1. HEARTSTRINGTM Proximal Seal System

2. 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, Vol 287, No. 11
2 Murkin JM et. al. Beating Heart Surgery: Why Expect Less Central Nervous System Morbidity? Ann Thorac Surg 1999;68:
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:
5 Newman, MF, et. al. Longitudinal Assesment of Neurocognitive Function After Coronary Artery Bypass Surgery. N Eng J Med. 2001; 344:

3. 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:

4. 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:
Barbut, D. Impact of Embolization During Coronary Artery Bypass Grafting on Outcome and Length of Stay. AnnThorac Surg 1997; 63:

5. 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:

6. 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

7. 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

8. 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

9. 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

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

11. Create the anastomotic hole
Pull Some Strings
Create the anastomotic hole

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

13. 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

14. Pull Some Strings Suture the anastomosis
Complete anastomosis using inside-out suturing technique

15. 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

16. Cut Tension Spring Tether
Pull Some Strings
Cut Tension Spring Tether

17. HEARTSTRINGTM Proximal Seal System