Delayed discharge from hospital following transfemoral transcatheter aortic valve replacement (TAVR) appears to be significantly associated with increased mortality, regardless of the presence of procedure-related complications, according to two research groups.
Their findings support the trend toward early discharge as a result of clinicians’ greater acceptance of “minimalistic TAVR,” which previous studies had found offers better outcomes thanks to improvements in techniques, devices, and clinician experience, according to the authors of the two studies in JACC: Cardiovascular Interventions.
“Delayed discharge was an independent predictor of 1-year all-cause mortality (adjusted hazard ratio [HR] 1.45, 95% CI 1.30-1.60, P< 0.01), even after adjusting for in-hospital complications," said the authors of the first study, led by Siddharth Wayangankar, MD, of the University of Florida in Gainesville.
Writing in an accompanying editorial, Marco Barbanti, MD, of Policlinico–Vittorio Emanuele Hospital in Catania, Italy, said: “I am confident that the ‘minimalistic TAVR’ will be adopted more frequently in the future, and this is the right path to walk. However, I firmly believe that ‘timely’ discharge, rather than ‘early’ discharge, should be the main objective of our practice.”
Wayangankar and co-authors compared outcomes in 24,285 patients (40% of whom were ages 85 or older) who underwent transfemoral TAVR from 2011 to 2015, and survived to discharge; 55% were categorized as having early discharge (within 72 hours) and 45% as late discharge (after 72 hours). The observational subanalysis used data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry.
Over that 4-year period, delayed discharge rates declined from 62% to 34% (P<0.01), and this trend persisted when patients were stratified based on the STS risk or by Transcatheter Valve Therapy (TVT) risk scores, the researchers reported.
Advanced age (85 years and over) as well as exceeding 10 seconds on a walk test (a surrogate marker for frailty) were among many independent predictors for delayed discharge (ORs 1.14 and 1.28, respectively, both P<0.001); these effects may be underestimated, however, since patients discharged to nursing homes were not included, the team noted. Patients in the late-discharge group were likely to have underlying severe lung disease (OR 1.10, P=0.03), history of mitral valve procedure (OR 1.62, P<0.001), and a core valve versus Sapien valve (OR 1.53, P<0.001).
“Our study shows interesting phenomena with respect to length of stay and institutional volume, in that institutions performing 200 to 399 cases per year – [but not those performing fewer than 100 or more than 400 TAVRs per year] – were associated with delayed discharge,” the group wrote. “This may be due to a combination of [optimized] patient selection and proficiency of TAVR programs – whereas institutions who are in between may be trying to increase their institutional volumes but have not yet perfected the art of careful patient selection.”
“Further work needs to be done to determine if predictors of early discharge could be utilized to develop length of stay scores,” Wayangankar said. “These scores could be instrumental in administrative, financial, or clinical policy development regarding delivery of TAVR procedures.”
Study limitations, Wayangankar and co-authors noted, were the observational design; that TAVR practice standards are evolving rapidly; and the use of outcomes data from an administrative database, which introduces the potential for overestimation.
The second study, a smaller, prospective analysis of the safety and efficacy of the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway, found that next-day discharge to home following TAVR was achieved in 80.1% of patients, and within 48 hours in 90%, reported David Wood, MD, of St. Paul’s and Vancouver General Hospitals in British Columbia.
The other primary endpoint, a composite of all-cause mortality or stroke by 30 days, occurred in 2.9% of patients (95% CI 1.7%-5.1%), with low rates of periprocedural complications.
Furthermore, despite a median age of 84 and 14.6% of patients having an STS score ≥8%, readmissions for any reason were noted in 9.2% of patients, with 5.7% related to cardiac causes. Secondary outcomes at 30 days included major vascular complication in 2.4% of patients (n=10), readmission in 9.2% (n =36), cardiac readmission in 5.7% (n =22), a new permanent pacemaker in 5.7% (n =23), and mild paravalvular regurgitation in 3.8% (n=15).
Of 1,400 screened patients, 411 were enrolled at 13 centers, and 55% of screened patients were treated at centers enrolling exclusively in the study. Patients received balloon-expandable SAPIEN XT or SAPIEN 3 transcatheter heart valves (Edwards Lifesciences, Irvine, California).
Investigators chose to enroll patients from six low-volume (<100 TAVR/year), four medium-volume, and three high-volume (>200 TAVR/year) centers in Canada and the U.S. Notably, in contrast to the results in the study by Wayangankar and colleagues, hospital TAVR volume had no effect on either of the primary (P=0.51) or the secondary endpoints.
“The missing center effect of TAVR volume on primary and secondary outcome … cannot be explained with the present limited dataset of selected patients,” wrote Wood and colleagues. They cited other findings suggesting that “concentrating experience in higher volume heart valve centers might be a means of improving outcomes.”
Study limitations, the researchers said, included the use of institutions’ self-reported clinical and hemodynamic outcomes, heterogeneity in patient enrollment, and the potential risk of selection bias.
The 3M TAVR study was funded by an unrestricted grant from Edwards Lifesciences.
Wood reported grant support from Edwards Lifesciences. Several coauthors reported financial relationships with Edwards Lifesciences, Medtronic, and other companies.
Wayangankar is a proctor for Medtronic Valve Therapies. Co-authors reported having no relationships relevant to the contents of the paper.
Barbanti reported financial relationships with Edwards Lifesciences and Biotronik.