IMPROVE PATIENT OUTCOMES AND SAFETY IN ADULT CARDIAC SURGERY.

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1 Clinical Evidence Guide IMPROVE PATIENT OUTCOMES AND SAFETY IN ADULT CARDIAC SURGERY. With the INVOS cerebral/somatic oximeter An examination of controlled studies reveals that responding to cerebral desaturation events using the information from the INVOS system paired with an interventional algorithm has been associated with: Reduced cerebral desaturation load during surgery1 Less acute kidney injury2 Lower incidence of stroke2,3 Less need for prolonged postoperative ventilation3 Shorter time on ventilation3 Shorter hospital length of stay3 Fewer patients requiring blood transfusion4 Fewer units of blood transfused2,4

2 Cerebral desaturation during high-risk cardiac surgery is common and can be identified using INVOS monitoring technology and reversed, reducing desaturation load during surgery. Reversal of decreases in cerebral saturation in high-risk cardiac surgery. Deschamps A, Lambert J, Couture P, et al. Single center trial (Canada): PART 1: prospective, observational PART 2: pilot randomized, controlled Arms PART 1: Single arm: INVOS monitoring and use of an interventional protocol to restore cerebral saturation levels (rso 2 ) PART 2: Control: blinded INVOS monitoring Intervention: INVOS monitoring and use of an interventional protocol to restore rso 2 Objective PART 1: test of the efficacy of an interventional algorithm to restore decreases in rso 2 N PART 1: 279 PART 2: verify that interventions resulted in a reduction of the desaturation load during surgery PART 2: 48 Population Definition of desaturation High-risk cardiac surgery on cardiopulmonary bypass (CPB) < 80% of baseline rso 2 for > 15 seconds < 80% of baseline rso 2 for > 15 seconds Results PART 1: Desaturation occurred in 136 patients (48.8%) Reversal was successful in 120/136 patients (88.2%) PART 2: Incidence of desaturation was not statistically different between the intervention (69.9%) and control groups (76%) Total mean desaturation load during surgery was lower in the intervention group (154.3% minutes vs % minutes; p = 0.041) Cerebral desaturation was common in this high-risk cardiac surgery population. It was successfully reversed in the majority of patients by employing an interventional protocol. Monitoring and intervention was associated with a reduction in the total cerebral desaturation load during surgery. 2

3 A strategy to improve outcomes using INVOS monitoring technology to continuously monitor for changes in cerebral perfusion during cardiac surgery. A multidisciplinary perioperative strategy for attaining more physiologic cardiac surgery. Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. Arms Objective Single-center retrospective analysis before vs. after implementing a more physiologic anesthetic approach (Greece) ROUTINE CARE CONTROL: cardiac surgery patients treated with routine anesthetic strategy PHYSIOLOGIC APPROACH: cardiac surgery patients treated according to a goal-directed strategy using cardiac index, SvO 2, DO 2 i, DO 2 i/vco 2 i, and rso 2 (using the INVOS monitor), and using a minimally invasive extracorporeal circulation INTERVENTION INCLUDED: Increasing hemoglobin levels to more than 8 g/dl Increasing cardiac output/circulatory flow to 120% Initiating inotropic/vasoactive support To use real-time monitoring to prevent malperfusion during surgery N 120 Population ROUTINE CARE: coronary artery bypass graft (CABG) only (n = 60) PHYSIOLOGIC APPROACH: 24 CABG, 36 valve and complex procedure (n = 60) Results < 20% drop from baseline There were no differences in the baseline characteristics of the two groups The physiologic approach group: Experienced fewer strokes (0% vs. 5%, p < 0.05) Less acute kidney injury (AKI) (stage 2 and 3; 3.3% vs. 8.3%, p < 0.05) Required less intraoperative blood transfusion (1 vs. 1.5 units, p < 0.05) End-organ function can be protected by continually monitoring perfusion and taking immediate action to maintain optimal perfusion throughout the perioperative period. This strategy also improves patient outcomes after cardiac surgery. 3

4 Monitoring with INVOS technology and intervention is associated with reduced permanent stroke rates, a need for mechanical ventilation, and length of hospital stay. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Goldman S, Sutter F, Ferdinand F, Trace C. Arms Objective N Population Results Single center, retrospective data analysis (U.S.) CONTROL: 18 months prior to implementing INVOS monitoring technology INTERVENTION: 18 months after INVOS monitoring technology was implemented and interventions were prescribed to maintain baseline rso 2 Demonstrate that monitoring with INVOS technology and intervening to optimize cerebral oxygen delivery variables could reduce the incidence of stroke 2,279 (including 1,245 controls) All cardiac surgery Any rso 2 decrease from baseline Intervention group had a higher incidence of baseline cardiovascular risk factors, including more New York Heart Association (NYHA) class III and IV patients Monitoring and intervention was associated with: Lower rate of permanent stroke (0.97% vs. 2.01%; p < 0.044) in NYHA class I through III patients Shorter time on ventilation (4 vs. 5 hours; p < ) Fewer patients requiring prolonged ventilation (6.8% vs. 10.6%; p < ) Reduction in hospital length of stay by between 0.2 days and 2.3 days, depending on NYHA class (p < 0.046) In a subsequent publication, the authors estimate that they had avoided 12 cerebrovascular incidents in the intervention group, with a potential avoidance of $254,214 in direct costs and $425,000 in total costs 5 Although patients in the intervention group were sicker and had more comorbidity, they had a lower incidence of permanent stroke, less need for prolonged ventilation, and a shorter hospital stay. 4

5 Inclusion of INVOS monitoring technology into a blood conservation protocol is associated with fewer blood transfusions and fewer units of blood transfused. Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial. Vretzakis G, Georgopoulou S, Stamoulis K, et al. Arms Objective Single-center randomized controlled trial (Greece) CONTROL: blood transfusion need determined by hematocrit (Hct) INTERVENTION: blood transfusion need determined by rso 2 and Hct To determine whether incorporation of INVOS monitoring technology into an intraoperative Hct-based blood conservation algorithm reduces blood use N 150 Population Results Cardiac surgery on CPB CONTROL: During aortic cross-clamp: Hct 17% After clamp removal, before weaning from CPB: Hct 21% After CPB weaning and retransfusion of salvaged blood: Hct 24% In the intensive care unit (ICU): Hct 24% INTERVENTION (must meet both criteria): rso 2 < 60% or < 20% decrease from mean value during pulmonary arterial catheter insertion Fulfills Hct-based threshold for transfusion as listed above Based on a per-protocol analysis, incorporation of an rso 2 threshold into a blood conservation algorithm was associated with: Fewer patients receiving transfusions during surgery (15.7% vs. 29.8%; p = 0.048) and during their hospital stay (65.7% vs. 82.1%; p = 0.029) Fewer units per patient transfused in the OR (p = 0.021) INVOS monitoring technology could be incorporated into a blood conservation strategy with hematocrit levels to guide blood transfusions during cardiac surgery. Protocol violations were identified in 8.7% of patients and were not included in the final analysis. 5

6 A selection of clinical studies using INVOS technology intraoperatively in broad cardiac surgery patient populations Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining more physiologic cardiac surgery. Perfusion. 2017;32(6): Deschamps A, Hall R, Grocott H, et al. Cerebral oximetry monitoring to maintain normal cerebral oxygen saturation during highrisk cardiac surgery: a randomized controlled feasibility trial. Anesthesiology. 2016;124(4): Brassard P, Pelletier C, Martin M, Gagné N, Poirier P, Ainslie PN, Caouette M, Bussières JS. Influence of norepinephrine and phenylephrine on frontal lobe oxygenation during cardiopulmonary bypass in patients with diabetes. J Cardiothorac Vasc Anesth. 2014;28(3): Deschamps A, Lambert J, Couture P, et al. Reversal of decreases in cerebral saturation in high-risk cardiac surgery. J Cardiothorac Vasc Anesth. 2013;27(6): Vretzakis G, Georgopoulou S, Stamoulis K, et al. Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial. J Cardiothorac Surg. 2013; 8:145. Schoen J, Husemann L, Tiemeyer C, et al. Cognitive function after sevoflurane- vs. propofol-based anaesthesia for on-pump cardiac surgery: a randomized controlled trial. Br J Anaesth. 2011;106(6): Vretzakis G, Kleitsaki A, Stamoulis K, et al. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial. J Cardiothorac Surg. 2010;5:7. Bonaros N, Wiedemann D, Nagiller J, et al. Distal leg protection for peripheral cannulation in minimally invasive and totally endoscopic cardiac surgery. Heart Surg Forum. 2009;12(3):E Piquette D, Deschamps A, Bélisle S, et al. Effect of intravenous nitroglycerin on cerebral saturation in high-risk cardiac surgery. Can J Anaesth. 2007;54(9): Goldman SM, Sutter FP, Wertan MA, Ferdinand FD, Trace CL, Samuels LE. Outcome improvement and cost reduction in an increasingly morbid cardiac surgery population. Semin Cardiothorac Vasc Anesth. 2006;10(2): Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E References 1. Deschamps A, Lambert J, Couture P, et al. Reversal of decreases in cerebral saturation in high-risk cardiac surgery. J Cardiothorac Vasc Anesth. 2013;27(6): Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining more physiologic cardiac surgery. Perfusion. 2017;32(6): Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E Vretzakis G, Georgopoulou S, Stamoulis K, et al. Monitoring of brain oxygen saturation (INVOS) in a protocol to direct blood transfusions during cardiac surgery: a prospective randomized clinical trial. J Cardiothorac Surg. 2013;8: Goldman SM, Sutter FP, Wertan MC, Ferdinand FD, Trace CL, Samuels LE. Outcome improvement and cost reduction in an increasingly morbid cardiac surgery population. Sem Cardiothorac Vasc Anesth. 2006;10(2): Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 03/ PM-0093(2) [WF# ] 6135 Gunbarrel Avenue Boulder, CO medtronic.com/covidien