ABSTRACT: Background. The radial approach to cardiac catheterization is increasingly popular due to shorter procedural and recovery times and greater patient comfort. Methods. Comparative cost analysis between radial or femoral (with/without closure device) approaches were performed. Results. Radial (R), femoral (F), and femoral with a closure device (F ± C) approaches were used in 70, 62 and 49 consecutive cases, respectively. Group R had higher access equipment cost ($93.0 ± 9.5 vs. $40.5) in group F (p < 0.001), but lower catheter cost ($19.7 ± 12.7 vs. $31.1 ± 9.3; p < 0.001) than Group F, and lower contrast cost ($26.9 ± 17.0 vs. $42.9 ± 25.0) in Group F ± C (p < 0.001). There was a lower postprocedure recovery cost ($185.2 ± 52.7) in Group R compared to $337.5 ± 59.0 in Group F (p < 0.001) and $208 ± 70.4 in Group F ± C (p < 0.001), with a median recovery time of 126.0 ± 36.0 minutes in group R vs. 240.0 ± 42.0 minutes, and 150.0 ± 48.0 minutes in groups F and F ± C, respectively (both p < 0.05). The total variable procedural cost, which includes approach-dependent equipment and recovery room stay, was significantly lower in the Radial group than in the Femoral group ($369.5 ± 74.6 vs. $446.9 ± 60.2 and $553.4 ± 81.0; p < 0.001). Conclusion. The radial artery approach to diagnostic cardiac catheterization is clearly more cost effective than the femoral approach, with or without the use of a femoral closure device. J INVASIVE CARDIOL 2007;19:349–353

       The radial artery approach to diagnostic cardiac catheterization has emerged as an attractive alternative to the femoral artery approach in recent years, especially in Canada and Europe, due to more familiarity and training.^1,2 In experienced hands, the radial approach has been shown to minimize patient discomfort, achieve early ambulation and discharge,^3,4 with a reduced incidence of bleeding and other vascular complications compared with the femoral approach.^5–8

       Cost comparisons have been made between the radial and femoral approaches to diagnostic cardiac catheterization, demonstrating reduced cost with the radial approach.^3,9–11 However, previous studies did not include patients who received femoral puncture closure devices.

       Therefore, we sought to determine the cost effectiveness of the radial artery approach to diagnostic cardiac catheterization compared with the femoral artery approach in two groups, one with and one without the utilization of closure devices.

Methods

       Patient population. Patients who underwent diagnostic cardiac catheterization between October 2004 and December 2005 at Salem Veterans Affairs Medical Center were identified for cost analysis. Patients were excluded if they required additional adjunct procedures such as coronary intervention, peripheral angiography or intervention, right heart catheterization, cardiac biopsy, intra-aortic balloon pumping or coronary artery bypass graft cannulation.

       Catheterization approaches. The femoral approach was performed through the right or left femoral artery based on femoral pulse strength, patient anatomy and operator discretion using 18 gauge, 70 mm long Cook needles (Cook, Inc., Bloomington, Indiana), and 5 or 6 Fr Cordis sheaths (Cordis Corp., Miami, Florida) and Judkins catheters. At the end of the procedure, the femoral sheath was removed and hemostasis was achieved either manually, with a mechanical device, or using a closure device — the Angio-Seal^™ (St. Jude Medical, St. Paul, Minnesota) or Perclose^® (Abbott Vascular, Abbott Park, Illinois).

       The radial approach was performed only in patients who had a normal Allen’s test, preferentially through the right radial artery. Access into the radial artery was achieved using a 21 gauge, 25 mm long Cook needle. This was followed by the introduction of a 5 Fr Cook Flexor Check-Flo Performer Introducer set with hydrophilic coating. Then a “cocktail” of nitroglycerin (50 mcg), heparin (2,000 U), lidocaine 1% (10 mg), verapamil (1.25 mg) and 0.9% normal saline (3.5 cc) was injected intra-arterially through the radial introducer. A 5 Fr multipurpose MPA 2 Cordis catheter was the initial choice in all patients. At the end of the procedure, hemostasis was achieved with manual compression and a D-Stat Radial band (Vascular Solutions, Inc., Minneapolis, Minnesota).

       Our catheterization laboratory policies for recovery times were concordant with the 2001 ACC/SCAI Catheterization Standards recovery times of 2–6 hours for the femoral approach and 1–2 hours for the radial approach. All femoral and radial procedures were performed by the same operator.

       Data collection. Patient demographics and catheterization data were obtained through the Veterans Administration computerized electronic medical record (CPRS), the Witt monitoring system and the catheterization laboratory and recovery area nursing notes and quality management data.

       Cost analysis. Hospital cost was obtained from the Veterans Administration accounting office. This included the cost for needles, sheaths, wires, catheters, closure devices, medicationsand nurse/technician utilization recovery cost.

       Statistical analysis. Variables of interest were analyzed to determine normality of distribution. Pair-wise comparisons between the three groups were performed using the two-tailed unpaired t-test.

Results

Tables 1-3

Table 1. Patient baseline characteristics. Proportions were tested for significant differences with the chi square procedure; means were tested using ANOVA. Table 2. Cardiac catherization findings. Proportions were tested for significant differences with the chi square procedure; means were tested using ANOVA. Table 3. Dye and catheters. Means were tested using ANOVA.

       Patient population and demographics. Between October 2004 and May 2006, a total of 181 patients who underwent diagnostic cardiac catheterization at Salem Veterans Affairs Medical Center were selected for the cost analysis. Seventy patients were in the Radial Group (R), 62 patients in the Femoral Group without the closure device (F) and 49 patients in the Femoral Group with the closure device (F ± C). The mean age was 63 ± 9 years in Group R versus 66 ± 10 in Group F and 61 ± 11 in Group F ± C. The majority of patients were white males. There were no significant differences between the three groups in the prevalence of hypertension, diabetes mellitus, congestive heart failure, chronic renal failure, cerebrovascular disease, peripheral vascular disease or previous myocardial infarction, as indicated in Table 1. During the same period, 334 patients were excluded for analysis because they had concurrent procedures such as right heart catheterization, coronary graft cannulation, peripheral angiograms or interventions, or use of intra-aortic balloon pumping. Three patients in the Radial Group had an unsuccessful procedure, and the femoral approach was subsequently adopted.

       Catheterization results. There were no significant differences in the number of patients with one-vessel, two-vessel, three-vessel or multivessel disease among the three groups, as shown in Table 2. The mean left ventricular ejection fractions, as determined by cardiac catheterization, were also similar.

       Contrast, catheters and closure devices. As shown in Table 3, while the amount of contrast used was not significantly different between the three groups, more catheters were utilized in both femoral groups compared to the radial group. Sixteen out of the 70 radial patients had a D-Stat radial band, while 49 closure devices (Angio-Seal or Perclose) were used in 49 patients.

Tables 4-5

Table 4. Fluoroscopy, procedure, and recovery time by access categories. Data are presented as means ± standard deviation. Comparisons are made by t-test. 1p-value < 0.05 for comparison between radial and femoral group, 2p-value < 0.05 for comparison between radial and femoral with closure group, 3p-value < 0.05 for comparison between femoral and femoral with closure group. Table 5. Cost of cardiac catheterization by access categories (total and for individual components). Data are presented as means ± standard deviation. Comparisons are made by t test. 1p-value <0.05 for comparison between radial and femoral group, 2p-value < 0.05 for comparison between radial and femoral with closure group, 3p-value < 0.05 for comparison between femoral and femoral with closure group.

       Time comparisons. As shown in Table 4, fluoroscopy time was longer in the Radial Group, at 7.4 ± 6.5 minutes, compared to the Femoral Group without closure device use, at 4.5 ± 3.3 minutes (p < 0.01), and was not significantly increased compared to the Femoral Group with closure device use, at 5.9 ± 5.1 minutes. At the same time, procedural duration was nearly identical in all three groups: R = 20.8 ± 12.5 minutes, F = 20.5 ± 9.4 minutes and F ± C = 20.2 ± 11.4 minutes. However, recovery time in the Radial Group, at 126 ± 36 minutes, was nearly half that of the Femoral Group without closure device use, at 240 ± 42 minutes (p < 0.001), and was also significantly shorter than the Femoral Group with closure device use, at 150 ± 48 minutes (p < 0.04).

       Cost comparisons. Table 5 depicts access cost, catheter cost, contrast cost, closure device cost and recovery cost for all three groups (R, F and F ± C). The results demonstrate the following:

• Access cost was significantly higher in the Radial Group, at $93.95, compared with either Femoral Groups, at $40.5 (p < 0.001).

• Catheter cost was significantly lower in the Radial Group, at $19.7 ± $12.7, compared with the Femoral Group without closure device use, at $31.1 ± $9.3 and $30.9 ± $9.6 in the Femoral Group with closure device use (both p < 0.001).

• Contrast cost was significantly lower in the Radial Group, at $26.9 ± $17.0, compared with Group F ± C, at $42.9 ± $25.0 (p < 0.001), as well as higher contrast cost in Group F ± C compared with Group F, $32.6 ± $18.9 (p < 0.001).

• Closure device cost was significantly higher in the Radial Group compared with the Femoral Group without closuredevice use, at $61.4 ± $12.9 versus $36.4 ± $24.9 (p < 0.001), but was significantly lower in than the F ± C Group, at $245.0 ± $0 (p < 0.001).

• Recovery cost was significantly lower in the Radial Group compared with the Femoral Group without closure device use, at $185.2 ± $52.7 versus $337.5 ± $59.0 (p < 0.001), and was also lower than the F ± C Group, at $208.0 ± $70.4 (p < 0.05). Total procedural costs including access, catheters, contrast, closure device and recovery costs were significantly lower in the Radial Group, at $369.5 ± $74.6, compared with the Femoral Group without closure device use, at $446.9 ± $60.2, and Group F ± C, at $553.4 ± $81.0 (both p < 0.001).

       Procedural complications. No patient in any of the three groups developed a postprocedural complication. It is noteworthy that no patient in the Radial Group developed radial artery spasm or other vascular complications.

Discussion

       Seventeen years after the introduction of the radial artery approach to diagnostic cardiac catheterization by Campeau,¹ the femoral approach remains much more commonly used in the United States because it is technically easier and allows the use of larger catheters. However, in Canada and Europe, the radial approach has gained greater acceptance due to more familiarity, while the cardiovascular training programs in the United States have not emphasized the importance of learning this technique.^12,13 In experienced hands, the radial approach to diagnostic cardiac catheterization has a number of advantages that need to be emphasized in order to bring greater acceptance of this procedure in the U.S.: (1) The radial artery, unlike the femoral or brachial artery, is not an end-artery. Therefore, even with its possible occlusion, adequate ulnar artery collaterals can salvage the hand from ischemia; (2) the radial artery is more superficial than the femoral artery, therefore it is easily compressible and sheath removal results in diminished risk of bleeding and other vascular complications. A meta-analysis by Agostoni et al⁵ of 3,244 patients who underwent radial or femoral artery catheterization showed that the former had less entry site complications (0.3% versus 2.8%; p < 0.0001) with similar MACE of 2.2% and 2.4%, respectively; (3) the radial approach carries less risk of nerve injury since there is no adjacent nerve; (4) the radial approach overcomes the limitations and risks of the femoral approach in aorto-iliac vascular disease8 and obese patients; (5) the radial approach allows for reduced postprocedural recovery time, earlier ambulation and earlier discharge, resulting in higher patient satisfaction scores as demonstrated by a number of randomized and nonrandomized clinical trials.^3,4 Cooper et al³ showed in a randomized clinical trial comparing 101 patients who underwent the radial technique to 99 patients who underwent the femoral technique, that measures of bodily pain, back pain and walking ability 1 day and 1 week after the procedure both favored the radial approach, which was associated with a mean reduction of length of stay of 6.8 hours. Accordingly, there was a strong patient preference for the radial approach (p < 0.0001).

       The radial approach has been shown to be more cost effective in general compared to the femoral approach in patients who do not receive femoral closure devices. Amoroso et al¹⁰ found in a prospective, nonrandomized comparison between radial and femoral artery catheterization, that the former was an independent predictor of reduced catheterization laboratory nurse workload, but none of those patients received a closure device. Cooper et al³ showed in a randomized trial of radial versus femoral artery catheterization that the former was associated with a shorter hospital stay (3.6 versus 10.4 hours) and reduced hospital costs ($2,010 versus $2,299) in patients who did not have a femoral closure device.

       Consequently, this study was conducted to compare the cost effectiveness of the radial artery approach to the femoralapproach, with or without the utilization of vascular closure devices, in consecutive patients undergoing diagnostic cardiac catheterization without concurrent procedures between October 2004 and May 2006. There were 70 patients in the Radial Group, 62 patients in the Femoral Group without closure device use and 49 patients in the Femoral Group with closure device use. Patients were excluded due to concurrent procedures. The majority of our patients were white males with a mean age of 63.0 ± 9.0 years, slightly younger than the Femoral Group, at 66.0 ± 10.0 years. No patient developed periprocedural complications. While the fluoroscopy time was longer in the Radial Group due to the more demanding nature of the procedure, the overall procedural time was not significantly different between the three groups. Recovery time was clearly lower in the Radial Group compared with the Femoral Group, as has been described before, but we also noted that it was lower compared to the Femoral Group with closure device use. While access cost in our study was significantly higher in the radial group attributed to the use of hydrophilic sheaths, catheter cost was less due to reduced need to use multiple catheters with the radial approach. Contrast cost was higher in the Femoral Group with closure device use due to additional dye consumption in this process. Closure device cost, as expected, contributed to additional expense in the F ± C Group. The significantly shortened recovery time with the radial approach resulted in significantly lower recovery cost compared with both femoral groups. The reduced catheter, contrast and recovery costs with the radial approach resulted in a significantly lower overall procedural cost compared with both femoral groups. Recovery cost savings in the Femoral Group with closure device use were outweighed by the cost of the closure device, bringing the total variable cost to $553.4 ± $81.0 (p < 0.001) compared to $369.5 ± $74.6 in Group R, and $446.9 ± $60.2 in Group F.

       Nurse staffing represents an important burden on resource consumption and hospital economics to the extent that even a 1–2% change in nurse staffing results in huge shifts in annual expenditure in the order of $140,000–$220,000.¹⁴ In addition, a shortage of adequately trained cardiac registered nurses is frequently encountered, with no solutions on the horizon.¹⁵ The potential of cost savings with the radial approach compared with the femoral (with or without closure device) approach could significantly impact the budget of cardiac catheterization laboratories and recovery units.

       It should be recognized that the radial approach has some limitations and contraindications. Currently, there is less familiarity and comfort with this approach, as very few U.S. cardiovascular training programs have emphasized the importance of learning this technique. Cannulating the radial artery successfully and without complications involves a steep learning curve.^12,13 Furthermore, this approach cannot be used in about 10–23% of patients who need a diagnostic cardiac catheterization due to an abnormal Allen’s test and a risk for hand ischemia.^16,17 A meta-analysis analysis by Agostoni et al⁵ comparing 1,668 patients who underwent radial catheterization compared to 1,556 patients who underwent femoral artery catheterization showed that the former had a higher number of procedural failures (7.2% versus 2.4%; p < 0.001). In addition, patients who require larger catheters for intervention or a balloon pump cannot undergo this approach. Radial artery spasm remains the most dreaded and frequent procedural complication of radial artery catheterization reported in 7% of patients,¹⁸ however its frequency has been drastically reduced with the use of hydrophilic sheaths,¹⁹ intra-arterial injection (nitroglycerin, heparin, verapamil), and improved operator experience.²⁰  

       Study limitations. The major limitations of this study are that it is not randomized or prospective, and operator discretion in the choice of radial versus femoral technique may have skewed the data. Also, the conclusions of this manuscript apply only to a demographic of white males, whereas radial artery spasm is known to be more prevalent in females. In addition, the absence of procedural complications prevents us from discerning to what extent such complications might have overshadowed the cost savings with the radial approach. Finally, recovery time costs are dependent on many extraneous factors such as who monitors the patient and what the hourly rate of pay for those individuals might be. These costs will vary widely around the country, and no doubt, the cost differentials may be much greater, or much narrower, than what we observed.

Conclusion

       In conclusion, although the cost savings per case may appear small (between $77.40 and $183.90 per patient), with more than 1 million diagnostic cardiac catheterizations performed yearly in the United States, there is potential for tremendous cost savings using the radial approach.