Incidence of Bleeding in 8172 Percutaneous Ultrasound-Guided Intraabdominal Diagnostic and Therapeutic Interventions – Results of the Prospective Multicenter DEGUM Interventional Ultrasound Study (PIUS Study)

Abstract

Purpose: To analyse the incidence of bleeding after percutaneous ultrasound guided diagnostic and therapeutic intraabdominal interventions in a prospective multicentre study (DEGUM percutaneous interventional ultrasound study).

Materials and Methods: Within a time period of 2 years diagnostic and therapeutic intraabdominal interventions (with the exclusion of ascites paracentesis) performed percutaneously under continuous ultrasound (US) guidance were prospectively assessed using a pseudonymized standardized web site entry form. Number and type of intervention, operator experience, patient characteristics, medication, lab data as well as technical aspects of the procedure and bleeding complications were analysed according to the interventional radiology standards.

Results: 8172 US-guided intraabdominal interventions (liver n = 5903; pancreas n = 501, kidney n = 434, lymph node = 272, biliary system n = 153, spleen n = 63, other abdominal organs and extra-organic targets n = 999) were analysed in 30 hospitals. The majority were diagnostic biopsies including 1780 liver parenchyma, 3400 focal liver lesions and 404 pancreatic lesions. 7525 interventions (92.1 %) were performed in hospitalized patients (mean age 62.6 years). Most operators were highly experienced in US-guided interventions (> 500 interventions prior to the study n = 5729; 70.1 %). Sedation was administered in 1131 patients (13.8 %). Needle diameter was ≥ 1 mm in 7162 punctures (87.9 %) with main focus on core needle biopsies (18 G, n = 4185). Clinically relevant bleeding complications with need of transfusion (0.4 %), surgical bleeding control (0.1 %) and radiological coiling (0.05 %) were very rare. Bleeding complications with fatal outcome occurred in four patients (0.05 %). The frequency of major bleeding complications was significantly higher in patients with an INR > 1.5 (p < 0.001) and patients taking a medication potentially interfering with platelet function or plasmatic coagulation (p < 0.0333).

Conclusion: This prospective multicentre study confirms the broad spectrum of percutaneous US-guided intraabdominal interventions. However diagnostic liver biopsies dominate with the use of core needle biopsies (18 G). Percutaneous US-guided interventions performed by experienced sonographers are associated with a low bleeding risk. Major bleeding complications are very rare. A pre-interventional INR < 1.5 and individual medication risk assessment are recommended.

Zusammenfassung

Ziel: Blutungskomplikationen sonografisch gesteuerter diagnostischer und therapeutischer intraabdomineller Punktionen sollten prospektiv multizentrisch untersucht werden.

Material und Methoden: Innerhalb von 2 Jahren wurden alle Punktionen (mit Ausnahme von Aszitespunktionen), die unter kontinuierlicher Ultraschallsicht perkutan erfolgten, mittels pseudonymisierter webbasierter Eingabemasken erfasst: Anzahl und Art der Interventionen, Untersuchererfahrung, Patientencharakteristika, Medikation, Laborbefunde und Blutungskomplikationen.

Ergebnisse: 8172 Punktionen wurden in 30 Krankenhäusern erfasst (Leber n = 5903; Pankreas n = 501, Nieren n = 434, Lymphknoten = 272, Biliäres System n = 153, Milz n = 63, andere abdominelle Organe and extraorganische Ziele n = 999). Die Mehrzahl der Punktionen waren diagnostische Biopsien (Leberparenchym n = 1780, fokale Leberläsionen n = 3400, Pankreasraumforderungen n = 404). 7525 Interventionen (92,1 %) erfolgten bei stationären Patienten (mittleres Alter 62,56 Jahre) durch erfahrene Untersucher (> 500 Punktionen vor Studienbeginn n = 5729; 70,1 %). 1131 Patienten (13,8 %) erhielten eine Sedierung. 7162 Interventionen (87,9 %) erfolgten mit Nadeln ≥ 1 mm Durchmesser mit dem Schwerpunkt auf 18-Gauge-Nadeln (n = 4185), 989 Punktionen (12,1 %) erfolgten mit Feinnadeln (< 1 mm). Schwere Blutungen waren selten: transfusionsbedürftige Blutungen (0,4 %), operative (0,1 %) und radiologische (0,06 %) Blutstillung, Blutungen mit Todesfolge (0,05 %). Schwere Blutungskomplikationen traten signifikant häufiger bei einer INR > 1,5 auf (p < 0,001) und bei einer Begleitmedikation mit Beeinträchtigung der Thrombozytenaggregration oder der plasmatischen Gerinnung (p < 0,0333).

Schlussfolgerungen: Das Spektrum ultraschallgesteuerter intraabdomineller Punktionen ist breit. Diagnostische Leberbiopsien sind die häufigsten durchgeführten intraabdominellen Punktionen und werden überwiegend mit 18-G-Nadeln durchgeführt. Schwerwiegende Blutungskomplikationen sind bei erfahrenen Untersuchern sehr selten. Die INR sollte präinterventionell < 1,5 sein. Eine Risikobeurteilung des individuellen Blutungsrisikos und der Begleitmedikation des Patienten sollte vor intraabdominellen Punktionen erfolgen.

Key words

abdomen - biopsy - interventional procedures - percutaneous - ultrasound

• References

• 1 Berlyne GM. Ultrasonics in renal biopsy: an aid to determination of kidney position. Lancet 1961 ; 2: 750-751
• 2 Goldberg BB, Pollack HM. Ultrasonic aspiration transducer. Radiology 1972 ; 102: 187-189
• 3 Rasmussen SN, Holm HH, Kristensen JK et al. Ultrasonically-guided liver biopsy. Br Med J 1972; 2: 500-502
• 4 Hancke S, Holm HH, Koch F. Ultrasonically guided percutaneous fine needle biopsy of the pancreas. Surg Gynecol Obstet 1975; 140: 361-364
• 5 Smith EH, Bartrum Jr RJ, Chang YC et al. Percutaneous aspiration biopsy of the pancreas under ultrasonic guidance. N Engl J Med 1975; 292: 825-828
• 6 Holm HH. Interventional ultrasound in Europe. Ultrasound Med Biol 1998; 24: 779-791
• 7 Nolsøe CP, Lorentzen T, Skjoldbye BO et al. The basics of interventional ultrasound. Ultraschall in Med 2007; 28: 248-263
• 8 Sheafor DH, Paulson EK, Simmons CM et al. Abdominal percutaneous interventional procedures: comparison of CT and US guidance. Radiology 1998; 207: 705-710
• 9 Weiss H, Düntsch U. Complications of fine needle puncture. DEGUM survey II. Ultraschall in Med 1996; 17: 118-130
• 10 Weiss H, Düntsch U, Weiss A. Complications of fine needle puncture. DEGUM survey I. Ultraschall in Med 1988; 9: 121-127
• 11 Longerich T, Schirmacher P. Recent developments in biopsy diagnosis of early and undefined liver tumors. Z Gastroenterol 2009; 47: 30-36
• 12 Schirmacher P, Fleig WE, Tannapfel A et al. German Society for Digestive and Metabolic Diseases. [Bioptic diagnosis of chronic hepatitis. Results of an evidence-based consensus conference of the German Society of Pathology, of the German Society for Digestive and Metabolic Diseases and of Compensated Hepatitis (HepNet)]. Pathologe 2004; 25: 337-348
• 13 Howlett DC, Drinkwater KJ, Lawrence D et al. Findings of the UK national audit evaluating image-guided or image-assisted liver biopsy. Part I. Procedural aspects, diagnostic adequacy, and accuracy. Radiology 2012; 265: 819-831
• 14 Terjung B, Lemnitzer I, Dumoulin FL et al. Bleeding Complications after Percutaneous Liver Biopsy. Digestion 2003; 67: 138-145
• 15 Padia SA, Baker ME, Schaeffer CJ et al. Safety and efficacy of sonographic-guided random real-time core needle biopsy of the liver. J Clin Ultrasound 2009; 37: 138-143
• 16 Frieser M, Lindner A, Meyer S et al. Spectrum and bleeding complications of sonographically guided interventions of the liver and pancreas. Ultraschall in Med 2009; 30: 168-174
• 17 Atwell TD, Smith RL, Hesley GK et al. Incidence of bleeding after 15181 percutaneous biopsies and the role of aspirin. Am J Roentgenol Am J Roentgenol 2010; 194: 784-789
• 18 Mueller M, Kratzer W, Oetztuerk S et al. Percutaneos ultrasonographically guided liver punctures: an analysis of 1961 patients over a period of ten years. BMC Gastroenterology 2012; 12: 173
• 19 Howlett DC, Drinkwater KJ, Lawrence D et al. Findings of the UK national audit evaluating image-guided or image-assisted liver biopsy. Part II. Minor and major complications and procedure-related mortality. Radiology 2013; 266: 226-235
• 20 van der Poorten D, Kwok A, Lam T et al. Twenty-year audit of percutaneous liver biopsy in a major Australian teaching hospital. Intern Med J 2006; 36: 692-699
• 21 Cadranel JF, Rufat P, Degos F. Practices of liver biopsy in France: results of a prospective nationwide survey. For the Group of Epidemiology of the French Association for the Study of the Liver (AFEF). Hepatology 2000; 32: 477-481
• 22 Sagnelli E, Sagnelli C, Pisaturo MA et al. SIMIT group. Liver biopsy in chronic hepatitis C: the experience of 15 Italian wards of infectious diseases. Infez Med 2012; 20: 31-36
• 23 Lindor KD, Bru C, Jorgensen RA et al. The role of ultrasonography and automatic-needle biopsy in outpatient percutaneous liver biopsy. Hepatology 1996; 23: 1079-1083
• 24 Seeff LB, Everson GT, Morgan TR. HALT–C Trial Group et al. Complication rate of percutaneous liver biopsies among persons with advanced chronic liver disease in the HALT-C trial. Clin Gastroenterol Hepatol 2010; 8: 877-883
• 25 de Man RA, van Buuren HR, Hop WC. A randomised study on the efficacy and safety of an automated Tru-Cut needle for percutaneous liver biopsy. Neth J Med 2004; 62: 441-445
• 26 Buscarini E. Review of Interventional Ultrasound in the Abdomen. Ultraschall in Med 2004; 25: 8-11
• 27 Livraghi T, Damascelli B, Lombardi C et al. Risk in fine-needle abdominal biopsy. J Clin Ultrasound 1983; 11: 77-81
• 28 Smith EH. The hazards of fine-needle aspiration biopsy. Ultrasound Med Biol 1984; 10: 629-634
• 29 Gebel M, Horstkotte H, Köster C et al. Ultrasound-guided fine needle puncture of the abdominal organs: indications, results, risks. Ultraschall in Med 1986; 7: 198-202
• 30 Fornari F, Civardi G, Cavanna L et al. Complica tions of ultrasonically guided fine-needle abdominal biopsy: results of a multicenter Italian study and review of the literature. The Cooperative Italian Study Group. Scand J Gastroenterol 1989; 24: 949-955
• 31 Nolsøe C, Nielsen L, Torp-Pedersen S et al. Major complications and deaths due to interventional ultrasonography: a review of 8000 cases. J Clin Ultrasound 1990; 18: 179-184
• 32 Chevallier P, Ruitort F, Denys A et al. Influence of operator experience on performance of ultrasound-guided percutaneous liver biopsy. Eur Radiol 2004; 14: 2086-2091
• 33 Gupta S, Wallace MJ, Cardella JF et al. Society of Interventional Radiology Standards of Practice Committee. Quality improvement guidelines for percutaneous needle biopsy. J Vasc Interv Radiol 2010; 21: 969-975
• 34 Gottschalk U, Ignee A, Dietrich CF. [Ultrasound-guided interventions and description of the equipment]. Z Gastroenterol 2010; 48: 1305-1316
• 35 Smith EH. Complications of percutaneous abdominal fine-needle biopsy. Review. Radiology 1991; 178: 253-258
• 36 Swobodnik W, Janowitz P, Kratzer W et al. Comparison of ultrasound-controlled fine needle and coarse needle puncture of defined lesions in the abdomen. Ultraschall in Med 1990; 11: 287-289
• 37 Binder T, Swobodnik W, Wechsler JG et al. [Ultrasound guided fine- and coarse-needle puncture of the abdominal and retroperitoneal space]. Dtsch Med Wochenschr 1987; 113: 43-48
• 38 Nyman RS, Cappelen-Smith J, Brismar J et al. Yield and complications in ultrasound-guided biopsy of abdominal lesions. Comparison of fine-needle aspiration biopsy and 1.2-mm needle core biopsy using an automated biopsy gun. Acta Radiol 1995; 36: 485-490
• 39 Gazelle GS, Haaga JR, Rowland DY. Effect of needle gauge, level of anticoagulation, and target organ on bleeding associated with aspiration biopsy. Work in progress. Radiology 1992; 183: 509-513
• 40 McGill DB, Rakela J, Zinsmeister AR et al. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology 1990; 99: 1396-1400
• 41 McVay PA, Toy PT. Lack of increased bleeding after liver biopsy in patients with mild hemostatic abnormalities. Am J Clin Pathol. Dec 1990; 94: 747-775
• 42 Patel IJ, Davidson JC, Nikolic B et al. Consensus guidelines for periprocedural management of coagulation status and hemostasis risk in percutaneous image-guided interventions. J Vasc Interv Radiol 2012; 23: 727-736
• 43 Patel IJ, Davidson JC, Nikolic B et al. Addendum of newer anticoagulants to the SIR consensus guideline. J Vasc Interv Radiol 2013; 24: 641-645