Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2019 Jun 17;19(1):146.
doi: 10.1186/s12872-019-1121-4.

Arrhythmic episodes in patients implanted with a cardioverter-defibrillator - results from the Prospective Study on Predictive Quality with Preferencing PainFree ATP therapies (4P)

François Regoli  1 , Denis Graf  2 , Beat Schaer  3 , Firat Duru  4 , Peter Ammann  5 , Lorenza Mangoni di S Stefano  6 , Barbara Naegli  7 , Haran Burri  8 , Rainer Zbinden  9 , Nazmi Krasniqi  10 , Martin Fromer  11 ; 4P Study Group
Collaborators, Affiliations
Observational Study

Arrhythmic episodes in patients implanted with a cardioverter-defibrillator - results from the Prospective Study on Predictive Quality with Preferencing PainFree ATP therapies (4P)

François Regoli et al. BMC Cardiovasc Disord. .

Abstract

Background: Little is known about the ICD performance using enhanced detection algorithms in unselected, non-trial patients. Performance of recent generation ICD equipped with SmartShock™ technology (SST) for detection and conversion of ventricular tachyarrhythmias (VTA) was investigated.

Methods: 4P was a prospective, multicenter, observational study conducted in 10 Swiss implanting centers. Patients with a Class I indication according to international guidelines were included and received an ICD with SST. ICD discrimination capability was assessed by evaluating SST performance; therapy efficacy was assessed by rate of VTA conversions by ATP and by rescue shocks.

Results: Overall, 196 patients were included in the analysis with a mean duration of follow-up of 27.7 months (452 patient-years of observation). Patient-specific rather than recommended programming was preferred. Device-detected episodes were frequent (5147 episodes in 146 patients, 74.5%). In 44 patients (22.4%), 1274 episodes were categorized as VTA; only 215 episodes were symptomatic. ATP was the first-line therapy and highly effective (99.9% success rate at the episode level, 100.0% at the patient level). Rescue shocks were rare (66 episodes in 28 patients); 7 shocks in 5 patients (2.6%) were inappropriate. Death and hospitalization rates were low.

Conclusions: In a cohort of non-trial, unselected ICD patients, VTA episodes were frequent. The 4P results confirm the robustness of VTA detection by SST and the effectiveness of ATP treatment, hence limiting overall ICD shock burden.

Keywords: Antitachycardia pacing; Implantable cardioverter-defibrillator; Shock; Ventricular tachyarrhythmia.

PubMed Disclaimer

Conflict of interest statement

Dr. François Regoli declares speaker and consultation fees from Bayer, Boston Scientific, Microport, Medtronic, and is associate editor for BMC Cardiovascular Disorders. Dr. Beat Schaer discloses speaker’s bureau fees from Medtronic and Microport. Dr. Peter Ammann is a European advisory board member for Medtronic. Lorenza Mangoni di S. Stefano is an employee of Medtronic Core Clinical Solutions. Dr. Martin Fromer is a consultant for Medtronic, Switzerland. Doctors Denis Graf, Firat Duru, Barbara Naegli, Haran Burri, Rainer Zbinden, Nazmi Krasniqi have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Patient-flow diagram
Fig. 2
Fig. 2
Sequential management of ventricular tachyarrhythmia (VTAs) by ICD devices, from the detection to the electrical therapy of categorized VTAs
Fig. 3
Fig. 3
Kaplan-Meier curves for survival (a) and freedom of hospitalization (b)
Fig. 4
Fig. 4
Last generation ICDs are primarily ATP devices with defibrillation backup (rescue shock)
Fig. 5
Fig. 5
Specific programming information handed out to implanters before trial initiation (primary prevention)
Fig. 6
Fig. 6
Specific programming information handed out to implanters before trial initiation (secondary prevention)
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Wilkoff BL, Fauchier L, Stiles MK, Morillo CA, Al-Khatib SM, Almendral J, et al. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. Europace. 2016;18:159–183. doi: 10.1093/europace/euv411. - DOI - PubMed
    1. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–237. doi: 10.1056/NEJMoa043399. - DOI - PubMed
    1. Wilkoff BL, Ousdigian KT, Sterns LD, Wang ZJ, Wilson RD, Morgan JM, et al. A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial. J Am Coll Cardiol. 2006;48:330–339. doi: 10.1016/j.jacc.2006.03.037. - DOI - PubMed
    1. Volosin KJ, Exner DV, Wathen MS, Sherfesee L, Scinicariello AP, Gillberg JM. Combining shock reduction strategies to enhance ICD therapy: a role for computer modeling. J Cardiovasc Electrophysiol. 2011;22:280–289. doi: 10.1111/j.1540-8167.2010.01918.x. - DOI - PubMed
    1. Sweeney MO. Antitachycardia pacing for ventricular tachycardia using implantable cardioverter defibrillators. Pacing Clin Electrophysiol. 2004;27:1292–1305. doi: 10.1111/j.1540-8159.2004.00622.x. - DOI - PubMed

Publication types

MeSH terms