Chronic safety assessment of hemostatic self-expanding foam: 90-day survival study and intramuscular biocompatibility.

BACKGROUND: Noncompressible hemorrhage is a significant cause of preventable death in trauma, with no effective presurgical treatments. We previously described the efficacy and 28-day safety of a self-expanding hemostatic foam in swine models. We hypothesized that the 28-day results would be confirmed at a second site and that results would be consistent over 90 days. Finally, we hypothesized that the foam material would be biocompatible following intramuscular implantation. METHODS: Foam treatment was administered in swine following a closed-cavity splenic injury. The material was explanted after 3 hours, and the animals were monitored to 28 days (n = 6) or 90 days (n = 4). Results were compared with a control group with injury alone (n = 6 at 28 days, n = 3 at 90 days). In a separate study, foam samples were implanted in rabbit paravertebral muscle and assessed at 28 days and 90 days relative to a Food and Drug Administration-approved polyurethane mesh (n = 3 per group). RESULTS: All animals survived the acute phase of the study, and the foam animals required enterorrhaphy. One animal developed postoperative ileus and was euthanized; all other animals survived to the 28-day or 90-day end point without clinically significant complications. Histologic evaluation demonstrated that remnant particles were associated with a fibrotic capsule and mild inflammation. The foam was considered biocompatible in 28-day and 90-day intramuscular implant studies. CONCLUSION: Foam treatment was not associated with significant evidence of end-organ dysfunction or toxicity at 28 days or 90 days. Remnant foam particles were well tolerated. These results support the long-term safety of this intervention for severely bleeding patients.

Acute and chronic performance evaluation of a novel epicardial pacing lead placed by percutaneous subxiphoid approach in a canine model.

BACKGROUND: Endovascularly implanted leads risk vascular injury and endocarditis, and can be difficult to locate in desired positions for LV pacing. We evaluated the acute and long-term stability, electric performance and histopathology of a percutaneously placed intrapericardial lead (IPL). METHODS AND RESULTS: Twelve adult mongrel dogs underwent defibrillator implants incorporating IPLs. Successful uncomplicated percutaneous implantation of an IPL was achieved in all. Early fluoroscopic shift noted with 3 of 6 of the initial version IPL-1 was not seen with the modified IPL-2. Mean±95% confidence interval bipolar capture threshold at 0.5-ms pulse width for the IPL increased from 0.69±0.14 V at implant to 1.50±0.34 V (P=0.003) at 12 weeks. The 12-week thresholds were higher for IPL compared with right ventricular endocardial leads (0.75±0.33 V; P=0.001) but not different compared with coronary sinus leads (1.33±0.58 V; P=0.994). IPL impedance increased from 742±46 Ω at implant to 1066±207 Ω at 12 weeks (P=0.007). R-wave amplitude at 12 weeks was 8.37±1.52 mV. There was no important phrenic nerve stimulation from IPL pacing. Histopathology in 8 animals showed adequate adhesion of the electrodes or mesh to the epicardium without damage to underlying vasculature. There was no evidence for late pericardial inflammation or effusion. CONCLUSIONS: The IPL demonstrated adequate stability of position and acceptable electric parameters without chronic pericardial inflammation in this canine model and offers a potential alternative to endocardial pacing leads.

Sealing of type III endoleaks with ethylene vinyl alcohol copolymer in a canine model.

PURPOSE: To test ethylene vinyl alcohol copolymer (EVOH) as a sealing agent for persistent abdominal aortic aneurysm (AAA) endograft leaks. MATERIALS AND METHODS: Twelve dogs underwent creation of AAAs with a Palmaz P4014 stent. A 10-mm x 5-cm Wallgraft endoprosthesis with a 4-mm-diameter hole cut into its side was deployed within the AAA. One week later, computed tomography (CT) and angiography were performed and the aneurysm sac was catheterized through the 4-mm hole. Then, EVOH was injected into the sac and lumbar arteries. Four weeks thereafter, all surviving animals underwent repeat CT scanning and angiography and were then euthanized. The AAA underwent gross and microscopic study. RESULTS: Three dogs died from aortic rupture within 24 hours of AAA creation and the remaining nine dogs survived to receive EVOH. All nine dogs had persistent flow into the sac and lumbar arteries at the time of EVOH delivery. Seven dogs survived to the end of the experiment, and all aneurysm sacs and lumbar arteries remained occluded on angiography and CT. Histologic examination revealed EVOH and thrombus admixed, with thrombus in varying stages of organization filling the aneurysm sac and lumbar arteries. CONCLUSIONS: Embolization of type III endoleaks with EVOH proved to be feasible in a canine model. Further work is warranted to determine its therapeutic utility.

An experimental model of saphenous vein-to-coronary artery anastomosis with the St. Jude Medical stainless steel connector.

BACKGROUND: A new stainless steel anastomosis device developed by St. Jude Medical Cardiovascular Group was studied in a canine model. METHODS: In 12 dogs, coronary saphenous vein grafts were made to the left anterior descending coronary artery and to the circumflex coronary artery; one anastomosis was completed with the St. Jude Medical stainless steel connector device, and the other with conventional suturing. A 30-day coronary angiogram was performed in surviving animals, and, after sacrifice, anastomoses were measured, examined grossly, and submitted for histologic study. RESULTS: All 12 animals survived the procedure, and 9 survived to sacrifice at 30 days. Comparing the connector grafts and sutured grafts, no significant differences were found between vessel diameters, intraoperative graft flows, graft patency, and histology. The average loading time for the connector was 8.5 minutes (range 4 to 16 minutes). Mean time for the 12 connector anastomoses was 3 minutes (range 2 to 5 minutes) compared with 8.4 minutes for suture (range 4 to 13 minutes). CONCLUSIONS: The side-to-side stainless steel connector anastomotic device produces a secure anastomosis with minimal variability; compared with suture methods, it is expeditious and has comparable 30-day histology and angiographic results. It promises to be an important addition to the surgical armamentarium for the treatment of coronary artery disease.