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Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool

Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool
Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool
Background

The sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator (S-ICD) pre-implant screening tool required clinical evaluation.

Methods

Bipolar vectors were derived from electrodes positioned at locations similar to those employed for S-ICD sensing and pre-implant screening electrodes, and recordings collected through 80-electrode PRIME®-ECGs, in six different postures, from 40 subjects (10 healthy controls, and 30 patients with complex congenital heart disease (CCHD); 10 with Tetralogy of Fallot (TOF), 10 with single ventricle physiology (SVP), and 10 with transposition of great arteries (TGA)). The resulting vectors were analysed using the S-ICD pre-implant screening tool (Boston Scientific) and processed through the sensing algorithm of S-ICD (Boston Scientific). The data were then evaluated using 2 × 2 contingency tables. Fisher exact and McNemar tests were used for a comparison of the different categories of CCHD, and p < 0.05 vs. controls considered to be statistically significant.

Results

57% of patients were male, mean age of 36.3 years. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the S-ICD screening tool were 95%, 79%, 59% and 98%, respectively, for controls, and 84%, 79%, 76% and 86%, respectively, in patients with CCHD (p = 0.0001).

Conclusion

The S-ICD screening tool was comparatively more sensitive in normal controls but less specific in both CCHD patients and controls; a possible explanation for the reported high incidence of inappropriate S-ICD shocks. Thus, we propose a pre-implant screening device using the S-ICD sensing algorithm to minimise false exclusion and selection, and hence minimise potentially inappropriate shocks.
sudden cardiac death, congenital heart disease, subcutaneous implantable cardioverter, sensing algorithm
0167-5273
205-209
Zeb, Mehmood
469fda8e-8318-4fe5-97f3-a46eec60f333
Curzen, Nick
70f3ea49-51b1-418f-8e56-8210aef1abf4
Allavatam, Venugopal
f1d2629f-bbf5-448e-a506-8315f2870b0c
Wilson, David
b183c158-f014-437e-bb70-29fb778cf003
Yue, Arthur
6bab01eb-b37c-4722-8e89-fa347e895e38
Roberts, Paul
91c17945-b751-4d09-989a-04b4429006b9
Morgan, John
b9446d5b-771e-4065-a84d-d05050c7bbe4
Zeb, Mehmood
469fda8e-8318-4fe5-97f3-a46eec60f333
Curzen, Nick
70f3ea49-51b1-418f-8e56-8210aef1abf4
Allavatam, Venugopal
f1d2629f-bbf5-448e-a506-8315f2870b0c
Wilson, David
b183c158-f014-437e-bb70-29fb778cf003
Yue, Arthur
6bab01eb-b37c-4722-8e89-fa347e895e38
Roberts, Paul
91c17945-b751-4d09-989a-04b4429006b9
Morgan, John
b9446d5b-771e-4065-a84d-d05050c7bbe4

Zeb, Mehmood, Curzen, Nick, Allavatam, Venugopal, Wilson, David, Yue, Arthur, Roberts, Paul and Morgan, John (2015) Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool. International Journal of Cardiology, 195, 205-209. (doi:10.1016/j.ijcard.2015.05.082). (PMID:26048376)

Record type: Article

Abstract

Background

The sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator (S-ICD) pre-implant screening tool required clinical evaluation.

Methods

Bipolar vectors were derived from electrodes positioned at locations similar to those employed for S-ICD sensing and pre-implant screening electrodes, and recordings collected through 80-electrode PRIME®-ECGs, in six different postures, from 40 subjects (10 healthy controls, and 30 patients with complex congenital heart disease (CCHD); 10 with Tetralogy of Fallot (TOF), 10 with single ventricle physiology (SVP), and 10 with transposition of great arteries (TGA)). The resulting vectors were analysed using the S-ICD pre-implant screening tool (Boston Scientific) and processed through the sensing algorithm of S-ICD (Boston Scientific). The data were then evaluated using 2 × 2 contingency tables. Fisher exact and McNemar tests were used for a comparison of the different categories of CCHD, and p < 0.05 vs. controls considered to be statistically significant.

Results

57% of patients were male, mean age of 36.3 years. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the S-ICD screening tool were 95%, 79%, 59% and 98%, respectively, for controls, and 84%, 79%, 76% and 86%, respectively, in patients with CCHD (p = 0.0001).

Conclusion

The S-ICD screening tool was comparatively more sensitive in normal controls but less specific in both CCHD patients and controls; a possible explanation for the reported high incidence of inappropriate S-ICD shocks. Thus, we propose a pre-implant screening device using the S-ICD sensing algorithm to minimise false exclusion and selection, and hence minimise potentially inappropriate shocks.

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More information

Accepted/In Press date: 14 May 2015
Published date: 15 September 2015
Keywords: sudden cardiac death, congenital heart disease, subcutaneous implantable cardioverter, sensing algorithm
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 378071
URI: http://eprints.soton.ac.uk/id/eprint/378071
ISSN: 0167-5273
PURE UUID: b8cb0cde-edf4-4f9d-b633-31c5946866e1
ORCID for Nick Curzen: ORCID iD orcid.org/0000-0001-9651-7829

Catalogue record

Date deposited: 24 Jun 2015 13:52
Last modified: 18 Feb 2021 17:04

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Contributors

Author: Mehmood Zeb
Author: Nick Curzen ORCID iD
Author: Venugopal Allavatam
Author: David Wilson
Author: Arthur Yue
Author: Paul Roberts
Author: John Morgan

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