P2626Outcome of patients in cardiogenic shock supported with a micro-axial blood pump providing 5 l/min blood flow

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Nersesian ◽  
F Spillmann ◽  
T Gromann ◽  
C Tschoepe ◽  
F Schoenrath ◽  
...  

Abstract Introduction Percutaneous mechanical circulatory support devices are increasingly used in acute cardiogenic shock (CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the full support Impella 5 and 5.5 as a short- term left ventricular device (LVAD) and to identify preoperative predictors of short -term mortality. Methods Data of patients in CS (n=51) treated with the Impella 5 (n=48) and 5.5 (n=3) devices at our institution were collected retrospectively. The primary endpoint was 30-day all-cause mortality. Clinical follow up including adverse events was analyzed. Results Mean age was 58.2±12.1 years; 80.4% were male. 13 patients had BMI >30 kg/m2. CS was caused by acute myocardial infarction (n=14), decompensated chronic heart failure (n=29), postcardiotomy syndrom and acute myocarditis (n=4 each). Before implantation, median Intermacs profile was 1 (range 1–3) and 31 patients (61%) were on respiratory support. In 49 patients the axillary artery was used for vascular access (n=4 left and n=45 right) employing a 10mm dacron graft tunneled through the skin, in one patient left femoral artery and ascending aorta, respectively. Median support time was 14 days. In 12 cases the pump was removed for myocardial recovery. In 15 patients a continuous flow permanent LVAD was implanted. Bleeding (n=9), thromboembolic event (n=5), pump dislodgement (n=7) requiring revision occurred during support. Seven patients developed ventricular arrhythmia requiring flow reduction. In 5 cases the pump was explanted for hemolysis, in 2 other patients pump exchange was performed. The overall 30-day survival was 53% (95% CI: 38.8–67.1%). Penalized multivariable logistic regression analysis identified preoperative elevated lactate (p=0.027) and CK-MB (p=0.022) as predictors for 30- day mortality. On the basis of these data, a nomogram to estimate 30d-mortality after Impella implantation was created. Conclusion Stabilization of patients suffering from CS employing temporary full support Impella LVAD is feasible and results in acceptable survival. Preoperative degree of shock and myocardial damage predict the short-term mortality. Effect of full support Impella LVAD in earlier stages of shock may prevent irreversible end organ damage.

2020 ◽  
Vol 31 (4) ◽  
pp. 475-482
Author(s):  
Gaik Nersesian ◽  
Carsten Tschöpe ◽  
Frank Spillmann ◽  
Tom Gromann ◽  
Luise Roehrich ◽  
...  

Abstract OBJECTIVES Short-term mechanical circulatory support is a life-saving treatment for acute cardiogenic shock (CS). This multicentre study investigates the preoperative predictors of 30-day mortality in CS patients treated with Impella 5.0 and 5.5 short-term left ventricular assist devices. METHODS Data of patients in CS (n = 70) treated with the Impella 5 (n = 63) and 5.5 (n = 7) in 2 centres in Berlin between October 2016 and October 2019 were collected retrospectively. RESULTS CS was caused by acute myocardial infarction (n = 16), decompensated chronic heart failure (n = 41), postcardiotomy syndrome (n = 5) and acute myocarditis (n = 8). Before implantation 12 (17%) patients underwent cardiopulmonary resuscitation and 32 (46%) patients were ventilated. INTERMACS level 1, 2 and 3 was established in 35 (50%), 29 (41%) and 6 (9%) of patients, respectively. The mean preoperative lactate level was 4.05 mmol/l. The median support time was 7 days (IR= 4–15). In 18 cases, the pump was removed for myocardial recovery, in 22 cases, durable left ventricular assist devices were implanted, and 30 patients died on support. The overall 30-day survival was 51%. Statistical analysis showed that an increase in lactate per mmol/l [odds ratio (OR) 1.217; P = 0.015] and cardiopulmonary resuscitation before implantation (OR 16.74; P = 0.009) are predictors of 30-day survival. Based on these data, an algorithm for optimal short-term mechanical circulatory support selection is proposed. CONCLUSIONS Impella treatment is feasible in severe CS. Severe organ dysfunction, as well as the level and duration of shock predict early mortality. An algorithm based on these parameters may help identify patients who would benefit from Impella 5+ support.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Shariff ◽  
R Doshi ◽  
I Pedreira Vaz ◽  
D Adalja ◽  
A Krishnan ◽  
...  

Abstract Introduction Cardiogenic shock is linked with eminent morbidity and mortality despite advances in treatment modality. Adjuvant treatment modalities to provide mechanical haemodynamic support in the form of intra-aortic balloon pump (IABP) or Impella are being used among patients with cardiogenic shock. The Impella prunes left ventricular preload, whereas, IABP persuades after load reduction and both contribute to improved cardiac output. A few underpowered randomised control trials (RCTs) and observational studies compared short term mortality benefit of Impella juxtaposed to IABP among patients with cardiogenic shock. Purpose A meta-analysis of RCTs and observational studies researching the short-term mortality in cardiogenic shock comparing Impella to IABP was executed. Methods The databases PubMed, EMBASE and Cochrane were searched systematically to identify relevant RCTs and observational studies contrasting Impella to IABP and reporting 30-days mortality as outcomes. The search terms used were “Impella”, “IAPB”, “intra-aortic balloon pump” and all word variations were utilised. The search was conducted from the debut of the databases up to January 2020. Two reviewers independently and in tandem performed data screening and extraction from identified articles. Inverse variance method with Paule-Mandel estimator for tau2 and Hartung-Knapp adjustment was used to calculate Risk Ratio with 95% confidence interval. Heterogeneity was assessed using I2 statistics. Furthermore, we calculated the 95% predictive interval for the pooled estimate. All statistical analysis for this meta-analysis was carried out using R statistical software version 3.6.2 using the package meta ( ). Additionally, Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria were used to assess the certainty of evidence. Results Five studies constituting 728 patients were included in the final analysis. Two were RCTs (ISAR-SHOCK trial and IMPRESS in Severe Shock trial), one study was a propensity score matched observational study and two were unmatched observational studies. There was no difference in the risk of 30-days mortality in patients treated with Impella as compared to IABP [Risk Ratio: 0.97, 95% confidence interval: 0.66–1.41, I2: 32%]. To account for the heterogeneity, we calculated 95% predictive interval: 0.46–2.02. Thus, very low certainty of evidence concluded no difference in the risk of 30-days mortality among cardiogenic shock patients treated with Impella in opposition to IABP. Conclusion This meta-analysis comparing Impella juxtaposed with IABP demonstrated no difference in the risk of 30-days mortality among patients with cardiogenic shock. 30-days Mortality Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
M Alonso Fernandez De Gatta ◽  
A Diego Nieto ◽  
S Merchan Gomez ◽  
M Gonzalez Cebrian ◽  
I Toranzo Nieto ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Instituto de Salud Carlos III in Spain (Co-funded by European Social Fund "Investing in your future"). INTRODUCTION The Coronavirus disease 19 (COVID-19) pandemic has impacted clinical practice with important changes in the most affected areas, resulting in increased mortality from heart disease (myocardial infarction). The feasibility of continuing a temporary mechanical circulatory support (MCS) program is unknown. PURPOSE Our objective was to analyze the survival of patients requiring short-term MCS with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella CP® during the COVID-19 pandemic. METHODS Retrospective study including all VA-ECMO and Impella CP® implants in a referral hospital since March 2020 compared to previous implants results. RESULTS Out of 167 short-term MCS implanted from 2013, 25 (15%) were conducted during the time of COVID-19 pandemic: 19 VA-ECMO and 6 Impella CP® (Table). Compared to preCOVID-19 implants, patients requiring MCS in the COVID era presented more frequently right ventricular dysfunction (p = 0.005) and showed a trend towards older age (p = 0.069) and lower left ventricular ejection fraction (p = 0.063), without other significant differences regarding the baseline situation and implant technique (Table). Encephalopathy was more frequent in the COVID-19 era, with no differences in other complications (Table). Survival at discharge was 43.7% in the pre-COVID era vs 36% during COVID-19 pandemic, without finding statistically significant differences (p = 0.313). CONCLUSION Survival after temporary MCS did not get worse significantly during the COVID-19 pandemic. The possibility of short-term MCS should be maintained for cardiogenic shock and other cases of hemodynamic instability. Comparison MCS before and during COVIDTime of implantP valueTime of implantP valuePre-COVID-192013-Feb 2020 (n = 142)COVID-19 timeMarch 2020-Nov 2020 (n = 25)Pre-COVID-192013-Feb 2020 (n = 142)COVID-19 timeMarch 2020-Nov 2020 (n = 25)Age (years) (mean+ SD)Male (n, %)62 ± 10 108 (76%)66 ± 10 15 (60%)0.069 0.079Support type VA-ECMO (n = 137) Impella CP® (n = 30) Percutaneous implant 118 (83.1%)24 (16.9%) 100 (70.4% 19 (76%) 6 (24%) 20 (80%)0.566 0.536Indication (n,%) Cardiogenic shock Refractory cardiac arrest Electrical storm0.63763 (44.4%)16 (11.3%)9 (6.3%)12 (48%) 4 (16%)2 (8%)Drugs at the implant Noradrenaline Dobutamine Adrenaline 115 (81%)114 (80.3%)51 (35.9%) 21 (84%) 21 (84%) 5 (20%) 0.370 0.312 0.108High-risk PCI Postcardiotomy shock Others17 (12%)36 (25.4%)1 (0.7%)3 (12%)4 (16%) 0 (0%)Time MCS (days)4.8 ± 53.9 ± 40.284 7.23 ± 0.16.8 ± 5 0.2920.495Complications (n,%) Vascular (bleeding, ischemia) Bleeding (minor or major) Critical care infections 35 (24.6%)59 (41.5%)67 (47.2%) 7 (28%) 9 (36%) 9 (36%) 0.096 0.117 0.096pH (mean + SD)lactate (mmol/L) (mean + SD)7.13 ± 16.03 ± 5LVEF (%) (mean + SD)Right ventricle dysfunction (n,%)28.7 ± 16 68 (47.9%)21.9 ± 15 20 (80%)0.063 0.005Ischemic/hemorragic stroke Renal replacement therapy Tracheostomy Encephalopathy9 (6.3%) 36 (25.4%) 23 (16.2%)14 (9.8%)2 (8%) 4 (16%) 5 (20%) 6 (24%)0.220 0.136 0.547 0.023Preimplant cardiac arrest (n,%)Cardiac arrest duration (min) (n,%)68 (47.9%) 28.7 ± 2312 (48%) 29.8 ± 230.364 0.880Survival at discharge (n,%)62 (43.7%)9 (36%)0.313


Author(s):  
Jacob C Jentzer ◽  
Benedikt Schrage ◽  
David R Holmes ◽  
Salim Dabboura ◽  
Nandan S Anavekar ◽  
...  

Abstract Aims Cardiogenic shock (CS) is associated with poor outcomes in older patients, but it remains unclear if this is due to higher shock severity. We sought to determine the associations between age and shock severity on mortality among patients with CS. Methods and results Patients with a diagnosis of CS from Mayo Clinic (2007–15) and University Clinic Hamburg (2009–17) were subdivided by age. Shock severity was graded using the Society for Cardiovascular Angiography and Intervention (SCAI) shock stages. Predictors of 30-day survival were determined using Cox proportional-hazards analysis. We included 1749 patients (934 from Mayo Clinic and 815 from University Clinic Hamburg), with a mean age of 67.6 ± 14.6 years, including 33.6% females. Acute coronary syndrome was the cause of CS in 54.0%. The distribution of SCAI shock stages was 24.1%; C, 28.0%; D, 33.2%; and E, 14.8%. Older patients had similar overall shock severity, more co-morbidities, worse kidney function, and decreased use of mechanical circulatory support compared to younger patients. Overall 30-day survival was 53.3% and progressively decreased as age or SCAI shock stage increased, with a clear gradient towards lower 30-day survival as a function of increasing age and SCAI shock stage. Progressively older age groups had incrementally lower adjusted 30-day survival than patients aged <50 years. Conclusion Older patients with CS have lower short-term survival, despite similar shock severity, with a high risk of death in older patients with more severe shock. Further research is needed to determine the optimal treatment strategies for older CS patients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Haurand ◽  
S Bueter ◽  
C Jung ◽  
M Kelm ◽  
R Westenfeld ◽  
...  

Abstract Background Percutaneous left ventricular assist devices such as the Impella pump, are used to hemodynamically stabilize patients with cardiogenic shock (CS) caused by acute myocardial infarction (AMI) until cardiac function has recovered after revascularization. Whether Impella mechanical circulatory support (MCS) is effective in stabilizing patients with CS not caused by AMI has so far not been thoroughly investigated. Purpose The aim of this study is to analyze whether MCS with Impella is effective to stabilize patients with non-AMI related CS compared to patients with AMI related CS. Method We retrospectively analyzed 106 patients with CS and Impella support in the years from 2011 to 2018. Efficacy to stabilize the patient was assessed by laboratory values such as lactate, hemodynamic parameters and clinical scores. The difference in mortality was calculated with the Log-Rank-Test, comparing Kaplan-Meier curves. Results 36 patients suffered from non-AMI CS and in 70 patients CS was caused by AMI. Regarding the clinical scores and hemodynamic parameters, both groups were severely ill, with no significant difference in APACHE II score, with a mean score of 17.9 in the non-AMI group compared to 20.5 in the AMI-group (p=0.103), the SOFA score (mean score of 6.3 in non-AMI group vs 6.8 in AMI group, p=0.467) and cardiac index (mean CI of 1.9 l/min/m2 in non-AMI group vs 2.2 l/min/m2 in AMI group, p=0.176). There was a comparable mean decrease in lactate levels in both groups 48 hours after initiation of MCS, from initially 4.1 mmol/l to 1.7 mmol/l (p<0.001) in the non-AMI group and from initially 3.6 mmol/l to 2.2 mmol/l (p=0.025) in the AMI group. The non-ACS group exhibited a trend of lower mortality compared to the AMI group, with 47% in the non-AMI group and 57% in the AMI group (p=0.067). In multivariate analysis, age, lactate levels, cardiopulmonary resuscitation, low platelets and higher doses of inotropes and vasopressors were independent predictors for mortality. An upgrade to LVAD was performed for 22% of the non-AMI group and for 6% of the AMI group (p=0.020). Conclusion Impella support is effective to hemodynamically stabilize patients with non-AMI related CS. Therefore, MCS can be used as bridge to recovery or enables further treatment options as upgrade to longterm mechanical support devices. Funding Acknowledgement Type of funding source: None


Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 747
Author(s):  
Rafal Berger ◽  
Hasan Hamdoun ◽  
Rodrigo Sandoval Boburg ◽  
Medhat Radwan ◽  
Metesh Acharya ◽  
...  

Background and Objectives: Over the past decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has developed into a mainstream treatment for refractory cardiogenic shock (CS) to maximal conservative management. Successful weaning of VA-ECMO may not be possible, and bridging with further mechanical circulatory support (MCS), such as urgent implantation of a left ventricular assist device (LVAD), may represent the only means to sustain the patient haemodynamically. In the recovery phase, many survivors are not suitably prepared physically or psychologically for the novel issues encountered during daily life with an LVAD. Materials and Methods: A retrospective analysis of our institutional database between 2012 and 2019 was performed to identify patients treated with VA-ECMO for CS who underwent urgent LVAD implantation whilst on MCS. Post-cardiotomy cases were excluded. QoL was assessed prospectively during a routine follow-up visit using the EuroQol-5 dimensions-5 level (EQ-5D-5L) and the Patient Health Questionnaire (PHQ-9) surveys. Results: Among 126 in-hospital survivors of VA-ECMO therapy due to cardiogenic shock without prior cardiac surgery, 31 (24.6%) urgent LVAD recipients were identified. In 11 (36.7%) cases, cardiopulmonary resuscitation (CPR) was performed (median 10, range 1–60 min) before initiation of VA-ECMO, and in 5 (16.7%) cases, MCS was established under CPR. Mean age at LVAD implantation was 51.7 (+/−14) years and surgery was performed after a mean 12.1 (+/−8) days of VA-ECMO support. During follow-up of 46.9 (+/−25.5) months, there were 10 deaths after 20.4 (+/−12.1) months of LVAD support. Analysis of QoL questionnaires returned a mean EQ-5D-5L score of 66% (+/−21) of societal valuation for Germany and a mean PHQ-9 score of 5.7 (+/−5) corresponding to mild depression severity. When compared with 49 elective LVAD recipients without prior VA-ECMO therapy, there was no significant difference in QoL results. Conclusions: Patients requiring urgent LVAD implantation under VA-ECMO support due to CS are associated with comparable quality of life without a significant difference from elective LVAD recipients. Close follow-up is required to oversee patient rehabilitation after successful initial treatment.


2019 ◽  
Vol 57 (1) ◽  
pp. 183-188 ◽  
Author(s):  
Charles-Henri David ◽  
Astrid Quessard ◽  
Ciro Mastroianni ◽  
Guillaume Hekimian ◽  
Julien Amour ◽  
...  

Abstract OBJECTIVES Postcardiotomy cardiogenic shock (PCCS) is associated with high mortality rates of 50–80%. Although veno-arterial extracorporeal membrane oxygenation has been used as mechanical circulatory support in patients with PCCS, it is associated with a high rate of complications and poor quality of life. The Impella 5.0 and Impella Left Direct (LD) (Impella 5.0/LD) are minimally invasive left ventricular assist devices that provide effective haemodynamic support resulting in left ventricular unloading and systemic perfusion. Our goal was to describe the outcome of patients with PCCS supported with the Impella 5.0/LD at La Pitié-Salpêtrière Hospital. METHODS We retrospectively reviewed consecutive patients supported with the Impella 5.0/LD for PCCS between December 2010 and June 2015. Survival outcome and in-hospital complications were assessed. RESULTS A total of 29 patients (63 ± 14 years, 17% women) with PCCS were supported with the Impella 5.0/LD. At baseline, 69% experienced chronic heart failure, 66% had dilated cardiomyopathy and 57% had valvular disease. The mean EuroSCORE II was 22 ± 17 and the ejection fraction was 28 ± 11%. Most of the patients underwent isolated valve surgery (45%) or isolated coronary artery bypass grafting (38%). The mean duration of Impella support was 9 ± 7 days. Weaning from the Impella was successful in 72.4%, and 58.6% survived to discharge. Recovery of native heart function was observed in 100% of discharged patients. Survival to 30 days and to 1 year from Impella implant was 58.6% and 51.7%, respectively. CONCLUSIONS The Impella 5.0 and the Impella LD represent an excellent treatment option for critically ill patients with PCCS and are associated with favourable survival outcome and native heart recovery.


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