59. VA-ECMO, Impella, Balloon Pump- Indications and Guidelines

Madeline L. Fryer MD, Katherine L. Wood MD
University of Rochester Medical Center
August 31, 2024

Abbreviations & Definitions

AATS – American Association for Thoracic Surgery
ACC – American College of Cardiology
ACCP – American College of Clinical Pharmacy
AHA – American Heart Association
AMI-CS – Acute Myocardial Infarction Cardiogenic Shock
ASPC – American Society of Preventative Cardiology
COR – Class of recommendation
CPB – Cardiopulmonary bypass
CPR – Cardiopulmonary resuscitation
CS – Cardiogenic shock
CSWG – Cardiogenic Shock Working Group
CVP – Central venous pressure
EACTS – European Association for Cardiothoracic Surgery
ECLS – Extracorporeal life support
ECPR – Extracorporeal cardiopulmonary resuscitation
ELSO – Extracorporeal Life Support Organization
HF-CS – Heart Failure Cardiogenic Shock
HFSA – Heart Failure Society of America
HTx – Heart transplant
IABP – Intra-aortic balloon pump counterpulsation
ISHLT – International Society for Heart and Lung Transplantation
LOE – Level of evidence
LT MCS – Long-term mechanical circulatory support
LV – Left ventricle
LVAD – Left ventricular assist device
LVOT VTI – Left ventricular outflow track velocity-time integral
MAP – Mean arterial pressure
MCS – Mechanical circulatory support
MI – Myocardial infarction
NIRS – Near-infrared spectroscopy
NLA – National Lipid Association
PC – Post-cardiotomy
PCI – Percutaneous coronary intervention
PCNA – Preventative Cardiovascular Nurses Association
PGD – Primary graft dysfunction
RCT – Randomized control trial
RV – Right ventricle
RVAD – Right ventricular assist device
SCAI – Society for Cardiovascular Angiography and Interventions
STS – The Society of Thoracic Surgeons
VAD – Ventricular assist device
VA-ECMO – Veno-arterial extracorporeal membrane oxygenation
VSD – Ventricular septal defect

Indications & Guidelines for Management by Grade/Stage of Disease

Temporary mechanical circulatory support (MCS) comprises a range of devices, including intra-aortic balloon pumps (IABP), percutaneous ventricular assist devices (VAD), and veno-arterial extracorporeal membrane oxygenation (VA-ECMO) that can be used alone or in combination for the treatment of cardiogenic shock (CS). Here, we review guidelines and evidence supporting the use of these devices, discuss ongoing clinical trials, and offer our own commentary and perspectives. Details regarding the technical aspects of these devices remain outside the scope of this chapter.

The Extracorporeal Life Support Organization’s (ELSO) most recent guidelines on VA-ECMO were published in 2021.1 Significant recommendations from this document include consideration of VA-ECMO within six hours of onset of cardiogenic shock that is refractory to conventional pharmacological and fluid therapy, in patients with reversible cardiocirculatory collapse, or those eligible for durable circulatory support. Although age alone should not be an absolute contraindication to VA-ECMO, poor life expectancy, severe liver disease, acute brain injury, vascular disease, immunocompromised status, and aortic insufficiency are all contraindications. Prognostication tools are also detailed within these recommendations that can help guide decision-making before initiation of VA-ECMO, which should include consideration of possible myocardial recovery or bridging to durable MCS or transplantation. When VA-ECMO is initiated, the family should be educated as soon as possible on prognosis and possible outcomes, including bridging to advanced therapies and a reasonable duration of VA-ECMO support.1

The ELSO guidelines1 make further recommendations regarding cannulation strategy and LV unloading. These include tailoring cannulation strategy to underlying pathology, pulmonary status, and presence of peripheral arterial disease, using ultrasound guidance for percutaneous cannulation, establishing ipsilateral leg reperfusion in the case of femoral artery cannulation, and immediate implementation of LV venting via non-invasive strategy or MCS at the first signs of LV distension.1 Recommendations for patient monitoring include assessment for differential oxygenation with right-sided tissue perfusion and cerebral near-infrared spectroscopy (NIRS) monitoring, laboratory assessments for bleeding and hemolysis, pulmonary artery catheters to assess left-sided pressures, protective lung ventilation strategies, and awakening and extubating patients when hemodynamically safe.1 In cases of inadequate flow and/or oxygenation, specific consideration should be made to cannula malposition, clot formation, and the need for supplementary return cannula. Extreme hypoxemia, hyperoxemia, and rapid hypocapnia upon VA-ECMO initiation should also be avoided.1

ELSO guidelines recommend VA-ECMO weaning as patients demonstrate stable hemodynamics despite reduced extracorporeal flow, which they define as MAP >60 mmHg, LVOT VTI >0.12 m/s, tissue Doppler lateral mitral annulus peak systolic velocity ≥6 cm/sec, CVP ≤10 mmHg, and LV ejection fraction ≥ 25%–30% on low doses of vasoactive and/or inotropic support. Removal of large-bore cannulas should be performed surgically.1 Finally, guidelines emphasize the importance of centralized ECMO teams with continuous training and education programs that provide highly specialized care for an entire region. 1

Another set of guidelines developed and endorsed by ELSO is the 2020 EACTS/ELSO/STS/AATS Expert Consensus on Post-Cardiotomy Extracorporeal Life Support in Adult Patients.2 Intuitively, many of the recommendations are similar between these two documents published in the same year; the novel recommendations specific to this inter-societal document focus specifically on patients undergoing cardiac surgery. Notable recommendations include early initiation of post-cardiotomy (PC) support in patients with likely myocardial recovery or eligibility for heart transplant (HTx) or left ventricular assist device (LVAD) placement in the absence of ongoing bleeding, indications for concomitant or isolated microaxial percutaneous LVAD or IABP, VA-ECMO as the preferred treatment option for post-transplant primary graft dysfunction (PGD), use of VA-ECMO for RV support after durable LVAD implantation, and pre-surgical initiation of VA-ECMO as a “bridge to surgery” in patients in cardiogenic shock in need of surgical intervention.2

Professional guidelines dedicated to other sub-topics, such as heart failure and coronary disease, also discuss temporary MCS. The 2022 AHA/ACC/HFSA Heart Failure Guidelines,3 for example, make a Class IIa (moderate) recommendation based upon Level B-NR (non-randomized) evidence that temporary MCS is “reasonable when end-organ function cannot be maintained by pharmacologic means to support cardiac function” in patients with cardiogenic shock. The same class of recommendation and level of evidence is used for the recommendation that temporary MCS is a reasonable bridge to recovery or decision for patients with advanced heart failure with reduced ejection fraction (HFrEF), hemodynamic compromise, and shock.3

Guidelines and applications of temporary MCS are not strictly limited to patients already in refractory cardiogenic shock. In the 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization,4 a Class IIb recommendation based upon Level B-R (randomized) data is made stating that “in selected high-risk patients, elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable to prevent hemodynamic compromise during PCI.”4 This recommendation primarily refers to Impella, however, it is not specifically delineated in the primary guidelines. In the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients with Chronic Coronary Disease,5 no specific recommendations or updates are made about the role of temporary MCS in revascularization.

Expert consensus statements from other key stakeholders, such as the 2021 SCAI Update on Best Practices in the Cardiac Catheterization Laboratory,6 make brief mention but provide little guidance on patient selection for temporary MCS. In the SCAI Shock Classification system,7 use of temporary MCS is used to delineate stages of shock; overt recommendations are not made regarding which patients are most appropriate for temporary MCS. The 2022 Scientific Statement from the AHA on Escalating and De-escalating MCS in CS provides algorithms for both Acute Myocardial Infarction Cardiogenic Shock (AMI-CS) and Heart Failure Cardiogenic Shock (HF-CF) but does not include formal guidelines.8 A consensus summary from the International Society for Heart and Lung Transplantation (ISHLT) published in 2024 that was based upon a 2022 meeting focuses specifically on HF-CF and works to clarify clinical definitions, elucidate CS phenotypes, and places large emphasis on the importance of multi-disciplinary shock teams and early, frequent patient re-assessment.9

Table 1. Major Guidelines and Consensus Statements Regarding Temporary MCS Patient Selection

Recommendation COR LOE Evidence
VA-ECMO should be considered for cardiogenic shock within 6 hours of its occurrence, refractory to conventional pharmacological and fluid therapy, and in patients with reversible cardiocirculatory collapse or those eligible for alternative cardiocirculatory assistance (i.e. VADs or transplantation). Not given None cited
In patients with cardiogenic shock, temporary MCS is reasonable when end-organ function cannot be maintained by pharmacologic means to support cardiac function. IIa B-NR 10-18
In patients with advanced HFrEF and hemodynamic compromise and shock, temporary MCS, including percutaneous and extracorporeal ventricular assist devices, are reasonable as a “bridge to recovery” or “bridge to decision.” IIa B-NR 19-23
It is recommended that PC support be initiated prior to end-organ injury or onset of anerobic metabolism (lactate level <4 mmol/l) in patients with likelihood of myocardial recovery and in the absence of uncontrollable bleeding not amenable to surgical repair. The early use of ECLS after cardiac surgery in a patient with an IABP and optimal medical therapy with failure to wean from CPB or marginal hemodynamics is recommended. I B 24, 25
PC-ECPR should be considered in the setting of adequate CPR when the time from arrest to ECLS is <60 min. IIa C None cited
When the likelihood of native myocardial recovery is low, PC-ECLS is recommended in patients who are eligible for LT-MCS or a HTx. I C None cited
ECLS should be considered as the preferred treatment option for severe PGD following a HTx. IIa B 26-28
ECLS may be considered as a temporary RVAD with an oxygenator to rescue patients with severe refractory RV failure following LVAD placement. IIb C None cited
Preoperative implant of ECLS may be considered in patients in very poor condition (hemodynamic or metabolic) or with structural cardiac anomalies (post-acute MI VSD or severe lung edema or dysfunction due to underlying cardiac disease) to facilitate perioperative management (bridge to surgery). IIb C None cited
The planned implantation of ECLS may be considered in patients with severe preoperative uni or biventricular dysfunction to assist resuscitation and/or myocardial recovery. IIb C None cited
In selected high-risk patients, elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable to prevent hemodynamic compromise during PCI. IIb B-R 29, 30
Poor life expectancy, severe liver disease, acute brain injury, vascular disease, and immunocompromise represent exclusion criteria for ECMO application. Etiologies compromising appropriate ECMO function (aortic insufficiency) should be considered to represent potential contraindications. Not given None cited
Significant comorbidities, advanced age, elevated lactate level, and renal injury are risk factors associated with death and should be considered prior to ECLS initiation. IIa B 25, 31, 32
The implantation of an IABP is not recommended in cases of severe LV or biventricular dysfunction as a primary treatment option in case of impossible CPB weaning or acute heart failure shortly after CPB weaning. III C None cited
The application of a percutaneous or axillary artery transvalvular microaxial device (Impella 5.0) in PC patients may be considered a primary or concomitant treatment option with ECLS in the presence of severe isolated LV dysfunction. IIb C None cited

Supporting Evidence for Current Indications & Guidelines

There are few notable landmark trials despite the heterogeneity of the patient population. One of the landmark studies establishing a benefit for ECPR is the ARREST trial,33 which randomized 30 patients with refractory ventricular fibrillation to conventional resuscitation or VA-ECMO. This study was terminated early due to the superiority of the ECPR intervention with significantly improved survival to hospital discharge and six months.33

Historically, the IABP SHOCK II trial34 was an RCT of 600 patients that demonstrated no difference in 30-day survival for post-MI cardiogenic shock patients receiving standard of care with or without IABP.

The BCIS-129 and PROTECT II30 studies were RCTs comparing IABP to standard care and IABP versus Impella 2.5 support, respectively, for high-risk PCI. BCIS-1 found no difference in major adverse cardiac and cardiovascular events between IABP and no-IABP patients;29 PROTECT II trended towards but did not demonstrate a statistical difference in adverse events between IABP and Impella 2.5.30

Multiple studies, including from the University of Utah,35 NCSI,36 and Inova Health37 have supported interdisciplinary shock team and protocolized approaches to CS. Numerous other retrospective observational studies, many of which are referenced in the summary table above, have helped establish prognosticating factors and appropriate clinical scenarios for temporary MCS.

Ongoing Trials/Recent Publications

One of the few RCTs examining VA-ECMO for refractory out-of-hospital cardiac arrest was published in January 2023,38 after most of the current guidelines and consensus statements were written. Although the authors did not find any difference in short-term survival with favorable neurologic outcomes between patients randomized to traditional versus ECPR, it is possible that the short time to decannulation (median of 26 hours) may have mitigated any potential differences.

The NEJM published results from the ECLS-SHOCK trial in August 2023 evaluating outcomes of 420 AMI-CS patients with planned early revascularization (PCI or CABG), randomized to ECLS vs standard medical care. There was no significant difference in mortality between the study groups in the initial trial39 or at one year of follow-up.40 Important limitations of this trial included a low rate of LV unloading at 5.8%, crossover from the medical therapy to MCS study arms, and high rates of revascularization with PCI compared to CABG.

Another recent RCT for temporary MCS is the DanGer Shock trial,41 which compared outcomes of ST-elevation MI patients in cardiogenic shock randomized to standard care with or without an Impella CP. The final analysis of 355 patients showed that Impella use led to lower all-cause mortality at 180 days,41 although notable criticisms include the 10-year enrollment period, randomization to medical care instead of IABP, and overall higher mortality compared to other published data. Results of DanGer Shock led to the early termination of the RECOVER IV trial, which would have compared Impella-supported PCI to PCI with standard medical support for AMI-CS.

Several recent and ongoing studies investigate the multi-disciplinary shock team approach and early escalation of care for AMI-CS. Results from the National Cardiogenic Shock Initiative published at the end of 2023 characterized the feasibility and effectiveness of early Impella deployment in over 400 patients presenting with AMI-CS across 80 centers between 2016 and 2020.42 These descriptive outcomes and study infrastructure laid the foundation for the ongoing Can Escalation Reduce Acute Myocardial Infarction in Cardiogenic Shock (CERAMICS) Trial, which examines a protocol for early MCS escalation driven by frequent hemodynamic assessments in AMI-CS.43 The Cardiogenic Shock Working Group (CSWG) is also demonstrating the importance of early assessment, intervention, escalation of care, and serial re-assessment in both AMI-CS and HF-CS cohorts.44, 45

Throughout the United States, Europe, and Asia, multiple clinical trials are underway investigating anticoagulation strategies, drug pharmacokinetics, transfusion practices, platelet function, blood oxygen levels, and long-term outcomes in ECMO patients. Among the most exciting currently enrolling studies are focused on LV venting strategies for patients on VA-ECMO, including one based out of Hamburg, Germany randomizing nearly 200 patients on VA-ECMO with or without Impella for LV unloading (NCT05577195). Results of a smaller, similar study from the University of Pennsylvania planned to enroll 15 patients (NCT03431467) have not yet been published. There are active trials at the University of Utah (NCT06336655) and in the Netherlands (NCT05913622) studying IABP for LV unloading in VA-ECMO, and a large registry of 500 patients requiring PC-ECLS is enrolling in Florence, Italy (NCT04330651).

Expert Commentary

Cohesively synthesizing the literature on temporary MCS is challenging due to heterogeneous patient conditions and enrollment criteria, perpetually evolving technology, and disparate institutional experience managing complex therapies for extremely high-risk patients. Ethical and logistical challenges have also made RCTs in this field expensive and challenging to execute, leading to a heterogeneous conglomerate of data.

Current guidelines on temporary MCS from multiple societies are essentially in agreement about indications for use, especially regarding VA-ECMO, but recommendations surrounding percutaneous LVAD (Impella devices) and IABP are less specific. Although it is generally accepted that IABP provides inadequate augmentation in patients with SCAI stage C or worse cardiogenic shock, current guidelines and consensus statements are either out-of-date or non-specific about the selection of microaxial flow pumps. The most recent Abiomed (Danvers, Massachusetts, United States) Impella model intended for left-sided support, the 5.5, only earned FDA approval in September 2019; early data specific to this device were not sufficiently robust to be included in the most recent iteration of societal recommendations, and existing recommendations regarding the Impella 2.5 and 5.0 are for devices no longer commercially available in the United States. As data on patient outcomes with percutaneous LVAD become more robust, appropriate applications for IABP are becoming less common.

Other gaps in the literature and societal guidelines include nuances in candidacy for ECPR and LV venting strategies. Patient age is discussed in both ELSO documents as a relative contraindication for VA-ECMO, and age >75 is noted to be associated with worse outcomes,2 but hard cut-offs are left to the discretion of individual institutions. Arterial lactate >20 mmol/L, pH <6.8, and CPR duration >20 minutes are likewise listed as poor prognostic factors but not formally incorporated into societal recommendations.2 LV venting strategies are similarly addressed but non-specific. The ELSO Guidelines1 warn against the consequences of inadequate LV unloading and describe escalating interventions from ECMO flow manipulations to concomitant IABP or Impella placement but offer little data or recommendations on how to select an optimal strategy. Hopefully, ongoing studies will provide evidence for further refinement of these guidelines with the next iteration.

In summary, early identification, shock team approach, and timely escalation of support are key to improving outcomes for patients with cardiogenic shock. Ongoing and future studies that further delineate cardiogenic shock phenotypes, improve risk stratification models, and more specifically address the gaps outlined above will ultimately improve outcomes.

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