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BACKGROUND: Anastomotic leak after esophagectomy carries important short and long-term sequelae. We conducted a systematic review and meta-analysis to determine its association with surgical volume. MATERIALS AND METHODS: A systematic literature review was performed to identify all studies reporting on anastomotic leak after esophagectomy. Studies with <100 cases were excluded. The primary outcome was post-esophagectomy anastomotic leak, while secondary outcomes were operative mortality overall and after anastomotic leak. Pooled event rates (PER) were calculated and association with annual esophagectomy volume by center was investigated. RESULTS: Of the 3,932 retrieved articles, 472 were included (n=177,566 patients). The PER of anastomotic leak was 8.91% [95%CI=8.32; 9.53%]. The PER of early mortality overall and after anastomotic leak was 2.49% [95%CI=2.27; 2.74] and 11.39% [95%CI=9.66; 13.39], respectively. Centers with <37 annual esophagectomies had a higher leak rate compared to those with ≥37 annual esophagectomies (9.58% vs. 8.34%; P=0.040). On meta-regression, surgical volume was inversely associated with the PER of esophageal leak and of early mortality. CONCLUSION: The frequency of anastomotic leaks after esophagectomy, perioperative and leak associated mortality are inversely associated with esophagectomy volume.
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OBJECTIVE: An inclusive contemporary analysis of spinal cord injury (SCI) rates in patients undergoing aneurysm repair and the factors associated with complications has not been performed. METHODS: Following a systematic literature search, studies from 2008 to 2018 on repair of descending thoracic aneurysm (DTA) and thoracoabdominal aortic aneurysm (TAAA) were pooled in a meta-analysis performed using the generic inverse variance method. The primary outcome was permanent SCI. Secondary outcomes were temporary SCI, operative mortality, long-term mortality, postoperative stroke, and cerebrospinal fluid (CSF) drain-related complications. RESULTS: One-hundred sixty-nine studies (22,634 patients) were included. The pooled rate of permanent SCI was 4.5% (95% confidence interval [CI], 3.8-5.4); 3.5% (95% CI, 1.8-6.7) for DTA and 7.6% (96% CI, 6.2-9.3) for TAAA repair (P for subgroups = .02), 5.7% (95% CI, 4.3-7.5) for open repair and 3.9% (95% CI, 3.1-4.8) for endovascular repair (P for subgroups = .03). Rates for Crawford extents I, II, III, IV, and V aneurysms were 4.0% (95% CI, 3.0-5.0), 15.0% (95% CI, 10.0-22.0), 7.0% (95% CI, 6.0-9.0), 2.0% (95% CI, 2.0-4.0), and 7.0% (95% CI, 2.0-23.0) respectively (P for subgroups <.001). The pooled rates for operative mortality, late mortality at a mean follow-up of 5.0 years, stroke, and temporary SCI were 7.4% (95% CI, 6.1-9.4), 1.0% (95% CI, 0.0-1.0), 4.2% (95% CI, 3.6-4.8), and 3.7% (95% CI, 3.0-4.6), respectively. The pooled rates for severe, moderate, and minor CSF-drain related complications were 5.1% (95% CI, 2.23-11.1), 4.1% (95% CI, 0.6-22.0), and 3.6% (95% CI, 1.2-8.0) respectively. CONCLUSIONS: Despite improvement, both open and endovascular aneurysm repair remain associated with a substantial risk of permanent SCI. The risk is greater for TAAA repair, especially extent II, III, and V.
Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Spinal Cord Injuries/etiology , Aged , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Male , Middle Aged , Risk Assessment , Risk Factors , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/mortality , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To discern the impact of depressed left ventricular ejection fraction (LVEF) on the outcomes of open descending thoracic aneurysm (DTA) and thoracoabdominal aneurysms (TAAA) repair. METHODS: Restricted cubic spline analysis was used to identify a threshold of LVEF, which corresponded to an increase in operative mortality and major adverse events (MAE: operative death, myocardial infarction, stroke, spinal cord injury, need for tracheostomy or dialysis). Logistic and Cox regression were performed to identify independent predictors of MAE, operative mortality, and survival. RESULTS: DTA/TAAA repair was performed in 833 patients between 1997 and 2018. Restricted cubic spline analysis showed that patients with LVEF <40% (n = 66) had an increased risk of MAE (odds ratio [OR], 2.17; 95% confidence interval [CI], 1.22-3.87; P < .01) and operative mortality (OR, 2.72; 95% CI, 1.21-6.12; P = .02) compared with the group with LVEF ≥40% (n = 767). The group with LVEF <40% had a worse preoperative profile (eg, coronary revascularization, 48.5% vs 17.3% [P < .01]; valvular disease, 82.8% vs 49.39% [P < .01]; renal insufficiency, 45.5% vs 26.1% [P < .01]; respiratory insufficiency, 36.4% vs 21.2% [P = .01]) and worse long-term survival (35.5% vs 44.7% at 10 years; P = .01). Nonetheless, on multivariate regression, depressed LVEF was not an independent predictor of operative mortality, MAE, or survival. CONCLUSIONS: LVEF is not an independent predictor of adverse events in surgery for DTA.
Subject(s)
Aortic Aneurysm, Thoracic/surgery , Stroke Volume , Ventricular Dysfunction, Left/complications , Aged , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/physiopathology , Female , Humans , Logistic Models , Male , Middle Aged , Proportional Hazards Models , Stroke Volume/physiology , Survival Analysis , Thoracotomy/methods , Thoracotomy/mortality , Treatment Outcome , Ventricular Dysfunction, Left/mortality , Ventricular Dysfunction, Left/physiopathologyABSTRACT
BACKGROUND AND AIM: The routine use of cerebrospinal fluid (CSF) drainage in patients undergoing operative repair of thoracoabdominal aneurysms (TAAA) has been associated with decreased rates of spinal cord ischemia. The use of CSF drains is not without consequence, however with complications including subarachnoid hemorrhage, epidural hematoma, meningitis, and, in 1% of cases, death. To date, a decision analysis tool to help clinicians decide when to use and not to use a CSF drain does not exist. In this analysis, we set out to develop a decision analysis tool for CSF drain placement in patients undergoing operative repair of TAAA. METHODS: A Markov state-transition cohort model that compared TAAA repair with adjunctive CSF drain insertion to TAAA repair without drain insertion for the outcome of life expectancy was developed in TreeAge 2020. The cycle length was 1 month and the time horizon was 60 months. RESULTS: The use of a CSF drain was associated with improved 5-year life expectancy (3.21 ± 0.10 vs. 3.09 ± 0.11 life-years gained). In the sensitivity analysis that varied the effectiveness of a CSF drain (odds ratio closer to 1 = less effective), the use of a CSF drain resulted in higher life expectancy in almost all scenarios. CONCLUSIONS: The routine use of a CSF drain in patients undergoing TAAA repair is safe and effective, with few exceptions. This decision analysis tool can be used by clinicians to develop a personalized approach.
Subject(s)
Aortic Aneurysm, Thoracic , Spinal Cord Ischemia , Aortic Aneurysm, Thoracic/surgery , Decision Support Techniques , Drainage , Humans , Postoperative Complications/prevention & control , Retrospective Studies , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: Aortic valve area (AVA) is commonly determined from 2-dimensional transthoracic echocardiography (2D TTE) by the continuity equation; however, this method relies on geometric assumptions of the left ventricular outflow tract which may not hold true. This study compared mean differences and correlations for AVA by planimetric (2-dimensional transesophageal echocardiography [2D TEE], 3-dimensional transesophageal echocardiography [3D TEE], 3-dimensional transthoracic echocardiography [3D TTE], multi-detector computed tomography [MDCT], and magnetic resonance imaging [MRI]) with hemodynamic methods (2D TTE and catheterization) using pairwise meta-analysis. METHOD: Ovid MEDLINE®, Ovid EMBASE, and The Cochrane Library (Wiley) were queried for studies comparing AVA measurements assessed by planimetric and hemodynamic techniques. Pairwise meta-analysis for mean differences (using random effect model) and for correlation coefficients (r) were performed. RESULTS: Forty-five studies (3014 patients) were included. Mean differences between planimetric and hemodynamic techniques were 0.12 cm2 (95%CI 0.10-0.15) for AVA (pooled r = 0.84; 95%CI 0.76-0.90); 1.36cm2 (95%CI 1.03-1.69) for left ventricular outflow tract area; and 0.13 cm (95%CI 0.07-0.20) for annular diameter (pooled r = 0.76; 95% CI 0.64-0.94); 0.67 cm2 (95%CI 0.59-0.76) for annular area (pooled r = 0.74; 95%CI 0.55-0.86). CONCLUSIONS: Planimetric techniques slightly, but significantly, overestimate AVA when compared to hemodynamic techniques.
Subject(s)
Aortic Valve Stenosis , Echocardiography, Three-Dimensional , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/diagnostic imaging , Echocardiography, Transesophageal , Hemodynamics , Humans , Reproducibility of ResultsABSTRACT
OBJECTIVES: The optimal revascularization strategy for patients with ischaemic left ventricular systolic dysfunction (iLVSD) remains controversial. We aimed to compare percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) and medical therapy (MT) in a network meta-analysis. METHODS: All randomized controlled trials and observational studies comparing any combination of PCI, CABG and MT in patients with iLVSD were analysed in a frequentist network meta-analysis (generic inverse variance method). Primary outcome was mortality at longest available follow-up. Secondary outcomes were cardiac death, stroke, myocardial infarction (MI) and repeat revascularization (RR). RESULTS: Twenty-three studies were included (n = 23 633; 4 randomized controlled trials). Compared to CABG, PCI was associated with higher mortality [incidence rate ratio (IRR) 1.32, 95% confidence interval (CI) 1.13-1.53], cardiac death (IRR 1.65, 95% CI 1.18-2.33), MI (IRR 2.18, 95% CI 1.70-2.80) and RR (IRR 3.75, 95% CI 2.89-4.85). Compared to CABG, MT was associated with higher mortality (IRR 1.52, 95% CI 1.26-1.84), cardiac death (IRR 3.83, 95% CI 2.12-6.91), MI (IRR 3.22, 95% CI 1.52-6.79) and RR (IRR 3.37, 95% CI 1.67-6.79). Compared to MT, PCI was associated with lower cardiac death (IRR 0.43, 95% CI 0.24-0.78). CABG ranked as the best revascularization strategy for mortality, cardiac death, MI and RR; MT ranked as the strategy associated with the lowest incidence of stroke. Left ventricular ejection fraction, year of study, use of drug-eluting stents did not affect relative treatment effects. CONCLUSIONS: CABG appears to be the best therapy for iLVSD, although mainly based on observational data. Definitive randomized controlled trials comparing CABG and PCI in iLVSD are required. PROSPERO REGISTRATION ID: 132414.
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Importance: Changes in evidence-based practice and guideline recommendations depend on high-quality randomized clinical trials (RCTs). Commercial device and pharmaceutical manufacturers are frequently involved in the funding, design, conduct, and reporting of trials, the implications of which have not been recently analyzed. Objective: To evaluate the design, outcomes, and reporting of contemporary randomized clinical trials of invasive cardiovascular interventions and their association with the funding source. Design, Setting, and Participants: This cross-sectional study analyzed published RCTs between January 1, 2008, to May 31, 2019. The trials included those involving coronary, vascular and structural interventional cardiology, and vascular and cardiac surgical procedures. Main Outcomes and Measures: We assessed (1) trial characteristics, (2) finding of a statistically significant difference in the primary end point favoring the experimental intervention, (3) reporting of implied treatment advantage in trials without significant differences in primary end point, (4) existence of major discrepancies between registered and published primary outcomes, (5) number of patients whose outcomes would need to switch from a nonevent to an event to convert a significant difference in primary end point to nonsignificant, and (6) association with funding source. Results: Of the 216 RCTs analyzed, 115 (53.2%) reported having commercial sponsorship. Most trials had 80% power to detect an estimated treatment effect of 30%, and 128 trials (59.3%) used composite primary end points. The median (interquartile range [IQR]) sample size was 502 (204-1702) patients, and the median (IQR) follow-up duration was 12 (1.0-14.4) months. Overall, 123 trials (57.0%) reported a statistically significant difference in the primary outcome favoring the experimental intervention; reporting strategies that implied an advantage were identified in 55 (65.5%) of 84 trials that reported nonsignificant differences. Commercial sponsorship was associated with a statistically significantly greater likelihood of favorable outcomes reporting (exponent of regression coefficient ß, 2.80; 95% CI, 1.09-7.18; P = .03) and with the reporting of findings that are inconsistent with the trial results. Discrepancies between the registered and published primary outcomes were found in 82 trials (38.0%), without differences in trial sponsorship. A median (IQR) number of 5 (2.8-12.5) patients experiencing a different outcome would have change statistically significant results to nonsignificant. Commercial sponsorship was associated with a greater number of patients (exponent of regression coefficient ß, 1.29; 95% CI, 1.00-1.66; P = .04). Conclusions and Relevance: These results suggest that contemporary RCTs of invasive cardiovascular interventions are relatively small and fragile, have short follow-up, and have limited power to detect large treatment effects. Commercial support appeared to be associated with differences in trial design, results, and reporting.
Subject(s)
Cardiovascular Diseases/surgery , Myocardial Revascularization/economics , Randomized Controlled Trials as Topic/economics , Cardiovascular Diseases/economics , Costs and Cost Analysis , HumansABSTRACT
BACKGROUND: Contemporary outcomes of open repair of thoracoabdominal aortic aneurysms (TAAAs) and descending thoracic aortic aneurysms (DTAs) have not been analyzed in an inclusive meta-analysis. METHODS: After a systematic literature search, studies from 2008 to 2018 reporting outcomes of open repair of DTAs or TAAAs were pooled in a single-arm meta-analysis performed using the generic inverse variance method. Primary outcome was operative mortality. Secondary outcomes were late mortality, postoperative stroke, permanent and temporary spinal cord injury, renal failure, respiratory failure, and myocardial infarction. RESULTS: Fifty-four studies with 12,245 patients were included. Pooled operative mortality for open repair was 10.4% (95% confidence interval [CI], 8.3-12.8): 6.6% (95% CI, 3.7-11.6) for DTA and 10.5% (95% CI, 7.5-14.5) for TAAA. Pooled incidence rate of late mortality was 0.6% (95% CI, 0.5-0.8) per person-year. Pooled rates for postoperative outcomes were 4.9% (95% CI, 3.9-6.1) for stroke; 5.7% (95% CI, 4.3-7.5) and 3.0% (95% CI, 2.1-4.2) for permanent and temporary spinal cord injury, respectively; 13.2% (95% CI, 9.9-17.3) for renal failure; 23.3% (95% CI, 17.5-30.4) for respiratory failure; and 2.7% (95% CI, 1.8-4.1) for myocardial infarction. At metaregression, year of publication, use of the clamp-and-sew technique, and use of the cerebrospinal fluid drain were associated with lower operative mortality. Ruptured aneurysms were associated with higher operative mortality. CONCLUSIONS: Despite improvement, open repair of DTAs and TAAAs continues to be associated with a considerable risk for operative death and perioperative complications. Use of the cerebrospinal fluid drain is associated with better outcomes.
Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Postoperative Complications/epidemiology , Aortic Aneurysm, Thoracic/mortality , Humans , Treatment OutcomeABSTRACT
BACKGROUND: The objective of this study was to assess the overall quality of study-level meta-analyses in high-ranking journals using commonly employed guidelines and standards for systematic reviews and meta-analyses. METHODS: 100 randomly selected study-level meta-analyses published in ten highest-ranking clinical journals in 2016-2017 were evaluated by medical librarians against 4 assessments using a scale of 0-100: the Peer Review of Electronic Search Strategies (PRESS), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Institute of Medicine's (IOM) Standards for Systematic Reviews, and quality items from the Cochrane Handbook. Multiple regression was performed to assess meta-analyses characteristics' associated with quality scores. RESULTS: The overall median (interquartile range) scores were: PRESS 62.5(45.8-75.0), PRISMA 92.6(88.9-96.3), IOM 81.3(76.6-85.9), and Cochrane 66.7(50.0-83.3). Involvement of librarians was associated with higher PRESS and IOM scores on multiple regression. Compliance with journal guidelines was associated with higher PRISMA and IOM scores. CONCLUSION: This study raises concerns regarding the reporting and methodological quality of published MAs in high impact journals Early involvement of information specialists, stipulation of detailed author guidelines, and strict adherence to them may improve quality of published meta-analyses.
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Meta-Analysis as Topic , Research Report , Humans , Multivariate AnalysisABSTRACT
BACKGROUND: Surgical animal models are used in pre-clinical scientific studies. To date there has not been an analysis of how effective these data are when translated to human/clinical research. In this retrospective review, we evaluate the impact of studies using surgical animal models on human/clinical research through study-level analysis of citations. METHODS: The top two ranking clinical journals based on impact factor for the top ten surgical specialties were identified and a search was run on PubMed to identify studies using surgical animal models published in the years 2007 and 2008. The translation to human/clinical research of each study was evaluated by analyzing the frequency of citation in human studies over the ten years following publication. Regression was used to identify predictors of citation in human/clinical research. RESULTS: 411 animal studies using surgical models were identified. Over the course of the 10 years following publication the original animal studies were cited 6063 times, with 1300 (21.4%) citations in human/clinical studies and 4763 (78.6%) in animal/basic science studies. The median number of citations in human/clinical research was 1 (IQR 0-5). Regression showed an association between citation in human/clinical research and the use of porcine models and the specialties of general surgery, oral and maxillofacial surgery, orthopedic surgery, transplant, and plastic surgery. CONCLUSION: The use of animal models in surgical research shows poor translation to human/clinical research. Alternative surgical models should urgently be explored.
Subject(s)
Models, Animal , Surgical Procedures, Operative , Translational Research, Biomedical , Animals , Cross-Sectional Studies , Humans , Journal Impact Factor , Models, Anatomic , Retrospective StudiesABSTRACT
PURPOSE OF REVIEW: The severity of low-flow, low-gradient aortic stenosis cases continue to be misunderstood because of challenging diagnosis, and treatment remains complex. We discuss current diagnostic and treatment modalities for low-flow, low-gradient aortic stenosis. RECENT FINDINGS: This article summarizes current guidelines and best practices for the management of low-flow, low-gradient aortic stenosis. SUMMARY: Low-flow, low-gradient aortic stenosis is a difficult entity to diagnose and treat. Various diagnostic modalities are needed to accurately determine the severity of aortic stenosis and potential treatment benefit. True-severe classical and paradoxical low-flow, low-gradient aortic stenosis can be distinguished from pseudo-severe aortic stenosis by dobutamine stress echocardiography and/or multidetector computed tomography. Once the distinction is made, aortic valve replacement results in better outcomes compared with conservative management. Although both surgical and transcatheter aortic valve replacement result in adequate outcomes, the decision between the two treatment strategies is based on patient characteristics, valve morphology, and other risk factors.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation , Aortic Valve/surgery , Humans , Severity of Illness Index , Stroke Volume , Treatment OutcomeSubject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve/diagnostic imaging , Echocardiography , Magnetic Resonance Imaging , Tomography, X-Ray Computed , Adolescent , Adult , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Stenosis/physiopathology , Child , Echocardiography, Doppler , Echocardiography, Three-Dimensional , Echocardiography, Transesophageal , Female , Humans , Male , Middle Aged , Network Meta-Analysis , Predictive Value of Tests , Reproducibility of Results , Young AdultABSTRACT
OBJECTIVE: Cerebral protection for aortic arch surgery has been widely studied, but comparisons of all the available strategies have rarely been performed. We performed direct and indirect comparisons of antegrade cerebral perfusion, retrograde cerebral perfusion, and deep hypothermic circulatory arrest in a network meta-analysis. METHODS: After a systematic literature search, studies comparing any combination of antegrade cerebral perfusion, retrograde cerebral perfusion, and deep hypothermic circulatory arrest were included, and a frequentist network meta-analysis was performed using the generic inverse variance method. The primary outcomes were postoperative stroke and operative mortality. Secondary outcomes were postoperative transient neurologic deficits, myocardial infarction, respiratory complications, and renal failure. RESULTS: A total of 68 studies were included with a total of 26,968 patients. Compared with deep hypothermic circulatory arrest, both antegrade cerebral perfusion and retrograde cerebral perfusion were associated with significantly lower postoperative stroke and operative mortality rates: antegrade cerebral perfusion (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.51-0.75; and OR, 0.63, 95% CI, 0.51-0.76, respectively) and retrograde cerebral perfusion (OR, 0.66; 95% CI, 0.54-0.82; and OR, 0.57; 95% CI, 0.45-0.71, respectively). Antegrade cerebral perfusion and retrograde cerebral perfusion were associated with similar incidence of primary outcomes. No difference among the 3 techniques was found in secondary outcomes. At meta-regression, circulatory arrest duration correlated with the neuroprotective effect of antegrade cerebral perfusion and retrograde cerebral perfusion compared with deep hypothermic circulatory arrest. Unilateral or bilateral antegrade cerebral perfusion and arrest temperature did not influence the results. CONCLUSIONS: Antegrade cerebral perfusion and retrograde cerebral perfusion are associated with better postoperative outcomes compared with deep hypothermic circulatory arrest, and the relative benefit increases with the duration of the circulatory arrest. No differences between antegrade cerebral perfusion and retrograde cerebral perfusion were found for all the explored outcomes.
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BACKGROUND: RCTs (randomized controlled trials) are the preferred source of evidence to support professional societies' guidelines. The fragility index (FI), defined as the minimum number of patients whose status would need to switch from nonevent to event to render a statistically significant result nonsignificant, quantitatively estimates the robustness of RCT results. We evaluate RCTs supporting current guidelines on myocardial revascularization using the FI and FI minus number of patients lost to follow-up. METHODS AND RESULTS: The FI and FI minus number of patients lost to follow-up of RCTs supporting the 2012 American College of Cardiology/American Heart Association Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease, the 2014 Focused Update of the American College of Cardiology/American Heart Association Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease, and the 2018 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for Myocardial Revascularization were calculated. Of 414 RCTs identified, 160 were eligible for FI calculation. The median FI was 8.0 (95% CI, 5.0-9.0) and the median FI minus number of patients lost to follow-up was 1.0 (95% CI, 0.0-3.0). FI was ≤3, indicating very limited robustness, in 44 (27.5%) RCTs, and was lower than the number LTF, indicating limited robustness, in 68 (42.5%) RCTs. FI was significantly (all P<0.05) correlated with the sample size, number of events, statistical power, journal impact factor, use of intention-to-treat analysis, and of composite end points and negatively correlated with the use of percutaneous interventions in the treatment arm and the P-value level. CONCLUSIONS: More than a quarter of RCTs that support current guidelines on myocardial revascularization have a FI of 3 or lower, and over 40% of trials reveal a FI that is lower than the number of patients lost to follow-up. These findings suggest that the robustness of the findings that support current myocardial revascularization guidelines is tenuous and vulnerable to change as new evidence from RCTs appears.
Subject(s)
Evidence-Based Medicine/statistics & numerical data , Models, Statistical , Myocardial Ischemia/therapy , Myocardial Revascularization/statistics & numerical data , Practice Guidelines as Topic , Randomized Controlled Trials as Topic/statistics & numerical data , Research Design/statistics & numerical data , Sample Size , Bias , Data Interpretation, Statistical , Humans , Lost to Follow-Up , Myocardial Revascularization/adverse effects , Treatment OutcomeABSTRACT
Background The ART (Arterial Revascularization Trial) showed no difference in survival at 10 years between patients assigned to the single versus bilateral internal thoracic artery grafting strategies. This finding is in contrast with the results of most observational studies, where the use of 2 internal thoracic arteries has been associated with improved survival. Methods and Results We selected propensity-matched studies from the most comprehensive observational meta-analysis on the long-term outcomes of patients receiving 1 versus 2 internal thoracic arteries. Individual participant survival data from each study and the ART were reconstructed using an iterative algorithm that was applied to solve the Kaplan-Meier equations. The reconstructed individual participant survival data were aggregated to obtain combined survival curves and Cox regression hazard ratios with 95% CIs. Individual participant survival data were obtained from 14 matched observational studies (24 123 patients) and the ART. The 10-year survival of the control group of ART was significantly higher than that of the matched observational studies (hazard ratio, 0.86; 95% CI, 0.80-0.93). The 10-year survival of the experimental group of ART was significantly lower than that of the bilateral internal thoracic artery group of the observational studies (hazard ratio, 1.11; 95% CI, 1.03-1.20). Conclusions Both the improved outcome of the control arm and the lower beneficial effect of the intervention had played a role in the difference between observational evidence and ART.
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Mammary Arteries/transplantation , Observational Studies as Topic , Randomized Controlled Trials as Topic , HumansABSTRACT
Animal models have provided invaluable information in the pursuit of medical knowledge and alleviation of human suffering. The foundations of our basic understanding of disease pathophysiology and human anatomy can largely be attributed to preclinical investigations using various animal models. Recently, however, the scientific community, citing concerns about animal welfare as well as the validity and applicability of outcomes, has called the use of animals in research into question. In this review, we seek to summarize the current state of the use of animal models in research.
Subject(s)
Animal Experimentation/ethics , Disease Models, Animal , Models, Animal , Animal Testing Alternatives , Animal Welfare , Animals , Data Interpretation, Statistical , Humans , Research Design , Species Specificity , Translational Research, Biomedical/methodsABSTRACT
Background Transcatheter aortic valve replacement (TAVR) is the standard of care for many patients with severe symptomatic aortic stenosis and relies on accurate sizing of the aortic annulus. It has been suggested that 3-dimensional transesophageal echocardiography (3D TEE) may be used instead of multidetector computed tomography (MDCT) for TAVR planning. This systematic review and meta-analysis compared 3D TEE and MDCT for pre-TAVR measurements. Methods and Results A systematic literature search was performed. The primary outcome was the correlation coefficient between 3D TEE- and MDCT-measured annular area. Secondary outcomes were correlation coefficients for mean annular diameter, annular perimeter, and left ventricular outflow tract area; interobserver and intraobserver agreements; mean differences between 3D TEE and MDCT measurements; and pooled sensitivities, specificities, and receiver operating characteristic area under curve values of 3D TEE and MDCT for discriminating post-TAVR paravalvular aortic regurgitation. A random effects model was used. Meta-regression and leave-one-out analysis for the primary outcome were performed. Nineteen studies with a total of 1599 patients were included. Correlations between 3D TEE and MDCT annular area, annular perimeter, annular diameter, and left ventricular outflow tract area measurements were strong (0.86 [95% CI, 0.80-0.90]; 0.89 [CI, 0.82-0.93]; 0.80 [CI, 0.70-0.87]; and 0.78 [CI, 0.61-0.88], respectively). Mean differences between 3D TEE and MDCT between measurements were small and nonsignificant. Interobserver and intraobserver agreement and discriminatory abilities for paravalvular aortic regurgitation were good for both 3D TEE and MDCT. Conclusions For pre-TAVR planning, 3D TEE is comparable to MDCT. In patients with renal dysfunction, 3D TEE may be potentially advantageous for TAVR measurements because of the lack of contrast exposure.
Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Echocardiography, Three-Dimensional , Heart Valve Prosthesis , Multidetector Computed Tomography , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Stenosis/physiopathology , Female , Humans , Male , Observer Variation , Predictive Value of Tests , Prosthesis Design , Radiographic Image Interpretation, Computer-Assisted , Reproducibility of Results , Severity of Illness Index , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: The primary objective of this study was to identify the specific predictors of early and late stroke in patients after open heart surgery. Secondary outcomes included (a) risk factors for perioperative stroke, (b) anatomic location of stroke according to time of presentation, and (c) the impact of stroke on operative mortality. METHODS: Adult patients undergoing open cardiac surgery with cardiopulmonary bypass from 2006 to 2016 at the New York Presbyterian Hospital/Weill Cornell Medicine were retrospectively reviewed. In total 7957 patients were included. We compared the demographic and perioperative variables in three groups: no stroke, early stroke, and late stroke using regression analysis. RESULTS: The incidence of perioperative stroke for the entire study period was 1.5% (117 of 7957). Early stroke occurred in 84 (71.8%) patients, whereas late stroke occurred in 33 (28.2%). Early strokes were usually embolic events (64 of 66, 97.0%, P = .66) on the right side (30 of 66, 45.5%, P < .001), in the anterior circulation (38 of 66, 57.6%, P = .001), or in multiple distributions (28 of 66, 42.4%, P = .002). Late strokes were more likely left-sided (16 of 28, 57.1%, P < .001) and uncommonly in both the anterior and posterior hemispheres (1 of 28, 3.6%, P = .001). Stroke, regardless of timing, was a significant predictor of operative mortality (odds ratio, 11.0, confidence interval, 6.1-19.7, P < .001). CONCLUSIONS: Early and late strokes after cardiac surgery have distinct incidence, location, and likely etiology. Both early and late strokes portend a very high incidence of operative mortality.