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Does defibrillation threshold increase as left ventricular ejection fraction decreases?
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PMID:  20047925     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: Advanced cardiac disease, entailing more hypertrophy, fibrosis, scarring, dilatation and conduction delays, poses the question of whether defibrillation thresholds (DFTs) increase as left ventricular ejection fraction (LVEF) decreases. This question has been approached indirectly or insufficiently in previous studies. In this study we add and expand on our previous work, stratifying DFT for various LVEF ranges.
METHODS AND RESULTS: This retrospective analysis included DFT data from three acute, multicentre, randomized studies that included 230 ICD/CRT-D patients. All DFTs were obtained with the SVC coil turned ON and with pulse-width optimized waveforms based on a 3.5 ms membrane time constant. As the LVEF decreased, DFT estimates increased from 395.2 +/- 115 V for LVEF > or = 46% to 425.8 +/- 117.6 V for LVEF < or = 25%. However, these changes in DFT estimates were very minor and not statistically significant. Only 3% of the patients in this population had an elevated DFT of >20 J.
CONCLUSION: This analysis shows that over a very broad range of LVEF, DFT changes minimally (approximately 1 J), if at all. Our results are consistent with previous studies that demonstrated no difference in the DFT estimates: (a) between patient groups receiving ICD (typically higher LVEF) vs. CRT-D (typically lower LVEF) and (b) between patient groups receiving a device for primary prevention indications (typically lower LVEF) vs. secondary prevention indications (typically higher LVEF).
Authors:
Jesus E Val-Mejias; Ashish Oza
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-01-03
Journal Detail:
Title:  Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology     Volume:  12     ISSN:  1532-2092     ISO Abbreviation:  Europace     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-22     Completed Date:  2010-05-07     Revised Date:  2013-05-31    
Medline Journal Info:
Nlm Unique ID:  100883649     Medline TA:  Europace     Country:  England    
Other Details:
Languages:  eng     Pagination:  385-8     Citation Subset:  IM    
Affiliation:
Galichia Heart Hospital, 2600 N. Woodlawn Avenue, Wichita, KS 67226, USA. val-y-mexia@hotmail.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Arrhythmias, Cardiac / physiopathology,  therapy*
Calibration / standards*
Defibrillators, Implantable / standards*
Electric Conductivity
Female
Heart Diseases / physiopathology,  therapy
Humans
Male
Middle Aged
Multicenter Studies as Topic
Predictive Value of Tests
Randomized Controlled Trials as Topic
Retrospective Studies
Severity of Illness Index
Stroke Volume*
Ventricular Function, Left*
Comments/Corrections
Comment In:
Europace. 2010 Mar;12(3):309-10   [PMID:  20118113 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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Journal ID (nlm-ta): Europace
Journal ID (publisher-id): europace
Journal ID (hwp): europace
ISSN: 1099-5129
ISSN: 1532-2092
Publisher: Oxford University Press
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Published on behalf of the European Society of Cardiology. All rights reserved. ? The Author 2010. For permissions please email: journals.permissions@oxfordjournals.org.
creative-commons:
Received Day: 17 Month: 9 Year: 2009
Accepted Day: 23 Month: 11 Year: 2009
Print publication date: Month: 3 Year: 2010
Electronic publication date: Day: 3 Month: 1 Year: 2010
pmc-release publication date: Day: 3 Month: 1 Year: 2010
Volume: 12 Issue: 3
First Page: 385 Last Page: 388
ID: 2825386
PubMed Id: 20047925
DOI: 10.1093/europace/eup408
Publisher Id: eup408

Does defibrillation threshold increase as left ventricular ejection fraction decreases?
Jesus E. Val-Mejias1*
Ashish Oza2
1Galichia Heart Hospital, 2600 N. Woodlawn Avenue, Wichita, KS 67226, USA
2St Jude Medical, Sylmar, CA, USA
*Corresponding author. Tel: +1 316 858 2200, Fax: +1 316 858 2535, Email: val-y-mexia@hotmail.com

Introduction

Implantation of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) has significantly increased after the positive results of some landmark primary prevention trials showing the efficacy of ICD therapy in reducing mortality.1?3 Defibrillation threshold (DFT) testing at implant is routinely done to ensure that the ICDs/CRT-Ds deliver appropriate amounts of energy and are functioning appropriately. The left ventricular ejection fraction (LVEF) of ICD patients implanted for either primary or secondary prevention can range from normal or near-normal (>45%) to severely impaired (<25%). Typically, patients with a low LVEF also have underlying cardiac disease that has progressed to an advanced degree. Among various other clinical parameters, depressed LVEF has been shown to be a potential predictor of high DFTs in patients implanted with unipolar or bipolar defibrillation systems.4?8

While clinical predictors of high DFTs have been extensively studied in patients receiving ICDs/CRT-Ds, stratification of DFTs by LVEF, one of the most commonly used indices for cardiac impairment, has never been done before. Accordingly, this analysis was undertaken to assess the change in DFT estimates as the LVEF goes from being normal to impaired in patients who are implanted with left-sided, active pectoral defibrillation lead systems.


Methods

This retrospective analysis included data from three different multicentre, prospective, randomized studies that were reviewed and approved by the appropriate Human Research Ethical Committees of each of the participating medical centres.9?11 Study-specific objectives, inclusion, and exclusion criteria for all the three studies are listed in Table?1. Patients were enrolled by the study site after appropriate informed consent was obtained. The patient population consisted of 230 patients who were implanted with any FDA-approved Atlas?, Epic?, Current?, and Promote? ICDs/CRT-Ds and a compatible dual-coil defibrillation lead system. All patients who met the inclusion criteria in these three studies and underwent DFT testing using SVC coil turned ON were included in this analysis.

Defibrillation threshold testing

Two of three studies required the use of a binary search protocol and 72% of the data contributing to this analysis came from those studies.9,10 One of the three studies required the use of a binary search protocol guided by upper limit of vulnerability and 28% of the data contributing to this analysis came from that study.11 The defibrillation waveform for all patients was programmed to the optimal pulse width settings based on a theoretical 3.5 ms membrane time constant using a commercially available chart of optimal defibrillation pulse width (Phase 1/Phase 2) durations.12 The RV coil was programmed as the anode for the first phase and the SVC coil was always turned on. Ventricular fibrillation was induced by T-wave shock, burst-pacing, or ?DC (direct current) Fibber? through the ICDs. For all the methods, DFT estimate was established only after observation of a failed shock.

Analysis

DFT estimates were stratified into four different LVEF groups (?25%, 26?35%, 36?45%, and ?46%). A linear model in which the LVEF group is treated as a factor was used to analyse the data. A P-value < 0.05 was considered statistically significant.


Results

There were 230 patients included in this analysis (Table?2). The average age, LVEF, NYHA class, and gender distribution grouped by LVEF range is shown in Table?3. The mean DFT voltage for LVEF ?25% was 425.8 ? 117.6 V, 26?35% was 417.5 ? 121.1 V, 36?45% was 394.1 ? 133.3 V, and ?46% was 395.2 ? 115 V (Table?3). Similarly, the mean DFT energies for LVEF ?25% was 8.6 ? 4.9 J, 26?35% was 8.4 ? 5.1 J, 36?45% was 7.6 ? 4.4 J, and ?46% was 7.5 ? 4.2 J (Table?3). DFTs (voltage and energy) trended higher for lower LVEF but this trend is not statistically significant (P = 0.58 for DFT voltage and P = 0.69 for DFT energy). Only 3% of the patients (n = 7) had a DFT of >20 J and all of these high-DFT patients had an LVEF <35% (Figure?1). Of these seven high-DFT patients, a >10 J safety margin could not be achieved in three patients.

All of the patients (n = 7) with DFT > 20 J were men with an LVEF ? 35%. In this group, five patients received an ICD/CRT-D for primary prevention, four had ischemic cardiomyopathy, four had hypertension, and four had undergone previous ablation for sustained ventricular tachycardia. Two of these patients were below the age of 50 years, three of them were between 50 and 65 years, and two were above 65 years of age. Similarly, each of the patients (n = 4) with DFT > 25 J had received an ICD/CRT-D for primary prevention; two had ischaemic cardiomyopathy and two had hypertension. One of the patients was younger than 50 years, two were between 50 and 65 years, and one was above 65 years.

A multiple variable regression estimation model constructed to estimate the effect of age, gender, NYHA class, LVEF, implant indication, type of study, and method of VF induction on DFTs revealed that gender was the only significant predictor of higher DFTs in this patient population, with men having higher DFTs than women (P = 0.02). The mean DFT in men was greater than that in women by 58.7 V (15.2%) and 2.3 J (31.3%).


Discussion

This is the first analysis that attempts to stratify the DFT estimates by LVEF in patients tested with biphasic, tuned waveforms that are optimized based on the high-voltage lead impedance. The primary results indicate that both DFT voltage and energy increase as LVEF decreases, but the difference in DFT energy between each adjacent LVEF group is very small and, even between the highest and the lowest LVEF groups is minimal (approximately 1 J).

In previous studies, the association of LVEF and DFT has been inconsistent.4,7,8,13?18 Burke et al.13 analysed DFTs in 50 ICD/CRT-D patients. Although the mean LVEF in CRT-D group was significantly lower than that of the ICD group (23 ? 5% for the CRT group vs. 31 ? 10% for the control group), the mean DFTs of the two groups were not significantly different (10.2 ? 6.1 J for the CRT group vs. 9.5 ? 5.0 J for the control group). Similarly, Cuoco Jr. et al.14 found no significant difference in DFT between ICD and CRT-D groups (n = 537). In the ASSURE study,15 Doshi et al. showed that patients receiving CRT-D devices do not have higher defibrillation energy requirements when compared with ICD patients. Val-Mejias et al.16 found no difference in the DFT estimates between ICD/CRT-D patients implanted with primary and secondary prevention indications, in spite of significant differences in the LVEF between the two indication groups. In an analysis of 128 patients who received Ventak ICDs, Horton et al.17 did not find LVEF to be a significant factor in predicting high DFT. However, several studies have shown that LVEF was one of the significant predictors of a high DFT. In their review of 1139 patient records with all manufacturer's devices, Russo et al.18 found that 71 patients (6.2%) had high DFTs (<10 J safety margin). Lower LVEF had a borderline predictive value for the need for system revision owing to lack of a 10 J safety margin (P = 0.054). Similarly, Shukla et al.17 analysed 968 patients with Medtronic devices and found that patients with higher threshold (?18 J) had lower LVEF, a worse functional class, less frequently done bypass surgery, amiodarone and history of more frequent VF. Both Lubinski et al.7 (n = 168) and Pinski et al.8 (n = 125) found that low LVEF was a significant predictor of high DFT. In an older study involving 128 patients who received epicardial defibrillators, high LVEF was found to be an important determinant of improved defibrillation efficacy.4

In this study, only 7 of the 230 patients had a DFT > 20 J which is slightly lower than the incidence reported in other studies that employed fixed tilt waveforms.5?8,19,20 This could be because the DFT protocol in some of these studies was neither uniform nor was it followed consistently and the definition of high DFT was different from the current study. Interestingly, all the ?high DFT? patients in our study had an LVEF of <35% suggesting that the occurrence of high DFT is not a common problem in patients with normal to near-normal LVEF. It should be noted that the results from the current study were obtained with fixed pulse-width waveforms that are optimally tuned per impedance and assumed cardiac membrane time constant. Fixed pulse-width waveforms have been shown to provide lower voltage and energy DFTs than fixed-tilt waveforms, particularly when DFT is higher than 400 V. This might explain our lower DFT per LVEF range as well as our lower incidence of ?high DFT?.21,22 It should be noted that concerns regarding DFTs between 20 and 26 J may not be as great when a device with maximum delivered energy capability of 36 J is used because a 10 J safety margin would be available.

This analysis should be interpreted under the light of certain limitations. First, this is a retrospective analysis, hence there is an unequal number of patients in the four stratified LVEF groups. Second, DFT estimates in all the patients were obtained with a left-sided, active pectoral pulse generator that utilized biphasic, tuned waveforms with SVC coil turned ON. We cannot assure that similar results would be observed if the different waveforms, generator pocket location, shocking vector, or lead configurations are used. In addition, the impact of infiltrative cardiomyopathy (i.e. sarcoidosis, amyloidosis, etc.) could not be assessed because there were no patients in the cohort with those diseases. The impact of kidney disorders could not be evaluated because data reflecting renal function was not collected in any of the three studies.


Conclusion

This analysis shows that across a very broad range of LVEF, changes in DFT are minimal. No patient with a near-normal to preserved LVEF had an occurrence of high DFT, and among the patients with severely impaired LVEF only a few (3%) had high DFTs. These results should reassure implanters that patients with severely impaired LVEF implanted with left-sided ICD/CRT-D devices employed with tuned defibrillation waveforms and dual-shocking leads will not necessarily have elevated DFTs.

Conflict of interest: J.E.V.-M. has received research support and fellows program support from St. Jude Medical. A.O. is an employee of and holds stock in St. Jude Medical.


Funding

The studies mentioned in this article were funded by St. Jude Medical. Funding to pay the Open Access publication charges for this article was provided by St. Jude Medical.


References
1. Moss AJ,Hall WJ,Cannom DS,Daubert JP,Higgins SL,Klein H,et al. Improved survival with an implantable defibrillator in patients with coronary disease at high risk for ventricular arrhythmiaN Engl J MedYear: 19963551933408960472
2. Buxton AE,Lee KL,Fisher JD,Josephson ME,Prystowsky EN,Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery diseaseN Engl J MedYear: 199934118829010601507
3. Moss AJ,Zareba W,Hall WJ,Klein H,Wilber DJ,Cannom DS,et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fractionN Engl J MedYear: 20023468778311907286
4. Shukla HH,Flaker GC,Jayam V,Roberts D. High defibrillation thresholds in transvenous biphasic implantable defibrillators: clinical predictors and prognostic implicationsPACEYear: 20032644812685138
5. Leitch JW,Yee R. Predictors of defibrillation efficacy in patients undergoing epicardial defibrillator implantation: the multicenter Pacemaker-Cardioverter-Defibrillator (PCD) Investigators GroupJ Am Coll CardiolYear: 1993216321637
6. Raitt MH,Johnson G,Dolack GL,Poole JE,Kudenchuk PJ,Bardy GH. Clinical predictors of the defibrillation threshold with the unipolar implantable defibrillation systemJ Am Coll CardiolYear: 1995251576837759708
7. Lubinski A,Lewicka-Nowak E,Zienciuk A,Krolak T,Kempa M,Pazdyga A,et al. Clinical predictors of defibrillation threshold in patients with implantable cardioverter-defibrillatorsKardiol PolYear: 2005623172815928737
8. Pinski SL,Vanerio G,Castle LW,Morant VA,Simmons TW,Trohman RG,et al. Patients with a high defibrillation threshold: clinical characteristics, management, and outcomeAm Heart JYear: 199112289952063767
9. Natarajan S,Henthorn R,Burroughs J,Esberg D,Zweibel S,Ross T,et al. Fixed duration ?tuned? defibrillation waveforms outperform fixed 50/50% tilt defibrillation waveforms: a randomized, prospective, pair-sampled multicenter studyPacing Clin ElectrophysiolYear: 200730S139S14217302691
10. Gold MR,Val-Mejias J,Leman RB,Tummala R,Goyal S,Kluger J,et al. Optimization of superior vena cava coil position and usage for transvenous defibrillationHeart RhythmYear: 20085394918313597
11. Doshi S,Val-Mejias JE,Pittaro M,Reeves R,Boyce K,Payne J,et al. Efficacy of tuned waveforms based on different membrane time constants on defibrillation thresholds: primary results from the POWER trialEuropaceYear: 200810i100
12. ICD Alternative Defibrillation Bi-phasic Waveform Pulse Width Recommendations Rev. 1Sylmar, CASt Jude Medical CRMD
13. Burke SW,Sturdivant LJ,Leman RB,Wharton MJ,Gold MR. Defibrillation thresholds in patients with cardiac resynchronization therapy defibrillatorsHeart RhythmYear: 20063S165
14. Cuoco FA Jr,Leslie DL,Luff M,Maran A,Klein MH,Forcina MS,et al. Elevated defibrillation threshold in CRT-D and ICD patients: comparison and predictorsHeart RhythmYear: 20085S237
15. Doshi RN,Crandall BG,Osborn JS,Weiss P,Kfoury A,Wang S,et al. Do biventricular pacemaker defibrillators patients have higher defibrillation thresholds?Heart RhythmYear: 20052S243
16. Val-Mejias JE,Gold M,Natarajan S,Oza A. Is there a difference in defibrillation thresholds between patients with primary vs. secondary prevention indications?Europace SupplYear: 20079iii186
17. Horton RP,Canby RC,Roman CA,Hull ML,Kaye SA,Jessen ME,et al. Determinants of nothoractomy biphasic defibrillationPACEYear: 1997206049121972
18. Russo AM,Sauer W,Gerstenfeld EP,Hsia HH,Lin D,Cooper JM,et al. Defibrillation threshold testing: Is it really necessary at the time of implantable cardioverter-defibrillator insertion?Heart RhythmYear: 200524566115840466
19. Schuger C,Ellenbogen KA,Faddis M,Knight BP,Yong P,Sample R. Defibrillation energy requirements in an ICD population receiving cardiac resynchronization therapyJ Cardiac ElectrophysiolYear: 20061724750
20. Mainigi SK,Cooper JM,Russo AM,Nayak HM,Lin D,Dixit S,et al. Elevated defibrillation thresholds in patients undergoing biventricular defibrillator implantation: incidence and predictorsHeart RhythmYear: 200631010616945792
21. Mouchawar G,Kroll MW,Val-Mejias JE,Schwartzman D,McKenzie J,Fitzgerald D,et al. ICD waveform optimization: a randomized, prospective, pair-sampled multicenter studyPACEYear: 2000231992511139975
22. Denman RA,Umesan C,Martin PT,Forbes RN,Kroll MW,Anskey EJ,et al. Benefit of millisecond waveform durations for patients with high defibrillation thresholdsHeart RhythmYear: 200635364116648057

Figures

[Figure ID: EUP408F1]
Figure?1 

Distribution of DFT energies by different LVEF ranges.



Tables
[TableWrap ID: EUP408TB1] Table?1 

Study inclusion/exclusion criteria


Study 19 Study 210 Study 311
Objective To compare the DFT efficacy between 50/50% tilt and tuned defibrillation waveforms To compare DFT efficacy between SVC coil ON and OFF un-tuned defibrillation waveforms To compare DFT efficacy between the 2.5, 3.5, and 4.5 ms membrane time constant-based defibrillation waveforms
Inclusion criteria Patient is a candidate for ICD implantation Patient is a candidate for ICD implantation Patient is a candidate for ICD/CRT-D implantation
Patient is able to tolerate DFT testing Patient has had an echocardiogram, multiple gated acquisition (MUGA), or cath procedure within 6 months of ICD implant Patient has a compatible transvenous defibrillation lead system
Patient is able to tolerate DFT testing Patient has had an echocardiogram, MUGA, or cath procedure within 6 months of ICD implant
Patient is able to tolerate upper limit of vulnerability-guided DFT testing
Exclusion criteria Patient has a mechanical valve in the tricuspid position Patient has a mechanical valve in the tricuspid position Patient has a mechanical valve in the tricuspid position
Patient is pregnant Patient has a chronic defibrillation lead, which will not be removed Patient has epicardial defibrillation electrodes
Patient is <18 years old Patient has a right-sided ICD implant Patient is pregnant
Patient is pregnant Patient is <18 years old
Patient is <18 years old

[TableWrap ID: EUP408TB2] Table?2 

Patient population (n = 230)


Age 66.6 ? 12.4 years
Gender 81% males
NYHA class
?I 12.6%
?II 40%
?III 25.2%
?IV 1.3%
?Unknown 20.9%
?Ischaemia 74.3%
Implant indication
?Primary 63%
?Secondary 33%
?Unknown 4%
?Hypertension 54%
?Amiodarone usage 9.1%

[TableWrap ID: EUP408TB3] Table?3 

Patient population and DFT estimates grouped by LVEF


LVEF range LVEF (%) Gender Age (years) NYHA class Impedance (?) DFT voltage (V) DFT energy (J)
?25% (n = 102) 20.7 ? 4.0 85% male 65 ? 12.2 2.5 ? 0.6 40.9 ? 6.6 425.8 ? 117.6 8.6 ? 4.9
26?35% (n = 90) 32.7 ? 4.3 82% male 67 ? 12.2 2.0 ? 0.7 41.2 ? 6.3 417.5 ? 121.1 8.4 ? 5.1
36?45% (n = 17) 41.2 ? 3.4 71% male 67 ? 11.6 1.8 ? 0.7 40.1 ? 6.2 394.1 ? 133.3 7.6 ? 4.4
?46% (n = 21) 54.9 ? 5.2 62% male 74 ? 12.4 1.3 ? 0.6 40.5 ? 5.2 395.2 ? 115.0 7.5 ? 4.2

P = not significant.



Article Categories:
  • Clinical Research
    • Implantable Cardioverter-Defibrillators

Keywords: Defibrillation threshold, Implantable cardioverter defibrillator, Ejection fraction.

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