Permanent Pacemaker Predictors with SAPIEN 3

The aim of this study was to identify permanent pacemaker (PPM) predictors after transcatheter aortic valve replacement (TAVR) with last generation balloon expandable valve Edwards SAPIEN 3.

The new conduction disturbances requiring PPM are one of the biggest concerns after TAVR, and their predictors have not yet been defined.

229 patients undergoing TAVR with balloon expandable SAPIEN 3 were analyzed looking into:

• influence of angiographic implantation depth
• device landing zone calcium volume
• oversizing
• pre and post dilation
• baseline conduction disturbances

In all, 14.4% of patients required PPM implantation.

Those requiring PPM presented higher left ventricular outflow tract (LVOT) in the area below the left coronary cusp (23.7 mm3 vs. 3.0 mm3; p<0.001) and under the right coronary cusp (6.6 mm3 vs. 0.3 mm3; p=0.014).

There was also higher prevalence of right bundle branch block in patients receiving PPM (15% vs. 2%, p=0.004) and lower implantation depth (ventricular portion 29 ± 12% vs. 21 ± 5%; p<0.001).

After multivariable analysis PPM predictors were:

• LVOT calcium volume in the area below the left coronary cusp higher than 13.7 mm3
• LVOT calcium volume in the area below the right coronary cusp higher than 4.8 mm3
• Baseline bundle branch block
•  25.5% or higher ventricular portion, as regards implantation depth.

When modifying implantation technique aiming at higher valve implantation, implantation depth decreased from 24% to 21% (p = 0.012) ventricular portion, accompanied by a decrease in PPM rate (19.2% vs. 9.2%; p=0.038).

Conclusion

Left ventricular outflow track below the left and right coronary cusps, right bundle branch block and implantation depth are independent predictors of PPR need after TAVR. Patients can be stratified using all four variables. Slightly higher implantation could reduce PPM rate.

Editorial Comment

This analysis addresses the fact that PPM need is not as innocuous as we used to think. Initially, a systematic review and meta-analysis carried out by Dr. Ander Regueiro and published in Circ Cardiovasc Interv had concluded that PPM need does not increase mortality rate.

However, later studies by Dr. Opeyemi and Dr. Gennaro Giustino, published in J Am Coll Cardiol Intv and EuroIntervention respectively, showed PPM need was associated to events such as death.

Recent studies comparing the SAPIEN XT with the SAPIEN 3 have suggested the last generation valves (SAPIEN 3) show less paravalvular leak but more PPM need (Fernando De Torres-Alba et al. J Am CollCardiolIntv).

We should bear in mind all the above mentioned studies were published in 2016, which means there is nothing permanent about PPM need after TAVR.

Original Title: Predictors of Permanent Pacemaker Implantation after Transcatheter Aortic Valve Replacement with the SAPIEN 3.

Reference: Victor Mauri et al. J Am Coll Cardiol Intv. 2016;9(21):2200-2209.

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