Gomberg-Maitland Mardi, Bourge Robert C, Shapiro Shelley M, Tarver James H, Zwicke Dianne L, Feldman Jeremy P, Chakinala Murali M, Frantz Robert P, Torres Fernando, Bag Remzi, Murphy Jeffrey A, Lautenbach Amy A, Morris Marty, Peterson Leigh, Waxman Aaron B
George Washington University Medicine and Health Sciences, Washington, DC, USA.
University of Alabama at Birmingham, Birmingham, AL, USA.
Pulm Circ. 2019 Nov 5;9(4):2045894019878615. doi: 10.1177/2045894019878615. eCollection 2019 Oct-Dec.
The DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study utilizing a fully implantable, programmable intravascular delivery system consisting of a pump and a catheter for intravenous treprostinil. The study met its primary endpoint and demonstrated that the intravascular delivery system significantly reduced catheter related complications at 22,000 subject-days of follow-up compared with a predefined objective performance criterion. Here we summarize the results obtained during a 6.4-year follow-up period.
Throughout study follow-up, participants had clinic visits and medication refills at least every 12 weeks (dependent on the subjects' dose). All adverse events and intravascular delivery system complications were evaluated and recorded.
Sixty pulmonary arterial hypertension subjects were followed post device implantation for approximately 282 patient-years (range 87 days to 6.4 years). Of the 60 subjects, 14 died (1 related to intravascular delivery system pump failure), 2 withdrew after lung transplants, and 2 withdrew due to pump pocket infection. No catheter-related bloodstream infections, catheter thrombosis or occlusions, or catheter kinks occurred through 282 patient-years. Two participants had adverse events of abdominal pain, rash, due to subcutaneous treprostinil "leaks" after one catheter puncture and one catheter laceration during pump refill and replacement, respectively. Eight pump failure events occurred: seven pump motor stalls and one early replacement (faulty battery).
Delivery of treprostinil with an intravascular delivery system is a safe alternative to an external delivery system, while providing enhanced life experiences. To preserve the risk-benefit ratio, treatment at specialized pulmonary arterial hypertension centers is recommended until training is disseminated at other sites.
肺动脉高压的可植入式输送系统临床试验是一项多中心、前瞻性、单臂、研究器械豁免研究，使用了一种完全可植入的、可编程的血管内输送系统，该系统由一个泵和一根用于静脉注射曲前列尼尔的导管组成。该研究达到了其主要终点，并表明与预先定义的客观性能标准相比，在22000受试者日的随访中，血管内输送系统显著降低了导管相关并发症。在此，我们总结了在6.4年随访期内获得的结果。
在整个研究随访期间，参与者至少每12周进行一次门诊就诊和药物补充（取决于受试者的剂量）。对所有不良事件和血管内输送系统并发症进行评估和记录。
60名肺动脉高压受试者在植入装置后接受了约282患者年的随访（范围为87天至6.4年）。在这60名受试者中，14人死亡（1人死于血管内输送系统泵故障），2人在肺移植后退出，2人因泵袋感染退出。在282患者年中，未发生与导管相关的血流感染、导管血栓形成或闭塞，或导管扭结。两名参与者分别在一次导管穿刺后因皮下曲前列尼尔“渗漏”出现腹痛、皮疹的不良事件，以及在泵重新填充和更换期间出现一次导管撕裂。发生了8次泵故障事件：7次泵电机失速和1次早期更换（电池故障）。
使用血管内输送系统输送曲前列尼尔是外部输送系统的一种安全替代方案，同时能提供更好的生活体验。为保持风险效益比，建议在专门的肺动脉高压中心进行治疗，直到其他机构也开展相关培训。
