TAVI in Rabin Medical Center -

Transcription

1 Long-Term Outcomes of 560 Consecutive Patients treated with TAVI and Propensity Score Matched- Analysis of Early Versus New Generation Valves Amos Levi, MD, Uri Landes, MD, Abid R Assali, MD, Katia Orvin, MD, Ram Sharony, MD, Hanna Vaknin-Assa, MD, Ashraf Hamdan, MD, Yaron Shapira, MD, Shmuel Schwartzenberg, MD,Pablo Codner, MD, Alexander Sagie, MD, and Ran Kornowski, MD, FACC, FESC

2 We have no conflict of interests to disclose

3 n = 587

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5 TAVI in Rabin First Medical tertile Second Center tertile - Last tertile P value Long-Term Outcomes of 560 Consecutive (n=186) Patients (n=187) treated with TAVI (n=187) and Propensity Score Matched-Analysis Nov 2008-Sep of Early Versus Sep New 2012-Feb Generation Feb Valves Oct2016 Age (years) 82.1 ± ± ± Male gender 39% 48% 43% 0.27 Body mass index (kg/m2) 26.5 ± ± ± 5.4 <0.001 Mean GFR (ml/min/1.73m2) 66 ± ± ± GFR % 34% 44% 0.14 GFR % 4.8% 4.8% 0.9 GFR < % 3.2% 1.6% 0.62 Peripheral vascular disease 19.5% 15% 7.5% Chronic obstructive lung disease 26% 16% 12% 0.01 Atrial fibrillation 27% 37% 27% 0.07 Society of Thoracic Surgeons score 8.5 ± ± ± 3.4 <0.001 Logistic Euroscore 21.4 ± ± ± 10.7 <0.001 NYHA Functional Class III - IV 97% 93% 78% <0.001 Hospitalization 6 months prior TAVI 53% 53% 42% LV DYS Moderate + 17% 13.5% 13% 0.52 Frailty 18% 17% 19% 0.87 Peak aortic valve gradient (mmhg) 79 ± ± ± Mean aortic valve gradient (mmhg) 50 ± ± ± Mean Aortic Valve Area (cm 2 ) 0.63 ± ± ± Coronary and Peripheral Angiography 98% 99.5% 88% <0.001 Trans-esophageal Echocardiography 173 (93%) 86% 72% <0.001

6 First tertile Second tertile TAVI in Rabin Medical Center - Last tertile P value Long-Term Outcomes of 560 Consecutive (n=186) Patients (n=187) treated with TAVI (n=187) and Propensity Score Matched-Analysis Nov 2008-Sep of Early Versus Sep New 2012-Feb Generation Feb Valves Oct2016 Age (years) 82.1 ± ± ± Male gender 39% 48% 43% 0.27 Body mass index (kg/m2) 26.5 ± ± ± 5.4 <0.001 Mean GFR (ml/min/1.73m2) 66 ± ± ± GFR % 34% 44% 0.14 GFR % 4.8% 4.8% 0.9 GFR < % 3.2% 1.6% 0.62 Peripheral vascular disease 19.5% 15% 7.5% Chronic obstructive lung disease 26% 16% 12% 0.01 Atrial fibrillation 27% 37% 27% 0.07 Society of Thoracic Surgeons score 8.5 ± ± ± 3.4 <0.001 Logistic Euroscore 21.4 ± ± ± 10.7 <0.001 NYHA Functional Class III - IV 97% 93% 78% <0.001 Hospitalization 6 months prior TAVI 53% 53% 42% LV DYS Moderate + 17% 13.5% 13% 0.52 Frailty 18% 17% 19% 0.87 Peak aortic valve gradient (mmhg) 79 ± ± ± Mean aortic valve gradient (mmhg) 50 ± ± ± Mean Aortic Valve Area (cm 2 ) 0.63 ± ± ± Coronary and Peripheral Angiography 98% 99.5% 88% <0.001 Trans-esophageal Echocardiography 173 (93%) 86% 72% <0.001 Cardiac Computed Tomography 50% 42% 88% <0.001

7 TAVI in Rabin First Medical tertile Second Center tertile - Last tertile P value Long-Term Outcomes of 560 Consecutive (n=186) Patients (n=187) treated with TAVI (n=187) and Propensity Score Matched-Analysis Nov 2008-Sep of Early Versus Sep New 2012-Feb Generation Feb Valves Oct2016 Age (years) 82.1 ± ± ± Male gender 39% 48% 43% 0.27 Body mass index (kg/m2) 26.5 ± ± ± 5.4 <0.001 Mean GFR (ml/min/1.73m2) 66 ± ± ± GFR % 34% 44% 0.14 GFR % 4.8% 4.8% 0.9 GFR < % 3.2% 1.6% 0.62 Peripheral vascular disease 19.5% 15% 7.5% Chronic obstructive lung disease 26% 16% 12% 0.01 Atrial fibrillation 27% 37% 27% 0.07 Society of Thoracic Surgeons score 8.5 ± ± ± 3.4 <0.001 Logistic Euroscore 21.4 ± ± ± 10.7 <0.001 NYHA Functional Class III - IV 97% 93% 78% <0.001 Hospitalization 6 months prior TAVI 53% 53% 42% LV DYS Moderate + 17% 13.5% 13% 0.52 Frailty 18% 17% 19% 0.87 Peak aortic valve gradient (mmhg) 79 ± ± ± Mean aortic valve gradient (mmhg) 50 ± ± ± Mean Aortic Valve Area (cm 2 ) 0.63 ± ± ± Coronary and Peripheral Angiography 98% 99.5% 88% <0.001 Trans-esophageal Echocardiography 93% 86% 72% <0.001

8 First tertile Second tertile Last tertile P value (n=177) (n=178) (n=178) 30 day All cause death 6 (3.2%) 7 (3.7%) 6 (3.2%) 1 30 day cardiovascular death 5 (2.7%) 5 (2.7%) 4 (2.1%) 0.95 Periprocedural MI 0 (0%) 1 (0.5%) 2 (1.1%) 0.78 In hospital stroke Disabling 2 (1.1%) 2 (1.1%) 7 (3.9%) None-disabling / transient 6 (3.3%) 4 (2.2%) 0 (0%) 0.82 Bleeding Life-Threatening Bleeding 9 (5.1%) 3 (1.7%) 1 (0.6%) Major bleeding 12 (6.8%) 11 (6.2%) 6 (3.4%) Acute Kidney Injury AKIN Stage I 19 (10%) 20 (11%) 24 (13%) 0.24 AKIN Stage II 3 (1.6%) 7 (3.8%) 1 (0.5%) AKIN Stage III 7 (3.8%) 8 (4.3%) 3 (1.6%) Vascular Complications Minor Vascular Complication 39 (21%) 25 (13.4%) 35 (18.7%) 0.14 Major Vascular Complication 4 (2.2%) 3 (1.6%) 7 (3.7%) Need for pacemaker * 31 (17.8%) 23 (13.5%) 29 (17.4%) 0.49 Tamponade 7 (3.8%) 0 (0%) 1 (0.5%) Paravalvular leak > Mild 23 (12.4%) 30 (16%) 14 (7.6%) 0.029

9 First tertile Second tertile Last tertile P value (n=177) (n=178) (n=178) 30 day All cause death 6 (3.2%) 7 (3.7%) 6 (3.2%) 1 30 day cardiovamiscular death 5 (2.7%) 5 (2.7%) 4 (2.1%) 0.95 Periprocedural MI 0 (0%) 1 (0.5%) 2 (1.1%) 0.78 In hospital stroke Disabling 2 (1.1%) 2 (1.1%) 7 (3.9%) None-disabling / transient 6 (3.3%) 4 (2.2%) 0 (0%) 0.82 Bleeding Life-Threatening Bleeding 9 (5.1%) 3 (1.7%) 1 (0.6%) Major bleeding 12 (6.8%) 11 (6.2%) 6 (3.4%) Acute Kidney Injury AKIN Stage I 19 (10%) 20 (11%) 24 (13%) 0.24 AKIN Stage II 3 (1.6%) 7 (3.8%) 1 (0.5%) AKIN Stage III 7 (3.8%) 8 (4.3%) 3 (1.6%) Vascular Complications Minor Vascular Complication 39 (21%) 25 (13.4%) 35 (18.7%) 0.14 Major Vascular Complication 4 (2.2%) 3 (1.6%) 7 (3.7%) Need for pacemaker * 31 (17.8%) 23 (13.5%) 29 (17.4%) 0.49 Tamponade 7 (3.8%) 0 (0%) 1 (0.5%) Paravalvular leak > Mild 23 (12.4%) 30 (16%) 14 (7.6%) 0.029

10 First tertile (n=177) Second tertile (n=178) Last tertile (n=178) P value Pre-dilatation balloon valvuloplasty 171 (92%) 67 (36%) 45 (24%) <0.001 Post-dilatation balloon valvuloplasty 10 (6.1%) 53 (29%) 43 (23%) <0.001 Need for a second valve 7 (3.8%) 12 (6.4%) 6 (3.2%) 0.32 Hospital stay (days) 5.1 ± ± ± Anesthesia type Conscious sedation 132 (71%) 147 (79%) 158 (84.5%) 0.01 General anesthesia 54 (29%) 40 (21%) 29 (15.5%) Access Transfemoral 144 (77.4%) 173 (92.5%) 181 (96.8%) <0.001 Alternative 42 (22.6%) 14 (7.5%) 6 (3.2%)

11 47% 9.7% 4.8% 29% 9% 10.6%

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13 Independent predictors of long term All cause death (median follow up 25 months) Covariate Multivariate cox analysis HR (95% CI) P Value GFR < 45 ml/min/1.73m ( ) Chronic obstructive lung disease 1.54 ( ) Hospitalization 6 months prior TAVI 1.62 ( ) Mean AV gradient (per 10 mmhg decrease) 1.16 ( ) 0.02 Frailty 1.58 ( ) In hospital stroke 1.94 ( ) Independent predictors of 1-year death Covariate Multivariable cox analysis HR (95% CI) P Value Mean AV gradient (per 10 mmhg decrease) 1.32 ( ) LV Dysfunction moderate or greater 1.92 ( ) Frailty 2.82 ( ) <0.001 In hospital stroke 3.65 ( ) Major Vascular Complication 3.93 ( ) Paravalvular leak greater than mild 3 (1.5-6) 0.002

14 propensity score matched cohort - new generation versus early generation devices Early generation New generation p value 30 day All cause death 4 (2.3%) 6 (3.4%) day cardiovascular death 4 (2.3%) 4 (2.3%) 1 In hospital stroke 2 (1.1%) 7 (4%) 0.17 Bleeding Life-Threatening Bleeding 5 (2.9%) 2 (1.1%) 0.49 Major bleeding 6 (3.4%) 5 (2.9%) Acute Kidney Injury AKIN Stage I 18 (10%) 23 (13%) 0.69 AKIN Stage II 2 (1.1%) 1 (0.6%) AKIN Stage III 5 (2.9%) 3 (1.7%) Vascular Complications Minor Vascular Complication 37 (21%) 34 (19%) 0.39 Major Vascular Complication 2 (1.1%) 6 (3.4%) Need for pacemaker 26 (14.9%) 27 (15.4%) 1 Ventricular perforation 3 (1.7%) 1 (0.6%) 0.62 Paravalvular leak None/Trace 89 (59%) 120 (83%) <0.001 Mild 36 (27%) 16 (9.3%) > Mild 25 (14%) 12 (7.6%) Mean transaortic gradient 7.5 ± ± Hospital stay (days) 4.1 ± ± Combined composite outcome 59 (33.7%) 59 (33.7%) 1

15 Summary Patient selection - shift towards lower risk, better functional class Procedural technique less invasive Long term mortality - ~1/2 within 5 years, mostly due to non-cardiac causes Hemodynamic & functional improvement - sustained for up to 5 years PVL - Incidence decreasing, new generation valves perform better TAVI in Rabin Medical Center -

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