Valve Replacement In Low-Risk Patients Research Articles

TCT-890 Transcatheter Aortic Valve Replacement in Low-Risk Patients at Four or More Years: A Meta-Analysis of Randomized Trials

TCT-890 Transcatheter Aortic Valve Replacement in Low-Risk Patients at Four or More Years: A Meta-Analysis of Randomized Trials

TCT-141 Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement in Low-Risk Patients at Long-Term Follow-Up: Meta-Analysis of Randomized Controlled Trials

TCT-141 Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement in Low-Risk Patients at Long-Term Follow-Up: Meta-Analysis of Randomized Controlled Trials

Long-Term Results Following Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis: A Systematic Review and Meta-Analysis of Randomized Trials

Transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for patients with severe aortic stenosis at intermediate or high surgical risk. Results after TAVR in low-risk patients are very encouraging at midterm follow-up, whereas limited long-term (≥3 year) data are available in this subset of patients. This meta-analysis aims to compare the long-term follow-up after TAVR versus surgical aortic valve replacement (SAVR) in low-risk patients. We searched databases up to July 7, 2024 for randomized clinical trials comparing TAVR versus SAVR in low-risk patients (defined as Society of Thoracic Surgeons Predicted Risk of Mortality score <4%) (PROSPERO ID: CRD42023480495). Primary outcome analyzed was all-cause death at a minimum of 3 years of follow-up. The secondary outcomes were cardiovascular death, disabling stroke, myocardial infarction, aortic valve reintervention, endocarditis, new-onset atrial fibrillation, permanent pacemaker implantation, and bioprosthetic valve failure. A total of 3 randomized clinical trials with 2,644 patients (TAVR n = 1,371 patients; SAVR n = 1,273 patients) were included. The follow-up time was 6 ± 2.9 years. TAVR resulted noninferior to SAVR for all-cause death (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.84 to 1.17, p = 0.89, I2 = 28%), cardiovascular death (RR 0.94, 95% CI 0.76 to 1.15, p = 0.54, I2 = 0%), myocardial infarction (RR 1.06, 95% CI 0.71 to 1.57, p = 0.79, I2 = 61%), aortic valve reintervention, endocarditis, and bioprosthetic valve failure. New-onset atrial fibrillation was more common in the SAVR group, whereas permanent pacemaker implantation was more common in the TAVR group. In conclusion, our meta-analysis showed that TAVR is associated with similar long-term outcomes compared with SAVR in selected low-risk patients.

Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis.

In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup. The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the firstFDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes. From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm². The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.

Short- and intermediate-term outcomes of transcatheter aortic valve replacement in low-risk patients: A meta-analysis and systematic review

Transcatheter aortic valve replacement (TAVR) being currently employed in low surgical risk patients with severe symptomatic aortic stenosis (AS). The durability and extended outcomes of TAVR as compared to surgical aortic valve replacement (SAVR) in low-risk patients remains uncertain. We selected randomized controlled trials (RCT) comparing outcomes of TAVR vs. SAVR in low surgical risk patients having severe AS using online databases. The primary outcome was all-cause death. The secondary outcomes were composite of all-cause death & disabling stroke, cardiovascular (CV) death, stroke, myocardial infarction (MI), permanent pacemaker (PPM) placement, new onset atrial fibrillation (AF), valve re-intervention and valve thrombosis. The outcomes were stratified at short- (1-year) and intermediate-term (≤5 years) follow-up. We used a random effect model to report outcomes as relative risk (RR) with a 95% confidence interval (CI). The analysis consisted of six RCTs comprising 5,122 subjects with a mean age of 75.4years. At short-term follow up, there was a significant reduction in all-cause death (RR: 0.62, 0.46-0.82, p=0.001) and composite of all-cause death and disabling stroke (RR: 0.62, 0.45-0.83, p=0.002) in patients undergoing TAVR. At intermediate-term follow-up, there was no significant difference in survival (RR:0.95, 0.73-1.24, p=0.71) and composite outcome (RR: 0.95, 0.74-1.22, p=0.71). TAVR patients had lower incidence of new onset AF, however, higher PPM placement. In patients with severe AS having low-surgical risk, patients undergoing TAVR had improved short-term survival as compared to SAVR. This survival advantage was absent at intermediate-term follow-up. The long-term outcomes remain uncertain.

Transcatheter Aortic Valve Replacement in Low-Risk Patients at Four or More Years

Transcatheter aortic valve replacement (TAVR) is accepted as an alternative to surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic valve stenosis. Prior studies have shown that TAVR has comparable or superior outcomes to SAVR in intermediate and high-risk patients. However, there is paucity of data about outcome of TAVR vs SAVR in low-surgical-risk patients evaluated at 4 or more years post-procedure. A systematic review of all published randomized controlled trials comparing TAVR and SAVR in low-risk patients was completed. A random-effects model meta-analysis was performed to study major outcomes, including all-cause mortality, stroke, myocardial infarction, and aortic valve reintervention. Three randomized trials comprising 2644 patients (1371 TAVR and 1273 SAVR) with a mean age of 74.3 ± 5.8 years were included in this analysis. There was no significant difference in all-cause and cardiovascular mortality, stroke, myocardial infarction, or aortic valve reintervention between the TAVR and SAVR groups at long-term follow-up. Transcatheter aortic valve replacement was associated with higher rate of pacemaker implantation, whereas SAVR was associated with more atrial fibrillation. At 4 or more years of follow-up, TAVR is safe and has comparable outcomes to SAVR in low-surgical-risk patients. Possibility of TAVR and its risks and benefits should be discussed with low-surgical-risk patients.

Short-Term Outcomes of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Pure Severe Aortic Regurgitation

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for patients with pure severe aortic regurgitation (PSAR) who are contraindicated for surgery or have a high surgical risk. However, the therapeutic efficacy and safety of TAVR in low Society of Thoracic Surgeons (STS) score risk patients remain to be clarified. This study aimed to explore the feasibility of TAVR treatment in different STS-risk patients and to compare the adverse events between the groups. In this study, patients with PSAR who underwent TAVR at Zhongshan Hospital, Fudan University, China, during the inclusion period were included and categorized into 3 groups based on STS scores. The baseline data, imaging results, and follow-up data of the patients were documented. Therefore, of 75 TAVR patients, 38 (50.7%) were categorized as low risk (STS <4), and 37 (49.3%) patients were categorized as intermediate and high risk (STS ≥4). Compared with patients at intermediate and high risk, those in the low-risk group were younger, had a lower body mass index, had a lower prevalence of hypertension, chronic obstructive pulmonary disease, and previous percutaneous coronary intervention, and had better cardiac function (p all <0.05). In the hospital and at the 1-month follow-up, the degree of aortic regurgitation and cardiac function were significantly improved. No significant difference was found between the 2 groups in the hospital or during the 30-day follow-up. In conclusion, TAVR for PSAR in low-STS-risk patients is safe and efficient during 30 days of follow-up compared with intermediate- and high-STS-risk groups. TAVR for PSAR should not be limited to inoperable or STS-defined high-risk patients. Long-term follow-up is needed for further investigation.

Midterm Clinical Outcomes after Isolated Surgical and Transcatheter Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis

This study aimed to compare the clinical outcomes of isolated surgical aortic valve replacement (SAVR) and transfemoral (TF)-transcatheter aortic valve replacement (TAVR) in low-risk aortic stenosis (AS) patients. A total of 696 low-risk (Society of Thoracic Surgeons score <4%) AS patients underwent isolated SAVR or TF-TAVR at five centers. After 1:1 propensity score matching, 159 pairs were identified. Early and follow-up events, including cardiac mortality and major adverse cardiac and cerebrovascular events (MACCE: all-cause mortality, heart failure admission, reoperation, prosthetic valve endocarditis, and stroke), were compared. Baseline characteristics are similar between the matched groups. There were no 30-day cardiac mortalities in either group. All-cause mortality and MACCE at 30 days did not differ. During 5-year follow-up (median 3.1 [range 0-7.2] years), the incidence of cardiac mortality (1.3% vs. 18.9%; adjusted hazard ratio [aHR], 8.89; 95% confidence interval [CI], 2.68-29.53; P <0.001), all-cause mortality (4.2% vs. 33.9%; aHR, 8.56; 95% CI, 3.41-21.45; P <0.001), and MACCE (25.1% vs. 47.0%; aHR, 2.36; 95% CI, 1.54-3.63; P <0.001) were lower in the SAVR group than in the TAVR group. Isolated SAVR demonstrated better outcomes in low-risk AS patients. TAVR in this subset should be chosen carefully.

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.

Survival After Surgical Aortic Valve Replacement in Low-Risk Patients: A Contemporary Trial Benchmark

The use of transcatheter aortic valve replacement for severe aortic stenosis in low-risk patients necessitates an evaluation of contemporary long-term, real-world outcomes of similar patients undergoing surgical aortic valve replacement (SAVR) in a national cohort. All patients undergoing primary, isolated SAVR in The Society of Thoracic Surgeons (STS) database between 2011 and 2019 were examined. The study population of 42,586 adhered to the inclusion/exclusion criteria of the Placement of Aortic Transcatheter Valves (PARTNER) 3 and Evolut Low Risk randomized trials. Patients were further stratified by STS predicted risk of mortality (PROM), age, and left ventricular ejection fraction. The primary end-point was all-cause National Death Index mortality. Unadjusted survival to 8 years was estimated using the Kaplan-Meier method. Mean age was 74.3 ± 5.7 years and mean STS PROM was 1.9% ± 0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1, 3, 5, and 8 years was 2.6%, 4.5%, 7.1%, and 12.4%, respectively. In subset analyses, survival was significantly better for (1) lower STS PROM (P < .001), (2) younger vs older age (P < .001), and (3) higher vs lower left ventricular ejection fraction (P < .001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival after SAVR was 95%. The results of this national study confirm that long-term survival after SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and transcatheter aortic valve replacement and may assist in the clinical decision-making process for patients of lower surgical risk.

Three-year outcomes of transcatheter vs surgical aortic valve replacement in low-risk patients with severe aortic stenosis

Three-year outcomes of transcatheter vs surgical aortic valve replacement in low-risk patients with severe aortic stenosis

TCT-444 Mid to Long-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis: A Systematic Review and Meta-Analysis

TCT-444 Mid to Long-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis: A Systematic Review and Meta-Analysis

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95%CI: 0.49-1.00; P=0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mildparavalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P< 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were<1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1mmHg TAVR vs 12.1mmHg surgery; P< 0.001) at 3 years. Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgerywith respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

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 Aortic Valve Replacement in Low-Risk Patients With Bicuspid vs. Tricuspid Aortic Stenosis – 2-Year Follow-Up

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Bicuspid vs. Tricuspid Aortic Stenosis – 2-Year Follow-Up

Redefining “low risk”: Outcomes of surgical aortic valve replacement in low-risk patients in the transcatheter aortic valve replacement era

Guidelines suggest aortic valve replacement (AVR) for low-risk asymptomatic patients. Indications for transcatheter AVR now include low-risk patients, making it imperative to understand state-of-the-art surgical AVR (SAVR) in this population. Therefore, we compared SAVR outcomes in low-risk patients with those expected from Society of Thoracic Surgeons (STS) models and assessed their intermediate-term survival. From January 2005 to January 2017, 3493 isolated SAVRs were performed in 3474 patients with STS predicted risk of mortality <4%. Observed operative mortality and composite major morbidity or mortality were compared with STS-expected outcomes according to calendar year of surgery. Logistic regression analysis was used to identify risk factors for these outcomes. Patients were followed for time-related mortality. With 15 observed operative deaths (0.43%) compared with 55 expected (1.6%), the observed:expected ratio was 0.27 for mortality (95% confidence interval [CI], 0.14-0.42), stroke 0.65 (95% CI, 0.41-0.89), and reoperation 0.50(95% CI, 0.42-0.60). Major morbidity or mortality steadily declined, with probabilities of 8.6%, 6.7%, and 5.2% in 2006, 2011, and 2016, respectively, while STS-expected risk remained at approximately 12%. Mitral valve regurgitation, ventricular hypertrophy, pulmonary, renal, and hepatic failure, coronary artery disease, and earlier surgery date were residual risk factors. Survival was 98%, 91%, and 82% at 1, 5, and 9years, respectively, superior to that predicted for the US age-race-sex-matched population. STS risk models overestimate contemporary SAVR risk at a high-volume center, supporting efforts to create a more agile quality assessment program. SAVR in low-risk patients provides durable survival benefit, supportingearly surgery and providing a benchmark for transcatheter AVR.

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Valve Stenosis in Chinese Patients.

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Valve Stenosis in Chinese Patients.

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

The 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. The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. A 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. An 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. The 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).

Why Does the NOTION Trial Show Poorer than Expected Outcomes in the Surgical Arm?

The NOTION trial compares transcatheter aortic valve implantation versus surgical aortic valve replacement in low-risk patients. Looking carefully at the outcomes of this trial, there is no doubt that the transcatheter aortic valve implantation results were outstanding. The same thing cannot be said for the results of the surgery. We tried to understand the reason for that.

Minimally Invasive Versus Full Sternotomy for Isolated Aortic Valve Replacement in Low-Risk Patients

Surgical aortic valve replacement can be performed through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI vs FS for isolated surgery among patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 3 low-risk trial. Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment. The primary outcome was the composite end point of death, stroke, or rehospitalization (valve-, procedure-, or heart failure-related) at 1 year. Secondary outcomes included the individual components of the primary end point as well as patient-reported health status at 30 days and 1 year. In the PARTNER 3 study, 358 patients underwent isolated valve replacement at 68 centers through an MI (n= 107) or FS (n= 251) approach (8 patients were converted from MI to FS). Mean age and Society of Thoracic Surgeons score were similar between groups. The Kaplan-Meier estimate of the primary outcome was similar in the MI vs FS groups (16.9% vs 14.9%; hazard ratio, 1.15; 95% CI, 0.66-2.03; P= .618). There were no significant differences in the 1-year rates of all-cause death (2.8% vs 2.8%), all stroke (1.9% vs 3.6%), or rehospitalization (13.3% vs 10.6%, P > .05 for all). Quality of life, as assessed by the Kansas City Cardiomyopathy Questionnaire score at 30 days or 1 year, was comparable in both groups. For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes.