Dunlay, Shannon M.

Abstract Various risk models with differing discriminatory power and predictive accuracy have been used to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. There remains an unmet need for a contemporary risk score for continuous flow (CF)‐LVADs. We sought to independently validate and compare existing risk models in a large cohort of patients and develop a simple, yet highly predictive risk score for acute, severe RVF. Data from the Mechanical Circulatory Support Research Network (MCSRN) registry, consisting of patients who underwent CF‐LVAD implantation, were randomly divided into equal‐sized derivation and validation samples. RVF scores were calculated for the entire sample, and the need for a right ventricular assist device (RVAD) was the primary endpoint. Candidate predictors from the derivation sample were subjected to backward stepwise logistic regression until the model with lowest Akaike information criterion value was identified. A risk score was developed based on the identified variables and their respective regression coefficients. Between May 2004 and September 2014, 734 patients underwent implantation of CF‐LVADs [HeartMate II LVAD, 76% ( n = 560), HeartWare HVAD, 24% ( n = 174)]. A RVAD was required in 4.5% ( n = 33) of the patients [Derivation cohort, n = 15 (4.3%); Validation cohort, n = 18 (5.2%); P = 0.68)]. 19.5% of the patients ( n = 143) were female, median age at implant was 59 years (IQR, 49.4–65.3), and median INTERMACS profile was 3 (IQR, 2–3). RVAD was required in 4.5% ( n = 33) of the patients. Correlates of acute, severe RVF in the final model included heart rate, albumin, BUN, WBC, cardiac index, and TR severity. Areas under the curves (AUC) for most commonly used risk predictors ranged from 0.61 to 0.78. The AUC for the new model was 0.89 in the derivation and 0.92 in the validation cohort. Proposed risk model provides very high discriminatory power predicting acute severe right ventricular failure and can be reliably applied to patients undergoing placement of contemporary continuous flow left ventricular assist devices.

Abstract Background The majority of aging adults with heart failure (HF) receive support from a family caregiver. Most literature has emphasized the stressors and burden of caregiving, with less focus on positive self-gains associated with caregiving. Methods and Results Using an explanatory sequential design, we assessed self-gain by administering a survey to caregivers of a person with HF (n = 108) and then conducted qualitative semi-structured interviews with a subset (n = 16) of these caregivers. Quantitative results indicate spousal caregivers, and caregivers with higher preparedness and higher mastery had greater odds of reporting high self-gain. Content analysis of qualitative data revealed 3 themes of self-gain including (i) caregiving as a means to enhancing relationships, (ii) success in negotiating care and healthy behaviors with people with HF, and (iii) caregiving as a means of preparing caregivers for the future. Conclusions HF caregivers experience a range of positive self-gains and the ability to find meaning in the stressful caregiving role. Caregivers’ ability to garner intrinsic gains from their role can have important benefits well after caregiving has ended.

Abstract Heart failure (HF) is an increasingly prevalent condition with a very high symptom burden. To address challenges faced by palliative care clinicians, we assembled a team of experts to provide high-yield tips for the management of these patients. Prognosis is unpredictable in HF and many patients and physicians overestimate survival. Ejection fraction, notably, is not predictive of prognosis. It is important to have thorough discussions about implantable cardioverter defibrillators in terminally ill HF patients. Diuresis is the mainstay of managing volume overload and dyspnea in these patients and it is important to be aggressive and creative to achieve symptom relief. However, HF patients have a high burden of comorbidities and have many symptoms beyond dyspnea as well. Management in hospice remains challenging for these patients, with a significant risk for readmission to the hospital. Almost a quarter of HF patients discharged to hospice from the hospital die in less than three days.

Background: There are contrasting reports on the effectiveness of a concomitant intra-aortic balloon pump (IABP) in cardiogenic shock patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study sought to compare short-term mortality in patients with cardiogenic shock treated with VA-ECMO with and without IABP. Methods and Results: We reviewed the published literature from 2000 to 2018 for studies evaluating adult patients requiring VA-ECMO for cardiogenic shock with concomitant IABP. Studies reporting short-term mortality were included. Meta-analysis of the association of IABP with mortality was performed using Mantel-Haenszel models. Subgroup analyses were performed in patients with cardiogenic shock complicating acute myocardial infarction (AMI) and postcardiotomy cardiogenic shock. Twenty-two observational studies with 4653 patients were included. These studies showed high heterogeneity for the total and postcardiotomy cardiogenic shock cohorts and low heterogeneity for the AMI cohort. Short-term mortality was not significantly different in patients with and without IABP 42.1% versus 57.8%; risk ratio, 0.80; 95% CI, 0.52–1.22; P =0.30. However, concomitant IABP with VA-ECMO was associated with lower mortality in patients with AMI (50.8% versus 62.4%; risk ratio, 0.56; 95% CI, 0.46–0.67; P <0.001). There was no difference in mortality in postcardiotomy cardiogenic shock and mixed causes for cardiogenic shock. Conclusions: In cardiogenic shock patients requiring VA-ECMO support, the use of IABP did not influence mortality in the total cohort. In patients with AMI, use of IABP with VA-ECMO was associated with 18.5% lower mortality in comparison to patients on VA-ECMO alone. Further randomized studies are warranted to corroborate these observational data.

Background There are limited data on the use of venoarterial extracorporeal membrane oxygenation ( VA ‐ ECMO ) or cardiopulmonary bypass ( CPB ) to provide hemodynamic support periprocedurally during transcatheter aortic valve replacement. This study sought to evaluate patients receiving transcatheter aortic valve replacement with concomitant use of CPB / VA ‐ ECMO . Methods and Results We systematically reviewed the published literature from 2000 to 2018 for studies evaluating adult patients requiring CPB / VA ‐ ECMO periprocedurally during transcatheter aortic valve replacement. Studies reporting short‐term and long‐term mortality were included. Given the significant methodological and statistical differences between published studies, meta‐analysis of the association of CPB / VA ‐ ECMO with mortality was not performed. Of the 537 studies identified, 9 studies representing 5191 patients met our inclusion criteria. Median ages were between 75 and 87 years with 33% to 75% male patients. Where reported, the Edwards SAPIEN ™ transcatheter heart valve was the most frequently used. A total of 203 (3.9%) patients received periprocedural hemodynamic support with CPB / VA ‐ ECMO . Common indications for CPB / VA ‐ ECMO included left ventricular or aortic annular rupture, rapid hemodynamic deterioration, aortic regurgitation, cardiac arrest, and left main coronary artery obstruction. The use of CPB / VA ‐ ECMO was predominantly an emergent strategy and was used for durations of 1 to 2 hours. Short‐term mortality (in‐hospital and 30‐day) was 29.8%, and 1‐year mortality was 52.4%. Major complications such as bleeding, vascular injury, tamponade, stroke, and renal failure were noted in 10% to 50% of patients. Conclusions CPB / VA ‐ ECMO was used in 4% in the early experience of patients undergoing transcatheter aortic valve replacement, most commonly for periprocedural complications. There are limited data on preprocedural planned use of VA ‐ ECMO , and the characteristics of this population remain poorly defined.

Pump thrombosis is a major adverse event in patients supported on continuous-flow left ventricular assist devices (CF-LVAD). The aim of this systematic review and meta-analysis was to determine the outcomes of various treatment approaches for pump thrombosis, including surgical as compared to medical therapy. Electronic search was performed to identify all studies in the English literature addressing surgical and medical management of pump thrombosis in the modern CF-LVAD era. All identified articles were systematically assessed for inclusion and exclusion criteria. In the meta-analysis, because of significant overlap of the data, reports based on trials, registries, and individual cohort studies were analyzed separately. Forty-three studies were included in the analysis (2 trials, 4 registry reports, and 37 individual cohort studies). 2,281/28,728 (10.6%) patients developed pump thrombosis, of which 44.4% and 55.1% were supported on the HeartWare and HeartMate II, respectively. To avoid overlap in studies and to seek more granular data, pooled individual cohort studies were found to be representative of the entire population, and further in-depth analysis of this category was performed. Of the 610/5,545 (11.8%) patients with pump thrombosis in these individual cohort studies, 225 patients had surgical pump exchange, and 186 were treated medically. Surgical therapy resulted in higher success as compared to medical therapy (81.3% vs. 45.4%; p < 0.001), lower 30 day mortality rate (16.7% vs. 34.5%; p = 0.013) and recurrence rate (11.8% vs. 38.3%; p < 0.001). Meta-regression of all studies demonstrates a possible temporal increase of pump thrombosis rate (p = 0.040). Surgical pump exchange is superior to medical therapy with a higher success rate of pump thrombosis resolution, lower mortality rate, and lower recurrence rate. Randomized controlled prospective studies are needed to compare these clinical approaches and their resultant outcomes to guide decision-making for the management of CF-LVAD thrombosis.

Objectives To characterize the individual and combined effects of multimorbidity and functional limitation on healthcare use and mortality in a large, community cohort of individuals with heart failure (HF). Design Prospective cohort study. Setting Eleven southeastern Minnesota counties. Participants Individuals (mean age 74, 54% male) with a first‐ever HF code ( International Classification of Diseases, Ninth Revision code 428 or Tenth Revision code I50) between January 1, 2013 and March 31, 2016 (N=2,692). Measurements Eight activities of daily living measured using a survey on a Likert scale (1=without any difficulty, 5=unable to do; median=8). Participants with a score greater than 8 were categorized as having functional limitation. Multimorbidity was defined as having 2 or more noncardiac comorbidities. Results Twenty‐five percent of participants had neither multimorbidity nor functional limitation, 35% had multimorbidity, 9% had functional limitation, and 31% had both. After adjustment, participants with multimorbidity and functional limitation had greater risks of all outcomes (death: hazard ratio (HR)=4.92, 95% confidence interval (CI)=3.03–8.00; emergency department (ED) visit: HR=3.67, 95% CI=2.94–4.59; hospitalization: HR=3.66, 95% CI=2.85–4.70; outpatient visit: HR=1.73, 95% CI=1.52–1.96) than those with neither. Participants with functional limitation alone had greater risks of death (HR=4.84, 95% CI=2.78–8.43), ED visits (HR=2.35, 95% CI=1.75–3.16), and hospitalizations (HR=2.10, 95% CI=1.52–2.88) but not outpatient visits. Those with multimorbidity alone had similar risks of ED visits and hospitalizations as those with functional limitation alone but were more likely to have outpatient visits (HR=1.50, 95% CI=1.34–1.67). Conclusion Individuals with both multimorbidity and functional limitation have the highest risk of death and healthcare use. Individuals with only functional limitation have similar rates of hospitalizations and ED visits as those with only multimorbidity, underscoring the need to consider both when managing individuals with HF.

Background: The US Food and Drug Administration approved the use of sacubitril/valsartan in patients with heart failure with reduced ejection fraction in July 2015. We aimed to assess the adoption and prescription drug costs of sacubitril/valsartan in its first 18 months after Food and Drug Administration approval. Methods and Results: Using a large US insurance database, we identified privately insured and Medicare Advantage beneficiaries who filled a first prescription for sacubitril/valsartan between July 1, 2015, and December 31, 2016. We compared them to patients treated with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Outcomes included adoption, prescription drug costs, and 180-day adherence, defined as a proportion of days covered ≥80%. A total of 2244 patients initiated sacubitril/valsartan. Although the number of users increased over time, the proportion of heart failure with reduced ejection fraction patients taking sacubitril/valsartan remained low (<3%). Patients prescribed sacubitril/valsartan were younger, more often male, with less comorbidity than those taking an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Although a majority of prescription costs were covered by the health plan (mean, $328.37; median, $362.44 per 30-day prescription), out-of-pocket costs were still high (mean, $71.16; median, $40.27). By comparison, median out-of-pocket costs were $2 to $3 for lisinopril, losartan, carvedilol, and spironolactone. Overall, 59.1% of patients were adherent to sacubitril/valsartan. Refill patterns suggested that nearly half of nonadherent patients discontinued sacubitril/valsartan within 180 days of starting. Conclusions: Adoption of sacubitril/valsartan after Food and Drug Administration approval has been slow and may be associated with the high cost.