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SAVR Beats Expectations in Intermediate Risk Trial

— Lower mortality than surgical risk score predicted in PARTNER 2A

Last Updated January 25, 2017
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HOUSTON -- Detailed analysis of the intermediate surgical risk cohort of the PARTNER 2 trial turned up better than expected survival after surgical aortic valve replacement (SAVR), researchers reported here.

The all-cause 30-day operative mortality rate of 4.1% was a relative 22% lower than the expected 5.8% rate predicted by STS surgical risk score, , of Emory University in Atlanta, reported at the Society of Thoracic Surgeons annual meeting.

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Renal failure requiring dialysis was also 56% lower than expected among these 937 intermediate-risk patients who got SAVR as part of the PARTNER 2A trial, whereas deep sternal wound infections were about twice expected.

Although the 5.4% in-hospital stroke rate was twice what was predicted, that was likely the effect of looking harder, Thourani suggested, because the trial prespecified neurologic assessment for all patients postoperatively.

The overall 2-year results showing noninferiority between surgical and transcatheter approaches for intermediate-risk patients were published last year in the New England Journal of Medicine, which many considered a win for the less invasive approach.

But, "the bottom line is patients who end up with SAVR can expect great results," said , of the University of Southern California in Los Angeles, as moderator of a press conference.

Thourani agreed calling the results "excellent," and noted that surgery does still hold the advantage of more long-term data showing very little degradation and less paravalvular leakage.

Beyond surgical risk score alone, age matters in these decisions too, noted Cohen. "We need to flesh out the data a little more specifically, rather than just rely on percentile STS to answer some of these questions."

Other findings of note in the analysis included that, among the about 80% of patients with isolated AVR, minimally invasive AVR did not result in increased mortality or more strokes compared to full sternotomy.

Also, the one-third of patients who had severe prosthesis-patient mismatch, had similar survival to those without severe mismatch.

Disclosures

The PARTNER 2 trial was supported by Edwards Lifesciences.

Thourani disclosed relevant relationships with Edwards Lifesciences.

Primary Source

Society of Thoracic Surgeons

Thourani V, et al "Clinical and echocardiographic outcomes in 937 intermediate-risk patients undergoing surgical aortic valve replacement in PARTNER 2A" STS 2017.