Balloon pulmonary angioplasty versus riociguat in inoperable chronic thromboembolic pulmonary hypertension (MR BPA): an open-label, randomised controlled trial

Kawakami, Takashi; Matsubara, Hiromi; Shinke, Toshiro; Abe, Kohtaro; Kohsaka, Shun; Hosokawa, Kazuya; Taniguchi, Yu; Shimokawahara, Hiroto; Yamada, Yoshitake; Kataoka, Masaharu; Ogawa, Aiko; Murata, Mitsushige; Jinzaki, Masahiro; Hirata, Ken‐ichi; Tsutsui, Hiroyuki; Sato, Yasunori; Fukuda, Keiichi

doi:10.1016/s2213-2600(22)00171-0

Cited by 56 publications

(52 citation statements)

References 26 publications

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“…Baseline PVR for the 97 patients included for hemodynamic analysis at our center was lower, 398.6 ± 221.4 versus 767.2 ± 251.2 dynes s cm −5 in the RACE trial and 645 ± 266.7 in the MR BPA trial. 27 Additionally, 41 of the 97 patients at our center had a baseline PVR < 320 dynes s cm −5 and 16 patients had previously undergone PTE surgery. Interpretation of the hemodynamic results is also limited by the absence of invasive hemodynamic assessment to capture the final BPA session(s).…”

Section: Discussionmentioning

confidence: 99%

Patient selection for balloon pulmonary angioplasty: Six‐year results from a high volume PTE surgical center

et al. 2022

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Chronic thromboembolic pulmonary hypertension (CTEPH) is the result of incompletely resolved pulmonary emboli (PE) that lead to chronic right heart failure. The two mechanical treatment options are pulmonary thromboendarterectomy (PTE) and balloon pulmonary angioplasty (BPA). There are no formal criteria for BPA patient selection and treatment decisions vary according to a center's experience with BPA and PTE. We performed a retrospective review of consecutive patients treated with PTE and BPA at UCSD from March 2015 to 2021. Clinical and hemodynamic data were collected. Patients were categorized according to the rationale for BPA. One hundred fifty three patients underwent 643 BPA sessions, and 1104 patients underwent PTE. Patients selected for PTE had worse baseline hemodynamics with mean pulmonary artery pressure 41.1 ± 11.7 versus 34.6 ± 11.2 mmHg, p < 0.001. 59% of patients selected for BPA had surgically inaccessible disease, 21% had residual CTEPH after PTE, 10% had a discordance between disease burden and symptoms/hemodynamics, 7% had comorbidities that prevented PTE and 3% refused PTE surgery. 28% of patients who underwent PTE had exclusively level III or IV disease based on surgical specimen. There were no BPA procedure‐related mortalities and minor pulmonary vascular complication rates during BPA were 9.2%. The most common reason for BPA selection was surgically inaccessible disease followed by residual CTEPH after PTE. Almost one third of patients who underwent PTE had exclusively distal disease by surgical criteria and might have been directed to BPA at a less experienced surgical center.

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Section: Discussionmentioning

confidence: 99%

Patient selection for balloon pulmonary angioplasty: Six‐year results from a high volume PTE surgical center

et al. 2022

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“…In our study, the oxygen delivery in patients treated with PEA was significantly higher than that in patients treated with BPA ( P = 0.016), attributable to a better cardiac output after the intervention. Based on the evidence that the cardiac output was significantly improved, even superior to BPA, in inoperable CTPEH patients who received riociguat ( 38 ), combination therapy of BPA and riociguat could be prescribed to better improve the oxygen delivery in inoperable CTEPH patients. Interestingly, despite an improvement of SaO 2 , the oxygen content decreased in patients post-PEA ( P = 0.011), which can be explained by the decrease of hemoglobin after PEA (from 14.8 ± 1.9 to 12.9 ± 2.0 g/dl, P = 0.001, Supplementary Table 1 ).…”

Section: Discussionmentioning

confidence: 99%

Different response of the oxygen pathway in patients with chronic thromboembolic pulmonary hypertension treated with pulmonary endarterectomy versus balloon pulmonary angioplasty

Tao

Xie

et al. 2022

Front. Cardiovasc. Med.

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BackgroundOxygen pathway limitation exists in chronic thromboembolic pulmonary hypertension (CTEPH). Pulmonary endarterectomy (PEA) and balloon pulmonary angioplasty (BPA) are two effective interventions for CTEPH, but their effects and comparison of these two interventions on the oxygen pathway are not well demonstrated.MethodsCTEPH patients with available pulmonary function test, hemodynamics, and blood gas analysis before and after the interventions were included for comparison of oxygen pathway in terms of lung ventilation, lung gas exchange, oxygen delivery, and oxygen extraction between these two interventions.ResultsThe change in the percentage of the predicted forced expiratory volume in the 1 s (−3.4 ± 12.7 vs. 3.8 ± 8.7%, P = 0.006) and forced vital capacity (−5.5 ± 13.0 vs. 4.2 ± 9.9%, P = 0.001) among the PEA group (n = 24) and BPA group (n = 46) were significantly different. Patients in the PEA group had a significant increase in their arterial oxygen saturation (from 92.5 ± 3.6 to 94.6 ± 2.4%, P = 0.022), while those in the BPA group had no change, which could be explained by a significant improvement in ventilation/perfusion (−0.48 ± 0.53 vs. −0.17 ± 0.41, P = 0.016). Compared with patients post-BPA, patients post-PEA were characterized by higher oxygen delivery (756.3 ± 229.1 vs. 628.8 ± 188.5 ml/min, P = 0.016) and higher oxygen extraction (203.3 ± 64.8 vs. 151.2 ± 31.9 ml/min, P = 0.001).ConclusionPartial amelioration of the oxygen pathway limitations could be achieved in CTEPH patients treated with PEA and BPA. CTEPH patients post-PEA had better performance in lung gas exchange, oxygen delivery, and extraction, while those post-BPA had better lung ventilation. Cardiopulmonary rehabilitation may assist in improving the impairment of the oxygen pathway.

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“…Studies comparing the effect of guideline‐recommended treatments for CTEPH are scarce. While two randomized controlled trials recently found that BPA was more effective than riociguat in reducing PVR and improving functional class after 26 weeks, 17 , 18 only two reports compare outcomes after PEA and BPA. 19 , 20 …”

Section: Introductionmentioning

confidence: 99%

Pulmonary endarterectomy and balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: Comparison of changes in hemodynamics and functional capacity

et al. 2023

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The treatment of choice for chronic thromboembolic pulmonary hypertension (CTEPH) is pulmonary endarterectomy (PEA). Balloon pulmonary angioplasty (BPA) is an emerging option for inoperable patients. Comparisons of the hemodynamic and functional outcome between these treatments are scarce. In this single‐center observational cohort study, we compared hemodynamics by right heart catheterization and peak oxygen consumption before and 5 months (±14 days) after either PEA or BPA. Comprehensive evaluation and selection for PEA or BPA was performed by an expert CTEPH team. Fourty‐two and fourty consecutive patients were treated with PEA or BPA, respectively. Demographics were similar between groups. Both PEA and BPA significantly reduced mean pulmonary artery pressure (from 46 ± 11 mmHg at baseline to 28 ± 13 mmHg at follow‐up; p < 0.001 and from 43 ± 12 mmHg to 31 ± 9 mmHg; p < 0.001) and pulmonary vascular resistance (from 686 ± 347 dyn s cm −5 at baseline to 281 ± 197 dyn s cm −5 at follow‐up; p < 0.001 and from 544 ± 322 dyn s cm −5 to 338 ± 180 dyn s cm −5 ; p < 0.001), with significantly lower reductions for both parameters in the former group. However, cardiopulmonary exercise testing revealed no significant between group differences in exercise capacity. Diffusion capacity for carbon monoxide at baseline was the only follow‐up predictor for peak VO 2 . In our study, PEA reduced pulmonary pressures more than BPA did, but similar improvements were observed for exercise capacity. Thus, while long term data after BPA is lacking, BPA treated CTEPH patients can expect physical gains in line with PEA.

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Balloon pulmonary angioplasty versus riociguat in inoperable chronic thromboembolic pulmonary hypertension (MR BPA): an open-label, randomised controlled trial

Cited by 56 publications

References 26 publications

Patient selection for balloon pulmonary angioplasty: Six‐year results from a high volume PTE surgical center

Patient selection for balloon pulmonary angioplasty: Six‐year results from a high volume PTE surgical center

Different response of the oxygen pathway in patients with chronic thromboembolic pulmonary hypertension treated with pulmonary endarterectomy versus balloon pulmonary angioplasty

Pulmonary endarterectomy and balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: Comparison of changes in hemodynamics and functional capacity

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