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

D. Strobel; T. Bernatik; W. Blank; U. Will; A. Reichel; M. Wüstner; V. Keim; D. Schacherer; A. P. Barreiros; G. Kunze; D. Nürnberg; A. Ignee; E. Burmester; A. A. Bunk; M. Friedrich-Rust; E. Froehlich; A. Schuler; C. Jenssen; W. Bohle; M. Mauch; K. Dirks; J. Kaemmer; C. Pachmann; J. Stock; M. Hocke; A. Kendel; C. Schmidt; C. Jakobeit; H. Kinkel; W. Heinz; G. Hübner; M. Pichler; T. Müller

doi:10.1055/s-0034-1399282

Ultraschall in der Medizin - European Journal of Ultrasound, Table of Contents

Ultraschall Med 2015; 36(02): 122-131
DOI: 10.1055/s-0034-1399282

Original Article

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

Blutungskomplikationen bei 8172 sonografisch gesteuerten diagnostischen und therapeutischen intraabdominellen Punktionen – Ergebnisse der prospektiven DEGUM Interventionsstudie (PIUS-Studie)

Authors

D. Strobel

¹Internal Medicine 1, University Hospital Erlangen, Germany
T. Bernatik

²Department of Internal Medicine, District Hospital Ebersberg, Germany
W. Blank

³Department of Internal Medicine 1, Municipal Hospital Steinenberg, Reutlingen, Germany
U. Will

⁴Department of Gastroenterology, Municipal Hospital (Waldklinikum Gera gGmbH), Gera, Germany
A. Reichel

⁴Department of Gastroenterology, Municipal Hospital (Waldklinikum Gera gGmbH), Gera, Germany
M. Wüstner

⁵Central Interdisciplinary Ultrasound, Municipal Hospital Trier (Barmherzige Brüder), Trier, Germany
V. Keim

⁶Department of Gastroenterology, Central Ultrasound Unit, University Hospital Leipzig, Germany
D. Schacherer

⁷Department of Internal Medicine 1, University Hospital Regensburg, Germany
A. P. Barreiros

⁸Department of Internal Medicine 1, University Hospital Mainz, Germany
G. Kunze

⁹Department of Internal Medicine 1, Municipal Hospital (Schwarzwald-Baar), Villingen-Schwenningen, Germany
D. Nürnberg

¹⁰Department of Internal Medicine B, Gastroenterology, District Hospital (Ruppiner Kliniken), Neuruppin, Germany
A. Ignee

¹¹Department of Internal Medicine 2, Municipal Hospital (Caritas), Bad Mergentheim, Germany
E. Burmester

¹²Department of Internal Medicine/Gastroenterology, Municipal Hospital (Sana Kliniken Lübeck GmbH), Lübeck, Germany
A. A. Bunk

¹³Surgery, University Hospital Dresden, Germany
M. Friedrich-Rust

¹⁴Department of Internal Medicine 1, University Hospital Frankfurt, Germany
E. Froehlich

¹⁵Department of Internal Medicine 1, Municipal Hospital (Karl-Olga-Krankenhaus), Stuttgart, Germany
A. Schuler

¹⁶Department of Internal Medicine, District Hospital Helfenstein, Geislingen, Germany
C. Jenssen

¹⁷Department of Internal Medicine, District Hospital (Krankenhaus Märkisch Oderland GmbH), Wriezen, Germany
W. Bohle

¹⁸Department of Medicine and Gastroenterology, Municipal Hospital (Katharinen), Stuttgart, Germany
M. Mauch

¹⁹Innere Medicine, District Hospital (SRH Kliniken Sigmaringen), Sigmaringen, Germany
K. Dirks

²⁰Department of Interal Medicine and Gastroenterology, District Hospital Rems-Murr, Winnenden, Germany
J. Kaemmer

²¹Depatment of Internal Medicine, Hospital St Hedwig, Berlin, Germany
C. Pachmann

²²Department of Internal Medicine, Israeli Hospital, Hamburg, Germany
J. Stock

²³Gastroenterology, Hospital Vivantes Humboldt, Berlin, Germany
M. Hocke

²⁴Department of Medicine 2 and Gastroenterology, District Hospital Helios Meiningen, Germany
A. Kendel

²⁵Department of Internal Medicine, District Hospital Gummersbach, Germany
C. Schmidt

²⁶Department of Internal Medicine, Hospital Albertinen, Hamburg, Germany
C. Jakobeit

²⁷Gastroenterology, St. Josefs Hospital (Helios), Bochum, Germany
H. Kinkel

²⁸Department of Internal Medicine 2, Municipal Hosital Düren, Germany
W. Heinz

²⁹Department of Internal Medicine, Hospital Leonberg, Germany
G. Hübner

³⁰Department of Internal Medicine, District Hospital Köthen, Germany
M. Pichler

³¹Campus Innenstadt Gastroenterology, University Hospital Munich, Germany
T. Müller

³Department of Internal Medicine 1, Municipal Hospital Steinenberg, Reutlingen, Germany

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

Full Text

References

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