Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results.
BACKGROUND
The use of directional atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract.


METHODS
From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had life limiting claudication (LLC) (n=18) and 12 a critical limb ischemia (CLI) with baseline Rutherford class 4.2±1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis>50%) by visual estimation. After the intervention patients were followed up to 12 months.


RESULTS
Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2±1.2, ABI was 0.8±0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n=30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR=10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure.


CONCLUSIONS
The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.
Division of Invasive Cardiology, Montevergine Clinic, Mercogliano, Avellino, Italy. cioppa68@gmail.com
Angelo
A
Cioppa
Eugenio
E
Stabile
Grigore
G
Popusoi
Luigi
L
Salemme
Linda
L
Cota
Armando
A
Pucciarelli
Vittorio
V
Ambrosini
Giovanni
G
Sorropago
Tullio
T
Tesorio
Alessia
A
Agresta
Giancarlo
G
Biamino
Paolo
P
Rubino
D000368:Aged; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D057785:Catheters; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016638:Critical Illness; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000628:therapy; D007511:Ischemia / Q000209:etiology / Q000628:therapy; D007558:Italy; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011859:Radiography; D012008:Recurrence; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D018084:Ultrasonography, Interventional; D061205:Vascular Calcification / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014654:Vascular Patency
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel