Balloon Pulmonary Angioplasty Sessions Research Articles

Feasibility of revascularization after gelatin sponge embolization for hemoptysis during balloon pulmonary angioplasty

BackgroundVessel injury is a common complication during balloon pulmonary angioplasty (BPA). For persistent hemoptysis, gelatin sponge embolization (GSE) is considered, but its impact on subsequent perfusion in embolized vessels remains unknown. This study explores the feasibility of revascularization in vessels post-GSE. MethodsWe included 64 vessels from 50 patients with chronic thromboembolic pulmonary hypertension who experienced hemoptysis during BPA in 2012–2023. Twenty-four vessels were treated conservatively (conservative group), while 40 were treated with GSE for persistent hemoptysis or desaturation despite conservative treatment (GSE group). We assessed hemoptysis-related parameters, perfusion of injured vessels pre- and post-treatment, and hemodynamic parameters through multiple BPA sessions. ResultsHemoptysis resolved immediately after the procedure in 67% of patients, including 70% of those in the GSE group, and all cases resolved by the next day. Of 37 embolized vessels, 41% showed spontaneous perfusion improvement in subsequent sessions. BPA was reperformed in 22 embolized vessels, with 86% showing further improvement, resulting in 70% of all embolized vessels finally showing improvement in perfusion. In both groups, clinical and hemodynamic parameters significantly improved after BPA. ConclusionsPerfusion of embolized vessels improved after GSE, suggesting that GSE is safe for the treatment of severe persistent hemoptysis after conservative treatment.

Insufficiency of quality of life as the treatment endpoint for balloon pulmonary angioplasty in inoperable chronic thromboembolic pulmonary hypertension.

The ability of a quality of life (QoL) to guide balloon pulmonary angioplasty (BPA) among patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) has not been fully investigated. This study explored the relationship between QoL scores and hemodynamics in CTEPH patients after BPA and examined whether QoL could be applied as a treatment endpoint. This cohort study included patients with inoperable CTEPH who had undergone at least four sessions of BPA. The patients' demographic and clinical data as well as hemodynamic parameters and scores from the RAND 36-item short-form QoL questionnaire were recorded and compared before and after BPA. After BPA treatments, clinical characteristics, hemodynamic parameters, as well as QoL score improved significantly. A physical component summary (PCS) score of 35 or 46 can be used as the cutoff value for predicting better World Health Organization functional classification (WHO FC). Patients who had a higher PCS would have longer 6-min walk distance (6MWD), lower pulmonary vascular resistance (PVR), and better cardiac output (CO) both before and after BPA. However, 19 patients (55.9%) with a higher PCS score after BPA did not achieve the goal of mean pulmonary arterial pressure (mPAP) ≤30 mmHg. During the follow-up period, a significant reduction of PVR was observed, but the PCS score improved a little. QoL is a useful tool for assessing the exercise endurance of patients with inoperable CTEPH treated with BPA, but is insufficient to serve as a treatment endpoint for BPA.

The Initial Experience of Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension in Latvia.

Background: Treatment options for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent pulmonary hypertension after pulmonary endarterectomy (PEA) include targeted medical therapy and balloon pulmonary angioplasty (BPA). BPA is an emerging treatment modality that has been reported to improve functional capacity, pulmonary hemodynamics, and right ventricular function. Reports from expert centers are promising, but more data are needed to make the results more generalizable. Materials and Methods: We conducted a prospective analysis of nine consecutive CTEPH patients who underwent balloon pulmonary angioplasty (BPA) sessions at Pauls Stradins Clinical University Hospital in Riga, Latvia between 1 April 2022 and 1 July 2023. We assessed World Health Organization (WHO) functional class, 6 min walk distance (6MWD), blood oxygen saturation (SpO2), brain natriuretic peptide (BNP) level at baseline and 3 months after the first BPA session. For two patients on whom repeated BPA sessions were performed, we additionally assessed cardiac output (CO), pulmonary vascular resistance (PVR), and mean pulmonary artery pressure (mPAP). Results: A total of 12 BPA procedures for nine patients were performed; repeated BPA sessions were performed for two patients. Our results show a reduction in BNP levels and improvement in WHO functional class, 6MWD, and SpO2 after the first BPA session. Improvement in 6MWD was statistically significant. Additionally, an improvement in pulmonary hemodynamic parameters was observed. Conclusions: Our data show that BPA is an effective interventional treatment modality, improving both the pulmonary hemodynamics and functional status. Moreover, BPA is safe and excellently tolerated.

Hemodynamic changes with serial balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension

Objective: To monitor hemodynamic changes during serial balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension (CTEPH). Methods: General clinical data of CTEPH patients diagnosed from October 2017 to January 2022 in Beijing Chaoyang Hospital were collected, and 83 patients who underwent at least 1 BPA treatment were included to analyze their 6 min walking distance, WHO functional class, N-terminal B-type natriuretic peptide precursor (NT-proBNP), troponin I (cTnI) and haemodynamic indices. Baseline and follow-up after the final BPA clinical data and hemodynamics, functional status and serial hemodynamics before each series of BPA were collected to evaluate the efficacy of BPA for CTEPH patients. Complications and managements were documented to confirm the safety of BPA for CTEPH patients. Results: Three hundred and forty BPA procedures were performed in 83 CTEPH patients. The median number of BPA procedures was 4.0 and a total of 2104 vessels were dilated. In general, mPAP [from 50.0(42.0-55.25) mmHg(1 mmHg=0.133 kPa) to 32.0(27.0-42.0) mmHg, P<0.001], PVR[from (806.6±323.2) dyn·s·cm-5 to 420.0(295.0-613.5) dyn·s·cm-5, P<0.001] were significantly improved compared with baseline, but not CO and CI. Functional parameters including WHO functional class Ⅰ/Ⅱ/Ⅲ/Ⅳ (from 0/35/34/14 to 43/32/7/1, P<0.001), 6MWD [from 364.5(300.0-429.5)m to 461.0(409.0-501.0)m, P<0.001], NT-proBNP [from 1 357.0(232.0-2 715.0) ng/L to 141.0(57.0-627.8) ng/L,P<0.001] were significantly improved compared with baseline. A cumulative (compared to baseline) and serial (compared to preceding BPA session) analysis of the sequential BPA session confirmed that a major hemodynamic improvement in PVR and mPAP occurred in the first 3 serial BPA treatments. There was a dose-response relationship: the more segments that were treated, the greater were the subsequent reduction in PVR and mPAP. There were 32.0 complications (9.4%) associated with BPA procedures, and the most common complication was pulmonary hemorrhage caused by catheter-related vascular injury. Conclusions: BPA is an effective and safe alternative for technically non-operable CTEPH patients. The hemodynamic benefits of BPA in CTEPH patients were cumulative and correlated with the total number of vessels successfully dilated.

Optimal short-term outcomes in balloon pulmonary angioplasty: the minimum frequency of three sessions annually.

Balloon pulmonary angioplasty (BPA) is typically performed in a sequential manner. This study aimed to determine the lowest frequency of BPA for patients who could not reach treatment goals in a short period. Retrospective cohort. We retrospectively enrolled 186 BPA-treated patients diagnosed with chronic thromboembolic pulmonary hypertension. According to the accumulative number of performed BPA sessions or treated pulmonary vessels or the ratio of the number of treated pulmonary vessels/the number of baseline lesions (T/P) prior to the initial occurrence of clinical outcome or censored date, we divided patients into different groups. The principal outcome was clinical worsening. After stratifying patients by the number of performed BPA sessions, most baseline parameters were comparable among groups. During follow-up, 31 (16.7%) of 186 patients experienced clinical worsening. The 6-month cumulative clinical worsening-free survival rates of ⩾2 performed sessions group were significantly higher than that of 1 performed session group. The 12-month cumulative rates of clinical worsening-free survival exhibited a declining pattern in the subsequent sequence: ⩾3, 2, and 1 performed BPA sessions, and this trend persisted when follow-up time exceeded 12 months. The 6-, 12-, and 24-month cumulative clinical worsening-free survival rates were comparable between patients with 3 and ⩾4 performed BPA sessions. Similar results were also observed when stratifying patients by the accumulative number of treated pulmonary vessels (⩽8, 9-16, ⩾17) and T/P (⩽0.789, 0.790-1.263, ⩾1.264). To achieve optimal short-term outcomes, patients might need to undergo ⩾2 BPA sessions or have ⩾9 pulmonary vessels treated or have T/P ⩾0.790 within 6 months, and undergo ⩾3 BPA sessions or have ⩾17 pulmonary vessels treated or have T/P ⩾1.264 within 12 months.

Safety and efficacy of balloon pulmonary angioplasty for technically operable chronic thromboembolic pulmonary hypertension.

Balloon pulmonary angioplasty (BPA) has been proven effective for addressing technically inoperable chronic thromboembolic pulmonary hypertension (CTEPH). However, the effectiveness of BPA in technically operable CTEPH patients who, for various reasons, did not undergo the procedure remains an area requiring exploration. This study sought to assess the safety and efficacy of BPA in such cases. We collected and reviewed data from CTEPH patients who underwent BPA in a consecutive manner. Following multidisciplinary team (MDT) decisions, patients were classified into two groups: technically inoperable (group A) and operable (group B). Group B comprised patients deemed technically suitable for pulmonary endarterectomy (PEA) but who did not undergo the procedure for various reasons. All patients underwent a comprehensive diagnostic work-up, including right heart categorization at baseline and the last intervention. This study compared changes in hemodynamic parameters, functional capacity, and quality of life between the two groups. In total, 161 patients underwent 414 procedures at our center, with Group A comprising 112 patients who underwent 282 BPA sessions and group B comprising 49 patients who underwent 132 BPA sessions. Significantly, both groups exhibited improvements in hemodynamics, functional capacity, and quality of life. The occurrence rate of complications, including hemoptysis and lung injury, was similar [12 (63.2%) vs. 7 (36.8%), p = 0.68]. BPA demonstrated favorable outcomes in patients with proximal CTEPH who did not undergo pulmonary endarterectomy. However, the clinical impact of BPA in technically operable CTEPH was found to be less significant than in inoperable cases.

Clinical-radiological-pathological correlation in chronic thromboembolic pulmonary hypertension.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening complication of acute pulmonary embolism. It is characterised by persistent fibro-thrombotic pulmonary vascular obstructions and elevated pulmonary artery pressure leading to right heart failure. The diagnosis is based on two steps, as follows: 1) suspicion based on symptoms, echocardiography and ventilation/perfusion scan and 2) confirmation with right heart catheterisation, computed tomography pulmonary angiography and, in most cases, digital subtraction angiography. The management of CTEPH requires a multimodal approach, involving medical therapy, interventional procedures and surgical intervention. This clinical-radiological-pathological correlation paper illustrates the diagnostic and therapeutic management of two patients. The first had chronic thromboembolic pulmonary disease without pulmonary hypertension at rest but with significant physical limitation and was successfully treated with pulmonary endarterectomy. The second patient had CTEPH associated with splenectomy and was considered unsuitable for surgery because of exclusive subsegmental lesions combined with severe pulmonary hypertension. The patient benefited from multimodal treatment involving medical therapy followed by multiple sessions of balloon pulmonary angioplasty. Both patients had normalised functional capacity and pulmonary haemodynamics 3-6 months after the interventional treatment. These two examples show that chronic thromboembolic pulmonary diseases are curable if diagnosed promptly and referred to CTEPH centres for specialist treatment.

Learning curve and analysis of curative effects after balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

Learning curve and analysis of curative effects after balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

The original and two new derivative versions of the COMPERA 2.0 risk assessment model: useful tools for guiding balloon pulmonary angioplasty

BackgroundThe COMPERA 2.0 4-stratum (4-S) risk score has been demonstrated superior over the 3-stratum (3-S) one in patients with pulmonary arterial hypertension and medically managed patients with chronic thromboembolic pulmonary hypertension (CTEPH). We aimed to determine the prognostic value of the original 4-S and 3-S COMPERA 2.0 risk score and two new derivative versions in CTEPH patients who underwent balloon pulmonary angioplasty (BPA).MethodsWe retrospectively enrolled 175 BPA-treated patients with CTEPH. We assessed the risk stratification before and after each BPA session of CTEPH patients by the original 4-S and 3-S COMPERA 2.0 risk score (by rounding decimal to the nearest integer) and two new proposed derivative versions: the modified version (by rounding decimal to the next integer) and a hybrid version that fuses the original and modified versions. The primary endpoint was clinical worsening events. The secondary outcomes were achieving low-risk profile and mean pulmonary arterial pressure (mPAP) < 30 mmHg at follow-up. We used the Kaplan–Meier curve analysis to assess the survival differences between stratified patients. The comparative model’s performance was evaluated in terms of discrimination by Harrell’s C-index.ResultsAll versions of COMPERA 2.0 4-S model outperformed the 3-S one in discriminating the differences in echocardiographic and hemodynamic parameters and clinical worsening-free survival rates. The original and hybrid 4-S model could independently predict the primary and secondary endpoints, and the hybrid version seemed to perform better. The first BPA session could significantly improve risk profiles, and these changes were associated with the likelihood of experiencing clinical worsening events, achieving a low-risk profile and mPAP < 30 mmHg at follow-up. The number of BPA sessions required to achieve low risk/mPAP < 30 mmHg increased as the baseline risk score escalated.ConclusionsThe COMPERA 2.0 4-S model outperformed the 3-S one in BPA-treated patients with CTEPH. The 4-S model, especially its hybrid version, could be used to predict clinical outcome before the initiation of BPA and monitor treatment response.

Abstract 10190: Recurrent Pulmonary Hypertension After Balloon Pulmonary Angioplasty in Patients With Inoperable Thromboembolic Pulmonary Hypertension

Backgrounds: Balloon pulmonary angioplasty (BPA) improves hemodynamics and prognosis in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Though it has been reported that recurrent pulmonary hypertension (PH) after pulmonary endarterectomy is rare, the recurrence rate of PH after BPA remains to be clarified. In this study, we examined the frequency of recurrent PH after BPA in the long-term period and the risk factors. Methods: We retrospectively reviewed consecutive 200 CTEPH patients (65±12yrs., Male 43(22%)) who completed BPA procedures from July 2009 to December 2020 and had hemodynamic evaluation after the procedures and extracted the patients with recurrent PH who had a mean pulmonary arterial pressure (mPAP) &lt;25 mm Hg after BPA and developed PH (mPAP ≥25 mm Hg) during follow-up and had a clinical deterioration requiring additional treatment. As risk factors for recurrent PH, we investigated the known risk factors for the development of CTEPH, and the types of oral anticoagulants (warfarin or direct oral anticoagulant). Results: The median follow-up period from final BPA session was 42 [24,62] months. BPA significantly improved mPAP (39±10 to 22±5mmHg, P&lt;0.01) and cardiac output (CO) (3.6±1.1 to 4.1±1.1 L/min, P&lt;0.01). Recurrent PH was observed in 13 of the 200 patients (6.5%) during the follow-up period and the estimated 5-year recurrence rate was 8.9%. The median period from final BPA to recurrence was 20 months [12,47 months], and 6 cases (46%) recurred PH within a year after BPA. In these patients, mPAP deteriorated from 21±2 to 29±5mmHg (P&lt;0.01) but not CO (4.07±0.69 to 3.81±0.50L/min, P=0.46). Of the 13 recurrent PH patients, 9 required additional BPA, and 6 required additional medication. However, the 5-year survival in the recurrent PH and non-recurrent PH groups were comparable (100% and 96.1%, P=0.50). Any risk factors for recurrent PH were not detected. The recurrence rate of PH in those with direct oral anticoagulant (83 cases (42%)) was similar to that in those with warfarin (3.6% and 8.6%, P=0.16). Conclusions: Recurrent PH after BPA is rare and not associated with the known risk factors for CTEPH. The prognosis in the recurrent PH group with additional treatments is similar to that in the non-recurrent group.

High incidence of pulmonary artery thrombosis after balloon pulmonary angioplasty in CTEPH patients receiving direct oral anticoagulants

Abstract Background Chronic thromboembolic pulmonary hypertension (CTEPH) requires life-long anticoagulant therapy, whereas limited data exist on the safety and efficacy of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) along with balloon pulmonary angioplasty (BPA). Objectives To evaluate outcomes and complications in CTEPH following BPA for individuals receiving DOACs or VKAs. Methods Consecutive CTEPH patients underwent BPA from September 2014 to August 2021 were included in a retrospective analysis. Complications during BPA, post-BPA hemodynamics and bleeding events were obtained from patient's medical records. Our routine follow-up “selective” pulmonary angiography, to evaluate all segmental pulmonary arteries one by one at six months and every year after final BPA session, was performed to elucidate the incidence of in-situ fresh floating thrombus. Results Of total 250 individuals, 104 were treated with DOACs and 146 with VKAs following BPA. Mean observation period was 905 (SD ± 660) days. Total 1278 BPA sessions were performed among the period in which 409 sessions were treated with DOACs and 869 sessions with VKAs. Significant improvements in hemodynamics and functional status were observed in both groups following BPA. There was no significant difference of hemoptysis during BPA between DOACs and VKAs (7.1% vs 10.1%, P=0.131). Major bleeding events during observation period were equivalent in those treated with DOACs and VKAs. No significant re-elevation of pulmonary artery pressure was observed in both groups after BPA. Follow-up selective pulmonary angiography identified in-situ fresh floating thrombus in pulmonary artery in 22 cases of total 769 follow-up sessions. The occurrence of fresh thrombus was significantly higher in those receiving DOACs than VKAs in therapeutic range of PT-INR &amp;gt;1.8 (3.9% vs 1.2%, P=0.023) whereas no significant difference between DOACs and overall VKAs (3.9% vs 2.4%, P=0.177) Conclusions Post-BPA hemodynamic outcomes and bleeding events appear unaffected by choice of anticoagulant. However, the incidence of in-situ pulmonary thrombosis detected by selective pulmonary angiography was significantly higher in those receiving DOACs than VKAs in therapeutic range, suggesting inadequate anticoagulation under current dose of DOACs. Our study provides a rationale for further examination to evaluate the efficacy of DOACs in CTEPH. Funding Acknowledgement Type of funding sources: None.

Acute lung injury after balloon pulmonary angioplasty results in a similar haemodynamic response and possible clinical advantage at follow-up.

Acute lung injury (ALI) is a common but poorly defined and understood complication of balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension (CTEPH). Little data are available on the medium term clinical outcomes of BPA complicated by ALI.We analyzed per-procedure data from 282 procedures in 109 patients and per-patient data from 85 patients. Serial right heart catheterization at baseline, after each BPA and at 3-month follow-up measured pulmonary vascular resistance (PVR), mean pulmonary artery pressure (mPAP), and cardiac output (CO). ALI (ALI+) was identified by chest radiography alone (ALIr+) or in association with hypoxia clinically (ALIcr+). Procedural predictors of ALI and patient outcomes at 3-months were compared no ALI (ALI-).ALI+ occurred in 17/282 (6.0%) procedures (ALIcr+: 2.5%, ALIr+: 3.5%). Prevailing haemodynamics (PVR: p < 0.01; mPAP: p < 0.05) at a procedural and patient level, as well as number of BPA sessions (p < 0.01), total number of vessels (p < 0.05), and occlusions (p < 0.05) treated at a patient level predicted ALI+. Those with ALI had greater percentage improvement in ΔCAMPHOR symptoms score (ALI+: -63.5 ± 35.7% (p < 0.05); ALIcr+: -84.4 ± 14.5% (p < 0.01); ALI-: -27.2 ± 74.2%) and ΔNT-proBNP (ALIcr+: -78.4 ± 11.9% (p < 0.01); ALI-: -42.9 ± 36.0%) at follow-up. There was no net significant difference in haemodynamic changes in ALI+ versus ALI- at follow-up.ALI is predicted by haemodynamic severity, number of vessels treated, number of BPA sessions, and treating occlusive disease. ALI in this cohort was associated with a clinical advantage at follow-up.

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

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.

Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study

Riociguat and balloon pulmonary angioplasty (BPA) are treatment options for inoperable chronic thromboembolic pulmonary hypertension (CTEPH). However, randomised controlled trials comparing these treatments are lacking. We aimed to evaluate the efficacy and safety of BPA versus riociguat in patients with inoperable CTEPH. In this phase 3, multicentre, open-label, parallel-group, randomised controlled trial done in 23 French centres of expertise for pulmonary hypertension, we enrolled treatment-naive patients aged 18-80 years with newly diagnosed, inoperable CTEPH and pulmonary vascular resistance of more than 320 dyn·s/cm5. Patients were randomly assigned (1:1) to BPA or riociguat via a web-based randomisation system, with block randomisation (block sizes of two or four patients) without stratification. The primary endpoint was change in pulmonary vascular resistance at week 26, expressed as percentage of baseline pulmonary vascular resistance in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of riociguat or had at least one BPA session. Patients who completed the RACE trial continued into an ancillary 26-week follow-up during which symptomatic patients with pulmonary vascular resistance of more than 320 dyn·s/cm5 benefited from add-on riociguat after BPA or add-on BPA after riociguat. This trial is registered at ClinicalTrials.gov, NCT02634203, and is completed. Between Jan 19, 2016, and Jan 18, 2019, 105 patients were randomly assigned to riociguat (n=53) or BPA (n=52). At week 26, the geometric mean pulmonary vascular resistance decreased to 39·9% (95% CI 36·2-44·0) of baseline pulmonary vascular resistance in the BPA group and 66·7% (60·5-73·5) of baseline pulmonary vascular resistance in the riociguat group (ratio of geometric means 0·60, 95% CI 0·52-0·69; p<0·0001). Treatment-related serious adverse events occurred in 22 (42%) of 52 patients in the BPA group and five (9%) of 53 patients in the riociguat group. The most frequent treatment-related serious adverse events were lung injury (18 [35%] of 52 patients) in the BPA group and severe hypotension with syncope (two [4%] of 53 patients) in the riociguat group. There were no treatment-related deaths. At week 52, a similar reduction in pulmonary vascular resistance was observed in patients treated with first-line riociguat or first-line BPA (ratio of geometric means 0·91, 95% CI 0·79-1·04). The incidence of BPA-related serious adverse events was lower in patients who were pretreated with riociguat (five [14%] of 36 patients vs 22 [42%] of 52 patients). At week 26, pulmonary vascular resistance reduction was more pronounced with BPA than with riociguat, but treatment-related serious adverse events were more common with BPA. The finding of fewer BPA-related serious adverse events among patients who were pretreated with riociguat in the follow-up study compared with those who received BPA as first-line treatment points to the potential benefits of a multimodality approach to treatment in patients with inoperable CTEPH. Further studies are needed to explore the effects of sequential treatment combining one or two medications and BPA in patients with inoperable CTEPH. Programme Hospitalier de Recherche Clinique of the French Ministry of Health and Bayer HealthCare. For the French translation of the abstract see Supplementary Materials section.

POSITIVE PULMONARY ARTERY REMODELING AFTER A SERIES OF BALLOON PULMONARY ANGIOPLASTIES IN A PATIENT WITH CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION

Objective: To demonstrate positive pulmonary artery remodeling after balloon pulmonary angioplasty (BPA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH). Design and method: A 68-year old female was admitted to pulmonary hypertension department with swelling of the feet and legs, low level of arterial blood saturation (92%). She passed two episodes of pulmonary embolism – 7 and 5 years before the hospitalization. The patient was treated with anticoagulants (warfarin), diuretics (furosemide, spironolactone). Invasive pulmonary angiography confirmed thromboembolic lesions of pulmonary artery. Another types of pulmonary hypertension, except CTEPH, were excluded. Multidisciplinary commission considered her as inoperable due to obesity and anemia of unknown origin. But it was technically possible to perform BPA. The patient underwent 5 sessions of BPA. Before and just after the first BPA and 3 months after the last BPA intravascular ultrasound (IVUS) of pulmonary arteries was performed. Results: According to the results of treatment the functional class improved in the patient (from 4 to 3), the distance in 6-minute walking test slightly increased (from 290 to 303 m), and the mean preassure in pulmonary artery decreased from 40 to 35 mm Hg. When assessing the size of the pulmonary arteries, underwent angioplasty, there were determined signs of positive remodeling (Table 1). According to invasive angiography the diameter of branches of the subsegmental arteries increased up to 14.3%. According to the results of IVUS, comparable results were obtained: 10% increase of the lumen diameter. Conclusions: successful series of BPA in patients with CTEPH can lead to the significant positive remodeling of pulmonary arteries.

Changes in Inflammatory Markers in Patients with Chronic Thromboembolic Pulmonary Hypertension Treated with Balloon Pulmonary Angioplasty.

Background: Inflammatory response and endothelial dysfunction contribute to the progression of chronic thromboembolic pulmonary hypertension (CTEPH). We aimed to assess changes in biomarkers involved in those processes in inoperable CTEPH patients treated with balloon pulmonary angioplasty (BPA). Methods: We enrolled 20 patients with inoperable CTEPH qualified for BPA and a control group. Interleukin 6, 8, 10 (IL-6, IL-8, IL-10), monocyte chemoattractant protein-1 (MCP-1), and C-reactive protein (hsCRP) constituted the markers of systemic inflammation. Endothelin 1 (ET-1) served as a marker of endothelial dysfunction. Selected markers were assessed before the BPA treatment, 24 h after the first BPA, and six months after completion of the BPA treatment. Results: At baseline, the CTEPH patients had increased serum concentrations of IL-6, IL-8 and ET-1. Twenty-four hours after a BPA session, we observed an increase in concentrations of IL-6 (∆ = 3.67 (1.41; 7.16); p < 0.001), of IL-10 (∆ = 0.25 (0; 0.47); p = 0.003), of MCP-1 (∆ = 111 (60.1; 202.8); p = 0.002), and of hsCRP (∆ = 4.81 (3.46; 8.47); p < 0.001). Six months after completion of the BPA treatment, there was a decrease in concentrations of IL-6 (∆ = −1.61 (−3.11; −0.20); p = 0.03), of IL8 (∆ = −3.24 (−7.72; 0.82); p = 0.01), and of ET-1 (∆ = −0.47 (−0.96; 0.05); p = 0.005). Conclusions: Patients with inoperable CTEPH exhibit increased systemic inflammation and endothelial dysfunction, which improves after completion of the BPA treatment. A single BPA session evokes an acute inflammatory response.

Balloon Pulmonary Angioplasty Results in Anatomically Operable CTEPH Patients

<h3>Purpose</h3> Pulmonary endarterectomy (PEA) is the recommended treatment for patients with operable CTEPH. Balloon pulmonary angioplasty (BPA) is an emerging treatment option for inoperable patients with good preliminary results. Although deemed operable, we see more and more patients reluctant to surgery and referred to BPA. To evaluate efficacy of BPA in proximal disease, we reviewed our experience and compared results in patients who refused surgery (rPEA) to those with severe comorbidities preventing surgery (cBPA). <h3>Methods</h3> We retrospectively reviewed all CTEPH patients treated by BPA in our National Referral Center. From 2014 to 2020, 220 patients were included and assessed clinically and hemodynamically after completion of BPA treatment. Among them 36 (16%) had on angio CT a proximal disease as evaluated by our expert CTEPH multidisciplinary team: 27 (75%) were in the cBPA group and 9 in the rPEA group. <h3>Results</h3> Before BPA, pulmonary hypertension (PH) severity and the number of patients on PH targeted therapy was similar in both groups. There was no significant difference in the number of BPA sessions (6 vs. 5) and in duration of follow-up (10.7 months vs. 13.2 months) between the rPEA the cBPA groups (p=NS). Clinically, we found a significant improvement in the cBPA group (NYHA status: II vs. III; p=0.03 and 6MWT: 383 vs. 238 m; p=0.08) and not in the rPEA group (NYHA II vs. II; p=0.7 and 6MWT 409 vs. 376 m; p=0.8). Similarly, hemodynamic data improved in the cBPA group (mean PAp: 30 vs. 42 mmHg, p<0.001; CO: 5.9 min vs 4.7 L/min; p=0.1; PVR 3.3 vs 5.7 WU, p<0.001) but not in the rPEA group (mean PAp 25 vs. 35mmHg, p=0.15; CO 4.3 vs. 3.9 L/min, p=0.37; PVR 3.9 vs. 5.9 WU, p=0.18). <h3>Conclusion</h3> BPA for CTEPH patients with proximal disease is associated with better outcome in patients contraindicated to surgery because of severe comorbidities than in patients who refused PEA. When feasible, PEA remains the treatment of choice of CTEPH patients. Further prospective studies are needed to confirm these results

CXCL10 levels in diagnosis and improved hemodynamics in patients with chronic thromboembolic pulmonary hypertension undergoing balloon pulmonary angioplasty.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive pulmonary vascular disease characterized by pulmonary artery stenosis or obstructions resulting from insufficient thrombus resolution. Chemokine (C‐X‐C motif) ligand 10 (CXCL10) is a chemokine that contributes to the pathogenesis of many autoimmune diseases and cancers. The present study aims to investigate the levels of CXCL10 in patients with CTEPH throughout balloon pulmonary angioplasty (BPA) and its correlation with the improvement of pulmonary hemodynamics. Plasma CXCL10 levels were measured in 38 CTEPH patients with 100 BPA sessions and in 28 healthy controls. Correlations between CXCL10 and pulmonary hemodynamics were investigated. Receiver operating characteristic (ROC) curves were plotted to display the diagnostic value and the predictive ability for perioperative complications of CXCL10 and CXCL10‐related models. Nomograms were plotted to visualize the diagnostic value and the predictive ability for perioperative complications of CXCL10 and CXCL10‐related models. CXCL10 levels are higher in CTEPH patients compared with healthy controls (36.5 [95% confidence interval {CI}: 25.0–51.1] vs. 14.8 [95% CI: 11.1–30.9], p < 0.0001) and decreased significantly after BPA treatment (36.5 [95% CI: 25.0–51.1] vs. 24.7 [95% CI: 17.2–36.6], p < 0.0005). Preoperative CXCL10 levels positively correlated with mean right atrial pressure (r = 0.25), systolic pulmonary artery pressure (PAP; r = 0.28), diastolic PAP (r = 0.33), mean PAP (r = 0.36), pulmonary vascular resistance (r = 0.31), and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP; r = 0.46). Furthermore, plasma CXCL10 levels adjusting for age and sex displayed a sensitivity of 86.0% and a specificity of 67.9% for discriminating CTEPH patients from healthy controls. Preoperative CXCL10 levels, in combination with NT‐proBNP, predicted perioperative complications with a sensitivity of 100.0% and a specificity of 46.9% as displayed in ROC analysis. In conclusion, circulating CXCL10 might contribute to the evaluation of disease severity in CTEPH patients and be useful to evaluate the treatment effect of BPA. Future studies are warranted to further study the relationship between pulmonary hemodynamics and circulating CXCL10.

Preprocedural frailty is strongly associated with symptoms after balloon pulmonary angioplasty.

Balloon pulmonary angioplasty (BPA) has improved the survival rate of patients with chronic thromboembolic pulmonary hypertension (CTEPH). The resolution of symptoms is one of the remaining goals of BPA. Frailty affects the outcome of cardiovascular diseases or treatments. The aim of this study is to assess the association between frailty and outcome of BPA. The resolution of symptoms is evaluated by the post-BPA World Health Organization functional class (WHO-FC). A total of 54 patients with CTEPH were divided into 2 groups by post-BPA WHO-FC (WHO-FC I group; n = 34 vs. WHO-FC ≥ II group; n = 20). Frailty was assessed by physicians using the clinical frailty scale (CFS) at the point of patient admission for their first BPA sessions. Compared to the WHO-FC ≥ II group, the WHO-FC I group was younger (65.6 ± 13.9 years vs. 74.3 ± 8.0 years) and had a lower CFS (3 [3, 4] vs. 4 [4, 6]) (median [25th, 75th percentiles]). The WHO-FC I achievement rates for each CFS score were CFS 3: 82.8%; 4: 53.8%; 5: 25.0%; 6: 33.3%; and 7: 20.0%. Logistic regression analysis showed that CFS was an independent predictor of WHO-FC I achievement (odds ratio 0.50, p = 0.012), but pre-BPA hemodynamic parameters and age were not independent predictors. Whether WHO-FC I can be achieved is predicted by pre-BPA patient frailty but not by pre-BPA hemodynamic parameters and age.

Refined balloon pulmonary angioplasty for inoperable chronic thromboembolic pulmonary hypertension: a prospective multicenter registry

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): the National Key Research and Development Program of China Background Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening disease with a poor prognosis if left untreated. Pulmonary endarterectomy is the standard treatment for CTEPH, but around 40% of CTEPH patients are non-eligible for surgery. Purpose To investigate the efficacy and safety of refined balloon pulmonary angioplasty (BPA) for inoperable CTEPH in a prospective multicenter registry from China. Methods We conducted a prospective multicenter cohort study using the data from National Rare Disease Registry System of China. Total 140 consecutive patients with inoperable CTEPH who completed BPA between Jan 2016 and Dec 2020 were enrolled. The key efficacy outcomes were changes from baseline to re-evaluation in mean pulmonary arterial pressure, pulmonary vascular resistance, and six-minute walking distance. The safety outcomes were procedure-related complications. The survival outcome was all-cause mortality. Results Among the 140 patients who completed BPA, the mean age at diagnosis was 58 ± 14 years and 60.0% were female. At re-evaluation, the least-squares mean change from baseline was -18.3 mm Hg (95% confidence interval [CI], -19.9 to -16.6, P &amp;lt; 0.001) in mean pulmonary arterial pressure, -5.3 Wood U (95% CI, -5.9 to -4.6, P &amp;lt; 0.001) in pulmonary vascular resistance, and 87 meters (95% CI, 74 to 101, P &amp;lt; 0.001) in six-minute walking distance. BPA procedure-related complications occurred in 109 of 650 BPA sessions (16.8%), but severe complications requiring noninvasive positive pressure ventilation only occurred in 4 (0.6%) BPA sessions. During a mean follow-up time of 32 ± 14 months, 4 patients died, including 2 peri-procedural deaths, contributing to the survival rates of 97.8% (95% CI, 93.4 to 99.3) at 1 year and 96.9% (95% CI, 91.9 to 98.8) at 3 and 5 years. Conclusion Refined BPA appears to be an effective therapeutic option for inoperable CTEPH patients with acceptable safety profiles. Abstract Figure. Images of BPA Efficacy in a Patient Abstract Figure. Efficacy outcomes of BPA