Fernando Ramirez Del Val1, Sameer A. Hirji1, Edward T. Carreras2, Ahmed A. Kolkailah1, Ritam Chowdhury3, Siobhan McGurk1, Jiyae Lee1, Charles B. Nyman4, Douglas C. Shook4, Piotr S. Sobieszczyk2, Marc P. Pelletier1, Pinak B. Shah2, Tsuyoshi Kaneko1,51Division of Cardiac Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA
2Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA
3Harvard School of Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA
4Department of Anesthesia and Pain Management, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA
5Electronic correspondence: firstname.lastname@example.org
Background and aim of the study: A lower rate of permanent pacemaker (PPM) has been linked to a target aortic implantation height (AIH) >0.70, following transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. Based on clinical experience, it was hypothesized that a higher AIH (≥0.85) would lower the rate of PPM implantation.
Methods: A total of 127 patients (66 females, 61 males; mean age 82 ± 8 years) underwent TAVR with the SAPIEN 3 valve between May 2015 and July 2016. AIH was defined as the proportion of the valve frame above the aortic annulus in the post-deployment aortogram. A target AIH (≥0.70) was achieved in 113 patients (89%). Cases were stratified into a High Implantation (HI) group (AIH ≥0.85; 33 patients) or a Standard Implantation (SI) group (AIH <0.85; 94 patients).
Results: The mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of all patients was 6.4 ± 3.5%. Preoperative right bundle branch block (RBBB) was prevalent in 13% of SI patients, and in 18% of HI patients
(p = 0.56). There were no significant differences in operative mortality (3.2% versus 0%), median length of stay (2 days versus 3 days) and incidence of moderate-to-severe paravalvular leak (3.2% versus 0%; all p >0.410) between SI and HI patients, respectively. Likewise, the incidence of new PPM did not differ between the two groups (12% in HI versus 13% in SI; p ≥0.99). The mean AIH was similar for patients with PPM implantation (0.80 ± 0.08) compared to those without (0.78 ± 0.06; p = 0.520). Preoperative RBBB was significantly associated with PPM implantation (odds ratio (OR) 10.1; p = 0.002), and patients who underwent PPM implantation had a higher operative mortality (12.5% versus 1%; p = 0.040).
Conclusions: Among TAVR patients who received the SAPIEN 3 heart valve, a higher AIH (≥0.85) was not associated with a lower rate of PPM implantation or increased operative mortality. Prior RBBB was the only independent risk factor for new PPM implantation. Long-term follow up is crucial in determining the clinical significance of PPM implantation.
The Journal of Heart Valve Disease 2018;27:9-16
|Clinical Significance of Greater Implantation Height with SAPIEN 3 Transcatheter Heart Valve|
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