Interventional procedure overview of percutaneous insertion of a catheter-based intravascular microaxial flow pump for cardiogenic shock
Closed for comments This consultation ended on at Request commenting lead permission
Appendix B: Other relevant studies
Other potentially relevant studies that were not included in the main evidence summary (tables 2 and 3) are listed in tables below. Case reports of safety outcomes that are not included in the main evidence are listed first in table 5a, followed by other studies that were not prioritised in table 5b. Non-randomised studies with fewer than 100 people, other than case reports of adverse events, and systematic reviews published before 2021 were excluded.
Study | Number of people and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Abdallah N, Mohamoud A, Almasri T et al. (2025) Relationships between sex and in-hospital outcomes of patients with acute cardiogenic shock receiving mechanical circulatory support. Cardiovascular Revascularization Medicine 73: 76-80 | Retrospective registry (US National Inpatient Sample database) n=2,622,939 hospitalised for acute myocardial infarction. | Females admitted for AMICS were less likely to have temporary MCS despite a higher mortality rate and a slightly longer length of stay compared to males. | Retrospective study focusing on the relationship between sex and outcomes of MCS. Another study using data from the same source is included (Movahed 2024). |
Abdullah KQA, Roedler JV, Vom Dahl J et al. (2021) Impella use in real-world cardiogenic shock patients: Sobering outcomes. PloS one 16: e0247667 | Retrospective single centre cohort study n=125 cardiac arrest or cardiogenic shock Impella 2.5, 3.5 or CP | Hospital mortality was high (81%). Baseline lactate was 4.7 mmol/litre. In multivariable logistic regression, only age (adjusted OR 1.13 95% CI 1.06 to 1.20; p<0.001) and lactate (adjusted OR 1.23 95% CI 1.00 to 1.52; p=0.046) were associated with hospital mortality, and the respective optimal cut-offs were more than 3.3mmol/litre and age over 66 years. | Larger or more recent studies were prioritised. |
Abusnina W, Ismayl M, Al-Abdouh A et al. (2022) Impella versus extracorporeal membrane oxygenation in cardiogenic shock: a systematic review and meta-analysis. Shock 58: 349-357 | Systematic review and meta-analysis n=1,827 (10 studies) | In-hospital mortality was statistically significantly lower with Impella compared with ECMO (RR 0.80; 95% CI 0.65 to 1.00, p=0.05). There was no statistically significant difference in 30-day (RR 0.97, 95% CI 0.82 to 1.16, p=0.77) and 12-month mortality (RR 0.90, 95% CI 0.74 to 1.11, p=0.32). There was less risk of bleeding and stroke in the Impella group compared with the ECMO group. | More recent systematic reviews are included. |
Ahmad S, Ahsan MJ, Ikram S et al. (2023) Impella Versus Extracorporeal Membranous Oxygenation (ECMO) for Cardiogenic Shock: A Systematic Review and Meta-analysis. Current Problems in Cardiology 48: 101427 | Systematic review and meta-analysis n=7,884 (6,652 Impella; 13 studies) | Impella use was associated with lower in-hospital mortality (RR 0.88, 95% CI 0.80 to 0.94, p=0.0004), stroke (RR 0.30, 95% CI 0.21 to 0.42, p<0.00001), access-site bleeding (RR 0.50, 95% CI 0.37 to 0.69, p<0.0001), major bleeding (RR 0.56, 95% CI 0.39 to 0.80, p=0.002), and limb ischaemia (RR 0.42, 95% CI 0.27 to 0.65, p=0.0001). Baseline lactate levels were lower in the Impella group (SMD -0.52, 95% CI -0.73 to -0.31, p<0.00001). There was no statistically significant difference in mortality at 6 to 12 months, MCS duration, need for MCS escalation, bridge-to-LVAD or heart transplant, and renal replacement therapy use between Impella and ECMO groups. | More comprehensive and more recent systematic reviews are included. |
Albulushi A, Tawfek A, Al Lawatia H (2024) Evaluating the efficacy and safety of temporary mechanical circulatory support devices in acute cardiogenic shock: A subgroup-specific systematic review. Current Problems in Cardiology 49: 102619 | Systematic review and meta-analysis n=3,450 (15 studies) | Mortality was 35% for Impella compared to 38% for other MCS modalities (p=0.07). The incidence of limb ischaemia was 5%, and haemolysis was 7%. People with AMICS had a 15% reduction in mortality with Impella compared to a 25% reduction with other devices (p=0.04). Age-based subgroup analysis showed that people younger than 65 years benefited more from MCS devices, showing a 20% improvement in survival, compared to 10% in the older cohort (p=0.01). | More comprehensive systematic reviews are included. |
Ali S, Kumar M, Khlidj Y et al. (2025) Trends and outcomes of different mechanical circulatory support modalities for refractory cardiogenic shock in Takotsubo cardiomyopathy. American Heart Journal Plus: Cardiology Research and Practice 54: 100545 | Retrospective registry (US Nationwide Readmission Database) n=2,025 (1,790 Impella) | In Takotsubo cardiomyopathy-associated cardiogenic shock, Impella and ECMO use has increased, while IABP use has declined from 2016 to 2020. In the absence of LV unloading, ECMO utilisation showed higher mortality, major bleeding, and adverse events than Impella. | Retrospective study, focusing on Takotsubo cardiomyopathy. |
Ali S, Kumar M, Badu I et al. (2024) Trends and outcomes of different mechanical circulatory support modalities for acute myocardial infarction associated cardiogenic shock in patients undergoing early revascularization. American Heart Journal Plus: Cardiology Research and Practice 46: 100468 | Retrospective registry (US Nationwide Readmission Database) n=20,950 (19,628 Impella) | On propensity-matched cohorts (n=742), the ECMO cohort had higher adverse events, including mortality (52% versus 42%), sudden cardiac arrest (41% versus 32%), acute stroke (9% versus 5%) and major bleeding (16% versus 12%), p<0.05. | A larger study from a US registry is included. Study is included in systematic review by Bogerd (2025). |
Alushi B, Douedari A, Froehlig G et al. (2019) Impella versus IABP in acute myocardial infarction complicated by cardiogenic shock. Open Heart 6: e000987 | Retrospective single-centre cohort study n=116 (62 Impella) AMICS | In people with AMICS, haemodynamic support with the Impella device had no statistically significant effect on 30-day mortality as compared with IABP. | Larger and more recent studies were prioritised. |
Ancona MB, Montorfano M, Masiero G et al. (2021) Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy. European Heart Journal. Acute Cardiovascular Care 10: 999-1006 | Multicentre registry (IMPella Mechanical Circulatory Support Device in Italy) n=406 (cardiogenic shock and high-risk PCI) | The most frequent complication was haemolysis (12%), which occurred almost exclusively in cardiogenic shock population. Access-site bleeding was observed in 10% of the overall population. Limb ischaemia was observed in 8% of the overall population, with a higher rate in the cardiogenic shock group compared to the PCI group. cardiogenic shock and right ventricular dysfunction appear as the strongest independent predictors of device-related complications. | Larger and more recent studies were prioritised. |
Ando T, Nakamaru R, Kohsaka S et al. (2023) Access Site-Stratified Analysis of the Incidence, Predictors, and Outcomes of Impella-Supported Patients With Cardiogenic Shock. The American Journal of Cardiology 205: 198-203 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=2,564 | 167 (6%) procedures used the transaxillary or trans-subclavian access approach rather than transfemoral. Predictors of the transaxillary or trans-subclavian approach included acute coronary syndrome, cardiogenic shock, and inotropic use. 30-day mortality was comparable between approaches. | Retrospective study focusing on the effect of different access approaches on outcomes. |
Attachaipanich T, Attachaipanich S, Kaewboot K (2025) Timing of mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: A systematic review and meta-analysis. American Heart Journal Plus: Cardiology Research and Practice 50: 100506 | Systematic review and meta-analysis n=6,218 (36 studies) | Early MCS insertion (before PCI) was associated with a lower risk of in-hospital mortality compared to late insertion (after PCI), with an OR of 0.46 (95% CI 0.36 to 0.57), p<0.01. Subgroup analysis by MCS type (IABP, Impella, and ECMO) showed that early insertion significantly reduced in-hospital mortality, regardless of the MCS type. Early MCS insertion was also associated with lower 30-day mortality (OR 0.62, 95% CI 0.43 to 0.89, p=0.01) and 6-month mortality (OR 0.53, 95% CI 0.34 to 0.83, p=0.01) compared to late insertion. There was no difference in 1-year mortality or in MCS-related complications. | There is considerable overlap with other systematic reviews included in the key evidence. |
Badiye AP, Hernandez GA, Novoa I et al. (2016) Incidence of Hemolysis in Patients with Cardiogenic Shock Treated with Impella Percutaneous Left Ventricular Assist Device. ASAIO Journal 62: 11-4 | Retrospective cohort study n=118 devices cardiogenic shock | The average time of support was 86.6 hours, and the 30 and 90 days of survival were 65% and 60%, respectively. The cumulative incidence of haemolysis was 62%. | Larger and more recent studies were prioritised. |
Baldetti L, Romagnolo D, Festi M et al. (2025) Impella malrotation affects left ventricle unloading in cardiogenic shock patients. ESC Heart Failure 12: 542-553 | Retrospective single-centre cohort study n=100 cardiogenic shock Impella CP, 5.0, 2.5 and 5.5 | Impella malrotation was identified in 36% of people with available echocardiography during Impella support and pulmonary artery catheter assessment before and during Impella support. Impella malrotation was associated with suboptimal unloading of the left ventricle, worse pulmonary haemodynamics and worse indexes of right ventricular afterload. | Small retrospective study. |
Basir MB, Lemor A, Gorgis Sarah et al. (2023) Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative. Journal of the American Heart Association 12: e031401 | Retrospective multicentre single arm trial (National Cardiogenic Shock Initiative) n=406 | Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. Early use of MCS in AMICS was feasible across varying health care settings and resulted in improvements to early haemodynamics and perfusion. | Larger studies were prioritised. |
Batchelor RJ, Wheelahan A, Zheng WC et al. (2022) Impella versus Venoarterial Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Cardiogenic Shock: A Systematic Review and Meta-Analysis. Journal of Clinical Medicine 11 | Systematic review and meta-analysis n=7,093 (6 studies) | Pooled in-hospital mortality was 42% in the Impella group versus 50% in the VA-ECMO group. Impella support for AMICS was associated with an 11% relative risk reduction in in-hospital mortality compared to VA-ECMO (RR 0.89; 95% CI 0.83 to 0.96, I2=0%). Of the 6 studies, 3 adjusted outcome measures via propensity-score matching with reported reductions in in-hospital mortality with Impella compared to VA-ECMO (RR 0.72; 95% CI 0.59 to 0.86, I2=35%). Pooled analysis of 6- or 12-month mortality data reported a 14% risk reduction with Impella over the medium-to-long-term (RR 0.86; 95% CI 0.76 to 0.97, I2=0%). | More recent systematic reviews were prioritised. |
Benenati S, Toma M, Canale C et al. (2022) Mechanical circulatory support in patients with cardiogenic shock not secondary to cardiotomy: a network meta-analysis. Heart Failure Reviews 27: 927-934 | Network meta-analysis n=11,117 (346 Impella) Most were Impella 2.5 | Data indicate that, in cardiogenic shock with various aetiologies, ECMO statistically significantly decreases short-term mortality as compared with other types of MCS or no support, especially when used in association with Impella or IABP. This finding should be considered hypothesis-generating and inform larger and adequately powered randomised controlled trials. The risk of bleeding is enhanced by MCS. | More recent systematic reviews were prioritised. |
Bhuiyan R, Bimal T, Fishbein J et al. (2023) Percutaneous coronary intervention with Impella support with and without intra-aortic balloon in cardiogenic shock patients. Cardiovascular Revascularization Medicine 55: 68-73 | Retrospective multicentre cohort study n=101 (61 Impella only, 40 Impella and IABP) Most people had acute myocardial infarction. | In people with cardiogenic shock who have PCI with either the Impella device alone or with Impella and IABP, major bleeding complications and major adverse cardiac and cerebrovascular events rates were high but not significantly different between the 2 groups. In hospital mortality was relatively low in both groups despite the high-risk characteristics of this cohort. | Larger studies were prioritised. |
Bochaton T, Huot L, Elbaz M et al. (2020) Mechanical circulatory support with the Impella R LP5.0 pump and an intra-aortic balloon pump for cardiogenic shock in acute myocardial infarction: The IMPELLA-STIC randomized study. Archives of Cardiovascular Diseases 113: 237-243 | Randomised controlled trial n=12 (6 Impella 5.0, 6 IABP) | In people with AMICS stabilised by initial treatment with inotropes and an IABP, the Impella 5.0 did not provide additional haemodynamic support or improvement in LVEF at 1 month. | Small sample size. |
Bogerd M, Ten Berg S, Peters EJ et al. (2023) Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction. European Journal of Heart Failure 25: 2021-2031 | Multicentre retrospective cohort (Institut für das Entgeltsystem im Krankenhaus GmbH, InEK). n=4,088 (2,700 Impella) | In-hospital mortality was lower in the Impella versus VA-ECMO cohort (61% versus 67%, p=0.001). Adverse events occurred less frequently in Impella-supported patients: acute haemorrhagic anaemia (36% versus 68%, p<0.001), cerebrovascular accidents (4% versus 11%, p<0.001), thromboembolism of the extremities (5% versus 8%, p<0.001), systemic inflammatory response syndrome (21% versus 25%, p=0.004), acute kidney injury (44% versus 53%, p<0.001), and acute liver failure (7% versus 12%, p<0.001). Impella patients were discharged home directly more often (20% versus 11%, p<0.001) whereas VA-ECMO patients were more often discharged to another care facility (22% versus 19%, p=0.031). Impella patients had shorter hospital stays and lower hospital costs. | Retrospective study, which is included in the systematic review by Bogerd (2025). |
Bossi E, Marini C, Gaetti G et al. (2022) Efficacy and safety of Impella 5.0 in cardiogenic shock: an updated systematic review. Future Cardiology 18: 253-264 | Systematic review and meta-analysis 17 studies Impella 5.0 | Thirty-day survival rates ranged from 40 to 94%, myocardial recovery from 18 to 93%. Impella 5.0 is associated with a lower rate of vascular complications than other MCS such as VA-ECMO and is characterised by greater stability of the device position because of the surgical insertion and fixation. The main limitations of the work were linked to the quality and availability of included studies. | More recent systematic reviews were prioritised. |
Bravo-Jaimes K, Mejia MO, Abelhad NI et al. (2022) Gender Differences in the Outcomes of Cardiogenic Shock Requiring Percutaneous Mechanical Circulatory Support. The American Journal of Cardiology 174: 20-26 | Retrospective registry (US National Inpatient Sample database) n=113,305 percutaneous MCS for AMICS | Women needing percutaneous MCS had a higher comorbidity load, in-hospital mortality, acute respiratory failure, blood transfusions, and lower pulmonary artery catheter use. | A more recent study that uses the same database is included (Movahed 2024) |
Briasoulis A, Kampaktsis P, Emfietzoglou M et al. (2023) Temporary Mechanical Circulatory Support in Cardiogenic Shock due to ST-Elevation Myocardial Infarction: Analysis of the National Readmissions Database. Angiology 74: 31-38 | Retrospective registry (US Nationwide Readmission Database) n=80,997 people with cardiogenic shock because of STEMI (9,055 Impella) Type of Impella device not reported | 30-day readmission rates did not differ among groups, whereas 90-day readmissions were higher among those with combined ECMO and IABP or Impella support (p=0.027). In-hospital mortality and complications including haemodialysis, transfusion, and stroke were the highest in the Impella and combined ECMO and IABP with Impella groups. Heart failure was the most common cause of readmission. Multivariable logistic regression showed female gender, diabetes, prior myocardial infarction, heart failure, chronic kidney, and peripheral artery disease as risk factors for 90-day readmissions. | Another US registry study is included. This study was included in review by Bogerd (2025) but it was identified as a distorting outlier and was therefore excluded from the primary meta-analysis. |
Brush JE Jr, Harper AM, Kohan LC et al. (2025) Real-world interventional outcomes for cardiogenic shock complicating acute myocardial infarction. American Heart Journal Plus: Cardiology Research and Practice 53: 100540 | Retrospective registry (American College of Cardiology's National Cardiovascular Data Registry) n=505 people with AMICS (73 MCS) | In MCS-inclined hospitals as compared with IABP-inclined hospitals, people had higher 180-day mortality (45% versus 34%, p=0.017), and bleeding rates (15% versus 1%, p<0.001), with trends toward higher 30-day mortality (41% versus 33%, p=0.064) and access site injury (5% versus 1%, p=0.063). | Larger studies were prioritised. |
Buda KG, Hryniewicz K, Eckman PM et al. (2024) Early vs. delayed mechanical circulatory support in patients with acute myocardial infarction and cardiogenic shock. European Heart Journal: Acute Cardiovascular Care 13: 390-397 | Retrospective registry (US Nationwide Readmission Database) n=294,839 people with AMICS (33,577 Impella) | There was no survival benefit of temporary MCS in all-comers with AMICS. The need for Impella and VA-ECMO was independently associated with higher mortality, likely because of the acuity of people in this group. Among people having temporary MCS for AMICS, early intervention was associated with fewer complications, shorter lengths of stay, lower hospital costs, and fewer deaths and readmissions at 30 days. | Retrospective study, focusing on the effect of timing of MCS on outcomes. |
Chieffo A, Ancona MB, Burzotta F et al. (2020) Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry. EuroIntervention 15: e1343-e1350 | Multicentre registry (IMPella Mechanical Circulatory Support Device in Italy) n=406 (cardiogenic shock and high-risk PCI) Impella 2.5, Impella CP, Impella 5.0 and Impella RP | Rates of in-hospital and 1-year mortality in people with cardiogenic shock were 47% and 57%, respectively; 19% had LVAD implantation or heart transplant at 1 year. Rates of device-related complications were 37% in the setting of cardiogenic shock. | Larger and more recent studies were prioritised. Study is included in systematic review by Sassani (2025). |
Chung JS, Emerson D, Ramzy D et al. (2020) A New Paradigm in Mechanical Circulatory Support: 100-Patient Experience. The Annals of Thoracic Surgery 109: 1370-1377 | Retrospective single-centre cohort study n=100 acutely decompensated heart failure Impella 5.0 | People had the device as a bridge to recovery (n=30), bridge to durable device (n=23), or bridge to transplantation (n=47). All devices were placed using an axillary artery approach. Overall survival was 64%. Survival was 50% for bridge to recovery, 48% for bridge to durable device and 81% for bridge to transplantation (p=0.007). Survival improved during the study period and was 90% overall in the most recent 30 people. | Larger and more recent studies were prioritised. |
De Ferrari T, Pistelli L, Franzino M et al. (2024) MI2AMI-CS: A meta-analysis comparing Impella and IABP outcomes in Acute Myocardial Infarction-related Cardiogenic Shock. International Journal of Cardiology 414: 132411 | Systematic review and meta-analysis n=10,628 (8 studies) After excluding overlapping data, 4 studies (n=2,795) were used for mortality data. | In unselected people with AMICS, Impella use showed higher mortality than IABP (57% versus 46%; OR 1.44, 95% CI 1.29 to 1.60; p<0.001) and higher rates of major bleeding (30% versus 15%; OR 2.93, 95% CI 1.67 to 5.13; p<0.001). | There is a lot of overlap with the systematic review by Panuccio (2022), which includes more studies. |
Del Rio-Pertuz G, Benjanuwattra J, Juarez M et al. (2022) Efficacy of Mechanical Circulatory Support Used Before Versus After Primary Percutaneous Coronary Intervention in Patients with Cardiogenic Shock From ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis. Cardiovascular Revascularization Medicine 42: 74-83 | Systematic review and meta-analysis n=1,352 (203 Impella; 10 studies) STEMI complicated by cardiogenic shock | In people with STEMI complicated by cardiogenic shock who have primary PCI, the use of Impella or VA-ECMO before PCI statistically significantly decreased mortality, in contrast to IABP, in which no difference in mortality was found between using it before or after PCI. | More recent systematic reviews were prioritised. |
Desai R, Hanna B, Singh S et al. (2021) Percutaneous Ventricular Assist Device vs. Intra-Aortic Balloon Pump for Hemodynamic Support in Acute Myocardial Infarction-Related Cardiogenic Shock and Coexistent Atrial Fibrillation: A Nationwide Propensity-Matched Analysis'. American Journal of the Medical Sciences 361: 55 | Propensity score matched analysis using retrospective registry data (US National Inpatient Sample database) n=886 in the matched group (443 Impella) AMICS and atrial fibrillation | There was no difference in the in-hospital mortality (40% versus 37%, p=0.25); however, the percutaneous VAD group had a lower incidence of post-procedural myocardial infarction and higher incidences of stroke (8% versus 4%, p=0.03), haemorrhage (6% versus 2%, p=0.01), discharges to home health care (14% versus 10%, p<0.001) and to other facilities (29% versus 25%, p<0.001) as compared to IABP group. There was no difference between the groups in terms of mean length of stay or hospital charges. | Study focuses on outcomes in people with coexistent atrial fibrillation. |
Dodoo SN, Kwapong YA, Agyemang-Sarpong A et al. (2024) Comparative Healthcare Resource Utilization of Percutaneous Mechanical Circulatory Support Using Impella Versus Intra-aortic Balloon Pump Use for Patients With Acute Coronary Syndrome and Cardiogenic Shock Undergoing Percutaneous Coronary Interventions: Insights From National Inpatient Sample. Current Problems in Cardiology 49: 102053 | Retrospective registry (US National Inpatient Sample database) n=439,610 people admitted with acute coronary syndrome complicated by cardiogenic shock, supported by Impella or IABP | 1:1 propensity score matching identified 2,620 people who had Impella with comparable severity index with people who had IABP. Impella was associated with higher in-hospital mortality compared with IABP (55% versus 46%, p<0.0001). People who had Impella developed more periprocedural complications, including vascular injury (5% versus 1%, p<0.0001), acute kidney injury (58% versus 42%, p<0.0001), end-stage renal disease needing dialysis (9% versus 1%, p=0.002) than those who had IABP. | Another study with more recent data from the same source is included (Movahed 2024). |
Duan J, Shi Y, Luo G et al. (2021) Short-term efficacy and safety of different mechanical hemodynamic support devices for cardiogenic shock or high-risk PCI: A network meta-analysis of thirty-seven trials. Shock 55: 5 | Network meta-analysis n=11,270 (38 studies) | The analysis suggested that ECMO with IABP might be a more suitable intervention measure in improving short-term mortality for people with cardiogenic shock and who had high-risk PCI. However, the result was limited by the lack of sufficient direct comparisons and evidence from randomised controlled trials. Moreover, bleeding and other device-related complications should be considered in clinical applications. | More recent systematic reviews were prioritised. |
Feistritzer H-J, Desch S, Freund A et al. (2020) Prognostic Impact of Active Mechanical Circulatory Support in Cardiogenic Shock Complicating Acute Myocardial Infarction, Results from the Culprit-Shock Trial. Journal of Clinical Medicine 9 | Subanalysis of randomised controlled trial (CULPRIT- SHOCK) and prospective registry n=1,055 people with AMICS (112 Impella) | The primary endpoint was a composite of all-cause death or renal replacement therapy at 30 days. It occurred more often in people who had active MCS devices compared with those without active MCS devices (72% versus 45%; p<0.001). All-cause mortality and bleeding rates were higher in the active MCS group (all p<0.001). After multivariable adjustment, the use of active MCS was associated with the primary endpoint (OR 4.0, 95% CI 2.7 to 5.9; p<0.001). | Larger and more recent studies were prioritised. |
Haberkorn S, Uwarow A, Haurand J et al. (2020) Percutaneous left ventricular assist support is associated with less pulmonary congestion and lower rate of pneumonia in patients with cardiogenic shock. Open Heart 7: no. 2 | Retrospective cohort study n=100 (50 Impella) cardiogenic shock | Pulmonary congestion decreased in people who had Impella at each time point post-implantation. No change in congestion status was observed in people supported with IABP. Multivariate analysis indicated Impella support as an independent predictor for pulmonary decongestion (OR 4.06, 95% CI 1.15 to 14.35, p=0.030). The rate of early pneumonia was lower in the Impella group compared with the IABP group (54% vs 74%, p=0.037). Failure of pulmonary decongestion during mechanical circulatory support independently predicted early pneumonia (OR 0.28, 95% CI 0.12 to 0.70, p=0.006) | Larger studies were prioritised. |
Hill MA, Kwon JH, Shorbaji K et al. (2022) Waitlist and transplant outcomes for patients bridged to heart transplantation with Impella 5.0 and 5.5 devices. Journal of Cardiac Surgery 37: 5081-5089 | Retrospective registry (United Network for Organ Sharing registry) n=738 Impella 5.0 and 5.5 | There were 344 people waitlisted and 394 people transplanted with an Impella 5.0 (n=212 and 251) or 5.5 (n=132 and 143) device. In the transplanted cohort, unadjusted 1-year post-transplant survival was comparable at 91% versus 95% (p=0.661) for people supported by Impella 5.0 or 5.5 device, respectively, a finding that persisted after risk-adjustment (HR 1.22, p=0.699). Post-transplant complication rates were also comparable between 5.0 and 5.5. | More recent studies were prioritised. |
Iannaccone M, Franchin L, Burzotta F et al. (2023) Impact of in-Hospital Left Ventricular Ejection Fraction Recovery on Long-Term Outcomes in Patients Who Underwent Impella Support for HR PCI or Cardiogenic Shock: A Sub-Analysis from the IMP-IT Registry. Journal of Personalized Medicine 13: no. 5 | Multicentre registry, Italy (IMP-IT) n=279 cardiogenic shock (n=116) and high-risk PCI (n=163) Impella 2.5 or CP | Significant LVEF recovery was associated with improved outcomes in people with cardiogenic shock who had PCI during mechanical circulatory support with Impella, whereas complete revascularisation showed a significant clinical relevance in high-risk PCI. | Larger studies were prioritised. |
Iannaccone M, Franchin L, Hanson ID et al. (2022) Timing of impella placement in PCI for acute myocardial infarction complicated by cardiogenic shock: An updated meta-analysis. International Journal of Cardiology 362: 47-54 | Systematic review and meta-analysis n=6,810 (13 studies) AMICS | Short-term mortality was reduced in those who had Impella support before PCI rather than during or after (37% versus 54%, RR 0.7; CI 0.56 to 0.88). Midterm mortality was also lower in the pre-PCI Impella group (48% versus 73%, RR 0.81; CI 0.68 to 0.97). The rate of device-related bleeding (RR 1.05; CI 0.47 to 2.33) and limb ischaemia (RR 1.6; CI 0.63 to 2.15) were similar between the 2 groups. | More recent systematic reviews were prioritised. |
Iannaccone M, Albani S, Giannini F et al. (2021) Short term outcomes of Impella in cardiogenic shock: A review and meta-analysis of observational studies. International Journal of Cardiology 324: 44-51 | Systematic review and meta-analysis n=3,933 (17 studies) | 30-day mortality=48% (CI 44 to 52%). Based on metaregression analysis, the Impella 5.0 and the Impella CP devices were related to a higher survival rate, whereas the Impella 2.5 was not. Furthermore, a correlation with reduced mortality was found when Impella was initiated in cardiogenic shock not complicated by cardiac arrest, and before revascularisation. The vascular complication and major bleeding rate were 7% (95% CI 6 to 10%) and 15% (95% CI 11 to 21%) respectively, and were associated with older age and comorbidities, while the implantation of an Impella CP or 2.5 was associated with fewer complications. | More recent systematic reviews were prioritised. |
Ikeda Y, Ishii S, Nakahara S et al. (2025) Device-related adverse events and flow capacity of percutaneous ventricular assist devices. European Heart Journal. Acute Cardiovascular Care 14: 93-103 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=5,717 Drug-refractory acute heart failure, including cardiogenic shock | The overall incidence of major device-related problems, including haemolysis, major bleeding, kidney injury, sepsis, and pump stop, was 13%, 21%, 7%, 3%, and 1%, respectively. The all-cause mortality rate was 34%. The incident risks of haemolysis (HR 0.38, 95% CI 0.24 to 0.58), kidney injury (HR 0.32, 95% CI 0.18 to 0.57), and pump stop (HR 0.38, 95% CI 0.16 to 0.91) were lower in patients with high-flow PVAD compared with those with low-flow PVAD. The risks of major bleeding or sepsis did not differ significantly between groups. The risk of all-cause mortality was lower in people with high-flow PVAD compared with those with low-flow PVAD (HR 0.79, 95% CI 0.65 to 0.96). | A high proportion (45%) of people had concomitant VA-ECMO. |
Ikeda Y, Ako J, Toda K et al. (2023) Short-Term Outcomes of Impella Support in Japanese Patients With Cardiogenic Shock Due to Acute Myocardial Infarction - Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD). Circulation Journal 87: 588-597 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=593 AMICS | Overall 30-day survival was 63%. The 30-day survival of the Impella alone and Impella plus VA-ECMO (ECPELLA) groups was 81% and 46%, respectively. Cox regression analysis revealed that older age and comorbid renal disturbance were common risk factors affecting 30-day mortality in both groups. Major adverse events were haemolysis (11%), haemorrhage or haematoma (8%), peripheral ischaemia (4%), stroke (1%), and thrombosis (1%). LVEF improved in both groups during support. | Larger studies were prioritised. |
Jang S-J, Malaguez W, Fabricio A et al. (2023) Early Clinical Outcomes of Patients With Stress-Induced Cardiomyopathy Receiving Acute Mechanical Support in the US. Journal of the Society for Cardiovascular Angiography & Interventions 2: 101185 | Retrospective registry (US Nationwide Readmission Database) n=902 Stress-induced cardiomyopathy complicated by cardiogenic shock | People with ECMO or Impella had higher in-hospital mortality rates than those with IABP (37% versus 29% versus 18%, respectively). There was an increased adjusted risk of in-hospital death with Impella (adjusted OR 1.98; 95% CI 1.12 to 3.49) and ECMO (adjusted OR 4.15; 95% CI 1.85 to 9.32) versus IABP. Impella was associated with an increased risk of 30-day readmission compared to IABP (adjusted OR 2.53; 95% CI 1.16 to 5.51). People with ECMO or Impella had a higher incidence of renal replacement therapy and vascular or bleeding complications compared to those who had IABP. | Larger studies were prioritised. |
Javaid AI, Michalek JE, Gruslova AB et al. (2024) Mechanical circulatory support versus vasopressors alone in patients with acute myocardial infarction and cardiogenic shock undergoing percutaneous coronary intervention. Catheterization and Cardiovascular Interventions 103: 30-41 | Propensity score matched analysis using retrospective registry data (US National Inpatient Sample database) n=17,762 AMICS and PCI | Impella use was associated with higher in-hospital major bleeding (31% versus 14%; p<0.001) and hospital charges (p<0.001) compared to IABP use, with no benefit in mortality (34% versus 27%; p=0.06). Impella use was associated with higher mortality (42% versus 36%; p=0.02), major bleeding (34% versus 23%; p=0.001), and hospital charges (p<0.001), when compared to the use of vasopressors without MCS. There were no statistically significant differences in clinical outcomes between IABP use and the use of vasopressor without MCS. | Another study reporting outcomes from the same database is included (Movahed 2024). |
Jensen PB, Kann SH, Veien KT et al. (2018) Single-centre experience with the Impella CP, 5.0 and RP in 109 consecutive patients with profound cardiogenic shock. European Heart Journal. Acute Cardiovascular Care 7: 53-61 | Retrospective single-centre cohort study n=109 cardiogenic shock after myocardial infarction, acute heart failure, or cardiac surgery Impella CP, 5.0, RP | During Impella therapy, 26 people (28%) died among those with myocardial infarction or acute heart failure. Of data available before placement lactate (HR 1.14, 95% CI 1.04 to 1.25, p=0.004) was the only predictor of death on support. During support, 5 people (5%) developed leg ischaemia needing intervention. Bleeding from the Impella insertion site was seen in 14 people (13%). | Larger and more recent studies were prioritised. |
Jin C, Yandrapalli S, Yang Y et al. (2022) A Comparison of In-Hospital Outcomes Between the Use of Impella and IABP in Acute Myocardial Infarction Cardiogenic Shock Undergoing Percutaneous Coronary Intervention. The Journal of Invasive Cardiology 34: e98-e103 | Propensity score matched analysis of retrospective registry data (US National Inpatient Sample database) n=51,150 (6,885 Impella) AMICS and PCI | After propensity matching, compared with the Impella group (n=1,592), the IABP group (n=8,638) had lower rates of sepsis (6% versus 13%; p=0.01), blood transfusion (9% versus 14%; p=0.01), and mortality (29% versus 50%; p<0.01). The IABP group had similar rates of cardiac arrest (20% versus 22%; p=0.32), in-hospital stroke (1.5% versus 1.6%; p=0.37), and length-of-stay (8.6 days versus 8.6 days; p=0.26) compared with the Impella group. | More recent studies were prioritised. |
Joseph SM, Brisco MA, Colvin M et al. (2016) Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry. Journal of Interventional Cardiology 29: 248-56 | International registry (cVAD) n=180 cardiogenic shock and PCI Impella 2.5 | Early initiation of haemodynamic support before PCI with Impella 2.5, in the setting of AMI complicated by cardiogenic shock, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularisation failure rate for women. | Larger and more recent studies were prioritised. |
Karami M, Eriksen E, Ouweneel DM et al. (2021) Long-term 5-year outcome of the randomized IMPRESS in severe shock trial: percutaneous mechanical circulatory support vs. intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. European Heart Journal. Acute Cardiovascular Care 10: 1009-1015 | Multicentre randomised controlled trial n=48 (24 Impella) AMICS | 5-year mortality was 50% for percutaneous MCS and 63% for IABP (RR 0.87, 95% CI 0.47 to 1.59, p=0.65). MACCE rate was 50% in the percutaneous MCS group and 79% in the IABP group (p=0.07). There were no differences in left ventricular ejection fraction between the groups. | Small randomised controlled trial, which is included in Ardito V (2023) and Bogerd (2025). |
Karami M, den Uil CA, Ouweneel DM et al. (2020) Mechanical circulatory support in cardiogenic shock from acute myocardial infarction: Impella CP/5.0 versus ECMO. European Heart Journal. Acute Cardiovascular Care 9: 164-172 | Retrospective 2-centre cohort study n=128 (90 Impella) AMICS Impella CP or 5.0 | People who had Impella CP or 5.0, or ECMO for cardiogenic shock after myocardial infarction did not differ in 30-day mortality. More device-related complications happened with ECMO compared to Impella support. | Larger studies were prioritised. |
Karatolios K, Chatzis G, Markus BL et al. (2021) Comparison of mechanical circulatory support with venoarterial extracorporeal membrane oxygenation or Impella for patients with cardiogenic shock: a propensity-matched analysis. Clinical Research in Cardiology 110: 1404-1411 | Retrospective single-centre propensity score matched analysis n=423 (300 Impella 2.5 or CP) | Survival rates were similar in both groups (hospital survival: Impella 48% and VA-ECMO 37%, p=0.07; 6-month survival Impella 46% and VA-ECMO 36%, p=0.07). There was no significant difference in survival rates, even after adjustment for baseline differences (hospital survival: Impella 51% and VA-ECMO 39%, p=0.16; 6-month survival Impella 46% and VA-ECMO 39%, p=0.43). Access-site bleeding and leg ischaemia was more common in people who had VA-ECMO (17% versus 7%, p=0.004; 17% versus 8%, p=0.008). | Larger studies were prioritised. Study is included in Panuccio (2022) and Stub (2025). |
Katagiri Y, Kasai Y, Miyazaki M et al. (2025) Effect of Body Mass Index in Patients With Cardiogenic Shock Requiring Microaxial Flow Pump. JACC. | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=3,636 | Crude 30-day mortality increased incrementally with higher BMI categories. Adjusted HRs for 30-day mortality (BMI 18.5 to 22.9 kg/m2 as reference) were 0.71 (95% CI 0.56 to 0.90; p=0.005) for underweight, 1.03 (95% CI 0.88 to 1.21; p=0.681) for overweight, 1.37 (95% CI 1.19 to 1.57; p<0.001) for obesity, and 2.00 (95% CI 1.66 to 2.41; p<0.001) for severe obesity. People in the underweight and severe obesity groups had a higher incidence of bleeding after percutaneous coronary intervention under microaxial flow pumps, whereas haemolysis increased with higher BMI categories. Bleeding and haemolysis were associated with mortality only in people who were underweight. | Study focuses on effect of body mass index on outcomes. |
Khalid N, Rogers T, Shlofmitz E et al. (2019) Adverse events and modes of failure related to the Impella percutaneous left ventricular assist devices: A retrospective analysis of the maude database. EuroIntervention; 15: 44 | US FDA MAUDE database n=407 reports | 54% of reports were for Impella CP, 20% Impella 2.5, and 12% Impella 5.0. Most people had the Impella device for high-risk PCI. The most reported complication was bleeding (38% of reports), of which 70% needed blood transfusion. Significant vascular complications, including dissection and perforation, were documented in 67 reports (16%). Device malfunction and device separation were reported in 70 (17%) and 39 (10%) reports, respectively. | More recent studies are included with complication rates. The FDA MAUDE data does not include a denominator so incidence rates could not be determined. |
Kim Y, Shapero K, Ahn SS et al. (2022) Outcomes of mechanical circulatory support for acute myocardial infarction complicated by cardiogenic shock. Catheterization and Cardiovascular Interventions 99: 658-663 | Retrospective registry (US National Inpatient Sample database) n=54,480 (5,750 Impella) | After propensity score matching, Impella was associated with higher in-hospital mortality (OR 1.74, 95% CI 1.41 to 2.13) and transfusions (OR 1.97, 95% CI 1.40 to 2.78) than IABP, without association with acute kidney injury or stroke. | More recent studies were prioritised. |
Klein A, Beske RP, Hassager C et al. (2025) Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous? Journal of the American College of Cardiology 85: 595-603 | Multicentre randomised controlled trial (DanGer Shock) n=355 STEMI-related cardiogenic shock Impella CP | The predicted risk of mortality was higher in the standard-care group until about 77 years, after which the predicted risk became higher in the microaxial flow pump group (p=0.20). In people younger than 77 years, a reduced 180-day mortality was seen in people randomised to the microaxial flow pump (OR 0.45; 95% CI 0.28 to 0.73; p=0.001), compared to people aged 77 or above (OR 1.52; 95% CI 0.57 to 4.08; p=0.40). | Secondary analysis of trial that is included in the key evidence. |
Kuchtaruk AA, Sparrow RT, Azzalini L et al. (2023) Unplanned readmissions after Impella mechanical circulatory support. International Journal of Cardiology 379: 48-59 | Retrospective registry (US Nationwide Readmission Database) n=22,055 | 30-day readmissions after Impella MCS are relatively common and relate to sex, baseline comorbidities, presentation, expected primary payer, discharge destination and initial length of hospital stay. Heart failure was the leading cause of cardiac readmissions, whereas infections were the most common cause among non-cardiac readmissions. | Registry studies with more comprehensive outcomes are included. |
Kuno T, Takagi H, Ando T et al. (2021) Safety and efficacy of mechanical circulatory support with Impella or intra-aortic balloon pump for high-risk percutaneous coronary intervention and/or cardiogenic shock: Insights from a network meta-analysis of randomized trials. Catheterization and Cardiovascular Interventions 97: e636-e645 | Network meta-analysis n=1,996 (9 randomised controlled trials) cardiogenic shock or high-risk PCI | There was no statistically significant difference with Impella or IABP on all-cause mortality when compared with no MCS. Impella increased major bleeding compared with no MCS. | More recent systematic reviews were prioritised. |
Lauten A, Engstrom AE, Jung C et al. (2013) Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circulation. Heart Failure 6: 23-30 | Retrospective multicentre registry (EUROSHOCK) n=120 AMICS Impella 2.5 | 30-day mortality=64% After Impella 2.5 implantation, lactate levels decreased from 5.8 mmol/litre to 4.7 mmol/litre (p=0.28) and 2.5 mmol/litre (p=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) people. Major bleeding at the vascular access site, haemolysis, and pericardial tamponade occurred in 34 (29%), 9 (8%), and 2 (2%) people, respectively. The parameters of age over 65 and lactate level above 3.8 mmol/litre at admission were identified as predictors of 30-day mortality. After 317 days of follow-up, survival was 28%. | Larger and more recent studies were prioritised. |
Lazkani M, Murarka S, Kobayashi A et al. (2017) A retrospective analysis of Impella use in all-comers: 1-year outcomes. Journal of Interventional Cardiology 30: 577-583 | Retrospective single-centre registry n=262 | For people with need for an Impella device, regardless of the indication, early implantation is associated with better in-hospital and 1-year outcomes as compared to when the device is implanted late as a bailout. | Larger and more recent studies were prioritised. |
Lemor A, Dabbagh MF, Cohen D et al. (2022) Rates and impact of vascular complications in mechanical circulatory support. Catheterization and Cardiovascular Interventions 99: 1702-1711 | Retrospective registry (US National Inpatient Sample database) n=221,700 (IABP, Impella or ECMO) | The rates of vascular complications were greatest with ECMO (16%) when compared with IABP (3%) and Impella (6%). Among people with vascular complications, in-hospital mortality was higher with ECMO (56%) when compared with IABP (26%) and Impella (34%). Peripheral arterial disease was the strongest predictor of vascular complications (adjusted OR 10.96, p<0.001). In risk-adjusted models, when compared with IABP, the use of Impella (adjusted OR 1.73, p<0.001), ECMO (adjusted OR 5.35, p<0.001), or a combination of MCS devices (adjusted OR 3.47, p<0.001) was associated with higher odds of vascular complications. | More recent studies were prioritised. |
Lemor A, Hosseini D, Seyed H et al. (2020) Impella Versus Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Cardiogenic Shock. Cardiovascular revascularization medicine 21: 1465-1471 | Retrospective registry (US National Inpatient Sample database) n=6,290 (5,730 Impella) AMICS and PCI | After propensity-match analysis, the ECMO cohort had significantly higher in-hospital mortality than Impella (43% versus 27%, OR 2.10, p=0.021). The incidence of acute respiratory failure and vascular complications were lower in the Impella cohort. Hospital stay was shorter, and hospital costs were lower in the Impella cohort compared to those who had ECMO. | More recent studies were prioritised. |
Leon SA, Rosen JL, Ahmad D et al. (2023) Microaxial circulatory support for percutaneous coronary intervention: A systematic review and meta-analysis. Artificial Organs 47: 934-942 | Systematic review and meta-analysis n=543 (5 articles) cardiogenic shock and PCI | People presenting with AMICS were similar at baseline in both pre-PCI and post-PCI groups. The pre-PCI group showed better early survival compared to post-PCI group. | More comprehensive reviews are included. |
Leung C, Fong YH, Chiang MCS et al. (2025) Protocol-Driven Best Practices and Cardiogenic Shock Survival in Asian Patients. Journal of the American Heart Association 14: e037742 | Prospective multicentre registry, Hong Kong (Queen Elizabeth Hospital PVAD Registry) n=109 The primary cause of cardiogenic shock was AMI (67%) | A suggestive trend of improving 30-day survival was observed (57%, 64%, and 7%) in successive one thirds of the cohort paralleling a similar trend in achievement of best practices. Achievement of protocol-advocated best practices, especially early shock recognition and prompt percutaneous VAD support in appropriate patients, was associated with improved outcomes. | Larger studies were prioritised. |
Levine D, Volk L, Vagaonescu T et al. (2022) Risk of Stroke with Impella Placement Is Not Associated with Access Vessel. Innovations 17: 25-29 | Retrospective single-centre cohort study n=349 | Most devices were inserted through a minimally invasive approach (61%), while the remainder used central access (39%). The risk of stroke for the entire cohort was 10% (n=36), with no difference observed in any group. Overall mortality was 44% (n=155). Of the people who initially had a minimally invasive Impella, those who were upgraded had higher rates of mortality (57% versus 39%, p=0.03), postoperative dialysis (50% versus 27%, p<0.01), and sepsis (43% versus 20%, p<0.01). | Larger and more recent studies were prioritised. |
Lewin D, Rojas SV, Billion M et al. (2024) Durable left ventricular assist devices following temporary circulatory support on a microaxial flow pump with and without extracorporeal life support. JTCVS Open 21: 168-179 | Retrospective multicentre registry n=332 people bridged to durable LVAD Impella 5.5, 5.0 and CP | 125 people (39%) also needed extracorporeal life support before or during microaxial flow pump therapy. The 30-day and 1-year survival were 88% and 71%, respectively. The following risk factors for 1-year mortality were identified: age (OR 1.02), specifically age over 55 years (OR 1.09), body mass index above 30 kg/m2 (OR 2.2), female sex (OR for male sex, 0.43), elevated total bilirubin (OR 1.12), and low platelet count (OR 0.996). | Retrospective registry data, focusing on outcomes of durable LVAD after microaxial flow pump support. |
Luiz L, Mesadri GD, Picado-Loaiza S et al. (2025) Sex-related outcomes during short-term mechanical circulatory support: A systematic review and meta-analysis of propensity-score matched studies. Perfusion 2676591251324643 | Systematic review and meta-analysis n=18,720 (6 propensity score matched studies) Type of Impella device not reported | Subgroup analysis showed higher 30-day mortality during ECMO (OR 1.11; 95% CI 1.01 to 1.22; p=.038; I2=0%) in males, but lower 30-day mortality during Impella therapy than females (OR 0.87; 95% CI 0.80 to 0.94; p=0.001; I2=0%). Males had a higher need of myocardial revascularisation (OR 3.09; 95% CI 1.56 to 5.99; p=0.001; I2=0%), but a higher risk of acute kidney injury (OR 1.20; 95% CI 1.09 to 1.31; p<0.001; I2=18%). | Study focuses on sex-related outcomes. |
Mangner N, Mierke J, Baron D et al. (2025) DanGer Shock-like profile predicts the outcome in ST-elevation myocardial infarction-related cardiogenic shock. ESC Heart Failure | Prospective single-centre registry n=478 STEMI-CS | Out of 225 people with STEMI-CS, 64 (28%) were considered DGS-like (met the criteria used in DanGerShock trial). All-cause mortality at 180 days was lower in the DGS-like compared to the DGS-unlike cohort (62% versus 72%, p=0.014) as was 30-day all-cause mortality (48% versus 70%, p<0.001). DGS-like remained an independent predictor of both 180-day (HR 0.57, 95% CI 0.39 to 0.83) and 30-day mortality (HR 0.48, 95% CI 0.32 to 0.72) in a multivariable analysis. | Small registry study comparing outcomes in a cohort similar to the DanGer Shock trial. |
Medina ML, Lewin D, Treede H et al. (2025) Multicentre comparison of various microaxial pump devices as a bridge to durable assist device implantation. ESC Heart Failure | Retrospective multicentre cohort n=339 (247 Impella high flow [5+], 92 low flow [CP]) Acute de-compensated advanced heart failure | High-flow microaxial flow pump devices (+5) provided superior haemodynamic support, enhanced left ventricular unloading, and reduced dependence on catecholamines compared to lower-flow CP devices. These improvements were associated with lower rates of right ventricular failure, renal dysfunction, and liver injury. However, there was no statistically significant difference between groups regarding 30-day mortality rates. | Small, retrospective study comparing different microaxial flow pump devices. |
Mierke J, Nowack T, Poege F et al. (2024) Sex-Related Differences in Outcome of Patients Treated With Microaxial Percutaneous Left Ventricular Assist Device for Cardiogenic Shock. Heart, Lung & Circulation 33: 1670-1679 | Retrospective analysis of prospective single-centre registry (Dresden Impella Registry) n=432 Impella CP | The study showed no differences in all-cause mortality at 30 days between males and females who had microaxial percutaneous LVAD in cardiogenic shock. | Small study focusing on sex-related outcomes. |
Mierke J, Nowack T, Loehn T et al. (2022) Predictive value of the APACHE II score in cardiogenic shock patients treated with a percutaneous left ventricular assist device. International Journal of Cardiology. Heart & Vasculature 40: 101013 | Analysis of data from prospective single-centre registry (Dresden Impella Registry) n=180 Impella CP | The predicted mortality calculated by the APACHE 2 score is overestimated in modern guideline-based treated cardiogenic shock with microaxial heart pumps. Nevertheless, the APACHE II score has an acceptable accuracy for prediction of intrahospital mortality, which can be more precisely estimated by using an adjusted diagnostic category weight. | The study focuses on the predictive value of APACHE 2 score. |
Miller PE, Bromfield SG, Ma Q et al. (2022) Clinical Outcomes and Cost Associated With an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Internal Medicine 182: 926-933 | Retrospective propensity-matched cohort study n=3,077 people who had PCI for AMICS | In this propensity-matched analysis of people having PCI for AMI complicated by cardiogenic shock, intravascular LVAD use was associated with increased short-term and 1-year risk of mortality, bleeding and kidney replacement therapy compared with IABP. | More recent studies were prioritised. |
Miyashita S, Banlengchit R, Marbach JA et al. (2022) Left Ventricular Unloading Before Percutaneous Coronary Intervention is Associated With Improved Survival in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Systematic Review and Meta-Analysis. Cardiovascular Revascularization Medicine 39: 28-35 | Systematic review and meta-analysis n=432 (5 studies) AMICS and PCI Impella 2.5, CP and 5.0 | In the pooled analysis, people who had Impella before PCI had statistically significantly lower in-hospital mortality compared to those who had Impella after PCI (RR 0.62, 95% CI 0.50 to 0.76, I2=0%). The lower mortality rate in the pre-PCI group remained evident at 30 days (HR 0.60, 95% CI 0.47 to 0.78, I2=0%) and at 6 months (HR 0.66, 95% CI 0.44 to 0.97, I2=0%). | More recent systematic reviews were prioritised. |
Moustafa A, Khan MS, Saad M et al. (2022) Impella Support Versus Intra-Aortic Balloon Pump in Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Meta-Analysis. Cardiovascular Revascularization Medicine 34: 25-31 | Systematic review and meta-analysis n=3,921 (7 studies) AMICS | There was no difference in short-term mortality between Impella and IABP (RR 1.08, 95% CI 0.87 to 1.33, p=0.49). For safety endpoints, Impella was associated with higher incidence of major bleeding (RR 2.03, 95% CI 1.56 to 2.64, p<0.0001), limb complications (RR 3.67, 95% CI 1.56 to 8.65, p=0.003) as well as haemolysis (RR 9.46, 95% CI 1.75 to 51.22, p=0.009) compared with IABP. No statistically significant difference was observed for the incidence of stroke (RR 1.07 95% CI 0.34 to 3.31 p=0.91). | More recent systematic reviews were prioritised. |
Movahed MR, Bradshaw S, Hashemzadeh M (2025) Mortality With Impella Is Lowest in Overweight and Obese but Is Highest in Morbid Obesity. Artificial Organs | Retrospective registry (US National Inpatient Sample database) n=86,810 | Overall mortality=30% Using multivariate analysis adjusting for comorbid conditions, overweight and obesity remained statistically significantly associated with the lowest mortality (overweight: OR 0.3, CI 0.16 to 0.68, p=0.003, Obese: OR 0.8, CI 0.71 to 0.91, p<0.001) whereas morbid obesity was associated with the highest mortality (OR 1.17, CI 1.02 to 1.34, p=0.02). | Studies with more comprehensive outcomes were prioritised. |
Munoz Tello C, Jamil D, Tran HH-V et al. (2022) The Therapeutic Use of Impella Device in Cardiogenic Shock: A Systematic Review. Cureus 14: e30045 | Systematic review 30 articles | Most people with cardiogenic shock have an improvement using the Impella device. This evaluation was founded on the LVEF, improvement in the cardiogenic shock criteria signs and symptoms, and favourable response in the follow-ups. | More recent systematic reviews with meta-analyses were prioritised. |
Murthi M, Baskaran N, Memdani A et al. (2024) Comparison of in-hospital outcomes of ST-elevation myocardial infarction patients with cardiogenic shock receiving left ventricular mechanical circulatory support devices based on transfer status. Catheterization and Cardiovascular Interventions 104: 437-443 | Retrospective registry (US National Inpatient Sample database) n=21,189 STEMI and cardiogenic shock | 75% of people had in-house left ventricular support and (25%) were transferred. Primary outcome mortality did not significantly differ (45% versus 44%, p=0.66). After multivariate analysis, the transferred group had higher rates of ECMO, acute kidney injury, renal replacement therapy, major bleeding, and ischaemic stroke. Length of stay (8 versus 15 days, p<0.001) was higher in the transferred group. | Retrospective study, focusing on in-hospital outcomes according to transfer status. |
Nair RM, Kumar S, Saleem T et al. (2024) Impact of Age, Gender, and Body Mass Index on Short-Term Outcomes of Patients With Cardiogenic Shock on Mechanical Circulatory Support. The American Journal of Cardiology 217: 119-126 | Retrospective single-centre cohort study n=393 Type of Impella device not reported | People over 80 years had higher 30-day mortality (82% versus 49%, p=0.006). Patients with BMI 30 or above had higher 30-day mortality than those with BMI less than 30 (60% versus 45%, p=0.007). There was no difference in 30-day mortality between men and women. On multivariable logistic regression, both age and BMI had a positive linear relation with adjusted 30-day mortality whereas gender did not have a major effect. | Larger studies were prioritised. |
Nakamura M, Imamura T, Ueno H et al. (2023) Sex-Related Differences in Short-Term Prognosis in Patients with Acute Myocardial Infarction-Related Cardiogenic Shock Receiving Impella Support in Japan: From the J-PVAD Registry. Medicina 59 (no. 7) | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=924 AMICS | Among the people with AMICS who had Impella support and revascularisation, female sex was independently associated with a lower 30-day survival. For females, early initiation of Impella support before revascularisation may improve their clinical outcomes. | Larger studies were prioritised. |
Nasu T, Ninomiya R, Koeda Y et al. (2024) Impella device in fulminant myocarditis: Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) registry analysis on outcomes and adverse events. European Heart Journal. Acute Cardiovascular Care 13: 275-283 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=269 (107 Impella alone, 162 Impella combined with ECMO) Fulminant myocarditis | 30-day survival=74%. The success rate was 68% for the ECPELLA group and 83% for the Impella standalone group. Cox regression highlighted that lower estimated glomerular filtration rate and pre-Impella systolic blood pressure increased adverse event risk, while Swan-Ganz catheterisation use reduced it. Adverse events were noted in 49% of patients, such as bleeding (32%) and deteriorating renal function (9%). | Larger studies were prioritised. |
Nersesian G, Potapov EV, Nelki V et al. (2021) Propensity score-based analysis of 30-day survival in cardiogenic shock patients supported with different microaxial left ventricular assist devices. Journal of Cardiac Surgery 36: 4141-4152 | Retrospective propensity score-adjusted analysis from 2 centres n=126 cardiogenic shock Impella CP, 5.0 and 5.5 | The unadjusted 30-day survival was higher in the Impella 5.0 or 5.5 group (58% versus 36%, p=0.021, OR 3.68, 95% CI 1.46 to 9.90, p=0.0072). After adjustment, the 30-day survival was similar for both devices (OR 1.23, 95% CI 0.34 to 4.18, p=0.744). Lactate levels above 8 mmol/litre and preoperative cardiopulmonary resuscitation were associated with a statistically significant mortality increase in both cohorts (OR 10.7, 95% CI 3.45 to 47.34, p<0.001; OR 13.2, 95% CI 4.28 to 57.89, p<0.001, respectively). | Larger and more recent studies were prioritised. |
Nishimoto Y, Inohara T, Kohsaka S et al. (2023) Changing Trends in Mechanical Circulatory Support Use and Outcomes in Patients Undergoing Percutaneous Coronary Interventions for Acute Coronary Syndrome Complicated With Cardiogenic Shock: Insights From a Nationwide Registry in Japan. Journal of the American Heart Association 12: e031838 | Retrospective nationwide Japanese Percutaneous Coronary Intervention (J-PCI) registry n=12,171 (622 Impella) Acute coronary syndrome complicated with cardiogenic shock | In‐hospital mortality in people needing MCS=36%. In‐hospital mortality was highest in the VA‐ECMO alone group (58%) and lowest in the Impella group (25%), with the IABP‐alone group at 26%, VA‐ECMO plus IABP group at 56%, and ECPella group at 47%. Bleeding needing a blood transfusion was most prevalent in the ECPella group (8% and 6% for access and nonaccess sites, respectively), and least prevalent in the IABP‐alone group (1%). | Study focuses on trends in MCS use. |
Nishimura T, Toda K, Ako J et al. (2024) Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device. Journal of Artificial Organs 27: 375-384 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=1,344 (653 Impella alone, 685 Impella with ECMO) | Overall 30-day survival was 67%, with Impella alone at 82% and ECPELLA at 53%. Overall bleeding or haematoma adverse events with a relation or not-excluded relation to Impella was 7%. Among them, the rates of haematoma and bleeding from medical device access sites were 1% and 4%, respectively. There was no difference between aetiologies for these events. | Studies with more comprehensive outcomes are included. |
Nouri SN, Malick W, Masoumi A et al. (2022) Impella percutaneous left ventricular assist device as mechanical circulatory support for cardiogenic shock: A retrospective analysis from a tertiary academic medical center. Catheterization and Cardiovascular Interventions 99: 37-47 | Retrospective single-centre cohort study n=115 cardiogenic shock (67% AMICS) | In-hospital mortality= 57%, numerically greater survival was noted with earlier device implantation. There was a statistically significant cardiac output improvement and pharmacological support reduction. 48 (42%) people needed ECMO. Complications were predominantly access site related (bleeding [10%], vascular injury [5%], and limb ischaemia [3%]). | Larger studies were prioritised. |
O'Neill BP, Cohen MG, Basir MB et al. (2019) Outcomes Among Patients Transferred for Revascularization With Impella for Acute Myocardial Infarction With Cardiogenic Shock from the cVAD Registry. The American Journal of Cardiology 123: 1214-1219 | Multicentre US registry n=475 cardiogenic shock and PCI Impella 2.5 or CP | Despite baseline differences, the mortality was similar in the transfer versus direct groups (47% versus 54% p=0.19). In a multivariate model, the factors independently associated with 30-day mortality in AMICS treated with revascularisation and Impella support were cardiopulmonary resuscitation (p<0.01), age (p<0.01), and STEMI (p=0.02). Whether the person was transferred or directly admittedly with AMICS was not an independent predictor of death. | More recent studies were prioritised. |
O'Neill WW, Grines C, Schreiber T et al. (2018) Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device. American Heart Journal 202: 33-38 | Multicentre US registry n=15,259 people with AMICS | 51% survived to explantation of Impella. Survival was higher when Impella was used as first support strategy, when invasive haemodynamic monitoring was used, and at centres with higher Impella implantation volume. | More recent studies were prioritised. |
O'Neill WW, Schreiber T, Wohns DHW et al. (2014) The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. Journal of Interventional Cardiology 27: 1-11 | Multicentre US registry (USpella) n=154 cardiogenic shock and PCI Impella 2.5 | People who had Impella before PCI had better survival to discharge compared to those in the post-PCI group (65% versus 41%, p=0.003). Survival remained favourable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support before PCI with Impella 2.5 was an independent predictor of in-hospital survival (OR 0.37, 95% CI 0.17 to 0.79, p=0.01) in multivariate analysis. | Larger and more recent studies were prioritised. |
Ouazani Chahdi H, Berbach L, Boivin-Proulx L-A et al. (2022) Percutaneous Mechanical Circulatory Support in Post-Myocardial Infarction Cardiogenic Shock: A Systematic Review and Meta-analysis. The Canadian Journal of Cardiology 38: 1525-1538 | Systematic review and meta-analysis 54 studies (including all types of percutaneous MCS) | There was a lack of adequately powered randomised data. The 2 meta-analyses of Impella compared with both conventional therapy and IABP support failed to show a clinical advantage. However, the high degree of interstudy heterogeneity among Impella studies suggests the possibility that either the studies may have targeted 2 different post-AMI cardiogenic shock populations or there was differential application of Impella support between studies, such as differences in the timing of support either in relation to PCI or in the course of cardiogenic shock. | More recent systematic reviews are included and there is considerable overlap between this and other included systematic reviews. |
Ouweneel DM, de Brabander J, Karami M et al. (2019) Real-life use of left ventricular circulatory support with Impella in cardiogenic shock after acute myocardial infarction: 12 years AMC experience. European Heart Journal. Acute cardiovascular care 8: 338-349 | Single-centre registry n=172 cardiogenic shock Impella 2.5, 5.0 and CP | Overall 30-day mortality was 56% and 6-month mortality was 61%. Complications consisted of device-related vascular complications (17%), non-device-related bleeding (12%), haemolysis (7%) and stroke (4%). In a multivariate analysis, pH before Impella placement was a predictor of 6-month mortality. | Larger and more recent studies were prioritised. |
Ouweneel DM, Eriksen E, Sjauw KD et al. (2017) Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction. Journal of the American College of Cardiology 69: 278-287 | Randomised controlled trial (IMPRESS) n=48 (24 Impella CP) | At 30 days, mortality in people treated with either IABP or Impella was similar (50% and 46%, respectively; HR with Impella: 0.96; 95% CI 0.42 to 2.18; p=0.92). At 6 months, mortality for both groups was 50% (HR 1.04; 95% CI 0.47 to 2.32; p=0.923). | Larger and more recent studies were prioritised. Study is included in reviews by Ardito (2023), Panuccio (2022) and Sassani (2025). |
Patel N, Sharma A, Dalia T et al. (2020) Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective. Catheterization and Cardiovascular Interventions 95: 309 | Retrospective registry (US National Inpatient Sample database) n=31,263 percutaneous LVAD placements | Overall incidence of vascular complications was 14%, out of which 56% needed surgical treatment. Acute limb thromboembolism and bleeding needing transfusion accounted for 28% and 22% of all vascular complications. Occurrence of a vascular complication was associated with higher in-hospital mortality (38% versus 30%, p<0.001) and length of stay (23 versus 12 days, p<0.001) | More recent studies were prioritised. |
Philipson DJ, Cohen DJ, Fonarow GC et al. (2021) Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). The American Journal of Cardiology 140: 91-94 | US FDA MAUDE database n=885 reports related to Impella (1,206 complications) | Among people with adverse events reported, bleeding (33%), device deployment or retrieval issues (18%), vascular complications (16%), and death (12%) were the most common, and 8% of all complications were attributable to operator decision-making or technique. | More recent studies with large populations are included, which report complications. The FDA MAUDE data does not include a denominator so incidence rates could not be determined. |
Pieri M, Iannaccone M, Burzotta F et al. (2024) Can a mechanical circulatory support comprehensive approach to cardiogenic shock at referral centers reduce 30-day mortality? Frontiers in Cardiovascular Medicine 11: 1509162 | 2-centre cohort study n=170 Acute myocardial infarction was the prevalent cause of cardiogenic shock (71%). Impella 2.5, 5.0, CP and RP | 25% of people had out-of-hospital cardiac arrest. 34% of people had VA-ECMO, 39% had IABP before Impella support, and 59% had more than 1 inotrope. Expected mortality was higher than observed (52% versus 42%, p<0.001). | Larger studies were prioritised. |
Rohm CL, Gadidov B, Ray HE et al. (2021) Vasopressors and Inotropes as Predictors of Mortality in Acute Severe Cardiogenic Shock Treated With the Impella Device. Cardiovascular Revascularization Medicine 31: 71-75 | Retrospective single-centre cohort study n=276 Impella 2.5, CP and 5.0 | All-cause in-hospital mortality=45%. Mortality increased with escalating use of vasopressors and inotropes, with the most significant increase in mortality from use of 2 agents to the use of 3 agents (8% versus 40%, p<0.001). There was no difference in mortality whether dobutamine or milrinone was used (44% versus 36%, p=0.41); there was increased mortality with use of multiple inotropes. People who had only vasopressors had increased mortality compared to those who had a combination of agents that included 1 inotrope. | Larger studies were prioritised. |
Rohm CL, Gadidov B, Leitson M et al. (2019) Predictors of Mortality and Outcomes of Acute Severe Cardiogenic Shock Treated with the Impella Device. The American Journal of Cardiology 124: 499-504 | Retrospective single-centre study n=204 Acute severe cardiogenic shock Impella 2.5, CP and 5.0 | All-cause in-hospital mortality=45%. Non-survivors had a lower initial pH (7.24 versus 7.32, HR 1.03, p<0.0001), lower serum CO2 (19.1 versus 21.3 mmol/litre, HR 1.08, p=0.002), higher lactate (6.8 versus 3.3 mmol/litre, HR 1.17, p<0.0001), and used a greater number of vasopressors and inotropes (4.3 versus 2.6, HR 1.44, p<0.0001). People who had Impella more than 4 days (n=45) had a longer intensive care unit stay (12.6 versus 6.9 days, p<0.001), longer total hospital stay (16.4 versus 11.6 days, p=0.03), longer mechanical ventilation use (7.8 versus 4.4 days, p=0.002), and trend toward increased mortality (58 versus 42%, p=0.051). | Larger and more recent studies were prioritised. |
Saito Y, Shiko Y, Tateishi K et al. (2025) Combined Risk Stratification With Patient Characteristics and Biomarkers in Patients Treated With the Impella for Cardiogenic Shock. Journal of the American Heart Association 14: e040487 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=4,122 | Of the 4,122 people with cardiogenic shock, the Impella was indicated for acute myocardial infarction in 2,575 (62%). Multivariable analysis identified 4 patient characteristics (age, body mass index, out-of-hospital cardiac arrest, and blood pressure) and 6 biomarkers (lactate, lactate dehydrogenase, creatinine, total bilirubin, albumin, and creatinine kinase) with cutoff values as factors significantly associated with in-hospital mortality. | Study focuses on development of a risk-stratifying model for in-hospital mortality. |
Saito Y, Tateishi K, Toda K et al. (2023) Complications and Outcomes of Impella Treatment in Cardiogenic Shock Patients With and Without Acute Myocardial Infarction. Journal of the American Heart Association 12: e030819 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=2,047 AMICS (65%) versus non-AMICS | In the group without AMI, myocarditis was the leading cause of cardiogenic shock. Patients with AMICS were older and more likely to have cardiovascular risk factors than those with non-AMICS. The rates of in-hospital mortality (46% versus 44%, p=0.38) and major complications (35% versus 35%, p=0.85) were similar between the 2 groups. Overall, multivariable analysis identified older age, higher body mass index, previous transient ischaemic attack or stroke, out-of-hospital cardiac arrest, and the Impella 5.0 as factors significantly associated with the primary end point. | Larger registry studies were prioritised. |
Schafer A, Westenfeld R, Sieweke J-T et al. (2021) Complete Revascularisation in Impella-Supported Infarct-Related Cardiogenic Shock Patients Is Associated With Improved Mortality. Frontiers in Cardiovascular Medicine 8: 678748 | Retrospective multicentre cohort study n=202 AMICS Impella CP | Overall 30-day mortality was 47%. Mortality was higher when Impella was implanted after PCI (Impella-post-PCI: 57%, Impella-pre-PCI: 38%, p=0.0053) and if revascularisation was incomplete. People with both pre-PCI Impella implantation and complete revascularisation had statistically significantly lower mortality (33%) than those with incomplete revascularisation and implantation after PCI (72%, p<0.001). | Larger studies were prioritised. |
Schafer A, Werner N, Burkhoff D et al. (2020) Influence of Timing and Predicted Risk on Mortality in Impella-Treated Infarct-Related Cardiogenic Shock Patients. Frontiers in Cardiovascular Medicine 7: 74 | Retrospective multicentre cohort study n=166 AMICS Impella 2.5 and CP | Impella use was associated with lower mortality than predicted in people deemed at high risk based predominantly on assessment using a validated risk score, the CardShock score. Overall 30-day mortality was higher when Impella was implanted after PCI (51%) compared to when Impella was implanted before PCI (28%), p=0.0039. Survivors were younger, had lower admission lactate levels, lower shock score values, and trended to be less often resuscitated. There was no difference regarding type of Impella or renal function between survivors and non-survivors. | Larger studies were prioritised. |
Scherer C, Lusebrink E, Kupka D et al. (2020) Long-Term Clinical Outcome of Cardiogenic Shock Patients Undergoing Impella CP Treatment vs. Standard of Care. Journal of Clinical Medicine 9: no. 12 | Retrospective data from 2 centres n=140 (70 Impella) cardiogenic shock Impella CP | 41% of people without cardiocirculatory support and 54% of people with Impella support died during the first month (p=0.17). After 1 year, mortality rates were similar in both groups (55% in conventional versus 59% in Impella CP group, p=0.30) as was mortality rate at long-term 5-years follow-up (64% in conventional versus 73% in Impella CP group, p=0.33). The rate of any bleeding event (37% versus 74%, p<0.001) as well as the rate of clinically significant bleeding was lower in the conventional group than in Impella CP group (15% versus 43%, p=0.002). There were no vascular complications in the control group whereas 7% of people in the Impella group (p=0.07) had vascular complications. | Larger studies were prioritised. |
Schrage B, Sundermeyer J, Beer BN et al. (2023) Use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock. European Journal of Heart Failure 25: 562-572 | Propensity score-matched cohort n=534 (267 MCS) 132 people had pLVAD only (13 Impella 2.5, 118 Impella CP and 7 Impella 5.0 or 5.5) | In the matched cohort, MCS use was associated with a lower 30-day mortality (HR 0.76, 95% CI 0.59 to 0.97). However, complications were more frequent in people who had MCS, including severe bleeding (16.5% versus 6.4%) and access-site related ischaemia (6.7% versus 0%). | The study assessed a combination of MCS, including both percutaneous left ventricular assist devices and ECMO. |
Schrage B, Ibrahim K, Loehn T et al. (2019) Impella support for acute myocardial infarction complicated by cardiogenic shock: Matched-pair iabp-shock II trial 30-day mortality analysis. Circulation 139: 1249 | Retrospective multicentre cohort study n=574 (237 Impella) AMICS Impella 2.5 and CP | In this retrospective analysis of people with AMICS, the use of an Impella device was not associated with lower 30-day mortality compared with matched people from the IABP-SHOCK II trial treated with an IABP or medical therapy. | More recent studies were prioritised. |
Schultz J, Duval S, Shaffer A et al. (2022) Axillary or Subclavian Impella 5.0 Support in Cardiogenic Shock: A Systematic Review and Meta-analysis. ASAIO Journal 68: 233-238 | Systematic review and meta-analysis n=256 (13 studies) Impella 5.0 | 30-day survival=66% (95% CI 59 to 73). Survival to the next therapy=68% (95% CI 60 to 76). The occurrence of adverse events over an average of 13 (95% CI 12 to 14) days of support was the following: stroke 6%, haemolysis 27%, pump thrombosis 4%, limb ischaemia 0.1%, major bleeding 5%, device malfunction 11%, exchange 7%, and infection 14%. | More comprehensive reviews are included. |
Schurtz G, Rousse N, Saura O et al. (2021) IMPELLA R or Extracorporeal Membrane Oxygenation for Left Ventricular Dominant Refractory Cardiogenic Shock. Journal of Clinical Medicine 10: no. 4 | Retrospective single-centre cohort study n=128 (31 Impella) Refractory left ventricle dominant cardiogenic shock Impella CP (n=26) and 5.0 (n=5) | In unadjusted analysis, there was no statistically significant difference in 30-day mortality: 43% versus 58% in the VA-ECMO and Impella groups, respectively (p=0.152). After adjustment, VA-ECMO was associated with a statistically significant reduction in 30-day mortality (HR 0.25, p=0.004). A higher rate of MCS escalation was observed in the Impella group: 32% versus 10% (p=0.003). | Larger studies were prioritised. |
Seyfarth M, Sibbing D, Bauer I et al. (2008) A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. Journal of the American College of Cardiology 52: 1584-8 | Randomised controlled trial n=25 (12 Impella) AMICS Impella 2.5 | The cardiac index after 30 minutes of support was statistically significantly increased in people who had Impella compared with those who had IABP. 30-day mortality was 46% in both groups. | More recent and larger studies were prioritised. Study is included in review by Panuccio (2022). |
Shah T, Lansky AJ, Grines CL et al. (2022) Mechanical Circulatory Support in Myocardial Infarction Complicated by Cardiogenic Shock: Impact of Sex and Timing. Journal of the Society for Cardiovascular Angiography & Interventions 1: 100002 | Prospective multicentre postmarket registry (RECOVER 3) n=358 AMICS Impella 2.5, CP and 5.0 | Overall survival to hospital discharge was 52%, with no difference in survival between women and men (46% versus 54%; p=0.25) Women had a survival benefit from early percutaneous LVAD use before PCI compared to after PCI (58% versus 34%; p=0.03), whereas post-PCI was not associated with worse survival in men (56% versus 50%, p=0.39). Outcomes in women and men who had percutaneous LVAD support before PCI were similar, whereas women who had it after PCI tended to have a higher mortality compared with men (p=0.08). | Larger studies were prioritised. |
Shirakabe A, Matsushita M, Shigihara S et al. (2025) Age-specific differences of Impella support in Japanese patients: The Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) registry analysis on outcomes and adverse events. Journal of Cardiology 85: 343-351 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=5,282 | Increasing age was identified as a significant factor associated with higher 30-day mortality. While the incidence of major adverse events did not differ significantly across age categories, the occurrence of 2 or more additional adverse events was linked to increased 30-day mortality among older individuals. | Study focuses on age-related outcomes. |
Singh H, Mehta RH, O'Neill W et al. (2021) Clinical features and outcomes in patients with cardiogenic shock complicating acute myocardial infarction: early vs recent experience with impella. American Heart Journal 238: 66-74 | Retrospective cohort study n=649 AMICS | Use of Impella for AMICS during recent years is associated with lower unadjusted in-hospital mortality, which may reflect better patient selection, earlier device implantation, and improved management algorithms. | Larger and more recent studies were prioritised. |
Suzuki S, Teraoka N, Ito K et al. (2025) A Novel Predictive Score Model for Successful Weaning From Mechanical Circulatory Support in Patients With Cardiogenic Shock. Journal of Cardiac Failure 31: 791-799 | Retrospective single centre cohort study n=114 cardiogenic shock Impella 2.5, CP, 5.0 and 5.5 | 55 (48%) people were weaned from MCS successfully. The following variables were selected as the components of the simple version of the weaning score model: AMI, mean blood pressure 80 mmHg or above, lactate less than 10 mg/dL, QRS duration 95 milliseconds or less, and LVEF more than 35%. | Larger studies were prioritised. |
Syntila S, Chatzis G, Markus B et al. (2021) Comparison of Mechanical Support with Impella or Extracorporeal Life Support in Post-Cardiac Arrest Cardiogenic Shock: A Propensity Scoring Matching Analysis. Journal of Clinical Medicine 10: no. 16 | Retrospective single centre cohort study n=159 (105 Impella) Out of hospital cardiac arrest with post-cardiac arrest cardiogenic shock following AMI Impella 2.5 and CP | The use of Impella 2.5 or CP, or extracorporeal life support in post-cardiac arrest cardiogenic shock after AMI was associated with comparable adjusted hospital and 12-month survival. People who had Impella had a greater LVEF improvement. Device-related access-site complications occurred more frequently with extracorporeal life support. | Larger studies were prioritised. |
Takahashi K, Kubo S, Ikuta A et al. (2022) Incidence, predictors, and clinical outcomes of mechanical circulatory support-related complications in patients with cardiogenic shock. Journal of Cardiology 79: 163-169 | Retrospective cohort study n=403 | Haemolysis, major bleeding, thromboembolic events, and ischaemic stroke were observed in 42 (10%), 150 (37%), 52 (13%), and 30 people (7%), respectively. People with major bleeding had a higher in-hospital mortality than those without major bleeding (31% versus 56%, p<0.001). In multivariate analysis, both Impella and VA-ECMO were independent predictors of major bleeding and thromboembolic events. However, in-hospital mortality was similar between the Impella and IABP groups irrespective of the VA-ECMO insertion. | Larger studies were prioritised. |
Tarantini G, Masiero G, Burzotta F et al. (2021) Timing of Impella implantation and outcomes in cardiogenic shock or high-risk percutaneous coronary revascularization. Catheterization and Cardiovascular Interventions 98: e222-e234 | Multicentre propensity score weighting analysis (IMP-IT Registry) n=365 High-risk PCI and cardiogenic shock Impella 2.5 and CP | Pre-procedural insertion was associated with an improvement in 1-year survival in people with AMICS treated with PCI. Among people having high risk-PCI, early Impella support was also associated with a lower rate of the composite of mortality, re-hospitalisation for heart failure, and need for LVAD or heart transplantation at 1-year. Impella use during or after PCI was associated with an increased in-hospital life-threatening and severe bleeding among patients with AMI-CS having PCI (7 versus 16%, p=0.1) and high risk-PCI (1 versus 9%, p=0.02). | Larger studies were prioritised. |
Tariq MD, Jain H, Khan AM et al. (2024) Efficacy and safety of percutaneous mechanical circulatory support in patients with cardiogenic shock following acute myocardial infarction: A meta-analysis of randomized controlled trials. Medicine 103: e40595 | Systematic review and meta-analysis n=442 (4 randomised controlled trials) AMICS | The pooled analysis showed that the odds of 6-month all-cause mortality were significantly lower with Impella compared to standard of care (OR 0.64, 95% CI 0.43 to 0.95; p=0.03). However, 30-day mortality reported no statistically significant difference between the 2 groups (OR 1.03; 95% CI 0.43 to 2.48; p=0.95). Impella was associated with a statistically significant increase in the odds of major bleeding (OR 3.61; 95% CI 1.14 to 11.40; p=0.03), limb ischaemia (OR 4.91; 95% CI 1.37 to 17.6; p=0.01), and sepsis (OR 2.75; 95% CI 1.25 to 6.08; p=0.01). No statistical significance was found in LVEF at follow-up between the 2 groups. | The review only includes 4 trials, the largest of which is included in the key evidence. |
Thakkar S, Patel HP, Kumar A et al. (2021) Outcomes of Impella compared with intra-aortic balloon pump in ST-elevation myocardial infarction complicated by cardiogenic shock. American Heart Journal Plus: Cardiology Research and Practice 12: 100067 | Propensity score-matched analysis n=14,690 (7,345 Impella) STEMI complicated with cardiogenic shock | All-cause in-hospital mortality was higher in the hospitalisations needing Impella support as compared to IABP (42% versus 32%, adjusted OR 1.71; 95% CI 1.60 to 1.84, p<0.0001). Impella was associated with a higher risk of in-hospital complications and hospitalisation cost compared with IABP. | More recent studies were prioritised. |
Toda K, Ako J, Hirayama A et al. (2023) Three-year experience of catheter-based micro-axial left ventricular assist device, Impella, in Japanese patients: the first interim analysis of Japan registry for percutaneous ventricular assist device (J-PVAD). Journal of Artificial Organs 26: 17-23 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=823 Drug refractory acute heart failure (45% AMICS) Impella 2.5 (72%), CP (6%) or 5.0 (17%) | Combination use of Impella and VA-ECMO=47% Pump stop=3% Major adverse events included haemolysis (11%), haemorrhage or haematoma (6%), peripheral ischaemia (2%), and stroke (2%). The overall 30-day survival was 62%. Survival of people with single Impella support was statistically significantly higher than people with Impella combined with VA-ECMO support (81% versus 50%; p<0.01), who had lower blood pressure, lower LVEF, and higher degree of inotropic support. | Larger studies were prioritised. |
Udesen NLJ, Beske RP, Hassager C et al. (2025) Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial. JAMA Cardiology 10: 9-16 | Substudy of randomised controlled trial (DanGer Shock) n=324 STEMI-CS | Use of a microaxial flow pump reduces the use of vasopressors and inotropic medication while maintaining haemodynamic stability and achieving faster normalisation of lactate level in patients with STEMI-CS. | The primary trial publication is included in the key evidence. |
Virk HUH, Tripathi B, Gupta S et al. (2018) Trends, etiologies, and predictors of 90-day readmission after percutaneous ventricular assist device implantation: A national population-based cohort study. Clinical Cardiology 41 561-568 | Retrospective registry (US Nationwide Readmission Database) n=7,074 | 1,562 (22%) people were readmitted within 90 days. Acute decompensated heart failure (23%) and acute coronary syndromes (11%) were the most common aetiologies and heart failure (OR 1.39, 95% CI 1.17 to 1.67), chronic obstructive pulmonary disease (OR 1.26, 95% CI 1.07 to 1.49), peripheral vascular disease (OR 1.30, 95% CI 1.09 to 1.56), and discharge into short- or long-term facility (OR 1.28, 95% CI 1.08 to 1.51) were independently associated with an increased risk of 90-day readmission following percutaneous VAD use. | More recent studies were prioritised. |
Wernly B, Karami M, Engstrom AE et al. (2021) Impella versus extracorporal life support in cardiogenic shock: a propensity score adjusted analysis. ESC Heart Failure 8: 953-961 | Retrospective cohort study n=149 (73 Impella) Impella 2.5 | The rates of vascular injuries (adjusted OR 0.95; 95% CI 0.10 to 3.50; p=0.56) and bleeding needing transfusion (adjusted OR 0.44; 95% CI 0.09 to 2.10; p=0.29) were similar in the 2 groups (Impella and extracorporeal life support). The use of Impella or extracorporeal life support was not associated with increased odds of mortality (adjusted OR 4.19; 95% CI 0.53 to 33.25; p=0.17), after correction for propensity score and baseline lactate level. Baseline lactate level was independently associated with increased odds of 30-day mortality (per mmol/litre increase; OR 1.29; 95% CI 1.14 to 1.45; p<0.001). | Larger studies were prioritised. |
Whitehead EH, Thayer KL, Burkhoff D et al. (2020) Central Venous Pressure and Clinical Outcomes During Left-Sided Mechanical Support for Acute Myocardial Infarction and Cardiogenic Shock. Frontiers in Cardiovascular Medicine: 155 | Retrospective multicentre cohort study n=132 cardiogenic shock (72% STEMI) Impella 2.5, CP, 5.0 and 5.5 | 59 people (45%) died in the hospital and 73 survived to discharge. Statistically significant differences between those who died in hospital and those who survived to discharge were noted in the rates of CPR (54 versus 36%, p=0.032) and mechanical ventilation (63 versus 40%, p=0.009). Central venous pressure was higher among those who died in the hospital (14.0 versus 11.7 mmHg, p=0.014), and a central venous pressure above 12 identified people at higher risk for in-hospital mortality (65 versus 45%, p=0.02). Central venous pressure remained statistically significantly associated with in-hospital mortality even after adjustment in a multivariable model (adjusted OR 1.10, 95% CI 1.02 to 1.19 per 1 mmHg increase). | Larger studies were prioritised. |
Yahagi K, Gonda Y, Yoshiura D et al. (2025) Impact of lactate levels on admission in STEMI patients with cardiogenic shock treated with IMPELLA. Heart and Vessels | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=852 STEMI-CS | In-hospital mortality=42%. The rate of VA-ECMO combined with Impella use was 38%. The in-hospital mortality of Impella alone and ECPELLA group were 30% and 61%, respectively. The median lactate level was higher in non-survivors than in survivors (5.7 mmol/litre versus 3.5 mmol/litre, p<0.0001). A lactate cut-off value of 6.9 mmol/litre showed the best discrimination for in-hospital mortality. Patients classified as the SCAI SHOCK stage E have a higher mortality rate with Impella support alone. | Larger studies were prioritised. |
Yokoi M, Ito T, Shintani Y et al. (2025) Clinical characteristics and short-term outcomes in patients with cardiogenic shock undergoing mechanical circulatory support escalation from intra-aortic balloon pump to impella: From the J-PVAD registry. Journal of Cardiology 85: 337-342 | Multicentre registry (Japanese Percutaneous Ventricular Assist Device registry) n=2,578 | Compared to people with primary Impella support, those who had IABP-Impella escalation showed similar 30-day mortality and major complications despite poorer clinical conditions before Impella support and a more complicated clinical course after Impella insertion. | Study focuses on short-term outcomes after IABP-Impella escalation. |
Zaiser AS, Fahrni G, Hollinger A et al. (2021) Adverse Events of Percutaneous Microaxial Left Ventricular Assist Devices-A Retrospective, Single-Centre Cohort Study. Journal of Clinical Medicine 10 | Retrospective single-centre cohort study n=281 | 93% of people had at least 1 adverse event. Rates of in-hospital, 90-day, and 1-year mortality were 48%, 47%, and 50%, respectively. Complication rates: bleeding (62%), haemolysis (42%), acute kidney injury (50%), renal replacement therapy (35%) and limb ischaemia (13%). | Larger studies were prioritised. |
Zhang Q, Han Y, Sun S et al. (2022) Mortality in cardiogenic shock patients receiving mechanical circulatory support: a network meta-analysis. BMC Cardiovascular Disorders 22: 48 | Network meta-analysis n=10,985 (39 studies) cardiogenic shock aetiology: unstable angina, AMI, in-hospital cardiac arrest, out-of-hospital cardiac arrest, ischaemic cardiomyopathy and dilative cardiomyopathy | Regarding in-hospital mortality, the results showed no statistically significant differences between IABP and Impella, VA-ECMO plus IABP, Tandem Heart and medical therapy. IABP more effectively reduced the incidence of 30-day mortality compared with VA-ECMO and Impella for the treatment of cardiogenic shock. | More recent reviews are included. |
Zweck E, Hassager C, Beske RP et al. (2024) Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial. Circulation 150: 1990-2003 | Substudy of randomised controlled trial (DanGer Shock) n=355 (179 microaxial flow pump) STEMI-CS | Shock severity, allocation to microaxial flow pump, and device-related complications were associated with an increased risk of acute kidney injury. Acute kidney injury was generally associated with higher mortality, but the allocation to microaxial flow pump consistently led to lower mortality at 180 days irrespective of the occurrence of acute kidney injury with or without renal replacement therapy initiation. | The primary trial publication is included in the key evidence. |
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions