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Background Transcatheter aortic valve implantation (TAVI) has seen indication expansion and thus exponential growth in demand over the past decade. In many jurisdictions, the growing demand has outpaced capacity, increasing wait times and preprocedural adverse events. In this study, we derived prediction models that estimate the risk of adverse events on the waitlist and developed a triage tool to identify patients who should be prioritized for TAVI. Methods and Results We included adult patients in Ontario, Canada referred for TAVI and followed up until one of the following events first occurred: death, TAVI procedure, removal from waitlist, or end of the observation period. We used subdistribution hazards models to find significant predictors for each of the following outcomes: (1) all‐cause death while on the waitlist; (2) all‐cause hospitalization while on the waitlist; (3) receipt of urgent TAVI; and (4) a composite outcome. The median predicted risk at 12 weeks was chosen as a threshold for a maximum acceptable risk while on the waitlist and incorporated in the triage tool to recommend individualized wait times. Of 13 128 patients, 586 died while on the waitlist, and 4343 had at least 1 hospitalization. A total of 6854 TAVIs were completed, of which 1135 were urgent procedures. We were able to create parsimonious models for each outcome that included clinically relevant predictors. Conclusions The Canadian TAVI Triage Tool (CAN3T) is a triage tool to assist clinicians in the prioritization of patients who should have timely access to TAVI. We anticipate that the CAN3T will be a valuable tool as it may improve equity in access to care, reduce preventable adverse events, and improve system efficiency.

Indigenous peoples in Canada are at an increased risk of cardiovascular disease compared to non-Indigenous people. Contributing factors include historical oppression, racism, healthcare biases, and disparities in terms of the social determinants of health. Access to and inequity in cardiovascular care for Indigenous peoples in Canada remain poorly studied and understood. A rapid review of the literature was performed using the PubMed/MEDLINE, Web of Science, and Indigenous Studies Portal (iPortal) databases to identify articles describing access to cardiovascular care for Indigenous peoples in Canada between 2002 and 2021. Included articles were presented narratively in the context of delays in seeking, reaching, or receiving care, or as disparities in cardiovascular outcomes, and were assessed for their successful engagement in indigenous health research using a preexisting framework. Current research suggests that gaps most prominently present as delays in receiving care and as poorer long-term outcomes. The literature is concentrated in Alberta, Manitoba, and Ontario, as well as among First Nations people, and is largely rooted in a biomedical worldview. Additional community-driven research is required to better elucidate the gaps in access to holistic cardiovascular care for Indigenous peoples in Canada. Healthcare professionals, researchers, and policymakers should reflect further upon their actions and privilege, educate themselves about historical facts and the Truth and Reconciliation Commission, tackle prevailing disparities and systemic barriers in the healthcare systems, and develop culturally safe and ethically appropriate healthcare interventions to improve the health of all Indigenous peoples in Canada. Résumé: Le risque de maladies cardiovasculaires est plus élevé chez les populations autochtones du Canada que chez les populations non autochtones. L’oppression historique, le racisme, les préjugés dans les soins de santé et les disparités quant aux déterminants sociaux de la santé sont des facteurs qui contribuent à ce phénomène. L’accès aux soins cardiovasculaires et l’équité des soins pour les personnes autochtones du Canada sont des questions peu étudiées et mal comprises. Une revue rapide de la littérature a été réalisée dans les bases de données PubMed/MEDLINE, Web of Science et Indigenous Studies Portal (iPortal) pour recenser les articles publiés entre 2002 et 2021 qui décrivent l’accès aux soins cardiovasculaires pour les peuples autochtones du Canada. Les articles retenus sont présentés de manière narrative et font état de retards dans la recherche de soins, dans l’atteinte d’un établissement de soins et dans l’obtention des soins, ou de certaines disparités quant aux résultats de santé cardiovasculaire. Ces articles ont également été évalués d’après leur intégration réussie des principes de recherche en santé autochtone à partir d’un cadre déjà établi. Selon les recherches actuelles, les écarts se manifestent principalement par des retards dans l’obtention des soins et par des résultats de santé plus défavorables à long terme. Les études publiées se concentrent surtout sur l’Alberta, le Manitoba et l’Ontario, portent principalement sur les Premières Nations et sont en grande partie abordées selon une perspective biomédicale. Des recherches plus approfondies, menées avec les communautés autochtones, sont nécessaires pour mieux comprendre les écarts dans l’accès à des soins cardiovasculaires holistiques pour les peuples autochtones du Canada. Les professionnels de la santé, les chercheurs et les décideurs politiques devraient entreprendre un processus de réflexion approfondie sur leurs actions et leurs privilèges, s’informer sur les réalités historiques ainsi que sur la Commission de vérité et réconciliation, s’attaquer aux disparités qui perdurent et aux barrières systémiques dans l’accès aux soins de santé, et mettre en place des interventions de soins culturellement sécuritaires et éthiquement adaptées, pour améliorer la santé de l’ensemble de la population autochtone du Canada.

ABSTRACT Introduction: The second best conduit for coronary artery bypass grafting is uncertain. The objective of this study is to determine the second best conduit according to graft patency results from randomized controlled trials using a network meta-analysis. Methods: A systematic literature search was conducted for randomized controlled trials comparing the angiographic patency rate of the no-touch saphenous vein (NT-SV), the radial artery (RA), the right internal thoracic artery (RITA), and the gastroepiploic artery (GEA) in reference to the conventionally harvested saphenous vein (CON-SV). The primary outcome was graft occlusion, and the secondary outcome was all-cause mortality. Results: A total of 859 studies were retrieved, of which 18 were included. A total of 6,543 patients and 8,272 grafts were analyzed. The weighted mean angiographic follow-up time was 3.5 years. Compared with CON-SV, RA (incidence rate ratio [IRR] 0.56; 95% confidence interval [CI], 0.43-0.74) and NT-SV (IRR 0.56; 95% CI, 0.44-0.70) demonstrated lower graft occlusion. NT-SV and RA were ranked as the best conduits (rank score for NT-SV 0.88 vs. 0.87 for RA, 0.29 for GEA, 0.27 for CON-SV, and 0.20 for RITA). There was no significant difference in late mortality between different conduit types. Conclusion: RA and NT-SV are associated with significantly lower graft occlusion rates and are comparably ranked as the best conduit for patency.

Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification. Methods We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial’s statistical results with respect to patients lost to follow up. Results The analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness. Conclusions The LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.

Background: Although cardiac rehabilitation (CR) has proven to have short- and mid-term benefit in treatment of coronary artery disease, its long-term benefit in patients who have undergone coronary artery bypass grafting (CABG) is less certain. Our objective was to examine the late outcomes of patients who attended CR within the first year after CABG. Methods: Adult CABG patients referred to Toronto Rehabilitation Institute (CR group: were referred and attended at least 1 session; No-CR group: were referred but did not attend) between January 1996 and September 2008 were identified through linkages with clinical and provincial administrative databases for comorbidities and outcome ascertainment. The primary outcome was a composite of all-cause mortality, acute myocardial infarction, stroke or repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]). The secondary outcome was all-cause mortality. Multivariable Cox proportional hazard models were used to assess the CR treatment effect, adjusting for baseline characteristics. Results: The study cohort consisted of 5,000 patients—3,685 (73.7%) in the CR group and 1,315 (26.3%) in the No-CR group. Median referral time was 32.5 days, and follow-up was 13.1 years. The CR group patients, compared with the No-CR group, were younger (age 62.6 ± 9.6 vs 64.0 ± 10.5 years), were more likely to be male (85.0% vs 79.5%), and had fewer cardiac comorbidities. In adjusted analyses, the CR group was associated with decreased MACCE (hazard ratio 0.83, 95% confidence interval 0.75-0.91, P < 0.0001) and a higher adjusted survival at 15 years (66.3% vs 60.1%, hazard ratio 0.76, 95% confidence interval 0.68-0.84, P < 0.0001), as compared with the No-CR group. Conclusions: There was a reduction in MACCE and late mortality associated with CR attendance, highlighting the importance of patient referral and participation in CR after CABG. Résumé: Contexte: La réadaptation cardiaque (RC) s’est révélée bénéfique à court et à moyen terme dans le traitement des coronaropathies, mais on en sait moins sur ses bienfaits à long terme chez les patients ayant subi un pontage aortocoronarien (PAC). Nous avons donc examiné les issues à long terme chez des patients ayant participé à un programme de RC dans l’année suivant un PAC. Méthodologie: À partir des données couplées des bases de données des cliniques et de l’administration provinciale, nous avons relevé tous les patients adultes ayant subi un PAC qui ont été orientés vers l’Institut de réadaptation de Toronto (groupe RC : patients orientés vers le programme et ayant participé à au moins 1 séance; groupe sans RC : patients orientés vers le programme, mais n’ayant participé à aucune séance) entre janvier 1996 et septembre 2008, afin d’établir les affections concomitantes et les résultats obtenus. Le critère d’évaluation principal composé comprenait la mortalité toutes causes confondues, l’infarctus du myocarde aigu, l’accident vasculaire cérébral (AVC) ou une nouvelle revascularisation en raison d’un événement cardiaque ou cérébrovasculaire majeur (ECCVM). Le critère d’évaluation secondaire était la mortalité toutes causes confondues. Nous avons utilisé des modèles à risques proportionnels de Cox multivariés pour évaluer l’effet thérapeutique de la RC, en apportant les corrections nécessaires pour tenir compte des caractéristiques initiales des patients. Résultats: La cohorte de l’étude réunissait 5 000 patients – 3 685 (73,7 %) dans le groupe RC et 1 315 (26,3 %) dans le groupe sans RC. Les valeurs médianes du temps écoulé avant l’orientation vers un programme de RC et de la période du suivi étaient de 32,5 jours et de 13,1 ans, respectivement. Comparativement aux patients du groupe sans RC, les patients du groupe RC étaient plus jeunes (62,6 ± 9,6 ans vs 64,0 ± 10,5 ans), étaient dans une plus forte proportion des hommes (85,0 % vs 79,5 %) et présentaient un moins grand nombre d’affections cardiaques concomitantes. À l’issue des analyses après corrections, on a observé dans le groupe RC une réduction du taux d’ECCVM (rapport des risques instantanés de 0,83; intervalle de confiance [IC] à 95 %, de 0,75 à 0,91; p < 0,0001) et une augmentation du taux de survie à 15 ans corrigé (66,3 % vs 60,1 %; rapport des risques instantanés de 0,76; IC à 95 %, de 0,68 à 0,84; p < 0,0001), comparativement au groupe sans RC. Conclusions: La participation à un programme de RC a été associée à une diminution du risque d’ECCVM et de mortalité tardive, ce qui fait ressortir l’importance d’orienter les patients ayant subi un PAC vers de tels programmes et de les encourager à y participer.

Abstract Background The objective of this study was to assess the overall quality of study-level meta-analyses in high-ranking journals using commonly employed guidelines and standards for systematic reviews and meta-analyses. Methods 100 randomly selected study-level meta-analyses published in ten highest-ranking clinical journals in 2016–2017 were evaluated by medical librarians against 4 assessments using a scale of 0–100: the Peer Review of Electronic Search Strategies (PRESS), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Institute of Medicine’s (IOM) Standards for Systematic Reviews, and quality items from the Cochrane Handbook. Multiple regression was performed to assess meta-analyses characteristics’ associated with quality scores. Results The overall median (interquartile range) scores were: PRESS 62.5(45.8–75.0), PRISMA 92.6(88.9–96.3), IOM 81.3(76.6–85.9), and Cochrane 66.7(50.0–83.3). Involvement of librarians was associated with higher PRESS and IOM scores on multiple regression. Compliance with journal guidelines was associated with higher PRISMA and IOM scores. Conclusion This study raises concerns regarding the reporting and methodological quality of published MAs in high impact journals Early involvement of information specialists, stipulation of detailed author guidelines, and strict adherence to them may improve quality of published meta-analyses.

Background The degree of hospital‐level variation in the ratio of percutaneous coronary interventions to coronary artery bypass grafting procedures (PCI:CABG) and the association of the PCI:CABG ratio with clinical outcome are unknown. Methods and Results In a multicenter population‐based study conducted in Ontario, Canada, we identified 44 288 patients from 19 institutions who had nonemergent diagnostic angiograms indicating severe multivessel coronary artery disease (2013–2017) and underwent a coronary revascularization procedure within 90 days. Hospitals were divided into tertiles according to their adjusted PCI:CABG ratio into low (0.70–0.85, n=17 487), medium (1.01–1.17, n=15 275), and high (1.18–1.29, n=11 526) ratio institutions. Compared with low PCI:CABG ratio hospitals, hazard ratios (HRs) for major adverse cardiac and cerebrovascular events were higher at medium (HR, 1.19; 95% CI, 1.14–1.25) and high ratio (HR, 1.21; 95% CI, 1.15–1.27) hospitals during a median 3.3 (interquartile range 2.1–4.6) years follow‐up. When interventional cardiologists performed the diagnostic angiogram, the odds of the patient receiving PCI was higher (odds ratio, 1.37; 95% CI, 1.23–1.52) than when it was performed by noninterventional cardiologists, after accounting for patient characteristics. Having the diagnostic angiogram at an institution without cardiac surgical capabilities was independently associated with a higher risk of major adverse cardiac and cerebrovascular events (HR, 1.07; 95% CI, 1.02–1.11), death (HR, 1.09; 95% CI, 1.02–1.18), and myocardial infarction (HR, 1.10; 95% CI, 1.03–1.17). Conclusions Patients undergoing diagnostic angiography in hospitals with higher PCI:CABG ratio had higher rates of adverse outcomes, including major adverse cardiac and cerebrovascular events, myocardial infarction, and repeat revascularization. Presence of on‐site cardiac surgery was associated with better survival and lower major adverse cardiac and cerebrovascular events.

Background Women have traditionally been underrepresented in randomized clinical trials (RCTs). We performed a systematic evaluation of the inclusion of women in cardiac surgery RCTs published in the past 2 decades. Methods and Results MEDLINE, EMBASE, and the Cochrane Library were searched (2000 to July 2020) for RCTs written in English, comparing ≥2 adult cardiac surgical procedures. The percentage of women enrolled and its association with year of publication, sample size, mean age, funding source, geographic location, number of sites involved, and interventions tested were analyzed using a meta‐analytic approach. Fifty‐one trials were included. Of 25 425 total patients, 5029 were women (20.8%; 95% CI, 17.6–24.4; range, 0.5%–57.9%). The proportion of women dropped significantly during the study period (29.6% in 2000 versus 13.1% in 2019, P

Background Quality of the peer‐review process has been tested only in small studies. We describe and summarize the randomized trials that investigated interventions aimed at improving peer‐review process of biomedical manuscripts. Methods and Results All randomized trials comparing different peer‐review interventions at author‐, reviewer‐, and/or editor‐level were included. Differences between traditional and intervention‐modified peer‐review processes were pooled as standardized mean difference (SMD) in quality based on the definitions used in the individual studies. Main outcomes assessed were quality and duration of the peer‐review process. Five‐hundred and seventy‐five studies were retrieved, eventually yielding 24 randomized trials. Eight studies evaluated the effect of interventions at author‐level, 16 at reviewer‐level, and 3 at editor‐level. Three studies investigated interventions at multiple levels. The effects of the interventions were reported as mean change in review quality, duration of the peer‐review process, acceptance/rejection rate, manuscript quality, and number of errors detected in 13, 11, 5, 4, and 3 studies, respectively. At network meta‐analysis, reviewer‐level interventions were associated with a significant improvement in review quality (SMD, 0.20 [0.06 to 0.33]), at the cost of increased duration of the review process (SMD, 0.15 [0.01 to 0.29]), except for reviewer blinding. Author‐ and editor‐level interventions did not significantly impact peer‐review quality and duration (respectively, SMD, 0.17 [−0.16 to 0.51] and SMD, 0.19 [−0.40 to 0.79] for quality, and SMD, 0.17 [−0.16 to 0.51] and SMD, 0.19 [−0.40 to 0.79] for duration). Conclusions Modifications of the traditional peer‐review process at reviewer‐level are associated with improved quality, at the price of longer duration. Further studies are needed. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42020187910.

Background The multidisciplinary Heart Team (HT) is recommended for management decisions for transcatheter aortic valve replacement (TAVR) candidates, and during TAVR procedures. Empiric evidence to support these recommendations is limited. We aimed to explore temporal trends, drivers, and outcomes associated with HT utilization. Methods and Results TAVR candidates were identified in Ontario, Canada, from April 1, 2012 to March 31, 2019. The HT was defined as having a billing code for both a cardiologist and cardiac surgeon during the referral period. The procedural team was defined as a billing code during the TAVR procedure. Hierarchical logistical models were used to determine the drivers of HT. Median odds ratios were calculated to quantify the degree of variation among hospitals. Of 10 412 patients referred for TAVR consideration, 5489 (52.7%) patients underwent a HT during the referral period, with substantial range between hospitals (median odds ratio of 1.78). Utilization of a HT for TAVR referrals declined from 69.9% to 41.1% over the years of the study. Patient characteristics such as older age, frailty and dementia, and hospital characteristics including TAVR program size, were found associated with lower HT utilization. In TAVR procedures, the procedural team included both cardiologists and cardiac surgeons in 94.9% of cases, with minimal variation over time or between hospitals. Conclusions There has been substantial decline in HT utilization for TAVR candidates over time. In addition, maturity of TAVR programs was associated with lower HT utilization.

Abstract Background Single centre studies support No Touch (NT) saphenous vein graft (SVG) harvesting technique. The primary objective of the SUPERIOR SVG study was to determine whether NT versus conventional (CON) SVG harvesting was associated with improved SVG patency 1 year after coronary artery bypass grafting surgery (CABG). Methods Adults undergoing isolated CABG with at least 1 SVG were eligible. CT angiography was performed 1-year post CABG. Leg adverse events were assessed with a questionnaire. A systematic review was performed for published NT graft patency studies and results aggregated including the SUPERIOR study results. Results Two hundred and-fifty patients were randomized across 12-centres (NT 127 versus CON 123 patients). The primary outcome (study SVG occlusion or cardiovascular (CV) death) was not significantly different in NT versus CON (NT: 7/127 (5.5%), CON 13/123 (10.6%), p = 0.15). Similarly, the proportion of study SVGs with significant stenosis or total occlusion was not significantly different between groups (NT: 8/102 (7.8%), CON: 16/107 (15.0%), p = 0.11). Vein harvest site infection was more common in the NT patients 1 month postoperatively (23.3% vs 9.5%, p

Abstract Background Studies have shown that patients who undergo trans-catheter aortic valve replacement (TAVR) have high rates of hospital readmission. Our objectives were to identify the causes of readmission after TAVR, determine whether transitional care factors were associated with a reduction in readmission and to identify other predictors that could be used to target quality improvement efforts. Methods We conducted a chart abstraction study that included all patients who underwent TAVR in Ontario, Canada between 2007 and 2013 and survived to hospital discharge. These data were linked to provincial administrative databases. The association between transitional care factors (home care, rehabilitation, family physician and cardiologist follow-up) and 1-year hospital readmission was examined using a time-to-event analysis. Cause-specific hazards models were used to account for the competing risk of death. Results There were 937 patients in the cohort and the rate of readmission at 1-year was 49%. The most common causes of readmission were heart failure and bleeding. Rehabilitation (HR 1.34, 95% CI 1.11–1.62; p = 0.002) and cardiologist follow-up (HR 1.41, 95% CI 1.14–1.75; p = 0.002) were both associated with higher readmission rates. While, home care (HR 1.18, 95% CI 0.96–1.44; p = 0.12) and family physician follow-up (HR 1.04, 95% CI 0.85–1.28; p = 0.71) were not associated with readmission. Conclusion Readmission post TAVR is common; however, we did not identify any transitional care factors associated with reductions in hospital readmission. This suggests ongoing research is required to identify targets for improvement in post-procedural care.

Background Several randomized trials have compared the patency of coronary artery bypass conduits. All of the published studies, however, have performed pairwise comparisons and a comprehensive evaluation of the patency rates of all conduits has yet to be published. We set out to investigate the angiographic patency rates of all conduits used in coronary bypass surgery by performing a network meta‐analysis of the current available randomized evidence. Methods and Results A systematic literature search was conducted for randomized controlled trials comparing the angiographic patency rate of the conventionally harvested saphenous vein, the no‐touch saphenous vein, the radial artery (RA), the right internal thoracic artery, or the gastroepiploic artery. The primary outcome was graft occlusion. A total of 4160 studies were retrieved of which 14 were included with 3651 grafts analyzed. The weighted mean angiographic follow‐up was 5.1 years. Compared with the conventionally harvested saphenous vein, both the RA (incidence rate ratio [IRR] 0.54; 95% CI, 0.35–0.82) and the no‐touch saphenous vein (IRR 0.55; 95% CI, 0.39–0.78) were associated with lower graft occlusion. The RA ranked as the best conduit (rank score for RA 0.87 versus 0.85 for no‐touch saphenous vein, 0.23 for right internal thoracic artery, 0.29 for gastroepiploic artery, and 0.25 for the conventionally harvested saphenous vein). Conclusions Compared with the conventionally harvested saphenous vein, only the RA and no‐touch saphenous vein grafts are associated with significantly lower graft occlusion rates. The RA ranks as the best conduit. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42020164492.

Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted using 2015–2018 data and forecasted for 2019–2020). The study endpoints were early trial stoppage, normal trial completion, and trial activation. There were 161,377 non-COVID-19 trials analyzed. The number of active trials increased annually through 2019 but decreased in 2020. According to the piece-wise regression models, trial completion was not affected by the pandemic (p = 0.56) whereas trial stoppage increased (p = 0.001). There was a pronounced decrease in trial activation early during the pandemic (p < 0.001) which then recovered. The findings from the time series models were consistent comparing forecasted and observed results (trial completion p = 0.22; trial stoppage p < 0.01; trial activation, p = 0.01). During the pandemic, there was an increase in non-COVID-19 RCTs stoppage without changes in RCT completion. There was a sharp decline in new RCTs at the beginning of the pandemic, which later recovered.

Abstract Background Most patients undergoing Transcatheter aortic valve implantation (TAVR) are elderly with significant co-morbidities and there is limited information available regarding factors that influence length of stay (LOS) post-procedure. The aim of this study was to identify the patient, and procedural factors that affect post-TAVR LOS using a contemporary multinational registry. Methods We conducted a retrospective cohort study, with patients recruited from three high volume tertiary institutions. The primary outcome was the LOS post-TAVR procedure. We examined patient and procedural factors in a cause-specific Cox multivariable regression model to elucidate their effect on LOS, accounting for the competing risk of post-procedural death. Hazard ratios (HR) greater than 1 indicate a shorter LOS, while HRs less than 1 indicate a longer LOS. Results The cohort consisted of 809 patients. Patient factors associated with longer LOS were older age, prior atrial fibrillation, and greater patient urgency. Patient factors associated with shorter LOS were lower NYHA class, higher ejection fraction and higher mean aortic valve gradients. Procedural characteristics associated with shorter LOS were conscious sedation (HR = 1.19, 95% CI 1.06–1.35, p = 0.004). Transapical access was associated with prolonged LOS (HR = 0.49, 95% CI 0.41–0.58, p

Background The ART (Arterial Revascularization Trial) showed no difference in survival at 10 years between patients assigned to the single versus bilateral internal thoracic artery grafting strategies. This finding is in contrast with the results of most observational studies, where the use of 2 internal thoracic arteries has been associated with improved survival. Methods and Results We selected propensity‐matched studies from the most comprehensive observational meta‐analysis on the long‐term outcomes of patients receiving 1 versus 2 internal thoracic arteries. Individual participant survival data from each study and the ART were reconstructed using an iterative algorithm that was applied to solve the Kaplan‐Meier equations. The reconstructed individual participant survival data were aggregated to obtain combined survival curves and Cox regression hazard ratios with 95% CIs. Individual participant survival data were obtained from 14 matched observational studies (24 123 patients) and the ART. The 10‐year survival of the control group of ART was significantly higher than that of the matched observational studies (hazard ratio, 0.86; 95% CI, 0.80–0.93). The 10‐year survival of the experimental group of ART was significantly lower than that of the bilateral internal thoracic artery group of the observational studies (hazard ratio, 1.11; 95% CI, 1.03–1.20). Conclusions Both the improved outcome of the control arm and the lower beneficial effect of the intervention had played a role in the difference between observational evidence and ART.

Background Crossover dilutes treatment effect and reduces statistical power of intention‐to‐treat analysis. We examined incidence and impact on cardiac surgery randomized controlled trial (RCT) outcomes of crossover from experimental to control interventions, or vice versa. Methods and Results MEDLINE, EMBASE, and Cochrane Library were searched, and RCTs (≥100 patients) comparing ≥2 adult cardiac surgical interventions were included. Crossover from the initial treatment assignment and relative risks (RRs) for each trial's primary end point and mortality at longest available follow‐up were extracted. All RRs were calculated as >1 favored control group and

Background Transcatheter aortic valve replacement (TAVR) is the standard of care for many patients with severe symptomatic aortic stenosis and relies on accurate sizing of the aortic annulus. It has been suggested that 3‐dimensional transesophageal echocardiography (3D TEE) may be used instead of multidetector computed tomography (MDCT) for TAVR planning. This systematic review and meta‐analysis compared 3D TEE and MDCT for pre‐TAVR measurements. Methods and Results A systematic literature search was performed. The primary outcome was the correlation coefficient between 3D TEE– and MDCT‐measured annular area. Secondary outcomes were correlation coefficients for mean annular diameter, annular perimeter, and left ventricular outflow tract area; interobserver and intraobserver agreements; mean differences between 3D TEE and MDCT measurements; and pooled sensitivities, specificities, and receiver operating characteristic area under curve values of 3D TEE and MDCT for discriminating post‐TAVR paravalvular aortic regurgitation. A random effects model was used. Meta‐regression and leave‐one‐out analysis for the primary outcome were performed. Nineteen studies with a total of 1599 patients were included. Correlations between 3D TEE and MDCT annular area, annular perimeter, annular diameter, and left ventricular outflow tract area measurements were strong (0.86 [95% CI, 0.80–0.90]; 0.89 [CI, 0.82–0.93]; 0.80 [CI, 0.70–0.87]; and 0.78 [CI, 0.61–0.88], respectively). Mean differences between 3D TEE and MDCT between measurements were small and nonsignificant. Interobserver and intraobserver agreement and discriminatory abilities for paravalvular aortic regurgitation were good for both 3D TEE and MDCT. Conclusions For pre‐TAVR planning, 3D TEE is comparable to MDCT. In patients with renal dysfunction, 3D TEE may be potentially advantageous for TAVR measurements because of the lack of contrast exposure.

Background There remains uncertainty regarding the second‐best conduit after the internal thoracic artery in coronary artery bypass grafting. Few studies directly compared the clinical results of the radial artery (RA), right internal thoracic artery (RITA), and saphenous vein (SV). No network meta‐analysis has compared these 3 strategies. Methods and Results MEDLINE and EMBASE were searched for adjusted observational studies and randomized controlled trials comparing the RA, SV, and/or RITA as the second conduit for coronary artery bypass grafting. The primary end point was all‐cause long‐term mortality. Secondary end points were operative mortality, perioperative stroke, perioperative myocardial infarction, and deep sternal wound infection (DSWI). Pairwise and network meta‐analyses were performed. A total of 149 902 patients (4 randomized, 31 observational studies) were included (RA, 16 201, SV, 112 018, RITA, 21 683). At NMA, the use of SV was associated with higher long‐term mortality compared with the RA (incidence rate ratio, 1.23; 95% CI, 1.12–1.34) and RITA (incidence rate ratio, 1.26; 95% CI, 1.17–1.35). The risk of DSWI for SV was similar to RA but lower than RITA (odds ratio, 0.71; 95% CI, 0.55–0.91). There were no differences for any outcome between RITA and RA, although DSWI trended higher with RITA (odds ratio, 1.39; 95% CI, 0.92–2.1). The risk of DSWI in bilateral internal thoracic artery studies was higher when the skeletonization technique was not used. Conclusions The use of the RA or the RITA is associated with a similar and statistically significant long‐term clinical benefit compared with the SV. There are no differences in operative risk or complications between the 2 arterial conduits, but DSWI remains a concern with bilateral ITA when skeletonization is not used.

Background Rapid growth in transcatheter aortic valve replacement (TAVR) demand has translated to inadequate access, reflected by prolonged wait times. Increasing wait times are associated with important adverse outcomes while on the wait‐list; however, it is unknown if prolonged wait times influence postprocedural outcomes. Our objective was to determine the association between TAVR wait times and postprocedural outcomes. Methods and Results In this population‐based study in Ontario, Canada, we identified all TAVR procedures between April 1, 2010, and March 31, 2016. Wait time was defined as the number of days between initial referral and the procedure. Primary outcomes of interest were 30‐day all‐cause mortality and all‐cause readmission. Multivariable regression models incorporated wait time as a nonlinear variable, using cubic splines. The study cohort included 2170 TAVR procedures, of which 1741 cases were elective and 429 were urgent. There was a significant, nonlinear relationship between TAVR wait time and post‐TAVR 30‐day mortality, as well as 30‐day readmission. We observed an increased hazard associated with shorter wait times that diminished as wait times increased. This statistically significant nonlinear relationship was seen in the unadjusted model as well as after adjusting for clinical variables. However, after adjusting for case urgency status, there was no relationship between wait times and postprocedural outcomes. In sensitivity analyses restricted to either only elective or only urgent cases, there was no relationship between wait times and postprocedural outcomes. Conclusions Wait time has a complex relationship with postprocedural outcomes that is mediated entirely by urgency status. This suggests that further research should elucidate factors that predict hospitalization requiring urgent TAVR while on the wait list.

Background The debate on the relative benefits of off‐pump and on‐pump coronary artery bypass surgery (OPCABG and ONCABG) is still open. We aimed to provide an updated and complete summary of the evidence on the differences between OPCABG and ONCABG and to explore whether the length of the follow‐up and the surgeons’ experience in OPCABG modify the comparative results. Methods and Results All randomized clinical trials comparing OPCABG and ONCABG were included. Primary outcome was follow‐up mortality. Secondary outcomes were operative mortality, perioperative stroke, perioperative myocardial infarction, and late repeated revascularization. Subgroup analyses were performed based on the length of the follow‐up and the percentage of crossover from the OPCABG group (used as a surrogate of surgeon experience with OPCABG). One hundred four trials were included (20 627 patients, OPCABG: 10 288; ONCABG: 10 339). Weighted mean follow‐up time was 3.7 years (range 1–7.5 years). OPCABG was associated with a higher risk of follow‐up mortality (incidence rate ratio 1.11, 95% confidence interval 1.00–1.23, P=0.05). The difference was significant only for trials with mean follow‐up of ≥3 years and for studies with a crossover rate of ≥10%. There was a trend toward lower risk of perioperative stroke and higher need for late repeated revascularization in the OPCABG arm. Conclusions OPCABG is associated with a higher incidence of incomplete revascularization, an increased need for repeated revascularization, and decreased midterm survival compared with ONCABG. Surgeon inexperience in OPCABG is associated with late mortality.

BackgroundThis meta‐analysis was designed to assess whether center experience affects the short‐ and long‐term results and the relative benefits of bilateral internal thoracic artery grafting (BITA) for coronary artery bypass grafting. Methods and ResultsMEDLINE and EMBASE were searched to identify all articles reporting the outcome of BITA in patients undergoing coronary artery bypass grafting. The BITA center experience was gauged according to the percentage use of BITA in the institutional overall coronary artery bypass grafting population (%BITA). The primary outcome was long‐term all‐cause mortality. Secondary outcomes were operative mortality, perioperative myocardial infarction, perioperative stroke, deep sternal wound infections (DSWIs), and major postoperative adverse event. The rates of the primary and secondary outcomes were calculated after adjusting for %BITA. Primary and secondary outcomes were also compared between the BITA and the single internal thoracic artery arms in the adjusted studies. Meta‐regression was used to evaluate the effect of %BITA on the primary and secondary outcomes. Thirty‐four studies (27 894 patients undergoing BITA) were included. In the pooled analysis, the incidence rate for long‐term mortality was 2.83% (95% confidence interval, 2.21%–3.61%). %BITA was significantly and inversely associated with long‐term mortality and the rate of DSWI. In the pairwise comparison, %BITA was significantly and inversely associated with the risk of long‐term mortality and DSWI in the group undergoing BITA. ConclusionsBITA series with higher %BITA report significantly lower long‐term mortality and DSWI rate as well as higher long‐term survival advantage and lower relative risk of DSWI in their BITA cohort. These findings suggest that a specific volume‐outcome relationship exists for BITA grafting.

BackgroundObservational studies suggest a survival advantage with bilateral single internal thoracic artery (BITA) versus single internal thoracic artery grafting for coronary surgery, whereas this conclusion is not supported by randomized trials. We hypothesized that this inconsistency is attributed to unmeasured confounders intrinsic to observational studies. To test our hypothesis, we performed a meta‐analysis of the observational literature comparing BITA and single internal thoracic artery, deriving incident rate ratio for mortality at end of follow‐up and at 1 year. We postulated that BITA would not affect 1‐year survival based on the natural history of coronary artery bypass occlusion, so that a difference between groups at 1 year could not be attributed to the intervention. Methods and ResultsWe searched MEDLINE and Pubmed to identify all observational studies comparing the outcome of BITA versus single internal thoracic artery. One‐year and long‐term mortality for BITA and single internal thoracic artery were compared in the propensity‐score–matched (PSM) series, that is, the form of observational evidence less prone to confounders. Thirty‐eight observational studies (174 205 total patients) were selected for final comparison. In the 12 propensity‐score–matched series (34 019 patients), the mortality reduction for BITA was similar at 1 year and at the end of follow‐up (incident rate ratio, 0.70; 95% confidence interval, 0.60–0.82 versus 0.77; 95% confidence interval, 0.70–0.85; P for subgroup difference=0.43). ConclusionsUnmeasured confounders, rather than biological superiority, may explain the survival advantage of BITA in observational series.

BackgroundEthnicity is an important predictor of coronary artery bypass graft surgery (CABG) outcomes. South Asians (SA), one of the largest ethnic groups with a high burden of cardiovascular disease, are hypothesized to have inferior outcomes after CABG compared to other ethnic groups. Given the paucity and controversy of literature in this area, the objective of this study was to examine the impact of SA versus the general population (GP) on long‐term outcomes following CABG. Method and ResultsUsing administrative databases and a surname algorithm, 83 850 patients (SA: 2653, GP: 81 197) who underwent isolated CABG in Ontario, Canada from 1996 to 2007 were identified; mean follow‐up was 9.1±3.9 years. SA were younger (SA: 61.7±9.4, GP: 64.1±10.0 years, standardized difference=0.25) with more cardiac risk factors, including diabetes (SA: 54.1%, GP: 34.9%, standardized difference =0.40). Propensity‐score matching resulted in 2473 matched pairs between SA and GP with all baseline covariates being balanced (standardized difference