HEARTSTRINGTM Proximal Seal System

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Presentation transcript:

HEARTSTRINGTM Proximal Seal System

CABG is associated with post-op neurocognitive dysfunction Clinical Motivation Dysfunction present in up to 80-90% at discharge, and persists in 40% of CABG patients five years after surgery1 Avoiding the effects of CPB has reduced post-op cognitive dysfunction2-4 However, concerns remain due to the embolic potential from the continued use of the side-biting clamp5 CABG is associated with post-op neurocognitive dysfunction 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.

Use of the partial occluding clamp liberates emboli Clinical Motivation Use of the partial occluding clamp liberates emboli Barbut, D. Cerebral Emboli Detected During Bypass Surgery are Associated with Clamp Removal. Stroke 1994: 25: 2398-402.

Clinical Motivation Neuropsychological Deficit Stroke and Cardiac Complications Neuropsychological deficit: 8 weeks post-op, 1 SD from pre op Cardiac complications: Defined as ventricular arrhythmia requiring therapy, myocardial infarction, cardiogenic shock, failure to come off bypass, or the need for placement of an intraaortic balloon pump. Stroke: Defined as a focal deficit persisting for more than 24 hours A variety of studies consistently link atherosclerotic embolization to adverse outcomes. 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 dramatically with increased emboli release. Clinical Motivation The two patients with the greatest embolic load died during the study. Length of stay increases dramatically with increased emboli release. Barbut, D. Impact of Embolization During Coronary Artery Bypass Grafting on Outcome and Length of Stay. AnnThorac Surg 1997; 63: 998-1002.

Clinical Motivation Summary 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

Meet the HEARTSTRING™ Surgical Flexibility: Elegant design: safety tab Surgical Flexibility: Distals or proximals first, or mixed distal/proximal Angled take-offs Hooded anastomoses Venous and arterial grafts Grafts of any length anchor tension spring seal stem seal tension spring tether Elegant design: Low profile, compliant seal Single hole anastomoses Small operational footprint No foreign material left inside vessel

Meet the HEARTSTRING™ Corkscrew Punch Designed to create circular hole for Heartstring insertion One-step device; both aortotomy and punch are performed using the Punch aortic stop corkscrew tip finger grip plunger

Meet the HEARTSTRING™ Delivery Device and Seal plunger seal Seal is partially packed in tube Delivers Seal into aorta via plunger press safety tab anchor delivery tube Designed to create a hemostatic window for anastomosis Unravels with gentle traction when anastomosis is complete tension spring seal stem seal tension spring tether

Pull Some Strings Load the Seal into the Delivery Tube Gently fold the Seal and insert into the end of the delivery tube

Create the anastomotic hole Pull Some Strings Create the anastomotic hole

Insert the Seal into the aorta Pull Some Strings Insert the Seal into the aorta

Pull back Delivery Tube to complete Seal delivery 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

Cut Tension Spring Tether Pull Some Strings Cut Tension Spring Tether

HEARTSTRINGTM Proximal Seal System