scholarly journals One-Year Echocardiographic, Functional, and Quality of Life Outcomes After Ultrasound-Facilitated Catheter-Based Fibrinolysis for Pulmonary Embolism

2020 ◽  
Vol 13 (8) ◽  
Author(s):  
Gregory Piazza ◽  
Keith M. Sterling ◽  
Victor F. Tapson ◽  
Kenneth Ouriel ◽  
Andrew S.P. Sharp ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Functional Status ◽  
Left Ventricular ◽  
Diameter Ratio ◽  
Left Ventricular Diameter ◽  
Submassive Pulmonary Embolism ◽  
Dosing Regimens ◽  
Minute Walk

Background: Accelerated tPA (tissue-type plasminogen activator) dosing regimens for ultrasound-facilitated, catheter-directed fibrinolysis improve short-term computed tomographic-measured right ventricular (RV)-to-left ventricular diameter ratio in massive and submassive pulmonary embolism. The impact on RV remodeling, functional status, and quality of life over the long-term remains unclear. Methods: To study 1-year changes in RV remodeling, functional status, and quality of life, we assessed patients with acute submassive pulmonary embolism randomly assigned to 1 of 4 tPA dosing regimens for ultrasound-facilitated, catheter-directed fibrinolysis in the OPTALYSE-PE trial (Optimum Duration and Dose of r-tPA With the Acoustic Pulse Thrombolysis Procedure for Intermediate-Risk Pulmonary Embolism; 8 mg/2 hours, 8 mg/4 hours, 12 mg/6 hours, and 24 mg/6 hours). Echocardiographic assessment included RV-to-left ventricular diameter ratio within 4 hours of treatment end, and at 48 hours, 30 days, 90 days, and 1 year. Functional status was assessed by 6-minute walk test at 30 days, 90 days, and 1 year and PROMIS-PF-6b scores at 30 days, 90 days, 180 days, 270 days, and 1 year. Quality of life was evaluated by PEmb-QOL scores at 30 days, 90 days, 180 days, 270 days, and 1 year. Results: Mean RV-to-left ventricular diameter ratio decreased from baseline to 4 hours and further at 48 hours and 30 days, with reductions maintained at 90 days and 1 year in all groups. Mean 6-minute walk distance, PROMIS-PF-6b, and PEmb-QOL scores improved over the course of 1 year in all groups. Conclusions: Accelerated lower-dose tPA regimens for ultrasound-facilitated, catheter-directed fibrinolysis resulted in sustained recovery of RV-to-left ventricular diameter ratio and tricuspid annular plane systolic excursion and improvements in functional status and quality of life over 1 year. Registration: URL: https://www.ClinicalTrials.gov . Unique Identifier: NCT02396758.

scholarly journals Mid-term outcomes with the use of extracorporeal membrane oxygenation for cardiopulmonary failure secondary to massive pulmonary embolism

2020 ◽  
Vol 58 (5) ◽  
pp. 923-931
Author(s):  
Federico Sertic ◽  
Dieynaba Diagne ◽  
Lexy Chavez ◽  
Thomas Richards ◽  
Ashley Berg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Hospital Mortality ◽  
Functional Status ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Acute Pe

Abstract OBJECTIVES There has been increasing interest in using extracorporeal membrane oxygenation (ECMO) to rescue patients with pulmonary embolism (PE) in the advanced stages of respiratory or haemodynamic decompensation. We examined mid-term outcomes and risk factors for in-hospital mortality. METHODS We conducted a retrospective study of 36 patients who required ECMO placement (32 veno-arterial ECMO, 4 veno-venous) following acute PE. Survival curves were estimated using the Kaplan–Meier method. Risk factors for in-hospital mortality were assessed by logistic regression analysis. Functional status and quality of life were assessed by phone questionnaire. RESULTS Overall survival to hospital discharge was 44.4% (16/36). Two-year survival conditional to discharge was 94% (15/16). Two-year survival after veno-arterial ECMO was 39% (13/32). In patients supported with veno-venous ECMO, survival to discharge was 50%, and both patients were alive at follow-up. In univariable analysis, a history of recent surgery (P = 0.064), low left ventricular ejection fraction (P = 0.029), right ventricular dysfunction ≥ moderate at weaning (P = 0.083), on-going cardiopulmonary resuscitation at ECMO placement (P = 0.053) and elevated lactate at weaning (P = 0.002) were risk factors for in-hospital mortality. In multivariable analysis, recent surgery (P = 0.018) and low left ventricular ejection fraction at weaning (P = 0.013) were independent factors associated with in-hospital mortality. At a median follow-up of 23 months, 10 patients responded to our phone survey; all had acceptable functional status and quality of life. CONCLUSIONS Massive acute PE requiring ECMO support is associated with high early mortality, but patients surviving to hospital discharge have excellent mid-term outcomes with acceptable functional status and quality of life. ECMO can provide a stable platform to administer other intervention with the potential to improve outcomes. Risk factors for in-hospital mortality after PE and veno-arterial ECMO support were identified.

scholarly journals First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism

2020 ◽  
Author(s):  
Akhilesh K. Sista ◽  
Rohit Bhatheja ◽  
Parth Rali ◽  
Kannan Natarajan ◽  
Philip Green ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Right Ventricular ◽  
Human Study ◽  
Left Ventricular ◽  
Diameter Ratio ◽  
Tissue Type ◽  
Intermediate Risk ◽  
Unique Identifier ◽  
Left Ventricular Diameter

Background: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE). Methods: Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy. Results: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 ( P =0.0009 [95% CI, 0.33–0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 ( P =0.0005; [95% CI, 5.5–13.4]; 37.1% reduction). Conclusions: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03927508.

Abstract 062: Physiological and Psychological Stress Response are Related to QOL and Functional Status Among People Living With a Left Ventricular Assist Device

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Martha Abshire ◽  
Gayle G Page ◽  
Chakra Budhathoki ◽  
Patricia M Davidson ◽  
Stuart D Russell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Stress Response ◽  
Sleep Quality ◽  
Functional Status ◽  
Psychological Stress ◽  
Healthcare Utilization ◽  
Perceived Stress ◽  
Left Ventricular ◽  
Cortisol Awakening Response

Background: Advanced heart failure patients with left ventricular assist device (LVAD) have experienced emotional distress and psychological sequelae following implant. However, few studies have examined stress among patients with LVAD. The purpose of this study was to describe physiological and psychological stress response and then to examine relationships between physiological and psychological stress response and outcomes (quality of life (QOL), functional status and healthcare utilization) in patients with LVAD. Design: A descriptive observational study design was used to examine physiological and psychological stress response among LVAD patients. Methods: Data was collected for patients more than 3 months post-LVAD implantation (N = 44). Relationships among indicators of physiological (salivary cortisol, sleep quality) and psychological stress, (perceived stress, depression and fatigue) and outcomes (quality of life, functional status as measured by Six Minute Walk Test (6MWT) and healthcare utilization, using hospitalization rate) were examined using descriptive statistics and logistic regression models. Results: The sample was average age 57.7 years, mostly male (73%), married (70.5%) and racially diverse (white 46%, black 43%, other 11%). Median LVAD support was 18.2 months. Normal cortisol awakening response was seen in most participants (61%). LVAD patients reported moderate levels of psychological stress and sleep quality and enjoy a good quality of life (73 out of 100, SD ± 13.5). At the bivariate level, normal cortisol awakening response was correlated with low depressive symptoms (p< 0.02). Poor sleep quality was correlated with increased psychological stress response and QOL (p< 0.01). Perceived stress was positively associated with healthcare utilization (p<0.01). In multivariate analysis, cortisol and sleep quality were independent predictors of 6MWT > 300 meters (R 2 = 0.33, chi 2 = 0.002), but not for QOL and healthcare utilization when controlling for psychological stress. Conclusions: This is the first report of salivary cortisol and perceived stress in outpatients with LVAD. Associations were seen between sleep quality, psychological stress response and QOL. Cortisol and sleep quality were predictive of functional status among patients with LVAD. Future research should explore if those with a higher stress profile (abnormal cortisol awakening response, worse sleep quality, perceived stress, depression, fatigue) would benefit from tailored supportive interventions to lower perceived stress, improve sleep quality and improve QOL.

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