Kevin R. Bainey

Long-Term Outcomes After Transcatheter Aortic Valve Implantation Insights on Prognostic Factors and Valve Durability From the Canadian Multicenter Experience

OBJECTIVES This study sought to evaluate the long-term outcomes after transcatheter aortic valve implantation (TAVI) in the Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability. BACKGROUND Very few data exist on the long-term outcomes associated with TAVI. METHODS This was a multicenter study including 339 patients considered to be nonoperable or at very high surgical risk (mean age: 81 ± 8 years; Society of Thoracic Surgeons score: 9.8 ± 6.4%) who underwent TAVI with a balloon-expandable Edwards valve (transfemoral: 48%, transapical: 52%). Follow-up was available in 99% of the patients, and serial echocardiographic exams were evaluated in a central echocardiography core laboratory. RESULTS At a mean follow-up of 42 ± 15 months 188 patients (55.5%) had died. The causes of late death (152 patients) were noncardiac (59.2%), cardiac (23.0%), and unknown (17.8%). The predictors of late mortality were chronic obstructive pulmonary disease (hazard ratio [HR]: 2.18, 95% confidence interval [CI]: 1.53 to 3.11), chronic kidney disease (HR: 1.08 for each decrease of 10 ml/min in estimated glomerular filtration rate, 95% CI: 1.01 to 1.19), chronic atrial fibrillation (HR: 1.44, 95% CI: 1.02 to 2.03), and frailty (HR: 1.52, 95% CI: 1.07 to 2.17). A mild nonclinically significant decrease in valve area occurred at 2-year follow-up (p < 0.01), but no further reduction in valve area was observed up to 4-year follow-up. No changes in residual aortic regurgitation and no cases of structural valve failure were observed during the follow-up period. CONCLUSIONS Approximately one-half of the patients who underwent TAVI because of a high or prohibitive surgical risk profile had died at a mean follow-up of 3.5 years. Late mortality was due to noncardiac comorbidities in more than one-half of patients. No clinically significant deterioration in valve function was observed throughout the follow-up period.

Complete vs culprit-only revascularization for patients with multivessel disease undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a systematic review and meta-analysis.

BACKGROUND Patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease who undergo primary percutaneous coronary intervention (PCI) are most commonly treated with PCI to the culprit lesion only. Whether a strategy of complete revascularization in these patients is superior is unknown. We performed a meta-analysis comparing the benefits and risks of routine culprit-only PCI vs multivessel PCI in STEMI. METHODS MEDLINE, EMBASE, ISI Web of Science, and The Cochrane Register of Controlled Trials were searched from 1996 to January 2011. Relevant conference abstracts were searched from January 2002 to January 2011. Studies included STEMI with multivessel disease receiving primary PCI. The primary end point was long-term mortality. Data were combined using a fixed-effects model. RESULTS Of 507 citations, 26 studies (3 randomized, 23 nonrandomized; 46,324 patients, 7886 multivessel PCI and 38,438 culprit-only PCI) were included. There was no significant difference in hospital mortality with multivessel PCI vs culprit-only PCI (odds ratio [OR] 1.11, 95% CI 0.98-1.25, P = .10 [randomized OR 0.24, 95% CI 0.06-0.91, P = .04; nonrandomized OR 1.12, 95% CI 1.00-1.27, P = .06]). However, if multivessel PCI during index catheterization was performed, hospital mortality was increased (OR 1.35, 95% CI 1.19-1.54, P < .001). When multivessel PCI was performed as a staged procedure, hospital mortality was lower (OR 0.35, 95% CI 0.21-0.59; P < .001; P interaction < .001). Reduced long-term mortality (OR 0.74, 95% CI 0.65-0.85, P < .001[randomized OR 0.61, 95% CI 0.28-1.33, P = .22; nonrandomized OR 0.75, 95% CI 0.65-0.86, P < .001]) and repeat PCI (OR 0.65; 95% 0.46-0.90, P = .01[randomized OR 0.31, 95% CI 0.17-0.57, P < .001; nonrandomized OR 0.88, 95% CI 0.59-1.31, P = .54]) were observed with multivessel PCI. CONCLUSION Overall, staged multivessel PCI improved short- and long-term survival and reduced repeat PCI. Still, large randomized trials are required to confirm the benefits of staged multivessel PCI in STEMI.

Increased burden of coronary artery disease in South-Asians living in North America. Need for an aggressive management algorithm

Despite improvements in cardiovascular outcomes, coronary artery disease (CAD) continues to be a major cause of death worldwide. South-Asians (SAs) show an increased risk of atherosclerosis and have the highest mortality rates from CAD than any other ethnic group. The greater susceptibility of SAs to CAD cannot be explained entirely by conventional risk factors alone. Other factors are involved, such as genetic predisposition and high prevalence of the metabolic syndrome and type-2 diabetes. CAD is more severe, extensive and malignant among SAs. It is often unsuspected and associated with adverse outcome requiring a more aggressive management strategy. With the growing SA population in North America, physicians need to be aware of the epidemiology, conventional causes, associated contributors, and adverse outcomes of CAD in this group. Importantly, physicians need a structured approach and an aggressive management algorithm for the optimal care of the high-risk SA patient population.

Spontaneous reperfusion in ST-elevation myocardial infarction: Comparison of angiographic and electrocardiographic assessments

INTRODUCTION Spontaneous reperfusion (SR) in ST-elevation myocardial infarction has traditionally been assessed by coronary angiography. The frequency of SR varies widely in prior studies, and the clinical implications in the modern reperfusion era are unclear. Accordingly, using data from the ASSENT 4 PCI (ASsessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) study, we undertook a systematic assessment of SR using both electrocardiographic (ECG) and angiographic techniques. METHODS AND RESULTS Five hundred eighty-five patients randomized to the primary percutaneous coronary intervention (PCI) arm of ASSENT 4 PCI were studied: all had ECG and thrombolysis in myocardial infarction flow data available approximately 60 minutes after randomization and before PCI. Electrocardiographic SR (>/=70% ST-segment resolution) occurred in 14.9% (87/585) and angiographic SR (thrombolysis in myocardial infarction grade 3) in 14.7% (86/585) of patients. Thirty-day clinical outcomes of patients with ECG SR versus no ECG SR tended to have lower mortality (0% vs 3.4%, P = .091), a lower composite of death/shock/congestive heart failure (6.9% vs 12.2%, P = .148), and significant reductions in death/reinfarction (0% vs 5.6%, P = .014). By contrast, no such differences were evident in patients with angiographic SR versus no SR for death (2.3% vs 3.0%, P = 1.00), death/shock/congestive heart failure (9.3% vs 11.8%, P = .498), or death/reinfarction (2.3% vs 5.2%, P = .409). CONCLUSIONS Whereas the frequency of SR was comparable using either ECG or angiographic criteria, clinical outcomes were best aligned with ECG SR. These data support the role of the ECG in assessing reperfusion and likely reflect the overall impact of myocardial perfusion versus infarct-related artery epicardial patency alone.

Clinical perspectives on reperfusion injury in acute myocardial infarction

Prompt reperfusion therapy in acute myocardial infarction enhances clinical outcome. However, reperfusion itself may contribute to myocardial cell death. The current review outlines the multifocal mechanisms of reperfusion injury and focuses on understanding the potential role of each element and its contribution to the injury pattern inflicted upon the myocardium. We evaluate the spectrum of contemporary therapies that have been tested in an attempt to reduce myocardial injury. Finally, we explore promising innovative strategies targeting novel reperfusion injury pathways to protect ischemic myocardium during reperfusion.

Effects of withdrawing vs continuing renin-angiotensin blockers on incidence of acute kidney injury in patients with renal insufficiency undergoing cardiac catheterization: Results from the Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker and Contrast Induced Nephropathy in Patients Receiving Cardiac Catheterization (CAPTAIN) trial

BACKGROUND It is unclear if holding angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) prior to coronary angiography reduces contrast-induced acute kidney injury (AKI). We undertook a randomized trial to investigate the effect of holding ACEI/ARB therapy prior to coronary angiography on the incidence of AKI. METHODS We randomly assigned 208 patients with moderate renal insufficiency (creatinine ≥ 1.7mg/dL within 3 months and/or documented creatinine ≥ 1.5mg/dL within 1 week before cardiac catheterization) to hold ACEI/ARB ≥24 hours preprocedure or continue ACEI/ARB. The primary outcome was the incidence of AKI defined as an absolute rise in serum creatinine of ≥0.5mg/dL from baseline and/or a relative rise in serum creatinine of ≥25% compared with baseline measured at 48 to 96 hours postcardiac catheterization. RESULTS All patients were taking an ACEI (72.1%) or ARB (27.9%) prior to randomization. At 48 to 96 hours, the primary outcome occurred in 18.4% of patients who continued ACEI/ARB compared with 10.9% of the patients who held ACEI/ARB (hazard ratio 0.59, 95% CI 0.30-1.19, P = .16). In a prespecified secondary outcome, there was a lower rise in mean serum creatinine after the procedure in patients who held ACEI/ARB (0.3 ± 0.5 vs 0.1 ± 0.3mg/dL, P = .03). The clinical composite of death, myocardial infarction, ischemic stroke, congestive heart failure, rehospitalization for cardiovascular cause, or need for dialysis preprocedure occurred in 3.9% who continued ACEI/ARB compared with 0% who held the ACEI/ARB (hazard ratio 0.11, 95% CI 0.01-2.96, P = .06). CONCLUSION In this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization, with-holding ACEI/ARB resulted in a non-significant reduction in contrast-induced AKI and a significant reduction in post-procedural rise of creatinine. This low cost intervention could be considered when referring a patient for cardiac catheterization.

Altered health status and quality of life in South Asians with coronary artery disease.

BACKGROUND People of South Asian (SA) ancestry are susceptible to coronary artery disease (CAD). Although studies suggest that SA with CAD has a worse prognosis compared with Europeans, it is unknown whether corresponding differences in functional status and quality-of-life (QOL) measures exist. Accordingly, we compared symptoms, function, and QOL in SA and European Canadians with CAD using the Seattle Angina Questionnaire (SAQ). METHODS Using the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease, an outcomes registry that captures patients undergoing cardiac catheterization in Alberta, Canada, we identified 635 SA and 18,934 European patients with angiographic CAD from January 1995 to December 2006 who reported health status outcomes using the SAQ at 1 year after the index catheterization. To obtain comparable clinical variables among SA and Europeans, we used a propensity score-matching technique. RESULTS One-year adjusted mean (SD) scores were significantly lower in SA compared with European Canadians for most SAQ domains: exertional capacity (75 [23] vs 80 [23], P = .011), anginal stability (77 [28] vs 77 [27], P = .627), anginal frequency (86 [23] vs 88 [20], P < .001), treatment satisfaction (86 [19] vs 89 [16], P < .001), and SAQ QOL (71 [24] vs 76 [21], P < .001). These results could not be accounted for by differences in baseline QOL scores or changes in health status from baseline to 1 year. CONCLUSION South Asian Canadians with established CAD have significantly worse health status outcomes at 1 year after angiography compared with European Canadians. Further studies are warranted to improve functional outcomes in SA with CAD.

Comparison of Three Age Groups Regarding Safety and Efficacy of Drug-Eluting Stents (from the National Heart, Lung, and Blood Institute Dynamic Registry)

Limited data exist regarding drug-eluting stent (DES) versus bare metal stent (BMS) use in older patients. From the National Heart, Lung, and Blood Institute Dynamic Registry, 5,089 percutaneous coronary intervention (PCI)-treated patients were studied (October 2001 to August 2006). The differences in 1-year safety (death, myocardial infarction, and their composite) and efficacy (target vessel revascularization [TVR] with PCI and repeat revascularization) outcomes were compared between the patients who received DESs versus BMSs within each age group: <65 years (n = 2,680); 65 to 79 years (n = 1,942); ≥80 years (n = 443). No differences were found in the safety outcomes by stent type in any age group at 1 year. Regarding the effectiveness, lower rates of TVR with PCI and repeat revascularization were observed in the DES patients across all age groups. After propensity-adjusted analysis, the risk of TVR with PCI and repeat revascularization favored DES versus BMS with patients <65 years old (7.4% vs 14.6%, hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.32 to 0.60; 12.3% vs and 17.4%, HR 0.65, 95% CI 0.51 to 0.84, respectively), 65 to 79 years old (4.8% vs 9.5%, HR 0.50, 95% CI 0.31 to 0.80; and 7.6% vs 12.3%, HR 0.62, 95% CI 0.44 to 0.88, respectively), and ≥80 years old (4.5% vs 10.4%, HR 0.15, 95% CI 0.05 to 0.44; and 6.0% vs 14.5%, HR 0.18, 95% CI 0.08 to 0.40, respectively). In conclusion, significant reductions in TVR with PCI and repeat revascularization were noted in all 3 age groups without increases in death or myocardial infarction in this large multicenter PCI registry. Our data support the use of DES, regardless of age.

2018 Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology Focused Update of the Guidelines for the Use of Antiplatelet Therapy

Antiplatelet therapy (APT) has become an important tool in the treatment and prevention of atherosclerotic events, particularly those associated with coronary artery disease. A large evidence base has evolved regarding the relationship between APT prescription in various clinical contexts and risk/benefit relationships. The Guidelines Committee of the Canadian Cardiovascular Society and Canadian Association of Interventional Cardiology publishes regular updates of its recommendations, taking into consideration the most recent clinical evidence. The present update to the 2011 and 2013 Canadian Cardiovascular Society APT guidelines incorporates new evidence on how to optimize APT use, particularly in situations in which few to no data were previously available. The recommendations update focuses on the following primary topics: (1) the duration of dual APT (DAPT) in patients who undergo percutaneous coronary intervention (PCI) for acute coronary syndrome and non-acute coronary syndrome indications; (2) management of DAPT in patients who undergo noncardiac surgery; (3) management of DAPT in patients who undergo elective and semiurgent coronary artery bypass graft surgery; (4) when and how to switch between different oral antiplatelet therapies; and (5) management of antiplatelet and anticoagulant therapy in patients who undergo PCI. For PCI patients, we specifically analyze the particular considerations in patients with atrial fibrillation, mechanical or bioprosthetic valves (including transcatheter aortic valve replacement), venous thromboembolic disease, and established left ventricular thrombus or possible left ventricular thrombus with reduced ejection fraction after ST-segment elevation myocardial infarction. In addition to specific recommendations, we provide values and preferences and practical tips to aid the practicing clinician in the day to day use of these important agents.

Cost implication of an early invasive strategy on weekdays and weekends in patients with acute coronary syndromes.

BACKGROUND Early invasive intervention is associated with shorter length of stay (LOS) and similar outcomes in a delayed strategy in lower-risk patients with non-ST segment elevation acute coronary syndromes (NSTEACS), but is superior in higher-risk patients. However, early invasive intervention might be constrained by the need to mobilize the on-call team on weekends. We evaluated costs associated with an early vs delayed invasive intervention strategy, including patients who present on weekends. METHODS Health care utilization was extracted from the Timing of Intervention in Acute Coronary Syndromes (TIMACS) trial for Canadian patients from case report forms. Only direct costs were considered and only hospitalization events were included. Canadian unit costs were applied to health care resources consumed for all patients. Sensitivity and subgroup analyses were performed. RESULTS Early invasive intervention reduced LOS costs by