Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: a clinical consensus statement of the ESC working group on pulmonary circulation and right ventricular function.

The current treatment algorithm for chronic thromboembolic pulmonary hypertension (CTEPH) as depicted in the 2022 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines on the diagnosis and treatment of pulmonary hypertension (PH) includes a multimodal approach of combinations of pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and medical therapies to target major vessel pulmonary vascular lesions, and microvasculopathy. Today, BPA of >1700 patients has been reported in the literature from centers in Asia, the US, and also Europe; many more patients have been treated outside literature reports. As BPA becomes part of routine care of patients with CTEPH, benchmarks for safe and effective care delivery become increasingly important. In light of this development, the ESC Working Group on Pulmonary Circulation and Right Ventricular Function has decided to publish a document that helps standardize BPA to meet the need of uniformity in patient selection, procedural planning, technical approach, materials and devices, treatment goals, complications including their management, and patient follow-up, thus complementing the guidelines. Delphi methodology was utilized for statements that were not evidence based. First, an anatomical nomenclature and a description of vascular lesions are provided. Second, treatment goals and definitions of complete BPA are outlined. Third, definitions of complications are presented which may be the basis for a standardized reporting in studies involving BPA. The document is intended to serve as a companion to the official ESC/ERS guidelines.

Sexual dysfunction among males and females with bipolar disorder and healthy subjects: The burden of illness severity.

OBJECTIVES: Sexual dysfunction has wide-ranging impacts on the person's functioning and quality of life, being associated with higher severity of psychiatric illnesses and poor therapeutic response. Given the paucity of data on this topic in bipolar disorder (BD), we investigated sexual functioning among males and females with BD and healthy controls (HCs) as well as whether illness severity markers and subthreshold mood symptoms were associated with sexual dysfunctions in BD patients. METHODS: The study included 80 BD outpatients and 70 HCs. Sexual functioning was evaluated using the validated, gender-specific Changes in Sexual Functioning Questionnaire (CSFQ-14). RESULTS: BD patients had a significantly poorer sexual functioning than HCs (p < 0.00001). The odds of sexual dysfunction doubled given a one-unit increase in the number of suicide attempts (adjusted OR = 2.01, 95% CI:1.23-3.55; p < 0.01) and increased by 60% for every additional hospitalization (p < 0.05). Greater illness duration was associated with arousal/orgasmic (p < 0.05) and overall sexual dysfunctions (p < 0.01). BD patients with more mixed or (hypo)manic episodes had a lower likelihood of libido loss and arousal/orgasmic disturbances (p < 0.01), respectively. Higher levels of subthreshold depressive symptoms increased by 20% the odds of sexual interest/frequency dysfunctions (p < 0.05), and up to 60% regarding orgasmic disturbances (p < 0.01). CONCLUSIONS: Sexual functioning may be a useful proxy of illness severity as well as a relevant dimension to more deeply characterize BD patients. Further studies are warranted to replicate our findings, to evaluate temporal associations between sexual dysfunctions and illness severity across the BD mood and treatment spectrums and to explore neurobiological underpinnings of these associations.

ERS statement on chronic thromboembolic pulmonary hypertension.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism, either symptomatic or not. The occlusion of proximal pulmonary arteries by fibrotic intravascular material, in combination with a secondary microvasculopathy of vessels <500 µm, leads to increased pulmonary vascular resistance and progressive right heart failure. The mechanism responsible for the transformation of red clots into fibrotic material remnants has not yet been elucidated. In patients with pulmonary hypertension, the diagnosis is suspected when a ventilation/perfusion lung scan shows mismatched perfusion defects, and confirmed by right heart catheterisation and vascular imaging. Today, in addition to lifelong anticoagulation, treatment modalities include surgery, angioplasty and medical treatment according to the localisation and characteristics of the lesions.This statement outlines a review of the literature and current practice concerning diagnosis and management of CTEPH. It covers the definitions, diagnosis, epidemiology, follow-up after acute pulmonary embolism, pathophysiology, treatment by pulmonary endarterectomy, balloon pulmonary angioplasty, drugs and their combination, rehabilitation and new lines of research in CTEPH.It represents the first collaboration of the European Respiratory Society, the International CTEPH Association and the European Reference Network-Lung in the pulmonary hypertension domain. The statement summarises current knowledge, but does not make formal recommendations for clinical practice.

Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation.

OBJECTIVE: The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019. METHODS: Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery. RESULTS: Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan-Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001). CONCLUSION: For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240).

Secondary Extra-anatomic Infrainguinal Bypass following Lower Limb Tumoral Resection.

BACKGROUND: Soft tissue malignancy of lower limb can involve femoral triangle by direct tumoral invasion or secondary to ganglionic metastasis. Secondary arterial complications can appear during follow-up after initial tumoral resection and local radiation therapy. The aim of this study is to report our experience of secondary extra-anatomical lower limb revascularization following lower limb oncological resection with femoral bifurcation involvement. METHODS: This is a retrospective monocentric study including patients who underwent extra-anatomical iliopopliteal bypass, with a previous treated neoplasia involving homolateral femoral bifurcation. Proximal anastomosis was performed on the iliac artery, tunnelization was made through iliac wing, and distal anastomosis was done on distal superficial femoral or popliteal artery. RESULTS: Five patients underwent extra-anatomic iliopopliteal bypass for oncological purpose from 2008 to 2018 at our institution. Mean age at surgery time was 52 years (standard deviation = 19.3). Prosthetic graft was used in all cases. Primitive tumor involved Scarpa triangle in 3 cases (soft tissue sarcomas) and ganglionic metastasis involved Scarpa triangle in 2 cases (epidermoid carcinoma). Clinical presentation was ischemic in 4 cases and hemorrhagic in 1 case. One patient died during hospitalization. Of the 4 survivors, 3 patients had a patent bypass at the end of follow-up (2 had bypass thrombectomy, 1 patient had major amputation). CONCLUSIONS: Secondary iliopopliteal bypasses through the iliac wing following lower limb tumoral resection have acceptable results. It is a valid option for limb salvage especially after local radiation therapy and tumoral resection. Multidisciplinary management is necessary to obtain acceptable results and follow-up is mandatory.

French experience of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

AIMS: To evaluate safety and efficacy of balloon pulmonary angioplasty (BPA) in a large cohort of patients with chronic thromboembolic pulmonary hypertension (CTEPH). METHODS: From 2014 to 2017, 184 inoperable CTEPH patients underwent 1006 BPA sessions. Safety and efficacy during the first 21 months (initial period) were compared with those of the last 21 months (recent period). A total of 154 patients had a full evaluation after a median duration of 6.1 months. RESULTS: Overall, there was a significant improvement in New York Heart Association functional class, 6-min walk distance (mean change +45 m), and a significant decrease in mean pulmonary artery pressure (PAP) and in pulmonary vascular resistance (PVR) by 26% and 43%, respectively. The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period versus 30% and 49% in the recent period, respectively (p<0.05). The main complications included lung injury, which occurred in 9.1% of 1006 sessions (13.3% in the initial period versus 5.9% in the recent period; p<0.001). Per-patient multivariate analysis revealed that baseline mean PAP and the period during which BPA procedure was performed (recent versus initial period) were the strongest factors related to the occurrence of lung injury. 3-year survival was 95.1%. CONCLUSION: This study confirms that a refined BPA strategy improves short-term symptoms, exercise capacity and haemodynamics in inoperable CTEPH patients with an acceptable risk-benefit ratio. Safety and efficacy improve over time, underscoring the unavoidable learning curve for this procedure.

In Situ Antegrade Laser Fenestrations During Endovascular Aortic Repair.

INTRODUCTION: The technique and preliminary outcomes are reported for laser fenestrated endografting (LfEVAR), developed as an alternative procedure for endovascular repair of thoraco-abdominal aortic aneurysms (TAAAs), type IA endoleaks (T1AELs), and pararenal aortic aneurysms (PAAAs). METHODS: Patients with TAAA, T1AEL, and PAAA considered unfit for open repair by a multidisciplinary team and who could not benefit from a custom made device were selected. LfEVAR is a physician modified technique requiring sequential steps. After preliminary stenting of each target artery, a standard stent graft was deployed in the aorta. Laser fenestration was performed using a steerable sheath positioned in the stent graft lumen in front of each target artery ostium. After progressive dilation of the laser fenestration, bridging stents were placed and flared to insure accurate perfusion of the visceral arteries. RESULTS: Between August 2015 and March 2017, 16 consecutive patients were treated using LfEVAR including two TAAAs, four T1AELs, and 10 PAAAs. Thirty-three laser fenestrations were performed with a 94.3% success rate for visceral artery fenestration. The median ischaemic was 7.5 minutes for the superior mesenteric artery, 48 and 50 minutes for the left and right renal arteries, and 125 minutes for the coeliac trunk. Four secondary procedures were required: two endoleaks (type II and III), and two related to fenestrations: one renal stent dislocation, and one renal artery stent stenosis. During a mean follow up of 17 months, no deaths occurred. Follow up computed tomography (CT) scans performed at 30 days, 6, 12, and 18 months were satisfactory (4 endoleaks and two aneurysm enlargements were observed). The follow up CT scan imaging demonstrated 97% primary patency. CONCLUSION: In situ antegrade LfEVAR is feasible and a safe alternative option for high risk inoperable patients or for those not eligible for custom made device endografting, particularly in emergency cases.

Type II endoleak prevention with coil embolization during endovascular aneurysm repair in high-risk patients.

OBJECTIVE: This study evaluated endoleak level and size decrease of infrarenal abdominal aortic aneurysm (AAA) after endovascular aneurysm repair (EVAR) with coil embolization in patients at high risk for type II endoleak. METHODS: Between 2009 and 2013, 83 of 187 patients (44.3%) who underwent EVAR for AAA also underwent coil embolization of the aneurysm sac immediately after complete stent graft release because of risk factors for type II endoleak, including absence of a circumferential thrombus, two or more pairs of patent lumbar arteries, or a patent inferior mesenteric artery. Coil embolization was achieved using a 4F catheter with a microcatheter placed between the stent graft and the aneurysm wall. Computed tomography and color duplex ultrasound imaging were performed 1, 6, 12, and 24 months later to look for an endoleak and assess aneurysm sac diameter. RESULTS: Mean follow-up was 24 ± 11 months (range, 6-53 months). A mean of 12 coils (range, 4-23) was used. Technical success was achieved in all patients, with no procedurally related complications. Follow-up computed tomography showed type II endoleak in one patient. Aneurysm sac diameter was significantly decreased after 6 months (P = .001), 12 months (P = .001), and 24 months (P = .001). Surgery was required in one patient for common femoral artery occlusion unrelated to the procedure and in another patient for distal type I endoleak. CONCLUSIONS: Aneurysm sac coil embolization during EVAR for patients at risk for type II endoleak is technically feasible, safe, and effective in preventing type II endoleak. This procedure leads to rapid AAA shrinkage. Thus, coil embolization could be used routinely to improve EVAR outcomes for patients at risk for type II endoleak.

Closure of Isolated Congenital Coronary Artery Fistula: Long-Term Outcomes and Rate of Re-intervention.

Long-term outcome after closure of isolated congenital coronary artery fistula (ICCAF) is poorly documented. To assess late outcome after ICCAF closure, a 1983-2013 retrospective study included all patients who attempted an ICCAF closure and whose follow-up was ≥1 year. ICCAF was diagnosed in 23 patients [median age 6.9 years (0.1-70.5 years), 13 children]. ICCAF was symptomatic in 12 patients (52.2 %). First intervention was either a transcatheter embolization (n = 19 patients, 82.6 %) or a surgical ligation (n = 4 patients, 17.4 %). After a follow-up of 9.0 years (2.8-33.5), neither death nor late ischemic event occurred but one patient was transplanted, because of postoperative myocardial infarction. Late ICCAF recanalization occurred in eight patients, leading to successful embolization of the shunt in all patients after a delay of 9.8 years (5.7-13.8 years) from the first intervention. Re-intervention occurred later in children (p = 0.0027), with a 50 and 37.5 % freedom from re-intervention in adults compared to a 100 and 89.0 % in children, respectively, at 1 and 6 years of follow-up. At last follow-up, coronary artery diameter had decreased from a mean z score of 12.0 ± 7.7 to a mean z score of 6.0 ± 6.0 (p = 0.002). Long-term outcome after ICCAF closure is excellent, with neither death nor late ischemic event, and a significant decrease in coronary artery diameter with time. Late follow-up is of paramount importance, as one-third of patients will require a re-intervention for late shunt recanalization.

Catheter-based interventions for modified Blalock-Taussig shunt obstruction: a 20-year experience.

Thrombotic occlusion of a modified Blalock-Taussig (BT) shunt is rare, leading to life-threatening hypoxemia. Rescue percutaneous interventions may allow recanalization of the systemic-to-pulmonary shunt but data on large patients' scales are lacking. We aimed to describe safety and effectiveness of catheter-based interventions to restore modified BT shunt patency. All patients who attempted transcatheter intervention for thrombotic occlusion of a modified BT shunt at our Institution from 1994 to 2014 were reviewed. Characteristics, management, and outcomes of the 28 identified patients were analyzed. Thirty-three procedures were performed at a median age of 0.6 years old (range 0.03-32.1 years) and a median weight of 5.8 kg (range 2.2-82 kg). Percutaneous intervention consisted in 33 balloon angioplasty (100 %) and 14 stent implantations (42.4 %). Thrombolytic agents were also used in 6.1 % cases. No peri-procedural death occurred but complications were observed in five patients (15.2 %), including one catheter-induced transient complete atrioventricular block, one cardiac tamponade, and one massive thrombo-embolic stroke. Early procedural success was obtained in 28 patients (84.8 %) and remained long-lasting in 26 patients (78.8 %). A young age and a low body-weight at the time of the procedure were significantly associated with procedural failure (p = 0.0364 and p = 0.0247, respectively). Although technically challenging and carrying potential major complications, transcatheter intervention can be considered as an efficient rescue strategy to restore patency in case of thrombotic obstruction of a modified BT shunt.

Highlights from the International Chronic Thromboembolic Pulmonary Hypertension Congress 2021.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism. It is caused by persistent obstruction of pulmonary arteries by chronic organised fibrotic clots, despite adequate anticoagulation. The pulmonary hypertension is also caused by concomitant microvasculopathy which may progress without timely treatment. Timely and accurate diagnosis requires the combination of imaging and haemodynamic assessment. Optimal therapy should be individualised to each case and determined by an experienced multidisciplinary CTEPH team with the ability to offer all current treatment modalities. This report summarises current knowledge and presents key messages from the International CTEPH Conference, Bad Nauheim, Germany, 2021. Sessions were dedicated to 1) disease definition; 2) pathophysiology, including the impact of the hypertrophied bronchial circulation, right ventricle (dys)function, genetics and inflammation; 3) diagnosis, early after acute pulmonary embolism, using computed tomography and perfusion techniques, and supporting the selection of appropriate therapies; 4) surgical treatment, pulmonary endarterectomy for proximal and distal disease, and peri-operative management; 5) percutaneous approach or balloon pulmonary angioplasty, techniques and complications; and 6) medical treatment, including anticoagulation and pulmonary hypertension drugs, and in combination with interventional treatments. Chronic thromboembolic pulmonary disease without pulmonary hypertension is also discussed in terms of its diagnostic and therapeutic aspects.

Management of Etonogestrel implant migration into the pulmonary artery.

OBJECTIVES: To evaluate the relationship between time since contraceptive implant placement and retrieval outcomes in patients with implant migration into the pulmonary artery. STUDY DESIGN: We reviewed all cases of pulmonary artery implant migration referred to the Marie Lannelongue hospital from 2015 through 2020. Using our hospital database, we collected patients' clinical data and removal information to assess the success of therapeutic management according to the delay between implant insertion and removal. RESULTS: We identified 8 cases. Physicians located 2 in the upper and 6 in the lower lobe. Five patients had associated pulmonary symptoms, most commonly, chest pain and dyspnea. Physicians attempted an endovascular procedure in all cases with successful removal in 3 patients. In the 5 failures, angiography displayed arterial thrombosis distal to the implant. These patients had successful removal with an open mini-thoracotomy (< 5 cm). None of the 8 patients had serious post-operative complications. For the 3 patients with successful endovascular retrieval, 2 had early diagnosis (≤ 3 months). CONCLUSION: Endovascular approach with angiography should be performed as a first line treatment modality. Endothelialization and fibrosis within the vessel represent the principal limitations of endovascular strategy, but a retrieval could be attempted anyway with caution. In case of failure, an open approach is required. IMPLICATIONS STATEMENT: When a migration into the pulmonary artery is diagnosed, health care professionals should refer patients as soon as possible to a tertiary center with a vascular surgery and/or interventional radiology and thoracic surgery departments.

Pulmonary thromboendarterectomy: The Marie Lannelongue Hospital experience.

Background: Targeted medical therapy and balloon pulmonary angioplasty (BPA) entered the field of chronic thromboembolic pulmonary hypertension (CTEPH) treatment in the early 2010's. Multimodal therapy is emerging as the new gold standard for CTEPH management. Whether this change of paradigm impacted early outcomes of pulmonary endarterectomy (PEA) remains unknown. Our aim is to report our surgical experience in the era of CTEPH multimodal management. Methods: Patients who underwent PEA between 2016 and 2020 were included in the study. Early outcomes were described and compared between three groups of patients: PEA alone, PEA after targeted medical therapy induction and PEA after BPA. Results: A total of 418 patients, 225 males and 193 females, with a mean age of 59±14 years were included in the study. 336 patients underwent PEA alone, 69 after medical targeted therapy induction and 13 after unilateral BPA. Baseline preoperative pulmonary vascular resistance [4.99 (IQR, 1.71-8.48), 6.21 (IQR, 4.37-8.1), 5.03 (IQR, 4.44-7.19) wood units (WU), P=0.230, respectively] and PEA effectiveness [% decrease mean pulmonary artery pressure (mPAP), 24 (IQR, 7-42), 25 (IQR, 7-35), 23 (IQR, 3-29), P=0.580] did not differ between groups. Compared to PEA alone and PEA+BPA, the medical therapy induction group represented the most challenging group with higher baseline mPAP (45±10 vs. 42±11 and 43±11 mmHg, P=0.047), longer circulatory arrest time (30.1±15 vs. 26.6±10 and 19.6±6 min, P=0.005), higher post-PEA extracorporeal membrane oxygenation use (20.6% vs. 8.7 and 9.1%, P=0.004), higher duration on mechanical ventilation [4 (IQR, 1-12) vs. 1 (IQR, 0.5-5) and 2 (IQR, 1-3) days, P=0.005], higher complication rate (85.5% vs. 74.6% and 76.9%, P=0.052) and higher 90-day mortality (13% vs. 3.9% and 0%, P=0.002). Compared to PEA and PEA+ medical therapy induction groups, patients in the BPA induction group were older [72 (IQR, 62-76) vs. 60 (IQR, 48-69) and 62 (IQR, 52-72) years, P=0.005], and underwent shorter cardiopulmonary bypass (191.9±47.9 vs. 222±107.2 and 236.8±46.4 min, P<0.001), aortic cross clamping (54.8±21 vs. 82.7±31.4 and 80.1±32.9 min, P=0.002) and circulatory arrest time (19.6±6.2 vs. 26.6±10.8 and 30.1±15.1 min, P=0.008). Conclusions: Multimodal therapy approach to CTEPH patients did not affect effectiveness of PEA. Medical therapy and BPA could act in synergy with surgery to treat more challenging patients.

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.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: Programme Hospitalier de Recherche Clinique of the French Ministry of Health and Bayer HealthCare. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Hospital costs of Balloon Pulmonary Angioplasty (BPA) procedure and management for CTEPH patients: An observational study based on the French national hospital discharge database (PMSI).

INTRODUCTION: Since 2014, Balloon Pulmonary Angioplasty (BPA) has become an emerging and complementary strategy for chronic thromboembolic hypertension (CTEPH) patients who are not suitable for pulmonary endarterectomy (PEA) or who have recurrent symptoms after the PEA procedure. OBJECTIVE: To assess the hospital cost of BPA sessions and management in CTEPH patients. METHODS: An observational retrospective cohort study of CTEPH-adults hospitalized for a BPA between January 1st, 2014 and June 30th, 2016 was conducted in the 2 centres performing BPA in France (Paris Sud and Grenoble) using the French national hospital discharge database (PMSI-MCO). Patients were followed until 6 months or death, whichever occurred first. Follow-up stays were classified as stays with BPA sessions, for BPA management or for CTEPH management based on a pre-defined algorithm and a medical review using type of diagnosis (ICD-10), delay from last BPA procedure stay and length of stay. Hospital costs (including medical transports) were estimated from National Health Insurance perspective using published official French tariffs from 2014 to 2016 and expressed in 2017 Euros. RESULTS: A total of 191 patients were analysed; mainly male (53%), with a mean age of 64,3 years. The first BPA session was performed 1.1 years in median (IQR 0.3-2.92) after the first PH hospitalisation. A mean of 3 stays with BPA sessions per patient were reported with a mean length of stay of 8 days for the first stay and 6 days for successive stays. The total hospital cost attributable to BPA was € 4,057,825 corresponding to €8,764±3,435 per stay and €21,245±12,843 per patient. Results were sensitive to age classes, density of commune of residence and some comorbidities. CONCLUSIONS: The study generated robust real-world data to assess the hospital cost of BPA sessions and management in CTEPH patients within its first years of implementation in France.