Allen, Larry A.

ImportanceThe advanced ambulatory heart failure (HF) population comprises patients who have progressed beyond the pillars of recommended stage C HF therapies but can still find meaningful life-years ahead. Although these patients are commonly encountered in practice, national databases selectively capture the small groups accepted for heart transplant listing or left ventricular assist devices. The epidemiology, trajectories, and therapies for other ambulatory patients with advanced HF are poorly understood.ObservationsIn December 2022, the National Heart, Lung and Blood Institute convened a team of experts to identify knowledge gaps and research priorities for the ambulatory population with limiting daily symptoms and transition toward refractory end-stage D HF, designated as stage C2D. This article summarizes the findings from that 3-day workshop. Workshop participants surveyed the initial challenges and knowledge gaps for (1) recognition of ambulatory C2D HF, (2) estimation of the magnitude of the affected population and identifiable subpopulations, and (3) physiologic phenotypes, such as low cardiac output, right HF, cardiorenal syndromes, congestive hepatopathy and frailty, which offer distinct targets for existing and emerging therapies. Social drivers of HF and patient preferences for quality/length of survival were highlighted as essential modifiers for personalization of therapies.Conclusions and RelevanceTen key points summarized workshop findings, with target cohorts for study proposed as a crucial next step. This workshop summary is intended as a call for action to address knowledge gaps and develop new strategies to improve outcomes in the large ambulatory population with C2D HF.

BACKGROUND: Destination therapy left ventricular assist device (DT LVAD) is increasingly offered to patients with end-stage heart failure who are ineligible for heart transplantation. Implanting centers often require the identification of a dedicated caregiver prior to DT LVAD implantation; however, the caregiver experience surrounding this difficult decision is relatively unexplored. METHODS: Between October 2012 and July 2013, we conducted semi-structured, in-depth interviews of caregivers to understand their experiences with decision making for loved ones considering and living with DT LVADs. Data were analyzed using a mixed inductive and deductive approach. RESULTS: We interviewed 17 caregivers: 16 caregivers of patients who had received a DT LVAD and 1 caregiver of a patient who had declined a DT LVAD. At the time of the caregiver interview, 10 DT LVAD patients were living and 7 were deceased. The majority were women (n=16) of whom 12 were either spouses or widows of the patients. Median age of caregivers was 65 (range 35-79). Twelve caregivers reported spending more than 8 hours per week caring for their loved one, and 14 attended regular medical appointments. Throughout the interviews, caregivers reported that DT LVAD was a complex decision making process with many inherent tensions. The themes identified are broadly interpreted under three domains: 1) the stark decision context with tension between hopes and realities, “when we first started out¼we had hopes of a transplant¼but once the lung function was done, and the kidneys ¼there was pretty much nothing. There was no hope other than the LVAD”; 2) the challenging decision process and the tension between wanting their loved ones to live, “I said ‘Well, I'll tell you what. I didn't marry you to be a young widow” and wanting to respect their loved ones’ wishes, “My thoughts were this was his life and it was his choice”; and 3) the downstream decision outcome and the tension between gratitude, “I'm just thankful to have my dad here¼” and a feeling of burden, “I've never felt caregiver was my gift¼I tend to feel like I'm being imposed upon at times.” CONCLUSIONS: Despite the promise of significantly improved survival for some patients, DT LVAD has major implications for caregives as well as patients. Decision making surrounding DT LVAD requires education of both the patient and caregiver of potential stresses. Additionally, decision-making surrounding DT LVAD should seek to incorporate decision support for patients and caregivers. This should include a focus on caregiver burden and the tensions that caregivers may experience.

Background. Oral anticoagulation therapy (OAC) reduces the risk of thromboembolic events associated with atrial fibrillation (AF), yet a substantial proportion of patients with AF are not prescribed OAC. The frequencies of and factors associated with contraindications to OAC therapy in clinical practice are not well-described. Methods. We used data from the ORBIT-AF study, a national, prospective, outpatient registry of incident and prevalent AF. OAC contraindications were uniformly collected at study enrollment by site personnel. Patient and provider characteristics were compared between participants with documented OAC contraindications at baseline and those without OAC contraindications. Results. From June 2010 to August 2011, 10124 patients ≥18 years old with electrocardiographically documented AF were enrolled at 176 practices. Of these, 1409 (13.9%) had OAC contraindications documented at the baseline visit: prior bleed (26.2%), patient refusal/preference (26.0%), high bleeding risk (22.6%), frequent falls/frailty (16.6%), other (11.9%), need for dual antiplatelet therapy (9.8%), unable to adhere/monitor warfarin (5.7%), comorbid illness (5.0%), prior intracranial hemorrhage (4.7%), allergy (2.3%), occupational risk (0.8%), and pregnancy (0.2%). Compared to patients without contraindications, those with contraindications had higher stroke risk (CHADS2>2) and were older, more likely to be female, more likely to be seen by a cardiologist and less likely to be seen by an electrophysiologist (Table 1). Among those patients with reported contraindications, 28.4% were taking warfarin. Conclusions. Contraindications to OAC therapy among AF patients are common and often due to high bleeding risk. Furthermore, many patients with reported contraindications are taking warfarin, suggesting that many contraindications to warfarin therapy are minor, relative, or temporary.

Background: The use of evidence-based therapies to treat cardiovascular comorbidities and risk factors in patients with AF in outpatient clinical practice has not been well characterized. Methods: Using a large, community-based registry of patients with AF in the United States, the prevalence of cardiovascular comorbidities and corresponding use of evidence-based therapies were determined. Results: Among 9,589 enrolled patients with AF, the median age was 75 years; 57.8% were male; 10.7% were non-white; 69.9% had Medicare or Medicaid; 31.8% had coronary heart disease, 32.2% had heart failure, 13.0% had peripheral vascular disease, and 29.5% had diabetes mellitus. Among eligible patients, 62.8% of 3,612 were prescribed an antiplatelet agent, 72.1% of 4,674 were prescribed a β-blocker, 59.7% of 5,121 were prescribed an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, 15.7% of 624 were prescribed an aldosterone antagonist, 70.1% of 6,914 were prescribed a statin, 94.7% of 8,329 were prescribed an antihypertensive, 58.3% of 504 had an ICD, and 44.5% of 9,589 received all indicated evidence-based therapies ( Table ). Conclusion: Cardiovascular comorbidities and risk factors in patients with AF are often inadequately treated with evidence-based therapies in the outpatient practice setting, underscoring opportunities to improve care for patients with AF.

Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.

Background: Destination therapy left ventricular assist devices (DT-LVADs) have become a treatment option for carefully selected patients with end-stage heart failure. Death is inevitable despite DT-LVAD, with 1-year mortality approximately 20% and median survival 5 years. However, end-of-life processes for LVAD patients vary significantly by institution, provider, and patient preference. Palliative care has played an increasing role in the care of this patient population, yet there remains little data on the most effective way to integrate palliative care and hospice in the DT-LVAD population. Therefore, we aimed to understand the end-of-life perspectives regarding LVADs among both cardiology and palliative care/hospice providers. Methods: Using internet-based, secure methods, we administered a 41-item survey via electronic mail to members of the American Academy of Hospice and Palliative Medicine, European Society of Cardiology-Heart Failure Association, the International Society for Heart and Lung Transplantation, and the Heart Failure Society of America to assess their perspectives on end-of-life care in patients with LVADs. Descriptive statistics were used to analyze data. Fisher’s exact test was used to compare categorical data. Results: From October to November 2011, there were a total of 440 respondents (palliative care/hospice=137; cardiology=303). Most were physicians (80%; n=320) and male (59%; n=232). The majority of providers in both groups viewed an LVAD as a life-sustaining treatment. The groups differed in their attitudes, beliefs, and comfort with end-of-life care in patients with an LVAD. Few palliative care/hospice providers believed a patient needed to be imminently dying to turn off an LVAD; whereas most cardiology providers noted patients should be imminently dying in order to consider LVAD deactivation (2% vs 60%; p=<0.001). Most palliative care/hospice providers believed requests for turning off an LVAD in a patient who is not nearing death should be honored. In contrast, just over half of cardiology providers contended the request should be honored (88% vs 57%; p=<0.001). The provider groups also disagreed on requiring ethics consultation, with most cardiology providers stating it was necessary prior to turning off an LVAD near the end of life (67% vs 24%; p=<0.001). Conclusion: Cardiology providers and palliative care/hospice providers collectively have different perceptions on management of end of life in patients with an LVAD. Bridging the gaps between these two disciplines is a critical first step in creating a more cohesive approach to end-of-life care for these patients—one that honors autonomy but respects individual provider comfort levels.

Background: After left ventricular assist device (LVAD) for end-stage heart failure, cognitive function should improve due to increased cerebral perfusion. However, stroke (a well-known LVAD complication) and even subclinical cerebral ischemia may also occur and manifest as transient or permanent cognitive decline. We sought to describe the incidence and predictors of cognitive decline after LVAD using a valid, sensitive assessment tool. Methods: As part of the INTERMACS registry, cognitive function was assessed before LVAD and at each follow-up with the Trailmaking B Test (TBT), where a subject is timed connecting 25 dots labeled with alternating, consecutive numbers and letters (1, A, 2, B, etc.). The TBT can detect several forms of cognitive impairment, including subclinical stroke. Longer times are worse, and cognitive decline was defined as a clinically important increase from baseline to highest follow-up score using Cohen’s D Effect Size (0.2*baseline SD = 13 s). Patients who completed baseline and at least 1 follow-up TBT were included. Multivariable logistic regression was used to examine the association between patient characteristics and cognitive decline after LVAD. Results: Among 1151 LVAD patients, median age was 60-69, 19% were female, and 40% were INTERMACS profile 1-2 (cardiogenic shock or declining despite inotropes) at implant. Among patients with 12-mo follow-up, mean TBT score improved from 126 at baseline to 123 at 1 yr. In the total cohort, 333 (29%) patients had significant cognitive decline within 12 mo of LVAD placement. Increasing age, chronic renal disease, better baseline TBT score (shorter time), and higher INTERMACS profiles (≥ 3; less severe heart failure) were significantly associated with greater odds of cognitive decline (Figure). Conclusion: In a large LVAD registry, cognitive decline occurred in over a quarter of patients in the year after LVAD and was associated with older age, renal disease, higher baseline cognitive function, and more stable heart failure at implant. These results define the frequency of an important adverse event and provide new insights regarding outcomes after LVAD. Future studies are needed to explore the association of transient and permanent cognitive decline with subsequent stroke, health status, and mortality in patients after LVAD placement.

Introduction: The DECIDE-LVAD Trial demonstrated the benefit of a decision support tool for patients considering destination-therapy left ventricular assist device (DT LVAD) implantation. We hypothesized that patients with low health literacy or numeracy may have benefited most from the intervention. Methods: We used the Rapid Estimate of Adult Literacy in Medicine (REALM-R) and the Subjective Numeracy Scale (SNS) to assess patients’ health literacy and numeracy, respectively. A REALM-R score of six or less out of eight identified patients at risk for poor literacy based on the original measure validation. An SNS score less than four out of six identified patients with poor subjective numeracy based on the mean score of the DECIDE-LVAD cohort. We assessed the effect of the decision support tool on LVAD knowledge and values-treatment concordance—concordance between patients’ stated values and their treatment outcome of LVAD or continued medical therapy—and their interaction with health literacy and numeracy. This interaction was assessed using linear mixed models for LVAD knowledge and the difference in Kendall’s tau correlation coefficient for values-treatment concordance. Results: Of the 248 DECIDE-LVAD patients, 228 with complete literacy and numeracy data were analyzed: 51% (116) had high literacy and numeracy; 18 (8%) had low literacy and high numeracy; 55 (25%) had high literacy and low numeracy; 39 (17%) had low scores for both measures. Average age was 63, 15% were female, 19% were racial/ethnic minorities. Patients with high scores for both measures were older, had more formal education, and higher total household income compared to the other 3 groups. Patients with low literacy and/or numeracy had significantly lower LVAD knowledge scores at baseline. In all groups, LVAD knowledge improved over time. The difference in LVAD knowledge between those with low literacy and high literacy decreased over time (baseline difference 9.4%, p=0.002; 6 month follow-up difference 1.4%, p=0.65). In those with high literacy, the decision support tool intervention increased the LVAD knowledge score by 4.2% relative to the control (p=0.15), while in those with low literacy, the intervention increased the score by 10.6% (p=0.04). For patients with low literacy, values-treatment concordance improved with use of the decision support tool (control vs. intervention tau: 0.234 vs 0.673, p=0.028). We did not observe differences in the effect of the intervention by participant numeracy score. Conclusion: All patient groups in the DECIDE-LVAD cohort of patients considering DT LVAD had improved LVAD knowledge with the use of the decision support tool. We did not observe a differential effect of the intervention by numeracy score. Compared to those with higher health literacy, patients with low health literacy improved their LVAD knowledge and values-treatment concordance after the intervention.

Introduction: Patient understanding of available therapies for atrial fibrillation (AF) is foundational to shared medical decision making and long term medication adherence. Yet, there is a paucity of data regarding the extent to which patients newly diagnosed with AF in routine community practice understand their options. Hypotheses: 1) Understanding of warfarin, novel oral anticoagulants (NOAC), rhythm control therapy, cardioversion and radio frequency ablation changes little from baseline to 6 months and 2) treatment rates at 6 months are associated with patient understanding of therapies at baseline. Methods: We analyzed survey data from SATELLITE, a substudy of new-onset AF patients enrolled at 56 US sites participating in the ORBIT-AF registry. Patients were surveyed at the baseline and 6 month follow up clinic visit using Likert scales. Agreement between time points was assessed with the McNemar test, and the relationship between understanding and treatment was assessed only for the subset not on treatment at baseline. Results: Of 1000 patients enrolled in SATELLITE, 506 had 6-month survey data (data collection is continuing). Among these, the median age was 69.0 years (IQR 63.0 - 76.0) and 93.7% (474 of 506) were white. There was evidence of improvement in the self-reported understanding of warfarin and NOACs from baseline to 6 months, but not for rhythm control, ablation or cardioversion. The proportion reporting high understanding improved significantly for warfarin (p<.0001) and NOACs (p<.0001) from 47% (223 of 474) and 51% (245 of 481) at baseline to 60% (284 of 474) and 69% (332 of 481) at 6 months respectively (Figure 1). Patients with high understanding of the benefits of ablation (p=0.0005) and options for ablation (p=0.0093) at baseline were more likely to have this therapy at the 6 month follow up (N=590), but improved understanding was not associated with increased use of warfarin/NOACs (N=83) or rhythm control (N=444). Conclusions: Patients with new-onset AF had improved self-reported understanding of some treatment options over the first 6-months from diagnosis; however, factors other than patient understanding may influence AF treatments received at 6 months. Patient understanding of AF treatments remains suboptimal at 6 months, and our results suggest a need for ongoing patient education.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision—ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.