Anvar Babaev

Influence of age on atrial activation as measured by the P-wave signal-averaged electrocardiogram

We used the P-wave signal-averaged electrocardiogram (SAECG) prospectively in 93 healthy volunteers of different ages and observed: (1) a positive correlation between P-wave duration on the SAECG and age (r = 0.39, p < 0.0001); and (2) the proportion of subjects with prolonged P-wave duration was increased with older age. These findings confirm the hypothesis that age-related atrial conduction delay in healthy subjects is present, and detectable by the P-wave SAECG.

Sex and Race Are Associated With the Absence of Epicardial Coronary Artery Obstructive Disease at Angiography in Patients With Acute Coronary Syndromes

A substantial minority of patients with acute coronary syndromes (ACS) do not have a diameter stenosis of any major epicardial coronary artery on angiography (“no obstruction at angiography”) of ≥ 50%. We examined the frequency of this finding and its relationship to race and sex.

In-stent restenosis in the superficial femoral artery.

As the number of endovascular peripheral arterial interventions is increasing nationwide, so is the rate of observed in-stent restenosis, specifically in the superficial femoral artery. A paucity of literature is available regarding the pathophysiology, risk factors, and therapies associated with in-stent restenosis of the superficial femoral artery. This article summarizes the accumulated knowledge on these topics and sheds some light on the prospects for future therapies.

Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study)

Objective: The Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study assessed the performance of the orbital atherectomy system (OAS) to treat femoropopliteal arteries, including determining its effect on plaque removal. Methods: Patients with symptomatic femoropopliteal peripheral arterial disease were treated with the OAS followed by adjunctive balloon angioplasty (BA). Intravascular ultrasound (IVUS) images were collected pre- and post-OAS and post-OAS BA. Patients were followed through 12 months post-procedure. Results: Twenty-nine lesions were treated with OAS-BA in 25 patients. The mean maximum balloon inflation pressure was 5.2 ± 1.2 atm. Virtual histology IVUS (VH-IVUS) analysis revealed at the maximum calcium ablation site that calcium reduction was responsible for 86% of the lumen area increase. The minimum lumen area increased from 4.0 mm2 to 9.1 mm2 (<.0001), and the percentage of area stenosis decreased from 76.9% to 43.0% (<.0001) after OAS-BA. At 12 months, the target lesion revascularization rate was 8.2%, and ankle–brachial index and Rutherford classification improved significantly from baseline through follow-up. Conclusion: The VH-IVUS analysis reveals that OAS modifies the calcified component of the plaque burden. It is hypothesized that calcium modification by OAS changes the lesion compliance, allowing for low pressure adjunctive BA. The clinical outcomes were favorable through 12-month follow-up.

Relationship between neutrophil-lymphocyte ratio and severity of lower extremity peripheral artery disease.

BACKGROUND The aim of this study was to determine the association between neutrophil-lymphocyte ratio (NLR) and severity of lower extremity peripheral artery disease (PAD). METHODS A retrospective chart review identified 928 patients referred for peripheral angiography. NLR was assessed from routine pre-procedural hemograms with automated differentials and available in 733 patients. Outcomes of interest were extent of disease on peripheral angiography and target vessel revascularization. Median follow-up was 10.4months. Odds ratio (OR) [95% confidence intervals] was assessed using a logistic regression model. RESULTS There was a significant association between elevated NLR and presence of severe multi-level PAD versus isolated suprapopliteal or isolated infrapopliteal disease (OR 1.11 [1.03-1.19], p=0.007). This association remained significant even after adjustment for age (OR 1.09 [1.01-1.17], p=0.02); age, sex, race, and body mass index (OR 1.08 [1.00-1.16], p=0.046); and age, sex, race, body mass index, hypertension, diabetes mellitus, coronary artery disease, and creatinine (OR 1.07 [1.00-1.15], p=0.049). After additional adjustment for clinical presentation, there was a trend towards association between NLR and severe multi-level PAD (OR 1.07 [1.00-1.15], p=0.056), likely limited by sample size. In patients who underwent endovascular intervention (n=523), there was no significant difference in rate of target vessel revascularization across tertiles of NLR (1st tertile 14.8%, 2nd tertile 14.1%, 3rd tertile 20.1%; p=0.32). CONCLUSION In a contemporary cohort of patients undergoing peripheral angiography with possible endovascular intervention, elevated NLR was independently associated with severe multi-level PAD. Larger studies evaluating the association between this inexpensive biomarker and clinical outcomes are warranted.

A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial

BACKGROUND The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. METHODS In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of -10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. FINDINGS Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI -0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI -0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. INTERPRETATION The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. FUNDING Boston Scientific.

Minimal Medial Injury After Orbital Atherectomy: An Intravascular Ultrasound Analysis.

Figure 1. Intravascular ultrasound images of 2 femoropopliteal lesions before (upper panels) and after (lower panels) treatment with the orbital atherectomy system (OAS). In A, there is a monolayer appearance (arrowheads in lower panel) of the arterial wall after OAS, indicating disappearing medial and intimal layers in the middle of a medial dissection (small arrows). In B, there is neither a new arterial wall monolayer nor a new medial dissection after OAS. Previous peripheral intervention studies have shown that excessive vessel injury in the tunica media is the primary cause of subsequent restenosis. The TRUTH study assessed the performance of the Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc, St Paul, MN, USA) in the treatment of femoropopliteal lesions. In a post-hoc assessment of OAS-mediated vessel wall injury, intravascular ultrasound (IVUS) images from the TRUTH study were analyzed before and after OAS for signs of a monolayer appearance of the arterial wall, which indicates disappearing medial and intimal layers and external elastic lamina (Figure 1). One of the 23 preintervention images indicated medial injury vs only 2 cases in the post-OAS images, which suggests that OAS can treat calcific plaque while minimizing medial injury. These promising results suggest that additional studies should be completed to further understand the mechanism of action of OAS and its impact on the medial layer of the vessel being treated. This IVUS assessment method may allow the operating physician to detect medial injury intraprocedurally and alter treatment strategy for possible adjunctive antirestenosis therapy with drug-eluting technologies.

A single-center retrospective analysis of patency rates of intraluminal versus subintimal endovascular revascularization of long femoropopliteal occlusions

OBJECTIVE The evaluation of patency rates of intraluminal versus subintimal endovascular revascularization of long femoropopliteal (FP) lesions. BACKGROUND Chronic total occlusions (CTO) of the FP artery in peripheral interventions are crossed either with a support catheter-guidewire based technique or subintimal dissection and re-entry device assisted approach. Both techniques have a high procedural success rate, but their long term patency is not well studied. There is also lack of comparative data addressing the patency of long non-CTO vs. CTO occlusions. METHODS We performed a single center retrospective analysis, studying the patency rates in 215 patients (254 limbs) with TASC C and D FP lesions treated with stents. There were 3 patient groups: without CTO (non-CTO); CTO crossed using support catheter and guide-wire (CTO-SW) and CTO crossed with a re-entry device (CTO-RE). RESULTS There were 155 limbs in CTO-SW group; 50 in CTO-RE group and 49 in non-CTO. Lesion length (mean±SD) was 251.81±7.48mm in CTO-SW group; 280±13.18mm in CTO-RE group and 248.77±13.31 in non-CTO group (p=non-significant). In-stent restenosis (ISR) at a mean follow-up of 19.26±16.14months did not differ between groups occurring in 23 (47%) limbs in non-CTO; 66 (42%) in CTO-SW; and 24 (48%) in CTO-RE. Smoking and stent fracture were predictors of ISR by multivariate analysis. CONCLUSION In patients with long FP lesions, ISR rates were similar between patients with and without CTO. In the CTO group mid-term vessel patency was not affected by the crossing technique utilized.

Treatment of Angio-Seal-Related Femoral Artery Occlusion Using Directional Atherectomy-Primary Results and Midterm Follow-Up.

Objective: We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. Background: Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. Methods: We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 ± 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. Conclusion: The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes.

Management of Mesenteric Ischemia

Acute mesenteric ischemia is associated with a high mortality rate and requires emergent evaluation and surgical management. However, patients with chronic mesenteric ischemia can undergo either surgical or endovascular revascularization. Review of recent medical literature suggests lower rates of mortality and complications after endovascular revascularization, but higher rates of primary patency after surgical revascularization. The decision regarding method of revascularization in patients with chronic mesenteric ischemia should be based on the patients vascular anatomy, comorbidities, and life expectancy.