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Outcomes of Extracorporeal Membrane Oxygenation Support for Complex High-Risk Elective Percutaneous Coronary Interventions: A Single-Center Experience and Review of the Literature
Abstract: Objectives. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is most commonly used in patients with cardiac arrest and cardiogenic shock. There are limited data on the use of VA-ECMO for elective, high-risk percutaneous coronary intervention (PCI). We examined the in-hospital and mid-term clinical outcomes in patients undergoing complex, high-risk PCI with VA-ECMO support. Methods. We conducted a retrospective review of ECMO-supported elective high-risk PCIs performed at our institution between May 2012 and May 2017. The electronic medical records and angiograms were individually reviewed. We assessed the in-hospital and mid-term major adverse cardiovascular and cerebrovascular event (MACCE) rates, and reviewed bleeding and vascular complications. Results. Five patients underwent elective high-risk PCI with ECMO support. Mean age was 66.8 ± 8.6 years and all patients were men. The mean ejection fraction was 26.6 ± 18.0%. Most procedures were unprotected left main PCIs. All PCIs were successful; 1 patient required femoral artery surgical repair. The mean hospital stay post procedure was 6.4 ± 2.0 days. ECMO was successfully weaned in all cases, and the duration of ECMO was <24 hours in 4 cases. There was no occurrence of in-hospital and 1-year MACCE. Conclusion. ECMO can be successfully used for hemodynamic support during elective high-risk PCI.
J INVASIVE CARDIOL 2018;30(12):456-460.
Key words: extracorporeal membrane oxygenation, high-risk PCI
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is most commonly used in patients with cardiac arrest and cardiogenic shock with or without acute myocardial infarction (MI), and has been shown to be effective in these settings.1-8 There are limited data on the use of VA-ECMO for elective, high-risk percutaneous coronary intervention (PCI), a setting in which other mechanical circulatory support (MCS) devices, such as the Impella (Abiomed), are commonly used. We describe a single-center experience of complex, high-risk PCI procedures performed using VA-ECMO support.
Methods
We conducted a retrospective, single-center review of VA-ECMO supported elective high-risk PCIs performed at our institution between May 2012 and May 2017. Five patients were identified; they were deemed to be high risk based on a combination of clinical, anatomic, and hemodynamic factors by a Heart Team consisting of a primary cardiologist, an interventional cardiologist, and a cardiothoracic surgeon. The decision for using VA-ECMO for hemodynamic support was at the discretion of this team. The electronic medical records and angiograms of the identified patients were individually reviewed. We assessed the in-hospital and mid-term major adverse cardiovascular and cerebrovascular event (MACCE) rate, defined as a composite of death, MI, cerebrovascular accident (CVA), and urgent target-vessel revascularization (TVR). We also reviewed in-hospital bleeding and vascular access complications.
Study definitions and endpoints. Periprocedural MI was defined using the Society for Cardiovascular Angiography and Interventions (SCAI) criteria, ie, increase in CK-MB of ≥10x the upper limit of normal within the first 72 hours of the procedure.9MI after the periprocedural period was defined based on the third universal definition of MI.10Bleeding events were evaluated according to the Bleeding Academic Research Consortium (BARC) classification.11Angiographic success was defined as a final diameter stenosis of <30% as assessed by visual inspection with a final Thrombolysis in Myocardial Infarction (TIMI) flow grade 3.10
VA-ECMO procedure. The VA-ECMO system comprises a centrifugal pump, membrane oxygenator, heat exchanger, and bypass cannulas. Percutaneous cannulation was carried out in the cardiac catheterization laboratory (CCL) using the modified Seldinger technique. Fluoroscopic landmarks, ultrasound guidance, limited femoral angiography with a 5 Fr micropuncture catheter, and limited distal aortography with runoff were used for gaining arterial access. After obtaining retrograde common femoral artery access, a series of progressive dilations over an extra-stiff 0.035˝ guidewire were performed to allow the placement of the ECMO cannula. The venous cannula was placed with a similar method using a series of dilators over an extra-stiff wire. Depending on the patients’ biometric data, a range of 15 to 21 Fr arterial cannulas and a range of 22 to 25 Fr venous cannulas were used. Both the arterial and venous cannulas were then secured at the insertion site with a suture. The ECMO arterial cannula was inserted via the left common femoral artery in 4 cases and via the right femoral artery in 1 case. The ECMO venous cannula was placed through the left femoral vein in 3 cases and through the right femoral vein in 2 cases. The tip of the arterial cannula (patient inflow) was advanced and positioned in the common iliac artery or distal abdominal aorta; the tip of the venous cannula (patient outflow) was placed at the junction of the right atrium and superior vena cava. The centrifugal pump provided a non-pulsatile flow rate between 1 and 5 L/min. During the procedure, the flow was increased or decreased using inotropes or fluids as needed. The flow and gas supply rates were adjusted using blood gas measurements to meet the patients’ demand. During the study period, the CentriMag blood pump (Thoratec) and the Jostra Rotaflow pump (Maquet) were used. The Quadrox-D (Maquet) was used as the oxygenator. A 6 Fr, 24 cm Arrowflex sheath (Teleflex) was inserted into the superficial femoral artery for antegrade perfusion if the ECMO cannulas were not removed in the CCL. In these cases, the side arm of the ECMO arterial cannula was connected by tubing to the side arm of the antegrade Arrowflex sheath. The ECMO cannulas were removed in the CCL in 2 cases. In these cases, 2 Perclose Proglide devices (Abbott Vascular) were deployed using the “pre-close” technique at the time of cannula insertion. In the remaining 3 cases, the ECMO cannulas were removed after the procedure by vascular surgery.
PCI procedure. All patients were pretreated with a loading dose of 600 mg of clopidogrel, along with aspirin. At the beginning of the procedure, heparin was given to achieve and maintain an activated clotting time (ACT) of >250 seconds; ACTs were monitored every 30 minutes. All PCIs were performed via the femoral approach with 6-8 Fr guiding catheters. The PCI technique was at the discretion of the operator. Second-generation everolimus-eluting or zotarolimus-eluting stents were used in all patients.
Results
Five patients underwent elective high-risk PCI with ECMO support during the study period. Baseline clinical characteristics are shown in Table 1. Mean age was 66.8 ± 8.6 years (range, 55-76 years) and all patients were men. The mean ejection fraction (EF) was 26.6 ± 18.0%. Most procedures were unprotected left main PCIs (Table 2). One case (patient #5) was a chronic total occlusion (CTO) intervention through the last remaining conduit. The indication for PCI was left ventricular (LV) systolic dysfunction in 4 patients, and non-ST elevation MI in 1 patient. The procedure was done with general anesthesia in 2 patients, conscious sedation in 2 patients, and monitored anesthesia care in 1 patient. Mechanical ventilation was used in the 2 general anesthesia cases. The anesthetic method was decided by the primary operator and anesthesiology was based on each patient’s clinical status and anticipated length of procedure. A Swan Ganz catheter was utilized at the discretion of the primary operator in 4 cases. Mean procedure duration was 217 ± 157 minutes. All PCIs were angiographically successful (Figure 1). No sustained ventricular arrhythmias occurred during the procedures. Mean number of drug-eluting stents implanted per patient was 2.4 ± 1.2, with a mean stent length of 19.2 ± 3.9 mm. Mean fluoroscopy time was 38.4 ± 34.6 minutes and air kerma radiation dose was 1.69 ± 0.97 Gray. Mean residual SYNTAX score after PCI in patients without prior coronary artery bypass graft (CABG) surgery was 7.3 ± 5.5. One patient developed a left common femoral artery pseudoaneurysm at the ECMO arterial cannula insertion site and required surgical repair by vascular surgery. Two patients had groin hematomas (type 1 and 2 bleeding, respectively, according to the BARC criteria). Neither required blood transfusion or further intervention. Mean hemoglobin drop post procedure was 2.46 ± 1.45 g/dL. One patient had acute kidney injury without needing hemodialysis. There was no occurrence of limb ischemia or sepsis. The mean hospital stay after the procedure was 6.4 ± 2 days. VA-ECMO was successfully weaned in all cases; duration of ECMO was <24 hours in 4 cases and <48 hours in 1 case. There were no MACCEs during hospital stay and at 1-year follow-up. In all 4 patients with decreased LV systolic function, the EF improved at 1-year follow-up (mean increase, 24.3 ± 10.8%).
Discussion
The main finding of our study is that complex, high-risk PCI can be successfully performed using VA-ECMO. PCI is being increasingly performed in complex, high-risk patients.12,13 While the definition of high-risk PCI continues to evolve, it is widely accepted that this is a group of patients with a combination of complex clinical, hemodynamic, and anatomic characteristics.13,14 It includes patients who are poor surgical candidates, have had prior CABG, or choose not to have surgery.14
Such patients often have extensive coronary artery disease and have significant improvement in quality of life and reduced risk for adverse events after revascularization.14 Patients with reduced EF may also undergo reverse LV remodeling after PCI, which may lower the risk for subsequent adverse clinical events.15 There was evidence of this in our series of patients. Complete revascularization may also provide significant clinical benefit as compared to incomplete revascularization.16 The use of MCS in appropriately selected patients during high-risk PCI is supported by guidelines and a multisociety expert consensus document.17,18 Accordingly, there has been a substantial increase in the use of MCS for high-risk PCI in the United States.19
There are few prior retrospective studies of high-risk PCI supported with VA-ECMO. In a study by Tierstein et al published in the early 1990s, the prophylactic use of VA-ECMO was compared to standby use in high-risk percutaneous transluminal coronary angioplasty.20 Vascular and bleeding complications were more common in the prophylactic group, but procedural mortality was significantly lower. Vainer et al described their experience in 15 patients and reported no in-hospital death or periprocedural MI.21 Transfusion was necessary in 8 patients. All cases were performed under general anesthesia using mechanical ventilation and surgical cannulation and decannulation. During a mean follow-up of 15 months, there were 3 cardiac deaths. Similarly, Cho et al reported 10 patients who underwent elective high-risk PCI with VA-ECMO support at their center.22 There was no procedural or cardiac mortality at a mean follow-up of 541 days. In a study by Tomasello et al, 12 patients underwent PCI supported by VA-ECMO.23 PCI was successfully completed in all patients. There were no significant bleeding or vascular complications, and there was no death or MI at 6-month follow-up. A few other case reports have also been published.24,25 All these studies indicate the feasibility and efficacy of VA-ECMO for high-risk PCI, but vascular complications remain a concern.
Numerous other devices, including the intra-aortic balloon pump (IABP), TandemHeart (Cardiac Assist, Inc.), and Impella (Abiomed, Inc.), have been used in high-risk PCI. The IABP has been assessed in the BCIS-1 trial, a multicenter randomized controlled trial.26 The routine use of IABP compared to provisional use reduced procedural hypotension, but had no benefit in reducing the primary and secondary endpoints. The 5-year follow-up analysis showed lower all-cause mortality in the routine IABP group, but the causes of death were not known, and hence any robust cause-and-effect associations could not be made.27 Current data from registries and retrospective studies do not support routine IABP use in high-risk PCI.13
The Impella 2.5 device was compared to the IABP in the PROTECT II trial.28 At 90 days, there was no significant difference in major adverse events between the two groups in the intention-to-treat population. However, in the per-protocol analysis, outcomes were better with Impella. Data from real-world patients in the USpella registry have shown favorable clinical outcomes with an acceptable complication rate.29-31
The TandemHeart device has not been assessed in randomized controlled trials. In a single-center retrospective study of 54 patients conducted by Alli et al,32 survival at 6 months was 87%. However, major vascular complications occurred in 13% of patients. The device is limited in its use due to challenges with implantation (requires transseptal puncture), and bleeding and vascular complication risks. A meta-analysis by Briasoulis et al reported short-term mortality rates of 3.5% and 8.0% and major bleeding rates of 7.1% and 3.6% with Impella and TandemHeart, respectively.33
The major advantages of VA-ECMO are its ability to deliver full circulatory support, augment cardiac output, and provide blood oxygenation. Limitations of ECMO in the CCL include lack of direct LV unloading, increased LV afterload, and requirement of more personnel (CCL staff, anesthesiologist, perfusionist).34 Potential increases in LV afterload and myocardial ischemia were, however, well tolerated in our patient population who had short-term use. VA-ECMO does carry increased risk for major vascular complications, which could possibly be reduced with meticulous technique, use of smaller cannulae, as well as support from vascular surgery.6 High-volume VA-ECMO centers with extensive experience using the device for supporting advanced heart failure and cardiogenic shock patients are likely to also have favorable outcomes when using VA-ECMO for elective high-risk PCI. Overall, each of these MCS devices has a potential role in different patients. Instead of focusing on the type of device, emphasis should be placed on identifying the high-risk features that suggest MCS may be necessary, and customizing device selection to the unique needs of each patient.
Study limitations. Our study is limited by the small size and observational design. There is also the potential for selection bias in this highly selected group of patients. Prospective studies assessing the use of VA-ECMO in high-risk PCI should be conducted.
Conclusion
VA-ECMO can be successfully used for hemodynamic support during elective high-risk PCI, enabling successful revascularization in these patients.
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From the 1Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota; 2Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; and 3Cedars-Sinai Medical Center, Los Angeles, California.
Funding: This research was supported by the Minneapolis Heart Institute Foundation. However, no funds were used in conducting the study.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sun reports personal fees from Abbott Vascular. Dr Brilakis reports consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Cardiovascular Innovations Foundation (Board of Directors), CSI, Elsevier, GE Healthcare, Medtronic, and Boston Scientific; research support from Osprey, Siemens, and Regeneron; shareholder in MHI Ventures; Board of Trustees for the Society of Cardiovascular Angiography and Interventions. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted July 17, 2018, final version accepted July 23, 2018.
Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Minneapolis Heart Institute, 920 E. 28th Street #300, Minneapolis, MN 55407. Email: esbrilakis@gmail.com
