Publications by authors named "Parag Kale"

15 Publications

  • Page 1 of 1

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

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

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

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

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

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

BAYLOR UNIVERSITY MEDICAL CENTER, DALLAS, TEXAS.

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

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

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

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

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

Community-Acquired Acute Kidney Injury as a Risk Factor of de novo Heart Failure Hospitalization.

Cardiorenal Med 2019 10;9(4):252-260. Epub 2019 May 10.

Baylor Heart and Vascular Institute, Dallas, Texas, USA.

Objectives: Because patients with hospital-acquired acute kidney injury (AKI) are at risk for subsequent development of heart failure (HF) and little is known about the relation between community-acquired AKI (CA-AKI) and HF, we sought to determine if CA-AKI is a risk factor for incident HF hospitalization.

Methods: We utilized Baylor Scott & White Health databases at the primary care and inpatient hospitalization levels to identify adults without a prior history of HF who had 2 or more serum creatinine measurements within 13 months in the primary care setting. We defined CA-AKI as a serum creatinine increase ≥0.3 mg/dL or ≥1.5 times the baseline for consecutive values within a 13-month period. We created a flag for de novo HF hospitalization at 90, 180, and 365 days following CA-AKI evaluation.

Results: In the analyses, 210,895 unique adults were included, of whom 5,358 (2.5%) had CA-AKI. Those with CA-AKI had higher rates of comorbidities, higher rate of males (48 vs. 42%, p < 0.001), and were older (61.5 [50.3, 73.1] vs. 54.1 [42.8, 64.7] years, p < 0.001) than those who did not have CA-AKI. In total, 607 (0.3%), 833 (0.4%), and 1,089 (0.5%) individuals had an incident HF hospitalization in the 90, 180, and 365 days following the CA-AKI evaluation, respectively. After adjusting for demographic and clinical characteristics, patients with CA-AKI had >2 times the risk of de novo HF hospitalization compared with patients who did not have CA-AKI (90 days: 2.35 [1.83-3.02], p < 0.001; 180 days: 2.52 [2.04-3.13], p < 0.001; 365 days: 2.16 [1.77-2.64], p < 0.001). These multivariable models yielded strong predictive abilities, with the areas under the receiver-operating characteristic curve >0.90.

Conclusion: After controlling for baseline and clinical characteristics, patients with CA-AKI were at approximately twofold the risk of de novo HF hospitalization (within 90, 180, and 365 days) compared with those who did not have CA-AKI. Hence, detecting CA-AKI may provide an opportunity for early intervention at the primary care level to possibly delay HF development.
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http://dx.doi.org/10.1159/000499669DOI Listing
March 2020

Stage B Heart Failure: To Strain or Not to Strain.

JACC Cardiovasc Imaging 2018 10 16;11(10):1401-1404. Epub 2018 May 16.

Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas; Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott and White Research Institute, Dallas, Texas.

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http://dx.doi.org/10.1016/j.jcmg.2018.04.022DOI Listing
October 2018

Donor predicted heart mass as predictor of primary graft dysfunction.

J Heart Lung Transplant 2018 07 17;37(7):826-835. Epub 2018 Mar 17.

Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas, USA; Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott & White Research Institute, Dallas, Texas, USA.

Background: Concern over the hazards associated with undersized donor hearts has impeded the utilization of otherwise viable allografts for transplantation. Previous studies have indicated predicted heart mass (PHM) may provide better size matching in cardiac transplantation than total body weight (TBW). We investigated whether size-matching donor hearts by PHM is a better predictor of primary graft dysfunction (PGD) than matching by TBW.

Methods: Records of consecutive adult cardiac transplants performed between 2012 and 2016 at a single-center academic hospital were reviewed. We compared patients implanted with hearts undersized by ≥30% with those implanted with donor hearts matched for size (within 30%), and performed the analysis both for undersizing by PHM and for undersizing by TBW. The primary outcome was moderate/severe PGD within 24 hours, according to the 2014 International Society for Heart and Lung Transplantation consensus. Secondary outcome was 1-year survival.

Results: Of 253 patients, 21 (8%) and 30 (12%) received hearts undersized by TBW and PHM, respectively. The overall rate of moderate/severe PGD was 13% (33 patients). PGD was associated with undersizing if performed by PHM (p = 0.007), but not if performed by TBW (p = 0.49). One-year survival was not different between groups (log-rank, p > 0.8). Multivariate analysis confirmed that undersizing donor hearts by PHM, but not by TBW, was predictive of moderate/severe PGD (OR 3.3, 95% CI 1.3 to 8.6).

Conclusions: Undersized donor hearts by ≥30% by PHM may increase rates of PGD after transplantation, confirming that PHM provides more clinically appropriate size matching than TBW. Better size matching may ultimately allow for expanding the donor pool.
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http://dx.doi.org/10.1016/j.healun.2018.03.009DOI Listing
July 2018

Validation of Peripherally Inserted Central Catheter-Derived Fick Cardiac Outputs in Patients with Heart Failure.

Am J Cardiol 2018 Jan 10;121(1):50-54. Epub 2017 Oct 10.

Department of Internal Medicine, Texas A&M University College of Medicine Health Science Center, Dallas, Texas; Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas. Electronic address:

The pulmonary artery catheter (PAC) remains the gold standard to calculate Fick cardiac outputs (FCOs) in patients with heart failure admitted to the intensive care unit (ICU). The peripherally inserted central catheter (PICC) provides long-term intravenous access and is used outside the ICU; however, there is scant literature validating venous oxygen saturations (VOSs) from PICC lines. Heart failure patients in the ICU with an existing PAC requiring a PICC line to transition were enrolled. Three blood samples were taken per person (1 at PICC, 1 at central venous pressure [CVP], and 1 at distal PAC). We performed repeated measures analysis of variance, as well as reliability analysis on 31 subjects (77% male, 71% Caucasian, mean ± standard deviation age 60 ± 8 years, 80% on inotropes). The average VOSs were 62 ± 11%, 62 ± 12%, and 61 ± 9% for the PICC line, CVP, and distal port, respectively (p = 0.66); there was excellent reliability (0.79). The median FCOs were 5 [4, 6], 5 [4, 6], and 5 [4, 6] L/min at the PICC, CVP, and distal port, respectively (p = 0.91); there was fair-to-good reliability (0.67). In conclusion, VOS and FCO did not differ by location, on average. Reliable data may be obtained through the PICC line, after evaluation from the PAC. The PICC may provide longer-term hemodynamic assessment while improving patient comfort.
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http://dx.doi.org/10.1016/j.amjcard.2017.09.020DOI Listing
January 2018

Utilization of high donor sequence number grafts in cardiac transplantation.

Clin Transplant 2018 01 4;32(1). Epub 2017 Dec 4.

Department of Cardiac and Thoracic Surgery, Baylor University Medical Center, Dallas, TX, USA.

Donor sequence number (DSN) represents the number of candidates to whom a graft was offered and declined prior to acceptance for transplantation. We sought to investigate the outcomes of patients receiving high DSN grafts. Consecutive isolated adult cardiac transplantations performed at a single-center were reviewed. Recipients were grouped into standard (≤75th percentile) DSN and high (>75th percentile) DSN. A previously validated donor risk index was used to quantify the risk associated with donor grafts, and recipient outcomes were assessed. Overall, 254 patients were included: 194 standard DSN (range 1-79) and 60 high DSN (range 82-1723). High DSN grafts were harvested at greater distance (P < .001) with increased ischemia time (P < .001), resulting in a modest increase in donor risk index (1 point median difference, P = .014). High DSN recipients were less frequently listed as UNOS status 1A (P < .001). Despite a nonsignificant trend toward increased in-hospital/30-day mortality in high DSN recipients, there were no differences in primary graft dysfunction or 1-year survival (high DSN 89% vs standard DSN 88%, P = .82). After adjustment for risk factors, high DSN was not associated with increased 1-year mortality (hazard ratio 1.18, 95%-CI 0.54-2.58, P = .68).
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http://dx.doi.org/10.1111/ctr.13128DOI Listing
January 2018

Arrhythmogenic Right Ventricular Dysplasia: An Under-recognized Form of Inherited Cardiomyopathy.

Rev Cardiovasc Med 2017;18(1):37-43

Baylor University Medical Center and Baylor Heart and Vascular Hospital, Dallas, TX.

We report a case of arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVD) in order to evaluate the course of an under-recognized form of cardiomyopathy with a vast array of clinical manifestations. The patient is a 49-year-old white woman transferred from an outside hospital due to dyspnea and persistent hypoxia. She had a pertinent family history that included a sister who died suddenly in her 30s from unexplained heart failure. Initial work-up for hypoxia was unrevealing. Transthoracic echocardiography revealed isolated right ventricular dysfunction with dilation and multiple trabeculations. Further investigation, including cardiac computed tomography and magnetic resonance imaging, revealed fatty infiltration into the right ventricular wall suggestive of ARVD.
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July 2019

Goal-Directed Heart Failure Care in Patients With Chronic Kidney Disease and End-Stage Renal Disease.

JACC Heart Fail 2016 08 8;4(8):662-3. Epub 2016 Jun 8.

Baylor University Medical Center, Dallas, Texas; Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, Texas.

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http://dx.doi.org/10.1016/j.jchf.2016.03.014DOI Listing
August 2016

Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device.

Am J Cardiol 2016 05 4;117(10):1622-1628. Epub 2016 Mar 4.

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

Many patients with end-stage heart failure require mechanical circulatory support as a temporizing measure to enable multidisciplinary assessment for the most suitable therapeutic strategy. Impella 5.0 can be used as a bridge to decision to evaluate patients for potential recovery or bridge to next therapy (bridge to heart transplantation [BTHT] or bridge to durable left ventricular assist device or VAD [BLVAD]. Our goal was to examine single-center outcomes with the Impella 5.0 device as a bridge to next therapy (BTHT or BTLVAD). Forty patients underwent Impella 5.0 support from December 2009 to December 2015 with the intent of BTHT (n = 20) or BTLVAD (n = 20). The primary end point was survival to next therapy. Secondary end points included hemodynamic assessments and in-hospital/30-day complications. All patients were inotrope-dependent, with severely depressed left ventricular ejection fraction (12%) and renal insufficiency (creatinine 2.0 mg/dl). Most were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2 (66%) with biventricular failure (65%). Thirty patients (75%) survived to next therapy, including transplant (n = 13), durable LVAD (n = 15), and recovery of native heart function (n = 2). No strokes or major bleeding events requiring surgery were observed. Acute renal dysfunction, bleeding requiring transfusion, hemolysis, device malfunction, limb ischemia occurred in 13 (33%), 11 (28%), 3 (8%), 4 (10%), and 1 (3%) patients, respectively. Survival rate to discharge and/or 30 days was 68% (27 of 40). Temporary support with the Impella 5.0 allows for an effective bridge to decision strategy for hemodynamic stabilization and multidisciplinary heart team assessment of critically ill patients with heart failure. In conclusion, many of these patients can be subsequently bridged to the next therapy with favorable outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2016.02.038DOI Listing
May 2016

Thalidomide for treatment of gastrointestinal angiodysplasia in patients with left ventricular assist devices: case series and treatment protocol.

J Heart Lung Transplant 2015 Jan 4;34(1):132-134. Epub 2014 Nov 4.

Department of Medicine, Stanford University Hospital and Clinics, Stanford, California.

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http://dx.doi.org/10.1016/j.healun.2014.09.013DOI Listing
January 2015

Treatment of left ventricular assist device-associated arteriovenous malformations with thalidomide.

ASAIO J 2014 Jul-Aug;60(4):482-3

From the *Department of Cardiovascular Medicine, Stanford University, Stanford, California; †Stanford Cardiovascular Institute, Stanford University, Stanford, California; ‡Heart Transplant Department, Northern California Kaiser Permanente, Oakland, California; and §Department of Cardiothoracic Surgery, Stanford University, Stanford, California.

Gastrointestinal bleeding because of arteriovenous malformations (AVMs) is an increasingly recognized complication of continuous flow left ventricular assist devices (LVADs). Currently, therapeutic options for LVAD-associated AVMs are limited and often require repeated endoscopic procedures and reduction or cessation of anticoagulation. Thalidomide has been utilized in the treatment of refractory bleeding because of gastrointestinal vascular malformations. Here we describe the case of a 66-year-old man with severe ischemic cardiomyopathy implanted with a continuous flow HeartMate II. His postoperative course was complicated by multiple hospital admissions for gastrointestinal bleeding because of LVAD-associated AVMs refractory to repeated argon plasma laser coagulation. Anticoagulation was discontinued with subsequent pump stoppage because of thrombus requiring urgent surgical pump exchange. Following this, thalidomide was initiated and anticoagulation with warfarin was continued. Since initiation of thalidomide, the patient has not had further gastrointestinal bleeding or evidence of pump thrombus in the subsequent 1 year.
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http://dx.doi.org/10.1097/MAT.0000000000000087DOI Listing
November 2015

Devices in acute heart failure.

Crit Care Med 2008 Jan;36(1 Suppl):S121-8

Division of Cardiovascular Medicine, University Hospitals-Case Medical Center, Case Western Reserve University, Cleveland, OH, USA.

The optimal management strategy for patients with acutely decompensated heart failure has been limited to the use of various pharmacologic agents. However, with technological advances in mechanical devices, nonpharmacologic approaches now are available to supplement pharmacologic management. These devices range in sophistication and expertise and target various features of the acute heart failure patient, such as circulatory failure, volume overload, renal insufficiency, and respiratory failure. As more innovations and technologies emerge, these new devices may become a cornerstone of the management strategy in cardiac patients.
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http://dx.doi.org/10.1097/01.CCM.0000297318.39219.2DDOI Listing
January 2008
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