Quality assurance of high-dose i.v. heparin treatment exemplified by patients implanted with coronary Palmaz-Schatz stents.

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The need to standardize treatment with high-dose IV standard heparin by using activated partial thromboplastin time (APTT) reagents tested for their heparin sensitivity and by establishing a standard treatment schedule led to the development of the "Lainz concept" of heparin management. The determination of heparin sensitivity of the 2 APTT reagents used (APTT Micronized Silica and APTT Actin FSL), their good agreement (r = .9977; P = .000), and their therapeutic APTT ratio of 1.5-2.5 fold of baseline APTT (therapeutic range, forty-five to seventy-five seconds) equivalent to 0.3-0.7 antifactor Xa units are presented. The "Lainz concept" was tested in 29 patients receiving high-dose heparin after coronary artery stenting. A mean dose of 1,273 U of standard heparin/hour (15.7 U/kg body weight/hour) was shown to produce APTTs in the therapeutic range. From the introduction of the "Lainz concept" 81% of the APTTs were kept within the therapeutic range by using a defined heparin-monitoring schedule based on a guideline protocol for controlling heparin treatment. Only 19% of the APTTs were below the therapeutic range. Factors underlying subtherapeutic APTTs are discussed. The reduction in the rate of subtherapeutic APTTs to less than 3% seen after the introduction of the "Lainz concept" constitutes an important contribution toward quality assurance in high-dose heparin treatment.