EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

A Prospective Single Center Study to Evaluate Safety and Efficacy of the EUROSETS Extracorporeal Membrane Oxygenation ECMOLIFE SYSTEM in Clinical Extracorporeal Life Support Applications EUROSETS ECMO STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163925
• Other study ID #: ECMO Study CIP 2.0_04.05.2021
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: January 2023

Study information

• Verified date: January 2022
• Source: Eurosets S.r.l.
• Contact: Antonio Petralia, Dott.
• Phone: +39 0535 660370
• Email: apetralia[@]eurosets.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective single-center study designed for evaluation of safety and performance of the Conformitè Europëenne (CE)-marked EUROSETS ECMOLIFE SYSTEM, composed by: ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC) in all clinical ECLS applications (e.g. post-cardiotomy ECLS as well as application for cardiogenic shock after myocardial infarction or resulting from other etiologies, as well as ECLS application in patients under cardiopulmonary resuscitation (eCPR) and protected PCI) in 30 consecutive patients.

All demographic and perioperative variables (ECMOLIFE SYSTEM -related and unrelated ECLS complications, performances of the ECMOLIFE SYSTEM) will be analyzed. Surgical techniques will be recorded. Follow-up information on survival and any adverse cardiac and cerebrovascular events will be gathered routinely by outpatient clinic and telephone calls until 30 days after ECLS initiation or hospital discharge.

Description:

The prevalence of post-cardiotomy extracorporeal life support (PC-ECLS) varies between 0.6% and 3.6% of all cardiac surgical cases and represents one of the most common applications of ECLS. While a majority of patients can be weaned from cardiopulmonary bypass using inotropic and vasoactive medication, some experience refractory cardiac and/or pulmonary dysfunction requiring prolonged postoperative mechanical circulatory support. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support is a respected therapeutic option for short-term mechanical circulatory support in these critically ill patients. Indications for PC-ECLS usually include intra-operative failure to wean from cardiopulmonary bypass due to perioperative left, right or biventricular failure, or refractory cardiogenic shock/cardiac arrest in the postoperative period. While ECLS can be a life-saving therapy, it is characterized by a high mortality and morbidity due to neurologic and vascular complications amongst others.

Recently published studies reported that long-term prognosis of in-hospital survivors after ECMO support following cardiovascular surgery remains unsatisfactory, however, patients who survive have the chance to make a full recovery despite a very unfavorable prognosis without VA-ECMO. Predisposing risk factors influencing long-term survival are not fully known, however this knowledge is necessary for adequate patient selection and comprehensive decision-making prior to ECMO implantation in order to identify those patients who will truly benefit from ECMO support, since unrestrained use might disproportionately increase hospital costs and consume valuable resources.

Recently, the Extracorporeal Life Support Organization (ELSO) Registry reported a remarkable increase in the use of ECLS as a supportive therapy after cardiac surgery. However, a disappointing trend was observed with regards to the in-hospital survival rate, reaching only 15% in the latest period.

Despite this increase in use and new technological developments in this area, only a few comprehensive and dedicated reports about PC-ECLS have been presented. Nevertheless, PC-ECLS has represented the main indication for ECLS utilization and is characterized by specific aspects (duration and type of underlying disease, severity of comorbidities, indication and type of surgical procedure, modality of access and timing of implant, complication types and rates) when compared to other ECLS indication Cardiovascular diseases (CVD) are responsible for more than 4 million deaths in Europe per year. Thereby, CVD account for approximately 45% of mortality in Europe. Apart from medical and ethical aspects, this poses an economical disaster: annual costs of roughly 210 trillion USD. Among cardiovascular diseases, coronary heart disease alone is responsible for 1 million deaths per year. Myocardial infarction (MI) is often the initial manifestation of coronary heart disease, caused by myocardial ischemia and necrosis leading to an acute decrease of cardiac function. Clinically, patients in cardiogenic shock present hypotensive, unresponsive to intravenous fluid challenge and with clinical and laboratory signs of critical end organ malperfusion requiring pharmacologic and/or mechanical circulatory support.

Cardiogenic shock (CS) is the leading cause of death after myocardial infarction and occurs in 5-10% of all cases of MI. Trials such as SHOCK, IABP-SHOCK II and IMPRESS in Severe Shock all revealed a one-year mortality of approximately 50%, which reflects constant mortality rates over the last 20 years, in spite of the applied therapeutic strategies and devices.

The unacceptably high mortality and morbidity in CS is an unsolved clinical problem despite all available treatment options.

Protected PCI is the application of Mechanical Circulatory Support (MCS) during percutaneous coronary intervention in high-risk patients, meaning that in such cases MCS systems are implanted prophylactically despite hemodynamic stability to avoid deleterious complications. The overall patient condition and temporary impairment based on the acute situation of an underlying myocardial infarction or coronary ischemia, without a manifested cardiogenic shock, are potential reasons for a "prophylactic" use of MCS.

Due to the increasing complexity of procedures and patients, feasibility of such interventions is becoming more dependent on the availability of MCS, in order to guarantee hemodynamic support during revascularization. Safety and outcome of such high-risk PCIs can potentially be improved by the application of MCS and the onset of complications such as arrhythmias, hemodynamic instability and related complications during the procedure can be reduced.

In Patient without ROSC (return of spontaneous circulation) during CPR, reestablishment of circulation by emergent VA-ECLS implantation may be indicated, since eCPR is able to improve the outcome of patients after prolonged resuscitation and no-ROSC scenario.

In 2019, at the Medical University of Vienna 25 patients were treated with eCPR (approximately 9% of all CPR-patients), 20 of these patients after OHCA (out of hospital cardiac arrest). Five patients (20%) survived with a good neurologic outcome.

In the eCPR setting, time between circulatory arrest and its recovery by the ECMO circuit, is a major crucial and impacting factor as well. The ease of use in terms of device implantation would be of high importance in those cases in particular.

In summary, for every indication, devices used in ECLS require maximum reliability and must be able to generate adequate flow for full circulatory support and minimize blood trauma especially in the setting of prolonged support. Additionally, handling and monitoring should be non-complicated, the need for frequent patient transports (operating room - ICU - remote hospital facilities as required) should be taken into account. New devices should be evaluated considering these factors- next to assessment of outcome and device-related and unrelated ECLS complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients =18 years

• VA-ECLS application using the EUROSETS ECMOLIFE SYSTEM (e.g. cardiogenic shock, post cardiotomy low cardiac output syndrome, cardiac arrest, high risk percutaneous coronary intervention, eCPR)

Exclusion Criteria:

• Patients <18 years

• Pregnant and breastfeeding women

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Device:
• Eurosets ECMO Life System
ECMOLIFE System in combination with ECMOLIFE Centrifugal Pump and ECC (extra-corporeal-circulation) Tubing Set is intended to pump blood through the extracorporeal circuit to provide extracorporeal circulation. ECMOLIFE System must be used only in combination with ECMOLIFE Centrifugal Pump. ECMOLIFE System is intended to operate in the following hospital environments: Operating Room, Catheter Laboratory, Emergency Room, Intensive Care Unit and during intra-hospital patient transportation from one to another Unit. ECMOLIFE System is intended to be used by qualified healthcare professionals specifically trained in the field of extracorporeal circulation: Perfusionists (Thoracic Cardiovascular Surgery - OR), Intensivists, ICU Nurses (ICU), Emergency physicians / Intensivists (ER), Cardiologist (CathLab).

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Cardiac Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Eurosets S.r.l.

Country where clinical trial is conducted

Austria, 

References & Publications (21)

Elsharkawy HA, Li L, Esa WA, Sessler DI, Bashour CA. Outcome in patients who require venoarterial extracorporeal membrane oxygenation support after cardiac surgery. J Cardiothorac Vasc Anesth. 2010 Dec;24(6):946-51. doi: 10.1053/j.jvca.2010.03.020. — View Citation

Fukuhara S, Takeda K, Garan AR, Kurlansky P, Hastie J, Naka Y, Takayama H. Contemporary mechanical circulatory support therapy for postcardiotomy shock. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):183-91. doi: 10.1007/s11748-016-0625-4. Epub 2016 Feb 13. Review. — View Citation

Harjola VP, Lassus J, Sionis A, Køber L, Tarvasmäki T, Spinar J, Parissis J, Banaszewski M, Silva-Cardoso J, Carubelli V, Di Somma S, Tolppanen H, Zeymer U, Thiele H, Nieminen MS, Mebazaa A; CardShock Study Investigators; GREAT network. Clinical picture and risk prediction of short-term mortality in cardiogenic shock. Eur J Heart Fail. 2015 May;17(5):501-9. doi: 10.1002/ejhf.260. Epub 2015 Mar 28. Erratum in: Eur J Heart Fail. 2015 Sep;17(9):984. — View Citation

Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. — View Citation

McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22. — View Citation

Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ, Vis MM, Wykrzykowska JJ, Koch KT, Baan J, de Winter RJ, Piek JJ, Lagrand WK, de Mol BA, Tijssen JG, Henriques JP. Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2017 Jan 24;69(3):278-287. doi: 10.1016/j.jacc.2016.10.022. Epub 2016 Oct 31. — View Citation

Ouweneel DM, Schotborgh JV, Limpens J, Sjauw KD, Engström AE, Lagrand WK, Cherpanath TGV, Driessen AHG, de Mol BAJM, Henriques JPS. Extracorporeal life support during cardiac arrest and cardiogenic shock: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1922-1934. doi: 10.1007/s00134-016-4536-8. Epub 2016 Sep 19. Review. — View Citation

Poppe M, Schriefl C, Steinacher A, Clodi C, Warenits AM, Nürnberger A, Hubner P, Holzer M, Horvat J, Wiedemann D, Weiser C. Extracorporeal cardiopulmonary resuscitation at the emergency department: A retrospective patient selection evaluation. Eur J Anaesthesiol. 2020 Apr;37(4):280-285. doi: 10.1097/EJA.0000000000001142. — View Citation

Rastan AJ, Dege A, Mohr M, Doll N, Falk V, Walther T, Mohr FW. Early and late outcomes of 517 consecutive adult patients treated with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg. 2010 Feb;139(2):302-11, 311.e1. doi: 10.1016/j.jtcvs.2009.10.043. — View Citation

Sauer CM, Yuh DD, Bonde P. Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160. — View Citation

Saxena P, Neal J, Joyce LD, Greason KL, Schaff HV, Guru P, Shi WY, Burkhart H, Li Z, Oliver WC, Pike RB, Haile DT, Schears GJ. Extracorporeal Membrane Oxygenation Support in Postcardiotomy Elderly Patients: The Mayo Clinic Experience. Ann Thorac Surg. 2015 Jun;99(6):2053-60. doi: 10.1016/j.athoracsur.2014.11.075. Epub 2015 Apr 10. — View Citation

Schober A, Sterz F, Herkner H, Wallmueller C, Weiser C, Hubner P, Testori C. Emergency extracorporeal life support and ongoing resuscitation: a retrospective comparison for refractory out-of-hospital cardiac arrest. Emerg Med J. 2017 May;34(5):277-281. doi: 10.1136/emermed-2015-205232. Epub 2017 Feb 17. — View Citation

Smedira NG, Blackstone EH. Postcardiotomy mechanical support: risk factors and outcomes. Ann Thorac Surg. 2001 Mar;71(3 Suppl):S60-6; discussion S82-5. — View Citation

Thiele H, Schuler G, Neumann FJ, Hausleiter J, Olbrich HG, Schwarz B, Hennersdorf M, Empen K, Fuernau G, Desch S, de Waha S, Eitel I, Hambrecht R, Böhm M, Kurowski V, Lauer B, Minden HH, Figulla HR, Braun-Dullaeus RC, Strasser RH, Rochor K, Maier SK, Möllmann H, Schneider S, Ebelt H, Werdan K, Zeymer U; IABP-SHOCK II Trial Investigators. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: Design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial. Am Heart J. 2015 Apr;169(4):e7-8. doi: 10.1016/j.ahj.2015.01.009. Epub 2015 Jan 30. — View Citation

Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Böhm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26. — View Citation

Timmis A, Townsend N, Gale C, Grobbee R, Maniadakis N, Flather M, Wilkins E, Wright L, Vos R, Bax J, Blum M, Pinto F, Vardas P; ESC Scientific Document Group. European Society of Cardiology: Cardiovascular Disease Statistics 2017. Eur Heart J. 2018 Feb 14;39(7):508-579. doi: 10.1093/eurheartj/ehx628. — View Citation

Timmis A, Townsend N, Gale CP, Torbica A, Lettino M, Petersen SE, Mossialos EA, Maggioni AP, Kazakiewicz D, May HT, De Smedt D, Flather M, Zuhlke L, Beltrame JF, Huculeci R, Tavazzi L, Hindricks G, Bax J, Casadei B, Achenbach S, Wright L, Vardas P; European Society of Cardiology. European Society of Cardiology: Cardiovascular Disease Statistics 2019. Eur Heart J. 2020 Jan 1;41(1):12-85. doi: 10.1093/eurheartj/ehz859. Erratum in: Eur Heart J. 2020 Dec 14;41(47):4507. — View Citation

Townsend N, Wilson L, Bhatnagar P, Wickramasinghe K, Rayner M, Nichols M. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016 Nov 7;37(42):3232-3245. Epub 2016 Aug 14. Erratum in: Eur Heart J. 2019 Jan 7;40(2):189. — View Citation

van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18. Review. — View Citation

Wengenmayer T, Rombach S, Ramshorn F, Biever P, Bode C, Duerschmied D, Staudacher DL. Influence of low-flow time on survival after extracorporeal cardiopulmonary resuscitation (eCPR). Crit Care. 2017 Jun 22;21(1):157. doi: 10.1186/s13054-017-1744-8. — View Citation

Whitman GJ. Extracorporeal membrane oxygenation for the treatment of postcardiotomy shock. J Thorac Cardiovasc Surg. 2017 Jan;153(1):95-101. doi: 10.1016/j.jtcvs.2016.08.024. Epub 2016 Aug 31. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Device Malfunction	Rate of device malfunction of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.	in-hospital, 30 days
Primary	Rate of device related complications	Rate of device related complications of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.	in-hospital, 30 days
Secondary	Rate of Mortality	Rate of in-hospital and 30 day mortality.	in-hospital, 30 days
Secondary	Rate of Adverse Events	Rate of in-hospital and 30 day adverse events.	in-hospital, 30 days

External Links

•   eurosets announces the full commercial release of its novel extracorporeal life support system ecmolife