Publications by authors named "Shelley A Hall"

73 Publications

Observed elevated donor-derived cell free DNA in orthotopic heart transplant recipients without clinical evidence of rejection.

Clin Transplant 2021 Dec 4:e14549. Epub 2021 Dec 4.

Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas, USA.

Donor-derived cell free DNA (dd-cfDNA) has rapidly become part of rejection surveillance following orthotopic heart transplantation. However, some patients show elevated dd-cfDNA without clinical evidence of rejection. With the aim to provide a clinical description of this subpopulation, we retrospectively analyzed 35 cardiac transplant recipients at our center who experienced elevated (≥.20%) dd-cfDNA in the absence of clinical rejection, out of a total 106 recipients who had dd-cfDNA results available during the first year. The median time to first elevated dd-cfDNA level was 46 days, and the highest dd-cfDNA recorded within 1 year was .31% [inter-quartile range, .23-.45]. Twenty-two (63%) patients experienced infections (cytomegalovirus (CMV) or other), and 16 (46%) presented with de novo donor-specific antibodies. Cluster analysis revealed four distinct groups characterized by (a) subclinical rejection with 50% CMV (n = 16), (b) non-CMV infections and the longest time to first elevated dd-cfDNA (187 days) (n = 8), (c) right ventricular dysfunction (n = 6), and (d) women who showed the youngest median age (45 years) and highest median dd-cfDNA (.50%) (n = 5). Continued prospective analysis is needed to determine if these observations warrant changes in patient management to optimize the utilization of this vital non-invasive graft surveillance tool.
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http://dx.doi.org/10.1111/ctr.14549DOI Listing
December 2021

Urinary Cell-Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury After Ventricular Assist Device Implantation or Cardiac Transplantation.

J Cardiothorac Vasc Anesth 2021 Oct 16. Epub 2021 Oct 16.

Medical City Heart Hospital, Dallas, TX; University of Maryland Medical Center, Baltimore, Maryland.

Objectives: Acute kidney injury (AKI) remains a leading source of morbidity and mortality after cardiothoracic surgery. Insulin-like growth factor-binding protein 7 (IGFBP7), and tissue inhibitor of metalloproteinases-2 (TIMP-2), are novel early-phase renal biomarkers that have been validated as sensitive predictors of AKI. Here the authors studied the efficacy of these biomarkers for predicting AKI after left ventricular assist device (LVAD) implantation and cardiac transplantation.

Design/setting/participants/interventions: This was a prospective study of 73 patients undergoing LVAD implantation (n = 37) or heart transplant (n = 36) from 2016 to 2017 at the authors' center. TIMP-2 and IGFBP7 were measured with the NephroCheck Test on urine samples before surgery and one-to-six hours after surgery. NephroCheck scores were assessed as predictors of moderate/severe AKI (Kidney Disease International Global Outcomes 2/3 creatinine criteria) within 48 hours of surgery, and the association with survival to one year was investigated.

Measurements And Main Results: The LVAD and transplant cohorts overall were similar in demographics and baseline creatinine (p > 0.05), with the exception of having more African-American patients in the LVAD arm (p = 0.003). Eleven (30%) LVAD and 16 (44%) transplant patients developed moderate/severe AKI. Overall, AKI was associated with postsurgery NephroCheck (odds ratio [95% confidence interval] for 0.1 mg/dL increase: 1.36 [1.04-1.79]; p = 0.03), but not with baseline NephroCheck (p = 0.92). When analyzed by cohort, this effect remained for LVAD (1.68 [1.05-2.71]; p = 0.03) but not for transplant (p = 0.15). Receiver operating characteristic analysis showed postoperative NephroCheck to be superior to baseline creatinine in LVAD (p = 0.046). Furthermore, an increase of 0.1 mg/dL in postoperative NephroCheck was associated with a 10% increase in the risk of mortality (adjusted hazard ratio: 1.11 [1.01-1.21]; p = 0.04) independent of age and body mass index.

Conclusion: Assessment of TIMP-2 and IGFBP7 within six hours after surgery appeared effective at predicting AKI in patients with LVADs. Larger studies are warranted to validate these findings.
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http://dx.doi.org/10.1053/j.jvca.2021.10.013DOI Listing
October 2021

De novo tacrolimus extended-release tablets (LCPT) versus twice-daily tacrolimus in adult heart transplantation: Results of a single-center non-inferiority matched control trial.

Clin Transplant 2021 Dec 1;35(12):e14487. Epub 2021 Oct 1.

Baylor Scott & White Research Institute, Baylor Scott & White Health, Dallas, Texas, USA.

Extended-release tacrolimus for prophylaxis of allograft rejection in orthotopic heart transplant (OHT) recipients is currently not FDA-approved. One such extended-release formulation of tacrolimus known as LCPT allows once-daily dosing and improves bioavailability compared to immediate-release tacrolimus (IR-tacrolimus). We compared the efficacy and safety of LCPT to IR-tacrolimus applied de novo in adult OHT recipients. Twenty-five prospective recipients on LCPT at our center from 2017 to 2019 were matched 1:2 with historical control recipients treated with IR-tacrolimus based on age, gender, and baseline creatinine. The primary composite outcome of death, acute cellular rejection, and/or new graft dysfunction within 1 year was compared using non-inferiority analysis. LCPT demonstrated non-inferiority to IR-tacrolimus, with a primary outcome risk reduction of 20% (90% CI: -40%, -.5%; non-inferiority P = .001). Tacrolimus trough levels peaked at 2-3 months and were higher in LCPT (median 14.5 vs. 12.7 ng/ml; P = .03) with similar dose levels (LCPT vs. IR-tacrolimus: .08 vs. .09 mg/kg/day; P = .33). Cardiovascular-related readmissions were reduced by 62% (P = .046) in LCPT patients. The complication rate per transplant admission and all-cause readmission rate did not differ significantly. These results suggest that LCPT is non-inferior in efficacy to IR-tacrolimus with a similar safety profile and improved bioavailability in OHT.
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http://dx.doi.org/10.1111/ctr.14487DOI Listing
December 2021

Impact of risk-stratified mycophenolate dosing in heart transplantation.

Clin Transplant 2021 Nov 6;35(11):e14445. Epub 2021 Aug 6.

Department of Pharmacy, Baylor University Medical Center, Dallas, Texas, USA.

Mycophenolate mofetil (MMF), the prodrug of mycophenolic acid, is a highly effective immunosuppressive agent in heart transplant therapy. While the FDA approved dose is 1500 mg twice daily, dosing is often reduced due to dose-dependent adverse effects. However, empiric MMF dose reductions may lead to sub-therapeutic dosing and impair clinical outcomes. Our single center protocolized a risk-stratified approach based on age and weight to dose 500 mg twice daily or 1000 mg twice daily to patients after heart transplantation. This retrospective single-center study analyzed 140 consecutive heart transplant patients who were initiated on our risk-stratified MMF protocol post-transplant. The analysis revealed that the composite rate of biopsy-proven rejection, graft loss, or mortality at 1-year post-transplantation was similar between the two groups. Incidence of neutropenia, thrombocytopenia, infection, cardiac allograft vasculopathy, or acute kidney injury by 1-year also showed similar results between the two groups. Risk-stratification of MMF dosing appears to be a safe and effective strategy after heart transplantation.
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http://dx.doi.org/10.1111/ctr.14445DOI Listing
November 2021

Bradycardia in Recent Heart Transplant: Will the Microscope Illuminate the True Answer?.

Methodist Debakey Cardiovasc J 2021 16;17(2):e14-e17. Epub 2021 Jun 16.

BAYLOR UNIVERSITY MEDICAL CENTER, DALLAS, TEXAS.

Transplant recipients are at risk of developing rejection that may cause significant morbidity and mortality following transplantation The clinical presentation of rejection may be atypical, leading to difficulties in diagnosis and management especially in cases with a nondiagnostic biopsy specimen. The emergence of artificial intelligence may aid in clinical decision making when traditional techniques are inconclusive.
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http://dx.doi.org/10.14797/PREM9909DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287873PMC
October 2021

North American Practice-Based Recommendations for Transjugular Intrahepatic Portosystemic Shunts in Portal Hypertension.

Clin Gastroenterol Hepatol 2021 Jul 15. Epub 2021 Jul 15.

Division of Gastroenterology and Hepatology, Department of Medicine, Chicago, Illinois; Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address:

Complications of portal hypertension, including ascites, gastrointestinal bleeding, hepatic hydrothorax, and hepatic encephalopathy, are associated with significant morbidity and mortality. Despite few high-quality randomized controlled trials to guide therapeutic decisions, transjugular intrahepatic portosystemic shunt (TIPS) creation has emerged as a crucial therapeutic option to treat complications of portal hypertension. In North America, the decision to perform TIPS involves gastroenterologists, hepatologists, and interventional radiologists, but TIPS creation is performed by interventional radiologists. This is in contrast to other parts of the world where TIPS creation is performed primarily by hepatologists. Thus, the successful use of TIPS in North America is dependent on a multidisciplinary approach and technical expertise, so as to optimize outcomes. Recently, new procedural techniques, TIPS stent technology, and indications for TIPS have emerged. As a result, practices and outcomes vary greatly across institutions and significant knowledge gaps exist. In this consensus statement, the Advancing Liver Therapeutic Approaches group critically reviews the application of TIPS in the management of portal hypertension. Advancing Liver Therapeutic Approaches convened a multidisciplinary group of North American experts from hepatology, interventional radiology, transplant surgery, nephrology, cardiology, pulmonology, and hematology to critically review existing literature and develop practice-based recommendations for the use of TIPS in patients with any cause of portal hypertension in terms of candidate selection, procedural best practices and, post-TIPS management; and to develop areas of consensus for TIPS indications and the prevention of complications. Finally, future research directions are identified related to TIPS for the management of portal hypertension.
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http://dx.doi.org/10.1016/j.cgh.2021.07.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8760361PMC
July 2021

The Traditional Endomyocardial Biopsy: Opportunities to Rethink Its Role as the Gold Standard.

J Card Fail 2021 Jul 6. Epub 2021 Jul 6.

Baylor University Medical Center, Dallas, Texas; Texas A&M University College of Medicine, Bryan, Texas.

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http://dx.doi.org/10.1016/j.cardfail.2021.05.029DOI Listing
July 2021

Long-term outcomes of patients with primary graft dysfunction after cardiac transplantation.

Eur J Cardiothorac Surg 2021 11;60(5):1178-1183

Baylor University Medical Center, Dallas, TX, USA.

Objectives: The International Society of Heart and Lung Transplantation (ISHLT) criteria for primary graft dysfunction (PGD) after cardiac transplantation have been shown to stratify patient outcomes up to 1 year after transplantation, but scarce data are available regarding outcomes beyond the 1st year. We sought to characterize survival of patients with PGD following cardiac transplantation beyond the 1st year.

Methods: A retrospective review of consecutive patients undergoing isolated cardiac transplantation at a single centre between 2012 and 2015 was performed. Patients were diagnosed with none, mild, moderate or severe PGD by the ISHLT criteria. Survival was ascertained from the United Network for Organ Sharing database and chart review. Kaplan-Meier curves were plotted to compare survival. The hazard ratio for mortality associated with PGD severity was estimated using Cox-proportional hazards modelling, with a pre-specified conditional survival analysis at 90 days.

Results: A total of 257 consecutive patients underwent cardiac transplantation during the study period, of whom 73 (28%) met ISHLT criteria for PGD: 43 (17%) mild, 12 (5%) moderate and 18 (7%) severe. Patients with moderate or severe PGD had decreased survival up to 5 years after transplantation (log-rank P < 0.001). Landmark analyses demonstrated that patients with moderate or severe PGD were at increased risk of mortality during the first 90-days after transplantation as compared to those with none or mild PGD [hazard ratio (95% confidence interval) 18.9 (7.1-50.5); P < 0.001], but this hazard did not persist beyond 90-days in survivors (P = 0.64).

Conclusions: A diagnosis of moderate or severe PGD is associated with increased mortality up to 5 years after cardiac transplantation. However, patients with moderate or severe PGD who survive to post-transplantation day 90 are no longer at increased risk for mortality as compared to those with none or mild PGD.
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http://dx.doi.org/10.1093/ejcts/ezab177DOI Listing
November 2021

Dynamic albumin values as clinical surrogate for COVID-19 therapeutics.

J Investig Med 2021 08 28;69(6):1260. Epub 2021 May 28.

Baylor Scott & White Research Institute, Baylor Scott & White Health, Dallas, Texas, USA

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http://dx.doi.org/10.1136/jim-2021-001895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172265PMC
August 2021

Trends in post-heart transplant biopsies for graft rejection versus nonrejection.

Proc (Bayl Univ Med Cent) 2021 Jan 26;34(3):345-348. Epub 2021 Jan 26.

Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas.

With alternatives such as gene profiling available for surveillance after orthotopic heart transplantation, we sought to evaluate the utilization of endomyocardial biopsies (EMBs) for hospitalized patients after heart transplantation. Surveillance EMBs in patients with and without complications were evaluated from the 2004 to 2014 National Inpatient Sample. Over the study period, there was no significant change in the number of EMB procedures performed ( = 0.44). Of 37,955 EMBs, 2283 (6%) were in the setting of graft complications, while 35,672 EMBs were not related to graft complications. EMBs in graft complications did not show a significant increase in length of stay over time ( = 0.06), but had a significant increase in cost over time ( = 0.001). However, those with graft complications had an average of a 5-day longer length of stay ( < 0.001) and costs that were $88,816 ( < 0.001) more expensive compared with those without graft complications. In conclusion, the vast majority of in-hospital EMBs were not related to heart transplantation complications. Nevertheless, EMB hospitalizations with graft complications showed significantly greater length of stay and cost. With the COVID-19 pandemic, it seems more effective to use minimal-contact health surveillance methods rather than invasive EMBs.
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http://dx.doi.org/10.1080/08998280.2021.1873032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059886PMC
January 2021

Polypill in Persons without Cardiovascular Disease.

N Engl J Med 2021 04;384(17):1674

Baylor University Medical Center, Dallas, TX

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http://dx.doi.org/10.1056/NEJMc2102972DOI Listing
April 2021

The utility of boxing for cardiac prehabilitation.

Proc (Bayl Univ Med Cent) 2020 Sep 28;34(1):182-184. Epub 2020 Sep 28.

Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas.

A 56-year-old man with end-stage heart failure performed a 4-week, symptom-limited, progressive inpatient cardiac prehabilitation program while confined to the cardiovascular intensive care unit awaiting heart transplantation. Mobility was limited by an acute gout flare and multiple central venous access lines. He received a tailored prescription of intermittent boxing, supervised hallway ambulation, stair training, and golfing on a putting green on four consecutive weekdays and was encouraged to mobilize with nursing on the remaining days. The patient progressed and by the last week demonstrated increased activity tolerance. He had a successful transplant after 40 days in the intensive care unit and was discharged with stamina sufficient to participate in outpatient cardiac rehabilitation, demonstrating the value, safety, and feasibility of an individualized inpatient cardiac prehabilitation program for patients with advanced cardiac disease medically confined to the intensive care unit.
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http://dx.doi.org/10.1080/08998280.2020.1818050DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785167PMC
September 2020

ALLY in fighting COVID-19: magnitude of albumin decline and lymphopenia (ALLY) predict progression to critical disease.

J Investig Med 2021 03 11;69(3):710-718. Epub 2021 Jan 11.

Baylor Scott & White Research Institute, Baylor Scott and White Health, Dallas, Texas, USA

The global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic leading to coronavirus disease 2019 (COVID-19) is straining hospitals. Judicious resource allocation is paramount but difficult due to the unpredictable disease course. Once hospitalized, discerning which patients may progress to critical disease would be valuable for resource planning. Medical records were reviewed for consecutive hospitalized patients with COVID-19 in a large healthcare system in Texas. The main outcome was progression to critical disease within 10 days from admission. Albumin trends from admission to 7 days were analyzed using mixed-effects models, and progression to critical disease was modeled by multivariable logistic regression of laboratory results. Risk models were evaluated in an independent group. Of 153 non-critical patients, 28 (18%) progressed to critical disease. The rate of decrease in mean baseline-corrected () albumin was -0.08 g/dL/day (95% CI -0.11 to -0.04; p<0.001) or four times faster, in those who progressed compared with those who did not progress. A model of albumin combined with lymphocyte percentage predicting progression to critical disease was validated in 60 separate patients (sensitivity, 0.70; specificity, 0.74). ALLY (delta albumin and lmphocyte percentage) is a simple tool to identify patients with COVID-19 at higher risk of disease progression when: (1) a 0.9 g/dL or greater albumin drop from baseline within 5 days of admission or (2) baseline lymphocyte of ≤10% is observed. The ALLY tool identified >70% of hospitalized cases that progressed to critical COVID-19 disease. We recommend prospectively tracking albumin. This is a globally applicable tool for all healthcare systems.
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http://dx.doi.org/10.1136/jim-2020-001525DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802390PMC
March 2021

Commentary: History is prologue: If we fail to learn from our past, we are doomed to repeat it.

J Thorac Cardiovasc Surg 2021 05 3;161(5):1847-1848. Epub 2020 Sep 3.

Center for Advanced Heart and Lung Disease, Baylor Annette C. and Harold C. Simmons Transplant Institute, Baylor University Medical Center, Dallas, Tex; Division of Cardiology, Department of Advanced Heart Failure, Mechanical Support, and Transplant, Baylor Heart and Vascular Hospital, Dallas, Tex; Texas A&M University College of Medicine, Bryan, Tex. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.08.099DOI Listing
May 2021

The New Era of Cardiogenic Shock: Progress in Mechanical Circulatory Support.

Curr Heart Fail Rep 2020 12 16;17(6):325-332. Epub 2020 Sep 16.

Center for Advanced Heart and Lung Diseases, Baylor University Medical Center, 3410 Worth Street, Suite 250, Dallas, TX, 75246, USA.

Purpose Of Review: In recent decades, multiple left and right ventricular assist devices (VAD) have been developed, and the utilization of these devices has grown exponentially. We discuss the most common temporary mechanical circulatory support (tMCS) devices used for patients in cardiogenic shock, including the intra-aortic balloon pump (IABP), transvalvular axial flow support systems (Impella®), the Tandem™ collection, and extracorporeal membrane oxygenation (ECMO).

Recent Findings: In 2018 the United Network for Organ Sharing (UNOS) introduced new listing criteria for candidates awaiting heart transplantation in the USA. Analysis of the first 1300 transplants under these new listing criteria has shown that higher-risk patients are now undergoing transplantation. As technology has advanced, becoming more sophisticated and miniaturized, a new era has emerged with more rapidly deployable tMCS devices. For some patients presenting in cardiogenic shock, support with these tMCS devices can be a bridge to a more durable option. For others, their only option may be support with the hope of native cardiac recovery. Understanding the pros and cons of each device can lead to most appropriate utilization for the ultimate intended goal.
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http://dx.doi.org/10.1007/s11897-020-00490-yDOI Listing
December 2020

Rethinking the future with evolving technology: It's time to empower change in heart transplantation.

Am J Transplant 2021 02 23;21(2):453-455. Epub 2020 Aug 23.

Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott & White Research Institute, Dallas, Texas, USA.

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http://dx.doi.org/10.1111/ajt.16221DOI Listing
February 2021

Advanced heart failure with reduced ejection fraction.

Proc (Bayl Univ Med Cent) 2020 Jul 2;33(3):350-356. Epub 2020 Jun 2.

Division of Cardiology, Baylor Scott and White Medical Center - TempleTempleTexas.

Patients suffering advanced heart failure with reduced ejection fraction (HFrEF) account for a large portion of patients admitted to hospitals worldwide. Mortality and 30-day readmission rates for HFrEF are now a focus of value-based payment models, making management of this disease a priority for hospitals, physicians, and payers alike. Angiotensin-converting enzyme inhibitors have been the cornerstone of therapy for decades. However, with treatment, the prognosis for patients with advanced HFrEF remains poor. Fortunately, advances in medical therapy and mechanical support offer some patients improvement in both survival and quality of life. We review advances in short- and long-term mechanical support and explore changes to organ allocation for cardiac transplantation. In addition, we provide a guide to facilitate appropriate referral to an advanced heart failure team.
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http://dx.doi.org/10.1080/08998280.2020.1765663DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340451PMC
July 2020

Cardiogenic Shock in Patients with Advanced Chronic Heart Failure.

Methodist Debakey Cardiovasc J 2020 Jan-Mar;16(1):22-26

BAYLOR SCOTT & WHITE RESEARCH INSTITUTE, DALLAS, TEXAS; BAYLOR UNIVERSITY MEDICAL CENTER, DALLAS, TEXAS; TEXAS A&M HEALTH SCIENCE CENTER, DALLAS, TEXAS.

Patients with end-stage heart failure (HF) who have failed optimal medical therapy provide a unique set of challenges compared to the more prevalent population of patients with cardiogenic shock (CS) due to ST-segment elevation myocardial infarction. Progression from "preshock" into a refractory state of CS is associated with a dismal outcome due to difficulties with the patient's recognition, response to interventions, and candidacy for salvage options. Challenges include heterogeneity of CS (eg, different phenotypes, etiologies, duration, acuity of onset, hemodynamics, end-organ effects), lack of a universal definition of CS that is applicable to this patient population, and blunted hemodynamic response given the patient's prolonged compensatory state. Individuals with advanced HF in CS require a multidisciplinary team-based assessment regarding when to escalate from medical therapy into temporary mechanical circulatory support, and they need an eligibility evaluation to determine their candidacy for advanced therapy. In this review, we discuss the definition and clinical phenotypes of CS, classification of CS in advanced HF patients, the utility of temporary mechanical circulatory support, and the role of the CS team.
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http://dx.doi.org/10.14797/mdcj-16-1-22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137620PMC
July 2020

Initial skin cancer screening for solid organ transplant recipients in the United States: Delphi method development of expert consensus guidelines.

Transpl Int 2019 Dec 8;32(12):1268-1276. Epub 2019 Oct 8.

Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Skin cancer is the most common malignancy affecting solid organ transplant recipients (SOTR), and SOTR experience increased skin cancer-associated morbidity and mortality. There are no formal multidisciplinary guidelines for skin cancer screening after transplant, and current practices are widely variable. We conducted three rounds of Delphi method surveys with a panel of 84 U.S. dermatologists and transplant physicians to establish skin cancer screening recommendations for SOTR. The transplant team should risk stratify SOTR for screening, and dermatologists should perform skin cancer screening by full-body skin examination. SOTR with a history of skin cancer should continue regular follow-up with dermatology for skin cancer surveillance. High-risk transplant patients include thoracic organ recipients, SOTR age 50 and above, and male SOTR. High-risk Caucasian patients should be screened within 2 years after transplant, all Caucasian, Asian, Hispanic, and high-risk African American patients should be screened within 5 years after transplant. No consensus was reached regarding screening for low-risk African American SOTR. We propose a standardized approach to skin cancer screening in SOTR based on multidisciplinary expert consensus. These guidelines prioritize and emphasize the need for screening for SOTR at greatest risk for skin cancer.
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http://dx.doi.org/10.1111/tri.13520DOI Listing
December 2019

Gene expression profiling and racial disparities in outcomes after heart transplantation.

J Heart Lung Transplant 2019 08 24;38(8):820-829. Epub 2019 May 24.

Section of Heart Failure, Cardiac Transplant, and Mechanical Circulatory Support, and Department of Medicine, Stanford University, Stanford, California. Electronic address:

Background: African Americans (AAs) have lower survival rates after heart transplantation (HTx) than Caucasians. The aim of this analysis was to evaluate racial differences in gene expression and their associations with survival and the composite outcome of death, retransplant, rejection with hemodynamic compromise, and graft dysfunction in the Outcomes AlloMap Registry.

Methods: Registry participants included low-risk Caucasian and AA heart transplant recipients with a baseline and at least 1 follow-up gene expression test (AlloMap(C)) within the first year after HTx. The Kaplan-Meier method with delayed entry was used to describe differences in outcomes. Multivariable Cox hazard regression was used to evaluate the associations of overall gene expression profiling score, MARCH8 and FLT3 expression, and tacrolimus levels with each outcome, and stratified Cox models were developed to quantify race-specific associations.

Results: Among 933 eligible recipients, 737 (79%) were Caucasian and 196 (21%) were AA. Compared with Caucasians, AAs were significantly younger (55 vs 59 years, p < 0.001), with higher rates of non-ischemic cardiomyopathy (68% vs 50%, p < 0.001), sensitization (>10% panel reactive antibody, 16% vs 9.1%, p = 0.009), and human leukocyte antigen mismatches (7 vs 7, p = 0.01), but less frequent primary cytomegalovirus serostatus mismatch (14.31% vs 27.3%, p < 0.001). Overall, AAs had an increased adjusted mortality risk (hazard ratio [HR] 4.13, p = 0.007). Higher tacrolimus levels were associated with decreased mortality in AAs (HR 0.62, p = 0.009). Overall gene expression profiling score was associated with increased mortality among Caucasians (HR 1.21, p = 0.048). In Caucasians, but not AAs, overexpression of MARCH8 was associated with increased mortality (HR 2.90, p = 0.001). FLT3 upregulation was associated with increased mortality (HR 2.42, p = 0.033) in AAs. There was an inverse relationship between FLT3 expression and tacrolimus levels (-0.029 and -0.176, respectively) in Caucasians and AAs.

Conclusions: AAs have a significantly higher mortality risk after HTx than Caucasians, even in the low-risk Outcomes AlloMap Registry population. AAs and Caucasians had differential outcomes based upon the varying expression of MARCH8 and FLT3 genes following HTx.
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http://dx.doi.org/10.1016/j.healun.2019.05.008DOI Listing
August 2019

Outcomes of orthotopic heart transplantation and left ventricular assist device in patients aged 65 years or more with end-stage heart failure.

Proc (Bayl Univ Med Cent) 2019 Apr 28;32(2):177-180. Epub 2019 Mar 28.

Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott & White Research InstituteDallasTexas.

Age has traditionally been a limiting factor for advanced heart failure (HF) therapies. Orthotopic heart transplantation (OHT) age guidelines have become less restrictive, and left ventricular assist devices (LVADs) are increasingly utilized as destination therapy for patients ≥65 years. Although indications differ, we assessed outcomes for both modalities in this older population. We reviewed charts of consecutive advanced HF therapy recipients aged ≥65 years at our center from 2012 to 2016. Of 118 patients evaluated, 46 (39%) received an LVAD and 72 (61%) received OHT. Gender, body mass index, and rate of prior sternotomy were similar between groups; OHT recipients were younger, less likely to have diabetes mellitus, and more likely to have HF due to ischemic etiology. Forty-six percent of patients receiving LVADs were urgent need (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1-2), compared to 29% of patients receiving OHT (United Network for Organ Sharing 1A criteria;  = 0.068). OHT recipients had shorter lengths of stay and better 1-year survival compared to LVAD recipients. Although many centers do not offer advanced HF therapy to patients aged ≥65 years, our results indicate that age alone should not be prohibitive for advanced HF therapy, particularly OHT.
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http://dx.doi.org/10.1080/08998280.2019.1576095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541055PMC
April 2019

Predictors and impact of right heart failure severity following left ventricular assist device implantation.

J Thorac Dis 2019 Apr;11(Suppl 6):S864-S870

Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, TX, USA.

Background: Right heart failure (RHF) is a well-known consequence of left ventricular assist device (LVAD) placement, and has been linked to negative surgical outcomes. However, little is known regarding risk factors associated with RHF. This article delineates pre- and intra-operative risk factors for RHF following LVAD implantation and demonstrates the effect of RHF severity on key surgical outcomes.

Methods: We performed a retrospective analysis of consecutive LVAD patients treated at our center between 2008 and 2016. RHF was categorized using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition of none/mild, moderate, severe, and acute-severe. We constructed a predictive model using multivariable logistic regression and performed a competing risks analysis for survival stratified by RHF severity.

Results: Of 202 subjects, 52 (25.7%) developed moderate or worse RHF. Cardiopulmonary bypass (CPB) time and nadir hematocrit contributed jointly to the model of RHF severity (moderate or worse none/mild; area under the curve =0.77). Postoperative length of stay (LOS) was shortest in the non/mild group and longest in the acute-severe group (median 13 29.5 days; P<0.001). Stage 2/3 acute kidney injury (range, 26-57%, P=0.002), respiratory failure (13-94%, P<0.001), stroke (0-32%, P=0.02), and 1-year mortality (19-64%, P=0.002) differed by severity. Those with acute-severe RHF had 5.4 [95% confidence interval (CI), 2.5-11.8] times the risk of 1-year mortality compared to those who did not have RHF.

Conclusions: RHF remains a postoperative threat and is associated with worsened surgical outcomes. Ongoing research will reveal further opportunities to mitigate RHF post-LVAD.
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http://dx.doi.org/10.21037/jtd.2018.09.155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535485PMC
April 2019

SCAI clinical expert consensus statement on the classification of cardiogenic shock: This document was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society of Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS) in April 2019.

Catheter Cardiovasc Interv 2019 Jul 19;94(1):29-37. Epub 2019 May 19.

Westchester Medical Center and New York Medical College, Valhalla, New York.

Background: The outcome of cardiogenic shock complicating myocardial infarction has not appreciably changed in the last 30 years despite the development of various percutaneous mechanical circulatory support options. It is clear that there are varying degrees of cardiogenic shock but there is no robust classification scheme to categorize this disease state.

Methods: A multidisciplinary group of experts convened by the Society for Cardiovascular Angiography and Interventions was assembled to derive a proposed classification schema for cardiogenic shock. Representatives from cardiology (interventional, advanced heart failure, noninvasive), emergency medicine, critical care, and cardiac nursing all collaborated to develop the proposed schema.

Results: A system describing stages of cardiogenic shock from A to E was developed. Stage A is "at risk" for cardiogenic shock, stage B is "beginning" shock, stage C is "classic" cardiogenic shock, stage D is "deteriorating", and E is "extremis". The difference between stages B and C is the presence of hypoperfusion which is present in stages C and higher. Stage D implies that the initial set of interventions chosen have not restored stability and adequate perfusion despite at least 30 minutes of observation and stage E is the patient in extremis, highly unstable, often with cardiovascular collapse.

Conclusion: This proposed classification system is simple, clinically applicable across the care spectrum from pre-hospital providers to intensive care staff but will require future validation studies to assess its utility and potential prognostic implications.
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http://dx.doi.org/10.1002/ccd.28329DOI Listing
July 2019

Repeat Cardiac Transplant Indicated by Severe Cardiac Allograft Vasculopathy in a Patient With Danon Disease.

Rev Cardiovasc Med 2018 Jun;19(2):69-71

Division of Cardiology, Baylor University Medical Center, Dallas, TX, 75246.

Danon disease is a rare, X-linked dominant, lysosomal storage disorder, presenting with cardiomyopathy mostly in adolescent men. Male patients face a high mortality rate and rarely live to the age of 25 years unless they receive a heart transplant. Because they generally undergo heart transplantation at a young age, many patients ultimately face both short- and long-term complications. We present a 32-year-old man diagnosed with Danon disease; a nonsense mutation in the LAMP-2 gene. Progressive heart failure symptoms resulted in initial heart transplant at age 27 years. He subsequently developed severe cardiac allograft vasculopathy that led to graft failure requiring a redo orthotopic heart transplant. This is one of only two reported Danon disease cases described to date surviving repeat orthotopic heart transplants. We present this case to highlight the importance of heart transplantation in the management of Danon disease, to emphasize the risk of cardiac allograft vasculopathy post-transplant, and to discuss management strategies.
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http://dx.doi.org/10.31083/j.rcm.2018.02.903DOI Listing
June 2018

The Effect of Obstructive Sleep Apnea on 3-Year Outcomes in Patients Who Underwent Orthotopic Heart Transplantation.

Am J Cardiol 2019 07 10;124(1):51-54. Epub 2019 Apr 10.

Abbott, St. Paul, Minnesota.

Despite the well-known association between obstructive sleep apnea (OSA) and cardiovascular disease, there is a paucity of data regarding OSA in orthotopic heart transplant (OHT) recipients and its effect on clinical outcomes. Hence, we sought to determine the association between OSA, as detected by polysomnography, and late graft dysfunction (LGD) after OHT. In this retrospective review of consecutive OHT recipients from 2012 to 2014 at our center, we examined LGD, i.e., graft failure >1 year after OHT, through competing risks analysis. Due to small sample size and event counts, as well as preliminary testing which revealed statistically similar demographics and outcomes, we pooled patients who had treated OSA with those who had no OSA. Of 146 patients, 29 (20%) had untreated OSA, i.e., OSA without use of continuous positive airway pressure therapy, at the time of transplantation. Patients with untreated OSA were significantly older, heavier, and more likely to have baseline hypertension than those with treated/no OSA. Although there were no differences between groups in regard to short-term complications of acute kidney injury, cardiac allograft vasculopathy, or primary graft dysfunction, there were significant differences in the occurrence of LGD. Those with untreated OSA were at 3 times the risk of developing LGD than those with treated/no OSA (hazard ratio 3.2; 95% confidence interval 1.3 to 7.9; p = 0.01). Because OSA is a common co-morbidity of OHT patients and because patients with untreated OSA have an elevated risk of LGD, screening for and treating OSA should occur during the OHT selection period.
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http://dx.doi.org/10.1016/j.amjcard.2019.04.005DOI Listing
July 2019

Effect of Progressive Left Ventricular Dilatation on Degree of Mitral Regurgitation Secondary to Mitral Valve Prolapse.

Am J Cardiol 2019 06 13;123(11):1887-1888. Epub 2019 Mar 13.

Internal Medicine (Division of Cardiology), Baylor University Medical Center, Baylor Scott & White Health, Dallas, Texas.

Described herein is a 71-year-old man who at age 61 was found by echocardiogram to have severe mitral regurgitation (MR) from mitral valve prolapse. During the subsequent 9 years the MR progressively lessened as his left ventricular cavity dilated and his ejection fraction progressively fell such that just before orthotopic heart transplantation the degree of MR was no longer severe, and the prolapse of the mitral leaflets had disappeared. This report describes this unique patient.
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http://dx.doi.org/10.1016/j.amjcard.2019.02.046DOI Listing
June 2019

Morphological and Functional Characteristics of the Right Ventricle Functioning as a Systemic Ventricle for Decades After an Atrial Switch Procedure for Complete Transposition of the Great Arteries.

Am J Cardiol 2019 06 13;123(11):1863-1867. Epub 2019 Mar 13.

Department of Internal Medicine (Division of Cardiology), Baylor University Medical Center, Baylor Scott & White Health, Dallas, Texas.

Described herein are certain clinical and cardiac morphologic findings in 4 adults with complete transposition of the great arteries who underwent the Mustard procedure in the newborn period or in childhood and each lived >30 years thereafter before either having orthotopic heart transplantation (3 patients) or dying while awaiting orthotopic heart transplantation. Compared with the wall of the left ventricle, the wall of the right ventricle (the systemic one) was much thicker, the myofibers much larger, and either grossly-visible or microscopic-sized scars were present in its wall. Additionally, some intramural coronary arteries in the right ventricular wall were numerous, large, had thick walls, and often narrowed lumens. That the Mustard operation provided the necessary time for the right ventricle (the systemic one) to develop to its fullest is a tribute to this procedure.
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http://dx.doi.org/10.1016/j.amjcard.2019.02.052DOI Listing
June 2019

Salvage of severe primary graft dysfunction following heart transplantation using extracorporeal life support.

Proc (Bayl Univ Med Cent) 2018 10 18;31(4):482-486. Epub 2018 Oct 18.

Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott & White Research InstituteDallasTexas.

Primary graft dysfunction (PGD) is the leading cause of early mortality after heart transplantation. Typically, mechanical circulatory support is necessary to provide hemodynamic support and to enable graft recovery. However, both the reported incidence of PGD and the reported salvage rates with extracorporeal membrane oxygenation (ECMO) vary widely. This may partly be due to variations in the definition of PGD and its levels of severity. We analyzed a prospectively maintained database of 255 transplant recipients at our institution to determine the effectiveness of ECMO support in those who develop severe PGD as defined by the International Society for Heart and Lung Transplantation consensus guidelines. Nineteen (7.5%) patients (aged 32-69 years) developed severe PGD and were treated with veno-arterial (VA) ECMO, which was initiated in the operating room at the time of transplant in most patients. The majority received VA ECMO through femoral cannulation. Two patients required veno-venous ECMO for respiratory support after VA ECMO separation. The 30-day in-hospital survival rate following transplantation was 63% ( = 12). In conclusion, ECMO proved to be a viable option for early hemodynamic support in patients with severe PGD and has become our preferred modality for mechanical circulatory support in these patients.
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http://dx.doi.org/10.1080/08998280.2018.1498724DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6413990PMC
October 2018

Percutaneous temporary circulatory support devices and their use as a bridge to decision during acute decompensation of advanced heart failure.

Proc (Bayl Univ Med Cent) 2018 Oct 27;31(4):453-456. Epub 2018 Aug 27.

Division of Cardiology, Department of Internal Medicine, Baylor University Medical CenterDallas Texas.

Temporary mechanical cardiac support (TMCS) devices intend to restore systemic perfusion and prevent further end-organ damage in patients with refractory cardiogenic shock until the insult is addressed. TMCS has been associated with reductions in hospital costs and in-hospital mortality. We review the four primary TMCS modalities available: intra-aortic balloon pump, TandemHeart, veno-arterial extracorporeal membrane oxygenation, and Impella pump. All have their own implantation technique and hemodynamic profile, and their use may therefore be tailored to the specific patient's needs. The appropriate TMCS may thus help stabilize the patient, enabling the care team to make decisions about durable support or transplantation.
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http://dx.doi.org/10.1080/08998280.2018.1470853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6413984PMC
October 2018

Cardiac catheterization and percutaneous intervention procedures on extracorporeal membrane oxygenation support.

Ann Cardiothorac Surg 2019 Jan;8(1):123-128

Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott & White Research Institute, Dallas, TX, USA.

Extracorporeal membrane oxygenation (ECMO) is used to support critically ill patients when conventional therapies have failed. ECMO has been available for four decades and has gained use as a rescue therapy in severe refractory hypoxic disorders and in patients with refractory cardiogenic shock (RCS). Over recent years, several percutaneous cardiac interventions and implant devices have been developed that are now used frequently in conjunction with ECMO in order to maintain organ perfusion. Here, we review the literature on VA-ECMO cannulation location, the use of VA-ECMO in interventions (e.g., coronary interventions and structural heart interventions) and percutaneous cardiac device implantation in VA-ECMO recipients with RCS.
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http://dx.doi.org/10.21037/acs.2018.11.08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6379180PMC
January 2019
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