A registry study has linked the introduction of newer-generation medical devices to a decline in the need for patients to receive pacemakers after transcatheter aortic valve replacement procedures.
The 1,987-subject study found 7.4% of recipients of older transcatheter heart valves, such as Edwards Lifesciences’ Sapien and Medtronic’s CoreValve, required permanent pacemakers. The rate fell to 4.7% after the introduction of newer heart valves.
With the pacemaker rate coming in below the levels seen in other studies, the registry results provide encouragement that one of the primary complication concerns of TAVR is moving in the right direction. However, in an accompanying editorial, Colin Barker, an interventional cardiologist at Vanderbilt University Medical Center, contends "eliminating the risk that a pacemaker will be required after TAVR would be ideal but is unrealistic."
The risk of needing permanent pacemaker implantation is an established downside of TAVR. When Boston Scientific compared its Lotus valve to Medtronic's CoreValve, respectively 41.7% and 26.1% of participants needed new permanent pacemakers. That study began in 2014. Boston Scientific has since pulled its Lotus Edge valve off the market.
Studies of newer TAVR devices have suggested the rate is now lower but the evidence is limited.
Researchers at institutions around the world responded to the evidence gap by analyzing the multicenter VIVID Registry and publishing their findings in the Journal of the American College of Cardiology. The study provides evidence that the need for pacemakers fell when new TAVR devices came to market.
The researchers classed Medtronic's CoreValve and Edwards' Cribier-Edwards, Sapien and Sapien XT as older devices. All other valves, such as Medtronic's Evolut R and Edwards' Sapien 3, were classed as new-generation products.
The difference in the rates of pacemaker use in recipients of older and newer valves was driven by the Medtronic valves. In the registry, 9.0% of recipients of the first CoreValve needed a permanent pacemaker after the procedure. The rate of pacemaker use fell to 3.7% in recipients of the Evolut R and Evolut Pro valves.
In his editorial, Barker said the results "are encouraging considering the low pacemaker rate, but caution is warranted regarding the increased mortality rate in those who did require pacemakers." The study found no significant difference in 30-day mortality but saw "a trend toward higher mortality risk at follow-up" in patients with pacemakers.
Barker, who is an advisory board member for Medtronic and Boston Scientific, wants to see the rate of post-TAVR pacemaker implantation fall to below 1%. "One of the Achilles' heels of TAVR in native valve disease is the potential risk or need for permanent pacemaker implantation (PPI) after the procedure because of conduction disturbances," he wrote.
The interventional cardiologist said the "type of valve, balloon-expandable or self-expanding, is not an issue anymore" but new strategies are needed to predict who is likely to need pacemakers. Barker also proposed using "hybrid temporary pacemakers that can be removed or converted to permanent after discharge depending on the need."