Sandra Lauck

Transcatheter Aortic Valve Implantation Durability of Clinical and Hemodynamic Outcomes Beyond 3 Years in a Large Patient Cohort

Background— Although short- and medium-term outcomes after transcatheter aortic valve implantation are encouraging, long-term data on valve function and clinical outcomes are limited. Methods and Results— Consecutive high-risk patients who had been declined as surgical candidates because of comorbidities but who underwent successful transcatheter aortic valve implantation with a balloon-expandable valve between January 2005 and December 2006 and survived past 30 days were assessed. Clinical, echocardiographic, and computed tomographic follow-up examinations were performed. Seventy patients who underwent successful procedures and survived longer than 30 days were evaluated at a minimum follow-up of 3 years. At a median follow-up of 3.7 years (interquartile range 3.4 to 4.3 years), survival was 57%. Survival at 1, 2, and 3 years was 81%, 74%, and 61%, respectively. Freedom from reoperation was 98.5% (1 patient with endocarditis). During this early procedural experience, 11 patients died within 30 days, and 8 procedures were unsuccessful. When these patients were included, overall survival was 51%. Transaortic pressure gradients increased from 10.0 mm Hg (interquartile range 8.0 to 12.0 mm Hg) immediately after the procedure to 12.1 mm Hg (interquartile range 8.6 to 16.0 mm Hg) after 3 years (P=0.03). Bioprosthetic valve area decreased from a mean of 1.7±0.4 cm2 after the procedure to 1.4±0.3 cm2 after 3 years (P<0.01). Aortic incompetence after implantation was trivial or mild in 84% of cases and remained unchanged or improved over time. There were no cases of structural valvular deterioration, stent fracture, deformation, or valve migration. Conclusions— Transcatheter aortic valve implantation demonstrates good medium- to long-term durability and preserved hemodynamic function, with no evidence of structural failure. The procedure appears to offer an adequate and lasting resolution of aortic stenosis in selected patients.

Transcatheter Aortic Valve Implantation

Background—Although short- and medium-term outcomes after transcatheter aortic valve implantation are encouraging, long-term data on valve function and clinical outcomes are limited. Methods and Results—Consecutive high-risk patients who had been declined as surgical candidates because of comorbidities but who underwent successful transcatheter aortic valve implantation with a balloon-expandable valve between January 2005 and December 2006 and survived past 30 days were assessed. Clinical, echocardiographic, and computed tomographic follow-up examinations were performed. Seventy patients who underwent successful procedures and survived longer than 30 days were evaluated at a minimum follow-up of 3 years. At a median follow-up of 3.7 years (interquartile range 3.4 to 4.3 years), survival was 57%. Survival at 1, 2, and 3 years was 81%, 74%, and 61%, respectively. Freedom from reoperation was 98.5% (1 patient with endocarditis). During this early procedural experience, 11 patients died within 30 days, and 8 ...

Underexpansion and Ad Hoc Post-Dilation in Selected Patients Undergoing Balloon-Expandable Transcatheter Aortic Valve Replacement

OBJECTIVES This study sought to assess the clinical outcomes and hemodynamic performance associated with a strategy of underexpanding balloon-expandable transcatheter heart valves (THV) when excessive oversizing is a concern. BACKGROUND Transcatheter aortic valve replacement depends on the selection of an optimally sized THV. An undersized THV may lead to paravalvular regurgitation, whereas excessive oversizing may lead to annular injury. METHODS Patients (n = 47) who underwent transcatheter aortic valve replacement with an intentionally underexpanded THV (balloon-filling volume reduced ~10%) were compared with consecutive control patients who had nominal THV balloon deployment (n = 87). Pre- and post-procedural computed tomography imaging and echocardiography were performed to assess THV stent expansion and hemodynamics. RESULTS Underfilling resulted in THV underexpansion that was maximal at the THV inflow (85.0 ± 7.4% vs. 102.5 ± 6.2%, p < 0.001), in study versus control groups, respectively. The study group received larger THV, although annular injury was not observed. Post-dilation was required in 10.6% and 4.6% of patients of the study and control groups, respectively (p = 0.165). Echocardiographic THV area, gradient, paravalvular regurgitation, and in-hospital outcomes were similar. CONCLUSIONS Intentionally underexpanding balloon-expandable THV by underfilling the deployment balloon did not adversely affect procedural clinical outcomes, THV gradients, or THV areas. A strategy of underexpansion, with post-dilation as necessary, might play in role in reducing the risk of annular injury and paravalvular regurgitation in selected patients.

Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway

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.

Integrating a palliative approach in a transcatheter heart valve program: Bridging innovations in the management of severe aortic stenosis and best end-of-life practice

Severe aortic stenosis (AS) is the most prevalent structural heart disease and affects primarily older adults in their last decade of life. If the risk for surgery is high, transcatheter aortic valve implantation (TAVI) is the treatment of choice for many patients with suitable anatomy who are likely to derive significant benefit from this innovative and minimally invasive approach. In a large transcatheter heart valve (THV) centre that offers TAVI as one of the treatment options, of 565 consecutive referrals for the assessment of eligibility for TAVI over 18 months, 78 (14%) were deemed unsuitable candidates for TAVI or higher risk surgery by the interdisciplinary Heart Team because of their advanced disease, excessive frailty or comorbid burden. Concerns were raised for patients for whom TAVI is not an option. The integration of a palliative approach in a THV program offers opportunities to adopt best end-of-life practices while promoting innovative approaches for treatment. An integrated palliative approach to care focuses on meeting a patient’s full range of physical, psychosocial and spiritual needs at all stages of a life-limiting illness, and is well suited for the severe AS and TAVI population. A series of interventions that reflect best practices and current evidence were adopted in collaboration with the Palliative Care Team and are currently under evaluation in a large TAVI centre. Changes include the introduction of a palliative approach in patient assessment and education, the measurement of symptoms, improved clarity about responsibility for communication and follow-up, and triggering referrals to palliative care services.

Risk Stratification and Clinical Pathways to Optimize Length of Stay After Transcatheter Aortic Valve Replacement

BACKGROUND Transcatheter aortic valve replacement (TAVR) program experience and advances present opportunities to introduce minimalist clinical pathways. The purpose of this study was to determine the safety and feasibility of preprocedural individualized risk stratification for general anaesthesia and transesophageal echocardiography (GA/TEE) or awake TAVR and the postprocedural standard or rapid discharge TAVR clinical pathways. METHODS Standardized screening and multidisciplinary heart team consensus was used to evaluate individual periprocedural risk and requirements. Postprocedural clinical status and criteria guided the timing of discharge. We evaluated standardized TAVR outcomes and length of stay according to periprocedural practice and postprocedural trajectory. RESULTS In 144 consecutive patients who underwent TAVR in 2013 (mean age, 82.0 ± 7.1 years; 38.2% women; mean Society of Thoracic Surgeons score, 6.5% ± 4.1%), 101 (69.1%) were assigned to the GA/TEE protocol, whereas 43 (29.9%) were assigned to the minimalist awake TAVR protocol. Irrespective of mode of anaesthesia, 94 (65.3%) patients were discharged within the standard time, whereas 50 (34.7%) patients were suitable for rapid discharge. Overall outcomes at 30 days were 2.1% mortality, 1.4% stroke, and 2.1% life-threatening bleeding. Median length of stay was shortest in the awake TAVR group (2 days; interquartile range [IQR], 1-3 days) and rapid discharge group (2 days; IQR, 1-2 days) and longer in the GA/TEE and standard discharge (3 days, IQR, 3-4 days) groups. CONCLUSIONS Excellent outcomes and decreased length of stay can be achieved with individualized risk stratification to select the optimal periprocedural practice and determine the timing of discharge. These findings should be further evaluated in a large long-term clinical study.

Transcatheter aortic valve replacement program development: Recommendations for best practice

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.

Implementation of processes of care to support transcatheter aortic valve replacement programs

Transcatheter aortic valve replacement (TAVR) is increasingly accepted as a feasible and safe therapeutic alternative to open heart surgery in select patients. Procedural success and technological advances combined with favorable clinical outcomes and demonstrated prolonged survival are establishing TAVR as the standard of care in symptomatic patients who are at higher risk or not candidates for conventional surgery. The growing number of referrals and complexities of care of TAVR candidates warrants a program that ensures appropriate patient assessment and triage, establishes appropriate processes, and promotes continuity of care. To address these needs and prepare for the anticipated growth of transcatheter heart valve (THV) therapeutic options, the TAVR program at St. Paul’s Hospital, Vancouver, Canada, implemented an electronic centralized and clinically managed referral and triage program, and a THV Nurse Coordinator position to support the program and patients, conduct a global functioning assessment, and provide clinical triage coordination, waitlist management, patient and family education and communication with clinicians. Interdisciplinary rounds assist in the selection of candidates, while a clinical data management system facilitates standardized documentation and quality assurance from referral to follow-up. The unique needs of TAVR patients and programs require the implementation of unique processes of care and tailored assessment.

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.

Factors influencing the decision of older adults to be assessed for transcatheter aortic valve implantation: An exploratory study

Background: Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe symptomatic aortic stenosis at increased surgical risk and likely to derive benefit. Multimodality and multidisciplinary assessment is required for the heart team to determine eligibility for TAVI in a primarily older population. Little is known about patients’ motivation and perspectives on making the decision to undergo the complex assessment. Aims: To explore factors influencing patients’ decision making to undergo TAVI eligibility assessment to inform practice, programme development, health policy and future research. Methods: An exploratory qualitative approach was used. Semistructured interviews were conducted with 15 patients at the time of their referral for assessment to a quaternary cardiac and high volume TAVI centre. Results: Multiple, intersecting factors that included biomedical, functional, social and environmental considerations influenced patients’ decision. The six distinct factors were symptom burden, participants’ perception as ‘experienced’ patients, expectations of benefit and risks, healthcare system and informal support, logistical barriers and facilitators, and obligations and responsibilities. Conclusions: The decision to undergo TAVI eligibility assessment is multifaceted and complex. Programmatic processes of care must be in place to facilitate appropriate and patient-centered decision making and access to TAVI. Strategies are required to mitigate the risks associated with the rapid deterioration of severe aortic stenosis, address patient and referring physicians’ education needs, and provide individualised care and equitable access. Future research must focus on patients’ experiences throughout the trajectory of TAVI care.