SHA24/069004

Surgery or percutaneous aortic valve replacement, what is the best?

ď “

History

 The first successful surgical replacements of diseased human

heart valves were reported in 1960. 

We have been forced to rely on observational studies of patients receiving prosthetic valves.



Despite that, the effect of aortic valve replacement on survival was un-doubtful.

History

Effects of aortic valve replacement on survival Schwarz et al. Circulation, November 1982.

Natural history of aortic stenosis

ď “ Ross J, Braunwald E. Aortic stenosis, circulation 1968;38.

Natural history of aortic stenosis

ď “ Ross J, Braunwald E. Aortic stenosis, circulation 1968;38.

ACC/AHA Guidelines for Treatment of AS  Aortic Valve Replacement (AVR) is a Class I indication  in symptomatic patients with severe AS

>30% of Patients with Severe Symptomatic AS are “Untreated”!

First in man implantation

Building the clinical evidence

PARTNER B 2 year: All cause mortality (ITT)

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

PARTNER A Trial

Cost effectiveness TF vs AVR

Cost effectiveness TF vs AVR

Cost effectiveness TA vs AVR

Cost effectiveness TA vs AVR

How to decrease complications in TAVR?

Core valve 30 day mortality

Core valve 30 day stroke rate

Stroke following SAVR and TAVR

Core valve vascular complications

TAVR 2002-2012

November 2, 2011

FINALLY…we’re off and running!

TAVR 2002-2012

FDA approves “high surgical risk” indication for transcatheter Sapien heart valve (both TF and TA)

October 19, 2012

AND NOW…we’re catching up!

Can we extend the indications to lower risk surgical patients?

JACC 2012;59

RCT TAVI vs. SAVR Intermediate risk Medtronic SURTAVI Edward PARTNER II

RCT TAVI vs. SAVR Intermediate risk

RCT TAVI vs. SAVR Intermediate risk

Summary

 TAVI is transformational technology for suitable patients

with symptomatic severe AS who are inoperable or high risk for SAVR.  The impact of TAVI on both quality and quantity of life is

profound, but it is not free of potential complications.  Expanding the indications to intermediate risk patients will

be answered by SURTAVI and PARTNER II in the future.

Summary

ď “ TAVI or SAVR

does not matter?

ď “ Multidisciplinary team approach ( cardiac surgeon,

interventional cardiologist, echocardiographer, imaging, anesthesia) benefits patients.