Outflow Graft Anastomosis; Driveline Placement - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare
4) Perform a full-thickness cruciate incision inside the sewing ring using an 11-blade scalpel.
Using the apical coring tool (Figure 71), create and remove the apical core. To use the apical coring tool:
5)
Insert the thumb in the thumb ring and wrap the first two fingers around the handle. Push the ring forward
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with your thumb, extending the cutting head.
After the cutting head is completely extended, place the cutting head through the myocardium. Release
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tension.
Grasp the tool with one hand and use the other to rotate the cutting head as it retracts.
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Cored tissue is captured within the cutting head.
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6) Perform a visual inspection of the left ventricle and remove any thrombus or potential obstruction to the inflow cannula.
Place a clamp on the HVAD Pump outflow graft.
7) ®
Remove the inflow cap from the HVAD
8)
9) Insert the inflow cannula into the ventricle. Ensure that the HVAD
Use the sewing ring wrench (Figure 72) to tighten the sewing ring's screw around the HVAD
10)
the wrench to tighten the screw until an audible "click" is heard.
WARNING:
DO NOT loosen the sewing ring's screw by turning the screw counter-clockwise or it may fall off the sewing ring.
11) Verify no blood or air leakage around the sewing ring. Add reinforced pledgeted sutures as needed.

14.6 Outflow Graft Anastomosis

Gently stretch the outflow graft, measure and cut to length. The outflow graft should lie without kinking or
1)
overstretching.
2) Place a partial occlusion clamp on the portion of the ascending aorta where the outflow graft will be placed.
Make a longitudinal arteriotomy and sew the outflow graft to the aorta with 4-0 or 5-0 polypropylene suture.
3)
4) Remove the partial occlusion clamp from the aorta and ensure an intact anastomosis without bleeding, while
keeping the HVAD ® Pump outflow graft clamped.
CAUTION:
If the outflow graft is too short or too long, it may kink. Prior to chest closure ensure that the graft is not kinked or compressed.
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Gelweave is based on a woven structure and may be cut with a cautery to minimize fraying. Note: Immersion of the Gelweave prosthesis in saline immediately prior to use
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will prevent focal burning, which may result during cauterization. Grafts should be immersed in saline for no longer than 5 minutes.
Round body taper point needles should be used when implanting Gelweave prostheses to minimize fiber damage.
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14.7 Driveline Placement

Select the location where the driveline will exit the skin. Consider the position of major organs and structures when
determining the path of the tunneler. Massage antibiotic solution into the external surface of the driveline's woven
polyester velour.
The tunneler (Figure 73) is designed so that the handle can be attached and detached. To attach the handle to the
tunneling rod, depress the locking pin, insert the tunneling rod into the handle until it bottoms out, release the locking pin
and rotate the handle until the locking pops out. Using the tunneler, tunnel the driveline lead to the point of exit. Adjust
distance of exit site from costal margin to fit body habitus and prevent rubbing against the costal margin.
Once the tunneling path has been made, screw the driveline cap on to the tunneling rod tip, as shown (Figure 74). Ensure
that the two-piece driveline cap has not separated and remains tightly fastened. Pull the driveline through the tunneling
path once it is secured to the tunneling tool.
Disconnect the tunneling rod from the driveline cap. Do not remove the driveline cap until it is time to connect the
driveline to the controller. Make sure to protect the driveline connector from contamination during this time. Prior to
removing the driveline cap, put on clean, dry gloves. To remove the driveline cap, unscrew the outer sleeve, and pull
back on the grooved part of the connector. Next, place the white, rubber driveline cover over the driveline connector.
Verify that the connector is dry and clean before attaching to the controller. If the driveline connector contains any fluid, tissue or foreign material, thoroughly clean it with isopropyl
alcohol and dry it with a clean cloth. Attach the driveline to the controller and slide the driveline cover forward to completely cover the controller's silver driveline connector. After
the driveline is connected to the controller, the driveline cover is on, and the pump has started, immobilize the driveline at the exit site with retaining sutures.
WARNING:
To remove the driveline cap from the driveline, unscrew the outer sleeve, then pull back on the grooved part of the connector. DO NOT grasp the driveline
and pull because this may damage the driveline.
CAUTION: During HVAD Pump implantation and re-operation, be aware of the position of the driveline to avoid damage by surgical instruments and needles.
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26 HeartWare Ventricular Assist System
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Pump inflow cannula and keep the HVAD
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® Pump housing is flush with the sewing ring housing.
Pump outflow graft cross-clamped.
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Pump inflow conduit. Use
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Figure 71: Apical coring tool
Figure 72: Sewing ring wrench
Figure 73: Tunneler
Figure 74: Driveline cap attachment to tunneler