Interventional procedure overview of transvenous obliteration for gastric varices
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Summary of key evidence on PARTO for gastric varices
Study 9 Park JW (2020)
Study details
Study type | Retrospective, single centre, case series |
Country | Korea |
Recruitment period | 2012 to 2018 |
Study population and number | n=73 (54 followed up) People who had PARTO for bleeding gastric varices or for prophylaxis |
Age and sex | Mean 56.6 years; 68.5% male |
Patient selection criteria | People who had PARTO for bleeding gastric varices (active or recent bleeding) or for primary prophylaxis. One person was included who had PARTO for hepatic encephalopathy. |
Technique | PARTO. The catheter was inserted to the gastrorenal shunt via the femoral or jugular vein. Venograms were obtained to visualise the varices. The size of the vascular plug was selected according to the diameter of the narrowest gastrorenal shunt. The plug was deployed at the most dilated gastrorenal shunt to facilitate the entry into the gastrorenal shunt proximal to the vascular plug. A gelfoam slurry was used. |
Follow up | Mean 28 months (SD 19.8 months) |
Conflict of interest/source of funding | Conflict of interest: The authors declare that they have no conflict of interest. Source of funding: This study was supported by the Soonchunhyang University Research Fund. |
Analysis
Follow up issues: Of the 73 people who had PARTO, 15 were lost to follow up, and 4 died within a month after PARTO. The causes of death were deterioration of liver function (n=2), the oesophageal varices bleeding (n=1), and infection (n=1). It is not reported whether these deaths were assessed as related to the efficacy or safety of PARTO. These people were excluded from the analysis.
Study design issues: This retrospective case series evaluated the outcomes of PARTO for the treatment of gastric varices. People were identified retrospectively from medical records. As noted above, 19 people were excluded from the analysis. Outcomes included:
Technical success, defined by the complete occlusion of the efferent shunt and complete filling of gastric varices with a gelfoam slurry.
Eradication of gastric varices, defined by complete or marked shrinkage of gastric varices on follow-up endoscopy or computed tomography scan.
Hepatic function and bleeding.
Complications, including aggravation of oesophageal varices.
Study population issues: PARTO was performed for various indications: active bleeding, 11/54 (20.4%); recent bleeding, 13/54 (24.1%); primary prophylaxis for impending rupture 29/54 (53.7%); and just for hepatic encephalopathy control without gastric varices, 1/54 (1.9%). The aetiology was alcohol in 24 people (44.4%), hepatitis B in 14 (25.9%), hepatitis C in 2 (3.7%), and unspecified 'others' in 14 (25.9%). The mean MELD score was 11.46 ± 4.35. The location of gastric varices was GOV1 in 12 people, GOV2 in 36 people, and undefined 'others' in 5 people.
Key efficacy findings
Technical success
Number of people analysed: 54
The technical success rate was 100%.
The gastric variceal eradication rate was 92.6% (50/54).
Rebleeding
Number of people analysed: 54
Data on rebleeding is not well described.
In Table 2 of the publication, there is 1 case of rebleeding classified as a complication.
The results section describes 2 people who were refractory to PARTO as having 'additional' gastric varices bleeding.
Further in the results section, the oesophageal varices outcomes are described. In 25 people in whom the portal pressure was measured, oesophageal varices deterioration was found in 10. Of those 10, 2 people experienced rebleeding of oesophageal varices.
Hepatic outcomes
Number of people analysed: 54
There was a statistically significant increase in the hepatic venous pressure gradient before and after PARTO (12.52 ± 3.83 to 14.68 ± 5.03 mmHg, p<0.001).
The Child-Pugh score after PARTO showed statistically significant improvements at 1 and 6 months (both p<0.05), but did not show improve significantly during the overall follow-up period (p>0.05).
Key safety findings
Aggravation of oesophageal varices
Number of people analysed: 49
Oesophageal varices deterioration was observed in 26 people (53.1%).
Portal pressure after PARTO was statistically significantly associated with aggravation of oesophageal varices.
Aggravation of ascites
Number of people analysed: 48
Among 48 people with mild/moderate ascites except for 6 people with severe 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.
Improvement of hepatic encephalopathy
Number of people analysed: 4
In 4 people, hepatic encephalopathy improved to grade 0 at 1 month after PARTO. Such improvement continued until 6 months after PARTO.
Study 10 Kim YH (2016)
Study details
Study type | Retrospective, single centre, cohort |
Country | Korea |
Recruitment period | 2004 to 2015 |
Study population and number | n=95 (70 followed up) People with gastric varices |
Age and sex | Mean 62.9 years; 77% male |
Patient selection criteria | People with recent haematemesis, who had gastric varices, associated portal hypertension, and a gastrorenal shunt. |
Technique | 3 groups were studied:
BRTO: under local anaesthesia, balloon catheter was inserted via the femoral vein to the gastrorenal shunt. Varices were visualised. Embolisation was performed with ethanolamine oleate or sodium tetradecyl sulfate foam until the variceal flow was stopped. PARTO: Same basic procedure as BRTO but use of a vascular plug and gelfoam slurry to embolise the varix. |
Follow up | No mean reported, follow up recurrence rates reported to 2 years |
Conflict of interest/source of funding | Conflict of interest: the authors declare that they have no conflict of interest. Source of funding: Not reported. |
Analysis
Follow up issues: Of the 95 people identified, follow-up data was available for 70.
Study design issues: This retrospective cohort study compared the outcomes of BRTO with ethanolamine oleate, BRTO with sodium tetradecyl sulfate foam, and PARTO for the treatment of recently bleeding gastric varices. People were identified retrospectively from medical records. Outcomes included:
Technical success, defined as clotting of varices without blood aspiration and no variceal flow on the test injection of contrast media.
Clinical success, defined as the absence of residual enhancement within the gastric varices on follow up computed tomography scan and cessation of gastric bleeding on endoscopic evaluation.
Recurrence of gastric varices was defined as enlargement of gastric varices on endoscopy or computed tomography, or rebleeding was occurred.
Procedure time.
Major complications were defined as any undesired event that requires major therapy, prolonged hospitalisation or has permanent adverse sequelae or results in death. Pain as a minor complication was evaluated as mild, moderate, or severe.
The Chi-square test and Fisher's exact test were used to compare abdominal pain. The Kruskal–Wallis test and Mann–Whitney U test were used to verify relationship between procedure time and each procedure group. The Kaplan–Meier method and log-rank test were used to compare expected 1- and 2-year recurrence rates. p<0.05 was considered statistically significant.
Study population issues: There were no statistically significant differences in the baseline characteristics of the 3 groups. The aetiology of cirrhosis was hepatitis B in 26 people and hepatitis C in 5 people (other causes were not reported. There were 38 people (54%) who were classed as Child-Pugh grade A, 29 people (41%) were grade B, and 3 (4%) were grade C. Nineteen people (27%) had hepatocellular carcinoma.
Key efficacy findings
Technical outcomes
Number of people analysed: 95
Technical and clinical success was achieved in 90 people (94.7%).
Technical failure happened in only BRTO cases, causes included:
Severe angulation of left adrenal vein, n=2
Hirota grade 5 gastric varices, n=2
Rupture of the balloon during sclerotherapy, n=1
The procedure time of PARTO was statistically significantly shorter than the procedure time of the BRTO procedures (p<0.017).
Recurrence of gastric varices
Number of people analysed: 70 (34 BRTO with ethanolamine oleate, 18 BRTO with sodium tetradecyl sulfate, and 18 PARTO)
There were 3 recurrent cases with BRTO with EO and 4 cases with PARTO.
People treated with PARTO had a statistically significantly higher rate of recurrence than the BRTO procedures (p<0.05).
Rebleeding happened in 2 cases, both with PARTO.
Expected 6-month recurrence rate (%) | Expected 1-year recurrence rate (%) | Expected 2-year recurrence rate (%) | |
BRTO using EO | 3.2 | 3.2 | 16.5 |
BRTO using STS foam | 0 | 0 | 0 |
PARTO | 16.0 | 32.8 | 55.2 |
Key safety findings
Complications
Number of people analysed: 95
Death, n=1 (BRTO with ethanolamine oleate)
The balloon ruptured, causing migration of ethanolamine oleate into systemic circulation, which led to disseminated intravascular coagulation.
Haemoglobinuria, n=1 (BRTO with ethanolamine oleate)
Abdominal pain, n=17 (all BRTO with ethanolamine oleate)
Mild, n=13
Moderate, n=1
Severe, n=3
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