rome and Peripheral-Arterial-Disease

The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial.. From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group.. One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05).. Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Critical Illness; Drug Carriers; Equipment Design; Female; Femoral Artery; Hemodynamics; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Rome; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To compare the safety and efficacy of laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia (CLI) and superficial femoral artery (SFA) chronic stent occlusion in a prospective, randomized study.. Among 448 CLI patients treated from December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8 years) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB (n=24) or DEB angioplasty alone (n=24). Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (TLR) and clinical success at 12 months.. In the LD+DEB group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher (p=0.01) than in the DEB only patients (58.3% and 37.5%, respectively). TLR at 12 months was 16.7% in the LD+DEB group and 50% in the DEB only group (p=0.01). Two (8%) patients needed major amputations in the LD+DEB group vs. 11 (46%) in the DEB only group at 12 months (p=0.003).. In this small initial experience, combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chronic Disease; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Lasers; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Retreatment; Risk Factors; Rome; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To evaluate efficacy and safety of a new rotational atherectomy (RA), the Phoenix Atherectomy™ System, for the treatment of de novo and re-stenotic or occlusions atherosclerotic moderate-heavily lesions of the femoro-popliteal axis.. From January 2015 to August 2017, 52 patients with heavily calcified femoro-popliteal lesions causing severe stenosis or occlusions were enrolled in our center to be treated using Phoenix catheters. Primary endpoints of this study were acute efficacy and safety at 30 days. Secondary endpoints were freedom from restenosis and target lesion revascularization (TLR)/target vessel revascularization (TVR) at 1-, 6- and 12- months.. The mean lesion length was 9.2 cm (range 5-23 cm). The lesions were located in superficial femoral artery (SFA) in 61.5% (Fig. 1-A), in popliteal artery in 21.1% and involved femoral-popliteal axis in 15.4%. A primary technical success was achieved in 51/52 patients, with an optimal working channel after RA alone. Using Kaplan-Meyer analysis, primary vessel patency rates at 1, 6 and 12 -months was 96.1%, 86.5% and 76.9% respectively. Assisted primary patency at 1, 6- and 12 -months was 100%, 90.3% and 86.5% respectively.. Recanalisation with the Phoenix Atherectomy System is simple and safe, with a high technical success rate.

Topics: Aged; Angioplasty, Balloon; Atherectomy; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Rome; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Calcification; Vascular Patency

To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound energy delivered via a new dedicated ultrasound catheter followed by conventional balloon angioplasty to treat calcified infrapopliteal lesions.. A prospective, nonrandomized, single-center pilot study enrolled 12 patients (mean age 72.2±5.3 years; 8 men) with critical limb ischemia (9 Rutherford category 5 and 3 category 6) between January and November 2017. Of the 19 target lesions, 11 had severe calcification. Patients were treated with the Kapani ultrasound system before conventional balloon dilation. Primary safety endpoints included 30-day death, major target limb amputation, and target vessel acute occlusion. The main efficacy outcome was primary patency at 6 months, defined as freedom from both clinically-driven target lesion revascularization (TLR) and angiographically-defined restenosis (>50% lumen reduction).. Technical success (<30% residual stenosis) was achieved in all lesions without complications or stent implantation. Ultrasound energy was delivered over a mean 185.2±67.3 seconds followed by low-pressure dilation (mean 6.1±1.9 atm). Angiography confirmed primary patency at 6 months in 18 (95%) of 19 lesions. No death, TLR, or amputation was reported in follow-up. Complete ulcer healing was observed in all 12 patients at 6 months.. This pilot trial with a small number of patients suggests that low-frequency, high-intensity ultrasound energy delivery followed by plain balloon angioplasty is a safe approach to treat infrapopliteal atherosclerotic lesions. Angiographically-documented results at 6 months indicate a potential for this combined therapy in the treatment of CLI patients with calcified BTK lesions. Further studies on a larger randomized cohort are needed to confirm these positive clinical outcomes.

Topics: Aged; Amputation, Surgical; Angiography; Angioplasty, Balloon; Critical Illness; Female; Humans; Ischemia; Leg; Limb Salvage; Male; Peripheral Arterial Disease; Pilot Projects; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Recurrence; Rome; Time Factors; Treatment Outcome; Ultrasonic Therapy; Vascular Access Devices; Vascular Patency

The aim of this study is to analyze the effects of peripheral blood mononuclear cells (PBMNCs) therapy in diabetic patients with critical limb ischemia (CLI), with particular regard to its application, as adjuvant therapy in patients underwent endovascular revascularization.. Fifty diabetic patients affected by CLI were enrolled. All patients underwent PBMNCs therapy. Thirty-two patients underwent PBMNCs therapy associated with endovascular revascularization (adjuvant therapy group). In 18 patients, who were considered nonrevascularizable or underwent unsuccessful revascularization, regenerative therapy with PBMNCs was performed as the therapeutic choice (PBMNCs therapy group).. The role of cellular therapy with PBMNCs is decisive in the patients that are not susceptible to revascularization. In diabetic patients with CLI and healing resistant ulcers, the adjuvant PBMNCs therapy could represent a valid therapeutic option.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Critical Illness; Disease Progression; Endovascular Procedures; Female; Foot Ulcer; Humans; Ischemia; Leukocytes, Mononuclear; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Recovery of Function; Risk Factors; Rome; Time Factors; Treatment Outcome; Wound Healing

To evaluate the long-term results of endovascular and hybrid treatment in patients with Trans-Atlantic Inter-Society Consensus (TASC) II type "C" and "D" aortoiliac lesions and to highlight, in contrast to TASC II guidelines, the importance to analyze individually the lesions of a single iliac axis.. From January 2008 to December 2012, 50 patients with TASC II type C and D aortoiliac lesions underwent endovascular or hybrid treatment. In 38 patients (76%), the lesions were treated by endovascular approach, while in 12 (24%) patients surgical treatment was adopted. All patients underwent a postoperative surveillance program at 1, 3, and 6 months for the first year and every 6 months thereafter.. Technical success was achieved in all patients (100%). The postoperative complication rate was 4%. Primary patency rate was 93.3% at 1 year, 90.2% at 2 years, and 86.6% at 3 years. Cumulative secondary patency rate was 97.7% at 1, 2, and 3 years. Survival after 1 and 2 years was 94.8% and after 3 years was 91.1%. Limb salvage was 100% for the entire period of follow-up.. In contrast to TASC II guidelines, the endovascular or hybrid treatment should be considered a valid approach for type C and D lesions. The hybrid treatment, in selected cases, is an effective method to improve the runoff, which plays a key role in the success of the treatment of multilevel stenoocclusive lesions. In TASC II C to D iliac lesions, a specific overview of each axis is necessary in order to select the most appropriate treatment.

Topics: Adult; Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Graft Occlusion, Vascular; Humans; Iliac Artery; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Rome; Time Factors; Treatment Outcome; Vascular Patency

The aim of the study was to describe and analyze the results of a technique in which the inflow for distal bypasses is provided by the proximal superficial femoral artery, reopened through an eversion endarterectomy, to avoid a "difficult groin.". Twenty-one patients who underwent distal bypass for severe lower-limb ischemia and in whom the proximal superficial femoral artery was reopened with an eversion endarterectomy to provide inflow for the bypass itself were included in the study. As a comparison group, 20 patients in whom the inflow for a distal bypass was obtained by the distal deep femoral artery were randomly selected. In all 41 patients, the groin was considered "difficult" because of multiple previous operations.. Five-year cumulative patency rates were 53% for femoropopliteal bypasses and 40% for femorotibial bypasses. Similar patency rates were obtained when the distal deep femoral artery was used as inflow.. Eversion endarterectomy of the proximal superficial femoral artery provides a valid source of inflow for distal bypasses, and it should be kept in the armamentarium of the vascular surgeon, to be used in selected cases.

Topics: Endarterectomy; Femoral Artery; Groin; Humans; Ischemia; Kaplan-Meier Estimate; Lower Extremity; Peripheral Arterial Disease; Postoperative Complications; Regional Blood Flow; Reoperation; Retrospective Studies; Rome; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency