Publications by authors named "Richard Whitlock"

272 Publications

Histologic type predicts disparate outcomes in pediatric hepatocellular neoplasms: A Pediatric Surgical Oncology Research Collaborative study.

Cancer 2022 May 13. Epub 2022 May 13.

Division of Pediatric Surgery, Children's Hospital, London Health Sciences Center, London, Ontario, Canada.

Background: Hepatocellular carcinoma (HCC) is a rare cancer in children, with various histologic subtypes and a paucity of data to guide clinical management and predict prognosis.

Methods: A multi-institutional review of children with hepatocellular neoplasms was performed, including demographic, staging, treatment, and outcomes data. Patients were categorized as having conventional HCC (cHCC) with or without underlying liver disease, fibrolamellar carcinoma (FLC), and hepatoblastoma with HCC features (HB-HCC). Univariate and multivariate analyses identified predictors of mortality and relapse.

Results: In total, 262 children were identified; and an institutional histologic review revealed 110 cHCCs (42%; 69 normal background liver, 34 inflammatory/cirrhotic, 7 unknown), 119 FLCs (45%), and 33 HB-HCCs (12%). The authors observed notable differences in presentation and behavior among tumor subtypes, including increased lymph node involvement in FLC and higher stage in cHCC. Factors associated with mortality included cHCC (hazard ratio [HR], 1.63; P = .038), elevated α-fetoprotein (HR, 3.1; P = .014), multifocality (HR, 2.4; P < .001), and PRETEXT (pretreatment extent of disease) stage IV (HR, 5.76; P < .001). Multivariate analysis identified increased mortality in cHCC versus FLC (HR, 2.2; P = .004) and in unresectable tumors (HR, 3.4; P < .001). Disease-free status at any point predicted survival.

Conclusions: This multi-institutional, detailed data set allowed a comprehensive analysis of outcomes for children with these rare hepatocellular neoplasms. The current data demonstrated that pediatric HCC subtypes are not equivalent entities because FLC and cHCC have distinct anatomic patterns and outcomes in concert with their known molecular differences. This data set will be further used to elucidate the impact of histology on specific treatment responses, with the goal of designing risk-stratified algorithms for children with HCC.

Lay Summary: This is the largest reported granular data set on children with hepatocellular carcinoma. The study evaluates different subtypes of hepatocellular carcinoma and identifies key differences between subtypes. This information is pivotal in improving understanding of these rare cancers and may be used to improve clinical management and subsequent outcome in children with these rare malignancies.
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http://dx.doi.org/10.1002/cncr.34256DOI Listing
May 2022

Association of Intercostal Nerve Cryoablation during Nuss Procedure with Complications and Costs.

Ann Thorac Surg 2022 Apr 27. Epub 2022 Apr 27.

Department of Surgery, Baylor College of Medicine, Houston, TX; Division of Pediatric Surgery, Texas Children's Hospital, Houston, TX.

Background: Intercostal nerve cryoablation with the Nuss procedure has been shown to decrease opioid requirements and hospital length of stay; however, few studies have evaluated the impact on complications and hospital costs.

Methods: A retrospective cohort study was performed for all Nuss procedures at our institution from 2016-2020. Outcomes were compared across four pain modalities: cryoablation with standardized pain regimen (n=98), patient controlled analgesia (PCA) (n=96), epidural (n=36), and PCA with peripheral nerve block (PNB) (n=35). Outcomes collected included length of stay, opioid use, variable direct costs, and postoperative complications. Univariate and multivariate hierarchical regression analysis was used to compare outcomes between the pain modalities.

Results: Cryoablation was associated with increased total hospital cost compared to PCA (cryoablation $11,145; PCA $8975; p<0.01), but not when compared to epidural ($9678) or PCA with PNB ($10,303). The primary driver for increased costs was operating room supplies (PCA $2741, epidural $2767, PCA with PNB $3157, cryoablation $5938; p<0.01). With multivariate analysis, cryoablation was associated with decreased length of stay (-1.94, 95% confidence interval [-2.30 - -1.57]), opioid use during hospitalization (-3.54 [-4.81 - -2.28]), and urinary retention (0.13 [0.05-0.35]).

Conclusions: Cryoablation significantly reduces opioid requirements and length of stay relative to alternative modalities, but it was associated with an increase in total hospital costs relative to PCA, but not epidural or PCA with PNB. Cryoablation was not associated with allodynia or slipped bars requiring reoperation.
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http://dx.doi.org/10.1016/j.athoracsur.2022.04.022DOI Listing
April 2022

Concomitant Surgical Left Atrial Appendage Occlusion: a Review.

Curr Cardiol Rep 2022 Apr 30. Epub 2022 Apr 30.

Population Health Research Institute, 237 Barton Street E, Hamilton, ON, L8L 2X2, Canada.

Purpose Of Review: In this review, we discuss some of the observational studies that examined the impact of left atrial appendage occlusion on stroke, the Left Atrial Appendage Occlusion Study (LAAOS) III research program that provided definitive evidence for the benefit of surgical left atrial appendage occlusion on ischemic stroke, and high priority studies in the field that should be pursued by the surgical community.

Recent Findings: Atrial fibrillation is common in patients undergoing cardiac surgery. Oral anticoagulants are effective at preventing strokes related to atrial fibrillation; they have been the standard of care for stroke prevention in patients with atrial fibrillation for decades. Most strokes in patients with atrial fibrillation originate from the left atrial appendage. LAAOS III, a large randomized controlled trial, has recently demonstrated that concomitant left atrial appendage occlusion in patients undergoing cardiac surgery for another indication reduces the risk of stroke or systemic embolism on top of oral anticoagulation. Surgical left atrial appendage occlusion reduces the risk of ischemic stroke and systemic embolism in patients with atrial fibrillation and a CHADS-VASc score ≥ 2 undergoing cardiac surgery for another indication. The role of surgical left atrial appendage occlusion with patients without atrial fibrillation, as a substitute to anticoagulation and as a standalone procedure, remains unclear.
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http://dx.doi.org/10.1007/s11886-022-01705-5DOI Listing
April 2022

HepT1-derived murine models of high-risk hepatoblastoma display vascular invasion, metastasis, and circulating tumor cells.

Biol Open 2022 Apr 22. Epub 2022 Apr 22.

Divisions of Pediatric Surgery and Surgical Research, Michael E. DeBakey Department of Surgery, Pediatric Surgical Oncology Laboratory, Texas Children's Surgical Oncology Program, Texas Children's Liver Tumor Program, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX 77030, USA.

Hepatoblastoma (HB) is the most common pediatric primary liver malignancy, and survival for high-risk disease approaches 50%. Mouse models of HB fail to recapitulate hallmarks of high-risk disease. The aim of this work was to generate murine models that show high-risk features including multifocal tumors, vascular invasion, metastasis, and circulating tumor cells (CTCs). HepT1 cells were injected into the livers or tail veins of mice, and tumor growth was monitored with magnetic resonance and bioluminescent imaging. Blood was analyzed with fluorescence activated cell sorting to identify CTCs. Intra- and extra-hepatic tumor samples were harvested for immunohistochemistry and RNA and DNA sequencing. Cell lines were grown from tumor samples and profiled with RNA sequencing. With intrahepatic injection of HepT1 cells, 100% of animals grew liver tumors and showed vascular invasion, metastasis, and CTCs. Mutation profiling revealed genetic alterations in seven cancer-related genes, while transcriptomic analyses showed changes in gene expression with cells that invade vessels. Tail vein injection of HepT1 cells resulted in multifocal, metastatic disease. These unique models will facilitate further meaningful studies of high-risk HB.
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http://dx.doi.org/10.1242/bio.058973DOI Listing
April 2022

Management of a left atrial appendage thrombus due to atrial fibrillation complicating Quebec platelet disorder.

Can J Cardiol 2022 Apr 15. Epub 2022 Apr 15.

Departments of Pathology and Molecular Medicine, and Medicine, McMaster University, Hamilton, Ontario.

Quebec platelet disorder (QPD) is a bleeding disorder with accelerated, platelet-dependent fibrinolysis. We present a patient with QPD and atrial fibrillation who developed cardioembolic strokes from a left atrial appendage (LAA) thrombus. He was managed with surgical thrombus removal, LAA closure, anticoagulation and tranexamic acid.
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http://dx.doi.org/10.1016/j.cjca.2022.04.010DOI Listing
April 2022

Reply to sex differences in the clinical outcomes after left atrial appendage: A systematic review and meta-analysis.

Cardiovasc Revasc Med 2022 Mar 28. Epub 2022 Mar 28.

McMaster University, Hamilton, Ontario, Canada. Electronic address:

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http://dx.doi.org/10.1016/j.carrev.2022.03.024DOI Listing
March 2022

Tranexamic Acid in Patients Undergoing Noncardiac Surgery.

N Engl J Med 2022 Apr 2. Epub 2022 Apr 2.

From the Population Health Research Institute (P.J.D., M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., J.E., I.C., K. Balasubramanian, S.I.B., D. Stillo, T.C., P.S.R., E.P.B.-C., J.S., W.M., S.Y.), the Departments of Health Research Methods, Evidence, and Impact (P.J.D., M.M., D.C., F.K.B., S.N.O., M.K.W., A.X.G., S.I.B., J.S., G.G.), Medicine (P.J.D., M.M., D.C., F.K.B., M.K.W., A.P., V.T., J.E., P.L.G., E.P.B.-C., W.M., G.G., S.Y.), Surgery (A.L., R.P.W.), and Anesthesia (J.S., T.V.) and the School of Nursing (M.H.M.), McMaster University, Hamilton, the Departments of Medicine (A.X.G., P.S.R.) and Epidemiology and Biostatistics (A.X.G.), Western University, London, and the Department of Anesthesiology and Perioperative Medicine, Queen's University and Kingston Health Sciences Centre, Kingston (J.L.P.), ON, the Department of Medicine, Centre Hospitalier de l'Université de Montréal (E.D.), and the Department of Medicine, Jewish General Hospital, McGill University (T.C.), Montreal, and the Department of Medicine, University of Saskatchewan, Saskatoon (M.P.) - all in Canada; the Discipline of Acute Care Medicine, University of Adelaide (T.W.P.), and the Department of Anaesthesia, Royal Adelaide Hospital (T.W.P.), Adelaide, SA, and the Department of Anaesthesia and Perioperative Medicine, Monash University (T.R.), and the Department of Critical Care Medicine, Melbourne Medical School, University of Melbourne (K.L.), Melbourne, VIC - all in Australia; the Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center (V.L.), and the Department of Anesthesiology and Intensive Care (V.L.) and the Department of Anesthesiology, V. Zelman Institute of Medicine and Psychology (S.V.A.), Novosibirsk State University, Novosibirsk, Saint Petersburg State University Hospital, Saint Petersburg (S.E.), and V. Negovsky Reanimatology Research Institute, Anesthesia and Intensive Care Department, First Moscow State Medical University (Sechenov University), Moscow (V.V.L.) - all in Russia; the Departments of Outcomes Research (D.I.S., K.R., A.T.) and General Anesthesia (K.R., A.T.) and the Anesthesiology Institute (D.I.S., K.R., A.T.), Cleveland Clinic, Cleveland; Chinese University of Hong Kong, Shatin, China (M.T.V.C., W.K.K.W.); Iberoamerican Cochrane Center, Public Health and Clinical Epidemiology Service, Institut d'Investigació Biomèdica Sant Pau, Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (M.J.M.-Z.), the Department of Anesthesiology and Intensive Care, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona (M.N.), and the Anesthesiology Department, Santa Creu i Sant Pau University Hospital (P.P.), Barcelona, and the Trauma and Orthopedic Surgery Department, Hospital Clínico Universitario de Valladolid, Valladolid (H.J.A.) - all in Spain; the Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.-Y.W.); St. John's Medical College, Bangalore (D.X., M.R.), and the Department of Gastrointestinal Surgery, Surat Institute of Digestive Sciences Hospital and Research Center, Surat (K. Bhatt) - both in India; the Department of Anesthesiology and Intensive Care, IRCCS San Raffaele Scientific Institute, Vita Salute San Raffaele University, Milan (G.L.); the Department of Orthopedic and Trauma Surgery, Deventer Ziekenhuis, Deventer, the Netherlands (Y.V.K.); Jagiellonian University Medical College, Center for Intensive Care and Perioperative Medicine, Krakow, Poland (W.S.); Centre Hospitalier Universitaire Brugmann, Université Libre de Bruxelles, Brussels (D. Schmartz); the Department of Anesthesia, Auckland City Hospital, and the School of Health Sciences, University of Auckland, Auckland, New Zealand (T.G.S.); the Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany (M.W.); the Department of Anesthesia and Intensive Care, Copenhagen University Hospital-Bispebjerg and Frederiksberg, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen (C.S.M.); Shifa International Hospital, Islamabad, Pakistan (M.A.); Departamento de Epidemiología y Estudios en Salud, Universidad de Los Andes, and Servicio de Anestesiología, Clínica Santa María, Santiago, Chile (D.T.); the Department of Anesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna (E.F.); Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, National Institute for Health Technology Assessment, and Hospital Moinhos de Vento, Porto Alegre, Brazil (C.A.P.); and the Department of Anesthesia, Hospital Paris Saint Joseph, University of Paris, Paris (P.A.).

Background: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding.

Methods: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025.

Results: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority).

Conclusions: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).
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http://dx.doi.org/10.1056/NEJMoa2201171DOI Listing
April 2022

The Anti-Coronavirus Therapy (ACT) trials: design, baseline characteristics, and challenges.

CJC Open 2022 Mar 1. Epub 2022 Mar 1.

Departments of Pathology and Molecular Medicine and Health Evidence Methods, Evidence, and Impact, McMaster University. Hamilton, Canada.

Background: Effective treatments for COVID-19 are urgently needed but conducting randomized trials during the pandemic has been challenging.

Methods: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3,500 outpatients and 2,500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine versus usual care, and aspirin versus usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine versus usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily versus usual care. The primary outcome for the colchicine randomization is need for high flow oxygen, mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization is major thrombotic events, need for high flow oxygen, mechanical ventilation, or death.

Results: At the completion of enrolment on February 10, 2022, the outpatient trial had enrolled 3,917 patients and the inpatient trial 2,754 patients. Challenges encountered included lack of preliminary data about the interventions under evaluation, uncertainties related to the expected event rates, delays in regulatory and ethics approvals and in obtaining study interventions, as well as the changing pattern of the COVID-19 pandemic.

Conclusions: The ACT trials will determine the efficacy of anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin given alone or in combination with rivaroxaban across the spectrum of mild, moderate, and severe COVID-19. Lessons learned from the conduct of these trials will inform planning of future trials.
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http://dx.doi.org/10.1016/j.cjco.2022.02.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8887957PMC
March 2022

High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality.

N Engl J Med 2022 03;386(9):827-836

From McMaster University (P.J.D., A.L., M.H.M., E.P.B.-C., N.D., D.C., P.A.K., M.J.M., J.S., Y.L.M., R.M., S.F.L., S.I.B., S.H., F.K.B., G.H.G., S.Y., R.P.W.), Hamilton Health Sciences (P.J.D., A.L., E.P.B.-C., N.D., D.C., P.A.K., Y.L.M., F.K.B., G.H.G., S.Y., R.P.W.), and the Population Health Research Institute (P.J.D., A.L., M.H.M., E.P.B.-C., D.C., M.J.M., K.B., J.S., Y.L.M., R.M., S.F.L., S.I.B., F.K.B., S.P., J.V., S.Y., R.P.W.), Hamilton, Queen's University, Kingston (R.V.A., J.L.P.), and Sunnybrook Health Sciences Centre and the University of Toronto, Toronto (S.C., S.F.) - all in Ontario, Canada; the Chinese University of Hong Kong, Hong Kong (M.T.V.C., M.J.U.), and the First Affiliated Hospital of Xinjiang Medical University, Urumqi (H.Z.) - both in China; E. Meshalkin National Medical Research Center (V.V.L., M.A.) and Novosibirsk State University (V.V.L.), Novosibirsk, and the Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo (D.S.) - all in Russia; IRCCS San Raffaele Scientific Institute (G.L., E.F., F.M.) and Vita-Salute San Raffaele University (G.L., F.M.), Milan, the University of Foggia, Foggia (D.P.), and Santa Maria Hospital GVM Care and Research, Bari (D.P., V.M.) - all in Italy; the University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.); Hospital de la Santa Creu i Sant Pau (G.U., M.M.) and Institut d'Investigació Biomèdica Sant Pau-CIBERESP (G.U.) - both in Barcelona; Instituto do Coração, Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo (L.A.H.), and Hospital Moinhos de Vento (C.A.P.), Hospital de Clínicas de Porto Alegre (C.A.P.), and Instituto de Cardiologia do Rio Grande do Sul (R.S.), Porto Alegre - all in Brazil; Royal Perth Hospital and the University of Western Australia - both in Perth (G.S.H.); the University of Edinburgh, Edinburgh (N.L.M.), the Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool (J.D.M.), and the Royal Wolverhampton NHS Trust, Wolverhampton (J.S.B.) - all in the United Kingdom; the University of California, Los Angeles, Los Angeles (E.M.); the University of Arizona College of Medicine, Tucson (J.S.A.); and Auckland City Hospital and the University of Auckland - both in Auckland, New Zealand (H.D.W.).

Background: Consensus recommendations regarding the threshold levels of cardiac troponin elevations for the definition of perioperative myocardial infarction and clinically important periprocedural myocardial injury in patients undergoing cardiac surgery range widely (from >10 times to ≥70 times the upper reference limit for the assay). Limited evidence is available to support these recommendations.

Methods: We undertook an international prospective cohort study involving patients 18 years of age or older who underwent cardiac surgery. High-sensitivity cardiac troponin I measurements (upper reference limit, 26 ng per liter) were obtained 3 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We performed Cox analyses using a regression spline that explored the relationship between peak troponin measurements and 30-day mortality, adjusting for scores on the European System for Cardiac Operative Risk Evaluation II (which estimates the risk of death after cardiac surgery on the basis of 18 variables, including age and sex).

Results: Of 13,862 patients included in the study, 296 (2.1%) died within 30 days after surgery. Among patients who underwent isolated coronary-artery bypass grafting or aortic-valve replacement or repair, the threshold troponin level, measured within 1 day after surgery, that was associated with an adjusted hazard ratio of more than 1.00 for death within 30 days was 5670 ng per liter (95% confidence interval [CI], 1045 to 8260), a level 218 times the upper reference limit. Among patients who underwent other cardiac surgery, the corresponding threshold troponin level was 12,981 ng per liter (95% CI, 2673 to 16,591), a level 499 times the upper reference limit.

Conclusions: The levels of high-sensitivity troponin I after cardiac surgery that were associated with an increased risk of death within 30 days were substantially higher than levels currently recommended to define clinically important periprocedural myocardial injury. (Funded by the Canadian Institutes of Health Research and others; VISION Cardiac Surgery ClinicalTrials.gov number, NCT01842568.).
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http://dx.doi.org/10.1056/NEJMoa2000803DOI Listing
March 2022

Reply to left atrial appendage closure during cardiac surgery for atrial fibrillation: A meta-analysis.

Cardiovasc Revasc Med 2022 Feb 22. Epub 2022 Feb 22.

McMaster University, Hamilton, Ontario, Canada. Electronic address:

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http://dx.doi.org/10.1016/j.carrev.2022.02.014DOI Listing
February 2022

Minimally invasive mitral valve surgery versus conventional sternotomy mitral valve surgery: A systematic review and meta-analysis of 119 studies.

J Card Surg 2022 May 16;37(5):1319-1327. Epub 2022 Feb 16.

Division of Cardiac Surgery, McMaster University, Hamilton, Ontario, Canada.

Background And Aim Of The Study: Whether minimally invasive mitral valve surgery (MMVS) leads to better outcomes remains unclear. We conducted a systematic review and meta-analysis comparing various MMVS approaches with conventional sternotomy.

Methods: We searched Cochrane CENTRAL, MEDLINE, EMBASE, ClinicalTrials. gov, and the ISRCTN Register for studies comparing minimally invasive approach (thoracotomy, port access, partial sternotomy, or robotic) with median sternotomy for mitral valve surgery. We performed title and abstract, full-text screening, and data extraction independently and in duplicate. We pooled data using random effect models. Quality assessment was performed using validated tools. Certainty of evidence was established using the GRADE framework.

Results: One hundred and nineteen studies (n = 38,106) met eligibility criteria: eight randomized controlled trials (RCTs) and 111 observational studies. MMVS was associated with fewer days in hospital (RCT: MD: -2.2 days, 95% CI, [-3.7 to -0.8]; observational: MD: -2.4 days, 95% CI, [-2.7 to -2.1]). Observational studies suggested that MMVS reduced transfusion requirements with fewer units transfused per patient (MD: -1.2; 95% CI, [-1.6 to -0.9]) and fewer patients transfused (RR, 0.7; 95% CI, [0.6-0.7]). Observational data also suggested lower mortality with MMVS (RR, 0.6; 95% CI, [0.5-0.7], p < .001, I  = 0%), but this was not corroborated by RCT data. The risk of postoperative mitral regurgitation (≥2+ or requiring re-intervention) did not differ between the two groups.

Conclusions: MMVS may be associated with shorter length of hospital stay with no significant difference in short-term morbidity and mortality. There is a paucity of high-quality data on the long-term outcomes of MMVS when compared with conventional sternotomy.
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http://dx.doi.org/10.1111/jocs.16314DOI Listing
May 2022

Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery.

Trials 2022 Jan 31;23(1):101. Epub 2022 Jan 31.

Department of Anesthesia, General Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria.

Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes.

Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization.

Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality.

Trial Registration: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.
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http://dx.doi.org/10.1186/s13063-021-05992-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8805242PMC
January 2022

Short-term and Long-term Risk of Stroke in Patients With Perioperative Atrial Fibrillation After Cardiac Surgery: Systematic Review and Meta-analysis.

CJC Open 2022 Jan 16;4(1):85-96. Epub 2021 Sep 16.

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Background: Perioperative atrial fibrillation (POAF) after cardiac surgery has been associated with an increased risk of stroke in some studies. However, the exact magnitude of this association during short-term and long-term follow-up remains unclear.

Methods: We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for the time period from database inception to October 2020. We included observational studies with ≥ 100 patients that reported data on short-term or long-term stroke risk in patients with and without POAF after cardiac surgery. Data were pooled using random-effects models. We reported summary risk ratios (RRs) for studies reporting multivariable adjusted results and calculated absolute risk differences (ARDs) with 95% confidence intervals (CIs).

Results: A total of 55 studies with 540,209 patients were included. POAF was associated with both an increased relative risk (RR 1.69; 95% CI, 1.41-2.03; I = 82%; 9 studies) and absolute risk of short-term stroke (4.5% vs 2.5%; ARD 2.0%; 95% CI, 1.28-2.89). POAF was associated with an increased relative risk (RR 1.20; 95% CI, 1.12-1.29; I = 16%; 10 studies) and absolute risk of long-term stroke (1.06 vs 0.88 per 100 patient-years; ARD 0.18 per 100 patient-years; 95% CI, 0.07-0.26). Sensitivity analyses of high-quality studies and studies reporting either ischemic or embolic strokes yielded similar findings.

Conclusions: POAF after cardiac surgery was associated with an increased risk of both short-term and long-term stroke. However, the long-term stroke ARD was small, and whether these patients will benefit from long-term oral anticoagulation therapy is unclear.
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http://dx.doi.org/10.1016/j.cjco.2021.09.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8767142PMC
January 2022

Reply to Standard Versus Higher Intensity Anticoagulation for Patients With Mechanical Aortic Valve Replacement and Additional Risk Factors for Thromboembolism.

Am J Cardiol 2022 04 20;168:172-173. Epub 2022 Jan 20.

Divisions of Cardiology and Critical Care, Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.12.058DOI Listing
April 2022

Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial.

Can J Kidney Health Dis 2022 7;9:20543581211069225. Epub 2022 Jan 7.

Population Health Research Institute, Hamilton, ON, Canada.

Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery.

Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy.

Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy).

Intervention: If the presurgery systolic blood pressure (SBP) is <130 mmHg, all antihypertensive medications are withheld on the morning of surgery. If the SBP is ≥130 mmHg, some medications (but not angiotensin receptor blockers [ACEIs], angiotensin receptor blockers [ARBs], or renin inhibitors) may be continued in a stepwise manner. During surgery, the patients' mean arterial pressure (MAP) is maintained at ≥80 mmHg. During the first 48 hours after surgery, some antihypertensive medications (but not ACEIs, ARBs, or renin inhibitors) may be restarted in a stepwise manner if the SBP is ≥130 mmHg.

Control: Patients receive their usual antihypertensive medications before and after surgery. The patients' MAP is maintained at ≥60 mmHg from anesthetic induction until the end of surgery.

Setting: Recruitment from 108 centers in 22 countries from 2018 to 2021.

Patients: Patients (~6800) aged ≥45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications.

Measurements: The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours of randomization or ≥50% within 7 days of randomization.

Methods: The primary analysis (intention-to-treat) will examine the relative risk and 95% confidence interval of acute kidney injury in the intervention versus control group. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by preexisting chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate <60 mL/min/1.73 m.

Results: Substudy results will be analyzed in 2022.

Limitations: It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury.

Conclusions: This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury.
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http://dx.doi.org/10.1177/20543581211069225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8744204PMC
January 2022

Morbidity and mortality in patients managed with high compared with low blood pressure targets during on-pump cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.

Can J Anaesth 2022 03 10;69(3):374-386. Epub 2022 Jan 10.

Perioperative Research Division, Population Health Research Institute, Hamilton, ON, Canada.

Purpose: Many believe that blood pressure management during cardiac surgery is associated with postoperative outcomes. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to determine the impact of high compared with low intraoperative blood pressure targets on postoperative morbidity and mortality in adults undergoing cardiac surgery on cardiopulmonary bypass (CPB). Our primary objective was to inform the design of a future large RCT.

Source: We searched MEDLINE, EMBASE, Web of Science, CINAHL, and CENTRAL for RCTs comparing high with low intraoperative blood pressure targets in adult patients undergoing any cardiac surgical procedure on CPB. We screened reference lists, grey literature, and conference proceedings.

Principal Findings: We included eight RCTs (N =1,116 participants); all examined the effect of blood pressure management only during the CPB. Trial definitions of high compared with low blood pressure varied and, in some, there was a discrepancy between the target and achieved mean arterial pressure. We observed no difference in delirium, cognitive decline, stroke, acute kidney injury, or mortality between high and low blood pressure targets (very-low to low quality evidence). Higher blood pressure targets may have increased the risk of requiring a blood transfusion (three trials; n = 456 participants; relative risk, 1.4; 95% confidence interval, 1.1 to 1.9; P = 0.01; moderate quality evidence) but this finding was based on a small number of trials.

Conclusion: Individual trial definitions of high and low blood pressure targets varied, limiting inferences. The effect of high (compared with low) blood pressure targets on other morbidity and mortality after cardiac surgery remains unclear because of limitations with the body of existing evidence. Research to determine the optimal management of blood pressure during cardiac surgery is required.

Study Registration: PROSPERO (CRD42020177376); registered: 5 July 2020.
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http://dx.doi.org/10.1007/s12630-021-02171-3DOI Listing
March 2022

Meta-Analysis of Surgical Left Atrial Appendage Occlusion During Cardiac Surgery.

Am J Cardiol 2022 03 5;166:145-146. Epub 2022 Jan 5.

Department of Surgery, McMaster University, Hamilton, Ontario, Canada.

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http://dx.doi.org/10.1016/j.amjcard.2021.12.002DOI Listing
March 2022

60 Years After the First Woman Cardiac Surgeon: We Still Need More Women in Cardiac Surgery.

CJC Open 2021 Dec 24;3(12 Suppl):S89-S94. Epub 2021 Jul 24.

Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada.

In 1960, Dr Nina Starr Braunwald became the first woman to perform open heart surgery. Sixty years later, despite the fact that women outnumbered men in American medical school in 2017, men still dominate the field of cardiac surgery. Women surgeons remain underrepresented in cardiac surgery; 11% of practicing cardiac surgeons in Canada were women in 2015, and 6% of practicing adult cardiac surgeons in the US were women in 2019. Although women remain a minority in other surgical specialties also, cardiothoracic surgery remains one of the most unevenly-gender distributed specialties. Why are there so few women cardiac surgeons, and why does it matter? Evidence is emerging regarding the benefits of diversity for a variety of industries, including healthcare. In order to attract and retain the best talent, we must make the cardiac surgery environment more diverse, equitable, and inclusive. Some causes of perpetuation of the gender gap have been documented in the literature-these include uneven compensation and career advancement opportunities, outdated views on family dynamics, and disproportionate scrutiny of women surgeons, causing additional workplace frictions for women. Diversity is an organizational strength, and gender-diverse institutions are more likely to outperform their non-gender-diverse counterparts. Modifiable issues perpetuate the gender gap, and mentorship is key in helping attract, develop, and retain the best and brightest within cardiac surgery. Facilitating mentorship opportunities is key to reducing barriers and bridging the gap.
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http://dx.doi.org/10.1016/j.cjco.2021.07.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8712594PMC
December 2021

Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study.

JMIR Mhealth Uhealth 2022 02 28;10(2):e24916. Epub 2022 Feb 28.

Population Health Research Institute, Hamilton, ON, Canada.

Background: Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration.

Objective: Our aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics.

Methods: Included participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability.

Results: The validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time).

Conclusions: We found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality.

Trial Registration: ClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.
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http://dx.doi.org/10.2196/24916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8922156PMC
February 2022

Thoracoscopic Resection of Thoracic Inlet Neuroblastic Tumors in Young Children.

J Laparoendosc Adv Surg Tech A 2021 Dec 16;31(12):1475-1479. Epub 2021 Nov 16.

Michael E. Debakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.

Thoracic inlet (TI) tumors are rare, and can be particularly challenging to resect due to proximity to mediastinal vessels and nerves. Traditional resection is typically performed through "trapdoor" or sternoclavicular incisions. The purpose of our study was to evaluate the feasibility and effectiveness of thoracoscopic resection of this group of tumors. We performed a single-center retrospective chart review for children who presented with TI neuroblastic tumors between 2011 and 2020. Demographics, tumor characteristics, treatment, operative complications, and outcomes were collected and analyzed. Eight patients were identified. The median age at diagnosis was 13 months (interquartile range [IQR] 6-32) with median tumor size at diagnosis of 4.1 cm (IQR 3.6-4.4). Neoadjuvant chemotherapy was given in 50% (4/8) with 38% (3/8) undergoing upfront surgery; 1 patient was observed without chemotherapy or surgery. Ultimately, 6 patients had thoracoscopic resection. For thoracoscopic resections, median intraoperative estimated blood loss was 15 mL (IQR 10-28), median operative room time was 199 minutes (IQR 152-259), and median hospital length of stay was 2 days (IQR 2-3). There were two complications: one recurrent laryngeal nerve injury and one new-onset Horner's syndrome. Complete gross total resection was achieved for all children and there were no recurrences or mortalities with a median follow-up of 3 years. Thoracoscopic resection for TI neuroblastic tumors is feasible with minimal morbidity and can lead to adequate oncological resection.
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http://dx.doi.org/10.1089/lap.2021.0332DOI Listing
December 2021

Expertise-based design in surgical trials: a narrative review.

Can J Surg 2021 Nov-Dec;64(6):E594-E602. Epub 2021 Nov 10.

From the Division of Cardiac Surgery, Department of Surgery, McMaster University, Hamilton, Ont. (Alsagheir, Whitlock); the Faculty of Medicine, University of Toronto, Toronto, Ont. (Kozirarz); the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ont. (Belley-Côté, Whitlock); and the Department of Medicine, McMaster University, Hamilton, Ont. (Belley-Côté).

Randomized controlled trials (RCTs) are the most robust study design for evaluating the safety and efficacy of a therapeutic intervention. However, their internal validity are at risk when evaluating surgical interventions. This review summarizes existing expertise- based trials in surgery and related methodological concepts to guide surgeons performing this work. We provide caseloads required to reach the learning curve for various surgical interventions and report criteria for expertise from published and unpublished expertise-based trials. In addition, we review design and implementation concepts of expertise-based trials, including recruitment of surgeons, crossover, ethics, generalizability, sample size and definitions for learning curve. Several RCTs have used an expertise-based design. We found that the majority of definitions used for expertise were vague, heterogeneous, and inconsistent across trials evaluating the same surgical intervention. Statistical methods exist to adjust for the learning curve; however, there is limited guidance. We developed the following criteria for surgical expertise for future trials: 1) decide on the proxy to be used for the learning curve, and 2) assess eligible surgeons by comparing their performance to the previously defined expertise criteria.
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http://dx.doi.org/10.1503/cjs.008520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592777PMC
November 2021

The Second Heart Program-A multidisciplinary team supporting people who inject drugs with infective endocarditis: Protocol of a feasibility study.

PLoS One 2021 28;16(10):e0256839. Epub 2021 Oct 28.

Population Health Research Institute, Hamilton, Canada, Hamilton, Ontario, Canada.

Introduction: Infective endocarditis (IE) is a severe and highly prevalent infection among people who inject drugs (PWID). While short-term (30-day) outcomes are similar between PWID and non-PWID, the long-term outcomes among PWID after IE are poor, with 1-year mortality rates in excess of 25%. Novel clinical interventions are needed to address the unique needs of PWID with IE, including increasing access to substance use treatment and addressing structural barriers and social determinants of health.

Methods And Analysis: PWID with IE will be connected to a multidisciplinary team that will transition with them from hospital to the community. The six components of the Second Heart Team are: (1) peer support worker with lived experience, (2) systems navigator, (3) addiction medicine physician, (4) primary care physician, (5) infectious diseases specialist, (6) cardiovascular surgeon. A convergent mixed-methods study design will be used to test the feasibility of this intervention. We will concurrently collect quantitative and qualitative data and 'mix' at the interpretation stage of the study to answer our research questions.

Ethics And Dissemination: This study has been approved by the Hamilton Integrated Research Ethics Board (Project No. 7012). Results will be presented at national and international conferences and submitted for publication in a scientific journal.

Clinical Trail Registrarion: Trial registration number: ISRCTN14968657 https://www.isrctn.com/ISRCTN14968657.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0256839PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8553071PMC
November 2021

Efficacy and safety of low intensity vitamin K antagonists in Western and East-Asian patients with left-sided mechanical heart valves.

J Thromb Thrombolysis 2022 Apr 8;53(3):697-707. Epub 2021 Oct 8.

Division of Cardiac Surgery, Department of Surgery, McMaster University, Hamilton, Canada.

The optimal INR target in patients with mechanical heart valves is unclear. Higher INR targets are often used in Western compared with East Asian countries. The objective of this systematic review and meta-analysis was to summarize the evidence for the efficacy and safety of lower versus higher INR targets in Western and East Asian left-sided mechanical heart valve patients. We searched Western databases including Cochrane CENTRAL, Medline, and Embase as well as Chinese databases including SinoMed, CNKI, and Wanfang Data in addition to grey literature for Randomized Controlled Trials (RCTs) and observational studies. We pooled risk ratios (RRs) using random-effects model. Low and high INR targets were defined by the individual studies. We identified nine RCTs, including six Western (n = 5496) and three East Asian (n = 209) trials, and 17 observational studies, including two Western (n = 3199) and 15 East Asian (n = 5485) studies. In the RCTs, lower compared with higher targets were associated with similar rates of thromboembolism (2.4 vs. 2.3%; RR: 1.14, 95% CI 0.82, 1.60, I = 0%) and lower rates of both total bleeding (21.9 vs. 40.9%, RR: 0.46, 95% CI 0.28, 0.78, I = 88%) and major bleeding. RCT data showed no statistical heterogeneity by region. These effects were consistent in the observational data. We downgraded the quality of evidence due to serious risk of bias and imprecision. In patients with left-sided contemporary mechanical heart valves, low quality evidence suggests lower INR targets are associated with similar rates of thromboembolism and moderate quality evidence suggests lower rates of bleeding.
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http://dx.doi.org/10.1007/s11239-021-02568-3DOI Listing
April 2022

Outcomes of sutureless aortic valve replacement versus conventional aortic valve replacement and transcatheter aortic valve replacement, updated systematic review, and meta-analysis.

J Card Surg 2021 Dec 6;36(12):4734-4742. Epub 2021 Oct 6.

Population Health Research Institute, McMaster University, Hamilton, Canada.

Background: Sutureless aortic valve replacement (SuAVR) is an alternative to surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study compares the effectiveness of SuAVR to SAVR and TAVR.

Methods: We searched MEDLINE and EMBASE from inception to July 2021 for studies evaluating SuAVR, SAVR, and TAVR in adults with aortic stenosis. We performed screening, full-text assessment, data collection, and risk of bias evaluation independently and in duplicate. We evaluated risk of bias using by Cochrane and CLARITY's tools, and certainty in evidence using the GRADE framework. Data were pooled using a random-effects model.

Results: We identified one randomized and 78 observational studies (n = 60,689; SuAVR vs. SAVR = 39,171, vs. TAVR = 21,518). All studies were at high or unclear risk of bias, with very-low certainty in effect estimates. Compared to TAVR, SuAVR demonstrates no significant difference in mortality at 30-days (odds ratio [OR]: 0.52, 95% confidence interval [CI: 0.85, 1.16], I  = 0%), but decreased odds at 2-years (OR: 0.39, 95% CI [0.17, 0.88], I  = 0%). SuAVR also reduced odds of mild paravalvular regurgitation (OR: 0.11, 95% CI [0.06, 0.21], I  = 50%). Compared to SAVR, SuAVR was associated with a similar mortality at 30-days (OR: 0.99, 95% CI [0.85, 1.16], I  = 0%) and 2-years (OR: 0.99, 95% CI [0.43-2.30], I  = 7%). SuAVR significantly increased odds of permanent pacemaker implantation (OR: 2.5, 95% CI [2.25, 2.77], I  = 0%). Pooled effect estimates were consistent with results from the randomized trial comparing SuAVR and SAVR.

Conclusion: Based on very-low quality evidence, SuAVR is associated with similar short- and midterm outcomes compared to TAVR and SAVR. Comparative randomized data with long-term follow-up are required to clarify the role of SuAVR.
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http://dx.doi.org/10.1111/jocs.16044DOI Listing
December 2021

Author Correction: MDM4 inhibition: a novel therapeutic strategy to reactivate p53 in hepatoblastoma.

Sci Rep 2021 Oct 1;11(1):19916. Epub 2021 Oct 1.

Divisions of Pediatric Surgery and Surgical Research, Michael E. DeBakey Department of Surgery, Pediatric Surgical Oncology Laboratory, Texas Children's Surgical Oncology Program, Texas Children's Liver Tumor Program, Dan L. Duncan Cancer Center, Baylor College of Medicine, Texas Children's Hospital, 1102 Bates Ave., Suite 460G, Houston, TX, 77030-2399, USA.

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http://dx.doi.org/10.1038/s41598-021-98174-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8486835PMC
October 2021

Variations in Nuss Procedure Operative Techniques and Complications: A Retrospective Review.

Eur J Pediatr Surg 2021 Sep 24. Epub 2021 Sep 24.

Division of Pediatric Surgery, Texas Children's Hospital, Houston, Texas, United States.

Introduction:  The Nuss procedure is the most common and preferred operative correction of pectus excavatum. Surgeon preference and patient factors can result in variations in Nuss procedure technique. We hypothesize that certain techniques are associated with increased risk of complications.

Materials And Methods:  We performed a single-center retrospective review of Nuss operations from 2016 to 2020. Variations in intraoperative techniques included sternal elevator (SE) use, number of bars placed, and usage of bilateral stabilizing sutures. Patient demographics, intraoperative data, and postoperative outcomes were reported as median with interquartile ranges or percentages. Statistical significance ( < 0.05) was determined with Wilcoxon's rank-sum and chi-square tests. Multivariate analysis was performed to control for introduction of intercostal nerve cryoablation and surgeon volume, and reported as odds ratio with 95% confidence interval.

Results:  Two hundred and sixty-five patients were identified. Patients repaired with two bars were older with a larger Haller index (HI). Patient demographics were not significantly different for SE or stabilizing suture use. Placement of two bars was associated with significantly increased risk of readmission. Similarly, SE use was associated with increased risk of pleural effusion and readmission. Finally, the use of bilateral stabilizing sutures resulted in less frequent slipped bars without statistical significance.

Conclusion:  Older patients with a larger HI were more likely to need two bars placed to repair pectus excavatum. Placement of multiple bars and SE use are associated with significantly higher odds of certain complications.
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http://dx.doi.org/10.1055/s-0041-1735164DOI Listing
September 2021

Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial.

BMJ Open 2021 09 16;11(9):e046198. Epub 2021 Sep 16.

Cardiac Surgery, Bristol Royal Hospital for Children, Bristol, UK.

Introduction: In non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm.

Methods And Analysis: Ross for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 18-60 years undergoing AVR, comparing the Ross procedure versus one of the alternative approaches (mechanical vs stented or stentless bioprosthesis). The feasibility objectives will be assessed after randomising 60 patients; we will then make a decision regarding whether to expand the trial with the current protocol. We will ultimately examine the impact of the Ross procedure as compared with conventional AVR in non-elderly adults on survival free of valve-related life-threatening complications (major bleeding, systemic thromboembolism, valve thrombosis and valve reoperation) over the duration of follow-up. The objectives of the pilot trial will be analysed using descriptive statistics. In the full trial, the intention-to-treat principle will guide all primary analyses. A time-to-event analysis will be performed and Kaplan-Meier survival curves with comparison between groups using a log rank test will be presented.

Ethics And Dissemination: REVIVAL will answer whether non-elderly adults benefit from the Ross procedure over conventional valve replacement. The final results at major meetings, journals, regional seminars, hospital rounds and via the Reducing Global Perioperative Risk Multimedia Resource Centre.

Trial Registration Number: ClinicalTrials.gov Identifier: NCT03798782 PROTOCOL VERSION: January 29, 2019 (Final Version 1.0).
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http://dx.doi.org/10.1136/bmjopen-2020-046198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449981PMC
September 2021

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke. Reply.

N Engl J Med 2021 09;385(11):1054-1055

McMaster University, Hamilton, ON, Canada

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http://dx.doi.org/10.1056/NEJMc2111008DOI Listing
September 2021
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