Cardiac Stabilization Innovation Workshop Problem Statement: During off-pump cardiac surgery the heart is constantly moving. The movement increases the difficulty of the surgery which can in turn lead to longer surgical times and/or unfavorable patient outcomes. Procedures like this have their benefits since the patient does not have to go on-bypass which can introduce other possible problems. Currently there are cardiac stabilization instruments on the market, however when they are used, particularly when manipulating the heart and fully inverting it can cause the patient to lose systemic pressure and decrease the hearts performance. In summary, an instrument that could stabilize the heart while not inhibiting the proper function of the heart could be advantageous for both the physician and patient. Anatomy: <http://en.wikipedia.org/wiki/File:Mediastinum_anatomy.jpg> Location of the heart in relation to the major blood vessels and lungs. <http://www.heart-valve-surgery.com/surgeon-database/median-sternotomy.jpg> Typical view of a heart through a medial sternotomy. Currently Available Instruments: The tools that are used currently have either one of two functions, 1) to position the heart, 2) to stabilize the tissue. The former moves the heart into a position that is favorable for the physician and the latter reduces the movement of the tissue at a particular location. <http://www.ctsnet.org/graphics/experts/Adult/4165_13.gif> A focal tissue stabilization device from Guidant. It can be seen in use in the next two images. <http://www.ctsnet.org/graphics/experts/Adult/4165_7.jpg> Tissue stabilizer that utilizes suction to hold tissue still. <http://www.revespcardiol.org/ficheros/images/255/255v58n11/origen/255v58n1113081186fig02.jpg> The tissue stabilization device used during cardiac bypass grafting surgery. <http://cardiothoracicsurgeryservices.com/21.html> Other available stabilization and positioning tools for cardiac surgery. The instruments on the right are used to position the heart into a favorable location for the physician and utilize suction to achieve this goal. Both tissue stabilizer an positioned used to hold the heart during cardiac surgery. Alternative methods for holding and stabilizing the cardiac tissue. Most of the stabilizers on the market currently rely on suction to adhere to the epicardium and stabilize or position the heart. Minimally invasive cardiac surgery Minimally invasive cardiac surgery Minimally Invasive Cardiac Surgery, also known as MICS CABG (Minimally Invasive Cardiac Surgery/Coronary Artery Bypass Grafting) or The McGinn Technique is heart surgery performed through several small incisions instead of the traditional open-heart surgery that requires a median sternotomy approach. MICS CABG is a beating-heart multi-vessel procedure performed under direct vision through an aterolateral mini-thoracotomy.[1] Minimally Invasive Heart Surgery is favored by surgeons and patients because of reduced post-operative discomfort, faster healing times and lowered risk of infections or complications. This procedure makes heart surgery possible for patients who were previously considered to be too at risk for traditional surgery due to age or medical history.[2][3] Patients referred for this procedure may have Coronary Artery Disease (CAD); Triple Vessel Disease with median to large posterior descending artery (PDA); or previous unsuccessful stenting. The procedure MICS CABG is performed through one window incision that stretches 5–7 cm in the 4th intercostal space (ICS). In some cases the thoractomy may be necessary in the 5th ICS instead. A soft tissue refractor is used to allow for greater visibility and access. Two access incisions are also made at the 6th intercostal space and xphoid process to allow for operative Medtronic® instruments to pass through.[4] The McGinn Technique (Proximal Anastomoses) The McGinn Proximal Technique is performed with blood pressure lowered to 90-100 systolic which reduces stress to the aorta, reducing the risk of damage. A series of tools are used to position and stabilize vessels. The technique uses devices developed by Medtronic® to support the surrounding heart tissues while vital surgery takes place. The devices are managed externally and access the heart through small incisions between the ribs. Pump-assisted beating heart bypass A cannula with a pump and vacuum action is fed up through an artery in the groin to reduce the stress on the heart so that it may still function during the operation. This pump flows at 2-3L per minute to support circulation and eliminates the need for a heart-lung bypass machine. After surgery Using the McGinn Minimally Invasive technique, patients recover more quickly than from open-heart surgery and suffer fewer complications. Most patients can expect to resume all everyday activities within a few weeks of their operation. After surgery, patients are administered with a pain pump and drains that will be removed after one day. Patients are encouraged to move around as much as possible after their operation to recover quickly. Once discharged from hospital, patients require no further post-operative assistance.[5] Minimally invasive heart surgery procedures are a safe and broadly applicable technique for performing a wide range of complex heart procedures, including single or multiple heart valve procedures, bypass surgery, and congenital heart repairs. Minimally invasive heart surgery has been used as an alternative to traditional surgery for the following procedures: • Mitral valve repair and replacement • Aortic valve replacement • Atrial septal defects 1 Minimally invasive cardiac surgery • Coronary artery bypass Benefits of MICS CABG/ The McGinn Technique Eliminating the need for median sternotomy greatly reduces the trauma and pain associated with open-chest surgery and improves quality of life for patients. In the hospital, reduced post-operative discomfort enables patients to more quickly begin a much shorter recovery process with minimally invasive heart surgery. Most patients ambulate more easily and participate more actively in their personal care. Additionally, this approach lowers risk of complications such as bleeding and infection. Minimally invasive heart surgery dramatically improves cosmetic scarring. Rather than a prominent 10-inch scar down the middle of the chest, patients are left with smaller marks to the side of the ribs. For women, in many cases, this scar is completely unnoticeable as it sits below the breast. Benefits Include: • • • • No splitting of the breastbone Dramatic reduction in pain Lower risk of infection Lower risk of bleeding • • • • • Reduced ICU and hospital stay Improved postoperative pulmonary function Accelerated recovery/return to activity Improved quality of life Greatly improved cosmetic result History The Minimally Invasive Cardiac Surgery was invented by Dr Joseph T McGinn, Jr. The first minimally invasive heart cardiac surgery was performed in the United States on January 21, 2005 at The Heart Institute at Staten Island University Hospital in Staten Island, New York by a team led by Dr. Joseph T. McGinn. This technique is an off-pump coronary artery bypass surgery. The procedure is much less invasive than traditional bypass surgery because it is performed through three small incisions rather than the traditional sternotomy. Since its first procedure, over 900 MICS CABG procedures have been performed at The Heart Institute amongst many more around the world.[6] References [1] [2] [3] [4] [5] [6] "MICS CABG Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure", " (http:/ / medtronicmics. com/ )", 2010, p. 1 "NYU Langone Medical Center", " (http:/ / cardiac-surgery. med. nyu. edu/ )", December 29, 2009 "The Heart Institute"," (http:/ / www. theheartinstituteny. com/ pdf/ THI_March_24th_Press_Release. pdf)", March 25, 2011 "MICS CABG Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure", " (http:/ / medtronicmics. com/ )", 2010, p. 1 "Medtronic", " (http:/ / www. medtronic. com/ mics/ documents/ 200901133b_EN. pdf)", 2009 "The Heart Institute"," (http:/ / www. theheartinstituteny. com/ pdf/ THI_March_24th_Press_Release. pdf)", March 25, 2011 External links • The McGinn Technique at The Heart Institute at Staten Island University Hospital (http://www.theheartinstitute. com/) • Mitral Valve Repair at NYU Langone Medical Center's Cardiac and Vascular Institute (http://cardiac-surgery. med.nyu.edu/treatments-procedures/mitral-valve-repair) • Minimally Invasive Cardiac Surgery at NYU Langone Medical Center (http://cardiac-surgery.med.nyu.edu/ minimally-invasive-heart-surgery) 2 Minimally invasive cardiac surgery • Bypass technique is less taxing for patients- St. Louis Today (http://www.stltoday.com/lifestyles/ health-med-fit/fitness/bypass-technique-is-less-taxing-for-patients/ article_875cda99-ca34-578e-bb47-7185f1205e9b.html) • Heart and Lung surgery clinic-Dr. Mazhar Ur Rehman (http://heartsurgery.com.pk/our-services.html) 3 Article Sources and Contributors Article Sources and Contributors Minimally invasive cardiac surgery Source: http://en.wikipedia.org/w/index.php?oldid=570263677 Contributors: Camwolf72, Delirium, Dlodge, Ebbrock, FifteendegreesWiki, Hertz1888, Malcolma, Nono64, NuclearWarfare, Rd232, Rich Farmbrough, Richard Anthony Clarke, Richardaclarke, T. Canens, 11 anonymous edits License Creative Commons Attribution-Share Alike 3.0 //creativecommons.org/licenses/by-sa/3.0/ 4 MICS CABG Technique Overview : Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure thinking forward Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use. Medtronic is committed to the development of advanced technology to support MICS CABG with its multiple proven benefits for patients, surgeons, and hospitals. Table of Contents What is a MICS CABG Procedure?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Potential Benefits of MICS CABG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Key Procedural Steps (with general recommendations) 1. Patient Selection/Inclusion Criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. Patient Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4. Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5. Thoracotomy/Incisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 6. Access Portals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 7.Left Internal Mammary Artery (LIMA) Harvesting . . . . . . . . . . . . . . . . . . . . . 4 8.Pump-Assisted Beating Heart Bypass. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 9.Aorta Preparation for Proximal Anastomosis . . . . . . . . . . . . . . . . . . . . . . . . . . 5 10. Anastomoses (Distal). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 11. Chest Tube and Drains. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 12.Post-Op Pain Relief with a Pain Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 13. Interdisciplinary Post-Op Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 How Do I Begin?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 MICS CABG Instruments and Disposables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 This technique overview is based on a compilation of the surgical techniques of: Dr. Joseph McGinn, Staten Island University Hospital; Staten Island, New York Dr. Marc Ruel, University of Ottawa Heart Institute; Ottawa, Canada Dr. Mahesh Ramchandani, Methodist Hospital; Houston, Texas Dr. Steven Hoff, Vanderbilt Heart Institute; Nashville, TN Anesthesia techniques: Dr. Scott Sadel, Staten Island University Hospital; Staten Island, New York Dr. Ben Sohmer, University of Ottawa Heart Institute; Ottawa, Canada Expand your reach. Advance your practice. The views and teaching techniques expressed in this Technique Overview are those of medical professionals and not necessarily the views of Medtronic. 1 l Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure What is a MICS CABG Procedure? MICS CABG is a beating heart, multi-vessel CABG procedure in which the anastomoses are performed under direct vision through an anterolateral mini-thoracotomy. The internal mammary artery (IMA) harvest can be performed under direct vision, with video assistance, or robotically. Additionally, in order to achieve complete revascularization, a hybrid approach, or pump-assisted beating heart approach, can be employed. Potential Benefits of MICS CABG: » Improved satisfaction among patients and referring physicians1 » Complete revascularization can be achieved through a small thoracotomy » Surgeon differentiation For the Patient: » Shorter hospital stay2 » Faster return to daily living2 » Better cosmesis » No sternotomy, no risk of a sternal wound infection For the Hospital: » Competitive differentiation » Marketing opportunities » Direct vision MICS CABG: Lower cost per procedure than robotic cases MICS CABG MIDCAB Complete IMA Harvest ✔ — Access to Ascending Aorta for Proximal Attachment ✔ — Multi-Vessel Revascularization ✔ — Less Pain ✔ — Ability to Bypass Inferior & Lateral Coronaries, i.e., PDA, PL ✔ — Starfish® NS Heart Positioner PRODUC T RISK STATEMENT Not all patients are candidates for beating heart procedures. Some patients require cardiopulmonary support during surgery. Octopus® Nuvo Tissue Stabilizer Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure l Key Procedural Steps (with general recommendations) 1. Patient Selection/Inclusion Criteria 3. Patient Positioning » Coronary Anatomy -Left main coronary artery disease (CAD) with normal right coronary artery (RCA) -Triple vessel disease with medium to large posterior descending artery (PDA) -Complex proximal left sided lesions with or without large branch involvement -Previous unsuccessful stenting » Position patients in a 15° to 30° right lateral decubitus position (supine), with the right arm extended to allow harvest of the radial artery, if applicable. » Place a roll longitudinally between the left scapula and spine. » Drape the patient to allow access to the left groin and right thigh/leg for femoral cannulation (if needed) and saphenous vein harvest, respectively. » Slightly drape the left elbow from the patient’s side to expose the patient’s left lateral thoracic wall. » The patient’s iliac crest (top of the hip bone) should be near the flex break in the table, and the patient is placed in a slightly reversed Trendelenburg position. » Comorbidities: Includes patients who are at a high risk for problems with median sternotomy - Long-term steroid use -Severe chronic obstructive pulmonary disease (COPD) - Advanced age -Need for other major operative procedure - Severe deconditioning - Patients with arthritic or orthopedic problems -Patients who want the procedure, are active, and seek out less invasive surgery options 2. Contraindications » Contraindications -Emergency cases - Patients with hemodynamic instability » Potential Contraindications: - Previous CABG surgery - Morbid obesity - Patients with postero-lateral branch disease -Ejection Fraction <20% - Patients with peripheral vascular disease (PVD) - Moderate to severe aortic insufficiency 4. Anesthesia » Single-lung ventilation is required in off-pump MICS CABG procedures. » If pump assistance is used, both lungs can be deflated. However, note that deflating both lungs moves the heart away from the surgeon. » Perform intubation with either a double or single lumen oral endotracheal tube and a left bronchial blocker to deflate the left lung. The single lumen oral endotracheal tube and bronchial blocker are placed under fiber-optic guidance. TIP If CPB is necessary and the surgeon is considering using the right subclavian artery for arterial cannulation, the arterial line should be placed in the left radial artery or the femoral artery. 2 3 l Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure 4. Anesthesia (continued) » Place one external defibrillator pad high over the left scapula and one inferior to the right breast extending medially to the nipple line. » Vasopressors, such as phenylephrine and norepinephrine, and vasodilators, such as nicardipine and nitroglycerine, should be available to control blood pressure during proximal anastomosis. » A standard IV drip setup that includes: nitroglycerine, phenylephrine, norepineprine, vasopressin, insulin, and nicardipine is recommended. » An airway cart with a fiber optic bronchoscope is recommended for placement of a bronchial blocker. » Lines are routine and include an arterial line and PA catheter. If peripheral access is limited, at least a 16 gauge IV should be placed. A triple lumen catheter is placed along with the PAC – “double stick”. » After intubation, place a bronchial blocker into the left mainstem bronchus with fiber optic guidance. Place the proximal end of the balloon approximately 1 cm to 2 cm below the carina. TIP Look beyond the blocker to be sure it is not pushing on a secondary carina. This decreases the chance of trauma to the bronchial mucosa that may result in excessive bleeding after heparinization. Fig. 1 MICS CABG incisions 4. Anesthesia (continued) » Single-Lung Ventilation: -Deliver approximately 10 cc/kg of tidal volume prior to and during single-lung ventilation. The tidal volume may need to be decreased with single-lung ventilation because a large tidal volume causes shifting of the mediastinum, which may cause the MICS retractor to slip. -Keep the O2 saturation greater than 90%. If the saturation begins to decrease: -Add CPAP of 5 cm H2O to the deflated lung. This can be performed through the bronchial blocker by inserting a 7 ETT connector into the barrel of a 3 cc syringe. Insert the syringe tip into the lumen of the bronchial blocker. Attach the 7 ETT connector to a CPAP circuit. -CPAP can be increased, but if it is increased too much it will cause the lung to inflate and obscure the surgeon’s view. 5. Thoracotomy/Incisions T he "window incision" refers to the skin incision and the intercostal incision together. » The window incision is a 5 cm to 7 cm intercostal incision in the 4th ICS -Male patients: Over the 4th intercostal space (ICS) -Female patients: Inframammary -In some patients, this could be the 5th ICS, depending on the location of the apex of the heart -The medial two thirds of the window incision is medial to the anterior axillary line -Divide the intercostal muscles laterally to reduce the risk of rib fracture, then divide them medially to avoid damage to the left internal mammary artery (LIMA) -While making the window incision, deflate the left lung -A soft tissue retractor can be placed in the window incision to maximize access Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure 6. Access Portals » Two access incisions are recommend in multi-vessel MICS CABG procedures -An access incision at the 6th intercostal space -An access incision below the xyphoid process The incisions should be just large enough to allow the shaft of the Octopus® Nuvo Tissue Stabilizer or Starfish® NS Heart Positioner to enter the space. No trocars are needed for the portals. TIP Hybrid Note Anticoagulation Protocol* in Patients undergoing simultaneous Hybrid Coronary Revascularization: Anticoagulation should be modified for hybrid coronary revascularization procedures to reduce the risk of perioperative bleeding and maximize platelet inhibition. -Give aspirin and a loading dose of 300 mg of clopidogrel 30 minutes prior to the CABG procedure. -Utilize routine heparinization during the MICS CABG part of the hybrid procedure. -Do not reverse the heparin and proceed to completion arteriography and then percutaneous revascularization. -Generally, do NOT reverse protamine upon completion of percutaneous revascularization. -If bleeding is a concern, a half dose of protamine can be considered. - Administer 300 mg of clopidogrel in ICU. -Give 75 mg clopidogrel daily post-op. *Anticoagulation protocol utilized at Vanderbilt Heart Institute 7.Left Internal Mammary Artery (LIMA) Harvesting » Place a large Kelly clamp with a sponge in the 6th intercostal space to assist with harvesting the LIMA. Use the sponge to push away tissue for better IMA visualization. » Insert the MICS retractor system into the 4th intercostal space incision; then hook the MICS retractor system to the Rultract® to facilitate the LIMA harvest. » In order to prevent damage to the LIMA, make sure the superior portion of the retractor is placed and maintained in the lateral aspect of the incision. » Care should be taken not to fracture a rib. -The MICS retractor system should be cranked slowly, which allows tissue and bone to acclimate to the change in position to minimize the potential for rib fracture and pain. » The LIMA harvest is started at the 3rd intercostal space using direct vision through the window incision. » Use an extended electrocautery instrument, endoscopic forceps, suction, endoscopic clip applier, and small clips for the harvest. » The harvest is completed up to the subclavian vein and down past the left 5th intercostal space. » Take care to identify and avoid the phrenic nerve. » During the LIMA harvest, flexing the table may facilitate access to the superior portion of the LIMA. » The pedicle of the LIMA is anchored with silk ties to maintain the proper orientation. » Intravenous heparin is given prior to LIMA division. TIP An Army Navy placed at the inferior portion of the window incision retracted by an assistant or attached to the Rultract® may increase visibility when harvesting the distal IMA. Fig. 2 LIMA harvest l 4 5 l Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure 8. Pump-Assisted Beating Heart Bypass » Left groin cannulation is performed with the following cannulae: Bio-medicus® arterial cannula; Bio-medicus® venous cannula. » A reduced prime pump with vacuum-assist setup is preferred » Pump flow rate at 2-3 liters/minute should be sufficient to support circulation » A Perclose® A-T (auto-tie) Suture-Mediated Closure (SMC) device may be used to close femoral artery cannulation site Fig. 3 Pump-assist approach TIP Considerations for pump assistance 9.Aorta Preparation for Proximal Anastomosis » McGinn Proximal Technique 1.After placing the #1 or #2 MICS retractor blades in the window incision, angle the retractor superiorly and use the Rultract to pull the retractor cephalad to gain better access to the ascending aorta (Fig. 4). 2.Remove thymus tissue over the aorta and pulmonary artery. 3.Open the pericardium anterior to the pulmonary outflow track and extend cephalad to the inominate (brachiocephalic) vein. 4.Place pericardial retrection stitches on the right side of the pericardium, and bring the stitches out through separate parasternal stab wounds; these stitches enable you to roll the aorta toward the window incision. 5.Place the Octopus® Nuvo Tissue Stabilizer through the subxyphoid incision to depress the pulmonary artery and expose the ascending aorta. 6.Dissect around the aorta and place vaginal packing or a 1½ inch penrose drain behind the aorta to pull the aorta closer to the window incision. 7.After the blood pressure drops to 90-100 systolic, the proximal anastamoses can be performed by using U-Clip® anastomotic devices, proximal connector, or hand-sewn anastomoses. -A side-biting clamp can be placed on the ascending aorta to facilitate up to 3 hand-sewn anastamoses. Preparing the groin for cannulation at the beginning of the procedure is recommended for the following circumstances: -Cardiomyopathies -Difficult inferior and lateral vessels, i.e., PL and OM2 -Aortic Insufficiency -Surgeons in the early phase of MICS experience -If positioning of the heart causes hypotension that is not responsive to position changes and vasoactive medications, the surgeon can try to reposition the heart to allow for better hemodynamics. If all of these maneuvers fail, it may be necessary to perform the distal anastomoses with pump-assistance. Consider axillary arterial cannulation when femoral cannulation is a poor option, i.e., illiac disease (PVD). Fig. 4 Aorta preparation Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure TIP Anesthesia Considerations for the McGinn Proximal Technique TIP -Bring the systolic blood pressure down to 90 – 100 mm Hg. This makes the aorta more supple, making it easier to pass the tape around the vessel without damaging it. -Occasionally the surgeon will ask to check the superior vena cava (SVC) with the TEE during placement of the umbilical tape around the aorta. This is to be sure the SVC is not occluded by the strap. -It is extremely important to keep the SBP low to keep the side-biting clamp from slipping off, and to prevent damage to the aorta i.e., aortic dissection. -Keep control of the SBP by giving more anesthetics and by using boluses of nicardipine along with an infusion, if necessary. Anesthesia Considerations for the Ruel Proximal Technique Ottawa technique: Minimalize distention of the heart by decreased fluid administration; this keeps the patient dry and assists in avoidancy overfilling with CVP kept below 14 mm Hg. A concern with this technique is patients with decreased renal function. -Single-lung ventilation with left lung down (bronchial blocker or double-lumen endotracheal tube) during the proximal anastomosis -During ascending aorta isolation, the following maneuvers are taken: -Increased tidal volume -Decreased inspiratory/expiratory ratio -Increased Peep Be aware that these maneuvers can result in decreased O2 saturation and shunting. 9.Aorta Preparation for Proximal Anastomosis Note: Check RV pressure when completing proximal anastomosis to ensure the RCA has not been clamped. (continued) » Ruel Proximal Technique 1.Place the MICS Retractor with #1 or #2 blades in the window incision. 2.To expose the ascending aorta, the pericardium is opened anteriorly and retracted inferolaterally toward the thoracotomy by using several traction sutures. 3.Position the MICS retractor in a cephalomedial direction with the Rultract® Skyhook. 4.A 6-mm incision is made in the left 7th intercostal space to allow introduction of an Octopus ® Nuvo tissue stabilizer. 5.Position the Octopus ® Nuvo over the pulmonary artery trunk or right ventricular outflow tract, to gently depress it in a left postero-inferior direction. 6.Pack an open gauze against the right lateral aspect of the aorta, anterior to the superior vena cava. 7.Place a Kay-Lambert, side-biting clamp on the ascending aorta, and up to 3 hand-sewn proximal anastomoses can be performed by using 6-0 polypropylene sutures, under direct vision. 10. Anastomoses (Distal) » Open the pericardium down to the diaphragm and then toward the right pleura. » Heart positioning is accomplished using the Starfish® NS Heart Positioner placed through the subxyphoid portal. » Cases involving the left anterior descending artery (LAD), Diagonal, 1st obtuse marginal (OM), 2nd OM, or ramus intermedius, require the Starfish® NS Heart Positioner to be placed through the subxyphoid portal. l 6 7 l Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure 10. Anastomoses (Distal) (continued) » Divide the rectus fascia just prior to the Starfish® NS Heart Positioner insertion. » A red rubber catheter is placed through the subxyphoid portal and pulled out through the window. » Attach the red rubber catheter to the Starfish® NS Heart Positioner shaft. » Pull the tip of the shaft through the window and attach the Starfish® NS Heart Positioner head onto the shaft. » Next, attach the head of the Starfish® NS Heart Positioner to the obtuse marginal side of the apex of the heart, and apply suction. TIP In order to keep the heart midline for optimal stabilization, during a left circumflex anastomosis, use bilateral, low-tidal ventilation. Alternatively, use lap pads to pack the left lung and achieve the same result. Helpful hint -All distal anastomoses can be created using the U-Clip® Anastomotic Device or standard suturing techniques. TIP » Overall Positioning Guidelines -Diagonal and ramus intermedius: Neutral position of the Starfish® NS Heart Positioner -LAD Position: Clockwise rotation of the Starfish® NS Heart Positioner -OM: Counterclockwise rotation of the Starfish® NS Heart Positioner, while moving the heart medially -PDA: Rotate and move the heart toward the patient's left shoulder with the Starfish® NS Anesthesia Considerations for Distal Anastomosis Staten Island technique: Prior to the distal anastomosis, patients can be given a loading dose of Milrinone (50μg/Kg) over approximately 20 minutes; even if the cardiac index is adequate. This technique has the effect of decreasing the cardiac size, allowing the smaller heart to be more easily positioned in the confined space of the closed chest. It also has the effect of shifting the heart’s Frank-Starling curve upward, allowing for better hemodynamics in the face of decreased preload secondary to the positioning of the heart for distal anastomoses. TIP For lateral coronary vessels, place the patient in the Trendelenberg position and rotate the patient away from the surgeon to better expose the left lateral wall of the heart. -Once the heart is positioned and visible through the window, place the Octopus® Nuvo Tissue Stabilizer through the 6th intercostal space incision and stabilize the vessel using suction. -Once the artery is stabilized, the artery is occluded and bypass is created using routine forceps, coronary scissors, and coronary needle holders. Optimal Stabilization TIP Re-inflate the left lung under direct vision to prevent avulsion of the LIMA-LAD with the expanding lung tissue. 11. Chest Tube and Drains » A chest drain can be placed through each of the portals that have already been created for the Starfish® NS Heart Positioner and Octopus® Nuvo Tissue Stabilizer. Technique Overview: Minimally Invasive CABG (MICS CABG) Procedure 12. Post-Op Pain Relief with a Pain Pump 13. Interdisciplinary Post-Op Guide (continued) » After protamine administration, 2 soaker catheters can be placed: -One subpleura -One subcutaneous » Unless contraindicated, resume antihypertensive medications on the first postoperative day. » Patients undergoing MICS CABG with a radial artery graft are prescribed dihydropyridine calcium channel blockers for 6 months. » Catheters remain in place per pain pump instructions. » Administer Marcaine® in a .25% dosage level. 13. Interdisciplinary Post-Op Guide » Extubation is usually achieved 2-6 hours after surgery. » Pain management: Pain pump » Start patients on daily enteric-coated 325 mg aspirin on the day of the operation. » Resume clopidogrel, 75 mg, in patients with coronary stents. TIP All patients are treated with medical therapy as with conventional CABG via sternotomy, including aspirin, beta-blockers, ace inhibitors, and statin therapy. » Post-op Day 1 -Patient ambulating and all drains out -Evaluate discharge needs and prepare for discharge -Transfer to telemetry -Bedside exercise, ambulate with assistance » Post-op Day 2 and Beyond -Ambulate with minimal or no assistance -Evaluate for discharge -Ad-lib activities -Visiting nurse referral » At Home -No physical restrictions -Remove pain pump as instructed These are recommendations based on optimal patient recovery. How do I begin? Medtronic offers peer-to-peer education for surgeons interested in learning how to do a MICS CABG procedure. Please contact your CardioVascular sales representative for more information. l 8 MICS CABG Instruments and Disposables 1. ThoraTrak® MICS Retractor System 2. Octopus® Nuvo Stabilizer 3. Starfish® NS Positioner 4. U-CLIP® Anastomotic Device 5. Mounting System for Octopus® Nuvo and Starfish® NS 6.Rultract® with Skyhook Retractor 7.Optional Rotating Extender Bar with Cross Square (Rultract®) 8. Small and Medium Endoscopic Clip Appliers 9. Knot Pusher 10. Minimally Invasive (MI) Needle Holder 11. Minimally Invasive Curved Scissors 12. Minimally Invasive Debakey Forceps 13. 14"Chest Tube Passer w/ Lock 14.Tangential Occlusion Clamp - 34 mm w/ DeBakey Atraumatic Jaws, Slightly Curved 15.DeBakey Aorta Clamp - Full Curved DeBakey Atraumatic Jaws, Curved Shanks, Stainless Steel,10.5 inch 16. Soft Tissue Retractor 17. 16 and 18 Fr Red Rubber Catheter 18.Extended Bovie Blade 19. Biomedicus® Femoral Cannula - Arterial 20. Biomedicus® Femoral Cannula - Venous 21. Pain Pump 22. Standard Off-Pump CABG tray * Medtronic products in bold. ** T he instruments/disposables listed are in addition to essential instruments necessary to perform surgery. Refer to MICS CABG instrumentation list for complete details. *** Cannula sizing should be determined by the surgeon. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use. References: 1. Poston R, Tran R, Collins M, Reynolds M, Connerney I, et al. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008:248: 638-646. 2. M cGinn JT, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual center experience in 450 consecutive patients. Circulation. 2009; 120:S78-S84. Rultract is a registered trademark of Rultract. Used without permission. Marcaine is a registered trademark of AstraZeneca. Used without permission. Perclose is a registered trademark of Abbott Vascular. Used without permission. Bio-Medicus, Starfish, Octopus, ThoraTrak, and U-Clip are registered trademarks of Medtronic, Inc. www.medtronicMICS.com www.medtronic.com World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 E-mail: rs.cstechsupport@medtronic.com Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals) UC200901133b EN © Medtronic, Inc. 2009, 2010. All Rights Reserved. Printed in USA Octopus Nuvo Setup Guide ® De vice Se tup 1.Attach the rail clamp to the surgical table. Position the rail clamp and mounting rail at the patient’s hip. 4. Transfer the Octopus ® Nuvo and vacuum line extension to the sterile field using aseptic technique. 2.Attach the mounting rail to the rail clamp. 5. Connect the vacuum line extension to the luer connector of the canister tubing set and attach the canister tubing set to the regulated vacuum source. Set the regulated vacuum to (–)400 mm Hg. 3.If using a Medtronic mounting rail, insert the flex-arm post into the mounting rail. Secure the flex arm in the mounting rail by locking the mounting rail lever. Whale tail Flex-arm post Flex arm Flex-arm clamp Whale tail Blunt tip Stabilizer headlink Blunt tip Stabilizer headlink Shaft Placement 1.Loosen the Octopus® Nuvo whale tail by turning it counterclockwise to the out position. (Figure 1.) 2.Tether the blunt tip of the Octopus® Nuvo with a suture to prevent accidentally dropping the blunt tip in the thoracic cavity. 3.Press the whale tail forward, hold and connect the blunt tip to the shaft of the Octopus® Nuvo. 4.Release pressure on the whale tail then turn the whale tail clockwise to fully tighten and prevent the blunt tip from becoming dislodged. 5.Insert the shaft of the stabilizer with the blunt tip through the port incision. 6.Loosen the whale tail by rotating it counterclockwise until reaching a stop while grasping the blunt tip with a surgical instrument. 7.Press the whale tail forward and remove the blunt tip. 11.Release pressure on the whale tail, then turn the whale tail counterclockwise until you feel resistance. This attaches the headlink to the shaft of the device, but still allows for movement and flexibility in order to position the headlink. 12.Make sure the headlink is attached to the shaft. There should not be a gap between the headlink and the shaft. (Figure 2.) 13.Position the headlink on the desired coronary target and then fully tighten the whale tail. 4. When the Octopus® Nuvo is properly positioned, fully tighten the flex arm 1 whale tail in order to lock the stabilizer in that position. 15.Turn suction on to (-)400 mm Hg. In position Out position Connected Not connected 8.Grasp the headlink at the plastic overmold with a surgical instrument. 9.Place the headlink in the thoracotomy incision, bring the suction line out through the stabilizer shaft incision or through the thoracotomy. 10.Pressing the whale tail forward, insert the collet of the headlink into the shaft of the Octopus® Nuvo. (Figure 1) (Figure 2) Inserting the headlink Ball joint Plastic overmold Repositioning 1.Loosen the flex arm whale tail. O rd er in g informat i on TSMICS1 Octopus® Nuvo Tissue Stabilizer 2. Loosen the Octopus® Nuvo whale tail. 3. Turn suction off. 4.Manipulate the headlink as desired and fixate again as in steps 13–15. Removing Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use. Octopus, Starfish and ThoraTrak are registered trademarks of Medtronic, Inc. 1.Loosen the flex arm whale tail and remove the flex arm. 2. Loosen the Octopus ® Nuvo whale tail. 3.Turn suction off. 4.While grasping the headlink with a surgical instrument, press the whale tail forward to release the headlink. 5.Remove the headlink through the thoracotomy and then remove the shaft of the device from the thoracic cavity. LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 E-mail: rs.cstechsupport@medtronic.com www.medtronicmics.com UC201003673 EN © Medtronic, Inc. 2010. All Rights Reserved. Printed in USA Collet clampless beating heart surgery | 2 | CLAMPLESS BEATING HEART | Cardiovascular | A comprehensive solution designed To optimize outcomes ACROBAT Mechanical, ACROBAT SUV, and ACROBAT V HEARTSTRING III Seal Loader and Delivery Device, Aortic Cutter, and Seal HEARTSTRING ® III PROXIMAL SEAL SYSTEM ACROBAT ® OFF-PUMP SYSTEMs Do more—clamp less. HEARTSTRING III brings proximal Suture with ease. The ACROBAT Off-Pump System provides anastomotic technology into the future. A hemostatic seal the strength, visibility, and stability necessary in a variety enables surgeons to eliminate partial occlusion clamps and of surgical situations. minimize aortic manipulation that can lead to complications. Safety: Helps avoid embolic release and reduces the potential for neurologic complications Patency: Allows use of the surgeon’s own hand-suturing technique for optimal anastomotic quality and procedural flexibility Ease of use: The innovative loading device makes HEARTSTRING III Seal placement fast and easy Excellent stabilization: Malleable feet provide ideal stabilization and superb vessel presentation; tri-slot socket wrist design provides access to difficult vessels in “toes-up” position, for maximum visibility Strength and flexibility: Low-profile arm is designed for increased strength, and innovative FlexLink™ technology features interlocking links that enable greater maneuverability PRODUCT ORDERING INFORMATION Offer more patients the proven benefits of clampless beating heart surgery: reduced mortality, improved cognition, and more rapid recovery.1-3 MAQUET Cardiovascular offers an integrated system that complements a range of surgical approaches. Description Code HEARTSTRING® III Proximal Seal System HEARTSTRING III Seal, Delivery Device, Loader, and 4.3 mm Aortic Cutter HEARTSTRING III Seal, Delivery Device, Loader, and 3.8 mm Aortic Cutter HEARTSTRING III Seal, Delivery Device, and Loader HSK-3043 HSK-3038 HS-3045 XPOSE® Access Device XPOSE 3 Device XPOSE 4 Device XP-3000 XP-4000 ACROBAT ® Off-Pump Systems and ULTIMA OPCAB™ System HEARTSTRING® Proximal Seal System allows clampless anastomoses, easy use with hand-suturing, and reduced risk of embolic release4 ACROBAT® Off-Pump System offers uncompromising strength and stability AXIUS Blower/Mister. CO blower with mist, 16.5 cm malleable shaft and IV set AXIUS Coronary Shunt Tip diameter (mm) Standard length (mm) Long length (mm) 1.00 16.25 1.25 16.25 1.50 16.25 20.25 1.75 17.50 2.00 18.00 22.00 2.25 18.50 2.50 19.00 2.75 19.50 3.00 20.00 3.50 24.00 2 hemodynamics while providing a simple way to position target vessels AXIUS® Beating Heart Accessories help optimize operative conditions and maintain perfusion MAQUET Cardiovascular strives to be the gold standard in surgical technology, delivering exceptional stability, flexibility, and visibility. For more information about the HEARTSTRING III ® Proximal Seal System and the complete line of clampless beating heart surgery devices, www.maquet.com. D = deep OM-9000S OM-9100S OM-6000S OM-2001S OM-2001D OM-2003S XO3-9000S XO4-9000S XO3-9100S XO4-9100S XO3-6000S XO4-6000S XO3-2001S XO3-2001D XO4-2001S XO4-2001D XO3-2003S XO4-2003S AXIUS® Beating Heart Accessories XPOSE® Access Device maintains contact a MAQUET representative or visit S = standard ACROBAT SUV Stabilizer ACROBAT V Vacuum Stabilizer ACROBAT Mechanical Stabilizer ULTIMA Mechanical Stabilizer ULTIMA Mechanical Stabilizer ULTIMA Mechanical Stabilizer* XPOSE 3 + ACROBAT SUV Stabilizer XPOSE 4 + ACROBAT SUV Stabilizer XPOSE 3 + ACROBAT V Stabilizer XPOSE 4 + ACROBAT V Stabilizer XPOSE 3 + ACROBAT Mechanical Stabilizer XPOSE 4 + ACROBAT Mechanical Stabilizer XPOSE 3 + ULTIMA Mechanical Stabilizer XPOSE 3 + ULTIMA Mechanical Stabilizer XPOSE 4 + ULTIMA Mechanical Stabilizer XPOSE 4 + ULTIMA Mechanical Stabilizer XPOSE 3 + ULTIMA Mechanical Stabilizer* XPOSE 4 + ULTIMA Mechanical Stabilizer* CB-1000 Code OF-1000 OF-1250 OF-1500/OF-1500L OF-1750 OF-2000/OF-2000L OF-2250 OF-2500 OF-2750 OF-3000 OF-3500 * With offset wide foot. References: 1. Diegeler A, Hirsch R, Schneider F, et al. Neuromonitoring and neurocognitive outcome in off-pump versus conventional coronary bypass operation. Ann Thorac Surg. 2000;69:1162-1166. 2. Murkin JM, Boyd WD, Ganapathy S, Adams SJ, Peterson RC. Beating heart surgery: why expect less central nervous system morbidity? Ann Thorac Surg. 1999;68:1498-1501. 3. Puskas JD, Wright CE, Ronson RS, Brown WM, Gott JP, Guyton RA. Clinical outcomes and angiographic patency in 125 consecutive off-pump coronary bypass patients. Heart Surg Forum. 1999;2:216-221. 4. Wolf LG, Abu-Omar Y, Choudhary BK, Pigott D, Taggart DP. Gaseous and solid cerebral microembolization during proximal aortic anastomoses in off-pump coronary surgery: the effect of an aortic side-biting clamp and two clampless devices. J Thorac Cardiovasc Surg. 2007;133:485-493. | Cardiovascular | CLAMPLESS BEATING HEART | 4 | INSTRUCTIONS FOR USE HEARTSTRING® III Proximal Seal System CAUTION Federal (USA) law restricts the use of this device to sale, distribution, and use by or on the order of a physician. INDICATIONS The HEARTSTRING® III Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp. CONTRAINDICATIONS 1. Do not use the HEARTSTRING® III Proximal Seal System in the portion of the aorta where conventional surgical anastomoses would typically not be created due to the presence of palpable disease. Such determination may also be based upon echocardiograms. 2. Do not use the HEARTSTRING® III Proximal Seal System on patients with aortas less than 2.5 cm in diameter. WARNINGS AND PRECAUTIONS 1. Physicians should be properly trained prior to using the HEARTSTRING® III Proximal Seal System. 2. Physicians should not use the HEARTSTRING® III Proximal Seal System on portions of the aorta where a partial occlusion clamp cannot be applied, to prevent patient compromise due to hemorrhage. 3. The HEARTSTRING® III Proximal Seal System should not be used in patients with thin-walled aortas due to the potential risk of the tether lacerating the side of the aortotomy. 4. When performing multiple anastomoses, ensure that all anastomotic sites are at least 1.5 cm apart to ensure hemostasis. 5. Do not reuse or resterilize the HEARTSTRING® III Proximal Seal System or any of its components. 6. Do not use the HEARTSTRING® III Proximal Seal System if the packaging is damaged or opened. 7. Inspect the devices to ensure no damage has occurred during transit. 8. The Aortic Cutter is a single use (one aortotomy) device. Any attempt to reuse the Aortic Cutter may result in the introduction of air emboli into the aorta. 9. The Aortic Cutter is for use on unaltered tissue only. Use on altered tissue (eg, cardioplegia hole, aortotomy incision) may cause the aortic plug to not be captured by the device and result in the introduction of emboli into the aorta. are supplied nonsterile and must be cleaned and sterilized prior to each use. Never use saline solution for cleaning surgical instruments. 8. Steam sterilization is recommended to sterilize the Activator Drive Mechanisms. Other methods of sterilization have not been demonstrated as effective and are not recommended. 9. The maximum vacuum setting for the Acrobat SUV Vacuum Stabilizer is 400 mm Hg. XPOSE® Access Device CAUTION Federal (USA) law restricts the use of this device to sale, distribution, and use by or on the order of a physician. INDICATIONS The XPOSE Access Device is intended to expose coronary arteries during minimally invasive, off-pump cardiac surgery through a sternotomy incision approach with a Stabilization System. CONTRAINDICATIONS Do not engage the XPOSE Access Device over a coronary artery, or newly infarcted or aneurysmal tissue. If hemodynamic instability is experienced, gently return the heart to its resting position. WARNINGS AND PRECAUTIONS Physicians should be properly trained to perform cardiac surgical procedures with instruments prior to use. Many variables, including patient anatomy, pathology, and surgical techniques, may influence procedural outcomes. Patient and procedure selection is a responsibility of the medical professional. Care should be taken to ensure that mount and mount lever are clear of tissue when device is positioned on sternal retractor. AXIUS® Blower/Mister CAUTION Federal (USA) law restricts the use of this device to sale, distribution, and use by or on the order of a physician. INDICATIONS ACROBAT® Off-Pump System CAUTION The AXIUS Blower/Mister is intended to clear an anastomotic site for improved visibility. Federal (USA) law restricts the use of this device to sale, distribution, and use by or on the order of a physician. 1. DO NOT set flow at a rate greater than 8 liters per minute (l/min). 2. Use caution when moving the tip of the AXIUS Blower/Mister closer than 3 cm to the surgical site. Do not allow tip to contact tissue. 3. DO NOT USE OXYGEN WITH THIS DEVICE. 4. This product is for single use only. DO NOT RESTERILIZE. DO NOT REUSE. INDICATIONS Each ACROBAT Vacuum Stabilizer System is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. The AccessRail® Platform, in combination with an Activator ® Drive Mechanism, is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The stabilizer isolates and provides local immobilization of the target vessel on the beating heart. WARNINGS AND PRECAUTIONS AXIUS® Coronary Shunts CAUTION Federal (USA) law restricts the use of this device to sale, distribution, and use by or on the order of a physician. CONTRAINDICATIONS INDICATIONS Do not position the stabilizer foot over a coronary artery, or newly infarcted or aneurysmal heart tissue. The AXIUS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy during the anastomosis. The AXIUS Coronary Shunt is not an implant and is removed prior to completion of the anastomosis. WARNINGS AND PRECAUTIONS 1. Physicians should be properly trained to perform cardiac surgical procedures with instruments prior to use. 2. As with all surgical retractors, care should be taken to use only as much retraction as necessary to provide adequate access and visualization. 3. Perform the anastomosis only when the stabilizer foot is properly seated on the epicardium and adequate stabilization of the surgical site is achieved. 4. When removing the stabilizer from the epicardium, care should be taken not to disrupt the anastomotic site. 5. Take care not to adjust or move the AccessRail Platform while pericardial sutures are engaged in the platform. 6. Suture holder features are designed for “0” size sutures. 7. The Activator Drive Mechanisms WARNINGS AND PRECAUTIONS 1. Use care during insertion and removal of the shunt to avoid tearing of the vessel wall and/or intimal dissection. 2. During insertion of the shunt, avoid engaging shunt in septal or side branches. 3. Discontinue use and remove if significant resistance is felt during insertion of the shunt. 4. Care should be exercised upon removal of the shunt to prevent the shunt from getting entangled in sutures. 5. Take care not to stitch the shunt while suturing anastomosis. 6. Once shunt has been removed, do not reinsert as residual blood may remain in the lumen. | Cardiovascular | CLAMPLESS BEATING HEART | 5 | XPOSE 4 and XPOSE 3 AXIUS Blower/Mister and Coronary Shunts XPOSE ® ACCESS DEVICE AXIUS ® BEATING HEART ACCESSORIES Reach target vessels easily. The XPOSE Access Device See more clearly. The AXIUS Coronary Shunt and Blower/ is designed for apical or nonapical placement, and securely Mister help to optimize operative conditions during coronary lifts the heart for access to vessels in any location. revascularization procedures. Maintain stable hemodynamics: Active suspension technology allows normal cardiac motion Ensure secure contact: Tissue-conforming suction cup uses gentle vacuum to stay in place Reveal hard-to-reach vessels: Low-profile arm makes it easy to see and gain access to any target vessel Create a clear work area: Shunt provides a bloodless field at the anastomotic site Minimize ischemia: Shunt helps maintain distal perfusion Maintain moisture: Blower/Mister helps prevent dessication of graft Increase visibility: Blower/Mister gently displaces blood with a controlled flow of saline and CO2 Copyright MAQUET Cardiovascular LLC or its affiliates. All rights reserved. 04/08 • ® MAQUET Registered Trademark of MAQUET GmbH & Co. KG MAQUET Cardiovascular LLC 170 Baytech Drive San Jose, CA 95134 Phone: 1-888-880-2874 Fax: 1-888-899-2874 www.maquet.com GETINGE Group is a leading global provider of equipment and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. Equipment, service and technologies are supplied under the brands ArjoHuntleigh for patient handling and hygiene, disinfection, DVT prevention, medical beds, therapeutic surfaces and diagnostics, GETINGE for infection control and prevention within healthcare and life science and MAQUET for Surgical Workplaces, Cardiovascular and Critical Care. LT7900243 392 NEW TECHNOLOGY IN CARDIAC SURGERY Techniques of Exposure and Stabilization in Off-Pump Coronary Artery Bypass Graft Paulo Soltoski, M.D., Jacob Bergsland, M.D., Tomas A. Salerno, M.D., Hratch L. Karamanoukian, M.D., Giuseppe D'Ancona, M.D., Marco Ricci, M.D., Ph.D., and Anthony L. Panos, M.D. Division of Cardiothoracic Surgery, Kaleida Health and VA Medical Center, State University of New York at Buffalo, Buffalo, New York ABSTRACT Recent advances in techniques of coronary artery exposure and myocardial stabilization in off-pump myocardial revascularization have provided cardiac surgeons with a wide variety of new devices and techniques. Until recently, the main obstacle t o performing complete myocardial revascularization without using cardiopulmonary bypass (CPB) has been the technical difficulties of exposing and stabilizing coronary targets, especially those located on the lateral and inferior wall of t h e heart. The extraordinary cardiac tolerance t o nonconstrictive anterior elevation and lateral displacement, however, has allowed t h e development of new strategies of coronary exposure. These advances, in combination with the development of new techniques of mechanical myocardial stabilization, have impacted on the feasibility and safety with which coronary anastomoses on the beating heart can be constructed. The aim of this article is t o describe the technical aspects involved in off-pump coronary revascularization, focusing primarily on the most recent strategies of cardiac elevation and coronary exposure, t h e various techniques of myocardial stabilization, and some of t h e technical details of constructing distal anastomoses on the beating heart. (J Card Surg 7 999; 14:392-400) Myocardial revascularization on the beating heart was introduced in the late 194Os, when Dr. Vineberg first reported on the implantation of the left internal mammary artery directly on the myocardium in an attempt to improve its perfusion.l,* The importance of coronary artery occlusion as a key element in the pathogenesis of ischemic heart disease, however, was recogAddress for correspondence: Tomas A. Salerno, M.D., Department of Cardiothoracic Surgery, Kaleida Health-Buffalo General Hospital Site, 100 High Street, Buffalo, NY 14203. Fax: (716)859-4697; e-mail sur237@pol.bgh.edu Dr. Sclerno is a consultant for CTS, Cupertino, California. nized and investigated in experimental studies only in the early 1950s by Murray and coworkers.3 A few years later, Bailey et al. reported on a successful case of coronary endarterectomy performed in the setting of coronary artery occlusive d i ~ e a s e It. ~was not until the early 1960s, however, that many of the most significant contributions to coronary artery surgery were made, primarily as a result of the revolutionary approach to cardiac surgery determined by the introduction of the cardiopulmonary bypass circuit by Dr. Gibbon in Philadelphia.5,6 Using such innovative techniques, Dr. Sabiston at Johns Hopkins pioneered the initial development of coronary surgery, and J CARD SURG 1999;14:392-400 in 1962 performed the first human coronary artery bypass grafting using the extracorporeal circulation, which consisted of a saphenous vein graft from the aorta to the right coronary artery.' The following two decades were characterized by the most important advances in the field of extracorporeal circulation, which significantly contributed to the popularization of coronary artery revascularization. Not surprisingly, the attractiveness of a bloodless and perfectly motionless operative field largely overshadowed the risks associated with the use of CPB, until initial reports on the adverse neurological events resulting from the use of extracorporeal circulation were published by Rosenblum and coworkers.8 Despite the growing enthusiasm for the new techniques of extracorporeal circulation and its widespread popularization in cardiac surgery, attempts were made a t performing coronary surgery without CPB. This innovative approach was pioneered by Kolessov in 1967,9 who reported on a patient in whom the left internal mammary artery (LIMA) was anastomosed to the left anterior descending coronary artery (LAD) through a left thoracotomy, without using CPB. The technique of coronary revascularization without CPB was subsequently adopted and refined by DeBakeylO and Favalorol in the late 1960s and early 1970s. During the years following, as a consequence of the technical difficulties related to the initial experience with off-pump myocardial revascularization and the refinements of techniques of extracorporeal circulation and myocardial preservation, the offpump approach was largely abandoned in favor of CPB. Nevertheless, in the 1980s two independent groups of investigators lead by Benetti in Argentina12-14and Buffolo in Brazill5,l6 relentlessly continued their work on off-pump coronary revascularization and reported favorable outcomes from their large series of patients. Not surprisingly, those reports determined a remarkable resurgence of interest for techniques of off-pump CABG in an attempt to eliminate the untoward systemic effects of CPB. Despite the growing enthusiasm, however, this technique was initially adopted predominantly, and perhaps almost exclusively, for revascularization of the LAD territory for the technical difficulties of exposing coronary arteries located on the lateral and inferior wall of the heart. Only during the last decade have the innovative techniques of myocardial elevation, coronary exposure, and mechanical stabilization SOLTOSKI. ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG 393 lead to the widespread use of this approach and, more importantly, have allowed the development of complete revascularization of all coronary territories, including those on the "topographically difficult" areas. As such, this new approach to minimally invasive CABG without CPB has been recently proposed as a new alternative to conventional myocardial revascularization. In this perspective, the aim of this article is to describe some of the technical details of off-pump coronary revascularization, focusing predominantly, but not exclusively, on recent advances in coronary artery exposure and mechanical myocardial stabilization. In addition, pitfalls and strategies commonly adopted are described. TECHNICAL ASPECTS OF OFF-PUMP REVASCULARIZATION As previously described,17the feasibility of myocardial revascularization without CPB is largely dependent on the ability to expose all target vessels, minimize their motion during construction of distal anastomoses, and preserve visualization by maintaining a bloodless operative field. Surgical approaches in off-pump CABG A variety of different approaches may be used in the setting of myocardial revascularizationwithout CPB. These include median sternotomy, partial sternotomy, left anterior small thoracotomy (LAST),I8 left posterolateral thoracotomy, s u b xyphoid access, and "hybrid approaches" (such as the LAST procedure in combination with the s u b xyphoid access). While some of these may be useful, especially during redo operations, complete myocardial revascularization in the setting of primary operation is most commonly performed through a median sternotomy. In our experience, however, complete revascularization also can be accomplished through a partial sternotomy (only the distal two thirds of the sternum are divided), although the operative time may be slightly prolonged. This a p proach still allows complete access to the great vessels in a few patients in whom cardiopulmonary bypass is required, and it may decrease the risk of wound complications in the postoperative period. More importantly, it may be particularly advantageous in patients with severe emphysema, COPD, and impaired respiratory mechanics in whom the improved stability of the chest wall and the reduc- 394 SOLTOSKI, ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG tion in postoperative pain may beneficially affect ventilation and respiratory function. Exposure of the coronary targets Adequate exposure of the coronary arteries identified as potential targets on preoperative coronary angiography cannot be obtained without a combination of variable degrees of elevation and lateral displacement of the heart. Obviously, the degree of cardiac elevation and displacement necessary to obtain adequate visualization are primarily determined by the location of the target coronary artery on the surface of the heart, although other factors such as size of the cardiac chambers and morphology of the chest wall may play a role. In this regard, the principles of vessel exposure do not differ significantly from those used in conventional coronary operations on the electromechanically arrested heart. However, in "off-pump" revascularization this has to be accomplished while the heart is beating, thereby maintaining cardiac function and preserving hemodynamics. In our experience, exposure is best accomplished by placing several stitches in the posterior pericardium and connecting them to a "vaginal tape," which can them be manipulated and pulled in various directions, thus lifting the heart and exposing the areas where the targets are located. This technique, originally described by Ricardo Lima from Brazil and never published, initially consisted of placing four stitches at the level of the aorto-pericardial reflection, right superior and inferior pulmonary veins, and half-way between the left inferior pulmonary vein and the inferior vena cava. Alternatively, in an attempt to simplify this approach, we have described and currently use a modification to this technique that essentially consists of placing a single suture in the oblique sinus of the posterior pericardium ("single suture" technique) (Fig. l ) . 1 9 After the sternum is divided and the heart is exposed, the surgeon, standing on the right side of the patient, uses his left hand to rapidly elevate the heart and expose the posterior pericardium. Then the "single suture," usually a O-silk, is placed on the oblique sinus of the pericardium, situated between the right and left, superior and inferior pulmonary veins. Care must be taken to place the stitch only through the pericardial layers, because the esophagus and descending thoracic aorta are J CARD SURG 1999;14:392-400 commonly located in close proximity. As soon as the suture is placed, the heart is rapidly relocated within the pericardial cradle and the silk suture is secured to a "vaginal tape," which is pushed down with a snare to the posterior pericardium. This is commonly performed because the vaginal tape, in contrast to the silk suture, does not traumatize the heart ("sewing effect") once it is used to obtain cardiac elevation. Only a few seconds of cardiac lifting usually are necessary to place the suture in the posterior pericardium. As a result, any drop in blood pressure is usually transient and of no clinical relevance. Once the "single suture" is placed, manipulation and traction on the vaginal tape allow cardiac elevation and lateral displacement, which allows proper visualization of all coronary targets, including those located on the lateral and inferior wall of the heart, which are the most difficult to expose. The vaginal tape is gently secured under tension to the left blade of the sternal retractor, only slightly lifting the heart upward and toward the right, if the LAD system has to be exposed. Alternatively, just by opening the vaginal tape in two arms, the apex of the heart can be elevated toward the ceiling and laterally displaced toward the left shoulder, thereby exposing the posterior descending coronary artery or the posterolateral branches of the right coronary artery. In addition, exposure of the circumflex system can be obtained by brining the two arms of the vaginal tape to the left of the heart and securing them to the right blade of the sternal retractor. Although adequate exposure of the circumflex system may be the most difficult to obtain, opening the right pleuropericardial space may considerably facilitate exposure by allowing the heart to herniate into the right chest. Hemodynamic consequences of cardiac elevation and displacement Concerns have been raised regarding the possibility of deterioration of the hemodynamic parameters during cardiac elevation and manipulation, which may be more pronounced in the case of exposure of the circumflex territory. A significant decrease in systolic, and particularly diastolic arterial pressure would invariably determine a significant reduction in coronary perfusion pressure, particularly detrimental in patients affected with underlying coronary artery disease. Furthermore, suboptimal myocardiac perfusion during cardiac J CARD SURG 1999;14:392-400 elevation and manipulation, in theory, may further decrease left ventricular performance, thereby further aggravating hemodynamics. However, in our experience20,21 as well as those reported by others,22 alteration of left ventricular geometry with deterioration of hemodynamic parameters even during maximal cardiac elevation is usually an uncommon event if some principles are followed. In this regard, we have observed that cardiac elevation should be accomplished progressively, occasionally over several minutes, to obtain adequate exposure, allowing the heart to hemodynamically adjust to the new position. Moreover, suboptimal exposure for limited cardiac elevation or lateral displacement may be compensated for by changing the position of the operating table (Trendelenburg position, inclination toward one side or the other). Not surprisingly, positioning of the patient in the Trendelenburg position considerably facilitates exposure of the inferior wall of the heart. Similarly, rotation of the table toward the right side of the patient (surgeon's side) improves exposure of the circumflex territory. Moreover, as reported by other^,^^,^^ the Trendelenburg position may significantly improve systemic venous return and preload to the rightsided heart chambers, thus maintaining adequate cardiac output. In the very few patients in whom cardiac elevation and adequate exposure cannot be accomplished avoiding hemodynamic instability, in spite of additional administration of volume and inotropic support, conversion to cardiopulmonary bypass is promptly undertaken and generally does not adversely affect perioperative outcomes.21 Preserving hemodynamics during cardiac elevation In recent years, the advances made in the field of mechanical stabilization have lead to the popularization of strategies of coronary grafting without CPB. Similarly, the introduction and development of mechanical stabilizers of the new generation have rendered pharmacologicaltechniques of stabilization virtually obsolete, so that the use of betablockers, calcium channel blockers, and adenosine, previously used by some investigators to reduce -- ,motion by reducing inotropism and chronotropisrn, is no longer required. In this perspective, because a motionlessfield can be obtained effectively by using the new stabilizers, pharmacological manipula- SOLTOSKI, ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG 395 tion of the cardiovascular system using drugs that may adversely affect cardiac performance is avoided. Conversely, various strategies are frequently used to improve contractility and chronotropism in an attempt to maintain hemodynamics during maximal cardiac elevation. These primarily include the use of temporary pacing wires, volume administration, and thoughtful inotropic support. Not surprisingly, their use may be particularly important when exposing the coronaryarteries located on the inferior and lateral wall of the heart because this commonly results in deformation of the right-sidedcardiac chambers and impaired right ventricular diastolic filling. As a result, temporary epicardial pacing wires may be used advantageously in the patients in whom bradycardia is thought to adversely affect cardiac performance. Placement of temporary epicardial atrial and ventricular pacing wires is also recommended when revascularizingthe right coronary artery, particularly in its proximal portion. In this setting, transient ischemia due to right coronary manipulation may result in hypoperfusion of the AV node, which may lead to transient complete AV block. Similarly, in the vast majority of patients, fluctuations of the systemic arterial pressureoften can be managed by increasing preload administering volume. lnotropic support (dopamine or neosynephrine) may be required in a minority of patients who display refractory hypotension despite fluid administration. Mechanical stabilizers Optimal target stabilization remains the most important technical aspect of off-pump coronary revascularization. Mechanical stabilization, in contradistinction to the pharmacological stabilization no longer used, can be accomplished by direct pressure or suction. The pressure-type stabilizers originally introduced were hand-held by an assistant. Newer types of pressure stabilizers can be connected to one of the arms of the sternal retractor. In both cases, mechanical stabilization is effectively accomplished by the pressure on the epicardium surrounding the coronary target by adjusting a U-shaped footplate (Figs 2 and 3). We currently use the CTS Access Ultima System (CTS, Cupertino, CA, USA), which is the latest version of the CTS stabilizers. This device combines a sternal spreader-type retractor that can be connected to an adjustable arm and horseshoe- 396 SOLTOSKI, ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG J CARD SURG 1999:14:392-400 shaped stabilizing platform. This platform can be articulated in a tridimensional fashion (alongthe x, y, and zaxes) to reach any target vessel. Optimal stabilization is accomplished securing the arm and footplate into position. The most popular suction-type mechanical stabilizer available is the Medtronic Octopus 2 (Medtronic Inc., Minneapolis, MN, USA), which was originally introduced and then developed by Borst and Grundeman from the Netherlands (Figs. 4-7). This device consists of two paddles with 4 or 5 small (6 mm) suction cups on each paddle.*5 The paddles are connected to two different arms that can be held in position by securing them to the operating table rail or, the arms of the sternal retractor. A negative pressure of approximately 400 mmHG within the cups can then Figure 3. Exposure of the posterolateral vessels of the heart with a pressure stabilizer. Figure 1. The posterior pericardial stitches combined with proper positioning of the patient provide adequate exposure of all cardiac vessels. Figure 4. Medtronic Octopus 2, suction-type stabilizer. Figure 2. CTS Access Ultima System pressure-type stabilizer. Figure 5. Equipment required for stabilization using the Octopus 2. SOLTOSKI, ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG J CARD SURG 1999:14:392-400 Figure 6. tion stabilizer. of the Same using a sue- 397 required, is frequently accomplished after all other distal anastomosis have been completed, in offpump CABG revascularization we generally construct the distal anastomosis of the LIMA-to-LAD graft first. There are several reasons for this strategy. First, exposure of the LAD territory requires only minimal cardiac elevation and displacement, so that hemodynamics are usually well preserved while the distal LAD anastomosis is constructed. Second, this strategy allows expeditious revascularization of the anterior wall of the left ventricle. Accordingly, this may confer additional ischemic protection to the anterior wall of the left ventricle when more drastic cardiac elevation to expose other territories is used. Furthermore, early revascularization of the left ventricle may theoretically improve cardiac performance during maximal elevation. Last, we have noted that constructing the LIMA-to-LAD graft first does not adversely affect the ability to manipulate, elevate, or laterally displace the heart provided that care is taken not to damage the LIMA-LAD graft during cardiac manipulations. After revas,cularizationof the LAD is accomplished, the circumflex and right coronary territories can be revascularized if needed. The use of the coronary "snare" After a target coronary has been identified and adequate exposure along with mechanical stabilization have been accomplished, we routinely place a 4-0 Prolene suture around the coronary Figure 7. Exposure of the posterolateral vessels of the heart with a suction-type device. be created to accomplish effective immobilization. No significant complications have been observed at the suction cup sites. Visualization and exposure of various coronary territories can be accomplished by adjusting and optimizing the position of the flexible arms. In our experience, both devices described can accomplish epicardial stabilization efficiently, and the decision as to whether one or the other should be used is based on surgeons preference. Sequence of coronary grafting In contrast to conventional coronary surgery, during which revascularization of the LAD, when Figure 8. Photograph illustrating proximal and distal snares used for hemostasis and ischemic preconditioning. In this case, adequate exposure is obtained using a pressure stabilizer in combination with a 6-0 Prolene suture to retract the perivascular tissues. 398 SOLTOSKI, ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG artery, proximally to the area where the distal anastomosis will be constructed (Fig. 8). To avoid injury to the coronary artery, care is taken to place the stitch deep into the myocardium surrounding the vessel. In addition, the technical detail of placing a deep bite into the myocardium could also eliminate, or at least reduce, the likelihood of injuring the artery when this Prolene "loop" is snared, because a greater portion of myocardium would be interposed between the suture and the artery. In our experience, the advantages of using such a technique (the "snare") overshadow the theoretical disadvantages. The Prolene suture can be easily snared down so that the coronary target can be gently occluded, thereby gaining proximal control and improving visualization as the coronary artery is entered. This strategy also permits a brief period (3-5 minutes) of ischemic preconditioning,2"28which may improve myocardial tolerance to ischemia and may allow detection of ischemic electrocardiographic changes or ventricular dysfunction as the coronary artery is occluded, thus allowing modification of the strategy of revascularization. Intermittent occlusion of the native coronary may be particularly advantageous during graft flow assessment of Dopplerbased techniques (Transit Time Flow Measurement [TTFMI),as described later in this article. The theoretical disadvantages of inadvertent injury to the target coronary artery during placement of the stitch can be easily avoided, and the possibility of dislodgment of atherosclerotic material within the coronary artery once the Prolene suture is snared may also be prevented by properly choosing the site where the "snare" is applied. Accordingly, this technique should not be used in the presence of heavily calcified coronary arteries because it may fail to completely occlude the lumen of the heavily calcified vessel and may increase the risk of distal embolization. In addition, placement of the snare may not provide any advantage in the presence of a totally occluded native coronary artery. In this case it may be advantageous to place the Prolene suture distal to the site of construction of the anastomosis, particularly if there is angiographic evidence that the target coronary artery is perfused by collaterals in a retrograde fashion. J CARD SURG 1999;14:392-400 Figure 9. Assortment of intraluminal shunts. Different models are commercially available. The major benefit is usually obtained using shunts of 2-mm diameter or larger. during construction of distal anastomoses has been introduced as a method for improving distal perfusion while the vessel is grafted. As a result, this approach could prevent ischemia and preserve regional contractility of the territory supplied by the coronary artery, although its importance would invariably diminish in the face of total occlusion of the native coronary. In addition, the use of intracoronary shunts may also improve visualization as the distal anastomosis is constructed, thereby improving accuracy during suturing and reducing the possibility of technical errors. Improving visualization: The CO, blower/saline aerosolizer The CO, blower/saline aerosolizer has been introduced in an attempt to improve visualization during construction of distal an as tor nose^.^^ In our experience, this device along with the intracoronary shunt contributes remarkably to maintaining a bloodless field. It should be noted, that such a device is not entirely harmless, because it may result in inadvertent injury to the target coronary artery and intimal dissection if used too close to the area where the anastomosis is being constructed. lntracoronary shunts Coronary graft hemodynamic assessment by Transit Time Flow Measurement (TTFM) The use of intracoronary shunts (FloCoil, CTS) (Fig. 9) inserted within the target coronary arteries Doppler-based techniques of coronary graft flow measurement recently have been intro- SOLTOSKI, ET AL. EXPOSURE AND STABILIZATION IN OFF-PUMP CABG J CARD SURG 1999:14:392-400 duced and popularized as a method to intraoperatively assess graft patency during coronary revascularization. This technical aspect may be particularly important in the setting of myocardial revascularization without CPB, because it was originally believed that the technical challenge of performing distal anastomoses on the beating heart may increase the risk of technical failure. Although advances in techniques of mechanical stabilization and target visualization have considerably circumvented this problem and facilitated construction of distal anastomoses on the beating heart, we believe that flow measurement of the coronary grafts may play an important role in decreasing the risk of early graft occlusion due to technical error. Although there has been evidence that even Doppler-based techniques of flow measurement, more reliable than electromagnetic-based techniques, may fail to detect mild or moderate graft stenosis of up to 75% of the cross-sectional area.30,31 The correct interpretation of graft hemodynamics allows early intraoperative detection and immediate correction of graft dysfunction in all patients with severe graft stenosis or occlusion without considerably delaying the operation or increasing costs. As previously described,32a patent coronary graft usually presents a predominantly diastolic flow pattern in combination with a pulsatility index (PI) of < 5. In contrast, a systolic flow pattern along with PI figures > 5 are often associated with severe graft dysfunction or occlusion. In this regard, the appropriate use of the snare during graft flow measurements may allow further investigation exclusion of distal runoff obstruction, and evaluation of the proportion of competitive flow in the native coronary artery.28 CONCLUSION Historically, one of the main obstacles to complete myocardial revascularization without CPB has been represented by the inability to adequately expose the coronary targets and minimize their motion, preserving cardiac function and hemodynamic stability. However, the introduction of the stabilizers of the new generation in combination with the refinements in techniques of coronary revascularization on the beating heart have improved the feasibility and reliability with which distal anastomosis to all coronary arteries can now be constructed. In this 399 perspective, we believe that the only absolute contraindication to off-pump coronary grafting is represented by the inability to preserve hemodynamics while obtaining exposure and stabilization of the target vessels. Accordingly, although a variety of other factors such as left main disease, acute myocardial infarction, or the presence of an intramyocardial LAD have been considered as contraindications to off-pump CABG, we believe that they do not represent absolute contraindications, although their presence may require modification of the operative strategies used and may be associated with a higher rate of conversion to CPB. REFERENCES 1 . 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