Goal-Directed Therapy to Improve Outcomes in Surgical Patients Michael R. Pinsky, MD, Dr hc

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1 Goal-Directed Therapy to Improve Outcomes in Surgical Patients Michael R. Pinsky, MD, Dr hc Department of Critical Care Medicine University of Pittsburgh & Department of Anesthesiology UC San Diego

2 Potential Conflicts of Interest Michael R. Pinsky, MD is the inventor of a US patent Use of aortic pulse pressure and flow in bedside hemodynamic management owned by the University of Pittsburgh, plus two other complexity patents. Michael R. Pinsky, MD is a co-founder and stockholder of Intelomed Michael R. Pinsky, MD is a medical advisor for: Edwards Lifesciences LiDCO Ltd Masimo Michael R. Pinsky, MD received research funding from: Edwards LifeSciences Pulsion Ltd Michael R. Pinsky, MD is receiving research funding as Principal Investigator or Co-Investigator from the NIH T32 HL07820, R01 GM126811, R01 NR and UM1 HL120877, R01 HL074316

3 Monitoring Truth No monitoring device, no matter how accurate or insightful its data will improve outcome, Unless coupled to a treatment, which itself improves outcome Pinsky & Payen. Functional Hemodynamic Monitoring, pp 1-4, 2004 Pinsky & Payen. Crit Care 9: Pinsky. Chest 132:2020-9, 2007

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5 Why Measure Cardiac Output? Cardiac output varies with metabolic rate Threshold levels define low output disease states But does knowing cardiac output improve diagnosis, treatment or outcome from critical illness?

6 Survivorship Relative to TO Survivors (%) Oxygen Transport (ml/min/m 2 ) Bland et al. Crit Care Med 13:85-92, 1985

7 Survivorship and Goal-Directed Therapy Resuscitation following organ injury increased mortality Does resuscitation prior to the development of injury decrease mortality?

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9 Pre-optimization Improves Outcome Kern & Shoemaker. Crit Care Med 30: , 2002

10 Pre-optimization Improves Outcome But only in High-Risk Patients Kern & Shoemaker. Crit Care Med 30: , 2002

11 ICD-10 Coding October 1, 2015 marked the official date of mandatory ICD-10 implementation, which is a tough transition for everyone in healthcare. Where ICD-9 had a mere 13,000 codes, ICD-10 has upped the ante with a whopping 68,000 codes. The new codes are extremely comprehensive and incredibly specific--sometimes laughably so.

12 ICD-10 Coding W55.21 Bitten by a cow Z63.1 Problems in relationship with in-laws Y Injured at the opera W56.22 Struck by an orca, initial encounter V91.07 Burn due to water skis on fire R46.1 Bizarre personal appearance

13 Preoptimization Pre- and intra-operative goal-directed therapy in high risk surgical patients Resuscitation to relatively higher levels of DO 2 Boyd et al. JAMA 270: , 1993 Sinclair et al. BMJ 315:909-12, 1997 Venn et al. Br J Anaesth 88: 65-71, 2002 Prevent occult tissue hypoperfusion Mythen & Webb. Arch Surg 130: 423-9, 1995 Reduces vasopressor requirements during cardiac surgery Goepfert et al. Intensive Care Med 33: , 2007

14 Preoptimization

15 Maximizing TO 2 in high-risk elderly surgery patients 37 high-risk patients >60 yrs of age Protocol: Control- TO ml/min/m 2 (n=18) Protocol- TO 2 > 600 ml/min/m 2 (n=19) Results 13 made TO 2 goals, 24 did not (non-achievers) More post-op complications in control group Infections 12/18 Control v. 6/19 Protocol (RR 0.47,.2-.9) Cardiovascular dysfunction (RR 0.34,.1-.8) Mortality at 28 days 33% Control v. 16% Protocol (RR 0.32, ) These benefits also seen in the Non-Achiever subgroup Lobo et al. Crit Care Med 28: , 2000

16 Fluids v. Fluids + Dobutamine n=25 n=25 Lobo et al. Crit Care 10:R72-R82, 2006

17 Fluids v. Fluids + Dobutamine Fluids + dobutamine Fluids Lobo et al. Crit Care 10:R72-R82, 2006

18 Fluids v. Fluids + Dobutamine Complications Volume Only Cardiovascular Acute heart failure 2 Pulmonary edema 8 Acute MI 0 # pt CV complications 13 (52%) Other Acute renal failure 3 Acute respiratory failure 5 Dobutamine (18%)* 1 2 Lobo et al. Crit Care 10:R72-R82, 2006

19 Goal-Directed Intra-op Fluid Administration Reduces LOS 100 elective major surgery patients (ASA 1-3) Esophageal Doppler-titrated fluid resuscitation vs. Standard care Similar total fluids, RBC, EBL, urine output Higher cardiac output (5.6± 1.6 v. 5.0± 1.7) No difference in HR or MAP Less post-op nausea 7 (14%) v. 18 (36%) Shorter LOS 6.4 v days Gan et al. Anesthesiology 97:820-6, 2002

20 Perioperative goal-directed hemodynamic monitoring based therapy: a multi-center, prospective, randomized study Salwedel et al. Crit Care 17:R191, 2013

21 Perioperative goal-directed hemodynamic monitoring based therapy: a multi-center, prospective, randomized study Salwedel et al. Crit Care 17:R191, 2013

22 Perioperative goal-directed hemodynamic monitoring based therapy: a multi-center, prospective, randomized study Salwedel et al. Crit Care 17:R191, 2013

23 Perioperative goal-directed hemodynamic monitoring based therapy: a multi-center, prospective, randomized study Salwedel et al. Crit Care 17:R191, 2013

24 Effect of Goal-Directed Therapy on the Rate of postoperative Major GI complications Giglio et al. Br J Anaesth 103:637-46, 2009

25 Effect of Goal-Directed Therapy on the Rate of postoperative Minor GI complications Giglio et al. Br J Anaesth 103:637-46, 2009

26 Effect of Goal-Directed Therapy on the Rate of postoperative Liver complications Giglio et al. Br J Anaesth 103:637-46, 2009

27 Protocolized Care: Theory Protocolized minimizes practice variance Allows individualization of care only as exception Improves process in the real world Where error are a major course of impairment Decreases process in the ideal world Where excellence 24/7 is the standard of care

28 Pearse et al. Crit Care 9:R687-93, 2005

29 Post-operative Preload-Optimization Therapy Pearse et al. Crit Care 9:R687-93, 2005

30 Post-operative Preload-Optimization Therapy Pearse et al. Crit Care 9:R687-93, 2005

31 Post-operative Preload-Optimization Therapy Pearse et al. Crit Care 9:R687-93, 2005

32 Fluid Liberal or Conservative in ARDS Probability of Survival to Hospital Discharge and of Breathing without Assistance during the First 60 Days after Randomization Although restrictive fluid strategies decreased time of Mechanical Ventilation, it had no effect of LOS or mortality NHLBI ARDS Clinical Trials Network. N Engl J Med 354: , 2006

33 ARDS Cognitive Outcomes Study Telephone-based neuropsychological test battery used to assess risk of long-term neuropsychological impairment 406 eligible survivors 261 approached 213 consented. Mikkelsen et al. Am J Respir Crit Care Med 185: , 2012

34 ARDS Cognitive Outcomes Study Odds Ratio 4.03 ( ) However, restrictive fluid strategies caused long- term loss of Executive Function and increased Neurocongitive Impairment Mikkelsen et al. Am J Respir Crit Care Med 185: , 2012

35 Protocolized care is no better than good bedside care in the management of acute septic shock ProCESS ARISE OPtIMise

36 ProCESS: Effect on Resuscitation Protocol on Mortality for Patients with Severe Sepsis and Septic Shock No difference in 60 day or 1 year mortality: EGDT Protocolized-based care Standard Care 18% 60-day Mortality The ProCESS Investigators. N Engl J Med 370: , 2014

37 ProCESS: No Difference in Outcomes Among Treatment Groups The ProCESS Investigators. N Engl J Med 370: , 2014

38 The ProCESS Investigators. N Engl J Med 370: , 2014

39 Effect of GDT on Overall Mortality Gu et al. Crit Care 18:570, 2014

40 Effect of Timing of GDT on Mortality Early Late Gu et al. Crit Care 18:570, 2014

41 Effectiveness of Goal-Directed Therapy Clinical Trials Meta-analysis of Number of Patients Developing Complications After Surgery Pearse et al. JAMA 311: , 2014

42 Can we do even better? Using functional hemodynamic monitoring to guide resuscitation Give fluids only to those patients who are volume responsive

43 Goal-Directed Therapy Using PPV in High-Risk Surgery Patients Lopes et al. Crit Care 11:R100-7, 2007

44 Goal-Directed Therapy Using PPV in High-Risk Surgery Patients Fluid resuscitation to keep PPV or SVV <10% 16 pt in Intervention Group v. 17 in Control Group Both groups were comparable in terms of demographic data, ASA score, type, and duration of surgery. Intervention Group (n=16) Control Group (n=17) Intra-op fluids 4,618 ± 1,557 1,694 ± 705 ml (P < ) ΔPP decrease 22 ± 75 to 9 ± 1% (P < 0.05) no change Median post-op LOS 7 17 days (P < 0.01) # post-op comp/pt 1.4 ± ± 2.8 (P < 0.05) Median mech vent 1 5 days (P < 0.05) ICU stay 3 9 days (P < 0.01) Lopes et al. Crit Care 11:R100-7, 2007

45 Goal-Directed Therapy Using PPV in High-Risk Surgery Patients Lopes et al. Crit Care 11:R100-7, 2007

46 Effects of Goal-Directed Therapy based on Dynamic Parameters on post-surgical outcomes A Meta-analysis of randomized controlled trials Benes et al. Critical Care 18:584, 2014

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48 Pre-operative Hemodynamic Optimization Is Cost-Effective Fenwick et al. Intensive Care Med 28: , 2002

49 Goal-directed Therapy Improves Long- Term Survival: 15-year follow up Median increase in survival 1107 days (> 3 years) Hazard ratio 1.8 (95% CI 1.2 to 2.8) Rhodes et al. Intensive Care Med 36: , 2010

50 15 years survival Any Complication Rhodes et al. Intensive Care Med 36: , 2010

51 Goal-directed Therapy: 15-year follow up Any Cardiac Lung Renal Rhodes et al. Intensive Care Med 36: , 2010

52 Goal-directed Therapy: 15-year follow up Control Group Protocol Group Rhodes et al. Intensive Care Med 36: , 2010

53 Clinical Implications Pre-optimization in high-risk patients is costeffective Enhanced Recovery After Surgery (ERAS) Target audience: Anesthesiologists Location: Peri- and Intra-operative Care Post-operative preload-optimization of cardiac surgery patients is cost-effective Target audience: ICU physicians and nurses Any device that gives real time accurate measures of cardiac output and its change should also be effective are driving clinically-proven resuscitation protocols.

54 Thank You