Clinical evaluation of a novel occluder device (Occlutech<Superscript>®</Superscript>) for percutaneous transcatheter closure of patent foramen ovale (PFO)

Background

We investigated the safety, feasibility and usefulness for closure of PFO with the new nitinol meshwire PFO-occluder device (Occlutech Figulla^®-single layer occluder) with an unique braiding technology which allows a 50% reduction of meshwork material on the left atrial side in combination with a greater flexibility as compared to the Amplatzer^® occluder device.

Methods

The retention discs of the new PFO Occlutech Figulla^® single layer device (23/25 mm) are connected by a 3 mm waist in the centre with only one right atrial side hub. The left atrial disc is a single flat layer covered by an ultrathin polyethylene terephthalate (PET) patch. We investigated the safety, feasibility and usefulness for closure of PFO in a multicenter clinical trial. Indications for closure included cryptogenic stroke with evidence of a patent foramen ovale in transesophageal echocardiography (PFO max. diameter 13 mm according to sizing balloon). The device was implanted in 36 patients (mean age 57, 18–80 years) by means of fluoroscopy and transesophageal echocardiography (TEE) using a 9 French delivery sheath and employing a femoral vein approach. Both acetylsalicylacid 100 mg/d (6 months) and clopidogrel 75 mg/d (3 months) were administered post interventional. A transthoracal (TTE) and transesophageal echocardiography follow-up examination was performed after 1, 2 and 6 months (TTE day 30 and 180; TEE day 60).

Results

The device was successfully implanted in 36 pts. In one patient PFO implantations was attempted but not crossed with a guide wire. Perioperativly there were no major in-hospital-adverse events or complications thromboembolism, occluder dislodgement, infection or myocardial infarction. One patient had transient atrial fibrillation 2 h after implantation, which terminated medically after 12 h. TEE studies in the remaining 35 pts (one pt was unwilling to further participate) showed a residual shunt in 8.6% (3/35) after 60 days and a left-to-right shunt in 2.6% (1/35) of pts. After 180 days one pt with severe arteriosclerotic heart disease and A.carotic stenosis revealed a stroke without evidence of cardioembolic origin or devices thrombosis.

Conclusions

The novel Occlutech Figulla^® PFO N single layer device appears to be safe, feasible and useful for PFO closure despite a 50% reduction of the meshwire, no distal hub and an improved flexibility of the left atrial disc.

     

Patent foramen ovale (PFO): is there life before death in the presence of PFO?

Patent foramen ovale (PFO) is an embryologic remnant with incomplete postnatal adhesion of the cardiac atrial septum primum and secundum. After birth, the prevalence of PFO decreases from about 35% at young to approximately 20% at old age. PFO has been associated with numerous conditions such as decompression illness in divers, migraine, high‐altitude pulmonary oedema, cerebrovascular and coronary ischaemia, and obstructive sleep apnoea syndrome. PFO is the cause of intermittent atrial right‐to‐left shunt, and it can be the source of cardiac paradoxical embolism. So far, randomized controlled trials have not documented a reduced rate of cerebrovascular recurrent events in patients receiving PFO device closure as compared to those on medical treatment. The purpose of this article was to critically evaluate evidence on the pathophysiologic, clinical as well as prognostic relevance of PFO.     

Sustained risk of recurrent thromboembolic events in patients with patent foramen ovale and paradoxical embolism: long-term follow-up over more than 15 years

Background  

Patients with patent foramen ovale (PFO) and cryptogenic stroke are at risk of recurrence. Therapeutic regimens range from no treatment to anticoagulation treatment to surgical or interventional closure. However, long-term follow-up is only available for up to 4 years.     

Patent foramen ovale in patients with tension headache: is it as common as in migraineurs? An age- and sex-matched comparative study

The association of patent foramen ovale (PFO) and atrial septal aneurysm (ASA) with migraine headache attack (MHA) has been clearly shown. The same findings have been recently demonstrated also in cluster headache. Although tension-type headaches (TTH) are the most common kind of headache, their association with these atrial septal abnormalities has never been studied before. The study was conducted to clarify whether there was a significant association between the presence of such atrial septal abnormalities and tension headache, when compared with migraineurs. One hundred consecutive patients with migraine and 100 age- and sex-matched subjects with TTH and 50 healthy volunteers with no headache were enrolled in the study and underwent a complete transesophageal echocardiographic study with contrast injections at rest and with the Valsalva maneuver. There was no significant difference between the age and the sex of the participants of the three groups. The overall prevalence of PFO was 23% in patients with TTH and that of large PFOs was only 11%. The 23% prevalence of PFO in patients with TTH was not statistically different from 16% found in our normal control group. Furthermore, we found a significantly higher prevalence of PFO in migraineurs (50%) when compared with patients with tension headache (p < 0.001). This was also true for the collective presence of large PFOs and ASAs (35%) (p < 0.001). Although atrial septal anomalies have an association with MHA, they do not have a significant association with TTH.     

Enlargement of umbilical incision in standard laparoscopic cholecystectomy is frequently necessary: An argument for the single incision approach?

Objective: Cosmetic result after cholecystectomy is up for debate. The aim of this study was to investigate the incidence and extent of enlargement of initial skin and fascia incision in standard laparoscopic cholecystectomy and to detect predictive factors for such an enlargement. Material and methods: The size of the umbilical incision was measured before and after standard laparoscopic gallbladder removal in 391 patients from August 2009 to October 2012. Predisposing factors for the need of enlargement of the umbilical incision were analysed. Results: Additional enlargement of the umbilical incision for gallbladder removal was required in 35.8% of the patients at skin level, and in 40.4% at fascia level. The median enlargement of the umbilical skin incision was 11 mm, from 25 mm to 36 mm. Gallbladder weight, total stone weight, maximum diameter of largest stone and shorter initial length of incision were independent predisposing factors for enlargement of the incision. Conclusions: In standard laparoscopic cholecystectomy the umbilical incision frequently requires secondary enlargement, especially if a large stone mass is involved. Therefore, the cosmetic result after laparoscopic cholecystectomy depends on more than only the technique used for access and the surgical technique for cholecystectomy should be chosen individually for each patient according to the stone mass.     

DeepSuture®, a novel device for closure of trocar sites in minimally invasive surgery

Summary

Trocar hole closure may be desirable in minimally invasive surgery (MIS). Methods: DeepSuture r` is a device designed to aid the MIS surgeon in the closure of trocar holes. Results: It introduces two needles into the abdominal cavity and when activated simultaneously points them in an outward direction. Long custom-designed doubled-armed needles, which have side-attached thread, further facilitate its use. Techniques for closing fascia in both superficial and deep trocar incisions are presented. Conclusions: MIS surgeons who wish to close their trocar incisions may consider evaluating DeepSuture r` as an addition to their armamentarium.     

Constructions of dignity: a pre-requisite for flourishing in the workplace?

yalden b.j. & mccormack b. (2010) Constructions of dignity: a pre-requisite for flourishing in the workplace? International Journal of Older People Nursing 5 , 137–147 Aims. To explore the relationship between nurses’ understanding of dignity and how it is enhanced and developed in their practice environment. Background. Dignity is a ubiquitous concept in an era of healthcare reform yet is referred to almost exclusively in terms of the quality of care delivered to support the experience of the patient rather than the caregivers engaged in the relationships of care. This article focuses on dignity in the professional life of nurses in aged care. Method. This is part of a doctoral study of the implementation of a palliative approach in residential aged care using emancipatory practice development methodology. Constructions of dignity were co-created with participants through creative reflective activities and subsequently analysed using reflexive methods and data from other sources within the study. Results. Constructions of dignity and subsequent actions taken by nurses on their own behalf to articulate their experiences of transforming practice are interconnected with dignity enhancing relationships and emancipatory ways of working in practice development. Conclusions. Dignity enhancing ways of working in an active learning group and workplace have been interlinked with actions that promote person-centredness in developing a palliative approach to care.     

An exploration of physiotherapists’ experiences of robotic therapy in upper limb rehabilitation within a stroke rehabilitation centre

Purpose: Strokes are the world’s leading cause of adult disability, with movement impairment being more common in the upper limb (UL). Robotic therapy (RT) is identified as an effective adjunct to promote movement but with limited effect on functional capabilities. There is currently limited research in user experience of RT, specifically that of physiotherapists. This study sought to explore physiotherapists’ experience of using RT in rehabilitation of the UL, within a stroke rehabilitation centre in the north of England.

Method: Physiotherapists (n?=?6) shared their experiences of working with the InMotion2 robot through semi-structured interviews. Thematic analysis was employed to interpret data, identify emergent themes and interdependent relationships between them.

Findings: Five interdependent themes were identified focused around individualized care, influenced by evidence for practice, human relationships, skill mix, and resources and resource management. All physiotherapists valued the use of RT as an adjunct to conventional therapy, although barriers to successful implementation seemed to dominate the views of some.

Conclusions: RT was perceived positively by physiotherapists, regarded as an adjunct to conventional therapy. A framework to summarize the relationships of participants’ views and experiences is proposed in an attempt to understand the influences on the clinical use of RT.

• Implications for Rehabilitation

• Robotic therapy (RT) is valued as an adjunct to (conventional) person-centred rehabilitation.

• Resource management and skill mix are viewed as two key challenges to the successful implementation of RT.

• The production of evidence-based guidelines would be a useful development in the advancement.

     

Dislocation of the Knee: An Epidemic in Waiting?

Background

Knee dislocation is an uncommon but serious injury that has traditionally been associated with high velocity injuries such as motor vehicle accidents. More recently, individual cases of obese individuals sustaining knee dislocation from a low velocity mechanism have been noted. Associated injuries of knee dislocation are common and include popliteal vessel damage requiring surgical repair and injuries to the peroneal nerve. Prompt diagnosis and reduction is essential to reduce the risk of these complications.

Objectives

We aim to highlight the importance of prompt diagnosis and management of obese patients presenting with knee pain after a seemingly innocuous injury who may have a knee dislocation.

Cases

We present a series of four cases of dislocation of the knee that have presented to our hospital over the course of 1 year. Each was sustained by a morbidly obese female of body mass index range 35–41, age range 33–52 years, experiencing a simple mechanical fall from standing. Magnetic resonance image scanning revealed multiple knee ligament rupture in all four cases. One case had peroneal nerve palsy.

Conclusion

This is the first series of such injuries that we are aware of and highlights a potential future increase in incidence of these major injuries as body mass in society increases, placing more strain on health care resources. Practitioners in the Emergency Department need to be aware that serious injury can be present in morbidly obese patients that have sustained no more than a fall from standing height. Prompt investigation and management is essential.     

Is inhaled prophylactic heparin useful for prevention and management of pneumonia in ventilated ICU patients?

PurposeThe purpose was to determine the efficacy of prophylactic inhaled heparin for the prevention and treatment of pneumonia in patients receiving mechanical ventilation (MV).MethodsA phase 2, double-blind, randomized controlled trial stratified for study center and patient type (nonoperative, postoperative) was conducted in 3 university-affiliated intensive care units. Patients aged at least 18 years and requiring invasive MV for more than 48 hours were randomized to usual care, nebulization of unfractionated sodium heparin (5000 U in 2 mL), or nebulization with 0.9% sodium chloride (2 mL) 4 times daily with the main outcome measures, the development of ventilator-associated pneumonia (VAP), ventilator-associated complication, and Sequential Organ Failure Assessment scores in patients with admission pneumonia or developing VAP. Trial registration: ACTRN12612000038897.ResultsA total of 214 patients were enrolled (72 usual care, 71 inhaled sodium heparin, 71 inhaled sodium chloride). There were no differences between treatment groups in terms of the development of VAP using either Klompas criteria (6%-7%, P = 1.00) or clinical diagnosis (24%-26%, P = .85).ConclusionLow-dose nebulized heparin cannot be recommended for prophylaxis against VAP or to hasten recovery from pneumonia in patients receiving MV.     

Is there a role for the funeral service provider in bereavement support within the context of compassionate communities?

Abstract

This is the first study to explore bereaved individuals’ experiences of funeral service providers using these services’ databases. A total of 839 Australians participated in a postal survey, 6–24?months into their bereavement. Funeral providers were reported to be the third most prevalent form of bereavement support after friends and family. Analysis found six themes related to perceived helpful or unhelpful support: instrumental support, professionalism, informational support, financial tension, communication, and emotional support. Funeral providers could improve their support by adopting a proactive approach to bereavement needs and offering personalized and ongoing support. We develop these suggestions by exploring their potential contributions to building community capacity around death, dying and bereavement.