences, Irvine USA) was almost exclusively used for the TA route.
Overall, TAVI patients were treated with prostheses from Edwards Lifesciences (n = 2061) or Medtronic CoreValve (n = 1614). Only a minority was treated with second generation prostheses from Symetis SA (n = 53) or JenaValve (n = 53). The remaining patients (n = 94) received either devices under clinical evaluation or no device due to different reasons.
In the majority of patients, the native aortic valve was treated. Within the TAVI group, however, 81 patients (2.1%) received a valve-in-valve due to deterioration of a previously implanted surgical bioprosthesis.
Most TA patients (95%) were operated under general anaesthesia, whereas this was only the case in 44% of the TV patients. A small proportion of TAVI patients underwent the procedure electively with under support of a heart lung machine (0.5%).
A true 'Heart team approach' with at least one cardiologist and one cardiac surgeon performing the procedure together was present in 40.3% of the TV and 69.4% of the TA cases. The mean fluoroscopy time was lower in the TA (9 ± 19 min) than in the TV group (18 ± 11 min).
The intra-operative complication rates were low. Conversion to sternotomy was necessary in 2.0% of the TA and 1.4% of the TV cases. Unplanned cardiopulmonary bypass was necessary in 2.1% of the TA cases and 0.7% of the TV cases.
Vascular complications (intra- and post-operative) were expectedly highest in the TV AVI patients (15.9%). Other complication rates are listed in Table 3 .
Peri-operative Outcome
The different pre-operative risk profiles led to differences in the unadjusted post-operative outcome parameters. In-hospital mortality for all patients (including emergent procedures, endocarditis, and similar high-risk patients) was 2.1% in the surgical group for AVR alone and 4.5% for patients with AVR plus CABG. In the TV group, the in-hospital mortality was 5.1% (CoreValve 4.3%, Sapien 5.8%, n.s.) and in-patients who underwent TA AVI 7.7% (Figure 2). The in-hospital stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV TAVI), and 2.3% (TA TAVI). More outcome data are given in Table 4 .
(Enlarge Image)
Figure 2.
In-hospital outcome.
The incidence of post-interventional atrioventriclar block requiring pacemaker implantation was highest in TV-treated patients (25.0%) when compared with the TA group (11.3%) and conventionally treated patients (5.2% without; 4.5% with CABG).
Catheter-based valve implantations may be associated with residual aortic regurgitation. The GARY registry found very good results in both catheter-treated groups with either no regurgitation (TV 37.2, TA 57.3%) or non-valve academic research consortium-relevant regurgitation grade I (TV 55.5, TA 38.6%). Grade II-regurgitation occurred more often in the TV group (7.3%) when compared with the TA group (4.0%; Table 4 ). The duration of post-intervention mechanical ventilation was shorter in the TV group in comparison with TA (29 ± 108 vs. 37 ± 124 h) (Figure 3).
(Enlarge Image)
Figure 3.
Residual aortic regurgitation.
Risk Assessment
The EuroScore grossly overestimated the real mortality in the GARY registry for all groups (each EuroScore vs. observed mortality: conventional surgery without CABG 8.8 vs. 2.1%; conventional surgery with CABG 11.0 vs. 4.5%; TV-AVI 25.9 vs. 5.1%; TA-AVI 24.5 vs. 7.7%).
The German AV-Score demonstrated reliable risk discrimination for the low-to-intermediate risk patients in all groups. In the TV-AVI group and in conventionally operated patients without bypass surgery, the observed mortality for high-risk patients was significantly lower than expected from the German AV-Score (Figure 4).
(Enlarge Image)
Figure 4.
Observed (bars) vs. predicted (lines) in-hospital mortality by the German AV-Score. Low-risk groups showed a good correlation. The risk was lower in the high-risk groups undergoing aortic valve replacement without CABG and transvascular TAVI.
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