Versus Surgical Aortic Valve Replacement Research Articles

OR7-6 | The Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Pure Aortic Regurgitation: A Systematic Review and Meta-analysis

OR7-6 | The Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Pure Aortic Regurgitation: A Systematic Review and Meta-analysis

E-22 | Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Aortic Stenosis and Cardiogenic Shock

E-22 | Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Aortic Stenosis and Cardiogenic Shock

Clinical Profiles and Outcomes of Prosthesis-Specific Infective Endocarditis Subsequent to Transcatheter Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Clinical Profiles and Outcomes of Prosthesis-Specific Infective Endocarditis Subsequent to Transcatheter Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Transcatheter Aortic Valve Replacement (TAVR) Versus Surgical Aortic Valve Replacement (SAVR): A Review on the Length of Stay, Cost, Comorbidities, and Procedural Complications.

This review provides an in-depth analysis of the effect of length of stay (LOS), comorbidities, and procedural complications on the cost-effectiveness of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR). We found that the average LOS was shorter for patients undergoing TAVR, contributing to lower average costs associated with the procedure, although the LOS varied between patients due to the severity of illness and comorbidities present. TAVR has also been found to improve the quality of life for patients receiving aortic valve replacement compared to SAVR. Although TAVR has a lower rate of most post-operative complications caused by SAVR, such as bleeding and cardiac complications, TAVR shows an increased rate of permanent pacemaker (PPM) implantation due to mechanical trauma on the heart's conduction system. In addition, our findings suggest that the cost-effectiveness of each procedure varies based on the types of valve, the patient history of other medical conditions, and the procedural methods. Our findings show that TAVR is preferred over SAVR in terms of cost-effectiveness across a variety of patients with other coexisting medical conditions, including cancer, advanced kidney disease, cirrhosis, diabetes mellitus, and bundle branch block. TAVR also appears to be superior to SAVR with fewer post-operative complications. However, TAVR appears to have a higher rate of PPM implantation rates as compared to SAVR. The comorbidities of the valve recipient must be considered when deciding whether to use TAVR or SAVR as cost-effectiveness varies with the patient background.

Days at Home After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

Days at home (DAH) represents an important patient-oriented outcome that quantifies time spent at home after a medical event; however, this outcome has not been fully evaluated for low-surgical-risk patients undergoing transcatheter aortic valve replacement (TAVR). We sought to compare 1- and 2-year DAH (DAH365 and DAH730) among low-risk patients participating in a randomized trial of TAVR with a self-expanding bioprosthesis versus surgical aortic valve replacement (SAVR). Using Medicare-linked data from the Evolut Low Risk trial, we identified 619 patients: 606 (322 TAVR/284 SAVR) and 593 (312 TAVR/281 SAVR) were analyzed at 1 and 2 years, respectively. DAH was calculated as days alive and spent outside a hospital, inpatient rehabilitation, skilled nursing facility, long-term acute care hospital, emergency department, or observation stay. Mean DAH was compared using the t test. The mean (SD) age and female sex were 74.7 (5.1) and 74.3 (4.9) years and 34.6% (115/332) and 30.3% (87/287) in TAVR and SAVR, respectively. Postprocedural discharge to rehabilitation occurred in ≤3.0% (≤10/332) in TAVR and 4.5% (13/287) in SAVR. The mean DAH365 was comparable in TAVR versus SAVR (352.2±45.4 versus 347.8±39.0; difference in days, 4.5 [95% CI, 2.3-11.2]; P=0.20). DAH730 was also comparable in TAVR versus SAVR (701.6±106.0 versus 699.6±94.5; difference in days, 2.0 [-14.1 to 18.2]; P=0.81). Secondary outcomes DAH30 and DAH90 were higher in TAVR (DAH30, 26.0±3.6 versus 20.7±6.4; difference in days, 5.3 [4.5-6.2]; P<0.001; DAH90, 85.1±8.3 versus 78.7±13.6; difference in days, 6.4 [4.6-8.2]; P<0.001). In the Evolut Low Risk trial linked to Medicare, low-risk patients undergoing TAVR spend a similar number of days at home at 1 and 2 years compared with SAVR. Days spent at home at 30 and 90 days were higher in TAVR. In contrast to higher-risk patients studied in prior work, there is no clear advantage of TAVR versus SAVR for DAH in the first 2 years after AVR in low-surgical-risk patients.

EE436 Economic Evaluation of Transcatheter Versus Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients with Severe Aortic Stenosis in China

EE436 Economic Evaluation of Transcatheter Versus Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients with Severe Aortic Stenosis in China

Midterm Survival of Low-Risk Patients Treated With Transcatheter Versus Surgical Aortic Valve Replacement: Meta-Analysis of Reconstructed Time-to-Event Data.

Background We performed a meta-analysis of reconstructed time-to-event data from randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) to evaluate midterm outcomes in patients considered low risk for SAVR. Methods and Results Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of RCTs and PSM studies published by December 31, 2022 was conducted. Eight studies (3 RCTs, 5 PSM studies) met our eligibility criteria and included 5444 patients; 2639 patients underwent TAVR, and 2805 patients underwent SAVR. TAVR showed a higher risk of all-cause mortality at 8 years of follow-up (hazard ratio [HR] 1.22, [95% CI, 1.03-1.43], P=0.018). Up to 2 years of follow-up, TAVR was not inferior to SAVR (HR, 1.08 [95% CI, 0.89-1.31], P=0.448); however, we observed a statistically significant difference after 2 years with higher mortality with TAVR (HR, 1.51 [95% CI, 1.14-2.00]; P=0.004). This difference was driven by PSM studies; our sensitivity analysis showed a statistically significant difference between TAVR and SAVR when we included only PSM studies (HR, 1.41 [95% CI, 1.16-1.72], P=0.001) but no statistically significant difference when we included only RCTs (HR, 0.89 [95% CI, 0.69-1.16], P=0.398). Conclusions In comparison with TAVR, SAVR appeared to be associated with improved survival beyond 2 years in low-risk patients. However, the survival benefit of SAVR was observed only in PSM studies and not in RCTs. The addition of data from ongoing RCTs as well as longer follow-up in previous RCTs will help to confirm if there is a difference in mid- and long-term survival between TAVR versus SAVR in the low-risk population.

A Review of the Cost Effectiveness of Transcatheter Aortic Valve Replacement (TAVR) Versus Surgical Aortic Valve Replacement (SAVR).

The cost of transcatheter aortic valve replacement (TAVR) has been studied in the context of high-risk or specific comorbidity populations; this paper provides a comprehensive overview of broader patient populations' outcomes and costs with TAVR in comparison to surgical aortic valve replacement (SAVR). In the past, SAVR had been the more cost-effective option than TAVR, but in recent years, TAVR has been becoming more cost-effective.Though the cost of TAVR can vary due to several factors the major focus of this review will focus on the surgical technique, medicare reimbursements, insertion point, and varying risk populations. In conclusion, the price of TAVR is declining as more cost-efficient valves arrive on the market. Climbing healthcare costs play a significant role in clinical decisions when deciding on which procedures are most cost-effective for the patient and healthcare system. The declining price of TAVR could lead to the preference of TAVR over SAVR for both low-risk and high-riskaortic stenosis patients.

National Trends of Transcatheter Versus Surgical Aortic Valve Replacement With and Without Coronary Artery Bypass Graft

National Trends of Transcatheter Versus Surgical Aortic Valve Replacement With and Without Coronary Artery Bypass Graft

A Systematic Review and Meta-Analysis of Transcatheter Versus Surgical Aortic Valve Replacement in Kidney Transplant Patients

A Systematic Review and Meta-Analysis of Transcatheter Versus Surgical Aortic Valve Replacement in Kidney Transplant Patients

EE112 Budget Impact Analysis of Transcatheter Aortic Valve Replacement (TAVR) Versus Surgical Aortic Valve Replacement (SAVR) in Low, Intermediate, and High-Risk Patients with Severe, Symptomatic Aortic Stenosis in the United States

A budget impact analysis (BIA) comparing transcatheter aortic valve replacement (TAVR) with SAPIEN 3 versus surgical aortic valve replacement (SAVR) for severe, symptomatic aortic stenosis (SSAS) among patients of low, intermediate, and high surgical risk.

Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial.

In patients with severe symptomatic aortic stenosis at low surgical risk, transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has been shown to reduce the composite of death, stroke, or rehospitalization at 2-year follow-up compared with surgical aortic valve replacement (SAVR). Whether TAVR is cost-effective compared with SAVR for low-risk patients remains uncertain. Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). Of these patients, 929 underwent valve replacement, were enrolled in the United States, and were included in the economic substudy. Procedural costs were estimated using measured resource use. Other costs were determined by linkage with Medicare claims or by regression models when linkage was not feasible. Health utilities were estimated using the EuroQOL 5-item questionnaire. With the use of a Markov model informed by in-trial data, lifetime cost-effectiveness from the perspective of the US health care system was estimated in terms of cost per quality-adjusted life-year gained. Although procedural costs were nearly $19 000 higher with TAVR, total index hospitalization costs were only $591 more with TAVR compared with SAVR. Follow-up costs were lower with TAVR such that TAVR led to 2-year cost savings of $2030/patient compared with SAVR (95% CI, -$6222 to $1816) and a gain of 0.05 quality-adjusted life-years (95% CI, -0.003 to 0.102). In our base-case analysis, TAVR was projected to be an economically dominant strategy with a 95% probability that the incremental cost-effectiveness ratio for TAVR would be <$50 000/quality-adjusted life-year gained (consistent with high economic value from a US health care perspective). These findings were sensitive to differences in long-term survival, however, such that a modest long-term survival advantage with SAVR would render SAVR cost-effective (although not cost saving) compared with TAVR. For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective.

Real-World Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in the Era of Current-Generation Devices.

Few studies have reported comparisons of out-of-hospital clinical outcomes after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) in the era of current-generation valves that reflect the real-world situation. Data on patients with severe AS aged 65 years or older who underwent TAVR or SAVR between 2015 and 2018 were obtained from the National Health Insurance Service in Korea and clinical event rate was analyzed. The primary endpoint was all-cause death at 1 year. The cohort included a total of 4623 patients over 65 years of age, of whom 1269 (27.4%) were treated with TAVR. After 1:1 propensity score matching, 2120 patients were included in the study. TAVR was associated with reduced 1-year mortality (hazard ratio (HR): 0.55; 95% confidence interval (CI): 0.42-0.70; p &lt; 0.001). There was no difference between the groups in the incidence of ischemic stroke (HR: 0.72, 95% CI: 0.43-1.20; p = 0.21) and intracranial hemorrhage (HR: 1.10; p = 0.74). Permanent pacemaker insertion was observed more frequently in the TAVR cohort (9.4% vs. 2.5%, HR: 3.95, 95% CI: 2.57-6.09; p &lt; 0.001), whereas repeat procedures were rare in both treatments (0.5% vs. 0.3%, p = 0.499). In the nation-wide real-world data analysis, TAVR with current-generation devices showed significantly lower 1-year mortality compared to SAVR in severe AS patients.

Cost-Effectiveness of SAPIEN3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk.

In the randomized PARTNER3 trial, transcatheter aortic valve implantation (TAVI) with the SAPIEN3 device significantly reduced a composite of all-cause death, stroke, and rehospitalization, compared with surgical aortic valve replacement (SAVR), in patients with severe symptomatic aortic stenosis and low risk of surgical mortality. Furthermore, TAVI has been shown to be cost-effective in low-risk patients, compared with SAVR, in a number of countries. This study aimed to determine the cost-effectiveness of TAVI with SAPIEN3 versus SAVR in Germany. A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER3 trial was adapted for the German context using the German Statutory Health Insurance perspective. The model had a lifetime horizon. The cost-utility analysis estimated changes in direct healthcare costs as well as survival and health-related quality of life using TAVI with SAPIEN3 compared with SAVR. TAVI with SAPIEN3 increased quality-adjusted life years (QALYs) by + 0.72 at an increased cost of €8664 per patient. The incremental cost-effectiveness/QALY ratio was €12,037, which fell below that of other cardiovascular interventions in use in Germany. The cost-effectiveness of TAVI over SAVR remained robust across multiple challenging scenarios and was driven by lower longer-term management costs compared with SAVR. TAVI with SAPIEN3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and low risk for surgical mortality in Germany. www. gov identifier: NCT02675114.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Low-risk Patients: A Meta-Analysis Based on a 2-Year Follow-Up.

Previous studies have shown that transcatheter aortic valve implantation is the best alternative therapy to surgical aortic valve replacement in high-risk surgical patients with aortic stenosis. However, it is not clear whether transcatheter aortic valve implantation can be utilized in low-risk surgical patients with aortic stenosis. This studyaimed to evaluate the safety and efficacy of transcatheter aortic valve implantation in low-risk patients. From the outset of our initiative until April 2022, PubMed, EMBASE, and the Cochrane database were thoroughly searched, yielding the selection of 3 randomized controlled trials including 2644 patients with aortic stenosis, to assess outcome measures at distinct follow-up time. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score of patients was 2.2. At the 30-day and 1-year follow-up, transcatheter aortic valve implan- tation was associated with a lower incidence of all-cause mortality, cardiovascular mor- tality, acute kidney injury (stage 2 or 3), life-threatening or significant bleeding, and new atrial fibrillation but an increased risk of permanent pacemaker implantation. At the 2-year follow-up, transcatheter aortic valve implantation only had an advantage in new atrial fibrillation (relative risk, 0.27; 95% CI, 0.14-0.51; P &lt; .0001), with no significant differ- ence in all-cause mortality or cardiovascular mortality. For low-risk surgical patients with aortic stenosis, compared to surgical aortic valve replacement, transcatheter aortic valve implantation was associated with lower all-cause mortality at 30-day follow-up and lower cardiovascular mortality at 1-year follow-up. Except for the advantages in new atrial fibrillation, transcatheter aor- tic valve implantation had no significant impact on mortality at 2-year follow-up.

Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-risk Patients with Severe Aortic Stenosis

Aortic stenosis is a common form of acquired degenerative valvular disease associated with poor survival after the onset of symptoms. Treatment options for patients with aortic stenosis in addition to medical therapy include surgical aortic valve replacement (SAVR) with either tissue or mechanical valves, or transcatheter aortic valve replacement (TAVR) with either balloon-expandable or self-expanding valves via either transfemoral or alternative access routes. In this review, the authors discuss the current evidence and special considerations regarding the use of TAVR versus SAVR in the management of severe aortic stenosis in young (&lt;65 years of age), low-risk patients, highlighting the history of aortic stenosis treatment, the current guidelines and recommendations, and important issues that remain to be addressed. Ultimately, until ongoing clinical trials with long-term follow-up data shed light on whether interventions for aortic stenosis can be broadened to a low-risk population, TAVR in young, low-risk patients should be undertaken with caution and with guidance from a multidisciplinary heart team.

Five-Year Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Low- to Intermediate-Risk Patients

Five-Year Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Low- to Intermediate-Risk Patients

Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients

BackgroundTranscatheter aortic valve replacement (TAVR) is an alternative therapeutic modality to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS). In the current analysis, we compare the characteristics and outcomes of AVR procedures in patients <60 years of age. MethodsWe queried the Nationwide Readmissions Database for all AVR hospitalizations in patients 18–59 years of age between January 2012 and December 2017. We performed a propensity score matching analysis (1:1) and compared baseline characteristics, procedural complications, and outcomes between TAVR and SAVR patients. ResultsA total of 72,356 hospitalizations for AVR were identified in patients <60 years of age. Compared to their SAVR counterparts, TAVR patients were older (52.5 ± 7.6) vs. 48.8 ± 9.6, p < 0.001), more likely to be women (37.9% vs. 28.0%, p < 0.001), and have history of prior radiation (8.3% vs. 0.7%, p < 0.001).After propensity score matching, TAVR patients had lower procedural complications, but a similar mortality rate compared to SAVR patients (2.9% vs. 3.0%, p = 0.77). TAVR was associated with a shorter length of hospital stay [4 [2–9] vs. 6 [5–11], p < 0.001), but no significant difference in the 30-day readmission rate was noted (16.2% vs. 16.8%, p-value = 0.49). ConclusionOur study demonstrates favorable short-term outcomes in younger patients undergoing TAVR, which improved over time. Further investigation of long-term outcomes in TAVR performed younger patients is warranted to draw a comprehensive picture of TAVR safety and efficacy in low-risk patients.

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

BackgroundThe Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. ObjectivesThe goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. MethodsA total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. ResultsAn attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: −1.4%; 95% Bayesian credible interval: −4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. ConclusionsThe complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283)

Contemporary Costs Associated With Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries.

In patients with severe aortic stenosis, treatment with transcatheter aortic valve replacement (TAVR) has been shown to be cost-effective in the high-risk surgical population and cost-saving in the intermediate-risk population when compared with surgical aortic valve replacement (SAVR) in early pivotal clinical trials. Whether TAVR is associated with comparable or lower costs when compared with SAVR in contemporary clinical practice is unknown. Using data from the Medicare Dataset Standard Analytic Files 5% Fee for Service database, patients receiving either TAVR or SAVR between 2016 and 2018 were identified. Patients were categorized as low, intermediate, or high mortality risk based on 2 validated indices-the Hospital Frailty Risk Score and the logEuroScore. Health care costs out to 1 year were compared between TAVR and SAVR among the low, intermediate, and high-risk groups, after adjustment for patient demographics. Nine thousand seven hundred forty-six patients were identified (4834 TAVR; 3760 SAVR) and included in the analysis. Patients receiving TAVR were older and more likely to be female. Index hospitalization costs were significantly lower with TAVR compared with SAVR across all risk strata (logEuroScore: low: $61 845 versus $68 986; intermediate: $64 658 versus $76 965; high: $65 594 versus $91 005; P<0.001 for all). Follow-up costs through 1 year were generally lower with TAVR and this difference was more pronounced in the low risk groups (logEuroScore: $9763 versus $14 073; Hospital Frailty Risk Score: $10 116 versus $12 880). Accordingly, cumulative 1-year costs were substantially lower with TAVR compared with SAVR. At 1 year, TAVR is associated with lower health care costs across all risk strata when compared with SAVR in contemporary practice. If long-term data continue to demonstrate similar clinical outcomes and valve durability with TAVR and SAVR, these findings suggest that TAVR may be the preferred treatment strategy for patients with aortic stenosis from an economic standpoint.