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Minimized modular perfusion circuit ROCsafe®RX offers better patient outcome at lower cost

15/11/2011 - Leuven, Belgium

Optimizing Cardiac Surgery

According to a recently published randomized multicenter study, the use of ROCsafe ®RX, a minimized modular perfusion circuit for extracorporeal circulation (mini-ECC), reduces the amount of blood transfusions as well as the incidence of atrial fibrillation and other severe postoperative complications associated with cardiac surgery. In the study, the ROCsafe ®RX circuit was compared to a conventional circuit for extracorporeal circulation (ECC). The results of this and other studies on minimized perfusion circuits have led to a change in international guidelines for reducing the amount of blood transfusions in cardiac surgery. The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists now strongly recommend the use of minimized perfusion circuits and have rated the use of minimized circuits for blood conservation in cardiac surgery with the highest level of clinical evidence Class I, Level A.

The prospective, randomized, multicenter study included 500 patients with a mean age of 65 years who underwent elective coronary bypass surgery and / or aortic valve replacement (1). 252 patients operated on using the ROCsafe®RX minimized extracorporeal perfusion circuit (mini-ECC) were compared to a control group of 248 patients who underwent surgery using a conventional heart-lung machine set up.

Transfusion requirements in the ROCsafe®RX group were 254 mL lower compared to the control group, representing an average savings of one unit of blood per patient. Moreover, the incidence of atrial fibrillation and severe postoperative complications (death, myocardial infarction, cerebrovascular accident, and re-operation) occurred significantly less often when the ROCsafe®RX system was used. In particular, the rate of myocardial infarction was significantly lower in the ROCsafe®RX group as compared to the control group (1.6% vs. 5.2%). Patients in the ROCsafe®RX group also required fewer re-operations (3.6% vs. 10.1%). This indicates that ROCsafe®RX provides better myocardial protection during cardiac surgery as is demonstrated by significant differences in the postoperative rise in creatine kinase (CK) and CK-MB which favor mini-ECC. If optimal outcome is accessed in terms of the absence of postoperative complications and the need for blood transfusions, then better patient outcomes can be achieved using the ROCsafe®RX system, the authors of the study conclude. This is also reflected in a significantly shorter hospital stay among ROCsafe®RX patients. This group was discharged from the hospital an average of 1.5 days earlier.

"The ROCsafe®RX minimized perfusion circuit has the potential of improving the quality of patient care in cardiac surgery. This is evidenced by a reduction in transfusion requirements and postoperative complications, both of which bear a cost saving potential for hospitals. We are pleased to see that the other centers involved in the multicenter clinical trial have confirmed our positive findings and expect that the ROCsafe technology will be quickly adopted for routine clinical use", concludes Principle Investigator Dr. Aschraf El-Essawi (Braunschweig).

New guidelines recommend minimized perfusion circuits

The benefit of minimized perfusion circuits is confirmed by the fact that the Society of Thoracic Surgeons (STS) and the Society of Cardiovascular Anesthesiologists (SCA) recently revised their guidelines for reducing blood transfusion during cardiac surgery to include a strong recommendation for the use of minimized perfusion systems (2). Nine randomized clinical trials and a metaanalysis confirmed the efficacy of minimized perfusion systems in reducing hemodilution and consequently lowering transfusion requirements and the risk of postoperative bleeding. The new guidelines recommend the use of minimized perfusion circuits with the highest level of clinical evidence (Class I, Level A) because they show clear patient benefit.

SIRS no longer a concern

A serious complication of cardiac procedures is Systemic Inflammatory Response Syndrome (SIRS) which can occur when blood comes into contact with foreign surfaces during extracorporeal circulation. SIRS manifests itself clinically by increased bleeding, a higher need for blood transfusion and in severe cases, multiorgan failure. Blood transfusions in cardiac patients are, in turn, associated with serious adverse events and poor prognosis. Correlations have been shown between red blood cell transfusion and infection, ischemia and other postoperative complications as well as prolonged hospital stay, increased early and late mortality, and increased hospital costs (3).

To reduce these side effects, minimized ECC (mini-ECC) systems were developed which offer lower priming volume and a smaller foreign surface area compared to conventional heart-lung machine set ups. The first generation mini-ECC systems in fact led to a reduction in blood loss and decreased the need for blood transfusion, but users were concerned by the absence of a venous/ cardiotomy reservoir and potentially insufficient air elimination. Therefore, the use of minimized perfusion was only recommended with Class II, Level B clinical evidence in the STS / SCA guidelines published in 2007 (4).

ROCsafe®RX offers superior air-elimination and excellent biocompatibility

These initial concerns were addressed with the development of ROCsafe®RX, a minimized closed perfusion system of the second generation with a modular concept. The latest version consists of three high-performance components with a lower priming volume and more efficient airelimination. The system is treated with a biocompatible surface coating (X-Coating™) that minimizes platelet adhesion and activation. As a modular system, ROCsafe®RX can quickly and easily be adapted for use in a whole array of surgical procedures such as heart valve repair / replacement and combined procedures.

"In the current economic situation, innovation in medical device technology means improving the quality of patient care and at the same time reducing healthcare costs. With ROCsafe®RX we are proud to offer a perfusion system which meets both objectives" said Masao Hitotsuyanagi, President, Terumo Europe Surgical Products.

References:

1. El-Essawi A et al.: Are minimized perfusion circuits the better heart lung machines? Final results of a prospective randomized multicentre study. Perfusion 2011; 26: 470-478.
2. Ferraris VA et al.: 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg 2011; 91: 944-982
3. Murphy GJ et al.: Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation 2007; 116: 2544-2552
4. Ferraris VA et al.: Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline. Ann Thorac Surg 2007; 83: S27-86

About Terumo Corporation

Tokyo-based Terumo Corporation, developer of the ROCsafe®RX minimized perfusion circuit, is one of the world's leading medical device manufacturers with $4 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use.

Terumo contributes to society by providing valued products and services to the healthcare market and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.