PB1031 - Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal with 4F-PCC: KVAD Study

Tuesday, June 27, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Katelyn W. Sylvester, PharmD, BCPS, CACP

Pharmacy Manager
Brigham and Women's Hospital
Boston, Massachusetts, United States

Co-Author(s)

JG

Jessica Grandoni

Clinical Pharmacy Specialist
Brigham and Women's Hospital
Boston, Massachusetts, United States
MR

Megan Rhoten

Clinical Pharmacy Specialist
Brigham and Women's Hospital
Boston, Massachusetts, United States
LC

Lara Coakley

Mechanical Circulatory Support Nurse Practitioner
Brigham and Women's Hospital
Boston, Massachusetts, United States
EM

Erin L. Matiello

Cardiovascular Inpatient Physicians Assistant
Brigham and Women's Hospital
Boston, Massachusetts, United States
KF

Katie Frankel

Cardiovascular Inpatient Physicians Assistant
Brigham and Women's Hospital
Boston, Massachusetts, United States
BF

Brooke Fortin

Research Assistant, Hematology Division
Brigham and Women's Hospital
Boston, Massachusetts, United States
KJ

Kate Jolley

Research Assistant, Hematology Division
Brigham and Women's Hospital
Boston, Massachusetts, United States
HP

Hae Soo Park

Research Assistant, Hematology Division
Brigham and Women's Hospital
Boston, Massachusetts, United States
RF

Revital Freedman

Instructor, Hematology Division
Brigham and Women's Hospital
Boston, Massachusetts, United States
MM

Mandeep R. Mehra

Executive Director Center for Advanced Heart Disease
Brigham and Women's Hospital
Boston, Massachusetts, United States
MG

Michael M. Givertz

Medical Director, Heart Transplant and Mechanical Circulatory Support
Brigham and Women's Hospital
Boston, Massachusetts, United States
Jean M. Connors, MD (she/her/hers)

Hematologist, Medical Director Hemostatic and Antithrombotic Stewardship Service
Brigham and Women's Hospital
Boston, Massachusetts, United States

Background: Patients with left ventricular assist devices (LVAD) require warfarin anticoagulation. Stopping warfarin for procedures requires bridging with parenteral anticoagulation, and increases complexity of management, cost, and risk of periprocedural bleeding. Prothrombin complex concentrates (4F-PCC) can restore plasma clotting factors to facilitate temporary reversal of anticoagulation.

Aims: Impact of temporary warfarin reversal with 4F-PCC on coagulation factor levels and time to return to therapeutic anticoagulation in LVAD patients receiving uninterrupted warfarin.

Methods: Single center prospective study of LVAD patients performed from March 2018 to August 2022. IRB approval and informed consent were obtained (NCT03473132). Baseline INR was used to determine 4F-PCC dose to achieve surgeon-directed, pre-procedure goal INR. INR and factor levels 2, 7, 9, 10, and proteins C and S were collected 1-hour post 4F-PCC administration, and at 6, 12, 18, 24, 36, and 48-hours post infusion. Patients were followed for 30 days for ISTH major bleeding and thrombosis. Warfarin was continued throughout the peri-procedure period.

Results: Twenty episodes of 4F-PCC warfarin reversal were analyzed (Table). Median baseline INR was 2.7 (IQR 2.2-3.2); consistent with baseline factor levels (Figure). Median dose of 4F-PCC was 17 units/kg (IQR 14-22). Median INR within 1 hour of 4F-PCC administration was 1.4 (IQR 1.2-1.5). At 48 hours post-administration, median INR was 2.0 (IQR 1.9-2.4). Factor 7 and 10 levels remained adequately suppressed; however, factor 2 and 9 levels were above 30%. Time to therapeutic INR of 2.0-3.0 (± 0.2) was 2.5 days (IQR 1-4). Two patients required bridging with a parenteral anticoagulant. Within 72 hours post-procedure one patient experienced bleeding, and two bleeding events occurred at days 7 and 9 (Table). No thromboembolic events occurred.

Conclusion(s): Administration of 4F-PCC facilitating temporary reversal of anticoagulation for planned procedures in patients with LVADs allowed for continued warfarin dosing with minimal use of post-intervention bridging, limited bleeding, and no thrombotic events.