Sapien 3 Ups Need for Pacemaker Compared With Its Predecessor, But Reduces Moderate-Severe Paravalvular Leak

The newer Edwards Sapien 3 transcatheter heart valve carries a higher risk of permanent pacemaker implantation than does the older Sapien XT valve, a difference stemming from low (deeper) valve placement, according to a single-center study published online November 19, 2014, ahead of print in EuroIntervention. High valve placement seems to mitigate the added risk with the newer valve.

“From a clinical standpoint, a slight modification of the implantation technique of the Edwards Sapien 3 to get a higher final aorto-ventricular ratio may improve significantly the outlook of patients treated with this kind of valve in terms of the need for permanent pacemaker implantation,” Giuseppe Tarantini, MD, PhD, of the University of Padova (Padova, Italy), and colleagues write. 

The researchers examined data from 209 patients who underwent TAVR at their center from July 2010 to July 2014 and who had no prior history of pacemaker implantation; 179 received the Sapien XT and 30 received the Sapien 3 valve (both Edwards Lifesciences).

Pacemaker Rates Doubled at 30 Days 

At 30 days after TAVR, the rate of permanent pacemaker implantation with guideline-defined class I or IIa indications (primary endpoint) was 20.7% with Sapien 3 and 10.0% with Sapien XT (P = .009). Most of the pacemaker implantations resulted from third-degree atrioventricular (AV) block, either persistent (85.4%) or paroxysmal (9.9%).

The higher pacemaker requirement with Sapien 3 remained in a propensity-matched analysis that included 29 patients in each group (20.6% vs 3.4%; P < .001). Rates of death, stroke, MI, congestive heart failure, bleeding, and other outcomes did not differ based on valve type.

The odds of needing a permanent pacemaker by 30 days were higher overall for Sapien 3 compared with Sapien XT (OR 7.51; 95% CI 1.17-48.04). However, that disparity was driven by patients with low Sapien 3 placement, defined by a valve depth ≥ 8 mm (OR 16.46; 95% CI 2.24-120.97). When patients with high placement were compared, regardless of whether they received Sapien 3 or XT, the need for pacemaker was similar between both devices (OR 3.27; 95% CI 0.37-28.69).

Furthermore, ROC curve analysis suggested that a valve depth < 8 mm represented “the best compromise” in terms of reducing need for permanent pacemaker with Sapien 3 (sensitivity 63%, specificity 86%, and area under the curve 71.4%). 

“With respect to the relationship between the predeployment position of the central marker and valve implantation depth, when the initial position of the central marker was from 0 to 3 mm above the ‘base-of-the-cusps’ line, the final [Sapien 3] depth was never ≥ 8 mm,” the authors note. 

Sapien 3 Lessens Paravalvular Leak 

Paravalvular leak and permanent pacemaker implantation following TAVR have both been associated with worse outcomes, albeit inconsistently.

According to the study authors, Sapien 3 was designed with an external fabric cuff to minimize paravalvular leak, and the valve was associated with numerically lower rates of moderate-to-severe paravalvular regurgitation in both the overall study population (0% vs 10%; P = .06) and the propensity-matched cohort (0% vs 6.9%; P = .16) compared with Sapien XT.

The findings are consistent with those of the SAPIEN 3 trial, which showed a low rate of paravalvular leak (3.4%) and a relatively high 30-day rate of permanent pacemaker implantation (13.3%).

“However, higher valve implantation… significantly reduces the risk of [permanent pacemaker implantation] with [Sapien 3], without affecting the risk of paravalvular leak development or valve malposition,” Dr. Tarantini and colleagues write. “These data are consistent both with the early experiences with [Sapien XT] as well as with pathology findings showing that the AV conduction system arises on the left side of the interventricular septum at least 7 mm below the interleaflet triangle located between the right and the noncoronary cusps. 

“In view of this, a valve depth < 8 mm as a ‘safety threshold’ might prevent direct interactions between the valve frame and the AV conduction system,” they write.  

 


Source: 

Tarantini G, Mojoli M, Purita P, et al. Unraveling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2014;Epub ahead of print.

Disclosure: 

  • Dr. Tarantini reports receiving lecture fees from Edwards Lifesciences.

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