{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T13:46:21Z","timestamp":1780667181966,"version":"3.54.1"},"reference-count":25,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2014,3,25]],"date-time":"2014-03-25T00:00:00Z","timestamp":1395705600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pacing Clinical Electrophis"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Implantable defibrillators (ICD) are highly effective in reducing arrhythmia\u2010related mortality. ICD shock therapy has been shown to increase psychological distress, health care utilization, and is associated with increased mortality. The Protecta ICDs (Medtronic Inc., Minneapolis, MN, USA) have algorithms designed to reduce unnecessary and inappropriate shock therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>The PainFree SmartShock\u2122 Technology (PainFree SST) study is a prospective, multicenter, clinical trial with two consecutive phases, a premarket phase safety study and a postmarket phase effectiveness study. We report the results of the PainFree SST safety study.<\/jats:p><jats:p>The premarket phase aimed to investigate safety in the first year postimplant, and to determine if the novel algorithms (T\u2010wave discrimination, right ventricular lead noise discrimination and confirmation+) affect appropriate ventricular fibrillation (VF) detection. Patients (total: n = 246 [male 78%, mean age 63 year, primary prevention indication in 76%]) were implanted either with a Protecta XT dual\u2010chamber ICD (n = 114 [46%]) or a defibrillator with cardiac resynchronization therapy (n = 132 [54%]). Appropriate VF detection was measured during VF induction at implantation when the novel algorithms were programmed ON. A two\u2010second delay in VF detection was classified as clinically significant. No delay in VF detection was observed with all algorithms programmed ON. No unanticipated serious adverse device effects occurred during first year postimplant.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The results of the premarket phase of the PainFree SST trial demonstrate the safety of the Protecta XT defibrillators. Detection of induced VF was not delayed with SmartShock\u2122 algorithms ON.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pace.12390","type":"journal-article","created":{"date-parts":[[2014,3,26]],"date-time":"2014-03-26T03:09:01Z","timestamp":1395803341000},"page":"1198-1209","source":"Crossref","is-referenced-by-count":21,"title":["Implantable Defibrillators With Enhanced Detection Algorithms: Detection Performance and Safety Results from the PainFree SST Study"],"prefix":"10.1111","volume":"37","author":[{"given":"CHRISTIAN G.","family":"WOLLMANN","sequence":"first","affiliation":[{"name":"Hospital of St. P\u00f6lten\u2010Lilienfeld Department of Cardiology  St. P\u00f6lten Austria"},{"name":"Karl Landsteiner Society Institute of Cardiovascular Research  St. P\u00f6lten Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"THOMAS","family":"LAWO","sequence":"additional","affiliation":[{"name":"Berufsgenossenschaftliche Universit\u00e4tsklinik Bergmannsheil GmbH  Bochum Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"VOLKER","family":"K\u00dcHLKAMP","sequence":"additional","affiliation":[{"name":"Herz Zentrum Bodensee  Konstanz Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R\u00dcDIGER","family":"BECKER","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Heidelberg  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"CLAUDIO","family":"GARUTTI","sequence":"additional","affiliation":[{"name":"Medtronic Bakken Research Center  Maastricht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"TROY","family":"JACKSON","sequence":"additional","affiliation":[{"name":"Medtronic Inc.  Minneapolis Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MARK L.","family":"BROWN","sequence":"additional","affiliation":[{"name":"Medtronic Inc.  Minneapolis Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"HARALD","family":"MAYR","sequence":"additional","affiliation":[{"name":"Hospital of St. P\u00f6lten\u2010Lilienfeld Department of Cardiology  St. P\u00f6lten Austria"},{"name":"Karl Landsteiner Society Institute of Cardiovascular Research  St. P\u00f6lten Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,3,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"crossref","first-page":"1576","DOI":"10.1056\/NEJM199711273372202","article-title":"A comparison of antiarrhythmic\u2010drug therapy with implantable defibrillators in patients resuscitated from near\u2010fatal ventricular arrhythmias. 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