Peri-operative results and complications in 15,964 transcatheter aortic valve implantations from the German Aortic valve RegistrY (GARY)

Transcription

1 Peri-operative results and complications in 15,964 transcatheter aortic valve implantations from the German Aortic valve RegistrY (GARY) Thomas Walther, Christian W. Hamm, Gerhard Schuler, Alexander Berkowitsch, Joachim Kötting, Norman Mangner, Harald Mudra, Andreas Beckmann, Jochen Cremer, Armin Welz, Rüdiger Lange, Karl-Heinz Kuck, Friedrich W. Mohr, and Helge Möllmann on behalf of the GARY executive board Hotline session ACC March 15, 2015 online publication JACC

2 Procedures German AV registry nationwide registry on AVR + T-AVI 93 active hospitals; 82,577 consented pat. 12/14 Documented Procedures since ,710 consented patients in Total AVR V-TAVI A-TAVI Total: AVR: Documentation in Progress Year V-TAVI: A-TAVI: 4.479

3 T-AVI patients n = 15,964 retrograde transfemoral: n = 11, % antegrade transapical: n = 4,304 27% alternative access: n = % In-hospital outcome data were analyzed.

4 Valves implanted T-AVI n = 15,964 Balloon expandable (SAPIEN XT, SAPIEN 3 ) 52.6% n = 8,390 Self expandable (Corevalve ) 37.7% n = 6,026 Self expandable and Other 9.7% n = 1,548

5 Definitions Severe vital complications (SVC): death on day of intervention, conversion to sternotomy, acute PCI, low cardiac output requiring mechanical circulatory support, cardiac tamponade requiring treatment, aortic dissection, annular rupture Technical complications of the procedures (TCO): repositioning or retrieval of valve prosthesis, valve-in-valve procedure, valve embolization, closure of a paravalvular leak Other complications: aortic regurgitation, new-onset pacemaker implantation, stroke, major vascular complications, major bleeding Conversion to sternotomy In-hospital death

6 Baseline data Total Patients 100 % Female 54 % Age [years] 81 ±6 Euroscore [Median] 18.3 GER AV Sc. [Median] STS Score [Median] NYHA III IV 86 % * indicates p<0.01 versus all other patients

7 Baseline data Total SVC TCO Sternotomy Death Patients 100 % 5.0% 4.7% 1.3% 5.2% Female 54 % Age [years] 81 ±6 Euroscore [Median] 18.3 GER AV Sc. [Median] STS Score [Median] NYHA III IV 86 % * indicates p<0.01 versus all other patients

8 Baseline data Total SVC TCO Sternotomy Death Patients 100 % 5.0% 4.7% 1.3% 5.2% Female 54 % 59.5% * 47.6% * 59.2% 53.4% * Age [years] 81 ± ± ± ± ±6.3 Euroscore [Median] * 21.5 * * GER AV Sc. [Median] STS Score [Median] * 6.1 * 5.8 * 8.1 * * 5.5 * 5.5 * 6.9 * NYHA III IV 86 % 88.0% 86.1% 88.6% 90.2% * * indicates p<0.01 versus all other patients

9 Baseline data (b) Total SVC TCO Sternotomy Death Patients 100% 5.0% 4.7% 1.3% 5.2% CAD 55.1% 58.0% 58.2% 50.2% 61.8% * Previous card. Surgery 21.0% 23.0% 25.1% * 19.4% 23.3% Pulmonary hypertension 35.7% 35.6% 35.9% 34.2% 45.4% * COPD requ.med. 14.2% 12.8% 13.8% 11.9% 16.2% EF < 30% 9.5% 12.8% * 13.6% * 8.5% 16.3% * Renal repl. tx. 5.0% 4.8% 5.2% 5.5% 8.2% * Peripheral vasc. disease 19.5% 22.3% * 19.7% 22.4% 30.1% * * indicates p<0.01 versus all other patients

10 Procedural data Total SVC TCO Sternotomy Death Patients 15, In-hospital mortality 5.2% 40.8% * 17.1% * 42.3% * 100% * indicates p<0.01 versus all other patients

11 Total SVC TCO Sternotomy Death Patients 15, In-hospital 5.2% 40.8% * 17.1% * 42.3% * 100% mortality CPB used 2.4% 28.7% * 13.9% * 56.7% * 13.6% * Conversion open heart surgery Cardiac tamponade Transfemoral approach Transapical approach * indicates p<0.01 versus all other patients Procedural data 1.3% 25.4% * 12.0% * 100.0% * 10.3% * 1.0% 20.7% * 3.9% * 31.5% * 8.0% * 70.7% 66.3% * 79.0% * 67.7% 58.6% * 27.0% 31.3% * 20.2% * 30.3% 37.6% *

12 Other complications Total SVC TCO Sternotomy Death Patients 15, Residual AR 2 New-onset pacer implant 5.8% 10.7% * 12.8% * 16.7% * 12.0% * 17.5% 13.3% * 25.2% * 12.8% 13.9% * Stroke 1.5% 4.2% * 4.1% * 3.5% * 6.3% * Major vasc. complication 4.1% 8.0% * 10.3% * 7.0% * 8.0% * Major bleeding # 26.3% 54.7% * 40.3% * 70.1% * 59.8% * * indicates p<0.01 versus all other patients # VARC II definition, 2 RBC units

13 Predictors for death OR 95% conf. interval p Residual aortic regurgitation Peripheral vascular disease Mitral regurgitation > Ejection fraction < 30% Pulmonary hypertension NYHA class IV Body mass index < Sternotomy Low cardiac output Cardiogenic shock Tamponade Aortic dissection Annular rupture PCI due to complications Technical complications Post-operative stroke Post-operative new-onset dialysis Post-operative myocardial infarction Post-operative ischemia Bleeding Severe vital complications (SVC) multivariate analysis

14 multivariate analysis Predictors for SVC OR 95% conf. interval p Female gender NYHA class IV LVEF 30 % i.v. Inotropes Arterial vascular disease Higher degree of calcification Higher degree of aortic stenosis

15 multivariate analysis Predictors for TCO OR 95% conf. interval p Year of procedure Male gender LVEF 30 % Neurological dysfunction Cardiac decompensation i.v. Inotropes

16 multivariate analysis Predictors for Sternotomy OR 95% conf. interval p none

17 Regression in risk profiles Total p 100% 24.7% 34.6% 40.6% Log ES [mean / median] < German AV Score [mean / median] < STS Score [mean / median] < 0.001

18 Overall incidence of complications in % Total SVC TCO Sternotomy Death Patients p - < SVC = severe vital complication TCO = technical complication

19 Conclusions: T-AVI T-AVI is safe with acceptable complication rates, all-comers and high-risk population (n= 15,964) Decrease in complications over years: (learnings, screening+selection, technical progress) Severe vital complications + TCO remain ~ 4 %. Independent predictors for complications (p<0.01): (gender, reduced ejection fraction, arterial vascular disease) Sternotomy stable at ~ 1.2 %, no predictors In-hospital death rate ~ 5 %, no change

20 Thank you!