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1.
Article En | MEDLINE | ID: mdl-38274303

The profunda femoral artery is an uncommon location for a pseudoaneurysm and is technically challenging to resolve with traditional techniques, such as ultrasound-guided compression or thrombin injection, owing to its deep anatomical location. Balloon-assisted thrombin injection (BATI) is a technique that has been shown to be effective using contralateral access for technically difficult pseudoaneurysms in high-risk surgical patients. We report a case of BATI using radial access in a patient with a profunda femoral artery pseudoaneurysm.


Aneurysm, False , Thrombin , Humans , Thrombin/adverse effects , Aneurysm, False/diagnostic imaging , Aneurysm, False/drug therapy , Ultrasonography, Interventional , Femoral Artery/diagnostic imaging , Pressure
2.
Circ Cardiovasc Interv ; 16(10): e013406, 2023 10.
Article En | MEDLINE | ID: mdl-37847768

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.


Pulmonary Embolism , Thrombectomy , Humans , Multicenter Studies as Topic , Observational Studies as Topic , Prospective Studies , Pulmonary Embolism/therapy , Pulmonary Embolism/etiology , Thrombectomy/adverse effects , Thrombectomy/methods , Thrombolytic Therapy/adverse effects , Treatment Outcome
3.
Cardiovasc Intervent Radiol ; 46(11): 1571-1580, 2023 Nov.
Article En | MEDLINE | ID: mdl-37580422

PURPOSE: Mechanical thrombectomy for the treatment of deep vein thrombosis (DVT) is being increasingly utilized to reduce symptoms and prevent postthrombotic syndrome (PTS), but more data on clinical outcomes are needed. Mechanical thrombectomy was studied in the ClotTriever Outcomes (CLOUT) registry with 6-month full analysis outcomes reported herein. MATERIALS AND METHODS: The CLOUT registry is a prospective, all-comer study that enrolled 500 lower extremity DVT patients across 43 US sites treated with mechanical thrombectomy using the ClotTriever System. Core-lab assessed Marder scores and physician-assessed venous patency by duplex ultrasound, PTS assessment using Villalta score, venous symptom severity, pain, and quality of life scores through 6 months were analyzed. Adverse events were identified and independently adjudicated. RESULTS: All-cause mortality at 30 days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30 days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30 days and 8.0% at 6 months. Between baseline and 6 months, venous flow increased from 27.2% to 92.5% of limbs (P < 0.0001), and venous compressibility improved from 28.0% to 91.8% (P < 0.0001), while median Villalta scores improved from 9.0 at baseline to 1.0 at 6 months (P < 0.0001). Significant improvements in venous symptom severity, pain, and quality of life were also demonstrated. Outcomes from iliofemoral and isolated femoral-popliteal segments showed similar improvements. CONCLUSION: Outcomes from the CLOUT study, a large prospective registry for DVT, indicate that mechanical thrombectomy is safe and demonstrates significant improvement in symptoms and health status through 6 months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.


Postthrombotic Syndrome , Venous Thrombosis , Humans , Thrombectomy/adverse effects , Femoral Vein , Follow-Up Studies , Quality of Life , Iliac Vein , Treatment Outcome , Vascular Patency , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy , Thrombolytic Therapy/adverse effects
4.
J Vasc Interv Radiol ; 34(5): 879-887.e4, 2023 05.
Article En | MEDLINE | ID: mdl-37105663

PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.


Thrombectomy , Venous Thrombosis , Humans , Thrombectomy/adverse effects , Treatment Outcome , Prospective Studies , Quality of Life , Thrombolytic Therapy , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy , Venous Thrombosis/etiology , Registries , Iliac Vein , Retrospective Studies
5.
Article En | MEDLINE | ID: mdl-36626294

OBJECTIVE: The radiofrequency (RF) needle has been shown to improve transseptal puncture efficiency and safety compared to mechanical needles. This study aimed to investigate the use of VersaCross RF transseptal wire system (Baylis Medical) to improve procedural efficiency of left atrial appendage closure (LAAC) compared to the standard RF needle-based workflow. METHODS: Eighty-one LAAC procedures using WATCHMAN FLX were retrospectively analyzed comparing the standard RF needle-based workflow to a RF wire-based workflow. Study primary endpoint was time to WATCHMAN device release, and secondary endpoints were transseptal puncture time, LAAC success, fluoroscopy use, and procedural complications. RESULTS: Twenty-five cases using standard RF needle-based workflow were compared to 56 cases using the RF wire-based workflow. Baseline patient characteristics were similar between both groups. LAAC was successful in all patients with no differences in intraprocedural complication rates (p = 0.40). Transseptal puncture time was 1.3 min faster using the RF wire-based workflow compared to the standard RF needle-based workflow (6.5 ± 2.3  vs. 7.8 ± 2.3 min, p = 0.02). Overall, time to final WATCHMAN device release was 4.5 min faster with the RF wire-based workflow compared to the RF needle-based workflow (24.6 ± 5.6 vs. 29.1 ± 9.6 min, p = 0.01). Fluoroscopy time was 21% lower using the RF wire-based workflow (7.6 ± 2.8 vs. 9.6 ± 4.4 min; p = 0.05) and fluoroscopy dose was 67% lower (47.1 ± 35.3 vs. 144.9 ± 156.9 mGy, p = 0.04) and more consistent (F-test, p ˂ 0.0001). CONCLUSIONS: The RF wire-based workflow streamlines LAAC procedures, improving LAAC efficiency and safety by reducing fluoroscopy, device exchanges, and delivery sheath manipulation.

6.
EuroIntervention ; 18(14): 1201-1212, 2023 Feb 20.
Article En | MEDLINE | ID: mdl-36349702

BACKGROUND: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. AIMS: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. METHODS: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. RESULTS: Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001).  Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.


Pulmonary Embolism , Thrombectomy , Humans , Thrombectomy/methods , Treatment Outcome , Pulmonary Embolism/therapy , Fibrinolytic Agents/therapeutic use , Registries , Thrombolytic Therapy/methods
7.
J Vasc Surg Venous Lymphat Disord ; 10(6): 1251-1259, 2022 11.
Article En | MEDLINE | ID: mdl-35714903

OBJECTIVE: The all-comer ClotTriever Outcomes registry assessed indicators of thrombus chronicity in patients with acute, subacute, and chronic lower extremity deep vein thrombosis (DVT). The effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) by chronicity subgroup was also assessed and reported here in this subanalysis. METHODS: All-comer patients with lower extremity DVT were enrolled, with no limitation based on the patients' symptom duration. Chronicity was assessed three times and compared: before the procedure based on symptom duration, during the procedure based on available pre-thrombectomy imaging, and visual inspection of the extracted thrombus morphology after thrombectomy. Patients were grouped into acute, subacute, and chronic subgroups according to their post-thrombectomy thrombus chronicity based on thrombus morphology. Analyses on baseline and procedural characteristics along with thrombus removal were performed across subgroups. The effectiveness of thrombus removal was determined by Marder scores adjudicated by an independent core laboratory, with a prespecified primary effectiveness end point of complete or near-complete (≥75%) thrombus removal. RESULTS: Of the 260 treated limbs from 250 patients, using symptom duration alone, 70.7% were considered acute, 20.9% subacute, and 8.4% chronic. Upon visual inspection, the extracted thrombus chronicity was approximately one-third in each subgroup: 32.7% had acute thrombus, 35.4% subacute thrombus, and 31.9% chronic thrombus. Chronicity assessed using symptom duration alone mismatched the post-thrombectomy chronicity in 55.1% of limbs (P < .0001) with 49.0% being more chronic than suggested by the patients' duration of symptoms. Chronicity assessed using pre-thrombectomy imaging mismatched the post-thrombectomy chronicity in 17.5% of limbs (P < .0001). No patients received thrombolytics and 99.6% were treated in a single session. Complete or near-complete thrombus removal was achieved in a high percentage of limbs regardless of thrombus chronicity: 90.8%, 81.9%, and 83.8% in limbs with acute, subacute, and chronic thrombus, respectively. CONCLUSIONS: This subanalysis from the all-comer ClotTriever Outcomes registry demonstrates that extracted thrombus in DVT may be more chronic than suggested by the patients' duration of symptoms. The addition of imaging is helpful to determine the ability of thrombus to respond to therapy. Irrespective of thrombus chronicity, the ClotTriever system can be effective at removing acute, subacute, and chronic thrombus in a single-session procedure without the need for thrombolytics.


Thrombolytic Therapy , Venous Thrombosis , Fibrinolytic Agents/therapeutic use , Humans , Iliac Vein , Registries , Retrospective Studies , Thrombectomy/adverse effects , Thrombectomy/methods , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy
8.
J Vasc Surg Venous Lymphat Disord ; 10(4): 832-840.e2, 2022 07.
Article En | MEDLINE | ID: mdl-35218955

OBJECTIVES: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. METHODS: All-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. RESULTS: The median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. CONCLUSIONS: The 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.


Postphlebitic Syndrome , Postthrombotic Syndrome , Venous Thrombosis , Fibrinolytic Agents , Humans , Iliac Vein , Middle Aged , Pain/etiology , Postphlebitic Syndrome/etiology , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Prospective Studies , Quality of Life , Registries , Retrospective Studies , Thrombectomy/adverse effects , Thrombectomy/methods , Thrombolytic Therapy , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/surgery
9.
Catheter Cardiovasc Interv ; 99(4): 1345-1355, 2022 03.
Article En | MEDLINE | ID: mdl-35114059

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.


Pulmonary Embolism , Thrombectomy , Hemorrhage/etiology , Humans , Prospective Studies , Pulmonary Embolism/therapy , Registries , Thrombectomy/adverse effects , Thrombectomy/methods , Treatment Outcome
10.
Vasc Endovascular Surg ; 55(8): 903-906, 2021 Nov.
Article En | MEDLINE | ID: mdl-34355600

Venous thromboembolism from a "thrombotic storm"-like syndrome is a major cause of morbidity and mortality in patients with active or "recovered" COVID-19. Patients should be risk-stratified, optimally by a pulmonary embolism (PE) response team (PERT), and considered for escalation of care if found with intermediate or high-risk PE. We present a series of patients with COVID-19-associated PE and thrombotic storm with D-dimer >10 000 ng/mL who underwent successful mechanical thrombectomy for intermediate to high-risk PE. All patients had immediate improvement in hemodynamics and large amounts of thrombi were retrieved.


Blood Coagulation , COVID-19/complications , Pulmonary Embolism/therapy , Thrombectomy , Aged , Biomarkers/blood , COVID-19/diagnosis , COVID-19/virology , Female , Fibrin Fibrinogen Degradation Products/metabolism , Humans , Male , Middle Aged , Pulmonary Embolism/blood , Pulmonary Embolism/diagnosis , Pulmonary Embolism/virology , Treatment Outcome , Young Adult
12.
Circ Cardiovasc Interv ; 12(10): e007939, 2019 10.
Article En | MEDLINE | ID: mdl-31607155

BACKGROUND: Invasive fractional flow reserve (FFRINV) is the standard technique for assessing myocardial ischemia. Pressure distortions and measurement location may influence FFRINV interpretation. We report a technique for performing invasive fractional flow reserve (FFRINV) by minimizing pressure distortions and identifying the proper location to measure FFRINV. METHODS: FFRINV recordings were obtained prospectively during manual hyperemic pullback in 100 normal and diseased coronary arteries with single stenosis, using 4 measurements from the terminal vessel, distal-to-the-lesion, proximal vessel, and guiding catheter. FFRINV profiles were developed by plotting FFRINV values (y-axis) and site of measurement (x-axis), stratified by stenosis severity. FFRINV≤0.8 was considered positive for lesion-specific ischemia. RESULTS: Erroneous FFRINV values were observed in 10% of vessels because of aortic pressure distortion and in 21% because of distal pressure drift; these were corrected by disengagement of the guiding catheter and re-equalization of distal pressure/aortic pressure, respectively. There were significant declines in FFRINV from the proximal to the terminal vessel in normal and stenotic coronary arteries (P<0.001). The rate of positive FFRINV was 41% when measured from the terminal vessel and 20% when measured distal-to-the-lesion (P<0.001); 41.5% of positive terminal measurements were reclassified to negative when measured distal-to-the-lesion. Measuring FFRINV 20 to 30 mm distal-to-the-lesion (rather than from the terminal vessel) can reduce errors in measurement and optimize the assessment of lesion-specific ischemia. CONCLUSIONS: Meticulous technique (disengagement of the guiding catheter, FFRINV pullback) is required to avoid erroneous FFRINV, which occur in 31% of vessels. Even with optimal technique, FFRINV values are influenced by stenosis severity and the site of pressure measurement. FFRINV values from the terminal vessel may overestimate lesion-specific ischemia, leading to unnecessary revascularization.


Cardiac Catheterization/methods , Coronary Artery Disease/diagnosis , Coronary Stenosis/diagnosis , Coronary Vessels/physiopathology , Fractional Flow Reserve, Myocardial , Aged , Case-Control Studies , Clinical Decision-Making , Coronary Artery Disease/physiopathology , Coronary Artery Disease/therapy , Coronary Stenosis/physiopathology , Coronary Stenosis/therapy , Female , Humans , Hyperemia/physiopathology , Male , Middle Aged , Predictive Value of Tests , Prognosis , Prospective Studies , Reproducibility of Results , Severity of Illness Index , Vasodilator Agents/administration & dosage
13.
Int J Cardiol ; 271: 169-173, 2018 Nov 15.
Article En | MEDLINE | ID: mdl-30093137

BACKGROUND: Sacubitril/valsartan is the newest neurohormonal agent approved for therapy in patients with heart failure with reduced ejection fraction (HFrEF). Little is known about its acute and incremental hemodynamic effects. We aimed to evaluate the change in hemodynamic profiles measured using an implanted monitoring device in HFrEF patients initiated on sacubitril/valsartan therapy. METHODS: We prospectively enrolled 13 subjects with HFrEF and pre-implanted CardioMEMS™ device on maximally tolerated guideline-directed medical therapy and no contraindications to sacubitril/valsartan therapy. Transmitted pulmonary artery diastolic pressures (PAdP) from CardioMEMS™ were averaged and compared for one week before and after initiation of sacubitril/valsartan, as well as after change in medication strength and finally at three months. RESULTS: Sacubitril/valsartan dose increase was tolerated in 7/13 subjects with drug discontinuation in one subject after a week due to renal dysfunction. There was a significant reduction in mean PAdP after sacubitril/valsartan initiation compared to standard therapy (20.8 vs 18.3 mm Hg, p = 0.020). No further PAdP reduction was noted after sacubitril/valsartan dose increase (19.7 vs 20 mm Hg, p = 0.673) and at 3-month follow-up compared to baseline (20.8 vs 19.2 mm Hg, p = 0.352). CONCLUSIONS: Sacubitril/valsartan causes an acute reduction mean pulmonary artery pressures after initiation. However, no incremental reduction in PAdP was noted after dose increase and short-term follow-up. The current study demonstrates the utility of CardioMems™ device to study the drug's impact on hemodynamic profile in both short- and long-term follow-up.


Aminobutyrates/administration & dosage , Angiotensin Receptor Antagonists/administration & dosage , Hemodynamics/drug effects , Stroke Volume/drug effects , Tetrazoles/administration & dosage , Ventricular Dysfunction, Left/drug therapy , Aged , Aged, 80 and over , Biphenyl Compounds , Drug Combinations , Feasibility Studies , Female , Follow-Up Studies , Hemodynamics/physiology , Humans , Male , Middle Aged , Pilot Projects , Prospective Studies , Stroke Volume/physiology , Treatment Outcome , Valsartan , Ventricular Dysfunction, Left/diagnosis , Ventricular Dysfunction, Left/physiopathology
14.
JACC Cardiovasc Interv ; 7(7): 810-6, 2014 Jul.
Article En | MEDLINE | ID: mdl-24954573

OBJECTIVES: This study sought to assess radiation exposure and operator discomfort when using left radial approach (LRA) versus right radial approach (RRA) for coronary diagnostic and percutaneous interventions. BACKGROUND: The transradial approach is increasingly being adopted as the preferred vascular access for coronary interventions. Currently, most are performed using an RRA. This is in part due to the perceived increased operator physical discomforts as well increased radiation exposure with an LRA. METHODS: One hundred patients were randomized to an LRA or RRA. Each operator (n = 5) had an independent randomization process, and patients were stratified according to obesity status. Operator radiation was measured using separate sets of radiation dosimeter badges placed externally on the head and thyroid and internally on the sternum. Operator physical discomfort was surveyed at 2 time points: during vascular access and at the end of the procedure. Moderate to severe physical discomfort was defined as a score of >4. RESULTS: There were no significant differences in baseline and procedural variables between groups. There was a significant increase in external radiation exposure using the RRA versus LRA (head: median: 6.12 [interquartile range (IQR): 2.6 to 16.6] mRems vs. median: 12.0 [IQR: 6.4 to 22.0] mRems, p = 0.02; thyroid: median: 10.10 [IQR: 4.3 to 25] mRems vs. median: 18.70 [IQR: 11.0 to 38] mRems, p = 0.001). More discomfort was reported with the LRA during access (LRA: 22% vs. RRA: 4%; p = 0.017), but not during the procedure (LRA: 10.0% vs. RRA: 4.0%, p = 0.43). This difference was almost entirely noted in obese patients (LRA: 30.0% vs. RRA: 3.7%, p = 0.005). CONCLUSIONS: LRA is as effective as RRA, showing a safer profile with decreased radiation exposure to the operator, at the expense of more operator discomfort only during vascular access and limited to obese patients.


Cardiac Catheterization/methods , Coronary Angiography , Occupational Exposure/prevention & control , Percutaneous Coronary Intervention/methods , Radial Artery/diagnostic imaging , Radiation Dosage , Radiography, Interventional , Aged , Cardiac Catheterization/adverse effects , Coronary Angiography/adverse effects , Female , Film Dosimetry , Florida , Humans , Male , Middle Aged , Obesity/complications , Occupational Exposure/adverse effects , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Radiography, Interventional/adverse effects , Risk Factors
15.
Am J Emerg Med ; 31(7): 1098-102, 2013 Jul.
Article En | MEDLINE | ID: mdl-23706572

OBJECTIVE: ST-elevation myocardial infarction (STEMI) identification by emergency medicine services (EMS) leading to pre-hospital catheterization laboratory (CL) activation shortens ischemic time and improves outcomes. We examined the incremental value of addition of a screening clinical tool (CT), containing clinical information and a Zoll electrocardiogram (ECG)-resident STEMI identification program (ZI) to ZI alone. METHODS: All EMS-performed and ZI-analyzed ECGs transmitted to a percutaneous coronary intervention hospital from October 2009 to January 2011 were reviewed for diagnostic accuracy. ZI performance was also compared to ECG interpretations by 2 experienced readers The CT was then retrospectively applied to determine the incremental benefit above the ZI alone. RESULTS: ST-elevation myocardial infarction was confirmed in 23 (7.5%) of 305 patients. ZI was positive in 37 (12.1%): sensitivity: 95.6% and specificity: 94.6%, positive predictive value (PPV), 59.5%, negative predictive value (NPV), 99.6%, and accuracy of 93.8%. Moderate agreement was observed among the readers and ZI. CT criteria for CL activation were met in 24 (7.8%): 20 (83.3%) were confirmed STEMIs: sensitivity: 86.9%, specificity: 98.5%, a PPV: 83.3%, and NPV: 98.6%, accuracy of 97.7%. CT + ZI increased PPV (P<0.05) and specificity (P<0.003) by reducing false positive STEMI identifications from 15 (4.9%) to 4 (1.3%). CONCLUSIONS: In an urban cohort of all EMS transmitted ECGs, ZI has high sensitivity and specificity for STEMI identification. Whereas the PPV was low, reflecting both low STEMI prevalence and presence of STEMI-mimics, the NPV was very high. These findings suggest that a simplified CT combined with computer STEMI interpretation can identify patients for pre-hospital CL activation. Confirmation of these results could improve the design of STEMI care systems.


Algorithms , Decision Making, Computer-Assisted , Decision Support Techniques , Electrocardiography , Emergency Medical Services/methods , Myocardial Infarction/diagnosis , Adolescent , Adult , Aged , Aged, 80 and over , False Positive Reactions , Female , Humans , Male , Middle Aged , Retrospective Studies , Sensitivity and Specificity , Young Adult
16.
Cardiovasc Toxicol ; 12(2): 175-9, 2012 Jun.
Article En | MEDLINE | ID: mdl-22231478

The intentional consumption and use of stimulants, such as caffeine, are known to have numerous interactions with the human cardiovascular system. Ex vivo studies have shown caffeine-induced vasoconstriction of coronary arteries (Forman et al. in Ann Emerg Med 29:178-180, 1997). We report on a case of a 17-year-old male who presented with angina and an abnormal electrocardiogram (ECG) concerning for ST elevation myocardial infarct. He was found to have diffuse ECG changes and markedly elevated cardiac enzymes. A transthoracic echocardiogram revealed a reduced left ventricular (LV) systolic function as well as segmental wall motion abnormalities consistent with an ischemic insult. The patient admitted to consuming near lethal doses of caffeine immediately preceding his angina. He was diagnosed with coronary vasospasms as a result of stimulant use. During hospitalization, ECG changes resolved, cardiac enzymes started trending downward, and LV systolic function returned to normal, all consistent with stunned myocardium that fully recovered. This case strongly suggests that overuse of stimulants, such as caffeine, should be considered in patients presenting with coronary vasospasms, particularly in teenagers and young adults.


Caffeine/adverse effects , Coronary Vasospasm/chemically induced , Coronary Vasospasm/diagnosis , Adolescent , Caffeine/administration & dosage , Coronary Vasospasm/physiopathology , Electrocardiography/drug effects , Humans , Male
17.
Cardiovasc Toxicol ; 12(1): 90-2, 2012 Mar.
Article En | MEDLINE | ID: mdl-21904803

The intentional inhalation of fumes from gasoline or solvents for recreational purposes is commonly known as Huffing, Sniffing or Dusting (Anderson and Loomis in Am Fam Physician 68(5):869-874, 2003). Inhalant abuse is known to be "Cardio-toxic", causing sudden death and chronic myocardial damage (Meadows and Verghese in South Med J 89(5):455-462, 1996; Anderson and Loomis in Am Fam Physician 68(5):869-874, 2003). We report a 20-year-old white man who presented with altered mental status following ingestion of multiple alprazolam and oxycodone tablets. He was found to have diffused ST-T changes on his EKG. Cardiac enzymes were found to be elevated-CK: 599 U/L, CK-MB: 16.8 ng/mL and Troponin: 0.78 ng/mL. A transthoracic echocardiogram (TTE) revealed global left ventricular (LV) dysfunction with an ejection fraction (EF) of 10-15%. During hospitalization, the cardiac enzymes started trending downward and this was followed by spontaneous resolution of the LV dysfunction. The patient also admitted to inhaling "Dust-Off" spray 2-3 days prior to admission. Inhalant abuse can cause cardiomyopathy and should be considered a probable cause in patients presenting with cardiac dysfunction of unknown etiology, particularly in teenagers and young adults.


Aerosol Propellants/poisoning , Cardiomyopathies/chemically induced , Cardiomyopathies/diagnosis , Cardiomyopathies/physiopathology , Electrocardiography , Humans , Male , Young Adult
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