Dataset Information

Physicians' perspectives and attitudes toward surgical bailout in transcatheter aortic valve replacement.

ABSTRACT:

Objectives

The incidence of surgical bailout during transcatheter aortic valve replacement (TAVR) is ∼1%, with an associated 50% in-hospital mortality. We performed an exploratory qualitative study of TAVR team perceptions regarding routine surgical bailout planning with patients.

Methods

We developed a semistructed interview guide to explore clinician perspectives on the TAVR consent process, managing intraoperative emergencies, and involving patients in surgical contingency planning. We interviewed surgeons, cardiologists, and anesthesiologists involved with TAVR in 4 hospitals. We performed qualitative thematic analysis via independent coding of salient quotations from the transcribed texts. Codes were categorized based on shared meaning and the final themes were derived by identifying key content, and examining its relational nature.

Results

Thirteen interviews were conducted, identifying 4 major themes. Participants agreed that eliciting patient preference for bailout is crucial, particularly when surgical outcome is ambiguous. In those cases, participants offered criteria for determining which patients should be engaged in a more nuanced discussion. The ethos of specialty clinicians impacted anticipation and response to procedural emergencies. Finally, physician attitudes reflected strong emotional responses to patient death/morbidity, particularly in iatrogenic injury. Participants expressed anxiety with performing TAVR without surgical backup, while also demonstrating willingness to respect patients' wishes.

Conclusions

The TAVR team supports engaging patients regarding potential surgical bailout and honoring their preferences in the event of complication. However, clinical judgment about the expected outcome of bailout would frame that discussion. Participants described the emotional weight of not pursuing bailout if indicated and the importance of good coping mechanisms.

SUBMITTER: Robbins AJ

PROVIDER: S-EPMC9390286 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Physicians' perspectives and attitudes toward surgical bailout in transcatheter aortic valve replacement.

Robbins Alexandria J AJ Grande Stuart W SW Alwan Fatima F Soule Matthew R MR Raveendran Ganesh G Helmer Gregory G Andrade Rafael R Perry Tjorvi T

JTCVS open 20220121

<h4>Objectives</h4>The incidence of surgical bailout during transcatheter aortic valve replacement (TAVR) is ∼1%, with an associated 50% in-hospital mortality. We performed an exploratory qualitative study of TAVR team perceptions regarding routine surgical bailout planning with patients.<h4>Methods</h4>We developed a semistructed interview guide to explore clinician perspectives on the TAVR consent process, managing intraoperative emergencies, and involving patients in surgical contingency plan ...[more]

PMID: 36003484

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Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Project description:Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve replacement (rAVR) have shown inconsistent results. Methods and Results PubMed/MEDLINE, Google Scholar, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through December 2021. Meta-Analysis of Observational Studies in Epidemiology guidelines were followed. The protocol was registered at the International Prospective Register of Systematic Reviews. Random effects models were applied. The primary outcomes of interest were short-term and midterm mortality. Secondary outcomes included stroke, myocardial infarction, acute renal failure, and permanent pacemaker implantation, as well as prosthetic aortic valve regurgitation, mean transvalvular gradient, and severe prosthesis-patient mismatch. Of 8881 patients included in 15 studies, 4458 (50.2%) underwent ViV and 4423 (49.8%) rAVR. Short-term mortality was 2.8% in patients undergoing ViV compared with 5.0% in patients undergoing rAVR (risk ratio [RR] 0.55 [95% CI, 0.34-0.91], P=0.02). Midterm mortality did not differ in patients undergoing ViV compared with patients undergoing rAVR (hazard ratio, 1.27 [95% CI, 0.72-2.25]). The rate of acute kidney failure was lower following ViV, (RR, 0.54 [95% CI, 0.33-0.88], P=0.02), whereas prosthetic aortic valve regurgitation (RR, 4.18 [95% CI, 1.88-9.3], P=0.003) as well as severe patient-prothesis mismatch (RR, 3.12 [95% CI, 2.35-4.1], P<0.001) occurred more frequently. The mean transvalvular gradient was higher following ViV (standard mean difference, 0.44 [95% CI, 0.15-0.72], P=0.008). There were no significant differences between groups with respect to stroke (P=0.26), myocardial infarction (P=0.93), or pacemaker implantation (P=0.21). Conclusions Results of this meta-analysis demonstrate better short-term mortality after ViV compared with rAVR. Midterm mortality was similar between groups. Given the likely selection bias in these individual reports, an adequately powered multicenter randomized clinical trial with sufficiently long follow-up in patients with low-to-intermediate surgical risk is warranted. Registration URL: crd.york.ac.uk/prospero/. Unique identifier: CRD42021228752.

Project description:BackgroundRandomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged.ObjectivesThe aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort.MethodsUsing data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities.ResultsIn a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients.ConclusionsAmong unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.

Dataset Information

Physicians' perspectives and attitudes toward surgical bailout in transcatheter aortic valve replacement.

Objectives

Methods

Results

Conclusions

Publications

Physicians' perspectives and attitudes toward surgical bailout in transcatheter aortic valve replacement.

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