Room Setup, Access, and Closure

August 2013

Innovating for life.

UC201301196a EE

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Objectives

• Discuss room setup

• Understand access steps

• Discuss wound closure

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Example Hybrid OR Setup

Anesthesia

Equipment / Valve Preparation Table

Echo

Ste

rile

Tab

le

Oth

er B

ack

-up

E

qu

ipm

ent

Mo

nit

ors

Implanter1st Assist

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Pre-case Planning

Determine incision site by using any of the follow modalities:

• Palpating the point of maximum impulse (PMI)• Multi Slice Cat Scan (MSCT)• Transthoracic Echocardiography• By placing a hemostat over the left ventricular

apex under fluoroscopic guidance• Root angiography using implanters view (~AP

projection, typically in the range between RAO 15 and LAO 15 with mild caudal or cranial angulation)

Performed in a surgical environment under sterile technique

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

• Perform small left anterior thoracotomy at the 5th or 6th intercostal space

• Start incision near the mid-clavicular line and extend toward the nipple approximately 5-6 cm

Surgical Exposure

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

• Insert soft tissue retractor into the wound, and secure retractor limbs with four sutures

• Insert metal rib retractor within the soft tissue retractor

• Perform pericardiotomy in a linear fashion

• Use pericardial stay sutures to retract the pericardium and facilitate positioning of the heart’s apex into the operative field

• Fix ventricular pacing wires to the right ventricle

• Test rapid pacing at 160-200 bpm with the result of a mean pressure <50 mm Hg or pulse pressure < 10 mm Hg

Apical Exposure

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Purse-string Sutures

• Left ventricular purse-string sutures are placed with pledgets - which are large in size (using a clock face paradigm)

• A second set of purse-string sutures should be placed in between the initial set

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

• Place two 5 Fr sheaths into the femoral artery (radial access can also be used) and vein

• Insert a pigtail guide catheter via the femoral artery over a 0.035 inch (0.89 mm) guidewire into the base of non-coronary cusp under fluoroscopic guidance to mark aortic valve basal plane

• Administer heparin to achieve an ACT > 250 seconds (100 IU/kg, intravenously). ACTs’ should be repeated every 30 minutes

• Perform root aortogram shot using a power injector to demonstrate the location of the aortic valve and the severity of aortic valvular insufficiency

Baseline Aortogram

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Apical Puncture

• Puncture with an 18 g needle in the middle of the pre-set purse-string sutures

• Advance an 0.035 inch (0.89 mm) super stiff J-tip wire into the ascending aorta

• Place wire deep into the descending aorta where it will remain for the entire procedure

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Apical Closure

• Perform a TEE & angiogram to confirm valve function• Remove delivery system and wire, ensuring control arm

sleeve fully mates with introducer tube prior to withdrawal

• Rapid ventricular pacing may be used to reduce cardiac output and blood pressure during this portion of the procedure

• Stop rapid ventricular pacing and add additional Teflon reinforced sutures if necessary to achieve complete hemostasis

• Take a final root shot with contrast after wire removal to confirm valve function and coronary patency

• Measure transvalvular pressure gradients• Record ECG for potential arrhythmias and/or heart block• Deliver protamine in standard dose• Loosely approximate the pericardium over the apex

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Wound Closure

• Insert a chest tube or soft drain into the left pleural space

• Administer a long-acting local anesthetic into the intercostals spaces

• Optional: Pain pump may be inserted (e.g., On-Q)• Pull temporary pacing wires or secure to skin at

closing• Close the chest wall only after the bleeding is

controlled• Close thoracotomy in standard fashion; i.e., PDS

suture for closing intercostals space, vicryl muscular closure and a subcuticular skin closure

• Depending on local practice, some patients may be extubated immediately in the operating room or shortly thereafter in the intensive care or post anesthetic care unit

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

Summary

• The transapical procedure is a surgical approach performed in a sterile environment

• A small left anterior thoracotomy is performed at the 5th-6th intercostal space

• After apical access is secure the TAVR procedure is completed

• Apical and wound closure is completed at the end of the procedure

Engager is a registered trademark of Medtronic, Inc.

For more information and a complete list of adverse events, warning and contraindications reference Engager IFU.