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.