Randomized Trial of Cutting Balloon Compared With High-Pressure Angioplasty for the Treatment of Resistant Pulmonary Artery Stenosis

Abstract

Background-We sought to determine the safety and efficacy of Cutting Balloon therapy (CB) compared with conventional high-pressure balloon therapy (HPB) for the treatment of pulmonary artery stenosis. Methods and Results-This prospective, randomized, multicenter, investigational device exemption trial compared CB with HPB. Patient eligibility was determined at the precatheterization assessment; vessel eligibility was determined at catheterization. In all vessels, low-pressure balloon dilation to 8 atm was performed, and if it was not successful, the vessel was randomized to CB or HPB. The primary efficacy outcome was percent change in minimum lumen diameter.A core laboratory performed all vessel measurements and angiographic assessment of vessel damage. The primary safety outcome was any serious adverse event attributable to vessel dilation as assessed by the Data and Safety Monitoring Board. Seventy-three patients from 8 institutions were enrolled between 2004 and 2008. In these patients, 72 vessels responded to low-pressure balloon dilation. Of the 173 vessels that met eligibility criteria, 107 were randomized to CB and 66 to HPB. In randomized vessels, CB therapy was associated with greater percent increase in lumen diameter (85% versus 52%; Pϭ0.004). After crossover was introduced, 26 of 47 vessels treated with HPB underwent CB therapy and experienced an additional 48% increase in lumen diameter; the final diameter after CB was 99% greater than the initial diameter. There were no serious adverse events related to treatment in a study vessel. Conclusion-CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile.

Outcomes After Primary Transcatheter Therapy in Infants and Young Children With Severe Bilateral Peripheral Pulmonary Artery Stenosis

“…Patients generally underwent right and left heart hemodynamic catheterization, angiography, and interventions on the PAs including standard angioplasty, high-pressure angioplasty, cutting balloon angioplasty, and stent implantation, at the discretion of the operator, [9][10][11][12][13]17 with postintervention angiography and hemodynamic measurements. During the more recent portion of our experience, interventions were generally performed through a long sheath positioned in the PAs, which was used for delivery of balloons and stents, angiography before and after serial interventions, and pressure monitoring.…”

“…Angioplasty and stent implantation have been shown to increase vessel diameter and decrease RV pressure in patients with PA stenosis in various clinical circumstances. [9][10][11][12][13][14] Although several studies have focused on acute outcomes of catheterization in patients with Williams syndrome, 12,15 little is known about long-term outcomes in patients who underwent transcatheter intervention for severe PPS early in life. Characterizing long-term outcomes in this population and identifying genetic, procedural, and hemodynamic factors associated with outcomes may help inform decision-making and prognosis.…”

Atherotome Dislodgement and Successful Retrieval During Cutting Balloon Pulmonary Angioplasty

“…4 In a pediatric randomized study comparing CB to high-pressure balloons, a CB was trapped on a stent with difficult removal in 2 cases, and delivery of a CB out of the sheath was difficult in 1 case, but no atherotome fracture or dislodgement was reported. 1 There is one case in the Food and Drug Administration adverse outcomes registry of fracture and dislodgement of a Flextome CB (Boston Scientific) atherotome during angioplasty of a PA 3 that could not be retrieved. The small, thin blade may not have been visible because the dislodged atherotome in the present case was only visualized with modern fluoroscopic equipment.…”

“…1 There are rare reports of atherotome fracture 2 and a Food and Drug Administration adverse event report of a fractured atherotome dislodging and remaining in the patient. 3 We report CB atherotome dislodgement and embolization with successful retrieval in a patient with Alagille syndrome and branch PA stenosis.…”

Circulation Editors' Picks

“…The primary findings of this study were as follows 1 : Postural changes in the QT interval were useful in distinguishing LQTS patients from control subjects but were not useful to discriminate between LQT1 and LQT2 genotypes. 2 A threshold heart rate-corrected QT interval (QTc) value of Ͼ460 ms during an extended recovery phase (7 minutes) of EST was useful in distinguishing LQTS children from both control patients and children with "concealed" LQTS. 3 LQT1 and LQT2 patients demonstrated unique QT interval adaptation patterns during exercise and the recovery phase.…”