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PubMed1993

Implantable cardioverter defibrillator: Ventritex Cadence.

The Ventritex Cadence Model V-100 Tiered Therapy Defibrillator is a third generation antitachyarrhythmia device currently completing clinical trials in the United States. The implantable pulse generator is capable of high energy defibrillation, low energy cardioversion, as well as antitachycardia and bradycardia pacing. In addition, this microprocessor controlled device can deliver monophasic or biphasic defibrillation/cardioversion shocks, is noncommitted to deliver shock therapy after initiating charging for defibrillation or cardioversion therapy, and can store electrograms of spontaneous tachyarrhythmia episodes. These expanded device capabilities should improve therapy efficacy and patient management, and represent a major advance in the treatment of patients with ventricular tachyarrhythmias.

Bradycardia↗
PubMed1994

Double-pulse defibrillation using pulse separation based on the fibrillation cycle length.

INTRODUCTION: We investigated a method of defibrillation in which two shocks were delivered to the same electrodes with a separation based on the cycle length of the fibrillation event (FCL). METHODS AND RESULTS: In pentobarbital anesthetized dogs, a computerized system determined the FCL from the fibrillation event, computed the desired double-pulse (DP) shock separation, and immediately delivered the DP shocks. In group 1, energy for 50% success at defibrillation (E50) was measured using separations from 55% to 95% of the FCL and remeasured after administration of flecainide, clofilium, or vehicle to change the FCL. Both drugs increased FCL by approximately 25%. Plots of E50 versus %FCL aligned before and after drug showed that the optimum pulse separation followed the FCL. In group 2, E50s were measured for 55% to 185% FCL separations in clofilium or vehicle-treated animals. The optimum DP E50 was at 85% FCL and was not significantly different from the single-shock E50. In group 3, no differences were found when comparing the probability of success versus total energy relationships for single and optimum DP shocks. Group 4 compared E50s for single and DP shocks using a single-catheter configuration and three-electrode configurations (catheter-subdermal patch). E50s for single and DP shocks were equal using the single-catheter configuration but DP shocks required approximately 20% more energy in the three-electrode configurations. CONCLUSION: In single-pathway lead configurations, two shocks with 85% FCL separation can be reliably combined to defibrillate using the same total energy as a larger single shock. Since the energy is unchanged but the total duration is doubled, DP shock currents are reduced by 20% to 30%.

Animals↗
PubMed1995

Serial defibrillation threshold measures in man: a prospective controlled study.

UNLABELLED: Serial DFT Measures in Man. INTRODUCTION: The defibrillation threshold (DFT) may change throughout the first year following implantation of a cardioverter defibrillator, but it remains uncertain if changes are a consequence of changes in clinical condition or are related to fundamental alterations at the electrode-tissue interface. The purpose of this study was to evaluate the extent and time course of DFT changes over the first year following implantable cardioverter defibrillator (ICD) surgery when extraneous clinical and device variables potentially affecting the DFT were excluded. METHODS AND RESULTS: We prospectively enrolled 61 patients undergoing epicardial or nonthoracotomy/transvenous ICD therapy into a series of follow-up studies where the DFT was measured at implant and at 1, 6, 12, and 52 weeks following implantation in a uniform manner. Stored energy DFT was measured and recorded for all patients. Patient exclusion criteria were: (1) inability to complete all five measures of the DFT; (2) institution of Class I or Class III antiarrhythmic drugs at any time during the study; (3) lead system changes (relocation or new leads) or programming changes in pulse width or current pathway; or (4) development of a significant change in their clinical status, such as decompensated congestive heart failure or acute ischemia. Only 20 of the 61 patients satisfied the criteria required to complete the study. Two of the excluded patients developed high DFTs, which required reprogramming of the current pathway. Eight patients had an epicardial lead system, and 12 had a nonthoracotomy lead system.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1998

Enhanced detection criteria in implantable defibrillators.

INTRODUCTION: Enhanced detection criteria in third-generation implantable defibrillators have been implemented to avoid inappropriate therapy of fast supraventricular arrhythmias. We prospectively analyzed the use of these criteria in patients with an implantable defibrillator with electrogram storing capability. METHODS AND RESULTS: In 82 consecutive patients with a Guidant-CPI implantable defibrillator, sudden onset > 9% and stability < 40 msec were systematically programmed in zone 1 of therapy together with a sustained rate duration security mechanism. All detected tachycardia episodes were analyzed. The study population consisted of 59 patients who had at least one episode of tachycardia detected in zone 1 during follow-up. The tachycardia rate in zone 1 never exceeded 210 beats/min. Twenty patients had no episodes during follow-up, and three patients had episodes detected exclusively in zone 2 of therapy. Supraventricular arrhythmias were detected frequently in the ventricular tachycardia zone (193 of 690 tachycardia episodes in 23 of 59 patients). Use of sudden onset was very effective in detecting sinus tachycardias (65 of 67 episodes), and stability was very useful in detecting atrial fibrillation (31 of 32 episodes). However, sensitivity in detecting ventricular tachycardia was only 90% (451 of 497 episodes). Application of the sustained rate duration criterion allowed appropriate treatment of all ventricular tachycardia episodes, increasing sensitivity to 100%; however, specificity in appropriate nontreatment of supraventricular decreased from 96% to 83%. Subsequent analysis of different algorithms applied to our data showed that sudden onset > 9% and stability < 40 msec was the algorithm with the best specificity and sensitivity. CONCLUSION: Programming sudden onset and stability detection criteria with a sustained rate duration safety net for triggering tachycardia therapy results in appropriate device management in most patients with supraventricular and slow (< 210 beats/min) ventricular tachycardias.

Algorithms↗
PubMed2000

New approach to biphasic waveforms for internal defibrillation: fully discharging capacitors.

INTRODUCTION: The use of two independent, fully discharging capacitors for each phase of a biphasic defibrillation waveform may lead to the design of a simpler, smaller, internal defibrillator. The goal of this study was to determine the optimal combination of capacitor sizes for such a waveform. METHODS AND RESULTS: Eight full-discharge (95/95% tilt), biphasic waveforms produced by several combinations of phase-1 capacitors (30, 60, and 90 microF) and phase-2 capacitors (1/3, 2/3, and 1.0 times the phase-1 capacitor) were tested and compared to a single-capacitor waveform (120 microF, 65/65% tilt) in a pig ventricular fibrillation model (n = 12, 23+/-2 kg). In the full-discharge waveforms, phase-2 peak voltage was equal to phase-1 peak voltage. Shocks were delivered between a right ventricular lead and a left pectoral can electrode. E50s and V50s were determined using a ten-step Bayesian process. Full-discharge waveforms with phase-2 capacitors of < or =40 microF had the same E50 (6.7+/-1.7 J to 7.3+/-3.9 J) as the single-capacitor truncated waveform (7.3+/-3.7 J), whereas waveforms with phase-2 capacitors of > or =60 microF had an extremely high E50 (14.5+/-10.8 J or greater, P < 0.05). Moreover, of the former set of energy-efficient waveforms, those with phase-1 capacitors of > or =60 microF additionally exhibited V50s that were equivalent to the V50 of the single-capacitor waveform (344+/-65 V to 407+/-50 V vs 339+/-83 V). CONCLUSION: Defibrillation efficacy can be maintained in a full-discharge, two-capacitor waveform with the proper choice of capacitors.

Animals↗
PubMed2000

Virtual electrodes and deexcitation: new insights into fibrillation induction and defibrillation.

Previous models of fibrillation induction and defibrillation stressed the contribution of depolarization during the response of the heart to a shock. This article reviews recent evidence suggesting that comprehending the role of negative polarization (hyperpolarization) also is crucial for understanding the response to a shock. Negative polarization can "deexcite" cardiac cells, creating regions of excitable tissue through which wavefronts can propagate. These wavefronts can result in new reentrant circuits, inducing fibrillation or causing defibrillation to fail. In addition, deexcitation can lead to rapid propagation through newly excitable regions, resulting in the elimination of excitable gaps soon after the shock and causing defibrillation to succeed.

Computer Simulation↗
PubMed2006

Intraoperative comparison of a subthreshold test pulse with the standard high-energy shock approach for the measurement of defibrillation lead impedance.

UNLABELLED: There are two methods to measure shocking lead impedance: delivery of high-energy shocks that require patient sedation, and the painless measurement of impedance from subthreshold test pulses. The aim of this study was to compare the two methods. METHODS: The study included 131 patients implanted with a standard DR (n = 71) or VR (n = 60) ICD connected to either single-coil (n = 39) or dual-coil (n = 92) defibrillation leads. The noninvasive high-energy impedance test was done using a 17 J shock after induction of ventricular tachyarrhythmias and compared to a 0.4 microJ test pulse used by the ICD for the subthreshold measurements. RESULTS: Defibrillation lead impedance measurements were not significantly different between patients with the same shocking vector configuration. In patients with a single-coil defibrillation lead the impedance was 62 +/- 9 Omega with the high-energy shock and 62 +/- 8 Omega with the subthreshold test pulses (P = 0.13). Patients with a dual-coil configuration recorded average impedances of 40 +/- 5 Omega from both tests (P = 0.44). While there was no difference in values recorded within each lead configuration, there was a significant difference in impedance between the single-coil and the dual-coil patient groups (P = 0.001). CONCLUSIONS: There was no significant difference between shocking lead impedances measured with the high-energy shock or the subthreshold test pulses. This offers the possibility of noninvasive, low-energy serial measurements of shocking lead impedance at follow-up visits and removing the need for sedation.

Defibrillators, Implantable↗
PubMed1993

Does ventricular fibrillation cause myocardial stunning during defibrillator implantation?

Induction of ventricular fibrillation (VF) is an important part of the process of inserting implantable cardioverter defibrillators (ICDs), allowing the measurement of defibrillation thresholds. However, animal studies have revealed that repeated cycles of VF and defibrillation result in depressed left ventricular (LV) function and reduced cardiac output. Short intervals of VF do not affect myocardial contractility but longer periods produce heart failure. Induced VF was used in a canine model to study profound myocardial stunning leading to heart failure, as well as the therapeutic potential of the phosphodiesterase inhibitor, amrinone (combined with epinephrine and norepinephrine). Amrinone was found to significantly (p < 0.05) increase contractility when added to a stable preparation supported by epinephrine and norepinephrine infusion; amrinone or catecholamines alone had no effect. In the clinical setting, the following factors may affect LV contractility during ICD surgery: catecholamines released as a result of hypotension; negative VF; ischemia; antiarrhythmic drugs; anesthetics; and bradycardia after device testing. Patients (n = 125) have tolerated ICD insertion well. Early data reveals no significant changes in ejection fraction. Though rare, death due to myocardial stunning and LV power failure can occur during ICD insertion. It may be possible to use arterial pressure monitoring to predict this event in vulnerable patients.

Animals↗
PubMed1998

Cardiomyoplasty and implantable cardioverter defibrillator: efficacy and safety of concomitant device implantation: sudden death and cardiomyoplasty.

Sudden death represents a common event in the natural history of patients affected by chronic heart failure. Such an outcome also has been shown to characterize the follow-up of the cardiomyoplasty procedure. We report two cases of patients who had cardiomyoplasty and experienced witnessed episodes of ventricular arrhythmia at variable times after surgery (2 years and 2 months, respectively). In the first case, an implantable cardioverter defibrillator (ICD) was implanted subsequent to the arrhythmic episode, whereas the second patient had a combined cardiomyoplasty and ICD implantation procedure. In particular, this patient underwent a modified wrapping technique, herein described, because of a large left ventricular dilatation. In both cases, ventricular defibrillation did not affect the correct functioning of the implanted cardiomyostimulator. Our article confirms that ventricular arrhythmia is common in cardiomyoplasty patients. The combined use of a skeletal muscle stimulator and implantable defibrillator may therefore be effective in preventing arrhythmia-related sudden death without any concurrent effect on the correct functioning of the wrapped muscle/heart circuit, with likely benefit on long-term cardiomyoplasty patient survival.

Aged↗
PubMed2004

Incidence and electrophysiological characteristics of spontaneous ventricular tachyarrhythmias in high risk coronary patients and prophylactic implantation of a defibrillator.

OBJECTIVES: To assess the incidence and electrophysiological characteristics of spontaneous ventricular tachyarrhythmias after implantable cardioverter-defibrillator (ICD) implantation for primary prevention. DESIGN: Prospective observational study. PATIENTS: 41 consecutive patients, who fulfilled MADIT (multicenter automatic defibrillator implantation trial) I criteria, except for suppressibility by procainamide, and who received a prophylactic ICD. INTERVENTIONS: Subpectoral implantation of an ICD. MAIN OUTCOME MEASURES: Incidence of ventricular tachyarrhythmias and their electrophysiological characteristics with respect to timing of the arrhythmia, tachyarrhythmia cycle length, mode of termination, and clinical relevance. RESULTS: During a mean (SD) follow up of 30 (21) months 18 of 41 (43.9%) patients experienced 142 appropriate ICD treatments. The mean (SD) time to first event was 9.6 (15.1) months. One patient had ventricular fibrillation (VF), 12 patients ventricular tachycardia (VT), and five both VT and VF. The mean (SD) cycle length of monomorphic VT was 306 (42) ms. Of 142 episodes, 117 (82.3%) were terminated by antitachycardia pacing and another 25 (17.6%) by ICD discharges. Cumulative survival of hypothetical death, defined as treated VT with a cycle length < 260 ms or VF, was 83.2% after one year and 78.4% after two years. CONCLUSIONS: Patients with a left ventricular ejection fraction < 35%, a history of myocardial infarction, non-sustained VT, and inducible VT/VF are at high risk of VT/VF early after implantation. Therefore, implantation of a tiered treatment defibrillator seems to be justified.

Aged↗
PubMed1993

Experience of cardioverter-defibrillators inserted without thoracotomy: evaluation of transvenously inserted intracardiac leads alone or with a subcutaneous axillary patch.

OBJECTIVES: To compare the efficacy of a purely transvenous cardioverter-defibrillator (ICD) system with that of a system with a supplementary subcutaneous patch. To evaluate clinical follow up of these lead arrangements that do not require thoracotomy. DESIGN: A simplified defibrillation protocol to test two different lead arrangements during implantation, with routine clinical follow up after implantation. SETTING: Tertiary referral centre for treatment of arrhythmia. PATIENTS: 22 consecutive patients selected for implantation of an ICD because of life-threatening ventricular arrhythmias (ventricular fibrillation or sustained ventricular tachycardia) of whom 20 entered the test protocol. INTERVENTION: Implantation of an ICD with transvenously inserted intracardiac leads and a subcutaneous patch and assessment of effective defibrillation followed by testing of the purely transvenous approach. MAIN OUTCOME MEASURES: Reproducible conversion of ventricular fibrillation to sinus rhythm at a certain energy level, providing a safety margin of at least 10 J for both lead arrangements. Confirmation of efficacy during clinical follow up (mean 6 months). RESULTS: A transvenous lead system combined with a subcutaneous axillary patch was implanted in 20/22 patients and it provided adequate and acceptable energy levels. In 10/20 tested patients a purely transvenous lead configuration provided an acceptable safety margin as well. Nine patients had clinical recurrences: all these arrhythmias were successfully converted. CONCLUSION: A transvenous lead system was sufficient in 50% of the patients at the time of implantation. Data on long-term clinical follow up of this arrangement are not available. The approach without thoracotomy with a subcutaneous patch is feasible and effective in most patients selected for ICD treatment.

Adult↗
PubMed1993

Efficacy of a tiered therapy defibrillator system used to treat recurrent ventricular arrhythmias refractory to drugs.

OBJECTIVE: To evaluate an implantable tiered therapy defibrillator system that delivered antitachycardia pacing treatment for slower well tolerated ventricular tachycardias and cardioversion or defibrillation for fast tachycardias or ventricular fibrillation. METHODS: A tiered treatment device (Ventritex Cadence V-100) was implanted in 30 patients with ventricular tachycardia that was refractory to drugs. Efficacy was evaluated by the responses of induced or spontaneous arrhythmias to the treatments delivered. RESULTS: Antitachycardia pacing successfully terminated 80% of episodes of ventricular tachycardia induced by non-invasive programmed stimulation, but acceleration was brought about by pacing in six patients in 10% of episodes. During a follow up of two to 17 (mean seven) months, 18 patients (60%) had recurrence of ventricular arrhythmias. Antitachycardia pacing terminated ventricular tachycardia in 17 of 18 patients in 87% of episodes. Twelve patients received shocks for ventricular tachycardia or fibrillation. Failure of pacing, with subsequent cardioversion, occurred in nine patients (50%) in one or more episodes. Acceleration of tachycardia by pacing occurred in 10 patients in 5% of episodes. Only two of these patients had experienced acceleration of previously induced arrhythmia. Five patients had spontaneous fast ventricular tachycardia or fibrillation treated by cardioversion or defibrillation. Spurious treatment was delivered in nine patients (30%), during atrial fibrillation in five, sinus tachycardia in two, and because of fracture of the sensing lead system in two patients. The retrieval of stored intracardiac electrograms was of clinical value in assessing spurious treatment. CONCLUSIONS: Tiered treatment was effective in terminating recurrent ventricular arrhythmias in these selected patients. Most episodes were treated successfully by pacing, and resistant tachycardias, pacing induced acceleration, or haemodynamically compromising arrhythmias were treated by shocks.

Adolescent↗
PubMed1998

Differential effects of defibrillation on systemic and cardiac sympathetic activity.

OBJECTIVE: To assess the effect of defibrillation shocks on cardiac and circulating catecholamines. DESIGN: Prospective examination of myocardial catecholamine balance during dc shock by simultaneous determination of arterial and coronary sinus plasma concentrations. Internal countershocks (10-34 J) were applied in 30 patients after initiation of ventricular fibrillation for a routine implantable cardioverter defibrillator test. Another 10 patients were externally cardioverted (50-360 J) for atrial fibrillation. MAIN OUTCOME MEASURES: Transcardiac noradrenaline, adrenaline, and lactate gradients immediately after the shock. RESULTS: After internal shock, arterial noradrenaline increased from a mean (SD) of 263 (128) pg/ml at baseline to 370 (148) pg/ml (p = 0.001), while coronary sinus noradrenaline fell from 448 (292) to 363 (216) pg/ml (p = 0.01), reflecting a shift from cardiac net release to net uptake. After external shock delivery, there was a similar increase in arterial noradrenaline, from 260 (112) to 459 (200) pg/ml (p = 0.03), while coronary sinus noradrenaline remained unchanged. Systemic adrenaline increased 11-fold after external shock (p = 0.01), outlasting the threefold rise following internal shock (p = 0.001). In both groups, a negative transmyocardial adrenaline gradient at baseline decreased further, indicating enhanced myocardial uptake. Cardiac lactate production occurred after ventricular fibrillation and internal shock, but not after external cardioversion, so the neurohumoral changes resulted from the defibrillation process and not from alterations in oxidative metabolism. CONCLUSIONS: A dc shock induces marked systemic sympathoadrenal and sympathoneuronal activation, but attenuates cardiac sympathetic activity. This might promote the transient myocardial depression observed after electrical discharge to the heart.

Adult↗
PubMed2002

Effect of implantable defibrillators on arrhythmic events and mortality in the multicenter unsustained tachycardia trial.

BACKGROUND: The Multicenter Unsustained Tachycardia Trial (MUSTT) was designed to evaluate an antiarrhythmic treatment strategy, including drugs and implantable defibrillators (ICDs), guided by electrophysiological (EP) testing. We performed several statistical analyses to assess the contribution of defibrillators to the observed treatment benefit. METHODS AND RESULTS: First, the effects of defibrillators were indirectly examined by comparing the randomized treatment arms (EP-guided therapy versus no antiarrhythmic therapy) within subgroups that varied according to ICD usage. Use of ICDs increased during the trial; hence, the randomized treatments were compared according to date of enrollment. There were also site-specific differences in ICD use; hence, the randomized arms were compared within groups of sites defined by level of ICD use. There was a distinct "dose response" in relation to ICD use. Where ICD use was high, EP-guided therapy produced significant reductions in arrhythmic death or cardiac arrest (P<0.004). Where ICD use was low, there was no benefit of EP-guided therapy. Finally, outcomes of EP-guided therapy patients who received an ICD were directly compared with outcomes of other patients using the Cox proportional hazards model with receipt of an ICD as a time-dependent covariate. Adjusted for other prognostic factors, patients who received an ICD had risk reductions of >70% in arrhythmic death or cardiac arrest and >50% in total mortality (P<0.001 for both end points). CONCLUSIONS: The benefit of EP-guided antiarrhythmic therapy observed in MUSTT was due to improved outcomes among patients who received an ICD but not among patients who received antiarrhythmic drugs.

Anti-Arrhythmia Agents↗
PubMed2003

Determination of the upper limit of vulnerability using implantable cardioverter-defibrillator electrograms.

BACKGROUND: The upper limit of vulnerability (ULV) correlates with the defibrillation threshold and can be determined with 1 episode of ventricular fibrillation (VF). To automate the ULV in an implantable cardioverter-defibrillator (ICD), the most vulnerable intervals must be identified from an ICD electrogram rather than the latest-peaking surface T wave (Tpeak). We hypothesized that the recovery time (TR), defined as the maximum derivative (dV/dt) of the T wave of the shock electrogram, correlates with the most vulnerable intervals. METHODS AND RESULTS: We determined ULV, defibrillation threshold, and the most vulnerable intervals in 25 patients at ICD implantation. The ULV was the weakest T-wave shock that did not induce VF. The most vulnerable intervals were the ones associated with the strongest shocks that induced VF. Telemetered shock electrograms were stored on digital tape and differentiated offline to measure TR. Tpeak and TR were highly correlated (Tpeak-TR=-2+/-11 ms; rho=0.80, P<0.001). At least 1 most vulnerable interval timed between -20 ms and +20 ms relative to Tpeak in all patients and between -40 ms and +20 ms relative to TR in 96% of patients. CONCLUSIONS: The recovery time of shock electrograms provides accurate information about global repolarization. TR closely approximates Tpeak. The ULV method may be automated in an ICD by timing T-wave shocks relative to TR.

Aged↗
PubMed2003

Proarrhythmic effect of pacemaker stimulation in patients with implanted cardioverter-defibrillators.

BACKGROUND: We sought to determine the potential of right ventricular VVI backup pacing to induce ventricular tachyarrhythmias in patients with implanted cardioverter-defibrillators. METHODS AND RESULTS: All consecutive patients presenting exclusively with pacemaker-induced tachycardias (PITs) were included in a prospective study using a crossover protocol. Patients were randomized to either group 1 (augmentation of the baseline frequency of the pacemaker to 60 bpm) or group 2 (pacemaker turned off) and were followed up for 1 year and then crossed over to the other programming, looking for reoccurrence of PIT. Of 150 consecutive patients, 39 (26%) had PIT, 13 of them exclusively (8.6%). Forty of 1063 analyzed tachyarrhythmias of all the patients were PIT (3%). Before inclusion in the study, the patients had 2.7+/-0.9 PITs in 11+/-6.5 months with their pacemakers programmed empirically at 42.3 bpm. During the study phase, no PIT occurred while the pacemaker was turned off, whereas programming to 60 bpm led to the recurrence of PIT in 5 of 6 patients (1.4+/-0.6 per patient). At the end of the study, 9 patients underwent a prolonged follow-up with their pacemakers turned off, resulting in spontaneous episodes of ventricular tachycardia/fibrillation in 5 patients, but PITs were no longer observed. CONCLUSIONS: This crossover protocol proves the potential proarrhythmic effect of pacemaker stimulation in implantable cardioverter-defibrillator patients. Resulting PITs led to clinical symptoms and antitachycardia therapy by the implantable cardioverter-defibrillator. Thus, in patients presenting with PIT but without a pacemaker indication, the pacemaker feature should be turned off, or, alternatively, the longest possible escape interval should be programmed.

Arrhythmias, Cardiac↗
PubMed2004

Life-years gained from defibrillator implantation: markedly nonlinear increase during 3 years of follow-up and its implications.

BACKGROUND: Although treatment benefit in randomized controlled trials of defibrillators is often summarized by the numbers of lives saved (absolute risk difference), this may not be a good representation of what matters most to patients, namely, the amount of life they should expect to gain from implantation. The estimate of gain in life-years may depend on duration of follow-up. In this study, we examine this dependency. METHODS AND RESULTS: We estimated, from published data of 8 landmark defibrillator trials, the cumulative benefit in life-years gained at time points from 3 months to 3 years. Because the trial populations, clinical status, and prognosis varied widely between studies, we expressed for each study the benefit at each time point as the proportion of benefit at 3 years. The average dependency of the benefit on duration of follow-up was then calculated. We found that the number of life-years gained from 1 device implantation increases with length of follow-up considered. Importantly, this increase is markedly nonlinear. Within the 3-year span addressable, the benefit rises with the square of time (gain infinity t(1.94), R2=0.998, P<0.001). CONCLUSIONS: Measurable benefit from a defibrillator to patients' life spans (life-years gained) is dramatically dependent on the time window over which the benefit is assessed. Because the effort of implantation is front loaded, yet benefit grows with time, the choice of an early time point artificially reduces apparent benefit and artificially increases the apparent number needed to treat to prevent an event. These are useful considerations for the formulation of treatment policy (and even for planning of the follow-up phase of clinical trials).

Clinical Trials as Topic↗
PubMed1999

Initial experience with larger laser sheaths for the removal of transvenous pacemaker and implantable defibrillator leads.

BACKGROUND: In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-à-vis the 12F laser sheath. METHODS AND RESULTS: In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size. CONCLUSIONS: The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath.

Adolescent↗