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1 Radiology Department, Level 2, Westmead Hospital, Westmead 2145, NSW,
Australia.
2 Department of Public Health and Community Medicine, Westmead Hospital,
Westmead 2145, NSW, Australia.
Received November 6, 2003;
accepted after revision February 6, 2004.
Address correspondence to N. Young.
Abstract
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MATERIALS AND METHODS. Data were collected prospectively for 2,683 procedures performed on an outpatient basis in 2,248 patients from the period March 1997 to March 2002. Patients were assessed by nursing or medical staff within 2–4 hr of the procedure and again via telephone 24–48 hr after the procedure. The collected data were summarized on the basis of procedure type into four main groupings: aortofemoral studies, cerebral studies, interventional procedures, and other studies. Complication frequency distribution was determined for each procedure type. An interim summary of complication rates was prepared for the period March 1997 to June 1999. Statistical analysis using a two-tailed z-test for the comparison of two proportions was performed to determine if a significant difference existed in the rates of complications from data collected before and after the June 1999 summary.
RESULTS. Ninety-one percent of cases completed follow-up. In total, 561 complications were identified in 2,436 cases (23%). Most complications consisted of either local pain or puncture site hematoma and bruising. No deaths occurred. In the 1,128 diagnostic aortofemoral studies performed, 211 complications (19%) occurred. In the 359 cerebral studies, 87 complications (24%) occurred. The 441 interventional procedures resulted in 146 complications (33%). In the remaining 508 procedures, 117 complications (23%) occurred. Major complications in each group are presented.
CONCLUSION. We observed a low incidence of complications requiring further treatment or resulting in a permanent deficit. The rates are comparable to published data from similar studies and practice standards guidelines. A statistically significant improvement was seen in the total complication rate between the periods March 1997–June 1999 and July 1999–March 2002 (p = 0.01).
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Patients were admitted to the inpatient section of the radiology department and were assessed by nursing staff to confirm that they were suitable to proceed with angiography. This assessment included checking for any recent clinical deterioration, a routine check of vital signs, and ensuring that the patient had adequate transportation home and adult supervision for at least 24 hr after the procedure. Informed consent was obtained by the radiologist in the angiography suite. Procedures were performed on a Philips digital subtraction unit, either a V3000 or a V5000, with road mapping capabilities.
The procedures were performed by interventional radiologists with experience ranging from 5 to 25 years. The staff of interventional radiologists performing the procedures remained stable throughout the study period. Fellows and residents in interventional radiology also performed some of the procedures under the direct supervision of a radiologist.
Lignocaine 1% local anesthetic was used at the intended puncture site (predominately the groin). In general, 4-French catheters were used for diagnostic studies, and 5-French catheters and 5- to 7-French sheaths were used for interventional procedures. If angioplasty or stent insertion was performed, intraarterial heparin was given before the intervention at doses of 2,500–5,000 U per patient, the dose depending on the estimated time required for the intended procedure. If the procedure was thought to take up to 1 hr, as was usually the case, then 5,000 U was routinely given. The standard Seldinger technique was used to introduce the catheter over a guidewire. The single-wall, microstick technique of vascular access was not routinely used. ECG, blood pressure, and pulse oximetry monitoring were routine. Procedure length was usually less than 1 hr. If the patient had diabetes, the blood glucose level was monitored before, during, and after the procedure. Sedation was not routinely used.
Patients were given dimer, nonionic contrast material (iodixanol) to a usual limit of less than 3 mL/kg of body weight. If this dose was not sufficient to complete diagnostic studies, then such studies were completed at another time.
Once the procedure was finished, the puncture site was closed using digital compression by the radiologist, interventional fellow, or resident who performed the procedure. Patients were kept supine and were observed every half hour by nursing or medical staff for blood pressure, pulse, groin puncture inspection, peripheral vascular state, and neurologic state if a cerebral study had been performed. Patients were observed for at least 2 hr after diagnostic angiography using a 4-French catheter (4 hr for cerebral angiography) and up to 6 hr after angioplasty or stent insertion. Patients who remained stable were discharged in the care of a supervising adult with instructions and contact details in the event of a problem or complication.
Patients were followed up 24–48 hr later by telephone and questioned regarding complications. If patients were admitted after the procedure, they were visited on the ward. Information was recorded in a standardized database for each patient, listing the date of the procedure, procedure type, and a description of any complications that occurred.
Data were summarized on the basis of procedure type into four main categories: aortofemoral studies, cerebral studies, interventional procedures (e.g., angioplasty, stent, embolization), and other procedures (e.g., renal study, mesenteric or abdominal aortography, arch aortography, subclavian venography). Complication rates were calculated for the total number of procedures and also for the four main subgroups. Complications were divided into three major groups: local, including hematoma or bruising and postprocedure pain at the puncture site; (2) neurologic, including transient ischemic attacks and cerebrovascular accidents in cerebral studies; and (3) other, including idiosyncratic complications such as nausea, gastrointestinal upset, headache, weakness in the limb associated with arterial puncture, and contrast hypersensitivity reactions. Both minor and major complication rates were determined as defined by the Society of Cardiovascular & Interventional Radiologists Standards of Practice Committee [4].
An interim summary of data collected from March 1997 to June 1999 was previously reported [2]. These data were compared with findings for the period July 1999–March 2002. Statistical analysis using a two-tailed z-test for the comparison of two proportions was performed to determine if a significant difference existed in the rates of complication before and after the June 1999 summary. At the end of the study period, medical records were reviewed for further details regarding complications that necessitated admission for observation or treatment.
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In the 1,128 diagnostic aortofemoral studies performed, 211 complications occurred (19%), but no major complications occurred in this group. The total hematoma and bruise rate was 9.7%. Puncture site pain was present in 7% of cases. These data are presented in more detail in Table 2. One patient died of a ruptured abdominal aortic aneurysm more than 48 hr after undergoing aortofemoral angiography. We thought it unlikely that this was the result of the angiographic study because we positioned the tip of the 4-French pigtail catheter above the aneurysm neck, thereby ameliorating any direct pressure on the aneurysm sac. Furthermore, we expected that a contrast injection–induced rupture of the aneurysm would become apparent soon after the procedure.
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Three hundred fifty-nine cerebral studies were performed with a total of 87 complications (24%), which included one cerebrovascular accident (0.3%) and six transient ischemic attacks (1.7%) (Table 3). All patients with a temporary or permanent neurologic deficit were admitted for treatment and further investigation with unenhanced CT and MRI. In two patients who had a transient ischemic attack, the cause was identified as an intimal tear of the internal carotid artery causing dissection and associated vasospasm. These events were successfully treated with IV heparin or urokinase, stenting, and papaverine infusion. Full neurologic function was restored.
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In the interventional procedures group, 146 complications occurred in 441 procedures (33%). These complications are further described in Table 4: five cases of hematoma and bleeding requiring blood transfusion (1%); one case of anaphylaxis (clinically developing angioedema and hypotension) that was satisfactorily treated; one case of an infected hematoma requiring surgical débridement and IV antibiotics for sepsis; and one case of pulmonary edema resulting from fluid overload.
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In the remaining 508 procedures, 117 complications occurred (23%). Details are shown in Table 5. No major complications occurred in this group. The rate of hematomas and bruising was 12.8%. The rate for puncture site pain after the procedure was 7.8%.
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Table 6 shows the relative frequency of complications during the two periods, March 1997–June 1999 and July 1999–March 2002, as well as the combined total complication rate. A significant (p = 0.01) improvement was seen in the total complication rate. A statistically significant improvement was also seen in the incidence of complications associated with aortofemoral studies. We noted a general trend toward improvement in complication rates for most subgroups; however, these improvements did not achieve statistical significance.
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The most prevalent complication identified in this study was hematoma and bruising. As expected, the rate of this complication was greater in the interventional procedures that used larger (5-French) catheters. Hematoma, defined as a lump at the puncture site, is reported to occur in 10–50% of diagnostic angiograms [3, 4, 6–8]. The combined hematoma and bruising complication rate identified in this study was 11.5%, which equated to a rate of 10.2% for diagnostic studies and 17% for interventional procedures and is consistent with published data. All hematomas occurring in the diagnostic angiography we performed were self-limiting and did not require further treatment. Major complications associated with hematoma were observed only in the interventional cohort of this study, at a rate of 1.6%. The next most frequent complication described in this study was puncture site pain, which occurred in 8% of all procedures (7.4% diagnostic, 11.1% interventional). Fitzgerald et al. [7] described an 18.7% incidence of groin discomfort after femoral access using 4-French catheters. Dowling et al. [9] described a puncture site discomfort rate of 9–10%, also using 4-French catheters and sheaths.
Numerous studies have defined complication rates in cerebral angiography. Transient ischemic attacks and cerebrovascular accidents are reported to occur in as many as 4% of cases. Published data for these complication rates range from 0.9% to 4%; the total incidence is 0.4–2.3% for transient ischemic attacks and 0.1–1% for cerebrovascular accident or permanent neurologic deficit [10–16]. Cloft et al. [17] showed in a meta-analysis that the risk of developing neurologic deficit was significantly greater if the indication for the test was transient ischemic attack or ischemic stroke. In our study, we defined a complication rate of 1.7% for transient ischemic attack and 0.3% for stroke, which is comparable to published data.
Our study design did not allow quantification of contrast material–associated nephrotoxicity. Patients received iodixanol dimer, a nonionic contrast material limited to 3 mL/kg per procedure. Although this contrast agent is more expensive than other monomer nonionic contrast agents, it has been identified as potentially less nephrotoxic than other types of agents such as iohexol [18]. We had one substantial allergic reaction, a case of anaphylaxis, for a rate of 0.0004%, which is comparable to reports in the literature of a 0–3.58% incidence of major adverse reactions to contrast material [4].
Finally, our study shows a significant temporal reduction in the total complication rate when data from the period March 1997–June 1999 were compared with those collected in July 1999–March 2002. This improvement was most marked in the cohort undergoing aortofemoral studies. We attribute this reduction in complications to the following factors: greater use of 4-French catheters throughout the procedure, with less reliance on switching to 5-French catheters in difficult procedures; better postprocedural care, particularly of the groin puncture sites, and more stringent monitoring by nursing staff in the immediate postprocedural time; better titration of the amount of local anesthetic used in response to patient discomfort; and technology enhancements available from industry—in particular, improved catheter and stent technology, such as catheters with improved torquability and stents with lower delivery profiles and improved ability to maneuver catheters and stents around tortuous vessels.
Current activities for outpatient angiography and interventional procedures have shown a low incidence of major complications, falling well within recommended safe practice guidelines. A significant reduction was seen in the overall rate of complications during the study period (p = 0.01) as a result of ongoing improvements in patient care and technology developments.
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