Transradial Coronary Angiography and Percutaneous Intervention in the Era of Health Care Reform, Cost Containment, and Patient-Centered Care

ABSTRACT: There has been tremendous pressure on cardiovascular services to reduce costs in health care delivery while maintaining the quality of care. The transradial approach to coronary angiography and interventions has been demonstrated to answer this call by offering superior outcomes while reducing the cost burden of vascular complications compared to traditional transfemoral approaches. Herein, we discuss the cost effectiveness of the transradial approach as a valid modality for angiography and interventions in this era of health care reform.

J INVASIVE CARDIOL 2011;23:383–385

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The cardiology community has been under tremendous pressure to reduce costs. The Centers for Medicare and Medicaid Services (CMS) released proposed Medicare payment rules that include drastic reductions for reimbursement within cardiology while the initial health care reform bill was signed into legislation, generating additional pressure to be cost effective. The CMS proposals will reduce payment in cardiology, with cuts ranging from 4% to 14% in interventional cardiology procedures,¹ to as much as 50% for echocardiography.² The overall initial projection in the health care bill was to reduce the deficit by several billion dollars in the first decade. However, recent estimates report a potential increase in costs of 0.9% over 10 years.³ Our challenge is to reduce costs while simultaneously maintaining high quality of care.

It is recognized that the cost of cardiac catheterization is not limited to the procedure and resources used in the laboratory, but also to procedural complications resulting in increased length of hospital stay. It has been shown that complications associated with percutaneous coronary intervention (PCI) lead to significantly higher cost and health care resource ultilization than uncomplicated PCI.⁴

During the last decade, we have learned that bleeding complications after PCI have significant impact on outcomes and may be the single most important preventable complication. There is a direct relationship between the severity of bleeding and mortality at 30 days.⁵ Transfusion and bleeding severity appear to be directly related to adverse outcomes post PCI, especially in patients with acute coronary syndrome (ACS). Blood transfusion in patients with ACS undergoing PCI is associated with significantly higher unadjusted 30-day mortality and myocardial infarction (MI) compared with patients not receiving transfusions.⁶ The overall cost increases as the severity of bleeding increases, as reported by Rao et al:⁷ there was a stepwise increase in length of stay (no bleeding: 5.4 days, mild bleeding: 6.9 days, moderate bleeding: 15.0 days, severe bleeding: 16.4 days; p ≤ 0.01) and unadjusted total costs (no bleeding: $14,282, mild bleeding: $21,674, moderate bleeding; $45,798, severe bleeding; $66,564; p ≤ 0.01). Similarly, Ewen et al⁸ analyzed the economic impact of bleeding in the setting of non-emergent PCI and also found that the estimated cost was incremental as the severity of bleeding increased from mild, to moderate, to severe bleeding, with an estimated cost of $4,037, $6,980 and $14,006, respectively.

Reducing bleeding complications, most of which are attributable to femoral arterial access in combination with the use of potent antiplatelet and anticoagulant medications, has been a key objective in the management of patients undergoing coronary angiography and interventions. Risk factors such as anemia, female gender, age, and renal function⁹ have been identified, but the rates of bleeding have not changed significantly using the traditional femoral approach; however, recent data from the ACUITY trial¹⁰ showed that the use of vascular closure devices was independently associated with lower rates of access-site bleeding (odds ratio, 0.78; 95% CI, 0.61–0.99; p = 0.04). The risk of bleeding can be decreased by a number of pharmacologic and non-pharmacologic strategies, such as the use of bivalirudin¹¹ and the TR approach to catheterization and intervention.¹² In 2008, the HORIZONS-AMI trial¹¹ showed that the use of bivalirudin alone in comparison to heparin plus a glycoprotein IIb/IIIa inhibitor decreased the rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46–0.77; p < 0.001).

Transradial Approach

The transradial (TR) approach to coronary angiography was shown to be effective in reducing costs more than a decade ago, when Cooper et al¹³ demonstrated that among patients undergoing diagnostic cardiac catheterization, TR access leads to improved quality of life post procedure, was strongly preferred by patients, and furthermore, reduced hospital costs. However, despite widespread enthusiasm about the TR approach in Europe and Canada, it was not embraced by most U.S. practices until recently.

Access via the radial artery offers a variety of advantages over the femoral approach: the radial artery is easily compressible against a bony structure and does not traverse a joint that can be affected by early ambulation or motion; there is sufficient collateralization of blood flow to avoid ischemia; and there are no major adjacent vascular or nerve structures. The likelihood of high or low entry, which can lead to major access-site complications in the femoral approach, is essentially negligible in the TR approach.

TR access, beyond reduction in risk of bleeding with similar clinical outcomes, additionally provides improved quality of life (QOL). Cooper CJ et al¹³ analyzed QOL and overall cost of diagnostic catheterization by randomizing 200 patients to transfemoral or TR access. QOL was measured with the short form-36 (SF-36) health survey questionnaire and visual analog scales at baseline, 1 day, and 1 week. Patients were examined at 1 day and 1 week post procedure for complications. Costs were measured and analyzed prospectively. The results showed that over the first day after the procedure, measures of bodily pain, back pain, and walking ability favored the TR group (p < 0.05 for all comparisons). Over the week after the procedure, changes in role limitations caused by physical health, bodily pain, and back pain also favored the TR group (p < 0.05 for all comparisons). Moreover, there was a strong patient preference for TR catheterization (p < 0.0001). Further economic analysis demonstrated that TR catheterization led to significant reductions in bed, pharmacy, and total hospital costs ($2.010 vs $2.299, p < 0.0001). Data from developing countries have shown similar reductions in cost.¹⁴

Early reports from randomized trials showed the clear superiority of the TR approach versus the traditional femoral and transbrachial approach in terms of access-site complications.¹⁵ Today, there is enough evidence to support the TR approach as safe and feasible with equal or perhaps better clinical outcomes than the femoral approach but with minimal bleeding risk, as reported by a meta-analysis of 12 randomized trials comparing TR PCI versus transfemoral PCI in acute STEMI.¹⁶ TR PCI reduced major bleeding by 70% compared to transfemoral PCI (0.77% vs. 2.61%; OR 0.30; 95% CI 0.16–0.55; p = 0.0001), and significant reductions were found in the composite of death, myocardial infarction, or stroke (3.65% vs. 6.55%; OR 0.56; 95% CI 0.39–0.79; p = 0.001). Furthermore, reduction in hard endpoints such as mortality was also noted in the TR group (2.04% vs. 3.06%; OR 0.54; 95% CI 0.33–0.86; p = 0.01). Recent data from the large randomized multicenter RIVAL (Radial Vs Femoral access for coronary intervention) trial17 involving 7021 patients confirmed the safety and efficacy of TR PCI with a lower rate of vascular complications. The primary outcome, which was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft-related major bleeding at 30 days, was comparable in both groups (3.7% vs. 4.0%; HR 0.92; 95% CI 0.72–1.17; p = 0.50). However, at 30 days, there were significantly lower large hematomas (1.2% vs. 3.0%; HR 0.40; 95% CI 0.28–0.57; p < 0.0001) and pseudoaneurysms needing closure (0.2% vs. 0.6%; HR 0.30; 95% CI 0.13–0.71; p = 0.006) in the TR group.

There is definite economic advantage of the TR approach over the traditional femoral approach based on reports from Europe, Latin America, and the United States.^13,14,18 Early reports from the Netherlands in the 1990s demonstrated a significant cost reduction in the TR group when differences between subjects in the two groups were translated to hospital costs. Although more guiding catheters were used in the TR group (1.69 ± 0.87 vs. 1.08 ± 0.28; p = 0.001), fewer patients in the TR group required diagnostic (2 vs. 7; p = 0.027) and therapeutic (0 vs. 5; p = 0.01) procedures for bleeding complications (cost reduction: 93%). Hospitalization in the TR group was shorter (6.4 ± 4.7 vs. 11.6 ± 9.9 days; p = 0.005), caused by early and safe mobilization, fewer vascular complications, and preprocedural adjustment of warfarin (cost reduction: 45%).¹⁸ Bridging of anticoagulation in patients with prosthetic mechanical valves can save one to two days of hospital stay. Moreover, cost reduction in TR is not merely due to early discharge, but additionally due to less nursing workload related to less time spent for sheath removal, early patient ambulation, and shorter recovery time.¹⁹

Despite these recognized benefits, the use of the TR approach in the United States is currently less than 5% of cases,²⁰ even though resources for learning and practicing TR angiography and interventions have been widely available for the past few years. Various factors influence the slow acceptance of the TR approach: there is a learning curve for successful TR access, and this translates into a higher cross-over to the femoral approach at the beginning of the curve; there are occasionally technical and anatomical issues requiring tips and tricks to navigate through the upper extremity; and the engagement of coronary ostia may require unfamiliar manipulation of catheters. These technical issues increase the time needed for the procedure while the operator gains experience and may result in greater exposure to radiation for both the operator and patient during the initial phase of the learning curve. It has been documented that, beyond the learning curve, outcomes are quite similar, and with experienced operators, the TR approach to primary PCI achieves similar door-to-balloon times as the transfemoral approach, with significantly fewer access site-related complications.²¹

Since the TR approach, by substantial reduction in bleeding complications and by early ambulation, has translated into less nursing care and early discharge, certain centers in Europe have adopted “drive-through PCI” (ambulatory PCI with same-day discharge), which is likely to further reduce costs and increase patient satisfaction. A UK group recently reported their 4-year experience of 442 consecutive patients undergoing elective TR PCI.²² Exclusion criteria were an ischemic Allen’s test, impalpable radial artery, unprotected left main stem stenosis, acute coronary syndrome, inability to obtain informed consent, and the absence of a caretaker at home following the procedure. They found that more than 95% of patients had excellent angiographic results and 85% were discharged on the same day, with radial access being successful in 94%. The reasons for failed same-day discharge were not related to major vascular or bleeding complications, but rather to known PCI complications such as coronary artery dissection, prolonged chest pain following PCI, suboptimal PCI results, IIb/IIIa inhibitor infusion or cross-over to the femoral approach. This strategy requires further evaluation, but suggests that patients might be selectively chosen for same-day discharge.

An increase in the choice of the TR approach is expected as more interventional cardiologists receive formal TR training and as more catheterization laboratories adopt a primary radial approach position. Today, there are still few programs that use the radial artery as their standard approach to diagnostic angiography and PCI in the United States, although there are efforts to increase the utility of this technique, via programs such as SCAI-TRIP (Society for Cardiac Angiography and Interventions-Transradial Interventional Program).²³ This program covers the basic background and history of the technique, patient selection, catheter manipulation tips, potential complications, and advanced interventional tips (bypass patients, bifurcations etc.). Despite the leading obstacle for new operators being unfamiliarity with use of specialized TR catheters, the first international TR practice survey,²⁴ which included cardiologists from 75 countries around the globe, revealed that the most commonly used catheters for diagnostic angiography and interventions were standard catheters used in femoral cases, and the use of radial specific catheters was less than 20%.

Special situations involving complex interventions and coronary artery bypass graft (CABG) patients have been addressed as well by vaious groups. Burzotta et al²⁵ analyzed the time to left internal mammary artery (IMA) cannulation in a randomized fashion using homolateral TR versus transfemoral approaches. Results showed that the time to left IMA cannulation and the time needed for left IMA evaluation were 39% and 46%, respectively, in the TR group, lower than those in the transfemoral group, whereas total procedure time was similar, unlike the popular belief that TR approach may be more troublesome in patients with prior CABG. An analogous report by Rathore et al²⁶ showing their comparative experience in saphenous vein graft interventions using TR versus transfemoral approaches, showed that angiographic success, total fluoroscopy time, total procedure time, and the use of total contrast volume were similar in the radial and femoral groups, respectively.

Summary. The initial results of the first multicenter, international, randomized trial comparing TR versus femoral approach (RIVAL trial, ClinicalTrials.gov identifier NCT01014273)¹⁷ have endorsed the use of TR access as a safe and efficacious strategy for PCI with lower vascular complications. Ongoing and future trials will address specific questions, such as comparison between left radial versus right radial artery approach (TALENT trial, ClinicalTrials.gov identifier NCT00821106), and radial artery patency after the TR approach (RADAR trial, ClinicalTrials.gov identifier NCT00597324 and NAUSICA trial, ClinicalTrials.gov identifier NCT00815997).

Increasingly, reports are now focusing on the reduced costs associated with the TR approach along with improved quality and outcomes. The lower costs, reduction in bleeding complications, and patient preferences, may lead to the TR approach becoming more widely accepted and available in the United States, in this era of increasing economic strain and pressure to find alternative techniques to conserve health care resources while delivering high quality of care. The TR approach to angiography and PCI currently seems to be a safe and feasible option, which will benefit not only our patients and their families, but also our ailing health care economy.

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From the ¹Division of Cardiology, ²Department of Interventional Cardiology, Department of Medicine, ³Cardiovascular Research Center, Temple University Hospital, Philadelphia, Pennsylvania.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. No authors reported conflicts regarding the content herein.
Manuscript submitted May 9, 2011 and accepted May 16, 2011.
Address for correspondence: Jon C. George, MD, FACC, FSCAI, Cardiovascular Research Center, Temple University School of Medicine, 3500 North Broad Street, MERB 1040, Philadelphia, PA 19140. Email: jcgeorgemd@hotmail.com