Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension

Irene Lang; Bernhard C. Meyer; Takeshi Ogo; Hiromi Matsubara; Marcin Kurzyna; Hossein-Ardeschir Ghofrani; Eckhard Mayer; Philippe Brenot

doi:10.1183/16000617.0119-2016

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FIGURE 1
a) Pulmonary angiography, showing a stenosis in the subsegment of the 10th segmental artery (anterior view); b) the catheter is introduced into a web stenosis; c) the wire is introduced between the fibrotic material and the balloon is inflated, leading to rupture of the web. d) Angiography after balloon pulmonary angioplasty shows an improvement of blood flow with better perfusion of the parenchyma and quick venous return. In contrast to pulmonary endarterectomy, the fibrous material is not removed from the arteries, but is crushed against the vessel wall.
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FIGURE 2
Pulmonary arterial imaging before and after percutaneous balloon pulmonary angioplasty (BPA). a) Pre-procedure pulmonary angiogram demonstrating an intra-arterial fibrous “web” lesion; b) the corresponding intravascular ultrasound image showing the intravascular filling defect; c) the BPA balloon in place; d) pulmonary angiogram after the BPA procedure, showing the patent arterial lumen.
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FIGURE 3
a–d) Selective angiograms and e–h) digital-subtraction angiograms of the right and left pulmonary arteries in a 76-year-old female with chronic thromboembolic pulmonary hypertension manifestation at the level of segmental and subsegmental branching. e–h) Image acquisition in the digital-subtraction angiography technique in frontal or lateral (90° left anterior oblique) projection using intra-arterial contrast injection (iomeprol 300 mg iodine·mL⁻¹, flow rate 12 mL·s⁻¹, volume per injection 35 mL, frame rate 7.5·s^-1).
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FIGURE 4
a) Conventional pulmonary angiogram, with b) and c) corresponding optical coherence tomography images from a patient with chronic thromboembolic pulmonary hypertension, showing the nature of vascular obstructions at two locations. ^#: location for b); ^¶: location for c). Scale bars=1 mm.

TABLE 1

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.