Paul J. Degroot

Prospective Randomized Multicenter Trial of Empirical Antitachycardia Pacing Versus Shocks for Spontaneous Rapid Ventricular Tachycardia in Patients With Implantable Cardioverter-Defibrillators Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) Trial Results

Background—Successful antitachycardia pacing (ATP) terminates ventricular tachycardia (VT) up to 250 bpm without the need for painful shocks in implantable cardioverter-defibrillator (ICD) patients. Fast VT (FVT) >200 bpm is often treated by shock because of safety concerns, however. This prospective, randomized, multicenter trial compares the safety and utility of empirical ATP with shocks for FVT in a broad ICD population. Methods and Results—We randomized 634 ICD patients to 2 arms—standardized empirical ATP (n=313) or shock (n=321)—for initial therapy of spontaneous FVT. ICDs were programmed to detect FVT when 18 of 24 intervals were 188 to 250 bpm and 0 of the last 8 intervals were >250 bpm. Initial FVT therapy was ATP (8 pulses, 88% of FVT cycle length) or shock at 10 J above the defibrillation threshold. Syncope and arrhythmic symptoms were collected through patient diaries and interviews. In 11±3 months of follow-up, 431 episodes of FVT occurred in 98 patients, representing 32% of ventricular tachyarrhythmias and 76% of those that would be detected as ventricular fibrillation and shocked with traditional ICD programming. ATP was effective in 229 of 284 episodes in the ATP arm (81%, 72% adjusted). Acceleration, episode duration, syncope, and sudden death were similar between arms. Quality of life, measured with the SF-36, improved in patients with FVT in both arms but more so in the ATP arm. Conclusions—Compared with shocks, empirical ATP for FVT is highly effective, is equally safe, and improves quality of life. ATP may be the preferred FVT therapy in most ICD patients.

Appropriate and Inappropriate Ventricular Therapies, Quality of Life, and Mortality Among Primary and Secondary Prevention Implantable Cardioverter Defibrillator Patients Results From the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) Trial

Background—Implantable cardioverter defibrillators (ICDs) reduce mortality in primary and secondary prevention. Quality of life, mortality, appropriate therapies for specific ventricular rhythms, and inappropriate therapies for supraventricular tachycardia (SVT) were compared among 582 patients (primary prevention=248; secondary prevention=334) in PainFREE Rx II, a 634-patient prospective, randomized study of antitachycardia pacing or shocks for fast ventricular tachycardia (FVT). Methods and Results—ICDs were programmed identically with 3 zones (ventricular tachycardia [VT] <188 bpm; FVT=188 to 250 bpm; ventricular fibrillation [VF] >250 bpm) but randomized to antitachycardia pacing or shock as initial therapy for FVT. All treated episodes with electrograms were adjudicated. Primary prevention patients had lower ejection fractions and more coronary artery disease. β-Blocker use, antiarrhythmic drug use, and follow-up duration were similar. Over 11±3 months, 1563 treated episodes were classified as VT (n=740), FVT (n=350), VF (n=77), and SVT (n=396). The distribution of VT, FVT, and VF was not different between primary and secondary prevention patients (respectively, VT 52% versus 54%, FVT 35% versus 35%, and VF 14% versus 10%). More secondary prevention patients had appropriate therapies (26% versus 18%, P=0.02), but among these patients, the median number of episodes per patient was similar. Inappropriate therapies occurred in 15% of both groups and accounted for similar proportions of all detected and treated episodes (46% in primary prevention patients versus 34% in secondary prevention patients, P=0.09). Quality of life improved modestly in both groups, and mortality was similar. Conclusions—Primary prevention patients are slightly less likely to have appropriate therapies than secondary prevention patients, but episode density is similar among patients with appropriate therapies. SVT resulted in more than one third of therapies in both groups, but quality of life and mortality were similar.

Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients

BACKGROUND Implantable cardioverter-defibrillator (ICD) shocks have been associated with an increased risk of death. It is unknown whether this is due to the ventricular arrhythmia (VA) or shocks and whether antitachycardia pacing (ATP) termination can reduce this risk. OBJECTIVE The purpose of this study was to determine whether mortality in ICD patients is influenced by the type of therapy (shocks of ATP) delivered. METHODS Cox models evaluated effects of baseline characteristics, ventricular tachycardia (VT; <188 bpm), fast VT (FVT; 188-250 bpm), ventricular fibrillation (VF; >250 bpm), and therapy type (shocks or ATP) on mortality among 2135 patients in four trials of ATP to reduce shocks. RESULTS Over 10.8 +/- 3.3 months, 24.3% patients received appropriate shocks (50.6%) or ATP only (49.4%), and 6.6% died. Mortality predictors were age (hazard ratio 1.07, 95% confidence interval 1.04-1.08, P <.0001), New York Heart Association class III/IV (3.50 [2.27-5.41]; P <.0001), coronary disease (3.08 [1.31-7.25]; P = .01), and cumulative VA (VT + FVT + VF) episodes shocked (1.20 [1.13, 1.29]; P <.0001). Beta-blockers (0.65, 0.46-0.92; P <.0001) and remote myocardial infarction (0.53, [0.38-0.76] P = .0004) predicted reduced risk. Since 92% of VT and all VF received a single therapy type (ATP and shocks, respectively), the effect of therapy on episode risk could not be established. For FVT (32% shocked, 68% ATP), episode and therapy effects could be uncoupled; ATP-terminated FVT did not increase episode mortality risk, whereas shocked FVT increased risk by 32%. Survival rates were highest among patients with no VA (93.8%) of ATP-only (94.7%) and lowest for shocked patients (88.4%). Monthly episode rates were 80% higher among shocked versus ATP-only patients. CONCLUSIONS Shocked VA episodes are associated with increased mortality risk. Shocked patients have substantially higher VA episode burden and poorer survival compared with ATP-only-treated patients.

Prospective comparison of biphasic and monophasic shocks for implantable cardioverter-defibrillators using endocardial leads

Bidirectional shocks using 2 current pathways have been used in endocardial lead systems for implantable cardioverter-defibrillators, but the optimal shock waveform for endocardial defibrillation is unknown. The clinical efficacy and electrical characteristics of bidirectional monophasic and biphasic shocks for endocardial cardioversion-defibrillation of fast monomorphic or polymorphic ventricular tachycardia (VT), or ventricular fibrillation (VF) were evaluated. Thirty-three patients (mean age 60 +/- 12 years, and mean left ventricular ejection fraction 34 +/- 13%) were studied. Defibrillation catheter electrodes were located in the right ventricular apex and superior vena cava/right atrial junction. A triple-electrode configuration including the 2 catheter electrodes and a left thoracic patch was used to deliver bidirectional shocks from the right ventricular cathode to an atrial anode (pathway 1) and the thoracic patch (pathway 2). The shock waveforms examined were sequential and simultaneous monophasic, and simultaneous biphasic. The efficacy of 580 V (20 J) shocks for fast monomorphic VT were comparable for the 3 waveforms (73% for sequential monophasic, 73% for simultaneous monophasic, and 100% for simultaneous biphasic). However, for polymorphic VT and VF, 580 V sequential monophasic shocks had a significantly lower efficacy (25%) than did simultaneous monophasic (75%; p = 0.01) or biphasic (89%; p less than 0.001) shocks. Single-shock defibrillation thresholds with simultaneous biphasic shocks were significantly lower (9 +/- 5 J) than were those with simultaneous monophasic shocks (15 +/- 4 J; p less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Low-energy endocardial defibrillation using an axillary or a pectoral thoracic electrode location.

BackgroundA significant proportion of patients receiving endocardial defibrillation lead systems must accept either high defibrillation thresholds (DFTs) with lower safety margins or lead implantation by thoracotomy. We examined the feasibility of achieving universal application of endocardial leads and lower defibrillation energy requirements by optimizing the lead system location in conjunction with biphasic shocks. Methods and ResultsTwo defibrillation catheter electrodes were positioned in the right ventricle and superior vena cava. Thoracic patch electrodes were placed at three sites (apical, pectoral, and axillary). Fifteen-joule, 10-J, and 5-J bidirectional simultaneous biphasic shocks were delivered across three different triple electrode configurations (right ventricle, superior vena cava, and patch) after inducing ventricular fibrillation (VF), and DFT was determined. All patients in whom VF was reproducibly inducible (14 patients) could be reproducibly defibrillated at 15 J at one or more patch electrode locations. Fifteen-joule shocks were effective at three thoracic electrode locations in 12 patients and at two electrode locations in 6 patients. The lowest mean single-shock DFI was 8.1±3.8 J. In 4 patients, ventricular flutter was reproducibly induced and reverted at 15 J in all patients. Mean DFT for the axillary location was 83±3.5 J and was significantly lower than apical (12.8±5.6 J, P=.008) and pectoral (11.6±4.1 J, p>.04) patch locations. The probability of success was significantly higher at 10 J with axillary location (78% of patients, p>.03 compared with both other sites) and at 15 J (P<.05 compared with the apical location). Low-energy endocardial defibrillation (s10 J) was feasible in 10 of 14 tested patients at more than 1 thoracic electrode location at 10 J, whereas only 1 of 7 successful patients could be reverted at more than 1 electrode location at 5 J (P<.02). ConclusionsThe use of axillary or pectoral patch lead location can allow endocardial defibrillation with biphasic shocks at energies s15 J in this lead configuration. Virtually universal application of endocardial defibrillation lead systems can be predicted from these data. Reduction in maximum pulse generator output to 525 J using these two thoracic electrode locations with bidirectional shocks can be feasible and maintain an adequate safety margin and permit thoracic pulse generator implantation. Lowering endocardial defibrillation energy <10 J requires increasing specificity of thoracic electrode location.

A prospective randomized comparison in humans of biphasic waveform 60-μF and 120-μF capacitance pulses using a unipolar defibrillation system

Background Improving unipolar implantable cardioverter-defibrillator (ICD) effectiveness has favorable implications for ICD safety, efficacy, and size. Advances in defibrillation efficacy would accelerate ICD ease of use by decreasing device size and by minimizing morbidity and mortality related to an improved defibrillation safety margin. The specific purpose of the present study was to determine whether unipolar defibrillation efficacy could be improved further in humans by lowering biphasic waveform capacitance. Methods and Results We prospectively and randomly compared the defibrillation efficacy of a 60-μF and a 120-μF capacitance asymmetrical 65% tilt biphasic waveform using a unipolar defibrillation system in 38 consecutive cardiac arrest survivors before implantation of a presently available standard transvenous defibrillation system. The right ventricular defibrillation electrode had a 5-cm coil located on a 10.5F lead and was used as the anode. The system cathode was the electrically active 108-...

Prospective randomized comparison of 50%/50% versus 65%/65% tilt biphasic waveform on defibrillation in humans.

SWEENEY, M.O., et al.: Prospective Randomized Comparison of 50%/50% Versus 65%/65% Tilt Biphasic Waveform on Defibrillation in Humans. It is unknown if there is a single optimal biphasic waveform for defibrillation. Biphasic waveform tilt may be an important determinant of defibrillation efficacy. The purpose of this study was to compare acute defibrillation success with a three‐electrode configuration in humans using 50%/50% versus 65%/65% tilt truncated exponential, biphasic waveforms delivered through a 110‐μF capacitor. Acute DFTs for biphasic waveforms with 50%/50% versus 65%/65% tilt were measured in random order in 60 patients using a binary search method. The electrode configuration consisted of a RV coil as the cathode, and a SVC coil plus a pectoral active can emulator (CAN) as the anode. The waveforms were derived from an external voltage source with 110‐μF capacitance, and the leading edge voltage of phase 2 was equal to the trailing edge voltage of phase 1. Stored energy DFT (9.2 ± 5.7 [50%/50%] vs 10.8 ± 6.4 [65%/65%] J, P = 0.007), current DFT (10.9 ± 4.0 [50%/50%] vs 12.0 ± 4.4 [65%/65%] A, P = 0.002) and voltage DFT (391 ± 118 [50%/50%] vs 424 ± 128 [65%/65%] V, P = 0.004) were significantly lower for the 50%/50% tilt waveform versus the 65%/65% tilt waveform using this three‐electrode configuration and a 110‐μF capacitor. For an RV (‐)/SVC plus CAN (+) electrode configuration and a 110‐μF capacitor, a 50%/50% tilt biphasic waveform results in a 15% reduction in energy DFT, 9% reduction in current DFT, and 8% reduction in voltage DFT versus a 65%/65% tilt biphasic waveform.

Derivation of a Defibrillator Implant Criterion Based on Probability of Successful Defibrillation

Common criteria for implant of a cordioverter defibrillator include verification of a 2:1 energy safety margin or a fixed safety margin of 10 joules. These criteria have been established empirically. We present a statistical model based on defibrillation efficacy curves which may be used to establish a criterion which would meet a predetermined target. As an example, an implant criterion is derived based on a goal of 1–year sudden cardiac death survival of at least 99% by selecting an expected first–shock efficacy to meet that target. Logistic regression was performed on data from over 1,500 defibrillator implants including successful epicardial and transvenous electrode system implants as well as data from unsuccessful implants. A random sample from these curves was used to generate a representative sample of 1,000 potential implant candidates, By assuming successful defibrillation using a series of shocks at specified energies, i.e., choosing an implant criterion, the probability of successful defibrillation of the patient by a single shock at a predetermined maximum output can be established. Independent data are used to validate the models accuracy in predicting defibrillation efficacy within the derived example.

A Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Size on Unipolar Defibrillation System Efficacy

BACKGROUND The active can unipolar implantable cardioverter-defibrillator (ICD) has been shown to defibrillate efficiently, but its current 80-cc size limits use in the pectoral position in many patients. Decreasing can size will facilitate pectoral insertion and will soon be feasible as an inevitable consequence of technological advancements. However, decreasing the can size has the potential to compromise unipolar defibrillation efficacy. It is the purpose of this study, therefore, to prospectively and randomly compare unipolar defibrillation efficacy with 80-cc, 60-cc, and 40-cc can sizes in patients immediately before ICD surgery in anticipation of advances in technology that will make smaller ICDs possible. METHODS AND RESULTS Twenty-four consecutive patients underwent prospective, randomized evaluation of the effect of ICD can size on defibrillation efficacy during standard ICD surgery. Each patient had the unipolar defibrillation threshold (DFT) measured with 80-cc, 60-cc, or 40-cc active can placed in the left subcutaneous infraclavicular region. The system included a 10.5F tripolar right ventricular electrode that served as the shock anode. The shock waveform used in each instance was a single capacitor biphasic 65% pulse delivered from a 120-microF capacitor. Stored energy at the DFT for the 80-cc, 60-cc, and 40-cc cans were 8.1 +/- 4.7 J, 8.7 +/- 5.8 J, and 9.5 +/- 4.8 J, respectively. There was no statistical significant difference between the DFTs for the three unipolar can electrodes (P = 39). Leading edge voltage also did not differ significantly among the three unipolar cans (356 +/- 92 V, 365 +/- 110 V, and 387 +/- 94 V, respectively, P = .29). There was, however, a slight progressive increase in resistance with decreasing can size (57 +/- 7 omega, 60 +/- 9 omega, and 65 +/- 9 omega, respectively, P < .001). CONCLUSIONS Decreasing can volume from 80 cc to 60 cc to 40 cc does not compromise unipolar defibrillation efficacy despite a slight rise in shock resistance. These findings indicate that technological advances that allow for smaller-volume ICDs will not compromise defibrillation efficacy for unipolar systems.

A Prospective Randomized Comparison in Humans of 90‐μF and 120‐μF Biphasic Pulse Defibrillation Using a Unipolar Defibrillation System

90‐μF and 120‐μF Biphasic Pulse Transvenous Defibrillation. Introduction: Capacitance is known to influence defibrillation. Optimal biphasic waveform capacitance for transvenous unipolar defibrillation systems in man is currently being defined. In an effort to improve defibrillation efficacy, we examined the relative defibrillation efficacy of a 65% tilt biphasic pulse from a 90‐μF capacitor compared to a 65% tilt biphasic pulse from a 120‐μF capacitor in a prospective, randomized fashion in 16 consecutive cardiac arrest survivors undergoing defibrillator surgery.