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Percutaneous Imaging-Guided Solid Organ Core Needle Biopsy: Coaxial Versus Noncoaxial Method

¹ All authors: Milwaukee Radiologists, Ltd., affiliated with Aurora St. Luke's Medical Center, Milwaukee, WI, and Department of Radiology, St. Mary's Medical Center, Wheaton Franciscan Healthcare Racine, 3801 Spring St., Racine, WI 53405.

Received June 5, 2007; accepted after revision August 7, 2007.

 
Address correspondence to M. K. Hatfield (Hatfield{at}pol.net).

Abstract

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OBJECTIVE. The purpose of our study was to compare the diagnostic yield and complication rate of coaxial technique with those of noncoaxial technique in percutaneous imaging-guided renal and hepatic core biopsies. We also compared bleeding complication rates with and without absorbable gelatin sponge occlusion of the biopsy track.

MATERIALS AND METHODS. The records of 1,060 consecutively registered patients who underwent percutaneous imaging-guided hepatic or renal biopsy at two hospitals were retrospectively reviewed. Core specimens were obtained in all biopsies. Indications for biopsy included acquisition of general tissue specimens to evaluate for hepatic (n = 495) or renal disease (n = 243) and acquisition of specimens of specific hepatic (n = 289) and renal (n = 33) lesions. Samples were acquired with a coaxial set of needles (n = 764) or with a noncoaxial needle (n = 296 patients). Absorbable gelatin sponge was injected before removal of the outer needle in 269 of the 764 coaxial biopsies. Gelatin sponge was not injected in the other 495 coaxial biopsies. Complication rates were evaluated in a comparison of the two methods and of the coaxial biopsies with and without postprocedural injection of gelatin sponge. Complications were considered minor if follow-up imaging in the 7 days after the procedure showed a complication that did not necessitate treatment other than conservative pain management. Complications were considered major if treatment such as blood product transfusion or surgery was needed or if the patient died.

RESULTS. Specimens were immediately given to a pathologist, who typically was present during the procedure. Specimens were evaluated and judged adequate for a specific diagnosis by the histopathology staff. The rates of minor complications were 3.4% (10/296) for the noncoaxial method and 2.6% (20/764) for the coaxial method. The rates of major complications were 1.0% (3/296) for the noncoaxial method and 0.9% (7/764) for the coaxial method. Six cases of major complications necessitating blood product transfusion were documented for the coaxial method and one case for the noncoaxial method. One (0.1%) of the patients undergoing coaxial biopsy died. One patient undergoing noncoaxial biopsy needed surgical repair of an arterial injury that was refractory to blood transfusion, and another developed pancreatitis and needed a blood transfusion. The percentage of minor complications of the coaxial method with absorbable gelatin sponge injection was 3.7% (10/269), and that of major complications was 0.7% (2/269). There was no statistical difference in complication rates between the various methods of percutaneous hepatic and renal biopsy.

CONCLUSION. In regard to complications, there are no differences between coaxial and noncoaxial biopsy methods or between the coaxial method with or without injection of absorbable gelatin sponge.

Keywords: coaxial biopsy • complication rate • hepatic biopsy • noncoaxial biopsy • renal biopsy

Introduction

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Percutaneous imaging-guided biopsy is a common procedure. Sonography- or CT-guided percutaneous biopsy is regarded as an effective, safe, and high-yield method for tissue diagnosis of hepatic and renal abnormalities. Several reports [1–14], however, have revealed that such procedures are associated with a mortality of 0.006–0.031% and that 0.05–0.18% of patients who undergo the procedure experience complications such as hematoma, hemoperitoneum, hepatic arterial pseudoaneurysm, bile peritonitis, pneumothorax, local infection, and, rarely, anaphylactic shock. Another report [15] describes biopsy-related complications in as many as 13% of patients, the rate of minor complications being 6.6%; the rate of major complications, 6.4%; and the mortality, 0.1%. In none of the studies cited was coaxial needle technique compared with noncoaxial technique, nor was the efficacy of injection of absorbable gelatin sponge evaluated. The purpose of our study was to compare the complication rates of coaxial and noncoaxial techniques and the usefulness of injection of absorbable gelatin sponge for renal and hepatic biopsies.

Materials and Methods

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Subjects
The records were reviewed of all patients who underwent imaging-guided percutaneous renal or hepatic biopsy at two institutions over 39 consecutive months, July 2003–September 2006. Institutional review board approval was not required for this retrospective review of quality assessment data. The clinical indication for biopsy was evaluation of a specific lesion or general tissue diagnosis. A total of 784 hepatic biopsies and 276 renal biopsies were reviewed. More than 85% of the specimens were acquired by fellowship-trained vascular and interventional radiologists. An additional 10% of the specimens were acquired by a senior radiologist with more than 20 years of extensive interventional experience. In some cases, radiology residents performed the biopsy, but they were immediately supervised. Seven renal biopsies were performed by referring nephrologists. All biopsy specimens were core specimens. For general tissue samples acquired from the liver, two or three core specimens deemed adequate by the interventional radiologist were sent to the pathology laboratory in formalin. Lesion-specific hepatic and renal and general renal core samples were given directly to a histopathologist for evaluation. Core samples were acquired until the histopathologist was satisfied that enough specimen had been acquired for diagnosis. The total number of punctures was not always documented. No difference in specimen adequacy was noted. Midazolam hydrochloride (Versed, Ben Venue) and fentanyl citrate (Sublimaze, Akron) were administered routinely for IV conscious sedation.

Biopsy Procedure
Before the procedure, patients were screened with a blood coagulation testing system (ProTime, ITC), international normalized ratio, and platelet count. Biopsy was performed if the blood coagulation result was 16 seconds or less or the international normalized ratio was 1.5 or less and the platelet count was greater than 50,000/µL. If necessary, a transjugular approach was used for hepatic biopsy, and platelets or fresh frozen plasma were administered during the procedure. For patients with ascites before hepatic biopsy, a transjugular approach was used or paracentesis was performed before percutaneous hepatic biopsy. This decision was left to the discretion of the referring physician and the radiologist. The general indication for transvenous biopsy was coagulopathy or massive ascites. The transvenous biopsies were eliminated from review. Eleven patients with mild ascites underwent percutaneous biopsy, and 10 patients with moderate ascites underwent paracentesis before percutaneous biopsy. None of these patients experienced complications.

In most cases, percutaneous biopsy was performed under the guidance of real-time sonography with freehand technique or with a probe-specific biopsy guide. CT guidance also was used, though to a lesser extent. Guidance technique was left to the discretion of the radiologist performing the procedure. Coaxial specimens were acquired with either a Cook (Bloomington) or Uresil SBN spring-loaded biopsy needle (Skokie) coaxial set using a 17- or 19-gauge outer needle and an 18- or 20-gauge coaxial spring-loaded mechanism. Noncoaxial specimens were obtained with either an 18-gauge Biopince VSL biopsy gun, needle length 150 cm (Stenlose), or with a Uresil spring-loaded 20-gauge needle. In 95% of the biopsies, an 18-gauge core needle was used for noncoaxial procedures and a 17/18-gauge set for coaxial procedures. The other 5% of biopsies were performed with a 20-gauge noncoaxial core needle or a 19/20-gauge coaxial set. The 20-gauge needles were used predominantly by the small number of inexperienced radiologists and nephrologists who performed the procedure. In addition, a 20-gauge needle was used when ascites was present. During coaxial biopsies, at the preference of the physician performing the procedure, pledgets of absorbable gelatin hemostatic sponge (Gelfoam, Pfizer) were placed into the biopsy track through the outer cannula.

Follow-Up
All outpatients were monitored in the radiology department 2–5 hours after the procedure and discharged to home when discharge criteria were met. All patients were accompanied home by a reliable person the first night after the procedure. Patients were admitted overnight only if they experienced complications related to the procedure, if they were noncompliant, or if they did not have a reliable person to stay with them the first night after the procedure. Inpatients were sent to their rooms after initial postprocedural monitoring criteria were met. All patients were given a telephone number to call if they believed they had problems related to the procedure. Patients were typically called several days after the procedure for follow-up. Information collected at the time of biopsy included age, sex, race, systolic and diastolic blood pressure, prothrombin time, activated partial thromboplastin time, and hemoglobin concentration.

A computer-based search of all medical records and radiology reports was conducted. All records for patients undergoing additional imaging of the abdomen or chest during the 7 days after biopsy were reviewed. In addition, the records of patients who were admitted to the hospital or who visited the emergency department during the 7 days after biopsy were reviewed. The timing of a complication was defined by the first indication (gross hematuria, severe flank pain, hypotension, decrease in hemoglobin concentration necessitating transfusion) that a clinically relevant problem existed. The severity of the complication was categorized as minor or major. Complications were classified in accordance with guidelines published by the Society of Interventional Radiology [16]. Minor renal complications were defined as those resulting in gross hematuria or perinephric hematoma but that spontaneously resolved without further intervention. Minor hepatic complications were defined as additional pain, change in vital signs, or both, necessitating additional imaging but spontaneously resolving without additional intervention other than IV fluids and pain medication. Major complications were those necessitating intervention such as transfusion of blood products or an invasive radiographic or surgical procedure and those resulting in acute renal obstruction or failure, septicemia, pancreatitis, or death.

Statistical Analysis
Chi-square analysis was performed to compare the complication rates of the coaxial and noncoaxial techniques and to compare the complication rates of the coaxial procedures with track occlusion and those without track occlusion with absorbable gelatin sponge.

Results

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The reports of 1,060 biopsies were reviewed. Coaxial technique was used in 764 biopsies, 495 without and 269 with absorbable gelatin sponge occlusion of the biopsy track. Noncoaxial technique was used in 296 biopsies. Forty of the 1,060 patients had complications: 30 had minor complications, and 10 had major complications (Table 1). A total of 276 renal biopsies were performed, and the major complication rate was 1.4% (4/276). All four patients underwent blood transfusion. The minor complication rate for renal biopsy was 4% (11/276).

The major complication rate for hepatic biopsy was 0.8% (6/784), and the minor complication rate was 2.4% (19/784). One patient died, and the death was attributed to coaxial hepatic biopsy with a 17/18-gauge needle set. This patient underwent angiography, but the radiologist was unable to localize the bleeding and embolize the artery. The patient died during emergency surgery. One patient who underwent 18-gauge noncoaxial biopsy had arterial bleeding refractory to blood transfusion, and the artery was repaired surgically. The patient recovered uneventfully. One patient who underwent noncoaxial hepatic biopsy presented with hemobilia that necessitated transfusion, and pancreatitis subsequently developed. This patient also recovered uneventfully. Three hepatic biopsy patients underwent blood transfusion, accounting for the other major complications. None of the patients with major complications had underlying coagulopathy.

Minor complications occurred in 3.8% (10/269) of coaxial biopsies performed with absorbable gelatin sponge occlusion. Minor complications occurred in 2.0% (10/495) of coaxial biopsies without gelatin occlusion. There was no statistical difference between the groups (p < 0.1606). The major complication rate was 0.7% (2/269) for biopsies with gelatin occlusion and 1.0% (3/269) for biopsies without gelatin occlusion. There were no statistical differences in major complication rates with and without gelatin occlusion of the biopsy track (p < 1.0). The total complication rates were 4.4% (12/269) for the procedures performed with absorbable gelatin sponge and 3.0% (15/495) for the procedures performed without absorbable gelatin sponge. Again, there was no statistical difference between the groups (p < 0.3063).

Minor complications occurred in 2.6% (20/764) of biopsies performed with coaxial technique and 3.3% (10/296) of biopsies performed with noncoaxial technique. There was no statistical difference between the groups (p < 0.55). Major complications occurred in 0.9% (7/764) of biopsies performed with coaxial technique and 1.0% (3/296) of biopsies performed with noncoaxial technique. There was no statistical difference between the groups (p < 1.5). The total complication rates were 3.5% (27/764) for coaxial technique and 4.4% (13/296) for noncoaxial technique. No statistical difference was found (p < 0.51).

Minor complications occurred in 2.0% (10/495) of coaxial biopsies performed without absorbable gelatin sponge compared with 3.3% (10/296) of noncoaxial biopsies. There was no statistical difference (p < 0.2390). Major complications occurred in 1.0% (5/495) of coaxial biopsies performed without absorbable gelatin and in 1.0% (3/296) of noncoaxial biopsies. There was no statistical difference (p < 1.0). The total complication rate for coaxial biopsy without absorbable gelatin was 3.0% (15/495) and for noncoaxial biopsy was 4.4% (13/296). There was no statistical difference (p < 0.3159) between the total complication rates of the two techniques.

Minor complications occurred in 3.7% (10/269) of coaxial biopsies performed with absorbable gelatin sponge occlusion and in 3.4% (10/296) of noncoaxial biopsies. There was no statistical difference (p < 0.8275) between the minor complication rates of these two groups. Major complications occurred in 0.7% (2/269) of coaxial biopsies performed with absorbable gelatin sponge occlusion and in 1.0% (3/296) of noncoaxial biopsies. There was no statistical difference (p < 1.0). The total complication rates were 4.5% (12/269) for coaxial biopsy performed with gelatin occlusion and 4.4% (13/296) for noncoaxial biopsy. There was no statistical difference (p < 0.9682) in total complication rates of these two techniques.

The age, sex, blood pressure, or coagulation results before biopsy of patients with complications were not significantly different from those of patients without complications. The final histologic finding was not predictive of a complication. Among the 48 biopsies performed by clinicians who were not radiologists and by relatively inexperienced radiologists, there was one (2%) case of a minor complication and one (2%) case of a major complication. Most of the hepatic biopsies were performed through a subcostal approach. A midaxillary intercostal approach was used approximately 22% of the time. A total of 21 chest radiographs were empirically requested because of concern about pneumothorax. None of findings on these chest radiographs was abnormal, and there were no cases of pneumothorax related to the biopsy procedure. Screening for platelet aggregate inhibitors was not performed, and percutaneous biopsy was performed despite concurrent therapy. None of the 10 patients with major complications was undergoing concurrent aspirin, clopidogrel, or ticlopidine therapy.

Discussion

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We found percutaneous biopsy of the liver and kidneys safe with minimal risk of serious complication. During the course of 3 years, only two (0.2%) of the biopsies led to invasive procedures. Both patients needed emergency surgery for repair of a presumed hepatic arterial injury. One (0.1%) of these patients died. Although percutaneous biopsy was found safe, complications occurred in 3.8% of the procedures, and 0.9% of the cases of complications were considered major, primarily because of the need for blood transfusion after biopsy. Major complications were apparent in nine of 10 patients within 4 hours of the procedure. Each of these patients was admitted for observation or was already an inpatient. One patient who eventually needed a transfusion was discharged to home and returned to the emergency department that night. Four (13%) of the 30 patients with minor complications were discharged and returned to the emergency department later that evening. No patients were sent home without a reliable companion who would spend the night with the patient. Patients without a reliable companion were admitted for overnight empiric observation.

Percutaneous solid organ biopsy is safe and free of complications in most cases. On average, clinically significant complications of renal biopsies occur in 7.4% of biopsies, but complication rates as high as 19.5% have been reported [17]. Most complications are minor and resolve spontaneously; however, major complications have occurred in as many as 7.3% of biopsies [17]. Predisposing factors to complications of renal biopsy include renal insufficiency (creatinine concentration > 1.2 mg/dL) and poorly controlled hypertension (diastolic blood pressure > 110 mm Hg) [18, 19]. Despite understanding of predisposing risk factors, there is no definitive way to predict which patients will have a serious complication.

Although it has been shown that complication rates have improved with the use of automated needles, it has been suggested that postbiopsy complications may be even less frequent with the use of smaller-gauge needles (16- or 18-gauge compared with 14-gauge) [17]. Studies that have addressed this issue in native renal biopsies have been flawed because complications in patients who underwent biopsy with smaller-gauge automated needles were compared with complications in patients who underwent biopsy with larger-gauge manual needles. Thus the results may reflect the effect of biopsy technique rather than needle size [20–22].

Although serious complications are infrequent, the potential for these complication after solid organ biopsy does exist. Although clinically significant hematoma occurs in 6% or fewer of biopsies, perinephric hematoma has been found 24–72 hours after biopsy in more than 90% of cases evaluated prospectively [17, 23]. Most hematomas are asymptomatic and small, but in as many as 50% of biopsies, they are moderate to large [24, 25]. Some authors [17, 23] recommend 24-hour inpatient monitoring. We consider this practice unnecessary unless the patient is noncompliant, demented, or in a social setting that would not allow feedback if the patient believed complications had developed that were related to the procedure. Most of our patients were compliant, lived with relatives, and were able to return on the postbiopsy night in case of emergency. Other authors [26, 27] agree that solid organ biopsy can be performed as an outpatient procedure. Unfortunately, there are no reliable measures with which to predict which patients will have clinically significant hematoma. Radiographic evaluation immediately after biopsy detects fewer than 15% of hematomas [20, 26].

Further review of the literature shows that for 484 percutaneous hepatic biopsies performed, the total complication rate was 6.4%; 4.5% of the cases of were due to major bleeding, and the death rate was 1.6% [28]. A 1-g/dL or greater decrease in hemoglobin concentration after percutaneous biopsy is common and has been reported to occur in almost 50% of renal biopsies [29]. Although some authors [28, 29] believe it is due to hemorrhage, in most cases this effect is associated with an uneventful course. The cause of the change in hemoglobin concentration is likely the development of small subclinical hematomas, hemodilution as a result of routine infusion of saline solution after biopsy, or postural hemodilution [30] resulting from resorption of interstitial fluid in severely edematous patients after prolonged bedrest after a biopsy. One author [29] found overall poor correlation between percentage change in postbiopsy hemoglobin concentration 6 hours after biopsy and hemoglobin level 24 hours after biopsy. This finding was particularly common among patients with the largest change in hemoglobin concentration (> 10%) at 24 hours. An initial decrease in hemoglobin concentration after renal biopsy must raise suspicion of a possible complication, but it is not a reliable predictor of outcome.

In our department, recovering patients are supervised by staff nurses. The cost saving at our institution for discharging a patient after a 3- to 4-hour stay compared with an overnight 23-hour admission was significant. Unfortunately, no reliable measure is absolutely predictive of which patients will have a complication. Neither assessment with sonography or CT after biopsy nor initial change in hematocrit after biopsy is reliable for differentiation of patients at risk of a serious complication from patients who can safely be discharged to home soon after the procedure [17]. Patients who have comorbid conditions typically need hospital admission for other reasons.

The advantage of use of a noncoaxial needle is that the needle is in the patient for only the few seconds required to document needle position with either sonography or CT and then to fire the spring mechanism. In addition, samples can be obtained in other areas. The disadvantage is that the portions of the organ not sampled and the organ capsule are punctured several times if additional samples are needed. The advantages of the coaxial system are that the interventionalist needs to puncture the capsule only once with the outer needle and then can acquire as many samples as needed. This method saves time if additional samples are needed. If desired, the operator can easily embolize the needle track with absorbable gelatin sponge while removing the outer needle. The major disadvantage is that a larger outer needle is needed. The puncture site therefore is larger than the needle used to obtain the core specimen. In addition, the outer coaxial needle is typically left in place while the histopathologist stains the initial sample. This practice can lead to further laceration of the hepatic or renal capsule. One limitation of our study was that the total number of passes was not always documented. However, one pass usually was made for the coaxial sampling and three or four passes were made for noncoaxial sampling.

In our series, bleeding led to all of the complications. None of the patients had complications from infection or from traversal of other organs, such as the lung. Bleeding complications typically arise from inadvertent puncture of branches of the arterial supply to the organ. These branches are larger in the central part of the organ. The two surgical complications were due to arterial bleeding arising near the falciform ligament. Operator experience appeared to be associated with a lower complication rate. The rate of major complications for the relatively inexperienced operators was twice that for experienced operators (2% vs 0.9%), and the rates of minor complications were similar (2% vs 2.9%).

The major limitation of our study was its retrospective nature based on database review. This limitation might have influenced the capture rate for finding complications in patients not reached for telephone interviews the week after biopsy. In addition, patients with complications might have sought treatment at an institution outside the health systems included in the practice of our radiology group. The database review would have missed those complications. Patients presenting with complications at another hospital or clinic within the health care systems would be captured in the systemwide information network.

Percutaneous imaging-guided hepatic and renal biopsies are safe and effective for obtaining histopathologic core specimens. Coaxial versus noncoaxial technique does not appear to influence the rate of bleeding complications. Obstructing the biopsy path with absorbable gelatin sponge before removing the outer cannula in coaxial techniques is not an advantage in reducing bleeding complications.

Acknowledgments
 
We thank Madonna Bahr, Jessica Foster, and Lexi Antonchorgy.

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Hatfield, M. K. Articles by Zaleski, G. X. Search for Related Content PubMed PubMed Citation Articles by Hatfield, M. K. Articles by Zaleski, G. X. Social Bookmarking                      What's this? Hotlight (NEW!) What's Hotlight?