History of syncope, right bundle branch block (RBBB), QRS duration ≥140 ms, and valve oversizing ≥16% are independent predictors of the need for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR), according to study results published in JACC Cardiovascular Interventions.
In this retrospective, single-center study, researchers evaluated consecutive patients undergoing successful first-time TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve System from October 2013 through December 2018 (N=1266). During the initial study period, eligible cases were included in the initial cohort (n=797); patients who did not have preprocedural computed tomographic scans were included in the final derivation cohort (n=731). Researchers subsequently collected data on all eligible cases from September 2017 through December 2018 (n=424) to develop and validate a risk score for pacemaker implantation to be used as a validation cohort and analyzed data for patients with complete preprocedural computed tomographic data (n=367). This model was used to develop the Emory risk score (ERS).
In the derivation cohort, 7.3% of the patients required PMI (n=57). Independent risk factors for PMI included history of syncope (odds ratio [OR] 2.482; 95% CI, 1.112-5.54; P =.026), baseline RBBB (OR 4.333; 95% CI, 2.098-8.951; P <.001), QRS duration ≥138 ms (OR 2.487; 95% CI, 1.174-5.267; P =.017), and valve oversizing >15.6% (OR 1.928; 95% CI, 1.027-3.62; P =.041). These factors were included in the ERS and were strongly associated with PMI (per point increase: OR 2.2; P <.001).
Limitations of this study include its single-center, retrospective design, which limits the ability to make causal associations. The possibility of selection bias in the cohort cannot be ruled out. Researchers did not include a distal landing zone calcium burden as a risk factor. The initial and validation cohorts were different with respect to baseline characteristics. Generalizability of these results may be limited because this study focused exclusively on the SAPIEN 3 valve.
“The [ERS] was highly correlated to and performed well for prediction of need for PMI in the validation cohort. Notably, our risk score performed as well in the validation cohort as it did in the derivation cohort despite notable differences in baseline comorbidities,” the researchers stated.
“To our knowledge, this is the first proposed risk score for the need for PMI after TAVR… A prospective evaluation of the predictive utility of the [ERS] among those receiving this prosthesis should be undertaken. Furthermore, validation of the [ERS] among those receiving other prosthesis types is warranted.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Kiani S, Kamioka N, Black GB, et al. Development of a risk score to predict new pacemaker implantation after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2019;12(21):2133-2142.