Influence of
Two Different Reporting Systems on Counts of Thromboembolic and Bleeding
Complications after St. Jude Medical Valve Replacement: Results from
the GELIA Study
Detlef Hering MD, Cornelia Piper MD, Rito Bergemann
MD, Carina Hillenbach PhD, Dieter Horstkotte MD
Department of Cardiology, Heart Center North-Rhine
Westphalia, Bad Oeynhausen, Institute for Medical Outcome Research (IMOR),
Loerrach, Germany |
Background and aim of the study: Different standards
for the reporting of morbid events and different follow up techniques
have a profound impact on reported morbidity after prosthetic valve replacement.
Most studies follow the guidelines of The American Association of Thoracic
Surgery (AATS) and The Society of Thoracic Surgeons (STS); the present
authors’ group has now developed an adapted Karnofsky scale which
allows a more precise grading of the severity of morbid events.
Methods: The AATS/STS criteria and the adapted Karnofsky
criteria were applied to the database of the German Experience
with Low-Intensity Anticoagulation (GELIA) study. In a study population
of 2,735 patients, GELIA compared three different intensities of
oral anticoagulation in a prospective and randomized design. Patients
registered morbid events
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prospectively by means of documentation cards.
Results: The overall rate of complications was comparable
when utilizing the two classification systems. However, use of the
AATS/STS criteria resulted in the counting of fewer bleeding complications,
because only major bleedings were recorded. In contrast, the incidence
of embolic complications was higher compared to the Karnofsky criteria
because all events were counted, irrespective of their severity,
while clinically insignificant (transient, reversible within 24 h)
events were disregarded when using the Karnofsky grading.
Conclusion: The adapted Karnofsky criteria provide a precise
and easily understandable framework for the assessment of complications,
with equal weighting of both hemorrhagic and embolic events.
The Journal of Heart Valve Disease 2005;14:467-471 |