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.

Canadian Cardiovascular Society 2022 Guidelines for Peripheral Arterial Disease.

Patients with widespread atherosclerosis such as peripheral artery disease (PAD) have a high risk of cardiovascular and limb symptoms and complications, which affects their quality of life and longevity. Over the past 2 decades there have been substantial advances in diagnostics, pharmacotherapy, and interventions including endovascular and open surgical to aid in the management of PAD patients. To summarize the evidence regarding approaches to diagnosis, risk stratification, medical and intervention treatments for patients with PAD, guided by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework, evidence was synthesized, and assessed for quality, and recommendations provided-categorized as weak or strong for each prespecified research question. Fifty-six recommendations were made, with 27% (15/56) graded as strong recommendations with high-quality evidence, 14% (8/56) were designated as strong recommendations with moderate-quality evidence, and 20% (11/56) were strong recommendations with low quality of evidence. Conversely 39% (22/56) were classified as weak recommendations. For PAD patients, strong recommendations on the basis of high-quality evidence, include smoking cessation interventions, structured exercise programs for claudication, lipid-modifying therapy, antithrombotic therapy with a single antiplatelet agent or dual pathway inhibition with low-dose rivaroxaban and aspirin; treatment of hypertension with an angiotensin converting enzyme or angiotensin receptor blocker; and for those with diabetes, a sodium-glucose cotransporter 2 inhibitor should be considered. Furthermore, autogenous grafts are more effective than prosthetic grafts for surgical bypasses for claudication or chronic limb-threatening ischemia involving the popliteal or distal arteries. Other recommendations indicated that new endovascular techniques and hybrid procedures be considered in patients with favourable anatomy and patient factors, and finally, the evidence for perioperative risk stratification for PAD patients who undergo surgery remains weak.

Antithrombotic Therapy in Peripheral Artery Disease: Risk Stratification and Clinical Decision Making.

Patients with peripheral artery disease (PAD) are an underrecognised group with significant thrombotic risk. This risk is modifiable with the use of aggressive secondary preventative efforts, including optimisation of antithrombotic therapy. Appropriate antithrombotic selection for patients with PAD requires appropriate assessment of thrombotic and bleeding risk. Recent Canadian guidelines have recommended dual pathway therapy initiation for stable PAD and post-revascularisation patients. However, there is ongoing discussion about how to identify PAD patients who stand to benefit most from these therapies while trying to minimise harm from bleeding. Clinical equipoise also persists around questions such as the utility of dual antiplatelet therapy in conjunction with rivaroxaban after high-risk endovascular interventions and the optimal therapy for patients experiencing acute limb ischemia. In patients with chronic PAD and high-risk comorbidities or limb features, or in patients after revascularisation, dual pathway therapy with low-dose rivaroxaban and aspirin has emerged as the only regimen to reduce major adverse cardiovascular and limb events while maintaining an acceptable bleeding profile. After endovascular revascularisation, limited-duration (< 30 days) clopidogrel may be added to rivaroxaban and aspirin in selected high-risk patients at the provider's discretion. After acute limb ischemia, the risk of another vascular event is exceptionally high, but there is no high-quality evidence to guide decision making for intensified antithrombotic therapy. Randomised investigations addressing this question are urgently needed to better serve this high-risk and vulnerable population.

Social Deprivation and Peripheral Artery Disease.

The link between peripheral artery disease and socioeconomic status is complex. The objective of this narrative review is to explore that relationship in detail, including how social factors affect the development, management, and outcomes of peripheral artery disease. Although the current literature on this topic is limited, some patterns do emerge. Populations of low socioeconomic status appear to be at increased risk for the development of peripheral artery disease, owing to factors such as increased prevalence of cardiovascular risk factors (eg, cigarette smoking) and decreased access to care. However, variables that are more difficult to quantify, such as chronic stress and health literacy, also likely play a significant role. Among those who are living with peripheral artery disease, socioeconomic status can affect disease management as well. Secondary prevention strategies, such as medication use, smoking cessation, and exercise therapy, are underutilised in socially deprived populations. This underutilisation of evidence-based management leads to adverse outcomes in these groups, including increased rates of amputation and decreased postoperative survival. The recognition of the importance of social factors in prognosis is an important first step toward addressing this health disparity. Moving forward, interventions that help to identify those who are at high risk and improve access to care in populations of low socioeconomic status will be critical to improving outcomes.

Medical Therapy Following Urgent/Emergent Revascularization in Peripheral Artery Disease Patients (Canadian Acute Limb Ischemia Registry [CANALISE I]).

BACKGROUND: Following severe limb ischemia requiring urgent/emergent revascularization, peripheral arterial disease patients suffer a high risk of recurrent atherothrombosis. METHODS: Patients discharged from Hamilton General Hospital (Hamilton, Ontario) between April 2016 and September 2017 following severe limb ischemia requiring urgent/emergent revascularization were identified via the Local Health Integration Network CorHealth database, with supplemental information from chart review. RESULTS: A total of 158 patients admitted for urgent/emergent revascularization were identified (148 alive at discharge). Among patients without a pre-existing indication for anticoagulation, 38.8% (n = 47) were discharged on single-antiplatelet therapy, 27.3% (n = 33) on dual-antiplatelet therapy, 19.8% (n = 24) on anticoagulants plus antiplatelet therapy, 6.6% (n = 8) on anticoagulants alone, and 2.6% (n = 3) on unknown therapy. Patients who received angioplasty with stenting were more likely be discharged on dual-antiplatelet therapy (hazard ratio [HR]: 7.14; 95% confidence interval [CI]: 2.87-17.76; P < 0.01); patients who received an embolectomy/thrombectomy were more likely be discharged on an anticoagulant alone (HR: 2.61; 95% CI: 1.00-6.81; P = 0.049); and patients who received peripheral bypass grafting were more likely be discharged on single-antiplatelet therapy (HR: 2.28; 95% CI: 1.11-4.69; P = 0.024). Neither statins (60.8% vs 56.3%; P = 0.23) nor renin-angiotensin-aldosterone system inhibitors (48.7% vs 50.6%; P = 0.58) were prescribed at higher rates at discharge, compared with the rate at admission. CONCLUSIONS: Substantial heterogeneity exists in antithrombotic prescription following urgent/emergent revascularization. No intensification of non-antithrombotic vascular protective medications occurred during hospitalization. Clinical trials and health system interventions to optimize medical therapy in peripheral arterial disease patients are urgently needed.

INTRODUCTION: Après une ischémie grave d'un membre ayant nécessité une revascularisation urgente/nouvelle revascularisation, les patients atteints d'une maladie artérielle périphérique ont un risque élevé de récidive d'athérothrombose. MÉTHODES: Nous avons recensé les patients qui ont obtenu leur sortie de la Hamilton General Hospital (Hamilton, Ontario) entre avril 2016 et septembre 2017 à la suite d'une ischémie grave d'un membre ayant nécessité une revascularisation urgente/nouvelle revascularisation via la base de données Local Health Integration Network CorHealth et grâce aux renseignements complémentaires issus de la revue des dossiers. RÉSULTATS: Nous avons recensé un total de 158 patients admis pour une revascularisation urgente/nouvelle revascularisation (148 patients en vie à la sortie de l'hôpital). Parmi les patients chez lesquels l'anticoagulation n'avait pas antérieurement été indiquée, 38,8 % (n = 47) avaient reçu à leur sortie de l'hôpital un simple traitement antiplaquettaire; 27,3 % (n = 33), une bithérapie antiplaquettaire; 19,8 % (n = 24), des anticoagulants plus un traitement antiplaquettaire; 6,6 % (n = 8), des anticoagulants seuls; 2,6 % (n = 3), un traitement inconnu. Les patients qui avaient subi une angioplastie et une pose d'endoprothèse étaient plus susceptibles d'obtenir à leur sortie de l'hôpital une bithérapie antiplaquettaire (rapport de risque [RR] : 7,14; intervalle de confiance [IC] à 95 % : 2,87-17,76; P < 0,01); les patients qui avaient subi une embolectomie, ou thrombectomie, étaient plus susceptibles d'obtenir à leur sortie de l'hôpital un anticoagulant seul (RR : 2,61; IC à 95 % : 1,00-6,81; P = 0,049); les patients qui avaient subi un pontage périphérique étaient plus susceptibles d'obtenir à leur congé de l'hôpital un simple traitement antiplaquettaire (RR : 2,28; IC à 95 % : 1,11-4,69; P = 0,024). Comparativement à l'admission, ni les statines (60,8 % vs 56,3 %; P = 0,23) ni les inhibiteurs du système rénine­angiotensine­aldostérone (48,7 % vs 50,6 %; P = 0,58) n'avaient été prescrits à des taux plus élevés à la sortie de l'hôpital. CONCLUSIONS: Nous observons une hétérogénéité substantielle de l'ordonnance des antithrombotiques après la revascularisation urgente/nouvelle revascularisation. L'hospitalisation n'a donné lieu à aucune augmentation des médicaments de protection vasculaire non antithrombotiques. Des essais cliniques et des interventions du système de santé qui permettent d'optimiser le traitement médical des patients atteints d'une maladie artérielle sont d'une urgente nécessité.

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

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).

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.

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.

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.

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.

A National Canadian Survey of Antithrombotic Therapy After Urgent and Emergent Limb Revascularization.

Patients with peripheral artery disease who undergo urgent or emergent lower extremity revascularization have the highest risk of major adverse cardiac and limb events. Although available evidence suggests that antithrombotic therapy reduces this risk, optimal antithrombotic therapy is unclear. In this report, we aim to describe current practice patterns for use of antithrombotic therapies after urgent/emergent peripheral artery revascularization. A self-administered online survey was distributed to all active vascular surgeons registered through the Canadian Society of Vascular Surgery (n = 149) between March 19 and April 29, 2019. The overall response rate was 53% (79/149). More than half of the respondents use a medical specialist service in aiding decision-making (52% (95% confidence interval [CI], 40.9%-63.0%). When concerned for high rethrombosis risk, respondents most commonly favoured initiation of either aspirin plus full dose anticoagulation (60% [95% CI, 49.2%-70.8%]) or dual antiplatelet therapy (58% (95% CI, 47.1%-68.9%]). Intraoperative findings and patient characteristics prompting concern for high rethrombosis risk include residual proximal/distal occlusive disease (75% [95% CI, 65.5%-84.5%]), poor-quality venous conduit (76% [95% CI, 66.6%-85.4%]), distal/infrapopliteal synthetic conduit (77% [95% CI, 67.7%-86.3%]), and history of multiple previous failed vascular interventions (98% [95% CI, 94.9%-100%]). More than 90% of respondents believe significant uncertainty exists in antithrombotic decision-making after urgent/emergent peripheral revascularization. Substantial uncertainty exists regarding antithrombotic therapy after urgent/emergent revascularization. In patients at high perceived rethrombosis risk, vascular surgeons preferentially choose aspirin with full-dose anticoagulation or dual antiplatelet therapy. Because of the clinical uncertainty in this domain, trials to determine optimal antithrombotic therapy in this high-risk population are required.

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.

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.

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.

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.