Perioperative Outcomes Associated with Inhibitor Status in Patients with Hemophilia - a Retrospective Cohort Study
Notice bibliographique
Résumé
Abstract Background The development of antibodies (inhibitors) to clotting factors compromises the treatment of people with Hemophilia A (HA) and B (HB), and results in ineffective clotting-factor therapy, higher risk of complications, and need for bypassing agents to achieve hemostatic control. Objectives To evaluate the association between presence of inhibitors and peri-operative hemostatic control, complications, and deviations from pre-surgery plans. Methods We conducted a retrospective study using data from the Indiana Hemophilia and Thrombosis Center (IHTC) surgical database (1998 - 2019). Association between specified outcomes and inhibitor status at surgery was assessed using generalized linear models while controlling for patient and procedural characteristics. Results A total of 1,492 surgeries were conducted in 539 patients with HA or HB, 4.8%(72/1492) of which were conducted in 20 (15 HA; 5HB) patients with inhibitors. Of the 72 surgeries involving inhibitors, 30 were high-titer, 10 low-titer and 32 with unreported inhibitor titers. Adjusting for patient's age, hemophilia diagnosis, surgery setting, and surgery type, the risk of achieving perioperative hemostasis was lower in surgeries involving inhibitors compared to non-inhibitor surgeries (65.6% vs 91.4%; aRR=0.78; 95% CI= 0.61-0.99; p=0.038). Complications including hemorrhage, fever, pain, thrombosis, and infections occurred more frequently in surgeries involving inhibitors (31.7% vs 14.6%; aRR= 1.67, 95% CI= 1.07 - 2.63; p=0.025). Deviation from pre-surgical plans, usually due to the development of complications including lack of effective hemostatic control, also occurred more frequently in surgeries involving inhibitors compared to those without inhibitors (70.8 vs 39.5%; aRR= 1.63, 95% CI= 1.33 - 2.01; p<0.001). Conclusion Procedures involving patients with inhibitors have increased risk of adverse perioperative outcomes compared to those without inhibitors. Key Words: Inhibitors, Hemophilia, Surgery, Perioperative outcomes, Database. Disclosures Iorio: McMaster University: Current Employment; Bayer (funding to the institution): Research Funding; BioMarin (funding to the institution): Research Funding; NovoNordisk (funding to the institution): Research Funding; Octapharma (funding to the institution): Research Funding; Pfizer (funding to the institution): Research Funding; Roche (funding to the institution): Research Funding; Sanofi (funding to the institution): Research Funding; Sobi (funding to the institution): Research Funding; Takeda (funding to the institution): Research Funding. Malec: CSL Behring: Consultancy; Genentech: Consultancy; HEMA Biologics: Consultancy; Pfizer: Consultancy; Sanofi: Consultancy, Research Funding; Takeda: Consultancy. Matino: Bayer: Membership on an entity's Board of Directors or advisory committees, Other: research grants and personal fees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Other: research grants and personal fees; Novo Nordisk: Membership on an entity's Board of Directors or advisory committees, Other: research grants and personal fees; Sanofi: Membership on an entity's Board of Directors or advisory committees, Other: research grants and personal fees; Spark: Other: research grants; Octopharma: Membership on an entity's Board of Directors or advisory committees, Other: research grants and personal fees; Sobi: Membership on an entity's Board of Directors or advisory committees, Other: personal fees. Shapiro: Pfizer: Research Funding; Novartis: Research Funding; Sangamo: Other: Advisory board fees, Research Funding; Sigilon Therapeutics: Other: Advisory board fees, Research Funding; Bioverativ (a Sanofi company): Other: Advisory board fees, Research Funding; Daiichi Sankyo: Research Funding; Genentech: Other: Advisory board fees, Research Funding, Speakers Bureau; Glover Blood Therapeutics: Research Funding; Kedrion Biopharma: Research Funding; Novo Nordisk: Other: Advisory board fees, Research Funding, Speakers Bureau; Prometric BioTherapeutics: Research Funding; Octapharma: Research Funding; OPKO: Research Funding; Agios: Research Funding; BioMarin: Research Funding; Takeda: Research Funding.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».