Angelo Auricchio1, Edward J Schloss2, Takashi Kurita3, Albert Meijer4, Bart Gerritse5, Steven Zweibel6, Faisal M AlSmadi7, Charles T Leng8, Laurence D Sterns9. 1. Fondazione Cardiocentro Ticino, Lugano, Switzerland. Electronic address: angelo.auricchio@cardiocentro.org. 2. The Christ Hospital/The Ohio Heart & Vascular Center, Cincinnati, Ohio. 3. Kinki University School of Medicine, Osaka, Japan. 4. Catharina Ziekenhuis, Eindhoven, The Netherlands. 5. Medtronic Bakken Research Center, Maastricht, The Netherlands. 6. Hartford Hospital, Hartford, Connecticut. 7. Prince Salman Heart Centre-King Fahad Medical City, Riyadh, Saudi Arabia. 8. University of Pennsylvania, Philadelphia, Pennsylvania. 9. Royal Jubilee Hospital, Victoria, Canada.
Abstract
BACKGROUND: The benefits of implantable cardioverter-defibrillators (ICDs) have been well demonstrated in many clinical trials, and ICD shocks for ventricular tachyarrhythmias save lives. However, inappropriate and unnecessary shock delivery remains a significant clinical issue with considerable consequences for patients and the healthcare system. OBJECTIVE: The purpose of the PainFree SmartShock Technology (SST) study was to investigate new-generation ICDs to reduce inappropriate and unnecessary shocks through novel discrimination algorithms with modern programming strategies. METHODS: This prospective, multicenter clinical trial enrolled 2790 patients with approved indication for ICD implantation (79% male, mean age 65 years; 69% primary prevention indication, 27% single-chamber ICD, 33% replacement or upgrade). Patients were followed for a minimum of 12 months, and mean follow-up was 22 months. The primary end-point of the study was the percentage of patients remaining free of inappropriate shocks at 1 year postimplant, analyzed separately for dual/triple-chamber ICDs (N = 2019) and single-chamber ICDs (N = 751). RESULTS: The inappropriate shock rate at 1 year was 1.5% for patients with dual/triple-chamber ICDs and 2.5% for patients with single-chamber devices. Two years postimplant, the inappropriate shock rate was 2.8% for patients with dual-/triple chamber ICDs and 3.7% for those with single-chamber ICDs. The most common cause of an inappropriate shock in both groups was atrial fibrillation or flutter. CONCLUSION: In a large patient cohort receiving ICDs for primary or secondary prevention, the adoption of novel enhanced detection algorithms in conjunction with routine implementation of modern programming strategies led to a very low inappropriate shock rate.
RCT Entities:
BACKGROUND: The benefits of implantable cardioverter-defibrillators (ICDs) have been well demonstrated in many clinical trials, and ICD shocks for ventricular tachyarrhythmias save lives. However, inappropriate and unnecessary shock delivery remains a significant clinical issue with considerable consequences for patients and the healthcare system. OBJECTIVE: The purpose of the PainFree SmartShock Technology (SST) study was to investigate new-generation ICDs to reduce inappropriate and unnecessary shocks through novel discrimination algorithms with modern programming strategies. METHODS: This prospective, multicenter clinical trial enrolled 2790 patients with approved indication for ICD implantation (79% male, mean age 65 years; 69% primary prevention indication, 27% single-chamber ICD, 33% replacement or upgrade). Patients were followed for a minimum of 12 months, and mean follow-up was 22 months. The primary end-point of the study was the percentage of patients remaining free of inappropriate shocks at 1 year postimplant, analyzed separately for dual/triple-chamber ICDs (N = 2019) and single-chamber ICDs (N = 751). RESULTS: The inappropriate shock rate at 1 year was 1.5% for patients with dual/triple-chamber ICDs and 2.5% for patients with single-chamber devices. Two years postimplant, the inappropriate shock rate was 2.8% for patients with dual-/triple chamber ICDs and 3.7% for those with single-chamber ICDs. The most common cause of an inappropriate shock in both groups was atrial fibrillation or flutter. CONCLUSION: In a large patient cohort receiving ICDs for primary or secondary prevention, the adoption of novel enhanced detection algorithms in conjunction with routine implementation of modern programming strategies led to a very low inappropriate shock rate.
Authors: Johann Christoph Geller; Armin Wöhrle; Mathias Busch; Albrecht Elsässer; Thomas Kleemann; Frank Birkenhauer; Peter Bramlage; Christian Veltmann Journal: J Interv Card Electrophysiol Date: 2020-07-14 Impact factor: 1.900
Authors: Babak Nazer; Zack Dale; Gianmarco Carrassa; Nosheen Reza; Tuna Ustunkaya; Nikolaos Papoutsidakis; Andrew Gray; Stacey J Howell; Miriam R Elman; Paolo Pieragnoli; Giuseppe Ricciardi; Daniel Jacoby; David S Frankel; Anjali Owens; Iacopo Olivotto; Stephen B Heitner Journal: Heart Rhythm Date: 2020-02-18 Impact factor: 6.343
Authors: Bruce L Wilkoff; Laurent Fauchier; Martin K Stiles; Carlos A Morillo; Sana M Al-Khatib; Jesœs Almendral; Luis Aguinaga; Ronald D Berger; Alejandro Cuesta; James P Daubert; Sergio Dubner; Kenneth A Ellenbogen; N A Mark Estes; Guilherme Fenelon; Fermin C Garcia; Maurizio Gasparini; David E Haines; Jeff S Healey; Jodie L Hurtwitz; Roberto Keegan; Christof Kolb; Karl-Heinz Kuck; Germanas Marinskis; Martino Martinelli; Mark McGuire; Luis G Molina; Ken Okumura; Alessandro Proclemer; Andrea M Russo; Jagmeet P Singh; Charles D Swerdlow; Wee Siong Teo; William Uribe; Sami Viskin; Chun-Chieh Wang; Shu Zhang Journal: J Arrhythm Date: 2016-02-01