Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study.

Objective: To determine timing and risk factors associated with readmission within 30 days of discharge following noncardiac surgery. Background: Hospital readmission after noncardiac surgery is costly. Data on the drivers of readmission have largely been derived from single-center studies focused on a single surgical procedure with uncertainty regarding generalizability. Methods: We undertook an international (28 centers, 14 countries) prospective cohort study of a representative sample of adults ≥45 years of age who underwent noncardiac surgery. Risk factors for readmission were assessed using Cox regression (ClinicalTrials.gov, NCT00512109). Results: Of 36,657 eligible participants, 2744 (7.5%; 95% confidence interval [CI], 7.2-7.8) were readmitted within 30 days of discharge. Rates of readmission were highest in the first 7 days after discharge and declined over the follow-up period. Multivariable analyses demonstrated that 9 baseline characteristics (eg, cancer treatment in past 6 months; adjusted hazard ratio [HR], 1.44; 95% CI, 1.30-1.59), 5 baseline laboratory and physical measures (eg, estimated glomerular filtration rate or on dialysis; HR, 1.47; 95% CI, 1.24-1.75), 7 surgery types (eg, general surgery; HR, 1.86; 95% CI, 1.61-2.16), 5 index hospitalization events (eg, stroke; HR, 2.21; 95% CI, 1.24-3.94), and 3 other factors (eg, discharge to nursing home; HR, 1.61; 95% CI, 1.33-1.95) were associated with readmission. Conclusions: Readmission following noncardiac surgery is common (1 in 13 patients). We identified perioperative risk factors associated with 30-day readmission that can help frontline clinicians identify which patients are at the highest risk of readmission and target them for preventive measures.

Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study.

BACKGROUND: Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration. OBJECTIVE: Our aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics. METHODS: Included participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability. RESULTS: The validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time). CONCLUSIONS: We found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.

Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study.

INTRODUCTION: Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES: In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION: This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT01842568.

The need for novel strategies to address postoperative pain associated with cardiac surgery: A commentary and introduction to "SMArTVIEW".

Background: With coronary heart disease affecting over 2.4 million Canadians, annual cardiac and major vascular surgery rates are on the rise. Unrelieved postoperative pain is among the top five causes of hospital readmission following surgery; little is done to address this postoperative complication. Barriers to effective pain assessment and management following cardiac and major vascular surgery have been conceptualized on patient, health care provider, and system levels. Purpose: In this commentary, we review common patient, health care provider, and system-level barriers to effective postoperative pain assessment and management following cardiac and major vascular surgery. We then outline the SMArTVIEW intervention, with particular attention to components designed to optimize postoperative pain assessment and management. Methods: In conceptualizing the SMArTVIEW intervention design, we sought to address a number of these barriers by meeting the following design objectives: (1) orchestrating a structured process for regular postoperative pain assessment and management; (2) ensuring adequate clinician preparation for postoperative pain assessment and management in the context of virtual care; and (3) enfranchising patients to become active self-managers and to work with their health care providers to manage their pain postoperatively. Conclusions: Innovative approaches to address these barriers are a current challenge to health care providers and researchers alike. SMArTVIEW is spearheading this paradigm shift within clinical research to address barriers that impair effective postoperative pain management by actively engaging health care providers and patients in an accessible format (i.e., digital health solution) to give primacy to the need of postoperative pain assessment and management following cardiac and major vascular surgery.

Contexte: Alors que la maladie cardiaque coronarienne touche plus de 2,4 millions de Canadiens, les taux annuels de chirurgie cardiaque et de chirurgie vasculaire majeure sont en augmentation. Bien que la douleur postopératoire non soulagée compte parmi les cinq principales causes de réadmission à l'hôpital après une chirurgie, peu de choses sont faites pour remédier à cette complication postopératoire. Les barrières à l'évaluation et à la prise en charge efficaces de la douleur après une chirurgie cardiaque ou une chirurgie vasculaire majeure ont été conceptualisées aux niveaux du patient, du prestataire de soins et du système.But: Dans ce commentaire, nous examinons les barrières à l'évaluation et à la prise en charge efficace de la douleur postopératoire après une chirurgie cardiaque et une chirurgie vasculaire majeure au niveau du patient, du prestataire de soins et du système. Nous présentons ensuite l'intervention SMArTVIEW, en portant une attention particulière aux composantes conçues pour optimiser l'évaluation et la prise en charge de la douleur postopératoire.Méthodes: Au moment de conceptualiser l'intervention SMArTIEW, nous avons cherché à remédier à un certain nombre de ces barrières à partir des objectifs de conception suivants : 1) orchestrer un processus structuré pour l'évaluation et la prise en charge de la douleur postopératoire régulière; 2) assurer une préparation adéquate des cliniciens pour l'évaluation et la prise en charge de la douleur postopératoire dans un contexte de soins virtuels; et 3) affranchir les patients afin qu'ils puissent activement prendre en charge leur douleur postopératoire et travailler de concert avec les prestataires de soins.Conclusions: Les approches innovantes pour remédier à ces barrières sont un défi constant, tant pour les prestataires de soins que pour les chercheurs. SMArTVIEW est à l'avant-garde de ce changement de paradigme dans la recherche clinique qui a pour but de remédier aux barrières qui nuisent à la prise en charge efficace de la douleur postopératoire en engageant activement les prestataires de soins et les patients dans un format accessible (i.e. solution de santé numérique), afin que la primauté soit accordée à la nécessité d'évaluer et de prendre en charge la douleur postopératoire après une chirurgie cardiaque ou une chirurgie vasculaire majeure.

Postoperative Remote Automated Monitoring: Need for and State of the Science.

Worldwide, more than 230 million adults have major noncardiac surgery each year. Although surgery can improve quality and duration of life, it can also precipitate major complications. Moreover, a substantial proportion of deaths occur after discharge. Current systems for monitoring patients postoperatively, on surgical wards and after transition to home, are inadequate. On the surgical ward, vital signs evaluation usually occurs only every 4-8 hours. Reduced in-hospital ward monitoring, followed by no vital signs monitoring at home, leads to thousands of cases of undetected/delayed detection of hemodynamic compromise. In this article we review work to date on postoperative remote automated monitoring on surgical wards and strategy for advancing this field. Key considerations for overcoming current barriers to implementing remote automated monitoring in Canada are also presented.

User-centered Development of a Decision Aid for Patients Facing Implantable Cardioverter-Defibrillator Replacement: A Mixed-Methods Study.

BACKGROUND: Because of battery depletion, an implantable cardioverter-defibrillator (ICD) generator requires surgical replacement every 5 to 7 years. Routine replacement is the norm without discussion with patients about whether or not to proceed. OBJECTIVE: The aim of this study was to develop a patient decision aid (PDA) for patients facing ICD replacement and plan for its implementation. METHODS: An embedded mixed-methods study was conducted using questionnaires and semistructured interviews focused on current ICD replacement practices; PDA acceptability, usability, and content; and PDA implementation. Transcripts were analyzed using constant comparative analysis. RESULTS: Eighteen PDA end users in 16 interviews characterized the current ICD replacement approach as automatic without consideration for patient preferences. The PDA was positively received, and the content was iteratively revised 4 times during the interviews. Changes were related to missing and excess information, language, and wording. The PDA was identified as a means to support a shared decision-making (SDM) process, not to be used as a standalone instrument. To shift current practices to an SDM process, participants identified that an invitation to discuss the option of ICD replacement is required-whether initiated by the patient or the clinician. CONCLUSION: Currently, the option of ICD replacement is rarely offered, and patient preferences are seldom elicited. Participants believed the PDA to be a useful intervention that could help facilitate an SDM process for patients facing ICD replacement. Preparing for implementation during the development phase will allow us to strategize effectively to overcome perceived barriers and capitalize on perceived facilitators during actual implementation.

Technology-Enabled Remote Monitoring and Self-Management - Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol.

BACKGROUND: Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT-VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. OBJECTIVE: Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). METHODS: CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise-death, myocardial infarction, and nonfatal stroke- all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups. RESULTS: Study start-up is underway and usability testing is scheduled to begin in the fall of 2016. CONCLUSIONS: Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS.

The Canadian Arrhythmogenic Right Ventricular Cardiomyopathy Registry: Rationale, Design, and Preliminary Recruitment.

BACKGROUND: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a complex and clinically heterogeneous arrhythmic condition. Incomplete penetrance and variable expressivity are particularly evident in ARVC, making clinical decision-making challenging. METHODS: Pediatric and adult cardiologists, geneticists, genetic counsellors, ethicists, nurses, and qualitative researchers are collaborating to create the Canadian ARVC registry using a web-based clinical database. Biological samples will be banked and systematic analysis will be performed to examine potentially causative mutations, variants, and biomarkers. Outcomes will include syncope, ventricular arrhythmias, defibrillator therapies, heart failure, and mortality. RESULTS: Preliminary recruitment has enrolled 365 participants (aged 42.7 ± 17.1 years; 50% women), including 129 probands and 236 family members. Previous cardiac arrest occurred in 28 (8%) participants, syncope occurred in 43 (12%) participants, and 46% of probands had a family history of sudden death. Overall yield of genetic testing was 36% for a disease-causing mutation and 20% for a variant of unknown significance. Target enrollment is 1000 affected patients and 500 unaffected family member controls over 7 years. The cross-sectional and longitudinal data collected in this manner will allow a robust assessment of the natural history and clinical course of genetic subtypes. CONCLUSIONS: The Canadian ARVC Registry will create a population-based cohort of patients and their families to inform clinical decisions regarding patients with ARVC.

Transition to palliative care when transcatheter aortic valve implantation is not an option: opportunities and recommendations.

PURPOSE OF REVIEW: Transcatheter aortic valve implantation (TAVI) is the recommended treatment for most patients with symptomatic aortic stenosis at high surgical risk. However, TAVI may be clinically futile for patients who have multiple comorbidities and excessive frailty. This group benefits from transition to palliative care to maximize quality of life, improve symptoms, and ensure continuity of health services. We discuss the clinical determination of utility and futility, explore the current evidence guiding the integration of palliative care in procedure-focused cardiac programs, and outline recommendations for TAVI programs. RECENT FINDINGS: The determination of futility of treatment in elderly patients with aortic stenosis is challenging. There is a paucity of research available to guide best practices when TAVI is not an option. Opportunities exist to build on the evidence gained in the management of end of life and heart failure. TAVI programs and primary care providers can facilitate improved communication and processes of care to provide decision support and transition to palliative care. SUMMARY: The increased availability of transcatheter options for the management of valvular heart disease will increase the assessment of people with life-limiting conditions for whom treatment may not be an option. It is pivotal to bridge cardiac innovation and palliation to optimize patient outcomes.

Left Atrial Appendage Occlusion Study (LAAOS): results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke.

AIM: This pilot study assessed the safety and efficacy of left atrial appendage (LAA) occlusion, performed at the time of coronary artery bypass grafting (CABG). METHODS AND RESULTS: At the time of CABG, 77 patients with risk factors for stroke were randomized to LAA occlusion or control. The LAA was occluded using sutures or a stapling device. Completeness of occlusion was assessed with transesophageal echocardiography. There were no significant differences in cardiopulmonary bypass duration, perioperative heart failure, atrial fibrillation, or bleeding between the 2 groups. During surgery, there were 9 appendage tears, all of which were repaired easily with sutures. Among patients having a postoperative transesophageal echocardiography, complete occlusion of the LAA was achieved in 45% (5/11) of cases using sutures and in 72% (24/33) using a stapler, P = .14. The rate of LAA occlusion by individual surgeons increased from 43% (9/21) to 87% (20/23) after performing 4 cases (P = .0001). After a mean follow-up of 13 +/- 7 months, 2.6% of patients had thromboembolic events. CONCLUSIONS: LAA occlusion at the time of CABG is safe. The rate of complete occlusion improves, to acceptable levels, with increased experience and the use of a stapling device. A large trial is needed to determine if LAA occlusion prevents stroke.

Double-blind, placebo-controlled, randomized trial of prophylactic metoprolol for reduction of hospital length of stay after heart surgery: the beta-Blocker Length Of Stay (BLOS) study.

BACKGROUND: Atrial fibrillation (AF) is a common complication of heart surgery. Previous studies have shown that there is an association between postoperative AF and prolongation of hospital length of stay. No previous trials have been primarily directed at demonstrating that the use of drugs that prevent AF would shorten length of stay and reduce the costs of postoperative care. METHODS: A randomized, double-blind, placebo-controlled trial of metoprolol was performed in patients immediately after nonemergent heart surgery. Metoprolol was given orally at a dose of 100 mg per day after the patient's arrival in the intensive care unit until hospital discharge or 14 days, whichever was sooner. This dose was increased to 150 mg per day after the enrollment of 411 patients. The primary outcome measure of the study was hospital length of stay from admission to intensive care unit until hospital discharge. There were 1000 patients enrolled, evenly distributed to the metoprolol and placebo groups. RESULTS: There was a 20% reduction in the risk of AF developing with metoprolol, from 39% of patients to 31% of patients (P =.01). There was no effect of treatment on hospital length of stay, which was 152 +/- 61 hours for placebo and 155 +/- 90 hours for metoprolol (P = 0.79). The cost of postoperative care in the 2 treatment groups was similar. CONCLUSION: Prophylactic metoprolol reduces the risk of AF after heart surgery. It does not reduce hospital length of stay. Although it is cost effective for the reduction of AF, it did not reduce the overall cost of care.

High dose alfentanil pre-empts pain after abdominal hysterectomy.

This study tested the hypothesis that high dose systemic alfentanil administered before and during abdominal hysterectomy would pre-empt post-operative pain to a greater extent than administration of either low dose alfentanil or no alfentanil perioperatively. Patients (ASA 1 or 2) were randomly assigned to group 1 (n = 15), no opioid; group 2 (n = 15), low dose alfentanil; or group 3 (n = 15), high dose alfentanil. Anaesthesia was induced in group 1 with midazolam and thiopentone and was maintained with isoflurane and 70% N2O in O2. Anaesthesia was induced in group 2 with midazolam, thiopentone and i.v. alfentanil (30 microg kg(-1)), and was maintained with isoflurane, 70% N2O in O2, and bolus doses of i.v. alfentanil (10-20 microg kg(-1)) every hour. Anaesthesia was induced in group 3 with midazolam and i.v. alfentanil (100 microg kg(-1)), and was maintained with 70% N2O in O2, and an infusion of i.v. alfentanil (1-2 microg kg(-1) min(-1)). Blood samples were drawn at 30 and 120 min after surgery and assayed for plasma alfentanil. Morphine consumption and VAS pain scores were consistently lowest in group 3 over the 48 h study period. A composite measure of pain and morphine consumption was significantly lower in group 3 than group 2 up to 6 h after surgery, and significantly lower than group 1 up to 12 h. No adverse effects were observed. A 6-month follow-up did not reveal any significant differences among the three groups. It is concluded that intra-operative high dose alfentanil anaesthetic pre-empts post-operative pain after abdominal hysterectomy, but the effects are small and of short duration. Surgical procedures carried out under general anaesthesia using standard (and even high) doses of opioids intraoperatively provide suboptimal protection from the injury barrage brought about by incision and subsequent noxious surgical events.