Abstract Number: PB0279
Meeting: ISTH 2020 Congress
Background: Left ventricular assist device (LVAD) patients require interruptions of warfarin for invasive procedures, which frequently requiring bridging with IV anticoagulation. Prothrombin complex concentrates (4F-PCC) can facilitate temporary reversal of anticoagulation and allow for continued warfarin.
Aims: To evaluate temporary reversal of warfarin with 4F-PCC in LVAD patients receiving continuous warfarin therapy, correlation of coagulation factor levels with INR, and return time to therapeutic INR.
Methods: A single center prospective analysis of LVAD patients was performed from March 2017 to December 2019. Baseline INR and subsequent INR with coagulation factor levels 2, 7, 9, 10, protein C/S were collected within 1-hour post 4F-PCC, and at 6, 12, 18, 24, 36, and 48-hours post infusion. 4F-PCC dose was based on baseline INR and target INR for the procedure. Informed consent was obtained.
Clinical Trials.gov Identifier: NCT03473132
Results: Nine LVAD patients received 4F-PCC to temporarily reverse warfarin, with a median baseline INR of 3.1 (IQR: 2.3-3.2). Target INR goal for procedures ranged from < 2.0 to ≤ 1.4. Median dose of 4F-PCC was 1104 units (IQR: 1091-1952) or 12 units/kg (IQR: 10-22). The median INR at T0 was 1.5 (IQR: 1.3-1.6). Time to return to therapeutic INR of 2.0 -3.0 (± 0.2) was 1 day (range 1-7 days; Figure). Two patients required bridging with an IV/SQ anticoagulant due to conservative warfarin dosing. One GI bleed occurred day 1 following polypectomy, requiring transfusion and intervention, INR was 1.6. At 7 and 30 days, no other bleeding or thrombotic events occurred. Corresponding factor levels and INR results will be reported at completion of the analysis.
Conclusions: In LVAD patients undergoing invasive procedures and receiving continued warfarin, 4F-PCC allowed for temporary warfarin reversal avoiding the need for IV AC bridging in most patients. One bleeding event occurred despite achieving target INR for the procedure. No thrombotic events were observed.
|Patient||Device & Strategy||Procedure||Baseline INR; Goal INR for procedure Achieved INR goal: achieved/not achieved||4F-PCC Dose units, units/kg||IV/SQ AC Bridge||Days to therapeutic INR (+/- 0.2)||Bleeding event intra-operative, 7 days, 30 days||Thrombotic event|
|1||HM3 LVAD DT||Robotic prostatectomy||3.2 Goal: ≤ 1.4 Achieved||2302 units 29 u/kg||No||1||Minor-expected hematuria; None None||None|
|2||HW LVAD DT||Colonoscopy w/ polypectomy||4.9 Goal: < 1.8 Achieved||4406 units 42 u/kg||No||3||Major: 2 U PRBC for Hgb drop 11.1 to 9.4 on POD1 and placed 2 hemostatic clips at active bleeding site POD2. INR at time of event was 1.6; None; None||None|
|3||HW BiVAD DT||Image guided right thoracentesis||3.2 Goal: ≤ 1.8 Achieved||1091 units 16 u/kg||No||2||None None None||None|
|4||HMII LVAD DT||Endoscopy and biopsy||3.5 Goal: < 2.0 Achieved||1094 units 10 u/kg||Yes – IV heparin POD 1||7||None None None||None|
|5||HM3 LVAD DT||Arthroplasty and unicondylar knee replacement||3.2 Goal: < 1.4 Achieved||2068 units 25 u/kg||No||1||None None None||None|
|6||HM3 LVAD DT||Colonoscopy w/ polyp clips||2.2 Goal: < 1.4 Achieved||2182 units 27 u/kg||No||4||None None None||None|
|7||HM3 LVAD DT||Left parotidectomy||2.9 Goal: ≤ 2.0 Achieved||1091 units 10 u/kg||Yes – SQ Enoxaparin POD4||1||None None None||None|
|8||HW LVAD DT||Laparoscopic sleeve gastrectomy||2.1 Goal: < 1.5 Achieved||1606 units 14 u/kg||No||1||None None None||None|
|9||HM3 DT||Colonoscopy||1.9 Goal: ≤ 1.5 Achieved||533 units 6 u/kg||No||1||None None None||None|
[Table: Details and Outcomes of LVAD Patients with Warfarin Continued Prior to Procedure and Temporarily Reversed for Procedure]
To cite this abstract in AMA style:Rimsans J, Sylvester KW, Coakley L, Matiello-Lyons E, Frankel K, Hickey M, Melanson F, Givertz MM, Connors JM. Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal with 4F-PCC (KVAD Study) [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/assessment-of-coagulation-factor-levels-in-lvad-patients-following-temporary-warfarin-reversal-with-4f-pcc-kvad-study/. Accessed November 30, 2023.
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