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.

Carotid Artery Stenting in Asymptomatic Carotid Artery Stenosis: JACC Review Topic of the Week.

The advance of therapies to reduce the stroke impact of asymptomatic carotid artery stenosis has proved difficult over the last decade. Disagreement concerning the underlying randomized control trials has limited entry into the care arena of endovascular therapies. Recently, advances in percutaneous therapies for carotid artery disease have been reported and provide a substantial database supporting the further incorporation of endovascular-based therapies in patients who need revascularization and meet selection criteria. With a second randomized control trial now published, it is time for a re-evaluation of endovascular therapy as a component of carotid artery care. This review describes the advances in the field in the last 5 years, clarifying the current position of these therapies in the care of the patient with asymptomatic carotid artery disease.

SCAI/ACVP expert consensus statement on cardiovascular catheterization laboratory economics: If the cath lab is your home you should understand its finances: This statement was endorsed by the Alliance of Cardiovascular Professionals (ACVP) in April 2019.

This article is intended for any physician, administrator, or cardiovascular catheterization laboratory (CCL) staff member who desires a fundamental understanding of finances and economics of CCLs in the United States. The authors' goal is to illuminate general economic principles of CCL operations and provide details that can be used immediately by CCL leaders. Any article on economics in medicine should start by acknowledging the primacy of the principles of medical ethics. While physicians have been trained to act in the best interests of their patients and avoid actions that would harm patients it is vitally important that all professionals in the CCL focus on patients' needs. Caregivers both at the bedside and in the office must consider how their actions will affect not only the patient they are treating at the time, but others as well. If the best interests of a patient were to conflict with any recommendation in this article, the former should prevail. KEY POINTS: To be successful and financially viable under current payment systems, CCL physicians, and managers must optimize the outcomes and efficiency of care by aligning CCL leadership, strategy, organization, processes, personnel, and culture. Optimizing a CCL's operating margin (profitability) requires maximizing revenues and minimizing expenses. CCL managers often focus on expense reduction; they should also pay attention to revenue generation. Expense reduction depends on efficiency (on-time starts, short turn-over time, smooth day-to-day schedules), identifying cost-effective materials, and negotiating their price downward. Revenue optimization requires accurate documentation and coding of procedures, comorbidities, and complications. In fee-for-service and bundled payment reimbursement systems, higher volumes of procedures yield higher revenues. New procedures that improve patient care but are expensive can usually be justified by negotiating with vendors for lower prices and including the "halo effect" of collateral services that accompany the new procedure. Fiscal considerations should never eclipse quality concerns. High quality CCL care that prevents complications, increases efficiency, reduces waste, and eliminates unnecessary procedures represents a win for patients, physicians, and CCL administrators.

Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions.

OBJECTIVES: The aim of this study was to assess actual procedural costs and outcomes comparing wire-catheter and dedicated chronic total occlusion (CTO) device strategies to cross peripheral artery CTOs. BACKGROUND: Peripheral artery CTO interventions are frequently performed, but there are limited data on actual procedural costs and outcomes comparing wire-catheter and dedicated CTO devices. METHODS: The XLPAD (Excellence in Peripheral Artery Disease Intervention) registry (NCT01904851) was accessed to retrospectively compare cost and 30-day and 12-month outcomes of wire-catheter and crossing device strategies for treatment of infrainguinal peripheral artery CTO. RESULTS: Of all 3,234 treated lesions, 42% (n = 1,362) were CTOs in 1,006 unique patients. Wire-catheter approaches were used in 82% of CTOs, whereas dedicated CTO devices were used in 18% (p < 0.0001). CTO crossing device use was associated with significantly higher technical success (74% vs. 65%; p < 0.0001) and mean procedure cost ($7,800.09 vs. $4,973.24; p < 0.0001). Because 12-month repeat revascularization (11.3% vs. 17.2%; p = 0.02) and amputation rates (2.8% vs. 8.5%; p = 0.002) in the CTO crossing device arm were lower compared with the wire-catheter group, the net cost for an initial CTO crossing device strategy was $423.80 per procedure. CONCLUSIONS: An initial wire-catheter approach to cross a peripheral artery CTO is most frequently adopted. The use of dedicated CTO crossing devices provides significantly higher technical success and lower reintervention and amputation rates, at a net cost of $423.80 per procedure at 12 months.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

PURPOSE: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). METHODS: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. RESULTS: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. CONCLUSION: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial.

OBJECTIVES: The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. BACKGROUND: Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. METHODS: We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents>5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. RESULTS: Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). CONCLUSIONS: Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

Transcutaneous ultrasound-guided endovascular crossing of infrainguinal chronic total occlusions.

Currently available techniques for the endovascular treatment of infrainguinal arterial chronic total occlusions (CTOs) require long procedure duration, large contrast volumes, complex subintimal dissection technique, and have low-intermediate success rates. Inability to remain intraluminal and/or reenter the true lumen after subintimal dissection remains the main reasons for procedural failure. We report for the first time a novel, simple, and reproducible technique that can significantly improve both the success and safety of endovascular intraluminal crossing of totally occluded peripheral arterial segments: the transcutaneous ultrasound-guided (TUG)-CTO technique. We used transcutaneous ultrasound guidance to cross long segments of superficial femoral artery CTO using a blunt-microdissection technique.

Treatment of complex superficial femoral artery lesions with PolarCath cryoplasty.

Use of cryoplasty in patients with severely symptomatic (Rutherford category > or =3) superficial femoral artery (SFA) disease has not been systematically evaluated. From August 2006 to October 2007, 27 consecutive, severely symptomatic patients with 39 lesions in 36 limbs underwent SFA cryoplasty using the PolarCath at 2 centers. Mean age was 74 +/- 12 years and 48% were men; 41% had diabetes, 59% had coronary artery disease, and 61% had complex lesions (ostial, calcified, chronic total occlusion, in-stent restenosis, or length > or =150 mm). Adjunctive stenting was required after cryoplasty in 11 of 39 lesions. Immediate procedural success was 100%. After a mean follow-up of 1.2 +/- 0.7 years, primary patencies were 67% overall, 75% in the cryoplasty-only group (28 lesions), and 46% in the group requiring adjunctive stent placements. Symptom improvement by > or =1 Rutherford category was seen in 31 (86%) limbs from a mean baseline Rutherford category of 3.16 +/- 0.56 to 1.14 +/- 1.12 (p <0.0003). Follow-up ankle-brachial index was available for 30 (83%) of the 36 treated limbs, and improvements in mean ankle-brachial index from baseline to follow-up were 0.60 +/- 0.10 and 0.85 +/- 0.16 respectively (p <0.0007). In conclusion, cryoplasty appears to be effective in the treatment of complex lesions in the SFA distribution with significant intermediate term improvements of peripheral arterial disease symptoms.

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 > or = 2.5 mm and < or = 5.0 mm and target lesion stenosis > or = 50%. The primary study endpoints were acute technical success (the ability to achieve < or = 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 (> or = 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.

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.

High-risk patients referred for transcatheter aortic valve implantation: management and outcomes.

BACKGROUND: Aortic valve replacement (AVR) is the treatment of choice for critical aortic stenosis. Selected patients have not previously been referred for AVR because of excessive risk of mortality and morbidity with surgery. The option of transcatheter aortic valve implantation (TAVI) has increased referral of this high-risk cohort for therapeutic intervention. We report the management and outcomes of these patients. METHODS: Patients referred for TAVI from December 2005 to December 2007 were evaluated and followed up for intermediate-term all cause mortality. Patients received medical management, TAVI, conventional AVR, or balloon valvuloplasty (BAV) based on risk profile, hemodynamic and echocardiographic criteria, physician judgment, or patient choice. Patients were compared for demographics, Society of Thoracic Surgeons predicted risk of mortality score, and outcomes after AVR, TAVI, or BAV. RESULTS: One hundred five patients were referred for TAVI during a 24-month period. Fifty-two patients (49.5%) received medical management, 16 (15.2%) conventional AVR, 21 (20.0%) received TAVI, and 16 (15.2%) received BAV. Patients were classified as medical management because of physician or patient choice, not meeting TAVI criteria, or underevaluation for a possible procedure. For all patients the average length of follow-up was 159 +/- 147 days. Patients receiving BAV had a Society of Thoracic Surgeons predicted risk of mortality score greater than those having medical management, AVR, or TAVI. Thirty-day mortality was 1 of 16 patients (6.3%) for AVR, 2 of 21 patients (9.5%) with TAVI, 2 of 16 patients (12.5%) for BAV, and 7 of 52 patients (13.5%) for the medical management cohort. Overall mortality during follow-up was 42.3% (22 of 52 patients) for medical management, 19.1% (4 of 21 patients) for TAVI, 12.5% (2 of 16 patients) for AVR, and 37.5% (6 of 16 patients) for BAV. CONCLUSIONS: The population of patients screened for transcatheter therapy is complex and heterogeneous. Medical management alone demonstrates a high mortality rate, and BAV, although providing transient symptomatic relief, does not favorably impact survival. The majority of referred patients (65.7%), including those that declined intervention, were candidates for some form of valve replacement therapy, either TAVI or AVR. Transcatheter aortic valve implantation can be performed in appropriately selected patients with good early and immediate-term outcomes.

Usefulness of optical coherent reflectometry with guided radiofrequency energy to treat chronic total occlusions in peripheral arteries (the GRIP trial).

Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.