Clinical Experience With a Novel Perfusion Balloon Catheter in Patients With Coronary Artery Perforation: Primary Results From the Ringer Clinical Study.

BACKGROUND

The Ringer perfusion catheter (Teleflex) features a novel design with a spiral-shaped inflatable balloon that approximates a hollow cylinder when inflated to manage hemorrhage associated with coronary artery perforation (CAP) during percutaneous coronary intervention while enabling distal perfusion.

METHODS

In a multicenter, prospective, single-arm study, the safety and efficacy of using the Ringer device in the treatment of CAP were assessed. The primary efficacy end point included successful Ringer delivery across the perforation site, angiographic confirmation of no extravasation with balloon inflation, and demonstration of antegrade coronary flow. The primary safety end point was freedom from device-related thrombosis and coronary dissection. Clinical and angiographic outcomes were independently adjudicated.

RESULTS

Among 30 patients with CAP, lesion characteristics included: chronic total occlusion, 50%; severe calcification, 63.3%; lesion length 34.1 ± 23.4 mm. Ellis type II and III perforations occurred in 50% and 30% of patients, respectively. For all patients, the primary efficacy end point was 73.3% by intention to treat analysis. However, among the 26 patients with successful Ringer delivery across the perforation site, the primary end point was 84.6%. In this latter group, acute resolution of contrast extravasation was 84.6%, and maintenance of thrombolysis in myocardial infarction 2/3 antegrade flow during device inflation was 100%. No device-related safety events were observed.

CONCLUSIONS

Treatment of CAP with a novel perfusion balloon catheter achieved favorable rates of deliverability and reduction in hemorrhage while maintaining antegrade flow. These results demonstrate that the Ringer perfusion catheter is a safe and effective method to manage CAP until definitive treatment is decided.