Frailty Ups Early Death, Stroke Risk After Either TAVR or SAVR

Larry Hand

November 02, 2016

WASHINGTON, DC — Frailty among the elderly may increase the hazard for death and other adverse events after transcatheter aortic-valve replacement (TAVR) or surgical aortic-valve replacement (SAVR), according to research presented at TCT 2016 and published simultaneously as an abstract in the Journal of the American College of Cardiology[1].

"If patients have several markers of frailty and they're otherwise at intermediate risk, 2-year outcomes are similar. But there's probably an increased early hazard for death and stroke among the frail, which should be taken seriously," Dr Philip Green (Columbia University Medical Center, New York) told heartwire from Medscape.

As part of the Placement of Aortic Transcatheter Valves 2A (PARTNER 2A) randomized trial, Green and colleagues analyzed outcomes of 1998 participants (mean age 82) after TAVR or SAVR. Of those patients, 958 (48%) were frail based on a composite assessment of gait speed, grip strength, activity of daily living, and albumin levels.

"Frail patients were slightly older. There was a greater proportion of those older than 90," Green said during the presentation. Body-mass index "was actually much higher in the frail group. The frail group had more lung disease, more renal failure, more atrial fibrillation."

Of the 958 frail patients, 476 had been randomized to TAVR and 482 to SAVR. Of the 1040 nonfrail patients, 526 had been randomized to TAVR and 514 to SAVR.

"Bleeding rates were slightly higher among the frail group" at 30 days postprocedure (63.5% vs 57.0%), Green said. Other 30-day outcome comparisons included death or disabling stroke (7.8% vs 6.5%) and acute kidney injury (26.8% vs 25.6%).

"There's a strong increased hazard for death at 2 years between the frail group and not-frail group," Green said, although the risk curve begins to even out between the two groups after a few months. Risk of death at 2 years was 20.1% among the frail, compared with 14.8% among the not-frail (hazard ratio [HR] 1.40, 95% CI 1.13–1.74; P=0.002).

Major Predictors of Death

Predictor HR 95% CI P
Renal disease 1.65 1.12–2.41 0.01
Prior MI 1.62 1.25–2.09 0.0003
Atrial fibrillation 1.57 1.26–1.96 <0.0001
Frailty 1.27 1.02–1.58 0.03

"It's important to note that there was no interaction between TAVR or SAVR and frailty status. Among the frail there's no difference between transcatheter and surgical treatment. And among the nonfrail there was no difference," Green said.

"When we looked at the frail cohort, surgical patients did experience an increased hazard of disabling stroke the first 3 months after the procedure," he said, but that was attenuated over 2 years.

Green reported no relevant financial relationships.

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