Is the outcome of elective vs non-elective patients undergoing transcatheter aortic valve implantation different? Results of a single-centre, observational assessment of outcomes at a large university clinic.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients. METHODS: This single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed. RESULTS: Patients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p < 0.001), including a median postprocedural stay of 5 days (elective 4 days versus non-elective 7 days; p < 0.001). All-cause mortality at 30 days was 1.1% for the elective group and 3.7% for non-elective patients (p = 0.030). At 1 year, all-cause mortality among elective TAVI patients was disproportionately lower than in non-elective patients (5.0% versus 18.7%, p < 0.001). In the elective group, 54.5% of patients could not be discharged early due to comorbidities or procedural complications. Factors associated with a failure of achieving a total length of stay of ≤ 5 days comprised frailty syndrome, renal impairment as well as new permanent pacemaker implantation, new bundle branch block or atrial fibrillation, life-threatening bleeding, and the use of self-expanding valves. After multivariate adjustment, new permanent pacemaker implantation (odds ratio 6.44; 95% CI 2.59-16.00), life-threatening bleeding (odds ratio 4.19; 95% confidence interval 1.82-9.66) and frailty syndrome (odds ratio 5.15; 95% confidence interval 2.40-11.09; all p < 0.001, respectively) were confirmed as significant factors. CONCLUSIONS: While non-elective patients had acceptable periprocedural outcomes, mortality rates at 1 year were significantly higher compared to elective patients. Approximately only half of elective patients could be discharged early. Improvements in periprocedural care, follow-up strategies and optimized treatment of both elective and non-elective TAVI patients are needed.

Responding to the COVID-19 pandemic: Development of a critical care nursing surge model to meet patient needs and maximise competencies.

BACKGROUND: The current coronavirus disease 2019 (COVID-19) pandemic is creating unprecedented and unchartered demands on critical care units to meet patient needs and adapt the delivery of health services. Critical care nurses play a pivotal role in developing models of care that are effective, flexible, and safe. OBJECTIVES: We report on the accelerated development of a critical care nursing surge model responsive to escalating needs for intensive care capacity. METHODS: We conducted an exploratory prospective observational cohort study that included (i) a self-assessment and survey of learning needs of noncritical care nurses identified as candidate groups for redeployment in the intensive care unit and (ii) a pilot implementation of a team nursing model evaluated by individual questionnaires and the conduct of focus groups. We used descriptive statistics and qualitative content analysis to analyse the exploratory findings. RESULTS: We surveyed 147 noncritical care nurses; 99 (67.3%) self-assessed at the lowest level of critical care competency, whereas 33 (24.3%) reported feeling able to help care for a critically ill patient under the direction of a critical care nurse. Identified learning needs included appropriate use of personal protective equipment in the intensive care unit (n = 123, 83.7%), use of specialised equipment (n = 103, 85.1%), basic mechanical ventilation, and vasoactive medication. We completed 11 team nursing pilot assignments with dyads of critical care and noncritical care nurses categorised in tiers of competencies. Nurses reported high levels of perceived support and provision of safe care; multiple recommendations were identified to improve the model of care delivery and communication. CONCLUSIONS: The complexity, acuity, and unpredictability of the COVID-19 pandemic is placing new demands on critical care nurses to modify existing processes for care delivery while ensuring excellent outcomes and professional satisfaction. The study findings provide a road map to support nursing engagement in meeting patient needs.

Post-procedure protocol to facilitate next-day discharge: Results of the multidisciplinary, multimodality but minimalist TAVR study.

BACKGROUND: Evidence is lacking to standardize post-procedure care after transcatheter aortic valve replacement (TAVR). OBJECTIVE: We report on the findings of the post-procedure sub-study of the multimodality, multidisciplinary but minimalist TAVR (3M TAVR) study. METHODS: A standardized protocol to guide monitoring, early mobilization, reconditioning, communication, and criteria-driven discharge was implemented in a multicenter, prospective, sequential case series study in 13 North American low, medium, and high-volume centers in 2015-2017. Outcome measures pertaining to post-procedure care included avoidance of invasive lines and delirium, in-hospital bed utilization, patient disposition at the time of discharge, and 30-day use of nonelective medical services. RESULTS: Four hundred eleven participants were enrolled. In the post-procedure phase, 365 (88.8%) participants were admitted without a temporary pacemaker; urinary catheterization was avoided in 402 (97.8%) participants. Of note, 91.7% received care in a single unit (critical care: 72.5%; cardiac telemetry: 19.2%); 99.0% were discharged home. At the time of 30-day follow-up, 6 (1.6%) participants required admission to a rehabilitation or a skilled nursing facility; 30-day emergency department visits were 13.5%. CONCLUSIONS: The implementation of the 3M TAVR standardized accelerated reconditioning protocol is a safe and effective strategy to facilitate next-day discharge home after TAVR in centers of varying size.

What to expect after open heart valve surgery? Changes in health-related quality of life.

PURPOSE: To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. METHODS: A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. RESULTS: Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. CONCLUSIONS: This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

Temporal Trends and Clinical Consequences of Wait Times for Transcatheter Aortic Valve Replacement: A Population-Based Study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) represents a paradigm shift in the therapeutic options for patients with severe aortic stenosis. However, rapid and exponential growth in TAVR demand may overwhelm capacity, translating to inadequate access and prolonged wait times. Our objective was to evaluate temporal trends in TAVR wait times and the associated clinical consequences. METHODS: In this population-based study in Ontario, Canada, we identified all TAVR referrals from April 1, 2010, to March 31, 2016. The primary outcome was the median total wait time from referral to procedure. Piecewise regression analyses were performed to assess temporal trends in TAVR wait times, before and after provincial reimbursement in September 2012. Clinical outcomes included all-cause death and heart failure hospitalizations while on the wait list. RESULTS: The study cohort included 4461 referrals, of which 50% led to a TAVR, 39% were off-listed for other reasons, and 11% remained on the wait list at the conclusion of the study. For patients who underwent a TAVR, the estimated median wait time in the postreimbursement period stabilized at 80 days and has remained unchanged. The cumulative probability of wait-list mortality and heart failure hospitalization at 80 days was ≈2% and 12%, respectively, with a relatively constant increase in events with increased wait times. CONCLUSIONS: Postreimbursement wait time has remained unchanged for patients undergoing a TAVR procedure, suggesting the increase in capacity has kept pace with the increase in demand. The current wait time of almost 3 months is associated with important morbidity and mortality, suggesting a need for greater capacity and access.

Exploring the synergies between focused ethnography and integrated knowledge translation.

BACKGROUND: Issues with the uptake of research findings in applied health services research remain problematic. Part of this disconnect is attributed to the exclusion of knowledge users at the outset of a study, which often results in the generation of knowledge that is not usable at the point of care. Integrated knowledge translation blended with qualitative methodologies has the potential to address this issue by working alongside knowledge users throughout the research process. Nevertheless, there is currently a paucity of literature about how integrated knowledge translation can be integrated into qualitative methodology; herein, we begin to address this gap in methodology discourse. The purpose of this paper is to describe our experience of conducting a focused ethnography with a collaborative integrated knowledge translation approach, including the synergies and potential sources of discord between integrated knowledge translation and focused ethnography. METHODS: We describe the specific characteristics and synergies that exist when using an integrated knowledge translation approach with focused ethnography, using a research exemplar about the experiences of frail, older adults undergoing a transcatheter aortic valve implantation. RESULTS: Embedding integrated knowledge translation within focused ethnography resulted in (1) an increased focus on the culture and values of the context under study, (2) a higher level of engagement among researchers, study participants and knowledge users, and (3) a commitment to partnership between researchers and knowledge users as part of a larger programme of research, resulting in a (4) greater emphasis on the importance of reciprocity and trustworthiness in the research process. CONCLUSIONS: Engaging in integrated knowledge translation from the outset of a study ensures that research findings are relevant for application at the point of care. The integration of integrated knowledge translation within focused ethnography allows for real-time uptake of meaningful and emerging findings, the strengthening of collaborative research teams, and opportunities for sustained programmes of research and relationships in the field of health services research. Further exploration of the integration of knowledge translation approaches with qualitative methodologies is recommended.

Nursing leadership of the transcatheter aortic valve implantation Heart Team: Supporting innovation, excellence, and sustainability.

Transcatheter Aortic Valve Implantation (TAVI) is an innovative and resource-intensive treatment of valvular heart disease. Growing evidence and excellent outcomes are contributing to increased patient demand. The Heart Team is foundational to TAVI programs to manage the complexities of case selection and other aspects of care. The competencies and expertise of nurses are well suited to provide administrative and clinical leadership within the TAVI Heart Team to promote efficient, effective, and sustainable program development. The contributions of nursing administrative and clinical leaders exemplify the leadership roles that nurses can assume in healthcare innovation.

Transcatheter aortic valve replacement program development: recommendations for best practice.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an increasingly available therapy for the management of aortic stenosis in higher risk populations. Beyond addressing the procedural challenges, centers must attend to the unique requirements of developing TAVR programs from referral to follow-up. AIM: The aim of this article is to outline the recommendations for best practice for program development from centers with early and extensive experience. RECOMMENDATIONS: The guideline-recommended Heart Team approach requires interdisciplinary agreements, delineation of roles and responsibilities, and the development of the role of the TAVR Coordinator. To support appropriate case selection, the screening and evaluation must be organized in a comprehensive clinic visit. In addition to the multimodality imaging tests, the assessment of functional status and frailty is pivotal to the eligibility decision. Throughout the TAVR trajectory, careful attention must be afforded to the integration of geriatric best practices. Pre-procedure care requires patient and family education to manage expectations and facilitate early discharge planning. Peri-procedural care planning, including equipment requirements, monitoring protocols, and emergency intervention agreements, contributes to procedural success. The aims of post-procedure care are to monitor the recovery, facilitate the rapid return to baseline status, and optimize length of stay. TAVR programs require data management strategies to facilitate and monitor program growth, support program evaluation, and meet the requirements for submission to national registries. CONCLUSION: TAVR represents a paradigm shift in the management of structural heart disease. Programmatic success and patient outcomes depend on the development of a comprehensive and collaborative program tailored to TAVR.

Early mobilization after transcatheter aortic valve implantation: observational cohort study.

AIMS: Early mobilization is associated with improved outcomes in hospitalized older patients. We sought to determine the effect of a nurse-led protocol on mobilization 4 h after transfemoral transcatheter aortic valve implantation (TAVI) across different units of care. METHODS AND RESULTS: We conducted a prospective observational cohort single-centre study of consecutive patients. We implemented a standardized protocol for safe early recovery and progressive mobilization in the critical care and cardiac telemetry units. We measured the time to first mobilization and conducted descriptive statistics to identify patient and system barriers to timely ambulation. We recruited 139 patients (82.5 years, SD = 6.7; 46% women). At baseline, patients who were mobilized early (≤4 h) and late (>4 h) did not differ, except for higher rates of diabetes (25.5% vs. 43.9%, P = 0.032) and peripheral arterial disease (8.2% vs. 26.8%, P = 0.003) in the late mobilization group. The median time to mobilization was 4 h [inter-quartile range (IQR) 3.25, 4]; 98 patients (70.5%) were mobilized successfully after 4 h of bedrest; 118 (84.9%) were walking by the evening of the procedure (<8 h bedrest); and 21 (15.1%) were on bedrest overnight and mobilized the following day. Primary reasons for overnight bedrest were arrhythmia monitoring (n = 10, 7.2%) and haemodynamic and/or neurological instability (n = 6, 4.3%); six patients (4.3%) experienced delayed ambulation due to system issues. Procedure location in the hybrid operating room and transfer to critical care were associated with longer bedrest times. CONCLUSION: Standardized nurse-led mobilization 4 h after TF TAVI is feasible in the absence of clinical complications and system barriers.

Accelerating knowledge translation to improve cardiovascular outcomes and health services: opportunities for bridging science and clinical practice.

Knowledge translation (KT) is the exchange between knowledge producers and users to understand, synthesize, share, and apply evidence to accelerate the benefits of research to improve health and health systems. Knowledge translation practice (activities/strategies to move evidence into practice) and KT science (study of the methodology and approaches to promote the uptake of research) benefit from the use of conceptual thinking, the meaningful inclusion of patients, and the application of intersectionality. In spite of multiple barriers, there are opportunities to develop strong partnerships and evidence to drive an impactful research agenda and increase the uptake of cardiovascular research.

The road to a transcatheter edge-to-edge repair: patient experiences leading up to the procedure and in the early recovery period.

AIMS: Mitral valve transcatheter edge-to-edge repair (TEER) is a minimally invasive treatment option for patients with severe symptomatic mitral regurgitation who are at increased risk for cardiac surgery and are receiving optimal medical therapy. Little is known about patients' perspectives on their journey of care, including their experiences leading up to treatment and their early recovery period. The aim of this study was to explore patients' experiences of their journey to TEER and their perspectives on early recovery. METHODS AND RESULTS: We conducted a qualitative study using interpretive description. A purposive sample of 12 patients from a purposive sample, 3-6 monthspost-TEER procedure, were recruited from a tertiary hospital. The median age of the patients was 79 years, with seven males and five females. Data collection included semi-structured interviews over the phone. Data analysis followed an iterative process and utilized thematic analysis. There were four central themes highlighting the experiences of the patients leading up to their procedure: (i) escalating challenges with everyday life; (ii) plummeting losses; (iii) choosing and readiness to proceed with TEER; and (iv) the long and uncertain waiting time. The theme-improved health status highlights the experiences of patients in their early recovery. CONCLUSION: Patients' experiences of waiting for TEER are complex and involve multifaceted challenges related to their worsening cardiac symptoms and navigating the healthcare system. Therefore, care pathways must be put in place to provide continuity of care and support.

Temporal Changes in Quality Indicators in a Regional System of Care After Surgical and Transcatheter Aortic Valve Replacement.

Background: Historically, quality-of-care monitoring was performed separately for transcatheter and surgical aortic valve replacement (TAVR, SAVR). Using consensus indicators, we provide a global report on the quality of care for treatment of aortic stenosis across the highest-volume treatments: transfemoral (TF) TAVR, isolated SAVR, and SAVR combined with coronary artery bypass graft. Methods: Retrospective observational cohort study of consecutive patients in a regional system of care. Primary endpoint was 30-day and 1-year mortality (2015-2019). Secondary endpoints included rate of new pacemaker, rate of readmission, and length of stay (2012-2019). Following multivariable logistic regressions, we developed mortality case-mix adjustment models to report risk estimates. Results: The proportion of patients receiving TAVR grew from 32% to 53% (2015-2019). Those receiving TF TAVR were significantly older, with higher rates of comorbidities. Observed 30-day and 1-year all-cause mortality after TF TAVR decreased from 3.1% to 0.6% (P = 0.03), and 13.6% to 6.6% (P = 0.09), respectively; surgical mortality rates for isolated SAVR and SAVR combined with coronary artery bypass graft were low and did not change significantly over time, ranging from 0.3% to 1.4% and from 0.9% to 3.4%, respectively at 30 days, and from 0.9% to 3.4% and from 4.7% to 6.7 at 1 year. In the TF TAVR cohort, the observed vs expected ratio for 30-day and 1-year mortality decreased significantly from 1.9 (95% confidence interval [CI] 0.9, 3.5) to 0.3 (95% CI 0.1, 0.8), and from 1.3 (95% CI 0.9, 1.7) to 0.7 (95% CI 0.5, 0.99), respectively; no change occurred in risk-adjusted surgical mortality. Conclusions: Consensus quality indicators provide unique insights on the quality of care for patients receiving treatment for aortic stenosis.

Contexte: Par le passé, la surveillance de la qualité des soins était réalisée séparément pour l'implantation valvulaire aortique par cathéter (IVAC) et la chirurgie de remplacement valvulaire aortique (CRVA). À l'aide d'indicateurs consensuels, nous dressons un rapport général de la qualité des soins dans les traitements les plus courants de la sténose aortique : IVAC fémorale, CRVA seule et CRVA combinée à un pontage coronarien. Méthodologie: Une étude de cohorte observationnelle et rétrospective a été menée pour évaluer les patients consécutifs ayant fréquenté un système de santé régional. Le critère d'évaluation principal était le taux de mortalité à 30 jours et à 1 an (2015 à 2019). Les critères d'évaluation secondaires comprenaient le taux de nouveaux sti-mulateurs cardiaques, le taux de réadmission et la durée du séjour (2012 à 2019). Après des régressions logistiques multivariées, nous avons élaboré des modèles d'ajustement selon les groupes de cas pour le taux de mortalité afin d'estimer les risques. Résultats: La proportion de patients qui ont subi une IVAC est passée de 32 % à 53 % (2015 à 2019). Les patients qui ont subi une IVAC transfémorale étaient significativement plus vieux que ceux des autres groupes et présentaient un plus haut taux d'affections concomitantes. Les taux de mortalité de toute cause observés à 30 jours et à 1 an après une IVAC transfémorale ont respectivement diminué de 3,1 % à 0,6 % (P = 0,03) et de 13,6 % à 6,6 % (P = 0,09). Les taux de mortalité pour une CRVA seule et une CRVA combinée à un pontage coronarien étaient faibles et n'ont pas changé de manière significative au fil du temps : les taux de mortalité à 30 jours sont passés de 0,3 % à 1,4 % et de 0,9 % à 3,4 %, respectivement, et les taux de mortalité à 1 an, de 0,9 % à 3,4 % et de 4,7 % à 6,7 %, respectivement. Dans la cohorte ayant subi une IVAC transfémorale, le rapport du taux de mortalité observé par rapport au taux de mortalité attendu à 30 jours et à 1 an a diminué de manière significative, soit de 1,9 (intervalle de confiance [IC] à 95 % : 0,9 à 3,5) à 0,3 (IC à 95 % : 0,1 à 0,8), et de 1,3 (IC à 95 % : 0,9 à 1,7) à 0,7 (IC à 95 % : 0,5 à 0,99), respectivement. Aucune variation n'a été notée quant au taux de mortalité ajusté selon les risques pour une intervention chirurgicale. Conclusions: Les indicateurs consensuels de la qualité fournissent des informations uniques sur la qualité des soins chez les patients traités pour une sténose aortique.

Psychometric Properties of the Kansas City Cardiomyopathy Questionnaire in a Surgical Population of Patients With Aortic Valve Stenosis.

The 12-item version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) was originally developed for patients with heart failure but has been used and tested among patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation. Whether the instrument is suitable for patients with AS who underwent surgical aortic valve replacement (SAVR) is currently unknown. Thus, we aimed to investigate the psychometric properties of the KCCQ-12 before and after SAVR among patients with severe AS. We conducted a prospective cohort of 184 patients with AS who completed the KCCQ-12 and the EuroQol 5 Dimension 5 Levels before and 4 weeks after surgery. Construct validity was investigated with hypothesis testing and an analysis of Spearman's correlation between the two instruments. Structural validity was investigated with explorative and confirmatory factor analyses and reliability with Cronbach's α. All analyses were conducted on data from the two time points (preoperatively and four weeks after surgery). The hypothesis testing revealed how the New York Heart Association class was significantly correlated with the preoperative KCCQ-12 total score (higher New York Heart Association class, worse score). A longer length of hospital stay and living alone were significantly associated with poorer postoperative KCCQ-12 total score. KCCQ-12 and EuroQol 5 Dimension 5 Levels were moderately correlated in most domains/the total score/Visual Analogue Scale score. Principal component analyses revealed two 3-factor structures. The confirmatory factor analyses did not support the original model at any time point. Cronbach's α ranged from 0.22 to 0.84 in three preoperative factors and from 0.39 to 0.76 in the postoperative factors. The total Cronbach's α was 0.83 for the suggested preoperative 3-factor model and 0.83 for the postoperative model. In conclusion, the Danish version of the KCCQ-12 tested in a population of patients with AS who underwent SAVR appears to have acceptable construct validity, whereas structural validity cannot be confirmed for the original four-factor model. Overall reliability is good.

Perceived self-efficacy and empowerment in patients at increased risk of sudden cardiac arrest.

Background: The role of multidisciplinary clinics for psychosocial care is increasingly recognized for those living with inherited cardiac conditions (ICC). In Canada, access to healthcare providers differ between clinics. Little is known about the relationship between access to specialty care and a patient's ability to cope with, and manage their condition. Methods: We leveraged the Hearts in Rhythm Organization (HiRO) to conduct a cross-sectional, community-based survey of individuals with ICC and their family members. We aimed to describe access to services, and explore the relationships between participants' characteristics, cardiac history and self-reported health status and self-efficacy (GSE: General Self-Efficacy Scale) and empowerment (GCOS-24: Genetic Counseling Outcome Scale). Results: We collected 235 responses from Canadian participants in 10 provinces and territories. Overall, 63% of participants reported involvement of a genetic counsellor in their care. Access to genetic testing was associated with greater empowerment [mean GCOS-24: 121.14 (SD = 20.53) vs. 105.68 (SD = 21.69); p = 0.004]. Uncertain genetic test results were associated with lower perceived self-efficacy (mean GSE: uncertain = 28.85 vs. positive = 33.16, negative = 34.13; p = 0.01). Low global mental health scores correlated with both lower perceived self-efficacy and empowerment scores, with only 11% of affected participants reporting involvement of psychology services in their care. Conclusion: Differences in resource accessibility, clinical history and self-reported health status impact the perceived self-efficacy and empowerment of patients with ICC. Future research evaluating interventions to improve patient outcomes is recommended.

Setting a Benchmark for Quality of Care: Update on Best Practices in Transcatheter Aortic Valve Replacement Programs.

Transcatheter aortic valve replacement (TAVR) is an established therapy for the treatment of severe aortic stenosis. The evolution of technology and procedural approaches has facilitated the development of streamlined clinical pathways to optimize patient care and improve outcomes. The revision of historical practices and the adoption of contemporary best practices throughout patients' journey from referral to discharge create opportunities to drive quality improvement. Nursing expertise and leadership are essential to recalibrate preprocedure, periprocedure, and postprocedure practice to transform the way we care for TAVR, achieve excellent outcomes, and promote high-performing health services for the treatment of valvular heart disease.

Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study.

BACKGROUND: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR. METHODS: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data. RESULTS: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P<0.001). CONCLUSIONS: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02287662.

Can you picture it? Photo elicitation in qualitative cardiovascular health research.

Photo elicitation offers novel opportunities to augment the qualitative research toolbox. The use of photographs can enrich connections with participants, and empower them to be creative and engaged to communicate their insights, priorities, and perspectives. There is growing evidence of the effective use of photo elicitation in health research, with emerging interest in the cardiovascular community. Careful study planning, including attention to equipment, participant training, photograph selection, data collection, and ethical consideration, is essential. Detailed reporting of the study design and rationale for use of photographs, conceptual thinking underpinnings, elicitation process, and analytical plan contribute to strengthening the methodological approach.

"What Is the Right Decision for Me?" Integrating Patient Perspectives Through Shared Decision-Making for Valvular Heart Disease Therapy.

Innovations in the treatment of valvular heart disease have transformed treatment options for people with valvular heart disease. In this rapidly evolving environment, the integration of patients' perspectives is essential to close the potential gap between what can be done and what patients want. Shared decision-making (SDM) and the measurement of patient-reported outcomes (PROs) are two strategies that are in keeping with this aim and gaining significant momentum in clinical practice, research, and health policy. SDM is a process that involves an individualised, intentional, and bidirectional exchange among patients, family, and health care providers that integrates patients' preferences, values, and priorities to reach a high-quality consensus treatment decision. SDM is widely endorsed by international valvular heart disease guidelines and increasingly integrated in health policy. Patient decision aids are evidence-based tools that facilitate SDM. The measurement of PROs-an umbrella term that refers to the standardised reporting of symptoms, health status, and other domains of health-related quality of life-provides unique data that come directly from patients to inform clinical practice and augment the reporting of quality of care. Sensitive and validated instruments are available to capture generic, dimensional, and disease-specific PROs in patients with valvular heart disease. The integration of PROs in clinical care presents significant opportunities to help guide treatment decision and monitor health status. The integration of patients' perspectives promotes the shift to patient-centred care and optimal outcomes, and contributes to transforming the way we care for patients with valvular heart disease.

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.