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Background: 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., Methods: 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., Results: 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., Conclusions: For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: We investigated patient outcomes in relation to their postoperative length of stay after minimally invasive valve surgery., Methods: All adults who survived elective, uncomplicated minimally invasive aortic or mitral valve surgery at a single center between 2012 and 2019 were classified by postoperative length of stay: early discharge (≤3 days) or late discharge (>3 days). The trend in early discharge was investigated over the study period, predictors of early discharge were identified using multivariate logistic regression modeling, and 1:1 propensity score matching was used to determine which patients in the late-discharge cohort had similar health to patients discharged early. Adjusted outcomes of 30-day mortality, readmission, and direct costs were analyzed., Results: Among 1262 consecutive patients undergoing minimally invasive valve surgery, 618 were elective and uncomplicated, 25% (n = 162) of whom were discharged early. The proportion of early-discharge patients increased over time (P for trend < .05). A history of congestive heart failure, stroke, or smoking and higher Society of Thoracic Surgeons predictive risk of mortality score negatively predicted early discharge (P < .05). Propensity score matching identified 101 (22%) late-discharge patients comparable with early-discharge patients. Adjusted 30-day mortality and readmission rates were comparable between cohorts. The median direct costs per patient ($20,046 vs $22,124, P < .05) were significantly lower in the early-discharge cohort., Conclusions: In well-selected patients early discharge after minimally invasive valve surgery was associated with lower costs but comparable postoperative outcomes. About one-fifth of patients who remain in the hospital beyond postoperative day 3 may be candidates for earlier discharge., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: We evaluated the availability of transcatheter aortic valve replacement (TAVR) to determine its value across all severe symptomatic aortic stenosis (SSAS) patients, especially those untreated because of concerns regarding invasive surgical AVR (SAVR) and its impact on active aging., Methods: We performed payer perspective cost-utility analysis (CUA) and societal perspective cost-benefit analysis (CBA). The CBA's benefit measure is active time: salaried labor, unpaid work, and active leisure. The study population is a cohort of US elderly SSAS patients. We compared a "TAVR available" scenario in which SSAS patients distribute themselves across TAVR, SAVR, and medical management (MM); and a "TAVR not available" scenario with only SAVR and MM. We structured each scenario with a decision-tree model of SSAS patient treatment allocation. We measured the association between health and active time in the US Health and Retirement Study and used this association to impute active time to SSAS patients given their health., Results: The incremental cost-effectiveness ratio (ICER) and rate of return (RoR) of TAVR availability were $8,533 and 395%, respectively. CUA net monetary benefits (NMB) were $212,199 per patient and $43.4 billion population-wide. CBA NMB were $50,530 per patient and $10.3 billion population-wide., Limitations: Among study limitations were scarcity of evidence regarding key parameters and the lack of long-term survival, health utility, and treatment cost data. Our analysis did not account for TAVR durability, retreatments, and valve-in-valve treatments., Conclusion: Across risk-, age-, and treatment-eligibility groups, TAVR is the economically optimal treatment choice. It represents strong value-for-money per patient and population-wide. The vast majority of TAVR value involves raising treatment uptake among the untreated.

Introduction: The impact of transcatheter aortic valve replacement (TAVR) on sex disparities has not been well established. This study sought to examine the impact of sex on outcomes following aortic valve replacement (AVR) for aortic stenosis (AS) in the era of routine TAVR., Methods: We performed a cross-sectional analysis of the National Inpatient Sample (2009-18) to study AS visits for all AVR and in-hospital outcomes as a function of sex. Survey estimation commands were used to provide national estimates., Results: There were an estimated 431,344 surgical AVR (SAVR) and 189,137 TAVR inpatient visits. Mortality was higher in women after SAVR (3.8% ± 0.1 vs. 2.7% ± 0.07, p < 0.001) and TAVR (2.4% ± 0.1 vs. 1.7% ± 0.1, p < 0.001) compared to men. Female patients undergoing SAVR had higher rates of permanent pacemaker (PPM) implantation, stroke, and bleeding (5.9% ± 0.1 vs. 5% ± 0.1, 2.8% ± 0.1 vs. 2.3% ± 0.07, and 37.8% ± 0.8 vs. 29.8% ± 0.6; p < 0.001, respectively) but lower rates of acute kidney injury (AKI) (16.4% ± 0.3 vs. 20.3% ± 0.3, p < 0.001). Women undergoing TAVR had higher rates of stroke and bleeding (2.4% ± 0.1 vs. 1.6% ± 0.09 and 28.7% ± 0.6 vs. 22% ± 0.5; p < 0.001, respectively) but lower rates of PPM and AKI (9.5% ± 0.3 vs. 10.7% ± 0.2 and 11.3% ± 0.3 vs. 13.4% ± 0.3; p < 0.001, respectively). Compared with isolated SAVR, isolated TAVR was associated with lower mortality in women during 2016-18, both after multivariable adjustment (OR = 0.40; 95% CI, 0.27-0.60) and propensity matching (mean difference 0.66% ± 0.2); however, there was no difference in men., Conclusion: Although women continue to have higher in-hospital mortality following both TAVR and SAVR as compared to men, TAVR is associated with a lower in-hospital mortality in women compared to SAVR. Thus, TAVR may represent a potential intervention to narrow the sex-based disparities in the management of AS., (© 2022 S. Karger AG, Basel.)

Background: Minimally invasive heart valve surgery has previously been shown to be safe and feasible in obese patients. Within this population, we investigated the effect of obesity class on the patient outcomes of minimally invasive aortic valve replacement (mini-AVR)., Methods: A single-center retrospective cohort study of consecutive patients with obese body mass indices (BMIs) who underwent mini-AVR between 2012 and 2020. Patients were stratified into three groups according to Centers for Disease Control and Prevention adult obesity classifications: Class I (BMI: 30.0-<35.0), Class II (BMI: 35.0-<40.0), and Class III (BMI ≥ 40.0). The primary outcomes were postoperative length of stay (LOS), 30-day mortality, and direct cost., Results: Among 206 obese patients who underwent mini-AVR, LOS (Class I 5 [3-7] vs. Class II 6 [5-7] vs. Class III 6 [5-7] days; p = .056), postoperative 30-day mortality (Class I 2.44% [n = 3] vs. Class II 4.44% [n = 2] vs. Class III 7.89% [n = 3]; p = .200), and costs (Class I $24,118 [$20,237-$29.591] vs. Class II $22,215 [$18,492-$28,975] vs. Class III $24,810 [$20,245-$32,942] USD; p = .683) did not differ between obesity class cohorts., Conclusions: Mini-AVR is safe and feasible to perform for obese patients regardless of their obesity class. Patients with obesity should be afforded the option of minimally invasive aortic valve surgery regardless of their obesity class., (© 2021 Wiley Periodicals LLC.)

Undertreatment of patients with severe mitral regurgitation (MR) has been exaggerated during the coronavirus disease of 2019 (COVID-19) pandemic. Expedited workup and shortened post-procedural hospital stay after percutaneous mitral valve repair (PMVR) would be incredibly helpful to relieve the constrain in the era of the COVID-19 pandemic and immediately afterward. We report a patient who underwent PMVR with a simplified pre-operative workup, a shortened hospital stay, and expedited discharge., Competing Interests: Declaration of competing interest Mark J Russo, MD, MS, serves as a speaker for Edward Life Sciences and Abbott Laboratories. All other authors have no disclosures to declare., (Copyright © 2020. Published by Elsevier Inc.)

Background: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States., Methods: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry., Results: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P <0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P =0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P =0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%)., Conclusions: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.

Background: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk., Methods: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke., Results: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery., Conclusions: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)., (Copyright © 2020 Massachusetts Medical Society.)

Background: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar rates of death or stroke at 2 years. Whether TAVR is cost-effective compared with SAVR for intermediate-risk patients remains uncertain., Methods: Between 2011 and 2014, 3110 intermediate-risk AS patients were treated with TAVR or SAVR in the PARTNER 2 trial (Placement of Aortic Transcatheter Valves 2). A total of 2032 patients were randomized to receive TAVR using the SAPIEN XT valve (XT-TAVR) or SAVR in the PARTNER 2A trial, whereas the PARTNER S3i registry included an additional 1078 patients treated with TAVR using the SAPIEN 3 valve (S3-TAVR), which offers a lower delivery profile and sealing skirt designed to reduce paravalvular regurgitation compared with XT-TAVR. Procedural costs were estimated using measured resource utilization. Other in-trial costs were assessed by linkage of trial data with Medicare claims (n=2333) or by linear regression models for unlinked patients (n=682). Health utilities were estimated using the EQ-5D at baseline and 1, 12, and 24 months. Using a Markov model informed by in-trial costs, utilities, and survival data, lifetime cost-effectiveness from the perspective of the US healthcare system was estimated in terms of cost per quality-adjusted life-year gained., Results: Although procedural costs were ≈$20 000 higher with TAVR than SAVR, total cost differences for the index hospitalization were only $2888 higher with XT-TAVR ( P=0.014) and were $4155 lower with S3-TAVR ( P<0.001) owing to reductions in length of stay with TAVR. Follow-up costs were significantly lower with XT-TAVR (Δ=-$9304; P<0.001) and S3-TAVR (Δ=-$11 377; P<0.001) than with SAVR. Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years. XT-TAVR and S3-TAVR were found to be economically dominant compared with SAVR in 84% and 97% of bootstrap replicates, respectively., Conclusions: Among intermediate-risk AS patients, TAVR is projected to be economically dominant from the perspective of the US healthcare system by providing both greater quality-adjusted life expectancy and lower long-term costs than SAVR. If long-term data demonstrate comparable late mortality with TAVR and SAVR, these findings suggest that TAVR might be the preferred treatment strategy for intermediate-risk AS patients based on both clinical and economic considerations., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01314313.

Background: Aprotinin was the subject of recent controversy regarding adverse clinical outcomes following cardiac surgery. We compared the role of Aprotinin and epsilon-aminocaproic acid on clinical outcomes and the attenuation of the postcardiopulmonary bypass (CPB) response at the genomic expression and cytokine (protein) level., Methods: Thirty-nine low-risk patients undergoing coronary revascularization (CABG) and/or valve procedures using cardiopulmonary CPB were enrolled into a prospective cohort study. Aprotinin or epsilon-aminocaproic acid was administered to patients. Gene expression was assessed from whole blood mRNA samples collected preoperatively (PRE) and 6 hours (6H) postoperatively. Validation of gene expression was performed with SYBR Green real-time polymerase chain reaction. Cytokine values were quantified from serum preoperatively and postoperatively at 6 H and 4 days and analyzed in a blinded fashion., Results: No difference was detected in baseline characteristics. Inflammatory markers measured did not reveal significant difference between patients receiving Aprotinin (APR) and those receiving epsilon-aminocaproic acid (Amicar). Intraoperative parameters and postoperative outcomes were not significantly different. Compared with PRE samples, 6H samples had 264 upregulated and 548 downregulated genes uniquely in the APR group compared to 4826 upregulated and 1114 downregulated genes uniquely in the Amicar group (p < 0.001). Compared to patients in the Amicar group, APR patients had significantly different gene expression pathways involving NF-kappabeta regulation, programmed cell death and cell-cell adhesion. None of the patients developed postoperative stroke, myocardial infarction, or systemic infections., Conclusions: Aprotinin leads to significantly less genomic expression variability following CPB compared to Amicar and has a differential effect on specific genomic pathways.