Evaluation of the feasibility and efficacy of point-of-care antibody tests for biomarker guided management of COVID-19.

BACKGROUND: Biomarker guided therapy could improve management of COVID-19 inpatients. Although some results indicate that antibody tests are prognostic, little is known about patient management using point-of-care (POC) antibody tests. METHODS: COVID-19 inpatients were recruited to evaluate 2 POC tests: LumiraDX and RightSign. Ease of use data was collected. Blood was also collected for centralized testing using established antibody assays (GenScript cPass). A nested case-control study assessed if POC tests conducted on stored specimens were predictive of time to sustained recovery, mortality, and a composite safety outcome. RESULTS: While both POC tests exhibited moderate agreement with the GenScript assay (both agreeing with 89% of antibody determinations), they were significantly different from the GenScript assay. Treating the GenScript assay as the gold standard, the LumiraDX assay had 99.5% sensitivity and 58.1% specificity while the RightSign assay had 89.5% sensitivity and 84.0% specificity. The LumiraDX assay frequently gave indeterminant results. Both tests were significantly associated with clinical outcomes. CONCLUSIONS: Although both POC tests deviated moderately from the GenScript assay, they predicted outcomes of interest. The RightSign test was easier to use and was more likely to detect those lacking antibody compared to the LumiraDX test treating GenScript as the gold standard.

Long-term outcomes for hybrid aortic arch repair.

OBJECTIVE: Since its inception in the early 2000s, hybrid arch repair (HAR) has evolved from novel approach to well-established treatment modality for aortic arch pathology in appropriately selected patients. Despite this nearly 20-year history of use, long-term results of HAR remain to be determined. As such, objectives of this study are to detail the long-term outcomes for HAR within an expanded classification scheme. METHODS: From August 2005 to August 2022, 163 consecutive patients underwent HAR at a single referral institution. Operative approach was selected according to an institutional algorithm and included zone 0/1 HAR in 25% (n = 40), type I HAR in 34% (n = 56), and type II/III HAR in 41% (n = 67). Specific zone 0/1 technique was zone 1 HAR in 31 (78%), zone 0 with innominate snorkel (zone 0S HAR) in 7 (18%), and zone 0 with single side-branch endograft (zone 0B HAR) in 2 (5%). The 30-day and long-term outcomes, including overall and aortic-specific survival, as well as freedom from reintervention, were assessed. RESULTS: The mean age was 63 ± 13 years and almost one-half of patients (47% [n = 77]) had prior sternotomy. Presenting pathology included degenerative aneurysm in 44% (n = 71), residual dissection after prior type A repair in 38% (n = 62), chronic type B dissection in 12% (n = 20), and other indications in 6% (n = 10). Operative outcomes included 9% mortality (n = 14) at 30 days, 5% mortality (n = 8) in hospital, 4% stroke (n = 7), 2% new dialysis (n = 3), and 2% permanent paraparesis/plegia (n = 3). The median follow-up was 44 month (interquartile range, 12-84 months). Overall survival was 59% and 47% at 5 and 10 years, respectively, whereas aorta-specific survival was 86% and 84% at the same time points. At 5 and 10 years, freedom from major reintervention was 92% and 91%, respectively. Institutional experience had a significant impact on both early and late outcomes: comparing the first (2005-2012) and second (2013-2022) halves of the series, 30-day mortality decreased from 14% to 1% (P = .01) and stroke from 6% to 3% (P = .62). Improved operative outcomes were accompanied by improved late survival, with 78% of patients in the later era vs 45% in the earlier era surviving to 5 years. CONCLUSIONS: HAR is associated with excellent operative outcomes, as well as sustained protection from adverse aortic events as evidenced by high long-term aorta-specific survival and freedom from reintervention. However, surgeon and institutional experience appear to play a major role in achieving these superior outcomes, with a five-fold decrease in operative mortality and a two-fold decrease in stroke rate in the latter half of the series. These long-term results expand on prior midterm data and continue to support use of HAR for properly selected patients with arch disease.

A Randomized Trial of Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome from COVID-19.

Rationale: There are limited therapeutic options for patients with coronavirus disease (COVID-19)-related acute respiratory distress syndrome with inflammation-mediated lung injury. Mesenchymal stromal cells offer promise as immunomodulatory agents. Objectives: Evaluation of efficacy and safety of allogeneic mesenchymal cells in mechanically-ventilated patients with moderate or severe COVID-19-induced respiratory failure. Methods: Patients were randomized to two infusions of 2 million cells/kg or sham infusions, in addition to the standard of care. We hypothesized that cell therapy would be superior to sham control for the primary endpoint of 30-day mortality. The key secondary endpoint was ventilator-free survival within 60 days, accounting for deaths and withdrawals in a ranked analysis. Measurements and Main Results: At the third interim analysis, the data and safety monitoring board recommended that the trial halt enrollment as the prespecified mortality reduction from 40% to 23% was unlikely to be achieved (n = 222 out of planned 300). Thirty-day mortality was 37.5% (42/112) in cell recipients versus 42.7% (47/110) in control patients (relative risk [RR], 0.88; 95% confidence interval, 0.64-1.21; P = 0.43). There were no significant differences in days alive off ventilation within 60 days (median rank, 117.3 [interquartile range, 60.0-169.5] in cell patients and 102.0 [interquartile range, 54.0-162.5] in control subjects; higher is better). Resolution or improvement of acute respiratory distress syndrome at 30 days was observed in 51/104 (49.0%) cell recipients and 46/106 (43.4%) control patients (odds ratio, 1.36; 95% confidence interval, 0.57-3.21). There were no infusion-related toxicities and overall serious adverse events over 30 days were similar. Conclusions: Mesenchymal cells, while safe, did not improve 30-day survival or 60-day ventilator-free days in patients with moderate and/or severe COVID-19-related acute respiratory distress syndrome.

Implementation of Staging Guidelines in Early Esophageal Cancer: A Study of the Society of Thoracic Surgeons General Thoracic Surgery Database.

OBJECTIVE: To evaluate the adoption and clinical impact of endoscopic resection (ER) in early esophageal cancer. BACKGROUND: Staging for early esophageal cancer is largely inaccurate. Assessment of the impact of ER on staging accuracy is unknown, as is the implementation of ER. METHODS: We retrospectively reviewed 2608 patients captured in the Society of Thoracic Surgeons General Thoracic Surgery Database between 2015 and 2020. Patients with clinical T1 and T2 esophageal cancer without nodal involvement (N0) who were treated with upfront esophagectomy were included. Staging accuracy was assessed by clinical-pathologic concordance among patients staged with and without ER. We also sought to measure adherence to National Comprehensive Cancer Network staging guidelines for esophageal cancer staging, specifically the implementation of ER. RESULTS: For early esophageal cancer, computed tomography/positron emission tomography/endoscopic ultrasound (CT/PET/EUS) accurately predicts the pathologic tumor (T) stage 58.5% of the time. The addition of ER to staging was related to a decrease in upstaging from 17.6% to 10.8% ( P =0.01). Adherence to staging guidelines with CT/PET/EUS improved from 58.2% between 2012 and 2014 to 77.9% between 2015 and 2020. However, when ER was added as a staging criterion, adherence decreased to 23.3%. Increased volume of esophagectomies within an institution was associated with increased staging adherence with ER ( P =0.008). CONCLUSIONS: The use of CT/PET/EUS for the staging of early esophageal cancer is accurate in only 56.3% of patients. ER may increase staging accuracy as it is related to a decrease in upstaging. ER is poorly utilized in staging of early esophageal cancer. Barriers to the implementation of ER as a staging modality should be identified and corrected.

Association Between Device Type and Type IIIb Endoleaks Following Thoracic Endovascular Aortic Repair.

OBJECTIVE: Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices. METHODS: Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR > 2 and chi squared value > 4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE. RESULTS: There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material. CONCLUSION: The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric.

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978). SETTING: Multinational, multicenter trial. PARTICIPANTS: Adults hospitalized with COVID-19. INTERVENTION: Intravenous ensovibep, 600 mg, or placebo. MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. RESULTS: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep). LIMITATION: The trial was prematurely stopped because of futility, limiting power for the primary outcome. CONCLUSION: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified. PRIMARY FUNDING SOURCE: National Institutes of Health.

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation.

Importance: There are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting. Objective: To evaluate the outcomes of transcatheter mitral valve repair for degenerative MR. Design, Setting, and Participants: Cohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022. Exposure: Transcatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott). Main Outcomes and Measures: The primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or >5 to <10 mm Hg). Results: A total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P < .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P < .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P < .001). Conclusions and Relevance: In this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.

Long-term outcomes of aortic root replacement for endocarditis.

BACKGROUND: Infective endocarditis (IE) involving the aortic valve and root is associated with high risk requiring thoughtful surgical decision-making. The impact of valve and conduit choices and patient factors on long-term outcomes in this patient population is poorly documented. METHODS: From January 1976 to December 2013, 485 patients underwent aortic root and valve replacement at a single institution. Cox's proportional hazard model identified predictors of long-term survival and cumulative incidence functions were compared to assess need for reoperation with death as a competing risk. RESULTS: Median age at time of operation was 56.6 years (interquartile range: 23.1) with the indication for operation being endocarditis in 14.6% (n = 71). Stentless root replacement was used in 70% IE versus 34% non-IE (p < .001). Endocarditis at time of root replacement did not have a significant impact on survival through 15 years (IE: 37.3% vs. non-IE: 42.5%; log-rank; p = .13). After multivariable adjustment, survival was similar between patients with and without endocarditis (hazard ratio: 1.1; 95% confidence interval: [0.77, 1.62]; p = .57). Freedom from reoperation at 15 years did not vary significantly by endocarditis status (IE: 95.9% vs. non-IE: 73.6%; p = .07). Among endocarditis patients, freedom from reoperation at 10 years was similar between homograft and stentless bioprosthetic conduits (95.3% vs. 88.5%; log-rank; K-sample; p = .46). CONCLUSIONS: In a sample with frequent use of stentless prostheses, aortic root replacement for infective endocarditis had acceptable risk and long-term survival similar to root replacement for other indications. In the setting of endocarditis, root replacement with homograft or stentless bioprosthetic root has excellent durability through 15 years.

Association of Baseline Tricuspid Regurgitation With Health Status and Clinical Outcomes After TAVR and Mitral TEER.

BACKGROUND: Tricuspid regurgitation (TR) is associated with worse clinical outcomes after transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (M-TEER), but little is known about its association with health status outcomes. OBJECTIVES: The aims of this study were to explore, using the Society of Thoracic Surgeons and American College of Cardiology TVT (Transcatheter Valve Therapy) Registry, the association between baseline TR and health status after TAVR and M-TEER and to determine if baseline TR was associated with clinical endpoints. METHODS: Health status was assessed using Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score in patients enrolled in the TVT Registry who underwent isolated TAVR or M-TEER between January 2019 and June 2021. The association among baseline TR and KCCQ-OS score, being alive and well, and clinical outcomes was examined. RESULTS: In total, 130,097 TAVR patients (13.1% with moderate TR, 2.3% with severe TR) and 19,593 M-TEER patients (33.2% with moderate TR, 14.7% with severe TR) were included. Mean KCCQ-OS scores were lower with severe vs moderate vs none to mild TR at baseline prior to TAVR (39.4 ± 24.2 vs 45.2 ± 24.7 vs 51.3 ± 25.3; P < 0.01) or M-TEER (38.1 ± 23.9 vs 41.9 ± 24.7 vs 45.4 ± 25.2; P < 0.01) and similarly at 30 days and 1 year. The odds of being alive and well at 1 year were lower with moderate or severe TR before TAVR (adjusted OR: 0.79 [95% CI: 0.74-0.85] and adjusted OR: 0.81 [95% CI: 0.70-0.94], respectively) and severe TR before M-TEER (adjusted OR: 0.53; 95% CI: 0.40-0.71). Furthermore, moderate or severe TR before TAVR was associated with higher 1-year mortality and readmission, whereas moderate or severe TR before M-TEER was associated with higher 1-year mortality. CONCLUSIONS: In a large cohort of U.S. patients who underwent TAVR or M-TEER, greater baseline TR was associated with worse health status and clinical outcomes. Understanding adverse outcomes of TR in patients with coexisting valvular abnormalities is important, especially with rapidly evolving transcatheter tricuspid valve interventions.

Longitudinal Follow-up of Medicare Patients After Esophageal Cancer Resection in the STS Database.

BACKGROUND: Understanding characteristics associated with survival after esophagectomy for cancer is critical to preoperative risk stratification. This study sought to define predictors for long-term survival after esophagectomy for cancer in Medicare patients. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for patients aged ≥65 years who underwent esophagectomy for cancer between 2012 and 2020 and linked to Centers for Medicare and Medicaid Services (CMS) data using a deterministic matching algorithm. Patient, hospital, and treatment variables were assessed using a multivariable Cox proportional hazards model to evaluate characteristics associated with long-term mortality and readmission. Kaplan-Meier and cumulative incidence curves were generated and differences evaluated using the log-rank test and Gray's test, respectively. RESULTS: After CMS linkage, 4798 patients were included. Thirty-day and 90-day mortality in the study group was 3.84% and 7.45%, respectively. In the multivariable model, American Society of Anesthesiologists score >3, body mass index >35, and diabetes were associated with increased mortality <90 days post-surgery, while pN/pT upstaging was associated with increased mortality >90 days post-surgery. Patients upstaged to pN(+) had a 147% increased mortality risk (adjusted hazard ratio [aHR], 2.47; 95% CI, 2.02-3.02) and those that remained pN(+) a 75% increased mortality risk (aHR, 1.75; 95% CI, 1.57-1.95) compared with downstaged patients. Patients who were pT upstaged had a 109% (aHR, 2.09; 95% CI, 1.73-2.53) increased mortality risk compared with pT downstaged patients. Risk for readmission was independent of procedure type or approach and was higher in c stage ≥2, American Society of Anesthesiologists score ≥4, and pN+. CONCLUSIONS: Medicare patients undergoing esophagectomy for cancer have identifiable patient-specific predictors for short-term mortality and tumor-specific predictors for long-term mortality and readmission. In the absence of pathologic T and N downstaging, risk for long-term mortality and readmission are increased.

Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients With Functional Mitral Regurgitation.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair (MTEER) was approved in the United States for treatment of functional mitral regurgitation (FMR) based on results from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. OBJECTIVES: The authors sought to analyze outcomes of MTEER in FMR patients who would have been excluded from COAPT. METHODS: MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry between January 1, 2013, and April 30, 2020, were categorized as "trial-ineligible" if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH). RESULTS: Of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs 92.6%; P < 0.001) and more frequent in-hospital complications (11.8% vs 5.7%; P < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. There was a higher risk of 1-year death or HFH (HR: 1.73; 95% CI: 1.57-1.91; P < 0.001) in trial-ineligible patients. CONCLUSIONS: Among patients who underwent MTEER for FMR in the TVT Registry, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH.

Practice makes perfect? Institutional coronary artery bypass case volumes and outcomes.

OBJECTIVES: Older studies of coronary artery bypass grafting (CABG) institutional case volumes and outcomes reported conflicting results. We explored this association in the rapidly changing contemporary practice of American surgeons using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. METHODS: The 2018-2019 isolated primary CABG experience in the STS Adult Cardiac Surgery Database was analysed (241 902 patients; 1014 hospitals; 2718 surgeons). Generalized Estimating Equations were used to estimate coefficients between CABG institutional case volumes and outcomes. The observed-to-expected ratios based on STS risk models were used to assess risk-adjusted operative mortality (OM), mortality/major morbidity (MM) and deep sternal wound infections (DSWI) as a function of institutional case volumes. RESULTS: The mean (standard deviation) OM, MM and DSWI rates were 2.1% (2.7), 11.1% (9.2) and 0.6% (0.5), respectively. The mean (standard deviation) institutional case volumes per study period was 239 (192); 23% and 9% of institutions performed <100 and >500 cases/study period, respectively. There was a weak negative correlation between expected mortality (R2 -0.0014), OM (R2 -0.0272), MM (R2 -0.1213) and DSWI (R2 -0.003) and institutional case volumes. CONCLUSIONS: CABG outcomes generally improve with increasing institutional case volumes. Given the large number of CABG cases performed nationally, even the documented weak correlation has the potential to appreciably decrease OM, MM and DSWI if cases are performed at higher volume institutions. Studies focusing on additional hospital and surgeon factors are warranted to further define quality improvement opportunities.

Mid-term outcomes of aortic valve repair using an anatomically shaped internal annuloplasty ring.

OBJECTIVES: The Hemispherical Aortic Annuloplasty Reconstructive Technology (HAART) ring is a rigid, internal and geometric device. The objective of this article is to assess the mid-term outcomes of aortic valve repair (AVr) using this prosthesis. METHODS: A prospectively maintained database was used to obtain outcomes for adult patients undergoing AVr using the HAART ring between September 2017 and June 2023. All aortic patients at our institution undergo life-long surveillance with regular assessment and valve imaging. RESULTS: Seventy-one patients underwent AVr using the HAART device: 53 had a trileaflet valve and 18 a bicuspid valve. The median age was 54 years, and most were male (79%). Many required concomitant intervention: 46% had a root procedure and 77% an arch repair. There were no in-hospital deaths, and the median postoperative stay was 5 days. At a mean follow-up of 3.9 (±1.1) years, freedom from reoperation was 94%. Late imaging demonstrated: zero trace (25%), 1+ (54%), 2+ (15%) and 4+ (6%) aortic insufficiency (AI). Eleven patients have ≥moderate AI under surveillance, all of whom have a trileaflet valve (21% of trileaflet patients). Four patients required reoperation: 3 for ring dehiscence and 1 for endocarditis. CONCLUSIONS: Although early results using the HAART device are encouraging, mid-term results raise concern as 21% of trileaflet patients developed recurrent ≥moderate AI by 4 years post-repair. We experienced 3 incidences of ring dehiscence requiring reoperation. Based on this, we recommend caution using the sub-annular approach for stabilization in patients with trileaflet aortic valves. Long-term results are needed to assess outcomes against established techniques.

Choosing transcatheter aortic valve replacement in porcelain aorta: outcomes versus surgical replacement.

OBJECTIVES: Porcelain aorta complicates aortic valve replacement and is an indication for transcatheter approaches. No study has compared surgical and transcatheter valve replacement in the setting of porcelain aorta. We characterize porcelain aorta patients undergoing aortic valve replacement and the association of aortic calcification and outcomes. METHODS: Patients undergoing aortic valve replacement with porcelain aorta were identified. Aortic calcium volume was determined using 3D computed tomography thresholding techniques. Propensity scoring was performed to assess the effect of surgical versus transcatheter approaches. Risk factors for composite major hospital complications (death, stroke and dialysis) were identified using random forest machine learning. RESULTS: From January 2006 to January 2015, 164 patients with porcelain aorta underwent aortic valve replacement [105 (64%) surgical replacement, 59 (36%) transcatheter replacement]. Propensity scoring matched 29 pairs (49% of transcatheter patients). Before matching, 5-year survival was 41% [(43% surgical, 35% transcatheter, P(log-rank) = 0.9]. After matching, mortality for surgical versus transcatheter replacement was 3.4% (n = 1) vs 10% (n = 3), stroke 14% (n = 4) vs 3.4% (n = 1) and dialysis 6.9% (n = 2) versus 11% (n = 3). Matched 5-year survival was 40% after surgical replacement and 29% after transcatheter replacement [P(log-rank) = 0.4]. Total aortic calcium volume was greater in transcatheter than surgical patients [18 (8.0) vs 17 (7.7) ml] and was associated with more major hospital complications after either approach. CONCLUSIONS: Surgical and transcatheter approaches are complementary options for aortic stenosis with porcelain aorta. Surgical valve replacement remains an effective treatment for patients requiring concomitant procedures. Quantifying aortic calcium volume is a helpful risk predictor in all patients with porcelain aorta.

Robotic Esophagectomy Trends and Early Surgical Outcomes: The US Experience.

BACKGROUND: Recent esophagectomy trends were evaluated to describe the shift in surgical approach and outcomes using The Society of Thoracic Surgeons General Thoracic Surgery Database. METHODS: All patients who underwent an esophagectomy with gastric conduit from 2015 to 2019 were identified and analyzed according to original intended approach. After performing volume trend analysis of patients, operative outcomes were evaluated. RESULTS: Among 10,607 patients, esophagectomy was open in 5763 (54.3%), minimally invasive (MIE) in 3524 (33.2%), and robotic (RAMIE) in 1320 (12.4%). Within 5 years, MIE and RAMIE combined rose to majority approach (open from 58% to 42% of annual volume). While MIE and RAMIE were associated with higher rates of anastomotic leak, loss of conduit, pulmonary embolus, and reoperation, R0 resection and harvested number of lymph nodes exceeded those in open approaches. Operative mortality did not differ by approach (3.21% open vs 2.72% MIE vs 2.50% RAMIE; P = .2329). On multivariable analysis, RAMIE was independently associated with higher rate of anastomotic leak compared to open (adjusted odds ratio 1.53, 95% CI 1.14-2.04), while both MIE and RAMIE had lower mean length of stay. Propensity matching of 1320 pairs found a higher risk of anastomotic leak requiring surgery for RAMIE compared with MIE (adjusted odds ratio 1.39, 95% CI 1.01-1.92). CONCLUSIONS: In less than a decade, the dominant surgical approach in The Society of Thoracic Surgeons General Thoracic Surgery Database has become minimally invasive (RAMIE and MIE). While anastomotic leak and reoperation, more common in RAMIE, require a technical solution, these complications have not raised operative mortality. Further studies are needed to address long-term results and oncologic outcome.

Selective Sinus Replacement for Aortic Root Aneurysm: Durable Approach in Selected Patients.

BACKGROUND: Selective sinus replacement (SSR) allows a tailored repair approach in patients with sinus of Valsalva or asymmetric aortic root aneurysm. SSR avoids the need for coronary reimplantation for nondiseased sinuses and shortens operative time, although potential for late growth of retained sinuses exists. This study describes selection of patients and assesses operative outcomes and late root dimensions after SSR. METHODS: From 2006 to 2020, 60 patients underwent SSR at a single referral institution. Mixed effect models were used to assess trajectory of postoperative growth of remaining sinuses, adjusting for age of the patient, valve morphology, and baseline root diameter. RESULTS: Median age of the patients was 57 (interquartile range [IQR], 48-65) years. Twenty-four (40%) had a bicuspid aortic valve. Most patients (n = 55 [92%]) underwent single sinus replacement (n = 46 noncoronary, n = 9 right), whereas 5 (8%) underwent repair of both the right and noncoronary sinuses. Concomitant aortic valve replacement was performed in 15 patients (25%); aortic valve repair with internal ring annuloplasty or cusp plication was performed in 37 (62%). There was no operative death, stroke, renal failure, or respiratory failure. Median preoperative root diameter was 53 mm (IQR, 51-56 mm) vs 42 mm (IQR, 39-45 mm) at median imaging follow-up of 34 (IQR, 13-49) months. Rate of midterm root growth was 0.2 mm/y, and there were no late root reinterventions. CONCLUSIONS: For patients with sinus of Valsalva or asymmetric root aneurysm, SSR is associated with excellent operative outcomes, and midterm follow-up suggests that the technique is durable. Longer term follow-up is needed to confirm continued stability of the aortic root.

Long-term Outcomes and Anticoagulation in Mitral Valve Surgery-A Report From The Society of Thoracic Surgeons Database.

BACKGROUND: Anticoagulation after bioprosthetic mitral valve (MV) replacement (BMVR) and repair (MVrep) is controversial. We explore outcomes among BMVR and MVrep patients in The Society of Thoracic Surgeons Adult Cardiac Surgery Database based on discharge anticoagulation status. METHODS: BMVR and MVrep patients aged ≥65 years in The Society of Thoracic Surgeons Adult Cardiac Surgery Database were linked to the Centers for Medicare and Medicaid Services claims database. Long-term mortality, ischemic stroke, bleeding, and a composite of the primary end points were compared as a function of anticoagulation. Hazard ratios (HRs) were calculated using multivariable Cox regression. RESULTS: A total of 26,199 BMVR and MVrep patients were linked to the Centers for Medicare and Medicaid Services database; of these, 44%, 4%, and 52% were discharged on warfarin, non-vitamin K-dependent anticoagulant (NOAC), and no anticoagulation (no-AC; reference), respectively. Warfarin was associated with increased bleeding in the overall study cohort (HR, 1.38; 95% CI 1.26-1.52) and in the BMVR (HR, 1.32; 95% CI, 1.13-1.55) and MVrep subcohorts (HR, 1.42; 95% CI, 1.26-1.60). Warfarin was associated with decreased mortality only among BMVR patients (HR, 0.87; 95% CI, 0.79-0.96). Stroke and the composite outcome did not differ across cohorts with warfarin. NOAC use was associated with increased mortality (HR, 1.33; 95% CI 1.11-1.59), bleeding (HR, 1.37; 95% CI, 1.07-1.74), and the composite outcome (HR, 1.26; 95% CI, 1.08-1.47). CONCLUSIONS: Anticoagulation was used in fewer than half of mitral valve operations. In MVrep patients, warfarin was associated with increased bleeding and was not protective against stroke or mortality. In BMVR patients, warfarin was associated with a modest survival benefit, increased bleeding, and equivalent stroke risk. NOAC was associated with increased adverse outcomes.

Initial Management Strategy and Long-Term Outcomes in 186 Cases of Spontaneous Coronary Artery Dissection.

Spontaneous coronary artery dissection (SCAD) is a rare but important nonatherosclerotic cause of acute coronary syndrome. Indications for revascularization and long-term outcomes of SCAD remain areas of active investigation. We report our experience with initial management strategy and long-term outcomes in SCAD. We reviewed all patients treated at our institution from 1996-2021 with a SCAD diagnosis. Demographics, comorbidities, clinical presentations, angiography findings, and management strategies were obtained by chart review. The primary outcome was a composite of cardiac death, recurrent/progressive SCAD, subsequent diagnosis of congestive heart failure, or subsequent/repeat revascularization after the initial management. Unadjusted Kaplan-Meier survival analysis was performed. Of 186 patients with a SCAD diagnosis treated at our institution, 149 (80%) were female. Medical management was the initial treatment in 134 (72.0%) patients, percutaneous coronary intervention (PCI) in 43 (23.1%), and coronary artery bypass grafting in 9 (4.8%). Surgery/PCI intervention was associated with younger age (38.8 vs 47.7 years, P = 0.01), ST elevation myocardial infarction on presentation (67.0% vs 34.0%, P < 0.001), lower ejection fraction (45.0% vs 55.0%, P = 0.002), and left anterior descending coronary artery dissection (75.0% vs 51.0%, P = 0.006). Ten-year freedom from our composite outcome was similar between revascularized patients and those managed with medical therapy (P = 0.36). Median follow-up time was 4.5 years. SCAD in the setting of ST elevation myocardial infarction, left anterior descending coronary artery involvement, or decreased cardiac function suggests greater ischemic insult and was associated with initial percutaneous or surgical revascularization. Despite worse disease on initial presentation, long-term outcomes of patients undergoing revascularization are similar to medically managed patients with SCAD.

Long-term outcomes of aortic root operations in the United States among Medicare beneficiaries.

OBJECTIVE: The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aortic root repair in Medicare patients using The Society of Thoracic Surgeons Adult Cardiac Surgery Database-Centers for Medicare & Medicaid Services-linked data. METHODS: A retrospective cohort study was performed by querying the Society of Thoracic Surgeons Adult Cardiac Surgery Database for patients aged 65 years or more who underwent elective aortic root repair with or without aortic valve replacement. Primary long-term end points were mortality, any stroke, and aortic valve reintervention. Short-term outcomes and long-term survival were compared among each root repair strategy. Additional risk factors for mortality after aortic root repair were assessed with a multivariable Cox proportional hazards model. RESULTS: A total of 4173 patients aged 65 years or more underwent elective aortic root repair. Patients were stratified by operative strategy: mechanical Bentall, stented bioprosthetic Bentall, stentless bioprosthetic Bentall, or valve-sparing root replacement. Mean follow-up was 5.0 (±4.6) years. Relative to mechanical Bentall, stented bioprosthetic Bentall (adjusted hazard ratio, 0.80; confidence interval, 0.66-0.97) and stentless bioprosthetic Bentall (adjusted hazard ratio, 0.70; confidence interval, 0.59-0.84) were associated with better long-term survival. In addition, stentless bioprosthetic Bentall (adjusted hazard ratio, 0.64; confidence interval, 0.47-0.80) and valve-sparing root replacement (adjusted hazard ratio, 0.51; confidence interval, 0.29-0.90) were associated with lower long-term risk of stroke. Aortic valve reintervention risk was 2-fold higher after valve-sparing root replacement compared with other operative strategies. CONCLUSIONS: In the Medicare population, there was poorer late survival and greater late stroke risk for patients undergoing mechanical Bentall and a higher rate of reintervention for valve-sparing root replacement. Bioprosthetic Bentall may be the procedure of choice in older patients undergoing aortic root repair, particularly in the era of transcatheter aortic valve replacement.

Tailored approach and outcomes of aortic arch reconstruction after acute type A dissection repair.

OBJECTIVE: After limited root/ascending with or without hemiarch repair for acute type A aortic dissection (ATAAD), 20% to 30% of patients require distal reintervention, frequently for arch pathology. In this report, we describe an institutional algorithm for arch management after previous limited ATAAD repair and detail operative and long-term outcomes. METHODS: From August 2005 to April 2021, 71 patients status post previous limited ATAAD repair underwent reoperative arch repair involving zones 1 to 3 for aneurysmal degeneration of residual arch dissection including complete cervical debranching with zone 0/1 thoracic endovascular aortic repair in 6 (8%), open total arch in 13 (18%), type I hybrid arch repair in 23 (32%), and type II/III hybrid arch repair in 29 (41%). RESULTS: Mean age was 59 ± 12 years; time from index ATAAD repair to reoperation was 4 (interquartile range, 2-9) years. There were 2 (2.8%) in-hospital deaths and 2 (2.8%) postdischarge deaths within 30 days of surgery. Three patients suffered stroke (4.2%) and 2 (2.8%) had acute renal failure requiring dialysis. Overall Kaplan-Meier survival was 78%, 70%, and 58% at 1, 3, and 5 years, respectively. Institutional experience appeared to play a significant role in early and late outcomes, because there have been no operative mortalities in the past 9 years and improved survival of 87% versus 66%, 79% versus 58%, and 79% versus 40% at 1, 3, and 5 years in comparisons of the past 9 years with the previous era (P = .01). CONCLUSIONS: Aneurysmal degeneration of residual arch dissection after limited ATAAD repair presents a complex reoperative challenge. An algorithmic operative approach tailored to patient anatomy and comorbidities yields excellent early and late outcomes, which continue to improve with increasing institutional experience.