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Reduction of inappropriate implantable cardioverter-defibrillator therapies using enhanced supraventricular tachycardia discriminators: the ReduceIT study

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Abstract

Purpose

Inappropriate implantable cardioverter-defibrillator (ICD) shocks are associated with greater healthcare resource utilization, poorer quality-of-life, and higher mortality. We aimed to investigate the performance of enhanced supraventricular tachycardia (SVT) discrimination algorithms (morphology discrimination, rate stability, and sudden or chamber onset) for reducing inappropriate ICD therapies in patients with ICD/cardiac resynchronization therapy devices.

Methods

This prospective, non-randomized, multicenter study (ReduceIT) study took place at 56 sites across Germany and Estonia. Adults at risk of sudden cardiac death undergoing St. Jude Medical™ ICD or CRT-D implantation were included. The primary endpoint was freedom from inappropriate ICD shock at 12 months and was analyzed in the intention to treat (ITT) and per-protocol population.

Results

Overall, 733 patients (65.9 ± 11.4 years) were included, of which 40.9% and 59.1% received a single- and dual-chamber detection device, respectively. During follow-up (median 11.9 [0–21.6] months), 96.3% of patients experienced no inappropriate therapy (ITT). The sensitivity, specificity, and accuracy for VT/VF were 91.9%, 95.5%, and 94.7%, respectively. In the per-protocol population (n = 620), the proportion of patients free from inappropriate shock at 12 months was 98.4% (n = 610; 95% CI 97.1–99.2%) and exceeded the expected value of 93% (p < 0.0001) which was derived from the rates in the SPICE, ATPonFastVT, and DECREASE studies. A total of 44 patients (6.0%) died during follow-up, 19 deaths were cardiac-related which is consistent with a meta-analysis of EMPIRIC, MADIT-RIT, ADVANCE III, and PROVIDE. Serious device and procedure-related adverse effects occurred in 9.8% of patients.

Conclusions

In ICD/CRT-D devices with advanced SVT discriminators, device programming according to clinical setting and detection chamber significantly reduces the rate of inappropriate ICD shocks without compromising patient safety. The algorithms and settings described herein have particular clinical importance and their employment may be of benefit to ICD recipients.

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Acknowledgements

The authors would like to express their sincere thanks to Rita Omega Ella and Lixian Sun (Abbott) for providing statistical supervision and to Helen Sims (IPPMed, Cloppenburg, Germany) for their editorial support.

Investigators

Germany: Armin Wöhrle (Esslingen); Thomas Kleemann (Ludwigshafen); Christian Veltmann (Hannover); Stefan Asbach (Freiburg); Marcus Siry (Memmingen); Matthias Oehler (Bad Langensalza); Hansmartin Jetter (Bad Mergentheim); Marc Kollum (Singen); Johannes Brachmann (Coburg); Frank Eberhardt (Köln); Hans-Heinrich Minden (Hennigsdorf); Johann Christoph Geller (Bad Berka); Karlheinz Seidl (Ingolstadt); Mathias Busch (Greifswald); Frederik Voss (Trier); Torsten Beck (Kirchheim); Holger Sigusch (Zwickau); Philipp Kahlert (Essen); Carsten Zobel (Euskirchen); Wilfried Dänschel (Chemnitz); Rüdiger Dißmann (Bremerhaven); Alexander Hansen (Eichstätt); Bettina Götting (Quakenbrück); Helge Simon (Kronach); Christian Perings (Lünen); Martin Arnold (Erlangen); Joachim Schümmelfeder (Eisenach); Albrecht Elsässer (Oldenburg); Christoph Klein (Berlin); Jochen Michaelsen (Lingen); Krum Petrov (Sindelfingen); Ludwig Binner (Ulm); Jenny Gärtner (Leisnig); Lars Eckardt (Münster); Hans-Holger Ebert (Riesa); Alexander Vaisbord (Schönebeck); Ramiz Emini (Ulm); Claudius Hansen (Göttingen); Michael Markant (Marl); Heiko Stellmach (Chemnitz); Sabine-Susan Schulz (Holzminden); Andreas Götte (Paderborn); Christoph Axthelm (Pirna); Oliver Gastmann (Arnstadt); Simone Kimmel (Nürnberg); Heinrich Weglage (Osnabrück); Johannes Bernhardt (Annaberg-Buchholz); Johannes Sperzel (Bad Nauheim); Hendrik Bonnemeier (Kiel); Sven Fischer (Quedlinburg); Tammam Ali (Eilenburg); Stephan Willems (Hamburg); Marcus Wiemer (Minden); Edgar Zitron (Heidelberg); Jörg Otto Schwab (Bonn).

Estonia: Indrek Roose (Tartu); Jüri Voitk (Tallinn).

Funding

Abbott (formerly St. Jude Medical; Eschborn, Germany) funded the study.

Author information

Authors and Affiliations

  1. Klinik für Kardiologie, Abteilung für Rhythmologie und invasive Elektrophysiologie, Zentralklinik Bad Berka, Robert Koch Allee 9, 99437, Bad Berka, Germany

    Johann Christoph Geller

  2. Otto-von-Guericke University School of Medicine, Magdeburg, Germany

    Johann Christoph Geller

  3. Klinik für Kardiologie, Angiologie und Pneumologie, Klinikum Esslingen, Esslingen, Germany

    Armin Wöhrle

  4. Klinik und Poliklinik für Innere Medizin B, Zentrum für Innere Medizin, Universitätsmedizin Greifswald, Greifswald, Germany

    Mathias Busch

  5. Klinik für Kardiologie, Klinikum Oldenburg, Medizinischer Campus Universität Oldenburg, Oldenburg, Germany

    Albrecht Elsässer

  6. Medizinische Klinik B, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany

    Thomas Kleemann

  7. Abbott Medical GmbH, Eschborn, Germany

    Frank Birkenhauer

  8. Institut für Pharmakologie und Präventive Medizin, Mahlow, Germany

    Peter Bramlage

  9. Rhythmologie und Elektrophysiologie, Klinik für Kardiologie und Angiologie, Medizinische Hochschule Hannover, Hannover, Germany

    Christian Veltmann

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  1. Johann Christoph Geller
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Consortia

for the ReduceIT Investigators

  • Stefan Asbach
  • , Marcus Siry
  • , Matthias Oehler
  • , Hansmartin Jetter
  • , Marc Kollum
  • , Johannes Brachmann
  • , Frank Eberhardt
  • , Hans-Heinrich Minden
  • , Karlheinz Seidl
  • , Frederik Voss
  • , Torsten Beck
  • , Holger Sigusch
  • , Philipp Kahlert
  • , Carsten Zobel
  • , Wilfried Dänschel
  • , Rüdiger Dißmann
  • , Alexander Hansen
  • , Bettina Götting
  • , Helge Simon
  • , Christian Perings
  • , Martin Arnold
  • , Joachim Schümmelfeder
  • , Christoph Klein
  • , Jochen Michaelsen
  • , Krum Petrov
  • , Ludwig Binner
  • , Jenny Gärtner
  • , Lars Eckardt
  • , Hans-Holger Ebert
  • , Alexander Vaisbord
  • , Ramiz Emini
  • , Claudius Hansen
  • , Michael Markant
  • , Heiko Stellmach
  • , Sabine-Susan Schulz
  • , Andreas Götte
  • , Christoph Axthelm
  • , Oliver Gastmann
  • , Simone Kimmel
  • , Heinrich Weglage
  • , Johannes Bernhardt
  • , Johannes Sperzel
  • , Hendrik Bonnemeier
  • , Sven Fischer
  • , Tammam Ali
  • , Stephan Willems
  • , Marcus Wiemer
  • , Edgar Zitron
  • , Jörg Otto Schwab
  • , Indrek Roose
  •  & Jüri Voitk

Contributions

J. Christoph Geller and Peter Bramlage outlined the manuscript. All authors revised the manuscript for important intellectual content. All authors gave their final approval for submission.

Corresponding author

Correspondence to Johann Christoph Geller.

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Conflict of interest

Johann Christoph Geller is a consultant for Abbott and other device companies; Frank Birkenhauer is an employee of Abbott; Peter Bramlage is a consultant for Abbott and has received honoraria for the first draft of the manuscript; Christian Veltmann is a consultant for Medtronic, Biotronik and Boston Scientific, is on the speaker’s bureau of Medtronic, Biotronik, Abbott, Boston Scientific, Bayer, Bristol-Myers Squibb, and Boehringer, and has received research grant from Abbott and Medtronic; Mathias Busch, Armin Wöhrle, Albrecht Elsässer, and Thomas Kleemann have no conflict of interest.

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Geller, J.C., Wöhrle, A., Busch, M. et al. Reduction of inappropriate implantable cardioverter-defibrillator therapies using enhanced supraventricular tachycardia discriminators: the ReduceIT study. J Interv Card Electrophysiol 61, 339–348 (2021). https://doi.org/10.1007/s10840-020-00816-9

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