Surgical Aortic Valve Replacement Cohort Research Articles

Savings associated with surgical aortic valve replacement with a RESILIA tissue valve based on seven-year COMMENCE trial results

Introduction: Bioprostheses with RESILIA tissue demonstrate a reduction in calcification and improve health outcomes in pre-clinical and clinical studies. Prior economic analyses which relied on five years of evidence from the COMMENCE trial demonstrate financial savings for RESILIA tissue valves relative to mechanical valves after surgical aortic valve replacement (SAVR). Given the recent release of 7-year COMMENCE data, this economic evaluation updates the estimate for long-run savings of bioprosthetic valves with RESILIA. Methods: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients each in the US. The primary comparison calculated the SAVR-related expenditures associated with each valve type ($US, 2023). Health outcome probabilities were based on the COMMENCE trial though Year 7 and projected for an additional 8 years based on prior studies of tissue and mechanical SAVR. Costs for key outcomes (mortality, reoperation, bleeding, thromboembolism, endocarditis) and anticoagulant monitoring were sourced from the literature. Incidence rates of health outcomes associated with mechanical valves relied on relative risks of tissue valve versus mechanical valve patients. Results: Seven-year savings are $13,415 (95% CI: $10,472–$17,321) per patient when comparing RESILIA versus mechanical SAVR. Projected 15-year savings were $23,001 ($US, 2023; 95% CI: $17,802–$30,421). Most of the 15-year savings are primarily attributed to lower anti-coagulation monitoring costs ($21,073 in ACM savings over 15 years), but lower bleeding cost (savings: $2,294) and thromboembolism-related expenditures (savings: $852) also contribute. Reoperation and endocarditis expenditures were slightly larger in the RESILIA cohort. If reoperation relative risk reverts from 1.1 to 2.2 (the level in legacy tissue valves) after year 7, savings are $18,064. RESILIA SAVR also reduce costs relative to legacy tissue valves. Conclusion: Patients receiving RESILIA tissue valves are projected to have lower SAVR-related health expenditures relative to mechanical and legacy tissue valves.

Clinical Outcomes of Transcatheter Aortic Valve Replacement (TAVR) vs Surgical Aortic Valve Replacement (SAVR) in Patients With Sarcoidosis.

Introduction Data regarding clinical outcomes after transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) in patients with sarcoidosis is lacking. This study aims to clarify the clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Methods Data was collected from the National Inpatient Sample database from 2016-2019 using validated ICD-10-CM codes for sarcoidosis, TAVR, and SAVR. Patients were divided into two cohorts: those who underwent TAVR and those who underwent SAVR. Statistical analysis was performed using Pearson's chi-squared test to determine clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Results The prevalence of sarcoidosis was 0.23%among total study patients (n=142,420,378). After exclusions, the prevalence of TAVR was 650 (49%) and SAVR was 675 (51%) in patients with sarcoidosis. Patients who underwent TAVR were on average older (74 vs 65 years old, p=0.001), and more likely to be female (57 vs 40%, p<0.001) compared to patients who underwent SAVR. The TAVR cohort had higher rates of congestive heart failure (CHF) (77.7 vs 42.2%, p=0.001), chronic kidney disease (CKD) (42.3 vs 24.4% p=0.001), anemia (5.4 vs 2.2%, p=0.004), percutaneous coronary intervention (PCI) (1.5 vs 0%, p=0.004), and hypothyroidism (31.5 vs 16.3%, p=0.001) compared to the SAVR cohort. Inpatient mortality post-procedure was higher in the SAVR cohort compared to the TAVR cohort (15 vs 0, p=0.001). Regarding post-procedure complications, respiratory complications were more common in the SAVR cohort (4.4 vs 0%, p=0.001), while TAVR was associated with a higher incidence of permanent pacemaker (PPM) insertion (2.15 vs 0.8%, p=0.001). There was no statistical difference in the development of acute kidney injury (AKI) (0.8 vs 1.5%, p=0.33), AKI requiring hemodialysis (0 vs. 0.7%, p=0.08), or stroke (0.8 vs 0.7, p=1) post-procedure between the two cohorts. Conclusion This study found that in the sarcoidosis population, TAVR was associated with reduced mortality, shorter hospital length of stay, and lower hospitalization costs in comparison to SAVR.

Transcatheter Aortic Valve Replacement in Low Surgical Risk Patients: An Updated Metanalysis of Extended Follow-Up Randomized Controlled Trials

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients who underwent TAVR or SAVR. We calculated odds ratio (OR) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for permanent pacemaker implantation and paravalvular leaks. Three randomized controlled trials were included with a total of 2,611 low surgical risk patients (Society of Thoracic Surgeons score <4%). Compared with SAVR, the TAVR group had similar rates of all-cause mortality (OR 0.94,95% CI 0.65 to 1.37, p = 0.75) and disabling stroke (OR 0.84, 95% CI 0.52 to 1.36, p = 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95% CI 0.67 to 1.38, p = 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p = 0.31), valve thrombosis (OR 3.11, 95% CI 0.29 to 33.47, p = 0.35), endocarditis (OR 0.71,95% CI 0.35 to 1.48, p = 0.36), aortic valve reintervention (OR 0.93, 95% CI 0.52 to 1.66, p = 0.80), and rehospitalization (OR 0.80, 95% CI 0.52 to 1.02, p = 0.07) compared with SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95% CI 4.18 to 16.14, p <0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95% CI 0.17 to 0.30, p <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95% CI 0.88 to 1.97, p = 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm2/m2, 95% CI 0.05 to 0.15, p = 0.0001), but similar transvalvular mean gradients (0.60, 95% CI 3.94 to 2.73, p = 0.72). In conclusion, TAVR patients had similar long-term outcomes compared with SAVR, except for an elevated risk of paravalvular leaks in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.

Association between hospital racial composition and aortic valve replacement outcomes: A national inpatients sample database analysis.

Racial and ethnic disparities exist in the outcomes following surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). However, it is unclear whether hospital racial composition contributes to these racial disparities. We analyzed the National Inpatient Sample (NIS) database from 2015 to 2019 to identify patients with aortic stenosis (AS) who received SAVR and TAVI. The Racial/Ethnic Diversity Index (RDI) was used to assess hospital racial composition as the proportion of nonwhite patients to total hospital admissions. Hospitals were categorized into RDI quintiles. Textbook outcome (TO) was defined as no in-hospital mortality, no postoperative complications and no prolonged length of stay (LOS). Multivariable mixed generalized linear models were conducted to assess the association between RDI and post-SAVR and post-TAVI outcomes. Moreover, quantile regression was used to assess the additional cost and length of stay associated with the RDI quintile. The study included 82,502 SAVR or TAVI performed across 3285 hospitals, with 47.4% isolated SAVR and 52.5% isolated TAVI. After adjustment, quintiles 4 and 5 demonstrated significantly lower odds of TO than the lowest RDI quintile in both the SAVR cohort (quintile 4, 0.79 [95% CI, 0.73-0.85]; quintile 5, 0.79 [95% CI, 0.73-0.86]) and TAVI cohort (quintile 4, 0.88 [95% CI, 0.82-0.95]; quintile 5, 0.80 [95% CI, 0.74-0.86]). Despite non-observable differences in in-hospital mortality across all RDI quintiles, the rate of AKI and blood transfusion increased with increasing RDI for both cohorts. Further, Higher RDI quintiles were associated with increased costs and longer LOS. From 2015 to 2019, post-TAVI outcomes improved across all RDI quintiles. Hospitals with a higher RDI experienced lower TO achievements, increased AKI, and blood transfusion, along with extended LOS and higher costs. Importantly, post-TAVI outcomes improved from 2015 to 2019 across all RDI groups.

Right ventricular function in severe aortic stenosis assessed by echocardiography and MRI.

The prevalence of aortic valve stenosis (AS) is increasing due to an ageing population. Despite that right ventricular function has prognostic value for postoperative outcome, the right ventricle (RV) is not extensively studied and often not routinely assessed in AS. Our aim was to explore the relation between severe AS and RV function in a surgical aortic valve replacement (SAVR) cohort, comparing two imaging modalities for RV evaluation. Patients with severe AS, underwent cardiovascular magnetic resonance imaging (CMR) and transthoracic echocardiography (TTE) before SAVR. RV dysfunction was defined as one or more of the following: tricuspid annular plane systolic excursion (TAPSE) < 17 mm, RV free wall strain (RVFWS) > -20% by TTE and RV ejection fraction (RVEF) <50% by CMR. Sixteen (33%) patients were found to have RV dysfunction. Patients with RV dysfunction showed significantly lower indexed aortic valve area, left ventricular (LV) ejection fraction as well as RV and LV stroke volumes compared to patients with maintained RV function. All patients with reduced RVEF also had changes in TAPSE or RVFWS and a larger number of patients had a reduced longitudinal RV function despite a normal RVEF. In a SAVR cohort one-third of the patients had RV dysfunction, defined by RVEF, TAPSE or RVFW strain. Echocardiography detected subtle changes in RV function before RVEF was reduced. It is likely that the more pronounced the AS, the more frequent the occurrence of RV dysfunction.

Hemostatic Profiles of Patients Who Underwent Transcatheter Versus Surgical Aortic Valve Replacement Versus Percutaneous Coronary Intervention

Guidelines for transcatheter aortic valve replacement (TAVR) antithrombotic prophylaxis are extrapolated predominantly from percutaneous coronary intervention (PCI) data. Here, we examined temporal coagulation changes occurring in the early perioperative period to determine the pathobiologic validity of this supposition. This was a prospective observational study of consecutive patients who underwent transfemoral TAVR (n=27), PCI (n=12), or surgical aortic valve replacement (SAVR) requiring cardiopulmonary bypass and cross-clamping (n=12). Blood samples were taken at 4 time points: T1 (baseline), after general anesthesia or sedation; T2, after heparin administration; T3, at the end of the procedure; and T4, 6 hours after the procedure. The samples were assessed concurrently using standard laboratory coagulation tests and viscoelastic tests of whole blood clotting, including the latest generation thromboelastometry (ROTEM sigma) and thromboelastometry (TEG 6s). Patients in the TAVR cohort were older and a had lower baseline hemoglobin level than patients in the PCI and SAVR cohorts. The baseline platelet function was similar between the TAVR and PCI cohorts and impaired in the SAVR cohort Figure S1. The baseline hemostatic measures were comparable among cohorts. Regarding the per-patient change from baseline, the TAVR cohort showed an overall more prothrombotic state than the other cohorts, with the most marked differences from the SAVR cohort after intraoperative heparin administration and from the PCI cohorts 6hours after the procedure. In addition, the ROTEM and TEG parameters were well correlated but not interchangeable. In conclusion, patients who underwent TAVR have a more prothrombotic hemostatic profile than PCI and SAVR patients. These findings question the current guidelines that extrapolate antithrombotic regimens from PCI to TAVR settings.

Redo Surgical Aortic Valve Replacement After Prior Transcatheter Versus Surgical Aortic Valve Replacement

BackgroundAortic stenosis treatment should consider risks and benefits for lifetime management. Although the feasibility of redo transcatheter aortic valve replacement (TAVR) remains unclear, concerns are emerging regarding reoperation after TAVR. ObjectivesThe authors sought to define comparative risk of surgical aortic valve replacement (SAVR) after prior TAVR or SAVR. MethodsData on patients undergoing bioprosthetic SAVR after TAVR and/or SAVR were extracted from the Society of Thoracic Surgeons Database (2011-2021). Overall and isolated SAVR cohorts were analyzed. The primary outcome was operative mortality. Risk adjustment using hierarchical logistic regression as well as propensity score matching for isolated SAVR cases were performed. ResultsOf 31,106 SAVR patients, 1,126 had prior TAVR (TAVR-SAVR), 674 had prior SAVR and TAVR (SAVR-TAVR-SAVR), and 29,306 had prior SAVR (SAVR-SAVR). Yearly rates of TAVR-SAVR and SAVR-TAVR-SAVR increased over time, whereas SAVR-SAVR was stable. The TAVR-SAVR patients were older, with higher acuity, and with greater comorbidities than other cohorts. The unadjusted operative mortality was highest in the TAVR-SAVR group (17% vs 12% vs 9%, respectively; P < 0.001). Compared with SAVR-SAVR, risk-adjusted operative mortality was significantly higher for TAVR-SAVR (OR: 1.53; P = 0.004), but not SAVR-TAVR-SAVR (OR: 1.02; P = 0.927). After propensity score matching, operative mortality of isolated SAVR was 1.74 times higher for TAVR-SAVR than SAVR-SAVR patients (P = 0.020). ConclusionsThe number of post-TAVR reoperations is increasing and represent a high-risk population. Yet even in isolated SAVR cases, SAVR after TAVR is independently associated with increased risk of mortality. Patients with life expectancy beyond a TAVR valve and unsuitable anatomy for redo-TAVR should consider a SAVR-first approach.

Comparing Outcomes Between Surgical and Transcatheter Aortic Valve Replacement in Classical Low-Flow Low-Gradient Aortic Stenosis

Patients with classic low-flow low-gradient (cLFLG) aortic stenosis (AS) have a poor prognosis but still benefit from aortic valve replacement. There is a paucity of evidence to guide the choice between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). This study compared procedural and midterm outcomes in patients with cLFLG AS between TAVR and SAVR. Patients with cLFLG AS, defined as an aortic valve area ≤1 cm2, mean gradient <40 mm Hg, and left ventricular ejection fraction <50%, were selected from a single center between 2015 and 2020. Inverse probability weighting and regression were used to adjust for differences in baseline characteristics, the nonrandom assignment of treatment modalities, and procedural differences. The primary end point was all-cause mortality. A total of 322 patients (220 TAVR and 102 SAVR) were included. At a follow-up of 4.4 ± 1.5years, the adjusted hazard ratio (HR) for mortality after inverse probability weighting with SAVR was 0.66, 95% confidence interval (CI) 0.31 to 1.35; p=0.24. Worse renal function at baseline (per 10ml/min/m2 increase HR 0.92, 95% CI 0.84 to 1.00, p=0.04) and multiple valve interventions (HR 5.39, 95% CI 2.62 to 11.12, p <0.001) independently predicted mortality. There was no difference in stroke and permanent pacemaker implantation, but the rates of renal replacement therapy were higher among the SAVR cohort: 13.7% versus 0%; p <0.001. In conclusion, among patients with cLFLG AS, there was no difference in midterm mortality between TAVR and SAVR, supporting the use of either treatment. However, in patients with poor renal function or at risk of renal failure, TAVR may be the preferred option.

Long-run savings associated with surgical aortic valve replacement using a RESILIA tissue bioprosthetic valve versus a mechanical valve

BackgroundPrior economic analyses demonstrate that legacy tissue valves are associated with substantial financial savings over the long run after a surgical aortic valve replacement (SAVR). Bioprostheses with RESILIA tissue reduce calcification, the primary cause of structural valve deterioration (SVD), and have demonstrated promising pre-clinical and 5-year clinical results. This economic evaluation quantifies the expected long-run savings of bioprosthetic valves with RESILIA tissue relative to mechanical valves given 5-year clinical results and expected performance through year 15.MethodsSimulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients in the US over 15 years. One comparison evaluated RESILIA tissue valves relative to mechanical valves. The other compared legacy SAVR tissue and mechanical valves. Health outcome probabilities and costs were based on literature and expert opinion. Incidence rates of health outcomes associated with mechanical valve were calculated using relative risks of expected outcomes in tissue valve versus mechanical valve patients. The comparisons also accounted for anti-coagulation monitoring in both cohorts. Savings estimates are based on US healthcare costs and do not yet account for the premium associated use of RESILIA relative to a standard tissue valve.ResultsRelative to mechanical SAVR, the median net discounted savings for a patient receiving SAVR with a RESILIA tissue valve is $20,744 ($US, 2020; 95% CI = $15,835–$26,655) over a 15-year horizon. While 30-day and 1-year savings were not significant, expected savings after 5 years are $9,110 (95% CI = $6,634–$11,969). Net savings for RESILIA SAVR valves were approximately 30–50% larger than savings anticipated using legacy tissue SAVR valves.ConclusionRESILIA tissue valves are associated with lower health expenditures relative to mechanical valves.

1987. One-Year Mortality and Reoperation Among Patients with Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement

Abstract Background Treatment of severe aortic valve stenosis with transcatheter aortic valve implantation (TAVI) was initially developed for older patients at high surgical risk. However, with improving technology and experience, indications for TAVI have expanded to include younger patients and those at moderate surgical risk, leading to increasing use of TAVI as an alternative to surgical aortic valve replacement (SAVR). As a result, post-TAVI infective endocarditis (IE) is increasingly common. Data on post-TAVI IE in comparison to post-SAVR IE outcomes are limited. Methods Using data from the TriNetX Research Network, we identified (1) a cohort of patients who underwent TAVI between 1/1/2016 and 12/31/2020 (CPT procedure code 1021150) and developed IE (captured with ICD-10 codes I33, I38, or I39) after the procedure; and (2) a propensity score-matched cohort of patients who underwent SAVR (CPT procedure codes 1006141, excluding any associated transcatheter procedures) and developed IE. Both cohorts were required to have at least 1 week follow-up, i.e., deaths within 7 days of IE were excluded. We matched the cohorts for demographics and clinically relevant background characteristics. We used Kaplan-Meier estimates for 1-year mortality and aortic valve reoperation and Cox proportional hazards models to compare event rates. Results We identified 616 patients with post-TAVI IE and 616 matched patients with post-SAVR IE. The baseline characteristics of the cohorts were well balanced, as indicated by standardized mean differences &amp;lt; 0.1, Table 1. The Kaplan-Meier 1-year mortality between 7 days and 1 year (as deaths before 7 days were excluded) was 20.9% in the TAVI cohort (117 events) vs. 13.0% in the SAVR cohort (72 events), HR 1.66 (95%CI 1.24-2.22; P=0.001), Figure 1. Reoperation for the aortic valve by 1 year was uncommon in both groups, with 12 and 10 events in the TAVI and SAVR groups, respectively (2.0% vs. 1.4%; HR 1.49, 95%CI 0.61-3.65; P=0.56). Baseline Patient Characteristics After Matching Figure 1 One-year survival post infective endocarditis after transcatheter aortic valve implantation (TAVI IE) or surgical aortic valve replacement (SAVR IE). Deaths within 7 days of infective endocarditis diagnosis were excluded. Conclusion In this comparative, propensity-matched cohort study, 1-year mortality after an episode of IE was significantly higher among TAVI recipients vs their SAVR counterparts. Repeat aortic valve procedures were uncommon in both groups. Prospective studies are needed to elucidate the causes of excess mortality among TAVI recipients. Disclosures All Authors: No reported disclosures.

Racial Disparity Among Patients Undergoing Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement in the United States.

Transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive alternative to surgical aortic valve replacement (SAVR). However, racial disparities in the utilization of TAVR persist. This meta-analysis attempts to determine whether the prevalence of adverse outcomes (procedure-related complications) represent barriers to the use of TAVR among African Americans (AA). The TAVR cohort consisted of 89.6% Caucasian (C) and 4.7% AA, while the SAVR cohort included 86.9% C and 6.4% AA. The utilization rate (UR) of TAVR was 1.48 and .35 among C and AA, respectively, while the UR of SAVR was 1.44 and .48 among C and AA, respectively. Following TAVR, for AA the odds ratio (OR) was greater for stroke (OR = 1.22, P = .02) and transient ischemic attack (TIA) (OR = 1.57, P < .001) and lower for undergoing the insertion of a permanent pacemaker (OR = .81, P < .001). While there was a significant difference between C and AA in TAVR and SAVR utilization, outcomes between groups following TAVR are comparable; therefore, adverse outcomes do not appear to be a barrier to the use of TAVR among eligible AA.

Abstract 14994: One-Year Mortality and Reoperation Among Patients With Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement

Background: With improving technology and experience, indications for transcatheter aortic valve implantation (TAVI) have expanded to include younger patients and those at moderate surgical risk, leading to increasing use of TAVI as an alternative to surgical aortic valve replacement (SAVR). As a result, post-TAVI infective endocarditis (IE) is increasingly common. Data on post-TAVI IE in comparison to post-SAVR IE outcomes are limited. Methods: Using data from the TriNetX Research Network, we identified (1) a cohort of patients who underwent TAVI between 1/1/2016 and 12/31/2020 (CPT procedure code 1021150) and developed IE (captured with ICD-10 codes I33, I38, or I39) after the procedure; and (2) a propensity score-matched cohort of patients who underwent SAVR (CPT procedure codes 1006141, excluding any associated transcatheter procedures) and developed IE. Both cohorts were required to have at least 1 week follow-up, i.e., deaths within 7 days of IE were excluded. We matched the cohorts for demographics and clinically relevant background characteristics. Results: We identified 713 patients with post-TAVI IE and 713 matched patients with post-SAVR IE. The baseline characteristics were well balanced, as indicated by standardized mean differences &lt;0.1, Table 1. The Kaplan-Meier 1-year mortality between 7 days and 1 year (as deaths before 7 days were excluded) was 18.4% in the TAVI cohort (131 events) vs. 11.4% in the SAVR cohort (81 events), HR 1.62 (95%CI 1.23-2.14; P=0.001). Aortic valve reoperation was uncommon in both groups, with 13 and 10 events in the TAVI and SAVR groups, respectively (1.8% vs. 1.4%; HR 1.43, 95%CI 0.61-3.34; P=0.41). Conclusions: In this comparative, propensity-matched cohort study, 1-year mortality after an episode of IE was higher among TAVI recipients vs. their SAVR counterparts. Repeat aortic valve procedures were uncommon in both groups. Prospective studies are needed to elucidate the causes of excess mortality among TAVI recipients.

Abstract 14282: Outcomes Following Aortic Valve Replacement Among Kidney Transplant Recipients. A Systematic Review and Meta-Analysis

Introduction: While kidney transplant recipients (KTR) are high risk candidates for valve replacements, the safety of transcatheter aortic valve replacement (TAVR) is limited among this population as they are excluded from major trials. We aimed to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) among KTR by a systematic review and meta-analysis. Methods: We comprehensively searched PubMed, Embase, and Cochrane Library from its inception until April 20, 2022 for relevant studies. Outcomes were pooled using the DerSimonian and Laird random-effects model and reported as odd ratios (OR) or standardized mean difference (SMD) and 95% confidence intervals (CI). Results: 6 studies involving 5,452 patients (1,956 TAVR, 3,496 SAVR) were included in the analysis. TAVR patients were older (69.4 years vs 62.8 years), were less likely to be male (66.7% vs 67.9%) and had a higher prevalence of most comorbidities including coronary artery diseases (78% vs 58%), heart failure (71% vs 42%) and diabetes mellitus (52% vs 45%). Compared with SAVR, KTR undergoing TAVR had significantly lower risk of in-hospital all-cause mortality (OR 0.51, 95% CI: 0.39 to 0.67, p&lt;0.001), acute kidney injury (RR 0.49, 95% CI: 0.34 to 0.71, p&lt;0.001), blood transfusion (OR 0.29, 95% CI: 0.19 to 0.55, p&lt;0.001) and a shorter length of hospital stay (SMD -0.67, 95% CI: -1.10 to -0.24, p=0.002). In contrast, there was a higher need for permanent pacemaker implantation among the TAVR cohort compared to SAVR cohort (OR 3.44, 95% CI: 2.67-4.43, p&lt;0.001). Conclusions: TAVR appeared to be a safe alternative compared to SAVR in KTR, with a lower rate of short-term mortality, AKI and length of hospitalization but a higher rate of permanent pacemaker implantation. Further studies are encouraged to study the long-term outcomes among these patients.

Abstract 9809: Clinical Outcomes of Transcatheter Aortic Valve Replacement vs.surgical Aortic Valve Replacement in Patients With Durable Left Ventricular Assist Device

Introduction: Patients with left ventricular assist device (LVAD) often develop aortic insufficiency (AI) requiring an intervention on the aortic valve. We sought to analyze the outcomes of patients with a history of LVAD who underwent either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Methods: The Nationwide Readmission Database (NRD) was used to extract relevant patient information from January 1, 2016, to December 31, 2018. The NRD is a nationally representative sample of all-payer discharges from U.S. non-federal hospitals. The primary outcome of interest was in-hospital mortality. Secondary outcomes included length of stay, inpatient outcomes, costs, and 30-day all-cause readmissions. Complex samples multivariable logistic and linear regression models were used to determine the association of procedure type with outcomes. Results: Among 148 hospitalizations with a history of LVAD, 87 underwent TAVR, and 61 underwent SAVR. The inpatient mortality in SAVR group was numerically higher compared to the TAVR cohort, however, it did not reach statistical significance. The use of invasive mechanical ventilation, cardiogenic shock, bleeding, and vascular complications were higher in the SAVR cohort compared to the TAVR cohort. The mean length of stay (in days) and costs were higher in the SAVR cohort compared to the TAVR cohort. The 30-day all-cause readmission rate was numerically higher in the SAVR group, however, it was not statistically significant (Table 1). Conclusions: TAVR in patients with LVAD is a viable treatment option for AI and potentially leads to better inpatient mortality and inpatient outcomes compared to patients who undergo SAVR.

Outcome and Cost Comparisons Between Surgical and Transcatheter Aortic Valve Replacements.

Surgical aortic valve replacement (SAVR) has been the standard of care for severe aortic stenosis. In 2019, annual transcatheter aortic valve replacement (TAVR) implantations surpassed SAVR. We compared in-hospital costs and outcomes between these two procedures. A single-center retrospective review was performed of patients who underwent isolated SAVR or TAVR from October 2013 to December 2019. Baseline patient characteristics, operating room (OR) time, intensive care unit (ICU) length of stay (LOS), total LOS, cumulative cost, and complication rates were collected. Propensity matching was performed to identify differences in costs and outcomes between comparable groups. There were 515 patients who met inclusion criteria. TAVR was performed in 402 patients, while SAVR was performed in 113. Propensity matching resulted in 82 matched pairs. The SAVR cohort more frequently spent >1 day in the ICU, had longer total hospital LOS, longer OR time, and higher hospitalization cost. However, TAVR was associated with higher mean OR cost and higher valve cost. The cumulative index admission costs were not significantly different between groups. TAVR patients had less postoperative atrial fibrillation but more frequent pacemaker placement. One-year mortality was similar between SAVR (2.4%) and TAVR (3.8%), but 3-year (5.8% vs 19.2%) and 5-year (5.8% vs 37.2%) mortality favored SAVR. In propensity-matched groups, TAVR was associated with shorter ICU and hospital LOS and OR times but increased permanent pacemaker rates. In addition, while 1-year survival was similar between groups, SAVR had significantly improved 3-year and 5-year survival.

Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials.

Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR. We analyzed patients at intermediate- or high-surgical risk who underwent elective TAVR (n=4457) or SAVR (n=1129) in the PARTNER (Placement of Aortic Transcatheter Valve) 1 and 2 trials and registries according to time-of-day (morning versus afternoon) using the Kaplan-Meier event rates and multivariable Cox proportional hazards regression models. Sensitivity analysis was conducted using 1:1 propensity-score matching. The primary end point was all-cause death or rehospitalization at 2 years. At 2 years, no difference was observed between patients operated in the morning versus the afternoon within the SAVR (32.3% versus 30.6%, adjusted hazard ratio, 1.08 [95% CI, 0.82-1.41], P=0.58) and TAVR cohorts (35.7% versus 35.4%, adjusted hazard ratio, 1.01 [95% CI, 0.89-1.14], P=0.86) with regards to the primary end point. Rates of periprocedural myocardial infarction were low and similar between morning and afternoon in SAVR (1.6% versus 1.0%, P=0.51) and TAVR (0.4% versus 0.4%, P=0.86), as were all other clinical end points. Similar results were observed in propensity-score matched analysis. Procedure time-of-day was not associated with clinical outcomes after TAVR or SAVR. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00530894, NCT01314313, NCT03222141, and NCT03222128.

55. Infective Endocarditis After Surgical or Transcatheter Aortic Valve Replacement

BackgroundInfective endocarditis (IE) can complicate both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) with significant morbidity and mortality despite differing pathogenesis. In the presence of limited data from direct comparison studies and recent expansion of TAVI to younger and lower- risk patients, we compared the incidence and timing of IE in TAVI versus SAVR.MethodsUsing data from the TriNetX electronic health records network, we identified (1) a cohort of patients who underwent TAVI between January 2016 and December 2020 (CPT procedure code 1021150) and (2) a propensity score-matched cohort of patients who underwent SAVR (CPT procedure codes 1035167 or 1029693, without any associated transcatheter procedure). We examined the incidence of IE (captured with ICD-10 codes I33, I38, or I39) over a 5-year follow up period and matched the cohorts for demographic data and clinically relevant background history. We used Kaplan-Meier estimates and Cox proportional hazards models to compare incidence between matched cohorts.ResultsWe identified 6,302 patients with TAVI and 6,302 matched patients with SAVR. The baseline characteristics of the cohorts were well balanced, Table 1. All standardized mean differences were < 0.05, indicating adequate matching between cohorts. The Kaplan-Meier mortality at 5 years was 38.0% in the TAVI vs. 22.0% in the SAVR cohort (log-rank P < 0.001). There were 290 cases with IE in the TAVI and 604 cases in the SAVR cohort. The corresponding 5-year event rates were 10.0% vs. 16.9% (log-rank P < 0.001), respectively, Figure 1. The risk ratio of TAVI vs. SAVR related IE over the entire 5-year period was 0.48 (95%CI 0.42 — 0.55; P < 0.001). However, the relative risk for IE was non-proportional between groups over the 5-year period, with an early pronounced incidence among SAVR relative to TAVI patients and gradual convergence of the hazard rates over time, Figure 2. Figure 1. Cumulative 5-Year Incidence (Kaplan-Meier Estimates) of Infective Endocarditis Among Matched Transcatheter Aortic Valve Implantation (TAVI) vs. Surgical Aortic Valve Replacement (SAVR) Recipients Figure 2. Risk of Infective Endocarditis in SAVR vs. TAVI Recipients Over Time ConclusionIn this comparative study, the risk for IE was lower among TAVI vs. SAVR recipients, primarily due to the higher risk of IE during the early post-SAVR period. With increasing uptake of TAVI procedures, a better understanding of the temporal occurrence and pathophysiology of IE and application of effective treatment strategies in these patients is required.Disclosures All Authors: No reported disclosures

Abstract 14430: 5-year Outcomes After Transcatheter &amp; Surgical Aortic Valve Replacement in Advanced Chronic Kidney Disease Patients

Introduction: Advanced chronic kidney disease (CKD4,5) patients are known to have increased morbidity and mortality when undergoing surgical procedures. While short term outcomes among patients undergoing transcatheter (TAVR) or surgical aortic valve replacement (SAVR) have been studied, research assessing long term outcomes are scant. Therefore, the goal was to assess 5-year outcomes for these patients undergoing TAVR or SAVR. Methods: A retrospective cohort study was done using TriNetX, a national federated real time database of 69 million records. Patient cohorts were identified if they met the criteria for CKD and underwent TAVR or SAVR up until May 2016 for 5 year follow up. A 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% confidence intervals (CI) for complications of interest. Kaplan Meir (KM) analysis was done to calculate survival probability in 5 years among the 2 cohorts. Results: In a matched sample of 355 patients in each cohort, the TAVR did not show any significant differences in mortality (RR[CI]): (1.07[0.89-1.28]) compared to the SAVR Group. However, KM analysis revealed a significantly lower 5-year survival probability compared to the SAVR group (p&lt;0.035). There were no statistically significant differences among the 2 cohorts in other assessed long-term complications such as stroke (0.67[0.42-1.05]) and new pacemaker placement (1.31[0.81-2.17]). However, redo TAVR/SAVR was higher in the TAVR cohort than the SAVR cohort (3.1[1.54-6.23]). Conclusions: 5-year mortality appears to be similar in advanced CKD patients but repeat TAVR/SAVR were much higher suggesting decreased longevity of TAVR valves in this population.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire

BackgroundThe Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we...

Outcomes of trans-catheter versus surgical aortic valve replacement for patients with classic low-flow low-gradient aortic stenosis

Abstract Background Classical low-flow low-gradient aortic stenosis (cLFLG-AS) is frequently encountered within clinical practice [1], and is often associated with high mortality [2]. Whilst aortic valve replacement can improve outcomes, there is a lack of real-world data guiding the decision between trans-catheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) in this specific patient cohort. Purpose To compare outcomes between TAVI and SAVR in patients with cLFLG-AS. Methods cLFLG-AS was defined by an aortic valve area &amp;lt;1cm2, mean gradient &amp;lt;40mmHg or peak velocity &amp;lt;4m/s and left ventricular ejection fraction &amp;lt;50%. All patients who met cLFLG-AS criteria who underwent TAVI or SAVR at our tertiary referral centre between 2015 and 2020 were included. Inverse probability weighting was used to adjust for differences in baseline characteristics and the non-random assignment of treatment modalities. The primary end-point was all-cause mortality. Secondary end-points were procedure-related permanent pacemaker implantation, renal replacement therapy (RRT) and stroke. Results 322 patients were included (220 TAVI and 102 SAVR). Baseline characteristics were: male sex 70%, mean gradient 30mmHg (23–35), aortic valve area 0.8cm2 (0.6–0.9). Patients undergoing TAVI were older than the SAVR group (81.3±8.5 vs 70.6±11.1 years, p&amp;lt;0.0001) with higher Logistic Euroscore (19.3 (11.8–32.3) vs 7.1 (3.7–14.1), p&amp;lt;0.0001) (figure 1). At median follow-up of 2.7 years (1.5–4.1), 99 patients had died; 70 (31.8%) had TAVI and 29 (28.4%) had SAVR. Both unweighted and weighted Kaplan-Meier curve analysis was performed; there was similar survival between SAVR and TAVI (log rank test 0=0.27 and p=0.4 respectively) (figure 2). Adjusted hazard ratio (HR) for mortality with SAVR was 0.78 unweighted (95% CI 0.5–1.21; p=0.27) and 0.66 weighted (95% CI 0.26–1.64; p=0.37). In terms of contributory procedural factors, concomitant multiple valve intervention in the SAVR group independently affected mortality (HR 5.47, 95% CI 2.52–11.51, p&amp;lt;0.001). There was no difference in permanent pacemaker insertion or stroke across the two groups, but rates of RRT were higher in SAVR cohort (13.7% vs 0%, p&amp;lt;0.001). Conclusions Despite the TAVI cohort being both older and at higher risk, there was no observed difference in mortality between TAVI and SAVR in the mid-term. Deciding upon intervention choice can therefore be based upon criteria other than the specific presence of a classic low-flow low-gradient state. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Clinical training research fellowship from the British Heart Foundation Baseline characteristics by treatmentKaplan-Meier curves for TAVI vs SAVR