This was published by Dr. Ferral in a peer-reviewed academic journal based on a series of 107 procedures. Technical success in 97.4% of lesions! Not bad. I would like to see the full article to see how technical success was defined. Dr. Ferral uses IVUS in his procedures, and I wonder if that contributed to the high success rate. Thrombosis in only 3%. That's low but it also might only represent the patients on whom follow-up was available; if patients were not local, follow-up might not be available.June 2013, Volume 200, Number 6
Vascular and Interventional Radiology
Endovascular Diagnosis and Management of Chronic Cerebrospinal Venous Insufficiency: Retrospective Analysis of 30-Day Morbidity and Mortality in 95 Consecutive Patients
Hector Ferral1, 2, George Behrens1, Yanki Tumer1 and Magdalene Riemenschneider1
Affiliations: 1 Department of Radiology, Section of Interventional Radiology, Rush University Medical Center, Chicago, IL.
2 Present address: Department of Radiology, Section of Interventional Radiology, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL 60201.
OBJECTIVE. The purpose of this study is to report the 30-day morbidity and mortality associated with the endovascular diagnosis and management of chronic cerebrospinal venous insufficiency.
MATERIALS AND METHODS. The medical records of 95 consecutive patients (60 women and 35 men) with a mean age of 48 years (age range, 25–66 years) who underwent diagnostic endovascular evaluation and intervention for chronic cerebrospinal venous insufficiency between June 2010 and September 2011 were reviewed retrospectively. All patients had a diagnosis of multiple sclerosis by McDonald criteria. Endovascular evaluation of the internal jugular and azygos veins was performed with digital subtraction venography and intravascular ultrasound. Indications for percutaneous transluminal angioplasty (PTA) were venographic findings of a greater than 50% diameter stenosis, the presence of reflux on digital subtraction venography, greater than 50% cross-sectional area stenosis by intravascular ultra-sound, or a finding of abnormal thick valves or webs by either method. The primary endpoint of this study was the 30-day mortality, and the secondary endpoint was the presence of major complications. Results are presented as means and percentages.
RESULTS. A total of 107 procedures were performed in 95 patients. Endovascular evaluation showed venous lesions requiring intervention in 90 of 95 patients (94.7%) and was negative in five of 95 patients (5.3%). A total of 193 venous lesions were treated; angioplasty was technically successful in 188 of 193 (97.4%) lesions. Internal jugular vein thrombosis after PTA was identified in three of 95 (3.2%) of the treated patients. Bleeding at the puncture site not requiring transfusion occurred in four of 95 patients (4.2%). There were no reported procedure-related deaths.
CONCLUSION. The results of the current study suggest that endovascular evaluation and management of chronic cerebrospinal venous insufficiency is safe, with low morbidity and no procedure-related mortality.
Primary end-point of the study was 30-day mortality! But no one died, and there were only the handful of adverse outcomes including thrombosis, which since it was caught within 30 days would have had the potential to be retreated successfully and the vein salvaged. Overall the results of the study suggest that endovascular evaluation and treatment of CCSVI is safe.
I am curious about the 5 lesions in which angioplasty was not technically successful. What was the chosen cut-off for how large a balloon was use or how high of atm pressure? It does not sound like stenting was chosen, but did he consider this if the patient returned seeking greater relief? What sort of lesions were these? I always think of CCSVI lesions as the usual bad valves but perhaps these were trickier and thus the reason for the lack of success, or perhaps they were physiological or extrinsic compressions but if he is using IVUS that would have been already determined and not included in the count?
Bleeding at the puncture site occurred in 4% of patients. Dr. Sclafani recently mentioned that he no longer uses heparin during procedures due to procedural anticoagulation potentially being a factor in adverse outcomes seen at other centers. If heparin is not used during the procedure, would this 4% risk of puncture site bleeding be reduced?
The procedures being written about occurred between June 2010 and September 2011, so the earliest ones represent treatment choices made nearly 3 years ago. That would include Dr. Ferral's earliest CCSVI cases, so these statistics would include cases performed while he was on the CCSVI learning curve.
The study is a retrospective study, looking back at patients treated and data collected.