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PubMed2006

Global endometrial ablation: a modern day solution to an age-old problem.

Menorrhagia remains a significant health issue for women worldwide. Traditionally hysterectomy has been the treatment of choice when excessive menstrual bleeding remains unresolved by hormonal manipulation. In an attempt to provide a less invasive alternative to hysterectomy, traditional techniques such as rollerball endometrial ablation were developed 20 years ago. Although extremely effective, they possessed the potential of significant intra-operative risks and their success depended on high technical proficiency of the surgeon. As surgery and technology evolved, second generation endometrial ablation devices were developed which demonstrated improved safety and efficacy rates that paralleled traditional treatments. Since 1997, the Food and Drug Administration (FDA) has approved five such devices for use in the United States. Each possesses a unique technology profile with supporting level I evidence that allows for the treatment of a wide variety of uterine anatomy.

Endometrium↗
PubMed2006

[Endovascular stent-graft repair for thoracic aortic aneurysm].

Endovascular stent-grafting holds great potential as a minimally invasive alternative to open surgery for thoracic aortic aneurysm. Although there have been several commercially available stent graft systems applied to abdominal aortic aneurysm in the United States, Gore TAG is the only device that is approved by Food and Drug Association (FDA) for thoracic aortic aneurysm repair. Experience of endovascular aneurysm repair by our homemade system and TAG device which is crafted particularly for the thoracic aorta is reported. TAG was successfully delivered to the target region in 137 patients (98%). The aneurysm was successfully excluded by our homemade system in 258 patients (94%). The mortality rates of TAG and our homemade device groups were 2.1 and 3.6% respectively. Postoperative stroke incidence was 1.8% and was more frequent in patients with stent-graft deployed in the region between the landing zone map of Z3 and Z4. The rate of paraplegia/paraparesis with delayed onset was 2.8% in TAG group, and was almost similar in the homemade group (2.6%). The event-free rate of patients treated with stent-graft was low as compared to that of open surgery in 1 and 3 year follow-up period. Endovascular stent-grafting is feasible as one treatment option for thoracic aortic aneurysm. Selection of proper indications, development of the better device and technical improvement are keys to successful stent-grafting.

Aortic Aneurysm, Thoracic↗
PubMed1992

Transcatheter closure of atrial septal defect by "buttoned" devices.

During a 21-month period ending in August 1991, 12 patients underwent transcatheter closure of atrial septal defect (ASD) with a "buttoned" device through an 8Fr sheath, using an institutional review board-approved, custom-made device protocol initially, and Food and Drug Administration-approved clinical trials subsequently. Ten children had left-to-right shunts across the ASD and 2 adults had their patent foramen ovale closed to prevent recurrent paradoxical embolism (including cerebrovascular accidents). The device dislodged in 1 of the 4 patients in whom a first-generation device was used, and retrieval of the device, and surgical closure of the ASD were performed without incident. In the remaining 11 patients (age range 7 months to 45 years, weight 3.6 to 64 kg), the device remained intact, and pulmonary-to-systemic flow ratio decreased from 2.1 +/- 0.3 to 1.04 +/- 0.06. Follow-up chest x-ray and echo-Doppler studies were available in all patients 0.5 to 18 months after the procedure. The device was intact in all patients. Small residual shunt detected by color Doppler was seen in 2 children. Right ventricular size decreased (23 +/- 6 to 17 +/- 3 mm; p less than 0.01), and paradoxical septal motion disappeared in all patients. There was no recurrence of paradoxical embolism in the 2 adults. No complications occurred during follow-up. It is concluded that transcatheter closure of ASD with the buttoned device is feasible, effective and safe, and can be accomplished with small, 8Fr sheaths (even in infants weighing 3.6 kg), follow-up results are excellent, and clinical trials on a larger number of patients are needed.

Adolescent↗
PubMed2006

Angioseal use after antegrade femoral arteriotomy in patients undergoing percutaneous revascularization for critical limb ischemia: a case series.

Antegrade femoral artery access is commonly used for percutaneous transluminal revascularization of ipsilateral lower limbs in patients with critical limb ischemia. While hemostasis at the end of the procedure can be achieved by manual compression, this may lead to an increase in local vascular complications. Femoral artery closure devices, such as the Angioseal collagen plug and anchor device, have been approved and shown of benefit after retrograde femoral artery catheterization. To date, there are however no data on the use of such arteriotomy closure device after antegrade femoral access. We hereby report a case series of five patients in whom Angioseal was successfully used after antegrade femoral puncture and below-the-knee percutaneous transluminal angioplasty. In all cases the device enabled immediate and complete hemostasis without major complications, despite the intense antithrombotic regimen, including heparin, aspirin, and clopidogrel in all patients, as well as glycoprotein IIb/IIIa inhibitors (in two patients) and fibrinolytic therapy (in one).

Aged↗
PubMed1999

Devices for difficult airway management in academic emergency departments: results of a national survey.

STUDY OBJECTIVE: We conducted a national survey of emergency medicine residency program directors to determine which alternative devices were available in their emergency departments for difficult airway management. We also assessed the residency directors' experience in use of these devices. METHODS: After approval was received from the institutional review board at our institution, residency directors were contacted by mail, fax, or phone in October 1997. Alternative intubation devices were defined as devices that do not involve use of a laryngoscope and direct visualization for tracheal tube placement. Alternative ventilation devices were defined as those that do not use a face mask for ventilation. We asked whether the following alternative intubation devices were stocked in their department: a flexible fiberoptic bronchoscope, a rigid fiberoptic device (ie, Bullard, Wu-Scope), a lighted stylet, or a retrograde intubation kit. We also asked about the following alternative ventilation devices: a transtracheal jet ventilation system with a 50-psi oxygen source and control valve, the esophageal tracheal twin-lumen airway device (Combitube), or the laryngeal mask airway. Residency directors were also questioned about their duration of practice, intubation experience, and use of these devices. RESULTS: We obtained information from 95 of 118 (81%) programs. Of 95 programs, 61 (64%) had a fiberoptic bronchoscope, 43 (45%) a retrograde intubation kit, 33 (35%) a lighted stylet, and 6 (.06%) a rigid fiberoptic device. Forty-seven (49%) of the programs reported 2 or more devices, and 20 (21%) reported having no alternative intubation devices. Of 95 programs, 64 (67%) had a transtracheal jet ventilation system, 25 (26%) had the Combitube, and 25 (26%) had the laryngeal mask airway. Thirty-one (33%) programs had at least 2 alternative ventilation devices, and 20 (21%) had none. Ten (11%) programs had no alternative intubating or ventilation devices. Additional information on duration of practice, intubation experience, and actual use of alternative devices was obtained from 83 of the 95 (87%) emergency medicine residency directors contacted. Forty-one (49%) reported never having used an alternative device for intubation. The most commonly used alternative intubation device was the flexible fiberoptic bronchoscope (37%), and the mean number of times any alternative device was used was 7. CONCLUSION: The availability of devices for difficult airway management varies tremendously across emergency medicine residency programs. Only half of residency program directors had any experience with these devices, and among those that reported any experience, they are used rarely.

Airway Obstruction↗
PubMed2002

The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?

This article discusses the Food and Drug Administration (FDA) authority to regulate home use diagnostics for genetic disorders based on the social effects of the devices in the premarket approval process (PMA). It begins with a discussion of the potential social impacts of home use genetic diagnostics, focusing particularly on the psychological effects of the devices. The article then discusses the FDA's past experience in regulating home use diagnostics for HIV and for drugs of abuse testing under its PMA authority. In approving PMA applications for home tests for HIV and drugs of abuse, the FDA has considered various social effects of the devices and tailored its approval to these considerations. However, the agency did not deny approval because of social considerations. The author argues that the FDA's past experience in approving PMA applications indicates both a willingness to consider social considerations in the PMA process and that the agency may deny a PMA application based on social considerations in appropriate circumstances. The author also argues that the FDA may deny application if the social impacts and other health risks of the device greatly outweigh the therapeutic benefits of the device. For example, in applications involving late onset genetic disorders for which no therapeutic options currently exist, the social risks of the device may be found to outweigh the benefits to health and therefore the FDA may deny a PMA application in these situations.

Device Approval↗
PubMed2005

Differential exercise performance on ventricular assist device support.

BACKGROUND: Ventricular assist devices (VADs) are approved for destination therapy because they improve survival in end-stage heart failure (HF). VADs are powered pneumatically or electrically. Pneumatic and electric left ventricular assist devices (LVADs) and biventricular assist devices (BiVADs) provide excellent hemodynamic support at rest, but differences in their effects on exercise tolerance are unclear. We sought to evaluate the effect of devices with varying operating parameters on exercise capacity. METHODS: Exercise physiology data obtained during maximal exercise with on-line gas-exchange analysis were collected for 38 consecutive VAD-implanted HF patients referred for exercise testing. RESULTS: Electric LVADs were implanted in 18 patients, and pneumatic LVADs in 10 patients. Percent of predicted peak exercise oxygen consumption (VO2%) was significantly greater in pneumatic LVAD patients (52.1 +/- 11.1% vs 38.2 +/- 11.3%, p < 0.05). The 10 patients implanted with a pneumatically powered LVAD were compared to 10 patients implanted with a pneumatically powered BiVAD. LVAD-supported patients had a higher VO2% (52.1 +/- 11.1% vs 36.5 +/- 17.7%, p < 0.05). CONCLUSIONS: HF patients supported with a pneumatic LVAD appear to have better exercise tolerance than those receiving an electric LVAD. Patients on LVAD support have better exercise tolerance than BiVAD-supported patients. This highlights the importance of right ventricular function to exercise tolerance in HF patients, and may have implications for future VAD design.

Adult↗
PubMed1993

Results of directional coronary atherectomy during multicenter preapproval testing. The US Directional Coronary Atherectomy Investigator Group.

Between 1988 and 1990, clinical testing was performed at 12 US institutions using the Simpson Coronary AtheroCath under an Investigational Device Exemption. Data on 1,069 lesions (873 patients) were analyzed and presented to the Food and Drug Administration (FDA) advisory panel in the summer of 1990, forming the basis for approval of this device in September 1990. Analysis of these preapproval data shows a primary success rate of 85% (defined as tissue removal, > or = 20% reduction in stenosis, < 50% residual stenosis after directional atherectomy, and no major complication), with somewhat higher primary success in prior restenosis and noncalcified lesions. Including the use of conventional angioplasty performed after atherectomy, the overall success rate was 92%. One or more major complications occurred in 4.9% of procedures, and included death (0.5%), nonfatal Q-wave myocardial infarction (0.9%), and emergency bypass surgery (4.0%). These complications were more frequent in right coronary, de novo, and diffuse (> 20-mm length) lesions. Six-month angiography results were available in 384 (77%) of 498 lesions eligible for follow-up when the registry closed and showed a restenosis rate (late stenosis > 50%) of 42%. The restenosis rate in both native vessels (30 vs 46%) and bypass grafts (31 vs 68%) was lower in primary (de novo) lesions compared with lesions that had developed restenosis after a prior intervention. Despite the use of prototype atherectomy catheters and still evolving procedural technique, this preapproval experience provided an important initial indication of the situations in which directional coronary atherectomy was most useful and helped set clear standards for performance of this procedure following FDA approval.

Atherectomy, Coronary↗
PubMed2000

The CardioWest total artificial heart as a bridge to transplantation.

The CardioWest total artificial heart (TAH), formerly known as the Jarvik-7 and then the Symbion heart, is the only TAH in current clinical use. A new study, approved by the Food and Drug Administration (FDA), was initiated in 1993 with the goal of approving this pump for commercial release. Since then, 145 CardioWest TAHs have been implanted, including 37 pumps in 36 patients at our center. Our 36 patients were studied prospectively according to the investigational device exemption protocol approved by the FDA. Clinical and hemodynamic data obtained upon patients' entry into the study identified this group as mortally ill. After receiving a CardioWest TAH, 29 of the 36 patients (81%) survived to heart transplantation, and 26 (72% of the total group and 90% of the transplant recipients) have survived for up to 7 years (average, 24 months). Multicomponent anticoagulation, based on readily available tests, and the intrinsic properties of the TAH have resulted in a low linearized stroke rate of 0.48 event per patient-year. There have been no device-related mediastinal infections. In dying patients with nonexistent or severely compromised biventricular function, the CardioWest TAH has proved safe and effective, allowing a 72% survival rate for an average of 24 months.

Adult↗
PubMed2006

The physiologic basis for the management of ventricular assist devices.

Mechanical ventricular assist devices are now approved as destination therapy for terminal heart failure. It is the purpose of this review to discuss the physiology of this technology that is considered in outpatient care. The currently available pulsatile devices are solely dependent of preload volume and, when placed in the automatic mode, can maintain physiologic cardiac outputs with exercise. However, because of their dependence on preload volume, there are unique physiologic consequences; device bradycardia represents volume depletion, device tachycardia reflects volume overload. The differential diagnosis of left ventricular assist device dysfunction includes native right ventricular failure, native left ventricular recovery, or other technical considerations. The management of biventricular mechanical support as well as arrhythmia management and the role of echocardiographic assessment in this unique patient population will be discussed. Expertise in outpatient management of such devices is now a requisite for subspecialists in heart failure, In the future, technical innovations may simplify management for professionals, patients, and their families.

Blood Pressure↗
PubMed2005

The management of mechanical hearts.

Mechanical ventricular assist devices are now approved as destination therapy for terminal heart failure. It is the purpose of this review to discuss the physiology of this technology that is considered in outpatient care. The currently available pulsatile devices are solely dependent of preload volume, and when placed in the automatic mode, can maintain physiologic cardiac outputs with exercise. However, because of their dependence on preload volume, there are unique physiologic consequences; device bradycardia represents volume depletion, device tachycardia reflects volume overload. The differential diagnosis of left ventricular assist device dysfunction includes native right ventricular failure, native left ventricular recovery, or other technical considerations. The management of biventricular mechanical support will be discussed, as well as arrhythmia management and the role of echocardiographic assessment in this unique patient population. Expertise in outpatient management of such devices is now a requisite for subspecialists in heart failure. In the future, technical innovations may simplify management for professionals, patients and their families.

Arrhythmias, Cardiac↗
PubMed2001

Medical devices; reclassification of three anesthesiology preamendments class III devices into class II. Final rule.

The Food and Drug Administration (FDA) is reclassifying three anesthesiology preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.

Anesthesiology↗
PubMed2006

Patent foramen ovale: assessment, clinical significance and therapeutic options.

Foramen ovale plays an important function in the fetus but is of no physiologic significance after birth and closes in most individuals. In about one fourth of the population, however, foramen ovale remains open for life and has been associated with cerebrovascular accidents, especially in younger patients, presumably through paradoxical embolism. Patent foramen ovale (PFO) has also been associated with hypoxia, migraine headaches and neurologic findings of decompression illness in scuba divers. Availability of transesophageal echocardiography and its frequent use in the management of patients with stroke has lead to frequent detection of PFO. In addition, the recent development of devices and techniques for percutaneous closure of PFO has resulted in widespread enthusiasm for such interventions, even when a clear etiologic role for PFO may not be established. In the United States, the Federal Drug Administration (FDA) has approved two such devices through compassionate investigational device exemption without adequate data from large randomized clinical studies. Other such devices are undergoing evaluation in clinical trials. Expert opinions have been helpful for clinical decision making in management of patients with PFO associated with stroke, hypoxia, decompression sickness and migraine headaches.

Heart Septal Defects, Atrial↗
PubMed1995

[European regulations concerning medical devices].

The employment in clinical practice and prosthetic surgery of a number of medical devices implies a great responsibility to the operators so as to make the knowledge of existing regulations mandatory. The authors illustrate the problems concerning the free circulation of medical devices within the European market. They describe the new strategy of EEC which led to the definition of the directives which apply to all medical devices and of the harmonized standards for inspecting their biological effects. The appointment of certification bodies and the accreditation of Testing Laboratories are described. Finally, particular attention is given to product certification, which is compulsory for the pre-market approval of medical devices.

Accreditation↗
PubMed2003

Annual update: drugs, diagnostics and devices.

As NPs continue to play an important role in health care as administers of prescriptions, the value of reviewing the latest Food and Drug Administration (FDA) approvals for new drugs and devices is immeasurable. In 2002, the FDA approved several new drugs and devices, as well as monitored previously approved drugs for adverse reactions and untoward events. This article provides a brief review of relevant primary care topics.

Anti-Inflammatory Agents↗
PubMed1997

Assessment of a new ultrafiltration blood processing system.

PURPOSE: To report our clinical experience with a new blood processing device which uses ultrafiltration. We assessed safety and efficacy by evaluating: 1 ) the quality and the quantity of intraoperative shed blood processed and reinfused to the patient 2) homologous blood requirements 3) clinical status of the patient post-transfusion. METHODS: With Ethics Committee approval, the ultrafiltration device was used in six consenting patients undergoing major elective spinal surgery. Blood samples for haematology and biochemistry tests were collected from patients post-induction of anaesthesia (baseline), 1 hr and 24 hr post-autotransfusion. Volumes of blood collected and processed, and all autologous and homologous transfusions were recorded. Patients were assessed post-operatively for any adverse effects. RESULTS: Five patients had donated blood preoperatively. One patient required homologous blood products in addition to autologous blood. In two patients, the filtration cartridge became blocked and required changing midprocessing. No patient sustained device-related complications. One patient had postoperative haematuria which resolved spontaneously within two hours. CONCLUSION: The ultrafiltration device was safe and effective in reducing homologous blood requirements in six patients undergoing elective spinal surgery. Further evaluation of the ultrafiltration device will be necessary, especially in view of the blockage of the filtration cartridge.

Blood Transfusion, Autologous↗
PubMed2003

The expanding domain of implantable hearing devices: an update on current status in the United States.

Several implantable devices are now approved in the United States for rehabilitation of conductive, mixed, and sensorineural hearing loss. This paper will review current rehabilitative options including middle ear implants, used for mild to severe sloping sensorineural loss, and bone-anchored hearing aids, for conductive or mixed hearing loss. The indications for these devices differ, as do the bases for exclusion. Audiologic evaluation parameters will be reviewed as a guideline to selection, and as a baseline to determine potential rehabilitative impact. We will also describe emerging applications, based on our ongoing research projects, for these devices that are anticipated to broaden the indications.

Cochlear Implants↗
PubMed2004

Longitudinal change in quality of life and impact on survival after left ventricular assist device implantation.

BACKGROUND: The HeartMate vented electric left ventricular assist device has been approved for use as destination therapy. Thus, the study of quality-of-life outcomes, as well as morbidity and mortality, is imperative. The purpose of our study was to describe change with time (from 1 month to 1 year) in patients who received a HeartMate vented electric left ventricular assist device as a bridge to heart transplantation and to identify quality-of-life predictors of survival after left ventricular assist device implantation. METHODS: A nonrandom sample of 78 patients who received a HeartMate vented electric left ventricular assist device (primarily middle-aged, white married males) who had quality-of-life data at 1, 2, 3, 6, 9, or 12 months after implant was the subject of this report. The sample size decreased with time primarily because of heart transplantation. Patients completed the following booklets of questionnaires: Quality of Life Index, Rating Question Form, Heart Failure Symptom Checklist, and Sickness Impact Profile. Analyses included both descriptive analyses and modeling procedures (mixed-effects models and Cox proportional hazards models). RESULTS: Quality-of-life outcomes were fairly good and stable from 1 month to 1 year after HeartMate vented electric left ventricular assist device implantation. Both positive and negative changes were detected in all quality-of-life domains (physical and occupational function, social interaction, somatic sensation, and psychological state) after left ventricular assist device insertion. Items from the physical domain of quality of life, specifically walking and dressing oneself, were significantly associated with the risk of dying after left ventricular assist device implantation. CONCLUSIONS: Identifying poor quality-of-life outcomes within 1 year after left ventricular assist device implantation provides direction to develop strategies to improve outcomes. Physical and occupational rehabilitation, psychosocial intervention, and monitoring symptom distress and physical disability may contribute to improved quality-of-life outcomes and survival after left ventricular assist device implantation.

Adult↗