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THE RISE OF NEW TECHNOLOGIES FOR AORTIC VALVE STENOSIS: A PROPENSITY-SCORE ANALYSIS FROM TWO MULTICENTER REGISTRIES COMPARING SUTURELESS AND TRANS-CATHETER.

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Presentation on theme: "THE RISE OF NEW TECHNOLOGIES FOR AORTIC VALVE STENOSIS: A PROPENSITY-SCORE ANALYSIS FROM TWO MULTICENTER REGISTRIES COMPARING SUTURELESS AND TRANS-CATHETER."— Presentation transcript:

1 THE RISE OF NEW TECHNOLOGIES FOR AORTIC VALVE STENOSIS: A PROPENSITY-SCORE ANALYSIS FROM TWO MULTICENTER REGISTRIES COMPARING SUTURELESS AND TRANS-CATHETER AORTIC VALVE REPLACEMENT. A. D’Onofrio, S. Salizzoni, A. Rubino, L. Besola, C. Filippini, O. Alfieri, A. Colombo, M. Agrifoglio, T. Fischlein, F. Rapetto, G. Tarantini, M. Dalén, D. Gabbieri, B. Meuris, C. Savini, G. Gatti, M. Aiello, F. Biancari, U. Livi, P. Stefàno, M. Cassese, B. Borrello, M. Rinaldi, C. Mignosa and G. Gerosa. Padova, Torino, Catania, Milano, Nurnberg, Genova, Stockolm, Modena, Leuven, Bologna, Trieste, Pavia, Oulu, Udine, Firenze, Bari, Parma.

2 Disclosure Slide Dr. Augusto D’Onofrio is a physician proctor for Edwards Lifesciences

3 Background and aim According to recent data, TAVR and SU-AVR may be both considered reliable alternative approaches to surgical AVR for the treatment of patients with aortic valve disease The aim of this retrospective multicenter study was to compare early outcomes of TAVR and SU-AVR in patients with severe aortic valve stenosis.

4 Patients and Methods - TAVR
ITalian balloon-Expandable Registry (ITER) Sapien/Sapien XT TA/TF 33 Italian Institutions

5 Patients and Methods – SU-AVR
European SU-AVR study group Perceval S 6 European Institutions Catania, Nurnberg, Stockolm, Oulu, Leuven, Trieste

6 Propensity matching 1:1 All TAVR vs. SU-AVR TA-TAVR vs. SU-AVR
Age Sex Diabetes Extra cardiac artery disease Chronic lung disease Previous cardiac surgery Renal impairment Pulmonary hypertension Left ventricular ejection fraction Body mass index History of coronary artery disease (defined as previous coronary intervention or bypass grafting at the time of intervention) All TAVR vs. SU-AVR TA-TAVR vs. SU-AVR TF-TAVR vs. SU-AVR

7 Endpoints Primary endpoint Secondary endpoint
Evaluation of the following outcomes 30 days after the index procedure (according to VARC-2) All-cause mortality Device success Any stroke Bleeding (life-threating or major) Pace-maker AMI Paravalvular leaks Secondary endpoint Evaluation at discharge of: Peak and mean gradients LVEF Hours of intubation ICU Length of stay In-hospital Length of stay

8 Baseline Before matching After matching SU-AVR: 292 (13.4%)
SU-AVR n=292 TAVR n=1885 p-value Age 76.8±5 81.7±6 <0.0001 Female gender 188 (64.4) 1139(60.4) 0.1969 Body Mass Index 27.7±4.7 25.8±4.5 Diabetes 77 (26.4) 483 (25.6) 0.786 Arterial hypertension 263 (90.1) 1537 (81.5) 0.0003 Extracardiac arteriopathy 50 (17.1) 657 (34.9) Chronic lung disease 41 (14.0) 462 (24.5) Previous cardiac surgery 29 (9.9) 348 (18.5) Renal impairment >85 ml/min ml/min <51 ml/min dialysis 107 (36.6) 117 (40.1) 67 (23) 1 (0.3) 97 (5.2) 618 (33.2) 1090 (58.5) 59 (3.2) Pulmonary hypertension No 31-55 mmHg >55 mmHg 246 (84.3) 45 (15.4) 742 (39.4) 939 (49.8) 204 (10.8) History of coronary artery disease 12 (4.1) 767 (40.7) Left Ventricular Ejection Fraction (%) 58.4±9.0 53.6±12.3 Neurological dysfunction 170 (9.0) Logistic EuroSCORE 9.5±6 21.1±13.6 <0.001 Aortic valve area (cm2) 0.45±0.16 0.46±0.14 0.2603 Peak aortic gradient (mmHg) 87.4±22.8 81.3±22.5 Mean aortic gradient (mmHg) 52.3±15.1 50.3±15.0 0.0510 NYHA Functional Classification I II III IV 6 (2.1) 75 (25.7) 192 (65.8) 19 (6.5) 50 (2.7) 315 (16.7) 1285 (68.2) 235 (12.5) 0.0002 Baseline Before matching SU-AVR: 292 (13.4%) TAVR: 1885 (86.6%) After matching All-TAVR/SU-AVR: 292 matched pairs TA-TAVR/SU-AVR: 105 matched pairs TF-TAVR/SU-AVR: 206 matched pairs

9 Extracardiac artey disease Previous cardiac surgery
Balancing after Matching (1) SU-AVR TAVR P-value Age Before matching 76.8±5 81.7±6 <0.0001 All TAVR vs. SU-AVR (214 pairs) 77.4±5.4 77.7±7.9 0.0757 TA-TAVR vs. SU-AVR (105 pairs) 78.3±5.3 78.5±8.7 0.1746 After matching in TF (206 pairs) 77.7±5.0 77.7±7.0 0.5660 Female gender 188(64.4) 1139(60.4) 0.1969 138 (64.5) 139 (65.0) 0.9194 69 (65.7) >0.9999 TF-TAVR vs. SU-AVR (206 pairs) 139 (68.0) 131 (64.0) 0.4069 Body Mass Index 27.7±4.7 25.8±4.5 27.5±4.7 27.6±5.2 0.9854 26.9±4.6 26.8±4.8 0.7603 TF-TAVR vs. SU-AVR (206 pairs) 27.5±4.6 27.7±5.5 0.9321 Diabetes 77(26.4) 483(25.6) 0.786 59 (27.6) 58 (27.1) 0.9136 27 (25.7) 28 (26.7) 0.8753 55 (26.7) 56 (27.2) 0.9116 Extracardiac artey disease 50(17.1) 657(34.9) 46 (21.5) 48 (22.4) 0.8154 33 (31.4) 37 (35.2) 0.5582 38 (18.5) Chronic lung disease 41(14.0) 462(24.5) 39 (18.2) 36 (16.8) 0.7029 20 (19.1) 36 (17.5) 0.7974 Previous cardiac surgery 29(9.9) 348(18.5) 0.0003 22 (10.3) 21 (9.8) 0.8723 15 (14.3) 12 (11.4) 0.5363 19 (9.2) 22 (10.7) 0.6215

10 Balancing after Matching (2) SU-AVR TAVR P-value Renal impairment
SU-AVR TAVR P-value Renal impairment Before matching <51 ml/min dialysis 67(23) 1(0.3) 1090(58.5) 59(3.2) <0.0001 All TAVR vs. SU-AVR 66(30.8) 1(0.5) 69(32.2) 0.9685 TA-TAVR vs. SU-AVR 49 (46.7) 1 (1.0) 44 (41.9) 0.6547 TF-TAVR vs. SU-AVR 66 (32.0) 1 (0.5) 60 (29.1) 2 (1.0) 0.7013 Pulmonary hypertension >55 mmHg 204(10.8) 0.5996 2 (1.9)    0.6529 0.5743 History of CAD 12(4.1) 767(40.7) 12(5.6) 11(5.1) 0.8303 12 (11.4) 15 (14.3) 0.5363 12 (5.8) 15 (7.3) 0.5503 Left Ventricular Ejection Fraction (%) 58.4±9.0 53.6±12.3 57.7±9.3 58.2±10.2 0.4117 57.3±10.6 57.3±11.2 0.8788 57.6±9.3 57.7±9.5 0.8206

11 Results (1) SU-AVR TAVR P-value Mortality Device Success Any Stroke
SU-AVR TAVR P-value Mortality Before matching 6 (2) 134 (7) 0.0011 All TAVR vs. SU-AVR 5 (2.3) 8 (3.7) 0.3981 TA-TAVR vs. SU-AVR 3 (2.9) 4 (3.8) >0.9999 TF-TAVR vs. SU-AVR 5 (2.4) 9 (4.4) 0.2767 Device Success (absence of procedural mortality and correct positioning of a single valve in the proper anatomical location and good performance of the valve prosthesis) 288 (98.6) 1661 (88.1) <0.0001 211 (98.6) 190 (88.8) 103 (98.1) 99 (94.3) 0.2795 202 (98.1) 177 (85.9) Any Stroke 6 (2.1) 52 (2.8) 0.4871 4 (1.9) 2 (1.9) 1 (1.0) 2 (1.0) 3 (1.5)

12 Bleeding (life threatening or majotr) Any Miocardial Infarction
Results (2) SU-AVR TAVR P-value Bleeding (life threatening or majotr) Before matching 44 (15.1) 381 (20.4) 0.0322 All TAVR vs. SU-AVR 40 (18.7) 34 (16.1) 0.4835 TA-TAVR vs. SU-AVR 21 (20.0) 13 (13.0) 0.1780 TF-TAVR vs. SU-AVR 39 (19.0) 32 (15.0) 0.3612 PM implantation 26 (8.9) 116 (6.2) 0.0766 20 (9.4) 6 (2.8) 0.0046 10 (9.5) 4 (3.8) 0.0969 19 (9.2) 12 (5.8) 0.1911 Any Miocardial Infarction 1 (0.3) 28 (1.5) 0.1658 1 (0.5) 2 (0.9) >0.9999 1 (1.0) 2 (1.9)

13 Results (3) SU-AVR TAVR P-value Severe Paravalvular Leak Paravalvular
SU-AVR TAVR P-value Severe Paravalvular Leak Before matching 1 (0.3) 98 (5.2) <0.0001 All TAVR vs. SU-AVR 1 (0.5) 11 (5.1) 0.0057 TA-TAVR vs. SU-AVR 1 (1.0) >0.9999 TF-TAVR vs. SU-AVR 13 (6.3) 0.0015 Paravalvular No Mild > Mild 286 (98.0) 5 (1.7) 1125 (62.7) 571 (31.8) 98 (5.5) 208 (97.2) 5 (2.3) 134 (64.7) 62 (30.0) 11 (5.3) 101 (96.1) 3 (2.9) 66 (62.9) 38 (36.1) 199 (96.6) 5 (2.4) 2 (1.0) 137 (66.5) 56 (27.2)

14 Results (4) BEFORE MATCHING After matching (ALL TAVR vs.SU-AVR) SU-AVR
BEFORE MATCHING After matching (ALL TAVR vs.SU-AVR) SU-AVR (292) TAVR (1885) p-value (214) TAVR (214) PPG (mmHg) 27.2±11.7 20.0±7.8 <0.0001 26.7±12.1 20.3±8.1 MPG (mmHg) 13.8±6.3 10.8±4.5 13.7±6.6 11.0±4.6 LVEF (%) 56.5±7.9 54.5±11.1 0.2266 56.8±7.8 57.5±8.6 0.4161 Intubation (hours) 18 [8-30] 2 [0-10] 18 [8-36] 2 [0-7] ICU LOS 2 [1-3] 1 [1-3] Total LOS 11 [8-15] 7 [5-11] 11 [8-16] 7 [5-9]

15 Conclusions TAVI and SU-AVR are both reasonable therapeutic strategies in patients with severe symptomatic aortic valve stenosis After matching, we did not observe differences in 30-day mortality, stroke, bleeding or myocardial infarction TAVI patients are more likely to show less device success and more post-operative PVL, even if this is not evident in TA-TAVI SU-AVR seems to provide higher trans-aortic gradients, longer post-operative length of stay and a trend towards higher pacemaker implantation rate.

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