Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device.

OBJECTIVE: To report the initial clinical experience with the Impella 5.5® with SmartAssist®, a temporary left ventricular assist device that provides up to 6.2 L/min forward flow, with recent FDA approval for up to 14 days. METHODS: From October 2019 to March 2020, 200 patients at 42 US centers received the Impella 5.5 and entered into the IQ registry, a manufacturer-maintained quality database that captures limited baseline/procedural characteristics and outcomes through device explant. Post hoc subgroup analyses were conducted to assess the role of baseline and procedural characteristics on survival, defined as successful device weaning or bridge to durable therapy. RESULTS: Median patient age was 62 years (range, 13 to 83 years); 83.4% were male. The device was most commonly used for cardiomyopathy (45.0%), acute myocardial infarction complicated by cardiogenic shock (AMICS; 29.0%), and post cardiotomy cardiogenic shock (PCCS; 16.5%). Median duration of support was 10.0 days (range, 0.001 to 64.4 days). Through device explant, overall survival was 74.0%, with survival of 80.0%, 67.2%, 57.6%, and 94.7% in cardiomyopathy, AMICS, PCCS, and others (comprising high-risk revascularization, coronary artery bypass graft, electrophysiology/ablation, and myocarditis), respectively. Patients requiring extracorporeal membrane oxygenation and Impella support (35 patients, 17.5%) had significantly lower survival (51.4% vs 78.8%, P = 0.002). CONCLUSIONS: In the first 200 US patients treated with the Impella 5.5, we observed overall survival to explant of 74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly PCCS. Prospective studies assessing comparative performance of this device to conventional strategies are warranted in future.

Outcomes of patients with right ventricular failure requiring short-term hemodynamic support with the Impella RP device.

BACKGROUND: Right ventricular failure (RVF) after myocardial infarction, cardiotomy, or left ventricular assist device (LVAD) implantation increases morbidity and mortality. RVF also contributes to prolonged length of hospital stay and higher costs of care. The aim of this study was to evaluate the efficacy and safety of the Impella RP (Abiomed, Danvers, MA) in patients with severe RVF in these clinical settings. METHODS: This is a prospective cohort study of patients with severe RVF treated with a percutaneous right ventricular assist device (RVAD). Sixty patients with RVF refractory to medical treatment received the Impella RP device at 14 United States institutions as part of the Impella RP pre‒ and post‒market approval studies. The study population included 2 cohorts: Cohort A, patients with RVF post-(LVAD) implantation (n = 31); and Cohort B, patients with RVF post-cardiotomy, heart transplant, or myocardial infarction (n = 29). The primary end-point was survival at 30 days or hospital discharge (whichever was longer). RESULTS: Mean age of patients was 59 ± 15 years; 68% were males, 84% had a history of congestive heart failure, 44% had valvular disease, and 35% had pre-operative renal dysfunction. Patients received an average of 3.4 inotropes/vasopressors before the Impella RP implant. Patients were supported with the Impella RP for 4.0 ± 1.5 (0.5 to 14) days. Hemodynamics improved immediately after initiation of device support, with an increase in cardiac index from 1.9 ± 0.1 to 3.1 ± 0.2 liters/min/m2 (p < 0.001) and a decrease in central venous pressure from 19.0 ± 1 to 13 ± 1 mm Hg (p < 0.001). The overall survival at 30 days (or discharge) was 72%. CONCLUSIONS: To the best of our knowledge, this study represents the largest prospective study of patients with life-threatening RVF. Mechanical support with the Impella RP device in patients with RVF resulted in rapid hemodynamic improvement with reversal of shock and favorable survival.

Outcomes of Impella 5.0 in Cardiogenic Shock: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of the study was to comprehensively summarize the survival outcomes and complications of Impella 5.0 (Abiomed Inc, Danvers, MA USA) use in patients with cardiogenic shock (CS). METHODS: We performed a literature review for relevant studies by searching in Medline, Medline In-Process, EMBASE, and the CENTRAL bibliographic databases on April 30, 2017. Nonoverlapping studies with 10 patients or more supported for cardiogenic shock with Impella 5.0 or Impella left direct were included. Data on patient characteristics, indication of support, and outcomes were extracted. A random effect was used to pool the various outcomes. RESULTS: This meta-analysis included six studies totaling 163 patients (mean ± SD age = 56.3 ± 12.0, male 81%). Indications for support included 88 (54.0%) for acute on chronic decompensated heart failure, 35 (21.5%) for postcardiotomy cardiogenic shock, 27 (16.6%) for acute myocardial infarction complicated by cardiogenic shock, and, 13 (8.0%) for cardiogenic shock due to other reasons. Survival to next therapy was 73.5% in patients supported for acute on chronic decompensated heart failure. The survival to device explant among patients supported for postcardiotomy cardiogenic shock or acute myocardial infarction complicated by cardiogenic shock was 90.2%, and of those, myocardial recovery was achieved in 73.8%. The overall estimated survival to discharge, 30, 180, and 365 days was 73.5%, 72.6%, 62.7%, and 58.4%, respectively. Patients supported for postcardiotomy cardiogenic shock had the highest heart recovery among survivors to explant (92.1%) and highest survival at 30 (89.5%) and 365 days (69.5%). CONCLUSIONS: Impella 5.0/LD is associated with favorable survival outcomes and higher rate of myocardial recovery in patients with cardiogenic shock.

Acute Biventricular Mechanical Circulatory Support for Cardiogenic Shock.

BACKGROUND: Biventricular failure is associated with high in-hospital mortality. Limited data regarding the efficacy of biventricular Impella axial flow catheters (BiPella) support for biventricular failure exist. The aim of this study was to explore the clinical utility of percutaneously delivered BiPella as a novel acute mechanical support strategy for patients with cardiogenic shock complicated by biventricular failure. METHODS AND RESULTS: We retrospectively analyzed data from 20 patients receiving BiPella for biventricular failure from 5 tertiary-care hospitals in the United States. Left ventricular support was achieved with an Impella 5.0 (n=8), Impella CP (n=11), or Impella 2.5 (n=1). All patients received the Impella RP for right ventricular (RV) support. BiPella use was recorded in the setting of acute myocardial infarction (n=11), advanced heart failure (n=7), and myocarditis (n=2). Mean flows achieved were 3.4±1.2 and 3.5±0.5 for left ventricular and RV devices, respectively. Total in-hospital mortality was 50%. No intraprocedural mortality was observed. Major complications included limb ischemia (n=1), hemolysis (n=6), and Thrombolysis in Myocardial Infarction major bleeding (n=7). Compared with nonsurvivors, survivors were younger, had a lower number of inotropes or vasopressors used before BiPella, and were more likely to have both devices implanted simultaneously during the same procedure. Compared with nonsurvivors, survivors had lower pulmonary artery pressures and RV stroke work index before BiPella. Indices of RV afterload were quantified for 14 subjects. Among these patients, nonsurvivors had higher pulmonary vascular resistance (6.8; 95% confidence interval [95% CI], 5.5-8.1 versus 1.9; 95% CI, 0.8-3.0; P<0.01), effective pulmonary artery elastance (1129; 95% CI, 876-1383 versus 458; 95% CI, 263-653; P<0.01), and lower pulmonary artery compliance (1.5; 95% CI, 0.9-2.1 versus 2.7; 95% CI, 1.8-3.6; P<0.05). CONCLUSIONS: This is the largest, retrospective analysis of BiPella for cardiogenic shock. BiPella is feasible, reduces cardiac filling pressures and improves cardiac output across a range of causes for cardiogenic shock. Simultaneous left ventricular and RV device implantation and lower RV afterload may be associated with better outcomes with BiPella. Future prospective studies of BiPella for cardiogenic shock are required.

Patients with Infectious Endocarditis and Drug Dependence Have Worse Clinical Outcomes after Valvular Surgery.

BACKGROUND: Patients with infective endocarditis (IE) are at high risk for post-operative morbidity and death, which might be associated with drug abuse. The purpose of this study is to evaluate the impact of drug dependence on outcomes in patients who have IE and undergo valvular surgery (VS). PATIENTS AND METHODS: The Nationwide/National Inpatient Sample 2001-2012 was queried to select patients with IE who had elective VS using International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedure codes. Among them, patients with drug dependence (PDD) were identified, and their health status and post-operative outcomes were compared with those in patients without drug dependence (control group). Chi-square and Wilcoxon rank sum tests as well as multi-variable regression analysis were used for statistics. RESULTS: A total of 809 (12.9%) PDD of the 6,264 patients who underwent VS were evaluated. They were younger compared with those in the control group (39.0 ± 10.8 y vs. 54.4 ± 14.8 y; p < 0.0001), had less age-related co-morbidities such as hypertension, diabetes mellitus, congestive heart failure, renal failure, obesity, but greater rates of alcohol abuse, liver disease, and psychoses. Despite the younger age and fewer co-morbidities, PDD compared with control patients were more likely to have post-operative complications develop overall (odds ratio [OR] = 1.6; 95% confidence interval [CI] 1.34-2.01), including infectious complications (OR = 1.5; 95% CI 1.27-1.78), specifically pneumonia (OR = 1.4; 95% CI 1.14-1.74) and sepsis (OR = 1.4; 95% CI 1.16-1.63), renal complications (OR = 1.5; 95% CI 1.23-1.77), and pulmonary embolism (OR = 1.9; 95% CI 1.44-2.52). Further, PDD had 11% longer hospital length of stay than those in the control groups (p < 0.0001). We did not find significant difference in hospital deaths, however, between these groups. CONCLUSION: Drug dependence is associated with worse post-operative outcomes in patients with infective endocarditis who underwent valvular surgery and lengthens their hospital stay.

Femoral cannulation: a safe vascular access option for cardiopulmonary bypass in minimally invasive cardiac surgery.

Femoral cannulation during cardiopulmonary bypass has become a common approach for many cardiac procedures and serves as an important access option, especially during minimally invasive cardiac surgery. Opponents, however, argue that there is significant risk, including site-specific and overall morbidity, which makes the use of this modality dangerous compared to conventional aortoatrial cannulation techniques. We analyzed our institutional experience to elucidate the safety and efficacy of femoral cannulation. All data were collected from a single hospital's cardiac surgery database. A total of 346 cardiac surgeries were evaluated from September 2012 to September 2013, of which 85/346 (24.6%) utilized a minimally invasive approach. Of the 346 operations performed, 72/346 (20.8%) utilized femoral cannulation while 274/346 (79.2%) used aortoatrial cannulation. Stroke occurred in 1/72 (1.39%) after femoral cannulation, specifically, in a conventional sternotomy patient, while it occurred in 6/274 (2.19%) [p=0.67] after aortoatrial cannulation. When comparing postoperative complications between the femoral cannulation and aortoatrial cannulation groups, the rates of atrial fibrillation [10/72 (13.9%) versus 46/274 (16.8%), p=0.55], renal failure [2/72 (2.78%) versus 11/274 (4.01%), p=0.62], prolonged ventilation time [4/72 (5.56%) versus 27/274 (9.85%), p=0.26] and re-operation for bleeding [3/72 (4.17%) versus 13/274 (4.74%), p=0.84] showed no significant difference. Selective femoral cannulation provides a safe alternative to aortoatrial cannulation for cardiopulmonary bypass and is especially important when performing minimally invasive cardiac surgery. When comparing aortoatrial and femoral cannulation, we found no significant difference in the postoperative complication rates and overall mortality.

The effect of Clostridium difficile infection on cardiac surgery outcomes.

BACKGROUND: Clostridium difficile (CD) is a common cause of healthcare-associated infectious colitis that complicates about 1% of all hospital stays in the U.S. The impact of CD on outcomes after coronary artery bypass grafting (CABG) and valvular surgery (VS) is not well known. METHODS: The Nationwide Inpatient Sample (2002-2009) was queried to identify CABG and VS patients utilizing International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes. Rates of CD, post-operative endocarditis and mediastinitis, hospital mortality rate, and resource utilization were evaluated. RESULTS: We identified 421,294 and 90,923 patients of age 40 yrs and older who underwent CABG and VS, respectively. The CD infection was more likely to develop in patients undergoing VS than in those having CABG (odds ratio [OR] 1.8; 95% confidence interval [CI] 1.64-1.92) and was more likely after urgent or emergency admission than after elective admission (OR 1.8; 95% CI 1.68-1.94). There was a greater likelihood of mediastinitis in patients with CD after CABG than in non-complicated cases without CD, both by univariable (OR 6.0; 95% CI 3.07-11.62) and multivariable analysis with adjustment for patient age, gender, race, type of admission, and co-morbidities (OR 3.1; 95% CI 1.49-6.51). The infection thus was most likely a result of the antibiotics used to treat mediastinitis, as the patients treated for mediastinitis were most likely to develop CD. There was a significant association in patients with CD and endocarditis who underwent VS but not in patients who did not have CD. The CD infection in these patients thus was most likely a result of the antibiotics used to treat endocarditis. Endocarditis and CD developed 3.2 times (95% CI 2.65-3.97) as often as in patients without CD, a finding that was confirmed by multivariable analysis (OR 2.2; 95% CI 1.70-2.84). At the same time, in patients having VS, there was no significant association of CD and mediastinitis. Clostridium difficile infection affected the hospital mortality rate significantly after both CABG (OR 2.0; 95% CI 1.65-2.35) and VS (OR 1.9; 95% CI 1.51-2.39). Development of CD increased median hospital length of stay and cost dramatically after both CABG (from 7 d to 19 d and from $33,105 to $65,535, respectively; p<0.0001 for both) and VS (from 8 d to 24 d and from $41,876 to $95,699, respectively; p<0.0001 for both). CONCLUSIONS: The development of CD worsened significantly the outcomes of adult patients undergoing cardiac surgery. There was a greater risk of CD in patients with either mediastinitis or endocarditis. The infection was associated with a higher hospital mortality rate, longer hospital stays, and greater cost after both CABG and VS.

The Impella device for acute mechanical circulatory support in patients in cardiogenic shock.

BACKGROUND: Acute cardiogenic shock is associated with high mortality rates. Mechanical circulatory devices have been increasingly used in this setting for hemodynamic support. The Impella device (Abiomed Inc, Danvers, MA) is a microaxial left ventricular assist device that can be inserted using a less invasive technique. This study was conducted to determine the outcome of patients who have undergone placement of the Impella device for acute cardiogenic shock in our institution. METHODS: A retrospective record review of 47 patients who underwent placement of the Impella device was performed from January 1, 2006, to December 31, 2011. Records were evaluated for demographics, operative details, and postoperative outcomes. Operative mortality was defined as death within 30 days of the operation. RESULTS: The patients (33 male) were an average age of 60.23 ± 13 years. The indication for placement of the Impella device included cardiogenic shock in 15 patients (32%) and postcardiotomy cardiogenic shock in 32 (68%). Of the 47 patients, 38 (80%) received the Impella 5.0 and the rest the 2.5 device. Ventricular function recovered in 34 of 47 patients (72%), and the device was removed, with 4 patients (8%) transitioned to long-term ventricular assist devices. The 30-day mortality was 25% (12 of 47 patients). Complications occurred in 14 patients (30%), consisting of device malfunction, high purge pressures, tube fracture, and groin hematoma. CONCLUSIONS: This is one of the largest series of patients undergoing placement of the Impella device for acute cardiogenic shock. Our outcomes showed improved results compared with historical data. Myocardial recovery was accomplished in most patients. Finally, the 30-day mortality and complication rate was acceptable in these critical patients. These benefits were all achieved with the Impella device in a less invasive method.

Outcome of the impella device for acute mechanical circulatory support.

OBJECTIVE: The contribution of cardiogenic shock to in-hospital mortality has not decreased significantly despite prompt revascularization, advances in medical therapy, and mechanical circulatory support. For patients in cardiogenic shock, mechanical circulatory support has been provided by a variety of devices. We report the outcome of the Impella device for acute mechanical circulatory support in cardiogenic shock in a setting of a large-volume single institution. The primary end points include survival to 30 days and recovery of native heart function and survival to 90 days and 1 year. The secondary end points include device complications. METHODS: We performed a retrospective chart review of 36 consecutive patients who underwent placement of the Impella device from February 6, 2006, to December 31, 2010. The charts were evaluated for data relative to the patients' demographics, hemodynamics, operative details, 30-day outcome including the patients' native heart function recovery, and 90-day and 1-year survival. RESULTS: Thirty-six consecutive patients were included in our study. The mean ± SD age was 60.3 ± 13 years, and 69% were men. The indication for placement of the Impella device included postcardiotomy cardiogenic shock in 23 patients (64%), acute myocardial infarction complicated with cardiogenic shock in 10 patients (28%), acute decompensated ischemic cardiomyopathy in 2 patients (6%), and myocarditis with cardiogenic shock in 1 patient (3%). The mean ± SD duration of the Impella support was 4.5 ± 3.9 days (range, 1-18). The 30-day survival rate was 72% (26/36), and, of those, 96% (25/26) recovered their native heart function and one (4%) was bridged to long-term left ventricular assist device (HeartMate II; Thoratec, Inc, Pleasanton, CA USA). The 90-day and 1-year survival was 64% and 61%, respectively. CONCLUSIONS: The Impella devices yielded a very favorable outcome in patients with cardiogenic shock.

Insertion of the Impella 5.0 left ventricular assist device via right anterior mini-thoracotomy: a novel practical approach.

The Impella 5.0 microaxial pump is a miniaturized left ventricular assist device commonly used for circulatory support in acute cardiogenic shock. The catheter-based pump is designed to be inserted either into a peripheral artery or directly into the ascending aorta. We report the first case in which the Impella 5.0 device was placed directly into the ascending aorta via a small right anterior thoracotomy in a patient following acute myocardial infarction complicated by cardiogenic shock.