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. 2024 Jul 23;4(8):577-589.
doi: 10.1016/j.jacasi.2024.05.007. eCollection 2024 Aug.

Outcomes of Chronic Thromboembolic Pulmonary Hypertension After Balloon Pulmonary Angioplasty and Pulmonary Endarterectomy

Kohei Masaki  1 , Kazuya Hosokawa  1 , Kouta Funakoshi  2 , Yu Taniguchi  3 , Shiro Adachi  4 , Takumi Inami  5 , Jun Yamashita  6 , Hitoshi Ogino  7 , Ichizo Tsujino  8 , Masaru Hatano  9 , Nobuhiro Yaoita  10 , Nobutaka Ikeda  11 , Hiroto Shimokawahara  12 , Nobuhiro Tanabe  13 , Kayoko Kubota  14 , Ayako Shigeta  15 , Yoshito Ogihara  16 , Koshin Horimoto  17 , Yoshihiro Dohi  18 , Takashi Kawakami  19 , Yuichi Tamura  20 , Koichiro Tatsumi  15 , Kohtaro Abe  1 ; CTEPH AC Registry Study Group
Collaborators, Affiliations

Outcomes of Chronic Thromboembolic Pulmonary Hypertension After Balloon Pulmonary Angioplasty and Pulmonary Endarterectomy

Kohei Masaki et al. JACC Asia. .

Abstract

Background: The contemporary outcome of balloon pulmonary angioplasty (BPA) and pulmonary endarterectomy (PEA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) are unclear.

Objectives: This study aimed to clarify the characteristics and outcomes of CTEPH patients treated with BPA and PEA in Japan.

Methods: Among 1,270 participants enrolled between 2018 and 2023 in the CTEPH AC (Chronic Thromboembolic Pulmonary Hypertension Anticoagulant) registry, a Japanese nationwide CTEPH registry, 369 treatment-naive patients (BPA strategy: n = 313; PEA strategy: n = 56) and 690 on-treatment patients (BPA strategy: n = 561; PEA strategy: n = 129) were classified according to the presence of prior reperfusion therapy. Morbidity and mortality events (all-cause death, rescue mechanical reperfusion therapy, and/or initiation of parenteral pulmonary vasodilators), pulmonary hemodynamics, exercise tolerance, and relevant laboratory test results were evaluated.

Results: The BPA strategy was chosen in older patients than the PEA strategy (mean age, BPA vs PEA: 66.5 ± 12.6 years vs 62.5 ± 11.8 years; P = 0.028). Median follow-up period was 615 (Q1-Q3: 311-997) days in treatment-naive patients and 1,136 (Q1-Q3: 684-1,300) days in on-treatment patients. BPA strategy had as acceptable morbidity and mortality as PEA strategy (5-year morbidity and mortality event rate, BPA vs PEA: 10.2% [95% CI: 5.2%-19.5%] vs 16.1% [95% CI: 4.3%-50.6%] in treatment-naive patients; 9.7% [95% CI: 6.7%-13.8%] vs 6.9% [95% CI: 2.7%-17.3%] in on-treatment patients), with greater improvement of renal function; glomerular filtration rate in propensity score-matched population (difference between change: 4.9 [95% CI: 0.5-9.3] mL/min/1.73 m2; P = 0.030).

Conclusions: BPA strategy was more frequently chosen in older patients compared with PEA strategy and showed acceptable outcomes for efficacy with greater advantage for improvement in renal function. (Multicenter registry of chronic thromboembolic pulmonary hypertension in Japan; UMIN000033784).

Keywords: pulmonary embolism; pulmonary hypertension; registry; thromboembolism.

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Conflict of interest statement

This study is supported by the Japan Agency for Medical Research and Development (grant numbers JP20ek0109371, JP19lk0201102, JP22lk0201125, and JP19lk1601003), JSPS KAKENHI (grant number JP20286266), and grant from Konica Minolta based on a contract. The funding body had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Dr Hosokawa has received grants from Konica Minolta; and personal fees from Bayer Yakuhin, Nippon Shinyaku, Janssen Pharmaceutical, Pfizer, and Konica Minolta, outside the submitted work. Dr Taniguchi has received grants from Nippon Shinyaku and Janssen Pharmaceutical; and personal fees from Nippon Shinyaku, Janssen Pharmaceutical, and Bayer Yakuhin, outside the submitted work. Dr Inami has received personal fees from Janssen Pharmaceutical and Bayer Yakuhin, outside the submitted work. Dr Yamashita has received a grant from Abbott Vascular Japan; and personal fees from Kaneka Medix, Boston Scientific Japan, Nihon Kohden, Philips Japan, Janssen Pharmaceutical, and Bayer Yakuhin, outside the submitted work. Dr Ogino has received consulting fees from Terumo, Japan Lifeline, and Century Medical; and personal fees from Bayer Yakuhin, Daiichi-Sankyo, Pfizer, and Nippon Shinyaku, outside the submitted work. Dr Tsujino has received personal fees from Nippon Shinyaku and Janssen Pharmaceutical; and affiliation with the division supported by endowments from Nippon Shinyaku, Nippon Boehringer Ingelheim, Mochida Pharmaceutical, Kaneka Medix, Takeyama, and Medical System Network, outside the submitted work. Dr Hatano has received personal fees from Bayer Yakuhin and Janssen Pharmaceutical, outside the submitted work. Dr Yaoita has received personal fees from Bayer Yakuhin and Konica Minolta, outside the submitted work. Dr Ikeda has received personal fees from Janssen Pharmaceutical, Bayer Yakuhin, Nippon Shinyaku, Daiichi -Sankyo, and Bristol Myers Squibb, outside the submitted work. Dr Shimokawahara has received a grant from Bayer Yakuhin; and personal fees from Bayer Yakuhin and Nippon Shinyaku, outside the submitted work. Dr Tanabe has received personal fees from Janssen Pharmaceutical, Bayer Yakuhin, and Nippon Shinyaku, outside the submitted work. Dr Kubota has received personal fees from Janssen Pharmaceutical and Nippon Shinyaku, outside the submitted work. Dr Ogihara has received grants from Bayer Yakuhin; and personal fees from Janssen Pharmaceutical, Bayer Yakuhin, Nippon Shinyaku, Daiichi-Sankyo, and Bristol Myers Squibb, outside the submitted work. Dr Kawakami has received personal fees from Kaneka Medix and Abbott Medical Japan, and consulting fees from ACIST Japan, outside the submitted work. Dr Tamura has received grants from Bayer Yakuhin, Nippon Shinyaku, and Mochida Pharmaceutical; and personal fees from Bayer Yakuhin, Nippon Shinyaku, Daiichi-Sankyo, and Janssen Pharmaceutical, outside the submitted work. Dr Abe has received a grant from Konica Minolta and Daiichi-Sankyo, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Patient Disposition All patients with reperfusion data were divided into “on-treatment” or “treatment-naive” based on the history of reperfusion therapy at baseline, and each patient was categorized into the BPA or the PEA strategy group based on the details of reperfusion therapy. BPA = balloon pulmonary angioplasty; CTEPH = chronic thromboembolic pulmonary hypertension; PEA = pulmonary endarterectomy.
Figure 2
Figure 2
Kaplan-Meier Cumulative Event Curves for the Treatment-Naive Patients The figures show (A) morbidity and mortality events, (B) all-cause mortality, (C) rescue mechanical reperfusion therapy (BPA or PEA), (D) clinical worsening of CTEPH characterized by decreased 6MWD and worsening of WHO functional class, and (E) symptomatic venous thromboembolism. Red = BPA strategy group. Blue = PEA strategy group. Shaded areas = 95% CIs. 6MWD = 6-minute walk distance; WHO = World Health Organization; other abbreviations as in Figure 1.
Central Illustration
Central Illustration
Results From the Japanese Nationwide CTEPH Registry (August 2018 to July 2023) The Kaplan-Meier cumulative curve shows morbidity and mortality events for the treatment-naive patients who received the first reperfusion therapy after enrollment. 6MWD = 6-minute walk distance; BPA = balloon pulmonary angioplasty; CTEPH = chronic thromboembolic pulmonary hypertension; eGFR = estimated glomerular filtration rate; mPAP = mean pulmonary artery pressure; PEA = pulmonary endarterectomy; PSM = propensity score matching; PVR = pulmonary vascular resistance; WHO = World Health Organization.
See this image and copyright information in PMC

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