Tom Nguyen, MD: TAVR Explantation Outcomes with Balloon- vs Self-Expandable Valves

Few advancements since the turn of the century have been lauded by the cardiology community as transcatheter aortic valve replacement (TAVR). Since the first approval of TAVR fore severe aortic stenosis in 2011, the approach has become the dominant form of aortic valve replacement in the US as early as 2019, according to the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry.²

As demand, as well as the indications for TAVR, increased, the community has developed a need to better understand outcomes following TAVR explantation.

“I think in medicine, we are really moving in a direction where we are not just thinking about the now, explained study investigator Tom Nguyen, MD, chief medical executive Miami Cardiac and Vascular Institute and director of Minimally Invasive Surgery at Baptist Health. “But we really need to start thinking about the future and direction of what happens next for the patient and what's going to be best for the patient.”

A new study conducted on behalf of the EXPLANT-TAVR registry investigators is offering further insight into outcomes of surgical explantation following failed TAVR based on transcatheter heart valve type.¹

An analysis of the EXPLANT-TAVR registry, investigators assessed the database for individuals who underwent TAVR explantations during a separate admission from the initial TAVR between November 2009 to February 2022. an international, multicenter registry of patients who have had surgical explantation of a transcatheter heart valve after TAVR, the registry compiled data from 42 centers across the world and provided investigators with information related to 401 patients for inclusion in their analysis.¹

Of note, 10 of the 401 were excluded based on receipt of a mechanically expandable valve. Overall, 202 patients with failed balloon-expandable valves and 189 with failed self-expanding vales were identified for inclusion.¹

This 391 patient cohort had a mean age of 73.0 (Standard deviation, 9.8) yeas, 33.8% were female, and the median time from index TAVR to explantation was 13.3 (Interquartile range, 5.1-34.8) months, with no significant differences between groups. The most common indications for explantation among both groups were endocarditis (36.0% failed SEV vs 55.4% failed BEV; P <.001), paravalvular leak (21.2% vs 11.9%; P=.014), structural valve deterioration (30.2% vs 21.8%; P = .065), and prosthesis-patient mismatch (8.5% vs 10.4%; P = .61).¹

Upon analysis, investigators discovered a non-significant trend toward fewer urgent/emergency surgeries (52.0% vs 62.3%; P = .057) and more root replacement (15.3% vs 7.4%; P = .61)in the self-expandable valve group relative to the balloon-expandable valve group. Further analysis revealed 57.8% of patients underwent concomitant cardiac procedures during explantation, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups.¹

Additionally, investigators highlighted rates of in-hospital, 30-day, and 1-year mortality and stroke rates were between the study groups and no differences in cumulative mortality were observed at 3 years. In multivariable analysis, results indicated concomitant mitral surgery was an independent predictor of 1 year mortality for both balloon-expandable valve explant (Hazard ratio [HR], 2.00; 95% Confidence Interval [CI], 1.07-3.72) and self-expandable valve explant (HR 2.00; 95% CI, 1.08-3.69).¹

For more on the study and how it adds to the existing knowledge base, check out our interview with Nguyen.

Relevant disclosures for Nguyen include Edwards Lifesciences, CryoLife, and Abbott.

References:

1. _{^{Zaid S, Kleiman NS, Goel SS, et al. Impact of transcatheter heart valve type on outcomes of surgical explantation after failed transcatheter aortic valve replacement: the EXPLANT-TAVR international registry. EuroIntervention. 2024;20(2):e146-e157. Published 2024 Jan 15. doi:10.4244/EIJ-D-23-00722}}
2. _{^{American College of Cardiology. Report finds Tavr is dominant form of aortic valve replacement, outcomes steadily improving in the United States. American College of Cardiology. November 16, 2020. Accessed February 16, 2024. https://www.acc.org/about-acc/press-releases/2020/11/16/18/53/report-finds-tavr-is-dominant-form-of-aortic-valve-replacement-outcomes-steadily-improving-in-the-us.}}