USA – Overview of Prothrombin Complex Concentrate Industry and Healthcare Statistics in 2022

The global Prothrombin Complex Concentrate (PCC) market size was valued at USD 695.3 million in 2019 and is projected to reach USD 1,604.9 million by 2027, exhibiting a CAGR of 10.6 % during the forecast period

Abstract

Left ventricular assist devices (LVADs) require careful therapeutic anticoagulation with warfarin to prevent pump thrombosis. However, the best method to reverse warfarin for elective LVAD conversion surgery with massive bleeding remains unclear. We report the case of a 39-year-old Japanese man who was administered a four-factor prothrombin complex concentrate (4F-PCC) as warfarin reversal when he underwent conversion surgery from paracorporeal LVAD to implantable LVAD. 4F-PCC with co-administration of vitamin K reduced the international normalized ratio and R time in TEG6s (Haemonetics Corporation, USA) immediately. The effect was prolonged, and good hemostasis was achieved. 4F-PCC with vitamin K provided good hemostasis in our patient; therefore, 4F-PCC could be a useful tool for elective LVAD conversion surgery with expected massive bleeding and requiring immediate warfarin reversal.

Introduction

A left ventricular assist device (LVAD) requires careful therapeutic anticoagulation with warfarin to prevent pump thrombosis. Although prompt warfarin reversal is often required for patients with LVAD to undergo invasive procedures, including LVAD conversion surgery, the best method remains unclear. Four-factor prothrombin complex concentrate (4F-PCC) includes a vitamin K-dependent coagulation factor, and the effects appear immediately [1]. Although the current indication for 4F-PCC use is only for urgent surgery [1,2], it can be reasonable for patients who underwent elective LVAD conversion. On the other hand, thromboembolic complications following 4F-PCC administration can be a concern [3,4]; therefore, point-of-care (POC) monitoring is recommended to monitor the coagulation status frequently [5]. Nevertheless, there is limited clinical data regarding the efficacy of POC monitoring with 4F-PCC use in elective surgery with LVAD.

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Case Presentation

We report the case of a 39-year-old Japanese man (173 cm, 50.0 kg) who was administered 4F-PCC as warfarin reversal to undergo conversion surgery from paracorporeal LVAD to implantable LVAD. He was diagnosed with dilated cardiomyopathy when he was 29 years old. Because an infection caused acute exacerbation of congestive heart failure (ejection fraction was 20%), we implanted a paracorporeal LVAD as a bridge to recovery. It improved multiple organ failure but did not recover cardiac function. Therefore, we scheduled an LVAD conversion surgery. Because a white thrombus already existed in the pump circuit, the patient had been taking warfarin 5 mg/day, aspirin 100 mg/day, and heparin 10,000 U/day. The prothrombin time-international normalized ratio (PT-INR) was 2.64, and the activated partial thromboplastin time (APTT) was 62.9.

Key players covered in the global Prothrombin Complex Concentrate Market research report:

• Grifols, S.A. (Spain)
• CSL Behring (U.S.)
• Octopharma AG (Switzerland)
• Sanquin (Netherlands)
• Kedrion S.p.A (Italy)
• China Biologic Products Holdings, Inc. (China)
• Takeda Pharmaceutical Company Limited (Japan)
• Others

Massive bleeding was expected during this surgery due to a history of multiple sternotomies. Our multidisciplinary heart team, including cardiac surgeons, cardiologists, neurosurgeons, anesthesiologists, and perfusionist for mechanical circulatory support, decided to continue warfarin until the morning of surgery and to administer 4F-PCC with vitamin K. We injected 1,250 U of 4F-PCC based on PT-INR and body weight immediately before surgery, followed by 20 mg of vitamin K at two hours before the surgery. Effective hemostasis was obtained, and the calculated blood loss was 220 mL due to adhesiotomy and driveline creation.We assessed the hemostatic status using TEG6s (Haemonetics Corporation, USA) during surgery. Test points of the TEG6s test, time change of PT-INR, and other related tests are shown in Figure 1. From the value of TEG6s before 4F-PCC administration, coagulation function was inhibited probably due to warfarin and heparin (Figure 2). R time in TEG6s improved one hour after 4F-PCC administration (Figure 3). R time was slightly improved after protamine administration compared to the values before cardiopulmonary bypass (Figure 4). Blood tests showed a similar tendency. Fresh frozen plasma (FFP), platelets, and 3 g of fibrinogen were administered because of the reduction of platelet and fibrinogen.

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