Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

Technical aspects of entrapped coronary guidewire retrieval using rotational atherectomy device: A case series.

BACKGROUND: This article highlights four unique cases where rotational atherectomy (RA Rotapro, Boston Scientific) was used to cut and retrieve an entrapped coronary guidewire with parts extending into the aorta We discuss the technique and step by step approach to the retrieval procedure. CASE SUMMARY: Three of four cases described a guide wire entrapment in the right coronary artery (RCA), and one in the left anterior descending artery via retrograde route. In all cases the guide wire was intact within the intracoronary segment. In Case 1, the guide wire (Runthrough; Terumo) was entrapped in an acute marginal branch during chronic total occlusion (CTO) percutaneous coronary intervention. In Case 2, a whisper wire (Abbott) was entrapped during re-wiring of the right posterolateral branch through stent struts, the traction on the wire caused severe malformation of distal and proximal stents requiring second staged procedure to complete revascularization of the RCA CTO. In Case 3, a Runthrough wire was entrapped between two layers of stents and fractured at the proximal point with filaments extending into descending aorta. And in Case 4, a Pilot 200 (Abbott) wire was entrapped retrograde in the subintimal space via saphenous vein graft connection by tying a knot at the distal tip of the wire. In all four cases RA was used to successfully cut and remove the entrapped guide wires. DISCUSSION: Rotablation technique appears to be a safe and effective strategy for the management of entrapped coronary guidewire when conventional strategies fail.

Novel Mechanical Thrombectomy Device for the Treatment of Acute Myocardial Infarction: A Retrospective Report of Initial Results.

OBJECTIVE: The objective of this study was to assess the effectiveness of mechanical thrombectomy using the Aspire mechanical thrombectomy device (Control Medical) for the treatment of acute myocardial infarction (AMI) as measured by Thrombolysis in Myocardial Infarction (TIMI) flow post procedure compared with baseline. METHODS: This is a retrospective study for the treatment of acute myocardial infarction (AMI) in ST-segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI) patients. The study was approved by an independent ethical review board. Data were collected retrospectively from 48 subjects at three study sites. The primary endpoint was TIMI flow post thrombectomy compared with baseline. The safety endpoint was 30-day major adverse cardiac event, defined as death, MI, and target-vessel revascularization (TVR). Eligibility criteria included AMI patients ages 18-90 years who had previous treatment with the Aspire mechanical thrombectomy device, preprocedure TIMI flow 0 to 2, and ability to tolerate antiplatelet therapy. RESULTS: Of the 48 subjects, 81.2% were male, 33.3% were diabetics, 64.6% were hypertensive, 52.1% had hyperlipidemia, and 85.4% had STEMI, with 38.0% anterior and 56.0% inferior AMI. Baseline TIMI flow was 0-1 in 89.6% of subjects. Post-thrombectomy TIMI flow 2-3 was achieved in 85.4% and all subjects had TIMI flow 3 at the end of the intervention. The device did not track in 1 patient and was not used. There were 5 deaths (10.4%), all unrelated to the aspiration thrombectomy procedure, and 0% experienced a stroke. CONCLUSION: The Aspire mechanical thrombectomy device demonstrated initial effectiveness and safety. Further prospective studies using objective performance criteria to demonstrate effectiveness and safety using the Aspire mechanical thrombectomy device are necessary to determine whether short-term and long-term outcomes improve over previously published clinical trials.

Modified Sleeve Technique for Calcified Coronary Bifurcations.

Historically, in calcified coronary lesions, rotational atherectomy can result in side-branch occlusion in up to 10% of the cases. This can potentially result in significant ischemia depending on the territory involved. Our modification of the GuideLiner technique avoids the added risk of guide-catheter dissection from two guides in the left main and can also be used in non-left main bifurcations.

Excimer laser in contrast for the treatment of acute MI caused by thrombosis of underexpanded stent.

The use of excimer laser with contrast for treating an underexpanded stent in the setting of subacute stent thrombosis and hemodynamic instability is described. The patients presented with acute coronary syndromes and cardiogenic shock resulting from stent thrombosis of underexpanded stents. The stents were recalcitrant to aggressive balloon dilation and in the setting of an acute myocardial infarction; rotational atherectomy is a relative contraindication. The use of concurrent contrast during laser atherectomy resulted in plaque modification and subsequent stent expansion.

Reentry-Catheter Assisted SAFARI Technique.

Reentry catheters have become an important tool in the treatment of chronic total occlusion of the peripheral vasculature. Their use has been demonstrated in the treatment of aortoiliac disease as well as femoropopliteal disease. Success rates may vary depending on operator experience and lesion characteristics, but in general are reported to be around 85% in facilitating reentry. In the event of reentry failure, alternative strategies may be required to achieve procedural success. We describe an alternative strategy to achieve success with the use of Outback and Pioneer reentry catheters when initial reentry fails.

Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).

OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).

Transcollateral approach for percutaneous revascularization of complex superficial femoral artery chronic total occlusion.

Chronic total occlusions of the superficial femoral artery occur in approximately 40% of patients with symptomatic peripheral arterial disease. When antegrade revascularization fails or is not feasible, a retrograde approach should be considered. This is usually via the popliteal or tibial vessels. Alternatively, transcollateral revascularization has been reported. This report describes the use of transcollateral retrograde revascularization of the superficial femoral artery in two patients with failed antegrade crossing. Retrograde recanalization was achieved via a branch of the profunda femoris artery. Unlike previous reports that describe retrograde crossing and subsequent snaring of the wire, these cases were performed with retrograde passage of a low-profile balloon. Following retrograde balloon dilation, the vessel was rewired from an antegrade approach and the procedure was completed with complications.

Unstable Angina and Non-ST-Segment Elevation Myocardial Infarction.

In the last 20 years there have been enormous advances in our understanding of the acute coronary syndromes and how to manage patients presenting with them. In the 1980s, we began to understand the importance of thrombus formation was in the pathophysiology of acute coronary syndromes. Randomized studies also showed that appropriate antithrombotic therapy reduced the subsequent occurrence of myocardial infarction and death. In the 1990s, other therapeutic modalities and particularly percutaneous coronary intervention have come to the forefront as effective therapy in these syndromes. The glycoprotein IIb/IIIa receptor antagonists along with coronary stent implantation have proved extremely beneficial in short- and long-term management. We also have learned the importance of risk-factor modification in preventing subsequent events. In the future, greater efforts will focus on primary prevention.