Comparative study of five types of IABP balloons in terms of incidence of balloon rupture and other complications: a multi-institutional study.

The Multi-Institutional IABP Balloon Study Group in Japan (14 institutions) conducted a retrospective nonrandomized study to elucidate the incidence and type of IABP balloon-related complications relative to design and durability of five different clinically available balloons: TMP (n = 960), Kontron (n = 943). Datascope (n = 485), Mansfield (n = 226), and Aries (n = 189) balloons. A total of 2,803 patients (1,973 males, 830 females, mean age 62.1 years) spent a total of 243,856 h on the pump. Forty-nine balloons (1.7%) ruptured as recognized by the appearance of blood in the catheter (39 cases) or console alarm (4 cases). Ten patients required surgical removal of the balloon due to entrapment. Other IABP balloon-related complications requiring surgical intervention or with a lethal outcome occurred in 89 patients (3.2%). They included lower limb ischemia (61 cases), hematoma (11 cases), extensive dissection (6 cases), perforation (5 cases), entrapment without balloon rupture (3 cases), and mesenteric infarction (3 cases). The incidence of rupture, other major complications, and total complications, respectively, for each balloon was 0, 2.7, and 2.7 for TMP, 1.6, 4.3, and 5.9% for Kontron, 4.1, 1.9, and 6.0% for Datascope, 1.3, 2.7, and 4.0% for Mansfield, and 5.8, 3.7, and 9.5% for Aries. In conclusion, the TMP balloon demonstrates a significantly lower rate of rupture while the incidence of other complications for the 5 balloons is not significantly different.