Impact of aortic regurgitation after TAVI on thirty-day mortality, morbidity and quality of life

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1 Impact of aortic regurgitation after TAVI on thirty-day mortality, morbidity and quality of life An analysis from the German TAVI registry M. Abdel-Wahab, R. Zahn, M. Horack, G. Schuler, F.-J. Neumann, R. Hambrecht, K.-H. Kuck, H.-R. Figulla, J. Senges and G. Richardt; for the German TAVI registry investigators

2 Disclosure Statement of Financial Interest I, Mohamed Abdel-Wahab, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation

3 Background (I) TAVI has been shown to significantly improve survival and cardiac symptoms in elderly patients with severe aortic stenosis considered to be at high surgical risk. In spite of these encouraging results, a relatively high mortality rate must be taken into account. In addition, identifying patients with a poor treatment response to TAVI is of particular importance

4 Background (II) OR for in-hospital death 95% CI p-value Cardiogenic shock Post-procedural AR 2/ Operative TAVI LVEF 30% Peripheral arterial disease Abdel-Wahab et al. Heart 2011;97:

5 Background (III) It is generally believed that residual AR after TAVI improves with time and would not further impact the treatment success of TAVI. But so far, the effect of residual AR on 30-day mortality, relieve of symptoms and quality of life is not known

6 Objectives Extended analysis from the German TAVI registry aiming at evaluating the impact of residual AR on: 1. In-hospital and 30-day mortality 2. Functional status in survivors at 30 days (symptoms, quality of life)

7 German TAVI Registry Multi-center prospective registry, started in 01/2009. Aims at monitoring current use and outcome of TAVI in daily clinical practice in Germany, and to evaluate safety, effectiveness and health-economical data. Completely independent from industry, financed by the Institut für Herzinfarktforschung, Ludwigshafen

8 German TAVI Registry Patient Population 01/09 to 06/10 TAVI n = 1382 (100%) Percutaneous TAVI n = 1250 (90.4%) Surgical TAVI n = 132 (9.6%) Trans-femoral n = 1209 (87.5%) Trans-apical n = 122 (8.8%) Trans-subcalvian n = 41 (2.9%) Trans-aortic n = 10 (0.8%)

9 Evaluation of post-procedural AR The degree of post-procedural AR was angiographically evaluated at the end of the TAVI procedure after final device deployment and removal of the catheter and guidewire. Qualitative angiographic assessment of the severity of AR was performed by visual estimation of the concentration of contrast medium in the left ventricle, using the method of Sellers et al. AR was classified into 4 grades: absent (0) trace or mild (1/4) moderate (2/4) moderate-to-severe (3/4) severe (4/4) Significant AR was defined as AR 2/4. Abdel-Wahab et al. Heart 2011;97:

10 Aortic regurgitation before & after TAVI Incidence of AR before and after TAVI in 1370 patients n=1166 (85.5%) n=204 (14.9%)

11 Aortic regurgitation after TAVI 1370 TAVI patients stratified according to the degree of post-procedural AR AR 2/4 AR < 2/

12 Baseline Clinical Characteristics AR 2/4 (n=204) AR < 2/4 (n=1166) p OR (95%CI) Age (years) 81.2± ± Male gender 112 (54.9%) 467 (40.1%) < ( ) Cardiogenic shock/decomp. 66 (32.4%) 269 (23.2%) < ( ) Pulmonary hypertension 145 (72.5%) 757 (65.7%) ( ) Diabetes 63 (31.0%) 411 (35.3%) ( ) CAD 77 (37.9%) 466 (40.2%) ( ) PAD 66 (32.4%) 360 (31.0%) ( ) Previous stroke 22 (10.8%) 85 (7.3%) ( ) Renal failure req. dialysis 3 (1.5%) 44 (3.8%) ( ) Logistic Euroscore (%) 22.9± ±13.1 <0.05 Euroscore > 20% 88 (44.2%) 437 (38.1%) ( )

13 Echocardiographic Characetristics AR 2/4 (n=204) AR < 2/4 (n=1166) p OR (95%CI) Aortic valve area (cm 2 ) 0.65± ±0.37 <0.01 Mean gradient (mmhg) 47.3± ± LVEF (%) 49.3± ±14.4 <0.01 Bicuspid aortic valve 8 (4.0%) 24 (2.1%) ( ) Severe leaflet calcification 118 (59.0%) 785 (67.7%) < ( ) Annulus diameter 23.64± ± Annulus meas. with CT 48 (24.0%) 405 (35.6%) < ( ) Annulus meas. with TEE 152 (76.0%) 733 (64.4%) < ( )

14 Procedural Details AR 2/4 (n=204) AR < 2/4 (n=1166) p OR (95%CI) Operative TAVI 9 (4.4%) 118 (10.1%) < ( ) Percutaneous TAVI 195 (95.6%) 1048 (89.9%) < ( ) CoreValve prosthesis 184 (90.2%) 933 (80.1%) < ( ) Edwards prosthesis 20 (9.8%) 231 (19.8%) < ( ) Procedural duration (min) 92.0± ± Contrast amount (ml) 170.8± ± Postproc. mean PG (mmhg) 5.1± ±6.6 <

15 In-Hospital Outcome AR 2/4 (n=204) AR < 2/4 (n=1166) p OR (95%CI) Death 30 (14.7%) 78 (6.7%) < ( ) Myocardial infarction 1 (0.5%) 6 (0.5%) ( ) Stroke 8 (4.0%) 33 (2.9%) ( ) Major vascular compl. 7 (3.6%) 42 (3.7%) ( ) Advanced AV block 39 (19.4%) 252 (21.9%) ( ) Low cardiac output 32 (16.4%) 56 (4.9%) < ( ) Resp. failure 32 (16.1%) 98 (8.5%) < ( ) Delirium 34 (17.2%) 95 (8.3%) < ( )

16 Survival at 30 days 30 day follow-up for 1045/1145 patients (91.3%) 1,00 0,95 0,90 AR < 2/4 AR 2/4 0,85 0, Days after TAVI Log-Rank -Test: p < Wilcoxon-Test: p <

17 Symptoms at 30 days pre-tavi (n=1355) post-tavi (n=778) p<0.05 p=0.30 p=0.08 p<0.05 p=0.78 AR 2/4 AR < 2/

18 Quality of life at 30 days Percentage of patients with severe impairment of self-reported health status (EuroQol 5d, n=820) p= % vs. 7.7% described a worse health status after TAVI compared to p=0.26 their baseline health status before TAVI (p<0.001) p=0.05 p=0.41 p=

19 Limitations The study has all the shortcomings of a registry, yet its value lies in the large number of patients recruited. The degree of post-procedural AR and all adverse events were not centrally adjudicated, which may have contributed to the differences based on differences in self-reports, and the angiographic technique for AR assessment was not standardized. No formal audit of the participating hospitals has been performed

20 Conclusions Significant ( 2/4) AR after TAVI limits functional improvement and is associated with higher rates of mortality at 30 days. Preliminary one-year results of this cohort of TAVI patients will be presented later during this meeting (R. Zahn, Abstract P4978). Prevention and treatment of post-tavi AR would maximize the benefit obtained from this evolving technology

21 List of participating centers (in alphabetical order) -Asklepios Klinik St. Georg Hamburg -Augustinum Klinik München -Cardio Vasculäres Centrum (CVC) Frankfurt -Elisabeth Krankenhaus Essen -HELIOS Klinikum Wuppertal -Herzzentrum Bad Krozingen -Herzzentrum Ludwigshafen -Kathatinenhopsital Stuttgart -Klinikum Coburg -Klinikum Links der Weser Bremen -Klinikum Schwabing, München -Klinikum Siegburg -Klinikum Traunstein -Krankenhaus München Neuperlach -Krankenhaus der barmherzigen Brüder Trier -Robert-Bosch-Krankenhaus Stuttgart -Sana Herzzentrum Cottbus -Segeberger Kliniken GmbH -Städt. Kliniken Neuss Lukaskrankenhaus -Städt. Klinikum München -Unfallkrankenhaus Berlin -Universität Leipzig Herzzentrum -Universitäres Klinikum Regensburg -Universitätsklinik Rostock -Universitätsklinikum Bonn -Universitätsklinikum Essen -Universitätsklinikum Jena

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