Balloon pulmonary angioplasty may be a viable option for patients with chronic thromboembolic pulmonary hypertension who were ineligible for pulmonary endarterectomy, according to results from a multicenter registry.
The results showed that although complication rates were high, overall survival for those who received balloon pulmonary angioplasty were comparable to those who received pulmonary endarterectomy.
“The only potentially curative treatment for CTEPH is pulmonary endarterectomy,” Aiko Ogawa, MD, PhD, from the department of clinical science at the National Hospital Organization Okayama Medical Center in Japan, and colleagues wrote. “However, patients with peripherally located organized thrombus and patients with comorbidities are not good candidates for [pulmonary endarterectomy].”
To evaluate the efficacy and safety of balloon pulmonary angioplasty, researchers conducted a multicenter registry consisting of 308 patients (mean age, 61 years; 62 men) who underwent 1,408 procedures at seven institutes in Japan.
Ogawa and colleagues retrospectively reviewed data to evaluate clinical outcomes and complications in the patients included in the registry.
The researchers found that 249 patients who underwent 1,154 procedures with balloon pulmonary angioplasty showed significantly improved hemodynamics, primarily due to improvement in mean pulmonary arterial pressure or symptomatic improvement.
A total of 196 patients received follow-up right heart catheterization and maintained improved hemodynamic parameters.
According to the results, mean pulmonary arterial pressure decreased from 43.2 ± 11 mm Hg to 24.3 ± 6.4 mm Hg after final balloon pulmonary angioplasty and 22.5 ± 5.4 mm Hg at follow-up, with significant reduction of concomitant use of pulmonary hypertension-targeted therapy and oxygen supplementation.
There were complications in 36.3% of patients, including pulmonary injury (17.8%), hemoptysis (14%) and pulmonary artery perforation (2.9%).
During follow-up, there were 12 patient deaths, including eight patients who died within 30 days after balloon pulmonary angioplasty.
Researchers observed an overall survival rate of 96.8% (95% CI, 93.7-98.4) at 1 and 2 years and 94.5% (95% CI, 89.3-97.3) at 3 years after the initial balloon pulmonary angioplasty procedure for all 308 patients.
“The first multicenter registry in Japan demonstrated that [balloon pulmonary angioplasty] performed at experienced pulmonary hypertension centers is safe and effective therapeutic option in patients with CTEPH who are unsuitable for [pulmonary endarterectomy],” Ogawa and colleagues wrote. “Further investigation within a multicenter prospective study is needed to confirm these results.” – by Dave Quaile
Disclosure: Ogawa reports he receives lecture fees from Actelion Pharmaceuticals and GlaxoSmithKline. Please see the study for the other authors’ relevant financial disclosures.