Interventional procedure overview of transvenous obliteration for gastric varices
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Safety summary
Note: Gastric varices, liver cirrhosis, and portal hypertension can cause severe complications. It was not always clear from the studies included whether complications were attributable to the procedure or to the underlying illness.
Overall complication rate
BRTO
In the systematic review and meta-analysis of 23 studies (938 people), the pooled major complication rate was 2.6% (95% CI 1.1, 4.6; I2 99.34). Major complications were defined as those needing therapy and minor hospitalisation (less than 48 hours); needing major therapy with unplanned increase in level of care and prolonged hospitalisation (more than 48 hours); resulting in permanent adverse sequelae, or resulting in death (Park, 2015).
In the systematic review and meta-analysis of 3 studies (56 people [BRTO], 67 people [TIPS]), there was no difference in the rates of procedure-related complications between the BRTO and TIPS groups: OR=1.95 (95% CI, 0.44 to 8.72, p=0.38, no heterogeneity Ι2=0%) (Paleti, 2020).
Procedure-related death
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 2 procedure-related deaths (less than 1%). The cause of death was uncertain for 1 person. For the other, it was presumed to be secondary to multi-organ failure. These deaths were considered procedure-related as they happened within 24 hours of BRTO (Park, 2015).
The retrospective cohort study of 95 people (74 BRTO; 21 PARTO) reported 1 death because of balloon rupture and subsequent migration of ethanolamine oleate into systemic circulation (Kim, 2016).
Procedural complications
Balloon rupture
BRTO
The retrospective case series of 183 people reported 3 cases (1.6%) of pulmonary thromboembolism related to balloon rupture. The total number of balloon ruptures was not reported (Jang, 2012).
The retrospective cohort study of 95 people (74 BRTO; 21 PARTO) reported 1 death because of balloon rupture and subsequent migration of ethanolamine oleate into systemic circulation (Kim, 2016).
Migration of embolising material
Note, there have also been reports of migration of coils and vascular plugs. Because these complications are broadly similar to sclerosant migration (that is, migration of embolising material), the case reports describing them have not been included in the key evidence.
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of foam migration to liver and 5 cases of systemic sclerosant extravasation (less than 1%) (Park, 2015).
The retrospective cohort study of 95 people (74 BRTO; 21 PARTO) reported 1 death because of balloon rupture and subsequent migration of ethanolamine oleate into systemic circulation (Kim, 2016).
Gastrorenal shunt rupture
BRTO
The retrospective case series of 183 people reported 1 case of gastrorenal shunt rupture (Jang, 2012).
Iatrogenic injury
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of iatrogenic injury (Park, 2015).
Puncture site bleeding
PARTO
The retrospective case series of 54 people reported 1 case of puncture site bleeding (Park, 2020).
Microcoil embolisation
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 3 cases of microcoil embolisation (Park, 2015).
Aggravation of cirrhotic complications
Oesophageal varices
BRTO
The systematic review and meta-analysis of 20 studies reported a pooled oesophageal variceal recurrence rate of 33.3% (95% CI 24.6 to 42.6, I2 99.74) (Park, 2015).
The RCT of 32 people treated with BRTO versus 32 people treated with endoscopic cyanoacrylate injection reported no difference in the overall cumulative oesophageal varices worsening rates between the groups (BRTO 1 year=26.1%, 2 years=41.3%; endoscopic cyanoacrylate injection 1 year=23.1%, 2 years=37.8%) (Luo, 2021).
The retrospective case series of 183 people reported that oesophageal varices newly developed in 21 of 36 people without oesophageal varices before BRTO (58.3%), and that oesophageal varices progressed to a larger size in 33 of 100 people with oesophageal varices before BRTO (33.0%) (Jang, 2012).
The retrospective case series of 100 people reported an overall cumulative aggravation rate of oesophageal varices of 21% at 1 year, 41% at 3 years, 50% at 5 years, and 54% 10 years after BRTO. In multivariate analysis, overall aggravating rates correlated statistically significantly and independently with existence of oesophageal varices before BRTO (HR 18.114, 95% CI 2.463 to 133.219, p=0.004). (Naeshiro, 2014).
BATO
The retrospective case series of 71 people reported 6 cases of aggravated oesophageal varices (8%) (Tian, 2011).
PARTO
The retrospective case series of 54 people reported that oesophageal varices deteriorated in 26 people (53.1%) (Park, 2020).
Ascites
BRTO
The systematic review and meta-analysis of 11 studies reported a pooled ascites rate of 9.2% (95% CI 2.0 to 20.7, I2 99.89) (Park, 2015).
The RCT of 32 people treated with BRTO reported 9 cases of ascites aggravation (28%) (Luo, 2021).
The retrospective case series of 100 people reported 18 cases of ascites (18%) (Naeshiro, 2014).
BATO
The retrospective case series of 71 people reported 20 cases of ascites (28%) (Tian, 2011).
PARTO
The retrospective case series of 54 people reported that, of the 48 people with grade 1 or 2 ascites, an increase in the amount of ascites was detected in 8 people (16.7%) within 1 month and 0 people at 6 months after PARTO (Park, 2020).
Hepatic encephalopathy
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of procedure-related hepatic encephalopathy (Park, 2015).
In the systematic review and meta-analysis of 7 studies (462 people [BRTO], 214 people [TIPS]), the incidence of hepatic encephalopathy was statistically significantly lower in the BRTO group compared with the TIPS group, OR=0.06 (95% CI 0.02 to 0.15, p<0.00001, low heterogeneity Ι2=10%) (Paleti, 2020).
PARTO
The retrospective case series of 54 people reported that, of the 4 people with hepatic encephalopathy, hepatic encephalopathy improved to grade 0 at 1 month after PARTO. Such improvement continued until 6 months after PARTO (Park, 2020).
Thromboembolic events
Pulmonary embolism
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 4 cases of pulmonary emboli (less than 1%). The pooled pulmonary embolus rate was 0.13% (23 studies, 95% CI 0.0049 to 0.42, I2 97.12) (Park, 2015).
The retrospective case series of 183 people reported 5 cases (2.7%) of pulmonary thromboembolism (Jang, 2012).
Portal or splenic venous thrombus
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 11 cases of portal or splenic venous thrombus (1%) (Park, 2015).
The RCT of 32 people treated with BRTO reported 2 cases of portal vein thrombosis (6%) (Luo, 2021).
BATO
The retrospective case series of 71 people reported 2 cases of portal vein thrombosis (3%) (Tian, 2011).
Inferior vena cava or right iliac vein thrombus
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 6 cases of inferior vena cava or right iliac vein thrombus (less than 1%) (Park, 2015).
Renal vein thrombus
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 3 cases of renal vein thrombus (less than 1%) (Park, 2015).
Cardiac complications
Ventricular fibrillation
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of ventricular fibrillation (Park, 2015).
Stress cardiomyopathy
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of stress cardiomyopathy (Park, 2015).
Liver complications
Liver necrosis
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of liver necrosis (Park, 2015).
Urinary tract complications
Acute renal failure
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 3 cases of microcoil embolisation (Park, 2015).
Renal infarction
BRTO
The retrospective case series of 183 people reported 1 case of left renal infarction (Jang, 2012).
Haematuria
BRTO
The systematic review and meta-analysis of 13 studies reported a pooled haematuria rate of 69.8% (95% CI 49.6 to 86.7, I2 99.92) (Park, 2015).
The retrospective case series of 100 people reported 32 cases of gross haematuria (32%) (Naeshiro, 2014).
Haemoglobinuria
BRTO
The retrospective cohort study of 95 people (74 BRTO, 21 PARTO) reported 1 case of haemoglobinuria in a person who had BRTO (Kim, 2016).
Pulmonary oedema
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of pulmonary oedema (Park, 2015).
Infection
Bacteraemia
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of methicillin-sensitive staphylococcus aureus bacteraemia (Park, 2015).
BATO
The retrospective case series of 71 people reported 5 cases of bacteraemia (7%) (Tian, 2011).
Pneumonia
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of pneumonia (Park, 2015).
Bacterial peritonitis
BATO
The retrospective case series of 71 people reported 6 cases of abdominal pain (8%) (Tian, 2011).
Hepatic abscess
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 1 case of hepatic abscess (Park, 2015).
Haemorrhagic gastritis
BRTO
The systematic review and meta-analysis of 24 studies (1,016 people) reported 3 cases of haemorrhagic gastritis (Park, 2015).
Fever
BRTO
The systematic review and meta-analysis of 14 studies reported a pooled fever rate of 51.1% (95% CI 39.2 to 62.9, I2 99.92) (Park, 2015).
The RCT of 32 people treated with BRTO reported 2 cases of fever (6%) (Luo, 2021).
The retrospective case series of 100 people reported 35 cases of fever (35%) (Naeshiro, 2014).
BATO
The retrospective case series of 71 people reported 32 cases of fever (45%) (Tian, 2011).
PARTO
The retrospective case series of 54 people reported 1 case of fever (Park, 2020).
Pain
BRTO
The RCT of 32 people treated with BRTO reported 3 cases of pain (9%) (Luo, 2021).
The retrospective case series of 100 people reported 13 cases of pain (13%) (Naeshiro, 2014).
The retrospective cohort study of 95 people (74 BRTO, 21 PARTO) reported 17 cases of abdominal pain, all in people who had BRTO (Kim, 2016).
BATO
The retrospective case series of 71 people reported 25 cases of abdominal pain (35%) (Tian, 2011).
Anecdotal and theoretical adverse events
In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).
For this procedure, professional experts listed the following anecdotal adverse events: pleural effusion, cardiogenic shock, and anaphylactic reaction.
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