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.

Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial.

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

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.

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.

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

BACKGROUND: The long-term clinical performance of transcatheter heart valves (THV) is unknown. AIMS: This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up. METHODS: Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients. RESULTS: At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%. CONCLUSION: Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

The Relationship Between Heart-Failure Hospitalization and Mortality in Patients Receiving Transcatheter Aortic Valve Replacement.

BACKGROUND: Patients who have had transcatheter aortic valve replacement (TAVR) are at risk of hospitalization during the first year postprocedure. Few studies have examined the incidence of heart- failure hospitalizations (HFH) post-TAVR and the impact this has on subsequent hospitalizations and mortality. Our aim was to determine the incidence, predictors, and mortality associated with HFH post-TAVR. METHODS: We used prospectively collected data for all patients who underwent TAVR between August 1, 2010, and March 31, 2015; 742 consecutive patients who underwent TAVR during the study period were included. Patients were followed for a minimum of 1 year post-TAVR. RESULTS: Mean age was 80.9 ± 8.1, and 58.2% were men. Hospitalizations post-TAVR occurred in 20% of patients at 30 days and 59.7% at 1 year. Of patients hospitalized, HFH was the primary cause of hospitalization in 25.8% and 21.4% of patients at 30 days and 1 year post-TAVR, respectively. Patients with HFH at either 30 days or 1 year had higher subsequent rates of rehospitalization compared with patients who had non-HFH. Patients with HFH or non-HFH at 30 days had 1-year mortality rates of 23.1% and 21.4%, respectively, whereas those with HFH by 1 year had a higher 1-year rate of mortality compared with patients who had non-HFHs (25% vs 10.9%, P < 0.001). CONCLUSIONS: HF accounts for a quarter of all hospitalizations post-TAVR and is associated with higher rates of subsequent rehospitalization and death compared with those who had non-HFH. Understanding predictors of readmissions post-TAVR will allow for better risk stratification and improve outcomes in patients receiving TAVR.

Implications of Transcatheter Heart Valve Selection on Early and Late Pacemaker Rate and on Length of Stay.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can cause injury to the atrioventricular conduction system. We evaluated the effect of transcatheter heart valve (THV) type on the rate of new pacemaker implantation and length of hospital stay. METHODS: Patients across all hospitals performing transfemoral TAVR in the province of British Columbia between 2012 and 2016 participated in a mandated registry with linkages to provincial health databases. We evaluated 1141 patients undergoing successful transfemoral TAVR for native aortic valve stenosis with 5 commonly used valves. RESULTS: Valves implanted were balloon-expandable (BEV) (n = 728), self-expandable (SEV) (n = 341), and mechanically-expandable (MEV) (n = 72). Baseline clinical characteristics were similar between groups: mean age 82.5 years with multiple comorbidities. The mean Society of Thoracic Surgeons predicted risk of mortality was 6.0%. Indwelling temporary pacemakers after TAVR varied by THV type: (BEV) 4.0%, (SEV) 69.3%, and (MEV) 63.0% (P < 0.002). The need for a new permanent pacemaker varied by THV type: (BEV) 6.6%, (SEV) 24.0%, and (MEV) 32.8% at 30 days (P < 0.001). At 1 year, permanent pacemaker rates continued to rise, and remained divergent: (BEV) 8.9%, (SEV) 26.9%, and (MEV) 35.9% (P < 0.001). Median length of stay varied according to THV type: (BEV) 1, (SEV) 3, and (MEV) 4 days (P < 0.001 across groups). Crude mortality rates were not statistically different by THV type, either at 30 days (BEV 3.0%, SEV 2.9%, and MEV 0.0%; P = 0.33), or at 1 year (BEV 10.3%, SEV 15.0%, and MEV 8.3%; P = 0.11). CONCLUSIONS: The choice of a THV device was associated with significant differences in the need for post-TAVR temporary pacemakers, hospital length of stay, and both early and late pacemaker implantation rates. These differences may have an impact on patient morbidity and resource utilization.

Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay.

We describe the development, implementation, and evaluation of a standardized clinical pathway to facilitate safe discharge home at the earliest time after transfemoral transcatheter aortic valve replacement. Between May 2012 and October 2014, the Heart Team developed a clinical pathway suited to the unique requirements of transfemoral transcatheter aortic valve replacement in contemporary practice. The components included risk-stratified minimalist periprocedure approach, standardized postprocedure care with early mobilization and reconditioning, and criteria-driven discharge home. Our aim was to reduce variation in care, identify a subgroup of patients suitable for early discharge (≤48 hours), and decrease length of stay for all patients. We addressed barriers related to historical practices, complex multidisciplinary stakeholder engagement, and adoption of length of stay as a quality indicator. We retrospectively reviewed the experiences of 393 consecutive patients; 150 (38.2%) were discharged early. At baseline, early discharge patients had experienced less previous balloon aortic valvuloplasty, had higher left ventricular ejection fraction, better cognitive function, and were less frail than the standard discharge group (>48 hours). Early discharge was associated with the use of local anesthesia, implantation of balloon expandable device, avoidance of urinary catheter, and early removal of temporary pacemaker. Median length of stay was 1 day for early discharge and 3 days for other patients; 97.7% were discharged home. There were no differences in 30-day mortality (1.3%), disabling stroke (0.8%), or readmission (10.7%). The implementation of a transcatheter aortic valve replacement clinical pathway shifted the program's approach to combine standardized processes and individual risk stratification. The Vancouver transcatheter aortic valve replacement clinical pathway requires a rigorous assessment to determine its efficacy, safety, and reproducibility.

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

OBJECTIVES: This 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. BACKGROUND: Transcatheter 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. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: This 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.