The deltastream® system

CURRENT CARDIOSURGICAL TREATMENT STRATEGIES:ADVANCED PERFUSION TECHNOLOGIES

Cardiosurgical therapy of post perfusion cardiac failure andcardiopulmonary failure

THE ACHIEVEMENT

OF MODERN HEART SURGERY

The advent of cardiopulmonary bypass with the heart lung ma-

chine[1] opened the door for heart surgery to create surgical treatment

options for a broad variety of cardiovascular diseases. Especially

in complex congenital heart disease and for many acquired cardio-

vascular diseases, heart surgery still remains the major pillar in

advanced treatment strategies.

Upon the use of a heart-lung-machine about 3-5 % of patients

suffer from post perfusion cardiac failure[2] associated with the

sequelae of cardiopulmonary bypass, e.g. ischemia, reperfusion

damage or activation of the infl ammatory cascade.[2,3] The resultant

myocardial pump failure frequently leads to pulmonary congestion

necessitating intensifi ed therapeutic efforts to potentially cure the

patient.

CONSERVATIVE TREATMENT

AND ITS LIMITATIONS

Treatment with inotropic drugs and intra-aortic counterpulsation

might be suffi cient in the majority of cases with post perfusion myo-

cardial failure. However, about 1 % of patients require intensifi ed

treatment, e.g. with extracorporeal membrane oxygenation (ECMO)

or extracorporeal circulatory life support (ECLS)[4] as a bridge to re-

covery, to VAD or to transplantation. This creates life saving treat-

ment options in a patient cohort with high mortality and has been

proven for both adult[2,5] and pediatric patients. [6,7]

IN CARDIOGENIC SHOCK AND CARDIO-

PULMONARY RESUSCITATION

In all cardiogenic shock situations a rapid stabilization of the patient’s

native circulation is indispensible to minimize mortality caused by

malperfusion-related end organ failure. In such a situation cardio-

pulmonary assist with the help of ECMO/ECLS has been shown to

be a promising and successful treatment option.[4-8]

EXTRACORPOREAL SUPPORT SAVES LIVES

Extracorporeal support was successfully employed by several expe-

rienced groups in cardiopulmonary resuscitation of patients with acute

cardiogenic shock refractory to conventional therapy (see Figure 1).

Perfusion technology can thus be used to salvage patients lives by

means of extracorporeal cardiopulmonary reanimation (ECPR).[9-11]

ECLS STABILIZES PATIENTS WITH LIFE THREA-

TENING CIRCULATORY FAILURE

In patients suffering from massive acute pulmonary embolism with

consecutive life-threatening circulatory failure the use of ECMO/ECLS

enables stabilization of the patient’s circulation and guarantees suf-

fi cient gas exchange, thus improving outcome in these cases with

otherwise fatal prognosis.[12,13]

In patients with ventricular fi brillation, the use of therapeutic hypother-

mia offers a proven benefi t in terms of an improved outcome. However,

the majority of centers today use therapeutic hypothermia also for co-

matose survivors with other initial rhythms. Therapeutic hypothermia

following ECPR is easy to apply by means of the heater/cooler unit,

which is a component of the deltastream® system and avoids severe

side-effects or complications associated with mortality.[14,15]

STANDARD TREATMENT ECMO/ECLS IMPROVES OUTCOME2 3

REASONS FOR CARDIOGENIC

SHOCK:

n Acute myocardial infarction (AMI)

n Infarction-related complications, e.g.

n After papillary muscle rupture

n Infarction-related ventricular septal defect

n Rupture of the ventricular wall

ECLS SAVES PATIENTS IN ACUTE CARDIOGENIC SHOCK REFRACTORY TO CONVENTIONAL THERAPY

Figure 1: Modifi ed according to Combes A. et al. (2008) [10]

ECMO for Acute Cardiogenic Shockn = 81

Transplantn = 10

Othern = 5

PCCSn = 16

Myocarditisn = 16

AMIn = 16

DCMn = 18

9 Death after ECMO weaning

38 Death under ECMO

34 ICU survivors

29 Long-term survivors n = 4 n = 5 n = 9 n = 7 n = 3

n = 11 n = 10 n = 6 n = 5 n = 3 n = 3

n = 2 n = 1 n = 0 n = 3 n = 2 n = 1

n = 5 n = 5 n = 10 n = 8 n = 5 n = 1

n = 1

4 5STRATEGIES & INDICATIONS

BRIDGING STRATEGIES:

SAVING LIMITED RESOURCES

The use of ECLS protocols to support the circulation and provide ex-

tracorporeal gas exchange allows both perfusionist and cardiac sur-

geon to bridge the patient to surgical treatment, to recovery, to VAD

or to transplantation. ECMO treatment, for instance, can be used in

patients with pulmonary failure with end stage pulmonary disease as

a bridge to transplant.[16,17]

In myocardial failure, ECLS can be used in a staged therapy concept

as a bridge to bridge followed by the implant of an assist device

(LVAD, RVAD or BiVAD) in case myocardial recovery is an option or

organ transplantation is the fi nal target.[18]

However, when used to support a patient in cardiogenic shock such

a strategy is advantageous in preserving limited resources by avoi-

ding LVAD implantation when a poor outcome is most likely.[19]

Naturally, ECLS therapy and the associated treatment options can

also be used in acute post-transplant organ failure to allow time for

decision making in such a complex situation.[20,21]

deltastream® INDICATIONS

When used by experienced perfusionists and in the hands of experi-

enced cardiac surgeons the aforementioned treatment options offer

a broad spectrum of indications for the deltastream® system:

• Post-perfusion cardiac failure [2,4,5]

• Post-perfusion cardiac failure in congenital heart disease [6,7]

• Cardiopulmonary resuscitation [9,10]

• Acute pulmonary embolism [12,13]

• Patient cooling after cardiac arrest [14,15]

• Cardiogenic shock [4,6,8,17]

• Bridging strategies [16,17,18,19]

• Post-transplant acute rejection [20,21]

ILCOR* RECOMMENDATIONS [15]

n Unconscious adult patients with

spontaneous circulation after out-of-

hospital cardiac arrest should be

cooled to 32-34° C for 12-24 h when

the initial rhythm was VF

n Such cooling may also be benefi cial

for other rhythms or in-hospital cardiac

arrest

*International Liaison Committee On Resuscitation

4 5STRATEGIES & INDICATIONS

deltastream®:

FOR ALL CARDIOPULMONARY PATIENTS

Since the advent of ECLS treatment in clinical practice during the

1970´s[22,23] these initially complex technologies underwent a suc-

cessful evolution towards routine clinical use. Medos engineers suc-

ceeded in reducing the complexity of the ECLS equipment to a mini-

mum with reliable, compact, safer and more user-friendly equipment.

All of these requirements have to be met for current ECLS treatment

in modern perfusion and cardiothoracic surgery.

The deltastream® system serves as a complete system for all

patients requiring cardiopulmonary support.

YOUR ADVANTAGES

DURING PATIENT TREATMENT

The Medos deltastream® system is optimized for cardiosurgical the-

rapy and offers a unique combination of safety, mobility and ease

of use.

The deltastream® system consists of the MDC console user inter-

face, the completely new and unique DP3 rotational pump, the quiet

and powerful heater/cooler, and fi nally the unifying deltastream®

Trolley.

In consequence the complete deltastream® system offers optimized,

fl exible and individually adjustable treatment strategies for your pa-

tients of all ages: from neonates to adults.

6 7THE MEDOS SOLUTION: A COMPLETE & EFFICIENT SYSTEM

The deltastream® DP3 pump

AT A GLANCE:

n Optimized and individualized applicability

n Mobility and fl exibility during use

n Maximum safety and gentle treatment for the

patient

n Universal use for patients of all ages: from neo-

nates to adults

n Cooling and warming according to treatment

requirements

8 9SIMPLE, EFFECTIVE AND SAFE: THE deltastream® SYSTEM

deltastream® DP3 PUMP

• High hydraulic performance results from optimized fl ow

conduction in unique rotational pump device

• Pulsatile fl ow optional

• Flow range from 0 to 8 l/min

• Long run times due to high-tech ceramic bearing and

magnet coupling

• Approved for medium-term use of up to 7 days

• Minimal priming volume (16 ml)

• Minimized tubing length due to fl exible positioning

deltastream® TROLLEY

• Flexible trolley combines all components

• Maximized mobility with ergonomic and safe design

• Space-saving and compact design ideal for use

in crowded areas

deltastream® MDC CONSOLE

• Preload control prevents suction of the infl ow cannula

• Increased fl exibility due to modular positioning

• Precise and sensitive fl ow and pressure control enabling treat-

ment of neonates and adults with only one pump size

• Trend display of all operating parameters

• Zero-fl ow mode allows immediate discontinuation of any blood

fl ow by RPM reduction, preventing unwanted backfl ow

• Unique and variable power supply concept

• Mobility due to battery operation (hot swappable) and detachable

touch-screen

Further safety features are the fl ow sensor with integrated bubble

detector, four individually applicable pressure sensors and a level

sensor for use in an open ECC system. All these features qualify

the deltastream® system as a versatile and safe choice for modern

perfusion.

deltastream® HC

• Effi cient cooling and warming with one device

• Safe and precise temperature control

• Dense and robust design

• Simple and intuitive handling

• Quiet and powerful operation

The deltastream® drive

The deltastream® backup

MADE INGERMANY

[14]

[15]

[16]

[17]

[18]

[19]

[20]

[21]

[22]

[23]

EASY HANDLING ...

... IN DAILY CLINICAL PRACTICE

The deltastream® technology is different from the usual technology in

two distinct points: the compact design of the deltastream® pump of-

fers an extremely fl exible positioning of the pump system in addition

to comprehensive control and sensor options of the system offering

a high degree of safety and simple handling.

The extremely fl exible positioning of the deltastream® pump and all

of its components offers a minimized length of the tubing thereby re-

ducing priming volume and foreign surface contact. However, highly

simplifi ed and minimized systems require special control and safety

features: preload control prevents suction of the infl ow cannula. The

zero-fl ow mode allows an immediate discontinuation of the blood

fl ow by reduction of RPMs thereby preventing unwanted backfl ow.

Further safety features are a fl ow sensor with integrated bubble

sensor, four independent pressure sensors and a level sensor for

use with open ECC systems. These features allow the deltastream®

system to comply fl exibly with all of the requirements of perfusio-

nists and cardiac surgeons in daily clinical practice.

To summarize, the deltastream® system fulfi lls all user requirements

thus making ECLS therapy a more versatile and reliable tool for

perfusionists and cardiac surgeons in the treatment of their critically

ill patients.

On request we would be happy to send you the complete Compendium of Evidence containing the most relevant publications. Please send

an e-mail to info@medos-ag.com.

REFERENCES

Edmunds LH. Advances in the heart-lung machine after John and Mary Gibbon. Ann Thorac Surg 2003;76:S2220-3

Doll N et al. Five-Year Results of 219 Consecutive Patients Treated With Extracorporeal Membrane Oxygenation for Refractory Postoperative Cardiogenic Shock. Ann Thorac Surg 2004;77:151–7

Taylor KM. Brain damage during cardiopulmonary bypass. Ann Thorac Surg 1998;65(4 Suppl):S20–6; S27–8

Smith C, Bellomo R, Raman JS, et al. An extracorpore-al membrane oxygenation-based approach to cardio-genic shock in an older population. Ann Thorac Surg 2001;71:1421–7

Ko W-J et al. Extracorporeal Membrane Oxygenation Sup-port for Adult Postcardiotomy Cardiogenic Shock. Ann Thorac Surg 2002;73:538–45

Rogers AJ et al. Extracorporeal Membrane Oxygenation for Postcardiotomy Cardiogenic Shock in Children. Ann Thorac Surg 1989;47:903-6

Kumar TK et al. Extracorporeal membrane oxygenation in postcardiotomy patients: factors infl uencing outcome. J Thorac Cardiovasc Surg 2010;140(2):330-6

Formica F et al. ECMO support for the treatment of cardio-genic shock due to left ventricular free wall rupture. Inter-active CardioVascular and Thoracic Surgery 2005;4: 30–2

Mégarbane B et al. Emergency feasibility in medical inten-sive care unit of extracorporeal life support for refractory cardiac arrest. Intensive Care Med (2007) 33:758-764

Combes A. et al. Outcomes and long-term quality-of-life of patients supported by extracorporeal membrane oxygena-tion for refractory cardiogenic shock. Crit Care Med 2008; 36:1404-1411

Chen JS et al. Analysis of the outcome for patients expe-riencing myocardial infarction and cardiopulmonary resus-citation refractory to conventional therapy necessitating extracorporeal life support rescue. Crit Care Med 2006; 34:950-957

Misawa Y, Fuse K, Yamaguchi T, et al. Mechanical cir-culatory assist for pulmonary embolism. Perfusion. 2000;15:527–529

Maggio P et al. Extracorporeal life support for massive pulmonary embolism. J Trauma 2007 Mar;62(3):570-6 (ISSN: 0022-5282)

Sunde K, Søreide E. Therapeutic hypothermia after car-diac arrest: where are we now? Curr Opin Crit Care. 2011;17(3):247-53.

Nolan JP et al. Therapeutic hypothermia after cardiac ar-rest. An advisory statement by the Advanced Life Support Task Force of the International Liaison Committee on Re-suscitation. Resuscitation 2003;57:231-5

Haneya A et al. Extracorporeal circulatory systems as a bridge to lung transplantation at remote transplant centers. Ann Thorac Surg. 2011 Jan;91(1):250-5

Broomé M et al. Prolonged extracorporeal membrane oxy-genation and circulatory support as bridge to lung trans-plant. Ann Thorac Surg. 2008 Oct;86(4):1357-60

Hoefer D et al. Outcome Evaluation of the Bridge to Bridge Concept in Patients With Cardiogenic Shock. Ann Thorac Surg 2006;82:28 –34

Pagani FD et al. Extracorporeal Life Support to Left Ventri-cular Assist Device Bridge to Heart Transplant: A Strategy to Optimize Survival and Resource Utilization. Circulation 1999;100 [suppl II]:206 -10

Martìn-Suàrez S et al. Percutaneous circulatory support for myocardial recovery in cardiogenic shock for late acute rejection. Interactive Cardiovascular and Thoracic Surgery 200;5: 655–7

Bermudez CA et al. Extracorporeal membrane oxygenati-on for primary graft dysfunction after lung transplantation: long-term survival. Ann Thorac Surg 2009 Mar;87(3):854-60

Hill JD, O'Brien TG, Murray JJ, Dontigny L, Bramson ML, Osborn JJ, Gerbode F. Prolonged extracorporeal oxygena-tion for acute post-traumatic respiratory failure (shock-lung syndrome). Use of the Bramson membrane lung. N Engl J Med. 1972;286:629-34

Bartlett RH, Gazzaniga AB, Jefferies MR et al: Extracor-poreal membrane oxygenation (ECMO) cardiopulmona-ry support in infancy. Trans Am Soc Artif Intern Organs 1976;22:80-93

[1]

[2]

[3]

[4]

[5]

[6]

[7]

[8]

[9]

[10]

[11]

[12]

[13]

10 11CLINICAL EVIDENCE

deltastream® TECHNOLOGY:

n Extremely fl exible positioning

n High degree of safety

n Simple handling

n Reduced priming volume

CONTROL & SAFETY FEATURES:

n Preload control

n Zero-fl ow mode

n Flow & bubble sensor

n Level sensor

n 4 pressure sensors

www.artistic

.de

EN

-001

-201

1-11

Medos Medizintechnik AG

Obere Steinfurt 8-10

52222 Stolberg

Germany

Tel.: +49 2402 9664 – 0

Fax: +49 2402 9664 – 60

info@medos-ag.com

www.medos-ag.com