Health-Related Quality of Life in Patients With Atrial Fibrillation Treated With Catheter Ablation or Antiarrhythmic Drug Therapy: A Systematic Review and Meta-analysis.

BACKGROUND: Catheter ablation (CA) is performed in patients with atrial fibrillation (AF) to reduce symptoms and improve health-related quality of life (HRQL). METHODS: This systematic review and meta-analysis of randomized controlled trials (RCTs) evaluated CA of any energy modality compared with antiarrhythmic drugs (AADs) using inverse-variance random-effects models. We searched for RCTs reporting HRQL and AF-related symptoms at 3, 6, 12, 24, 48, and 60 months after treatment as well as the number of repeat ablations. RESULTS: Of 15,878 records, we included 13 RCTs of CA vs AADs for the analyses of HRQL, 7 RCTs for the analyses of AF-related symptoms, and 13 RCTs for the number of repeat ablations. For the HRQL analyses at 3 months, there were significant increases in both the Physical Component Summary score (3 months' standardized mean difference = 0.58 [0.39-0.78]; P < 0.00001, I 2 = 6%, 3 trials, n = 443) and the Mental Component Summary score (3 months' standardized mean difference = 0.57 [0.37-0.77]; P < 0.00001, I 2 = 0%, 3 trials, n = 443), favouring CA over AADs. These differences were sustained at 12 months but not >24 months after randomization. Similar results were seen for AF-related symptoms. The number of repeat ablations and success rates after procedure varied considerably across trials. CONCLUSIONS: Evidence from few trials suggests that CA improves physical and mental health and AF-related symptoms in the short term, but these benefits decrease with time. More trials, reporting both HRQL and AF-related symptoms, at consistent time points are needed to assess the effectiveness of CA for the treatment of AF.

CONTEXTE: L'ablation par cathéter (AC) est réalisée chez les patients atteints de fibrillation auriculaire (FA) afin d'atténuer les symptômes et d'améliorer la qualité de vie liée à la santé (QVLS). MÉTHODOLOGIE: Cette revue systématique et méta-analyse d'essais contrôlés à répartition aléatoire (ECRA) a permis d'évaluer l'AC, toutes modalités énergétiques confondues, comparativement aux agents antiarythmiques (AA) à l'aide de modèles à effets aléatoires à variance inverse. Nous avons recherché les ECRA qui faisaient état de la QVLS et des symptômes liés à la FA à 3, 6, 12, 24, 48 et 60 mois après le traitement et qui précisaient le nombre d'ablations répétées. RÉSULTATS: À partir de 15 878 entrées, nous avons retenu 13 ECRA comparant l'AC à des AA pour l'analyse de la QVLS, 7 autres pour l'analyse des symptômes liés à la FA et 13 de plus aux fins de calcul du nombre d'ablations répétées. L'analyse de la QVLS à 3 mois indique une augmentation significative du score sommaire de la composante physique (différence moyenne normalisée à 3 mois = 0,58 [0,39-0,78]; p < 0,00001, I 2 = 6 %, 3 essais, n = 443) et du score sommaire de la composante mentale (différence moyenne normalisée à 3 mois = 0,57 [0,37-0,77]; p < 0,00001, I 2 = 0 %, 3 essais, n = 443), faisant pencher la balance en faveur de l'AC plutôt que des AA. Ces différences persistaient à 12 mois après la répartition aléatoire, mais pas aux moments d'évaluation ultérieurs (24, 48 et 60 mois). Des résultats similaires ont été observés au chapitre des symptômes liés à la FA. Le nombre d'ablations répétées et le taux de réussite postopératoire variaient considérablement d'un essai à l'autre. CONCLUSIONS: Les données probantes de quelques essais donnent à penser que l'AC améliore la santé physique et mentale ainsi que les symptômes liés à la FA à court terme, mais que ces bienfaits s'atténuent avec le temps. D'autres essais faisant état de la QVLS et des symptômes liés à la FA, à des moments d'évaluation constants, devront être réalisés pour évaluer l'efficacité réelle de l'AC dans le traitement de la FA.

Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System Following Cardiac and Major Vascular Surgery: User Testing Study.

BACKGROUND: Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascular surgery. However, the science of deploying and evaluating these systems is complex and subject to risk of implementation failure. OBJECTIVE: As a precursor to a randomized controlled trial (RCT), this user testing study aimed to examine user performance and acceptance of a RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies, respectively. METHODS: Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom. Participants were video recorded and asked to think aloud while completing required user tasks and while being rated on user performance. Feedback was also solicited about the user experience, including user satisfaction and acceptance, through use of the Net Promoter Scale (NPS) survey and debrief interviews. RESULTS: A total of 37 participants (26 nurses and 11 patients) completed user testing. The majority of nurse and patient participants were able to complete most required tasks independently, demonstrating comprehension and retention of required Guardian and eTrAC system workflows. Tasks which required additional prompting by the facilitator, for some, were related to the use of system features that enable continuous transmission of patient vital signs (eg, pairing wireless sensors to the patient) and assigning remote patient monitoring protocols. NPS scores by user group (nurses using Guardian: mean 8.8, SD 0.89; nurses using eTrAC: mean 7.7, SD 1.4; patients using eTrAC: mean 9.2, SD 0.75), overall NPS scores, and participant debrief interviews indicated nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems. Both user groups stressed the need for additional opportunities to practice in order to become comfortable and proficient in the use of these systems. CONCLUSIONS: User testing indicated a high degree of user acceptance of Philips' Guardian and eTrAC systems among nurses and patients. Key insights were provided that informed refinement of clinical workflow training and systems implementation. These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.

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.

Comparison of health-related quality of life in patients with atrial fibrillation treated with catheter ablation or antiarrhythmic drug therapy: a systematic review and meta-analysis protocol.

INTRODUCTION: Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and causes patients considerable burden; symptoms such as palpitations and dyspnoea are common, leading to frequent emergency room visits. Patients with AF report reduced health-related quality of life (HQOL) compared with the general population; thus, treatments focus on the restoration of sinus rhythm to improve symptoms. Catheter ablation (CA) is a primary treatment strategy to treat AF-related burden in select patient populations; however, repeat procedures are often needed, there is a risk of major complications and the procedure is quite costly in comparison to medical therapy. As the outcomes after CA are mixed, an updated review that synthesises the available literature, on outcomes that matter to patients, is needed so that patients and their healthcare providers can make quality treatment decisions. The purpose of this review protocol is to extend previous findings by systematically analysing randomised controlled trials (RCTs) of CA in patients with AF and using meta-analytic techniques to identify the benefits and risks of CA with respect to HQOL and AF-related symptoms. METHODS AND ANALYSIS: We will include all RCTs that compare CA with antiarrhythmic drugs, or radiofrequency CA with cryoballoon CA, in patients with paroxysmal or persistent AF. To locate studies we will perform comprehensive electronic database searches from database inception to 4 April 2017, with no language restrictions. We will conduct a quantitative synthesis of the effect of CA on HQOL as well as AF-related symptoms and the number of CA procedures needed for success, using meta-analytic techniques. ETHICS AND DISSEMINATION: No ethical issues are foreseen and ethical approval is not required given that this is a protocol. The findings of the study will be reported at national and international conferences, and in a peer-reviewed journal using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. TRIAL REGISTRATION NUMBER: In accordance with the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 6 March 2017 and was last updated on 6 March 2017 (registration number CRD42017057427). PROTOCOL AMENDMENTS: Any protocol amendments will be documented on the International Prospective Register of Systematic Reviews (PROSPERO) and in the final manuscript and indicated as such.

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.