Clinical Data
Clinical data was presented at the Symposium on Vascular Innovations 2010 in Hungary by Dr. Lajos Mátyás and at the ASDIN 2011 meeting by Dr. Prabir Roy-Chaudhury.
Arteriovenous Anastomosis Creation using the Optiflow™ Anastomotic Connector
Lajos Mátyás MD, György Juhász MD, István Thomka MD, B.A.Z. Megyei Hospital, Miskolc, Hungary
István Mogán MD, Gábor Simó MD, Gábor Darabos, MD, St. Imre Hospital, Budapest, Hungary
Miltos Lazarides MD, Demokritos University Hospital, Alexandroupolis, Greece
Objectives
Early arteriovenous (AV) fistula maturation failure is a major clinical problem. AV fistula failure is frequently preceded by the occurrence of aggressive stenosis in the perianastomotic (PA) region. The Optiflow™ implant device is designed to protect the PA region from the development of stenosis and improve AV fistula hemodynamics. The main objective of this study was to evaluate the safety and clinical performance of the Optiflow™ implant for creation of an AV fistula.
Methods
Twenty-nine patients met the study criteria and received end to side AV fistulas created with a novel anastomotic device (Optiflow™). Per protocol unassisted primary patency is being evaluated at 42, 90, and 180 days. The safety endpoint is freedom from serious adverse events (SAE's) and unanticipated adverse device events (UADE's) during 180 day follow-up period.
Optiflow™ Anastomotic Connector
Figure 1: Optiflow™ Implant
Figure 2: Optiflow anastomosis
intra-op
Figure 3: Follow-up ultrasound 
Results
Table 1: Study Demographics
| No. Patients |
Mean Age (Years) |
Percent Male |
Percent Diabetic |
%Brachial Cephalic Fistulas |
%Brachial Basilic Fistulas (Transposed) |
| 29 | 63 (19-79) |
38% (11/29) |
48% (14/29) |
83% (24/29) |
10% (3/29) |
Table 2: Interim Study Results, Per-Protocol Unassisted Primary Patency
| 14 Day Primary Patency | 42 Day Primary Patency | 90 Day Primary Patency | 180 Day Primary Patency |
| 100% (25/25) |
92%** (22/24) |
83% (20/24) |
On-going |
**One patient received a kidney transplant prior to the 42day follow-up time point and was discharged from the study.
Of the 29 patients, four patients could not be evaluated for patency due to three immediate technical failures relating to device delivery in which the device was removed and one death immediately after surgery from a non-device related event. All three patients with technical failures were converted to hand-sewn AV fistulas with no long-term clinical sequelae.
Aside from the technical failures, there were no device related SAE's or UADE's.
One patient received a kidney transplant prior to the 90day follow-up time interval and was discharged from the study.
Conclusions
The results from the interim data support the technical feasibility and safety of the Optiflow™ device. The 83% unassisted primary patency rate at 90 days for Optiflow™ is favorable when compared to published unassisted primary patency rates of 70% (Falk, 2006) for hand sewn AV fistulas, suggesting possible improvement in the patency rates of AV fistula using the implant. Additionally, 180 day ultrasound follow-up performed on 9 patients to date has demonstrated an average vein diameter of 9mm, suggesting the Optiflow™ device can result in a mature outflow vein. Subsequent studies will be performed to compare the patency rates for the Optiflow™ implant to standard anastomosis.
The Optiflow™ received the CE mark in August 2010.