Megan Coylewright

PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial

Background— Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Result— We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P =0.034), and patients felt more informed ( P =0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusion— The PCI choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration— URL: . Unique identifier: [NCT01771536][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01771536&atom=%2Fcirccvoq%2Fearly%2F2016%2F11%2F01%2FCIRCOUTCOMES.116.002641.atomBackground—Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Results—We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P=0.034), and patients felt more informed (P=0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusions—The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration—URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.

Catheter-based intervention for pulmonary vein stenosis due to fibrosing mediastinitis: The Mayo Clinic experience

Introduction Fibrosing mediastinitis (FM) is a rare but fatal disease characterized by an excessive fibrotic reaction in the mediastinum, which can lead to life-threatening stenosis of the pulmonary veins (PV). Catheter-based intervention is currently the only viable option for therapy. However, the current literature on how best to manage these difficult cases, especially in regards to sequential interventions and their potential complications is very limited. Methods We searched through a database of all patients who have undergone PV interventions at the Earl H. Wood Cardiac Catheterization Laboratory in Mayo Clinic, Rochester. From this collection, we selected patients that underwent PV intervention to relieve stenosis secondary to FM. Results Eight patients were identified, with a mean age of 41 years (24–59 years). Five were men, and three were women. Three patients underwent balloon angioplasty alone, and five patients had stents placed. The majority of patients had acute hemodynamic and symptomatic improvement. More than one intervention was required in five patients, four patients had at least one episode of restenosis, and four patients died within four weeks of their first PV intervention. Conclusions We describe the largest reported case series of catheter-based intervention for PV stenosis in FM. Although catheter-based therapy improved hemodynamics, short-term vascular patency, and patient symptoms, the rate of life-threatening complications, restenosis, and mortality associated with these interventions was found to be high. Despite these associated risks, catheter-based intervention is the only palliative option available to improve quality of life in severely symptomatic patients with PV stenosis and FM. Patients with PV stenosis and FM (especially those with bilateral disease) have an overall poor prognosis in spite of undergoing these interventions due to the progressive and recalcitrant nature of the disease. This underscores the need for further innovative approaches to manage this disease.

The medically managed patient with severe symptomatic aortic stenosis in the TAVR era: Patient characteristics, reasons for medical management, and quality of shared decision making at heart valve treatment centers

Background Little is known about patients with severe symptomatic aortic stenosis (AS) who receive medical management despite evaluation at a heart valve treatment center. Objective We identified patient characteristics associated with medical management, physician-reported reasons for selecting medical management, and patients’ perceptions of their involvement and satisfaction with treatment selection. Methods and results Of 454 patients evaluated for AS at 9 established heart valve treatment centers from December 12, 2013 to August 19, 2014, we included 407 with severe symptomatic AS. Information was collected using medical record review and survey of patients and treating physicians. Of 407 patients, 212 received transcatheter aortic valve replacement (TAVR), 124 received surgical aortic valve replacement (SAVR), and 71 received medical management (no SAVR/TAVR). Thirty-day predicted mortality was higher in patients receiving TAVR (8.7%) or medical management (9.8%) compared with SAVR (3.4%) (P<0.001). Physician-reported reasons for medical management included patient preference (31.0%), medical futility (19.7%), inoperability/anatomic infeasibility (11.3%), and inadequate vascular access (8.5%). Compared with patients receiving AVR, medically managed patients were less likely to report that they received enough information about the pros and cons of treatment options (P = 0.03), that their physicians involved them in treatment decisions (P<0.001), and that final decisions were the right ones (P<0.001). Conclusions Patient preference was the most common physician-reported reason for selecting non-invasive AS management, yet patients not undergoing AVR after valve center evaluation reported being less likely to receive sufficient education about treatment options and more likely to feel uncertain about final treatment decisions. Greater attention to shared decision making may improve the experience of care for this vulnerable group of patients.

Building Blocks of Structural Intervention: A Novel Modular Paradigm for Procedural Training

Structural heart disease is a rapidly evolving field, and approaches to procedural training are not standardized. We describe a novel modular approach to procedural training that considers each procedure as a series of building blocks that may be taught and assessed separately. Ten key structural heart disease building blocks can be identified, which, when combined with the cognitive skills of structural intervention and device-specific training, allow appropriate planning and implementation of structural procedures. Structural procedures require careful navigation of the aorta, left atrium, and right heart, including detailed understanding of relational anatomy. Component blocks include large bore vascular access, navigation within the left atrium, occlusion, snaring, and 3-dimensional relational anatomy. These building blocks also provide the foundation for new procedures through innovative use of the skill sets and devices to approach new clinical problems. The addition of device-specific training may be provided via proctoring and industry support. Using this approach, competency in less common procedures may be achieved and maintained. We discuss each building block in detail, approaches specific to the structural heart disease patient, the need for cross-discipline training, and empirical recommendations for training using this approach. We postulate that this new paradigm may be the preferred approach for training and assessment of structural heart disease interventional skills.

Caution Regarding Government-Mandated Shared Decision Making for Patients With Atrial Fibrillation

Although cardiovascular clinicians are increasingly encouraged to incorporate a shared decision-making (SDM) approach with their patients with atrial fibrillation (AF) at risk for stroke, limited guidance is available on how to navigate this complex interaction. Referring physicians, who know their patients best, struggle to present risks and benefits of newer therapies, whereas subspecialists are challenged to rapidly learn new patients’ values and preferences. Decision aids are consistently shown to improve patient outcomes, such as knowledge, engagement, and satisfaction,1 yet poor implementation of an SDM approach by clinicians across routine practice speaks to the ongoing need for a greater understanding of where in the care process SDM is best used and with what tools.2 In this context, the Centers for Medicare and Medicaid Services (CMS) mandated SDM for patients with AF seeking to reduce their stroke risk. In March 2015, the US Food and Drug Administration approved Watchman (Boston Scientific), a cardiac device that occludes the left atrial appendage where most clots are formed in AF. The device was approved for patients with an appropriate rationale to select a percutaneously implanted device over anticoagulation, “taking into account the safety and effectiveness of the device.”3 CMS then released a National Coverage Determination, which prescriptively outlined the healthcare delivery processes required to take place before left atrial appendage closure (LAAC). Referring physicians (nonimplanters) must document evidence of an SDM interaction regarding anticoagulation …

Are Older Adults Willing to Consider New Strategies to Reduce Stroke Risk

Atrial fibrillation (AF) is a common arrhythmia that increases patients’ risk of stroke, and determining an optimal prevention therapy is a preference-sensitive decision appropriate for shared decision making (SDM). Utilizing community-based focus groups, we explored beliefs and values around options for stroke prevention. Interview transcripts from five independent focus groups were qualitatively assessed and organized into themes. Most participants were taking a blood thinner (93%) and more than half of participants (64%) reported having AF. Few participants were familiar with newer therapies. Qualitative analysis revealed three themes: (a) fearing loss of self-control through debilitating stroke, (b) recognizing uncertainty in how to weigh risks and benefits of new treatments, and (c) needing mutual respect between clinicians and patients to consider new/alternative treatment regimens. These findings help direct future research efforts examining optimal timing for SDM and decision aids to promote mutual respect.

Reduction of left ventricular outflow tract obstruction with transcatheter mitral valve repair

Many patients with severe mitral regurgitation cannot undergo conventional mitral valve surgery due to prohibitive surgical risk and are candidates for transcatheter repair with an edge‐to‐edge technique. Prior reports suggest efficacy with this approach for mitral regurgitation due to hypertrophic cardiomyopathy with left ventricular outflow obstruction. We present a case report of transcatheter mitral valve repair for posterior leaflet prolapse with concomitant left ventricular outflow tract obstruction due to systolic anterior motion of the mitral valve in the absence of hypertrophic cardiomyopathy.

Too Early to Tell: The Complexity of Decision Making for Aortic Stenosis Patients at Low Surgical Risk

The report from De Sciscio et al1 in this issue of Circulation: Cardiovascular Quality and Outcomes , suggestively titled “Quantifying the shift toward transcatheter aortic valve replacement in low-risk patients...,” illustrates the great interest of many stakeholders to predict the ultimate role of transcatheter aortic valve replacement (TAVR) in the treatment of severe aortic stenosis (AS). TAVR was commercially approved for patients with high to prohibitive surgical risk in 2011 and expanded to intermediate-risk patients in August of 2016. Now, ≈30% of TAVR centers in the United States are participating in 1 of 2 randomized trials comparing TAVR to surgery in low-risk patients.2,3 Our knowledge of the implications of TAVR in low-risk patients is limited, but apt to change in coming years with the results of ongoing trials. See Article by De Sciscio et al Not surprisingly, there is an inevitable desire by policy makers, industry, the medical community, and others to take our past experience with TAVR in high-risk patients and apply it to lower risk populations to understand how this disruptive technology will affect surgical practice. In this context, De Sciscio et al1 sought to summarize available studies examining the prevalence of AS, and rates of progression to valve replacement, to define who may be eligible for surgical aortic valve replacement (SAVR), TAVR, or both in the coming years. Although this is a worthwhile endeavor, it is in the concept of eligibility where the predictions may be severely limited in defining how many patients there will be to shift from a surgical to a transcatheter approach. …