Rapid Ambulation after Coronary Angiography via Femoral Artery Access: A Prospective Study of 1,000 Patients
March 2006
Individual protocols for mobilization after diagnostic cardiac catheterization differ widely between units. Prolonged bed rest increases patient discomfort, limits total numbers of procedures and increases healthcare costs. The current trend is to recommend earlier mobilization. This is beneficial in terms of patient comfort, provided there is no increase in vascular complications.
We conducted a prospective study of early ambulation following diagnostic cardiac catheterization. Our aim was to assess the safety and efficacy of a 90-minute bed rest protocol for patients having undergone elective 6 Fr femoral access coronary angiography.
Materials and Methods
One thousand consecutive patients undergoing elective femoral access day case coronary angiography were studied. All signed informed consent and all procedures used 6 Fr sheaths. After the procedure, sheaths were removed manually and hemostasis established using the Femostop®(RADI Medical Systems AB, Uppsala, Sweden) mechanical compression device for 30 minutes (see protocol, Table 1). The patient was then sat up and had 1 additional hour of bed rest before mobilization. All patients were mobilized after 90 minutes of bed rest.
The following exclusion criteria were applied:
1. Emergency angiography
2. Patients undergoing percutaneous coronary intervention
3. Operator preference for 7 Fr or larger sheaths
Complications were identified as follows:
1. Bleeding
• Minor = bleeding requiring compression but not requiring transfusion or causing hemodynamic instability (defined as tachycardia and hypotension)
• Major = bleeding causing hemodynamic instability or requiring transfusion
2. Hematoma formation: this was defined as a hard, palpable
swelling and was categorized as follows:
• Small = 5 cm
3. Pseudoaneurysm: confirmed on ultrasound imaging.
Patients were allowed to return home after 2 hours of mobilization in the absence of complications. All patients were given a telephone number to make direct contact with the senior nurse on the ward should they have had any concerns over the following 72 hours.
Results
Demographic data. Table 2 shows basic demographic data, including antithrombotic medications. The mean body mass index (BMI) of patients was high (median BMI = 28; mode BMI = 27). These data were further subdivided into the following BMI ranges:
BMI less than or equal to 25 = 27.2%
BMI > 25 25, the majority of patients in this study were obese.
Complications. Of 1,000 patients, 1 (0.1%) had a minor bleed and was treated successfully with with manual pressure and a pressure dressing. One patient had a false aneurysm requiring both surgical repair and a blood transfusion (0.1%). No other patients required transfusion or had hemodynamic instability.
One other patient developed a false aneurysm that was successfully treated by local thrombin injection. Demographic data of the 2 patients with false aneurysms are shown in Table 3. An additional 11 patients had discharges delayed because of hematoma formation and clinical suspicion of false aneurysm (Table 4). All patients underwent femoral artery ultrasound, revealing no pseudoaneurysm.
There was an excess of vascular complications in females (2.6% versus 0.6%). These values were analyzed using the Fisher’s exact test, giving an odds ratio of a 4.38 times higher rate of complication in females (95% confidence interval: 1.21, 19.57). This was statistically significant (p = 0.01). There were no cases of late complications following discharge.
Hospital stay. Delays in discharge were documented. Thirteen patients had delayed discharge (i.e., not discharged the day of the procedure). Of these, 10 patients were delayed by 1 day, 1 patient by 2 days and 1 patient each by 3 and 4 days.
The reasons for delay were commonly due to delay in obtaining an ultrasound scan to exclude pseudoaneurysm. The two longest delays (3 and 4 days) involved patients with pseudoaneurysms awaiting either thrombin injection or surgical repair. As for the other patients, had an ultrasound been available the same day, discharge may not have been delayed.
Eleven patients were delayed because of hematoma formation and the need to exclude a false aneurysm after examination. Of those with hematomas who were delayed, 5 had large (> 5 cm) hematomas (45.5%), 1 had a medium (1–5 cm) hematoma (9%), and 5 had small (1–3
Several studies suggest that shorter periods of groin pressure and earlier ambulation are safe in patients undergoing elective coronary angiography.4–7 Roebuck compared patients who ambulated at 2 and 4 hours post-elective femoral cardiac catheterization, and demonstrated no increase in vascular complications in the 2-hour group.8 Logemann compared 2-hour versus 6-hour mobilization with compression using the Femostop device, demonstrating that the shorter period before mobilization was safe.9 Two studies in the 1980s looked at discharge after 4 hours of bed rest, and in these studies, 94% and 96% of patients were safely discharged after this time period without complications.10,11
Reducing the period of immobilization has beneficial effects on patient comfort, particularly in terms of reduced back pain. Barkman directly compared ambulation at 3 and 6 hours and confirmed that patients with the faster ambulation time experienced significantly less back pain.12
The overall reported complication rates vary. This is undoubtedly due to the small numbers of patients in some of the studies. In 1989, Babu reported complication rates in 5,850 patients undergoing cardiac catheterization via the femoral artery approach. Surgical intervention for complications was required in 0.23% of patients.1 Other studies have reported high vascular complication rates: 28% reported by Brener and Couch,2 and 24% by Machleder et al. in 1972.13 More recently, Pollard and coworkers reported a bleeding rate of 7.3%, a hematoma formation rate of 12.8% and a false aneurysm rate of 0.3%, quoting an overall complication rate of 19.2% at a mobilization time of 2.5 hours postprocedure.14
Interestingly, complications were predominantly in those patients classed as obese (BMI > 25). The mean BMI for those patients was 29.67 (range 24.4–38.5). It is perhaps not surprising that patients with a large BMI are more prone to develop complications. The femoral artery pulse, by virtue of its deeper location, is diffuse, thus adding to the complexity of placing the manual compression device over the puncture site. The low complication rate reported in this study is remarkable, as the majority of patients were obese.
It is notable that complications seemed to predominate in females. This gender bias has been reported previously. Knight and colleagues identified female gender as an independent risk factor for the development of complications.3 Other studies have also identified female gender as a predictor of femoral access site complications.15
Our study’s results show early ambulation after 90 minutes to be safe for patients undergoing elective 6 Fr coronary angiography. Further studies are indicated to investigate whether this time could be reduced further, especially in patients with a BMI Clinical value. An increasing number of centers are turning to the radial artery as the preferred access route for invasive coronary procedures. Although reported vascular complication rates are lower than with the femoral route for an equivalent sheath size,16 the number of possible repeat procedures is limited with the radial artery approach. This is particularly true in females and patients with diabetes mellitus. For two-stage procedures (diagnostic followed by intervention) or diagnostic catheterization alone, a case can be made for undertaking the diagnostic procedure using the femoral artery approach.
Many centers are also using femoral closure devices in order to facilitate early mobilization. These devices are expensive in relation to compression devices, and add considerably to healthcare costs. Their role in early mobilization after coronary intervention is well recognized. However, a similar case can be made on the grounds of cost for using manual compression devices for diagnostic procedures.
Limitations. The study was limited to patients undergoing elective coronary angiography with 6 Fr sheaths. The data cannot be extrapolated to interventional procedures, where more powerful antithrombotic agents are routinely administered. Also, there was no control group using manual pressure.
Acknowledgements. We are grateful to the nursing staff on ward 24 of Freeman Hospital for helping with this study, and to Professor John Matthews, from the Department of Statistics, Newcastle University, for his input.
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