Tony Das

Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial

Objective: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30‐day safety and effectiveness of the MO.MA® Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Background: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion “endovascular clamping” system to achieve cerebral protection prior to crossing the carotid stenosis. Methods: This prospective registry enrolled 262 subjects, 37 roll‐in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30‐day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. Results: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30‐day MACCE rate was 2.7% [95% CI (1.0–5.8%)] with a 30‐day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. Conclusions: The ARMOUR trial demonstrated that the MO.MA® Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date.

Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study.

The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in‐stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis.

Technique Optimization of Orbital Atherectomy in Calcified Peripheral Lesions of the Lower Extremities: The CONFIRM Series, A Prospective Multicenter Registry

The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA.

Cryoplasty Therapy for Limb Salvage in Patients with Critical Limb Ischemia

Purpose: To report the 6-month outcomes from a prospective multicenter study investigating the use of cryoplasty (cold balloon angioplasty) to treat below-knee occlusive disease in patients with critical limb ischemia (CLI). Methods: Between August 2004 and October 2005, 108 patients (77 men; mean age 73±12 years, range 41–101) with CLI involving 111 limbs were enrolled in a prospective multicenter trial (Below-the-Knee Chill Study), which was conducted at 16 institutions. The primary study endpoints were acute technical success, defined as the ability to achieve ≤50% residual stenosis and continuous inline flow to the foot, and absence of major (above or below-knee) amputation of the target limb 180 days post procedure. Results: Acute technical success was achieved in 108 (97.3%) of the 111 limbs treated, with only 1 (0.9%) clinically significant dissection (≥type C) and 2 residual stenoses >50%. During the 180-day follow-up, 15 (13.9%) of the initial 108 patients either withdrew or were lost to follow-up. Five (4.6%) deaths occurred, leaving 88 (81.5%) patients with 91 (82.0%) treated limbs available for 180-day assessment. The rate of freedom from major amputation at 180 days was 93.4%. Amputation-free survival was 89.3% at 180 days (5 deaths, 6 major amputations). Stratifying data by diabetics (n=71) versus non-diabetics (n=34), the 180-day death and amputation rates were 4.9% and 10.0%, respectively, for diabetics versus 6.7% and 0.0%, respectively, for non-diabetics. Conclusion: Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent acute outcomes and a high rate of limb salvage in patients with CLI. Study outcomes support the use of cryoplasty therapy as a primary treatment option for patients with CLI secondary to below- knee disease.

Excimer laser revascularisation: current indications, applications and techniques.

Abstract. The ultraviolet pulsed excimer laser (308 nm wavelength) is currently the only laser approved by the FDA for percutaneous intervention in patients with ischemic coronary artery disease. The clinical presentation of the treated patients varies from stable and unstable angina to acute myocardial infarction. Potential advantages of excimer laser revascularisation in acute coronary syndromes and in ischaemic obstructive peripheral vascular disease include concomitant plaque debulking and thrombus removal; absence of systemic lytic state; shortened thrombus clearing time and facilitation of adjunct balloon angioplasty and stenting. Improved understanding of laser–tissue interactions and positive clinical outcomes through the use of safe lasing techniques have led to expansion of indications/applications for laser angioplasty. These include stent restenosis, complex lesions and thrombotic stenoses, bifurcation lesions, balloon failure, total occlusions, focal saphenous vein graft lesions and peripheral arterial obstructions. The excimer laser can be effectively utilised in patients with depressed left ventricular ejection fraction and does not require implantation of a temporary pacemaker as no-reflow phenomenon and severe arrhythmias are rarely encountered. Careful case selection, proper utilisation of equipment and incorporation of efficient lasing techniques play a crucial role in effective and safe cardiovascular laser applications.

Primary Cryoplasty Therapy Provides Durable Support for Limb Salvage in Critical Limb Ischemia Patients with Infrapopliteal Lesions: 12-Month Follow-up Results from the BTK Chill Trial

Purpose: To report the 12-month follow-up data from the prospective 16-center Below-the-Knee (BTK) Chill Trial, which examined the use of primary cryoplasty for BTK occlusive disease in patients with critical limb ischemia (CLI). Methods: The trial included 108 patients (77 men; mean age 73±11 years, range 41–101) with CLI (Rutherford categories 4–6) involving 111 limbs with 115 target infrapopliteal lesions. Angiographic inclusion criteria were reference vessel diameter ≥2.5 mm and ≤5.0 mm and target lesion stenosis ≥50%. The primary study endpoints were acute technical success (the ability to achieve ≤50% residual stenosis and continuous inline flow to the foot) and absence of major amputation of the target limb at 6 months. Secondary endpoints were serious adverse events specifically related to use of primary cryoplasty and absence of major amputation of the target limb at 1, 3, and 12 months. Results: Acute technical success was achieved in 108 (97.3%) of treated limbs, with only 1 clinically significant dissection (≥type C) and 2 residual stenoses >50%; stent placement was required following cryoplasty in only 3 (2.7%) procedures. At 6 months and 1 year, major amputation was avoided in 93.4% (85/91) and 85.2% (69/81) of patients, respectively. Through 1 year, 21% (17/81) of patients underwent target limb revascularization. Rates of major amputation and death at 1 year were 0% for limbs of patients with initial Rutherford category 4; 11.4% and 0%, respectively, for initial category 5; and 40.0% and 31.8% for initial category 6. One-year rates of major amputation and death were 20.4% and 8.8%, respectively, for diabetics, versus 4.0% and 10.7% for non-diabetics. At 1 year, major amputation occurred in 16.7% (2/12) of limbs that were expected to be amputated at the time of treatment. Conclusion: Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent results and a high rate of limb salvage in patients with CLI. Study outcomes through 1 year support the use of cryoplasty as a primary treatment option for patients with CLI secondary to BTK occlusive disease.

Prevention of distal embolization and no-reflow in patients with acute myocardial infarction and total occlusion in the infarct-related vessel: A subgroup analysis of the cohort of acute revascularization in myocardial infarction with excimer laser-carmel multicenter study

To overcome the adverse complications of percutaneous coronary interventions in thrombus laden lesions (i.e., distal embolization, platelet activation, no‐reflow phenomenon), mechanical removal of the thrombus or distal embolization protection devices are frequently required. Pulsed‐wave ultraviolet excimer laser light at 308 nm can vaporize thrombus, suppress platelet aggregation, and, unlike other thrombectomy devices, ablate the underlying plaque. The following multicenter registry was instituted to evaluate the safety and efficacy of laser ablation in patients presenting with acute myocardial infarction (AMI) complicated by persistent thrombotic occlusions. Patients with AMI and complete thrombotic occlusion of the infarct‐related vessel were included in eight participating centers. Patients with further compromising conditions (i.e., cardiogenic shock, thombolysis failures) were also included. Primary endpoint was procedural respective laser success; secondary combined endpoints were TIMI flow and % stenosis by quantitative coronary analysis and visual assessment at 1‐month follow‐up. Eighty‐four percent of all patients enrolled (n = 56) had a very large thrombus burden (TIMI thrombus scale ≥ 3), and 49% were compromised by complex clinical presentation, i.e., cardiogenic shock (21%), degenerated saphenous vein grafts (26%), or thrombolysis failures (5%). Laser success was achieved in 89%, angiographic success in 93%, and the overall procedural success rate was 86%. The angiographic prelaser total occlusion was reduced angiographically to 58% ± 25% after laser treatment and to 4% ± 13% final residual stenosis after adjunctive balloon angioplasty and/or stent placement. TIMI flow increased significantly from grade 0 to 2.7 ± 0.5 following laser ablation (P < 0.001) and 3.0 ± 0.2 upon completion of the angioplasty procedure (P > 0.001 vs. baseline). Distal embolizations occurred in 4%, no‐reflow was observed in 2%, and perforations in 0.6% of cases. Laser‐associated major dissections occurred in 4% of cases, and total MACE was 13%. The safety and efficacy of excimer laser for thrombus dissolution in a cohort of high‐risk patients presenting with AMI and total thrombotic occlusion in the infarct‐related vessel are encouraging and should lead to further investigation. Catheter Cardiovasc Interv 2005;64:67–74.

Optimal therapeutic approaches to femoropopliteal artery intervention

Superficial femoral artery disease presents a complex challenge for therapy. The extent of vascular involvement may vary from focal disease with symptoms of intermittent claudication to long total occlusions manifest as critical limb ischemia. Optimal therapy requires understanding the available options including exercise programs, pharmacologic medical therapy, surgery and interventional endovascular therapy. Rapidly advancing endovascular technology for enabling safe intervention in complex, long occlusive segments of the superficial femoral artery continues to emerge. New devices like the SafeCross wire, Excimer laser, Silverhawk Atherectomy catheter, Cryoplasty catheter and new generations of bare metal and drug‐eluting nitinol stents are shifting the paradigm for therapy from surgical to more endovascular treatment even for the most complex disease presentation. Catheter Cardiovasc Interv 2004;63:21–30.

Excimer Laser-Assisted Angioplasty for Infrainguinal Artery Disease

After nearly 2 decades of research and experimentation with laser-assisted angioplasty, the xenon-hydrogen chloride excimer laser emerged as the laser device best suited for the treatment of peripheral artery disease. Emitting light at a wavelength of 308 nm, this laser utilizes a nonthermal mechanism of action to ablate plaque and thrombus in powerful discrete pulses. The excimer laser is particularly useful for the treatment of complex conditions, such as long chronic occlusions in the superficial femoral artery and in those patients with below-the-knee disease and critical limb ischemia who may not be good candidates for bypass surgery. A number of investigators have noted that the excimer laser will often uncover distinct, more focal lesions in what appears to be an extensive and complex occlusion, potentially simplifying treatment of these segments. The Laser Angioplasty for Critical Limb Ischemia phase 2 trial, a prospective registry of 145 patients at 11 US and 3 German sites, achieved good procedural success (86%) and an excellent 6-month limb salvage rate (93%). A new specialized deflecting sheath designed to direct excimer ablation in blockages of the larger main arteries above the knee has produced clinical improvement in a single-center feasibility study and a 16-center prospective registry. Less promising results were reported in a single-center real-world retrospective registry, warranting careful case selection with this device for patients with diabetes and renal failure.

Impact of lesion location on procedural and acute angiographic outcomes in patients with critical limb ischemia treated for peripheral artery disease with orbital atherectomy: A CONFIRM registries subanalysis.

This analysis compares the procedural and acute angiographic outcomes in patients with critical limb ischemia (CLI) treated with orbital atherectomy in above‐the‐knee (ATK)/popliteal (POP) lesions versus below‐the‐knee (BTK) lesions.