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Objective: To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes., Methods: Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 definition for bioprosthetic valve failure was applied., Results: A Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2% were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3% (range, 2.1%-6.2%), and 33.4% had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9% vs 1.9% for small and 55.1% vs 19.5% for medium; P < .001). The mean aortic valve gradients decreased significantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient-prosthesis mismatch (with an effective orifice area/m 2 of >0.8). Significant LV mass regression was documented regardless valve sizes, plateaued at -9.1% at 5 years. Freedom from SVD and reintervention were 95.2% and 96.3%, respectively, at 5 years and were independent of implanted valve size (P = .22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8% at 5 years., Conclusions: The Perceval valve demonstrated low and stable mean gradients, significant LV mass regression, and low SVD and reintervention rates across all valve sizes., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience., Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients., Results: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m 2 at discharge to 95.8 ± 27.1 g/m 2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001)., Conclusions: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to further evaluate clinical outcomes in patients with and without PCS., Background: Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear., Methods: In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke., Results: Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (p interaction  <0.0001). A similar interaction was observed for life-threatening or disabling bleeding., Conclusions: In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR., Study Design: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018., Conclusions: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been shown to be feasible, yet the safety and efficacy in relation to native valve (NV) TAVR are not known., Objectives: This study sought to evaluate the safety and effectiveness of ViV TAVR for failed surgical aortic valve replacement (SAVR) by comparing it with the benchmark of NV TAVR., Methods: Patients who underwent ViV-TAVR (n = 1,150) were matched 1:2 (on sex, high or extreme risk, hostile chest or porcelain aorta, 5-m-walk time, and Society of Thoracic Surgeons Predicted Risk of Mortality for reoperation) to patients undergoing NV-TAVR (n = 2,259). Baseline characteristics, procedural data, and in-hospital outcomes were obtained from the Transcatheter Valve Therapy Registry. The 30-day and 1-year outcomes were obtained from linked Medicare administrative claims data., Results: Unadjusted analysis revealed lower 30-day mortality (2.9% vs. 4.8%; p < 0.001), stroke (1.7% vs. 3.0%; p = 0.003), and heart failure hospitalizations (2.4% vs. 4.6%; p < 0.001) in the ViV-TAVR compared with NV-TAVR group. Adjusted analysis revealed lower 30-day mortality (hazard ratio: 0.503; 95% confidence interval: 0.302 to 0.839; p = 0.008), lower 1-year mortality (hazard ratio: 0.653; 95% confidence interval: 0.505 to 0.844; p = 0.001), and hospitalization for heart failure (hazard ratio: 0.685; 95% confidence interval: 0.500 to 0.939; p = 0.019) in the ViV-TAVR group. Patients in the ViV-TAVR group had higher post-TAVR mean gradient (16 vs. 9 mm Hg; p < 0.001), but less moderate or severe aortic regurgitation (3.5% vs. 6.6%; p < 0.001). Post-TAVR gradients were highest in small SAVRs and stenotic SAVRs., Conclusions: Comparison with the benchmark NV-TAVR shows ViV-TAVR to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To compare mitral valve repair (MVRepair) and mitral valve replacement (MVReplace) trends in the Veterans Affairs (VA) Surgical Quality Improvement Program., Methods: Trends were compared by bivariate analyses, followed by backward stepwise selection and multivariable logistic modeling to determine the effect of preoperative comorbidities and facility-level factors on MVRepair (vs MVReplace) rate. A subgroup analysis focused on patients who underwent elective surgery for isolated primary degenerative mitral regurgitation. Propensity matching was done in the overall and primary degenerative cohorts., Results: From October 2000 to October 2013, 4165 veterans underwent MVRepair (n = 2408) or MVReplace (n = 1757) for MV disease of any cause at 40 VA medical centers (procedural volume, 0-29/y; median 7/y). The MVRepair percentage increased from 48% in 2001 to 63% in 2013 (P < .001). MVRepair rates varied widely among centers; center volume explained only 19% of this variation after adjustment for case mix (R 2  = 0.19, P = .005). Unadjusted 30-day and 1-year mortality rates were lower after MVRepair than after MVReplace (3.5% vs 4.8%, P = .04; 9.8% vs 12.1%, P = .02). Among the propensity-matched patients (n = 2520), 30-day and 1-year mortality were similar after MVRepair and MVReplace. In the propensity-matched primary degenerative subgroup (n = 664), unadjusted long-term mortality for up to 10 years postoperatively was lower after MVRepair (28% vs 37%, P = .003), as was risk-adjusted long-term mortality (hazard ratio, 0.78; 95% confidence interval, 0.61-1.01)., Conclusions: In the VA Health System, mortality after MV operations is low. Despite the survival advantage associated with MV repair in primary mitral regurgitation, repair is infrequent at some centers, representing an opportunity for quality improvement., (Copyright © 2017 The American Association for Thoracic Surgery. All rights reserved.)

Background: Sex-related differences in morbidity and survival in bicuspid aortic valve (BAV) adults are fundamentally unknown. Contemporary studies portend excellent survival for BAV patients identified at early echocardiographic-clinical stages. Whether BAV adults incur a survival disadvantage throughout subsequent echocardiographic-clinical stages remains undetermined., Methods and Results: Analysis was done of 3 different cohorts of consecutive patients with echocardiographic diagnosis of BAV identified retrospectively: (1) a community cohort of 416 patients with first BAV diagnosis (age 35±21 years, follow-up 16±7 years), (2) a tertiary clinical referral cohort of 2824 BAV adults (age 51±16 years, follow-up 9±6 years), and (3) a surgical referral cohort of 2242 BAV adults referred for aortic valve replacement (AVR) (age 62±14 years, follow-up 6±5 years). For the community cohort, 20-year risks of aortic regurgitation (AR), AVR, and infective endocarditis were higher in men (all P≤0.04); for a total BAV-related morbidity risk of 52±4% vs 35±6% in women (P=0.01). The cohort's 25-year survival was identical to that in the general population (P=0.98). AR independently predicted mortality in women (P=0.001). Baseline AR was more common in men (P≤0.02) in the tertiary cohort, with 20-year survival lower than that in the general population (P<0.0001); age-adjusted relative death risk was 1.16 (95% confidence interval [CI] 1.05-1.29) for men versus 1.67 (95% CI 1.38-2.03) for women (P=0.001). AR independently predicted mortality in women (P=0.01). Baseline AR and infective endocarditis were higher in men (both ≤0.001) for the surgical referral cohort, with 15-year survival lower than that in the general population (P<0.0001); age-adjusted relative death risk was 1.34 (95% CI 1.22-1.47) for men versus 1.63 (95% CI 1.40-1.89) for women (P=0.026). AR and NYHA class independently predicted mortality in women (both P≤0.04)., Conclusions: Within evolving echocardiographic-clinical stages, the long-term survival of adults with BAV is not benign, as both men and women incur excess mortality. Although BAV-related morbidity is higher in men in the community, and AR and infective endocarditis are more prevalent in men, women exhibit a significantly higher relative risk of death in tertiary and surgical referral cohorts, which is independently associated with AR., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Extreme-risk patients (ie, Society of Thoracic Surgeons [STS] risk 15% or higher) with severe aortic valve stenosis may not obtain mortality benefit from aortic valve replacement (AVR). We reviewed our experience with this group of patients to better understand our triage process and outcomes., Methods: We performed a retrospective review of 97 patients with severe aortic valve stenosis and STS risk of 15% or higher treated from 2008 through 2013. The median patient age was 85 years (minimum, 44; maximum, 97 years), and 47 patients (48.5%) were male. The STS risk of mortality was 19.8% (minimum, 15.1%; maximum, 60.9%). Patients were assigned to treatment groups based on the first aortic valve intervention of balloon aortic valvuloplasty (BAV group, 66 [68%]) or de novo AVR (d-AVR group, 31 [32%])., Results: Patients in the BAV group were sicker, with a reduced ejection fraction (0.35 vs 0.57; p = 0.002) and greater prevalence of urgent/emergency operative status (32% vs 10%; p = 0.004) compared with those in the d-AVR group. After BAV, 33 patients (50%) demonstrated clinical improvement and went on to receive subsequent staged AVR after a median of 64 days (minimum, 3; maximum, 390 days). The mortality rate at 2 years was worse in the BAV group (57.3% ± 6.3%) than in the d-AVR group (29.5% ± 8.3%; p = 0.015), but was similar in patients who received BAV followed by staged AVR and de novo AVR (p = 0.426)., Conclusions: BAV may triage select patients with STS risk 15% or higher who are questionable candidates for AVR. Patients with clinical improvement after BAV experience benefit from staged AVR., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: In this study, we sought to determine the clinical outcomes after transcatheter aortic valve replacement (TAVR) among patients with chronic lung disease (CLD) and to evaluate the safety of transaortic versus transapical alternate access approaches in patients with varying severities of CLD., Methods: Clinical records for patients undergoing TAVR from 2011 to 2014 in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Medicare hospital claims (n = 11,656). Clinical outcomes were evaluated across strata of CLD severity, and the risk-adjusted association between access route and post-TAVR mortality was determined among patients with severe CLD., Results: In this cohort (median age, 84 years; 51.7% female), moderate to severe CLD was present in 27.7% (14.3%, moderate; 13.4%, severe). Compared with patients with no or mild CLD, patients with severe CLD had a higher rate of post-TAVR mortality to 1-year (32.3% versus 21.0%; adjusted hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.31 to 1.66), as did those with moderate CLD (25.5%; adjusted HR, 1.16; 95% CI, 1.03 to 1.30). The adjusted rate of mortality was similar for transapical versus transaortic approaches to 1 year (adjusted HR, 1.17; 95% CI, 0.83 to 1.65)., Conclusions: Moderate or severe CLD is associated with an increased risk of death to 1-year after TAVR, and among patients with severe CLD, the risk of death appears to be similar with either transapical or transaortic alternate-access approaches. Further study is necessary to understand strategies to mitigate risk associated with CLD and the long-term implications of these findings., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Pulmonary hypertension (PH) is associated with increased mortality after surgical or transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS), and when the pulmonary artery pressure is particularly elevated, there may be questions about the clinical benefit of TAVR. We aimed to identify clinical and haemodynamic factors associated with increased mortality after TAVR among those with moderate/severe PH., Methods: Among patients with symptomatic AS at high or prohibitive surgical risk receiving TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) I randomised trial or registry, 2180 patients with an invasive measurement of mean pulmonary artery pressure (mPAP) recorded were included, and moderate/severe PH was defined as an mPAP ≥35 mm Hg., Results: Increasing severity of PH was associated with progressively worse 1-year all-cause mortality: none (n=785, 18.6%), mild (n=838, 22.7%) and moderate/severe (n=557, 25.0%) (p=0.01). The increased hazard of mortality associated with moderate/severe PH was observed in females, but not males (interaction p=0.03). In adjusted analyses, females with moderate/severe PH had an increased hazard of death at 1 year compared with females without PH (adjusted HR 2.14, 95% CI 1.44 to 3.18), whereas those with mild PH did not. Among males, there was no increased hazard of death associated with any severity of PH. In a multivariable Cox model of patients with moderate/severe PH, oxygen-dependent lung disease, inability to perform a 6 min walk, impaired renal function and lower aortic valve mean gradient were independently associated with increased 1-year mortality (p<0.05 for all), whereas several haemodynamic indices were not. A risk score, including these factors, was able to identify patients with a 15% vs 59% 1-year mortality., Conclusions: The relationship between moderate/severe PH and increased mortality after TAVR is altered by sex, and clinical factors appear to be more influential in stratifying risk than haemodynamic indices. These findings may have implications for the evaluation of and treatment decisions for patients referred for TAVR with significant PH., Trial Registration: NCT00530894., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objectives: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement., Methods: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients., Results: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement., Conclusions: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) with the balloon-expandable Sapien transcatheter heart valve improves survival compared to standard therapy in patients with severe aortic stenosis (AS) and is noninferior to surgical aortic valve replacement (AVR) in patients at high operative risk. Nonetheless, a significant proportion of patients may require pre-emptive or emergent support with cardiopulmonary bypass (CPB) and/or intra-aortic balloon pump (IABP) during TAVR due to pre-existing comorbid conditions or as a result of procedural complications., Objectives: We hypothesized that patients who required CPB or IABP would have increased periprocedural complications and reduced long-term survival. In addition, we sought to determine whether preprocedural variables could predict the need for CPB and IABP., Methods: The study population included 2,525 patients in the PARTNER Trial (Cohort A and B) and the continuing access registry (CAR). Patients that received CPB or IABP were compared to patients that did not receive either, and then further divided into those that received support pre-TAVR and those that were placed on support emergently., Results: One-hundred sixty-three patients (6.5%) were placed on CPB and/or IABP. The use of CPB or IABP was associated with higher 1 year mortality (49.1% vs. 21.6%, P < 0.001). In multivariable analysis, utilization of CPB or IABP was an independent predictor of 30 day (HR 6.95) and 1-year (HR 2.56) mortality. Although mortality was highest in emergent cases, mortality was also greater in planned CPB and IABP cases compared with non-CPB/IABP cases (53.3% and 40.3% vs. 21.6%, P < 0.001)., Conclusions: These findings indicate that CPB and IABP use in TAVR portends a poor prognosis and its utilization, particularly in the setting of pre-emptive use, needs reconsideration., (© 2015 Wiley Periodicals, Inc.)

Background: In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR., Methods and Results: Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization., Conclusions: In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant-related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT00530894., (© 2014 American Heart Association, Inc.)

Robotic-assisted mitral valve repair represents the least invasive surgical approach currently available for anatomical mitral valve repair in patients with myxomatous mitral valve disease. Standard mitral valve repair techniques utilized during conventional sternotomy/right thoracotomy are exactly replicated with the robotic instrumentation through 1-2 cm port-like incisions with superior 3D visualization. This is performed on cardiopulmonary bypass by peripheral cannulation of the femoral vessels/right internal jugular vein. The ascending aorta is occluded with a transthoracic aortic cross-clamp. Antegrade cardioplegia is delivered centrally into the aortic root through a cardioplegia vent catheter. By replicating conventional mitral valve repair done via an open sternotomy approach, the quality of mitral valve repair is ensured while providing the patients with advantages of less invasive surgery including shorter hospital stay, rapid recovery and return to normal activities, less blood transfusion, superior cosmesis and complete elimination of sternotomy-related morbidities such as deep sternal wound infection and sternal dehiscence. We reviewed the first consecutive 200 patients undergoing robotic mitral valve repair at Mayo Clinic Rochester between 24 January 2008 and 28 January 2011. Successful mitral valve repair was completed in all patients. There were no early (30-day) deaths. One patient suffered a stroke (0.5%). One patient required reoperation for bleeding (0.5%). Two patients (1%) required reoperation for recurrent mitral regurgitation. Twelve patients (6%) required transfusion of allogeneic blood products. We have noted a significant reduction in operative times and resource utilization over time., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The Placement of Aortic Transcatheter Valves (PARTNER) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting (CABG) operation who received surgical aortic valve replacement (SAVR) in comparison with transcatheter aortic valve replacement (TAVR). We sought to further evaluate these groups., Methods: We reviewed the database of the 699 patients enrolled in the PARTNER trial. The cohort for this study consisted of 288 patients (41.2%) who had a history of CABG operation before enrollment in the PARTNER trial. All patients were followed up for 2 years., Results: The mean age was 81.5±6.6 years, and 231 patients (80.2%) were men. The preoperative characteristics were similar in 140 patients (48.6%) who received SAVR and 148 (51.4%) who received TAVR. There were no differences between the two groups with respect to the operative outcomes of death, stroke, and myocardial infarction, but the TAVR patients experienced more paravalvular regurgitation (p<0.0001). At 2 years, there was a trend toward greater all-cause mortality in the TAVR patients (hazard ratio [HR] 1.53; 95% confidence interval [CI]: 0.99, 2.35; p=0.052). Furthermore, the TAVR patients had more repeated hospitalization (HR 1.75; 95% CI: 0.99, 3.07; p=0.05), death of any cause or repeated hospitalization (HR 1.52; 95% CI: 1.06, 2.19; p=0.02), and death of any cause or stroke (HR 1.51; 95% CI: 1.00, 2.27; p=0.05)., Conclusions: The 2-year follow-up of patients with a history of previous CABG operation in the PARTNER trial demonstrated improved outcomes with SAVR in comparison with TAVR. Further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

This study evaluated preoperative balloon aortic valvuloplasty (BAV) as a technique to decrease aortic valve replacement (AVR) risk in patients who have severe symptomatic aortic valve stenosis with substantial comorbidity. We report the outcomes of 18 high-risk patients who received BAV within 180 days before AVR from November 1993 through December 2011. Their median age was 78 years (range, 51-93 yr), and there were 11 men (61%). The pre-BAV median calculated Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) was 18.3% (range, 9.4%-50.7%). Preoperative left ventricular ejection fraction measured a median of 0.23 (range, 0.05-0.68), and the median aortic valve area index was 0.4 cm(2)/m(2) (range, 0.2-0.7 cm(2)/m(2)). The median interval from BAV to AVR was 28 days (range, 1-155 d). There were no strokes or deaths after BAV; however, 4 patients (22%) required mechanical circulatory support, 3 (17%) required femoral artery operation, and 1 (6%) developed severe aortic valve regurgitation. After BAV, the median STS PROM fell to 9.1% (range, 2.6%-25.7%) (compared with pre-BAV, P <0.001). Echocardiography before AVR showed that the median left ventricular ejection fraction had improved to 0.35 (range, 0.15-0.66), and the aortic valve area index to 0.5 cm(2)/m(2) (range, 0.3-0.7 cm(2)/m(2)) (compared with pre-BAV, both P <0.05). All patients received AVR. Operative death occurred in 2 patients (11%), and combined operative death and morbidity in 7 patients (39%). Staged BAV substantially reduces the operative risk associated with AVR in selected patients.

Objective: Multiple-valve (MUV) procedures currently exhibit higher operative mortality than do single-valve procedures, but a paucity of scientific information exists to explain the observation. This topic was examined using The Society of Thoracic Surgeons Database., Methods: All patients in the The Society of Thoracic Surgeons data set undergoing valve surgery (except pulmonary valve and aortic root operations) from 1993 through 2007 were identified (N = 623,039). Baseline characteristics and postoperative outcomes were contrasted between all seven combinations of single-valve and MUV procedures involving aortic, mitral, and tricuspid valves. Seven independent logistic regression analyses were performed, based on the seven procedures, and multivariable risk factors for mortality were compared, with emphasis on single-valve versus MUV procedures., Results: Baseline characteristics for MUV procedures (n = 67,926) shared many similarities to those for single-valve procedures (n = 555,113), including age, ejection fraction, and comorbidities. Preoperative renal failure, New York Heart Association class III to IV, nonelective presentation, and reoperation were slightly more common in MUV subsets, and coronary bypass was less frequent. Operative mortality was almost double for MUV as compared with single-valve procedures (10.7% vs 5.7%, P = 0.0001). Categorical predictors with the largest odds ratios for mortality were emergency status, renal failure, and second reoperation. However, predictors for mortality were generally consistent in order and magnitude between the single-valve and MUV subgroups., Conclusions: Despite similarities in preoperative profiles of the patients undergoing single-valve and MUV procedures, mortality for MUV surgery remains considerably higher. Determinants of operative mortality and morbidity differ little across the procedural groups, and these findings serve as a benchmark for future studies, as well as suggest a continued search for explanations of poorer MUV outcomes.

Objective: To determine whether technically innovative cardiac surgical platforms (ie, robotics) deployed in conjunction with surgical process improvement (systems innovation) influence total hospital costs to address the concern that expanding adoption might increase health care expenses., Patients and Methods: We studied 185 propensity-matched patient pairs (370 patients) undergoing isolated conventional open vs robotic mitral valve repair with identical repair techniques and care teams between July 1, 2007, and January 31, 2011. Two time periods were considered, before the implementation of system innovations (pre-July 2009) and after implementation. Generalized linear mixed models were used to estimate the effect of the type of surgery on cost while adjusting for a time effect., Results: Baseline characteristics of the study patients were similar, and all patients underwent successful mitral valve repair with no early deaths. Median length of stay (LOS) for patients undergoing open repair was unchanged at 5.3 days (P=.636) before and after systems innovation implementation, and was lower for robotic patients at 3.5 and 3.4 days, respectively (P=.003), throughout the study. The overall median costs associated with open and robotic repair were $31,838 and $32,144, respectively (P=.32). During the preimplementation period, the total cost was higher for robotic ($34,920) than for open ($32,650) repair (P<.001), but during the postimplementation period, the median cost of robotic repair ($30,606) became similar to that of open repair ($31,310) (P=.876). The largest decrease in robotic cost was associated with more rapid ventilator weaning and shortened median intensive care unit LOS, from 22.7 hours before July 2009 to 9.3 hours after implementation of systems innovations (P<.001)., Conclusion: Following the introduction of systems innovation, the total hospital cost associated with robotic mitral valve repair has become similar to that for a conventional open approach, while facilitating quicker patient recovery and diminished utilization of in-hospital resources. These data suggest that innovations in techniques (robotics) along with care systems (process improvement) can be cost-neutral, thereby improving the affordability of new technologies capable of improving early patient outcomes., (Copyright © 2013 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Importance: The optimal management of severe mitral valve regurgitation in patients without class I triggers (heart failure symptoms or left ventricular dysfunction) remains controversial in part due to the poorly defined long-term consequences of current management strategies. In the absence of clinical trial data, analysis of large multicenter registries is critical., Objective: To ascertain the comparative effectiveness of initial medical management (nonsurgical observation) vs early mitral valve surgery following the diagnosis of mitral regurgitation due to flail leaflets., Design, Setting, and Participants: The Mitral Regurgitation International Database (MIDA) registry includes 2097 consecutive patients with flail mitral valve regurgitation (1980-2004) receiving routine cardiac care from 6 tertiary centers (France, Italy, Belgium, and the United States). Mean follow-up was 10.3 years and was 98% complete. Of 1021 patients with mitral regurgitation without the American College of Cardiology (ACC) and the American Heart Association (AHA) guideline class I triggers, 575 patients were initially medically managed and 446 underwent mitral valve surgery within 3 months following detection., Main Outcomes and Measures: Association between treatment strategy and survival, heart failure, and new-onset atrial fibrillation., Results: There was no significant difference in early mortality (1.1% for early surgery vs 0.5% for medical management, P=.28) and new-onset heart failure rates (0.9% for early surgery vs 0.9% for medical management, P=.96) between treatment strategies at 3 months. In contrast, long-term survival rates were higher for patients with early surgery (86% vs 69% at 10 years, P < .001), which was confirmed in adjusted models (hazard ratio [HR], 0.55 [95% CI, 0.41-0.72], P < .001), a propensity-matched cohort (32 variables; HR, 0.52 [95% CI, 0.35-0.79], P = .002), and an inverse probability-weighted analysis (HR, 0.66 [95% CI, 0.52-0.83], P < .001), associated with a 5-year reduction in mortality of 52.6% (P < .001). Similar results were observed in relative reduction in mortality following early surgery in the subset with class II triggers (59.3 after 5 years, P = .002). Long-term heart failure risk was also lower with early surgery (7% vs 23% at 10 years, P < .001), which was confirmed in risk-adjusted models (HR, 0.29 [95% CI, 0.19-0.43], P < .001), a propensity-matched cohort (HR, 0.44 [95% CI, 0.26-0.76], P = .003), and in the inverse probability-weighted analysis (HR, 0.51 [95% CI, 0.36-0.72], P < .001). Reduction in late-onset atrial fibrillation was not observed (HR, 0.85 [95% CI, 0.64-1.13], P = .26)., Conclusion and Relevance: Among registry patients with mitral valve regurgitation due to flail mitral leaflets, performance of early mitral surgery compared with initial medical management was associated with greater long-term survival and a lower risk of heart failure, with no difference in new-onset atrial fibrillation.

Cardiac surgical procedures via traditional sternotomy are safe and effective operations performed by cardiothoracic surgeons worldwide. However, postoperative limitations in upper extremity activity during bone healing are seen as undesirable by some. Percutaneous catheter-based attempts to emulate the outcomes of traditional cardiac surgical procedures have largely fallen short of established standards of efficacy and durability. The field of minimally invasive heart valve surgery thus developed out of a need to offer smaller, better-tolerated incisions to patients while maintaining high-quality clinical outcomes. These operations are safe and effective when performed by proficient surgical teams, allowing patients to resume normal activities more rapidly. We explore current evidence supporting the practice of minimally invasive heart valve surgery in 2012 and analyze the clinical impact of these nascent surgical platforms.