Publications by authors named "Nisha A Gilotra"

52 Publications

The role of sex and inflammation in cardiovascular outcomes and mortality in COVID-19.

Int J Cardiol 2021 May 8. Epub 2021 May 8.

Division of Cardiology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address:

Objective: Higher mortality in COVID-19 in men compared to women is recognized, but sex differences in cardiovascular events are less well established. We aimed to determine the independent contribution of sex to stroke, myocardial infarction and death in the setting of COVID-19 infection.

Methods: We performed a retrospective cohort study of hospitalized COVID-19 patients in a racially/ethnically diverse population. Clinical features, laboratory markers and clinical events were initially abstracted from medical records, with subsequent clinician adjudication.

Results: Of 2060 patients, myocardial injury (32% vs 23%, p = 0.019), acute myocardial infarction (2.7% vs 1.6%, p = 0.114), and ischemic stroke (1.8% vs 0.7%, p = 0.007) were more common in men vs women. In-hospital death occurred in 160 men (15%) vs 117 women (12%, p = 0.091). Men had higher odds of myocardial injury (odds ratio (OR) 2.04 [95% CI 1.43-2.91], p < 0.001), myocardial infarction (1.72 [95% CI 0.93-3.20], p = 0.085) and ischemic stroke (2.76 [95% CI 1.29-5.92], p = 0.009). Despite adjustment for demographics and cardiovascular risk factors, male sex predicted mortality (HR 1.33; 95% CI:1.01-1.74; p = 0.041). While men had significantly higher markers of inflammation, in sex-stratified analyses, increase in interleukin-6, C-reactive protein, ferritin and d-dimer were predictive of mortality and myocardial injury similarly in both sexes.

Conclusions: Adjusted odds of myocardial injury, ischemic stroke and all-cause mortality, but not myocardial infarction, are significantly higher in men compared to women with COVID-19. Higher inflammatory markers are present in men but associated similarly with risk in both men and women. These data suggest that adverse cardiovascular outcomes in men vs. women are independent of cardiovascular comorbidities.
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http://dx.doi.org/10.1016/j.ijcard.2021.05.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8106202PMC
May 2021

Response to letter to the editor: "Ambulatory management of cardiac amyloidosis".

Am Heart J 2021 Jun;236:103

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.

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http://dx.doi.org/10.1016/j.ahj.2021.02.022DOI Listing
June 2021

Angiotensin Receptor-Neprilysin Inhibition Improves Blood Pressure and Heart Failure Control in Left Ventricular Assist Device Patients.

ASAIO J 2021 Apr 19. Epub 2021 Apr 19.

From the Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland Division of Cardiothoracic Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Angiotensin receptor-neprilysin inhibitors (ARNIs) greatly benefit functional capacity and longevity in heart failure with reduced ejection fraction (HFrEF). Angiotensin receptor-neprilysin inhibitors remain underutilized and unstudied, however, in left ventricular assist device (LVAD) recipients, in spite of their underlying HFrEF. In this case series, we studied the feasibility and short-term efficacy of ARNI utilization in 21 LVAD patients. Angiotensin receptor-neprilysin inhibitor initiation was successful in most, resulting in significant consolidation of blood pressure (BP) medical management and marked improvements in both functional capacity and diuretic requirements. Angiotensin receptor-neprilysin inhibitors are safe, feasible, and within a short timeframe benefit BP and heart failure control in LVAD recipients.
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http://dx.doi.org/10.1097/MAT.0000000000001435DOI Listing
April 2021

Anomalous Origin of the Right Coronary Artery Causing Myocardial Ischemia: A Case for a Multimodality Imaging Approach.

Case Rep Cardiol 2021 19;2021:6686227. Epub 2021 Mar 19.

Division of Cardiology, Department of Medicine, Johns Hopkins Hospital, Baltimore, MD, USA.

A 46-year-old man was admitted with non-ST elevation myocardial infarction and newly diagnosed acutely decompensated heart failure. Echocardiogram demonstrated left ventricular ejection fraction of 30% with basal inferior and inferolateral akinesis. Coronary angiography showed mild diffuse coronary artery disease and an anomalous right coronary artery arising from the left coronary cusp. Further imaging was consistent with ischemia in the right coronary distribution. Etiology of ischemia was thought to be the anomalous right coronary artery, and surgical unroofing of the right coronary ostium was performed. Here, we report a multimodality imaging approach, including cardiac magnetic resonance, cardiac computed tomographic angiography, and single-photon emission computed tomography, to support the diagnosis and management of a patient with anomalous right coronary artery arising from the left coronary cusp.
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http://dx.doi.org/10.1155/2021/6686227DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8004557PMC
March 2021

Multimodality Imaging for Cardiac Evaluation in Patients with COVID-19.

Curr Cardiol Rep 2021 03 15;23(5):44. Epub 2021 Mar 15.

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Carnegie 568, Baltimore, MD, 21287, USA.

Purpose Of Review: A growing number of cardiovascular manifestations resulting from the novel SARS-CoV-2 coronavirus (COVID-19) have been described since the beginning of this global pandemic. Acute myocardial injury is common in this population and is associated with higher rates of morbidity and mortality. The focus of this review centers on the recent applications of multimodality imaging in the diagnosis and management of COVID-19-related cardiovascular conditions.

Recent Findings: In addition to standard cardiac imaging techniques such as transthoracic echocardiography, other modalities including computed tomography and cardiac magnetic resonance imaging have emerged as useful adjuncts in select patients with COVID-19 infection, particularly those with suspected ischemic and nonischemic myocardial injury. Data have also emerged suggesting lasting COVID-19 subclinical cardiac effects, which may have long-term prognostic implications. With the spectrum of COVID-19 cardiovascular manifestations observed thus far, it is important for clinicians to recognize the role, strengths, and limitations of multimodality imaging techniques in this patient population.
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http://dx.doi.org/10.1007/s11886-021-01483-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957471PMC
March 2021

Clozapine-Associated Myocarditis: A Protocol for Monitoring Upon Clozapine Initiation and Recommendations for How to Conduct a Clozapine Rechallenge.

J Clin Psychopharmacol 2021 Mar-Apr 01;41(2):180-185

Department of Psychiatry.

Background: Clozapine is the only medication with Food and Drug Administration approval for treatment-resistant schizophrenia. However, it is underutilized in the United States because of several life-threatening adverse effects, including clozapine-associated myocarditis (CAM), and a limited understanding of how to manage these complications. To date, recommendations for rechallenging patients with CAM that incorporate the cardiac literature or cardioprotective medications have not been developed.

Findings: In this article, we outline a protocol developed with cardiologists and guided by the cardiac literature that provides direction on how to monitor for the initial development of CAM and how to rechallenge patients with CAM. Furthermore, we present 2 successful cases of clozapine rechallenge that were managed using this protocol.

Conclusions: In both cases, the patients showed marked improvement in their psychiatric symptoms and functioning, demonstrating the importance of considering rechallenge in patients after CAM.
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http://dx.doi.org/10.1097/JCP.0000000000001358DOI Listing
February 2021

Decreased Nutritional Risk Index is associated with mortality after heart transplantation.

Clin Transplant 2021 May 25;35(5):e14253. Epub 2021 Feb 25.

Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Introduction: Validated scoring tools, such as the Nutritional Risk Index (NRI), can aid clinicians in quantifying the degree of malnourishment in patients prior to an operation. We evaluated the association between NRI and outcomes after heart transplantation.

Methods: The United Network for Organ Sharing (UNOS) database was used to identify adult patients (age > 18) undergoing heart transplantation between 1987 and 2016. NRI was calculated and categorized into previously established groupings representing severity of malnutrition. Multivariate Cox proportional hazards modeling were used to assess the primary outcome of all-cause mortality.

Results: A total of 25,236 patients were included in the analysis. Most patients (75.4%) were male. Malnourishment was absent (NRI ≥ 100) in 11,022 (44%) patients, while 2,898 (12%) were mildly malnourished (97.5 ≤ NRI < 100), 8,685 (34%) were moderately malnourished (83.5 ≤ NRI < 97.5), and 2,631 (10%) were severely malnourished (NRI < 83.5). Moderate-to-severe malnutrition was associated with increased mortality (HR = 1.18, p < .001, 95%CI: 1.13-1.24), and post-transplant renal failure requiring dialysis (OR: 1.13, p < .001, 95%CI: 1.03-1.23).

Conclusion: Malnourishment determined by NRI is independently associated with mortality and post-transplant dialysis after heart transplant. This is the largest study of NRI in heart transplant recipients.
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http://dx.doi.org/10.1111/ctr.14253DOI Listing
May 2021

Less invasive surgical implant strategy and right heart failure after LVAD implantation.

J Heart Lung Transplant 2021 Apr 12;40(4):289-297. Epub 2021 Jan 12.

Medical University of South Carolina, Charleston, South Carolina. Electronic address:

Background: Conventional median sternotomy (CMS) is still the standard technique utilized to implant left ventricular assist devices (LVADs). Recent studies suggest that less invasive surgery (LIS) may be beneficial; however, robust data on differences in right heart failure (RHF) are lacking. This study aimed to determine the impact of LIS compared with that of CMS on RHF outcomes after LVAD implantation.

Methods: An international multicenter retrospective cohort study was conducted across 5 centers. Patients were grouped according to their implantation technique (LIS vs CMS). Only centrifugal devices were included. RHF was defined as severe or severe acute RHF according to the 2013 Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. Logistic multivariate regression and propensity score‒matched analyses were performed to account for confounding.

Results: Overall, 427 implantations occurred during the study period, with 305 patients implanted using CMS and 122 using LIS. Pre-operative extracorporeal membrane oxygenation (ECMO) and intra-aortic balloon pump (IABP) use was more common in the CMS group; off-pump implantation was more common in the LIS group. Other pre-implant variables, including age, creatinine, hemodynamics, and tricuspid regurgitation, did not differ between the 2 groups. Post-operative RHF was less common in the patients who underwent LIS than in those who underwent CMS as was post-operative right ventricular assist device (RVAD) use. LIS remained associated with less RHF in the multivariate analysis. After propensity score matching conditional for age, sex, INTERMACS profile, ECMO, and IABP use in a ratio of 2:1 (CMS to LIS), RHF (29.9% vs 18.6%, p = 0.001) and the need for post-operative RVAD (18.6% vs 8.2%; p = 0.009) remained more common in the CMS group than in the LIS group. There were no significant differences in survival up to 1 year between the groups.

Conclusions: LIS may be associated with less RHF after LVAD implantation compared with CMS. Despite the possible reduction in RHF, there was no difference in 1-year survival. LIS is an alternative to traditional CMS.
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http://dx.doi.org/10.1016/j.healun.2021.01.005DOI Listing
April 2021

Arrhythmogenic Right Ventricular Cardiomyopathy Presenting as Clinical Myocarditis in Women.

Am J Cardiol 2021 04 15;145:128-134. Epub 2021 Jan 15.

Division of Cardiology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland. Electronic address:

Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) classically initially present with ventricular arrhythmias or, less commonly, heart failure. Myocardial inflammation has been implicated in pathogenesis, but clinical myocarditis in ARVC is less described. We therefore studied clinical myocarditis as an initial ARVC presentation, and hypothesized that these patients have distinct clinical and genetic characteristics. Using the Johns Hopkins ARVC Registry, we identified 12 patients (all female, median age 20) referred between 2014 and 2019 diagnosed with myocarditis at presentation who were subsequently diagnosed with ARVC by Task Force Criteria. Majority presented with chest pain (n = 7, 58%) or ventricular arrhythmia (n = 3, 25%). All patients had troponin elevations and left ventricular (LV) function was reduced in 5 (42%). Magnetic resonance imaging demonstrated LV delayed gadolinium enhancement and/or pericardial enhancement in 10 (83%); only 3 (25%) patients had right ventricular abnormalities. Pathogenic genetic variants were identified in 11 (92%) patients: 10 desmoplakin (DSP) and 1 desmoglein-2 (DSG2). Thus, nearly 1/3 (10/32, 31%) of overall DSP ARVC patients were originally diagnosed with myocarditis. Patients were diagnosed with ARVC 1.8 years (IQR 2.7 years) after presentation and 8 (75%) patients did not meet Task Force Criteria without genetic testing. ARVC diagnosis led to an additional 5 (42%) patients referred for implantable cardiac defibrillator and 17 family member diagnoses. In conclusion, ARVC may initially present as myocarditis and these patients have distinct characteristics including female gender, LV involvement and DSP gene variants. Genetic testing is key to ARVC diagnosis and should be considered in select myocarditis patients.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.090DOI Listing
April 2021

Management of heart failure in cardiac amyloidosis using an ambulatory diuresis clinic.

Am Heart J 2021 03 22;233:122-131. Epub 2020 Dec 22.

Division of Cardiology, Department of Medicine, Johns Hopkins Hospital, Baltimore, MD. Electronic address:

Background: Recurrent congestion in cardiac amyloidosis (CA) remains a management challenge, often requiring high dose diuretics and frequent hospitalizations. Innovative outpatient strategies are needed to effectively manage heart failure (HF) in patients with CA. Ambulatory diuresis has not been well studied in restrictive cardiomyopathy. Therefore, we aimed to examine the outcomes of an ambulatory diuresis clinic in the management of congestion related to CA.

Methods And Results: We retrospectively studied patients with CA seen in an outpatient HF disease management clinic for (1) safety outcomes of ambulatory intravenous (IV) diuresis and (2) health care utilization. Forty-four patients with CA were seen in the clinic a total of 203 times over 6 months. Oral diuretics were titrated at 96 (47%) visits. IV diuretics were administered at 56 (28%) visits to 17 patients. There were no episodes of severe acute kidney injury or symptomatic hypotension. There was a significant decrease in emergency department and inpatient visits and associated charges after index visit to the clinic. The proportion of days hospitalized per 1000 patient days of follow-up decreased as early as 30 days (147.3 vs 18.1/1000 patient days of follow-up, P< .001) and persisted through 180 days (33.6 vs 22.9/1000 patient days of follow-up, P< .001) pre- vs post-index visit to the clinic.

Conclusions: We demonstrate the feasibility of ambulatory IV diuresis in patients with CA. Our findings also suggest that use of a HF disease management clinic may reduce acute care utilization in patients with CA. Leveraging multidisciplinary outpatient HF clinics may be an effective alternative to hospitalization in patients with HF due to CA, a population who otherwise carries a poor prognosis and contributes to high health care burden.
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http://dx.doi.org/10.1016/j.ahj.2020.12.009DOI Listing
March 2021

Prevalence and Clinical Correlates of Echo-Estimated Right and Left Heart Filling Pressures in Hospitalized Patients With Coronavirus Disease 2019.

Crit Care Explor 2020 Oct 30;2(10):e0227. Epub 2020 Sep 30.

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.

Objectives: The prevalence of elevated right and left heart filling pressures in coronavirus disease 2019 is not well characterized. We aimed to characterize the prevalence of pulmonary hypertension and concurrent elevated left heart filling pressure in hospitalized patients with coronavirus disease 2019. We hypothesized that a significant proportion of coronavirus disease 2019 patients has evidence of pulmonary hypertension associated with elevated left heart filling pressure on transthoracic echocardiography.

Design: Retrospective cohort study.

Setting: Academic tertiary-care center.

Patients: Hospitalized coronavirus disease 2019 patients who underwent clinical transthoracic echocardiography.

Interventions: None.

Measurements And Main Results: The exposure variable of interest was right ventricular systolic pressure, calculated using the American Society of Echocardiography guidelines. Pulmonary hypertension was defined as right ventricular systolic pressure greater than 40 mm Hg. Left heart filling pressure was estimated with Nagueh's method for pulmonary artery occlusion pressure using E/e' ratio, and normal was considered pulmonary artery occlusion pressure less than 16 mm Hg. Clinical characteristics and outcomes were compared between the patients with and without pulmonary hypertension. A total of 73 patients (median age 66 yr [57-75 yr]; 46% women) were included. Median right ventricular systolic pressure was 39 mm Hg (interquartile range, 32-50 mm Hg), and 36 patients (49.3%) had evidence of pulmonary hypertension. Patients with pulmonary hypertension were more likely to require ICU admission (86% vs 65%; = 0.035) and have acute respiratory distress syndrome (72% vs 49%; = 0.0053) than those without. In-hospital mortality was 26% for those with pulmonary hypertension compared with 14% for those without ( = 0.19). Patients with pulmonary hypertension had higher median-estimated pulmonary artery occlusion pressure (17.4 mm Hg [12.7-21.3 mm Hg] vs 12.1 mm Hg [10.0-14.1 mm Hg]; = 0.0008), and elevated left heart filling pressure was present in 59% of those with pulmonary hypertension.

Conclusions: Pulmonary hypertension is common in hospitalized patients with coronavirus disease 2019 and is associated with poor clinical outcomes. Left ventricular filling pressure is elevated in over half of those with pulmonary hypertension and may represent a target to reduce right ventricular afterload and potentially improve outcomes in coronavirus disease 2019.
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http://dx.doi.org/10.1097/CCE.0000000000000227DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531757PMC
October 2020

Prominent Longitudinal Strain Reduction of Basal Left Ventricular Segments in Patients With Coronavirus Disease-19.

J Card Fail 2021 01 28;27(1):100-104. Epub 2020 Sep 28.

Division of Cardiology, Department of Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland. Electronic address:

Background: Coronavirus disease-19 (COVID-19) has been associated with overt and subclinical myocardial dysfunction. We observed a recurring pattern of reduced basal left ventricular (LV) longitudinal strain on speckle-tracking echocardiography in hospitalized patients with COVID-19 and subsequently aimed to identify characteristics of affected patients. We hypothesized that patients with COVID-19 with reduced basal LV strain would demonstrate elevated cardiac biomarkers.

Methods And Result: Eighty-one consecutive patients with COVID-19 underwent speckle-tracking echocardiography. Those with poor quality speckle-tracking echocardiography (n = 2) or a known LV ejection fraction of <50% (n = 4) were excluded. Patients with an absolute value basal longitudinal strain of <13.9% (2 standard deviations below normal) were designated as cases (n = 39); those with a basal longitudinal strain of ≥13.9% were designated as controls (n = 36). Demographics and clinical variables were compared. Of 75 included patients (mean age 62 ± 14 years, 41% women), 52% had reduced basal strain. Cases had higher body mass index (median 34.1; interquartile range 26.5-37.9 kg/m vs median 26.9, interquartile range, 24.8-30.0 kg/m, P = .009), and greater proportions of Black (74% vs 36%, P = .0009), hypertensive (79% vs 56%, P = .026), and diabetic patients (44% vs 19%, P = .025) compared with controls. Troponin and N-terminal pro-brain natriuretic peptide levels trended higher in cases, but were not significantly different.

Conclusions: Reduced basal LV strain is common in patients with COVID-19. Patients with hypertension, diabetes, obesity, and Black race were more likely to have reduced basal strain. Further investigation into the significance of this strain pattern is warranted.
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http://dx.doi.org/10.1016/j.cardfail.2020.09.469DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521413PMC
January 2021

Utility of Cardiac Magnetic Resonance Imaging Versus Cardiac Positron Emission Tomography for Risk Stratification for Ventricular Arrhythmias in Patients With Cardiac Sarcoidosis.

Am J Cardiol 2020 11 15;134:123-129. Epub 2020 Aug 15.

Division of Cardiology, Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland. Electronic address:

Abnormalities on cardiac magnetic resonance imaging (CMR) and positron emission tomography (PET) predict ventricular arrhythmias (VA) in patients with cardiac sarcoidosis (CS). Little is known whether concurrent abnormalities on CMR and PET increases the risk of developing VA. Our aim was to compare the additive utility of CMR and PET in predicting VA in patients with CS. We included all patients treated at our institution from 2000 to 2018 who (1) had probable or definite CS and (2) had undergone both CMR and PET. The primary endpoint was VA at follow up, which was defined as sustained ventricular tachycardia, sudden cardiac death, or any appropriate device tachytherapy. Fifty patients were included, 88% of whom had a left ventricular ejection fraction >35%. During a mean follow-up 4.1 years, 7/50 (14%) patients had VA. The negative predictive value of LGE for VA was 100% and the negative predictive value of FDG for VA was 79%. Among groups, VA occurred in 4/21 (19%) subjects in the LGE+/FDG+ group, 3/14 (21%) in the LGE+/FDG- group, and 0/15 (0%) in the FDG+/LGE- group. There were no LGE-/FDG- patients. In conclusion, CMR may be the preferred initial clinical risk stratification tool in patients with CS. FDG uptake without LGE on initial imaging may not add additional prognostic information regarding VA risk.
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http://dx.doi.org/10.1016/j.amjcard.2020.08.007DOI Listing
November 2020

Clinical and Imaging Response to Tumor Necrosis Factor Alpha Inhibitors in Treatment of Cardiac Sarcoidosis: A Multicenter Experience.

J Card Fail 2021 Jan 2;27(1):83-91. Epub 2020 Sep 2.

Medstar Heart and Vascular Institute, Washington, DC.

Background: Cardiac sarcoidosis (CS) is an increasingly recognized cause of cardiomyopathy; however, data on immunosuppressive strategies are limited. Treatment with tumor necrosis factor (TNF) alpha inhibitors is not well described; moreover, there may be heart failure-related safety concerns.

Methods: Retrospective multicenter study of patients with CS treated with TNF alpha inhibitors. Baseline characteristics, treatments, and outcomes were adjudicated.

Results: Thirty-eight patients with CS (mean age 49.9 years, 42% women, 53% African American) were treated with TNF alpha inhibitor (30 infliximab, 8 adalimumab). Prednisone dose decreased from time of TNF alpha inhibitor initiation (21.7 ± 17.5 mg) to 6 months (10.4 ± 6.1 mg, P = .001) and 12 months (7.3 ± 7.3 mg, P = .002) after treatment. On pre-TNF alpha inhibitor treatment positron emission tomography with 18-flourodoxyglucose (FDG-PET), 84% of patients had cardiac FDG uptake. After treatment, there was a significant decrease in number of segments involved (3.5 ± 3.8 to 1.0 ± 2.5, P = .008) and maximum standardized uptake value (3.59 ± 3.70 to 0.57 ± 1.60, P = .0005), with 73% of patients demonstrating complete resolution or improvement of cardiac FDG uptake. The left ventricular ejection fraction remained stable (45.0 ± 16.5% to 47.0 ± 15.0%, P = .10). Four patients required inpatient heart failure treatment, and 8 had infections; 2 required treatment cessation.

Conclusions: TNF alpha inhibitor treatment guided by FDG-PET imaging may minimize corticosteroid use and effectively reduce cardiac inflammation without significant adverse effect on cardiac function. However, infections were common, some of which were serious, and therefore patients require close monitoring for both infection and cardiac symptoms.
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http://dx.doi.org/10.1016/j.cardfail.2020.08.013DOI Listing
January 2021

Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.

JACC Heart Fail 2020 10 10;8(10):789-799. Epub 2020 Jun 10.

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).
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http://dx.doi.org/10.1016/j.jchf.2020.05.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7286640PMC
October 2020

In Full Flow: Left Ventricular Assist Device Infections in the Modern Era.

Open Forum Infect Dis 2020 May 17;7(5):ofaa124. Epub 2020 Apr 17.

Department of Medicine - Cardiology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.

With the rising prevalence of heart disease in the United States, there is increasing reliance on durable mechanical circulatory support (MCS) to treat patients with end-stage heart failure. Left ventricular assist devices (LVADs), the most common form of durable MCS, are implanted mechanical pumps that connect to an external power source through a transcutaneous driveline. First-generation LVADs were bulky, pulsatile pumps that were frequently complicated by infection. Second-generation LVADs have an improved design, though infection remains a common and serious complication due to the inherent nature of implanted MCS. Infections can affect any component of the LVAD, with driveline infections being the most common. LVAD infections carry significant morbidity and mortality for LVAD patients. Therefore, it is paramount for the multidisciplinary team of clinicians caring for these patients to be familiar with this complication. We review the epidemiology, prevention, diagnosis, treatment, and outcomes of LVAD infections.
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http://dx.doi.org/10.1093/ofid/ofaa124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7209633PMC
May 2020

Right Ventricular Strain Predicts Structural Disease Progression in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy.

J Am Heart Assoc 2020 04 3;9(7):e015016. Epub 2020 Apr 3.

Johns Hopkins University Baltimore MD.

Background Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited condition associated with ventricular arrhythmias and myocardial dysfunction; however, limited data exist on identifying patients at highest risk. The purpose of the study was to determine whether measures of right ventricular (RV) dysfunction on echocardiogram including RV strain were predictive of structural disease progression in ARVC. Methods and Results A retrospective analysis of serial echocardiograms from 40 patients fulfilling 2010 task force criteria for ARVC was performed to assess structural progression defined by an increase in proximal RV outflow tract dimensions (parasternal short or long axis) or decrease in RV fractional area change. Echocardiograms were analyzed for RV free-wall peak longitudinal systolic strain using 2-dimensional speckle tracking. Risk of structural progression and 5-year change in RV outflow tract measurements were compared with baseline RV strain. Of the 40 ARVC patients, 61% had structural progression with an increase in the mean parasternal short-axis RV outflow tract dimension from 36.2 to 38.5 mm (=0.022) and 68% by increase in parasternal long-axis RV outflow tract dimension from 36.1 to 39.2 mm (=0.001). RV fractional area change remained stable over time. Baseline RV strain was significantly associated with the risk of structural progression and 5-year rate of change. Patients with an RV strain more positive than -20% had a higher risk (odds ratio: 18.4; 95% CI, 2.7-125.8; =0.003) of structural progression. Conclusions RV free wall strain is associated with the rate of structural progression in patients with ARVC. It may be a useful marker in determining which patients require closer follow-up and treatment.
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http://dx.doi.org/10.1161/JAHA.119.015016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428652PMC
April 2020

Safety and Utility of Cardiopulmonary Exercise Testing in Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia.

J Am Heart Assoc 2020 02 3;9(3):e013695. Epub 2020 Feb 3.

Division of Cardiology Department of Medicine The Johns Hopkins Hospital Baltimore MD.

Background Arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D) is characterized by high arrhythmic burden and progressive heart failure, which can prompt referral for heart transplantation. Cardiopulmonary exercise testing (CPET) has an established role in risk stratification for advanced heart failure therapies, but has not been described in ARVC/D. This study sought to determine the safety and prognostic utility of CPET in patients with ARVC/D. Methods and Results Using the Johns Hopkins ARVC/D Registry, we examined patients with ARVC/D undergoing CPET. Baseline characteristics and transplant-free survival were compared on the basis of peak oxygen consumption (pVO2) (≤14 or >14 mL/kg per minute) and ventilatory efficiency (Ve/VCO slope ≤34 or >34). Thirty-eight patients underwent 50 CPETs. There were no sustained arrhythmic events. Twenty-nine patients achieved a maximal test. Patients with pVO2 ≤14 mL/kg per minute were more often men (=0.042) compared with patients with pVO2 >14 mL/kg per minute. Patients with Ve/VCO slope >34 tended to have more moderate/severe right ventricular dilation (7/9 [78%] versus 10/26 [38%]; =0.060) and clinical heart failure (8/9 [89%] versus 13/26 [50%]; =0.056) compared with patients with Ve/VCO slope ≤34. Patients who underwent heart transplantation were more likely to have clinical heart failure (10/10 [100%] versus 13/28 [46%]; =0.003). Patients with Ve/VCO slope >34 had worse transplant-free survival compared with patients with Ve/VCO slope ≤34 (n=35; hazard ratio, 6.57 [95% CI, 1.28-33.72]; log-rank =0.010), whereas transplant-free survival was similar on the basis of pVO2 groups (n=29; hazard ratio, 3.38 [95% CI, 0.75-15.19]; log-rank =0.092). Conclusions CPET is safe to perform in patients with ARVC/D. Ve/VCO slope may be used for risk stratification and guide referral for heart transplantation in ARVC/D.
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http://dx.doi.org/10.1161/JAHA.119.013695DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033873PMC
February 2020

Usefulness of Noninvasively Measured Pulse Amplitude Changes During the Valsalva Maneuver to Identify Hospitalized Heart Failure Patients at Risk of 30-Day Heart Failure Events (from the PRESSURE-HF Study).

Am J Cardiol 2020 03 27;125(6):916-923. Epub 2019 Dec 27.

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.

The pulse amplitude ratio (PAR), the ratio of pulse pressure at the end of the Valsalva maneuver to before the onset, correlates with cardiac filling pressure. We have developed a handheld device that uses finger photoplethysmography to measure PAR and estimate left ventricular end diastolic pressure (LVEDP). Patients hospitalized with heart failure (HF) performed three 10-second trials of a standardized Valsalva maneuver (at 20 mm Hg measured via pressure transducer), while photoplethysmography waveforms were recorded, at admission and discharge. Combined primary outcome was 30-day HF hospitalization, intravenous diuresis, or death. Fifty-two subjects had discharge PAR testing; 12 met the primary outcome. Median PAR on admission was 0.55 (interquartile range: 0.40 to 0.70, n = 48) and on discharge was 0.50 (interquartile range: 0.36 to 0.69). Mean PAR-estimated LVEDP was significantly higher in subjects that had an event (20.2 vs 16.9 mm Hg, p = 0.043). Subjects with PAR-estimated LVEDP >19.5 mm Hg had an event rate hazard ratio of 4.57 (95% confidence interval 1.37, 15.19, p = 0.013) compared with patients with LVEDP 19.5 mm Hg or below, with significantly lower 30-day event-free survival (log-rank p = 0.006). In conclusion, noninvasively estimated LVEDP using the pulse amplitude response to a Valsalva maneuver in patients hospitalized for HF changes with diuresis and identifies patients at high risk for 30-day HF events. Detection of elevated filling pressures before hospital discharge may be useful in guiding HF management to reduce HF events.
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http://dx.doi.org/10.1016/j.amjcard.2019.12.027DOI Listing
March 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

INTERMACS profiles and outcomes of ambulatory advanced heart failure patients: A report from the REVIVAL Registry.

J Heart Lung Transplant 2020 01 28;39(1):16-26. Epub 2019 Aug 28.

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

Background: Ambulatory patients with advanced heart failure (HF) are often considered for advanced therapies, including durable mechanical circulatory support (MCS). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are a commonly used descriptor of disease severity in patients receiving MCS devices, but their role in defining the prognosis of ambulatory patients is less well established, especially for Profiles 6 and 7.

Methods: Registry Evaluation of Vital Information on Ventricular Assist Devices in Ambulatory Life is a prospective observational study of 400 outpatients from 21 MCS and cardiac transplant centers. Eligible patients had New York Heart Association Class II to IV symptoms despite optimal medical and electrical therapies with a recent HF hospitalization, heart transplant listing, or evidence of high neurohormonal activation.

Results: The cohort included 33 INTERMACS Profile 4 (8%), 83 Profile 5 (21%), 155 Profile 6 (39%), and 129 Profile 7 (32%). Across INTERMACS profiles, there were no differences in age, gender, ejection fraction, blood pressure, or use of guideline-directed medical therapy. A lower INTERMACS profile was associated with more hospitalizations, greater frailty, and more impaired functional capacity and quality of life. The composite end point of death, durable MCS, or urgent transplant at 12 months occurred in 39%, 27%, 24%, and 14% subjects with INTERMACS Profiles 4, 5, 6, and 7, respectively (p = 0.004).

Conclusions: Among ambulatory patients with advanced HF, a lower INTERMACS profile was associated with a greater burden of HF across multiple dimensions and a higher composite risk of durable MCS, urgent transplant, or death. These profiles may assist in risk assessment and triaging ambulatory patients to advanced therapies.
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http://dx.doi.org/10.1016/j.healun.2019.08.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942215PMC
January 2020

Impact of the New Pulmonary Hypertension Definition on Heart Transplant Outcomes: Expanding the Hemodynamic Risk Profile.

Chest 2020 01 22;157(1):151-161. Epub 2019 Aug 22.

Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, SC. Electronic address:

Background: At the recent 6th World Symposium on Pulmonary Hypertension (PH), the definition of PH was redefined to include lower pulmonary artery pressures in the setting of elevated pulmonary vascular resistance (PVR). However, the relevance of this change to subjects with PH due to left-heart disease as well as the preoperative assessment of heart transplant (HT) recipients is unknown.

Methods: The United Network for Organ Sharing database was queried to identify adult recipients who underwent primary HT from 1996 to 2015. Recipients were subdivided into those with mean pulmonary artery pressure (mPAP) < 25 mm Hg and ≥ 25 mm Hg. Exploratory univariable analysis was undertaken to identify candidate risk factors associated with 30-day and 1-year survival (conditional on 30-day survival) in recipients with mPAP < 25 mm Hg, and subsequently, parsimonious multivariable Cox proportional hazards models were constructed to assess the independent association with PVR.

Results: Over the study period, 32,465 patients underwent HT, including 12,257 (38%) with mPAP < 25 mm Hg. The median age was 55 years (interquartile range, 47-62) and the median PVR was 1.5 Wood units (WU) (interquartile range, 1-2.2) in recipients with mPAP < 25 mm Hg. After controlling for confounders, PVR was independently associated with increased risk for 30-day mortality (hazard ratio, 1.16; 95% CI, 1.05-1.27; P < .01), but not conditional 1-year mortality (hazard ratio, 1.03; 95% CI, 0.94-1.12; P = .55). PVR ≥ 3 WU was associated with an absolute 1.9% increase in 30-day mortality in those with mPAP < 25 mm Hg, a similar risk to recipients with PVR ≥ 3 WU and mPAP ≥ 25 mm Hg.

Conclusions: Elevated PVR remains associated with a significant increase in the hazard for 30-day mortality after cardiac transplantation, even in the setting of lower pulmonary artery pressures. These data support the validity of the new definition of pulmonary hypertension.
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http://dx.doi.org/10.1016/j.chest.2019.07.028DOI Listing
January 2020

Pulmonary Arterial Elastance and INTERMACS-Defined Right Heart Failure Following Left Ventricular Assist Device.

Circ Heart Fail 2019 08 12;12(8):e005923. Epub 2019 Aug 12.

Division of Cardiology, Department of Medicine (B.T., B.R., M.L.C., A.B.V.B., B.A.H., R.J.T.), Medical University of South Carolina, Charleston.

Background: Acute right heart failure (RHF) after left ventricular assist device implantation remains a major source of morbidity and mortality, yet the definition of RHF and the preimplant variables that predict RHF remain controversial. This study evaluated the ability of (1) INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) RHF classification to predict post-left ventricular assist device survival and (2) preoperative characteristics and hemodynamic parameters to predict severe and severe acute RHF.

Methods And Results: An international, multicenter study at 4 large academic centers was conducted between 2008 and 2016. All subjects with hemodynamics measured by right heart catheterization within 30 days before left ventricular assist device implantation were included. RHF was defined using the INTERMACS definition for RHF. In total, 375 subjects were included (mean age, 57.4±13.2 years, 54% bridge-to-transplant). Mild RHF was most common (34%), followed by moderate RHF (16%), severe RHF (13%), and severe acute RHF (9%). Estimated on-device survival rates at 2 years were 72%, 71%, and 55% in the patients with none, mild-to-moderate, and severe-to-severe acute RHF, respectively (P=0.004). In addition, the independent hazard ratio for mortality was only increased in the patients with severe-to-severe acute RHF (hazard ratio, 3.95; 95% CI, 2.16-7.23; P<0.001). INTERMACS-defined RHF was superior to postimplant inotrope duration alone in the prediction of all-cause mortality. In multivariable analysis, older age, lower INTERMACS classes, and higher pulmonary arterial elastance (ratio of systolic pulmonary artery pressure to stroke volume) before left ventricular assist device, were identified as significant predictors of severe-to-severe acute RHF. Stratifying patients by ratio of systolic pulmonary artery pressure to stroke volume and right atrial pressure significantly improved the discrimination between patients at risk for severe-to-severe acute RHF.

Conclusions: The INTERMACS RHF classification correctly identifies patients at risk for mortality, though this risk is only increased in patients with severe-to-severe acute RHF. Several predictors for RHF were identified, of which ratio of systolic pulmonary artery pressure to stroke volume was the strongest hemodynamic predictor. Coupling ratio of systolic pulmonary artery pressure to stroke volume with right atrial pressure may be most helpful in identifying patients at risk for severe-to-severe acute RHF.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.005923DOI Listing
August 2019

Regional abnormalities on cardiac magnetic resonance imaging and arrhythmic events in patients with cardiac sarcoidosis.

J Cardiovasc Electrophysiol 2019 10 1;30(10):1967-1976. Epub 2019 Aug 1.

Division of Cardiology, Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland.

Background: Patients with cardiac sarcoidosis (CS) may present with arrhythmic events (AE): atrioventricular block (AVB) and/ or ventricular arrhythmias (VA). We sought to: (a) use regional analysis of cardiac magnetic resonance imaging (CMR) to describe anatomic and functional phenotypes of patients with CS and AE; (b) Assess the association of regional CMR abnormalities with the combined endpoint of death, heart transplantation (HT) and AE; and (c) use machine learning (ML) to predict the combined endpoint based on CMR features.

Methods: we included 76 patients with CS and CMR. We analyzed cine images to determine regional longitudinal (LS) and radial strain (RS); and late gadolinium enhancement imaging to determine regional scar burden (%scar).

Results: Patients with AVB (n = 7), compared with those without, had higher %scar in the anterior (21.8 ± 27.4 vs 5.1 ± 8.9; P = 0.0005) and anteroseptal (19.3 ± 24.5 vs 3.5 ± 5.5; P < .0001) walls. Patients with VA (n = 12), compared with those without, had higher %scar in the basal inferoseptum (20.4 ± 30.8 vs 8.3 ± 13.4; P = .03). During mean follow-up of 4.4 ± 3.3 years, four patients died or underwent HT; eight had VA; and zero developed AVB. Multiple regional abnormalities were associated with the combined endpoint, including scar in the anteroseptal wall (HR 1.06 [1.02-1.09] per 1%scar increase, P = .002). The ML algorithm predicted the combined endpoint with a C-statistic of 0.91.

Conclusion: Regional CMR abnormalities are associated with AE in patients with CS.
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http://dx.doi.org/10.1111/jce.14082DOI Listing
October 2019

Cardiac sympathectomy for refractory ventricular arrhythmias in cardiac sarcoidosis.

Heart Rhythm 2019 09 25;16(9):1408-1413. Epub 2019 Feb 25.

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address:

Background: Ventricular arrhythmias (VAs) in cardiac sarcoidosis (CS) are frequently refractory to both antiarrhythmic drug (AAD) therapy and catheter ablation (CA). Cardiac sympathetic denervation (CSD) has been shown to reduce VA burden and implantable cardioverter-defibrillator (ICD) shocks in patients with nonischemic cardiomyopathy.

Objective: We aimed to report our center's preliminary experience with CSD in patients with known or presumed CS and refractory VAs.

Methods: Patients with CS and refractory VAs who underwent CSD at our institution were included. Patient characteristics, procedural outcomes, and number of arrhythmic events including ICD shocks pre- and post-CSD are reported.

Results: Five patients with CS (mean age 53 ± 11 years; 2 men [40%]; mean left ventricular ejection fraction 38% ± 11%) underwent CSD for VA refractory to AAD therapy and CA. Four of 5 patients underwent bilateral CSD; 1 patient underwent right-sided sympathectomy only because of poor intraoperative visualization on the left. Procedural complications included hemothorax in 1 patient and azygous vein injury in 1 patient. The median number of ICD shocks in the 6 months pre-CSD was 5. During a median follow-up of 26 months (range 5-29 months), the median number of ICD shocks post-CSD was 0; 1 patient had sustained VA that was below the threshold for device therapy, and 1 patient had symptomatic premature ventricular contractions; both underwent repeat CA. In addition, 1 patient required cardiac transplantation for progressive heart failure.

Conclusion: CSD may be a feasible therapeutic adjunct for patients with CS and VA refractory to AAD therapy and CA.
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http://dx.doi.org/10.1016/j.hrthm.2019.02.025DOI Listing
September 2019

A Contemporary Analysis of Heart Transplantation and Bridge-to-Transplant Mechanical Circulatory Support Outcomes in Cardiac Sarcoidosis.

J Card Fail 2018 Jun 1;24(6):384-391. Epub 2018 Mar 1.

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address:

Background: Patients with end-stage cardiomyopathy due to cardiac sarcoidosis (CS) may be referred for mechanical circulatory support (MCS) and heart transplantation (HT). We describe outcomes of patients with CS undergoing HT, focusing on the use of MCS as a bridge to transplant (BTT).

Methods: Using the United Network for Organ Sharing Scientific Registry of Transplant Recipients, we identified all adult waitlisted patients and isolated HT recipients from 2006 to 2015. These were divided into those with and without CS and further divided into those who did or did not receive MCS as BTT. Outcomes included 1- and 5-year post-transplantation freedom from mortality and 5-year freedom from primary graft failure.

Results: Over the study period, 31,528 patients were listed for HT, 148 (0.4%) of whom had CS. Among the CS patients, 34 (23%) received MCS as BTT. 18,348 patients (58%) eventually underwent HT, including 67 (0.4%) with CS, 20 (30%) of whom had received BTT MCS. Compared with non-CS diagnoses, CS patients had similar 1-year (91% vs 90%; log rank P = .88) and 5-year (83% vs 77%; log rank P = .46) freedom from mortality. Survival was also similar between CS BTT and non-CS BTT groups at 1 year (89% vs 89%; log-rank P = .92) and 5 years (72% vs 75%; log-rank P = .77).

Conclusions: Survivals after HT were similar between CS and non-CS patients out to 5 years, and were also similar between CS and non-CS BTT cohorts. Both HT and BTT MCS should be considered in patients with CS.
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http://dx.doi.org/10.1016/j.cardfail.2018.02.009DOI Listing
June 2018