Strategies to reduce out-of-pocket medication costs for Canadians with peripheral arterial disease.

BACKGROUND: Given that peripheral arterial disease (PAD) disproportionately affects people of lower socioeconomic status, out-of-pocket expenses for preventive medications are a major barrier to their use. We carried out a cost comparison of drug therapies for PAD to identify prescribing strategies that minimize out-of-pocket expenses for these medications. METHODS: Between March and June 2019, we contacted outpatient pharmacies in Hamilton, Ontario, Canada, to assess pricing of pharmacologic therapies at dosages included in the 2016 American College of Cardiology/American Heart Association guideline for management of lower extremity PAD. We also gathered pricing information for supplementary charges, including delivery, pill splitting and blister packaging. We calculated prescription prices with and without dispensing fees for 30-day brand-name and generic prescriptions, and 90-day generic prescriptions. RESULTS: Twenty-four pharmacies, including hospital-based, independent and chain, were included in our sample. In the most extreme scenario, total 90-day medication costs could differ by up to $1377.26. Costs were affected by choice of agent within a drug class, generic versus brand-name drug, quantity dispensed, dispensing fee and delivery cost, if any. CONCLUSION: By opting for prescriptions for 90 days or as long as possible, selecting the lowest-cost generic drugs available in each drug class, and identifying dispensing locations with lower fees, prescribers can minimize out-of-pocket patient medication expenses. This may help improve adherence to guideline-recommended therapies for the secondary prevention of vascular events in patients with PAD.

Mechanical versus bioprosthetic valves in chronic dialysis: a systematic review and meta-analysis.

BACKGROUND: Many patients with end-stage kidney disease (ESKD) have valvular heart disease requiring surgery. The optimal prosthetic valve is not established in this population. We performed a systematic review and meta-analysis to assess outcomes of patients with dialysis-dependent ESKD who received mechanical or bioprosthetic valves. METHODS: We searched Cochrane Central, Medline and Embase from inception to January 2020. We performed screening, full-text assessment, risk of bias and data collection, independently and in duplicate. Data were pooled using a random-effects model. RESULTS: We identified 28 observational studies (n = 9857 patients, including 6680 with mechanical valves and 3717 with bioprosthetic valves) with a median follow-up of 3.45 years. Twenty-two studies were at high risk of bias and 1 was at critical risk of bias from confounding. Certainty in evidence was very low for all outcomes except bleeding. Mechanical valves were associated with reduced mortality at 30 days (relative risk [RR] 0.79, 95% confidence interval [CI] 0.65-0.97, I 2 = 0, absolute effect 27 fewer deaths per 1000) and at 6 or more years (mean 9.7 yr, RR 0.83, 95% CI 0.72-0.96, I 2 = 79%, absolute effect 145 fewer deaths per 1000), but increased bleeding (incidence rate ratio [IRR] 2.46, 95% CI 1.41-4.27, I 2 = 59%, absolute effect 91 more events per 1000) and stroke (IRR 1.63, 95% CI 1.21-2.20, I 2 = 0%, absolute effect 25 more events per 1000). CONCLUSION: Mechanical valves were associated with reduced mortality, but increased rate of bleeding and stroke. Given very low certainty for evidence of mortality and stroke outcomes, patients and clinicians may choose prosthetic valves based on factors such as bleeding risk and valve longevity. STUDY REGISTRATION: PROSPERO no. CRD42017081863.

Percutaneous closure of a post-surgical ascending aortic pseudoaneurysm with an amplatzer septal occluder device and steerable guiding sheath.

Thoracic pseudoaneurysm in the ascending aorta is an uncommon condition associated with significant risk of morbidity and mortality. Treatment is recommended in all cases regardless of symptoms as the mortality rate if left untreated has been documented to be as high as 61%. The current standard of care for managing these lesions is open surgical repair. However, this is associated with significant morbidity. In-hospital mortality reported for patients undergoing surgical repair of an ascending aortic pseudoaneurysm ranges from 6.7% to 41%. When anatomically suitable, a less invasive approach using amplatzer vascular plug or septal occluder is an attractive approach. We present a case report of repair of a post-surgical ascending aortic false aneurysm using an amplatzer septal occluder with an Oscor ™ steerable guiding sheath; a novel approach to increase platform stability when engaging an aneurysm neck. Endovascular occluder deployment for closure of aortic false aneurysms remains a relatively novel technique. It is limited by the requirement to develop a stable endovascular platform to deliver the device and avoid system prolapse, particularly when accessing challenging lesions on the inner aortic curvature. We present the first case to utilize a steerable guiding sheath system to improve system stability and facilitate successful device delivery. Given the significant morbidity associated with open repair of these lesions we hope this will further expand the range of lesions viewed as appropriate for endovascular repair.

Strategies to Reduce Out-of-Pocket Medication Costs for Canadians Living with Heart Failure.

INTRODUCTION: Daily medication is the cornerstone of evidence-based therapy to reduce mortality and morbidity in patients with heart failure (HF). Up to 20% of Canadian patients pay for medications out of pocket. We sought to identify strategies that patients and prescribers can employ to reduce these costs. METHODS: We collected data from outpatient pharmacies in Hamilton, Ontario. We determined prices for different medications in each of the drug classes recommended for HF with reduced ejection fraction in the Canadian Cardiovascular Society's guidelines. We examined differences in dispensing and delivery fees and inquired about other cost-saving strategies. RESULTS: We collected data from 24 different pharmacies, including a selection of hospital-based, independent, and larger chain pharmacies. In the most extreme scenario (i.e., 90-day prescription instead of a 30-day prescription and the least expensive generic drug instead of the most expensive brand name drug), total medication costs can differ by up to $495.56 per month. Costs were affected by choice of agent within a drug class, generic versus brand-name drug, quantity dispensed, dispensing fee, and delivery cost. CONCLUSIONS: Prescription content, dispensing practice, and pharmacy choice can remarkably impact out-of-pocket costs for HF medications. Prescribers can reduce costs by writing 90-day prescriptions and choosing the lowest-cost generic drugs in each therapeutic class. Patients should consider the services received for their pharmacy dispensing fees, use free delivery services where needed, and request inexpensive generic drugs. Pharmacists can facilitate cost minimization without compromising therapeutic efficacy.

Incidence and recurrence of new-onset atrial fibrillation detected during hospitalization for non-cardiac surgery: a systematic review and meta-analysis.

PURPOSE: This systematic review aimed to summarize reports of the incidence and long-term recurrence of new-onset atrial fibrillation (AF) associated with non-cardiac surgery. SOURCES: We searched CENTRAL, MEDLINE and EMBASE from inception to November 2019. We included studies that reported on the incidence of new-onset perioperative AF during hospitalization for non-cardiac surgery and/or AF recurrence in such patients following discharge. Reviewers screened articles and abstracted data independently and in duplicate. We assessed study quality by appraising methodology for collecting AF history, incident AF during hospitalization, and AF recurrence after discharge. PRINCIPAL FINDINGS: From 39,233 citations screened, 346 studies that enrolled a total of 5,829,758 patients met eligibility criteria. Only 27 studies used prospective, continuous inpatient electrocardiographic (ECG) monitoring to detect incident AF. Overall, the incidence of postoperative AF during hospitalization ranged from 0.004 to 50.3%, with a median [interquartile range] of 8.7 [3.8-15.0]%. Atrial fibrillation incidence varied with type of surgery. Prospective studies using continuous ECG monitoring reported significantly higher incidences of AF than those that did not (13.9% vs 1.9%, respectively; P < 0.001). A total of 13 studies (25,726 patients) with follow-up up to 5.4 years reported on AF recurrence following hospital discharge; only one study used a prospective systematic monitoring protocol. Recurrence rates ranged from 0 to 37.3%. CONCLUSIONS: Rates of AF incidence first detected following non-cardiac surgery and long-term AF recurrence vary markedly. Differences in the intensity of ECG monitoring and type of surgery may account for this variation. TRIAL REGISTRATION: PROSPERO (CRD42017068055); registered 1 September 2017.

RéSUMé: OBJECTIF: Cette revue systématique visait à résumer les comptes rendus sur l'incidence et la récurrence à long terme de la fibrillation auriculaire (FA) de novo associée à une chirurgie non cardiaque. SOURCES: Nous avons effectué des recherches dans les bases de données CENTRAL, MEDLINE et EMBASE de leur création à novembre 2019. Nous avons inclus les études ayant examiné l'incidence de nouvelle FA périopératoire pendant l'hospitalisation pour une chirurgie non cardiaque et/ou la récurrence de la FA chez de tels patients après leur congé. Les chercheurs ont passé en revue les articles et les données extraites de manière indépendante et en double. Nous avons estimé la qualité des études en évaluant la méthodologie de collecte des antécédents de FA, de l'incident de FA pendant l'hospitalisation et de la récurrence de FA après le congé. CONSTATATIONS PRINCIPALES: Sur les 39 233 citations examinées, 346 études portant sur un total de 5 829 758 patients ont répondu à nos critères d'admissibilité. Seulement 27 études ont utilisé un monitorage électrocardiographique (ECG) continu prospectif et des patients hospitalisés pour détecter les incidents de FA. Dans l'ensemble, l'incidence de FA postopératoire pendant l'hospitalisation allait de 0,004 à 50,3 %, avec une médiane [écart interquartile] de 8,7 [3,8-15,0] %. L'incidence de fibrillation auriculaire variait en fonction du type de chirurgie. Des études prospectives utilisant un monitorage continu par ECG ont fait état d'incidences significativement plus élevées de FA que celles sans monitorage continu (13,9 % vs 1,9 %, respectivement; P < 0,001). Au total, 13 études (25 726 patients) avec un suivi allant jusqu'à 5,4 ans ont rapporté leurs données sur la récurrence de FA après le congé de l'hôpital; seule une étude a utilisé un protocole de monitorage prospectif systématique. Les taux de récurrence allaient de 0 à 37,3 %. CONCLUSION: Les taux d'incidence de nouvelle FA détectés après une chirurgie non cardiaque et la récurrence à long terme de FA varient considérablement. Les différences du degré de monitorage par ECG et le type de chirurgie pourraient expliquer cette variation. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42017068055); enregistrée le 1er septembre 2017.

Prevention and Management of Urgent/Emergent Limb Ischemia.

PURPOSE OF REVIEW: Patients who require urgent or emergent peripheral revascularization represent one of the highest risk subgroups of PAD patients. They suffer unacceptably high complication rates including recurrent ALI, vascular amputation, and death. In this article, we examine (1) the burden of cardiovascular complications according to PAD severity, (2) discuss medical optimization to improve vascular outcomes in symptomatic LE-PAD patients, and (3) review the evidence for management of patients following urgent/emergent limb ischemia. RECENT FINDINGS: The VOYAGER trial recently demonstrated that rivaroxaban 2.5 mg BID + ASA daily significantly reduces major adverse cardiac and limb events in patients following lower extremity revascularization. A recent Canadian survey also demonstrated that significant heterogeneity exists in antithrombotic prescribing practices following urgent/emergent revascularization. COMPASS and VOYAGER have demonstrated the efficacy of aspirin 81 mg daily and rivaroxaban 2.5 mg twice daily at reducing MACE and MALE events in stable PAD patients and those undergoing elective revascularization. Patients who require urgent or emergent peripheral revascularization remain the highest thrombotic risk subgroup of PAD patients, in whom there is insufficient evidence to guide antithrombotic therapy. Despite clear evidence that multi-modal medical therapy (including statins, antihypertensive agents and smoking cessation) benefits patients with atherosclerosis, their use remains unacceptably low in PAD, and greater efforts are needed to understand and address patient, health provider, and system issues that prevent their optimal implementation in practice.

How Did We Get Here?: A Historical Review and Critical Analysis of Anticoagulation Therapy Following Mechanical Valve Replacement.

Managing severe valvular heart disease with mechanical valve replacement necessitates lifelong anticoagulation with a vitamin K antagonist. Optimal anticoagulation intensity for patients with mechanical valves remains uncertain; current recommendations are inconsistent across guideline bodies and largely based on expert opinion. In this review, we outline the history of anticoagulation therapy in patients with mechanical heart valves and critically evaluate current antithrombotic guidelines for these patients. We conclude that randomized trials evaluating optimal anticoagulation intensity in patients with mechanical valves are needed, and that future guidelines must better justify antithrombotic treatment recommendations.

Fibrin and Thrombin Sealants in Vascular and Cardiac Surgery: A Systematic Review and Meta-analysis.

OBJECTIVE: In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means to prevent or halt bleeding during surgery. Whether fibrin and thrombin sealants affect surgical outcomes is poorly established. A systematic review and meta-analysis was performed to examine the impact of fibrin or thrombin sealants on patient outcomes in vascular and cardiac surgery. DATA SOURCES: Cochrane CENTRAL, Embase, and MEDLINE, as well as trial registries, conference abstracts, and reference lists of included articles were searched from inception to December 2019. REVIEW METHODS: Studies comparing the use of fibrin or thrombin sealant with either an active (other haemostatic methods) or standard surgical haemostatic control in vascular and cardiac surgery were searched for. The Cochrane risk of bias tool and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) were used to assess the risk of bias of the included randomised and non-randomised studies; quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Two reviewers screened studies, assessed risk of bias, and extracted data independently and in duplicate. Data from included trials were pooled using a random effects model. RESULTS: Twenty-one studies (n = 7 622 patients) were included: 13 randomised controlled trials (RCTs), five retrospective, and three prospective cohort studies. Meta-analysis of the RCTs showed a statistically significant decrease in the volume of blood lost (mean difference 120.7 mL, in favour of sealant use [95% confidence interval {CI} -150.6 - -90.7; p < .001], moderate quality). Time to haemostasis was also shown to be reduced in patients receiving sealant (mean difference -2.5 minutes [95% CI -4.0 - -1.1; p < .001], low quality). Post-operative blood transfusions, re-operation due to bleeding, and 30 day mortality were not significantly different for either RCTs or observational data. CONCLUSION: The use of fibrin and thrombin sealants confers a statistically significant but clinically small reduction in blood loss and time to haemostasis; it does not reduce blood transfusion. These Results may support selective rather than routine use of fibrin and thrombin sealants in vascular and cardiac surgery.

Costs of surgical ablation of atrial fibrillation in Ontario, Canada from 2006 to 2017.

BACKGROUND: International guidelines currently recommend concomitant surgical ablation of atrial fibrillation (AF) in patients with AF undergoing cardiac surgery. However, a systematic review and meta-analysis of 23 randomized controlled trials (RCTs) showed no significant difference in mortality or stroke in patients who underwent surgical AF ablation compared with those who did not (moderate-quality evidence). METHODS: We estimated the Ontario-wide costs of surgical AF ablation between 2006 and 2017 using data from a systematic review and meta-analysis of RCTs, estimates of case volumes from Ontario Health Insurance Plan fee codes, the ongoing left atrial appendage occlusion study III trial (NCT01561651), institutional costs from large academic centers in Ontario, as well as professional fees based on the Ontario fee schedule. Device costs were obtained from Canadian industry data with expert input. RESULTS: We estimated the average extra cost of surgical AF ablation at $4,287 CAD (95% CI $4,113-4,619) per patient. Procedural costs (equipment costs and physician remuneration) comprise 82.2% of this, while smaller portions relate to the increased need for pacemaker (3.9%) and additional hospital length of stay (13.9%). Approximately 2,391 patients underwent surgical AF ablation between 2006 and 2017, corresponding to an estimated $10.2 million in incremental cost during that time span. CONCLUSION: Ontario taxpayers spend significant financial resources on surgical ablation of AF, a procedure lacking high-quality evidence demonstrating benefit in reducing mortality or stroke. Further large prospective studies examining clinically important outcomes are needed to justify its routine use in patient care and to guide allocation of healthcare funds.

Perspective and practice of surgical atrial fibrillation ablation: an international survey of cardiac surgeons.

AIMS: Despite recommendations stating that surgical atrial fibrillation (AF) ablation is reasonable for patients with AF undergoing cardiac surgery for other indications, the clinical impact of this procedure remains unclear. We aimed to describe surgeons' practices and perceptions of this procedure. METHODS AND RESULTS: We built a self-administered survey in collaboration with content and methodology experts. We surveyed 268 cardiac surgeons from 80 centres in 18 countries. The response rate was 76% (n = 204/276), 49% from North America, 39% Europe, and 12% other regions. Respondents performed a median 10 [interquartile range (IQR) 4-30] AF ablation procedures/year, with marked variation in proportions of patients with AF considered for ablation (median 25%, IQR 10-61). 94% and 80% of surgeons respectively, thought symptomatic and asymptomatic patients benefit from ablation. Surgeons estimated the added major complication rate of concomitant AF ablation at 16% [median (IQR) 7-25]. Of participating surgeons, 61% believed that evidence supported surgical AF ablation reducing the incidence of thrombo-embolic complications, and 46% modified anticoagulation decision-making based on whether they performed AF ablation. During coronary artery bypass grafting, isolated pulmonary vein isolation was the most commonly performed lesion set (70%), whereas complete left atrial ablation (46%) and biatrial ablation (44%) were favoured with valve surgery. CONCLUSION: In a multinational group of academic surgeons, surgical AF ablation utilization appears variable, and average case volumes are low. Despite no evidence to that effect, the majority believe that ablation reduces AF-related thrombo-embolic risk of patients. Reported practice patterns suggest clinical equipoise; a definitive trial appears feasible based on respondent willingness to participate.

Steroids in cardiac surgery trial: a substudy of surgical site infections.

PURPOSE: Postoperative infection, particularly in cardiac surgery, results in significant morbidity, mortality, and healthcare cost. Identification of novel predictors of postoperative infection can target high-risk populations for prophylactic intervention. METHODS: Steroids in cardiac surgery (SIRS) was a multi-centre randomized-controlled trial assessing intraoperative administration of methylprednisone during cardiac surgery, which enrolled 7,507 patients across 80 centres in 18 countries. It demonstrated that administration of steroids had no effect on mortality or major morbidity after cardiac surgery. Our primary objective was to identify risk factors for postoperative surgical site infections using SIRS participants as a cohort. We excluded patients who did not undergo surgery, died intraoperatively, or died within 48 hr of the operation. Patients were assessed for development of "surgical site infection" over the first 30 days postoperatively. Using theoretical and previously identified risk factors, we used forward stepwise entry to create a binary logistic regression model. RESULTS: Follow-up at 30 days was complete for all patients; 7,406 were included in the cohort. Surgical site infection occurred in 180 (4.8%) and 184 (5.0%) of patients in the placebo and steroid arms respectively. Significant risk factors (P < 0.05 level) included: diabetes managed with insulin (adjusted odds ratio [aOR]: 1.55; 95% confidence interval [CI] 1.13 to 2.12), oral hypoglycemics (aOR 1.60; 95% CI 1.18 to 2.16), or diet (aOR 1.81; 95% CI 1.16 to 2.83), female sex (aOR 1.34; 95% CI 1.05 to 1.71), renal failure with (aOR 2.03; 95% CI 1.06 to 3.91), and without (aOR 1.50; 95% CI 1.04 to 2.14) dialysis, > 96 min cardiopulmonary bypass (CPB) time (aOR 1.84; 95% CI 1.44 to 2.35), body mass index (BMI) < 22.3 (aOR 0.44; 95% CI 0.28 to 0.71) or > 30 (aOR 1.49; 95% CI 1.17 to 1.89), peak intensive care unit blood glucose (aOR 1.02 per mmol·L-1; 95% CI 1.00 to 1.04), and coronary artery bypass grafting (CABG) operation type (aOR 2.59; 95% CI 1.87 to 3.59). CONCLUSIONS: Patients undergoing CABG, requiring longer CPB, with higher BMI, or with diabetes, are at elevated risk of surgical site infection. Strategies to mitigate this risk warrant further investigation.

RéSUMé: OBJECTIF: L'infection postopératoire, en particulier en chirurgie cardiaque, entraîne une morbidité, une mortalité et des coûts en soins de santé significatifs. L'identification de nouveaux éléments prédictifs de l'infection postopératoire permettrait de cibler les populations à risque élevé pour offrir une intervention prophylactique. MéTHODES: L'étude des corticostéroïdes en chirurgie cardiaque (SIRS) était un essai multicentrique, randomisé et contrôlé évaluant l'administration de méthylprednisolone en peropératoire au cours de la chirurgie cardiaque; l'étude avait inclus 7 507 patients dans 80 centres répartis dans 18 pays. Elle a démontré que l'administration de stéroïdes n'avait aucun effet sur la mortalité ou morbidité majeure après la chirurgie cardiaque. Notre objectif principal était d'identifier les facteurs de risque d'infections postopératoires du site chirurgical en utilisant une cohorte constituée des participants à l'étude SIRS. Nous avons exclu les patients n'ayant pas subi de chirurgie, décédés en cours d'intervention ou dans les 48 heures suivant l'intervention. Les patients ont été évalués en fonction de l'apparition d'une « infection du site chirurgical ¼ au cours des 30 premiers jours postopératoires. Utilisant des facteurs de risque théoriques et précédemment identifiés, nous avons utilisé une introduction par étape ascendante pour créer un modèle de régression logistique binaire. RéSULTATS: Le suivi à 30 jours a été complet pour tous les patients; 7 406 patients ont été inclus dans la cohorte. Une infection du site chirurgical est survenue chez 180 (4,8 %) et 184 (5,0 %) des patients dans, respectivement, le groupe placebo et le groupe corticostéroïdes. Les facteurs de risque significatifs (pour P < 0,05) étaient notamment : un diabète géré avec de l'insuline (rapport de cotes ajusté [aOR] : 1,55; intervalle de confiance [IC] à 95 % : 1,13 à 2,12), les hypoglycémiants par voie orale (aOR : 1,60; IC à 95 % 1,18 à 2,16) ou un régime alimentaire (aOR : 1,81; IC à 95 % : 1,16 à 2,83), le sexe fémnin (aOR : 1,34; IC à 95 % : 1,05 à 1,71), une insuffisance rénale avec (aOR : 2,03; IC à 95 % : 1,06 à 3,91) et sans (aOR : 1,50; IC à 95 % : 1,04 à 2,14) dialyse, une durée de circulation extracorporelle (CEC) > 96 minutes (aOR : 1,84; IC à 95 % : 1,44 à 2,35), un indice de masse corporelle (IMC) < 22,3 (aOR : 0,44; IC à 95 % : 0,28 à 0,71) ou > 30 (aOR : 1,49; IC à 95 % : 1,17 à 1,89), un pic d'hyperglycémie en unité de soins intensifs (aOR : 1,02 par mmol·L−1; IC à 95 % : 1,00 à 1,04) et une intervention de type pontage coronarien (aOR : 2,59; IC à 95 % : 1,87 à 3,59). CONCLUSIONS: Les patients subissant des pontages coronariens, nécessitant une CEC prolongée, avec un IMC plus élevé ou un diabète sont à plus grand risque d'infection du site chirurgical. Des stratégies de limitation de ce risque justifient des investigations complémentaires.

The PROTROPIC feasibility study: prognostic value of elevated troponins in critical illness.

PURPOSE: Elevated cardiac troponin concentrations in people with critical illness are associated with an increased risk of death. We aimed to assess the feasibility of a larger study to ascertain the utility of cardiac troponin as a prognostic tool for mortality in critically ill patients. METHODS: Patients admitted to participating intensive care units during the one-month enrolment period were eligible. We excluded cardiac surgical patients and patients who were admitted and either died or were discharged within 12 hr. In enrolled patients, we measured high-sensitivity cardiac troponin I (hs-cTnI) and obtained electrocardiograms to ascertain the incidence of myocardial infarction (MI) and isolated troponin elevation. Our feasibility objectives were to measure recruitment rate, the proportion of patients who consented under a deferred consent model, and time required for data collection and study procedures. RESULTS: Over a four-week enrolment period, 280 patients were enrolled using a deferred consent model. We obtained subsequent consent from 81% of patients. Study procedures and data collection required 1.7 hr per participant. Overall, 86 (38%) suffered a MI, 23 (10%) had an isolated hs-cTnI elevation, and 117 (52%) had no hs-cTnI elevation. The crude hospital mortality rate was 10% without an hs-cTnI elevation, 29% with an isolated hs-cTnl elevation (relative risk [RR]) 2.2; 95% confidence interval [CI], 1.0 to 6.0) and 29% with an MI (RR, 2.6; 95% CI, 1.4 to 5.1). CONCLUSION: Myocardial injury with elevated hs-cTnI concentrations and MIs occur frequently during critical illness. This pilot study has established the feasibility of conducting a large-scale investigation addressing this issue.

Rivaroxaban and Aspirin in Peripheral Vascular Disease: a Review of Implementation Strategies and Management of Common Clinical Scenarios.

PURPOSE OF REVIEW: Peripheral artery disease (PAD) affects an estimated 200 million people worldwide and is associated with significant cardiovascular morbidity and mortality. Cardiovascular risk is further increased among individuals with polyvascular disease, where either cerebrovascular or coronary artery disease is present in addition to PAD. In this review, we present common clinical scenarios encountered when managing patients with PAD and provide an evidence-based approach to prescribing optimal antithrombotics in this population. RECENT FINDINGS: The COMPASS trial recently demonstrated that rivaroxaban 2.5 mg BID + ASA daily significantly reduces major adverse cardiac and limb events in patients with PAD. Despite these advances, morbidity following MALE events remains high. With widespread approval by federal health regulators, the COMPASS regimen should be strongly considered in PAD patients who do not have a high bleeding risk. Implementing the COMPASS regimen in patients with PAD, along with other vascular risk reduction strategies, will have a substantial impact on reducing atherothromboembolic risk in patients with established vascular disease.

Outcomes after Ross procedure in adult patients: A meta-analysis and microsimulation.

OBJECTIVE: We conducted a meta-analysis to estimate the risk of adverse events, life expectancy, and event-free life expectancy after the Ross procedure in adults. METHODS: We searched databases for reports evaluating the Ross procedure in patients aged more than or equal to 16 years of age. A microsimulation model was used to evaluate age- and gender-specific life expectancy for patients undergoing the Ross procedure. RESULTS: Data were pooled from 63 articles totaling 19 155 patients from 20 countries. Perioperative mortality was 2.5% (95% confidence interval [CI]: 1.9-3.1; N = 9978). We found a mortality risk of 5.9% (95% CI: 4.8-7.2) at a mean follow-up of 7.2 years (N = 7573). The rate of perioperative clinically significant bleeding was 1.0% (95% CI: 0.1-3.0); re-exploration for bleeding 4.6% (95% CI: 3.1-6.3); postoperative clinically significant bleeding from 30 days until a mean of 7.1 years was 0.5% (95% CI: 0.2-1.0). At a mean of 6.9 years of follow-up, reintervention rate of any operated valve was 7.9% (95% CI: 5.7-10.3). The risk of valve thrombosis was 0.3% (95% CI: 0.2-0.5) at 7.6 years; peripheral embolism 0.3% (95% CI: 0.2-0.4) at 6.4 years; stroke 0.9% (95% CI: 0.7-1.2) at 6.5 years; and endocarditis 2.1% (95% CI: 1.6-2.6) at 8.0 years. Microsimulation reported a 40-year-old undergoing the Ross procedure to have a life expectancy of 35.4 years and event-free life expectancy of 26.6 years. CONCLUSIONS: Ross procedure in nonelderly adults is associated with low mortality and low risk of adverse events both at short- and long-term follow-up. The surgical community must prioritize a large, expertize-based randomized controlled trial to definitively address the risks and benefits of the Ross procedure compared to conventional aortic valve replacement.

Surgical ablation of atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials.

Aims: The aim of this review was to assess the effect of concomitant surgical atrial fibrillation (AF) ablation on postoperative freedom from AF and patient-important outcomes. Methods and results: We searched Cochrane CENTRAL, MEDLINE, and EMBASE databases from inception to May 2016 for randomized controlled trials (RCTs) evaluating surgical AF ablation using any lesion set vs. no surgical AF ablation in adults with AF undergoing cardiac surgery. We performed screening, risk-of-bias evaluation, and data collection independently and in duplicate. We evaluated risk of bias with the modified Cochrane tool, quality of evidence using GRADE framework, and pooled data with a random-effects model. Of the 23 included studies, only one was considered at low risk of bias. Surgical AF ablation was associated with more freedom from AF at 12 months [relative risk (RR) = 2.32, 95% confidence interval (CI) 1.92-2.80; P < 0.001, low quality]. However, no significant difference was seen in mortality (RR = 1.07, 95% CI 0.72-1.52; P = 0.41, moderate quality), stroke (RR = 1.19, 95% CI 0.59-2.39; P = 0.63, moderate quality), or pacemaker implantation (RR = 1.28, 95% CI 0.85-1.95; P = 0.24, high quality). Comparing biatrial and left-sided lesion sets showed no difference in mortality (P-interaction = 0.60) or stroke (P-interaction = 0.12). At 12 months, biatrial procedures led to more freedom from AF (RR = 2.80, 95% CI 2.13-3.68; P < 0.0001) when compared with left-sided ablation (RR = 2.00, 95% CI 1.68-2.39; P < 0.0001) (P-interaction = 0.04) Biatrial procedures appear to increase the risk for pacemaker (RR = 2.68, 95% CI 1.41-5.11; P = 0.002) compared with no ablation while left-sided ablation does not (RR = 1.08, 95% CI 0.67-1.74; P = 0.76) (P-interaction = 0.03). Conclusion: Surgical AF ablation during cardiac surgery improves freedom from AF. However, impact on patient-important outcomes including mortality and stroke has not shown statistical significance in current RCT evidence. Biatrial compared with left-sided lesion sets showed no difference in mortality or stroke but were associated with significantly increased freedom from AF and risk for pacemaker requirement.

The Deferred Consent Model in a Prospective Observational Study Evaluating Myocardial Injury in the Intensive Care Unit.

BACKGROUND: Informed consent is a hallmark of ethical clinical research. An inherent challenge in critical care research is obtaining consent when patients lack decision-making capacity. One solution is deferred consent, which is often used for studies that are low risk or involve emergency interventions. Our objective was to describe a deferred consent model in a low-risk critical care study. METHODS: Prognostic Value of Elevated Troponins in Critical Illness Study was a prospective, pilot observational study of critically ill patients in 3 intensive care units, involving serial electrocardiograms and cardiac biomarkers. Newly admitted patients were enrolled over 1 month. When possible, informed consent was obtained a priori from the patient or substitute decision maker (SDM); otherwise, consent was deferred until the patient regained consent capacity or until their SDM was available. Logistic regression analysis was used to determine the association between patient's sex, Acute Physiology and Chronic Health Evaluation II score, study center, person providing consent (patient vs SDM), method of consent (telephone vs in person), and the provision or not of informed consent. RESULTS: The overall consent rate was 80.1% (213 of 266 persons approached). Of the 53 persons declining consent, 37 (69.8%) agreed to the use of data collected up until that point. Over half of all consent encounters were with patients rather than SDMs. Median interval delay between enrollment and the consent encounter was 1 day. On multivariate analysis, the only variable associated with consent was male sex of the patient (odds ratio for males 2.59, confidence interval: 1.19-5.63). CONCLUSION: Deferred consent facilitates implementation of time-sensitive research protocols until a consent encounter is possible. As a feasible alternative to exclusive a priori consent, the deferred consent model can be useful in low-risk studies in critically ill patients.

Benzodiazepine administration during adult cardiac surgery: a survey of current practice among Canadian anesthesiologists working in academic centres.

BACKGROUND: Benzodiazepines are commonly administered during cardiac surgery because of their limited effect on hemodynamics and presumed role in preventing intraoperative awareness. Recent concerns about an increased risk of delirium with benzodiazepines have resulted in decreased usage in the intensive care unit and in geriatric perioperative practice. Little is known, however, about current benzodiazepine usage in the setting of adult cardiac surgery. METHODS: We contacted all academic anesthesia departments in Canada to identify practicing attending cardiac anesthesiologists; this group constituted our sampling frame. Information regarding participant demographics, benzodiazepine usage, type, dose, and other administration details were obtained by electronic survey. Responses were analyzed descriptively. RESULTS: The survey was completed by 243/346 (70%) of cardiac anesthesiologists. Eleven percent of respondents do not administer benzodiazepines. Midazolam was the most commonly used benzodiazepine, with a mean (standard deviation) dose of 4.9 (3.8) mg given to an average patient. When respondents were asked the proportion of patients that they gave benzodiazepines, the response was bimodal. The most common considerations that influenced benzodiazepine use were patient age (73%), patient anxiety (63%), history of alcohol/drug/benzodiazepine use (60%), and the presence of risk factors for intraoperative awareness (44%). CONCLUSIONS: Benzodiazepine use is common among academic cardiac anesthesiologists in Canada. Nonetheless, heterogeneity exists between individual practices, suggesting clinical equipoise between restrictive and liberal administration of benzodiazepines for cardiac anesthesia. L'administration de benzodiazépines pendant la chirurgie cardiaque chez l'adulte: évaluation de la pratique actuelle des anesthésiologistes canadiens exerçant en milieu universitaire.