ICD Implant (icd + implant)

Distribution by Scientific Domains


Selected Abstracts


Is Defibrillation Testing Still Necessary?

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 4 2008
A Decision Analysis, Markov Model
Objective: To assess the impact of defibrillation threshold (DFT) testing of implanted cardioverter-defibrillators (ICDs) on survival. Background: DFT testing is generally performed during implantation of ICDs to assess sensing and termination of ventricular fibrillation. It is common clinical practice to defibrillate ventricular fibrillation twice at an output at least 10 J below the maximum output of the device, providing a 10 J safety margin. However, there are few data regarding impact of DFT testing on outcomes. Methods: Decision analysis and Monte Carlo simulation were used to assess expected outcomes of DFT testing. Survival of a hypothetical cohort of patients was assessed according to two strategies,routine DFT testing at time of ICD implant versus no DFT testing. Assumptions in the model were varied over a range of reasonable values to assess outcomes under a variety of scenarios. Results: Five-year survival with DFT and no-DFT strategies were similar at 59.72% and 59.36%, respectively. The results were not sensitive to changing risk estimates for arrhythmia incidence and safety margin. Results of the Monte Carlo simulation were qualitatively similar to the base case scenario and consistent with a small and nonsignificant survival advantage with routine DFT testing. Conclusions: The impact of DFT testing on 5-year survival in ICD patients, if it exists, is small. Survival appears higher with DFT testing as long as annual risk of lethal arrhythmia or the risk of a narrow safety margin is at least 5%, although the incremental benefit is marginal and 95% confidence intervals cross zero. A prospective randomized study of DFT testing in modern devices is warranted. [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]


Ancillary Tools in Pacemaker and Defibrillator Lead Extraction Using a Novel Lead Removal System

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 3 2001
ANTONIS S. MANOLIS
MANOLIS, A.S., et al.: Ancillary Tools in Pacemaker and Defibrillator Lead Extraction Using a Novel Lead Removal System. A previous report described our preliminary experience with a highly successful pacing lead removal system (VascoExtor). Extending this experience, we found it necessary to use additional tools to enhance the success of percutaneous lead extraction with this system. In the present series, we used the standard locking stylets (S and K), and recently, one newer type of stylet (Magic) over the last 3 years in 34 patients to extract 48 pacemaker leads in 31 patients and 3 defibrillator (ICD) leads in 3 patients. Lead extraction was carried out in 23 men and 11 women (aged 64 ± 17 years) because of pacemaker infection (n = 21), pacemaker (n = 8) or ICD (n = 3) lead malfunction, or prior to ICD implant (n = 2). Leads were in place for 3.5 ± 3.7 years. Infections, involving pocket and lead(s), were due to S. epidermidis (n = 13), S. aureus (n = 6), S. aureus plus E. coli (n = 1), or fungi (n = 1). Of the 48 pacing leads, 31 were ventricular, 15 atrial, and 2 were VDD leads. The ICD leads were two double-coil leads (CPI) and one single-coil lead (Telectronics). Using the S (n = 12), K (n = 8), or Magic (n = 3) stylets, all pacing leads in 23 patients and the ICD leads in 2 patients were successfully removed from a subclavian approach using the locking stylets. However, in nine (26.5%) patients ancillary tools were required. In four patients, lead fragments were captured with use of a noose catheter, a pigtail catheter, and a bioptome from a right femoral approach. In two patients, locking could not be effected and a noose catheter from the right femoral vein was used, aided by a pigtail and an Amplatz catheter and a bioptome to remove three leads. In a patient with an ICD lead, a combined subclavian (stylet S) and right femoral approach (noose catheter) was required. In a patient with a dysfunctional ventricular lead 12 years old, a motor drive unit was used to facilitate the exchange of locking stylets, but extraction failed. In another patient, a fragment of a dysfunctional ventricular lead remained intravascularly despite resorting to a femoral approach. Finally, lead removal was completely (32/34, 94%) or partially (1/34, 3%) successful in 33 (97%) of 34 patients for 50 (98%) of 51 leads without complications. In conclusion, to enhance the success of pacing or ICD lead extraction with use of the VascoExtor locking stylets, an array of ancillary tools were required in more than one fourth of patients. [source]


Transvenous Pacemaker Insertion Ipsilateral to Chronic Subclavian Vein Obstruction: An Operative Technique for Children and Adults

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 11 2000
MARC OVADIA
OVADIA, M., et al.: Transvenous Pacemaker Insertion Ipsilateral to Chronic Subclavian Vein Obstruction: An Operative Technique for Children and Adults. Subclavian vein occlusion limits insertion of pacing electrodes in children and adults. The concern is greatest in children with a long-term need for pacing systems necessitating use of the contralateral vein and potential bilateral loss of access in the future. We describe an operative technique to provide ipsilateral access in chronic subclavian vein occlusion in five consecutive pediatric (n = 4, mean age 6.5 years) and adult (n = 1, age 70 with bilateral subclavian vein occlusion) patients in whom this condition was noted at the time of pacemaker or ICD implant. Occlusion was documented by venography. Pediatric cardiac diagnoses included complete heart block in all patients, tetralogy of Fallot in three, and L-transposition of the great vessels in one. Percutaneous brachiocephalic (innominate) or deep subclavian venous access was achieved by a supraclavicular approach using an 18-gauge Deseret angiocath, a Terumo Glidewire, and dilation to permit one or two 9,11 Fr sheaths. Electrode(s) were positioned in the heart and tunneled (pre, or retroclavicularly) to a pre, or retropectoral pocket. Pacemaker and ICD implants were successful in all without any complication of pneumothorax, arterial or nerve injury, or need for transfusion. Inadvertent arterial access did not occur as compared with prior infraclavicular attempts. One preclavicularly tunneled electrode dislodged with extreme exertion and was revised. Ipsilateral transvenous access for pacemaker or ICD is possible via a deep supraclavicular percutaneous approach when the subclavian venous obstruction is discovered at the time of implant. In children, it avoids the use of the contralateral vein that may be needed for future pacing systems in adulthood. This venous approach provides access large enough to allow even dual chamber pacing in children and can be accomplished safely. [source]


A Comparison of ICD Implantations in the United States Versus Italy

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 2007
STEVEN M. GREENBERG M.D.
Background: The benefits conferred by implantable cardioverter defibrillators (ICDs) have expanded to primary prevention. The advancements in ICD therapy (ACT) registry in the United States and the Italian ICD registry (IIR) examine changing trends in ICD implantation in their respective countries. Data from these registries may be useful for comparison of transcontinental differences in ICD utilization. Methods: This study includes initial implantations in patients enrolled in ACT and IIR. A comparative analysis was performed for device indications based on primary or secondary prevention. Sub-group analyses by device types (single, dual chamber, or cardiac resynchronization) were performed. Results: This analysis included 4,547 primary implantations in ACT and 6,491 in IIR. The groups were similar with respect to age. There were 82% primary and 18% secondary prevention indications in ACT, versus 42% primary and 58% secondary prevention indications in IIR (P < 0.001). There was a significantly higher rate of dual chamber ICD implants in ACT than in IIR for both primary (35.7% vs 23.7%, P < 0.001) and secondary prevention (52.3% vs 36.9%, P < 0.001). Conversely, more CRT-D were implanted in IIR than in ACT (primary prevention 46.5% vs 32.0%; secondary prevention 29.0% vs 13.0%, P < 0.001). Conclusions: Significant differences were observed in the types of indications for ICDs between ACT and IIR. Device prescription differed significantly between countries. The specific reasons for differences in ICD implantation patterns in these two countries are unclear. These observations warrant further investigations to determine if these differences are associated with different qualities of life and clinical outcomes. [source]


Transvenous Pacemaker Insertion Ipsilateral to Chronic Subclavian Vein Obstruction: An Operative Technique for Children and Adults

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 11 2000
MARC OVADIA
OVADIA, M., et al.: Transvenous Pacemaker Insertion Ipsilateral to Chronic Subclavian Vein Obstruction: An Operative Technique for Children and Adults. Subclavian vein occlusion limits insertion of pacing electrodes in children and adults. The concern is greatest in children with a long-term need for pacing systems necessitating use of the contralateral vein and potential bilateral loss of access in the future. We describe an operative technique to provide ipsilateral access in chronic subclavian vein occlusion in five consecutive pediatric (n = 4, mean age 6.5 years) and adult (n = 1, age 70 with bilateral subclavian vein occlusion) patients in whom this condition was noted at the time of pacemaker or ICD implant. Occlusion was documented by venography. Pediatric cardiac diagnoses included complete heart block in all patients, tetralogy of Fallot in three, and L-transposition of the great vessels in one. Percutaneous brachiocephalic (innominate) or deep subclavian venous access was achieved by a supraclavicular approach using an 18-gauge Deseret angiocath, a Terumo Glidewire, and dilation to permit one or two 9,11 Fr sheaths. Electrode(s) were positioned in the heart and tunneled (pre, or retroclavicularly) to a pre, or retropectoral pocket. Pacemaker and ICD implants were successful in all without any complication of pneumothorax, arterial or nerve injury, or need for transfusion. Inadvertent arterial access did not occur as compared with prior infraclavicular attempts. One preclavicularly tunneled electrode dislodged with extreme exertion and was revised. Ipsilateral transvenous access for pacemaker or ICD is possible via a deep supraclavicular percutaneous approach when the subclavian venous obstruction is discovered at the time of implant. In children, it avoids the use of the contralateral vein that may be needed for future pacing systems in adulthood. This venous approach provides access large enough to allow even dual chamber pacing in children and can be accomplished safely. [source]


Electrophysiologist-Implanted Transvenous Cardioverter Defibrillators Using Local Versus General Anesthesia

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1 2000
ANTONIS S. MANOLIS
With the advent of smaller biphasic transvenous implantable Cardioverter defibrillators (ICDs) and the experience gained over the years, it is now feasible for electrophysioiogists to implant them safely in the abdominal or pectoral area without surgical assistance. Throughout the years, general anesthesia has been used as the standard technique of anesthesia for these procedures. However, use of local anesthesia combined with deep sedation only for defibrillation threshold (DFT) testing might further facilitate and simplify these procedures. The purpose of this study was to test the feasibility of using local anesthesia and compare it with the standard technique of general anesthesia, during implantation of transvenous ICDs performed by an electrophysiologist in the electrophysiology laboratory. For over 4 years in the electrophysiology laboratory, we have implanted transvenous ICDs in 90 consecutive patients (84 men and 6 women, aged 58 ± 15 years). Early on, general anesthesia was used (n = 40, group I), but in recent series (n = 50, group II) local anesthesia was combined with deep sedation for DFT testing. Patients had coronary (n = 58) or valvular (n = 4) disease, cardiomyopathy (n = 25) or no organic disease (n = 3), a mean left ventricular ejection fraction of 35%, and presented with ventricular tachycardia (n = 72) or fibrillation (n = 16), or syncope (n = 2). One-lead ICD systems were used in 74 patients, two-lead systems in 10 patients, andan AVICD in 6 patients. ICDs were implanted in abdominal (n = 17, all in group I) or more recently in pectoral (n = 73) pockets. The DFT averaged 9.7 ± 3.6 J and 10.2 ± 3.6 J in the two groups, respectively (P = NS) and there were no differences in pace-sense thresholds. The total procedural duration was shorter (2.1 ± 0.5 hours) in group II (all pectoral implants) compared with 23 pectoral implants of group I (2.9 ± 0.5 hours) (P < 0.0001). Biphasic devices were used in all patients and active shell devices in 67 patients; no patient needed a subcutaneous patch. There were six complications (7%), four in group I and two in group II: one pulmonary edema and one respiratory insufficiency that delayed extubation for 3 hours in a patient with prior lung resection, both probably related to general anesthesia, one lead insulation break that required reoperation on day 3, two pocket hematomas, and one pneumothorax. There was one postoperative arrhythmic death at 48 hours in group I. No infections occurred. Patients were discharged at a mean time of 3 days. All devices functioned well at predischarge testing. Thus, it is feasible to use local anesthesia for current ICD implants to expedite the procedure and avoid general anesthesia related cost and possible complications. [source]