Clinical Highlights

Mitroflow Aortic Pericardial Heart Valve
Mitroflow
Available for US and International market
Mitroflow Aortic Pericardial Heart Valve
Clinical Highlights
MITROFLOW LONG TERM RESULTS

MITROFLOW PERICARDIAL AORTIC VALVE REPLACEMENT: DURABILITY RESULTS UP TO 21 YEARS

C.A. Yankah, M.Pasic, M.Musci, J.Stein, C.Detschades, H.Siniawski, R.Hetzer
J Thorac Cardiovasc Surg. 2008 Sept; 136(3): 688-696


Number of patients 1516 isolated AVR
Implant time frame March 1986 - Dec 2007
Mean age 73.2 ± 0.22
Distribution 442 males (29.2%)
1071 females (70.8%)
Average follow up 4.07 ± 0.12 yrs
Total Patient Years 6163.5
Follow up completion 99.3%


HAEMODYNAMIC RESULTS




CLINICAL RESULTS

Actuarial freedom from structural valve deterioration at 20 years
EVENT Linearized rate
(%/pts-yr)
Actuarial Freedom
From Event
Thromboembolic Events
<65 yrs
≥65 yrs
0.79
0.50
0.93
94.1%
-
-
Bleeding 0.065 -
Endocarditis 0.28 96.8%
Paravalvular Leaks 0.016 -
Valve Related Death 0.40 82.9%


CONCLUSIONS

“The Mitroflow pericardial bioprosthesus 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 chioce with a predictable low rate of valve-related events, particularly for patients over the age of 65-70 and others with comorbidities.”