Transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion.

BACKGROUND: Improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (SFA) chronic total occlusions (CTO). A change in access site to radial (TRA) or tibiopedal (TPA) artery for the treatment of these SFA CTO has been reported. The feasibility, efficacy and safety of these two access sites for treatment of SFA CTO have not been reported. METHODS: We performed an as treated analysis of 184 SFA CTO interventions in 161 patients from 01/2014 to 09/2016 using either primary TRA or TPA (operator discretion) at two institutions. Primary end point was 30 day major adverse event (MAE) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure. RESULTS: Primary TRA was used in 46 patients with 47 CTO lesions .Primary TPA was used in 115 patients with 137 CTO lesions. Primary crossing success rate was higher with TRA compared to TPA (74% vs 54%, P = 0.01). Dual TRA-TPA was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively. The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively. The 30 day MAE was 5% in TRA arm, 0% in TPA arm and 2% in dual TRA-TPA arm, P = 0.08. All access sites were patent, confirmed by ultrasound. CONCLUSION: The treatment of SFA CTO is feasible and safe using both TRA or TPA approach providing high success rates and no access site complications.

Diagnosis of Peripheral Artery Disease Using Backflow Abnormalities in Proximal Recordings of Accelerometer Contact Microphone (ACM).

OBJECTIVE: The development of an accurate, non-invasive method for the diagnosis of peripheral artery disease (PAD) from accelerometer contact microphone (ACM) recordings of the cardiac system. METHODS: Mel frequency cepstral coefficients (MFCCs) are initially extracted from ACM recordings. The extracted MFCCs are then used to fine-tune a pre-trained ResNet50 network whose middle layers provide streams of high-level-of-abstraction coefficients (HLACs) which could provide information on blood pressure backflow caused by arterial obstructions in PAD patients. A vision transformer is finally integrated with the feature extraction layer to detect PAD, and stratify the severity level. This architecture is coined multi-stream-powered vision transformer (MSPViT). The performance of MSPViT is evaluated on 74 PAD and 21 healthy subjects. RESULTS: Sensitivity, specificity, F1 score, and area under the curve (AUC) of 99.45%, 98.21%, 99.37%, and 0.99, respectively, are reported for the binary classification which ensures accurate detection of PAD. Furthermore, MSPViT suggests average sensitivity, specificity, F1 score, and AUC of 96.66%, 97.34%, 96.29%, and 0.96, respectively, for the classification of subjects into healthy, mild-PAD, and severe-PAD classes. The silhouette score is calculated to assess the separability of clusters formed for classes in the penultimate layer of MSPViT. An average silhouette score of 0.66 and 0.81 demonstrate excellent cluster separability in PAD detection and severity classification, respectively. CONCLUSION: The achieved performance suggests that the proximal ACM-driven framework can replace state-of-the-art techniques for PAD detection. SIGNIFICANCE: This study presents a fundamental step towards prompt and accurate diagnosis of PAD and stratification of its severity level.

Diagnosis of Coexisting Valvular Heart Diseases Using Image-to-Sequence Translation of Contact Microphone Recordings.

OBJECTIVE: Development of a contact microphone-driven screening framework for the diagnosis of coexisting valvular heart diseases (VHDs). METHODS: A sensitive accelerometer contact microphone (ACM) is employed to capture heart-induced acoustic components on the chest wall. Inspired by the human auditory system, ACM recordings are initially transformed into Mel-frequency cepstral coefficients (MFCCs) and their first and second derivatives, resulting in 3-channel images. An image-to-sequence translation network based on the convolution-meets-transformer (CMT) architecture is then applied to each image to find local and global dependencies in images, and predict a 5-digit binary sequence, where each digit corresponds to the presence of a specific type of VHD. The performance of the proposed framework is evaluated on 58 VHD patients and 52 healthy individuals using a 10-fold leave-subject-out cross-validation (10-LSOCV) approach. RESULTS: Statistical analyses suggest an average sensitivity, specificity, accuracy, positive predictive value, and F1 score of 93.28%, 98.07%, 96.87%, 92.97%, and 92.4% respectively, for the detection of coexisting VHDs. Furthermore, areas under the curve (AUC) of 0.99 and 0.98 are respectively reported for the validation and test sets. CONCLUSION: The high performances achieved prove that local and global features of ACM recordings effectively characterize heart murmurs associated with valvular abnormalities. SIGNIFICANCE: Limited access of primary care physicians to echocardiography machines has resulted in a low sensitivity of 44% when using a stethoscope for the identification of heart murmurs. The proposed framework provides accurate decision-making on the presence of VHDs, thus reducing the number of undetected VHD patients in primary care settings.

Enhancing the diagnostic performance of troponins in the acute care setting.

BACKGROUND: Current guidelines define cardiac troponin I (TnI) as an indicator of necrosis when the concentration exceeds the 99% upper limit of a healthy reference population, a reference value near the assay's lowest detectable level. We assessed the utility of a modified TnI cutoff point derived from a population at low risk for coronary artery disease (CAD) and evaluated its utility in determining acute myocardial infarction (MI). METHODS: A modified TnI cutoff point was derived by the receiver operating characteristic (ROC) curve from 737 consecutive patients who underwent serial TnI measurements for exclusion of MI. Creatinine kinase isoenzyme MB (CK-MB) evolutionary change was used to define MI. The new derived cutoff point was validated using another subset of 320 patients who were evaluated for MI. RESULTS: ROC-derived TnI cutoff point (A) was 0.65 µg/L, and its performance was compared to the recommended cutoff point ([B] 0.15 µg/L). Cutoff point A had greater specificity (94.5% vs. 86.9%, p < 0.001) but slightly lower sensitivity (96.5% vs. 100%, p < 0.01). Cutoff point A provided significantly greater positive predictive value (PPV) for MI (74.1% vs. 55.5%, p < 0.0001) and fewer false-positive errors, while preserving comparable negative predictive value (NPV) (98.9% vs. 100%). CONCLUSION: A higher cutoff point derived from a reference population of patients at low risk for CAD may improve the TnI performance assay. The PPV for diagnosis of MI was significantly higher and false-positive values were fewer without affecting the NPV. The more reliable diagnosis of MI may have resulted, which, in turn, may have significant clinical and economic implications.

Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis.

BACKGROUND: Direct stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA). METHODS: ORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA. RESULTS: Procedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively). CONCLUSIONS: Orbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.

Effects of celecoxib and rofecoxib on blood pressure and edema in patients > or =65 years of age with systemic hypertension and osteoarthritis.

Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), including the cyclooxygenase-2 (COX-2) specific inhibitors, with antihypertensive medication is common practice for many patients with arthritis. This study evaluated the effects of celecoxib 200 mg/day and rofecoxib 25 mg/day on blood pressure (BP) and edema in a 6-week, randomized, parallel-group, double-blind study in patients > or =65 years of age with osteoarthritis who were treated with fixed antihypertensive regimens. One thousand ninety-two patients received study medication (celecoxib, n = 549; rofecoxib, n = 543). Significantly more patients in the rofecoxib group compared with the celecoxib group developed increased systolic BP (change >20 mm Hg plus absolute value > or =140 mm Hg) at any time point (14.9% vs 6.9%, p <0.01). Rofecoxib caused the greatest increase in systolic BP in patients receiving angiotensin-converting enzyme inhibitors or beta blockers, whereas those on calcium channel antagonists or diuretic monotherapy receiving either celecoxib or rofecoxib showed no significant increases in BP. Clinically significant new-onset or worsening edema associated with weight gain developed in a greater percentage of patients in the rofecoxib group (7.7%) compared with the celecoxib group (4.7%) (p <0.05). Thus, in patients with controlled hypertension on a fixed antihypertensive regimen, careful monitoring of BP is warranted after the initiation of celecoxib or rofecoxib therapy.

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).

Stent parameters predict major adverse clinical events and the response to platelet glycoprotein IIb/IIIa blockade: findings of the ESPRIT trial.

BACKGROUND: Only limited data describe relationships between stent parameters (length and diameter), adverse events after percutaneous coronary intervention, and effects of platelet glycoprotein IIb/IIIa blockade by stent parameters. METHODS AND RESULTS: In this post hoc analysis of the 1983 patients receiving a stent in the Enhanced Suppression of the Platelet Glycoprotein IIb/IIIa Receptor with Integrilin Therapy randomized percutaneous coronary intervention trial of eptifibatide versus placebo, rates of the major adverse cardiac event (MACE) end point (death, myocardial infarction, urgent target-vessel revascularization, or thrombotic bailout) at 48 hours and 1 year were correlated with stent parameters and then analyzed by randomization to eptifibatide versus placebo. In the placebo group, MACE increased with number of stents implanted, total stent length (by quartiles of <15, 15 to <18, 18 to <30, and >or=30 mm), and total stented vessel area (by quartiles of area <141, 141 to <188, 188 to <292, and >or=292 mm(2)). By stent parameters, MACE at 48 hours was reduced in the eptifibatide group at stent lengths of 18 to <30 mm (odds ratio [OR], 0.55; 95% CI, 0.32 to 0.94; P=0.030) and >or=30 mm (OR, 0.43; 95% CI, 0.25 to 0.75; P=0.003), stent diameters of >2.5 to <3.5 mm (OR, 0.56; 95% CI, 0.39 to 0.82; P=0.002), and with 2 stents implanted (OR, 0.39; 95% CI, 0.22 to 0.69; P=0.001). In the placebo group, near-linear relationships were observed between both increasing stent length and increasing stented vessel area and MACE at 48 hours and 1 year (all, P<0.001); these gradients were flattened in the eptifibatide group (P=0.005 for stent length). CONCLUSIONS: Stent parameters predict MACE after percutaneous coronary intervention. Glycoprotein IIb/IIIa blockade mitigates much of the hazard of increasing procedural complexity.

Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

OBJECTIVES: In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. BACKGROUND: Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. METHODS: High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. RESULTS: There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. CONCLUSIONS: Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

Acute upper extremity arterial occlusion: a novel role for the use of rheolytic thrombectomy and intravascular ultrasound.

Acute peripheral arterial occlusion may be caused by thrombosis or embolism. The objectives of therapy are to preserve limb and life by restoration of blood flow. Thrombolytic therapy has been the mainstay, but is limited by a high risk of bleeding. Surgical treatment, often required, is invasive with higher rates of morbidity and mortality. Rheolytic thrombectomy offers a percutaneous means of thrombus removal. A 62-year-old man with chronic atrial fibrillation, idiopathic dilated cardiomyopathy, and hypothyroidism presented with sudden onset of left arm pain. His medications included warfarin, digoxin, amiodarone, and synthroid. Examination revealed a harsh 3/6 systolic nonradiating murmur. The left arm was cold and weak with absent pulses. Laboratory data showed a prothrombin time (PT) of 12 sec and an international normalized ratio of 1.4. After heparinization, angiography was performed, showing a total occlusion of the brachial artery. A rheolytic thrombectomy catheter (RTC) was introduced to remove the thrombus. The RTC run time was 90 sec. Flow was restored to the vessel, but sluggish with angiographic evidence of stenosis. Intravascular ultrasound was performed, revealing a high-grade fibromuscular stenosis. Balloon angioplasty was performed, followed by intracatheter injection of alteplase restoring normal flow. Sudden arterial occlusion is a medical emergency, which can result in limb loss. RTC's have demonstrated a reduced need for thrombolytic agents and surgical intervention, thereby decreasing complications, procedural time, and resource utilization. While most reports have focused on infra-aortic thromboses, this case highlights its utility in the arm.