Sean Janzer

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.

Crossing chronic total occlusions with the Ocelot system: the initial European experience.

AIMS The aim of the study was to determine the safety, efficacy and feasibility of a new chronic total occlusion (CTO) device using optical coherence tomography (OCT) technology, the Ocelot catheter (Avinger, Inc., Redwood City, CA, USA), for crossing of SFA CTOs following guidewire failure. METHODS AND RESULTS Prospective, multicentre, market preference testing. Thirty-three patients with confirmed CTO (99-100% stenosis by visual estimate) of their superficial femoral artery (SFA) were treated between September 28, 2011, and December 9, 2011, at three European centres. Ocelot crossed 94% (31/33) of CTOs, allowing guidewire placement in the distal true lumen. All (100%) lesions were treated without any major adverse safety events. Procedural time and contrast dose were significantly reduced (p<0.0001) when compared with a similar, non-OCT-guided CTO crossing device (Wildcat catheter; Avinger, Inc.). Overall physician feedback on the catheter performance was positive with an 87% average rating of excellent or good across seven categories. Performance ratings of Ocelots OCT imaging guidance were consistently positive with an 86% average rating of excellent or good across five OCT categories. CONCLUSIONS The Ocelot catheter combines advanced CTO crossing technology with real-time OCT guidance. When compared with a similar non-OCT-guided catheter, crossing efficacy and safety profile improved. Total procedure time and contrast volumes were significantly reduced. The Ocelot is a safe, efficient and effective tool for crossing CTOs.

Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the e v aluat i on of the Pantheri S Opt i cal C O herence Tomography Imagi N g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study

Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)–guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: The VISION trial (ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. Results: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Trends, etiologies, and predictors of 90-day readmission after percutaneous ventricular assist device implantation: A national population-based cohort study

Percutaneous ventricular assist devices (pVADs) are indicated to provide hemodynamic support in high‐risk percutaneous interventions and cardiogenic shock. However, there is a paucity of published data regarding the etiologies and predictors of 90‐day readmissions following pVAD use. We studied the data from the US Nationwide Readmissions Database (NRD) for the years 2013 and 2014. Patients with a primary discharge diagnosis of pVAD use were collected by searching the database for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) procedural code 37.68 (Impella and TandemHeart devices). Amongst this group, we examined 90‐day readmission rates. Comorbidities as identified by “CM_” variables provided by the NRD were also extracted. The Charlson Comorbidity Index was calculated using appropriate ICD‐9‐CM codes, as a secondary diagnosis. A 2‐level hierarchical logistic regression model was then used to identify predictors of 90‐day readmission following pVAD use. Records from 7074 patients requiring pVAD support during hospitalization showed that 1562 (22%) patients were readmitted within 90 days. Acute decompensated heart failure (22.6%) and acute coronary syndromes (11.2%) were the most common etiologies and heart failure (odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.17–1.67), chronic obstructive pulmonary disease (OR: 1.26, 95% CI: 1.07–1.49), peripheral vascular disease (OR: 1.305, 95% CI: 1.09–1.56), and discharge into short‐ or long‐term facility (OR: 1.28, 95% CI: 1.08–1.51) were independently associated with an increased risk of 90‐day readmission following pVAD use. This study identifies important etiologies and predictors of short‐term readmission in this high‐risk patient group that can be used for risk stratification, optimizing discharge, and healthcare transition decisions.

SUPERA Stent Outcomes in Above-The-Knee IntervEntions: Effects of COMPression and ELongation (SAKE-COMPEL) Sub-Study

INTRODUCTION The interwoven nitinol design of the Supera stent has been shown to have superior radial strength and fracture resistance resulting in higher patency rates at 6 and 12months. A detailed sub-analysis of SUPERB trial showed differences in patency based on stent conformation post deployment. We evaluated the patency of the stent within the SAKE study cohort based on stent deployment conformation. METHODS We retrospectively evaluated the medical records of 63 patients (77 limbs) with Rutherford class 2-5 symptoms who received Supera stents in the femoro-popliteal artery from March 2010 through May 2011 as part of the SAKE study. These patients were followed for patency and the need for re-intervention over a mean follow up of 15months. Compression or Elongation was defined as follows based on previous sub-analyses: Moderate Compression (-40 to -21%); Minimal Compression (-20 to -11%); Nominal (-10 to 10%); Minimal Elongation (11 to 20%); Moderate Elongation (21 to 40%); and Severe Elongation (>40%). Significance was determined using Chi X2 test. RESULTS The best patency rates (85.2% primary patency and 92.6% assisted primary patency) and lowest re-intervention rates (14.8%) were achieved with stent compression, followed by nominal deployment or minimal elongation, and worst outcomes (64.7% primary patency; 82.3% assisted primary patency; and 35.3% re-intervention) with stent elongation to moderate or severe degree. CONCLUSIONS Patency rates and re-intervention rates are variable based on deployment characteristics of the Supera stent. Best outcomes are achieved with compression of the stent during deployment.

Validation of digital ankle-brachial index as a screening tool in symptomatic patients with peripheral arterial disease

INTRODUCTION There is scarcity of data validating portable digital ankle-brachial index (ABI) with contrast angiography in peripheral arterial disease (PAD). Our aim was to provide an objective analysis of the relationship between digital ABI (dABI) and peripheral angiographic data. METHODS Consecutive patients with symptoms of PAD between May 2014 to May 2015 at Einstein Medical Center, Philadelphia, who were undergoing simultaneous dABI and peripheral angiography, were evaluated. Measurements were made using the FloChec™ Digital ABI system (Bard) prior to the scheduled peripheral angiogram. RESULTS The final cohort consisted of 51 patients. Mean age was 68.8 ± 9.5 years with 55% being male. Aorto-iliac disease accounted for 13% of the total lesions, while femoro-popliteal lesions comprised 55%. The FloChec™ digital ABI had a sensitivity of 84% and a positive predictive value of 84%. The area under the receiver operating characteristic curve was 0.74 (p = 0.007). On multivariate analysis, FloChec™ digital ABI was still an independent predictor of PAD, Odds ratio 6.8 (2.3-20.6, p = 0.001). CONCLUSION A portable, point-of-care digital ABI system can be used as a valuable, simple, cost-effective and reliable screening tool with high sensitivity and accuracy. To date, ours is the first study validating FloChec™ digital ABI with the gold standard angiographic data.

Femoral pseudoaneurysm closure by direct access: To stick or not to stick?

Femoral artery pseudoaneurysms are usually the result of femoral artery cannulation for percutaneous cardiac or endovascular procedures. It causes compression of surrounding structures, may cause distal embolization, arteriovenous fistula formation, or might rupture. Most close spontaneously by thrombosis, and the remainder need intervention, either percutaneous or surgical repair. We describe a unique case of femoral pseudoaneurysm that was repaired percutaneously by excluding it via stenting and simultaneous closure of residual aneurysm by direct access and coil embolization.

Utility of adjunctive modalities in Coronary chronic total occlusion intervention

Coronary chronic total occlusion (CTO) intervention remains one of the most challenging domains in interventional cardiology. Due to the technical challenges involved and potential procedural complications, CTO percutaneous coronary intervention (PCI) attempt and success rates remain less than standard PCI. However, the use of several adjunctive tools such as intravascular ultrasound, optical coherence tomography, rotational atherectomy, orbital atherectomy, excimer laser coronary atherectomy and percutaneous left ventricular assist device may contribute to improved CTO PCI success rates or provide better hemodynamic assessment of CTO lesion (i.e., using fractional flow reserve). In this review we present the current literature describing the utility and efficacy of these adjunctive modalities in CTO intervention.

Crossing Techniques and Devices in Femoropopliteal Chronic Total Occlusion Intervention

Chronic total occlusions (CTO) are common in patients with symptomatic peripheral arterial disease. Endovascular CTO intervention remains a challenging endeavor for interventionalists, but is being increasingly considered as a plausible alternative to surgical revascularization, even for complex CTO lesions. We review common endovascular techniques using antegrade, retrograde and transcollateral approaches in femoropopliteal CTO intervention. In addition, we review the current literature on the utility, efficacy, and safety of novel crossing and re-entry devices in femoropopliteal CTO interventions.

Giant Left Atrium Causing Dysphagia.

A 65-year-old woman with atrial fibrillation (AF) and a mechanical mitral valve (MV) for rheumatic mitral stenosis presented with weight loss, lack of appetite, difficulty swallowing, and left pelvic pain. Physical examination was notable for cachexia, elevated jugular venous pressure, and decreased right-lower-lobe breath sounds. The patients international normalized ratio was 3.3. A 12-lead electrocardiogram revealed rate-controlled AF. A chest radiograph showed massive cardiomegaly, and a probable giant left atrium (LA) touching the right lateral wall of the chest (Fig. 1). A computed tomogram (CT), obtained to exclude gastrointestinal malignancy, showed a left ovarian cyst with no torsion or rupture. The CT incidentally revealed marked splaying of the carina (Fig. 2A), compression and partial atelectasis of the lungs right lower lobe (Fig. 2B), and partial compression of the esophagus against the mid-thoracic spine (Figs. 2B and C), all caused by severe LA enlargement (dimensions, 15 × 19 × 17 cm). A 2-dimensional echocardiogram showed a massively dilated LA, a normally functioning mechanical MV, and a normal-size left ventricle (ejection fraction, 0.35) (Fig. 3).