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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.
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Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Acidente Vascular Cerebral , Humanos , Pessoa de Meia-Idade , Idoso , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/etiologia , Resultado do Tratamento , Fatores de Risco , Estudos Retrospectivos , Estimativa de Kaplan-Meier , Complicações Pós-Operatórias , Acidente Vascular Cerebral/etiologiaRESUMO
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.
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COVID-19 , Células-Tronco Mesenquimais , Síndrome do Desconforto Respiratório , Humanos , COVID-19/terapia , SARS-CoV-2 , Pulmão , Síndrome do Desconforto Respiratório/terapia , Síndrome do Desconforto Respiratório/tratamento farmacológicoRESUMO
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.
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Neoplasias Esofágicas , Cirurgiões , Cirurgia Torácica , Humanos , Estudos Retrospectivos , Neoplasias Esofágicas/cirurgia , Neoplasias Esofágicas/patologia , Tomografia Computadorizada por Raios X , Endossonografia , Esofagectomia , Estadiamento de NeoplasiasRESUMO
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.
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Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Endoleak/etiologia , Endoleak/cirurgia , Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Correção Endovascular de Aneurisma , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Stents , Aneurisma da Aorta Torácica/cirurgia , Desenho de Prótese , Estudos RetrospectivosRESUMO
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.
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Tratamento Farmacológico da COVID-19 , Adulto , Proteínas de Repetição de Anquirina Projetadas , Método Duplo-Cego , Humanos , Proteínas Recombinantes de Fusão , SARS-CoV-2 , Resultado do TratamentoRESUMO
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 19â¯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.
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Procedimentos Cirúrgicos Cardíacos , Insuficiência da Valva Mitral , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Procedimentos Cirúrgicos Cardíacos/métodos , Estudos de Coortes , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/cirurgia , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/cirurgia , Cateterismo Cardíaco , Sistema de RegistrosRESUMO
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.
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Bioprótese , Endocardite , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Valva Aórtica/cirurgia , Endocardite/cirurgia , Humanos , Reoperação , Estudos RetrospectivosRESUMO
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.
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Insuficiência Cardíaca , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/cirurgia , Volume Sistólico , Função Ventricular Esquerda , Insuficiência Cardíaca/cirurgia , Choque CardiogênicoRESUMO
BACKGROUND: Understanding characteristics associated with survival following esophagectomy for cancer is critical to preoperative risk stratification. This study sought to define predictors for long-term survival following esophagectomy for cancer in Medicare patients. METHODS: The STS GTSD was queried for patients age>65 who underwent esophagectomy for cancer between 2012-2020 and linked to 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, 4,798 patients were included. 30-day and 90-day mortality in the study group was 3.84% and 7.45%, respectively. In the multivariable model, ASA>3, BMI>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 (aHR 2.47;95%CI2.02-3.02) and those that remained pN(+) a 75% increased mortality risk (aHR 1.75;95%CI1.57-1.95) compared to down-staged patients. Patients who were pT upstaged had a 109% (aHR 2.09;95%CI1.73-2.53) increased mortality risk compared to pT downstaged patients. Risk for readmission was independent of procedure type or approach and was higher in cStage>2, ASA>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.
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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.
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Neoplasias Esofágicas , Procedimentos Cirúrgicos Robóticos , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Esofagectomia/métodos , Fístula Anastomótica/etiologia , Neoplasias Esofágicas/cirurgia , Linfonodos/patologia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Resultado do Tratamento , Complicações Pós-Operatórias/etiologia , Estudos RetrospectivosRESUMO
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.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Porcelana Dentária , Cálcio , Aorta/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Fatores de Risco , Resultado do Tratamento , Acidente Vascular Cerebral/etiologiaRESUMO
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.
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Aneurisma da Aorta Torácica , Aneurisma da Raiz da Aorta , Insuficiência da Valva Aórtica , Humanos , Pessoa de Meia-Idade , Idoso , Insuficiência da Valva Aórtica/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Valva Aórtica/cirurgia , Reimplante , Resultado do Tratamento , Estudos RetrospectivosRESUMO
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.
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Procedimentos Cirúrgicos Cardíacos , Cirurgia Torácica , Adulto , Humanos , Estados Unidos , Ponte de Artéria Coronária/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Esterno , Fatores de Risco , Resultado do TratamentoRESUMO
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.
Assuntos
Insuficiência da Valva Aórtica , Anuloplastia da Valva Cardíaca , Implante de Prótese de Valva Cardíaca , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Valva Mitral/cirurgia , Anuloplastia da Valva Cardíaca/métodos , Insuficiência da Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Reoperação , Resultado do TratamentoRESUMO
BACKGROUND: Perioperative anemia and transfusions are associated with adverse operative outcomes after coronary artery bypass graft surgery (CABG). Their individual association with long-term outcomes is unclear. METHODS: Patients aged 65 years and older who had undergone CABG and were in The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (n = 504,596) from 2011 to 2018 were linked to Centers for Medicare and Medicaid Service data to assess long-term survival. The association of intraoperative anemia defined by intraoperative nadir hematocrit (nHct) and red blood cell (RBC) transfusions, and their interactions, on long-term mortality were assessed with Kaplan-Meier estimates and multivariable Cox regression. Restricted cubic splines were used to explore the association between nHct as a continuous variable and long-term mortality. RESULTS: 258,398 on-pump CABG STS Adult Cardiac Surgery Database patients surviving the perioperative period were linked to Centers for Medicare and Medicaid Service claims files. Per World Health Organization criteria, 41% had preoperative anemia. Mean intraoperative nHct was 24%; RBC transfusion rate was 43.7%. Univariable analysis associated both RBC transfusion and lower nHct with worse survival. Lower nHct was only marginally associated with risk-adjusted mortality: adjusted hazard ratio (AHR) 1.04 (95% CI, 1.01-1.06) and 1.07 (95% CI, 1.00-1.14) at nHct 20% and at nHct 14%, respectively. RBC transfusion was associated with significantly higher adjusted mortality irrespective of timing of transfusion: AHR intraoperative 1.21 (95% CI, 1.18-1.27); AHR postoperative 1.26 (95% CI, 1.22-1.30); AHR both 1.46 (95% CI, 1.40-1.52) and across all levels of nHct. RBC transfusion was not associated with improved survival at any level of nHct. CONCLUSIONS: Among Medicare CABG patients, RBC transfusions were associated with increased risk-adjusted late mortality across all levels of nHct whereas intraoperative anemia was only marginally so. Tolerance of lower intraoperative nHct than currently accepted may be preferable to transfusions.
Assuntos
Anemia , Procedimentos Cirúrgicos Cardíacos , Adulto , Humanos , Idoso , Estados Unidos , Medicare , Ponte de Artéria Coronária/efeitos adversos , Transfusão de Sangue , Procedimentos Cirúrgicos Cardíacos/efeitos adversosRESUMO
BACKGROUND: Public interest in stratifying hospital performance has led to the proliferation of commercial, consumer-oriented hospital rankings. In cardiac surgery, little is known about how these rankings correlate with clinical registry quality ratings. METHODS: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried for isolated coronary artery bypass grafting or coronary artery bypass grafting/valve patients at hospitals among the top 100 U.S. News & World Report (USNWR) Cardiology & Heart Surgery rankings from 2016 to 2020. Hospitals were grouped into deciles by risk-adjusted observed/expected (O/E) ratios for morbidity and mortality using the STS 2018 risk models. Agreement between STS Adult Cardiac Surgery Database and USNWR ranked deciles was calculated by Bowker symmetry test. The association between each center's annual change in STS O/E ratio and change in USNWR ranking was modeled in repeated measures regression analysis. RESULTS: Inclusion criteria were met by 524 393 patients from 149 hospitals that ranked in USNWR top 100 at least once during the study period. There was no agreement between USNWR ranking and STS major morbidity and mortality O/E ratio (P > .50 for all years). Analysis of patients undergoing surgery at the 65 hospitals that were consistently ranked in the top 100 during the study period demonstrated no association between annual change in hospital ranking and change in O/E ratio (P all > .3). CONCLUSIONS: There was no agreement between annual USNWR hospital ranking and corresponding risk-adjusted STS morbidity or mortality. Furthermore, annual changes in USNWR rankings could not be accounted for using clinical outcomes. These findings suggest that factors unrelated to key surgical outcomes may be driving consumer-directed rankings.
Assuntos
Hospitais , Cirurgia Torácica , Humanos , Adulto , Ponte de Artéria Coronária , Mortalidade HospitalarRESUMO
BACKGROUND: The impact of transcatheter edge-to-edge repair (TEER) on national surgical mitral valve repair (MVr) volume and outcomes is unknown. OBJECTIVES: This study aims to assess the impact of TEER availability on MVr volumes and outcomes for degenerative mitral regurgitation. METHODS: MVr volume, 30-day and 5-year outcomes, including mortality, heart failure rehospitalization and mitral valve reintervention, were obtained from the Society of Thoracic Surgeons database linked with Medicare administrative claims and were compared within TEER centers before and after the first institutional TEER procedure. A difference-in-difference approach comparing parallel trends in coronary artery bypass grafting outcomes was used to account for temporal improvements in perioperative care. RESULTS: From July 2011 through December 2018, 13,959 patients underwent MVr at 278 institutions, which became TEER-capable during the study period. There was no significant change in median annualized institutional MVr volume before (32 [IQR: 17-54]) vs after (29 [IQR: 16-54]) the first TEER (P = 0.06). However, higher-risk (Society of Thoracic Surgeons predicted risk of mortality ≥2%) MVr procedures declined over the study period (P < 0.001 for trend). The introduction of TEER was associated with reduced risk-adjusted odds of mortality after MVr at 30 days (adjusted OR: 0.73; 95% CI: 0.54-0.99) and over 5 years (adjusted HR: 0.75; 95% CI: 0.66-0.86). These improvements in 30-day and 5-year mortality were significantly greater than equivalent trends in coronary artery bypass grafting. CONCLUSIONS: The introduction of TEER has not significantly changed overall MVr case volumes for degenerative mitral regurgitation but is associated with a decrease in higher-risk surgical operations and improved 30-day and 5-year outcomes within institutions adopting the technology.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Idoso , Estados Unidos/epidemiologia , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Resultado do Tratamento , MedicareRESUMO
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.
Assuntos
Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Pessoa de Meia-Idade , Idoso , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Assistência ao Convalescente , Procedimentos Endovasculares/efeitos adversos , Alta do Paciente , Diálise RenalRESUMO
BACKGROUND: Over the past decade, there has been substantial improvement in outcomes after transcatheter aortic valve replacement. Many patient and procedural factors have also changed over that time, making it challenging to untangle the drivers of those improvements. METHODS: Among patients who underwent transcatheter aortic valve replacement from 2012 to 2018 within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we examined the relative contribution of changes in patient factors, device modifications, improving experience/skill, and advances in periprocedural care to the observed improvement in outcomes after transcatheter aortic valve replacement. Mediator clusters included demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors, and nondevice-related procedural factors. Using logistic regression, we serially adjusted for the mediator clusters to examine the contribution of each to the observed improvement in outcomes over time. RESULTS: Among 161 196 patients treated with transcatheter aortic valve replacement at 596 sites, outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%), and 1-year mortality (19.9% to 10.1%; all P<0.001). In sequential models, the unadjusted odds ratio for 30-day mortality was 0.82 per year (95% CI, 0.80-0.84), which was progressively attenuated with addition of each covariate cluster. Most of the improvement was explained by device factors and nondevice procedural factors. Results were similar for 30-day composite adverse events, although the observed temporal improvement was not fully explained by measured factors, suggesting improved technical skill as an additional mediator. In contrast to 30-day outcomes, each cluster of patient and procedural factors contributed similarly to the temporal improvement in 1-year mortality, indicating a greater impact of patient factors on longer-term outcomes. CONCLUSIONS: While US patients undergoing transcatheter aortic valve replacement have become younger, healthier, and lower risk over time, the most important factors contributing to improvements in short-term outcomes relate to advances in device technology and procedural factors, whereas changing patient characteristics had a greater impact on improvement in 1-year outcomes.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Estados Unidos , Resultado do Tratamento , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Fatores de Risco , Sistema de Registros , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgiaRESUMO
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.