Published results with balloon pulmonary angioplasty (BPA) in the management of patients with chronic thromboembolic pulmonary hypertension (CTEPH)
| First author, year [ref.] | Patients (location) | Procedures | CTEPH medical therapy pre-BPA | Mean age years | Reduction in mPAP mmHg | FC improvement | 6MWD improvement | Complications | Acute mortality (<30 days after BPA) | Long-term outcomes |
| Feinstein, 2001 [15] | 18 (USA) | 47 catheterisations 107 dilations Mean 2.6 procedures per patient | NR | 52±12 | 43.0±12.1 to 33.7±10.2 (p=0.007) | NYHA FC 3.3 to 1.8 (p<0.001) | 209 to 497 yards (p<0.0001) | 11/18 RPO 3/18 MV | 1 (5.6%) RPO + RHF, day 7 | 16/18 (89%) alive at 34.2 months |
| Mizoguchi, 2012 [43] | 68 (Japan) | 255 sessions; 2–8 sessions per patient; 1–14 vessels dilated per session | 68/68 epoprostenol 1–5 ng·kg−1·min−1 for ∼5 days pre-BPA | 62.2±11.9 | 45.4±9.6 to 24±6.4 (p<0.01) | WHO FC 3.0 to 2.0 (p<0.01) | 296 to 368 m (p<0.01) | 76/255 sessions RPO 4/68 patients MV | 1 RHF, day 28 | 66/68 (97%) alive at 2.2±1.4 years |
| Kataoka, 2012 [16] | 29 (Japan) | 51 procedures (mean 1.8 per patient) Mean 3 vessels dilated per session Mean 6.5 vessels per patient | 14/29 bosentan 2/29 ambrisentan 24/29 PDE-5i 15/29 beraprost | 62.3±11.5 | 45.3±9.8 to 31.8±10 (p<0.01) | At 6 months NYHA FC (p<0.01)# | NR | 27/51 procedures RPO 1/29 patients MV | 1 wire perforation of PA | NR |
| Sugimura, 2012 [17] | 12 with distal webs 39 controls (Japan) | Mean 5 procedures 14 lesions | 1–3 months pre-BPA: 7/12 epoprostenol 5/12 beraprost 11/12 sildenafil 5/12 bosentan | 58 | Mean±sem 47.8±11.6 to 24.8±4.9 (p<0.01) | WHO FC II/III/IV 33/42/25% at baseline; 100% FC II at follow-up | Mean±sem 350±105 m to 441±76 m (p<0.05) | 6/12 haemoptysis | 0 | All alive at mean 12 months |
| Andreassen, 2013 [18] | 20 (Norway) | 73 catheterisations Mean 3.7 procedures and 18.6 BPAs per patient | 2/20 sildenafil, stopped before BPA | 60±10 | 45±11 to 33±10 (p<0.001) | NYHA FC 3.0±0.5 to 2.0±0.5 (p<0.001) | NR | 7/20 RPO | 1 RVF, day 1 1 acute PE, day 9 | 17/20 (85%) patients alive at median 51 months |
| Fukui, 2014 [19] | 20 (Japan) | Mean 3.2±0.9 procedures per patient | 5/20 ERA 13/20 PCA 4/20 PDE-5i 6/20 combination therapy | 67±9.0 | 39.4±7.6 to 27.3±8.5 (p<0.001) | WHO FC 2.8 to 2.0 (p<0.001) | 361±104 m to 463±76 m (p<0.001) | No major events | 0 | NR (1-year retrospective study) |
| Shimura, 2015 [20] | 110, including 9 post-PEA (Japan) | 423 44 BPA sessions in 9 post-PEA patients | NR | 55.1 (post-PEA patients) | 43 to 26 (p<0.05) | NYHA FC I/II/III/IV 0/3/5/1 to 7/2/0/0 (p<0.05) | NR | 1 RPO | 0 | 9/9 alive at median 1.97 years after BPA |
| Inami, 2014 [21] | 103 (Japan) | 350 procedures; 145 with PEPSI + PWG | Bosentan, ambrisentan, sildenafil, tadalafil or beraprost | 65 | In patients with PEPSI + PWG, from 38 to ≈24¶ | NR | In patients with PEPSI + PWG, from ≈360 to ≈420 m¶ | 0 with PEPSI + PWG | 0 with PEPSI + PWG | 0 at median 6.4 months with BPA + PEPSI + PWG |
| Inami, 2014 [22] | 68 (Japan) | 213 sessions | For BPA and PEA patients combined (n=107) prostanoids 60% PDE-5i 66% ERAs 55% | 62 | 42.9 to 25.0 | NYHA FC improved (p<0.05) | 349±130 m to 424±111 m (p<0.0001) | RPO 7.0% Haemosputum 2.3% Haemoptysis 3.3% Dissection 2.3% Perforation 0.9% | 1.47% | Mortality 1.5% at 14.3±10.4 months |
| Yanagisawa, 2014 [23] | <65 years: 39 ≥65 years: 31 (Japan) | <65 years: mean 4 sessions ≥65 years: mean 3 sessions (p=0.054) | Bosentan, ambrisentan, sildenafil, tadalafil or beraprost | <65 years: 54 ≥65 years: 70 | <65 years: 42 to 26.0 ≥65 years: 41 to 23.5 (p=0.11) | Improved in both groups (p<0.05) More in age ≥65 years (p<0.0001) | <65 years: 380 to 441 m ≥65 years: 310 to 409 m (p=0.553) | 1 wire perforation | At 1 year <65 years: 0% ≥65 years: 3.2% | |
| Kurzyna, 2015 [9] | 20 (Poland) | 37 procedures 105 vessels | 82% of patients, mainly sildenafil | NR | 58±6 to 41±9 | WHO FC III/IV 95% at baseline; 35% at follow-up | Improved exercise tolerance | 2 RPO | 10% (RPO) | NR |
| Velázquez Martín, 2015 [24] | 7 (Spain) | 22 (mean 3 procedures per patient; each procedure mean 2.4 segments, 1.2 lobes) | ERA + sildenafil + epoprostenol in most patients | 61 | 56±17 to 36±10 (p<0.06) | NYHA FC 3.8±0.2 to 2.3±0.2 (p<0.001) | NR | 2 RPO | 1 CVA day 7 | NR |
| Roik, 2016 [25] | 9 (Poland) | 27 sessions in 9 patients Mean 3 per patient | 6/11 sildenafil | 76 | Median (IQR) 40 (32−54) to 34.5 (29−42) (p=0.01) | NYHA FC I/II/III/IV 0/0/6/3 to 0/7/2/0 (p=0.018) | Median (IQR) 304 (135−450) to 304 (205−530) (p=0.03) | 2 RPO 1 haemoptysis | 0 | NR |
| Aoki, 2016 [26] | 25 (Japan) | 113 procedures Mean 4.7 per patient | ERA 4% PDE-5i 71% Oral prostanoid 21% Epoprostenol 8% Riociguat 12% | Median (IQR) 70 (60–74) | Median (IQR) 37 (28–45) to 23 (19–27) (p<0.01) | WHO FC I/II/III/IV 0/50/46/4% at baseline; 24/76/0/0% at follow-up (p=0.04) | Median (IQR) 390 (286–484) m to 490 (411–617) m (p<0.01) | No severe complications | 0 | NR |
| Kawakami, 2016 [27] | 97 (Japan) | 500 procedures Mean 5.2 per patient (1936 lesions) | ERA 47.4% PDE-5i 36.1% Oral prostanoid 50.5% i.v. prostanoid 9.3% | 61.7±12.3 | 45.1±10.8 to 23.3±6.4 (p<0.01) | WHO FC I/II/III/IV 0/0/70/27% at baseline; 13/76/4/0% at follow-up | 276.3±123.2 m to 359.3±91.9 m (p<0.01) | Haemoptysis (19.6%) Pulmonary injury (26.0%) | 4% | NR |
| Kimura, 2016 [28] | 66 (Japan) | Mean 6.8 sessions per patient; mean 13.1 vessels per patient | ERA 41% PDE-5i 55% Prostanoid 29% Riociguat 11% | 63.2±13.2 | 39.2±10.5 to 20.9±5.4 (p<0.001) | NR | NR | Haemosputum (6.1%) RPO requiring NPPV (1.1%) | 0 | NR |
| Koike, 2016 [29] | 8 (Japan) | 16 procedures Mean 2 per patient | NR | 70.8±8.6 | 30.4±11.0 to 25.6±8.2 (p=0.04) | NR | 332.3±59.6 m to 352.1± 64.1 m (p<0.0001) | NR | 0 | NR |
| Ogo, 2016 [30] | 80 (Japan) | 385 sessions Mean 4.8 per patient (1155 lesions) | ERA 23% PDE-5i 25% Oral prostanoid 42% i.v. prostanoid 6% Riociguat 6% | Median (IQR) 68 (58–76) | 42±11 to 25±6 (p<0.01) | WHO FC 3.0±0.4 to 1.8±0.4 (p<0.01) | 372±124 m to 470±99 m (p<0.01) | Wire perforation (7.5%) RPO (4.7%) Haemoptysis (4.7%) | 0 | NR |
| Tsugu, 2016 [31] | 26 (Japan) | Mean 6 sessions per patient | ERA 46% PDE-5i 72% Prostanoid 40% | 63±16 | 38.3±8.4 to 18.0±4.2 (p<0.01) | WHO FC 2.9±0.6 to 1.2±0.4 (p<0.01) | 326.8±83.7 m to 400.3±77.4 m (p<0.01) | NR | NR | NR |
| Yamasaki, 2016 [32] | 29 (Japan) | Mean 2.7 sessions per patient | ERA 45% PDE-5i 50% Oral prostanoid 40% Riociguat 40% | 61.9±10.6 | 42.6±11.0 to 30.0±6.6 (p<0.0001) | NR | 391±75 m to 437±68 m (p<0.0001) | NR | 0 | NR |
Data are presented as n or mean±sd, unless otherwise stated. mPAP: mean pulmonary arterial pressure; FC: functional class; 6MWD: 6-min walking distance; NR: not reported; NYHA: New York Heart Association; RPO: reperfusion pulmonary oedema; MV: mechanical ventilation; RHF: right heart failure; PDE-5i: phosphodiesterase type-5 inhibitor; PA: pulmonary artery; WHO: World Health Organization; PE: pulmonary embolism; ERA: endothelin receptor antagonist; PCA: prostacyclin analogue; PEA: pulmonary endarterectomy; PEPSI: Pulmonary Edema Predictive Scoring Index; PWG: pressure-wire guidance; CVA: cerebrovascular accident; IQR: interquartile range; NPPV: non-invasive positive pressure ventilation. #: values not reported; ¶: estimated from graphs.