Assessment of Vascular Patency and Inflammation with Intravascular Optical Coherence Tomography in Patients with Superficial Femoral Artery Disease Treated with Zilver PTX Stents.

PURPOSE: Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents. METHODS: Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage. RESULTS: Percentage of malapposed struts decreased from 10.3 ±â€¯7.9% post-intervention to 1.1 ±â€¯2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ±â€¯4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ±â€¯19%. The average neointimal area was 7.8 ±â€¯3.8 mm2. Maximal luminal narrowing was 61.1 ±â€¯25.0%, and average luminal narrowing was 35.4 ±â€¯18.2%. Average peri-strut low-intensity area (PLIA) per strut was 0.017 ±â€¯0.018 mm2. Average number of neovessels per mm of stent was 0.138 ±â€¯0.181. Average macrophage angle per frame at follow-up was 7 ±â€¯11°. Average thrombus area at follow-up was 0.0093 ±â€¯0.0184 mm2. CONCLUSION: At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages. SUMMARY: Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

MitraClip Deployed via Left Femoral Vein in an 85-Year-Old Woman with Mitral Regurgitation.

The MitraClip system can be used to control regurgitant blood flow in patients with mitral regurgitation who cannot tolerate open surgery to replace the mitral valve. Technical limitations make the right femoral vein the standard access point for placing the MitraClip. However, this route is not always suitable. We present the case of an 85-year-old woman in whom we successfully used a left-sided approach for inserting a MitraClip because her right femoral vein was occluded. This apparently novel left femoral approach merits consideration as an option for device insertion when right femoral vein access is precluded.

Same versus next day discharge after elective transradial PCI: The RAdial SAme Day DischArge after PCI trial. (The RASADDA-PCI trial).

BACKGROUND AND PURPOSE: Transradial percutaneous coronary intervention (TR-PCI) has been increasingly popular over the last decade in the US. Previous studies have shown that same-day (SD) discharge after elective PCI is as safe as overnight (ON) observation. Our study was performed to assess the clinical and financial impact of early discharge in patients undergoing TR-PCI. METHODS: This is a single center registry of patients undergoing elective TR-PCI. Timing of discharge was determined by the treating physician. (Groups: Same Day Discharge -SD-; Overnight Stay -ON-). Demographic data, procedural characteristics and adverse outcomes were recorded. Outcomes included 30 day-MACE and procedure- related complications, as well as total operative costs in patients from both groups. Propensity score matching for patient demographics, coronary symptoms and procedure indicators was used to compare both groups. RESULTS: The entire cohort included 852 patients (429 in SD group and 423 in ON group) and the propensity score matched groups of 245 patients in the SD group and 245 patients in the ON group. The two groups had no significant baseline clinical differences, and had similar clinical outcomes. Specifically, no significant difference was noted in procedural complications (3.7% vs 2.5%, p = 0.43), re-hospitalization (4.1% vs 4.1%, p = 0.92), re-intervention (2.5% vs 2.1%, p = 0.77), myocardial infarction (0% vs 0.08%, p = 0.15), stroke (0% vs 0%, p = 1.0) and all-cause mortality (0% vs 0%, p = 1.0). SD Group patients had a significant lower procedure-related cost compared to overnight stay patients ($3,346.45 vs $4,681.99, p < 0.0001) and lower 30-day post procedure-associated cumulative costs/total operating costs ($4,493.22 vs $7,112.21, p < 0.0001). CONCLUSION: In elective patients undergoing low risk TR-PCI, same-day discharge seems to be a safe and feasible clinical practice, with significant potential savings to the US healthcare system.

Immediate and intermediate-term results of optical coherence tomography guided atherectomy in the treatment of peripheral arterial disease: Initial results from the VISION trial.

BACKGROUND: Long-term patency rates for percutaneous peripheral arterial interventions are suboptimal. Optical coherence tomography (OCT) guided atherectomy may yield superior patency by optimizing plaque removal while preserving the tunica media and adventitia. METHODS: The VISION study is a multicenter prospective study of patients with peripheral arterial disease undergoing OCT guided atherectomy with the Pantheris™ device. In 11 patients enrolled in a single center, we report procedural and clinical outcomes, at 30days and 6months. RESULTS: The mean age was 63±11years and 73% (n=8) were men. The target lesion was in the superficial femoral artery in 82% (n=9) of the patients. Mean stenosis severity was 87%±10% and mean lesion length was 39±31mm. Procedural success was observed in all patients with no device related complications. Mean post-atherectomy stenosis was 18%±15%. Almost all excised tissue consisted of intimal plaque (94%). At 30days, significant improvements in Rutherford class, VascuQoL scores and ABI were observed, 0.9±0.8 vs. 3.1±0.7 (p=0.01), 4.9±1.9 vs. 3.6±1.5 (p=0.03) and 1.04±0.19 vs. 0.80±0.19 (p<0.01) respectively. At 6months, there were significant improvements in Rutherford class (1.0±1.0 vs. 3.1±0.7, p=0.01) and ABI (0.93±0.19 versus 0.80±0.19, p=0.02) but not in VascuQoL scores (3.7±1.4 versus 3.6±1.5, p=0.48). Target lesion revascularization occurred in 18% (n=2) of the patients. CONCLUSION: OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging results up to 6months. Histological analysis suggested little injury to the media and adventitia. Larger studies are needed to confirm the efficacy of this approach.

Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent.

BACKGROUND/PURPOSE: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. METHODS/MATERIALS: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤28 mm long; diameter ≥2.25 mm to ≤4.50mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. RESULTS: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p<0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. CONCLUSIONS: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease.

Percutaneous implantation of a parachute device for treatment of ischemic heart failure.

Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute(TM) device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation.

A prospective multicenter registry of laser therapy for degenerated saphenous vein graft stenosis: the COronary graft Results following Atherectomy with Laser (CORAL) trial.

PURPOSE: The primary aim of this study was to prospectively evaluate the safety and efficacy of Excimer laser atherectomy as a primary treatment strategy in consecutively eligible patients presenting for percutaneous coronary intervention (PCI) of degenerated saphenous vein graft (SVG) lesions using a multicenter registry. Prior single-center experience suggested that laser atherectomy may decrease acute procedural complications during treatment of degenerated SVGs, including lesions not amenable to distal protection devices (DPDs). METHODS AND MATERIALS: The COronary graft Results following Atherectomy with Laser investigators enrolled 98 patients at 18 centers between June 23, 2003, and October 4, 2004, with greater than 50% stenosis of an SVG who presented for PCI due to angina pectoris or objective evidence of myocardial ischemia in a concordant myocardial distribution. Laser atherectomy was planned. Patients were excluded if the operator planned to utilize a DPD. Inclusion and exclusion criteria were aligned to those in the Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial. RESULTS: The primary end point [30-day major adverse cardiac events (MACE)] occurred in 18/98 (18.4%) patients driven primarily by non-q-wave myocardial infarction. Major procedural complications included no reflow (n=5) and major dissection (n=1). No perforations occurred. Univariate predictors of 30-day MACE included lesion length, vessel angulation, plaque burden, SVG degeneracy score, number of laser pulses used, and larger-sized laser catheters. CONCLUSIONS: This study demonstrated that Excimer laser atherectomy of diseased SVGs is feasible with results comparable to the 30-day MACE in the control population from the SAFER trial. Whether the addition of laser to embolic protection devices is of any clinical utility remains to be tested in future studies.

A poly-N-acetyl glucosamine hemostatic dressing for femoral artery access site hemostasis after percutaneous coronary intervention: a pilot study.

BACKGROUND: Arterial puncture closure devices have improved time to hemostasis and ambulation after percutaneous coronary intervention (PCI) relative to traditional manual compression, though complication rates for both methods leave room for improvement. In a pilot registry, the authors evaluated a topical hemostatic dressing containing poly-N-acetyl glucosamine (p-GlcNAc) post PCI in fully anticoagulated patients. METHODS AND RESULTS: In 100 patients undergoing PCI via the common femoral artery in the short-stay unit, the p-GlcNAc hemostatic dressing was applied with 15 minutes of manual compression at arterial access sites after arterial sheath removal. Procedural antiplatelet and anticoagulation therapies were aspirin, clopidogrel and bivalirudin. Patients were observed during 2 hours of bed rest and attempted to ambulate 2 hours post hemostasis. Effectiveness was assessed based on times to hemostasis and ambulation. Data were stratified by time elapsed since bivalirudin bolus or discontinuation of infusion (30 minutes, > 30-60 minutes, > 60 minutes). Mean time to hemostasis was 15.5 minutes. Mean time from hemostasis to ambulation was 2.08 hours; 87% of patients ambulated at 2 hours. Sheaths were removed at a mean 40.38 minutes after discontinuing bivalirudin. Anticoagulation status (as assessed by time since discontinuation of bivalirudin) did not influence time to hemostasis or ambulation. There was a single major complication (pseudoaneurysm), two minor rebleeds requiring additional manual compression, and 1 hematoma > 5 cm. CONCLUSIONS: This p-GlcNAc topical hemostatic dressing safely achieved hemostasis at arterial access sites and early ambulation, even with nearly immediate sheath removal after PCI with systemic anticoagulation using bivalirudin.