The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk patients.
...The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151).
The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 (p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 (p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) (p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1.
Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.
New-onset postoperative atrial fibrillation (POAF) is the most common complication following cardiac surgery. However, the magnitude of POAF on length of stay, resource utilization, and readmission ...rates remains an area of clinical interest. The purpose of this study was to examine the risk-adjusted impact of POAF on measures of mortality, hospital resources, and costs among multiple centers.
A total of 49,264 patient records from a multi-institutional Society of Thoracic Surgeons (STS) certified database for cardiac operations (2001 to 2012) were extracted and stratified by the presence of POAF (19%) versus non-POAF (81%). The influence of POAF on outcomes was assessed by hierarchic regression modeling, adjusted for calculated STS predictive risk indices.
Mean age was 64±11 years, and median STS predicted risk of mortality for patients who developed POAF were incrementally higher (2% vs 1%, p<0.001) compared with non-POAF patients. The rate of POAF was highest among those undergoing aortic valve replacement+coronary artery bypass grafting, aortic valve, and mitral valve replacement operations. The POAF patients had a higher unadjusted incidence of mortality, morbidity, hospital readmission, longer intensive care unit (ICU) and postoperative length of stay, and higher hospital costs. After risk adjustment, POAF was associated with a twofold increase in the odds of mortality (adjusted odds ratio=2.04, p<0.001), greater hospital resource utilization, and increased costs; POAF was associated with 48 additional ICU hours (p<0.001), 3 additional hospital days (p<0.001), and $3,000 (p<0.001) and $9,000 (p<0.001) of increased ICU and total hospital-related costs, respectively.
New onset POAF is associated with increased risk-adjusted mortality, hospital costs, and readmission rates. Protocols to reduce the incidence of POAF have the potential to significantly impact patient outcomes and the delivery of high-quality, cost-effective patient care.
Abstract Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). ...Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
Abstract Objective The purpose of this study was to establish a reliable, chronic model of abdominal aortic aneurysm (AAA). Methods Wild-type 8-week-old C56BL/6 male mice (n = 120) were equally ...divided into three groups: (1) BAPN group: 0.2% 3-aminopropionitrile fumarate salt (BAPN) drinking water was provided to mice 2 days before surgery until the end of study. Sham aneurysm induction surgery was performed using 5 μL of heat deactivated elastase. (2) Elastase group: mice were given regular drinking water without BAPN. During aneurysm induction surgery, 5 μL of the active form of elastase (10.3 mg protein/mL, 5.9 U/mg protein) was applied on top of the infrarenal abdominal aorta adventitia for 5 minutes. (3) BAPN+elastase group: mice were given BAPN drinking water and the active form of elastase application, as above. On postoperative days 7, 14, 21, 28, and 100, aortic samples were collected for histology, cytokine array, and gelatin zymography after aortic diameter measurement. Results Compared with the elastase group, the BAPN+elastase group had a higher AAA formation rate (93% vs 65%; P < .01) with more advanced AAAs (25 of 42 vs 1 of 40 for stage II and III; P < .001). Aneurysms from the BAPN+elastase group demonstrated persistent long-term growth (221.5% ± 36.6%, 285.8% ± 78.6%, and 801% ± 160% on days 21, 28, and 100, respectively; P < .001), with considerable thrombus formation (54%) and rupture (31%) at the advanced stages of AAA development. Cytokine levels (pro-matrix metalloproteinase 9, interleukin-1β, interleukin-6, chemokine C-C motif ligand 5, triggering receptor expressed on myeloid cells 1, monocyte chemotactic protein 1, and tissue inhibitor of metalloproteinase 1) in the BAPN+elastase group were higher than in the elastase group on day 7. After day 7, cytokine levels returned to baseline, with the exception of elevated matrix metalloproteinase 2 activity. By histology, CD3-positive T cells in the BAPN+elastase group were elevated on days 28 and 100. Conclusions A combination of oral BAPN administration and periaortic elastase application induced a chronic, advanced-stage AAA with characteristics of persistent aneurysm growth, thrombus formation, and spontaneous rupture. Future studies should use this model, especially for examining tissue remodeling during the late stages of aneurysm development.
Abstract Frailty has become high-priority theme in cardiovascular diseases due to aging and increasingly complex nature of patients. Low muscle mass is characteristic of frailty, in which invasive ...interventions are avoided if possible due to decreased physiological reserve. This study aimed to determine if the psoas muscle area (PMA) could predict mortality, and to investigate it utility in patients undergoing transcatheter aortic valve replacement (TAVR). We retrospectively reviewed 232 consecutive patients undergoing TAVR. Cross-sectional areas of the psoas muscles at the L4 level were measured by computed tomography and normalized to body surface area. Patients were divided into tertiles according to the normalized PMA for each gender (men: Tertile 1, 1708–1178 mm2 /m2 ; Tertile 2, 1176–1011 mm2 /m2 ; and Tertile 3, 1009–587 mm2 /m2 ; women: Tertile 1, 1436–962 mm2 /m2 ; Tertile 2, 952–807 mm2 /m2 ; and Tertile 3, 806–527 mm2 /m2 ). Smaller normalized PMA was independently correlated with women and higher New York Heart Association classification. After adjustment for multiple confounding factors, the normalized PMA tertile was independently associated with mortality at 6 months (adjusted hazard ratio, 1.53 95% confidence interval, 1.06–2.21). Kaplan-Meier analysis showed that Tertile 3 had higher mortality rates than Tertile 1 at 6 months (14% and 31%, respectively, p=0.029). Receiver-operating characteristic analysis showed that normalized PMA provided the increase of C -statistics for predicting mortality for a clinical model, and gait speed. In conclusion, PMA is an independent predictor of mortality after TAVR and can complement a clinical model and gait speed.
Objectives Vascular smooth muscle cells can undergo profound changes in phenotype, defined by coordinated repression of smooth muscle cell marker genes and production of matrix metalloproteinases in ...response to injury. However, little is known of the role of smooth muscle cells in aortic aneurysms. We hypothesized that smooth muscle cells undergo phenotypic modulation early in the development of aortic aneurysms. Methods Abdominal aortas from C57B6 mice (n = 79) were perfused with elastase or saline (control) and harvested at 1, 3, 7, or 14 days. Aortas were analyzed by means of quantitative polymerase chain reaction and immunohistochemistry for smooth muscle cell marker genes, including SM22A, smooth muscle α-actin, and matrix metalloproteinases 2 and 9. In complimentary experiments human aneurysms (n = 10) and control aorta (n = 10) were harvested at the time of surgical intervention and analyzed. Results By 14 days, aortic diameter was larger after elastase perfusion compared with control diameter (100% ± 9.6% vs 59.5% ± 18.9%, P = .0002). At 7 days, elastase-perfused mice had a 78% and 85% reduction in SM22α and smooth muscle α-actin expression, respectively, compared with that seen in control animals well before aneurysms were present, and these values remained repressed at 14 days. Immunohistochemistry confirmed less SM22α and smooth muscle α-actin in experimental aneurysms at 14 days in concert with increased matrix metalloproteinase 2 and 9 expression at 7 and 14 days. Similarly, human aneurysms had less SM22α and smooth muscle α-actin and increased matrix metalloproteinase 2 and 9 staining, compared with control values, as determined by means of quantitative polymerase chain reaction. Conclusions Aneurysms demonstrate smooth muscle cell phenotypic modulation characterized by downregulation of smooth muscle cell marker genes and upregulation of matrix metalloproteinases. These events in experimental models occur before aneurysm formation. Targeting smooth muscle cells to a reparative phenotype might provide a novel therapy in the treatment of aortic aneurysms.
Background Efforts to reduce blood product use have the potential to avoid transfusion-related complications and reduce health care costs. The purpose of this investigation was to determine whether a ...multi-institutional effort to reduce blood product use affects postoperative events after cardiac surgical operations and to determine the influence of perioperative transfusion on risk-adjusted outcomes. Methods A total of 14,259 patients (2006-2010) undergoing nonemergency, primary, isolated coronary artery bypass grafting operations at 17 different statewide cardiac centers were stratified according to transfusion guideline era: pre-guideline (n = 7059, age = 63.7 ± 10.6 years) versus post-guideline (n = 7200, age = 63.7 ± 10.5 years). Primary outcomes of interest were observed differences in postoperative events and mortality risk-adjusted associations as estimated by multiple regression analysis. Results Overall intraoperative (24% vs 18%, P < .001) and postoperative (39% vs 33%, P < .001) blood product transfusion were significantly reduced in the post-guideline era. Patients in the post-guideline era demonstrated reduced morbidity with decreased pneumonia ( P = .01), prolonged ventilation ( P = .05), renal failure ( P = .03), new-onset hemodialysis ( P = .004), and composite incidence of major complications ( P = .001). Operative mortality (1.0% vs 1.8%, P < .001) and postoperative ventilation time (22 vs 26 hours, P < .001) were similarly reduced in the post-guideline era. Of note, after mortality risk adjustment, operations performed in the post-guideline era were associated with a 47% reduction in the odds of death (adjusted odds ratio, 0.57; P < .001), whereas the risk of major complications and mortality were significantly increased after intraoperative (adjusted odds ratio, 1.86 and 1.25; both P < .001) and postoperative (adjusted odds ratio, 4.61 and 4.50, both P < .001) transfusion. Intraoperative and postoperative transfusions were associated with increased adjusted incremental total hospitalization costs ($4408 and $10,479, respectively). Conclusions Implementation of a blood use initiative significantly improves postoperative morbidity, mortality, and resource utilization. Limiting intraoperative and postoperative blood product transfusion decreases adverse postoperative events and reduces health care costs. Blood conservation efforts are bolstered by collaboration and guideline development.
Objective Up to 90% of embolic strokes that occur in patients with atrial fibrillation originate from the left atrial appendage. Exclusion of the left atrial appendage during cardiac surgery may ...decrease the future risk of stroke, especially in patients with atrial fibrillation or at high risk for developing atrial fibrillation. We report the initial results of a multicenter Food and Drug Administration trial to assess the safety and efficacy of a novel left atrial appendage exclusion clip. Methods Patients undergoing elective cardiac surgery via median sternotomy with atrial fibrillation or a Congestive Heart Failure, Hypertension, Age > 75 Years, Diabetes Mellitus, Stroke score greater than 2 were eligible for concomitant AtriClip (Atricure Inc, Westchester, Ohio) device insertion. Device insertion (35, 40, 45, and 50 mm) was performed at any point after sternotomy on or off cardiopulmonary bypass. Safety was assessed at 30 days, and efficacy of left atrial appendage exclusion was assessed at operation (by transesophageal echocardiography) and 3-month follow-up (by computed tomography angiography or transesophageal echocardiography). Results A total of 71 patients (mean age, 73 years) undergoing open cardiac surgery at 7 US centers were enrolled in the study. The left atrial appendage in 1 patient was too small and did not meet eligibility criteria; the remaining 70 patients had successful placement of an AtriClip device. Intraprocedural successful left atrial appendage exclusion was confirmed in 67 of 70 patients (95.7%). Although significant adverse events occurred in 34 of 70 patients (48.6%), there were no adverse events related to the device and no perioperative mortality. At 3-month follow-up, 1 patient died and 65 of 70 patients (92.9%) were available for assessment. Of the patients who underwent imaging, 60 of 61 patients (98.4%) had successful left atrial appendage exclusion by computed tomography angiography or transesophageal echocardiography imaging. Conclusions In this small study, safe and atraumatic exclusion of the left atrial appendage can be performed during open cardiac surgery with the AtriClip device with greater than 95% success and appears to be durable in the short term by imaging. Long-term studies are needed to evaluate the efficacy in the prevention of stroke.
Vasoplegic syndrome, defined by hypotension despite normal or increased cardiac output, is associated with high mortality rate after cardiopulmonary bypass. Methylene blue (MB) is reported to ...ameliorate vasoplegic syndrome through the nitric oxide pathway. We hypothesized that early administration of MB would improve outcomes in patients with vasoplegic syndrome after cardiopulmonary bypass.
All patients that underwent cardiopulmonary bypass at our institution (Jan 1, 2011 to Jun 30, 2016) were identified through our Society of Thoracic Surgery database. Pharmacy records identified patients receiving MB within 72 hours of cardiopulmonary bypass. Multivariate logistic regression identified predictors of major adverse events among patients receiving MB.
A total of 118 cardiopulmonary bypass patients (3.3%) received MB for vasoplegic syndrome. These patients had a higher incidence of comorbidities, and these cases were more commonly reoperative (76.1% versus 41.2%, p < 0.0001) and complex (70.3% versus 31.8%, p < 0.0001). The only difference in preoperative medications was that MB patients had a higher rate of amiodarone use (15.3% versus 2.2%, p < 0.0001). MB patients had significantly higher rates of postoperative complications, except atrial fibrillation. Early (operating room, 40.7%) versus late (intensive care unit, 59.3%) administration of MB was associated with significantly reduced operative mortality rate (10.4% versus 28.6%, p = 0.018) and risk-adjusted major adverse events (odd ratio 0.35, p = 0.037).
Operative mortality rate is high in patients receiving MB for the treatment of vasoplegia after cardiopulmonary bypass. Early administration of MB improves survival and reduces the risk-adjusted rate of major adverse events in these patients.
Abstract Background Several single-center studies have reported excellent outcomes with minimally invasive aortic valve replacement (mini-AVR). Although criticized as requiring more operative time ...and complexity, mini-AVR is increasingly performed. We compared contemporary outcomes and cost of mini-AVR versus conventional AVR in a multi-institutional regional cohort. We hypothesized that mini-AVR provides equivalent outcomes to conventional AVR without increased cost. Methods Patient records for primary isolated AVR (2011-2013) were extracted from a regional, multi-institutional Society of Thoracic Surgeons database and stratified by conventional versus mini-AVR, performed by either partial sternotomy or right thoracotomy. To compare similar patients, a 1:1 propensity-matched cohort was performed after adjusting for surgeon; operative year; and Society of Thoracic Surgeons risk score, including age and risk factors (n = 289 in each group). Differences in outcomes and cost were analyzed. Results A total of 1341 patients underwent primary isolated AVR, of which 442 (33%) underwent mini-AVR at 17 hospitals. Mortality, stroke, renal failure, and other major complications were equivalent between groups. Mini-AVR was associated with decreased ventilator time (5 vs 6 hours; P = .04) and decreased blood product transfusion (25% vs 32%; P = .04). A greater percentage of mini-AVR patients were discharged within 4 days of the operation (15.2% vs 4.8%; P < .001). Consequently, total hospital costs were lower in the mini-AVR group ($36,348 vs $38,239; P = .02). Conclusions Mortality and morbidity outcomes of mini-AVR are equivalent to conventional AVR. Mini-AVR is associated with decreased ventilator time, blood product use, early discharge, and reduced total hospital cost. In contemporary clinical practice, mini-AVR is safe and cost-effective.
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