First‐in‐Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions

Objectives

To describe the first‐in‐man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI.

Background

Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal.

Methods

Prospective, single‐centre, non‐randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria—TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST‐resolution >70% at 90 minutes after vessel reperfusion—was also evaluated.

Results

Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre‐specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration.

Conclusions

This first‐in‐man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155–161)

     

Serial pulmonary function tests in patients treated with low-dose amiodarone.

Problems with pulmonary toxicity have emerged as a potentially limiting factor for amiodarone use. We studied 24 consecutive patients receiving low-dose (i.e., less than or equal to 400 mg/day) amiodarone for refractory tachyarrhythmias. Serial pulmonary function test results were correlated with daily dose, serum concentration, cumulated dose, and duration of amiodarone treatment to determine the effect of the drug on pulmonary function. The mean follow-up period for the 24 patients, who completed baseline and follow-up evaluations, was 47 months (range 31 to 75 months). In 22 of the 24 patients a reduction in total diffusion capacity (TLCO) was noted after treatment; for all 24 patients the mean reduction in TLCO was 12.9% of the predicted value (SD 9.6% predicted) (p less than 0.02). The decrease in TLCO was found to be significantly related to an increasing cumulated dose of amiodarone (p = 0.007), whereas the reduction in TLCO was found to be unrelated to sex, age, underlying heart disease, arrhythmia, daily dose of amiodarone, duration of treatment, plasma concentration of amiodarone and desethylamiodarone, and pretreatment pulmonary function abnormalities. Seven (29%) of the patients had asymptomatic pulmonary toxicity with a decrease in TLCO greater than or equal to 20% of the predicted value. In conclusion, long-term treatment with low-dose amiodarone was associated with a substantial decrease in TLCO, a higher cumulative dose of the drug was related to an increasing reduction in TLCO, and pretreatment pulmonary function abnormalities were not predictive for development of subclinical pulmonary toxicity.     

Evaluation of left ventricular dimensions and function in Marfan's syndrome without significant valvular regurgitation

Left ventricular dimensions and systolic function were studied using echocardiography in 234 patients with Marfan's syndrome without significant valvular regurgitation. Left ventricular dimensions and systolic function were found to be normal in most patients with Marfan's syndrome. Some involvement of the left ventricle may have been present in a small group of these patients. No patients, however, fulfilled the criteria for dilated cardiomyopathy.     

Capillary transit time heterogeneity and flow-metabolism coupling after traumatic brain injury

Most patients who die after traumatic brain injury (TBI) show evidence of ischemic brain damage. Nevertheless, it has proven difficult to demonstrate cerebral ischemia in TBI patients. After TBI, both global and localized changes in cerebral blood flow (CBF) are observed, depending on the extent of diffuse brain swelling and the size and location of contusions and hematoma. These changes vary considerably over time, with most TBI patients showing reduced CBF during the first 12 hours after injury, then hyperperfusion, and in some patients vasospasms before CBF eventually normalizes. This apparent neurovascular uncoupling has been ascribed to mitochondrial dysfunction, hindered oxygen diffusion into tissue, or microthrombosis. Capillary compression by astrocytic endfeet swelling is observed in biopsies acquired from TBI patients. In animal models, elevated intracranial pressure compresses capillaries, causing redistribution of capillary flows into patterns argued to cause functional shunting of oxygenated blood through the capillary bed. We used a biophysical model of oxygen transport in tissue to examine how capillary flow disturbances may contribute to the profound changes in CBF after TBI. The analysis suggests that elevated capillary transit time heterogeneity can cause critical reductions in oxygen availability in the absence of ‘classic'' ischemia. We discuss diagnostic and therapeutic consequences of these predictions.     

Cholesteryl ester storage disease of clinical and genetic characterisation: A case report and review of literature

BACKGROUND Cholesteryl ester storage disease(CESD)is a rare genetic disease.Its symptoms and severity are highly variable.CESD is a systemic disease that can lead to the accumulation of fat and inflammation in the liver,as well as gastrointestinal and cardiovascular disease.The majority of patients require liver transplantation due to decompensated cirrhosis.Enzyme replacement therapy has been approved based on a randomized trial.Our study aims to clinically and genetically evaluate two siblings with CESD who underwent liver transplantation,as well as their first-degree family members.CASE SUMMARY The siblings were compound heterozygous for the missense variant in LIPA exon 8,c.894G>A,(p.Gln298Gln)and a single base pair deletion,c.482del(p.Asn161Ilefs*19).Analyses of single nucleotide polymorphisms showed variants with an increased risk of fatty liver disease and fibrosis for both patients.Clinically,both patients show signs of recurrence of CESD in the liver after transplantation and additional gastrointestinal and cardiovascular signs of CESD.Three family members who were LIPA heterozygous had a lysosomal acid lipase activity below the reference value.One of these carriers,a seven-year-old boy,was found to have severe dyslipidemia and was subsequently treated with statins.CONCLUSION Our study underlines that CESD is a multi-organ disease,the progression of which may occur post-liver transplantation.Our findings underline the need for monitoring of complications and assessment of possible further treatment.     

Situation analysis of quality of abortion care in the main maternity hospital in Hai Phòng, Viet Nam

Six months after a Comprehensive Abortion Care project was implemented in Phu-San Hospital, the main maternity hospital in Hai Phòng, northern Viet Nam, a study of quality of abortion services was carried out. The study explored the interaction between providers and women seeking abortion and how cultural values influenced quality of care. A quantitative and qualitative approach was employed: a three-part structured survey with 748 women before and after they had an abortion, 20 in-depth interviews with women just after abortion, seven informal interviews with health care staff and 100 participant observations. Both the women and the staff equated quality of care mainly with improved technical performance of abortion. Insufficient knowledge and skills had a negative impact on provision of information and good quality counselling in relation to understanding and uptake of contraception, treating reproductive tract infection and preventing post-abortion infection. To further improve abortion care in hospitals such as Phu-San, training programmes are needed that integrate counselling and clinical skills and address the cultural factors that hinder health staff and women from interacting in an equitable manner. A supportive supervisory system that holds health staff accountable for conducting high quality information and counselling sessions should also be established.     

Estrogen and phytoestrogens: Effect on eNOS expression and in vitro vasodilation in cerebral arteries in ovariectomized Watanabe heritable hyperlipidemic rabbits

OBJECTIVES: To evaluate the effect of estrogen replacement therapy or soy isoflavones supplement on endothelium-dependent relaxation in vitro and gene expression of endothelial nitric oxide synthase (eNOS) in cerebral arteries in a rabbit model of human hypercholesterolemia. STUDY DESIGN: Thirty-six female ovariectomized Watanabe heritable hyperlipidemic (WHHL) rabbits were randomised to treatment with 17beta-estradiol (17beta-E(2)), SoyLife 150 or control for 16 weeks. Ring segments of basilar artery (BA) and posterior cerebral artery (PCA) were mounted in myographs for isometric tension recordings. Concentration response curves to carbamylcholine chloride, sodium nitroprusside (SNP) and l-NAME were evaluated after precontraction with potassium. Total RNA was extracted, reverse transcribed and eNOS quantitated by real-time polymerase chain reaction (real-time PCR). RESULTS: Plasma cholesterol was significantly higher at termination in the SoyLife group (P<0.0001), whereas low-density lipoprotein (LDL) cholesterol was comparable in all treatment groups. Neither treatment influenced the endothelium-dependent responses to carbamylcholine chloride or l-NAME or the endothelium-independent response to SNP in any of the arteries. Correspondingly, eNOS mRNA was similarly expressed in all treatment groups in both arteries. CONCLUSIONS: Improvement of cerebral endothelial function by estrogen or soy isoflavones in ovariectomized WHHL rabbits is not supported by the present data. The findings may be unique to the WHHL rabbit in which the hypocholesterolemic effect of estrogens mediated by upregulation of liver LDL receptors is excluded.