Jude F Clancy1, Roger G Carrillo2, Ryan Sotak3, Rashmi Ram3, Robert K Ryu4, Charles Kennergren5. 1. Division of Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: jude.clancy@yale.edu. 2. Department of Cardiothoracic Surgery, University of Miami Hospital, Miami, Florida. 3. Spectranetics Corporation, Colorado Springs, Colorado. 4. Department of Interventional Radiology, University of Colorado Anschutz Medical Campus, Denver, Colorado. 5. Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
Abstract
BACKGROUND: Superior vena cava (SVC) perforation is a rare but potentially fatal complication of transvenous lead removal. OBJECTIVE: The aim of this study was to evaluate the feasibility of hemodynamic stabilization using an occlusion balloon during SVC tear in a porcine model. METHODS: A surgically induced SVC perforation was created in Yorkshire cross swine (n = 7). Three animals were used to develop and test surgical repair methods. Four animals were used to evaluate hemodynamic, behavioral, and neurological effects up to 5 days after SVC tear and repair. An occlusion balloon (Bridge Occlusion Balloon, Spectranetics Corporation, Colorado Springs, CO) was percutaneously delivered through the femoral vein to the location of the injury and inflated. Once hemodynamic control was achieved, the perforation was surgically repaired. RESULTS: After SVC perforation and clamp release, the rate of blood loss was 7.0 ± 0.8 mL/s. Mean time from SVC tear to occlusion balloon deployment was 55 ± 12 seconds, during which mean arterial pressure decreased from 56 ± 2 to 25 ± 3 mm Hg and heart rate decreased from 76 ± 7 to 62 ± 7 beats/min. After the deployment of the occlusion balloon, the rate of blood loss decreased by 90%, to 0.7 ± 0.2 mL/s. The mean time of balloon occlusion of the SVC was 16 ± 4 minutes and hemodynamic measures returned to baseline levels during this time. Study animals experienced no major complications, demonstrated stable recovery, and exhibited normal neurological function at each postoperative assessment. CONCLUSION: Endovascular temporary balloon occlusion may be a feasible option to reduce blood loss, maintain hemodynamic control, and provide a bridge to surgery after SVC injury.
BACKGROUND: Superior vena cava (SVC) perforation is a rare but potentially fatal complication of transvenous lead removal. OBJECTIVE: The aim of this study was to evaluate the feasibility of hemodynamic stabilization using an occlusion balloon during SVC tear in a porcine model. METHODS: A surgically induced SVC perforation was created in Yorkshire cross swine (n = 7). Three animals were used to develop and test surgical repair methods. Four animals were used to evaluate hemodynamic, behavioral, and neurological effects up to 5 days after SVC tear and repair. An occlusion balloon (Bridge Occlusion Balloon, Spectranetics Corporation, Colorado Springs, CO) was percutaneously delivered through the femoral vein to the location of the injury and inflated. Once hemodynamic control was achieved, the perforation was surgically repaired. RESULTS: After SVC perforation and clamp release, the rate of blood loss was 7.0 ± 0.8 mL/s. Mean time from SVC tear to occlusion balloon deployment was 55 ± 12 seconds, during which mean arterial pressure decreased from 56 ± 2 to 25 ± 3 mm Hg and heart rate decreased from 76 ± 7 to 62 ± 7 beats/min. After the deployment of the occlusion balloon, the rate of blood loss decreased by 90%, to 0.7 ± 0.2 mL/s. The mean time of balloon occlusion of the SVC was 16 ± 4 minutes and hemodynamic measures returned to baseline levels during this time. Study animals experienced no major complications, demonstrated stable recovery, and exhibited normal neurological function at each postoperative assessment. CONCLUSION: Endovascular temporary balloon occlusion may be a feasible option to reduce blood loss, maintain hemodynamic control, and provide a bridge to surgery after SVC injury.