The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillatorsRobert G Hauser
Minneapolis Heart Institute Foundation, 920 East 28th Street, Ste 300, Minneapolis, MN 55407, USA
J Am Coll Cardiol 45:2022-5. 2005
..One near-term solution is for manufacturers to provide devices with larger batteries so that most patients can have an ICD pulse generator that lasts a lifetime. For the long-term, more robust or renewable energy sources are needed...
Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extractionRobert G Hauser
Minneapolis Heart Institute Foundation, 920 East 28th Street, Suite 300, Minneapolis, MN 55407, USA
Europace 12:395-401. 2010
..The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective...
- Failure of a novel silicone-polyurethane copolymer (Optim™) to prevent implantable cardioverter-defibrillator lead insulation abrasions
Robert G Hauser
Minneapolis Heart Institute Foundation, 920 East 28th Street, Suite 500, Minneapolis, MN 55407, USA
Europace 15:278-83. 2013
..Sylmar, CA, USA) from abrasions that cause lead failure...
The subcutaneous implantable cardioverter-defibrillator: should patients want one?Robert G Hauser
Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota 55356, USA
J Am Coll Cardiol 61:20-2. 2013
..Thus, is this technology ready for widespread application? Specifically, should a patient want one?..
- Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads
Robert G Hauser
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA
Heart Rhythm 9:1227-35. 2012
..Riata and Riata ST leads (St Jude Medical, Sylmar, CA) were recalled in 2011. These leads are prone to externalized conductors. However, it is electrical malfunctions that may result in serious adverse events, including death...
- Riata implantable cardioverter-defibrillator lead failure: analysis of explanted leads with a unique insulation defect
Robert G Hauser
Minneapolis Heart Institute Foundation, Minneapolis, MN, USA
Heart Rhythm 9:742-9. 2012
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- Early detection of an underperforming implantable cardiovascular device using an automated safety surveillance tool
Robert G Hauser
Minneapolis Heart Institute Foundation, 920 E 28th St, Minneapolis, MN 55407, USA
Circ Cardiovasc Qual Outcomes 5:189-96. 2012
..The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable cardiac device was underperforming...
- Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead
Robert G Hauser
Minneapolis Heart Institute Foundation, Minneapolis, MN, USA
Heart Rhythm 4:892-6. 2007
..We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice...
- Safety and efficacy of transvenous high-voltage implantable cardioverter-defibrillator leads in high-risk hypertrophic cardiomyopathy patients
Robert G Hauser
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA
Heart Rhythm 5:1517-22. 2008
..However, recently concerns have been raised regarding the performance of transvenous high-voltage ICD leads (HVL) in this population...
- Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure
Robert G Hauser
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, and Mayo Clinic, Rochester, Minnesota 55407, USA
Heart Rhythm 6:605-10. 2009
..The rate of Sprint Fidelis lead failure may be increasing, and physicians are confronted with the decision to replace the lead prophylactically...
- Longevity of Sprint Fidelis implantable cardioverter-defibrillator leads and risk factors for failure: implications for patient management
Robert G Hauser
Minneapolis Heart Institute Foundation, 920 E 28th St, Ste 300, Minneapolis, MN 55407, USA
Circulation 123:358-63. 2011
..The results were compared with like data for Quattro Secure (Quattro) implantable cardioverter-defibrillator leads implanted at our centers...
- Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study
Robert G Hauser
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA
Heart Rhythm 4:154-60. 2007
..Pacemakers have improved the lives of patients worldwide. Unfortunately, the medical community has had little independent information regarding the performance of these vital medical devices...
- Feasibility and initial results of an Internet-based pacemaker and ICD pulse generator and lead registry
R Hauser
Minneapolis Heart Institute Foundation, 920 E 28th St, Ste 300, Minneapolis, MN 55407, USA
Pacing Clin Electrophysiol 24:82-7. 2001
..In conclusion, an Internet-based registry is feasible and capable of providing timely data regarding the signs, causes, and clinical consequences of pacemaker and ICD failures...
- Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress
R G Hauser
Minneapolis Heart Institute Foundation, 920 E 28th Street, Suite 300, Minneapolis, MN 55407, USA
Pacing Clin Electrophysiol 24:1046-54. 2001
..This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICD's following market release are inadequate...
- Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads
Robert G Hauser
Minneapolis Heart Institute Foundation, Minnesota, USA
Pacing Clin Electrophysiol 25:879-82. 2002
..Transvene models 6936 and 6966 coaxial polyurethane ICD leads are prone to failure over time. Patients who have these leads should be evaluated frequently. Additional studies are needed to identify safe management strategies...
- Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database
Robert G Hauser
Minneapolis Heart Institute Foundation, Minnesota 55407, USA
Heart Rhythm 1:399-405. 2004
..The aim of this study was to understand the causes of implantable cardioverter defibrillator (ICD) failure and complications so that adverse events, including unnecessary death, can be prevented...
- Lessons from the failure and recall of an implantable cardioverter-defibrillator
Robert G Hauser
Hypertrophic Cardiomyopathy Center, Minneapolis Heart Institute Foundation, Minneapolis, MN 55407, USA
Circulation 112:2040-2. 2005
- Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators
Robert G Hauser
Minneapolis Heart Institute Foundation, Minnesota 55407, USA
Heart Rhythm 3:640-4. 2006
..Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and longevity...
- Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter-defibrillator lead
Linda M Kallinen
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA
Heart Rhythm 5:775-9. 2008
..The Medtronic Sprint Fidelis implantable cardioverter-defibrillator high-voltage lead is prone to fracture. The October 2007 safety advisory recommended lead impedance monitoring to aid in identifying lead fractures...
- Sudden cardiac arrest in hypertrophic cardiomyopathy in the absence of conventional criteria for high risk status
Barry J Maron
Hypertrophic Cardiomyopathy Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA
Am J Cardiol 101:544-7. 2008
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- Clinical course of hypertrophic cardiomyopathy with survival to advanced age
Barry J Maron
Hypertrophic Cardiomyopathy Center, Minneapolis Heart Institute Foundation, 920 E 28th Street, Suite 60, Minneapolis, MN 55407, USA
J Am Coll Cardiol 42:882-8. 2003
..This study was designed to clarify and resolve the clinical profile of older patients with hypertrophic cardiomyopathy (HCM)...
- Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures
Linda M Kallinen
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA
Heart Rhythm 7:1048-55. 2010
..The Medtronic lead integrity alert (LIA) algorithm was designed to improve early detection of transient P/S conductor fractures and to decrease the incidence and number of inappropriate shocks...
- Unexpected loss of bipolar lead function associated with lead connection design in dual chamber pacemakers
Charles C Gornick
Minneapolis Heart Institute, Minnesota 55407, USA
Pacing Clin Electrophysiol 25:1394-6. 2002
..Reprogramming devices to the unipolar mode restored appropriate pacing thresholds and lead impedance. The changes in bipolar lead function are likely caused by failure of the QC2 header lead connection system over time...
- Unpredictable implantable cardioverter-defibrillator pulse generator failure due to electrical overstress causing sudden death in a young high-risk patient with hypertrophic cardiomyopathy
Charles C Gornick
Heart Rhythm 2:681-3. 2005
- Perspectives on the failure of pharmaceutical and medical device industries to fully protect public health interests
Barry J Maron
Am J Cardiol 100:147-51. 2007
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- Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and
Mark D Carlson
University Hospitals of Cleveland and Case Western Reserve University, OH, USA
Heart Rhythm 3:1250-73. 2006
