Computerized gradual balloon inflation: a novel strategy of coronary angioplasty superior to a standard manual approach.
BACKGROUND
Mechanical trauma caused by PCI is a primary reason for restenosis and subsequent target lesion revascularization (TLR). To minimize this trauma, we developed a computerized angioplasty pressure sensor and inflator device (CAPSID) for gradual inflation. The objective of this prospective randomized study was to examine whether use of CAPSID reduces early and late cardiac events in patients undergoing PCI.


METHODS
Patients undergoing PCI were eligible and randomized to CAPSID or standard balloon inflation (plain old balloon angioplasty). In the CAPSID group, a slow, gradual balloon inflation was performed by a personal computer. Stenting was used in both groups only for suboptimal results. Patients with total occlusions and vein grafts were excluded. Clinical follow-up for major adverse cardiac events (MACE) was performed at 6 and 12 months, with repeat coronary angiography performed for clinical symptoms or positive stress testing.


RESULTS
A total of 234 patients completed the study. At 1-year follow-up, the CAPSID group had a significantly lower rate of MACE (21% vs. 37%, P<.005). In patients who underwent angiography, there was a significantly lower rate of restenosis in the CAPSID group (20.2% vs. 35.5%). The reduction in TLR was even more pronounced in the subgroup undergoing stenting (8% vs. 24%; P<.001).


CONCLUSIONS
We conclude that gradual computerized balloon inflation is more effective than standard manual balloon inflation in reducing adverse coronary events. The combination of CAPSID and subsequent stent deployment was especially effective in reducing TLR.
Leibowitz
David
D
Department of Cardiology, Hadassah-Hebrew University Medical Center, Ein Kerem and Mount Scopus, Jerusalem, Israel.
Abu-Gazala
Mahmoud
M
Katz
Iony
I
Danenberg
Haim
H
Nassar
Hisham
H
Boguslavsky
Larissa
L
Mosseri
Morris
M
Varshitzsky
Boris
B
Lotan
Chaim
C
Weiss
A Teddy
AT
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D014160:Transducers, Pressure; D016896:Treatment Outcome