Response to Letter Regarding Article, “Complications Associated With Revision of Sprint Fidelis Leads: Report From the Canadian Heart Rhythm Society Device Advisory Committee”
2011; Lippincott Williams & Wilkins; Volume: 123; Issue: 10 Linguagem: Inglês
10.1161/circulationaha.110.003517
ISSN1524-4539
AutoresRatika Parkash, Eugene Crystal, Jamil Bashir, Christopher S. Simpson, David Birnie, Laurence D. Sterns, Derek V. Exner, Bernard Thibault, Sean P. Connors, Jeff S. Healey, Jean Champagne, Doug Cameron, Iqwal Mangat, Atul Verma, Kevin Wolfe, Vidal Essebag, Teresa Kuś, Félix Ayala-Paredes, Ted Davies, Shubhayan Sanatani, Robert M. Gow, Bernard Coutu, Soori Sivakumaran, Elizabeth A. Stephenson, Andrew D. Krahn,
Tópico(s)Cardiomyopathy and Myosin Studies
ResumoHomeCirculationVol. 123, No. 10Response to Letter Regarding Article, "Complications Associated With Revision of Sprint Fidelis Leads: Report From the Canadian Heart Rhythm Society Device Advisory Committee" Free AccessReplyPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReplyPDF/EPUBResponse to Letter Regarding Article, "Complications Associated With Revision of Sprint Fidelis Leads: Report From the Canadian Heart Rhythm Society Device Advisory Committee" Ratika Parkash, MD, MSc Eugene Crystal, MD Jamil Bashir, MD Christopher Simpson, MD David Birnie, MD Laurence Sterns, MD Derek Exner, MD Bernard Thibault, MD Sean Connors, MD Jeffrey S. Healey, MD, MSc Jean Champagne, MD Doug Cameron, MD Iqwal Mangat, MD Atul Verma, MD Kevin Wolfe, MD Vidal Essebag, MD, PhD Teresa Kus, MD Felix Ayala-Paredes, MD Ted Davies, MD Shubhayan Sanatani, MD Robert Gow, MB, BS Bernard Coutu, MD Soori Sivakumaran, MD Elizabeth Stephenson, MD Andrew Krahn, MD Ratika ParkashRatika Parkash QEII Health Sciences Centre Halifax, Nova Scotia (Parkash) Eugene CrystalEugene Crystal Sunnybrook Hospital Toronto, Ontario (Crystal) Jamil BashirJamil Bashir St. Paul's Hospital Vancouver, British Columbia (Bashir) Christopher SimpsonChristopher Simpson Queen's University Kingston, Ontario (Simpson) David BirnieDavid Birnie University of Ottawa Heart Institute Ottawa, Ontario (Birnie) Laurence SternsLaurence Sterns Royal Jubilee Hospital Victoria, British Columbia (Sterns) Derek ExnerDerek Exner Foothills Hospital Calgary, Alberta (Exner) Bernard ThibaultBernard Thibault Montreal Heart Institute Montreal, Quebec (Thibault) Sean ConnorsSean Connors Memorial University Health Sciences Center St. John's Newfoundland (Connors) Jeffrey S. HealeyJeffrey S. Healey Hamilton Health Sciences Center Hamilton, Ontario (Healey) Jean ChampagneJean Champagne Quebec Heart Institute Laval Hospital Quebec City, Quebec (Champagne) Doug CameronDoug Cameron University Health Network Toronto, Ontario (Cameron) Iqwal MangatIqwal Mangat St. Michael's Hospital Toronto, Ontario (Mangat) Atul VermaAtul Verma Southlake Regional Hospital NewMarket, Ontario (Verma) Kevin WolfeKevin Wolfe St. Boniface Hospital Winnipeg, Manitoba (Wolfe) Vidal EssebagVidal Essebag McGill University Health Center Montreal, Quebec (Essebag) Teresa KusTeresa Kus Hôpital Sacré-Coeur de Montréal Montreal, Quebec (Kus) Felix Ayala-ParedesFelix Ayala-Paredes Centre Hospitalier Universitaire de Sherbrooke Sherbrooke, Quebec (Ayala-Paredes) Ted DaviesTed Davies Scarborough Centenary Hospital Scarborough, Ontario (Davies) Shubhayan SanataniShubhayan Sanatani BC Children's Hospital Vancouver, British Columbia (Sanatani) Robert GowRobert Gow Children's Hospital of Eastern Ontario Ottawa, Ontario (Gow) Bernard CoutuBernard Coutu Centre Hospitalier Notre Dame Montreal, Quebec (Coutu) Soori SivakumaranSoori Sivakumaran Royal Alexander Hospital Edmonton, Alberta (Sivakumaran) Elizabeth StephensonElizabeth Stephenson The Hospital for Sick Children Toronto, Ontario (Stephenson) Andrew KrahnAndrew Krahn London Health Sciences Center London, Ontario (Krahn) Originally published15 Mar 2011https://doi.org/10.1161/CIRCULATIONAHA.110.003517Circulation. 2011;123:e376–e377We would like to thank Dr Maytin and colleagues for highlighting some important issues with regard to the Fidelis lead and its appropriate management. The experience that we reported is the only comprehensive experience regarding the Fidelis lead and complications related to its revision.1The complication classification that we used is based on prior reports on complications due to device advisories or replacements.2,3 Our study was not designed specifically to examine complications due to transvenous lead extraction, so the system of classification suggested by Maytin et al would not be applicable. If traction was attempted, but the lead was abandoned, the patient was classified as lead abandoned. The data reported by Maytin et al4 have significant potential referral bias, as patients with a higher degree of comorbid illness may not have been referred. In addition, the long-term complications of this complex procedure, where a greater degree of infection may be expected and which may lead to a significant degree of morbidity or mortality, were not reported.There are currently no data examining the outcome of systematic prophylactic removal of this lead, as our data reported summary data only. Complications related to prophylactic revision of this lead may be underestimated due to limited numbers. We agree completely with Maytin et al's statement that the decision to perform any procedure "mandates an assessment of risk." The issue of risk is dependent on patient factors, rather than just factors associated with the procedure. Given the constant risk of Sprint Fidelis failure (1% to 1.5% per year) and the significant reduction in inappropriate shocks through institution of the Lead Integrity Alert, careful observation remains prudent for this lead, particularly as the time from implant lengthens, which was the single predictor of need for laser extraction tools in the analysis of patients in the study by Maytin et al. If a system modification is going to be performed for another reason, insertion of either a new pace/sense lead or a new high voltage lead, without extraction, should be attempted at most centers. The role of regional high volume extraction centers is exemplified by the report of Maytin et al, so that if extraction is to be contemplated, it should be done in centers with significant experience.Ratika Parkash, MD, MSc QEII Health Sciences Centre Halifax, Nova ScotiaEugene Crystal, MD Sunnybrook Hospital Toronto, OntarioJamil Bashir, MD St. Paul's Hospital Vancouver, British ColumbiaChristopher Simpson, MD Queen's University Kingston, OntarioDavid Birnie, MD University of Ottawa Heart Institute Ottawa, OntarioLaurence Sterns, MD Royal Jubilee Hospital Victoria, British ColumbiaDerek Exner, MD Foothills Hospital Calgary, AlbertaBernard Thibault, MD Montreal Heart Institute Montreal, QuebecSean Connors, MD Memorial University Health Sciences Center St. John's NewfoundlandJeffrey S. Healey, MD, MSc Hamilton Health Sciences Center Hamilton, OntarioJean Champagne, MD Quebec Heart Institute Laval Hospital Quebec City, QuebecDoug Cameron, MD University Health Network Toronto, OntarioIqwal Mangat, MD St. Michael's Hospital Toronto, OntarioAtul Verma, MD Southlake Regional Hospital NewMarket, OntarioKevin Wolfe, MD St. Boniface Hospital Winnipeg, ManitobaVidal Essebag, MD, PhD McGill University Health Center Montreal, QuebecTeresa Kus, MD Hôpital Sacré-Coeur de Montréal Montreal, Quebec (Kus)Felix Ayala-Paredes, MD Centre Hospitalier Universitaire de Sherbrooke Sherbrooke, QuebecTed Davies, MD Scarborough Centenary Hospital Scarborough, OntarioShubhayan Sanatani, MD BC Children's Hospital Vancouver, British ColumbiaRobert Gow, MB, BS Children's Hospital of Eastern Ontario Ottawa, OntarioBernard Coutu, MD Centre Hospitalier Notre Dame Montreal, QuebecSoori Sivakumaran, MD Royal Alexander Hospital Edmonton, AlbertaElizabeth Stephenson, MD The Hospital for Sick Children Toronto, OntarioAndrew Krahn, MD London Health Sciences Center London, OntarioDisclosuresR.P. received funding from Medtronic, Inc. and St. Jude Medical; E.C. received funding from Medtronic, Inc., St. Jude Medical, Boston Scientific, and Sorin/ELA; D.B. received funding from Medtronic, Inc.; D.E. received funding from Medtronic, Inc., St. Jude Medical, Boston Scientific, and Sorin/ELA; B.T. received funding from St. Jude Medical, Medtronic, Inc., Sorin Group, and Boston Scientific; A.V. received honoraria and research grants from St. Jude Medical, Biosense Webster, Medtronic, Inc., Sanofi Aventis, and Boehringer Ingelheim; V.E. received honoraria and minor speaker fees from Medtronic, Inc; and S.S. received funding from Medtronic, Inc.References1. Parkash R, Crystal E, Bashir J, Simpson C, Birnie D, Sterns L, Exner D, Thibault B, Connors S, Healey JS, Champagne J, Cameron D, Mangat I, Verma A, Wolfe K, Essebag V, Kus T, Ayala-Paredes F, Davies T, Sanatani S, Gow R, Coutu B, Sivakumaran S, Stephenson E, Krahn A. Complications associated with revision of Sprint Fidelis leads: report from the Canadian Heart Rhythm Society Device Advisory Committee. Circulation. 2010; 121:2384–2387LinkGoogle Scholar2. Gould PA, Krahn ADCanadian Heart Rhythm Society Working Group on Device Advisories.Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA. 2006; 295:1907–1911CrossrefMedlineGoogle Scholar3. Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb RREPLACE Registry Investigators.Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010; 122:1553–1561LinkGoogle Scholar4. Maytin M, Love CJ, Fischer A, Carrillo RG, Garisto JD, Bongiorni MG, Segreti L, John RM, Michaud GF, Albert CM, Epstein LM. Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. J Am Coll Cardiol. 2010; 56:646–650CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails March 15, 2011Vol 123, Issue 10 Advertisement Article InformationMetrics © 2011 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.110.003517 Originally publishedMarch 15, 2011 PDF download Advertisement SubjectsArrhythmiasCatheter Ablation and Implantable Cardioverter-Defibrillator
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