Transradial Percutaneous Coronary Intervention in Patients Requiring Circulatory Assist Devices

Transradial access for diagnostic and interventional procedures has been gaining acceptance in the United States.¹ Advantages of transradial percutaneous coronary intervention (PCI) include improved patient satisfaction and potential decrease in costs related to early discharge.^2-4 Perhaps the greatest advantage of this access strategy is a decrease in vascular complications.^1,3-6 The radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL) study randomly assigned patients presenting with acute coronary syndrome (ACS) to a transfemoral or transradial access strategy. Although there was no difference in the primary composite endpoint of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding, post-hoc analysis showed a decrease in major vascular complications in the transradial group. Additionally, on subgroup analysis, the transradial strategy was associated with a decrease in mortality in the subset of patients presenting with ST-elevation myocardial infarction (STEMI).⁴ Transradial PCI (TR-PCI) has also been shown to be safe in those cases complicated by cardiogenic shock.⁷ Despite these demonstrated advantages, resistance to adopting this access strategy remains. Reasons for this may include the learning curve associated with performing a new technique, lack of familiarity with radial specific equipment, as well as hesitancy in using radial access to perform complex interventions. This clinical review will focus on the suitability of TR-PCI for complex cases.

Several studies have documented the feasibility of performing complex interventions via the radial approach.^7-9 These include interventions in which hemodynamic support is needed. The traditional method of percutaneous hemodynamic support has been via placement of an intra-aortic balloon pump (IABP). More recently, newer devices have gained acceptance as an alternative to the IABP.  One such device is the Impella^® 2.5 (Abiomed, Inc.).  The Impella device has been particularly useful for hemodynamic support for patients in cardiogenic shock.^7,10 It has also been used for temporary support in high-risk elective PCI cases in patients with left ventricular dysfunction.^11,12 The Impella 2.5 device is an axial pump that is placed into the left ventricle (LV) from the femoral artery. It is capable of providing 2.5 L/min of cardiac output. Although the Impella 2.5 has been shown to be safe, one of its potential drawbacks is the need for a relatively large access sheath (13 Fr). The association between larger sheath sizes and increased bleeding complications has been demonstrated.¹³ The risks of bleeding and vascular complications are further exacerbated by complex anticoagulation regimens that are utilized during PCI. While no currently available hemodynamic support system is suitable for placement via the radial approach, this access site can be used for performing the PCI with the support device inserted via the femoral artery. It stands to reason that rates of access-site bleeding will be lower with unilateral compared to bilateral femoral artery access. Here we present two cases in which the Impella 2.5  was used for hemodynamic support for elective PCI procedures done via the radial approach.

Case 1

A 73-year-old male with a history of diabetes mellitus, hypertension, and hyperlipidemia presented with chest pain which had been occurring with varying severity over 4 days with no chest pain in the last 24 hours. An electrocardiogram performed upon arrival to the emergency department revealed ST-segment elevation in the anterior leads. The patient was taken emergently to the catheterization lab, where angiography revealed a 95% proximal stenosis in the left anterior descending (LAD) coronary artery, an 80% stenosis in the right coronary artery (RCA), and an 80% stenosis in the left circumflex artery (LCX). Ventriculography revealed anterior wall hypokinesis. As there was no acute occlusion and the patient was chest-pain free, the decision was made to obtain viability information prior to revascularization. A cardiac magnetic resonance imaging study was obtained, which revealed an ejection fraction of 20% with anterior, inferolateral, and apical hypokinesis. Delayed enhancement imaging revealed viability in the mid anterior and septal walls with transmural infarction at the apex. 

A cardiac surgery consult was obtained for consideration for coronary artery bypass graft surgery, and the patient was felt to be at high risk for adverse perioperative events. The patient, when presented with the treatment options, elected to pursue percutaneous revascularization. In this patient with multivessel coronary artery disease and depressed LV function, the Impella 2.5 device provided hemodynamic support during the PCI procedure. Right femoral artery access was obtained and a 13 Fr sheath was placed into the artery after serial dilations. Unfractionated heparin was used for anticoagulation. An Impella 2.5  device was placed into the LV in a retrograde fashion and provided 2.5 L/min of cardiac output support. Using a 6 Fr Glidesheath^™ (Terumo Medical Coroporation) in the right radial artery, a 6 Fr Ikari^™ Left 3.5  (Terumo Medical Corporation) guide catheter engaged the left main coronary ostium. After balloon predilation, a 3.0 x 18 mm bare-metal stent was placed in the proximal LAD.  A 6 Fr Ikari Right 1.0 guide catheter engaged the right coronary ostium. The RCA lesion was treated with a 3.5 x 30 mm bare-metal stent. After the procedure, the right femoral artery sheath was removed with closure of the arteriotomy performed using two Perclose^® Proglide^™ closure devices (Abbott Vascular). In order to confirm successful hemostasis, angiography of the right femoral artery was performed using a 5 Fr MP catheter from the radial access site. The radial artery sheath was removed and a pneumatic compression device was used for hemostasis. The patient was transferred to the cardiac care unit for monitoring, where there were no bleeding or vascular complications.

Case 2

A 79-year-old male with known coronary artery disease presented with congestive heart failure as well as 1 month of progressive epigastric pain. His initial electrocardiogram showed LVH and cardiac biomarkers were within normal limits. An echocardiogram demonstrated severe LV dysfunction with an estimated ejection fraction of 25%. Diagnostic angiography revealed a severe stenosis in the LAD (Figure 1). Given the degree of LV dysfunction, the decision was made to proceed to PCI of the LAD lesion with percutaneous hemodynamic support. Right femoral artery access was obtained and a 13 Fr sheath was placed into the artery after serial dilations. Anticoagulation was given with intravenous heparin. An Impella 2.5 device was placed into the LV in a retrograde fashion and provided 2.5 L/min of cardiac output support. A 6 Fr Glidesheath was placed in the right radial artery, through which a 6 Fr XB LAD 3.5 guide catheter (Cordis Corporation) was used to engage the left main coronary ostium. Intervention was performed with two drug-eluting stents placed in overlapping fashion with a reduction in stenosis from 80% to 0% with TIMI-3 flow (Figure 2). After the procedure, the right femoral artery sheath was removed with closure of the arteriotomy performed using two Perclose Proglide closure devices. The radial artery sheath was removed and a pneumatic compression device was used for hemostasis. The patient was transferred to the cardiac care unit for monitoring. There were no bleeding or vascular complications.

Discussion

We present two cases in which a percutaneously placed left ventricular assist device supported a coronary intervention performed via radial access. The advantage of TR-PCI over transfemoral PCI (TF-PCI) with respect to vascular complications has been demonstrated. Eichhofer et al found a decreased incidence of vascular complications in TR-PCI versus TF-PCI (0.6% vs 1.5%, P<.001) in their registry review of 13,499 consecutive patients.¹⁴ Recently, the radial versus femoral access coronary angiography and intervention in patients with acute coronary syndromes (RIVAL) study compared the TR versus TF access strategy in a randomized fashion. The authors found no difference between groups with regard to non-CABG related major bleeding (0.7% TR vs 0.9% TF; HR, 0.73; 95% CI, 0.43-1.23; P=.23); which is seemingly contradictory to the findings of previous smaller studies. However, when the authors looked at vascular complications that were access-site specific, the TR route showed a lower event rate compared with the TF route (1.4% vs 3.7%, p<.0001).⁴ This decrease in vascular complications with radial access seems to persist even in patients undergoing high-risk PCI. Yang et al describe a cohort of patients who underwent PCI of an unprotected left main (UPLM) coronary artery lesion via the transradial as well as transfemoral route. The transradial group had decreased hospital stay duration (8.5 ± 5.9 days vs 9.9 ± 5.9 days, P=.001) as well as lower rates of bleeding (0.6% vs 2.8%, P=0.02). There was no statistical difference between the groups with respect to procedural success, cardiovascular death, nonfatal myocardial infarction, stent thrombosis, or target vessel revascularization.⁸  A similar finding was shown by Han et al in a series of patients undergoing coronary bypass graft intervention in which vascular complications were lower in the TR group versus TF group (2.9% vs 14.3%, P=.021).¹⁵ Vorobcsuk et al examined choice of access strategy in the setting of STEMI. Once again, the TR route was associated with a reduced rate of bleeding compared to the TF route (0.77% vs 2.61%; OR, 0.30; 95% CI, 0.16-0.55).⁶ In all studies, radial access was associated with similar rates of procedural success as compared to their respective transfemoral cohorts.

The transradial access strategy is not without vascular complications. The most frequently reported complications include radial artery spasm (RAS) and radial artery occlusion (RAO).^3,16 Although a case of hand ischemia as a result of radial artery occlusion has been reported,¹⁷ the clinical consequences of RAS and RAO are generally less dramatic, often resulting in procedural failure or limiting the use of that radial artery as an option for future arterial access.^2,18 Rare complications, such as radial artery pseudoaneurysm, radial artery eversion, and forearm hematoma leading to compartment syndrome, have more immediate consequences and can lead to catastrophic consequences if not properly treated.^19-21 Despite these complications, the rates of access-site specific major vascular complications, particularly bleeding, have been shown to be less frequent in patients undergoing transradial access.⁴ Excess bleeding has been related to suboptimal outcomes; therefore, all efforts should be made to minimize this complication.^22,23 It seems that limiting femoral access is one such strategy that can lower vascular complications.In certain high-risk cases, however, there may be a need for hemodynamic support systems, which are most often inserted via the femoral artery due to the need for relatively large-diameter sheaths. Although avoiding femoral arterial access may be impossible in these cases, it would seem beneficial to perform PCI via radial access, thereby exposing the patient to one rather than two femoral artery punctures. In cases where percutaneous hemodynamic support devices are needed, such as cardiogenic shock, radial PCI has been shown to be feasible. Bell et al described a case series in which patients developing cardiogenic shock had PCI performed via the transradial route with hemodynamic support provided by the Impella device. All cases were performed successfully with no vascular complications. In one case, only one femoral artery proved capable of accepting catheters due to severe peripheral vascular disease making the choice of radial access for PCI particularly fortuitous.⁷ Our report adds to the evidence that radial PCI in high-risk cases requiring hemodynamic support is not only safe, but may result in decreased vascular complications.

Conclusion

A transradial access strategy for percutaneous coronary intervention is feasible even in cases where a percutaneous left ventricular assist device is utilized from a femoral artery approach. The presence of one versus two femoral artery punctures may reduce vascular complications. With relatively experienced operators, unstable patients or patients at risk for hemodynamic instability can receive successful PCI using the TR approach.

References

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From the Division of Cardiology, University of Illinois-Chicago, Chicago, Illinois.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Dandekar reported no disclosures. Dr. Shroff is a consultant to Abiomed, Terumo Medical, and the Medicines Company.
Manuscript submitted October 3, 2011, provisional acceptance given October 14, 2011, final version accepted October 17, 2011.
Address for correspondence: Adhir R. Shroff, MD, MPH, FACC, FSCAI, 840 South Wood Street, MC 715, Chicago, IL 60612. Email: arshroff@uic.edu