Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin.

BACKGROUND: Patients with a mechanical heart valve (MHV) require oral anticoagulation. Poor anticoagulation control is thought to be associated with adverse outcomes, but data are limited. OBJECTIVE: To assess the risks of clinical outcomes in patients with a MHV and poor anticoagulation control on warfarin. PATIENTS/METHODS: We conducted a retrospective study of consecutive patients undergoing MHV implantation at a tertiary care center (2010-2019). Primary outcome was a composite of ischemic stroke, systemic embolism, or prosthetic valve thrombosis. Major bleeding and death were key secondary outcomes. We constructed multivariable regression models to assess the association between time in therapeutic range (TTR) on warfarin beyond 90 days after surgery with outcomes. RESULTS: We included 671 patients with a MHV (80.6% in aortic, 14.6% in mitral position; mean age 61 years, 30.3% female). Median follow-up was 4.9 years, mean TTR was 62.5% (14.5% TTR <40%, 24.6% TTR 40-60%, and 61.0% TTR >60%). Overall rates of the primary outcome, major bleeding, and death were 0.73, 1.41, and 1.44 per 100 patient-years. Corresponding rates for patients with TTR <40% were 1.31, 2.77, and 3.22 per 100 patient-years. In adjusted analyses, every 10% decrement in TTR was associated with a 31% increase in hazard for the primary outcome (hazard ratio [HR]: 1.31, 95% confidence interval [CI]: 1.13-1.52), 34% increase in major bleeding (HR: 1.34, 95% CI: 1.17-1.52), and 32% increase in death (HR: 1.32, 95% CI: 1.11-1.57). CONCLUSION: In contemporary patients with a MHV, poor anticoagulation control on warfarin was associated with increased risks of thrombotic events, bleeding, and death.

Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL).

Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%. Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease. Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide.

Introduction: Par rapport à l'abord radial, la limitation importante de l'abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L'abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l'utilisation systématique du guidage par US pour l'abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le B leeding A cademic R esearch C onsortium (BARC) ou les complications vasculaires majeures. Méthodes: L' U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l'insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l'abord fémoral guidé par US ou sans US. Le principal critère d'évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L'essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d'évaluation principal selon un taux d'événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L'essai UNIVERSAL qui sera l'un des plus vastes essais à répartition aléatoire sur l'abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.

Polypill with or without Aspirin in Persons without Cardiovascular Disease.

BACKGROUND: A polypill comprising statins, multiple blood-pressure-lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease. METHODS: Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed. RESULTS: A total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups. CONCLUSIONS: Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437.).

The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct.

BACKGROUND: It is hypothesized that in individuals without clinical cardiovascular disease (CVD), but at increased CVD risk, a 50% to 60% reduction in CVD risk could be achieved using fixed dose combination (FDC) therapy (usually comprised of multiple blood-pressure agents and a statin [with or without aspirin]) in a single "polypill". However, the impact of a polypill in preventing clinical CV events has not been evaluated in a large randomized controlled trial. METHODS: TIPS-3 is a 2x2x2 factorial randomized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population. This study aims to determine whether the Polycap (comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk. Additional interventions in the factorial design of the study will compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) vitamin D versus placebo on the risk of fractures, and (3) the combined effect of aspirin and the Polycap on CV events. RESULTS: The study has randomized 5713 participants across 9 countries. Mean age of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk score is 16.8, which is consistent with a study population at intermediate CVD risk. CONCLUSION: Results of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.

Laparoscopic peritoneal entry with the reusable threaded visual cannula.

STUDY OBJECTIVE: To estimate the feasibility, reproducibility, and safety of laparoscopic port establishment using a trocarless and externally threaded visual cannula (TVC). DESIGN: Multicentre, prospective, observational study (Canadian Task Force classification II-2). SETTING: Three university-affiliated teaching hospitals. PATIENTS: Four thousand seven hundred twenty-four women (median age, 34 years; median body mass index, 25) underwent laparoscopic surgery. INTERVENTION: After administration of general anesthesia, the Veress needle was inserted at the umbilicus or the left upper quadrant (LUQ) using Veress intraperitoneal pressure of 10 mm Hg or less as proxy for correct placement. Transient high intraperitoneal pressure of 20 to 30 mm Hg was attained, and primary and ancillary ports were established using the reusable trocarless TVC. MEASUREMENTS AND MAIN RESULTS: Institutional research ethics board approval and patient consent for video capture were obtained. Primary umbilical entry was established in 4598 patients (97.33%), primary LUQ entry in 123 (2.60%), and primary suprapubic entry in 3 (0.06%) patients. Peritoneal preinsufflation was abandoned when 3 consecutive umbilical or LUQ Veress needle insertion attempts failed. Some patients at high risk with known peritoneal adhesions or previous lower abdominal midline scars did not undergo preinsufflation, and the trocarless TVC was applied directly. Surgery was postponed in 3 patients in whom insufflation failed, to enable further counseling and appropriate consenting. There were no serious abdominal wall or intraabdominal vascular injuries. One transverse colon, densely adhered to the umbilical region, was injured, which was recognized and repaired intraoperatively. Residents, fellows, or faculty recorded entry-related data on forms postoperatively for study and analysis. CONCLUSIONS: Establishing peritoneal ports with the trocarless TVC is feasible, reproducible, and seems to be highly adoptable.

A retrospective review of general surgery training outcomes at the University of Toronto.

BACKGROUND: Surgical educators have struggled with achieving an optimal balance between the service workload and education of surgical residents. In Ontario, a variety of factors during the past 12 years have had the net impact of reducing the clinical training experience of general surgery residents. We questioned what impact the reductions in trainee workload have had on general surgery graduates at the University of Toronto. METHODS: We evaluated graduates from the University of Toronto general surgery training program from 1995 to 2006. We compared final-year In-Training Evaluation Reports (ITERs) of trainees during this interval. For purposes of comparison, we subdivided residents into 4 groups according to year of graduation (1995-1997, 1998-2000, 2001-2003 and 2004-2006). We evaluated postgraduate "performance" by categorizing residents into 1 of 4 groups: first, residents who entered directly into general surgery practice after graduation; second, residents who entered into a certification subspecialty program of the Royal College of Physicians and Surgeons of Canada (RCPSC); third, residents who entered into a noncertification program of the RCPSC; and fourth, residents who entered into a variety of nonregulated "clinical fellowships." RESULTS: We assessed and evaluated 118 of 134 surgical trainees (88%) in this study. We included in the study graduates for whom completed ITER records were available and postgraduate training records were known and validated. The mean scores for each of the 5 evaluated residency training parameters included in the ITER (technical skills, professional attitudes, application of knowledge, teaching performance and overall performance) were not statistically different for each of the 4 graduating groups from 1995 to 2006. However, we determined that there were statistically fewer general surgery graduates (p < 0.05) who entered directly into general surgery practice in the 2004-2006 group compared with the 1998-2000 and 2001-2003 groups. The graduates from 2004 to 2006 who did not enter into general surgery practice appeared to choose a clinical fellowship. CONCLUSION: These observations may indicate that recent surgical graduates possess an acceptable skill set but may lack the clinical confidence and experience to enter directly into general surgery practice. Evidence seems to indicate that the clinical fellowship has become an unregulated surrogate extension of the training program whereby surgeons can gain additional clinical experience and surgical expertise.

Laparoscopic peritoneal entry preferences among Canadian gynaecologists.

OBJECTIVES: To understand current laparoscopic entry practices among Canadian gynaecologists and to raise awareness of patient safety in accordance with the Society of Obstetricians and Gynaecologists of Canada clinical practice guideline, "Laparoscopic Entry: A Review of Techniques, Technologies, and Complications," published in May 2007. METHODS: A national survey was designed to determine different laparoscopic entry methods used by practising gynaecologists, to determine entry locations, and to gather information about mishaps. The survey was translated into French for francophone practitioners. In total, the survey was forwarded to 590 SOGC members. RESULTS: Of 269 responses (a 45.6% response rate), 224 responses were from obstetrician-gynaecologists who identified themselves as currently practising laparoscopy. Seventy-five percent of these respondents reported that they had read the SOGC laparoscopic entry guideline. There was no significant difference in practice patterns when comparing geographic practice location, gender, and number of years in practice. For laparoscopy in an unscarred abdomen, the most common entry method is Veress needle insufflation with closed trocar entry (78.9%). When adhesions are suspected, only 25.4% utilize the left upper quadrant. Of respondents, 28.7% use an insufflation pressure of 20-25 mm Hg. CONCLUSIONS: Our survey had a significant response rate and was able to delineate current laparoscopic entry practice patterns of gynaecologists, which were consistent across Canada. Despite 72.9% of respondents reporting familiarity with the recent SOGC clinical practice guideline, it appears that clinical practice does not necessarily coincide with current recommendations. These variances in gynaecological practice emphasize the need for further educational initiatives to ensure that the evidence from research is used to make clinical practice safer.