The cVAD registry for percutaneous temporary hemodynamic support: A prospective registry of Impella mechanical circulatory support use in high-risk PCI, cardiogenic shock, and decompensated heart failure

2018 ◽  
Vol 199 ◽  
pp. 115-121 ◽  
Author(s):  
George W. Vetrovec ◽  
Mark Anderson ◽  
Theodore Schreiber ◽  
Jeffrey Popma ◽  
William Lombardi ◽  
...  
2018 ◽  
Author(s):  
Behnam Tehrani ◽  
Alexander Truesdell ◽  
Ramesh Singh ◽  
Charles Murphy ◽  
Patricia Saulino

BACKGROUND The development and implementation of a Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. OBJECTIVE The objectives of this study are (1) to collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes; (2) to evaluate Inova Heart and Vascular Institute site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017; (3) to compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls; (4) to assess survival to discharge rate in patients receiving intervention from the designated shock team and (5) create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. METHODS This is an observational, retrospective, single center study. Retrospective and prospective data will be collected in patients treated at the Inova Heart and Vascular Institute with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data from patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. In the study group, all patients evaluated for documented cardiogenic shock (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) treated at the Inova Heart and Vascular Institute by the Cardiogenic Shock team will be included. An additional historical Inova Heart and Vascular Institute control group will be analyzed as a comparator. Means with standard deviations will be reported for outcomes. For categorical variables, frequencies and percentages will be presented. For continuous variables, the number of subjects, mean, standard deviation, minimum, 25th percentile, median, 75th percentile and maximum will be reported. Reported differences will include standard errors and 95% CI. RESULTS Preliminary data analysis for the year 2017 has been completed. Compared to a baseline 2016 survival rate of 47.0%, from 2017 to 2018, CS survival rates were increased to 57.9% (58/110) and 81.3% (81/140), respectively (P=.01 for both). Study data will continue to be collected until December 31, 2018. CONCLUSIONS The preliminary results of this study demonstrate that the INOVA SHOCK team approach to the treatment of Cardiogenic Shock with early team activation, rapid initiation of mechanical circulatory support, hemodynamic-guided management, and strict protocol adherence is associated with superior clinical outcomes: survival to discharge and overall survival when compared to 2015 and 2016 outcomes prior to Shock team initiation. What may limit the generalization of these results of this study to other populations are site specific; expertise of the team, strict algorithm adherence based on the INOVA SHOCK protocol, and staff commitment to timely team activation. Retrospective clinical outcomes (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) demonstrated an increase in current survival rates when compared to pre-Cardiogenic Shock team initiation, rapid team activation and diagnosis and timely utilization of mechanical circulatory support. CLINICALTRIAL ClinicalTrials.gov NCT03378739; https://clinicaltrials.gov/ct2/show/NCT03378739 (Archived by WebCite at http://www.webcitation.org/701vstDGd)


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Marini ◽  
V Pazzanese ◽  
M Pagnesi ◽  
M Gramegna ◽  
L F Bertoldi ◽  
...  

Abstract Background The Impella (Abiomed, Danvers, MA) mechanical circulatory support is a catheter-based axial-flow pump. It reduces left ventricular (LV) stroke work and myocardial oxygen demand while increasing systemic and coronary perfusion in the setting of cardiogenic shock (CS), and it provides hemodynamic support during high-risk percutaneous coronary intervention (PCI). Purpose To evaluate the outcomes of Impella-supported patients in the context of CS and protected-PCI. Methods This single-center registry includes all patients implanted with Impella device at our institution between February 2013 and June 2018. Indications for Impella support were CS (hypotension despite adequate filling status with signs of hypoperfusion) and protected-PCI (prophylactic hemodynamic support during non-emergent high-risk PCI). Results A total of 145 patients were implanted with Impella: 130 (89.7%) for CS and 15 (10.3%) for protected-PCI. Among CS patients, mean age was 61.6±12.9, 79.2% males. The prevalence of chronic heart failure (HF) was 26.1%, prior myocardial infarction (MI) 29% and myocardial revascularization 36.6%, chronic kidney disease (CKD) 18.3%. Among protected PCI patients, mean age was 73.4±8.7 years, 86.7% males. The prevalence of HF was 85.7%, prior MI 42.9%, myocardial revascularization 35.7%, CKD 57.1%. In CS group, the indications for Impella implantation were myocarditis in 8 (6.2%) patients, acute coronary syndromes in 77 (59.2%), periprocedural ventricular tachycardia ablation CS in 10 (7.7%), decompensated heart failure in 26.9%. Out of hospital cardiac arrest occurred in 35 (30.4%) patients, INTERMACS I class in 70 (59.3%), mean arterial pressure was 65.4±18.4 mmHg, serum lactate 6.7±5.5 mmol/l, at least 1 inotropic agent use in 73 (66.4%), mean LV EF 21.4±11,7%, right ventricular dysfunction in 53 (48.6%). The rate of device-related complications was not negligible in CS group: 18 (14.5%) patients had limb ischemia and vascular surgery was required in 14, 17 (14.3%) had access-site bleeding. A total of 42 (33.3%) had haemolysis, and 67 (56.8%) acute kidney injury (AKI), half of whom requiring renal replacement therapy. Escalation to other therapies was necessary in 43 cases. Conversely, in the protected-PCI group a low rate of AKI (n=4, 28.6%) and acute limb ischemia (n=1, 7.1%) was observed, whereas no cases of haemolysis nor need of escalation therapy were recorded. Mean Impella support was 135.5±167.21 days for CS group, 60.6±80 for protected-PCI group. Survival at 30 days was 60.33% for CS group and 92.9% for protected-PCI group. One-year all-cause death was 50% for CS group and 13.3% for protected-PCI group. Conclusion Mechanical circulatory support with Impella is associated with good outcomes and reasonable rates of complications in the protected-PCI group, whereas less favorable results were observed in CS population probably due to the greater severity of clinical presentation.


2021 ◽  
Vol 8 (08) ◽  
pp. 5578-5583
Author(s):  
Usman Sarwar ◽  
Nikky Bardia ◽  
Amod Amritphale ◽  
Hassan Tahir ◽  
MD Ghulam M.Awan

Statistical data has shown that patients now treated in cardiac catheterization laboratories are older with several comorbidities, including renal failure, diabetes, and heart failure [1]. In past patients who were not suitable candidates for percutaneous coronary intervention due to their numerous comorbidities now seems to be a suitable candidate due to tremendous advancements in the field of interventional cardiology like new stent design and availability of advance mechanical circulatory support devices, i.e., Impella performing PCI on these high-risk patients become a viable option. There are two areas of cardiology in which mechanical circulatory support devices keep evolving: one is high-risk (percutaneous coronary intervention) PCI, and the other is a cardiogenic shock that is refractory to initial pressor support.  In this article, we review evidence base data regarding the use of mechanical circulatory support devices in high-risk percutaneous intervention and cardiogenic shock.


2019 ◽  
Author(s):  
Dane A Coyne ◽  
Mitali P Shah ◽  
Kris M Mogensen ◽  
John C Klick

Heart failure is a devastating progressive disease process that is rising in incidence throughout the world. For patients with end-stage heart failure, orthotopic heart transplantation had been the only therapeutic option. Unfortunately, the number of patients requiring such therapy far exceeds the number of available organs. Recent advancements in technology have made implantable cardiac assist devices a reality. Outcomes with these devices are superior to maximal medical therapy and may serve either as a bridge to the availability of a donor organ or as “destination” therapy for the patient with end-stage heart failure. In addition, new technology can also provide temporary mechanical support for patients with acute decompensated cardiogenic shock, allowing preservation of end-organ function until more definitive long-term mechanical support can be coordinated. Patients with end-stage heart failure experience unique nutritional challenges. Mechanical circulatory support adds yet another unique dimension to the nutritional support challenges of this patient population. This review contains 2 figures, 5 tables, and 29 references. Key words: cardiogenic shock, enteral nutrition, extracorporeal membrane oxygenation, heart failure, mechanical circulatory support, nutritional support, parenteral nutrition, ventricular assist device


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jelani Grant ◽  
Louis Vincent ◽  
Bertrand Ebner ◽  
Jennifer Maning ◽  
Igor Vaz ◽  
...  

Introduction: Hospitalizations associated with advanced heart failure (HF) requiring mechanical circulatory support (MCS) are usually associated with a high morbidity, mortality and a protracted hospital course. Prior studies have shown that the early inclusion of palliative care specialist is associated with better end-of-life experiences. Methods: The National Inpatient Sample Database was queried from 2012 to 2017 for relevant International Classification of Diseases (ICD)-9 and ICD-10 procedural and diagnostic codes to identify patients above 18 years with advanced HF admitted with cardiogenic shock requiring MCS. Baseline characteristics and in-hospital outcomes were compared among patients evaluated by palliative care and those who were not. A p-value of <0.001 was considered statistically significant. Results: There were 748,360 patients hospitalized for advanced HF complicated by cardiogenic shock requiring MCS, of these a palliative care consult was placed in 118,015 (15.8%) patients. Patients evaluated by palliative care were older (70.6±14.9 vs. 64.9±16.3 years old, p<0.001) and had a higher prevalence of atrial fibrillation (39.3 vs. 35.1%,p<0.001) and chronic kidney disease (40.4 vs. 33.3, p<0.001), however had lower hypertension (57.4 vs. 59.7%, p<0.001), diabetes (35.4 vs. 36.5%, p<0.001), coronary artery disease (51.2 vs. 58.4%, p<0.001) and acute coronary syndromes (39.2 vs. 45.0%, p<0.001). Consulting palliative care was associated with a shorter length of stay (8.8±12.0 vs. 11.9±15.5 days, p<0.001), lower total hospital cost ($161,972±265,156 vs. $219,114±318,387, p<0.001) and higher Do Not Resuscitate (DNR) orders (30.8 vs. 5.8%, p<0.001). Mortality rates were higher in the palliative care cohort (73.4 vs. 29.4%, p<0.001). Conclusions: Despite the high morbidity and mortality associated with advanced HF patients with cardiogenic shock requiring MCS, the overall prevalence of palliative care consultation is exceedingly low. DNR orders were more prevalent in patients seen by the palliative care service. This study highlights the underutilization of palliative care services in this patient population, precluding any perceived benefit in end of life experiences.


Author(s):  
Holger Thiele ◽  
Pascal Vranckx

Coronary artery disease (CAD) has emerged as the dominant aetiologic factor in acute heart failure syndromes (AHFS) and cardiogenic shock (CS). The invasive management of the complex cardiac patient with advanced (decompensated) heart failure, CS, and/or potential haemodynamic compromise during and/after percutaneous coronary intervention (PCI) has become the remit of specialty myocardial intervention centres. Such centres provide state-of the art facilities for PCI, including experienced senior operators and critical care physicians who are available 24 hours per day, 7 days per week, with immediate access to cardiac surgery and mechanical circulatory support (MCS) systems.


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