MITROFLOW LONG TERM RESULTS

The Italian study on the Mitroflow postoperative results (ISTHMUS):
a 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis

The ISTHMUS Investigators - European Journal of Cardio-thoracic Surgery 39 (2011) 18-26
 

Number of patients	1591
Implant time frame	Nov 1988 - June 2008
Mean Age (yrs)	75.3 ± 6.8
Total patient ears	7.447
Mean Follow up (yrs)	61.9 months

“Our echocardio-graphic findings at discharge and at follow-up, obtained at rest, were consistent with satisfactory haemodynamic properties of the Mitroflow pericardial valve, particularly in small sizes, and confirmed excellent and constant haemodynamic performances in the majority of the patients also at long term, in accordance to the findings of Yankah and colleagues”

CLINICAL RESULTS
 

CONCLUSIONS

“This study indicates that the Mitroflow pericardial valve provides favourable postoperative results at long term in terms of valve durability, valve-related events and patient clinical conditions. Furthermore, good haemodynamic performance can be expected postoperatively, even in the presence of small prosthetic sizes, therefore representing, in our opinion, an extremely valuable bioprosthesis in case of planned aortic valve replacement with a tissue valve, particularly for patients older than 70 years or in the presence of a small aortic annulus.”

Aortic valve replacement with the Mitroflow pericardial bioprosthesis: Durability results up to 21 years
C.A. Yankah, M. Pasic, M. Musci, J. Stein, C. Detschades, H. Siniawski, and R. Hetzer - J Thorac Cardiovasc Surg. 2008  Sep;136(3):688-96
 

N° of patients	1513
Implant time frame	March 1986 - Apr 2007
Mean Age (yrs)	73.2 ± 0.22 yrs
Average Follow up	4.07 ± 0.12 yrs
Total patient years	6163.5

HEMODYNAMIC RESULTS

CLINICAL RESULTS

 

CONCLUSIONS

“The Mitroflow pericardial bioprosthesis exhibits very low pressure gradients combined with easy implantability. After two decades of follow-up, the Mitroflow pericardial aortic valve continues to be a valve of choice with a predictable low rate of valve-related events, particularly for patients over the age of 65 -70 and others with comorbidities.”

 

PRODUCT	SIZE (mm)	CODE
Mitroflow with PRT	19 21 23 25 27 29	DLA19 DLA21 DLA23 DLA25 DLA27 DLA29

 

ACCESSORIES	DESCRIPTION	CODE
Bendable dual-ended sizers	19-21 mm 23-25 mm 27-29 mm	ICV 1189
	Aortic Handle	AH-11

The attached file provides MRI information concerning Sorin Group Heart Valve Prostheses and Annuloplasty Devices

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Biological Valve Receipt, Handling and Storage Procedure
Each Mitroflow Aortic Pericardial Heart Valve is shipped with two temperature indicators: one that monitors cool temperatures and one that monitors warm temperatures. These indicators are placed on the inside of each Mitroflow Aortic Pericardial Heart Valve box. The hospital staff must check each temperature indicator immediately upon receipt of any shipment containing Mitroflow Aortic Pericardial Heart Valves. If either or both of the temperature sensors have been tripped, please contact your local distributor to have the product replaced.

The following images show a "Normal" and "Exposed or Activated" cold and hot temperature indicator. Hospital staff should be familiar with how to read these temperature indicators.

Hospital staff must also check each valve jar upon receipt to ensure that the tamper evident seal has not been tampered with or broken. If you receive a jar that has had the tamper evident seal broken or tampered with, please contact your local distributor to have the product replaced.

STORAGE
Mitroflow valves must be stored between 5°C and 25°C (41-77°F). Avoid locations where extreme temperature fluctuations may occur, i.e. near steam, hot water pipes, air conditioning ducts, direct sunlight, etc.
Refrigeration is not required. Although refrigeration at 5°C (41°F) is acceptable, the risk of undetected freezing must be considered. Freezing may seriously damage the valve and render it unfit for use.
Do not store under refrigeration unless continuous temperature monitoring is maintained.

Hospital staff should regularly inspect the inventory for damage, poor storage conditions or fluctuations in temperature that might affect the product.
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