Lower Extremity Venoplasty With the Shockwave Lithotripsy Balloon

Case Presentation

A 40-year-old man with a history of right leg deep vein thrombosis (DVT) that occurred 3 months prior in the setting of right leg trauma was seen for evaluation of edema and pain. The patient was experiencing aching and heaviness below the right knee that was not entirely relieved by compression hosiery. The revised venous clinical severity score (rCVSS) was 15. Venous ultrasound studies revealed no superficial reflux. There was evidence of post-thrombotic subtotal occlusion in the right popliteal and femoral vein. The patient was taking rivaroxaban, an oral direct thrombin inhibitor.

Invasive venography and intravascular ultrasound revealed subtotal occlusion of the right popliteal vein, a double femoral vein with stenosis, and extensive synechiae. No mobile thrombus was seen. There was no evidence of (May-Thurner) compression, stenosis or fibrosis in the right common femoral or iliac vein.

The right femoral vein was venoplastied with a 7 mm, then a 10 mm, balloon to nominal pressure (8 atmospheres [atm]). The popliteal and distal femoral vein were treated with a Shockwave 7 mm lithotripsy balloon (Shockwave Medical) for a total of 180 seconds at up to 8 atm. The popliteal vein stenosis yielded by fluoroscopy at 4 atm and the patient did not experience discomfort. The femoral venoplasties, even with the smaller 7 mm standard balloon, led to significant discomfort. The patient was discharged on rivaroxaban 15 mg po BID for 3 weeks and 20 mg daily thereafter, and was seen in clinic approximately 2 weeks later. The patient’s discomfort and edema had partially improved to a rVCSS of 7. A follow-up was scheduled in 4 weeks with the plan to maintain the patient on rivaroxaban for 6 months. At 3-month follow-up, the patient’s rVCSS had further improved to 5.

Discussion

Deep vein thrombosis (DVT) is a major health care problem with significant socioeconomic implications.¹ In addition to acute pain and edema, it can often lead to chronic symptoms of post-thrombotic syndrome (PTS) associated with venous outflow obstruction and/or valvular dysfunction.^2-4

Amongst patients with post-thrombotic syndrome, iliocaval stenting can be performed to relieve venous outflow obstruction and improve symptom scores.^5-7 However, treatment options in the post-thrombotic femoral and popliteal veins are largely limited to balloon venoplasty. A significant challenge of venoplasty of the post-thrombotic vein has been the presence of tough, collagen-rich synechiae as well as luminal fibrosis, which can lead to recoil and reocclusion. In addition, the patient often experiences pain during balloon inflations that sometimes necessitates general anesthesia.

Comerota et al performed histological analysis of common femoral vein post-thrombotic endovenectomy tissue and demonstrated that it contained predominantly type I, but also type III collagen and dystrophic calcification.⁸ In what is (to our knowledge) a first, we utilized the Shockwave Lithoplasty Balloon (Shockwave Medical) in a lower extremity vein.

Ultrasonic pressure waves have been used to treat nephrolithiasis.⁹ The lithoplasty balloon has also been evaluated for the treatment of calcified stenotic plaque in coronary and peripheral arterial disease.^10,11 The ultrasonic pressure waves pass through the balloon, creating microfractures in calcified tissue that allows for balloon expansion at lower pressures, potentially minimizing barotrauma. It is plausible that the lithoplasty may be able to target and modify the dystrophic calcification within the post-thrombotic vein.

There is limited data on alternative endovascular therapy for the post-thrombotic femoral and popliteal vein. To reduce discomfort in chronic post-thrombotic venoplasty, a scoring balloon was used in the iliofemoral segment in a small case series.¹² Lower inflation pressures were required, which presumptively led to less discomfort and the avoidance of heavy sedation or general anesthesia.

Our patient tolerated the lithotripsy venoplasty well and the vessel inflated at an acceptably low pressure. His rVCSS score, which can be utilized as a measure of the severity of post-thrombotic syndrome (possible  scores ranging from 0-30)¹³, improved from 15 to 7 at 2-week follow-up. There was sustained improvement at 3-month follow-up. However, this is a single case report and clearly, more data is required. Currently, the Shockwave balloon is only available up to 7 mm in diameter, so veins larger than the popliteal may not be amenable to use. It is also unclear whether the use of the Shockwave lithotripsy balloon will lead to better outcomes in the chronic post-thrombotic vein, in terms of long-term patency and symptom improvement.

Conclusion

To our knowledge, this is the first reported case of the use of the Shockwave lithoplasty balloon in a vein, in the treatment of post-thrombotic stenosis. The procedure was well tolerated with improved symptom score on follow-up. 

¹Assistant Professor, Cardiovascular Medicine, Yale University, New Haven, Connecticut; ²Fellow in Cardiovascular Medicine Yale University, New Haven, Connecticut; ³Associate Professor, Cardiovascular Medicine, Yale University, New Haven, Connecticut

Disclosures: Dr. Mena-Hurtado is site investigator for the Disrupt PAD III trial of the Shockwave Balloon. The authors report no financial disclosures.

The authors can be contacted via Robert Attaran, MD, FACC, FSCAI, RPVI, at robert.attaran@yale.edu.

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