XTRA

• Transfusion is often necessary in cardiac cases to correct coagulopathy, blood loss, and hemodilution from pump priming.¹
• Patients undergoing cardiac surgeries are likely to have comorbidities such as anemia and history of myocardial infarction, thereby increasing the risk of transfusion requirements and complications.^2,3,4
• 

• Cardiac surgeries generate the greatest need for blood transfusion.
• About 20% of all blood blood transfusions in US are associated with cardiac surgery.⁵
• Although the blood supply is the safest it has ever been, there are known risks associated with blood transfusion in cardiac surgery. ^6,7

Hospitals are developing Patient Blood Management strategies to minimize blood loss, reduce allogeneic blood transfusions and reduce health-care costs.⁸

Among the different active strategies, intraoperative autotransfusion plays a fundamental role.

European Guidelines for Perioperative Blood Management⁹

• Helpful for blood conservation in cardiac surgery with CPB (Level of evidence 1A)
• Reduces exposure to allogeneic RBC transfusions in major orthopedic surgery (Level of evidence 1A)

The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines¹⁰

• Use of blood salvage with centrifugation to include patients with known malignancy requiring cardiac procedures (class IIb - Level of evidence B)
• Pump salvage of residual blood in CPB circuit (class IIa - Level of evidence C)

XTRA, the extraordinarily innovative, intuitive and powerful ATS system, delivers washed, fresh and vital autologous RBCs, significantly decreasing the inflammatory response¹¹ and thanks to the Pfat protocol allows elimination of more than 99% of fat particles¹², reducing the risk of fat embolism.
 

*Using 225 ml bowl, averaging both inlet HCT of 10% and 25%.

*Using 225 ml bowl, with inlet HCT of 10% and 25%.

Powerful performance

Designed to obtain very high Hct, excellent supernatant removal and processing speed.

Timely and clinically relevant information displayed in realtime

Monitor inlet and outlet HCT, supernatant removal and waste line color indicators.

Advanced data management

Import XTRA case data to Connect^®, the innovative perfusion charting system focused on real time and retrospective calculations and trending tools to assist with CPB data management.

Cardiotomy suction blood processing

Cardio Kit available to connect Inspire Dual to XTRA bowl set and create direct access during and after bypass.

Process and reinfuse autologous blood in low bleeding case

Thanks to the 55ml bowl, the smallest size on the market, XTRA requires minimum red blood cell mass to obtain high quality product available for re-transfusion.¹⁶

1. Koch CG et al. - Tolerating anemia: taking aim at the right target before pulling the transfusion trigger - Transfusion. 2014
2. Robich MP et al - Trends in blood utilization in United States cardiac surgical patients - Transfusion. 2015
3. Geissler RG et al. -  Utilisation of blood components in cardiac surgery: a single-centre retrospective analysis with regard to diagnosis-related procedures - Transfus Med Hemother.2015     
4. Ad N et al. - Effect of patient age on blood product transfusion after cardiac surgery. - J Thorac Cardiovasc Surg. 2015
5. Laffey JG, Boylan JF, Cheng DC. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology. 2002 Jul
6. Kilic A, Whitman GJ. Blood transfusions in cardiac surgery: indications, risks, and conservation strategies. Ann Thorac Surg. 2014 Feb
7. Patel NN, Avlonitis VS, Jones HE, Reeves BC, Sterne JA, Murphy GJ. Indications for red blood cell transfusion in cardiac surgery: a systematic review and meta-analysis. Lancet Haematol. 2015 Dec
8. Hofmann A, Farmer S, Towler SC. Strategies to preempt and reduce the use of blood products: an Australian perspective. - Curr Opin Anaesthesiol. 2012 Feb
9. Kozek-Langenecker SA,  Management of severe perioperative bleeding Guidelines from the European Society of Anaesthesiology.  Eur J Anaesthesiol 2013
10. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines
11. Gäbel J. et al. A. Cell salvage of cardiotomy suction blood improves the balance between pro- and anti-inflammatory cytokines after cardiac surgery. Eur J Cardiothorac Surg. 2013 Sep
12. Seyfried TF. Et al. Fat removal during cell salvage: an optimized program for a discontinuous autotransfusion device - Transfusion. August 2015
13. “Clinical evaluation of the new Sorin Xtra® Autotransfusion System” - E.P. Overdevest, H.Feron, J.W.H. van Hees, P.Lanen, M.Sahin - 10th ECOPEAT Geneve - Switzerland, 2010
14. Seyfried TF, Gruber M, Streithoff F, Mandle RJ, Pawlik MT, Busse H, Hansen E  - The impact of bowl size, program setup, and blood hematocrit on the performance of a discontinuous autotransfusion system - Transfusion - 2018 MAR ; 57(3):589-598
15. Seyfried TF. Et al. Fat removal during cell salvage: an optimized program for a discontinuous autotransfusion device - Transfusion. August 2015
16. Baumann C, et al.  Evaluation of the minimum volume of salvage blood required for the successful use of two different autotransfusion devices. Paediatr Anaesth. 2015 Mar

• Clinical evidences confirm that anemia increases morbidity and mortality in patients undergoing non-cardiac surgery1–3 and presenting acutecoronary syndrome.⁴
• It has long been accepted that transfusion will correct the physiologic abnormalities associated with anemia and improve patient outcomes.
• Blood transfusion remains the cornerstone of the treatment of anemia.

Allogeneic red blood cell transfusions in non-cardiac surgery has been reported to be between 21% and 70%, with the majority of authors reporting figures in the middle of the range.⁵
Allogeneic RBC transfusions are often associated with a number of risks, including TRALI, immunomodulation, and transmission of pathogens^6,7 and may increase the risk of early and late morbidity and mortality.^8,9

Post partum Hemorrhage affects approximately 2% of all women who give birth and it is the single most significant cause of maternal mortality worldwide accounting for nearly 25% of all maternal deaths.¹⁰

In developed countries, pregnancy-related transfusion accounts for about 6% of red blood cell units transfused.¹¹ There are known risks associated with blood transfusion and also it does not cover the needs of special populations such as the Jehovah’s Witnesses.¹²

• Hospitals are developing Patient Blood Management (PBM) strategies to minimize blood loss, reduce allogeneic blood transfusions and reduce health-care costs.¹³
• Among the different active strategies, Washed Autotransfusion plays a fundamental role.

European Guidelines for Perioperative Blood Management¹⁴

• Helpful for blood conservation in cardiac surgery with CPB (Level of evidence 1A)
• Reduces exposure to allogeneic RBC transfusions in major orthopedic surgery (Level of evidence 1A)

XTRA, the extraordinarily innovative, intuitive and powerful ATS system, delivers washed, fresh and vital autologous RBCs, significantly decreasing the inflammatory response¹⁵ and thanks to the Pfat protocol allows elimination of more than 99% of fat particles¹⁶, reducing the risk of fat embolism.

*Using 225 ml bowl, averaging both inlet HCT of 10% and 25%.

*Using 225 ml bowl, with inlet HCT of 10% and 25%.

Cost effective standby technique

Mount the Collection Set to aspirate the blood lost intraoperatively and mount the Wash Set only if necessary.

Process and reinfuse autologous blood in low bleeding case.

Thanks to the 55ml bowl, the smallest size on the market, XTRA requires minimum red blood cell mass to obtain high quality product available for re-transfusion.²⁰

Timely and clinically relevant information displayed in realtime

Monitor inlet and outlet HCT, supernatant removal and waste line color indicators.

Reduction of fat embolism risk

Thanks to the Pfat protocol XTRA eliminates more than 99%* of fat particles from intra-operative and post-operative processed blood.¹⁷

 

A unique solution for Jehova Witness patients

Autologous transfusion provides a potentially life-saving blood management solution for Jehovah’s Witnesses, who can’t accept allogeneic blood. The XTRA system is the only device featuring the Prime IV function, to automatically initiate a continuous blood circuit.

Reliable solution to face critical bleeding situation

The emergency protocol can be easily activated by pressing the dedicated button always available on the main screen. It is designed to obtain a good HCT (≈ 45%) and a very good wash quality (supernatant removal >95%) in less than 3 minutes.¹⁹

Important Safety Information for XTRA/XVAC

1. INDICATIONS FOR USE / INTENDED PURPOSE
EU/International: XTRA is indicated for use for intraoperative recovery of blood, washing of blood collected in the postoperative period and preoperative sequestration (with indirect patient connection). The XVAC is indicated for use for intraoperative and postoperative recovery of blood for autotransfusion procedures. Intraoperative blood salvage is widely employed in surgical procedures where blood loss occurs during the course of the operation, whereas postoperative blood salvage is used in surgical procedures where bleeding may occur during the postoperative course. Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

US: The XTRA Autotransfusion System is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

The XVAC is indicated for use only with the XTRA, an autologous blood recovery system indicated for intra- and post-operative autotransfusion, as well as for pre-operative sequestration.

2. CONTRAINDICATIONS
There are no known contraindications for the XTRA. However, the use of blood processed by this device may be contraindicated under some circumstances. The responsibility for the use of the device in all cases belongs solely to the physician in charge.

3. WARNINGS
The device must be used in accordance with the instructions for use. For a complete listing of warnings, please refer to the Instructions for Use which accompany each product

4. PRECAUTIONS
The XTRA must be used only with XTRA disposables. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product

The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.

The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product.

Legal Manufacturer:
LivaNova Deutschland
Lindberghstrasse 25
D-80939 Munich, Germany

Distributed in the USA by:
LivaNova USA
14401 W 65th Way
Arvada, CO 80004