TAVI VS. OFFENER KLAPPENERSATZ: PRO

Berner Tage der Klinik

8 -11. November 2017, Bern, Switzerland

Stephan Windecker

Department of Cardiology

Swiss Cardiovascular Center

Bern University Hospital, Switzerland

10 YEARS OF TAVI - FIRST TAVI PROCEDURE IN

SWITZERLAND, INSELSPITAL, BERN – AUGUST 2007

THE SWISS TAVI REGISTRY CTU BERN

0

50

100

150

200

250

300

350 2013-2014 2014-2015 2015-2016

1197

2087

3309

4756

0

1000

2000

3000

4000

5000

6000

2013 2014 2015 2016

TOTAL NUMBER OF PROCEDURES

(2013-2016)

NUMBER OF PROCEDURES

BY SITES

>

=/>

=/>

TAVI superior to medical Rx

TAVI noninferior or superior to SAVR

TAVI noninferior or superior

(TF access) to SAVR

THE EVOLUTION OF CLINICAL EVIDENCE

TIME (MONTHS)

TAVI VS. CONSERVATIVE TREATMENT: INOPERABLE-EXTREME PATIENTS

PARTNER 1B: 5-Year Follow-up

CoreValve Extreme-Risk: 2-Year Follow-up

TIME (MONTHS)

Kapadia SR et al. Lancet 2015 Yakubov SJ et al. J Am Coll Cardiol 2015

All-Cause Mortality N=358 N=489

93.6%

71.8%

Number Need to Treat= 4 (2-year); 5 (5-year)

TAVI VS. SAVR: HIGH-RISK PATIENTS

TIME (MONTHS) TIME (MONTHS)

Mack MJ et al. Lancet 2015 Deeb M et al. J Am Coll Cardiol 2016

PARTNER 1A: 5-Year Follow-up

CoreValve High-Risk: 3-Year Follow-up

N=699

All-cause Mortality All-cause Mortality

62.4%

67.8%

N=797

N=1,746

TAVI VS. SAVR: INTERMEDIATE-RISK PATIENTS

TIME (MONTHS) TIME (MONTHS)

PARTNER 2A - Edwards SURTAVI - CoreValve

N=699

All-cause Mortality

62.4%

67.8% N=1746

Leon MB et al. N Engl J Med 2016 Reardon MJ et al. NEJM 2017

PARTNER 1A

US CoreValve

NOTION

PARTNER 2A

116/348 114/351

85/391 99/359

11/145 14/135

166/1011 170/1021

0.90 (0.71-1.15)

0.79 (0.61-1.01)

0.72 (0.33-1.59)

0.92 (0.74-1.13)

0.87 (0.76-0.99), P=0.038 Overall

Trial TAVR SAVR HR (95% CI)

All-cause Mortality at 2 years 4 randomized trials (N =3,806)

TAVI VS. SAVR

Subgroup Trials τ2 HR (95% CI) P-inter

Siontis et al. Eur Heart J. 2016 Dec 14;37(47):3503-3512

PROCEDURE

EARLY PERI-PROCEDURE

-50

-40 -40

-60

-40

-20

0

ATRIAL FIBRILLATION

MAJOR BLEEDING

RENAL FAILURE

MORTA

L I T

Y

-20%

OPEN THORACOTOMY CARDIOPULMONARY BYPASS OROTRACHEAL INTUBATION

GENERAL ANESTHESIA PROLONGED VENTILATION

TAVI vs. SAVR

ADVANTAGES OF TRANSCATHETER VS. SURGICAL AORTIC VALVE INTERVENTIONS

VALVE INSERTION: EDWARDS SAPIEN 3

IMPLANTATION SEQUENCE

VALVE IMPLANTATION RESULT

IMPLANTATION SEQUENCE

ACCESS SITE CLOSURE

IMPLANTATION SEQUENCE

STRATEGIES TO MITIGATE

PARAVALVULAR REGURGITATION

Advanced sealing: External Wrap

Internal skirts, external cuffs, sleeves

Imaging Tools:

Device Selection

Repositionability:

Partial or Full

95 99

5 1

0%

20%

40%

60%

80%

100%

EdwardsSAPIEN XT

EdwardsSAPIEN 3

moderate/severe AR

no/mild AR

p=0.04

N=598

Binder RK et al, Circ Cardiovasc Interv 2015

90 92

10 8

0%

20%

40%

60%

80%

100%

MedtronicCoreValve

MedtronicEvolut R

p=ns

N=995

Noble S et al, EuroIntervention 2017

BALLOON-EXPANDABLE SELF-EXPANDING

PARAVALVULAR REGURGITATION WITH EARLY AND

NEWER GENERATION TAVI PROSTHESES

TAVI VS. SAVR ECHOCARDIOGRAPHIC OUTCOMES

MEAN AORTIC VALVE AREA AND TRANSVALVULAR GRADIENT

Leon MB et al. N Engl J Med 2016;374:1609-1620

PARTNER 2A SURTAVI

Reardon MJ et al, N Engl J Med. 2017 Jul 13;377(2):197-198

PARTNER 1A

US CoreValve

NOTION

PARTNER 2A

116/348 114/351

85/391 99/359

11/145 14/135

166/1011 170/1021

0.90 (0.71-1.15)

0.79 (0.61-1.01)

0.72 (0.33-1.59)

0.92 (0.74-1.13)

0.87 (0.76-0.99), P=0.038 Overall

Trial TAVR SAVR HR (95% CI)

All-cause Mortality at 2 years (N =3,806)

Subgroup Trials τ2 HR (95% CI) P-inter

Siontis et al. Eur Heart J. 2016 Dec 14;37(47):3503-3512

TAVI VS. SAVR:

MORTALITY IN FEMALE PATIENTS

Balloon-expandable THV

Self-expandable THV

Siontis et al Eur Heart J. 2016 Dec 14;37(47):3503-3512

Meta-analysis of RCTs

Comparing TAVI vs. SAVR

PERMANENT PACEMAKER IMPLANTATION

0%

10%

20%

30%

40%

50%

0 6 12 18 24

All-

Cau

se M

ort

alit

y

Months Post-Procedure No. at Risk

PPI Prior to Procedure With New PPI Without New PPI

P-value (log-rank) = 0.32

10.5%

16.3%

10.1%

Reardon MJ et al N Engl J Med. 2017 Apr 6;376:1321-1331

SURTAVI

PROGNOSTIC IMPACT OF PACEMAKER IMPLANTATION

BALLOON-EXPANDABLE TRANSCATHETER AORTIC

VALVES AND PACEMAKER IMPLANTATION

PARTNER 2A

8.5

9.9

6.9

8.9

0

5

10

15

30-day 1-year

TAVI SAVR

%

P=0.17 P=0.43

Leon MB et al. N Engl J Med 2016

COREVALVE NOTION TRIAL:

LONG-TERM HEMODYNAMIC DATA Søndergaard L, EuroPCR 2017

TAVI SAVR

TAVI VS. SAVR:

TOTAL COSTS

Presented by Cohen D at TCT 2017

0

20000

40000

60000

80000

100000

120000

140000

SAVR XT-TAVR

Follow-up

Index Hosp

0

20000

40000

60000

80000

100000

120000

140000

SAVR S3-TAVR

PARTNER 2A- 2-YEAR SAPIEN 3 IR- 1-YEAR

$ 114,132

$ 55,857

$ 58,545

$ 107,716

$ 46,284

$ 61,433

$ 96,489

$ 38,238

$ 58,250

$ 80,977

$ 26,861

$ 54,117

∆= $ 6,416 (p= 0.014)

∆= $ 15,511 (p<0.001)

Valve costs based on current acquisition costs: TAVI $ 32,500, SAVR $ 5,000

TAVI VS. SAVR:

COST-EFFECTIVENESS @ 2 YEARS

Presented by Cohen D at TCT 2017

PARTNER 2A SAPIEN 3 IR

WILL TAVI REPLACE SURGERY? TAVI HAS THE POTENTIAL TO BECOME A PROCEDURE FOR (NEALRY) ALL PATIENTS WITH AORTIC STENOSIS

SAVR

TAVI

PATIENT – PROSTHESIS MISMATCH

NEW-ONSET AFIB

SAVR

TAVI

STROKE SAVR

TAVI

INVASIVENESS SAVR

TAVI

PACEMAKER SAVR

TAVI

COST EFFECTIVENESS

SAVR

TAVI

AORTIC REGURGITATION

SAVR

TAVI

SIMILAR OR LOWER RISK

NEW GENERATION TAVI DEVICES

BALLOON-EXPANDABLE DEVICES LOWER RISK IN LOW RISK PATIENTS

TAVI=Transcatheter aortic-valve implantation. New York Times. Building a Better Valve (June 20, 2015). Available from http://www.nytimes.com/2015/06/22/health/heart-failure-aortic-valve-disease-tavr.html?_r=0 (Accessed October 2015).

TAVI

Henry Kissinger, 92, the former secretary of state, has had the procedure (TAVI).

“I was getting out of breath more easily, and my cardiologist said something had to

happen,” he said in a telephone interview. “He said I would be in a wheelchair if I didn’t

have it, and my survival rate in a year would be only 50–50.”

“I am more energetic, people tell me I look better, and I feel much less tired,” Mr. Kissinger

said. He described the procedure as easier and less debilitating than the open-heart

bypass surgery he had previously. “There’s no comparison.”