September 29, 2017
2 min read

Moderate paravalvular regurgitation may increase 1-year mortality rates

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Moderate or severe paravalvular regurgitation, although rare, is linked to a significantly increased risk for mortality and HF rehospitalization at 1 year in patients undergoing transcather aortic valve replacement, according to new data from the PARTNER II SAPIEN 3 trial.

“Studies have shown that TAVR is equivalent to surgical aortic valve replacement in patients at intermediate surgical risk, Philippe Pibarot, DVM, PhD, from the Institut universitaire de cardiologie et de pneumologie de Québec, and colleagues wrote. “However, paravalvular regurgitation (PVR) is an important complication of TAVR that has been shown to be associated with increase mortality for both the balloon-expandable and the self-expanding transcatheter heart valves.”

Pibarot and colleagues examined the incidence, evolution and effect on 1-year outcomes of PVR after TAVR with the third-generation balloon-expandable transcatheter heart valve (Sapien 3, Edwards Lifesciences). A total of 1,592 patients were implanted with the valve and assessed for PVR.

  • A 30-day follow-up showed that of the patients who received the valve:
  • 55.7% had none or trace PVR;
  • 32.6% had mild PVR;
  • 8.2% had mild to moderate PVR; and
  • 3.5% had at least moderate PVR at 30 days.


A total of 9.3% of patients had died and 14.2% had been rehospitalized for HF at 1 year.

Compared with the other three groups, patients who had at least moderate PVR had significantly higher rates of 1-year mortality (HR = 2.4; 95% CI, 1.3-4.43) and a composite of mortality and rehospitalization (HR = 2.35; 95% CI, 1.52-3.62).

A 1,213-patient paired comparison showed that 73% of the patients with at least moderate PVR at 30 days showed a reduction in PVR severity of at least one class at 1 year.

“Given that patients with at least moderate PVR at 30 days harbor a 2.4-fold increase in 1-year mortality and that it is difficult to predict who among the survivors will exhibit a regression of PVR, it is essential to make every effort to avoid at least moderate PVR at the time of TAVR,” the researchers wrote. “This effort includes comprehensive periprocedural imaging to assess the presence and severity of PVR as well as the use of corrective procedures if at least moderate PVR is present.” – by Dave Quaile

Disclosures: The study was funded by Edwards Lifesciences. Pibarot reports he has a core lab contract with Edwards from which he receives no compensation. Please see the study for the other authors’ relevant financial disclosures.