In the Journals

Next-generation TAVR system linked to higher pacemaker implantation rate than previous designs

The rate of permanent pacemaker implantation is higher after transcatheter aortic valve replacement with a next-generation balloon-expandable compared with a previous generation of the balloon-expandable valve. However, researchers suggested that the increased need for permanent pacemaker implantation may be associated with the implantation height of the valve.

“It appears advisable to aim at an aortic extension of [greater than] 70% of the total length of the stent,” the researchers wrote in JACC: Cardiovascular Interventions.

The researchers evaluated the first 162 patients to undergo TAVR with the Sapien 3 system (Edwards Lifesciences) at the University Hospital Muenster, Germany, from 2010 to January 2015. These patients were compared with 287 preceding patients who underwent TAVR with the Sapien XT system (Edwards Lifesciences). Eligible participants did not have a pacemaker or implantable cardioverter defibrillator in place before TAVR, were treated for severe native aortic stenosis, and underwent TAVR via the transfemoral route. The two groups did not significantly differ in terms of age, sex, baseline risk profile or pre-existing conduction abnormalities. The researchers monitored all patients for 7 days post-TAVR with continuous electrocardiographic telemetry after implantation. Pre-existing and new conduction abnormalities were recorded, and valve implantation height was assessed in the Sapien 3 group by off-line analysis of procedural fluoroscopy.

The Sapien 3 group had a significant decrease in paravalvular regurgitation compared with the Sapien XT group. Although 2.8% of the patients in the Sapien XT group had moderate paravalvular regurgitation, none of the patients in the XT group had moderate or severe paravalvular regurgitation, the researchers wrote. The onset of any type of new atrioventricular conduction abnormalities was higher in the Sapien 3 group vs. the Sapien XT group (29% vs. 28.9%; P = .022). Moreover, the Sapien 3 group had a higher permanent pacemaker implantation rate compared with the Sapien XT group (19.1% vs. 12.2%; P = .049). Patients in the Sapien 3 group who required a permanent pacemaker had a lower mean implantation height vs. those who did not (aortic/ventricular stent extension: 67%/33% vs. 72%/28%; P = .032). Multivariate logistic regression analysis, which included presence of pre-existing right bundle branch block, implantation height, valve sizing, age and sex, revealed that only implantation height was independently predictive of the need for permanent pacemaker implantation (OR = 0.95; 95% CI, 0.91-0.99).

The researchers noted that a gradual change in the implantation technique toward a higher implantation yielded a significant decrease in the permanent pacemaker implantation rate with the Sapien 3 system.

“These results may have a major impact on the recommendations for how to implant the Sapien 3 in order to avoid unnecessarily high pacemaker rates with their negative impact on long-term outcome after this intervention.” – by Jennifer Byrne

Disclosure: One researcher reports receiving travel support from Abbott, Edwards Lifesciences, Medtronic and St. Jude Medical and consultant fees from Edwards Lifesciences.

 

The rate of permanent pacemaker implantation is higher after transcatheter aortic valve replacement with a next-generation balloon-expandable compared with a previous generation of the balloon-expandable valve. However, researchers suggested that the increased need for permanent pacemaker implantation may be associated with the implantation height of the valve.

“It appears advisable to aim at an aortic extension of [greater than] 70% of the total length of the stent,” the researchers wrote in JACC: Cardiovascular Interventions.

The researchers evaluated the first 162 patients to undergo TAVR with the Sapien 3 system (Edwards Lifesciences) at the University Hospital Muenster, Germany, from 2010 to January 2015. These patients were compared with 287 preceding patients who underwent TAVR with the Sapien XT system (Edwards Lifesciences). Eligible participants did not have a pacemaker or implantable cardioverter defibrillator in place before TAVR, were treated for severe native aortic stenosis, and underwent TAVR via the transfemoral route. The two groups did not significantly differ in terms of age, sex, baseline risk profile or pre-existing conduction abnormalities. The researchers monitored all patients for 7 days post-TAVR with continuous electrocardiographic telemetry after implantation. Pre-existing and new conduction abnormalities were recorded, and valve implantation height was assessed in the Sapien 3 group by off-line analysis of procedural fluoroscopy.

The Sapien 3 group had a significant decrease in paravalvular regurgitation compared with the Sapien XT group. Although 2.8% of the patients in the Sapien XT group had moderate paravalvular regurgitation, none of the patients in the XT group had moderate or severe paravalvular regurgitation, the researchers wrote. The onset of any type of new atrioventricular conduction abnormalities was higher in the Sapien 3 group vs. the Sapien XT group (29% vs. 28.9%; P = .022). Moreover, the Sapien 3 group had a higher permanent pacemaker implantation rate compared with the Sapien XT group (19.1% vs. 12.2%; P = .049). Patients in the Sapien 3 group who required a permanent pacemaker had a lower mean implantation height vs. those who did not (aortic/ventricular stent extension: 67%/33% vs. 72%/28%; P = .032). Multivariate logistic regression analysis, which included presence of pre-existing right bundle branch block, implantation height, valve sizing, age and sex, revealed that only implantation height was independently predictive of the need for permanent pacemaker implantation (OR = 0.95; 95% CI, 0.91-0.99).

The researchers noted that a gradual change in the implantation technique toward a higher implantation yielded a significant decrease in the permanent pacemaker implantation rate with the Sapien 3 system.

“These results may have a major impact on the recommendations for how to implant the Sapien 3 in order to avoid unnecessarily high pacemaker rates with their negative impact on long-term outcome after this intervention.” – by Jennifer Byrne

Disclosure: One researcher reports receiving travel support from Abbott, Edwards Lifesciences, Medtronic and St. Jude Medical and consultant fees from Edwards Lifesciences.