Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease.

OBJECTIVES: To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. METHODS: This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. RESULTS: 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. CONCLUSIONS: At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease.

OBJECTIVES: To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. BACKGROUND: The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. METHODS: This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12 months. RESULTS: Thirty-one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford-Becker classification. CONCLUSIONS: At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.

Percutaneous transapical access to facilitate complex thoracic endovascular aortic repair.

Thoracic endovascular aortic repair (TEVAR) provides an alternative to open surgery for a variety of aortic diseases. However, complex anatomy and previous operations may preclude traditional approaches to TEVAR. Percutaneous transapical access through the left ventricle is a feasible option to facilitate externalized "rail" wire support for complex TEVAR. We present the case of TEVAR for a residual type B aortic dissection facilitated by percutaneous transapical access.

Percutaneous Transapical Left Ventricular Access to Treat Paravalvular Leak and Ventricular Septal Defect.

BACKGROUND: Surgical transapical (TA) access is an established technique for structural heart (SH) procedures, but is associated with considerable morbidity. Percutaneous TA puncture provides direct access for SH procedures and may overcome the disadvantages of surgical access. This study sought to evaluate the safety of percutaneous TA left ventricular access for SH interventions. METHODS: We performed a retrospective analysis at a university hospital. Thirteen percutaneous TA procedures were performed on consecutive patients between January 2013 and July 2017 to provide LV access for transcatheter therapies. All procedures were performed under general anesthesia with three-dimensional transesophageal echocardiography guidance. RESULTS: All TA punctures were successful. Delivery sheath sizes ranged from 5 Fr to 7 Fr. Eleven of the 13 TA sites were closed with a device. Total median procedural and fluoroscopy times were 106 minutes (interquartile range, 39-117 minutes) and 26.5 minutes (interquartile range, 8.3-43.8 minutes), respectively. The planned procedure was completed successfully in all cases. One access-site complication occurred, involving embolism of a duct occluder into the pleural space and extravasation from the apical puncture site. Hemostasis of the apex site was achieved immediately with placement of three vascular plugs from a femoral approach. Two patients died prior to discharge and neither death was related to a procedural complication. There were no significant pericardial effusions. CONCLUSION: Percutaneous TA access can be achieved safely in most cases to provide access for transcatheter procedures with short procedure times. Device closure of the TA access site is reliable, with a low complication rate and no procedure-related mortality.

Cost-utility of extracorporeal cardiopulmonary resuscitation in patients with cardiac arrest.

BACKGROUND: Extracorporeal cardiopulmonary resuscitation (ECPR) is a resource-intensive tool that provides haemodynamic and respiratory support in patients who have suffered cardiac arrest. In this study, we investigated the cost-utility of ECPR (cost/QALY) in cardiac arrest patients treated at our institution. METHODS: We performed a retrospective review of patients who received ECPR following cardiac arrest between 2012 and 2018. All medical care-associated charges with ECPR and subsequent hospital admission were recorded. The quality-of-life of survivors was assessed with the Health Utilities Index Mark II. The cost-utility of ECPR was calculated with cost and quality-of-life data. RESULTS: ECPR was used in 32 patients (15/32 in-hospital, 47%) with a median age of 55.0 years (IQR 46.3-63.3 years), 59% male and 66% African American. The median duration of ECPR support was 2.1 days (IQR 0.9-3.8 days). Survival to hospital discharge was 16%. The median score of the Health Utilities Index Mark II at discharge for the survivors was 0.44 (IQR 0.32-0.52). The median operating cost for patients undergoing ECMO was $125,683 per patient (IQR $49,751-$206,341 per patient). The calculated cost-utility for ECPR was $56,156/QALY gained. CONCLUSIONS: The calculated cost-utility is within the threshold considered cost-effective in the United States (<$150,000/QALY gained). These results are comparable to the cost-effectiveness of heart transplantation for end-stage heart failure. Larger studies are needed to assess the cost-utility of ECPR and to identify whether other factors, such as patient characteristics, affect the cost-utility benefit.

Mechanical chest compressions improve rate of return of spontaneous circulation and allow for initiation of percutaneous circulatory support during cardiac arrest in the cardiac catheterization laboratory.

BACKGROUND: Performing advanced cardiac life support (ACLS) in the cardiac catheterization laboratory (CCL) is challenging. Mechanical chest compression (MCC) devices deliver compressions in a small space, allowing for simultaneous percutaneous coronary intervention and reduced radiation exposure to rescuers. In refractory cases, MCC devices allow rescuers to initiate percutaneous mechanical circulatory support (MCS) and extracorporeal life support (ECLS) during resuscitation. This study sought to assess the efficacy and safety of MCC when compared to manual compressions in the CCL. METHODS: We performed a retrospective analysis of patients who received ACLS in the CCL at our institution between May 2011 and February 2016. Baseline characteristics, resuscitation details, and outcomes were compared between patients who received manual and mechanical compressions. RESULTS: Forty-three patients (67% male, mean age 58 years) required chest compressions for cardiac arrest while in the CCL (12 manual and 31 MCC). Patients receiving MCC were more likely to achieve return of spontaneous circulation (ROSC) (74% vs. 42%, p=0.05). Of those receiving MCC, twenty-two patients (71%) were treated with MCS. Patients receiving percutaneous ECLS were more likely to achieve ROSC (100% vs. 53%, p=0.003) and suffered no episodes of limb loss or TIMI major bleeding. There were no significant differences in 30-day survival or survival to hospital discharge between groups. CONCLUSIONS: Use of MCC during resuscitation of cardiac arrest in the CCL increases the rate of ROSC. Simultaneous implantation of MCS, including percutaneous ECLS, is feasible and safe during MCC-assisted resuscitation in the CCL.

Sequential Organ Failure Assessment Score at Presentation Predicts Survival in Patients Treated With Percutaneous Veno-Arterial Extracorporeal Membrane Oxygenation.

BACKGROUND AND PURPOSE: This study sought to investigate demographic, clinical, and procedural determinants of outcomes in patients treated with percutaneous veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) initiated in the cardiac catheterization laboratory with a portable system. METHODS: We performed a retrospective review of patients treated with percutaneous VA-ECMO during the study period at our institution. A logistic regression model was applied to investigate the association between sequential organ failure assessment (SOFA) score and survivor status. Fisher's exact test was used to examine the association between survivor status and cannula size (15 Fr vs >15 Fr). RESULTS: Percutaneous VA-ECMO was initiated in 25 patients. At 30 days, 10 patients were alive (40%). Fifteen patients had cardiac arrest (CA) prior to ECMO initiation, of which 5 were alive at 30 days (33%). Survivors had a lower baseline median SOFA score (9 vs 16; P=.02; odds ratio, 0.577). Use of a smaller cannula was associated with survival (P=.01). There was an association between the size of the arterial cannula and increased blood transfusions (P<.01). CONCLUSIONS: Lower presenting SOFA score and smaller cannula size were associated with increased survival in patients with cardiogenic shock (CS) or CA who underwent percutaneous VA-ECMO placed in the cardiac catheterization laboratory using a portable system. Calculation of the SOFA score at presentation may help physicians determine which patients may derive benefit from ECMO. Smaller cannula size, while decreasing the amount of flow, may result in decreased bleeding and increased survival.

A Practical Scoring System to Select Optimally Sized Devices for Percutaneous Patent Foramen Ovale Closure.

BACKGROUND: Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing. METHODS: This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated. RESULTS: Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder "Cribriform" (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) (p = 0.027) and PFO tunnel length >10 mm (p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted (p = 0.006). CONCLUSIONS: A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.

Prehospital point-of-care testing for troponin: are the results reliable?

BACKGROUND: Swift assessment of patients presenting with chest pain results in faster treatment and improved outcomes. Allowing ambulance crews to use point-of-care (POC) devices to measure cardiac troponin I levels during transport of patients to the emergency department (ED) may result in earlier diagnosis of acute myocardial infarction, particularly in those patients without ST-segment elevation. The ability of POC devices to measure cardiac troponin I levels reliably in a moving ambulance has not previously been tested. Objective. This study was conducted to determine whether POC devices operated in a moving ambulance reliably duplicate the measurement of cardiac troponin I levels obtained by POC devices in the ED. METHODS: Blood samples were obtained in the ED and the hospital from patients reporting chest pain or other cardiac complaints. Troponin I assays were then performed in a moving ambulance using two POC devices. The POC devices were placed on flat surfaces in the rear of the ambulance. The ambulance driver was instructed to keep the ambulance moving in traffic while each assay was completed. A variety of routes were taken. Each set of two assays was completed entirely during a single simulated run. The results of the two assays performed in the moving ambulance were then compared with the results of the control assay, which was performed simultaneously in the ED on the same sample. RESULTS: Forty-two whole-blood samples underwent troponin I assays in a moving ambulance. Thirteen (30.9%) assays were positive. One (2.4%) was excluded because of cartridge error. Two (4.8%) were excluded because of interfering substance. No significant difference in whole-blood troponin results was found between the assays performed in the moving ambulance and those performed in the ED (intraclass correlation coefficient 0.997; 95% confidence interval 0.994 to 0.998; p < 0.005). CONCLUSIONS: When used in a moving ambulance, the POC device provided results of cardiac troponin I assays that were highly correlated to the results when the device was used in the ED. The feasibility, practicality, and clinical utility of prehospital use of POC devices must still be assessed. Key words: point-of-care systems; prehospital emergency care; troponin; reliability of results; ambulances; myocardial infarction; chest pain.