A study has shown that the use of re-entry devices significantly improved haemodynamic results in the treatment of chronic total occlusion in iliac arteries. The experience also showed a trend towards better technical success.
The results from the study on the use of re-entry devices with intravascular ultrasound (IVUS) on technical success, safety and patency of subintimal angioplasty of chronic total occlusion in iliac arteries were presented by Tareq Massimi, Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, USA, at the Society of Vascular Surgery Vascular Annual Meeting (30 May–1 June 2013, San Francisco, USA).
“Re-entry devices are adjuncts that can be used during subintimal angioplasty to obtain true lumen re-entry. IVUS technology can be used with re-entry devices to facilitate true lumen re-entry,” he said. “Sufficient data investigating re-entry device use with or without IVUS guidance in iliac subintimal angioplasty is still lacking.”
The objective of the study was to investigate the impact of re-entry devices, with or without IVUS, on success, safety and patency of subintimal angioplasty of iliac artery chronic total occlusions. It reviewed retrospectively iliac subintimal angioplasty interventions between 2003 and 2012 and compared two groups (re-entry device vs. non-re-entry device) and three additional subsets: IVUS re-entry device, non-IVUS re-entry device and non-re-entry device.
The primary endpoints were technical success (successful true lumen re-entry with re-establishment of flow), haemodynamic change (pre- to post- procedure ankle brachial index) and patency rates; the secondary endpoints were retrograde dissection (arterial dissection requiring proximal stent extension), iliac rupture and major adverse events (any retrograde dissection or iliac rupture).
Amongst 1,100 iliac interventions recorded during the period studied, 214 involved iliac chronic total occlusion and subintimal angioplasty; of these 72 used re-entry devices and 142 did not. In the re-entry device group, in half of the patients the treatment was performed with IVUS.
The results showed no difference in technical success between the re-entry and non-re-entry device groups. However, improvement in ankle brachial index was statistically significantly higher in patients treated with a re-entry device (p=0.004).
The primary patency rate at three years was 75% in the re-entry device group, and 58% in the non-re-entry device cohort (p=0.1).
In the subset analysis of IVUS re-entry device vs. non-IVUS re-entry device, the non-IVUS group had a larger number of retrograde proximal dissections (6 vs. 1, p=0.05) and more major adverse events (9 vs. 2, p=0.02).
In the analysis of IVUS-re-entry device vs. non-IVUS re-entry device and non-re-entry device, the IVUS re-entry device group showed lower rates of retrograde proximal dissection and major adverse events.
In his conclusions, Massimi noted that the use of re-entry devices showed significant improvement in haemodynamic results and a trend towards better technical success. He added, “IVUS-guided re-entry device significantly reduced retrograde dissections and overall major adverse events, and showed a trend towards improved primary patency.”
He stated that, in the study, retrograde dissections requiring proximal treatment were an independent negative factor on primary patency.