Case Series Shows Learning Curve of Controversial MS Angioplasty Procedure

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The safety of balloon angioplasty to correct perceived venous abnormalities in patients with multiple sclerosis (MS) increases with operator experience, leading to an overall low rate of adverse events at 30 days. The study, published online August 14, 2013, ahead of print in the Journal of Vascular Surgery, is one of the largest individual series published of endovascular therapy for MS.

Investigators led by Tommaso Lupattelli, MD, of Gruppo Villa Maria (Rome, Italy), treated 1,202 consecutive patients with jugular angioplasty via the femoral route for chronic cerebrospinal venous insufficiency (CCSVI) from September 2010 to October 2012. Patients were treated on an outpatient basis at 2 Italian institutions.

The ‘CCSVI theory’ of MS hypothesizes that CCSVI, which is diagnosed by Doppler sonography according to specific criteria, may initiate perivenous inflammation, a histopathological signature of MS. The purpose of the endovascular therapy is to open stenosed internal jugular veins. All patients in the study met at least 2 of the specified criteria for CCSVI and were symptomatic for MS.

Safe and Feasible, But Learning Curve Exists

Overall there were 1,219 interventions. The majority of patients had phlebography followed by endovascular recanalization with angioplasty alone (98.9%). Angioplasty with stenting was performed in 14 patients (0.2%) due to unsatisfactory response to angioplasty alone. All stents were self-expanding BMS, and none were placed in the internal jugular veins. Only 1 of the stented patients required multiple stents (2 overlapping). The procedure was primary in 86.5% and a reintervention in 13.5%.

Most patients (98.2%) were discharged at 4 hours after the intervention, while 19 patients were discharged the following day and 3 were discharged on days 2, 3, and 7.

Procedural success was 99.2%. The occurrence of major complications at 30 days, the primary endpoint, was low overall (0.6%) with no death, stroke, or major contrast medium-related complications. When the investigators separated the interventions into 2 groups, the first 400 cases performed and those after, adverse events occurred only in the former group (table 1).

Table 1. Major Complications at 30 Days

 

Cases 0-400

Cases 401-1,219

Postprocedural Venous Thrombosis

0.2%

0

Severe Groin Bleeding Requiring Open Surgery

0.1%

0

Vessel Rupture Requiring Blood Transfusion

0.1%

0

Surgical Opening of Common Femoral Vein to Remove Balloon Fragments

0.2%

0


At 30 days, the overall rate of minor complications was 2.5%. Unlike major complications, these were seen during both early and later cases. Events included minor contrast reaction, transient cardiac arrhythmia, puncture site bleeding, or hematoma.

The technical success rate was 90.4%, with persistent stenosis > 50% of at least 1 internal jugular vein seen in 6.8% of patients at confirmation phlebography. Repeat Doppler showed a rate of CCSVI, defined as either persistence or recurrence of at least 2 Zamboni criteria following angioplasty, of 11.8% at 6 months and 19.1% at 1 year.

According to the study authors, the findings confirm “that the rate of adverse events following catheter angioplasty is reasonably low with low risk of serious adverse events. However, a proper learning curve seems to highly reduce the rate of complications.”

A Missed Opportunity

In a telephone interview with TCTMD, Adnan H. Siddiqui, MD, PhD, of the University at Buffalo (Buffalo, NY), expressed disappointment and frustration with the study authors for not including any data on how patients fared following treatment.

“I was initially blown away to see that they had over 1,000 patients on whom they were reporting,” Dr. Siddiqui said. “But then you realize there are no [Kurtzke Expanded Disability Status Scale (EDSS)] data, nothing to tell you what happened with the patients’ multiple sclerosis. Yet they had EDSS data preprocedurally, so why did they not collect it after the procedure?”

He added that the study is “a disservice” to researchers and MS patients who believe there is something to the CCSVI theory. Dr. Siddiqui and colleagues recently published data from the randomized PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) trial (Karmon Y, et al. J Vasc Surg. 2013;Epub ahead of print), which utilized venous angioplasty in 30 patients with relapsing MS.

“Having done the work myself I think there is something to [CCSVI], but I don’t think it’s a simple matter of just doing angioplasty in the veins,” Dr. Siddiqui said. “We don’t know enough yet . . . and attempts like this discredit the possibility of real scientific investigation regarding the role of veins, venous flow, and outflow in patients with MS as well as other potentially degenerative disorders. There are anomalies in these patients that may be related to their underlying disease, but we don’t know that for a fact.”

Study Details

Slightly more than half (54.5%) of patients were female, and the mean age was 35 years. On average, patients had been diagnosed with MS for 11.3 years: 48.6% with relapsing remitting disease, 35.9% with secondary progressive, 9.3% with primary progressive, and 6.2% unknown.

 


Source:
Lupattelli T, Bellagamba G, Righi E, et al. Feasibility and safety of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Vasc Surg. 2013;Epub ahead of print.

 

 

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Disclosures
  • Dr. Lupattelli reports no relevant conflicts of interest.
  • Dr. Siddiqui reports serving as principal investigator of the PREMiSe trial, which is sponsored by ev3. Kaleida Health, and Volcano.

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