Publications by authors named "Keith Aaronson"

163 Publications

Non-patient factors associated with infections in LVAD recipients: A scoping review.

J Heart Lung Transplant 2021 Oct 22. Epub 2021 Oct 22.

Department of Cardiac Surgery.

Background: Infections are the most common complication in recipients of durable left ventricular assist devices (LVAD) and are associated with increased morbidity, mortality, and expenditures. The existing literature examining factors associated with infection in LVAD recipients is limited and principally comprises single-center studies. This scoping review synthesizes all available evidence related to identifying modifiable, non-patient factors associated with infections among LVAD recipients.

Methods: Published studies were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of factors associated with infections among recipients of contemporary, implantable, continuous flow LVADs. Key study characteristics were extracted by 4 independent reviewers and current literature described narratively. The Systems Engineering Initiative for Patient Safety (SEIPS) model was used to develop a taxonomy for non-patient related factors (e.g., tasks, tools, technologies, organization, and environment) associated with infections following LVAD implantation. All analyses took place between February 2019 and May 2021.

Findings: A total of 43 studies met inclusion criteria. The majority of included studies were observational (n = 37), single-center (n = 29), from the U.S. (n = 38), and focused on driveline infections (n = 40). Among the 22 evaluated sub-domains of non-patient related factors, only two: increasing center experience and establishing a silicone-skin interface at the driveline exit site, were identified as consistently being associated with a lower risk of infection.

Conclusion: This review identified 43 studies that described non-patient related factors associated with infection in LVAD recipients. Only two factors were consistently associated with lower infection risk in LVAD recipients: increasing experience and establishing a silicone-skin interface at driveline exit site. The large variability in reporting across multiple studied interventions limited the ability to discern their effectiveness.
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http://dx.doi.org/10.1016/j.healun.2021.10.006DOI Listing
October 2021

Mitral regurgitation severity at left ventricular assist device implantation is associated with distinct myocardial transcriptomic signatures.

J Thorac Cardiovasc Surg 2021 Sep 14. Epub 2021 Sep 14.

Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Mich. Electronic address:

Objectives: We examined for differences in pre-left ventricular assist device (LVAD) implantation myocardial transcriptome signatures among patients with different degrees of mitral regurgitation (MR).

Methods: Between January 2018 and October 2019, we collected left ventricular (LV) cores during durable LVAD implantation (n = 72). A retrospective chart review was performed. Total RNA was isolated from LV cores and used to construct cDNA sequence libraries. The libraries were sequenced with the NovaSeq system, and data were quantified using Kallisto. Gene Set Enrichment Analysis (GSEA) and Gene Ontology analyses were performed, with a false discovery rate <0.05 considered significant.

Results: Comparing patients with preoperative mild or less MR (n = 30) and those with moderate-severe MR (n = 42), the moderate-severe MR group weighted less (P = .004) and had more tricuspid valve repairs (P = .043), without differences in demographics or comorbidities. We then compared both groups with a group of human donor hearts without heart failure (n = 8). Compared with the donor hearts, there were 3985 differentially expressed genes (DEGs) for mild or less MR and 4587 DEGs for moderate-severe MR. Specifically altered genes included 448 DEGs for specific for mild or less MR and 1050 DEGs for moderate-severe MR. On GSEA, common regulated genes showed increased immune gene expression and reduced expression of contraction and energetic genes. Of the 1050 genes specific for moderate-severe MR, there were additional up-regulated genes related to inflammation and reduced expression of genes related to cellular proliferation.

Conclusions: Patients undergoing durable LVAD implantation with moderate-severe MR had increased activation of genes related to inflammation and reduction of cellular proliferation genes. This may have important implications for myocardial recovery.
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http://dx.doi.org/10.1016/j.jtcvs.2021.08.061DOI Listing
September 2021

A challenge to equity in transplantation: Increased center-level variation in short-term mechanical circulatory support use in the context of the updated U.S. heart transplant allocation policy.

J Heart Lung Transplant 2021 Sep 16. Epub 2021 Sep 16.

Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan.

Background: The United States National Organ Procurement Transplant Network (OPTN) implemented changes to the adult heart allocation system to reduce waitlist mortality by improving access for those at greater risk of pre-transplant death, including patients on short-term mechanical circulatory support (sMCS). While sMCS increased, it is unknown whether the increase occurred equitably across centers.

Methods: The OPTN database was used to assess changes in use of sMCS at time of transplant in the 12 months before (pre-change) and after (post-change) implementation of the allocation system in October 2018 among 5,477 heart transplant recipients. An interrupted time series analysis comparing use of bridging therapies pre- and post-change was performed. Variability in the proportion of sMCS use at the center level pre- and post-change was determined.

Results: In the month pre-change, 9.7% of patients were transplanted with sMCS. There was an immediate increase in sMCS transplant the following month to 32.4% - an absolute and relative increase of 22.7% and 312% (p < 0.001). While sMCS use was stable pre-change (monthly change 0.0%, 95% CI [-0.1%,0.1%]), there was a continuous 1.2%/month increase post-change ([0.6%,1.8%], p < 0.001). Center-level variation in sMCS use increased substantially after implementation, from a median (interquartile range) of 3.85% (10%) pre-change to 35.7% (30.6%) post-change (p < 0.001).

Conclusions: Use of sMCS at time of transplant increased immediately and continued to expand following heart allocation policy changes. Center-level variation in use of sMCS at the time of transplant increased compared to pre-change, which may have negatively impacted equitable access to heart transplantation.
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http://dx.doi.org/10.1016/j.healun.2021.09.004DOI Listing
September 2021

An early relook identifies high-risk trajectories in ambulatory advanced heart failure.

J Heart Lung Transplant 2021 Sep 16. Epub 2021 Sep 16.

Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.

Introduction: Patients with ambulatory advanced heart failure (HF) are increasingly considered for durable mechanical circulatory support (MCS) and heart transplantation and their effective triage requires careful assessment of the clinical trajectory.

Methods: REVIVAL, a prospective, observational study, enrolled 400 ambulatory advanced HF patients from 21 MCS/transplant centers in 2015-2016. Study design included a clinical re-assessment of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile within 120 days after enrollment. The prognostic impact of a worsening INTERMACS Profile assigned by the treating physician was assessed at 1 year after the Early Relook.

Results: Early Relook was done in 325 of 400 patients (81%), of whom 24% had a worsened INTERMACS Profile, associated with longer HF history and worse baseline INTERMACS profile, but no difference in baseline LVEF (median 0.20), 6-minute walk, quality of life, or other baseline parameters. Early worsening predicted higher rate of the combined primary endpoint of death, urgent MCS, or urgent transplant by 1 year after Early Relook, (28% vs 15%), with hazard ratio 2.2 (95% CI 1.2- 3.8; p = .006) even after adjusting for baseline INTERMACS Profile and Seattle HF Model score. Deterioration to urgent MCS occurred in 14% vs 5% (p = .006) during the year after Early Relook.

Conclusions: Early Relook identifies worsening of INTERMACS Profile in a significant population of ambulatory advanced HF, who had worse outcomes over the subsequent year. Early reassessment of ambulatory advanced HF patients should be performed to better define the trajectory of illness and inform triage to advanced therapies.
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http://dx.doi.org/10.1016/j.healun.2021.09.003DOI Listing
September 2021

Generalizability of Trial Data to Real-World Practice: An Analysis of The Society of Thoracic Surgeons Intermacs Database.

Ann Thorac Surg 2021 Oct 4. Epub 2021 Oct 4.

Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI; Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI.

Background: While the current wide-scale adoption of the HeartMate 3 left ventricular assist device (LVAD) can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of LVAD clinical trial outcomes and evaluated the prognostic value of specific inclusion/exclusion criteria.

Methods: MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy with HeartMate 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support who underwent HeartMate 3 implantation [n=4610] between August 2017-March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models.

Results: Indications for HeartMate 3 implant included destination therapy (n=2827, 61%), bridge-to-candidacy (n=969, 21%), and bridge-to-transplant (n=702, 15%). A total of 1941 (42%) recipients were trial-ineligible, with 1245 (27%) meeting 1 ineligibility criterion, 470 (10%) meeting 2, and 226 (5%) meeting ≥3. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17±1% vs. 10±1%, p<0.001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting 1 (15±1%), 2 (16±2%), and ≥3 (30±3%) ineligibility criteria. Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality.

Conclusions: Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.
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http://dx.doi.org/10.1016/j.athoracsur.2021.08.062DOI Listing
October 2021

Left Ventricular Assist Device Implantation in Patients with Preoperative Severe Mitral Regurgitation.

ASAIO J 2021 10;67(10):1139-1147

From the Department of Cardiac Surgery.

We examined cardiac features associated with residual mitral regurgitation (MR) following continuous-flow left ventricular assist device (cfLVAD) implant. From 2003 to 2017, 134 patients with severe MR underwent cfVLAD implant without mitral valve (MV) intervention. Echocardiographic (echo) assessment occurred pre-cfLVAD, early post-cfLVAD, and at last available echo. Ventricular and atrial volumes were calculated from established formulas and normalized to be predicted. Cluster analysis based on preoperative normalized left ventricular and atrial volumes, and MV height identified grades 1, 2, and 3 with progressively larger cardiac chamber sizes. Median early echo follow-up was 0.92 (0.55, 1.45) months and the last follow-up was 15.12 (5.28, 38.28) months. Mitral regurgitation improved early after cfLVAD by 2.10 ± 1.16 grades (p < 0.01). Mitral regurgitation severity at the last echocardiogram positively correlated with the preoperative left ventricular volume (p = 0.014, R = 0.212), left atrial volume (p = 0.007, R = 0.233), MV anteroposterior height (p = 0.032, R = 0.185), and MV mediolateral diameter (p = 0.043, R = 0.175). Morphologically, smaller grade 1 hearts were correlated with MR resolution at the late follow-up (p = 0.023). Late right ventricular failure (RVF) at the last clinical follow-up was less in grade 1 (4/48 [8.3%]) compared with grades 2 and 3 (26/86 [30.2%]), p = 0.004). Grade 1 cardiac dimensions correlates with improvement in severe MR and had less late RVF.
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http://dx.doi.org/10.1097/MAT.0000000000001379DOI Listing
October 2021

The prognostic value of positron emission tomography in the evaluation of suspected cardiac sarcoidosis.

J Nucl Cardiol 2021 Sep 9. Epub 2021 Sep 9.

Division of Cardiovascular Medicine, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.

Objectives: To assess the prognostic value of positron emission tomography (PET) imaging in patients undergoing evaluation for known or suspected cardiac sarcoidosis (CS) while not on active immunotherapy.

Background: Previous studies have attempted to identify the value of PET imaging to aid in risk stratification of patients with CS, however, most cohorts have included patients currently on immunosuppression, which may confound scan results by suppressing positive findings.

Methods: We retrospectively analyzed 197 patients not on immunosuppression who underwent F-fluorodeoxyglucose (FDG) PET scans for evaluation of known or suspected CS. The primary endpoint of the study was time to ventricular arrhythmia (VT/VF), or death. Candidate predictors were identified by univariable Cox proportional hazards regression. Independent predictors were identified by performing multivariable Cox regression with stepwise forward selection.

Results: Median follow-up time was 531 [IQR 309, 748] days. 41 patients met the primary endpoint. After stepwise forward selection, left ventricular ejection fraction (LVEF) (HR 0.98, 95% CI 0.96-0.99, P = 0.02), history of VT/VF (HR 4.19, 95% CI 2.15-8.17, P < 0.001), and summed rest score (SRS) (HR 1.06, 95% CI 1.02-1.12, P = 0.01) were predictive of the primary endpoint. Quantitative and qualitative measures of FDG uptake on PET were not predictive of clinical events.

Conclusions: Among untreated patients who underwent PET scans to evaluate known or suspected CS, LVEF, history of VT/VF, and SRS were associated with adverse clinical outcomes.
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http://dx.doi.org/10.1007/s12350-021-02780-xDOI Listing
September 2021

Detection of Low Cardiac Index using a Polyvinylidene Fluoride-Based Wearable Ring and Convolutional Neural Networks.

IEEE Sens J 2021 Jul 3;21(13):14281-14289. Epub 2020 Nov 3.

Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI, 48109 USA.

This study investigated the use of a wearable ring made of polyvinylidene fluoride film to identify a low cardiac index (≤2 L/min). The waveform generated by the ring contains patterns that may be indicative of low blood pressure and/or high vascular resistance, both of which are markers of a low cardiac index. In particular, the waveform contains reflection waves whose timing and amplitude are correlated with pulse travel time and vascular resistance, respectively. Hence, the pattern of the waveform is expected to vary in response to changes in blood pressure and vascular resistance. By analyzing the morphology of the waveform, our aim was to create a tool to identify patients with low cardiac index. This was done using a convolutional neural network which was trained on data from animal models. The model was then tested on waveforms that were collected from patients undergoing pulmonary artery catheterization. The results indicate high accuracy in classifying patients with a low cardiac index, achieving an area under the receiver operating characteristics and precision-recall curves of 0.88 and 0.71, respectively.
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http://dx.doi.org/10.1109/jsen.2020.3022273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423366PMC
July 2021

The Future of Mechanical Circulatory Support.

Circ Heart Fail 2021 08 3;14(8):e008861. Epub 2021 Aug 3.

Department of Cardiothoracic Surgery (J.D.P.), University of Colorado Anschutz Medical Campus, Aurora.

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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.121.008861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373791PMC
August 2021

Caregiver Health-Related Quality of Life, Burden, and Patient Outcomes in Ambulatory Advanced Heart Failure: A Report From REVIVAL.

J Am Heart Assoc 2021 07 10;10(14):e019901. Epub 2021 Jul 10.

Feinberg School of Medicine Northwestern University Chicago IL.

Background Heart failure (HF) imposes significant burden on patients and caregivers. Longitudinal data on caregiver health-related quality of life (HRQOL) and burden in ambulatory advanced HF are limited. Methods and Results Ambulatory patients with advanced HF (n=400) and their participating caregivers (n=95) enrolled in REVIVAL (Registry Evaluation of Vital Information for VADs [Ventricular Assist Devices] in Ambulatory Life) were followed up for 24 months, or until patient death, left ventricular assist device implantation, heart transplantation, or loss to follow-up. Caregiver HRQOL (EuroQol Visual Analog Scale) and burden (Oberst Caregiving Burden Scale) did not change significantly from baseline to follow-up. At time of caregiver enrollment, better patient HRQOL by Kansas City Cardiomyopathy Questionnaire was associated with better caregiver HRQOL (=0.007) and less burden by both time spent (<0.0001) and difficulty (=0.0007) of caregiving tasks. On longitudinal analyses adjusted for baseline values, better patient HRQOL (=0.034) and being a married caregiver (=0.016) were independently associated with better caregiver HRQOL. Patients with participating caregivers (versus without) were more likely to prefer left ventricular assist device therapy over time (odds ratio, 1.43; 95% CI, 1.03-1.99; =0.034). Among patients with participating caregivers, those with nonmarried (versus married) caregivers were at higher composite risk of HF hospitalization, death, heart transplantation or left ventricular assist device implantation (hazard ratio, 2.99; 95% CI, 1.29-6.96; =0.011). Conclusions Patient and caregiver characteristics may impact their HRQOL and other health outcomes over time. Understanding the patient-caregiver relationship may better inform medical decision making and outcomes in ambulatory advanced HF.
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http://dx.doi.org/10.1161/JAHA.120.019901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483456PMC
July 2021

Risk factors for heart transplant survival with greater than 5 h of donor heart ischemic time.

J Card Surg 2021 Aug 20;36(8):2677-2684. Epub 2021 May 20.

Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Michigan, USA.

Objective: Implantation of donor hearts with prolonged ischemic times is associated with worse survival. We sought to identify risk factors that modulate the effects of prolonged preservation.

Methods: Retrospective review of the United Network for Organ Sharing database (2000-2018) to identify transplants with >5 (n = 1526) or ≤5 h (n = 35,733) of donor heart preservation. In transplanted hearts preserved for >5 h, Cox-proportional hazards identify modifiers for survival.

Results: Compared to ≤5 h, transplanted patients with >5 h of preservation spent less time in status 1B (76 ± 160 vs. 85 ± 173 days, p = .027), more commonly had ischemic cardiomyopathy (42.3% vs. 38.3%, p = .002), and less commonly received a blood type O heart (45.4% vs. 50.8%, p < .001). Longer heart preservation time was associated with a higher incidence of postoperative stroke (4.5% vs. 2.5%, p < .001), and dialysis (16.4% vs. 10.6%, p < .001). Prolonged preservation was associated with a greater likelihood of death from primary graft dysfunction (2.8% vs. 1.5%, p < .001) but there was no difference in death from acute (2.0% vs. 1.7%, p = .402) or chronic rejection (2.0% vs. 1.9%, p = .618). In transplanted patients with >5 h of heart preservation, multivariable analysis identified greater mortality with ischemic cardiomyopathy etiology (hazard ratio [HR] = 1.36, p < 0.01), pre-transplant dialysis (HR = 1.84, p < .01), pre-transplant extracorporeal membrane oxygenation (ECMO, HR = 2.36, p = .09), and O blood type donor hearts (HR = 1.35, p < .01).

Conclusion: Preservation time >5 h is associated with worse survival. This mortality risk is further amplified by preoperative dialysis and ECMO, ischemic cardiomyopathy etiology, and use of O blood type donor hearts.
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http://dx.doi.org/10.1111/jocs.15621DOI Listing
August 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

Fate of preoperative moderate mitral regurgitation following left ventricular assist device implantation.

J Card Surg 2021 Jun 18;36(6):1843-1849. Epub 2021 Feb 18.

Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Michigan, USA.

Objective: We examined for improvements in preoperative moderate mitral regurgitation following continuous-flow left ventricular assist device (cfLVAD) implantation.

Methods: From 2006 to 2020, 190 patients with moderate MR underwent cfVLAD implant without concomitant mitral valve (MV) surgery. Cardiac dimensions and contractility, as well as valve function, were assessed with an echocardiogram (echo) pre-cfLVAD, and at approximately 1 month post-cfLVAD. Outcomes were determined by retrospective chart review.

Results: Median echo follow-up was 0.94 (0.53, 1.38) months. Residual significant moderate or greater MR was present in 30/190 (15.8%) on follow-up. Patients with significant residual MR had larger preoperative left ventricular internal diameters in diastole (74.4 ± 8.7 vs. 71.1.0 ± 9.1 mm, p = .034). Significant residual MR was associated with higher preoperative mean pulmonary artery pressures (OR = 1.055, p = .035) and pulmonary capillary wedge pressures (OR = 1.060, p = .034). Significant residual MR on echo was not associated with any survival difference (p = .325). The 1, 5, and 10 year survival were 89.9%, 55.2%, and 34.2%, respectively.

Conclusions: For patients with moderate MR undergoing LVAD implantation, the likelihood of significant residual MR is low and mitral intervention in this population is not recommended. However, select patients with larger preoperative left heart dimensions and pulmonary vascular pressures may be at risk for persistent residual MR.
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http://dx.doi.org/10.1111/jocs.15428DOI Listing
June 2021

Impact of donor blood type on outcomes after prolonged allograft ischemic times.

J Thorac Cardiovasc Surg 2021 Jan 12. Epub 2021 Jan 12.

Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Mich.

Objective: The study objective was to determine the influence of allograft ischemic time on heart transplant outcomes among ABO donor organ types given limited prior reports of its survival impact.

Methods: We identified 32,454 heart transplants (2000-2016) from the United Network for Organ Sharing database. Continuous and categoric variables were analyzed by parametric and nonparametric testing. Survival was determined using log-rank or Cox regression tests. Propensity matching adjusted for preoperative variables.

Results: By comparing allograft ischemic time less than 4 hours (n = 6579) with 4 hours or more (n = 25,875), the hazard ratios for death at 15 years after prolonged ischemic time (≥4 hours) for blood types O, A, B, and AB were 1.106 (P < .001), 1.062 (P < .001), 1.059 (P = .062), and 1.114 (P = .221), respectively. Unadjusted data demonstrated higher mortality for transplantation of O versus non-O donor hearts for ischemic time 4 hours or more (hazard ratio, 1.164; P < .001). After propensity matching, O donor hearts continued to have worse survival if preserved for 4 hours or more (hazard ratio, 1.137, P = .008), but not if ischemic time was less than 4 hours (hazard ratio, 1.042, P = .113). In a matched group with 4 hours or more of ischemic time, patients receiving O donor organs were more likely to experience death from primary graft dysfunction (2.5% vs 1.7%, P = .052) and chronic allograft rejection (1.9% vs 1.1%, P = .021). No difference in death from primary graft dysfunction or chronic allograft rejection was seen with less than 4 hours of ischemic time (P > .150).

Conclusions: Compared with non-O donor hearts, transplantation with O donor hearts with ischemic time 4 hours or more leads to worse survival, with higher rates of primary graft dysfunction and chronic rejection. Caution should be practiced when considering donor hearts with the O blood type when anticipating extended cold ischemic times.
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http://dx.doi.org/10.1016/j.jtcvs.2020.12.123DOI Listing
January 2021

Predictive Value of Cardiopulmonary Exercise Testing Parameters in Ambulatory Advanced Heart Failure.

JACC Heart Fail 2021 03 3;9(3):226-236. Epub 2021 Feb 3.

Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Objectives: This study sought to determine cardiopulmonary exercise (CPX) predictors of the combined outcome of durable mechanical circulatory support (MCS), transplantation, or death at 1 year among patients with ambulatory advanced heart failure (HF).

Background: Optimal CPX predictors of outcomes in contemporary ambulatory advanced HF patients are unclear.

Methods: REVIVAL (Registry Evaluation of Vital Information for ventricular assist devices [VADs] in Ambulatory Life) enrolled 400 systolic HF patients, INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles 4-7. CPX was performed by 273 subjects 2 ± 1 months after study enrollment. Discriminative power of maximal (peak oxygen consumption [peak VO]; VO pulse, circulatory power [CP]; peak systolic blood pressure • peak VO], peak end-tidal pressure CO [PEtCO], and peak Borg scale score) and submaximal CPX parameters (ventilatory efficiency [VE/VCO slope]; VO at anaerobic threshold [VOAT]; and oxygen uptake efficiency slope [OUES]) to predict the composite outcome were assessed by univariate and multivariate Cox regression and Harrell's concordance statistic.

Results: At 1 year, there were 39 events (6 transplants, 15 deaths, 18 MCS implantations). Peak VO, VOAT, OUES, peak PEtCO, and CP were higher in the no-event group (all p < 0.001), whereas VE/VCO slope was lower (p < 0.0001); respiratory exchange ratio was not different. CP (hazard ratio [HR]: 0.89; p = 0.001), VE/VCO slope (HR: 1.05; p = 0.001), and peak Borg scale score (HR: 1.20; p = 0.005) were significant predictors on multivariate analysis (model C-statistic: 0.80).

Conclusions: Among patients with ambulatory advanced HF, the strongest maximal and submaximal CPX predictor of MCS implantation, transplantation, or death at 1 year were CP and VE/VCO respectively. The patient-reported measure of exercise effort (Borg scale score) contributed substantially to the prediction of outcomes, a surprising and novel finding that warrants further investigation. (Registry Evaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407).
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http://dx.doi.org/10.1016/j.jchf.2020.11.008DOI Listing
March 2021

Assessment of Mortality Among Durable Left Ventricular Assist Device Recipients Ineligible for Clinical Trials.

JAMA Netw Open 2021 01 4;4(1):e2032865. Epub 2021 Jan 4.

Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor.

Importance: While wide-scale adoption of durable left ventricular assist devices (LVADs) can be attributed to favorable randomized clinical trial outcomes, restrictive selection criteria may be associated with a lack of generalizability to real-world experience.

Objective: To estimate the proportion of LVAD recipients who are eligible for clinical trials and to assess whether an association exists between trial eligibility and mortality.

Design, Setting, And Participants: This cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). To simulate a trial population, trial criteria from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) were mapped to INTERMACS variables. Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met. Follow-up in INTERMACS was complete for all patients through October 31, 2017. Data were analyzed from July 2019 through November 2020.

Exposures: Undergoing durable LVAD implantation.

Main Outcomes And Measures: Trial eligibility and postimplant mortality were analyzed using Kaplan-Meier estimates and Cox proportional hazards models.

Results: Among 14 679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure. A total of 6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both). Patients who were trial-ineligible had increased risk of mortality compared with patients who were trial-eligible if they met 1 trial ineligibility criterion (hazard ratio [HR], 1.16 [95% CI, 1.08-1.24]; P < .001), 2 trial ineligibility criteria (HR, 1.51 [95% CI, 1.36-1.67]; P < .001), or 3 or more trial ineligibility criteria (HR, 2.09 [95% CI, 1.84-2.39]; P < .001). Among patients meeting only 1 ineligibility criterion, 4 criteria were independently associated with mortality: prior or ongoing mechanical circulatory support (HR, 1.63 [95% CI, 1.23-2.16]; P = .001), elevated creatinine level (HR, 1.42 [95% CI, 1.17-1.72]; P < .001), elevated bilirubin level (HR, 1.39 [95% CI, 1.17-1.66]; P < .001), and low albumin or prealbumin level (HR, 1.18 [95% CI, 1.05-1.33]; P = .007).

Conclusions And Relevance: These findings suggest that while treatment for patients who are ineligible for LVAD trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.32865DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794668PMC
January 2021

Changes in Type of Temporary Mechanical Support Device Use Under the New Heart Allocation Policy.

Circulation 2020 10 19;142(16):1602-1604. Epub 2020 Oct 19.

Division of Cardiovascular Diseases (J.R.G., K.G., M.C., T.M.C., K.D.A., B.K.N.), University of Michigan, Ann Arbor.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.048844DOI Listing
October 2020

Changes in the United States Adult Heart Allocation Policy: Challenges and Opportunities.

Circ Cardiovasc Qual Outcomes 2020 10 29;13(10):e005795. Epub 2020 Sep 29.

Department of Cardiovascular Disease, Division of Internal Medicine, University of Michigan, Ann Arbor.

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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.005795DOI Listing
October 2020

COVID-19 Outcomes Among Solid Organ Transplant Recipients: A Case-control Study.

Transplantation 2021 01;105(1):128-137

Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI.

Background: Solid organ transplant (SOT) recipients are considered to be "vulnerable" to COVID-19 infection due to immunosuppression. To date, there are no studies that compared the disease severity of COVID-19 in SOT recipients with nontransplant patients.

Methods: In this case-control study, we compared the outcomes of COVID-19 between SOT recipients and their matched nontransplant controls. The cases were all adult SOT recipients (N = 41) from our academic health center who were diagnosed with COVID-19 between March 10, 2020 and May 15, 2020 using positive reverse transcriptase polymerase chain reaction for SARS-CoV2. The controls (N = 121) were matched on age (±5 y), race, and admission status (hospital or outpatient). The primary outcome was death and secondary outcomes were severe disease, intubation and renal replacement therapy (RRT).

Results: Median age of SOT recipients (9 heart, 3 lung, 16 kidney, 8 liver, and 5 dual organ) was 60 y, 80% were male and 67% were Black. Severe disease adjusted risk of death was similar in both the groups (hazard ratio = 0.84 [0.32-2.20]). Severity of COVID-19 and intubation were similar, but the RRT use was higher in SOT (odds ratio = 5.32 [1.26, 22.42]) compared to non-SOT COVID-19 patients. Among SOT recipients, COVID-19-related treatment with hydroxychloroquine (HCQ) was associated with 10-fold higher hazard of death compared to without HCQ (hazard ratio = 10.62 [1.24-91.09]).

Conclusions: Although African Americans constituted one-tenth of all SOT in our center, they represented two-thirds of COVID-19 cases. Despite high RRT use in SOT recipients, the severe disease and short-term death were similar in both groups. HCQ for the treatment of COVID-19 among SOT recipients was associated with high mortality and therefore, its role as a treatment modality requires further scrutiny.
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http://dx.doi.org/10.1097/TP.0000000000003447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7853506PMC
January 2021

Statin intensity and risk for cardiovascular events after heart transplantation.

ESC Heart Fail 2020 10 24;7(5):2074-2081. Epub 2020 Jun 24.

Department of Medicine, Division of Cardiology, University of Michigan, Ann Arbor, MI, USA.

Aims: Statins improve survival and reduce rejection and cardiac allograft vasculopathy after heart transplantation (HT). The impact of different statin intensities on clinical outcomes has never been assessed. We set out to determine the impact of statin exposure on cardiovascular outcomes after HT.

Methods And Results: We performed a retrospective study of 346 adult patients who underwent HT from 2006 to 2018. Statin intensity was determined longitudinally after HT based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines. The primary outcome was the time to the first primary event defined as the composite of heart failure hospitalization, myocardial infarction, revascularization, and all-cause mortality. Secondary outcomes included time to significant rejection and time to moderate-severe cardiac allograft vasculopathy. Adverse events were evaluated for subjects on high-intensity statin therapy. A Cox proportional hazards model was used to evaluate the relationship between clinical variables, statin intensity, and outcomes. Most subjects were treated with low-intensity statin therapy although this declined from 89.9% of the population at 1month after HT to 42.8% at 5years after HT. History of ischaemic cardiomyopathy, significant acute rejection, older donor age, and lesser statin intensity (p ≤ 0.001) were associated with reduced time to the primary outcome in a multivariable Cox model. Greater intensity of statin therapy was most beneficial early after HT. There were no statin-related adverse events for the 14 subjects on high-intensity statin therapy.

Conclusions: Greater statin intensity was associated with a reduction in adverse cardiovascular outcomes after HT.
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http://dx.doi.org/10.1002/ehf2.12784DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524051PMC
October 2020

Utility of routine evaluations for rejection in patients greater than 2 years after heart transplantation.

ESC Heart Fail 2020 08 3;7(4):1809-1816. Epub 2020 Jun 3.

Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.

Aims: Guidelines support routine surveillance testing for rejection for at least 5 years after heart transplant (HT). In patients greater than 2 years post-HT, we examined which clinical characteristics predict continuation of routine surveillance studies, outcomes following discontinuation of routine surveillance, and the cost-effectiveness of different surveillance strategies.

Methods And Results: We retrospectively identified subjects older than 18 who underwent a first HT at our centre from 2007 to 2016 and who survived ≥760 days (n = 217) post-HT. The clinical context surrounding all endomyocardial biopsies (EMBs) and gene expression profiles (GEPs) was reviewed to determine if studies were performed routinely or were triggered by a change in clinical status. Subjects were categorized as following a test-based surveillance (n = 159) or a signs/symptoms surveillance (n = 53) strategy based on treating cardiologist intent to continue routine studies after the second post-transplant year. A Markov model was constructed to compare two test-based surveillance strategies to a baseline strategy of discontinuing routine studies. One thousand twenty studies were performed; 835 were routine. Significant rejection was absent in 99.0% of routine EMBs and 99.8% of routine GEPs. The treating cardiologist's practice duration, patient age, and immunosuppressive regimen predicted surveillance strategy. There were no differences in outcomes between groups. Routine surveillance EMBs cost more and were marginally less effective than a strategy of discontinuing routine studies after 2 years; surveillance GEPs had an incremental cost-effectiveness ratio of $1.67 million/quality-adjusted life-year.

Conclusions: Acute asymptomatic rejection is rare after the second post-transplant year. Obtaining surveillance studies beyond the second post-transplant year is not cost-effective.
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http://dx.doi.org/10.1002/ehf2.12745DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373902PMC
August 2020

Comorbid Conditions and Health-Related Quality of Life in Ambulatory Heart Failure Patients: REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life REVIVAL).

Circ Heart Fail 2020 05 18;13(5):e006858. Epub 2020 May 18.

Division of Cardiovascular Disease, University of Michigan, Ann Arbor (T.M.C., M.P., K.D.A.).

Background: Patients with heart failure (HF) often have multiple chronic conditions that may impact health-related quality of life (HRQOL) despite HF therapy. We sought to determine the association between noncardiac comorbidities and HRQOL in ambulatory patients with advanced HF.

Methods: Baseline data from 373 subjects in REVIVAL (Registry Evaluation of Vital Information for Ventricular Assist Devices in Ambulatory Life) were analyzed using multivariable general linear models to evaluate the relationship between comorbidities and HRQOL (EuroQol Visual Analogue Scale, EQ-5D-3L Index Score, and Kansas City Cardiomyopathy Questionnaire). The primary independent variables were a comorbidity index (sum of 14 noncardiac conditions), a residual comorbidity index (without depression), and depression alone. The median (25th to 75th percentile) number of comorbidities was 3 (2-4).

Results: Increasing comorbidity burden was associated with a reduction in generic (EQ-5D Index, =0.005) and HF-specific (Kansas City Cardiomyopathy Questionnaire, =0.001) HRQOL. The residual comorbidity index was not associated with HRQOL when depression included in the model independently, while depression was associated with HRQOL across all measures. Participants with depression (versus without) scored on average 13 points (95% CI, 8-17) lower on the EuroQol Visual Analogue Scale, 0.15 points (95% CI, 0.12-0.18) lower on the EQ-5D Index, and 24.9 points (95% CI, 21.2-28.5) lower on the Kansas City Cardiomyopathy Questionnaire overall summary score.

Conclusions: While noncardiac comorbidities were prevalent in ambulatory advanced HF patients, only depression was associated with decreased generic and HF-specific HRQOL. Other than depression, the presence of noncardiac comorbidities should not impact expected gains in HRQOL following ventricular assist device implantation, provided the conditions are not a contraindication to implant. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01369407.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006858DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458108PMC
May 2020

Coronavirus Disease 2019 (COVID-19) Clinical Trial Oversight at a Major Academic Medical Center: Approach of Michigan Medicine.

Clin Infect Dis 2020 11;71(16):2187-2190

Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Clinicians, eager to offer the best care in the absence of guiding data, have provided patients with coronavirus disease 2019 (COVID-19) diverse clinical interventions. This usage has led to perceptions of efficacy of some interventions that, while receiving media coverage, lack robust evidence. Moving forward, randomized controlled clinical trials are necessary to ensure that clinicians can treat patients effectively during this outbreak and the next. To do so, academic medical centers must address 2 key research issues: (1) how to effectively and efficiently determine which trials have the best chance of benefiting current and future patients and (2) how to establish a transparent and ethical process for subject recruitment while maintaining research integrity and without overburdening patients or staff. We share here the current methods used by Michigan Medicine to address these issues.
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http://dx.doi.org/10.1093/cid/ciaa560DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239254PMC
November 2020

Early Detection of Heart Failure With Reduced Ejection Fraction Using Perioperative Data Among Noncardiac Surgical Patients: A Machine-Learning Approach.

Anesth Analg 2020 05;130(5):1188-1200

From the Department of Anesthesiology.

Background: Heart failure with reduced ejection fraction (HFrEF) is a condition imposing significant health care burden. Given its syndromic nature and often insidious onset, the diagnosis may not be made until clinical manifestations prompt further evaluation. Detecting HFrEF in precursor stages could allow for early initiation of treatments to modify disease progression. Granular data collected during the perioperative period may represent an underutilized method for improving the diagnosis of HFrEF. We hypothesized that patients ultimately diagnosed with HFrEF following surgery can be identified via machine-learning approaches using pre- and intraoperative data.

Methods: Perioperative data were reviewed from adult patients undergoing general anesthesia for major surgical procedures at an academic quaternary care center between 2010 and 2016. Patients with known HFrEF, heart failure with preserved ejection fraction, preoperative critical illness, or undergoing cardiac, cardiology, or electrophysiologic procedures were excluded. Patients were classified as healthy controls or undiagnosed HFrEF. Undiagnosed HFrEF was defined as lacking a HFrEF diagnosis preoperatively but establishing a diagnosis within 730 days postoperatively. Undiagnosed HFrEF patients were adjudicated by expert clinician review, excluding cases for which HFrEF was secondary to a perioperative triggering event, or any event not associated with HFrEF natural disease progression. Machine-learning models, including L1 regularized logistic regression, random forest, and extreme gradient boosting were developed to detect undiagnosed HFrEF, using perioperative data including 628 preoperative and 1195 intraoperative features. Training/validation and test datasets were used with parameter tuning. Test set model performance was evaluated using area under the receiver operating characteristic curve (AUROC), positive predictive value, and other standard metrics.

Results: Among 67,697 cases analyzed, 279 (0.41%) patients had undiagnosed HFrEF. The AUROC for the logistic regression model was 0.869 (95% confidence interval, 0.829-0.911), 0.872 (0.836-0.909) for the random forest model, and 0.873 (0.833-0.913) for the extreme gradient boosting model. The corresponding positive predictive values were 1.69% (1.06%-2.32%), 1.42% (0.85%-1.98%), and 1.78% (1.15%-2.40%), respectively.

Conclusions: Machine-learning models leveraging perioperative data can detect undiagnosed HFrEF with good performance. However, the low prevalence of the disease results in a low positive predictive value, and for clinically meaningful sensitivity thresholds to be actionable, confirmatory testing with high specificity (eg, echocardiography or cardiac biomarkers) would be required following model detection. Future studies are necessary to externally validate algorithm performance at additional centers and explore the feasibility of embedding algorithms into the perioperative electronic health record for clinician use in real time.
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http://dx.doi.org/10.1213/ANE.0000000000004630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467779PMC
May 2020

"The Secret Life of Human Donor Hearts": An Examination of Transcriptomic Events During Cold Storage.

Circ Heart Fail 2020 04 8;13(4):e006409. Epub 2020 Apr 8.

Department of Cardiac Surgery (I.L., Z.W., Y.E.C., W.H., E.K., F.D.P., P.C.T.).

Background: Ischemic tolerance of donor hearts has a major impact on the efficiency in utilization and clinical outcomes. Molecular events during storage may influence the severity of ischemic injury.

Methods: RNA sequencing was used to study the transcriptional profile of the human left ventricle (LV, n=4) and right ventricle (RV, n=4) after 0, 4, and 8 hours of cold storage in histidine-tryptophan-ketoglutarate preservation solution. Gene set enrichment analysis and gene ontology analysis was used to examine transcriptomic changes with cold storage. Terminal deoxynucleotidyl transferase 2´-Deoxyuridine, 5´-Triphosphate nick end labeling and p65 staining was used to examine for cell death and NFκB activation, respectively.

Results: The LV showed activation of genes related to inflammation and allograft rejection but downregulation of oxidative phosphorylation and fatty acid metabolism pathway genes. In contrast, inflammation-related genes were down-regulated in the RV and while oxidative phosphorylation genes were activated. These transcriptomic changes were most significant at the 8 hours with much lower differences observed between 0 and 4 hours. RNA velocity estimates corroborated the finding that immune-related genes were activated in the LV but not in the RV during storage. With increasing preservation duration, the LV showed an increase in nuclear translocation of NFκB (p65), whereas the RV showed increased cell death close to the endocardium especially at 8 hours.

Conclusions: Our results demonstrated that the LV and RV of human donor hearts have distinct responses to cold ischemic storage. Transcriptomic changes related to inflammation, oxidative phosphorylation, and fatty acid metabolism pathways as well as cell death and NFκB activation were most pronounced after 8 hours of storage.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006409DOI Listing
April 2020

Aortic Valve Repair Versus Replacement Associated With Durable Left Ventricular Assist Devices.

Ann Thorac Surg 2020 10 24;110(4):1259-1264. Epub 2020 Feb 24.

Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Michigan.

Background: Aortic valve (AV) repair (AVr) using a central coaptation stitch or bioprosthetic AV replacement (AVR) are most commonly performed at the time of durable left ventricular assist device implant to address AV insufficiency (AI).

Methods: Prospective data collection on 46 patients undergoing left ventricular assist device implant from 2007 through 2018 who received concomitant AVr (n = 40) or AVR (n = 6) was retrospectively analyzed to assess freedom from recurrent aortic insufficiency. Paired Wilcoxon rank-sum test was used to compare echocardiographic findings. Mantel-Cox statistics were used to analyze survival.

Results: For AVr, central coaptation led to a mean decrease in AI severity by 2.1 ± 1.0 grades (P < .001). Three patients (7.5%) had recurrence of at least moderate AI by 3 years. In comparison, all patients in the AVR group had mild or less AI on subsequent follow-up. Success of AVr in downgrading AI severity was associated with a smaller aortic root diameter (P = .011) and sinotubular junction diameter (P = .003). An aortic root diameter greater than 3.5 cm was predictive of less improvement in AI severity compared with 3.5 cm or less (1.83 ± 1.03 versus 2.47 ± 0.80 grades of improvement; P = .038). Duration of cardiopulmonary bypass was 32 minutes longer and duration of aortic cross-clamp was 38 minutes longer for AVR versus AVr cohorts. No difference in 30-day (P = .418) or overall survival (P = .572) between the AVr and AVR groups was seen.

Conclusions: Aortic valve repair for addressing AI has a recurrence rate of 7.5% at 3 years. Success in downgrading AI is more likely with a smaller aortic root. No difference in survival was observed between AVr and AVR.
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http://dx.doi.org/10.1016/j.athoracsur.2020.01.015DOI Listing
October 2020

Understanding and Addressing Variation in Health Care-Associated Infections After Durable Ventricular Assist Device Therapy: Protocol for a Mixed Methods Study.

JMIR Res Protoc 2020 Jan 7;9(1):e14701. Epub 2020 Jan 7.

Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI, United States.

Background: Durable ventricular assist device (VAD) therapy is reserved for patients with advanced heart failure who have a poor estimated 1-year survival. However, despite highly protocolized management processes, patients are at a unique risk for developing a health care-associated infection (HAI). Few studies have examined optimal strategies for HAI prevention after durable VAD implantation, despite variability in rates across centers and their impact on short- and long-term outcomes.

Objective: The objective of this study is to develop recommendations for preventing the most significant HAIs after durable VAD implantation. The study has 3 specific aims: (1) identify determinants of center-level variability in HAI rates, (2) develop comprehensive understanding of barriers and facilitators for achieving low center-level HAI rates, and (3) develop and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

Methods: This is a sequential mixed methods study starting with a cross-sectional assessment of current practices. To address aim 1, we will conduct (1) a systematic review of HAI prevention studies and (2) in-depth quantitative analyses using administrative claims, in-depth clinical data, and organizational surveys of VAD centers. For aim 2, we will apply a mixed methods patient tracer assessment framework to conduct semistructured interviews, field observations, and document analysis informed by findings from aim 1 at 5 high-performing (ie, low HAIs) and 5 low-performing (ie, high HAI) centers, which will be examined using a mixed methods case series analysis. For aim 3, we will build upon the findings from the previous aims to develop and field test an HAI preventive toolkit, acquire stakeholder input at an annual cardiac surgical conference, disseminate the final version to VAD centers nationwide, and conduct follow-up surveys to assess the toolkit's adoption.

Results: The project was funded by the Agency for Healthcare Research and Quality in 2018 and enrollment for the overall project is ongoing. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019.

Conclusions: This mixed methods study seeks to quantitatively assess the determinants of HAIs across clinical centers and qualitatively identify the context-specific facilitators and barriers for attaining low HAI rates. The mixed data findings will be used to develop and disseminate a stakeholder-acceptable toolkit of evidence-based HAI prevention recommendations that will accommodate the specific contexts and needs of VAD centers.

International Registered Report Identifier (irrid): PRR1-10.2196/14701.
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http://dx.doi.org/10.2196/14701DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6996720PMC
January 2020

Quality of life and treatment preference for ventricular assist device therapy in ambulatory advanced heart failure: A report from the REVIVAL study.

J Heart Lung Transplant 2020 01 20;39(1):27-36. Epub 2019 Nov 20.

University of Michigan Medical School, Ann Arbor, Michigan.

Background: The Registry Evaluation of Vital Information for Ventricular Assist Devices (VADs) in Ambulatory Life study is a prospective multicenter cohort of 400 ambulatory patients with advanced chronic systolic heart failure (HF). The aim of the study is to better understand disease trajectory and optimal timing of advanced HF therapies. We examined patient health-related quality of life (HRQOL) data collected at enrollment and their association with patient treatment preferences for VAD placement.

Methods: Baseline assessment of HRQOL included the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol EQ-5D-3L Visual Analogue Scale (VAS), along with patient self-assessment of remaining life (PSARL). Descriptive statistics were used to present baseline HRQOL data and Spearman correlation tests to assess the association between KCCQ, VAS, and VAD treatment preference with patient clinical characteristics of interest.

Results: The median age was 60 years, 75% were male, and the median left ventricular ejection fraction was 20%. The median (25th percentile, 75th percentile), baseline KCCQ summary score was 64 (48, 78), VAS score 65 (50, 75), and PSARL 7 years (5, 10). There were statistically significant associations of baseline KCCQ and VAS with New York Heart Association class and Interagency Registry of Mechanically Assisted Circulatory Support profile (p < 0.005 for all comparisons). Baseline KCCQ and VAS revealed a modest association with PSARL (correlation = 0.45 and 0.35, respectively; p < 0.001), and many patients were overly optimistic about their expected survival. VAD treatment preference was associated with KCCQ scores (p < 0.031), but the absolute differences were small. VAD treatment preference was independent of other key clinical characteristics such as subject age, VAS, and PSARL.

Conclusions: We found a lack of strong association between HRQOL and patient preference for VAD therapy. Better understanding of patients' perceptions of their illness and how this relates to HRQOL outcomes, clinician risk assessment, and patient decision-making is needed. This may in turn allow better guidance toward available HF therapies in this vulnerable population.
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http://dx.doi.org/10.1016/j.healun.2019.11.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942204PMC
January 2020

Impact of Socioeconomic Factors on Patient Desire for Early LVAD Therapy Prior to Inotrope Dependence.

J Card Fail 2020 Apr 4;26(4):316-323. Epub 2019 Dec 4.

Brigham and Women's Hospital, Boston, Massachusetts.

Background: Worsening heart failure (HF) and health-related quality of life (HRQOL) have been shown to impact the decision to proceed with left ventricular assist device (LVAD) implantation, but little is known about how socioeconomic factors influence expressed patient preference for LVAD.

Methods And Results: Ambulatory patients with advanced systolic HF (n=353) reviewed written information about LVAD therapy and completed a brief survey to indicate whether they would want an LVAD to treat their current level of HF. Ordinal logistic regression analyses identified clinical and demographic predictors of LVAD preference. Higher New York Heart Association (NYHA) class, worse HRQOL measured by Kansas City Cardiomyopathy Questionnaire, lower education level, and lower income were significant univariable predictors of patients wanting an LVAD. In the multivariable model, higher NYHA class (OR [odds ratio]: 1.43, CI [confidence interval]: 1.08-1.90, P = .013) and lower income level (OR: 2.10, CI: 1.18 - 3.76, P = .012 for <$40,000 vs >$80,000) remained significantly associated with wanting an LVAD.

Conclusion: Among ambulatory patients with advanced systolic HF, treatment preference for LVAD was influenced by level of income independent of HF severity. Understanding the impact of socioeconomic factors on willingness to consider LVAD therapy may help tailor counseling towards individual needs.
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http://dx.doi.org/10.1016/j.cardfail.2019.11.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141955PMC
April 2020
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