Socioeconomic disparities in midterm outcomes after repair for degenerative mitral regurgitation.

OBJECTIVE: The influence of socioeconomic disparities on survival after mitral repair is poorly defined. We examined the association between socioeconomic disadvantage and midterm outcomes of repair in Medicare beneficiaries with degenerative mitral regurgitation. METHODS: US Centers for Medicare and Medicaid Services data were used to identify 10,322 patients undergoing isolated first-time repair for degenerative mitral regurgitation between 2012 and 2019. Zip code-level socioeconomic disadvantage was dichotomized with the Distressed Communities Index, which incorporates education level, poverty, unemployment, housing security, median income, and business growth; those with Distressed Communities Index score ≥80 were classified as distressed. The primary outcome was survival, censored at 3 years. Secondary outcomes included cumulative incidences of heart failure readmission, mitral reintervention, and stroke. RESULTS: Of the 10,322 patients undergoing degenerative mitral repair, 9.7% (n = 1003) came from distressed communities. Patients from distressed communities underwent surgery at lower volume centers (11 vs 16 cases/year) and traveled further for surgical care (40 vs 17 miles) (both P values < .001). At 3 years, unadjusted survival (85.4%; 95% CI, 82.9%-87.5% vs 89.7%; 95% CI, 89.0%-90.4%) and cumulative incidence of heart failure readmission (11.5%; 95% CI, 9.6%-13.7% vs 7.4%; 95% CI, 6.9%-8.0%) were worse in patients from distressed communities (all P values < .001), whereas mitral reintervention rates were similar (2.7%; 95% CI, 1.8%-4.0% vs 2.8%; 95% CI, 2.5%-3.2%; P = .75). After adjustment, community distress was independently associated with 3-year mortality (hazard ratio, 1.21; 95% CI, 1.01-1.46) and heart failure readmissions (hazard ratio, 1.28; 95% CI, 1.04-1.58). CONCLUSIONS: Community-level socioeconomic distress is associated with worse outcomes in degenerative mitral repair among Medicare beneficiaries.

Left atrial appendage closure during mitral repair in patients without atrial fibrillation.

OBJECTIVE: Routine left atrial appendage closure during mitral repair in patients without atrial fibrillation (AF) is controversial. We aimed to compare the incidence of stroke after mitral repair in patients without recent AF according to left atrial appendage closure. METHODS: An institutional registry identified 764 consecutive patients without recent AF, endocarditis, prior appendage closure, or stroke undergoing isolated robotic mitral repair between 2005 and 2020. Left atrial appendages were closed via left atriotomy using a double-layer continuous suture in 5.3% (15 out of 284) patients before 2014, versus 86.7% (416 out of 480) after 2014. The cumulative incidence of stroke (including transient ischemic attack) was determined using statewide hospital data. Median follow-up was 4.5 years (range, 0-16.6 years). RESULTS: Patients undergoing left atrial appendage closure were older (63 vs 57.5 years, P < .001), with higher prevalence of remote AF requiring cryomaze (9%, n = 40 vs 1%, n = 3, P < .001). After appendage closure there were fewer reoperations for bleeding (0.7% [n = 3] vs 3% [n = 10]; P = .02), and more AF (31.8% [n = 137] vs 25.2% [n = 84]; P = .047). Two-year freedom from >2+ mitral regurgitation was 97%. Six strokes and 1 transient ischemic attack occurred after appendage closure compared with 14 and 5 in patients without (P = .002), associated with a significant difference in 8-year cumulative incidence of stroke/transient ischemic attack (hazard ratio, 0.3; 95% CI, 0.14-0.85; P = .02). This difference persisted in the sensitivity analysis, excluding patients undergoing concomitant cryomaze procedures. CONCLUSIONS: Routine left atrial appendage closure during mitral repair in patients without recent AF appears safe and was associated with a lower risk of subsequent stroke/transient ischemic attack.

Isolated Tricuspid Operations: The Society of Thoracic Surgeons Adult Cardiac Surgery Database Analysis.

BACKGROUND: Population-level data are limited regarding contemporary practice and outcomes of isolated tricuspid operations. We evaluated this using The Society of Thoracic Surgeons Adult Cardiac Surgery Database. METHODS: We identified 14,704 isolated tricuspid operations from The Society of Thoracic Surgeons Adult Cardiac Surgery Database from July 1, 2011 to June 30, 2020. After excluding patients with endocarditis, tricuspid stenosis, emergent/emergent salvage status, previous heart transplants, and missing tricuspid operation type, 6507 patients remained. Endpoints were operative mortality and composite major comorbidities (permanent stroke, renal failure, prolonged ventilation > 24 hours, deep sternal wound infection, cardiac reoperations, and new permanent pacemaker implantation). RESULTS: Isolated tricuspid operations increased from 2012 (983 cases) to 2019 (2155 cases, P < .001). Median annual center volume was 2 cases (range, 1-81). In the final cohort (n = 6507; median age, 65 years; 38.5% men), 40% had New York Heart Association class III/IV heart failure and 24% had nonelective operations. The operative mortality was 7.3% (1.7% in patients without these risk factors), and new permanent pacemaker implant rate was 10.8%. In the multivariable analysis, factors associated with operative mortality included New York Heart Association class III/IV heart failure (odds ratio [OR], 1.57), nonelective operations (OR, 1.91), tricuspid replacement (OR, 1.56), annual center volume ≤ 5 cases (OR, 1.37), and higher model for end-stage liver disease scores (all P < .05). Beating heart operation was associated with a lower adjusted risk of pacemaker implant (OR, 0.69), renal failure (OR, 0.75), and blood transfusions (OR, 0.8) compared with full cardioplegic arrest (all P < .05). CONCLUSIONS: Isolated tricuspid repair was associated with lower adjusted mortality and morbidities than replacement. Beating heart operation was associated with lower adjusted major morbidities. The preoperative model for end-stage liver disease scores may identify high-risk patients, and early referral to higher volume centers may help improve outcomes.

Trainee experience on ischemic times and outcomes following orthotopic heart transplantation.

OBJECTIVE: This study was designed to evaluate the association of surgical training on outcomes following orthotopic heart transplantation in all levels of cardiothoracic surgery fellows. METHODS: A retrospective cohort analysis was performed on all heart transplants at a single institution from 2011 to 2020. Transplants performed using organ preservation systems (n = 10) or with significant missing data were excluded (n = 37), resulting in 154 transplants performed by faculty surgeons and 799 total transplants performed by first-year Accreditation Council for Graduate Medical Education fellows (n = 73), second-year Accreditation Council for Graduate Medical Education fellows (n = 124), or non-Accreditation Council for Graduate Medical Education fellows (n = 602) in a transplantation and mechanical circulatory support fellowship. Primary outcome was warm ischemic time analyzed by year of fellowship. Additional secondary outcomes included 30-day mortality, primary graft dysfunction, reoperation for bleeding, and 5-year survival. Median follow-up was 3 years (interquartile range [IQR], 1.0-5.5 years) and 100% complete. RESULTS: The median number of transplants performed was 30 (IQR, 19.5-51.8) during the study period performed by 22 trainees. Baseline transplant characteristics performed were similar amongst the trainee years, although the first-year Accreditation Council for Graduate Medical Education fellows approached significantly fewer re-do transplants (1.4% vs 8.1% and 4.3%; P = .07). Warm ischemic time was lower in the first-year fellows (49 minutes; IQR, 42-63 minutes) versus second-year fellows (56.5 minutes; IQR, 45.5-69 minutes) and mechanical circulatory support/transplant fellows (56 minutes; IQR, 46-67 minutes) (P = .028). Crossclamp time was also lower in the first-year fellows than in second-year and mechanical circulatory support/transplant fellows, respectively (79 minutes; IQR, 65-100 minutes vs 147 minutes; IQR, 125-176 minutes and 143 minutes; IQR, 119-175 minutes) (P = .008). Secondary outcomes, including 30-day mortality (4.1% [n = 3] vs 2.4% [n = 3] vs 2.7% [n = 16]; P = .76), primary graft dysfunction (5.5% [n = 4] vs 4.0% [n = 5] vs 4.3% [n = 26]; P = .88), reoperation for bleeding (2.7% [n = 2] vs 4.8% [n = 6] vs 4.2% [n = 25]; P = .78), and 5-year survival (82.2%; 95% CI, 66.7%-84.9% vs 77.3%; 95% CI, 66.7%-84.9% vs 79.3%; 95% CI, 74.9%-83.1%; P = .84) were comparable in all groups. CONCLUSIONS: This cohort of nearly 800 operations demonstrates that orthotopic heart transplantation may be performed by cardiac fellowship trainees all levels of training with acceptable short- and long-term outcomes.

Robotic degenerative mitral repair: Factors associated with intraoperative revision and impact of mild residual regurgitation.

OBJECTIVES: National registry data show wide variability in degenerative mitral repair rates and infrequent use of intraoperative repair revision to eliminate residual mitral regurgitation (MR). The consequence of uncorrected mild residual MR is also not clear. We identified factors associated with intraoperative revision of degenerative mitral repair and evaluated long-term effects of intraoperative mild residual MR. METHODS: A prospective institutional registry of 858 patients with degenerative MR undergoing robotic mitral surgery was linked to statewide databases. Univariate logistic regression identified factors associated with intraoperative repair revision. Survival was estimated using the Kaplan-Meier method and adjusted with Cox regression. Late freedom from more-than-moderate MR or reintervention was estimated with death as a competing risk. RESULTS: Repair rate was 99.3%. Repair was revised intraoperatively in 19 patients and was associated with anterior or bileaflet prolapse, adjunctive repair techniques, and annuloplasty band size (all P < .05). Intraoperative repair revision did not result in increased postoperative complications. Intraoperative mild residual MR (n = 111) was independently associated with inferior 8-year survival (hazard ratio, 2.97; 95% CI, 1.33-6.23), worse freedom from more than moderate MR (hazard ratio, 3.35; 95% CI, 1.60-7.00), and worse freedom from mitral reintervention (hazard ratio, 6.40; 95% CI, 2.19-18.72) (all P < .01). CONCLUSIONS: A near 100% repair rate with acceptable durability may be achieved safely with intraoperative revision of postrepair residual MR. Mild residual MR was independently associated with reduced survival, worse freedom from more-than-moderate MR, and worse freedom from mitral reintervention at 8-year follow-up.

Robotic repair for Barlow mitral regurgitation: Repairability, safety, and durability.

OBJECTIVE: In Barlow disease, increased repair complexity drives decreased repair rates. We evaluated outcomes of a simplified approach to robotic mitral repair in Barlow disease. METHODS: A prospective institutional registry with vital-statistics, statewide admissions and echocardiographic follow-up was used to identify 924 consecutive patients undergoing robotic surgery for degenerative mitral regurgitation (MR) between 2005 and 2020, including 12% (n = 111) with Barlow disease. Freedom from >moderate (>2+) MR was analyzed with death as a competing risk and predictors of failure were analyzed using multivariable Cox regression. Median follow-up was 5.5 years (range, 0-15 years). RESULTS: Patients with Barlow disease were younger (median, age 59 years; interquartile range [IQR], 51-67 vs 62; IQR, 54-70 years, P = .05) than patients without Barlow disease. Replacements were performed in 0.9% (n = 1) of patients with Barlow disease and 0.8% (n = 6) of patients without Barlow disease (P = 1). Repairs comprised simple leaflet resection and annuloplasty band in 73.9% (n = 546) of non-Barlow valves versus 12.7% (n = 14) of patients with Barlow disease who required neochordae (53.6%, n = 59), chordal transfer (20%, n = 22), and commissural sutures (37.3%, n = 41), with longer cardiopulmonary bypass time (median 133; IQR, 117-149 minutes vs 119; IQR, 106-142 minutes, P < .01). Survival free from greater than moderate MR at 5 years was 92.0% (95% confidence interval [CI], 80.2%-98.1%) in patients with Barlow disease versus 96.0% (95% CI, 93.3%-98.0%) in patients without Barlow disease (P = .40). Predictors of late failure included Barlow disease (hazard ratio, 3.9; 95% CI, 1.7-9.0) and non-Barlow isolated anterior leaflet prolapse (hazard ratio, 5.6; 95% CI, 2.3-13.4). CONCLUSIONS: Barlow disease may be reliably and safely repaired with acceptable long-term durability by experienced robotic mitral surgery programs.

Minimally Invasive Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair.

OBJECTIVE: Up to 28% of patients may need mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). This study evaluates the outcomes of minimally invasive MV surgery after TEER. Methods: International multicenter registry of minimally invasive MV surgery after TEER between 2013 and 2020. Subgroups were stratified by the number of devices implanted (≤1 vs >1), as well as time interval from TEER to surgery (≤1 year vs >1 year). Results: A total of 56 patients across 13 centers were included with a mean age of 73 ± 11 years, and 50% were female. The median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score for MV replacement was 8% (Q1-Q3 = 5% to 11%) and the ratio of observed to expected mortality was 0.9. The etiology of mitral regurgitation (MR) prior to TEER was primary MR in 75% of patients and secondary MR in 25%. There were 30 patients (54%) who had >1 device implanted. The median time between TEER and surgery was 252 days (33 to 636 days). Hemodynamics, including MR severity, MV area, and mean gradient, significantly improved after minimally invasive surgery and sustained to 1-year follow-up. In-hospital and 30-day mortality was 7.1%, and 1-year actuarial survival was 85.6% ± 6%. Conclusions: Minimally invasive MV surgery after TEER may be achieved as predicted by the STS PROM. Most patients underwent MV replacement instead of repair. As TEER is applied more widely, patients should be informed about the potential need for surgical intervention over time after TEER. These discussions will allow better informed consent and post-procedure planning.

Durable Robotic Mitral Repair of Degenerative Primary Regurgitation With Long-Term Follow-Up.

BACKGROUND: Variation in degenerative mitral morphology may contribute to suboptimal repair rates. This study evaluates outcomes of a standardized mitral repair technique. METHODS: An institutional clinical registry was used to identify 1036 consecutive patients undergoing robotic mitral surgery between 2005 and 2020: 87% (n = 902) had degenerative disease. Calcification, failed transcatheter repair, and endocarditis were excluded, leaving 582 (68%) patients with isolated posterior leaflet and 268 (32%) with anterior or bileaflet prolapse. Standardized repair comprised triangular resection and true-sized flexible band in posterior leaflet prolapse. Freedom from greater than 2+ moderate mitral regurgitation stratified by prolapse location was assessed using competing risk analysis with death as a competing event. Median follow-up was 5.5 (range 0-15) years. RESULTS: Of patients with isolated posterior leaflet prolapse, 87% (n = 506) had standardized repairs and 13% (n = 76) had additional or nonresectional techniques vs 24% (n = 65) and 76% (n = 203), respectively, for anterior or bileaflet prolapse (P < .001). Adjunctive techniques in the isolated posterior leaflet group included chordal reconstruction (8.6%, n = 50) and commissural sutures (3.4%, n = 20). Overall, median clamp time was 80 (interquartile range, 68-98) minutes, 17 patients required intraoperative re-repair, and 6 required mitral replacement. Freedom from greater than 2+ regurgitation or reintervention at 10 years was 92% for posterior prolapse (vs 83% for anterior or bileaflet prolapse). Anterior or bileaflet prolapse was associated with late greater than 2+ regurgitation (hazard ratio, 3.0; 95% confidence interval, 1.3-7.0). CONCLUSIONS: Posterior leaflet prolapse may be repaired in greater than 99% of patients using triangular resection and band annuloplasty, with satisfactory long-term durability. Increased risk of complex repairs and inferior durability highlights the value of identifying anterior and bileaflet prolapse preoperatively.

Robotic Mitral Valve Repair After Failed Transcatheter Edge-to-Edge Repair.

Mitral valve repair is infrequently performed in patients undergoing corrective surgery for failed mitral transcatheter edge-to-edge repair in current United States practice. This article describes surgical techniques for reconstructive surgery after failed transcatheter edge-to-edge repair. Nine patients underwent robotic-assisted mitral surgery after failed transcatheter edge-to-edge repair between 2008 and 2020 at a single center. Repair was completed in 88.9% (n = 8) patients, and freedom from >2+ mitral regurgitation was 87.5% (n = 7) at a median follow-up of 1.9 years.

Recipient and surgical factors trigger severe primary graft dysfunction after heart transplant.

BACKGROUND: Primary graft dysfunction (PGD) is a major cause of early mortality following heart transplant (HT). The International Society for Heart and Lung Transplantation (ISHLT) subdivides PGD into 3 grades of increasing severity. Most studies have assessed risk factors for PGD without distinguishing between PGD severity grade. We sought to identify recipient, donor and surgical risk factors specifically associated with mild/moderate or severe PGD. METHODS: We identified 734 heart transplant recipients at our institution transplanted between January 1, 2012 and December 31, 2018. PGD was defined according to modified ISHLT criteria. Recipient, donor and surgical variables were analyzed by multinomial logistic regression with mild/moderate or severe PGD as the response. Variables significant in single variable modeling were subject to multivariable analysis via penalized logistic regression. RESULTS: PGD occurred in 24% of the cohort (n = 178) of whom 6% (n = 44) had severe PGD. One-year survival was reduced in recipients with severe PGD but not in those with mild or moderate PGD. Multivariable analysis identified 3 recipient factors: prior cardiac surgery, recipient treatment with ACEI/ARB/ARNI plus MRA, recipient treatment with amiodarone plus beta-blocker, and 3 surgical factors: longer ischemic time, more red blood cell transfusions, and more platelet transfusions, that were associated with severe PGD. We developed a clinical risk score, ABCE, which provided acceptable discrimination and calibration for severe PGD. CONCLUSIONS: Risk factors for mild/moderate PGD were largely distinct from those for severe PGD, suggesting a differing pathophysiology involving several biological pathways. Further research into mechanisms underlying the development of PGD is urgently needed.

Mitral Surgery After Transcatheter Edge-to-Edge Repair: Society of Thoracic Surgeons Database Analysis.

BACKGROUND: Transcatheter edge-to-edge (TEER) mitral repair may be complicated by residual or recurrent mitral regurgitation. An increasing need for surgical reintervention has been reported, but operative outcomes are ill defined. OBJECTIVES: This study evaluated national outcomes of mitral surgery after TEER. METHODS: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was used to identify 524 adults who underwent mitral surgery after TEER between July 2014 and June 2020. Emergencies (5.0%; n = 26), previous mitral surgery (5.3%; n = 28), or open implantation of transcatheter prostheses (1.5%; n = 8) were excluded. The primary outcome was 30-day or in-hospital mortality. RESULTS: In the study cohort of 463 patients, the median age was 76 years (interquartile range [IQR]: 67 to 81 years), median left ventricular ejection fraction was 57% (IQR: 48% to 62%), and 177 (38.2%) patients had degenerative disease. Major concomitant cardiac surgery was performed in 137 (29.4%) patients: in patients undergoing isolated mitral surgery, the median STS-predicted mortality was 6.5% (IQR: 3.9% to 10.5%), the observed mortality was 10.2% (n = 23 of 225), and the ratio of observed to expected mortality was 1.2 (95% confidence interval [CI]: 0.8 to 1.9). Predictors of mortality included urgent surgery (odds ratio [OR]: 2.4; 95% CI: 1.3 to 4.6), nondegenerative/unknown etiology (OR: 2.2; 95% CI: 1.1 to 4.5), creatinine of >2.0 mg/dl (OR: 3.8; 95% CI: 1.9 to 7.9) and age of >80 years (OR: 2.1; 95% CI: 1.1 to 4.4). In a volume outcomes analysis in an expanded cohort of 591 patients at 227 hospitals, operative mortality was 2.6% (n = 2 of 76) in 4 centers that performed >10 cases versus 12.4% (n = 64 of 515) in centers performing fewer (p = 0.01). The surgical repair rate after failed TEER was 4.8% (n = 22) and was 6.8% (n = 12) in degenerative disease. CONCLUSIONS: This study indicates that mitral repair is infrequently achieved after failed TEER, which may have implications for treatment choice in lower-risk and younger patients with degenerative disease. These findings should inform patient consent for TEER, clinical trial design, and clinical performance measures.

Mitral Valve Surgery After Failed MitraClip: A Single-Center Experience.

OBJECTIVE: To evaluate candidacy for surgical mitral valve (MV) repair of recurrent mitral regurgitation (MR) after failed MitraClip. BACKGROUND: Percutaneous mitral repair with MitraClip is safe and effective in patients with degenerative and functional MR with high surgical risk. However, some patients require subsequent mitral surgery for recurrence of significant MR. METHODS: This single-center, observational study includes consecutive patients who underwent mitral surgery after failed MitraClip. RESULTS: Twenty-five patients (age, 69 ± 15 years; 52% women) with severe symptomatic MR after failed MitraClip implantation underwent mitral surgery after a median interval of 5.1 months (interquartile range, 2.5-14 months). Ten patients underwent MV repair (8 with robotic minithoracotomy) and 15 underwent MV replacement (most with sternotomy). Two patients in whom MV repair was intended underwent MV replacement because MitraClip-related leaflet damage prohibited repair. Examples of relative contraindication for MV repair that led to pursuing MV replacement were advanced patient age in 4 patients (mean age, 85 ± 7.6 years), endocarditis in 1 patient, and severely calcified or rheumatic leaflets in 5 patients. Perioperative complications were rare and intermediate-term mortality was similar between groups (3 patients in the MV repair group [30%] vs 4 patients in the MV replacement group [27%]; P=.90). CONCLUSION: When performed by an experienced mitral surgeon and within 1 year of failed MitraClip implantation, surgical MV repair is feasible in most patients who were surgical repair candidates before the clip. Having the option for surgical MV repair after failed MitraClip is important to preserve optimal long-term outcomes for patients who undergo transcatheter mitral repair with MitraClip, especially as ongoing trials are shifting to study lower-risk patients who are also candidates for surgical repair.

Outcomes of Heart Transplantation in Cardiac Amyloidosis Patients: A Single Center Experience.

BACKGROUND: Indications for heart transplantation are expanding to include amyloid light chain (AL) and transthyretin-related (TTR) amyloidosis. Previously, AL amyloid had been a contraindication to heart transplantation given inferior outcomes. These patients typically have biventricular failure requiring mechanical circulatory support (MCS). We report the outcomes of patients with end-stage cardiac amyloidosis who underwent cardiac transplantation, including some who were bridged to transplantation with a durable biventricular MCS METHODS: The records for patients with cardiac amyloidosis who underwent cardiac transplant between 2010 and 2018 were reviewed. Primary endpoint was post-transplant 1-year survival. Secondary endpoints included 1-year freedom from cardiac allograft vasculopathy (as defined by stenosis ≥ 30% by angiography), nonfatal major adverse cardiac events (myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and any rejection. RESULTS: A total of 46 patients received heart transplantation with a diagnosis of either AL or TTR amyloidosis. Of these, 7 patients were bridged to transplantation with a durable biventricular MCS device (6 AL, 1 TTR) and 39 patients were transplanted without MCS bridging. The MCS group consisted of 5 total artificial hearts and 2 biventricular assist devices. The 1-year survival was 91% for the entire cohort, 83% for those with AL amyloidosis, 94% for those with TTR amyloidosis, and 86% for those who received MCS bridging. CONCLUSIONS: Cardiac transplantation can be safely performed in selected amyloidosis patients with reasonable short-term outcomes. Those bridged to transplantation with biventricular MCS appear to have short-term outcomes similar to those transplanted without MCS. Larger numbers and longer observation are required to confirm these findings.

Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy.

BACKGROUND: Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES: The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS: The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS: The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS: Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

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.).

A New Paradigm in Mechanical Circulatory Support: 100-Patient Experience.

BACKGROUND: Acutely decompensated heart failure presents a complicated challenge. Established temporary support measures have significant adverse effects. A minimally invasive temporary left ventricular assist device (LVAD), the Impella 5.0 (Abiomed, Danvers, MA), has been developed to support these patients. METHODS: Patients with acutely decompensated heart failure in whom medical management had failed and who required additional support using an Impella 5.0 device were evaluated from January 2014 to September 2018 at a single center in a retrospective manner using a prospectively maintained database. Patients were treated with the device as a bridge to recovery (BTR; n = 30), bridge to durable device (BTDD; n = 23), or bridge to transplantation (BTT; n = 47). All devices were placed using an axillary artery approach. Demographic features and outcomes were evaluated for each group and compared. RESULTS: A total of 100 patients underwent insertion of an axillary Impella 5.0 LVAD. Patients had an average age of 56.7 ± 13.2 years, were predominantly male (84%), and had a severely depressed left ventricular ejection fraction (average 16%), and most had an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 (57%) or 2 (33%) score. When divided into groups, there was no difference in age or INTERMACS score, but a statistical difference was noted in baseline left ventricular ejection fraction (20%, 14%, 15%) and creatinine level (1.0, 2.0, 1.6), in the BTR, BTDD, or BTT group, respectively (all P < .05). Survival was 64% overall, and it was 50%, 48%, and 81% for BTR, BTDD, and BTT, respectively (P = .007). Survival improved during this experience and was 90% overall in the most recent 30 patients. CONCLUSIONS: Use of this minimally invasive LVAD system is an attractive strategy to support patients with acute decompensated heart failure to recovery, durable LVAD, or heart transplantation.