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Aortic stenosis (AS) is a serious and complex condition, for which optimal management continues to evolve rapidly. An understanding of current clinical practice guidelines is critical to effective patient care and shared decision-making. This state of the art review of the 2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines and 2020 American College of Cardiology/American Heart Association Guidelines compares their recommendations for AS based on the evidence to date. The European and American guidelines were generally congruent with the exception of three key distinctions. First, the European guidelines recommend intervening at a left ventricular ejection fraction of 55%, compared with 60% over serial imaging by the American guidelines for asymptomatic patients. Second, the European guidelines recommend a threshold of ≥65 years for surgical bioprosthesis, whereas the American guidelines employ multiple age categories, providing latitude for patient factors and preferences. Third, the guidelines endorse different age cut-offs for transcatheter vs. surgical aortic valve replacement, despite limited evidence. This review also discusses trends indicating a decreasing proportion of mechanical valve replacements. Finally, the review identifies gaps in the literature for areas including transcatheter aortic valve implantation in asymptomatic patients, the appropriateness of Ross procedures, concomitant coronary revascularization with aortic valve replacement, and bicuspid AS. To summarize, this state of the art review compares the latest European and American guidelines on the management of AS to highlight three areas of divergence: timing of intervention, valve selection, and surgical vs. transcatheter aortic valve replacement criteria.

Randomized trials have compared percutaneous coronary intervention and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease undergoing nonemergent revascularization. However, there is a paucity of real-world contemporary observational studies comparing percutaneous coronary intervention (PCI) and CABG.To compare the long-term clinical outcomes of CABG versus PCI in patients with left main coronary disease.Clinical and administrative databases for Ontario, Canada, were linked to obtain records of all patients with angiographic evidence of left main coronary artery disease (≥50% stenosis) treated with either isolated CABG or PCI from 2008 to 2020. Emergent, cardiogenic shock, and ST-segment elevation myocardial infarction patients were excluded. Baseline characteristics of patients were compared and 1:1 propensity score matching was performed. Late mortality and major adverse cardiac and cerebrovascular events were compared between the matched groups using a Cox proportional hazard model.After exclusions, 1,299 and 21,287 patients underwent PCI and CABG, respectively. Prior to matching, PCI patients were older (75.2 vs 68.0 years) and more likely to be women (34.6% vs 20.1%), although they had less CAD burden. Propensity score matching on 25 baseline covariates yielded 1,128 well-matched pairs. There was no difference in early mortality between PCI and CABG (5.5% vs 3.9%; P = 0.075). Over 7-year follow-up, all-cause mortality (53.6% vs 35.2%; HR: 1.63; 95% CI: 1.42-1.87; P 0.001) and major adverse cardiac and cerebrovascular events (66.8% vs 48.6%; HR: 1.77; 95% CI: 1.57-2.00) were significantly higher with PCI than CABG.CABG was the most common revascularization strategy in this real-world registry. Patients undergoing PCI were much older and of higher risk at baseline. After matching, there was no difference in early mortality but improved late survival and freedom from major adverse cardiac and cerebrovascular events with CABG.

Background Coronary artery bypass grafting (CABG) and surgical aortic valve replacement (AVR) are the 2 most common cardiac surgery procedures in North America. We derived and externally validated clinical models to estimate the likelihood of death within 30 days of CABG, AVR or combined CABG + AVR. Methods We obtained data from the CorHealth Ontario Cardiac Registry and several linked population health administrative databases from Ontario, Canada. We derived multiple logistic regression models from all adult patients who underwent CABG, AVR or combined CABG + AVR from April 2017 to March 2019, and validated them in 2 temporally distinct cohorts (April 2015 to March 2017 and April 2019 to March 2020). Results The derivation cohorts included 13 435 patients who underwent CABG (30-d mortality 1.73%), 1970 patients who underwent AVR (30-d mortality 1.68%) and 1510 patients who underwent combined CABG + AVR (30-d mortality 3.05%). The final models for predicting 30-day mortality included 15 variables for patients undergoing CABG, 5 variables for patients undergoing AVR and 5 variables for patients undergoing combined CABG + AVR. Model discrimination was excellent for the CABG (c-statistic 0.888, optimism-corrected 0.866) AVR (c-statistic 0.850, optimism-corrected 0.762) and CABG + AVR (c-statistic 0.844, optimism-corrected 0.776) models, with similar results in the validation cohorts. Interpretation Our models, leveraging readily available, multidimensional data sources, computed accurate risk-adjusted 30-day mortality rates for CABG, AVR and combined CABG + AVR, with discrimination comparable to more complex American and European models. The ability to accurately predict perioperative mortality rates for these procedures will be valuable for quality improvement initiatives across institutions.

Background Transcatheter aortic valve replacement (TAVR)/intervention has become the standard of care for treatment of severe aortic stenosis across the spectrum of risk. There are socioeconomic disparities in access to TAVR. The impact of these disparities on postprocedural outcomes remains unknown. Our objective was to examine the association between neighborhood‐level social deprivation and post‐TAVR mortality and hospital readmission. Methods and Results We conducted a population‐based retrospective cohort study of all 4145 patients in Ontario, Canada, who received TAVR from April 1, 2017, to March 31, 2020. Our co‐primary outcomes were 1‐year postprocedure mortality and 1‐year postprocedure readmission. Using Cox proportional hazards models for mortality and cause‐specific competing risk hazard models for readmission, we evaluated the relationship between neighborhood‐level measures of residential instability, material deprivation, and concentration of racial and ethnic groups with post‐TAVR outcomes. After multivariable adjustment, we found a statistically significant relationship between residential instability and postprocedural 1‐year mortality, ranging from a hazard ratio of 1.64 to a hazard ratio of 2.05. There was a significant association between the highest degree of residential instability and 1‐year readmission (hazard ratio, 1.23 [95% CI, 1.01–1.49]). There was no association between material deprivation and concentration of racial and ethnic groups with post‐TAVR outcomes. Conclusions Residential instability was associated with increased risk for post‐TAVR mortality, and the highest quintile of residential instability was associated with increased post‐TAVR readmission. To reduce health disparities and promote an equitable health care system, further research and policy interventions will be required to identify and support economically and socially minoritized patients undergoing TAVR.

Background The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial decreased major adverse cardiovascular events with very low‐dose rivaroxaban and aspirin in patients with coronary artery disease and peripheral artery disease. We examined the eligibility and potential real‐world impact of this strategy on the COMPASS‐eligible population. Methods and Results COMPASS eligibility criteria were applied to the CANHEART (Cardiovascular Health in Ambulatory Care Research Team) registry, a population‐based cohort of Ontario adults. We compared 5‐year major adverse cardiovascular events and major bleeding rates stratified by COMPASS eligibility and by clinical risk factors. We applied COMPASS trial rivaroxaban/aspirin arm hazard ratios to estimate the potential impact on the COMPASS‐eligible cohort. Among 362 797 patients with coronary artery disease or peripheral artery disease, 38% were deemed eligible, 47% ineligible, and 15% indeterminate. Among eligible patients, a greater number of risk factors was associated with higher rates of cardiovascular outcomes, whereas bleeding rates increased minimally. Over 5 years, applying COMPASS treatment effects to eligible patients resulted in a 2.4% absolute risk reduction of major adverse cardiovascular events and a number needed to treat of 42, and a 1.3% absolute risk increase of major bleeding and number needed to harm (NNH) of 77. Those with at least 2 risk factors had a 3.0% absolute risk reduction of major adverse cardiovascular events (number needed to treat =34) and a 1.6% absolute risk increase of major bleeding (number needed to harm =61). Conclusions Implementation of very‐low‐dose rivaroxaban therapy would potentially impact ≈ $$ \approx $$ 2 in 5 patients with atherosclerotic disease in Ontario. Eligible individuals with ≥ $$ \ge $$ 2 comorbidities represent a high‐risk subgroup that may derive the greatest benefit‐to‐risk ratio. Selection of patients with high‐risk predisposing factors appears appropriate in routine practice.

The reverse fragility index (RFI) describes the number of event conversions needed to convert a statistically non-significant dichotomous outcome to significant. The objective of this study was to assess the RFI of vascular surgery randomized controlled trials (RCTs) comparing endovascular vs. open surgery in the treatment of abdominal aortic aneurysms (AAA), carotid artery stenosis (CAS), and peripheral artery disease (PAD).MEDLINE and Embase were searched for RCTs investigating AAA, CAS, or PAD with statistically non-significant binary primary outcomes. The primary outcome of this study was the median RFI. Calculation of the RFI was done by creating two-by-two contingency tables and subtracting events from the group with fewer events while adding non-events to the same group until a two-tailed Fisher exact test produced a statistically significant result (p≤0.05).Of 4187 articles, 49 studies reporting 103 different primary endpoints were included. The overall median RFI was 7 (IQR 5, 13). The specific RFIs for AAA, CAS, and PAD were 10 (6-15.5), 6 (5-9.5), and 7 (5.5 -10) respectively. 42 (47%) endpoints had a loss to follow-up greater than RFI, of which 10 (24%) were AAA trials, 23 (55%) CAS trials, and 9 (21%) PAD trials. Pearson correlation demonstrated a significant positive relationship between a study's RFI to the impact factor of its publishing journal (r=0.38 [95% CI 0.20 to 0.54], p0.01), length of follow-up (r=0.43 [95% CI: 0.26 to 0.58], p0.01), and sample size (r = 0.28, 95% CI: 0.09 to 0.45, p0.01).A small number of events (median 7) were required to change the outcome of negative RCTs from statistically non-significant to significant with 47% of studies missing data that could have reversed the finding of its primary outcome. Reporting of the RFI relative to the loss-to-follow-up may be of benefit in future trials and provide confidence towards the robustness of P-value.

Background The novel SARS-CoV-2 (COVID-19) pandemic has dramatically altered the delivery of healthcare services, resulting in significant referral pattern changes, delayed presentations, and procedural delays. Our objective was to determine the effect of the COVID-19 pandemic on all-cause mortality in patients awaiting commonly performed cardiac procedures. Methods Clinical and administrative data sets were linked to identify all adults referred for: (1) percutaneous coronary intervention; (2) coronary artery bypass grafting; (3) valve surgery; and (4) transcatheter aortic valve implantation, from January 2014 to September 2020 in Ontario, Canada. Piece-wise regression models were used to determine the effect of the COVID-19 pandemic on referrals and procedural volume. Multivariable Cox proportional hazards models were used to determine the effect of the pandemic on waitlist mortality for the 4 procedures. Results We included 584,341 patients who were first-time referrals for 1 of the 4 procedures, of whom 37,718 (6.4%) were referred during the pandemic. The pandemic period was associated with a significant decline in the number of referrals and procedures completed compared with the prepandemic period. Referral during the pandemic period was a significant predictor for increased all-cause mortality for the percutaneous coronary intervention (hazard ratio, 1.83; 95% confidence interval, 1.47-2.27) and coronary artery bypass grafting (hazard ratio, 1.96; 95% confidence interval, 1.28-3.01), but not for surgical valve or transcatheter aortic valve implantation referrals. Procedural wait times were shorter during the pandemic period compared with the prepandemic period. Conclusions There was a significant decrease in referrals and procedures completed for cardiac procedures during the pandemic period. Referral during the pandemic was associated with increased all-cause mortality while awaiting coronary revascularization.

Background: Waitlist management is a global challenge. For patients with severe cardiovascular diseases awaiting cardiac surgery, prolonged wait times are associated with unplanned hospitalizations. To facilitate evidence-based resource allocation, we derived and validated a clinical risk model to predict the composite outcome of death and cardiac hospitalization of patients on the waitlist for cardiac surgery. Methods: We used the CorHealth Ontario Registry and linked ICES health care administrative databases, which have information on all Ontario residents. We included patients 18 years or older who waited at home for coronary artery bypass grafting, valvular or thoracic aorta surgeries between 2008 and 2019. The primary outcome was death or an unplanned cardiac hospitalizaton, defined as nonelective admission for heart failure, myocardial infarction, unstable angina or endocarditis. We randomly divided two-thirds of these patients into derivation and one-third into validation data sets. We derived the model using a multivariable Cox proportional hazard model with backward stepwise variable selection. Results: Among 62 375 patients, 41 729 patients were part of the derivation data set and 20 583 were part of the validation data set. Of the total, 3033 (4.9%) died or had an unplanned cardiac hospitalization while waiting for surgery. The area under the curve of our model at 15, 30, 60 and 89 days was 0.85, 0.82, 0.81 and 0.80, respectively, in the derivation cohort and 0.83, 0.80, 0.78 and 0.78, respctively, in the validation cohort. The model calibrated well at all time points. Interpretation: We derived and validated a clinical risk model that provides accurate prediction of the risk of death and unplanned cardiac hospitalization for patients on the cardiac surgery waitlist. Our model could be used for quality benchmarking and data-driven decision support for managing access to cardiac surgery.

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.

OBJECTIVES We used individual patient data from 4 of the largest contemporary coronary bypass surgery trials to evaluate differences in long-term outcomes when radial artery (RA), right internal thoracic artery (RITA) or saphenous vein graft (SVG) are used to complement the left internal thoracic artery-to-left anterior descending graft. METHODS Primary outcome was all-cause mortality. Secondary outcome was a composite of major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction and stroke). Propensity score matching and Cox regression were used to reduce the effect of treatment selection bias and confounders. RESULTS A total of 10 256 patients (1510 RITA; 1385 RA; 7361 SVG) were included. The matched population consisted of 1776 propensity score-matched triplets. The mean follow-up was 7.9 ± 0.1, 7.8 ± 0.1 and 7.8 ± 0.1 years in the RITA, RA and SVG cohorts respectively. All-cause mortality was significantly lower in the RA versus the SVG [hazard ratio (HR) 0.62, 95% confidence interval (CI): 0.51–0.76, P = 0.003] and the RITA group (HR 0.59, 95% CI 0.48–0.71, P = 0.001). Major adverse cardiac and cerebrovascular event rate was also lower in the RA group versus the SVG (HR 0.78, 95% CI 0.67–0.90, P = 0.04) and the RITA group (HR 0.75, 95% CI 0.65–0.86, P = 0.02). Results were consistent in the Cox-adjusted analysis and solid to hidden confounders. CONCLUSIONS In this pooled analysis of 4 large coronary bypass surgery trials, the use of the RA was associated with better clinical outcomes when compared to SVG and RITA.

Background There remains a paucity of real-world observational evidence comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with diabetes and multivessel coronary artery disease (CAD). Objectives This study compared early and long-term outcomes of PCI versus CABG in patients with diabetes. Methods Clinical and administrative databases in Ontario, Canada were linked to obtain records of all patients with diabetes with angiographic evidence of 2- or 3-vessel CAD who were treated with either PCI or isolated CABG from 2008 to 2017. A 1:1 propensity score match was performed to account for baseline differences. All-cause mortality and the composite of myocardial infarction, repeat revascularization, stroke, or death (termed major cardiovascular and cerebrovascular events [MACCEs]) were compared between the matched groups using a stratified log-rank test and Cox proportional hazards model. Results A total of 4,519 and 9,716 patients underwent PCI and CABG, respectively. Before matching, patients who underwent CABG were significantly younger (age 65.7 years vs. 68.3 years), were more likely to be men (78% vs. 73%) and had more severe CAD. Propensity score matching based on 23 baseline covariates yielded 4,301 well-balanced pairs. There was no difference in early mortality between PCI and CABG (2.4% vs. 2.3%; p = 0.721) after matching. The median and maximum follow-ups were 5.5 and 11.5 years, respectively. All-cause mortality (hazard ratio [HR]: 1.39; 95% CI: 1.28 to 1.51) and overall MACCEs (HR: 1.99; 95% CI: 1.86 to 2.12) were significantly higher with PCI compared with CABG. Conclusions In patients with multivessel CAD and diabetes, CABG was associated with improved long-term mortality and freedom from MACCEs compared with PCI.

Unstructured Abstract (250 words) In Ontario, on March 16th, 2020, a directive was issued to all acute care hospitals to halt non-essential procedures in anticipation for a potential surge in COVID-19 patients. This included scheduled outpatient cardiac surgical and interventional procedures that required the use of intensive care units, ventilators, and skilled critical care personnel, given that these procedures would draw from the same pool of resources required for critically ill COVID-19 patients. We adapted the COVID-19 Resource Estimator (CORE) decision analytic model by adding a cardiac component to determine the impact of various policy decisions on the incremental waitlist growth and estimated waitlist mortality for three key groups of cardiovascular disease patients; coronary artery disease, valvular heart disease, and arrhythmias. We provided predictions based on COVID-19 epidemiology available in real-time, in 3 phases. First, in the initial crisis phase, in a worst case scenario, we showed that the potential number of waitlist related cardiac deaths would be orders of magnitude less than those who would die of COVID-19 if critical cardiac care resources were diverted to the care of COVID-19 patients. Second, with better local epidemiology data, we predicted that across five regions of Ontario, there may be insufficient resources to resume all elective outpatient cardiac procedures. Finally in the recovery phase, we showed that the estimated incremental growth in waitlist for all cardiac procedures is likely substantial. These outputs informed timely, data-driven decisions during the COVID-19 pandemic regarding the provision of cardiovascular care., In Ontario, on March 16th, 2020, a directive was issued to all acute care hospitals to halt non-essential procedures in anticipation for a potential COVID-19 patient surge. This manuscript provides examples of how decision analytic models have helped informed policy decisions and to assess the impact of these policies on incremental waitlist activity for cardiac procedures during the COVID-19 pandemic.

Background: Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain. Methods: Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years). Results: Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was Conclusions: According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

Aims The economic value of transcatheter aortic valve replacement (TAVR) in low surgical risk patients with severe, symptomatic aortic stenosis is not known. Our objective was to determine the cost-effectiveness of balloon-expandable TAVR and self-expandable TAVR relative to surgical aortic valve replacement (SAVR) in low-risk patients. Methods and results A fully probabilistic Markov cohort model was constructed to estimate differences in costs and effectiveness [quality-adjusted life years (QALYs)] over the patient’s life-time time from the third-party payer’s perspective. Clinical outcomes modelled were alive/well (no complications), permanent stroke, ≥moderate paravalvular leak, new pacemaker, rehospitalization, and death. A network meta-analysis of the PARTNER 3 and Evolut Low Risk trial was performed to compare balloon-expandable TAVR, self-expandable TAVR, and SAVR for the efficacy inputs. Incremental-cost effectiveness ratios (ICER) were calculated. The total life-time costs in the balloon-expandable TAVR, self-expandable-TAVR, and SAVR arms were $37 330 ± 4724, $39 660 ± 4862, and $34 583 ± 6731, respectively, and total life-time QALYs gained were 9.15 ± 3.23, 9.13 ± 3.23, and 9.05 ± 3.20, respectively. The ICERs for balloon-expandable TAVR and self-expandable TAVR against SAVR were $27 196/QALY and $59 641/QALY, respectively. Balloon-expandable TAVR was less costly and more effective than self-expandable TAVR. There was substantial uncertainty, with 53% and 58% of model iterations showing balloon-expandable TAVR to be the preferred option at willingness-to-pay thresholds of $50 000/QALY and $100 000/QALY, respectively. Conclusion Compared with SAVR, TAVR, particularly with balloon-expandable prostheses may be a cost-effective option for patients with severe aortic stenosis at low surgical risk.

Aortic valve-sparing operations theoretically have fewer stroke and bleeding complications but may increase late reoperation risk versus composite valve grafts.We meta-analyzed all studies comparing aortic valve-sparing (reimplantation and remodelling) and composite valve-grafting (bioprosthetic and mechanical) procedures. Early outcomes were all-cause mortality, reoperation for bleeding, myocardial infarction, and thromboembolism/stroke. Long-term outcomes included all-cause mortality, reintervention, bleeding, and thromboembolism/stroke. Studies exclusively investigating dissection or pediatric populations were excluded.A total of 3794 patients who underwent composite valve grafting and 2424 who underwent aortic valve-sparing procedures were included from 9 adjusted and 17 unadjusted observational studies. Mean follow-up was 5.8 ± 3.0 years. Aortic valve sparing was not associated with any difference in early mortality, bleeding, myocardial infarction, or thromboembolic complications. Late mortality was significantly lower after valve sparing (incident risk ratio, 0.68; 95% confidence interval [CI], 0.54-0.87; P.01). Late thromboembolism/stroke (incident rate ratio, 0.36; 95% CI, 0.22-0.60; P.01) and bleeding (incident rate ratio, 0.21; 95% CI, 0.11-0.42; P .01) risks were lower after valve sparing. Procedure type did not affect late reintervention.Aortic valve sparing appears to be safe and associated with reduced late mortality, thromboembolism/stroke, and bleeding compared with composite valve grafting. Late durability is equivalent. Aortic valve sparing should be considered in patients with favorable aortic valve morphology.

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.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

Objectives The aim of this study was to compare early and late outcomes between redo surgical aortic valve replacement (AVR) and valve-in-valve (ViV) transcatheter AVR. Background Published studies to date comparing redo surgical AVR (RS) with ViV transcatheter AVR for failed biological prostheses have been small and limited to early outcomes. Methods Clinical and administrative databases for Ontario, Canada’s most populous province, were linked to obtain patients undergoing ViV and RS for failed previous biological prostheses. Propensity score matching was performed to account for differences in baseline characteristics. Early outcomes were compared using the McNemar test. Late mortality was compared between the matched groups using a Cox proportional hazards model. Results A total of 558 patients undergoing intervention for failed biological prostheses between March 31, 2008, and September 30, 2017, at 11 Ontario institutions (ViV, n = 214; RS, n = 344) were included. Patients who underwent ViV were older and had more comorbidities. Propensity matching on 27 variables yielded similar groups for comparison (n = 131 pairs). Mean time from initial AVR to RS or ViV was 8.6 ± 4.4 years and 11.3 ± 4.5 years, respectively. Thirty-day mortality was significantly lower with ViV compared with RS (absolute risk difference: −7.5%; 95% confidence interval: −12.6% to −2.3%). The rates of permanent pacemaker implantation and blood transfusions were also lower with ViV, as was length of stay. Survival at 5 years was higher with ViV (76.8% vs. 66.8%; hazard ratio: 0.55; 95% confidence interval: 0.30 to 0.99; p = 0.04). Conclusions ViV TAVR was associated with lower early mortality, morbidity, and length of hospital stay and with increased survival compared with RS and may be the preferred approach for the treatment of failed biological prostheses.

Objective Cerebral protection for aortic arch surgery has been widely studied, but comparisons of all the available strategies have rarely been performed. We performed direct and indirect comparisons of antegrade cerebral perfusion, retrograde cerebral perfusion, and deep hypothermic circulatory arrest in a network meta-analysis. Methods After a systematic literature search, studies comparing any combination of antegrade cerebral perfusion, retrograde cerebral perfusion, and deep hypothermic circulatory arrest were included, and a frequentist network meta-analysis was performed using the generic inverse variance method. The primary outcomes were postoperative stroke and operative mortality. Secondary outcomes were postoperative transient neurologic deficits, myocardial infarction, respiratory complications, and renal failure. Results A total of 68 studies were included with a total of 26,968 patients. Compared with deep hypothermic circulatory arrest, both antegrade cerebral perfusion and retrograde cerebral perfusion were associated with significantly lower postoperative stroke and operative mortality rates: antegrade cerebral perfusion (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.51-0.75; and OR, 0.63, 95% CI, 0.51-0.76, respectively) and retrograde cerebral perfusion (OR, 0.66; 95% CI, 0.54-0.82; and OR, 0.57; 95% CI, 0.45-0.71, respectively). Antegrade cerebral perfusion and retrograde cerebral perfusion were associated with similar incidence of primary outcomes. No difference among the 3 techniques was found in secondary outcomes. At meta-regression, circulatory arrest duration correlated with the neuroprotective effect of antegrade cerebral perfusion and retrograde cerebral perfusion compared with deep hypothermic circulatory arrest. Unilateral or bilateral antegrade cerebral perfusion and arrest temperature did not influence the results. Conclusions Antegrade cerebral perfusion and retrograde cerebral perfusion are associated with better postoperative outcomes compared with deep hypothermic circulatory arrest, and the relative benefit increases with the duration of the circulatory arrest. No differences between antegrade cerebral perfusion and retrograde cerebral perfusion were found for all the explored outcomes.