45 research outputs found

    Decision analysis in cardiac surgery:a scoping review and methodological primer

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    OBJECTIVES: Randomized controlled trials are the gold standard for evidence generation in medicine but are limited by their real-world generalizability, resource needs, shorter follow-up durations and inability to be conducted for all clinical questions. Decision analysis (DA) models may simulate trials and observational studies by using existing data and evidence- and expert-informed assumptions and extend analyses over longer time horizons, different study populations and specific scenarios, helping to translate population outcomes to patient-specific clinical and economic outcomes. Here, we present a scoping review and methodological primer on DA for cardiac surgery research. METHODS: A scoping review was performed using the PubMed/MEDLINE, EMBASE and Web of Science databases for cardiac surgery DA studies published until December 2021. Articles were summarized descriptively to quantify trends and ascertain methodological consistency.RESULTS: A total of 184 articles were identified, among which Markov models (N = 92, 50.0%) were the most commonly used models. The most common outcomes were costs (N = 107, 58.2%), quality-adjusted life-years (N = 96, 52.2%) and incremental cost-effectiveness ratios (N = 89, 48.4%). Most (N = 165, 89.7%) articles applied sensitivity analyses, most frequently in the form of deterministic sensitivity analyses (N = 128, 69.6%). Reporting of guidelines to inform the model development and/or reporting was present in 22.3% of articles. CONCLUSION: DA methods are increasing but remain limited and highly variable in cardiac surgery. A methodological primer is presented and may provide researchers with the foundation to start with or improve DA, as well as provide readers and reviewers with the fundamental concepts to review DA studies.</p

    Are stentless valves hemodynamically superior to stented valves? Long-term follow-up of a randomized trial comparing Carpentier–Edwards pericardial valve with the Toronto Stentless Porcine Valve

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    ObjectiveThe benefit of stentless valves remains in question. In 1999, a randomized trial comparing stentless and stented valves was unable to demonstrate any hemodynamic or clinical benefits at 1 year after implantation. This study reviews long-term outcomes of patients randomized in the aforementioned trial.MethodsBetween 1996 and 1999, 99 patients undergoing aortic valve replacement were randomized to receive either a stented Carpentier–Edwards pericardial valve (CE) (Edwards Lifesciences, Irvine, Calif) or a Toronto Stentless Porcine Valve (SPV) (St Jude Medical, Minneapolis, Minn). Among these, 38 patients were available for late echocardiographic follow-up (CE, n = 17; SPV, n = 21). Echocardiographic analysis was undertaken both at rest and with dobutamine stress, and functional status (Duke Activity Status Index) was compared at a mean of 9.3 years postoperatively (range, 7.5–11.1 years). Clinical follow-up was 82% complete at a mean of 10.3 years postoperatively (range, 7.5–12.2 years).ResultsPreoperative characteristics were similar between groups. Effective orifice areas increased in both groups over time. Although there were no differences in effective orifice areas at 1 year, at 9 years, effective orifice areas were significantly greater in the SPV group (CE, 1.49 ± 0.59 cm2; SPV, 2.00 ± 0.53 cm2; P = .011). Similarly, mean and peak gradients decreased in both groups over time; however, at 9 years, gradients were lower in the SPV group (mean: CE, 10.8 ± 3.8 mm Hg; SPV, 7.8 ± 4.8 mm Hg; P = .011; peak: CE, 20.4 ± 6.5 mm Hg; SPV, 14.6 ± 7.1 mm Hg; P = .022). Such differences were magnified with dobutamine stress (mean: CE, 22.7 ± 6.1 mm Hg; SPV, 15.3 ± 8.4 mm Hg; P = .008; peak: CE, 48.1 ± 11.8 mm Hg; SPV, 30.8 ± 17.7 mm Hg; P = .001). Ventricular mass regression occurred in both groups; however, no differences were demonstrated between groups either on echocardiographic, magnetic resonance imaging, or biochemical (plasma B-type [brain] natriuretic peptide) assessment (P = .74). Similarly, Duke Activity Status Index scores of functional status improved in both groups over time; however, no differences were noted between groups (CE, 27.5 ± 19.1; SPV, 19.9 ± 12.0; P = .69). Freedom from reoperation at 12 years was 92% ± 5% in patients with CEs and 75% ± 5% in patients with SPVs (P = .65). Freedom from valve-related morbidity at 12 years was 82% ± 7% in patients with CEs and 55% ± 7% in patients with SPVs (P = .05). Finally, 12-year actuarial survival was 35% ± 7% in patients with CEs and 52% ± 7% in patients with SPVs (P = .37).ConclusionAlthough offering improved hemodynamic outcomes, the SPV did not afford superior mass regression or improved clinical outcomes up to 12 years after implantation

    A randomized comparison of intraoperative indocyanine green angiography and transit-time flow measurement to detect technical errors in coronary bypass grafts

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    BackgroundEarly coronary bypass graft failures may be preventable if identified intraoperatively. The purpose of this investigation was to compare the diagnostic accuracy of two intraoperative graft assessment techniques, transit-time ultrasound flow measurement and indocyanine green fluorescent-dye graft angiography.MethodsPatents undergoing isolated coronary artery bypass grafting with no contraindications for postoperative angiography were enrolled in the study. Patients were randomly assigned to be evaluated with either indocyanine green angiography (Novadaq Spy angiography system; Novadaq Technologies Inc, Concord, Ontario, Canada) and then transit-time ultrasonic flow measurement (Medtronic Medi-Stim Butterfly Flowmeter TTF measurement system; Medtronic Inc, Minneapolis, Minn) or transit-time flow then indocyanine green angiography. Patients underwent x-ray angiography on postoperative day 4. The primary end point of the trial was to determine the sensitivity and specificity of the two techniques versus reference standard x-ray angiography to detect graft occlusion or greater than 50% stenosis in the graft or perianastomotic area.ResultsBetween February 2004 and March 2005, 106 patients were enrolled and x-ray angiography was performed in 46 patients. In total, 139 grafts were reviewed with all three techniques and 12 grafts (8.2%) were demonstrated to have greater than 50% stenosis or occlusion by the reference standard. The sensitivity and specificity of indocyanine green angiography to detect greater than 50% stenosis or occlusion was 83.3% and 100%, respectively. The sensitivity and specificity of transit-time ultrasonic flow measurement to detect greater than 50% stenosis or occlusion was 25% and 98.4%, respectively. The P value for the overall comparison of sensitivity and specificity between indocyanine green angiography and transit-time flow ultrasonography was .011. The difference between sensitivity for indocyanine green angiography and transit-time flow measurement was 58% with a 95% confidence interval of 30% to 86%, P = .023.ConclusionIndocyanine green angiography provides better diagnostic accuracy for detecting clinically significant graft errors than does transit-time ultrasound flow measurement

    Decision analysis in cardiac surgery:a scoping review and methodological primer

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    OBJECTIVES: Randomized controlled trials are the gold standard for evidence generation in medicine but are limited by their real-world generalizability, resource needs, shorter follow-up durations and inability to be conducted for all clinical questions. Decision analysis (DA) models may simulate trials and observational studies by using existing data and evidence- and expert-informed assumptions and extend analyses over longer time horizons, different study populations and specific scenarios, helping to translate population outcomes to patient-specific clinical and economic outcomes. Here, we present a scoping review and methodological primer on DA for cardiac surgery research. METHODS: A scoping review was performed using the PubMed/MEDLINE, EMBASE and Web of Science databases for cardiac surgery DA studies published until December 2021. Articles were summarized descriptively to quantify trends and ascertain methodological consistency.RESULTS: A total of 184 articles were identified, among which Markov models (N = 92, 50.0%) were the most commonly used models. The most common outcomes were costs (N = 107, 58.2%), quality-adjusted life-years (N = 96, 52.2%) and incremental cost-effectiveness ratios (N = 89, 48.4%). Most (N = 165, 89.7%) articles applied sensitivity analyses, most frequently in the form of deterministic sensitivity analyses (N = 128, 69.6%). Reporting of guidelines to inform the model development and/or reporting was present in 22.3% of articles. CONCLUSION: DA methods are increasing but remain limited and highly variable in cardiac surgery. A methodological primer is presented and may provide researchers with the foundation to start with or improve DA, as well as provide readers and reviewers with the fundamental concepts to review DA studies.</p
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