Interventional procedure overview of surgical insertion of a catheter-based intravascular microaxial flow pump for cardiogenic shock
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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 5a and 5b below. Case reports of safety outcomes that are not included in the main evidence are listed in table 5a and other studies that were not prioritised are listed in table 5b. Non-randomised studies with fewer than 20 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. | It is unclear if any surgically implanted devices were included. |
Abiragi M, Singer-Englar T, Cole RM et al. (2023) Temporary Mechanical Circulatory Support in Patients with Cardiogenic Shock: Clinical Characteristics and Outcomes. Journal of Clinical Medicine 12 (no. 4) | Retrospective single-centre cohort study n=90 (31 Impella) Acute decompensated heart failure (98%), AMI (2%) Impella 5.5 (n=30), 5.0 (n=1) | Compared with people supported with IABP, those with Impella support had a longer median duration of support (15 versus 7 days, p<0.001). People with Impella support had a higher in-hospital mortality (19% versus 3%, p=0.018); however, there was no statistically significant difference in all-cause mortality over the course of follow-up. | Larger 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. | It is unclear if any surgically implanted devices were 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. | It is unclear if any surgically implanted devices were 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). | It is unclear if any surgically implanted devices were 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. | It is unclear if any surgically implanted devices were included. |
Ardito V, Sarucanian L, Rognoni C et al. (2023) Impella Versus VA-ECMO for Patients with Cardiogenic Shock: Comprehensive Systematic Literature Review and Meta-Analyses. Journal of Cardiovascular Development and Disease 10: 4 | Systematic review and meta-analysis n=44,951 (13,848 Impella) | Overall mortality (at 30 days, 6 months and 1 year) was 44% (95% CI 39 to 50%) in people who had Impella and 50% (95% CI 43 to 58%) in people who had VA-ECMO. The review highlighted the need to conduct more comparative studies in the field of MCS health technologies for treating cardiogenic shock. | Only 1 paper included Impella 5.5. |
Asher M, Iyengar A, Rekhtman D et al. (2025) Acute Hemodynamic and Echocardiographic Consequences of Impella 5.5 Placement in Patients With Advanced Cardiogenic Shock. ASAIO Journal | Retrospective single-centre cohort study n=87 Advanced cardiogenic shock (51% non-ischaemic cardiomyopathy) Impella 5.5 | 1-year survival=67% At 30 days, 27 (31%) people were transplanted and 13 (15%) were bridged to a durable LVAD. | Larger studies were prioritised. |
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. | It is unclear if any surgically implanted devices were included. |
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. |
Bandini M, D'Ettore N, Iannotti W et al. (2024) Midterm outcomes of patients with native heart recovery after Impella 5+ for cardiogenic shock. European Journal of Heart Failure | Retrospective single-centre cohort study n=20 Impella 5.5 | At 180 days, 19 (95%) people were alive. 40% of people had an implantable cardioverter-defibrillator and there were 2 admissions for heart failure. The mean LVEF was 34%, 5 (26%) people were NYHA class 1, 9 (47%) were NYHA class 2, and 5 (26%) were NYHA class 3. 1 person died from a non-cardiac cause. | Larger studies were prioritised. |
Bashline M, DiBridge J, Klass WJ et al. (2023) Outcomes of systemic bivalirudin and sodium bicarbonate purge solution for Impella 5.5. Artificial Organs 47: 361-369 | Retrospective single-centre cohort study n=34 Impella 5.5 | Most people were bridged to heart transplantation (58%) followed by recovery (27%) and LVAD implantation (15%). One person had ischaemic stroke, and 26% developed clinically significant bleeding. | Larger studies were prioritised. Study is included in systematic review by Kwon (2024). |
Bernhardt A, Potapov E, Schibilsky D et al. (2021) First in man evaluation of a novel circulatory support device: Early experience with the Impella 5.5 after CE mark approval in Germany. Journal of Heart and Lung Transplantation 40: 850-855 | Multicentre cohort study n=46 Impella 5.5 The main indication was ischaemic cardiomyopathy and AMI (48%). | The 30 days and 90 days survival rates were 74% (95% CI 63 to 89%) and 72% (95% CI 61 to 87%), respectively. Additionally, 16 people (35%) were weaned from the device for native heart recovery, and 19 (41%) were bridged to a durable device. 15 people (33%) were mobilised to a chair, and 15 (33%) were ambulatory. There was 1 stroke and no other thromboembolic complications. 7 people (15%) had pump thrombosis, and 9 (20%) had device exchange. 16 people (35%) had bleeding needing transfusion during the whole treatment course. In 10 people (22%), the inflow cannula dislocated into the aortic root. | Larger studies were prioritised. Study is included in systematic review by Kwon (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) | 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. | It is unclear if any surgically implanted devices were included. |
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). | It is unclear if any surgically implanted devices were included. |
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. | It is unclear if any surgically implanted devices were included. |
Cevasco M, Shin M, Cohen W et al. (2023) Impella 5.5 as a bridge to heart transplantation: Waitlist outcomes in the United States. Clinical Transplantation 37: e15066 | Retrospective registry (United Network for Organ Sharing) n=464 Impella 5.5 | 402 (87%) people had transplantation, with 378 (81%) being directly bridged to transplant with the device. Waitlist death (7%) and clinical deterioration (5%) were the most common reasons for waitlist removal. Device complications and failure were uncommon (less than 5%). The most common post-transplant complication was acute kidney injury needing dialysis (16%). Survival at 1-year post-transplant was 90%. | Another study using data from the same source is included (Iyengar 2023). |
Clothier JS, Kobsa S, Lester L et al. (2025) Evaluation of hemolysis in patients supported with Impella 5.5: a single center experience. Journal of Cardiothoracic Surgery 20: 143 | Retrospective single-centre cohort study n=123 Impella 5.5 | 11 (44%) people with low haemolysis and 19 (73%) with high haemolysis died, with no statistically significant differences between postoperative complications. Haemolysis in this high-risk cohort had a poor prognosis. People with high haemolysis spent more days on Impella 5.5, needed more MCS, and required more blood product transfusions. | Small retrospective study, focusing on the effect of haemolysis on mortality. |
Cohen WG, Rekhtman D, Iyengar A et al. (2023) Extended Support With the Impella 5.5: Transplant, ECMO, and Complications. ASAIO Journal (American Society for Artificial Internal Organs) 69: 642-648 | Retrospective single-centre cohort study n=40 BTT, BTDD, BTR Impella 5.5 | 30-day mortality=22.5% 25 people (62%) were successfully bridged to transplant or durable LVAD, while 4 (10%) recovered without any further cardiac support. 5 of 11 people initially supported with VA-ECMO were either transitioned to durable LVAD, transplanted, or recovered. Lower pulmonary artery systolic pressure (p=0.029), among other factors, was associated with mortality. | Larger studies were prioritised. |
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. | Only 1 study included in the review described surgical insertion (Impella 5.0). |
Dumitru I, Rinde-Hoffman D, Sevillano M et al. (2024) Single Center Experience With Impella 5.5 for Escalation and De-Escalation of Cardiogenic Shock Patients. Journal of Interventional Cardiology 2024: 7044608 | Retrospective single-centre cohort study n=36 Cardiomyopathy (72%), AMICS (28%) Impella 5.5 | As a cohort, overall survival was 69%, 39% survived to discharge, 31% bridged-to-heart transplant or durable LVAD, and 31% did not survive. | Larger studies were prioritised. |
Dwaah H, Jain N, Kapur NK et al. (2023) The impact of temporary mechanical circulatory support strategies on thrombocytopenia. Journal of Critical Care 73: 154216 | Retrospective single-centre cohort study n=77 (11 Impella) Impella 5.5 | VA-ECMO, venovenous ECMO, Impella 5.5, and IABP can all induce a drop in platelet count. The degree of platelet count drop, however, is higher in ECMO leading to an increased risk of thrombocytopenia compared to Impella 5.5, IABP, and Centrimag biventricular assist device. Platelet recovery occurred successfully in all MCS, suggesting reversibility of thrombocytopenia after MCS is explanted. | Small, retrospective study focusing on thrombo-cytopenia. |
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). | It is unclear if any surgically implanted devices were included. |
Funamoto M, Kunavarapu C, Kwan MD et al. (2023) Single center experience and early outcomes of Impella 5.5. Frontiers in Cardiovascular Medicine 10: 1018203 | Single centre cohort study n=70 Acute decompensated heart failure and cardiogenic shock Impella 5.5 | 57 (81%) people survived to discharge, and 51 (76%) people survived at the time of the first 30 days post-discharge visit. 31 people (44%) had Impella support for a bridge to advanced surgical heart failure therapy (transplant or durable LVAD), 27 (39%) were a bridge to recovery or decision and 12 (17%) were used for planned perioperative support for high-risk cardiac surgery. | Larger studies were prioritised. Study is included in systematic review by Kwon (2024). |
George TJ, Sheasby J, DiMaio JM et al. (2023) Outcomes of surgical Impella placement in acute cardiogenic shock. Baylor University Medical Center Proceedings 36: 415-421 | Retrospective single-centre cohort study n=90 Acute on chronic heart failure (56%), AMI (24%), and postcardiotomy (19%) Impella 5.0, 5.5 | Overall, 77% of people survived to device removal, and 65% survived to hospital discharge. 1-year survival=54%. Neither aetiology of heart failure nor device strategy was associated with 30-day or 1-year survival. On multivariable modelling, the number of vasoactive medications before device implantation was associated with 30-day mortality (HR 1.94, 95% CI 1.27 to 2.96, p<0.01). Surgical Impella placement was associated with a decreased need for vasoactive infusions (p<0.01) and decreased acidosis (p=0.01). | Larger studies were prioritised. |
George TJ, Schaffer JM, Harrington KB et al. (2022) Impact of preoperative Impella support on destination left ventricular assist device outcomes. Journal of Cardiac Surgery 37: 3576-3583 | Retrospective cohort study n=87 (27 Impella) People with durable LVADs Impella 5.0, 5.5 | Preoperative Impella support was not associated with increased short or long-term mortality but was associated with improved renal and hepatic function as well as total body perfusion before LVAD implantation. | 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. | Larger and more recent studies were prioritised. |
Hong Y, Agrawal N, Hess NR et al. (2024) Outcomes of Impella 5.0 and 5.5 for cardiogenic shock: A single-center 137 patient experience. Artificial Organs 48: 771-780 | Single centre cohort study n=137 cardiogenic shock caused by AMI, acute decompensated heart failure and postcardiotomy Impella 5.0 or 5.5 | The acute decompensated heart failure group had the highest survival rates at all time points. Acute kidney injury was the most common complication during Impella support in all 3 groups. Multivariable analysis demonstrated diabetes mellitus, elevated pre-insertion serum lactate, and elevated pre-insertion serum creatinine were independent predictors of in-hospital mortality, but the aetiology of cardiogenic shock did not impact mortality. | 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. | It is unclear if any surgically implanted devices were included. |
Jonna S, Olaizola G, Raavi L et al. (2025) Impella 5.5 as Heart Transplant Bridge Facilitated Rehabilitation and Improves Post-Transplant Outcomes: Retrospective Cohort Study. ASAIO journal | Retrospective cohort study n=65 People who had Impella support before heart transplantation Impella 5.5 | The Impella 5.5 device facilitates rehabilitation and may enhance outcomes after heart transplantation. | Larger studies were prioritised. |
Kataria R, Khalil A, Coglianese E et al. (2022) Effect of Impella 5.5 on Preexisting Functional Mitral Regurgitation in Patients with Heart Failure-Related Cardiogenic Shock. Structural Heart 6:100072 | Retrospective cohort study n=24 Heart failure-related cardiogenic shock Impella 5.5 | Despite maximally tolerated Impella unloading, 6 people (25%) had persistent moderate to severe or severe functional mitral regurgitation, and 9 (38%) people had persistent moderate functional mitral regurgitation. There was a decrease in central venous pressure, pulmonary artery diastolic pressure, serum lactate, and vasoactive-inotrope score at 24 hours after Impella, and survival was 83%. | Larger studies were prioritised. Study is included in systematic review by Kwon (2024). |
Khan S, Isath A, Gregory V et al. (2025) Axillary artery access considerations in Impella 5.5 insertion: Insights from exclusive axillary approach for successful support. Artificial Organs 49: 146-155 | Retrospective single-centre cohort study n=75 Impella 5.5 | 10 people had a small axillary artery, with a mean diameter of 6.3 mm and 59 people (80%) had insertion via the right axillary artery. There was no difference between the rates of stroke, ischaemia, bleeding, or infection when comparing by size or laterality. Survival to discharge was 60%, with 21% mortality on support, all in patients with a normal axillary artery diameter, but with no difference between right versus left. | Small study, focusing on axillary artery access. |
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. | It is unclear if any surgically implanted devices were included. |
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). | Small retrospective single centre study that focuses on the risk of stroke in association with access approach. |
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. |
Lewin D, Nersesian G, Lanmuller P et al. (2023) Complications related to the access site after transaxillary implantation of a microaxial left ventricular assist device. The Journal of Heart and Lung Transplantation 42: 679-687 | Retrospective single-centre cohort study n=203 Impella 5.0 or 5.5 | 78 (38%) died while on temporary MCS. 55 (27%) were successfully weaned from Impella 5+ and 70 (34%) were bridged to a durable LVAD with a median follow-up time of 232 days after Impella 5+ explantation. In 119 people, the Impella was explanted, and the vascular graft was shortened, ligated, and pushed under the pectoralis muscle; in 6 people early graft infection prompted complete graft removal during explantation. In addition, 13 people (11%) developed a late-onset graft infection after a median of 86 days, needing complete (n=10) or partial (n=2) explantation of the retained graft. 5 people (2%) developed a brachial plexus injury resulting in neurological dysfunction. | Larger studies were prioritised. Study is included in systematic review by Kwon (2024). |
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) | 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. It is unclear if any surgically implanted devices were included. |
Maigrot J-LA, Starling RC, Soltesz EG et al. (2025) Trajectories following Impella 5.5 support are associated with initial presentation acuity. Artificial Organs 49: 137-145 | Single-centre cohort study n=226 Impella 5.5 cardiogenic shock (decompensated heart failure, AMI and postcardiotomy) or assisted high-risk cardiac intervention | People in SCAI shock stage E had the highest mortality on Impella 5.5. Initial presentation acuity, as characterised by a clinically assessable stratification system (SCAI shock stages), was associated with immediate trajectories following Impella 5.5 support. Earlier escalation to Impella 5.5 in some people with cardiogenic shock with less severe acuity may have contributed to hemodynamic stabilisation and salvage of end-organ function that facilitated more favourable outcomes. | Studies with more people or longer follow-up were prioritised. |
Maigrot J-LA, Thuita L, Tong MZY et al. (2024) Are there etiology-specific risk factors for adverse outcomes in patients on Impella 5.5 support? JTCVS Open 21: 123-137 | Single-centre cohort study n=228 Impella 5.5 cardiogenic shock (AMI, decompensated heart failure, postcardiotomy, or other cause) or assisted high-risk cardiac intervention. | In patients with ischaemic cardiomyopathy, the primary composite outcome of death, stroke, or new-onset dialysis while actively receiving Impella 5.5 support occurred in 42 (34%) people. Mortality occurred in 21 (17%), stroke occurred in 12 (10%), and new-onset dialysis was initiated in 23 (19%) people while actively receiving Impella 5.5 support. Among those who survived past Impella 5.5 support, 21 (17%) transitioned to durable LVAD or heart transplant, whereas the others were weaned without advanced therapies. | Studies with more people or longer follow-up were prioritised. |
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. |
Mehdizadeh-Shrifi A, Ahmed HF, Chappell G et al. (2025) he Increasing Utilization of the Impella Device as a Bridge-to-Transplantation in Pediatric Heart Centers Across the United States. World Journal for Pediatric & Congenital Heart Surgery: 21501351251330272 | Retrospective multicentre registry (United Network for Organ Sharing database) n=50 Children with cardiogenic shock, refractory heart failure, arrhythmia Impella 5.5, CP, 5.0, RP | Of the 50 children, 42 (84%) had heart transplantation; 37 directly from an Impella and 5 from another device. The median age was 15 years, the youngest was 8 years old, 126 cm, and 27 kg. After transplant, 1-year survival was 94%. | Small retrospective study. |
Miller P, Akcelik A, Murillo A et al. (2025) Bridging to orthotopic heart transplant: Reducing the risk of intra-operative blood loss. JHLT Open 8: 100220 | Retrospective single-centre cohort study n=93 Impella 5.5 | Use of temporary MCS did not lead to an increased risk of blood transfusion, which suggests that Impella 5.5 may be a safe bridging strategy to heart transplantation. | Small study, focusing on the risk of blood loss during heart transplantation. |
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). | It is unclear if any surgically implanted devices were included. |
Movahed MR, Talle A, Hashemzadeh M (2024) Intra-aortic balloon pump is associated with the lowest whereas Impella with the highest inpatient mortality and complications regardless of severity or hospital types. Cardiovascular Intervention and Therapeutics 39: 252-261 | Retrospective registry (US National Inpatient Sample database) n=844,020 | Total inpatient mortality without any device was 34% versus 25% with IABP use (OR 0.65, 95% CI 0.62 to 0.67) but was highest at 41% with Impella use (OR 1.32, 95% CI 1.26 to 1.39). After adjusting for 47 variables, Impella use remained associated with the highest mortality (OR 1.33, 95% CI 1.25 to 1.41, p<0.001), whereas IABP remained associated with the lowest mortality (OR 0.69, 95% CI 0.66 to 0.72, p<0.001). | It is unclear if any surgically implanted devices were included. |
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. | No meta-analysis. |
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 | 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. | It is unclear if any surgically implanted devices were included. |
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. |
Nersesian G, Tschope C, Spillmann F et al. (2020) Prediction of survival of patients in cardiogenic shock treated by surgically implanted Impella 5+ short-term left ventricular assist device. Interactive Cardiovascular and Thoracic Surgery 31: 475-482 | Retrospective multicentre cohort study n=70 AMI (n=16), decompensated chronic heart failure (n=41), postcardiotomy (n=5) and acute myocarditis (n=8) Impella 5.0, 5.5 | 30-day survival=51%. Statistical analysis showed that an increase in lactate per mmol per litre (OR 1.22; p=0.015 and cardiopulmonary resuscitation before implantation (OR 16.74; p=0.009) were predictors of 30-day survival. | Larger studies were prioritsed. |
Paghdar S, Desai S, Jang J-M et al. (2023) One-year survival in recipients older than 50 bridged to heart transplant with Impella 5.5 via axillary approach. Journal of Geriatric Cardiology 20: 319-329 | Retrospective single-centre cohort study n=49 Ischaemic (63%) and non-ischaemic cardiomyopathy (37%) Impella 5.5 | 38 people aged 50 or older were supported with Impella 5.5 as BTT. 10 people had heart and kidney transplantation. For people that had reached the 1-year follow-up timeframe (22 of 38, 58%), the 1-year post-transplant survival was 95%. | Larger studies were prioritised. |
Pieri M, Ortalda A, Altizio S et al. (2024) Prolonged Impella 5.0/5.5 support within different pathways of care for cardiogenic shock: the experience of a referral center. Frontiers in Cardiovascular Medicine 11: 1379199 | Single-centre cohort study n=59 71% AMICS Impella 5.0, 5.5 | Axillary cannulation was feasible in most people, and 36% were mobilised during support. 44 people (75%) survived to the next therapy or recovery: 21 people had recovery and 15 and 8 were bridged to long-term LVAD and heart transplantation, respectively. The global survival rate was 66%. The predictors of native heart recovery at multivariate analysis were the number of days on temporary MCS before upgrade to Impella 5.0 or 5.5 and improvement of LVEF within the first 7 to 10 days of support. | Larger studies were prioritised. |
Ramzy D, Anderson M, Batsides G et al. (2021) Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device. Innovations 16: 365-372 | Retrospective multicentre cohort study n=200 Cardiomyopathy (45%), AMICS shock (29%), and post cardiotomy cardiogenic shock (16%) Impella 5.5 | Overall survival to explant=74%. Survival outcomes were improved compared to historic rates observed with cardiogenic shock, particularly postcardiotomy cardiogenic shock. | More recent studies were prioritised. |
Ramzy D, Soltesz E, Anderson M (2020) New Surgical Circulatory Support System Outcomes. ASAIO Journal 66: 746-752 | Multicentre cohort study n=55 Cardiomyopathy (45%), AMICS (29%), postcardiotomy cardiogenic shock (13%) Impella 5.5 | 35 people (64%) were successfully weaned off device with recovery of native heart function. 11 people (20%) were bridged to another therapy, 2 people (4%) died while on support, and in care was withdrawn in 7 people (13%). Overall survival was 84%. There were no device-related strokes, haemolysis, or limb ischaemia. 4 people had purge sidearm damage, resulting in a pump stop in 2. | Larger studies were prioritised. |
Rock JR, Kos CA, Lemaire A et al. (2022) Single center first year experience and outcomes with Impella 5.5 left ventricular assist device. Journal of Cardiothoracic Surgery 17: 124 | Retrospective single-centre cohort study n=24 Impella 5.5 | Survival rate for Impella 5.5 use longer than 14 days was 67%. In the entire cohort and subgroup of device implantation more than 14 days, evidence of end organ damage improved with Impella 5.5 use. Complications were similar to previously reported complication incidence of axillary inserted LVAD devices. | Larger studies were prioritised. Study is included in systematic review by Kwon (2024). |
Schmack L, Ali-Hasan-Al-Saegh S, Weymann A et al. (2024) Inflammatory and Hemolytic Responses of Microaxial Flow Pump Temporary Ventricular Assist Devices via Axillary Access in Cardiogenic Shock. Medicina 60 (no. 12) | Retrospective single-centre cohort study n=47 32% acute heart failure (n=15), 68% acute or chronic decompensated cardiomyopathy (n=32) Impella 5.5, 5.0, CP | 30-day survival=78%. At 30 days, 47% of survivors no longer required mechanical support, while 26% were upgraded to a durable LVAD. Interleukin-6 levels were lower in people who had Impella 5.5 immediately after implantation (p=0.03) compared with those with smaller devices. Haptoglobin levels were higher in the Impella 5.5 group with overall lower rates of haemolysis. | Larger studies were prioritised. |
Schurr JW, Pearson A, Delfiner MS et al. (2025) Hemodynamic Support With the Impella 5.5 Acute Mechanical Circulatory Support Device. ASAIO Journal 71: 300-307 | Single-centre cohort study n=150 Impella 5.5 | Primary outcome (recovery, durable LVAD, or heart transplant at 90 days)=59% Mortality=19% | Larger studies were prioritised. |
Seese L, Hickey G, Keebler ME et al. (2020) Direct bridging to cardiac transplantation with the surgically implanted Impella 5.0 device. Clinical Transplantation 34: e13818 | Retrospective registry (United Network for Organ Sharing registry) n=236 Bridge to transplantation | 24% (n=57) had bridge to heart transplantation. Early and late post-transplant survival was 96% at 30 days, 94% at 90 days, and 90% at 1-year follow-up. Post-transplant complications were infrequent, but the most common were renal failure needing dialysis (9%, n=5), cerebrovascular accidents (n=1), and pacemaker implant (n=1). The rate of waitlist removal for death or clinical deterioration was 20% (n=47). Bridge to durable continuous-flow LVAD=37% (n=87). | More recent studies were prioritised. |
Shapiro AB, Fritz AV, Kiley S et al. (2024) Comparison of Intraoperative Blood Product Use During Heart Transplantation in Patients Bridged with Impella 5.5 versus Durable Left Ventricular Assist Devices. Journal of Cardiothoracic and Vascular Anesthesia 38: 2567-2575 | Retrospective single-centre cohort study n=43 BTT Impella 5.5 | People who had BTT with Impella 5.5 had statistically significant lower median transfusions of cryoprecipitate, autologous blood salvage and platelets. Additionally, there was a trend toward lower transfusion of intraoperative packed red blood cells and fresh frozen plasma but these were not statistically significant. | Small retrospective study, focusing on blood product use during heart transplantation. |
Sicke M, Modi S, Hong Y et al. (2024) Cardiogenic shock etiology and exit strategy impact survival in patients with Impella 5.5. The International Journal of Artificial Organs 47: 8-16 | Retrospective single-centre cohort study n=67 34% AMICS, 66% acute decompensated heart failure Impella 5.5 | People with cardiogenic shock associated with acute decompensated heart failure who had Impella 5.5 support had a higher rate of survival than those with AMICS. They were also successfully bridged to heart transplant more often than people with AMICS, contributing to increased survival. | Larger studies were prioritised. |
Sommer W, Arif R, Kremer J et al. (2023) Temporary circulatory support with surgically implanted microaxial pumps in postcardiotomy cardiogenic shock following coronary artery bypass surgery. JTCVS open 15: 252-260 | Retrospective cohort study n=42 People with ischaemic cardiomyopathy having coronary artery bypass grafting Impella 5.0, 5.5 | Survival after 30 days (76% versus 48%, p=0.04) and 1 year (69% versus 30%, p=0.03) was better in the cohort who had Impella implantation during the initial surgery rather than delayed. | Larger studies were prioritised. |
Sugimura Y, Bauer S, Immohr MB et al. (2023) Clinical outcomes of hundred large Impella implantations in cardiogenic shock patients based on individual clinical scenarios. Artificial Organs 47: 1874-1884 | Retrospective single-centre cohort study n=100 Acute cardiogenic shock Impella 5.5 | In-hospital and 30-day mortality rates were 57% (n=51) and 49% (n=44), respectively. In-hospital mortality was lower in people with AMI compared to those with no AMI (p=0.07). | Larger studies were prioritised. |
Sugimura Y, Bauer S, Immohr MB et al. (2022) Outcome of Patients Supported by Large Impella Systems After Re-implantation Due to Continued or Recurrent Need of Temporary Mechanical Circulatory Support. Frontiers in Cardiovascular Medicine 9: 926389 | Retrospective single centre cohort study n=67 Acute coronary syndrome or ischaemic cardiomyopathy (82%), decompensation caused by dilated cardiomyopathy (13%). Impella 5.0, 5.5 | In-hospital mortality=52% Explantation of Impella was done in 39 people (58%), 22 of whom (33%) recovered under Impella, and 10 further people (15%) survived after a successful transition to permanent MCS. In univariate analysis, femoral artery access was a significant risk factor for Impella dysfunction compared to subclavian artery access (43% versus 10%, p<0.05, OR 6.88). | Larger studies were prioritised. |
Sugimura Y, Katahira S, Immohr MB et al. (2021) Initial experience covering 50 consecutive cases of large Impella implantation at a single heart centre. ESC Heart Failure 8: 5168-5177 | Retrospective single centre cohort study n=49 Acute heart failure Impella 5.0, 5.5 | 30-day survival=56% In-hospital mortality was higher in people with biventricular failure (p<0.01, OR 5.63) or dilated cardiomyopathy (p=0.02, OR 15.8), whereas ischaemic cardiomyopathy was associated with lower mortality (p=0.03, OR 0.24). | Larger studies were prioritised. |
Sugimura Y, Bauer S, Immohr MB et al. (2021) Heparin-Induced Thrombocytopenia under Mechanical Circulatory Support by Large Impella for Acute Cardiogenic Shock. Journal of Cardiovascular Development and Disease 8 (no. 12) | Retrospective single centre cohort study n=56 Impella 5.0, 5.5 | 21 people were tested for heparin-induced thrombocytopenia and 6 were positive at 10.5 days after the first heparin administration during current admission. Associated thrombotic events were observed in 2 people resulting in Impella dysfunction (pump thrombosis and left ventricular thrombus formation). | Larger 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. |
Valdes CA, Bilgili A, Reddy A et al. (2024) Impella 5.5: A Systematic Review of the Current Literature. Innovations 19: 380-389 | Systematic review n=573 (8 studies, all retrospective cohorts) Impella 5.5 | Overall, Impella support appeared to be associated with favourable survival rates and manageable complications in various populations. Complications associated with Impella use included bleeding, stroke, and device malfunctions. | No meta-analysis. All relevant studies are included in the key evidence or appendix. |
Valdes CA, Stinson G, Sharaf OM et al. (2024) Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support. Innovations 19: 46-53 | Retrospective single centre cohort study n=31 Impella 5.5 | 45% of people were supported for longer than 14 days and there were no statistically significant differences according to duration of support. The device-related complication rate was 10%. 30-day survival=71% In-hospital mortality=32% Among those surviving to explant, long-term strategy included bridge to durable ventricular assist device, cardiac transplant and cardiac recovery. | 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. |
Zubarevich A, Arjomandi Rad A, Szczechowicz M et al. (2022) Early experience with the Impella pump: Single-center registry. Artificial Organs 46:1689-1694 | Retrospective single-centre cohort study n=32 Acute cardiogenic shock Impella 5.0, 5.5 and CP | 30-day mortality=38% 17 people (53%) were weaned off Impella support and 10 (31%) were successfully bridged to durable LVAD. Of the whole cohort, 26 people (81%) were able to be mobilised during the Impella support. 13 people (41%) had bleeding that needed blood transfusion. | Larger studies were prioritised. Study is included in systematic review by Kwon (2024). |
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