Presentation on theme: "HEARTSTRING TM Proximal Seal System. CABG is associated with post-op neurocognitive dysfunction Dysfunction present in up to 80-90% at discharge, and."— Presentation transcript:
HEARTSTRING TM Proximal Seal System
CABG is associated with post-op neurocognitive dysfunction Dysfunction present in up to 80-90% at discharge, and persists in 40% of CABG patients five years after surgery 1 Avoiding the effects of CPB has reduced post-op cognitive dysfunction 2-4 However, concerns remain due to the embolic potential from the continued use of the side-biting clamp 5 1 Mark, DB and Newman MF. Protecting the Brain in Coronary Artery Bypass Grafting. JAMA, March 20, 2002- Vol 287, No. 11 2 Murkin JM et. al. Beating Heart Surgery: Why Expect Less Central Nervous System Morbidity? Ann Thorac Surg 1999;68:1498-501. 3 Lee JD et. al. Off Pump Coronary Artery Bypass Reduces Neurologic and Clinical Morbidity: A Prospective Randomized Trial. Presentation at the Asia Pacific Scientific Forum, Honolulu, HI, April 23-26, 2002. 4 Bowles JB et. al. Coronary Artery Bypass Performed Without the Use of Cardiopulmonary Bypass is Associated with Reduced Cerebral Microemboli and Improved Clinical Results. CHEST 2001; 110: 25-30. 5 Newman, MF, et. al. Longitudinal Assesment of Neurocognitive Function After Coronary Artery Bypass Surgery. N Eng J Med. 2001; 344: 395-402. Clinical Motivation
Use of the partial occluding clamp liberates emboli Clinical Motivation Barbut, D. Cerebral Emboli Detected During Bypass Surgery are Associated with Clamp Removal. Stroke 1994: 25: 2398-402.
A variety of studies consistently link atherosclerotic embolization to adverse outcomes. Neuropsychological Deficit Stroke and Cardiac Complications Clinical Motivation Pugsley W et al. The Impact of Microemboli During Cardiopulmonary Bypass on Neuropsychological Functioning. Stroke 1994; 25:1393-1399. Barbut, D. Impact of Embolization During Coronary Artery Bypass Grafting on Outcome and Length of Stay. AnnThorac Surg 1997; 63: 998-1002.
Length of stay increases dramaticallywith increased emboli release. Clinical Motivation Barbut, D. Impact of Embolization During Coronary Artery Bypass Grafting on Outcome and Length of Stay. AnnThorac Surg 1997; 63: 998-1002.
Elimination of CPB and cross-clamp has led to decreased emboli and improved clinical outcome Concerns remain due to the embolic potential from the continued use of the side-biting clamp Side-biting clamp has been shown to liberate large % of emboli Emboli have been linked to adverse clinical outcomes, both immediate and delayed Reducing aortic manipulation by eliminating the partial occlusion clamp has the potential to further improve patient outcomes Clinical Motivation Summary
Meet the HEARTSTRING™ Surgical Flexibility: Distals or proximals first, or mixed distal/proximalDistals or proximals first, or mixed distal/proximal Angled take-offsAngled take-offs Hooded anastomosesHooded anastomoses Venous and arterial graftsVenous and arterial grafts Grafts of any lengthGrafts of any length Elegant design: Low profile, compliant sealLow profile, compliant seal Single hole anastomosesSingle hole anastomoses Small operational footprintSmall operational footprint No foreign material left inside vesselNo foreign material left inside vessel safety tab tension spring tether tension spring anchor seal seal stem
Corkscrew Punch Designed to create circular hole for Heartstring insertionDesigned to create circular hole for Heartstring insertion One-step device; both aortotomy and punch are performed using the PunchOne-step device; both aortotomy and punch are performed using the Punch finger grip plunger corkscrew tip aortic stop Meet the HEARTSTRING ™
Delivery Device and Seal Seal is partially packed in tubeSeal is partially packed in tube Delivers Seal into aorta via plunger pressDelivers Seal into aorta via plunger press Designed to create a hemostatic window for anastomosisDesigned to create a hemostatic window for anastomosis Unravels with gentle traction when anastomosis is completeUnravels with gentle traction when anastomosis is complete Meet the HEARTSTRING ™ seal delivery tube plunger safety tab tension spring tether tension spring anchor seal seal stem
Pull Some Strings Load the Seal into the Delivery Tube Gently fold the Seal and insert into the end of the delivery tube
Pull Some Strings Create the anastomotic hole
Pull Some Strings Insert the Seal into the aorta
Pull Some Strings Pull back Delivery Tube to complete Seal delivery Use your finger to prevent delivered seal from backing out of aorta
Pull Some Strings Suture the anastomosis Complete anastomosis using inside-out suturing technique
Pull Some Strings Remove Seal Use your thumb and forefinger to provide support for anastomosis and surrounding tissue directly over location where Seal is being removed