EDITORIAL

Achieving Optimal Arterial Access for PCI

John S. Douglas, Jr., MD

John S. Douglas, Jr., MD

Achieving optimal arterial access for performance of percutaneous coronary intervention (PCI) should involve considerations of safety, efficacy, timeliness, and patient satisfaction with safety paramount. In this regard, there has been a heightened awareness of the importance of periprocedural access site bleeding due to its association with morbidity, mortality, and increased costs.1-3 In the current environment of intense scrutiny of procedural outcomes, quality monitoring and cost containment, bleeding avoidance strategies have emerged.4,5 Most notably, the pioneering works of Campeau and Kiemeneij, coupled with refinements of radial access equipment and strategy, have permitted skilled operators to perform coronary angiography and intervention radially with an almost total exclusion of major access site bleeding.6,7 However, adoption of radial access for PCI by international operators has far exceeded that of United States (US) operators. Observational and small randomized studies comparing outcomes based on access site, radial versus femoral, reported better outcomes with radial access with respect to bleeding and in some cases ischemic complications as well.8 These studies led to an outcry from a small but vocal cadre of radial operators urging wider adoption of radial access in the US, where fewer than 5% of PCIs are performed radially.8-11 While this conversion to use of more radial access seems highly appropriate given the potential benefits, the issue is not as simple as it appears. Not all patients are equally good candidates for radial access. Not all PCI operators have the time or volume of cases that would permit them to retrain and acquire the skill set necessary to perform PCI radially. In addition, the call-to-arms to adopt radial access is only one of several bleeding avoidance strategies that should be considered.5 Accessing the risk of bleeding of the individual patient is the first step toward the safest possible PCI, whether performed via radial or femoral access.

Assessing the Risk of PCI Bleeding

A number of national, regional, and single-center registries have reported access-site bleeding rates in recent years.5,12-14 Although the Cath PCI Registry reported that access-site bleeding complications were reduced from 1.2% in 2005 to 0.78% in 2009, Crudu recently reported a higher access-site complication rate of 4.7% with a four-fold increase in in-hospital mortality when a complication occurred.15 This and other studies have highlighted the fact that access-site complications are more likely in patients who are older, female, have peripheral vascular disease, have heart failure, are obese, have impaired renal function, or have received IIb/IIIa inhibitors or thrombolytics. Several models have been developed to predict bleeding during PCI.16-18 The observation that the risk of bleeding can be assessed using baseline variables permits institution of personalized bleeding avoidance strategies in patients at high risk. In over 1.5 million patients in the NCDR Cath PCI Registry, bleeding rates differed based on the NCDR bleeding risk model (low risk, 0.72%; intermediate risk, 1.73%; high risk, 4.69%) and use of bleeding avoidance strategies was associated with lower bleeding rates.4 The degree to which bleeding risks can be mitigated by optimal application of bleeding avoidance strategies remains to be determined, but the lowest possible bleeding risk in keeping with other risk/benefit considerations should be the goal of every interventional operator.

Advantages and Limitations of Radial Access

In addition to reduced access-site bleeding and complications (pseudoaneurysm, arterio-venous fistula, groin hematoma, retroperitoneal bleeding), advantages of radial access include improved patient comfort, shortened time to ambulation, applicability for outpatient PCI, intervention without warfarin cessation, and potential reductions in cost.19,20 A recent report from the Transradial Committee of the SCAI nicely summarized many aspects of radial artery access for coronary and peripheral intervention.21 A recently reported large, randomized multicenter trial, the Radial Versus Femoral Access for Coronary Intervention (RIVAL) trial tested whether radial access was superior to femoral access in patients with acute coronary syndromes.22 In this study of 7021 patients from 32 countries in which only high-volume PCI operators participated, radial access was not superior to femoral access with respect to the primary endpoint (death, myocardial infarction, stroke, or non-CABG related bleeding at 30 days). The primary outcome occurred in 3.7% in the radial access group and 4.0% of the femoral access group (p = 0.5). There was, however, a difference in less serious access-site complications with fewer in the radial access group compared to the femoral access group (large hematoma, 1.2% versus 3.0% [p <0.0001] and pseudoaneurysm, 0.2% versus 0.6% [p = 0.006], respectively). In patients with ST-elevation myoardial infarction (STEMI), radial access seemed to reduce the incidence of the primary endpoint and the secondary endpoints of death, MI, stroke, and overall mortality as well as access-site complications. However, rates of major bleeding were not less with radial access in patients with STEMI and the confidence interval for the primary endpoint was wide (0.38-0.94). Why ischemic complications were lower with radial access in the absence of a difference in major bleeding is puzzling and it was suggested that confirmation by future randomized trials was needed to ensure that this was not a chance finding.22,23 A previously reported meta analysis involving 3324 patients with STEMI also reported less major bleeding and a reduction in a composite of death, MI, or stroke (p = 0.001) with radial access, but longer fluoroscopy time and access-site crossover was 7%.24 However, the majority of these patients (2806) were from observational studies and subject to selection bias. Retroperitoneal bleeding, the most important access-site complication, occurred in only 0.1% of the femoral access group in RIVAL compared to a 0.4% rate in 112,340 patients in a large multicenter US registry.25 RIVAL was underpowered to evaluate this complication. In RIVAL, overall success rates were similar, but crossover from radial to femoral access was needed in 7.6% of patients and fluoroscopy times were about 20% longer with radial access.

Disadvantages of radial access relate primarily to its technical difficulty and a longer learning curve for operators as well as a higher failure rate than with femoral access. Ball and colleagues analyzed the learning curve for radial access PCI, noting that procedural failure, fluoroscopy time, and contrast media volume decreased after 50 procedures and suggested that a case volume ≥50 cases is required to achieve outcomes comparable to experienced operators26 and Sciahbasi et al reported a shorter learning curve with left versus right radial access, presumably because catheter manipulations from the left arm more closely simulated those of a femoral approach.27 In a recent Canadian study of 2100 patients who underwent PCI via a radial approach (38% of the total PCI population), PCI failure occurred in 98 patients (4.6%).28 Causes for failure were inadequate radial arterial puncture (13%), radial artery spasm (34%), radial artery dissection (10%), or loop (6%), subclavian tortuosity (18%), and inadequate guide catheter backup (17%). Age >75 years, prior CABG, and short stature were independent predictors of transradial PCI failure indicating a need to carefully weigh the decreased vascular complications expected with radial access against an increased failure rate with this approach. In tall patients, it is important to remember that standard length catheters (100 cm) may be too short for a radial artery approach.

Increased radiation to the patient29 and to the operator30 has been reported with about 23% more radiation occurring with radial access. Assuming a 20-year career, this exposure would equal that of 4 additional years if radial access were used exclusively.29 Operator-centric factors with radial access, in addition to increased radiation, include greater lower back strain, particularly with obese patients where the right or left arms cannot be brought to a more ideal centered location after radial artery puncture. Radial artery occlusion reported in 1.1–12% of patients31 is almost always asymptomatic in the presence of a patent ulnar artery and palmar arch, but radial artery occlusion jeopardizes future use as a fistula for dialysis complicating decision making in patients with renal failure where increased access bleeding is known to occur and in patients who may need a radial artery conduit for CABG in the future. Femoral access is usually preferred in the post-CABG patient with bilateral internal mammary artery (IMA) grafts. In patients with STEMI where relatively short delays may assume increased significance, radial access is recommended only to the experienced operator and femoral access may be preferred in hemodynamically unstable patients who may not tolerate the vasodilator “cocktail”21 that is necessary to prevent radial artery spasm shown to occur in about 30% of patients when the cocktail is omitted.32

Advantages and Limitations of Femoral Access

Arterial access by way of the femoral artery has been the most common route utilized for PCI and provides the advantages of familiarity, larger catheter lumen capability, higher probability of success and in most cases superior guide catheter support, which is required in some complex PCI procedures. Bleeding and other access complications have been substantially reduced in recent years by a number of changes including use of weight-based heparin, activated clotting time monitoring, lower heparin dosing, smaller catheters, avoidance of post-procedure heparin, less use of IIb/IIIa inhibitors, more use of bivalirudin, attempts to achieve “safe-zone” puncture of the common femoral artery, and perhaps by closure devices. Although use of fluoroscopy to guide puncture of the common femoral artery over the femoral head was recommended by Charles Dotter 35 years ago, this practice was not widely adopted until a few years ago. Among 158 patients undergoing femoral access, Garrett reported that when needle insertion in the artery was at the level of the middle of the femoral head, common femoral artery puncture occurred in 99% of patients.34 As puncture at or above the level of the most inferior sweep of the inferior epigastric artery increases the risk of retroperitoneal bleeding by almost 20-fold and puncture below the common femoral bifurcation is associated with increased risk of hematoma, pseudoaneurysm, and arterio-venous fistula, the goal is to puncture the common femoral artery between these vascular landmarks in the “safe zone.”33-36 In a very recent report from the Mayo Clinic, femoral puncture outside the “safe zone” occurred in 13% of 300 patients and vascular complications were over 4-fold higher when this occurred (18% versus 4%; p <0.001).37 The recommendations that needle entry into the femoral artery be just below the equator of the femoral head, that a 21-gauge micropuncture needle with a 0.018-inch guidewire be used, and that biplane femoral artery angiography through the sheath be done immediately in all cases are quite reasonable.36 Angiography at this time permits aborting an elective procedure if a “safe zone” arteriotomy was not achieved. The use of ultrasound guidance, which has proven very helpful in achieving venous access, would be expected to improve arterial access as well. In a multicenter randomized trial comparing fluoroscopic versus ultrasound guidance for femoral artery access, use of ultrasound shortened the time to access, reduced the risk of venipuncture, was associated with fewer vascular complications (1.4% versus 3.4%; p = 0.04), and improved the success rate of common femoral artery puncture when the bifurcation was high.38 However, lack of experience with ultrasound may have limited, to a degree, its value in this study where a minimum of only three proctored ultrasound procedures was required to be a primary operator.

Three additional potential bleeding avoidance strategies with femoral access merit discussion: the use of bivalirudin, arteriotomy closure devices, and use of ≤5 French catheters. The evidence base for efficacy is far greater for bivalirudin, which has been associated with an almost 50% reduction in bleeding compared to heparin and IIb/IIIa inhibitors in randomized trials39,40 and in large registries.4,14 Bleeding was also less compared to heparin alone at a dose of 140 U/kg.41,42 In a registry of over 100,000 US patients undergoing PCI between 2002 and 2009, the risk of a retroperitoneal bleed was 50% less in patients treated with bivalirudin.25 Reduced bleeding with bivalirudin was a consistent finding when bivalirudin was compared with heparin-based strategies. The use of arteriotomy closure devices (ACD) to reduce bleeding complications is quite controversial. Early studies with a variety of ACDs reported a higher complication rate with these devices (especially with VasoSeal; Datascope Corporation) compared to manual compression.43 In the Blue Cross Blue Shield of Michigan registry reporting retroperitoneal bleeding, the use of Angio-Seal ACD was an independent predictor of retroperitoneal bleeding (odds ratio, 1.61; p <0.0001).25 However, as nicely summarized by Dauerman and colleagues, a number of recently published large registries have reported a 22–50% decrease in vascular complications in patients treated with ACDs.5,13,14,44,45 In a recently published analysis of periprocedural bleeding in 1.5 million patients in the NCDR Cath PCI Registry, Marso et al reported bleeding complications in 2.8% of patients who received manual compression, compared with 2.1%, 1.6%, and 0.9% of patients receiving ACDs, bivalirudin, or both strategies, respectively (p <0.001).4 In patients with high risk of bleeding, the lowest bleeding rate occurred with bivalirudin plus ACDs (p <0.001). The lack of an adequately powered randomized study to address the current safety and efficacy of ACDs is a confounder. A recently published American Heart Association Scientific Statement indicated that use of ACDs after invasive cardiovascular procedures performed via the femoral artery was reasonable to achieve faster hemostasis, shorter bed rest and possibly improved comfort (Class 11a-Level of Evidence B), but routine use of ACDs was not recommended for the specific purpose of reducing vascular complications (Class III-Level of Evidence B).46 Whether a Class II recommendation will eventually be given for this indication as suggested by Dauerman et al remains to be seen.5 With respect to the safety and efficacy of very small guide catheters, it has been shown that PCI can be safely performed via 5 and even 4 Fr guide catheters from a femoral access and more recently with a sheathless 5 Fr approach.47-49 Although bleeding complications were low, they were not as low as via a radial approach, and the technical difficulty of use of such small catheters may rival that of radial access procedures.

In summary, arterial access-site complications of PCI, especially bleeding, are associated with patient discomfort, increased cost, morbidity, and mortality. Bleeding avoidance strategies, which may include the use of radial or femoral arterial access, will play an increasingly important role in the PCI patient with intermediate to high bleeding risk. In patients with low bleeding risk, the primary benefit of radial access is shortened time to ambulation, which is achievable with femoral access and ACDs. As the bleeding risk increases, the benefit of a radial approach is magnified. However, in order for interventional operators to become proficient with radial access PCI, a learning curve of 50–100 cases must be negotiated. A strategy of “radial access first” has been implemented by some experienced femoral-access oriented PCI operators and interventional cardiology training programs, including ours, and is highly recommended. This permits the femoral-access oriented physician to acquire the skill set to perform PCI radially in a stable, elective patient. The goal is to develop the substantial skills necessary to safely treat the high-risk, diminutive elderly female with acute coronary syndrome, smallish radial artery, and tortuous vessels whose bleeding risk with femoral access is significant. A skilled “radialist” would probably approach such a patient with 5 Fr catheters via the radial artery. Should radial access not be an option, a “safe zone” common femoral puncture, use of a 5 or 6 Fr catheter, bivalirudin, avoidance of IIb/IIIa inhibitors if possible, and perhaps use of an ACD may be the best approach. Achieving the optimal arterial access for PCI in a given patient requires risk stratification, awareness of bleeding avoidance strategies, and the ability to work safely from both arm and leg approaches. 

References

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From the Director, Interventional Cardiology Fellowship Program, Emory University School of Medicine, Atlanta, Georgia.
Disclosure: The author has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The author reports no conflicts of interest regarding the content herein.
Address for correspondence:  John S. Douglas, Jr., MD, Professor of Medicine, Emory University Hospital, 1364 Clifton Road, NE, Suite F606, Atlanta, GA 30322. Email: jdoug01@emory.edu