Fragmentation success was defined as a recanalization o( occluded area of s25%. The 48-h treatment success (including thrombolysis, if performed) was defined as circulatory stabilization 48 h after fragmentation with a shock index < 1, a mean pulmonary arterial pressure < 25 mm Hg, and a systemic arterial BP returned to normal values.
Overall treatment success was defined as the final clinical outcome of the patient (at the day of discharge from hospital), under consideration of all adverse events, which happened before or after fragmentation.
The paired Wilcoxon signed rank test was used for statistical analysis of prefragmentation and postfragmentation and 48-h follow-up data.
One patient was not included in the study due to a large embolus-in-transit in the right side of the heart detected by transesophageal echocardiography. In 10 patients, catheter fragmentation of pulmonary emboli was performed (Fig 2). The right pulmonary artery was treated in four cases, the left pulmonary artery in five cases, in one patient both sides were treated.
Seven of the 10 patients were receiving mechanical ventilation with a high fraction of inspired oxygen (0.8 ± 0.15) prior to fragmentation therapy (Table 1). Unstable hemodynamics required positive inotropic support with medium- to high-dose catecholamines in this group. Three patients underwent cardiopulmonary resuscitation (Table 1). In one patient (No. 3), a shock index > 1 at the time of inclusion decreased below the level of 1 immediately prior to fragmentation, due to inotropic support.
The study results are given in Tables 2-5.
Average shock index decreased significantly prefragmentation to postfragmentation from 1.52 to 1.22 (p = 0.03, Table 2) and to 0.81 48 h later (p < 0.001). The increase in systolic and diastolic systemic BP prefragmentation to postfragmentation was just beyond the level of significance (p = 0.06). Further development within the 48-h follow-up was clearly insignificant.
Figure 2. A .36-year-old male patient with traumatic fractures of the first cervical vertebra, right upper and lower leg, and thrombosis ol the right femoral vein. Top left: Prefragmentation complete occlusion of the left pulmonary artery. Top right: pigtail rotation catheter in place, from left femoral approach (right femoral thrombi, jugular approach not possible, because patient was wearing a “stiff-neck” bandage). Bottom left: after embolus fragmentation: partial recanalization and intraluminal fragments (arrows). Bottom right: final control angiography 3 days later (central venous digital subtraction angiography) after additional thrombolysis with 70 mg ol plasminogen activator.
Table 2—Circulatory Data
|Patient No.||Shock Index||Pulmonary Artery BP, mm Hg|
|(Heart Rate/Systolic Systemic BP)||Systolic||Mean||Diastolic|
|Before||After||48 h ‘||Before||After||48 h’||Before||After||48 h’||Before||After||48 h’|
|Mean ± SD||1.52 ± 0.56||1.22 ± 0.38||0.81 ± 0.38||52 ± 8||47 ±8||31 ± 12||33 ±4||31 ±5||21 ± 8||25 ± 7||21 ±6||14 ± 7|
Table 3—Fragmentation Procedure and Angiographic Outcome Data
|PatientNo.||Approach* Jug Fem||Procedure Time, min||Real Fragmentation Time, min||Technical Problems With Cathete:||Angiographic Severity Index (According to Walsh et al) Prefragmentation/Postfragmentation||Recanalization in Percent of Occluded Area|
|2||R jug||60||30||1. set:j||7||8/5 f||–||38|
|R jUg||2. set: no|
|4||L fem||35||15||No||2||9/6 f||–||33|
|5||R fem||8||4||No||8/6 f||2||25||–|
|6||R fem||55||15||Mismatch §||9/8 f||6||(11)||–|
|7||L jug||50||15||No||7/5 f||8/6 f||29||25|
|8||R fem||15||10||No||3||7/4 f||–||43|
|9||R fem||20||10||No||6||8/5 f||–||38|
|10||R fem||70||35||Mismatch^||9/8 f||–||(11)|
|Mean ± SD||41 ± 20||17 ± 9||29.2 ± 14.0% ||
Table 4—Medical Therapy Data
|PatientNo.||Heparin Dose, IU, Initial + Maintenance/d||Contraindication to Thrombolysis Treatment||Thrombolytic Agent Used||Thrombolysis Total Dose, mg||Time Relation to Fragmentation||Mode of Application|
|1||15,000 + 25,000||No||rt-PA||100||55 min before||IV|
|2||5,000 + 25,000||Relative: recent abdominal surgery (5 d ago)||rt-PA||40||13 h after||IV|
|3||_*||Relative: fractures||rt-P A/urokinase||60/+170,000 U/h||1 d before/3 h before (3 d)||IV|
|5||0 + 24,000||No||rt-PA||60||5 min after||Catheter|
|6||3,000 + 19,200f||No (surgery 2 wk ago)||rt-PA||22.5||90 min after||Catheter|
|7||7,500 + 21,600||Absolute: cranial surgery 1 d before||—||—||—||—|
|8||0 + 25,000||Absolute: fresh cranial trauma||—||—||—||—|
|9||5,000 + 0||Relative: cranial surgery (10 d ago)||rt-PA||100||10 min before||IV|
|10||5,000 + 25,000||Relative: infarction medial cerebral artery||rt-PA||50||Followingfragmentation||Catheter|
Table 5—Clinical Outcome Data
|Patient No.||Cardiopulmonary/ eurologic Deficits||Deficits Acquired Within 48-h-Interval||Circulator)/ Restitution at 48 h*||Deficits Acquired After 48-h Interval||Final Restitution/ Clinical Outcome|
|1||Pulmonary hypertension||Complete, (exceptpulmonary hypertension)||Sepsis + multiorgan failure (14 d after fragmentation)!||Death|
|3||Incomplete, elevated pulmonary pressure, thrombolysis continued||Complete|
|6||Right bundle block||—||Complete||—||Complete|
|7||Brain death (cardiac arrest of unknown duration)||Incomplete, circulation stable, but elevated pulmonary pressure||Circulation stable organ donor|
|9||Right heart insufficiency||Death (1 h postfragmentation)||Died||Death|
|10||Left hemiparesis||Incomplete, shock index elevated, catecholamines continued||Complete (except neurologic deficit)|