Room Setup, Access, and Closure August 2013 Innovating for life. UC a EE

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Objectives Discuss room setup Understand access steps Discuss wound closure

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Example Hybrid OR Setup Anesthesia Equipment /Valve Preparation Table Echo Sterile Table Other Back-up Equipment Monitors Implanter 1 st Assist

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Perform small left anterior thoracotomy at the 5 th or 6th intercostal space Start incision near the mid- clavicular line and extend toward the nipple approximately 5-6 cm Surgical Exposure

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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 bpm with the result of a mean pressure <50 mm Hg or pulse pressure < 10 mm Hg Apical Exposure

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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 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

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Apical Puncture Puncture with an 18 g needle in the middle of the pre-set purse-string sutures Advance an 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

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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

Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc 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.