TAVI: Good Outcomes with Intermediate Risk

Original Title: Transcatheter Aortic Valve Replacement versus Surgical Valve Replacement in Intermediate-Risk Patients: A Propensity Score Analysis. Reference: Vinod H Thourani et al. Lancet Published Online April 3, 2016.

Courtesy of Dr. Carlos Fava.

The transcatheter Aortic Valve Replacement (TAVI) has shown benefits in high risk patients or inoperable patients, but there is little evidence on intermediate and low patients.

The PARTNER 2 population receiving the SAPIENS 3 valve was compared to the PARTNER 2A cohort receiving surgery.

The clinical events committee and echocardiographic core laboratory methods were the same for both studies.

The Heart Team considered intermediate risk a STS <4. Those presenting bicuspid aorta, FEY <20% and severe kidney failure were excluded. Multislice computed tomography was mandatory.

Primary end point was a combination of all cause death, stroke and moderate to severe aortic regurgitation incidence.

1077 patients receiving TAVI and 944 receiving surgery were included. The sample was matched with propensity score.

TAVI resulted superior to surgery in primary end point at one year (weight proportion difference -9.2%; p<0.0001), in the individual of death (-5.2%; p=0.0003) and stroke (-3.5%; p=0.0038). Surgery was superior to TAVI in the presence of moderate to severe regurgitation (1.2%; p=0.149).

The presence of moderate to severe aortic regurgitation was associated to higher mortality (13.3% vs 4.5% p<0.01).
Hospitalization was higher in those undergoing surgery.

There was no difference in definite pacemaker requirement at one year (12.4% vs. 9.4%), neither in endocarditis, or rehospitalization.

Conclusion
The transcatheter aortic valve replacement with the latest generation balloon expandable SAPIENS 3 in patients with severe aortic stenosis and intermediate surgical risk is associated with low mortality, stroke and aortic regurgitation at one year. Propensity score matching indicates the superiority of TAVI compared to surgery, which could make it the preferred treatment for intermediate risk patients.

Editorial Comment
The development of the new valves in addition to operators and hospital experience, allows better outcomes and furthers progress in patients of lower risk.

It is necessary to show the durability of long term valves, since they are being implanted in patients with longer survival than inoperable and high risk patients.

Courtesy of Dr. Carlos Fava.
Interventional Cardiologist
Favaloro Foundation – Buenos Aires

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