Device Implant (device + implant)

Distribution by Scientific Domains


Selected Abstracts


Psychosocial Aspects of Patient-Activated Atrial Defibrillation

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 8 2003
Andrew R.J. Mitchell M.R.C.P.
Introduction: The atrial defibrillator empowers patients to cardiovert themselves from atrial arrhythmias at a time that is socially and physically acceptable, thereby preventing hospitalization. The long-term psychosocial effects of repeated use of the patient-activated atrial defibrillator at home are unknown. Methods and Results: Eighteen patients underwent placement of the Jewel AF atrial defibrillator for persistent atrial fibrillation only. All patients performed manually activated cardioversions at home under self-administered sedation. Automatic shock therapies were disabled. Hospital Anxiety and Depression Scale and Multidimensional Health Locus of Control questionnaires were obtained before implant. All patients completed questionnaires 1 year after device implant and at long-term follow-up. The spouse or partner of each patient was interviewed to identify positive and negative aspects of manual cardioversion at home. The baseline patient scores for both anxiety (5.7 ± 2.7) and depression (3.4 ± 2.3) fell within the predefined range of normality. At 1 year, there was no significant change in anxiety (4.9 ± 3.7, P = 0.39) or depression (2.4 ± 1.8, P = 0.06). At long-term follow-up (mean 28 months), a total of 377 patient-activated cardioversions were performed out of hospital (median 15 per patient). Scores for anxiety (6.0 ± 4.0, P = 0.70) and depression (3.2 ± 2.5, P = 0.68) remained unchanged. Conclusion: During long-term follow-up, patient-activated cardioversion using the atrial defibrillator was not associated with increased anxiety or depression. The procedure was well tolerated by patients and their partners, offering an acceptable treatment option for patients with recurrent persistent atrial fibrillation. (J Cardiovasc Electrophysiol, Vol. 14, pp. 812-816, August 2003) [source]


Predictors of Fracture Risk of a Small Caliber Implantable Cardioverter Defibrillator Lead

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 4 2010
ANDREW C.T.
Introduction: The Sprint Fidelis 6949 implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a high rate of fracture. Identification of predictors of subsequent fracture is useful in decision making about lead replacement and for future lead design. We sought to determine if there are clinical, procedural, or radiological features associated with a greater risk of subsequent lead fracture. Methods: Patients with Sprint Fidelis 6949 lead fractures (Fracture group) were identified from our institutional database. Each patient in the Fracture group was matched to two controls, immediately preceeding and succeeding Sprint Fidelis 6949 implant. Clinical and procedural characteristics were compared. Chest radiographs performed 2 weeks after ICD implant were reviewed by an observer blinded to outcomes. The following features were assessed: ICD tip location, lead slack, kinking of the lead body (,90°), and presence of lead "crimping" within the anchoring sleeve. Results: Twenty-six patients with Sprint Fidelis 6949 lead fractures were identified and were matched to 52 control patients. On univariate analysis, a higher left ventricular ejection fraction (LVEF), prior ipsilateral device implant, history of prior ICD lead fracture, and noncephalic venous access were associated with risk of lead fracture. On multivariate analysis, a higher LVEF was the only independent predictor of lead fracture (P = 0.006). Radiological features were similar between the two groups. Conclusions: In this study, a higher LVEF was associated with a greater risk of lead fracture in patients with Sprint Fidelis 6949 ICD leads. Radiographic features did not predict subsequent risk of lead fracture in our population. (PACE 2010; 437,443) [source]


Importance of Anterograde Visualization of the Coronary Venous Network by Selective Left Coronary Angiography Prior To Resynchronization

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1 2007
NICOLAS DELARCHE M.D.
Background: Understanding of coronary anatomy is essential to the advancement of cardiac resynchronization therapy (CRT) techniques. We determined whether the difficulties associated with catheterization of the coronary sinus (CS) and its lateral branches could be overcome by a preliminary angiographical study of the coronary venous system carried out during a pre-operative coronary angiography with examination of venous return. Methods and Results: All patients were scheduled for an exploratory angiography procedure and indicated for CRT. Group A patients were implanted with a CRT device after a right arterial angiographical procedure while group B patients had a selective left angiogram including examination of venous return. Data analyzed in group B were: position of CS ostium, number and distribution of lateral branches, and ability to preselect a marginal vein suitable for catheterization. Subsequent device implantation was guided by these parameters. A total of 96 and 89 patients were included in groups A and B, respectively. Implantation success rates were not different (98% and 100%, respectively), but CS catheterization time was reduced in group B (6 minutes vs 4 minutes; P < 10,6) as well as total time required to position the left ventricular lead (25 minutes vs 15 minutes; P < 10,6), fluoroscopy exposure (7 minutes vs 5 minutes; P < 10,6), and volume of contrast medium required (45 mL vs 15 mL; P < 10,6). Conclusion: A coronary angiographical study, including examination of the coronary venous return prior to implantation of a CRT device, can simplify the device implant and allows patient-specific preselection of appropriate tools for the procedure. [source]


Persistent Left Superior Vena Cava-Inferior Vena Caval Communication Complicating Implantation of an Implantable Cardioverter Defibrillator

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 11 2005
SANJEEV GOYAL
A persistent left superior vena cava has been observed in 0.3% of the general population on autopsy. Its presence can complicate left-sided device implantation. Commonly, a LSVC connects to the right atrium via the coronary sinus. A LSVC-accessory hemiazygous-hemiazygous-inferior vena caval communication has not been described previously. The presence of such a congenital venous anomaly will prohibit a left-sided device implant. [source]


Initial Clinical Experience With the HeartMate II Ventricular Assist System in a Pediatric Institution

ARTIFICIAL ORGANS, Issue 7 2010
William R. Owens
Abstract In many adult cardiac programs, intracorporeal mechanical circulatory support has become a routine treatment for end-stage cardiac failure. For the pediatric population, options are often limited by a small body habitus. Even when an adolescent's weight may suggest adequate space for device implant, most intracorporeal adult devices remain too large for adolescents. The Thoratec HeartMate II (HM II) (approved by the FDA in April of 2008) is a small, noiseless device that is easily operated and monitored. By having an uncomplicated operating system and small percutaneous drive line, the HM II provides an opportunity for these patients to aggressively rehabilitate to become a better transplant candidate and also provides the potential to be discharged home. The two youngest patients ever to utilize the HM II are also the first two cases of using the HM II at a freestanding pediatric hospital. A 12-year-old, 53 kg, girl with dilated cardiomyopathy was supported for 85 days before receiving her heart transplant. The second patient, a 13-year-old, 149 kg, Hispanic male suffering from morbid obesity and dilated cardiomyopathy, was supported for 128 days. The HM II allowed for rehabilitation and nutritional education, resulting in this patient losing 50 kg before heart transplant. Despite both of these patients' size, their thoracic cavities were that of a preadolescent and thus techniques were developed to avoid morbidities like chest wall abrasion and bleeding. Because of differences between adult and pediatric patients and institutions, these cases provided unique challenges. However, as pediatric device therapy is now maturing, pediatric programs such as Texas Children's Hospital have begun to develop strategies for mechanical support that factor in patient's size and need for long-term or temporary support, utilizing the growing number of devices (i.e., Jostra Rotoflow, Tandem Heart PTVA, Thoratec CentriMag, Berlin Heart EXCOR, etc.) that are now available to children. [source]


Safety and Acceptability of Implantation of Internal Cardioverter-Defibrillators Under Local Anesthetic and Conscious Sedation

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 8 2007
DAVID J. FOX B.M.Sc., M.B.Ch.B., M.R.C.P.
Background: Implantation and testing of implantable defibrillators (ICDs) using local anesthetic and conscious sedation is widely practiced; however, some centers still use general anesthesia. We assessed safety and patient acceptability for implantation of defibrillators using local anesthetic and conscious sedation. Methods: The records of 500 consecutive device implants from two UK cardiac centers implanted under local anesthetic and conscious sedation from January 1996 to December 2004 were reviewed. Procedure time, left ventricular ejection fraction (LVEF) sedative dosage (midazolam), analgesic dosage (fentanyl or diamorphine), requirement for drug reversal, and respiratory support were recorded. Patient acceptability of the procedure was also assessed. Results: Of 500 implants examined, 387 were ICDs, 88 were biventricular ICDs, and 25 were generator changes. Patients with biventricular-ICDs had significantly longer (mean ± SD) procedure times 129.7 ± 7.6 minutes versus 63.3 ± 32.3 minutes; P < 0.0001 and lower LVEF 24.4 ± 8.4% versus 35.7 ± 15.4%; P < 0.0001. There were no differences in the doses (mean ± SD) of midazolam 8.9 ± 3.5 mg versus 8.0 ± 3.1 mg; P = NS, diamorphine 4.3 ± 2.0 mg versus 3.8 ± 1.7 mg; P = NS or fentanyl 94.4 ± 53.7 mcg versus 92.2 ± 48.6 mcg; P = NS, between the two groups. There were no deaths or tracheal intubations in either group. Acceptability was available for 373 of 500 (75%) patients, 41 of 373 (11%) described "discomfort," but from these 41 patients only 14 of 373 (3.8%) declined a second procedure under the same conditions. Conclusions: Implantation of defibrillators under local anesthetic and sedation is safe and acceptable to patients. General anesthesia is no longer routinely required for implantation of defibrillators. [source]


Transcatheter closure of high-risk muscular ventricular septal defects with the CardioSEAL occluder: Initial report from the CardioSEAL VSD Registry

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2007
D. Scott Lim MD
Abstract Objectives: The CardioSEAL VSD registry was created to track safety of the device to close high-risk Ventricular Septal Defect (VSD). Background: This is the first report from the multi-centered CardioSEAL VSD registry reviewing demographics and initial results. Methods: Centers recruited patients with VSD who were high-risk for surgery due to medical condition or anatomic features. Results: 18 centers contributed data on 55 high-risk patients who had 61 VSD-occlusion procedures, with age of range of 5 days to 65 years and using one to six devices. Implantation approach was transvenous in 48, perventricular in five, and by combined approach in two patients. Ninety-two percent of intended VSD device implants were judged successful. Twenty-two patients had single VSD closed by single device in 18 and by two devices in four patients. All patients <8 kg underwent perventricular device implantation. Thirty-three patients had multiple VSDs which were closed by a single device in 23, and multiple devices in 10. At discharge echocardiography showed total residual flow through all VSDs in which devices were used was classified as "Small" or less in 74%, "More than small" in 11%, and "Uncertain" in 15%. Eight major adverse events occurred in 5/61 cases (8% event rate), with 3/81 devices embolized (4% embolization rate), 5/81 devices surgically explanted (6% explant rate), and no deaths judged to be procedure-related. Conclusion: This initial report from the multi-centered CardioSEAL VSD registry demonstrates the safety of the device to close high-risk VSDs. © 2007 Wiley-Liss, Inc. [source]