scholarly journals Prediction of heparin induced hypotension during cardiothoracic surgery: A retrospective observational study

2019 ◽  
pp. 145-150
Author(s):  
Masakazu Kotoda ◽  
Tadahiko Ishiyama ◽  
Hiroyuki Nakajima ◽  
Takashi Matsukawa
Keyword(s):  
Antihypertensive Medication ◽  
Resistance Index ◽  
Left Ventricular ◽  
Cardiothoracic Surgery ◽  
Left Ventricular Ejection ◽  
High Dose ◽  
Systemic Vascular Resistance Index ◽  
Ventricular Ejection Fraction ◽  
Induced Hypotension ◽  
Dose Heparin

Background: High-dose heparin occasionally causes severe hypotension during cardiothoracic surgery. Being able to predict the severity of the decrease in blood pressure prior to administration of heparin would improve hemodynamic and anesthetic management. The aim of this study was to investigate the predictors of heparininduced hypotension and the effects of high-dose heparin on various hemodynamic and physiologic parameters.Methodology: The records of adult patients who underwent elective cardiothoracic surgery at University of Yamanashi Hospital between January 2016 and December 2017 were retrospectively reviewed. Single and multiple linear regression analyses were conducted to identify the predictors of heparin-induced hypotension. Results: High baseline systemic vascular resistance index (SVRI) and non-use of preoperative antihypertensive medication were significant predictors of heparininduced hypotension with a following regression equation: Percent change in mean arterial pressure = 17.273 + 0.00457 × (baseline SVRI) - 14.043 × (antihypertensive medication), where antihypertensive medication is coded as 0 = no antihypertensive drug and 1 = one or more antihypertensive drug(s), F = 7.80, the multiple correlation coefficient is 0.68645, and R adjusted for degrees of freedom is 0.41078.Conclusion: The baseline SVRI and non-use of preoperative antihypertensive medication are significant predictors of the severity of heparin-induced hypotension.Abbreviations: MAP - Mean arterial blood pressure; CVP - central venous pressure; PAP - pulmonary arterial pressure; SVRI - systemic vascular resistance index; BMI: body mass index; ASA-PS: American Society of Anesthesiologists physical status classification; DM: diabetes mellitus; eGFR: estimated glomerular filtration rate; LVEF: left ventricular ejection fraction; EDVI: end-diastolic volume index; CI: cardiac index; SvO2: mixed venous oxygen saturation; LVEF: left ventricular ejection fraction; HR: heart rate. Preregistration: The study was approved by the institutional review board of University of Yamanashi (study H30036, registered May 28, 2018).Citation: Kotoda M, Ishiyama T, Nakajima H, Matsukawa T. Prediction of heparin induced hypotension during cardiothoracic surgery: A retrospective observational study. Anaesth pain & intensiv care 2019;23(2):145-150

Abstract 13135: Starting Beta-blockers in Hypertension is Followed by Excess Loop Diuretic Use: Beta-blocker Induced Heart Failure?

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Daniel N Silverman ◽  
Jeanne d de Lavallaz ◽  
Timothy B Plante ◽  
Margaret M Infeld ◽  
Markus Meyer
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Beta Blocker ◽  
Antihypertensive Medication ◽  
Temporal Relationship ◽  
Loop Diuretic ◽  
Beta Blockers ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction

Introduction: Recent investigation has identified that discontinuation of beta-blockers in subjects with normal left ventricular ejection fraction (LVEF) leads to a reduction in natriuretic peptide levels. We investigated whether a similar trend would be seen in a hypertension clinical trial cohort. Methods: In 9,012 subjects hypertensive subjects without a history of symptomatic heart failure, known LVEF <35% or recent heart failure hospitalization enrolled in the Systolic Blood Pressure Intervention Trial (SPRINT), we compared incidence of loop diuretic initiation and time to initiation following start of a new anti-hypertensive medication. The categorical relationship (new antihypertensive class followed by loop-diuretic use) and temporal relationship (time to loop diuretic initiation) were each analyzed. The categorical relationship was assessed using a Pearson’s chi-squared test and the temporal relationship using a Wilcoxon rank sum test. Bonferroni-corrected p-values were utilized for all comparisons. Results: Among the 9,012 subjects analyzed, the incidence of anti-hypertensive initiation and loop diuretic initiation was greatest following start of a beta-blocker (16.6%) compared with other antihypertensive medication classes (calcium channel blocker 13.8%, angiotensin converting enzyme-inhibitor/angiotensin receptor blocker 12.9% and thiazide diuretic 10.2%; p<0.001). In addition, the median time between starting a new antihypertensive medication and loop diuretic was the shortest for beta-blockers and longest for thiazides (both p <0.01). No significant differences in renal function were identified between groups. Conclusion: Compared to other major classes of hypertensive agents, starting beta-blockers was associated with more common and earlier initiation of a loop diuretics in a population without heart failure at baseline. This finding may suggest beta-blocker induced heart failure in a population with a predominantly normal ejection fraction.

scholarly journals Antibody-mediated rejection with detection of de novo donor-specific anti-human leucocyte antigen Class II antibodies 3 years after heart transplantation: a case report

2020 ◽  
Vol 4 (1) ◽  
pp. 1-4
Author(s):  
Bernd Ludwig ◽  
Johanna Schneider ◽  
Daniela Föll ◽  
Qian Zhou
Keyword(s):  
Heart Transplantation ◽  
De Novo ◽  
Survival Rates ◽  
Graft Function ◽  
Left Ventricular ◽  
Cardiac Allograft ◽  
Left Ventricular Ejection ◽  
High Dose ◽  
Ventricular Ejection Fraction ◽  
Antibody Mediated Rejection

Abstract Background Antibody-mediated rejection (AMR) in cardiac transplantation may manifest early within the first weeks after transplantation but also late after months to years following transplantation resulting in mild heart failure to cardiogenic shock. While patients with early cardiac AMR are less affected and seem to have survival rates comparable to transplant recipients without AMR, late cardiac AMR is frequently associated with graft dysfunction, fulminant forms of cardiac allograft vasculopathy, and a high mortality rate. Nevertheless, AMR of cardiac allografts remains difficult to diagnose and to treat. Case summary We report the case of a 47-year-old male patient with late AMR of the cardiac allograft 3 years after heart transplantation. Antibody-mediated rejection was confirmed by endomyocardial biopsy and the presence of donor-specific antibodies (DSA). The patient was treated with high dose of prednisolone, plasmapheresis, intravenous Gamma Globulin, rituximab, immunoadsorption, and bortezomib. Under this treatment regimen left ventricular ejection fraction and pro B-type natriuretic peptide recovered, and the patient improved to New York Heart Association Class I. Currently, 3 years after the diagnosis of cardiac AMR, graft function continues to be nearly normal, and there is no evidence for transplant vasculopathy. Discussion This case illustrates that AMR can occur at any time after transplantation. Although graft function fully recovered after treatment in our patient, the level of DSA remained high, suggesting that DSA may not be a reliable parameter to determine the intensity and duration of the therapy.

scholarly journals Transplantation of Endothelial Progenitor Cells in the Treatment of Coronary Artery Microembolism in Rats

2020 ◽  
Vol 29 ◽  
pp. 096368972091268
Author(s):  
Yajun Xue ◽  
Boda Zhou ◽  
Jian Wu ◽  
Guobin Miao ◽  
Kun Li ◽  
...  
Keyword(s):  
Growth Factor ◽  
Cardiac Function ◽  
Progenitor Cells ◽  
Endothelial Progenitor Cells ◽  
Low Dose ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
High Dose ◽  
Endothelial Progenitor ◽  
Ventricular Ejection Fraction

As the impairment of myocardial microenvironments due to coronary microembolization (CME) compromises the treatment effect of percutaneous coronary intervention and leads to adverse prognosis, we hypothesized that endothelial progenitor cells (EPCs) transplantation could improve cardiac function in the condition of CME. Low- (2 × 105) and high- (2 × 106) dose rat bone marrow-derived EPCs were transplanted in a model of CME. To develop a CME model, rats were injected with autologous micro-blood-clots into the left ventricle. Echocardiograph was examined before and 1, 7, and 28 days after EPC transplantation; serum cardiac troponin I (cTNI), von Willebrand factor (vWF), and cardiac microRNA expression were examined one day after EPCs transplantation. Heart morphology and vascular endothelial growth factor (VEGF), vWF, and basic fibroblast growth factor (bFGF) expression were examined one day after EPC transplantation. After 10 days of culture inductions, BM-EPCs have high purity as confirmed by flow cytometry. Cardiac function reflected by left ventricular ejection fraction significantly decreased after CME treatment and rescued by low-dose EPC. Compared to the sham group, cTNI and vWF serum levels increased significantly after CME treatment and rescued by low-dose EPC and high-dose EPC. Low-dose EPC treatment decreased myocardial necrosis and fibrosis and elevated cardiac expression of VEGF and vWF, while decreasing the cardiac expression of bFGF. Low-dose EPC treatment significantly suppressed cardiac expression of microRNA-19a but significantly enhanced microRNA-21, microRNA-214, and microRNA-486-3p expression. In conclusion, our results indicate that low-dose EPC transplantation may play a proangiogenic, antifibroblast, antifibrosis, and antinecrosis role and enhance cardiac function in a rat model of CME through a microRNA-related pathway.

P3550Changes in intrarenal venous flow and right ventricle-pulmonary circulation coupling from in-hospital admission to discharge in decompensated heart failure patients

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Labate ◽  
A Vella ◽  
G Carenini ◽  
M Losito ◽  
M M Caracciolo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Right Ventricle ◽  
Pulmonary Circulation ◽  
Laboratory Tests ◽  
Resistance Index ◽  
Resistive Index ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Venous Blood Flow ◽  
Ventricular Ejection Fraction

Abstract Background Intrarenal venous blood flow (IRVF) has been used to assess renal haemodynamics in heart failure (HF). In stable euvolemic HF patients, IRVF patterns are correlated with clinical outcomes independently of conventional prognostic factors. No studies are available about the use of IRVF in decompensated HF (DHF). Purpose We aimed at establishing the possible clinical use of IRVF and his relationship with right ventricle (RV)-pulmonary circulation (PC) coupling in a cohort of DHF patients admitted at our clinic. Methods 15 DHF patients (mean age 72.6±9.8 years) with signs and symptoms of volume overload underwent a transthoracic echocardiography followed by renal ultrasonography and routine laboratory tests at admission and at pre-discharge (in stable euvolemic state after diuretic treatment). The IRVF was evaluated by Venous Impedance Index (VII). Results At discharge after depletive treatment resulted in clinical decongestion, we observed a reduction of VII (from 0.74±0.28 to 0.42±0.40; p=0.016) associated with reduction of pulmonary pressures and better RV to PC coupling (TAPSE/PASP ratio from 0.33±0.18 to 0.46±0.15; p=0.031). No significant differences in resistive index (RI), LVEF and renal function laboratory tests were detected. Results are shown in Table 1. Patients characteristics Admission Discharge p Value VII 0.74±0.28 0.42±0.40 0.02 LVEF (%) 43.7±17.5 42.7±16.3 0.87 TAPSE (mm) 14.9±4.1 17.1±3.6 0.14 PASP (mmHg) 51.9±15.2 39.4±11.6 0.02 TAPSE/PASP (mm/mmHg) 0.33±0.18 0.46±0.15 0.03 RI 0.8±0.1 0.7±0.1 0.11 Creatinine (mg/dL) 1.1±0.3 1.1±0.3 0.74 eGRF (mL/min/1.73 mq) 68.2±17.7 67.1±21 0.89 NT-proBNP (ng/L) 5663±5805.4 2047.2±2090.5 0.05 LVEF = left ventricular ejection fraction; BNP = natriuretic peptide; PASP = Syst art pulm press; RI = resistance index; TAPSE = tricuspid annular plane systolic excursion. Conclusions VII is a new non-invasive index that could identify renal hemodynamics alterations in HF patients. A high VII may be indicative of a congestive cardio renal syndrome in which an aggressive diuretic strategy can be set up with greater scientific evidence and the possibility of instrumental monitoring of its efficacy. Moreover, the development of drugs aimed at the improvement of the RV to PC coupling could lead to a better outcome in HF.

Neoadjuvant chemotherapy (NACT) with prolonged high-dose (HD) doxorubicin (A) and cyclophosphamide (C) with G-CSF support in locally advanced breast cancer (LABC): Long-term follow-up data

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11090-11090
Author(s):  
S. Altintas ◽  
M. T. Huizing ◽  
I. Spoormans ◽  
J. Van den Brande ◽  
P. Wilmes ◽  
...  
Keyword(s):  
Residual Disease ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
High Dose ◽  
Axillary Lymph ◽  
Study Objective ◽  
Ventricular Ejection Fraction

11090 Background: NACT improves survival in LABC. The optimal regimen, dose and duration is still under study Objective: To determine the efficacy and safety of prolonged preoperative HD-AC plus G-CSF. Methods: LABC patients (pts) were treated with AC for 6 cycles (Cy): Cy 1: A 90 mg/m2, C 1000 mg/m2; Cy 2–3: A 82.5 mg/m2, C 875 mg/m2; Cy 4–6: A 75mg/m2, C 750 mg/m2) with prophylactic (peg)filgastrim q3wks. In case of cardiotoxicity or poor tumor response (TR) pts switched to Docetaxel (D) 100mg/m2 q3wks. Within 5 weeks after NACT, pts underwent mastectomy with axillary lymph node dissection followed by radiotherapy. In case of positive estrogen (ER) or progesteron receptor (PgR), hormonal treatment was given for 5 yrs. Toxicity was scored weekly (NCI-CTC 2), response every 3 wks (WHO). Kaplan-Meier analysis was performed to calculate disease free survival (DFS) and overall survival (OS). Results: Between 8/1997 and 10/2003 21 pts (median age 55 years, range 22–74) were enrolled. One pt had stage IIB, 6 stage IIIA, 14 stage IIIB disease (10 T4d). 10 tumors were ER+, 5 PgR+, none overexpressed Her-2/Neu. A total of 130 NACT Cy was given. 15 pts completed all 6 AC Cy, 6 switched to D because of a decrease in left ventricular ejection fraction (LVEF? >10%, n=2) or insufficient TR (n=4). Dose reduction of AC was needed in 1 pt (last Cy), dose delays in 4 pts. Nausea and vomiting were generally mild; grade 4 anorexia occured in one pt. Grade 4 leucopenia and neutropenia in 14 and 18 pts, respectively. Neutropenic fever requiring hospitalization occurred in 5 pts, thrombocytopenia grade 4 in 7 pts and grade 3 anemia in 3 pts. Two pts developed cardiomyopathy (9.5%) < 2 years after NACT. The overall TR rate (PR and CR) was 81%, clinical CR rate 14%, pathologic CR rate 10% and 14% had minimal residual disease. Three pts showed SD and only 1 pt had PD. The median follow up of all pts was 51 months (range 9–110), 5 yrs DFS 47%, OS 56%. 5 yrs DFS and OS for pT4d pts was 50% and 56%, respectively. Conclusions: NACT with HD-AC plus G-CSF for 6 Cy in this poor risk population is active and further supports the use of prolonged preoperative CT. The routine use of D after a restricted number of AC Cy may further improve results and decrease (cardio)toxicity. No significant financial relationships to disclose.

scholarly journals Tianxiangdan Improves Coronary Microvascular Dysfunction in Rats by Inhibiting Microvascular Inflammation via Nrf2 Activation

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Guligena Sawuer ◽  
Xue-Kuan Ma ◽  
Ya-Jie Zhang ◽  
Xuan-Ming Zhang ◽  
Zulihumaer Ainiwaer ◽  
...  
Keyword(s):  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Coronary Microvascular Dysfunction ◽  
Heme Oxygenase 1 ◽  
High Dose ◽  
Related Factor ◽  
Nuclear Factor ◽  
Necrosis Factor Alpha ◽  
Ventricular Ejection Fraction ◽  
Tnf Α

Background. Tianxiangdan (TXD) is used in traditional Chinese medicine because of its therapeutic and preventive effects in the treatment of coronary heart disease. However, the underlying mechanism of TXD in coronary microvascular disease (CMD) remains unclear. Methods. A rat model of CMD was developed to study the mechanism of TXD activity. Sodium laurate was injected into the left ventricle of Sprague–Dawley rats to induce CMD. The rats were divided into six groups: a sham-operated (sham) group, an untreated CMD group, a low-dose TXD group (0.81 g·kg−1·d−1), a mid-dose TXD (TXD-M) group (1.62 g·kg−1·d−1), a high-dose TXD (TXD-H) group (3.24 g·kg−1·d−1), and a nicorandil (NCR) group (1.35 mg·kg−1·d−1). The effect of TXD on rats with CMD was observed after four weeks, and the mechanism of TXD in lipopolysaccharide (LPS)-induced cardiac microvascular endothelial cells (CMECs) was explored through treatment with 50 μg/mL TXD. Results. Compared with the rats in the untreated CMD group, rats in the TXD-M and TXD-H groups showed higher left ventricular ejection fraction values, improved pathological structures, decreased expressions of interleukin (IL)-1β, tumor necrosis factor-alpha (TNF-α), phosphorylated nuclear factor-κB inhibitor α (IκBα) and phosphorylated p65, and increased expressions of nuclear factor erythroid 2-related factor 2 (Nrf2) and heme oxygenase-1 ( P < 0.05 ). These effects were more pronounced in the TXD-H group than in the TXD-M group. In vitro experiments showed that TXD treatment increased the viability of LPS-induced CMECs and decreased the expression of IL-1β, TNF-α, phosphorylated IκBα, and phosphorylated p65 ( P < 0.05 ). However, the effects of TXD on CMECs were markedly reversed upon treatment with ML385 (Nrf2 inhibitor). Conclusion. The results showed that TXD exerts a protective effect on rats with CMD and related inflammatory injuries, and its anti-inflammatory mechanism is related to the activation of Nrf2 signalling.

scholarly journals The prevalence and clinical significance of anemia in patients hospitalized with acute heart failure

F1000Research ◽  
2017 ◽  
Vol 5 ◽  
pp. 1006
Author(s):  
Attila Frigy ◽  
Zoltán Fogarasi ◽  
Ildikó Kocsis ◽  
Lehel Máthé ◽  
Előd Nagy
Keyword(s):  
Heart Failure ◽  
Acute Heart Failure ◽  
Clinical Laboratory ◽  
Renal Perfusion ◽  
Multiple Regression Model ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
High Dose ◽  
Ventricular Ejection Fraction ◽  
Prevalence Of Anemia

Abstract: In a cohort of patients hospitalized with acute heart failure (AHF) the prevalence of anemia and the existence of a correlation between anemia and the severity of the clinical picture were assessed. Methods: 50 consecutive patients (34 men, 16 women, mean age 67.5 years) hospitalized with AHF were enrolled.  Statistical analysis was performed for studying correlations between anemia and the presence/levels of diverse parameters (clinical, laboratory, echocardiographic, treatment related)  reflecting the severity and prognosis of AHF (α=0.05). Results: 21 patients (14 men, 7 women, mean age 69.6 years), representing 42%, had anemia  at admission. Comparing patients with and without anemia there were no significant differences regarding age,  gender,  presence of atrial fibrillation (p=0.75), diabetes (p=1), ischemic heart disease (p=0.9), left ventricular ejection fraction (EF) (p=1), hypotension (p=0.34) and tachycardia>100 b/min at admission (p=0.75), level of eGFR (p=0.72), and need of high dose (>80 mg/day)  loop diuretic (p=0.23). However, EF showed a significant positive correlation with eGFR only in AHF patients with anemia (r=0,65, p=0.001). In a multiple regression model, EF had a significant effect on the eGFR quartiles (p=0,004). Conclusions: Anemia is a frequent finding in patients hospitalized with AHF. The presence of anemia was not correlated with other factors related to AHF severity and prognosis. However, a low EF associated with low eGFR was characteristic for patients with anemia, suggesting that the decrease of renal perfusion by low cardiac output further aggravates anemia on the background of chronic kidney disease.

scholarly journals Loperamide overdose causing torsades de pointes and requiring Impella temporary mechanical support: a case report

2019 ◽  
Vol 3 (4) ◽  
pp. 1-6 ◽  
Author(s):  
Jonathan D Cicci ◽  
Sarah M Jagielski ◽  
Megan M Clarke ◽  
Robert A Rayson ◽  
Matthew A Cavender
Keyword(s):  
Ventricular Arrhythmias ◽  
Mechanical Circulatory Support ◽  
Torsades De Pointes ◽  
Left Ventricular ◽  
Polymorphic Ventricular Tachycardia ◽  
Left Ventricular Ejection ◽  
Circulatory Support ◽  
High Dose ◽  
Ventricular Ejection Fraction ◽  
Vein Thrombosis

Abstract Background Loperamide is a widely available oral μ-opioid receptor agonist, and loperamide abuse is increasing by those seeking intoxication. Loperamide has potent QTc-prolonging properties, placing patients at risk for ventricular arrhythmias and sudden cardiac death. Case summary A 23-year-old woman was found to be in pulseless ventricular fibrillation with a QTc of 554 ms and received multiple defibrillations and IV lidocaine. Her toxicology studies were negative. She subsequently experienced multiple episodes of torsades de pointes and was found to be in cardiogenic shock with a left ventricular ejection fraction of 5%. Following multiple defibrillations, an Impella® mechanical circulatory support device was placed, and she was given IV magnesium and IV lidocaine. After mechanical circulatory support was withdrawn, she experienced major bleeding and was found to have a deep vein thrombosis, bilateral radial artery thrombosis, and multiple pulmonary embolisms in the setting of heparin-induced thrombocytopenia. After stabilizing, she admitted to taking 80 tablets of loperamide 2 mg in pursuit of euphoria. Discussion Loperamide is an increasingly popular agent of abuse. Loperamide-associated ventricular arrhythmias are rare with normal doses but more common with high doses, chronic ingestion, or interacting medications. Loperamide cardiotoxicity may be prolonged due to a long half-life and accumulation. Loperamide abuse may be under-recognized, leading to delays in treatment. Intravenous fluids, magnesium supplementation, chronotropes, transcutaneous or transvenous pacing, and defibrillation may be helpful in mitigating loperamide-associated polymorphic ventricular tachycardia. Clinicians should monitor for drug interactions in patients taking loperamide and screen for electrocardiographic abnormalities in those taking chronic or high-dose loperamide.

Planned interim analysis of PATRICIA: An open-label, single-arm, phase II study of pertuzumab (P) with high-dose trastuzumab (H) for the treatment of central nervous system (CNS) progression post radiotherapy (RT) in patients (pts) with HER2-positive metastatic breast cancer (MBC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2074-2074 ◽  
Author(s):  
Nancy U. Lin ◽  
Alisha Stein ◽  
Alan Nicholas ◽  
Anita M. Fung ◽  
Priya Kumthekar ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Objective Response ◽  
Metastatic Breast ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
High Dose ◽  
Her2 Positive ◽  
Open Label ◽  
Ventricular Ejection Fraction ◽  
Safety Signals

2074 Background: There is currently no clear standard of care to address the management of recurring/multiple intracranial metastases post RT in HER2-positive MBC. The ongoing PATRICIA study (NCT02536339) is evaluating the safety and efficacy of P in combination with high-dose h for patients with HER2-positive MBC with CNS metastases who have CNS progression following RT. Reported herein are results from the protocol-specified interim analysis of PATRICIA. Methods: All eligible patients must have measurable (≥10 mm) CNS progression post RT, and stable non-CNS disease. Patients receive P (840-mg loading dose, then 420 mg every 3 weeks) and high-dose h (6 mg/kg weekly). The primary efficacy endpoint is objective response rate (ORR) in the CNS per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. The interim analysis was planned after 15 patients were enrolled and had ≥2 left ventricular ejection fraction (LVEF) measurements, 2 cycles of study drugs, and 2 response measurements. The study would proceed to full enrollment (n=40) if objective response or stable disease in the CNS was observed in ≥1 of 15 patients and <2 of 15 patients develop congestive heart failure (CHF) related to P or H. Results: As of Sept 6, 2016, 15 patients had been enrolled across 9 sites. Median treatment duration was 4.4 (range 1.2−8.3) months. Six patients discontinued treatment (5 for disease progression; 1 for symptomatic deterioration). Range for duration of response was 1.4−3.3 months. There were no new safety signals for P combined with high-dose h treatment. No patients had CHF or a clinically significant drop in LVEF. Conclusions: Based on early evidence of clinical benefit (ORR 20%) and a lack of new safety signals, the safety and futility boundaries for PATRICIA have been passed and study enrollment continues. Clinical trial information: NCT02536339. [Table: see text]

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