The clarity to consistently maintain patients in the optimal volume range.

FloTrac System

Advanced dynamic and flow-based parameters are demonstrated to be more reliable than conventional measurements in predicting fluid responsiveness.1–3

The FloTrac system automatically updates advanced parameters every 20 seconds, reflecting rapid physical changes in moderate to high-risk surgery more accurately. Advanced hemodynamic parameters provided by the FloTrac sensor offer you continuous insight to more accurately determine your patient’s fluid status.

The FloTrac sensor provides advanced hemodynamic parameters to help guide volume administration.

The minimally-invasive FloTrac sensor connects to any existing arterial catheter

Stroke Volume Optimization (SV)4–12 Stroke volume measurement with the FloTrac sensor enables an individualized approach for administering fluid until SV reaches a plateau on the Frank-Starling curve, to prevent hypovolemia and excessive fluid administration.

Stroke Volume Variation Optimization (SVV)13

For control-ventilated patients, SVV has proved to be a highly sensitive and specific indicator for pre-load responsiveness, serving as an accurate marker of patient status on the Frank-Starling curve.

Oxygen Delivery Optimization (DO2 with CCO)14

Continuous cardiac output (CCO) measured by the FloTrac system can be used (in combination with SaO2 and hemoglobin) to monitor and optimize DO2 with fluid (including red blood cells) and inotropic agents.

Hypoperfusion Organ dysfunction Adverse outcome

Hypovolemic

Optimal

Volume loadGraph 20

Edema Organ dysfuntion Adverse outcome

Hypervolemic

Com

plic

atio

ns

Frank-Starling relationship between preload and stroke volume (SV)

Hypo Hyper

Target zone

Preload

Stro

ke v

olum

e

Stroke Volume (SV)

Stroke Volume Variation (SVV)

Continuous Cardiac Output (CCO)

The value of advanced hemodynamic parameters in optimal volume management.

30+ randomized controlled trials and 14+ meta-analyses have demonstrated clinical benefits of hemodynamic optimization over traditional volume management.15–18

Advanced hemodynamic parameters, when implemented within a PGDT protocol, are demonstrated to reduce post-surgical complications in moderate to high-risk surgery patients.19 The FloTrac system provides advanced hemodynamic parameters that can be used in PGDT to control variability in volume administration and help you maintain your patient in the optimal volume range.

EV1000 Clinical PlatformChoose parameters, alarms and targets to meet your precise patient monitoring needs

randomized controlled trials demonstrate benefit21–54

meta-analyses confirm benefit55–68

An integrated hemodynamic monitoring systemThe FloTrac sensor integrates with the Edwards EV1000 clinical platform to show patient status at a glance, for visual clinical support and increased clarity in volume administration during moderate to high-risk surgical procedures. For your patients who may not typically receive an arterial line, Edwards’ noninvasive ClearSight system allows you to expand the benefits of continuous advanced hemodynamic monitoring to a broader range of patient conditions.

Continuity of care from the OR to the ICUUsing the FloTrac sensor, your surgical team can hemodynamically optimize a moderate to high-risk patient in the OR. After hand-off, ICU clinicians will have the same access to advanced hemodynamic parameters to help guide post-operative management and therapy.

The evidence-based value of Perioperative Goal-Directed Therapy (PGDT).

Visit Edwards.com/FloTrac or call 800-424-3278 to know more about how you can maintain your patients in the optimal volume range.

Helping to advance the care of surgical and critical care patients for over 40 years, Edwards Lifesciences seeks to provide the valuable information you need, the moment you need it. Through continuing collaboration with you, ongoing education and our never-ending quest for advancement, our goal is to deliver Clarity in Every Moment.

Edwards Lifesciences | edwards.comOne Edwards Way | Irvine, California 92614 USA Switzerland | Japan | China | Brazil | Australia | India

The ClearSight system is the noninvasive solution for expanding advanced hemodynamic monitoring to a broader range of surgical patients.

The FloTrac system has been used on over 2 million patients and is trusted by clinicians worldwide. It’s the practical, reliable and minimally-invasive solution for volume management.

The Swan-Ganz Advanced Technology pulmonary artery catheter delivers a comprehensive hemodynamic profile by a single device to guide your treatment strategy.

Unit of Description Length Model No. Measure

FloTrac sensor 84 in / 213 cm MHD8 EA

FloTrac sensor 84 in / 213 cm MHD85 5 EA

FloTrac sensor 60 in / 152 cm MHD6 EA

FloTrac sensor 60 in / 152 cm MHD65 5 EA

FloTrac sensor with 60 in / 152 cm MHD6AZ EA VAMP adult system

FloTrac sensor with 60 in / 152 cm MHD6AZ5 5 EA VAMP adult system

For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards Lifesciences devices placed on the European market, meet the essential requirements referred to in Article 3 of the Medical Device Directive 92/42/EEC, and bear the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Clarity In Every Moment, ClearSight, EV1000, FloTrac, Swan-Ganz, and VAMP are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

© 2015 Edwards Lifesciences Corporation. All rights reserved. E5620/05-15/CC

Edwards’ range of hemodynamic monitoring solutions offers continuous dynamic and flow-based parameters that may be used in PGDT to consistently maintain your moderate to high-risk surgery patients in the optimal volume range.

References inserted above

1. Marik & Cavallazzi. Does central venous pressure predict fl uid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med 2013

2. Le Manach et al. Can changes in arterial pressure be used to detect changes in cardiac output during volume expansion in the perioperative period? Anesthesiology 2013

3. Bennett D. Arterial Pressure: A Personal View. Functional Hemodynamic Monitoring. Berlin: Springer-Verlag, 2005. ISBN: 3-540-22349-5

4. Cecconi M, Fasano N, Langiano N, et al. Goal directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15:R132

5. Sinclair S, James S, Singer M. Intraoperative intravascular volume optimization and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. AMJ. 1997;315:909–912.

6. Gan T, Soppitt A, Maroof M, et al. Goal-directed intraoperative fl uid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002;97(4):820–826.

7. Venn R, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate infl uence of the fl uid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002;88(1):65–71.

8. Conway D, Mayall R, Abdul-Latif M, Gilligan S, Tackaberry C. Randomised controlled trial investigating the infl uence of intravenous fl uid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002;57(9):845–849.

9. McKendry M, McGloin H, Saberi D, Caudwell L, Brady A, Singer M. Randomised controlled trial assessing the impact of a nurse delivered, fl ow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ. 2004;329:358.

10. Wakeling H, McFall M, Jenkins C, Woods W, Barclay G, Fleming S. Intraoperative oesophageal Doppler-guided fl uid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005;95(5):634–642.

11. Noblett S, Snowden C, Shenton B, Horgan A. Randomized clinical trial assessing the eff ect of Doppler-optimized fl uid management on outcome after elective colorectal resection. BJS. 2006;93(9):1069–1076.

12. ChytraI, Pradl R, Bosman R, Pelnar P, Kasal E, Zidkova A. Esophageal Doppler-guided fl uid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial. Crit Care. 2007;11:R24.

13. Benes J, ChytraI, Altmann P, et al. Intraoperative fl uid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010;14:1-15.

14. Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007;132:1817–1824.

15. Grocott et al. Perioperative increase in global blood fl ow to explicit defi ned goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013

16. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46

17. Dalfi no L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154

18. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratifi ed Meta-Analysis. Anesthesia – Analgesia 2012

19. Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high risk surgical patients. Anesthesia – Analgesia 2011; 112: 1392–402

20. CL Gurudatt. Perioperative fl uid therapy: How much is not too much? Indian J Anaesth. 2012 Jul-Aug; 56(4): 323–325

References for the Edwards FloTrac system brochure

References continued on back

30+ randomized controlled trials confi rm benefi tRandomized controlled trials showing a benefi t in perioperative goal-directed therapy

21. Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk patients. Chest. 1988;94(6):1176-1186.

22. Berlauk JF, Abrams, JH, Gilmour, IJ, O’Connor, SR, Knighton, DR, and Cerra, FB. Preoperative optimization of cardiovascular hemodynamics improves outcome in peripheral vascular surgery. A prospective, randomized clinical trial. Ann Surg. Sep 1991; 214(3): 289–299.

23. Fleming A, Bishop M, Shoemaker W, Appel P, Suffi cool W, Kuvhenguwha A, Kennedy F, Wo CJ. Prospective trial of supranormal values as goals of resuscitation in severe trauma. Arch Surg. 1992 Oct;127(10):1175-9; discussion 1179-81.

24. Boyd O, Grounds RM, Bennett ED. A randomized clinical trial of the eff ect of deliberate perioperative increase of oxygen delivery on mortality in high-risk surgical patients. JAMA. 1993 Dec 8;270(22):2699-707.

25. Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995 Apr;130(4):423-9.

26. Sinclair S, James S, Singer M.Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12.

27. Ueno S, Tanabe G, Yamada H, Kusano C, Yoshidome S, Nuruki K, Yamamoto S, Aikou T. Response of patients with cirrhosis who have undergone partial hepatectomy to treatment aimed at achieving supranormal oxygen delivery and consumption. Surgery. 1998 Mar;123(3):278-86.

28. Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103.

29. Pölönen P, Ruokonen E, Hippeläinen M, Pöyhönen M, Takala J. A prospective, randomized study of goal-oriented hemodynamic therapy in cardiac surgical patients. Anesth Analg. 2000 May;90(5):1052-9.

30. Lobo SM, Salgado PF, Castillo VG, Borim AA, Polachini CA, Palchetti JC, Brienzi SL, de Oliveira GG. Eff ects of maximizing oxygen delivery on morbidity and mortality in high-risk surgical patients. Crit Care Med. 2000 Oct;28(10):3396-404.

31. Venn R, Steele A, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate infl uence of the fl uid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002 Jan;88(1):65-71.

32. Gan TJ, Soppitt A, Maroof M, El-Moalem H, Robertson KM, Moretti E, Dwane P, and Glass PSA. Goal-directed Intraoperative Fluid Administration Reduces Length of Hospital Stay after Major Surgery. Anesthesiology. 2002; 97:820–6.

33. Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, and Tackaberry C. Randomised controlled trial investigating the infl uence of intravenous fl uid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9.

34. McKendry M, McGloin H, Saberi D, Caudwell L, Brady AR, and Singer M. Randomised controlled trial assessing the impact of a nurse delivered, fl ow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ. 2004 Jul 31;329(7460):258. Epub 2004 Jul 8.

35. Wakeling HG, McFall MR, Jenkins CS, Woods WGA, Miles WFA, Barclay GR, and Fleming SC. Intraoperative oesophageal Doppler guided fl uid management shortens postoperative hospital stay after major bowel surgery. BJA. Volume 95, Issue 5Pp. 634-642.

36. Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, and Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial. Crit Care. November 2005, 9:R687.

37. Noblett SE, Snowden CP, Shenton BK, and Horgan AF. Randomized clinical trial assessing the eff ect of Doppler-optimized fl uid management on outcome after elective colorectal resection. Br J Surg. 2006 Sep;93(9):1069-76.

38. Chytra I, Pradl R, Bosman R, Pelnár P, Kasal E, and Zidková A. Esophageal Doppler-guided fl uid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial. Crit Care. 2007;11(1):R24.

62. Gurgel ST, do Nascimento Jr. P. Maintaining Tissue Perfusion in High-Risk Surgical Patients: A Systematic Review of Randomized Clinical Trials. 2011 International Anesthesia Research Society. DOI: 10.1213/ANE.0b013e3182055384.

63. Srinivasa S, Taylor MH, Sammour T, et al. Oesophageal Doppler-guided fluid administration in colorectal surgery: critical appraisal of published clinical trials. Acta Anaesthesiologica Scandinavica 2011;55(1):4-13.

64. Brienza N, Giglio MT, Marucci M, et al. Does perioperative hemodynamic optimization protect renal function in surgical patients? A meta-analytic study. Crit Care Med 2009; 37: 2079–90.

65. Giglio MT, Marucci M, Testini M, et al. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth; 2009;103(5):637-646.

66. Phan T, Ismail H, Heriot AG, et al. Improving Perioperative Outcomes: Fluid Optimization with the Esophageal Doppler Monitor, a Metaanalysis and Review. Journal of the American College of Surgeons, 2008 Dec;207(6):935-41.

67. Bundgaard-Nielsen M, Holte K, Secher NH, et al. Monitoring of peri-operative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand 2007 Mar;51(3):331-40.

68. Poeze M, Willem M Greve J, Ramsay G. Meta-analysis of hemodynamic optimization: relationship to methodological quality. Crit Care 2005, 9:R771-R779.

Edwards Lifesciences | edwards.comOne Edwards Way | Irvine, California 92614 USA Switzerland | Japan | China | Brazil | Australia | India

For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards Lifesciences devices placed on the European market, meet the essential requirements referred to in Article 3 of the Medical Device Directive 92/42/EEC, and bear the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Clarity In Every Moment, ClearSight, EV1000, FloTrac, Swan-Ganz, and VAMP are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

© 2015 Edwards Lifesciences Corporation. All rights reserved. E5620/05-15/CC

55. Arulkumaran N, Corredor C, Hamilton MA, et al. Cardiac complications associated with goal-directed therapy in high-risk surgical patients: a meta-analysis. Br J Anaesth. 2014 Apr;112(4):648-59.

56. Grocott MP, Dushianthan A, Hamiltom MA. et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth. 2013;111(4):535-548.

57. Aya HD, Cecconi M, Hamilton M, et al. Goal-directed therapy in cardiac surgery: a systematic review and meta-analysis. Br J Anaesth, 2013 Apr;110(4):510-7.

58. Cecconi M, Corredor C, Arulkumaran N, et al. Clinical review: Goal-directed therapy - what is the evidence in surgical patients? The eff ect on diff erent risk groups. Crit Care Med 2013, 17:209.

59. Corcoran T, Rhodes JE, Clarke S, et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012; 114(3): 640-651.

60. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care Med 2011; 15(3): R154.

61. Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high risk surgical patients. Anesthesia – Analgesia 2011; 112: 1392–402.

14 meta-analyses confi rm benefi tHemodynamic optimization through perioperative goal-directed therapy

39. Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, and Michard F. Goal-directed fl uid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100.

40. Donati A, Loggi S, Preiser JC, Orsetti G, Münch C, Gabbanelli V, Pelaia P, and Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. Epub 2007 Oct 9.

41. Mayer J, Boldt J, Mengistu A, Röhm KD, and Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010, 14:R18.

42. Benes J, Chytra I, Altmann P, Hluchy M, Kasal E, Svitak R, Pradl R, and Stepan M. Intraoperative fl uid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010; 14(3): R118.

43. Jhanji S, Vivian-Smith A, Lucena-Amaro S, Watson D, Hinds CJ, and Pearse RM. Haemodynamic optimisation improves tissue microvascular fl ow and oxygenation after major surgery: a randomised controlled trial. Crit Care. 2010;14(4):R151.

44. Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, and Rocca GD. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011, 15:R132.

45. Pillai P, McEleavy I, Gaughan M, Snowden C, Nesbitt I, Durkan G, Johnson M, Cosgrove J, and Thorpe A. A double-blind randomized controlled clinical trial to assess the eff ect of Doppler optimized intraoperative fl uid management on outcome following radical cystectomy. J Urol. 2011 Dec;186(6):2201-6.

46. Bisgaard J, Gilsaa T, Rønholm E, and Toft P. Haemodynamic optimisation in lower limb arterial surgery: room for improvement? Acta Anaesthesiol Scand. 2013 Feb;57(2):189-98.

47. Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fl uid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57.

48. Zakhaleva J, Tam J, Denoya PI, Bishawi M, and Bergamaschi R. The impact of intravenous fl uid administration on complication rates in bowel surgery within an enhanced recovery protocol: a randomized controlled trial. Colorectal Dis. 2013 Jul;15(7):892-9.

49. Scheeren TWL, Wiesenack C, Gerlach H, and Marx G. Gernot MarxGoal-directed intraoperative fl uid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. International Journal of Clinical Monitoring and Computing (Impact Factor: 1.45). 04/2013.

50. Zhang J, Qiao H, He Z, Wang Y, Che X, and Liang W. Intraoperative fl uid management in open gastrointestinal surgery: goal-directed versus restrictive. Clinics (Sao Paulo). Oct 2012; 67(10): 1149–1155.

51. Goepfert MS, Richter HP, Zu Eulenburg C, Gruetzmacher J, Raffl enbeul E, Roeher K, von Sandersleben A, Diedrichs S, Reichenspurner H, Goetz AE, and Reuter DA. Individually optimized hemodynamic therapy reduces complications and length of stay in the intensive care unit: a prospective, randomized controlled trial. Anesthesiology. 2013 Oct;119(4):824-36.

52. Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, and Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191.

53. Zheng H, Guo H, Ye JR, Chen L, Ma HP. Goal-directed fl uid therapy in gastrointestinal surgery in older coronary heart disease patients: randomized trial. World J Surg. 2013 Dec;37(12):2820-9.

54. Zeng K, Li Y, Liang M, Gao Y, Cai H, and Lin C. The infl uence of goal-directed fl uid therapy on the prognosis of elderly patients with hypertension and gastric cancer surgery. Drug Des Devel Ther. 2014; 8: 2113–2119.