Adverse events
Thrombus progression or recurrence occurred in 34.5% (n=10) of
patients; 40.9% (n=9) in those that received CDT and 14.3% (n=1) in
those that received “on-table” tPA. The median time to thrombus
progression or recurrence was 0.5 months (range 0.1-14 months) noted on
follow up imaging. Minor bleeding complications were noted in 10.3%
(n=3) of patients with 3.4% (n=1) experiencing a major bleeding episode
following their interventional procedure. The minor bleeding events were
minor oozing from venous access sites, epistaxis, and the development of
a large (8.2 cm) popliteal hematoma that did not require intervention
beyond temporary cessation of anticoagulation and tPA. The major
bleeding episode occurred in a neonate who had a large drop in
hemoglobin (decrease of 9.9 g/dL) requiring multiple transfusions. While
there was no bleeding source identified, this was counted as a major
bleeding event due to the large drop in hemoglobin requiring multiple
blood transfusions. Three of the bleeding events (including the major
bleed) occurred in the patients in the CDT group, with a frequency of
13.6%; one minor bleeding episode occurred in the patients that
received “on-table” tPA, a frequency of 14.3%. The median drop in
hemoglobin following the procedure was 2.3 g/dL from the pre-procedural
blood count; 24.1% of patients (n=7) required a blood transfusion for
an acute decline in hemoglobin following the procedure. As the use of
interventional devices may result in a decline in measured hemoglobin
due to intra-procedural red blood cell depletion (e.g. Indigo
thrombectomy, Angiojet thrombolysis and thrombectomy), post-procedural
drops in hemoglobin were not counted as bleeding events unless a
bleeding event was noted via physical examination or imaging. The median
decline in platelet count was 50,000 cells/dL from pre-procedural labs.
There were no noted cases of PE following a thrombolysis procedure.
Though our center did not use standardized PTS scoring scales in follow
up appointments, 17.2% (n=5) of patients exhibited symptoms of PTS at
follow up hematology outpatient visits. This represents 18.2% (n=4) of
the CDT and 14.3% (n=1) of the “on-table” groups. These symptoms
included lower extremity pain (10.3%, n=3), swelling (10.3%, n=3), and
redness/discoloration (3.4%, n=1). The median time from
diagnosis/intervention to the development of PTS symptoms was 15.3
months, with a range of 7 to 22.3 months. One patient in the cohort
died, though was unrelated to thrombolysis or anticoagulation (died of
complications of sepsis without bleeding symptoms noted; he was on
anticoagulation for continued therapy of his thrombosis during the
hospitalization).