Study objectives: The purpose of this study was the evaluation of the
efficacy and safety of mechanical fragmentation of acute massive pulmo
nary emboli with a rotatable pigtail catheter. Material and methods: T
en patients (4 female, 6 male, age 53.8 +/- 9.5 years) with acute mass
ive pulmonary embolism with hemodynamic impairment were included in th
e study, The fragmentation catheter device (William Cook Europe A/S; B
jaerverskov, Denmark) consisted of a 5F catheter embedded in a flexibl
e 5.5F sheath, Pulmonary emboli were fragmented by mechanical action o
f the recoiled rotating pigtail, while the guide wire was exiting an o
val side hole proximal to the pigtail tip. In eight cases, an addition
al thrombolysis was performed. Results: Fragmentation was successful i
n 7 of 10 patients, Average percentage of recanalization by fragmentat
ion was 29.2 +/- 14.0%, and 36.0 +/- 10.0% exclusively of the seven su
ccessful cases. Average shock index decreased significantly prefragmen
tation to postfragmentation from 1.52 to 1.22 (p = 0.03) and to 0.81 4
8 h later (p < 0.001). Decrease of the average mean arterial pulmonary
pressure prefragmentation to postfragmentation was insignificant (fro
m 33 to 31 mm Hg, p = 0.14); further decrease within the 48 h follow-u
p was highly significant (from 31 to 21 mm Kg, p < 0.001) due to a syn
ergy of fragmentation and thrombolysis (average dose 63 +/- 25 mg plas
minogen activator). There were no procedure-related complications. Ove
rall mortality rate was 20%. Conclusion: Fragmentation of massive pulm
onary emboli with the pigtail rotation catheter achieved rapid partial
recanalization in most cases, with ease of instrumentation, and witho
ut complications. Hemodynamic stabilization was completed in synergy w
ith thrombolysis.