A Strategy of Underexpansion and Ad Hoc Post-Dilation of Balloon-Expandable Transcatheter Aortic Valves in Patients at Risk of Annular Injury Favorable Mid-Term Outcomes

AbstractObjectivesThe aim of this study was to evaluate a strategy of intentional underexpansion of excessively oversized balloon-expandable transcatheter heart valves (THVs) in terms of clinical outcomes, valve function, and frame durability at 1 year.BackgroundTranscatheter aortic valve replacement requires the selection of an optimally sized THV to ensure paravalvular sealing and fixation without risking annular injury. However, some patients have “borderline” annular dimensions that require choosing between a THV that may be too small or another that may be too large.MethodsWe evaluated 47 patients at risk of annular injury who underwent transcatheter aortic valve replacement (TAVR) with an oversized, but deliberately underexpanded, THV followed by post-dilation if required. Clinical evaluation, echocardiography, and cardiac computed tomography were performed pre-TAVR, post-TAVR, and at 1 year.ResultsDeployment of oversized THVs with modest underfilling of the deployment balloon (<10% by volume) was not associated with significant annular injury. Paravalvular regurgitation was mild or less in 95.7% of patients, with post-dilation required in 10.7%. THV hemodynamic function was excellent and remained stable at 1 year. Computed tomography documented stent frame circularity in 87.5%. Underexpansion was greatest within the intra-annular THV inflow (stent frame area 85.8% of nominal). There was no evidence of stent frame recoil, deformation, or fracture at 1 year.ConclusionsIn carefully selected patients with borderline annulus dimensions and in whom excessive oversizing of a balloon-expandable SAPIEN XT valve (Edwards Lifesciences, Inc., Irvine, California) is a concern, a strategy of deliberate underexpansion, with ad hoc post-dilation, if necessary, may reduce the risk of annular injury without compromising valve performance

Regional Systems of Care to Optimize Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement

AbstractObjectivesThis study sought to describe the development of a multicenter, transcatheter aortic valve replacement program and regional systems of care intended to optimize coordinated, efficient, and appropriate delivery of this new therapy.BackgroundTranscatheter aortic valve replacement (TAVR) has become an accepted treatment option for patients with severe aortic stenosis who are at high surgical risk. Regional systems of care have led to improvements in outcomes for patients undergoing intervention for myocardial infarction, cardiac arrest, and stroke. We implemented a regional system of care for patients undergoing TAVR in British Columbia, Canada.MethodsWe describe a prospective observational cohort of 583 patients who underwent TAVR in British Columbia between 2012 and 2014. Regionalization of TAVR care in British Columbia refers to a centrally coordinated, funded, and evaluated program led by a medical director and a multidisciplinary advisory group that oversees planning, access to care, and quality of outcomes at the 4 provincial sites. Risk-stratified case selection for transfemoral TAVR is performed by heart teams at each site on the basis of consensus provincial indications. Referrals for lower volume and more complicated TAVR, including nontransfemoral access and valve-in-valve procedures, are concentrated at a single site. In-hospital and 30-day outcomes are reported.ResultsThe median age was 83 years (interquartile range [IQR]: 78 to 87 years) and median STS score was 6% (IQR: 4% to 8%). Transfemoral access was performed in 499 (85.6%) cases and nontransfemoral in 84 (14.4%). Transcatheter valve-in-valve procedures in for failed bioprosthetic valves were performed in 43 patients (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All-cause 30-day mortality was 3.5%. All-cause in-hospital mortality and disabling stroke occurred in 3.1% and 1.9%, respectively. Median length of stay was 3 days (IQR: 3 to 6 days), with 92.8% of patients discharged directly home.ConclusionsThis experience demonstrates the potential benefits of a regional system of care for TAVR. Excellent outcomes were demonstrated: most patients had short in-hospital stays and were discharged directly home

Sex is Associated with Differences in Individual Trajectories of Change in Social Health after Implantable Cardioverter-defibrillator

Social health is a dimension of quality of life, and refers to people’s involvement in, and satisfaction with social roles, responsibilities, and activities. The implantable cardioverter-defibrillator is associated with changes in overall quality of life, but little is known about sex differences in individual trajectories of change in social health. Methods and Results We prospectively measured changes in 3 subscales of the SF-36v2 generic health questionnaire (role physical, role emotional, and social functioning), 2 Patient-Reported Outcomes Measurement Information System short forms (satisfaction with participation in social roles and satisfaction with participation in discretionary social activities), and the Florida Patient Acceptance Survey before and at 1, 2, and 6 months after implantation. Individual growth models of temporal change were estimated. The scores of the 6 indicators improved with time. The unconditional model demonstrated significant (fixed effects: P&lt;0.05; covariance parameters: P&lt;0.10) residual variability in the individual trajectories. In the conditional model, men and women differed significantly in their rates of change in the scores of 3 of the 6 measures. Although men’s mean scores exceeded women’s mean scores on all indicators at baseline (range of relative mean difference: 11.0% to 17.8%), the rate of women’s change resulted in a reversal in relative standing at 6 months after implantation, with the mean scores of women exceeding the men’s by 4.5% to 5.6%. Conclusions Men and women differed in their trajectories of change in social health, both in terms of their starting points (ie, baseline scores) and their rates of change. &nbsp

Temporal Changes in Mortality After Transcatheter and Surgical Aortic Valve Replacement: Retrospective Analysis of US Medicare Patients (2012–2019)

BACKGROUND: The treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30‐day mortality, 30‐day readmission, and length of stay after TAVR and SAVR. METHODS AND RESULTS: We conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30‐day mortality; secondary end points were 30‐day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2‐way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7‐year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67–0.86]; 2016: HR, 0.39 [95% CI, 0.36–0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63–0.73]; 2016: HR, 0.43 [95% CI, 0.41–0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84–1.98]; 2019: HR, 5.34 [95% CI, 5.22–5.45]). These results were consistent in full aortic valve replacement hospitals. CONCLUSIONS: The rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U‐shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long‐term implications of lowering risk profiles across treatment options to guide case selection and clinical care

Bridging clinical practice and research in the hospital setting: Exploring the endless possibilities

As a practice discipline with an emerging research tradition, nursing is challenged to remain grounded in the clinical setting while building means to contribute to scientific evidence. The creation of new knowledge does not on its own lead to widespread implementation and impact on health outcomes. The hospital setting presents multiple opportunities for researchers to engage in projects amenable to rapid knowledge translation, by addressing issues ranging from innovations in practice, care processes to outcome measurement. This presentation will explore the opportunities and challenges of bridging clinical practice and research in the hospital setting by engaging in a dynamic and iterative process to promote research dissemination and exchange. I will explore how a research question that originated from a nursing staff meeting in a cardiology centre was developed into a Master’s thesis project, and how the findings were translated into changes in clinical practice. Other examples will include research projects aimed at informing the development of clinical practice guidelines for survivors of sudden cardiac death, incorporating the measurement of neurocognitive outcomes and quality of life in frail elderly patients undergoing innovative cardiac procedures, and highlighting patient-reported outcomes in cardiac device care. By discussing the mechanisms that facilitate the transfer of knowledge “from thesis to bedside”, I will highlight opportunities and recommendations to integrate knowledge translation by identifying questions of interest to stakeholders, adapting knowledge development to the local context, assessing and addressing the potential barriers to knowledge use, selecting, tailoring and implementing interventions, and sustaining knowledge use. This presentation will invite debate on how to optimize the rapid impact of research on patient care.Applied Science, Faculty ofNursing, School ofUnreviewedResearche

Factors associated with patient outcomes following same-day discharge percutaneous coronary intervention

Coronary artery disease continues to cause the majority of deaths and disability in Canada; the resultant demand for percutaneous coronary intervention (PCI) exercises constant pressure on health care systems to meet the growing needs of patients. The practice of same-day discharge PCI has emerged as a medically safe option to optimize resource utilization and to improve access to care. The purpose of this study was to describe elective same-day discharge PCI patients' health behaviour in the two to five days following their procedure. The concepts of cardiac self-efficacy and self-care agency provided a theoretical framework. A telephone questionnaire drawing from existing validated tools was developed to explore the relationships between patient and procedural characteristics, and individuals' capacity to care for themselves following PCI in a study sample of 98 participants. The findings revealed a high degree of adherence to the discharge guidelines, including following medication regimen, making a follow-up appointment, and managing the dressing. Yet, within 24 hours of discharge, over 30% of patients experienced symptoms of myocardial ischemia, with 80% opting to take no action, and a further 10% of the total sample presented to an emergency department. Participants' awareness of how to appropriately manage their chronic disease was low: although over 70% of patients understood the results of their PCI procedure, 38% believed that they no longer had coronary artery disease, 50% did not know how to prevent their heart disease from worsening, and 77% did not intend to participate in cardiac rehabilitation. To identify factors associated with lower levels of CSE and SCA, multiple linear regression analysis was carried out. Lack of social support emerged as a significant and consistent predictor of poorer outcomes. In addition, other aspects of psychoemotional distress were also significant factors in patients' cardiac self-efficacy and self-care agency in the recovery period. Same-day discharge PCI presents a feasible and safe option for delivery of care for most patients, but requires improved bridging between acute intervention and chronic disease management, and the identification of tailored interventions or support for individuals at higher risk during the recovery period.Applied Science, Faculty ofNursing, School ofGraduat

Change in patient-reported outcomes after cardioverter-defibrillator implantation

Some people, because they have a genetic predisposition or heart disease, are at high risk for cardiac arrhythmias that could cause their hearts to stop. The implantable cardioverter-defibrillator (ICD) is an effective therapy that recognises abnormal heart beats, can administer an electrical shock to stop a potentially lethal heart rhythm, and affords protection from the devastating consequences of sudden cardiac arrest. Patient-reported outcomes (PROs) are assessments provided directly by patients about various aspects of their health and quality of life. We sought to study the change in PROs after ICD implantation to identify people’s patterns of change, explore individual trajectories of change, and identify predictors of differences in individuals’ trajectories. The study was grounded in the Wilson and Cleary (1995) conceptual framework of quality of life and informed by the Patient-Reported Outcomes Measurement Information System domain framework. Using a prospective, longitudinal study design, data were obtained from 171 people undergoing ICD implantation at quaternary centres in British Columbia, Canada (55.5% response rate). PRO assessments were obtained immediately before implantation and at one, two, and six months following implantation. We employed individual growth modelling to analyse change within and between people. The participants had different physical, mental, and social health status PROs at baseline and, on average, demonstrated improvement. At most of the measurement occasions, the participants’ PROs remained poorer than those of average adult, urban-dwelling Canadians. There was significant individual variability in most of the trajectories, especially in the social functioning domains. Relative to men, women reported worse PROs initially (the relative mean difference in men’s and women’s scores ranged from 4.5% to 24.7% for 6 of the 12 indicators). Yet, the women’s rates of improvement were significantly faster than those of men. Women equalled or exceeded the men’s PROs at the six-month assessment (the relative mean difference ranged from 4.5% to 10.4%, depending on the PRO). Further research is needed to explore the individual change trajectories identified in this study, especially for those patients who did not improve over time, fully test the conceptual model that framed the research, and evaluate interventions aimed at improving PROs after ICD implantation.Applied Science, Faculty ofNursing, School ofGraduat