Publications by authors named "Joseph G Rogers"

212 Publications

Rinse, Wash, Repeat: The Evolution of the UNOS Heart Transplant Allocation System.

JACC Heart Fail 2022 Jan;10(1):24-26

Texas Heart Institute, Houston, Texas, USA.

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http://dx.doi.org/10.1016/j.jchf.2021.10.010DOI Listing
January 2022

Doing the wrong thing for the right reasons: The demise of the HVAD.

J Thorac Cardiovasc Surg 2021 Nov 25. Epub 2021 Nov 25.

Texas Heart Institute, Houston, Tex. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.10.058DOI Listing
November 2021

Impact of Obesity on Heart Transplantation Outcomes.

J Am Heart Assoc 2021 12 2;10(23):e021346. Epub 2021 Dec 2.

Division of Cardiac Surgery Yale School of Medicine New Haven CT.

Background Patients with obesity and advanced heart failure face unique challenges on the path to heart transplantation. There are limited data on waitlist and transplantation outcomes in this population. We aimed to evaluate the impact of obesity on heart transplantation outcomes, and to investigate the effects of the new organ procurement and transplantation network allocation system in this population. Methods and Results This cohort study of adult patients listed for heart transplant used the United Network for Organ Sharing database from January 2006 to June 2020. Patients were stratified by body mass index (BMI) (18.5-24.9, 25-29.9, 30-34.9, 35-39.9, and 40-55 kg/m). Recipient characteristics and donor characteristics were analyzed. Outcomes analyzed included transplantation, waitlist death, and posttransplant death. BMI 18.5 to 24.9 kg/m was used as the reference compared with progressive BMI categories. There were 46 645 patients listed for transplantation. Patients in higher BMI categories were less likely to be transplanted. The lowest likelihood of transplantation was in the highest BMI category, 40 to 55 kg/m (hazard ratio [HR], 0.19 [0.05-0.76]; =0.02). Patients within the 2 highest BMI categories had higher risk of posttransplantation death (HR, 1.29; <0.001 and HR, 1.65; <0.001, respectively). Left ventricular assist devices among patients in obese BMI categories decreased after the allocation system change (<0.001, all). After the change, patients with obesity were more likely to undergo transplantation (BMI 30-35 kg/m: HR, 1.31 [1.18-1.46], <0.001; BMI 35-55 kg/m: HR, 1.29 [1.06-1.58]; =0.01). Conclusions There was an inverse relationship between BMI and likelihood of heart transplantation. Higher BMI was associated with increased risk of posttransplant mortality. Patients with obesity were more likely to undergo transplantation under the revised allocation system.
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http://dx.doi.org/10.1161/JAHA.121.021346DOI Listing
December 2021

Race Differences in Quality of Life following a Palliative Care Intervention in Patients with Advanced Heart Failure: Insights from the Palliative Care in Heart Failure Trial.

J Palliat Med 2021 Dec 1. Epub 2021 Dec 1.

Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.

Black patients have a higher incidence of heart failure (HF) and worse outcomes than white patients. Guidelines recommend palliative care for patients with advanced HF, but no studies have examined outcomes in a black patient cohort. This is a analysis of the Palliative Care in Heart Failure trial, which randomized patients to usual care plus a palliative care intervention (UC+PAL) or usual care (UC). Quality of life (QoL) was measured using Kansas City Cardiomyopathy Questionnaire (KCCQ) and Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal). Black patients represented 41% of the 148 patients. At six months, QoL improved more in UC+PAL than UC for both racial subgroups. The difference was greater for black than white patients (difference: KCCQ 10.8 vs. 2.5; FACIT-Pal: 14.8 vs. 3.9). However, the findings were not statistically significant. Larger studies are needed to assess the benefits of palliative care for black patients with HF. ClinicalTrials.gov Identifier: NCT01589601.
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http://dx.doi.org/10.1089/jpm.2021.0220DOI Listing
December 2021

Trends and Outcomes of Cardiac Transplantation in the Lowest Urgency Candidates.

J Am Heart Assoc 2021 12 8;10(24):e023662. Epub 2021 Nov 8.

Section of Cardiovascular Medicine Yale School of Medicine New Haven CT.

Background Because of discrepancies between donor supply and recipient demand, the cardiac transplantation process aims to prioritize the most medically urgent patients. It remains unknown how recipients with the lowest medical urgency compare to others in the allocation process. We aimed to examine differences in clinical characteristics, organ allocation patterns, and outcomes between cardiac transplantation candidates with the lowest and highest medical urgency. Methods and Results We performed a retrospective analysis of the United Network for Organ Sharing database. Patients listed for cardiac transplantation between January 2011 and May 2020 were stratified according to status at time of transplantation. Baseline recipient and donor characteristics, waitlist survival, and posttransplantation outcomes were compared in the years before and after the 2018 allocation system change. Lower urgency patients in the old system were older (58.5 versus 56 years) and more likely female (54.4% versus 23.8%) compared with the highest urgency patients, and these trends persisted in the new system (<0.001, all). Donors for the lowest urgency patients were more likely older, female, or have a history of cytomegalovirus, hepatitis C, or diabetes (<0.01, all). The lowest urgency patients had longer waitlist times and under the new allocation system received organs from shorter distances with decreased ischemic times (178 miles versus 269 miles, 3.1 versus 3.5 hours; <0.001, all). There was no difference in posttransplantation survival (<0.01, all). Conclusions Patients transplanted as lower urgency receive hearts from donors with additional comorbidities compared with higher urgency patients, but outcomes are similar at 1 year.
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http://dx.doi.org/10.1161/JAHA.121.023662DOI Listing
December 2021

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience.

J Card Fail 2021 Oct 7. Epub 2021 Oct 7.

Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Texas Heart Institute, Houston, Texas.

Background: Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown.

Methods And Results: We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care vs interdisciplinary PC in advanced HF (N = 150). We describe differences in medication counts between arms at 2, 6, 12, and 24 weeks for HF (12 classes) and PC (6 classes) medications. General linear mixed models were used to evaluate associations between treatment arm and polypharmacy over time. The median age of the patients was 72 years (interquartile range 62-80 years), 47% were female, and 41% were Black. Overall, 48% had ischemic etiology, and 55% had an ejection fraction of 40% or less. Polypharmacy was present at baseline in 100% of patients. HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time point between arms.

Conclusions: In a trial of patients with advanced HF considered eligible for PC, polypharmacy was universal at baseline and increased during follow-up with no effect of the palliative intervention on medication counts relative to standard care.
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http://dx.doi.org/10.1016/j.cardfail.2021.08.021DOI Listing
October 2021

Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.

ASAIO J 2022 Jan;68(1):14-20

University of California San Francisco, San Francisco, California.

The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0-3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1-24 months postimplant and were categorized as: low TTR (10-39%), moderate TTR (40-69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p < 0.001), GI bleeding (1.22 vs. 0.38 EPPY; p < 0.001), stroke (0.47 vs. 0.17 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.02), infection (1.44 vs. 0.69 EPPY; p < 0.001), and renal dysfunction (0.23 vs. 0.05 EPPY; p < 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs. 0.54 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.007), cardiac arrhythmia (0.32 vs. 0.24 EPPY; p = 0.04), and infection (0.90 vs. 0.69 EPPY; p = 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p = 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management.
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http://dx.doi.org/10.1097/MAT.0000000000001572DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700308PMC
January 2022

Long-Term Neurocognitive Outcome in Patients With Continuous Flow Left Ventricular Assist Device.

JACC Heart Fail 2021 11 8;9(11):839-851. Epub 2021 Sep 8.

Neurological Institute, Cleveland Clinic, Cleveland, Ohio.

Objectives: The authors sought to examine the long-term cognitive outcome of patients with continuous flow left ventricular assist device (CF-LVAD).

Background: Data on long-term neurocognitive outcome in LVAD are limited. We examined the neurocognitive outcome of patients who received a CF-LVAD as destination therapy.

Methods: Patients with HeartWare (HVAD) and HeartMate II who were enrolled in the ENDURANCE and ENDURANCE Supplemental trials were eligible. Cognition was evaluated with neuropsychological testing preoperatively and at 6, 12, and 24 months after implantation. General linear models identified demographic, disease, and treatment factors that predicted decline on each neurocognitive measure.

Results: Of 668 patients who completed baseline testing and at least 1 follow-up evaluation, 552 were impaired at baseline on at least 1 cognitive measure. At each follow-up, approximately 23% of tested patients declined and 20% improved relative to baseline on at least 1 cognitive measure. Of those who were intact at baseline, only 10%-12% declined in delayed memory and 11%-16% declined in executive function at all 3 follow-ups. For patients impaired at baseline, delayed memory decline was associated with the HVAD device and male sex, whereas executive function decline was associated with the HVAD device and stroke during CF-LVAD support. For patients intact at baseline, male sex and history of hypertension were associated with decline in immediate memory and executive function, respectively.

Conclusions: Neurocognitive function remained stable or improved for most patients (∼80%) with CF-LVAD at 6, 12, and 24 months after implantation. Male sex, hypertension, HVAD, and stroke were associated with cognitive decline.
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http://dx.doi.org/10.1016/j.jchf.2021.05.016DOI Listing
November 2021

Evaluation of Racial and Ethnic Disparities in Cardiac Transplantation.

J Am Heart Assoc 2021 09 25;10(17):e021067. Epub 2021 Aug 25.

Section of Cardiovascular Medicine Yale School of Medicine New Haven CT.

Background Racial and ethnic disparities contribute to differences in access and outcomes for patients undergoing heart transplantation. We evaluated contemporary outcomes for heart transplantation stratified by race and ethnicity as well as the new 2018 allocation system. Methods and Results Adult heart recipients from 2011 to 2020 were identified in the United Network for Organ Sharing database and stratified into 3 groups: Black, Hispanic, and White. We analyzed recipient and donor characteristics, and outcomes. Among 32 353 patients (25% Black, 9% Hispanic, 66% White), Black and Hispanic patients were younger, more likely to be women and have diabetes mellitus or renal disease (all, <0.05). Over the study period, the proportion of Black and Hispanic patients listed for transplant increased: 21.7% to 28.2% (=0.003) and 7.7% to 9.0% (=0.002), respectively. Compared with White patients, Black patients were less likely to undergo transplantation (adjusted hazard ratio [aHR], 0.87; CI, 0.84-0.90; <0.001), but had a higher risk of post-transplant death (aHR, 1.14; CI, 1.04-1.24; =0.004). There were no differences in transplantation likelihood or post-transplant mortality between Hispanic and White patients. Following the allocation system change, transplantation rates increased for all groups (<0.05). However, Black patients still had a lower likelihood of transplantation than White patients (aHR, 0.90; CI, 0.79-0.99; =0.024). Conclusions Although the proportion of Black and Hispanic patients listed for cardiac transplantation have increased, significant disparities remain. Compared with White patients, Black patients were less likely to be transplanted, even with the new allocation system, and had a higher risk of post-transplantation death.
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http://dx.doi.org/10.1161/JAHA.120.021067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649228PMC
September 2021

Mechanical ventilation at the time of heart transplantation and associations with clinical outcomes.

Eur Heart J Acute Cardiovasc Care 2021 Oct;10(8):843-851

Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA.

Aims: The impact of mechanical ventilation (MV) at the time of heart transplantation is not well understood. In addition, MV was recently removed as a criterion from the new US heart transplantation allocation system. We sought to assess for the association between MV at transplantation and 1-year mortality.

Methods And Results: We utilized the United Network for Organ Sharing database and included all adult, single organ heart transplantations from 1990 to 2019. We utilized multivariable logistic regression adjusting for demographics, comorbidities, and markers of clinical acuity. We identified 60 980 patients who underwent heart transplantation, 2.4% (n = 1431) of which required MV at transplantation. Ventilated patients were more likely to require temporary mechanical support, previous dialysis, and had a shorter median waitlist time (21 vs. 95 days, P < 0.001). At 1 year, the mortality was 33.7% (n = 484) for ventilated patients and 11.7% (n = 6967) for those not ventilated at the time of transplantation (log-rank P < 0.001). After multivariable adjustment, patients requiring MV continued to have a substantially higher 90-day [odds ratio (OR) 3.20, 95% confidence interval (CI): 2.79-3.66, P < 0.001] and 1-year mortality (OR 2.67, 95% CI: 2.36-3.03, P < 0.001). For those that survived to 90 days, the adjusted mortality at 1 year continued to be higher (OR 1.48, 95% CI: 1.16-1.89, P = 0.002).

Conclusion: We found a strong association between the presence of MV at heart transplantation and 90-day and 1-year mortality. Future studies are needed to identify which patients requiring MV have reasonable outcomes, and which are associated with substantially poorer outcomes.
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http://dx.doi.org/10.1093/ehjacc/zuab063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8557439PMC
October 2021

The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation.

ASAIO J 2021 10;67(10):1159-1162

From the Duke University Medical Center, Durham, North Carolina.

Left ventricular assist devices (LVADs) improve quality of life (QoL) and functional capacity (FC) for patients with advanced heart failure. The association between adverse events (AEs) and changes in QoL and FC are unknown. Patients treated with the HeartWare ventricular assist device (HVAD) with paired 6-minute walk distance (6MWD, n = 263) and Kansas City Cardiomyopathy Questionnaires (KCCQ, n = 272) at baseline and 24 months in the ENDURANCE and ENDURANCE Supplemental Trial databases were included. Patients were stratified based upon occurrence of clinically significant AEs during the first 24 months of support and analyzed for the mean change in 6MWD and KCCQ. The impact of AE frequency on change in 6MWD and KCCQ from baseline to 24 months was evaluated. Of the AEs examined, only sepsis was associated with an improvement in 6MWD (109 m vs. 16 m, p = 0.002). Patients without improvement in 6MWD test from baseline to 24 months had significantly more AEs than those with FC improvement (p = 0.0002). Adverse events did not affect the KCCQ overall summary score. In this analysis, patients with fewer AEs had greater improvement in FC during the 24-month follow up. The frequency of AEs did not have a significant impact on QoL after LVAD implantation.
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http://dx.doi.org/10.1097/MAT.0000000000001378DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478694PMC
October 2021

Clinical outcomes and healthcare expenditures in the real world with left ventricular assist devices - The CLEAR-LVAD study.

J Heart Lung Transplant 2021 05 22;40(5):323-333. Epub 2021 Feb 22.

Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.

Background: Several distinctly engineered left ventricular assist devices (LVADs) are in clinical use. However, contemporaneous real world comparisons have not been conducted, and clinical trials were not powered to evaluate differential survival outcomes across devices.

Objectives: Determine real world survival outcomes and healthcare expenditures for commercially available durable LVADs.

Methods: Using a retrospective observational cohort design, Medicare claims files were linked to manufacturer device registration data to identify de-novo, durable LVAD implants performed between January 2014 and December 2018, with follow-up through December 2019. Survival outcomes were compared using a Cox proportional hazards model stratified by LVAD type and validated using propensity score matching. Healthcare resource utilization was analyzed across device types by using nonparametric bootstrap analysis methodology. Primary outcome was survival at 1-year and total Part A Medicare payments.

Results: A total of 4,195 de-novo LVAD implants were identified in fee-for-service Medicare beneficiaries (821 HeartMate 3; 1,840 HeartMate II; and 1,534 Other-VADs). The adjusted hazard ratio for mortality at 1-year (confirmed in a propensity score matched analysis) for the HeartMate 3 vs HeartMate II was 0.64 (95% CI; 0.52-0.79, p< 0.001) and for the HeartMate 3 vs Other-VADs was 0.51 (95% CI; 0.42-0.63, p < 0.001). The HeartMate 3 cohort experienced fewer hospitalizations per patient-year vs Other-VADs (respectively, 2.8 vs 3.2 EPPY hospitalizations, p < 0.01) and 6.1 fewer hospital days on average (respectively, 25.2 vs 31.3 days, p < 0.01). The difference in Medicare expenditures, conditional on survival, for HeartMate 3 vs HeartMate II was -$10,722, p < 0.001 (17.4% reduction) and for HeartMate 3 vs Other-VADs was -$17,947, p < 0.001 (26.1% reduction).

Conclusions: In this analysis of a large, real world, United States. administrative dataset of durable LVADs, we observed that the HeartMate 3 had superior survival, reduced healthcare resource use, and lower healthcare expenditure compared to other contemporary commercially available LVADs.
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http://dx.doi.org/10.1016/j.healun.2021.02.010DOI Listing
May 2021

The Cost-Effectiveness of Palliative Care: Insights from the PAL-HF Trial.

J Card Fail 2021 06 14;27(6):662-669. Epub 2021 Mar 14.

Duke Clinical Research Institute, Durham, North Carolina.

Background: In a randomized control trial, Palliative Care in Heart Failure (PAL-HF) improved heart failure-related quality of life, though cost-effectiveness remains unknown. The aim of this study was to evaluate the cost-effectiveness of the PAL-HF trial, which provided outpatient palliative care to patients with advanced heart failure.

Methods And Results: Outcomes for usual care and PAL-HF strategies were compared using a Markov cohort model over 36 months from a payer perspective. The model parameters were informed by PAL-HF trial data and supplemented with meta-analyses and Medicare administrative data. Outcomes included hospitalization, place of death, Medicare expenditures, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Simulated mortality rates were the same for PAL-HF and usual care cohorts, at 89.7% at 36 months. In the base case analysis, the PAL-HF intervention resulted in an incremental gain of 0.03 QALYs and an incremental cost of $964 per patient for an incremental cost-effectiveness ratio of $29,041 per QALY. In 1-way sensitivity analyses, an intervention cost of up to $140 per month is cost effective at $50,000 per QALY. Of 1000 simulations, the PC intervention had a 66.1% probability of being cost effective at a $50,000 willingness-to-pay threshold assuming no decrease in hospitalization. In a scenario analysis, PAL-HF decreased payer spending through reductions in noncardiovascular hospitalizations.

Conclusions: These results from this single-center trial are encouraging that palliative care for advanced heart failure is an economically attractive intervention. Confirmation of these findings in larger multicenter trials will be an important part of developing the evidence to support more widespread implementation of the PAL-HF palliative care intervention.
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http://dx.doi.org/10.1016/j.cardfail.2021.02.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8180496PMC
June 2021

Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure.

JACC Heart Fail 2021 04 10;9(4):293-300. Epub 2021 Mar 10.

Cardiovascular Research Foundation, New York, New York, USA.

Objectives: The authors estimated changes of stressed blood volume (SBV) induced by splanchnic nerve block (SNB) in patients with either decompensated or ambulatory heart failure with reduced ejection fraction (HFrEF).

Background: The splanchnic vascular capacity is a major determinant of the SBV, which in turn determines cardiac filling pressures and may be modifiable through SNB.

Methods: We analyzed data from 2 prospective, single-arm clinical studies in decompensated HFrEF (splanchnic HF-1; resting hemodynamics) and ambulatory heart failure (splanchnic HF-2; exercise hemodynamics). Patients underwent invasive hemodynamics and short-term SNB with local anesthetics. SBV was simulated using heart rate, cardiac output, central venous pressure, pulmonary capillary wedge pressure, systolic and diastolic systemic arterial and pulmonary artery pressures, and left ventricular ejection fraction. SBV is presented as ml/70 kg body weight.

Results: Mean left ventricular ejection fraction was 21 ± 11%. In patients with decompensated HFrEF (n = 11), the mean estimated SBV was 3,073 ± 251 ml/70 kg. At 30 min post-SNB, the estimated SBV decreased by 10% to 2,754 ± 386 ml/70 kg (p = 0.003). In ambulatory HFrEF (n = 14) patients, the mean estimated SBV was 2,664 ± 488 ml/70 kg and increased to 3,243 ± 444 ml/70 kg (p < 0.001) at peak exercise. The resting estimated SBV was lower in ambulatory patients with HFrEF than in decompensated HFrEF (p = 0.019). In ambulatory patients with HFrEF, post-SNB, the resting estimated SBV decreased by 532 ± 264 ml/70 kg (p < 0.001). Post-SNB, with exercise, there was no decrease of estimated SBV out of proportion to baseline effects (p = 0.661).

Conclusions: The estimated SBV is higher in decompensated than in ambulatory heart failure. SNB reduced the estimated SBV in decompensated and ambulatory heart failure. The reduction in estimated SBV was maintained throughout exercise. (Splanchnic Nerve Anesthesia in Heart Failure, NCT02669407; Abdominal Nerve Blockade in Chronic Heart Failure, NCT03453151).
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http://dx.doi.org/10.1016/j.jchf.2020.12.006DOI Listing
April 2021

Changes in Use of Left Ventricular Assist Devices as Bridge to Transplantation With New Heart Allocation Policy.

JACC Heart Fail 2021 06 10;9(6):420-429. Epub 2021 Mar 10.

Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA.

Objectives: The goal of this study was to describe outcomes of patients with bridge to heart transplantation (BTT) after changes were made to the donor heart allocation system.

Background: Left ventricular assist devices (LVADs) have been used as a BTT. On October 18, 2018, the donor heart allocation system in the United States was updated.

Methods: This study identified adults in the United Network for Organ Sharing database with durable, continuous-flow LVAD at listing or implanted while listed between April 2017 and April 2020. Baseline recipient and donor characteristics, waitlist survival, and post-transplantation outcomes were compared pre- and post-allocation system change.

Results: A total of 1,794 patients met inclusion criteria: 983 in the pre-change period and 814 afterward. The number of patients listed with LVAD decreased nationally over time from 102 in April 2017 to 12 in April 2020 (p < 0.001). The proportion of patients with LVAD at time of transplant decreased from 47% to 14%. Before the change, the majority were Status 1A (75.8%) at transplantation; afterward, most were Status 2/3 (67.8%). Transplantation rates were not different (85.4% vs. 83.6%; p = 0.225), but waitlist time decreased in the post period (82 vs. 65 days; p = 0.004). Donors were more likely to be high risk (39.0% vs. 32.2%; p = 0.005), and both ischemic times and distance traveled increased (3.4 h vs. 3.1 h; p < 0.001; 199 miles vs. 82 miles; p < 0.001). Waitlist survival did not change, but post-transplantation survival was worse in patients with BTT post-change (p < 0.001).

Conclusions: The number of patients with BTT on the transplant list decreased steadily and dramatically after the allocation system change. Although time to transplant decreased, there was an increase in post-transplant mortality. These data suggest that the risks and benefits of LVAD implantation as a BTT have changed under the new allocation system and that the appropriate indication for this treatment strategy warrants a re-evaluation.
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http://dx.doi.org/10.1016/j.jchf.2021.01.010DOI Listing
June 2021

Impact of the new heart allocation policy on patients with restrictive, hypertrophic, or congenital cardiomyopathies.

PLoS One 2021 2;16(3):e0247789. Epub 2021 Mar 2.

Yale School of Medicine, New Haven, Connecticut, United States of America.

Background: Patients with restrictive or hypertrophic cardiomyopathy (RCM/HCM) and congenital heart disease (CHD) do not derive clinical benefit from inotropes and mechanical circulatory support. Concerns were expressed that the new heart allocation system implemented in October 2018 would disadvantage these patients. This paper aimed to examine the impact of the new adult heart allocation system on transplantation and outcomes among patients with RCM/HCM/CHD.

Methods: We identified adult patients with RCM/HCM/CHD in the United Network for Organ Sharing (UNOS) database who were listed for or received a cardiac transplant from April 2017-June 2020. The cohort was separated into those listed before and after allocation system changes. Demographics and recipient characteristics, donor characteristics, waitlist survival, and post-transplantation outcomes were analyzed.

Results: The number of patients listed for RCM/HCM/CHD increased after the allocation system change from 429 to 517. Prior to the change, the majority RCM/HCM/CHD patients were Status 1A at time of transplantation; afterwards, most were Status 2. Wait times decreased significantly for all: RCM (41 days vs 27 days; P<0.05), HCM (55 days vs 38 days; P<0.05), CHD (81 days vs 49 days; P<0.05). Distance traveled increased for all: RCM (76 mi. vs 261 mi, P<0.001), HCM (88 mi. vs 231 mi. P<0.001), CHD (114 mi vs 199 mi, P<0.05). Rates of transplantation were higher for RCM and CHD (P<0.01), whereas post-transplant survival remained unchanged.

Conclusions: The new allocation system has had a positive impact on time to transplantation of patients with RCM, HCM, and CHD without negatively influencing survival.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247789PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7924739PMC
October 2021

OptiVol for Volume Assessment in Patients With Continuous Flow Left Ventricular Assist Device.

ASAIO J 2021 02;67(2):192-195

Duke Clinical Research Institute, Durham, North Carolina.

OptiVol (Medtronic PLC, Minneapolis, MN) is a diagnostic feature of some cardiac implantable electronic devices (CIEDs) based on changes in thoracic impedance (TI) over time. Changes in TI can predict heart failure (HF) hospitalizations and mortality in HF populations. However, the utility of this feature is unknown in patients with a left ventricular assist device (LVAD). To determine if OptiVol and TI correlate with clinical HF events in a population of LVAD patients, hospitalization outcomes were collected retrospectively from the electronic health records at a single academic medical center in 80 LVAD patients with an OptiVol-capable CIED. Demographics, medical history, and available clinical data were reviewed and reported. The primary outcomes of interest were TI and OptiVol trends before and after hospitalization, and association of trends before and after these events was evaluated. Most patients had a HeartMate II LVAD and most CIEDs were defibrillators, and 23 (29%) had at least one HF hospitalization during the study period. HF hospitalizations were preceded by signs of volume overload in Optivol (60%) and TI (78%) with recovery of these measures post hospitalization in 33% and 25% of patients, respectively. Monitoring of TI and OptiVol may be one effective component of HF management in LVAD patients as part of a comprehensive program.
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http://dx.doi.org/10.1097/MAT.0000000000001244DOI Listing
February 2021

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.

PLoS One 2020 3;15(12):e0242928. Epub 2020 Dec 3.

Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT, United States of America.

Importance: Patient outcomes in heart failure clinical trials are generally better than those observed in real-world settings. This may be related to stricter inclusion and exclusion criteria in clinical trials.

Objective: We study sought to characterize the clinical implications of differences between patients in clinical trials and those in a real-world registry of patients receiving left ventricular assist devices (LVADs).

Design, Setting, And Participants: This retrospective cohort study included all patients in INTERMACS (the Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with an axial flow LVAD from 2010 to 2015 to allow for equivalent comparisons.

Main Outcomes And Measures: Differences in patient characteristics and 2-year rates of adverse outcomes with those reported in the ENDURANCE and MOMENTUM 3 clinical trials. Survival analyses were used to assess the relationships between prespecified patient factors and clinical outcomes.

Results: Of the 10,937 LVAD recipients identified in INTERMACS between 2010-2015, 44% met at least 1 clinical trial exclusion criterion. The 2-year incidence of stroke and death amongst LVAD recipients in INTERMACS and the landmark clinical trials differed significantly (P<0.04, both). Nevertheless, patients who would have been excluded from the clinical trials did not have dramatically different 2-year mortality outcomes in INTERMACS [2y survival estimate: 66.4%, 95% CI (64.9-67.9%) versus 71.9%, 95% CI (70.6-73.1%)]. Clinical interventions driving a significantly increased risk of death were relatively rare (<5% of implants) and included mechanical ventilation, ECMO, severe thrombocytopenia, and dialysis.

Conclusions And Relevance: Most exclusion criteria used in LVAD clinical trials did not afford a substantially greater risk to patients in the real-world setting. In the relatively infrequent cases of end stage renal disease, thrombocytopenia, respiratory failure, and need for ECMO, the risks and benefits of LVAD therapy need careful weighting and further study.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242928PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7714148PMC
January 2021

The Journal of Heart and Lung Transplantation: A golden age draws to a close and a new dawn begins.

J Heart Lung Transplant 2021 01 2;40(1). Epub 2020 Nov 2.

Duke Clinical Research Institute, Duke University Medical Centre, Durham, North Carolina.

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http://dx.doi.org/10.1016/j.healun.2020.10.010DOI Listing
January 2021

Fully printed prothrombin time sensor for point-of-care testing.

Biosens Bioelectron 2021 Jan 26;172:112770. Epub 2020 Oct 26.

Department of Electrical and Computer Engineering, Duke University, Durham, NC, 27708, USA; Department of Chemistry, Duke University, Durham, NC, 27708, USA. Electronic address:

With an increasing number of patients relying on blood thinners to treat medical conditions, there is a rising need for rapid, low-cost, portable testing of blood coagulation time or prothrombin time (PT). Current methods for measuring PT require regular visits to outpatient clinics, which is cumbersome and time-consuming, decreasing patient quality of life. In this work, we developed a handheld point-of-care test (POCT) to measure PT using electrical transduction. Low-cost PT sensors were fully printed using an aerosol jet printer and conductive inks of Ag nanoparticles, Ag nanowires, and carbon nanotubes. Using benchtop control electronics to test this impedance-based biosensor, it was found that the capacitive nature of blood obscures the clotting response at frequencies below 10 kHz, leading to an optimized operating frequency of 15 kHz. When printed on polyimide, the PT sensor exhibited no variation in the measured clotting time, even when flexed to a 35 mm bend radius. In addition, consistent PT measurements for both chicken and human blood illustrate the versatility of these printed biosensors under disparate operating conditions, where chicken blood clots within 30 min and anticoagulated human blood clots within 20-100 s. Finally, a low-cost, handheld POCT was developed to measure PT for human blood, yielding 70% lower noise compared to measurement with a commercial potentiostat. This POCT with printed PT sensors has the potential to dramatically improve the quality of life for patients on blood thinners and, in the long term, could be incorporated into a fully flexible and wearable sensing platform.
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http://dx.doi.org/10.1016/j.bios.2020.112770DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903145PMC
January 2021

Cardiovascular Implantable Electronic Device Surgery Following Left Ventricular Assist Device Implantation.

JACC Clin Electrophysiol 2020 09 26;6(9):1131-1139. Epub 2020 Aug 26.

Division of Electrophysiology, Duke University Medical Center, Durham, North Carolina, USA.

Objectives: This study sought to determine the indications, characteristics, and outcomes of cardiovascular implantable electronic device (CIED) surgery in patients with LVAD.

Background: Many patients with a left ventricular assist device (LVAD) will require implantable cardioverter-defibrillator generator change or device revision or are candidates for de novo implantable cardioverter-defibrillator implantation following LVAD implantation.

Methods: We performed an observational retrospective study of all LVAD recipients who subsequently underwent CIED surgery at Duke University Hospital from 2009 to 2019.

Results: A total of 159 patients underwent CIED surgery following LVAD implantation, including generator change (n = 93), device revision (n = 38), and de novo implant (n = 28). The median (interquartile range) time from LVAD implantation to CIED surgery was 18.1 months (5.5 to 35.1 months). Pre-operative risk for infection was elevated in the overall cohort with a median (interquartile range) Prevention of Arrhythmia Device Infection Trial (PADIT) score of 7.0 (5.0 to 9.0). Pocket hematoma occurred in 21 patients (13.2%) following CIED surgery. Antimicrobial envelops were used in 43 patients (27%). Device infection due to CIED surgery occurred in 5 (3.1%) patients and occurred only in patients who developed post-operative pocket hematoma (p < 0.001). Mortality at 1 year following CIED surgery was 20% (n = 32).

Conclusions: CIED surgery following LVAD implantation is associated with an increased risk for pocket hematoma and CIED infection. Further studies are needed to determine the risk-benefit ratio of CIED surgery in patients with LVADs.
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http://dx.doi.org/10.1016/j.jacep.2020.04.030DOI Listing
September 2020

Cardiac computed tomography improves the identification of cardiomechanical complications among patients with suspected left ventricular assist device malfunction.

J Cardiovasc Comput Tomogr 2021 May-Jun;15(3):260-267. Epub 2020 Aug 28.

Division of Cardiology, Department of Medicine, Duke University Medical Center, United States. Electronic address:

Background: Left ventricular assist devices (LVAD) are increasingly used for durable mechanical circulatory support in advanced heart failure. While LVAD therapy provides substantial improvement in mortality and quality of life, long-term therapy confers increased risk for device complications. We evaluated if cardiac computed tomography (CCT) improves the detection of cardiomechanical complications among patients with LVAD and suspected device malfunction.

Methods: In this study, we compared the diagnostic performance of CCT and transthoracic echocardiography (TTE) for the identification of cardiomechanical LVAD complications, including thrombus or neointimal hyperplasia, inflow cannula malposition with dynamic obstruction, fixed outflow obstruction, device infection, and severe aortic regurgitation. Complications were confirmed with surgical evaluation, pathologic assessment, or response to therapeutic intervention.

Results: Among 58 LVAD patients, who underwent CCT and TTE for suspected LVAD dysfunction, there were 49 confirmed cardiomechanical LVAD complications among 43 (74.1%) patients. The most common LVAD complication was thrombus or neointimal hyperplasia (65.3%), followed by dynamic obstruction (26.5%). Individually, CCT identified 29 of the 49 (59.2%) confirmed LVAD cardiomechanical complications, whereas TTE alone identified a complication in 11 cases (22.4%). However, diagnostic performance was greatest when the two modalities were used in combination, yielding a sensitivity of 67%, specificity of 93%, PPV of 97%, NPV of 47% and diagnostic accuracy of 73%.

Conclusion: The novel and complementary use of CCT with TTE for the evaluation of suspected device malfunction improves the accurate identification of cardiomechanical LVAD complication compared to either modality alone.
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http://dx.doi.org/10.1016/j.jcct.2020.08.008DOI Listing
July 2021

Defining Optimal Outcomes in Patients with Left Ventricular Assist Devices.

ASAIO J 2021 04;67(4):397-404

Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.

Left ventricular assist devices (LVADs) have consistently and successfully improved mortality associated with end-stage heart failure. However, the definition of an "optimal" outcome post LVAD as a benchmark remains debatable. We retrospectively examined patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) between 2012 and 2016 to assess 1 year post-LVAD "optimal outcome" defined as a patient who was alive on device or transplanted, New York Heart Association functional class I/II, had no more than 2 hospitalizations at year 1, and no major adverse event. We identified the features predicting a nonoptimal outcome at 1 year. Finally, we focused on 3 years outcomes in patients implanted as destination therapy. Of the 12,566 patients in INTERMACS who received an LVAD, only 3,495 (27.8%) met our definition of optimal LVAD outcome at 1 year. These patients tended to be younger, male, and were four times more likely to be supported as bridge to transplantation. For those with optimal outcome at year 1, their chances of long-term survival were better than those who were alive at year 1, but did not meet criteria for an optimal outcome. In the destination therapy population, only 14% of patients met the definition of an optimal outcome at 3 years. Despite significantly improved survival in patients with end-stage heart failure treated with LVAD therapy, majority patients had nonoptimal outcomes at 1 and 3 years post implant, by our definition. There is a pressing need to create a benchmark to define optimal outcomes post LVAD, both in our clinical trials and practice.
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http://dx.doi.org/10.1097/MAT.0000000000001228DOI Listing
April 2021

Biomarkers in Advanced Heart Failure: Implications for Managing Patients With Mechanical Circulatory Support and Cardiac Transplantation.

Circ Heart Fail 2020 07 14;13(7):e006840. Epub 2020 Jul 14.

Division of Cardiology, Duke University School of Medicine, Durham, NC.

Biomarkers have a well-defined role in the diagnosis and management of chronic heart failure, but their role in patients with left ventricular assist devices and cardiac transplant is uncertain. In this review, we summarize the available literature in this patient population, with a focus on clinical application. Some ubiquitous biomarkers, for example, natriuretic peptides and cardiac troponin, may assist in the diagnosis of left ventricular assist device complications and transplant rejection. Novel biomarkers focused on specific pathological processes, such as left ventricular assist device thrombosis and profiling of leukocyte activation, continue to be developed and show promise in altering the management of the advanced heart failure patient. Few biomarkers at this time have been assessed with sufficient scrutiny to warrant broad, universal application, but encouraging limited data and large potential for impact should prompt ongoing investigation.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006840DOI Listing
July 2020

Advanced Heart Failure: Epidemiology, Diagnosis, and Therapeutic Approaches.

JACC Heart Fail 2020 07 10;8(7):523-536. Epub 2020 Jun 10.

Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina. Electronic address:

In broad terms, "advanced" heart failure describes a clinical syndrome characterized by persistent or progressive symptoms and ventricular dysfunction despite guideline-directed medical therapy. Clinically the definition is often dependent upon iterative and integrated clinical assessments to identify patients with worsening status and reliance on specific therapies. This review examines current consensus definitions, highlights strategies for risk stratification and prognostication, and examines short- and long-term treatment strategies. Lastly, this paper explores future directions of research and development for the field.
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http://dx.doi.org/10.1016/j.jchf.2020.01.014DOI Listing
July 2020

Heart Transplantation: An In-Depth Survival Analysis.

JACC Heart Fail 2020 07 10;8(7):557-568. Epub 2020 Jun 10.

Division of Biostatistics, University of Miami, Miami, Florida; Department of Public Health Sciences, University of Miami, Miami, Florida.

Objectives: This study aims to understand the complex factors affecting heart transplant survival and to determine the importance of possible sex-specific risk factors.

Background: Heart transplant allocation is primarily focused on preventing waitlist mortality. To prevent organ wastage, future allocation must balance risk of waitlist mortality with post-transplantation mortality. However, more information regarding risk factors after heart transplantation is needed.

Methods: We included all adults (30,606) in the Scientific Registry of Transplant Recipients database who underwent isolated heart transplantation from January 1, 2004, to July 1, 2018. Mortality (8,278 deaths) was verified with the complete Social Security Death Index with a median follow-up of 3.9 years. Temporal decomposition was used to identify phases of survival and phase-specific risk factors. The random survival forests method was used to determine importance of mortality risk factors and their interactions.

Results: We identified 3 phases of mortality risk: early post-transplantation, constant, and late. Sex was not a significant risk factor. There were several interactions predicting early mortality such as pretransplantation mechanical ventilation with presence of end-organ function (bilirubin, renal function) and interactions predicting later mortality such as diabetes and older age (donor and recipient). More complex interactions predicting early-, mid-, and late-mortality existed and were identified with machine learning (i.e., elevated bilirubin, mechanical ventilation, and dialysis).

Conclusions: Post-heart transplant mortality risk is complex and dynamic, changing with time and events. Sex is not an important mortality risk factor. To prevent organ wastage, end-organ dysfunction should be resolved before transplantation as much as possible.
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http://dx.doi.org/10.1016/j.jchf.2020.03.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7725193PMC
July 2020

Splanchnic Nerve Block for Chronic Heart Failure.

JACC Heart Fail 2020 09 10;8(9):742-752. Epub 2020 Jun 10.

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address:

Objectives: We hypothesized that splanchnic nerve blockade (SNB) would attenuate increased exercise-induced cardiac filling pressures in patients with chronic HF.

Background: Chronic heart failure (HF) is characterized by limited exercise capacity driven in part by an excessive elevation of cardiac filling pressures.

Methods: This is a prospective, open-label, single-arm interventional study in chronic HF patients. Eligible patients had a wedge pressure ≥15 mm Hg at rest or ≥25 mm Hg with exercise on baseline right heart catheterization. Patients underwent cardiopulmonary exercise testing with invasive hemodynamic assessment, followed by percutaneous SNB with ropivacaine.

Results: Nineteen patients were enrolled, 15 of whom underwent SNB. The average age was 58 ± 13 years, 7 (47%) patients were women and 6 (40%) were black. Left ventricular ejection fraction was ≤35% in 14 (93%) patients. No procedural complications were encountered. SNB reduced mean pulmonary arterial pressure at peak exercise from 54.1 ± 14.4 (pre-SNB) to 45.8 ± 17.7 mm Hg (p < 0.001) (post-SNB). Similarly, SNB reduced exercise-induced wedge pressure from 34.8 ± 10.0 (pre-SNB) to 25.1 ± 10.7 mm Hg (p < 0.001) (post-SNB). The cardiac index changed with peak exercise from 3.4 ± 1.2 (pre-SNB) to 3.8 ± 1.1 l/min/m (p = 0.011) (post-SNB). After SNB, patients exercised for approximately the same duration at a greater workload (33 ± 24 W vs. 50 ± 30 W; p = 0.019) and peak oxygen consumption VO (9.1 ± 2.5 vs. 9.8 ± 2.7 ml/kg/min; p = 0.053).

Conclusions: SNB reduced resting and exercise-induced pulmonary arterial and wedge pressure with favorable effects on cardiac output and exercise capacity. Continued efforts to investigate short- and long-term effects of SNB in chronic HF are warranted. Clinical Trials Registration (Abdominal Nerve Blockade in Chronic Heart Failure; NCT03453151).
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http://dx.doi.org/10.1016/j.jchf.2020.04.010DOI Listing
September 2020

Reassessing Recipient Mortality Under the New Heart Allocation System: An Updated UNOS Registry Analysis.

JACC Heart Fail 2020 07 14;8(7):548-556. Epub 2020 May 14.

Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.

Background: An early report of recipient heart transplantation outcomes under the new U.S. heart allocation system introduced in late 2018 found a lower post-transplant survival rate compared with that of the prior system.

Objectives: The aim of this study was to examine recipient survival under the new system by using an updated dataset.

Methods: The 2015 to 2019 United Network for Organ Sharing registry was queried for adult heart transplant recipients, stratified according to whether the subjects were listed and underwent transplant before or after October 18, 2018, when the new allocation system was implemented. The association between allocation system and recipient mortality was analyzed by using the Kaplan-Meier method and multivariable Cox proportional hazards regression.

Results: A total of 7,119 recipients met inclusion criteria: 6,004 (84%) and 1,115 (16%) listed and undergoing transplant in the old and new allocation systems, respectively. This registry update included 576 new-system recipients, more than double the amount previously analyzed. Recipients from the new system were more likely to be bridged to transplant with temporary mechanical circulatory support devices instead of durable left ventricular assist devices and had longer graft ischemic times. After adjustment, the new system was not associated with poorer survival on Kaplan-Meier survival analysis (log-rank test; p = 0.075) or multivariable Cox proportional hazards modeling (adjusted hazard ratio: 1.18; 95% confidence interval: 0.90 to 1.55).

Conclusions: The short-term survival of recipients listed and receiving a transplant under the old and new allocation systems seems to be comparable. The modification to the allocation system has resulted in several changes to the clinical profiles of patients undergoing transplants that must be closely monitored in the coming years.
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http://dx.doi.org/10.1016/j.jchf.2020.03.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335324PMC
July 2020
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