Author + information
- Costanza Pellegrini1,
- Oliver Husser1,
- Won Kim2,
- Andreas Holzamer3,
- Thomas Walther2,
- Tobias Rheude1,
- Teresa Trenkwalder1,
- Jonathan Michel4,
- Adnan Kastrati1,
- Heribert Schunkert1,
- Christof Burgdorf5,
- Michael Hilker3,
- Helge Möllmann6 and
- Christian Hengstenberg1
Preliminary reports show a low rate of permanent pacemaker implantation (PPI) in patients undergoing transcatheter aortic valve implantation (TAVI) with the novel self-expanding transcatheter heart valve ACURATE neo (NEO) (SYMETIS SA, Eclubens, Switzerland). However, the incidence of PPI and new-onset conduction abnormalities (CA) has not been studied in large populations. Further, PPI rate is largely influenced by parameters, such as prosthesis oversizing and implantation depth. Thus, we analyzed its influence on PPI and on the composite endpoint “PPI and new-onset CA” (PPI/new-onset CA).
Between January 2014 and January 2016, 312 patients underwent TAVR with NEO in three German TAVI centers. Of these, 276 consecutive patients without prior pacemaker and 189 patients without baseline CA were studied. Core lab evaluation of the final aortic angiogram showing the prosthesis in an orthogonal view was performed to thoroughly assess implantation depth in the left ventricular outflow tract and CT was used for sizing. ECGs before and after TAVI were evaluated for new-onset CA.
New PPI occurred in 9.8% (27/276). Patients requiring PPI had a higher BMI (27±5kg/m2 vs. 30±6kg/m2; p=0.024), increased prevalence of complete right bundle branch block (22% vs. 6%; p=0.004) and bradycardia (<60bpm, 30% vs. 13%; p=0.037). PPI/new- onset CA occurred in 27% (51/189) of patients having a higher logistic EuroSCORE of 19±12% vs. 16±9%; p=0.030. Neither prosthesis oversizing by area nor implantation depth influenced the rate of PPI or PPI/new-onset CA (see Table). Throughout quartiles of consecutive patients treated with NEO, there was no sign of a learning curve on the incidence of PPI (p= 0.70) and PPI/new-onset CA (p= 0.62).
|PPI +||PPI -||PPI/new-onset CA +||PPI/new-onset CA-||p-value|
|Prosthesis oversizing *||42.2±8.4%||42.4±10.2||41.6±7.5||42.2±10.7||0.68|
|Implantation depth#||6.9±1.2||7.1±1.4||7.3±1.5||7.2 ±1.5||0.67|
In this multicenter study with the novel self-expandable NEO, we found a low rate of new PPI and new-onset CA. Degree of prosthesis oversizing by aortic annular area or implantation depth was not associated with an increase in both, PPI alone or PPI/new-onset CA.
STRUCTURAL: Valvular Disease: Aortic