Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results

Cioppa, Angelo; Stabile, Eugenio; Popusoi, Grigore; Salemme, Luigi; Cota, Linda; Pucciarelli, Armando; Ambrosini, Vittorio; Sorropago, Giovanni; Tesorio, Tullio; Agresta, Alessia; Biamino, Giancarlo; Rubino, Paolo

doi:10.1016/j.carrev.2012.04.007

Cited by 125 publications

(106 citation statements)

References 14 publications

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“…Overall, it is calcium that is known for its ability to compromise performances of endovascular procedures in the short and long terms [8,9]. In the past years, very promising results have been reported using DEB in the femoro-popliteal region [19,20].…”

Section: Discussionmentioning

confidence: 99%

“…Only few studies have highlighted the importance of calcium [8,9,15,24] and a satisfactory scientific method to measure calcium level has not been found yet. Maybe this is the reason why calcium and its negative influence has not been systematically described and reported in clinical studies.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, it increases the occurrence of flow limiting dissections after PTA [8] and acute vessel recoil, with consequent increased use of stents. Also, in this condition calcium persists in playing an unfavourable role by increasing the risk of stent subexpansion, malposition, and fractures as shown in the coronary environment [5][6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

“…Overall, atherectomy devices, scoring, and cutting balloons have been utilized to improve results and patency rate but without a great success [7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

“…The efficacy of DEB in severely calcified arteries has not been specifically assessed with the exception of one registry where the use of DEB after atherectomy was explored in heavily calcific femoro-popliteal arterial segment with the rationale and the initial proof that removal of such a barrier allows drug to penetrate the vessel wall and effectively exert its antiproliferative action [9].…”

Section: Introductionmentioning

confidence: 99%

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Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Fanelli

Cannavale

Gazzetti

et al. 2014

Cardiovasc Intervent Radiol

300

223

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Purpose This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Methods Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis [ 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0°to 360°) and to its length (length \ or [ 3 cm) evaluated with digitalsubtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium.Results Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium ([270°vs. \90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Conclusions Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360°calcium presence.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Overall, atherectomy devices, scoring, and cutting balloons have been utilized to improve results and patency rate but without a great success [7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Fanelli

Cannavale

Gazzetti

et al. 2014

Cardiovasc Intervent Radiol

300

223

View full text Add to dashboard Cite

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Iliac and SFA Interventions in Patients with Critical Limb Ischemia

Irani

Gogna

Chua

et al. 2014

Urgent Interventional Therapies

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Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca⁺⁺ trial

Roberts

Niazi

Miller

et al. 2014

Cathet Cardio Intervent

101

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ObjectivesThe purpose of the DEFINITIVE Ca++ study was to evaluate the safety and effectiveness of directional atherectomy and distal embolic protection, used together to treat moderate to severely calcified femoropopliteal lesions.BackgroundDespite advances in endovascular treatment modalities, treatment of calcified lesions remains a challenge.MethodsA total of 133 subjects with 168 moderate to severely calcified lesions were enrolled. Lesions were treated with directional atherectomy devices, coupled with distal embolic protection.ResultsThe 30-day freedom from MAE rate was 93.1%. Per angiographic core laboratory assessment, the primary effectiveness endpoint (≤50% residual diameter stenosis) was achieved in 92.0% (lower confidence bound of 87.6%) of lesions. By core lab analysis, these results did not achieve the success criteria (90%) for the primary effectiveness objective. Per site assessment, the objective was met with the endpoint being achieved in 97.0% (lower confidence bound 93.8%). A mean residual diameter stenosis of 33.3% was achieved with the directional atherectomy device. This was further decreased to 24.1% with the use of adjunctive therapy. The proportion of asymptomatic subjects [Rutherford Clinical Category (RCC) = 0] increased from 0% at baseline to 52.3% at the 30-day follow-up visit. In total, 88.5% of subjects experienced an improvement of one or more Rutherford categories.ConclusionsThe results of the DEFINITIVE Ca++ study demonstrate that the SilverHawk™ and TurboHawk™ atherectomy devices are safe and effective in the endovascular treatment of moderate to severely calcified lesions in the superficial femoral and/or popliteal arteries when used with the SpiderFX™ distal embolic protection device. © 2014 Wiley Periodicals, Inc.

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Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results

Cited by 125 publications

References 14 publications

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Iliac and SFA Interventions in Patients with Critical Limb Ischemia

Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca⁺⁺ trial

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Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results

Cited by 125 publications

References 14 publications

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Iliac and SFA Interventions in Patients with Critical Limb Ischemia

Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca++ trial

Contact Info

Product

Resources

About

Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca⁺⁺ trial