Clinical Data
Clinical data for the Optiflow anastomotic connector was accepted for presentation at the Controversies in Dialysis Access (CiDA 2011) conference. The abstract was also published in the July–September, 2011 issue of the Journal of Vascular Access.
Arteriovenous Anastomosis Creation using the Optiflow™ Anastomotic Connector
Lajos Matyas et al.,* The Journal of Vascular Access, 12:2, April-June 2011, 527-528.
Accepted for presentation at Controversies in Dialysis Access Conference, October, 2011.
Background
Arteriovenous fistula (AVF) maturation failure and poor long term patency are major clinical problems. Recent data suggests that 20% of newly created AVF's thrombose within six weeks and 62% fail to attain suitability for dialysis. 1 In another study, 1.75 procedures per access year were required to maintain access patency.2
The geometry of the preformed Optiflow implant (Figs. 1&2) yields a reproducible laminar flow path which is designed to optimize hemodynamics. Further, the Optiflow provides a mechanical scaffold which shields the perianastomotic (PA) region from aggressive stenosis. Thus, the Optiflow™ implant is designed to improve AVF long term function by providing a highly controlled flow path.
Clinical data for patients treated with the Optiflow™ was collected and analyzed in order to evaluate safety and clinical performance.
Methods
End to side AV fistulae were created with a novel anastomotic device (Optiflow™). The study population included fifty three patients treated in Paraguay, Hungary, Greece, and the United Kingdom. Forty seven patients were evaluable for patency (5 were not assessed for patency due to acute technical failures and 1 patient due to a perioperative cardiac event). Unassisted primary patency was evaluated in two different study groups with follow-up time points of 14 (n=47), 42 (n=46) and 90 days (n=39) respectively. The safety endpoint was freedom from serious adverse events (SAE's) and unanticipated adverse device events (UADE's) during the follow-up period.
Figure 2: Optiflow AVF
Results
Of the 47 patients, 47% were male and 39% were diabetic. Table 1 describes the study results at different time points. Aside from the technical failures, there were no device related SAE's or UADE's.
Study Results
| 14d Primary Patency | 42d Primary Patency | 90d Primary Patency | 42d ultrasound Vein Size (mm) |
| 100% | 91% | 82% | 6.6 +/- 2.2 |
Conclusions
The results support the safety and effectiveness of the Optiflow. The 82% unassisted primary patency rate at 90 days for Optiflow™ is favorable when compared to published unassisted primary patency rates of 70% (Falk, 2006) for standard AVF. Additionally, 42 day ultrasound follow-up performed on 31 patients demonstrated an average vein diameter of 6.6mm. These initial results suggest that the Optiflow™ could potentially play an important role in enhancing AVF maturation.
The Optiflow™ received the CE mark in August 2010.
*Co-investigators: Istvan Mogan, MD,2 Adrian Ebner MD,3 Miltos Lazarides MD,4 Mark Mantell MD,5 Roberto Manson MD,6 Eric Chemla MD,7 Sandip Mitra MD,8 Milind Nikam MD,8 Afshin Tavakoli MD,8 and Prabir Roy-Chaudhury MD, PhD.9
1Megyei Hospital, Miskolc, Hungary,2 St. Imre Hospital, Budapest, Hungary,3 French Hospital, Asuncion Paraguay, 4 Demokritos University Hospital, Alexandroupolis, Greece, 5 University of Pennsylvania, Philadelphia, USA, 6 Duke University, Durham, North Carolina, 7 St. George’s hospital, London, UK, 8 Manchester Royal Infirmary, Manchester, UK, 9 University of Cincinnati, Cincinnati, OH.