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Predictors of permanent pacemaker implantations and new-onset conduction abnormalities with the SAPIEN 3 balloon-expandable transcatheter heart valve

Selected in JACC Cardiovascular Interventions by M Bollati

References

Authors

Husser O, Pellegrini C, Kessler T, Burgdorf C, Thaller H, Mayr NP, Kasel AM, Kastrati A, Schunkert H, Hengstenberg C

Reference

JACC Cardiovasc Interv. 2016 Feb 8;9(3):244-54

Published

February 2016

Link

Read the abstract

My Comment

What is known

The real clinical effect of conduction abnormalities and the need for permanent pacemaker (PPM) implantation following Trans Catheter Aortic Valve Replacement (TAVR) remain controversial.

With the widening of TAVR indication for moderate risk patients, PPM implantation may become an even more relevant entity.

Data from the literature are discordant: in the PARTNER (Placement of Aortic Transcatheter Valves) trial analysis, PPM implantation is not related to worse outcome (excluding higher in hospital stay and cost). On the other hand, some data suggest a mortality related to PPM implantation.

Research question

The trial by Mauri et al seek for new-onset conduction disturbances requiring PPMI factors after Edwards Sapien 3 (ES3) TAVR.

Methodology

Prospective registry of ES3TAVR between August 2013 and January 2016, excluding patients with previous PPM and TAVR procedural failure.

Major findings

229 patients with a mean age of 80 years and a European System for Cardiac Operative Risk Evaluation score of 15.6% underwent ES3TAVR. 44% were women and the baseline characteristics were similar between patients with or without PPMI, except preexisting right bundle branch block (RBBB, more frequent in PPMI group, 15.2% vs. 2.0%; p=0.004).

PPMI was required in 14.4% (88% atrioventricular complete block) of cases, with occurrence on the first day in 87.9%. PPMI related adverse events occurred in 9.1% (cardiac tamponade, bleeding or pneumothorax).

On multivariate regression analysis, calcium volume in the area below the left coronary cusp (LVOTLC) >13.7 mm3, LVOT below the right coronary cusp calcium volume >4.8 mm3, pre-existing right bundle branch block and implantation depth >25.5% resulted as independent PPMI predictors.

My comment

The PPMI occurrence after balloon expandable TAVR in the Mauri work report is lower than the one from the literature (up to 24% PPMI rate is reported by some trials) and there are some concerns about the PPMI outcome, considering the very high complication rate (up to 9%), including 3% of cardiac tamponade.

After that, reported PPMI predictors are intuitive and consistent, but other variables (as valve oversizing and post dilatation) seemed to be not related to the main endpoint just for the low statistical power of the registry.

Moreover, the main question point remains the PPMI influence on midterm events occurrence (including survival), considering the potential biased effect of variables as RBBB and calcium in LVOT.

Summarizing, PPMI post TAVR is an event depending from several factors, related to:

  • Valvular device type,
  • Implantation technique (higher ventricular protrusion),
  • Patient conditions (RBBB, calcium LVOT).

In conclusion, as every medical maneuver, we need to consider all these elements together when approaching TAVR, and give the right prosthesis with the right implantation technique to the right patient.

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