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.
Disclosure Slide
Dr. Augusto D’Onofrio is a physician proctor for Edwards Lifesciences
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.
Patients and Methods - TAVR
ITalian balloon-Expandable Registry (ITER) 2007-2012 Sapien/Sapien XT TA/TF 33 Italian Institutions
Patients and Methods – SU-AVR
European SU-AVR study group 2010-2014 Perceval S 6 European Institutions
Catania, Nurnberg, Stockolm, Oulu, Leuven, Trieste
Propensity matching 1:1 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
Endpoints Primary 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
SU-AVRn=292
TAVRn=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 <0.0001
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) <0.0001
Chronic lung disease 41 (14.0) 462 (24.5) <0.0001
Previous cardiac surgery 29 (9.9) 348 (18.5) 0.0003
Renal impairment>85 ml/min84-51 ml/min<51 ml/mindialysis
107 (36.6)117 (40.1)67 (23)1 (0.3)
97 (5.2)618 (33.2)1090 (58.5)59 (3.2)
<0.0001
Pulmonary hypertensionNo31-55 mmHg>55 mmHg
246 (84.3)45 (15.4)1 (0.3)
742 (39.4)939 (49.8)204 (10.8)
<0.0001
History of coronary artery disease 12 (4.1) 767 (40.7) <0.0001
Left Ventricular Ejection Fraction (%)
58.4±9.0 53.6±12.3 <0.0001
Neurological dysfunction 0 170 (9.0) <0.0001
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 0.0003
Mean aortic gradient (mmHg) 52.3±15.1 50.3±15.0 0.0510
NYHA Functional ClassificationIIIIIIIV
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
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
Baseline
SU-AVR TAVR P-value
Age
Before matching 76.8±5 81.7±6 <0.0001All 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
Before matching 188(64.4
)1139(60.
4)0.1969
All TAVR vs. SU-AVR (214 pairs)
138 (64.5) 139 (65.0) 0.9194
TA-TAVR vs. SU-AVR (105 pairs)
69 (65.7) 69 (65.7) >0.9999
TF-TAVR vs. SU-AVR (206 pairs)
139 (68.0) 131 (64.0) 0.4069
Body Mass Index
Before matching 27.7±4.7 25.8±4.5 <0.0001All TAVR vs. SU-AVR (214
pairs)27.5±4.7 27.6±5.2 0.9854
TA-TAVR vs. SU-AVR (105 pairs)
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
Before matching 77(26.4) 483(25.6) 0.786All TAVR vs. SU-AVR (214
pairs)59 (27.6) 58 (27.1) 0.9136
TA-TAVR vs. SU-AVR (105 pairs)
27 (25.7) 28 (26.7) 0.8753
TF-TAVR vs. SU-AVR (206 pairs)
55 (26.7) 56 (27.2) 0.9116
Extracardiac artey disease
Before matching 50(17.1) 657(34.9) <0.0001All TAVR vs. SU-AVR (214
pairs)46 (21.5) 48 (22.4) 0.8154
TA-TAVR vs. SU-AVR (105 pairs)
33 (31.4) 37 (35.2) 0.5582
TF-TAVR vs. SU-AVR (206 pairs)
38 (18.5) 38 (18.5) >0.9999
Chronic lung disease
Before matching 41(14.0) 462(24.5) <0.0001All TAVR vs. SU-AVR (214
pairs)39 (18.2) 36 (16.8) 0.7029
TA-TAVR vs. SU-AVR (105 pairs)
20 (19.1) 20 (19.1) >0.9999
TF-TAVR vs. SU-AVR (206 pairs)
36 (17.5) 38 (18.5) 0.7974
Previous cardiac surgery
Before matching 29(9.9) 348(18.5) 0.0003All TAVR vs. SU-AVR (214
pairs)22 (10.3) 21 (9.8) 0.8723
TA-TAVR vs. SU-AVR (105 pairs)
15 (14.3) 12 (11.4) 0.5363
TF-TAVR vs. SU-AVR (206 pairs)
19 (9.2) 22 (10.7) 0.6215
Balancing after Matching (1)
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 <51 ml/min
dialysis
66(30.8)
1(0.5)
69(32.2)
1(0.5)
0.9685
TA-TAVR vs. SU-AVR<51 ml/min
dialysis
49 (46.7)
1 (1.0)
44 (41.9)
0
0.6547
TF-TAVR vs. SU-AVR<51 ml/min
dialysis
66 (32.0)
1 (0.5)
60 (29.1)
2 (1.0)
0.7013
Pulmonary hypertension
Before matching >55 mmHg
1(0.3)
204(10.
8)
<0.0001
All TAVR vs. SU-AVR>55 mmHg
1(0.5)
1(0.5)
0.5996
TA-TAVR vs. SU-AVR>55 mmHg
1 (1.0)
2 (1.9)
0.6529
TF-TAVR vs. SU-AVR>55 mmHg
1 (0.5)
0
0.5743
History of CAD
Before matching 12(4.1)767(40.
7)<0.0001
All TAVR vs. SU-AVR 12(5.6) 11(5.1) 0.8303
TA-TAVR vs. SU-AVR 12 (11.4) 15 (14.3) 0.5363TF-TAVR vs. SU-AVR 12 (5.8) 15 (7.3) 0.5503
Left Ventricular Ejection Fraction
(%)
Before matching 58.4±9.053.6±12
.3<0.0001
All TAVR vs. SU-AVR 57.7±9.358.2±10.
20.4117
TA-TAVR vs. SU-AVR 57.3±10.657.3±11.
20.8788
TF-TAVR vs. SU-AVR 57.6±9.3 57.7±9.5 0.8206
Balancing after Matching (2)
Results (1) 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)
Before matching 288 (98.6) 1661 (88.1) <0.0001
All TAVR vs. SU-AVR 211 (98.6) 190 (88.8) <0.0001
TA-TAVR vs. SU-AVR 103 (98.1) 99 (94.3) 0.2795
TF-TAVR vs. SU-AVR 202 (98.1) 177 (85.9) <0.0001
Any Stroke
Before matching 6 (2.1) 52 (2.8) 0.4871
All TAVR vs. SU-AVR 4 (1.9) 4 (1.9) >0.9999
TA-TAVR vs. SU-AVR 2 (1.9) 1 (1.0) >0.9999
TF-TAVR vs. SU-AVR 2 (1.0) 3 (1.5) >0.9999
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
Before matching 26 (8.9) 116 (6.2) 0.0766
All TAVR vs. SU-AVR 20 (9.4) 6 (2.8) 0.0046
TA-TAVR vs. SU-AVR 10 (9.5) 4 (3.8) 0.0969
TF-TAVR vs. SU-AVR 19 (9.2) 12 (5.8) 0.1911
Any Miocardial Infarction
Before matching 1 (0.3) 28 (1.5) 0.1658
All TAVR vs. SU-AVR 1 (0.5) 2 (0.9) >0.9999
TA-TAVR vs. SU-AVR 1 (1.0) 2 (1.9) >0.9999
TF-TAVR vs. SU-AVR 1 (0.5) 1 (0.5) >0.9999
Results (3) 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) 1 (1.0) >0.9999
TF-TAVR vs. SU-AVR 1 (0.5) 13 (6.3) 0.0015
Paravalvular Leak
Before matchingNoMild> Mild
286 (98.0)
5 (1.7)1 (0.3)
1125 (62.7)571 (31.8)
98 (5.5)
<0.0001
All TAVR vs. SU-AVRNoMild> Mild
208 (97.2)
5 (2.3)1 (0.5)
134 (64.7)62 (30.0)11 (5.3)
<0.0001
TA-TAVR vs. SU-AVRNoMild> Mild
101 (96.1)
3 (2.9)1 (1.0)
66 (62.9)38 (36.1)
1 (1.0)
<0.0001
TF-TAVR vs. SU-AVRNoMild> Mild
199 (96.6)
5 (2.4)2 (1.0)
137 (66.5)56 (27.2)13 (6.3)
<0.0001
Results (4)
BEFORE
MATCHING
After matching
(ALL TAVR vs.SU-AVR)
SU-AVR
(292)
TAVR
(1885)p-value
SU-AVR
(214)TAVR (214) p-value
PPG
(mmHg)27.2±11.7 20.0±7.8 <0.0001 26.7±12.1 20.3±8.1 <0.0001
MPG (mmHg)13.8±6.3 10.8±4.5 <0.0001 13.7±6.6 11.0±4.6 <0.0001
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] <0.0001 18 [8-36] 2 [0-7] <0.0001
ICU LOS2 [1-3] 1 [1-3] <0.0001 2 [1-3] 1 [1-3] <0.0001
Total LOS11 [8-15] 7 [5-11] <0.0001 11 [8-16] 7 [5-9] <0.0001
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.