Publications by authors named "Sandeep Jain"

266 Publications

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report: NIH cGVHD WG2a.

Transplant Cell Ther 2021 Apr 8. Epub 2021 Apr 8.

Division of Stem Cell Transplantation and Cellular Therapy, Dana-Farber Cancer Institute, Boston, MA, USA.

Recognition of the earliest signs and symptoms of chronic graft versus host disease (GVHD) that lead to severe manifestations remains a challenge. The standardization provided by the National Institutes of Health (NIH) 2005 and 2014 consensus projects have helped improve diagnostic accuracy and severity scoring for clinical trials, but utilization of these tools in routine clinical practice is variable. Additionally, when patients meet the NIH diagnostic criteria, many already have significant morbidity and possibly irreversible organ damage. The goals of this early diagnosis project are two fold. First, we provide consensus recommendations regarding implementation of the current NIH diagnostic guidelines into routine transplant care, outside of clinical trials, aiming to enhance early clinical recognition of chronic GVHD. Second, we propose directions for future research efforts to enable discovery of new, early laboratory as well as clinical indicators of chronic GVHD, both globally and for highly morbid organ-specific manifestations. Identification of early features of chronic GVHD that have high positive predictive value for progression to more severe manifestations of the disease could potentially allow for future pre-emptive clinical trials.
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http://dx.doi.org/10.1016/j.jtct.2021.03.033DOI Listing
April 2021

Outcomes of Direct Oral Anticoagulants in Atrial Fibrillation Patients Across Different Body Mass Index Categories.

JACC Clin Electrophysiol 2021 Mar 25. Epub 2021 Mar 25.

University of Pittsburgh Medical Center Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. Electronic address:

Objectives: This study sought to evaluate direct oral anticoagulant (DOAC) outcomes (vs. warfarin) in patients with atrial fibrillation (AF) across body mass index (BMI) categories, including ≥40 and <18.5 kg/m.

Background: Clinical trials have not systematically tested the fixed DOAC dosing in underweight and morbidly obese patients.

Methods: We retrospectively included consecutive patients with nonvalvular AF with CHADS-VASc (Congestive heart failure, Hypertension, Age ≥75, Diabetes, Stroke/transient ischemic attack/systemic thromboembolism, Vascular disease, Age 65-74, Sex) of ≥1 receiving OACs at our hospital system (2010-2018). Patients were categorized into groups 1 (underweight: BMI of <18.5 kg/m), 2 (normal/overweight: BMI of 18.5 to <30 kg/m), 3 (grade 1/2 obesity: BMI of 30 to <40 kg/m), and 4 (grade 3 obesity: BMI of ≥40 kg/m). We further classified patients by DOAC versus warfarin use. Outcomes were ischemic stroke, significant bleeding events (i.e., resulting in hospitalization), and mortality.

Results: We included 36,094 patients with a mean age of 74 ± 11 years and CHADS-VASc of 3.4 ± 1.5. Groups 1 through 4 included 455 (1.3%), 18,339 (50.8%), 13,376 (37.1%), and 3,924 (10.9%) patients, respectively. DOAC use ranged from 49% to 56%. At 3.8 follow-up years, with multivariable Cox regression, DOACs (vs. warfarin) were associated with lower risk of ischemic stroke, bleeding, and mortality across all BMI groups, with hazard ratios (HRs) (95% confidence intervals [CIs]) of 0.73 (0.63 to 0.85), 0.75 (0.64 to 0.87), 0.75 (0.65 to 0.88), and 0.75 (0.64 to 0.87) (p < 0.001 for all) for ischemic stroke; 0.42 (0.19 to 0.92), 0.41 (0.19 to 0.89), 0.45 (0.20 to 1.00), and 0.43 (0.20 to 0.94) (p < 0.05 for all) for bleeding; and 0.90 (0.68 to 1.19; p = 0.5), 0.70 (0.66 to 0.75; p < 0.0001), 0.65 (0.60-0.71; p < 0.0001), and 0.66 (0.56 to 0.77; p < 0.0001) for mortality, in groups 1 to 4, respectively.

Conclusions: In patients with nonvalvular AF, DOACs compared to warfarin were associated with better safety and effectiveness across all BMI categories, including underweight and morbidly obese patients.
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http://dx.doi.org/10.1016/j.jacep.2021.02.002DOI Listing
March 2021

Prevalence of Atrial Fibrillation and Thromboembolic Risk in Wild-Type Transthyretin Amyloid Cardiomyopathy.

Circulation 2021 Mar 29;143(13):1335-1337. Epub 2021 Mar 29.

Division of Cardiology, Department of Medicine, University of Pittsburgh, PA.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052136DOI Listing
March 2021

Entry receptor bias in evolutionarily distant HSV-1 clinical strains drives divergent ocular and nervous system pathologies.

Ocul Surf 2021 Mar 22. Epub 2021 Mar 22.

Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, 60612, USA; Department of Microbiology and Immunology, University of Illinois at Chicago, Chicago, IL, 60612, USA. Electronic address:

Purpose: Herpes simplex virus-1 (HSV-1) infection leads to varying pathologies including the development of ocular lesions, stromal keratitis and encephalitis. While the role for host immunity in disease progression is well understood, the contribution of genetic variances in generating preferential viral entry receptor usage and resulting immunopathogenesis in humans are not known.

Methods: Ocular cultures were obtained from patients presenting distinct pathologies of herpes simplex keratitis (HSK). Next-generation sequencing and subsequent analysis characterized genetic variances among the strains and estimated evolutionary divergence. Murine model of ocular infection was used to assess phenotypic contributions of strain variances on damage to the ocular surface and propagation of innate immunity. Flow cytometry of eye tissue identified differential recruitment of immune cell populations, cytokine array probed for programming of local immune response in the draining lymph node and histology was used to assess inflammation of the trigeminal ganglion (TG). Ex-vivo corneal cultures and in-vitro studies elucidated the role of genetic variances in altering host-pathogen interactions, leading to divergent host responses.

Results: Phylogenetic analysis of the clinical isolates suggests evolutionary divergence among currently circulating HSV-1 strains. Mutations causing alterations in functional host interactions were identified, particularly in viral entry glycoproteins which generated a receptor bias to herpesvirus entry mediator, an immune modulator involved in immunopathogenic diseases like HSK, leading to exacerbated ocular surface pathologies and heightened viral burden in the TG and brainstem.

Conclusions: Our data suggests receptor bias resulting from genetic variances in clinical strains may dictate disease severity and treatment outcome.
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http://dx.doi.org/10.1016/j.jtos.2021.03.005DOI Listing
March 2021

Inclusion of Orogastric Tube in the Staple Line During Laparoscopic Roux-en-Y Gastric Bypass: an Avoidable Complication.

Obes Surg 2021 Mar 10. Epub 2021 Mar 10.

Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar (East), New Delhi, 110029, India.

Purpose: Laparoscopic Roux-en-Y gastric bypass (LRYGB) involves creation of a small gastric pouch by sequential firing of stapler. During stapler firing, the orogastric tube (OGT) needs to be withdrawn to avoid inclusion in the staple line. We report a rare complication of inadvertent stapling of the OGT during creation of the gastric pouch.

Materials And Methods: A 37-year old man with body mass index (BMI) of 52.5 kg/m and type 2 diabetes mellitus, obstructive sleep apnoea, and gastro-oesophageal reflux disease, underwent LRYGB, with a biliopancreatic limb of 70 cm and an alimentary limb of 130 cm. Before firing the stapler for gastric pouch, the anaesthesia team was requested to withdraw the OGT, and they confirmed that it was done. The stapler was fired without any difficulty. Gastrojejunostomy was also done using linear stapler without any hindrance. The enterotomies were closed with absorbable sutures. Methylene blue leak test was found to be negative. Just before extubation, the anaesthesia team asked us if the OGT could be removed! To our horror, the OGT could not be pulled out on gentle tugging, confirming inclusion of the OGT in the staple line. The patient was induced again and re-explored immediately, with endoscopic guidance. Both the pouch and remnant stomach were opened, the cut ends of OGT freed from both staple lines, and the tube removed. The openings in the pouch and remnant stomach were closed with stapler. Methylene blue leak test and air insufflation test were done and found to be negative.

Results: Postoperative recovery was uneventful and the patient was discharged on day 5. Review of the recorded video was done but the OGT was not visualised through the initial gastrotomy as the OGT had possibly been stapled during the last vertical firing higher up near the fundus.

Discussion: Stapler firing over the OGT can occur insidiously without the surgeon's awareness. In this case, it was only suspected when the anaesthesia team asked us matter-of-factly whether the OGT could be removed. We had presumed that it had been removed before the first firing. Some surgeons prefer to keep the OGT for a day after surgery. Had that been our practice, this complication would have mandated a re-surgery in the early postoperative period. Such complications occur when the surgeon fails to request the anaesthesia team to remove the OGT or if there is poor communication between the surgical and anaesthesia teams. Sometimes, it can be due to change in the anaesthesia team during the procedure. In our case, though the anaesthesia team was the same, there was a new anaesthesia registrar who was involved in a bariatric surgical case for the first time. Use of transparent drapes, if available, may be advantageous, enabling the surgical team to see the OGT. The openings in the pouch and remnant stomach were closed with a stapler, as it was thought to be a more secure and faster method than oversewing. However, if the pouch is too small to allow stapler closure, simple suture closure should be done.

Conclusion: Inclusion of orogastric tube in the staple line should be a 'never event'. This case report highlights the importance of good communication between the surgical and anaesthesia teams, not only during the staple fire, but throughout the procedure.
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http://dx.doi.org/10.1007/s11695-021-05322-zDOI Listing
March 2021

Inverse association of mortality and body mass index in patients with left ventricular systolic dysfunction of both ischemic and non-ischemic etiologies.

Clin Cardiol 2021 Apr 6;44(4):495-500. Epub 2021 Mar 6.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburg, Pennsylvania, USA.

Background: Obesity is a worldwide epidemic that has been associated with poor outcomes. Previous studies have demonstrated an inverse relationship between body mass index (BMI) and outcomes, the 'obesity paradox', in several diseases.

Hypothesis: We sought to evaluate whether the obesity paradox is present in patients with left ventricular systolic dysfunction (LVSD) of all etiologies, using all-cause mortality as the primary endpoint and hospitalization as the secondary endpoint.

Methods: We conducted a retrospective cohort study of LVSD patients (n = 18 003) seen within the University of Pittsburgh Medical Center network between January 2011 and December 2017. Patients were divided into four BMI categories (underweight, normal weight, overweight, and obese) and stratified by left ventricular ejection fraction (LVEF): <20%, 20-35%, and 35-50%.

Results: Over a median follow-up of 2.28 years, higher BMI (mean 28.9 ± 6.8) was associated with better survival for the overall cohort and within LVEF strata (p < .0001). The most common cause of hospitalization was subendocardial infarction among underweight and normal weight patients and heart failure among overweight and obese patients. Cox proportional hazards model showed that BMI, age, and comorbid conditions of diabetes mellitus, chronic obstructive pulmonary disease, chronic kidney disease, and prior myocardial infarction are independent predictors of death.

Conclusions: Our results support the existence of an obesity paradox impacting all-cause mortality in patients with LVSD of ischemic and non-ischemic etiologies even after adjusting for LVEF and comorbidities. Additional research is needed to understand the effect of weight loss on survival once a diagnosis of LVSD is established.
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http://dx.doi.org/10.1002/clc.23556DOI Listing
April 2021

Outcomes of Blacks Versus Whites with Cardiomyopathy.

Am J Cardiol 2021 Mar 3. Epub 2021 Mar 3.

Cardiology Division of the Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address:

Racial disparities in health outcomes have been widely documented in medicine, including in cardiovascular care. While some progress has been made, these disparities have continued to plague our healthcare system. Patients with cardiomyopathy are at an increased risk of death and cardiovascular hospitalizations. In the present analysis, we examined the baseline characteristics and outcomes of black and white men and women with cardiomyopathy. All patients with cardiomyopathy (left ventricular ejection fraction (LVEF) < 50%) cared for at University of Pittsburgh Medical Center (UPMC) between 2011 and 2017 were included in this analysis. Patients were stratified by race, and outcomes were compared between Black and White patients using Cox proportional hazard models. Of a total of 18,003 cardiomyopathy patients, 15,804 were white (88%), 1,824 were black (10%) and 375 identified as other (2%). Over a median follow-up time of 3.4 years, 7,899 patients died. Black patients were on average a decade younger (p <0.001) and demonstrated lower unadjusted all-cause mortality (hazard ratio [HR]: 0.83%; 95% CI 0.77 to 0.90; p < 0.001). However, after adjusting for age and other comorbidities, black patients had higher all-cause mortality compared to white patients (HR: 1.15, 95% CI 1.07 to 1.25; p < 0.001). These differences were seen in both men (HR:1.19, 95% CI 1.08 to 1.33; p < 0.001) and women (HR:1.12, 95% CI 0.99 to 1.25; p = 0.065). In conclusion, our data demonstrate higher all-cause mortality in black compared to white men and women with cardiomyopathy. These findings are likely explained, at least in part, by significantly higher rates of comorbidities in black patients. Earlier interventions targeting these comorbidities may mitigate the risk of progression to heart failure and improve outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2021.02.039DOI Listing
March 2021

Ocular surface disease associated with immune checkpoint inhibitor therapy.

Ocul Surf 2021 Feb 19;20:115-129. Epub 2021 Feb 19.

Department of Ophthalmology, State University of New York Downstate Health Sciences University, 450 Clarkson Avenue, Brooklyn, NY, 11203, USA. Electronic address:

Immune-related adverse events (irAEs) is a term used to describe the various toxicities associated with immune checkpoint inhibitor (ICI) use. As this class of cancer immunotherapy grows, the diversity of documented irAEs also continues to expand. Ocular toxicities secondary to ICI use are relatively rare, with dry eye and uveitis as the most frequently reported ocular side effects. This article specifically investigates the relationship between ocular surface disease and ICI therapy through a review of the existing literature. Dry eye disease (DED), conjunctivitis, and keratitis were the most commonly reported irAEs affecting the ocular surface across the 29 studies reviewed. Keratoplasty graft rejection was also described in two case reports. Our review of eight clinical trials found the incidence of DED, the most common ocular surface irAE, to range from 1 to 4%. Nearly all cases of ocular surface irAEs were graded as mild or moderate in severity and were often self-limited or controlled with conservative treatment. Duration of checkpoint inhibitor use prior to onset of ocular surface side effects varied widely, ranging from days to months. Ocular surface toxicities associated with checkpoint immunotherapy appear to be under-reported and under-investigated. Further work remains to be done to investigate the full breadth of ocular surface pathologies and the molecular mechanisms by which these toxicities occur.
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http://dx.doi.org/10.1016/j.jtos.2021.02.004DOI Listing
February 2021

Obesity and Sarcopenia in Survivors of Childhood Acute Lymphoblastic Leukemia.

Indian Pediatr 2021 Jan 2. Epub 2021 Jan 2.

Department of Biostatistics, Rajiv Gandhi Cancer Institute and Research Centre, Rohini, Delhi, India.

Objectives: To describe the prevalence of obesity and sarcopenia among survivors of childhood acute lymphoblastic leukemia (ALL) using DEXA scan, and study associated risk factors.

Method: This case control study was conducted between July, 2013 and June, 2014 at a tertiary care cancer centre in India. Study participants included 65 survivors of childhood ALL who were <18 years of age at diagnosis, treated between years 1996 and 2008, and were at least two years since completion of therapy. The controls included 50 matched siblings. Dual energy X-ray absorptiometry (DEXA) was used to study the body composition (body fat percentage, BF% and lean body mass, LBM) of the participants and controls. McCarthy's body fat reference data were applied and logistic regression analysis was used to study various risk factors.

Results: At a median (range) follow-up of 5 (7.2-17.2) years, BF% (DEXA) identified a significantly higher prevalence of obesity of 21.5% (14/65) and sarcopenic obesity (14%) among survivors as compared to the controls (0/50, P<0.001), while the prevalence of sarcopenia as detected by LBM was similar at 60% (39/65) and 56% (28/50), respectively. On multivariate analysis, age at evaluation, high-risk disease and cranial irradiation were independently associated with high likelihood of obesity, while none of the factors predicted sarcopenia.

Conclusion: High prevalence of obesity and sarcopenic obesity were observed among survivors of childhood ALL.
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January 2021

Olanzapine for the Treatment of Breakthrough Vomiting in Children Receiving Moderate and High Emetogenic Chemotherapy.

Indian Pediatr 2020 11;57(11):1069-1070

Pediatric Hematology and Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi, India.

The efficacy of olanzapine (mean dose 0.09 mg/kg/dose) was evaluated in 31 children 2-18 years of age, for chemotherapy induced breakthrough vomiting. Among 42 chemotherapy blocks with emesis, complete and partial responses were observed in 34 (80.9%) and 6 (14.3%) blocks, respectively, while 1/31(2.4%) patient had refractory vomiting. Mild sedation and transient transaminitis were the observed side effects.
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November 2020

Risk Factor Modification for Atrial Fibrillation: An Ounce of Prevention.

JACC Clin Electrophysiol 2020 10;6(10):1288-1290

Heart and Vascular Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

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http://dx.doi.org/10.1016/j.jacep.2020.06.029DOI Listing
October 2020

Management of systemic fungal infections in the presence of a cardiac implantable electronic device: A systematic review.

Pacing Clin Electrophysiol 2021 Jan 21;44(1):159-166. Epub 2020 Oct 21.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Evidence to inform the management of systemic fungal infections in the setting of a cardiac implantable electronic devices (CIED), such as a permanent pacemaker or implantable cardioverter-defibrillator, is scant and limited to case reports and series. The available literature suggests high morbidity and mortality. To better characterize the shared experience of these cases and their outcomes, we performed a systematic review. We investigated all published reports of systemic fungal infections-fungemia and fungal vegetative disease-in the context of CIED, drawing from PubMed, EMBASE, and the Cochrane database of systematic reviews, inclusive of patients who received treatment between January 2000 and May 2020. Exclusion criteria included presence of ventricular assist device and concurrent bacteremia, bacterial endocarditis, bacterial vegetative infection, or viremia. Among 6261 screened articles, 48 cases from 41 individual studies were identified. Candida and Aspergillus species were the most commonly isolated fungi. There was significant heterogeneity in antifungal medication selection and duration. CIED extraction-either transvenous or surgical-was associated with increased survival to hospital discharge (92%) and clinical recovery at latest follow-up (81%), compared to cases where CIED extraction was deferred (56% and 40%, respectively). Importantly, there were no prospective data, and the data were limited to individual case reports and one small case series. In summary, CIED extraction is associated with improved fungal clearance and patient survival. Reported antifungal regimens are heterogeneous and nonuniform. Prospective studies are needed to verify these results and define optimal antifungal regimens.
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http://dx.doi.org/10.1111/pace.14090DOI Listing
January 2021

IAP Chemotherapy Regimen Is a Viable and Cost-effective Option in Children and Adolescents With Osteosarcoma: A Comparative Analysis With MAP Regimen on Toxicity and Survival.

J Pediatr Hematol Oncol 2020 Sep 11. Epub 2020 Sep 11.

Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, Delhi, India.

Background: Cisplatin and doxorubicin are integral components of chemotherapy regimens in the treatment of osteosarcoma. Choice of third agent high-dose methotrexate (HDMTX) or an alkylating agent such as ifosfamide is debatable. The present study compared the impact of MAP (HDMTX-doxorubicin-cisplatin) and IAP (ifosfamide-doxorubicin-cisplatin) chemotherapy regimens on toxicity and survival in children and adolescents with osteosarcoma.

Materials And Methods: This was a retrospective study including patients 18 years and younger with osteosarcoma during the study period. Clinical, demographic, chemotherapy regimen, and surgical details and treatment-related toxicity were retrieved from hospital medical records. Prognostic factors affecting overall survival (OS) and event-free survival (EFS) were analyzed.

Results: Among 102 patients included in the study, 59 (57.8%) and 43 (42.2%) patients were treated with MAP and IAP regimens, respectively. Two groups were comparable in terms of pretreatment characteristics and surgical treatment. Overall, 95.9% patients underwent limb salvage surgery. There was a statistically increased incidence in supportive care admissions and delay in starting the next cycle of chemotherapy in the MAP group. Among the MAP cohort, the 5-year OS and EFS were 62% and 55% compared with 47% and 44%, respectively, in the IAP cohort (P=0.143 and 0.316, respectively). On univariate and multivariate analyses, statistically significant factors affecting EFS of the whole group included tumor size, stage, site of metastasis, histologic necrosis, and type of surgery.

Conclusions: OS and EFS with both regimens were similar. However, the MAP regimen was associated with a statistically significant increase in incidence of supportive care admissions, delay in next cycle of chemotherapy, and predicted higher cost of treatment.
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http://dx.doi.org/10.1097/MPH.0000000000001946DOI Listing
September 2020

Image-guided device therapy: An opportunity for personalized medicine.

J Nucl Cardiol 2020 Sep 8. Epub 2020 Sep 8.

Division of Cardiology and The Heart and Vascular Institute, University of Pittsburgh Medical Center, A-429 Scaife Hall, 200 Lothrop Street, Pittsburgh, PA, 15213, USA.

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http://dx.doi.org/10.1007/s12350-020-02327-6DOI Listing
September 2020

Maternal focal atrial tachycardia during pregnancy: A systematic review.

J Cardiovasc Electrophysiol 2020 11 21;31(11):2982-2997. Epub 2020 Sep 21.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

Introduction: The presentation and optimal management of maternal focal atrial tachycardia (AT) during pregnancy are unknown. The objective of this study is to conduct a comprehensive summary of the existing evidence.

Methods And Results: A systematic review of all reported cases of maternal focal AT during pregnancy was performed. The primary search queried PubMed using the MeSH terms "supraventricular tachycardia" and "pregnancy." A stepwise ancillary search included article bibliographies, citations listed by the Google internet search engine, and PubMed using the MeSH terms "atrial tachycardia" and "pregnancy." In total, 28 citations that described 32 patients were retrieved. A case from our institution was added. Detailed information was available for 30 patients. Clinical characteristics at presentation included a mean ± standard deviation of 28.3 ± 5.7 years for maternal age and 24.6 ± 7.7 weeks for gestation age. Suspected tachycardia-induced cardiomyopathy was present in 20 of 30 (67%) patients and left ventricular ejection fraction improved in 15 of 15 (100%) patients with follow-up measurements. Medication failure was common. Focal AT resolved spontaneously after delivery in eight of nine (89%) patients treated with only medications. Automaticity was suggested by discrete electrograms at sites of origin and lack of reported inducibility and termination with programmed stimulation in all patients who underwent electrophysiology studies. There were nine cases of successful catheter ablation with zero fluoroscopy since 2010.

Conclusions: Automaticity is the dominant mechanism for patients with maternal focal AT during pregnancy. Catheter ablation with zero fluoroscopy is an emerging therapy for medically refractory cases.
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http://dx.doi.org/10.1111/jce.14738DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7719585PMC
November 2020

Elective implantable cardioverter-defibrillator removal with extraction of leads following catheter ablation of idiopathic ventricular fibrillation and long-term surveillance.

HeartRhythm Case Rep 2020 Jul 5;6(7):464-468. Epub 2020 May 5.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

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http://dx.doi.org/10.1016/j.hrcr.2020.04.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7361130PMC
July 2020

Choice of Local Therapy in Children With Ewing Sarcoma.

Indian Pediatr 2020 06;57(6):503-504

Department of Pediatric Hematology Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi.

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June 2020

Use Trends and Adverse Reports of SelectSecure 3830 Lead Implantations in the United States: Implications for His Bundle Pacing.

Circ Arrhythm Electrophysiol 2020 07 15;13(7):e008577. Epub 2020 Jun 15.

UPMC Heart and Vascular Institute, University of Pittsburgh, PA (A.F.B., L.A., N.C.W., A.B., D.W., M.G., J.S., S.J., A.V., R.B., N.A.M.E., S.S., K.K.).

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http://dx.doi.org/10.1161/CIRCEP.120.008577DOI Listing
July 2020

Impact of Diabetes Mellitus on Mortality and Hospitalization in Patients With Mild-to-Moderate Cardiomyopathy.

JACC Clin Electrophysiol 2020 05 26;6(5):552-558. Epub 2020 Feb 26.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. Electronic address:

Objectives: This study examined the independent predictors of all-cause mortality, all hospitalizations, and cardiac hospitalizations in patients with mild-to-moderate cardiomyopathy (left ventricular ejection fractions [LVEFs] of 36% to 50%).

Background: Patients with severe cardiomyopathy have high rates of death. Implantable cardioverter-defibrillators (ICDs) improve survival in this setting. It is not known whether the same applies to patients with mild-to-moderate cardiomyopathy.

Methods: All patients with cardiomyopathy of any etiology seen at our institution between 2011 and 2017 were included. Baseline characteristics and outcomes were compared between patients with mild-to-moderate cardiomyopathy and severe cardiomyopathy (LVEF ≤35%).

Results: Of the 18,003 patients with cardiomyopathy, 5,966 (33%) had a LVEF between 36% and 50%. Over a median follow-up of 3.35 years, 8,037 patients (45%) died and 11,056 (61%) were hospitalized for cardiac reasons. Independent predictors of all-cause mortality included older age (p < 0.001) and a history of diabetes mellitus (DM) (p = 0.005) or heart failure (p = 0.043). A higher baseline hemoglobin was protective (hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.71 to 0.89; p < 0.001). Importantly, patients with a history of DM and mild-to-moderate cardiomyopathy had worse survival than those with severe cardiomyopathy and no DM (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.010).

Conclusions: A history of DM predicts mortality in patients with cardiomyopathy and is associated with worse outcome than the actual severity of cardiomyopathy. Patients with mild-to-moderate cardiomyopathy and DM may therefore benefit from the same life-saving therapies (e.g., ICDs) that are indicated for patients with severe cardiomyopathy. This finding needs to be verified in a prospective, randomized setting.
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http://dx.doi.org/10.1016/j.jacep.2019.12.008DOI Listing
May 2020

Sex-specific efficacy and safety of cryoballoon versus radiofrequency ablation for atrial fibrillation: An individual patient data meta-analysis.

Heart Rhythm 2020 08 20;17(8):1232-1240. Epub 2020 Apr 20.

Cardiovascular Research Institute, University Hospital Basel, Basel, Switzerland; Department of Cardiology, University Hospital Basel, Basel, Switzerland. Electronic address:

Background: Atrial fibrillation (AF) is a growing health burden, and pulmonary vein isolation (PVI) using cryoballoon (CB) or radiofrequency (RF) represents an attractive therapeutic option. Sex-specific differences in the epidemiology, pathophysiology, and clinical presentation of AF and PVI are recognized.

Objective: We aimed at comparing the efficacy, safety, and procedural characteristics of CB and RF in women and men undergoing a first PVI procedure.

Methods: We searched for randomized controlled trials and prospective observational studies comparing CB and RF ablation with at least 1 year of follow-up. After merging individual patient data from 18 data sets, we investigated the sex-specific (procedure failure defined as recurrence of atrial arrhythmia, reablation, and reinitiation of antiarrhythmic medication), safety (periprocedural complications), and procedural characteristics of CB vs RF using Kaplan-Meier and multilevel models.

Results: From the 18 studies, 4840 men and 1979 women were analyzed. An analysis stratified by sex correcting for several covariates showed a better efficacy of CB in men (hazard ratio for recurrence 0.88; 95% confidence interval 0.78-0.98, P = .02) but not in women (hazard ratio 0.98; 95% confidence interval 0.83-1.16; P = .82). For women and men, the energy source had no influence on the occurrence of at least 1 complication. For both sexes, the procedure time was significantly shorter with CB (-22.5 minutes for women and -27.1 minutes for men).

Conclusion: CB is associated with less long-term failures in men. A better understanding of AF-causal sex-specific mechanisms and refinements in CB technologies could lead to higher success rates in women.
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http://dx.doi.org/10.1016/j.hrthm.2020.04.020DOI Listing
August 2020

Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial.

JAMA Cardiol 2020 05;5(5):598-607

Duke Clinical Research Institute, Durham, North Carolina.

Importance: Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.

Objective: To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method.

Design, Setting, And Participants: This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020.

Interventions: Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily.

Main Outcomes And Measures: The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment.

Conclusions And Relevance: As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD.

Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.
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http://dx.doi.org/10.1001/jamacardio.2020.0116DOI Listing
May 2020

Presentation, Treatment, and Outcome of Survivors of In-Hospital Versus Out-of-Hospital Sudden Cardiac Arrest.

Am J Cardiol 2020 04 29;125(8):1137-1141. Epub 2020 Jan 29.

The Heart and Vascular Institute and the Department of Medicine, University of Pittsburgh Medical Center, Falls Church, Virginia. Electronic address:

We examined the baseline characteristics, rates of implantable cardioverter defibrillator implantation, and long-term all-cause mortality for survivors of in-hospital (IHSCA) versus out-of-hospital (OHSCA) sudden cardiac arrest (SCA). A total of 1,433 SCA survivors (807 IHSCA and 626 OHSCA) from 2002 to 2012 were followed through February 2017. Baseline characteristics and potential triggers of SCA, including significant electrolyte and metabolic abnormalities and acute myocardial infarction and ischemia, were collected. Adjusted survival analyses were performed using a multivariate Cox model. The presence of SCA triggers was similar between IHSCA and OHSCA patients (39% vs 35%, p = 0.3), but OHSCA was more likely associated with cardiac ischemia and drug abuse, whereas IHSCA was more associated with new antiarrhythmic drugs (p <0.05). OHSCA survivors were more likely to receive an implantable cardioverter defibrillator (38% vs 18%, p <0.001). Over a median follow-up of 3.6 years, 674 (47%) patients died. After adjusting for unbalanced baseline characteristics, survival was similar between IHSCA and OHSCA survivors (hazard ratio 1.1, 95% confidence interval 0.9 to 1.3, p = 0.4). In conclusion, survivors of IHSCA and OHSCA differed in baseline characteristic, potential SCA triggers, and treatment interventions but their adjusted survival was comparable.
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http://dx.doi.org/10.1016/j.amjcard.2020.01.007DOI Listing
April 2020

Impact of Change in 2010 American Heart Association Cardiopulmonary Resuscitation Guidelines on Survival After Out-of-Hospital Cardiac Arrest in the United States: An Analysis From 2006 to 2015.

Circ Arrhythm Electrophysiol 2020 02 18;13(2):e007843. Epub 2020 Feb 18.

University of Pittsburgh Medical Center, PA (D.K.P., A.B., S.J., N.C.W., S.S., A.B.).

Background: In October 2010, the American Heart Association/Emergency Cardiovascular Care updated cardiopulmonary resuscitation guidelines. Its impact on the survival rate among out-of-hospital cardiac arrest patients (OHCA) is not well studied. We sought to assess the survival trends in OHCA patients before and after the introduction of the 2010 American Heart Association cardiopulmonary resuscitation guidelines in the United States.

Methods: A retrospective observational study from the National Emergency Department (ED) Sample was designed to identify patients presenting to the ED primarily after an OHCA in the United States between January 1, 2006, and December 31, 2015. The main outcome studied was the change in trends of ED survival and survival-to-discharge rates before and after guideline modification.

Results: Among 1 282 520 patients presenting to the ED after OHCA (mean [SD] age, 65.8 [17.2] years; 62% men), ED survival rate (23%) and survival-to-discharge rate (16%) trends showed significant improvement after implementation of the 2010 American Heart Association cardiopulmonary resuscitation guidelines, 1.25% ([95% CI, 0.72%-1.78%] =0.001) and 0.89% ([95% CI, 0.35%-1.43%] =0.006), respectively. Notably, among patients with nonshockable rhythm (change in ED survival rate trend, 1.3% [95% CI, 0.89%-1.74%]; <0.001 and survival-to-discharge trend, 0.94% [95% CI, 0.42%-1.47%]; =0.004). Among patients admitted to the presenting hospital (n=145 592), 46% were discharged alive, of which 49% were discharged home. Significant decrease in discharge to home was noted (-1.7% [95% CI, -3.18% to -0.22%]; =0.03), while a significant increase in neurological complication (0.17% [95% CI, 0.06%-0.28%]; =0.007) was noted with the guideline modification.

Conclusions: The change in 2010 American Heart Association cardiopulmonary resuscitation guidelines was associated with only slight improvement in ED survival and survival-to-discharge trends among US OHCA patients and only 1 in 6 OHCA patients survival to discharge.
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http://dx.doi.org/10.1161/CIRCEP.119.007843DOI Listing
February 2020

Novel method of superior vena cava electrical isolation with close proximity to the phrenic nerve.

HeartRhythm Case Rep 2019 Sep 11;5(9):461-464. Epub 2019 Jul 11.

Division of Cardiology, UPMC Heart and Vascular Institute, Pittsburgh, Pennsylvania.

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http://dx.doi.org/10.1016/j.hrcr.2019.06.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6951328PMC
September 2019

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin in Patients With Chronic Kidney Disease and Atrial Fibrillation.

Am J Cardiol 2020 01 1;125(2):210-214. Epub 2019 Nov 1.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address:

Patients with atrial fibrillation (AF) commonly have impaired renal function. The safety and efficacy of direct oral anticoagulants (DOACs) in patients with chronic kidney disease (CKD) and end-stage renal disease has not been fully elucidated. This study evaluated and compared the safety outcomes of DOACs versus warfarin in patients with nonvalvular AF and concomitant CKD. Patients in our health system with AF prescribed oral anticoagulants during 2010 to 2017 were identified. All-cause mortality, bleeding and hemorrhagic, and ischemic stroke were evaluated based on degree of renal impairment and method of anticoagulation. There were 21,733 patients with a CHADS-VASc score of ≥2 included in this analysis. Compared with warfarin, DOAC use in patients with impaired renal function was associated with lower risk of mortality with a hazard ratio (HR): 0.76 (95% confidence interval [CI] 0.70 to 0.84, p value <0.001) in patients with eGFR >60, HR 0.74 (95% CI 0.68 to 0.81, p value <0.001) in patients with eGFR >30 to 60, and HR 0.76 (95% CI 0.63 to 0.92, p value <0.001) in patients with eGFR ≤30 or on dialysis. Bleeding requiring hospitalization was also less in the DOAC group with a HR 0.93 (95% CI 0.82 to 1.04, p value 0.209) in patients with eGFR >60, HR 0.83 (95% CI 0.74 to 0.94, p value 0.003) in patients with eGFR >30 to 60, and HR 0.69 (95% CI 0.50 to 0.93, p value 0.017) in patients with eGFR ≤30 or on dialysis. In conclusion, in comparison to warfarin, DOACs appear to be safe and effective with a lower risk of all-cause mortality and lower bleeding across all levels of CKD.
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http://dx.doi.org/10.1016/j.amjcard.2019.10.033DOI Listing
January 2020

Documentation of shared decision making around primary prevention defibrillator implantations.

Pacing Clin Electrophysiol 2020 01 25;43(1):100-109. Epub 2019 Dec 25.

Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Introduction: Patients eligible for primary prevention implantable cardioverter-defibrillator (ICD) therapy are faced with a complex decision that needs a clear understanding of the risks and benefits of such an intervention. In this study, our goal was to explore the documentation of primary prevention ICD discussions in the electronic medical records (EMRs) of eligible patients.

Methods: In 1523 patients who met criteria for primary prevention ICD therapy between 2013 and 2015, we reviewed patient charts for ICD-related documentation: "mention" by physicians or "discussion" with patient/family. The attitude of the physician and the patient/family toward ICD therapy during discussions was categorized into negative, neutral, or positive preference. Patients were followed to the end-point of ICD implantation.

Results: Over a median follow-up of 442 days, 486 patients (32%) received an ICD. ICD was mentioned in the charts of 1105 (73%) patients, and a discussion with the patient/family about the risks and benefits of ICD was documented in 706 (46%) charts. On multivariable analyses, positive cardiologist (hazard ratio [HR]: 7.9, 95% confidence of intervals [CI]: 1.0-59.7, P < .05), electrophysiologist (HR: 7.7, 95% CI: 1.9-31.7, P < .001), and patient/family (HR: 9.9, 95% CI: 6.2-15.7, P < .001) preferences toward ICD therapy during the first documented ICD discussion were independently associated with ICD implantation.

Conclusions: In a large cohort of patients eligible for primary prevention ICD therapy, a discussion with the patient/family about the risks and benefits of ICD implantation was documented in less than 50% of the charts. More consistent documentation of the shared decision making around ICD therapy is needed.
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http://dx.doi.org/10.1111/pace.13846DOI Listing
January 2020

Severe chronic kidney disease is associated with poor survival after initial CRT-defibrillator tachyarrhythmia therapy.

Pacing Clin Electrophysiol 2020 01 5;43(1):78-86. Epub 2019 Dec 5.

UPMC Heart and Vascular Institute, Pittsburgh, Pennsylvania.

Background: Implantable cardioverter-defibrillator (ICD) recipients who receive appropriate device therapies have limited survival, and survival benefit in chronic kidney disease (CKD) has been questioned. We examined the association between CKD and survival after cardiac resynchronization therapy (CRT)-defibrillator tachyarrhythmia therapies.

Methods: We compared overall survival after appropriate shocks or anti-tachycardia pacing in 439 CRT-defibrillator recipients with left ventricular ejection fraction (LVEF) ≤35%, non-right bundle-branch block QRS pattern, and QRS duration >130 ms according to glomerular filtration rate (GFR) at implant, including 31 patients with GFR ≤30, 164 patients with GFR 31-60, and 244 patients with GFR >60. At least one shock occurred in 302 patients (24 with GFR ≤30, 102 with GFR 31-60, and 176 with GFR >60). Serial echocardiograms were also compared.

Results: Patients were followed 64 months (interquartile range [IQR]: 29-94) after implant, including 32 months (IQR: 12-61) after first therapy. Time to first therapy or shock was similar across GFR groups. However, survival after first therapy declined directly with declining GFR (P < .001), with median postshock survival of 90 days for GFR ≤30 (95% confidence of interval [CI]: 0-233), 612 days (95% CI: 365-859) for GFR 31-60, and 1672 days (95% CI: 1396-1948) for GFR >60. Declining GFR category, ischemic heart disease, diabetes, and increasing age were independently associated with increased postshock mortality. Echocardiographic response was similar across GFR groups and was not associated with post-therapy survival.

Conclusions: Survival after appropriate tachyarrhythmia therapies, particularly shocks, is attenuated in patients with GFR ≤30. This raises concern over potential lack of survival benefit conferred by CRT-defibrillators versus CRT-pacemakers in this population.
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http://dx.doi.org/10.1111/pace.13823DOI Listing
January 2020

Sustained quality-of-life improvement post-cryoballoon ablation in patients with paroxysmal atrial fibrillation: Results from the STOP-AF Post-Approval Study.

Heart Rhythm 2020 03 10;17(3):485-491. Epub 2019 Oct 10.

Northwestern University, Chicago, Illinois.

Background: Pulmonary vein isolation by catheter ablation is a class IA indication for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation (PAF). Quality of life (QoL) has been identified as a clinically meaningful endpoint but has not been comprehensively evaluated to date.

Objective: The purpose of this study was to evaluate the effects of cryoballoon ablation on long-term QoL.

Methods: As part of the STOP-AF Post-Approval Study, QoL was assessed using the Short Form-12 Health Survey (SF-12) along with evaluation of arrhythmia-related symptoms through 36 months. A multivariate linear mixed effects regression was used to determine the association between atrial fibrillation symptoms and QoL scores, and univariate linear regressions were used to assess predictors of 36-month change in QoL scores.

Results: Three hundred thirty-five subjects fully completed SF-12 forms at baseline, with 319, 308, 291, and 278 subjects completing surveys at the subsequent follow-up visits. Both physical and mental composite scores increased significantly from baseline (P <.001), and all arrhythmia symptoms significantly decreased from baseline (P <.001), with 62.0% of subjects reporting no symptoms at 6 months compared to 5.7% at baseline (P <.001). Presence of dyspnea and fatigue at baseline were univariate predictors of physical QoL improvement (P = .045 and 0.0497, respectively), whereas each year of age and each year of PAF duration were predictors of a decrease in mental QoL (P = .014 and .04, respectively).

Conclusion: Cryoballoon ablation for treatment of PAF results in a significant, and sustained, QoL improvement. The observed improvement in physical and mental health likely may be mediated by a reduction in symptom and arrhythmia burden.
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http://dx.doi.org/10.1016/j.hrthm.2019.10.014DOI Listing
March 2020