Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study.

BACKGROUND: Post-operative AF (POAF) is the most common complication following cardiac surgery, occurring in 30% to 60% of patients undergoing bypass and/or valve surgery. POAF is associated with longer intensive care unit/hospital stays, increased healthcare utilization, and increased morbidity and mortality. Injection of botulinum toxin type A into the epicardial fat pads resulted in reduction of AF in animal models, and in two clinical studies of cardiac surgery patients, without new safety observations. METHODS: The objective of NOVA is to assess the use of AGN-151607 (botulinum toxin type A) for prevention of POAF in cardiac surgery patients. This randomized, multi-site, placebo-controlled trial will study one-time injections of AGN-151607 125 U (25 U / fat pad) and 250 U (50 U / fat pad) or placebo during cardiac surgery in ∼330 participants. Primary endpoint: % of patients with continuous AF ≥ 30 s. Secondary endpoints include several measures of AF frequency, duration, and burden. Additional endpoints include clinically important tachycardia during AF, time to AF termination, and healthcare utilization. Primary and secondary efficacy endpoints will be assessed using continuous ECG monitoring for 30 days following surgery. All patients will be followed for up to 1 year for safety. CONCLUSIONS: The NOVA Study will test the hypothesis that injections of AGN-151607 will reduce the incidence of POAF and associated resource utilization. If demonstrated to be safe and effective, the availability of a one-time therapy for the prevention of POAF would represent an important treatment option for patients undergoing cardiac surgery.

Coronary endarterectomy in patients with diffuse coronary artery disease: assessment of graft patency with computed tomography angiography.

BACKGROUND: With a growing population of patients with advanced coronary artery disease (CAD), many of whom have undergone prior percutaneous coronary interventions, coronary endarterectomy (CE) allows for the extension of revascularization in patients with otherwise limited options. Whether adjunctive CE associated with standard surgery, combined with contemporary antiplatelet therapy, improves outcomes remains largely unknown. METHODS: We studied 147 consecutive patients who underwent 154 adjunctive CE procedures for advanced CAD between January 2015 and January 2018. We used computed tomography angiography (CTA) in a subgroup of 32 consecutive patients who underwent CE during coronary artery bypass grafting after June 2016 to assess graft and coronary patency. RESULTS: Patients (mean age 67 ± SD 10 yr) underwent CE of the right (102 patients), the left anterior descending (LAD, 22 patients) and the circumflex (17 patients) coronary arteries. Seven patients (5%) experienced a procedural myocardial infarction and there were no perioperative deaths. Among the 32 patients who underwent CTA 3 months after surgery, the mean patency of the endarterectomized coronary arteries and bypass grafts was 90% and 88%, respectively. All 6 arterial grafts on the LAD artery were patent. The mean survival rate and the mean rate of freedom from major adverse cardiovascular events was 95% ± 2% and 95% ± 6%, respectively. The patency rate was 100 % for patients evaluated at 3-year follow up. CONCLUSION: Coronary endarterectomy offers a surgical option for patients with diffuse CAD who may be unsuitable for coronary bypass alone. Grafts and endarterectomized coronary artery patency remain adequate and explain the excellent patient survival and the freedom rate from major adverse cardiovascular events.

Cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented impact on health care and cardiac surgery. We report cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic. METHODS: A detailed survey was sent to recruit participating adult cardiac surgery centers in North America. Data regarding cardiac surgeons' perceptions and changes in practice were analyzed. RESULTS: Our study comprises 67 institutions with diverse geographic distribution across North America. Nurses were most likely to be redeployed (88%), followed by advanced care practitioners (69%), trainees (28%), and surgeons (25%). Examining surgeon concerns in regard to COVID-19, they were most worried with exposing their family to COVID-19 (81%), followed by contracting COVID-19 (68%), running out of personal protective equipment (PPE) (28%), and hospital resources (28%). In terms of PPE conservation strategies among users of N95 respirators, nearly half were recycling via decontamination with ultraviolet light (49%), followed by sterilization with heat (13%) and at home or with other modalities (13%). Reuse of N95 respirators for 1 day (22%), 1 week (21%) or 1 month (6%) was reported. There were differences in adoption of methods to conserve N95 respirators based on institutional pandemic phase and COVID-19 burden, with higher COVID-19 burden institutions more likely to resort to PPE conservation strategies. CONCLUSIONS: The present study demonstrates the impact of COVID-19 on North American cardiac surgeons. Our study should stimulate further discussions to identify optimal solutions to improve workforce preparedness for subsequent surges, as well as facilitate the navigation of future healthcare crises.

Mesenchymal stem cell mediates cardiac repair through autocrine, paracrine and endocrine axes.

In the past decade, despite key advances in therapeutic strategies following myocardial infarction, none can directly address the loss of cardiomyocytes following ischemic injury. Cardiac cell-based therapy is at the cornerstone of regenerative medicine that has shown potential for tissue repair. Mesenchymal stem cells (MSC) represent a strong candidate to heal the infarcted myocardium. While differentiation potential has been described as a possible avenue for MSC-based repair, their secreted mediators are responsible for the majority of the ascribed prohealing effects. MSC can either promote their own survival and proliferation through autocrine effect or secrete trophic factors that will act on adjacent cells through a paracrine effect. Prior studies have also documented beneficial effects even when MSCs were remotely delivered, much akin to an endocrine mechanism. This review aims to distinguish the paracrine activity of MSCs from an endocrine-like effect, where remotely transplanted cells can promote healing of the injured myocardium.

The Department of Surgery of the Université de Montréal, 70th anniversary.

SUMMARY: The Department of Surgery of the Université de Montréal was officially chartered in 1961, but the structure had been in place since since 1951. The department grew as a fusion of hospital-based surgery training programs from the largest French-speaking hospitals in Montreal. Currently 448 professors (135 women and 313 men) teach in the department. The research activity, both clinical and applied, is in strong progression. The Department of Surgery is the largest French and bilingual training centre in Canada and North America. In 2021 the department will celebrate its 70th anniversary. As members, we should be proud of the work achieved by our predecessors and by the current rank of professors, teachers and researchers. The department strives to promote the essential role of and highlight the rewards and benefits of academic surgery.

Malnutrition and Mortality in Frail and Non-Frail Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be determined. METHODS: The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. RESULTS: There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01-1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001-1.12). CONCLUSIONS: Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.

Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation.

BACKGROUND: In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial. METHODS: We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed. RESULTS: Among surviving patients, the mean (±SD) 2-year LVESVI was 52.6±27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6±39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P<0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07). CONCLUSIONS: In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00807040.).

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.

BACKGROUND: Atrial fibrillation after cardiac surgery is associated with increased rates of death, complications, and hospitalizations. In patients with postoperative atrial fibrillation who are in stable condition, the best initial treatment strategy--heart-rate control or rhythm control--remains controversial. METHODS: Patients with new-onset postoperative atrial fibrillation were randomly assigned to undergo either rate control or rhythm control. The primary end point was the total number of days of hospitalization within 60 days after randomization, as assessed by the Wilcoxon rank-sum test. RESULTS: Postoperative atrial fibrillation occurred in 695 of the 2109 patients (33.0%) who were enrolled preoperatively; of these patients, 523 underwent randomization. The total numbers of hospital days in the rate-control group and the rhythm-control group were similar (median, 5.1 days and 5.0 days, respectively; P=0.76). There were no significant between-group differences in the rates of death (P=0.64) or overall serious adverse events (24.8 per 100 patient-months in the rate-control group and 26.4 per 100 patient-months in the rhythm-control group, P=0.61), including thromboembolic and bleeding events. About 25% of the patients in each group deviated from the assigned therapy, mainly because of drug ineffectiveness (in the rate-control group) or amiodarone side effects or adverse drug reactions (in the rhythm-control group). At 60 days, 93.8% of the patients in the rate-control group and 97.9% of those in the rhythm-control group had had a stable heart rhythm without atrial fibrillation for the previous 30 days (P=0.02), and 84.2% and 86.9%, respectively, had been free from atrial fibrillation from discharge to 60 days (P=0.41). CONCLUSIONS: Strategies for rate control and rhythm control to treat postoperative atrial fibrillation were associated with equal numbers of days of hospitalization, similar complication rates, and similarly low rates of persistent atrial fibrillation 60 days after onset. Neither treatment strategy showed a net clinical advantage over the other. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT02132767.).

Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation.

BACKGROUND: In a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. METHODS: We randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. RESULTS: At 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, -14.1 ml per square meter and -14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-procedure group (hazard ratio in the combined-procedure group, 0.90; 95% confidence interval, 0.45 to 1.83; P=0.78). There was no significant between-group difference in the rank-based assessment of the LVESVI (including death) at 2 years (z score, 0.38; P=0.71). The 2-year rate of moderate or severe residual mitral regurgitation was higher in the CABG-alone group than in the combined-procedure group (32.3% vs. 11.2%, P<0.001). Overall rates of hospital readmission and serious adverse events were similar in the two groups, but neurologic events and supraventricular arrhythmias remained more frequent in the combined-procedure group. CONCLUSIONS: In patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not lead to significant differences in left ventricular reverse remodeling at 2 years. Mitral-valve repair provided a more durable correction of mitral regurgitation but did not significantly improve survival or reduce overall adverse events or readmissions and was associated with an early hazard of increased neurologic events and supraventricular arrhythmias. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).

Best practices for enhancing surgical research: a perspective from the Canadian Association of Chairs of Surgical Research

Summary: The Canadian Association of Chairs of Surgical Research was created in 2014, with representation from every departmental surgical research committee across Canada, to establish Canadian surgical research as a beacon for health care innovation and to propose solutions for the daily challenges facing surgeon-researchers. Our key mandate has been to identify challenges for surgeons and scientists performing research to prevent further erosion of this vital area of activity that benefits patients, health care service providers and Canadian society. This article outlines the findings of a nationwide survey sent to all members of departments of surgery across Canada, seeking input on current threats and potential solutions. The results suggest that surgical research in Canada is experiencing a decline in funding and an increase in challenges affecting research productivity of academic surgeons, such as pressures to be clinically active, unpredictable surgical schedules, growing administrative demands, and increasing complexity of patient populations. Although surgeons are productive in their research endeavours, institutional changes and sharing of best practices are needed to ensure sustainable growth of research programs.

Pharmacokinetics and Pharmacodynamics of Nebulized and Intratracheal Milrinone in a Swine Model of Hypercapnia Pulmonary Hypertension.

OBJECTIVES: Milrinone pulmonary administration is used currently for the treatment of pulmonary hypertension. Several methods are available: simple jet nebulization, vibrating mesh nebulization, intratracheal instillation, and intratracheal atomization. The aim of this study was to explore the concentration-effect relationship of milrinone for each of these methods. DESIGN: Observational open-label pharmacokinetic/pharmacodynamics cohort study. SETTING: Single-center, hospital animal laboratory. PARTICIPANTS: Twelve swine. INTERVENTIONS: After hypercapnia pulmonary hypertension, swine were administered equivalent inhaled milrinone doses of 15 or 50 µg/kg through simple jet nebulization, vibrating mesh nebulization, intratracheal instillation, and intratracheal atomization. MEASUREMENTS AND MAIN RESULTS: Blood and urine samples were taken up to 360 minutes postadministration. The ratio of mean systemic arterial pressure to mean pulmonary arterial pressure was monitored continuously. Right heart echographies were taken before and after hypercapnia and after drug administration. Mean elimination half-lives were similar for the 4 administrations. Mean percent changes in the ratio were of 37 (60%), 18 (31%), 17 (36%), and 20 (20%), for simple jet nebulization, vibrating mesh nebulization, intratracheal instillation, and intratracheal atomization, respectively. Mean maximum plasma concentrations for intratracheal administrations were reached at 8 and 45 min for atomization and instillation, respectively. Significant increases in right atrial diameter and right ventricular end-diastolic area were witnessed during pulmonary hypertension as well as a return to baseline values after milrinone administration. CONCLUSIONS: The intratracheal methods, particularly intratracheal atomization, showed less hemodynamic effect than nebulizations and, in the case of intratracheal instillation, unpredictable drug exposure. Nebulization methods on the other hand, especially simple jet nebulization, suggest better efficacy and sensitivity but are less fit for emergency situations.

The effect of storage solutions, gene therapy, and antiproliferative agents on endothelial function and saphenous vein graft patency.

Vein graft failure remains a major concern after coronary artery bypass graft operations, and is initiated by loss of endothelial cell integrity. Preservation of saphenous vein grafts in the optimal solution after meticulous harvesting can limit the endothelial damage. Despite both experimental and clinical results in favor of buffered solutions, normal saline is still the most widely used solution. This review examines the literature to identify the most optimal storage solutions currently available for vein graft preservation.

Mitral-valve repair versus replacement for severe ischemic mitral regurgitation.

BACKGROUND: Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. METHODS: We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. RESULTS: At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months. CONCLUSIONS: We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).

Surgical treatment of moderate ischemic mitral regurgitation.

BACKGROUND: Ischemic mitral regurgitation is associated with increased mortality and morbidity. For surgical patients with moderate regurgitation, the benefits of adding mitral-valve repair to coronary-artery bypass grafting (CABG) are uncertain. METHODS: We randomly assigned 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus mitral-valve repair (combined procedure). The primary end point was the left ventricular end-systolic volume index (LVESVI), a measure of left ventricular remodeling, at 1 year. This end point was assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized as the lowest LVESVI rank. RESULTS: At 1 year, the mean LVESVI among surviving patients was 46.1±22.4 ml per square meter of body-surface area in the CABG-alone group and 49.6±31.5 ml per square meter in the combined-procedure group (mean change from baseline, -9.4 and -9.3 ml per square meter, respectively). The rate of death was 6.7% in the combined-procedure group and 7.3% in the CABG-alone group (hazard ratio with mitral-valve repair, 0.90; 95% confidence interval, 0.38 to 2.12; P=0.81). The rank-based assessment of LVESVI at 1 year (incorporating deaths) showed no significant between-group difference (z score, 0.50; P=0.61). The addition of mitral-valve repair was associated with a longer bypass time (P<0.001), a longer hospital stay after surgery (P=0.002), and more neurologic events (P=0.03). Moderate or severe mitral regurgitation was less common in the combined-procedure group than in the CABG-alone group (11.2% vs. 31.0%, P<0.001). There were no significant between-group differences in major adverse cardiac or cerebrovascular events, deaths, readmissions, functional status, or quality of life at 1 year. CONCLUSIONS: In patients with moderate ischemic mitral regurgitation, the addition of mitral-valve repair to CABG did not result in a higher degree of left ventricular reverse remodeling. Mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation but an increased number of untoward events. Thus, at 1 year, this trial did not show a clinically meaningful advantage of adding mitral-valve repair to CABG. Longer-term follow-up may determine whether the lower prevalence of mitral regurgitation translates into a net clinical benefit. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00806988.).

Use of nebulized milrinone in cardiac surgery; Comparison of vibrating mesh and simple jet nebulizers.

Cardiopulmonary bypass triggers an ischemia-reperfusion injury with endothelial dysfunction in the pulmonary circulation which can result in pulmonary hypertension. Inhaled milrinone reduces this reperfusion phenomenon and two methods commonly available for administering it are simple jet and vibrating mesh nebulizations. However, neither their generated milrinone particle size profiles, nor their ability to aid endothelial relaxation have been compared. Simple jet and vibrating mesh particle size distributions of milrinone were verified through cascade impaction and their efficacy was tested on a cardiopulmonary bypass (CPB) swine model. Post-nebulizations, animals underwent 90 min of CPB, followed by 60 min of reperfusion and lung excision. Pulmonary arterial endothelium-dependent relaxations to acetylcholine and bradykinin were then performed on pulmonary vasculature rings and were subsequently modeled as inhibitory Emax functions. In vitro studies showed lower emitted and inhaled doses from the simple jet nebulizer and its particle size distribution indicated upper and middle airway targeting. During in vivo studies, milrinone pre-treated, unlike saline groups maintained baseline pulmonary pressures up to 30 min post-CPB. Ex vivo studies showed better endothelial relaxation of arteries from the two milrinone groups over those from the control group in an administration/pathway-dependent manner, favoring simple jet administration.

Tackling the Issue of High Postoperative Pacemaker Implantation Rates in Sutureless Aortic Valve Replacement: Should Balloon Inflation be Removed from the Implantation Method of the Perceval Prosthesis?

BACKGROUND: Sutureless aortic valve replacement (AVR) is an emerging alternative to standard AVR in elderly and high-risk patients. This procedure is associated with a high rate of postoperative permanent pacemaker implantation (PPI). The study aim was to assess the impact on the rate of PPI of implanting the Perceval prosthesis without using balloon inflation. METHODS: A total of 159 patients who underwent sutureless AVR using the Perceval prosthesis was included. Balloon inflation was used in 132 patients (Balloon group) and not used in the remaining 27 (No-Balloon group). Clinical, echocardiographic and electrocardiographic outcomes were assessed. RESULTS: There was no significant difference in PPI rate between the two groups (26% for Balloon group versus 22% in No-Balloon group; p = 0.700). Balloon inflation had no significant impact on the incidence of paravalvular leaks (p = 0.839), or on the need to return to cardiopulmonary bypass (CPB) intraoperatively due to paravalvular leak or unsatisfactory deployment (p >0.999). Mean and peak transaortic pressure gradients were similar between the two groups (p = 0.417 and p = 0.522, respectively). Cross-clamp and CPB times were shorter in the No-Balloon group (49.6 ± 15.9 min versus 61.1 ± 25.6 min and 64.1 ± 26.3 min versus 79.6 ± 35.4 min, respectively; p = 0.027 and p = 0.012, respectively). CONCLUSIONS: The two groups had similar postoperative PPI rates. Implanting the Perceval prosthesis without balloon inflation is safe and had no impact on paravalvular leaks, intraoperative complications or hemodynamic results. Reductions in aortic cross-clamp time and CPB time were observed when the balloon was not used.

Aerosolized Vasodilators for the Treatment of Pulmonary Hypertension in Cardiac Surgical Patients: A Systematic Review and Meta-analysis.

BACKGROUND: In cardiac surgery, pulmonary hypertension is an important prognostic factor for which several treatments have been suggested over time. In this systematic review and meta-analysis, we compared the efficacy of inhaled aerosolized vasodilators to intravenously administered agents and to placebo in the treatment of pulmonary hypertension during cardiac surgery. We searched MEDLINE, CENTRAL, EMBASE, Web of Science, and clinicaltrials.gov databases from inception to October 2015. The incidence of mortality was assessed as the primary outcome. Secondary outcomes included length of stay in hospital and in the intensive care unit, and evaluation of the hemodynamic profile. METHODS: Of the 2897 citations identified, 10 studies were included comprising a total of 434 patients. RESULTS: Inhaled aerosolized agents were associated with a significant decrease in pulmonary vascular resistance (-41.36 dyne·s/cm, P= .03) and a significant increase in mean arterial pressure (8.24 mm Hg, P= .02) and right ventricular ejection fraction (7.29%, P< .0001) when compared to intravenously administered agents. No significant hemodynamically meaningful differences were observed between inhaled agents and placebo; however, an increase in length of stay in the intensive care unit was shown with the use of inhaled aerosolized agents (0.66 days, P= .01). No other differences were observed for either comparison. CONCLUSIONS: The administration of inhaled aerosolized vasodilators for the treatment of pulmonary hypertension during cardiac surgery is associated with improved right ventricular performance when compared to intravenously administered agents. This review does not support any benefit compared to placebo on major outcomes. Further investigation is warranted in this area of research and should focus on clinically significant outcomes.

Del Nido cardioplegia in the setting of minimally invasive aortic valve surgery.

The purpose of this study is to report our experience with del Nido cardioplegia (DNC) in the setting of minimally invasive aortic valve surgery. Forty-six consecutive patients underwent minimally invasive aortic valve replacement (AVR) through a "J" ministernotomy: twenty-five patients received the DNC (Group 1) and 21 patients received standard blood cardioplegia (SBC) (Group 2). The rate of ventricular fibrillation at unclamping was significantly lower in the DNC group (12% vs 52%, p=0.004), as well as postoperative creatinine kinase-MB (CK-MB) values (11.4±5.2 vs 17.7±6.9 µg/L, p=0.004). There were no deaths, myocardial infarctions or major complications in either group. Less postoperative use of intravenous insulin (28% vs 81%, p<0.001) was registered in the DNC group. In conclusion, the DNC is easy to use and safe during minimally invasive AVR, providing a myocardial protection at least equivalent to our SBC, improved surgical efficiency, minimal cost and less blood glucose perturbations.

Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial.

Importance: Stroke is a major complication of surgical aortic valve replacement (SAVR). Objective: To determine the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during SAVR. Design, Setting, and Participants: A randomized clinical trial of patients with calcific aortic stenosis undergoing SAVR at 18 North American centers between March 2015 and July 2016. The end of follow-up was December 2016. Interventions: Use of 1 of 2 cerebral embolic protection devices (n = 118 for suction-based extraction and n = 133 for intra-aortic filtration device) vs a standard aortic cannula (control; n = 132) at the time of SAVR. Main Outcomes and Measures: The primary end point was freedom from clinical or radiographic CNS infarction at 7 days (± 3 days) after the procedure. Secondary end points included a composite of mortality, clinical ischemic stroke, and acute kidney injury within 30 days after surgery; delirium; mortality; serious adverse events; and neurocognition. Results: Among 383 randomized patients (mean age, 73.9 years; 38.4% women; 368 [96.1%] completed the trial), the rate of freedom from CNS infarction at 7 days was 32.0% with suction-based extraction vs 33.3% with control (between-group difference, -1.3%; 95% CI, -13.8% to 11.2%) and 25.6% with intra-aortic filtration vs 32.4% with control (between-group difference, -6.9%; 95% CI, -17.9% to 4.2%). The 30-day composite end point was not significantly different between suction-based extraction and control (21.4% vs 24.2%, respectively; between-group difference, -2.8% [95% CI, -13.5% to 7.9%]) nor between intra-aortic filtration and control (33.3% vs 23.7%; between-group difference, 9.7% [95% CI, -1.2% to 20.5%]). There were no significant differences in mortality (3.4% for suction-based extraction vs 1.7% for control; and 2.3% for intra-aortic filtration vs 1.5% for control) or clinical stroke (5.1% for suction-based extraction vs 5.8% for control; and 8.3% for intra-aortic filtration vs 6.1% for control). Delirium at postoperative day 7 was 6.3% for suction-based extraction vs 15.3% for control (between-group difference, -9.1%; 95% CI, -17.1% to -1.0%) and 8.1% for intra-aortic filtration vs 15.6% for control (between-group difference, -7.4%; 95% CI, -15.5% to 0.6%). Mortality and overall serious adverse events at 90 days were not significantly different across groups. Patients in the intra-aortic filtration group vs patients in the control group experienced significantly more acute kidney injury events (14 vs 4, respectively; P = .02) and cardiac arrhythmias (57 vs 30; P = .004). Conclusions and Relevance: Among patients undergoing SAVR, cerebral embolic protection devices compared with a standard aortic cannula did not significantly reduce the risk of CNS infarction at 7 days. Potential benefits for reduction in delirium, cognition, and symptomatic stroke merit larger trials with longer follow-up. Trial Registration: clinicaltrials.gov Identifier: NCT02389894.

Experience with the SynCardia total artificial heart in a Canadian centre.

BACKGROUND: The SynCardia total artificial heart (TAH) provides complete circulatory support by replacing both native ventricles. Accepted indications include bridge to transplantation and destination therapy. We review our experience with TAH implantation during a period when axial flow pump became available. METHODS: We retrospectively analyzed the demographics, clinical characteristics and survival of all patients receiving the TAH. RESULTS: From September 2004 to November 2016, 13 patients (12 men, mean age 45 ± 13 yr) received the TAH for refractory cardiogenic shock secondary to idiopathic (56%) or ischemic (17%) cardiomyopathy and to other various causes (33%). Before implantation, mean ejection fraction was 14% ± 4%, 7 (54%) patients had previous cardiac surgery, 4 (31%) were on mechanical ventilation, and 3 (23%) patients were on dialysis. The mean duration of TAH support was 46 ± 40 days. Three (23%) patients died while on support after a mean of 15 days. Actuarial survival on support was 77% ± 12% at 30 days after implantation. Complications on support included stroke (n = 1, 8%), acute respiratory distress syndrome requiring prolonged intubation (n = 5, 38%) and acute renal failure requiring temporary dialysis (n = 5, 38%). Ten (77%) patients survived to be transplanted after a mean of 52 ± 42 days of support. Actuarial survival rates after transplant were 67% ± 16% at 1 month and 56% ± 17% at 1 year after transplantation. CONCLUSION: The TAH provides an alternative with low incidence of neurologic events in extremely fragile and complex patients waiting for heart transplantation. Complex and unusual anatomic conditions explained the current use of TAH.

CONTEXTE: Le cœur artificiel total (CAT) SynCardia offre un soutien circulatoire complet en remplaçant les 2 ventricules naturels. Parmi ses indications acceptées, mentionnons la transition pré-greffe et l'assistance permanente. Nous passons ici en revue notre expérience en matière d'implantation de CAT à partir de l'avènement des pompes à flux axial. MÉTHODES: Nous avons analysé de manière rétrospective les caractéristiques démographiques et cliniques et la survie de tous les patients ayant reçu un CAT. RÉSULTATS: De septembre 2004 à novembre 2016, 13 patients (12 hommes, âge moyen 45 ± 13 ans) ont reçu le CAT pour un choc cardiogénique réfractaire dû à la cardiomyopathie idiopathique (50 %) ou ischémique (17 %) ou à d'autres causes (33 %). Avant l'implantation, la fraction d'éjection était en moyenne de 14 % ± 4 %, 7 patients (54 %) avaient déjà subi une chirurgie cardiaque, 4 (31 %) étaient sous ventilation mécanique et 3 (23 %) étaient dialysés. La durée moyenne du soutien par CAT a été de 46 ± 40 jours. Trois patients (23 %) sont décédés malgré l'implantation du dispositif après une moyenne d'utilisation de 15 jours. La survie actuarielle pendant l'utilisation du dispositif a été de 77 % ± 12 % 30 jours suivant l'implantation. Les complications ont inclus : accident vasculaire cérébral (n = 1, 8 %), syndrome de détresse respiratoire aigüe nécessitant une intubation prolongée (n = 5, 38 %) et insuffisance rénale aigüe nécessitant une dialyse temporaire (n = 5, 38 %). Dix patients (77 %) ont survécu jusqu'à leur greffe après une moyenne d'utilisation de 52 ± 42 jours. Les taux de survie actuarielle après la greffe ont été de 67 % ± 16 % après 1 mois et de 56 % ± 17 % après 1 an suivant la greffe. CONCLUSION: Le CAT est une solution de rechange qui s'accompagne d'une incidence faible de complications neurologiques chez des patients à l'état extrêmement fragile et complexe en attente d'une greffe cardiaque. Des complications anatomiques inhabituelles ont expliqué l'utilisation du CAT.