WASHINGTON (FRONTLINE MEDICAL NEWS) – Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

SOURCE: Bashir R. CRT 2018