Transplant-Free Survival and Interventions at 6 Years in the SVR Trial
Authors' conclusion
By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock-Taussig shunt groups.
Study context
- Population
- Patients with hypoplastic left heart and related syndromes randomised and treated in the SVR trial
- Participants
- 549 patients
- Comparison
- Norwood with right ventricle-to-pulmonary artery shunt (RVPAS) vs modified Blalock-Taussig shunt
- Primary endpoint
- Transplant-free survival
- Follow-up
- 6 years
Methodological detailslong-term follow-up
- Long-term follow-up
Primary result
As reported in the abstract
P = 0.25
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Death or transplant, by stage (nonproportional hazards P=0.009)Before stage II surgery | 0.66 (0.48–0.92) | ||
| Death or transplant, by stage (nonproportional hazards P=0.009)Stage II to Fontan | 1.36 (0.86–2.17) | P = 0.17 | |
| Death or transplant, by stage (nonproportional hazards P=0.009)After Fontan | 0.76 (0.33–1.74) | P = 0.52 | |
| Catheter interventions · by 6 yearsInterventions between stage II and Fontan | 1.72 (1.00–3.03) | ||
| 0.20.5125Hazard ratio (log scale) |
Catheter interventions · by 6 years
P < 0.001
| Outcome | P value |
|---|---|
| Transplant-free survival, all available follow-up (7.1±1.6 years) | log-rank P=0.13 |
Safety
Complications · by 6 years
- Thrombotic event
- 1 in 5
- Seizures
- 1 in 6
- Complications did not differ by shunt type
Original publication
Transplant-Free Survival and Interventions at 6 Years in the SVR Trial. Circulation. Published 1 February 2018. doi:10. 1161/ circulationaha. 117. 029375
Summarised from the published abstract; every number is checked against it