Journal of vascular and interventional radiology : JVIR · 2015
Root Cause Analysis of Rebleeding Events following Transjugular Intrahepatic Portosystemic Shunt Creation for Variceal Hemorrhage.
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Lakhoo Janesh, Bui James T, Zivin Sean P, Lokken R Peter, Minocha Jeet, Ray Charles E, Gaba Ron C
Аннотация
PURPOSE: To identify fundamental causes underlying recurrent variceal hemorrhage (VH) after transjugular intrahepatic portosystemic shunt (TIPS) to ascertain opportunities for improvement of TIPS-based management of VH and prevention of rebleeding.
MATERIALS AND METHODS: This single-center retrospective study comprised 166 patients (male-to-female ratio 101:65; median age, 52 y; median Model for End-Stage Liver Disease score, 14) who had TIPS created for VH in 1998-2014. Medical record review was used to identify patients who had recurrent VH events, and root cause analysis allowed identification of the most probable causal factors. A 5-person interventional radiology physician group generated quality improvement (QI) recommendations for process changes to address causal factors, with consensus achieved using a modified Delphi method.
RESULTS: Variceal rebleeding occurred after TIPS in 25 (15%) patients. The 1-, 3-, and 5-year variceal rebleeding incidence was 17%, 21%, and 21%, respectively. Variceal rebleeding was associated with high 90-day all-cause mortality incidence (10/25; 40%). Male sex (P = .018) and Model for End-Stage Liver Disease score (P = .009) were statistically associated with variceal rebleeding. The most common primary and secondary causes of recurrent VH were lack of or insufficient variceal embolization (64%). Other causal factors included TIPS stenosis or occlusion (28%) with recurrent portosystemic gradient (PSG) elevation (20%), severe coagulopathy (20%), inadequate portosystemic gradient reduction (12%), and TIPS underdilation (4%). To potentially address variceal rebleeding, 14 preventive QI recommendations were developed.
CONCLUSIONS: Although recurrent VH rates after TIPS are not trivial, rebleeding may be related to addressable underlying causal factors. Further investigation may assess the efficacy of QI-based procedure methodologic enhancements in reducing rebleeding incidence after TIPS.
MATERIALS AND METHODS: This single-center retrospective study comprised 166 patients (male-to-female ratio 101:65; median age, 52 y; median Model for End-Stage Liver Disease score, 14) who had TIPS created for VH in 1998-2014. Medical record review was used to identify patients who had recurrent VH events, and root cause analysis allowed identification of the most probable causal factors. A 5-person interventional radiology physician group generated quality improvement (QI) recommendations for process changes to address causal factors, with consensus achieved using a modified Delphi method.
RESULTS: Variceal rebleeding occurred after TIPS in 25 (15%) patients. The 1-, 3-, and 5-year variceal rebleeding incidence was 17%, 21%, and 21%, respectively. Variceal rebleeding was associated with high 90-day all-cause mortality incidence (10/25; 40%). Male sex (P = .018) and Model for End-Stage Liver Disease score (P = .009) were statistically associated with variceal rebleeding. The most common primary and secondary causes of recurrent VH were lack of or insufficient variceal embolization (64%). Other causal factors included TIPS stenosis or occlusion (28%) with recurrent portosystemic gradient (PSG) elevation (20%), severe coagulopathy (20%), inadequate portosystemic gradient reduction (12%), and TIPS underdilation (4%). To potentially address variceal rebleeding, 14 preventive QI recommendations were developed.
CONCLUSIONS: Although recurrent VH rates after TIPS are not trivial, rebleeding may be related to addressable underlying causal factors. Further investigation may assess the efficacy of QI-based procedure methodologic enhancements in reducing rebleeding incidence after TIPS.
Предметные рубрики MeSH
AdultAgedAged, 80 and overCausalityComorbidityDiagnosis, DifferentialEnd Stage Liver DiseaseEsophageal and Gastric VaricesFemaleGastrointestinal HemorrhageHumansIllinoisIncidenceMaleMiddle AgedPortasystemic Shunt, Transjugular IntrahepaticPostoperative ComplicationsRecurrenceRetrospective StudiesRisk AssessmentSurvival RateTreatment OutcomeYoung Adult