News | December 07, 2008

Study in the HeartRhythm Journal Shows Increased Complication Rates After ICD Replacement

December 8, 2008 - New research reveals patients with implantable cardioverter defibrillators (ICDs) who have had multiple, previous pocket procedures are at an increased risk of complications after ICD replacement.

The new study published in the December 2008 edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, further reports a higher than expected overall ICD replacement complication rate compared to findings from earlier studies.

The large, multicenter study, led by Andrew Krahn, M.D., from the London Health Sciences Center in London, Ontario, involved participation from 12 of the largest ICD implanting centers in Canada. The purpose of the study was to identify predictors of ICD replacement complications and investigate those complications in order to determine what causes patients to be at a greater risk. The study proves that multiple, previous pocket procedures are a predictor of ICD replacement complications. Patients who have already had multiple pocket procedures are at a greater risk of complication.

“No prior research has investigated the potential risk factors associated with ICD replacement, more specifically, what makes some patients more at-risk than others,” said author Andrew Krahn, M.D. “Study findings will help physicians better understand complication risks for patients who may need ICD replacement, and ultimately provide better care for their patients.”

Among the 12 participating centers, 451 out of 2,635 advisory ICD devices were replaced between October 2004 and October 2005. Over a one-year follow-up period, results show that patients experience various levels of complications, both major and minor. Major complications can include serious infection requiring system removal, and bleeding or ICD malfunction necessitating re-operation, while minor complications can include minor infection or worsening of other medical conditions. Of the 451 patients who underwent ICD replacement, 41 (9.1 percent) experienced complications, 27 (5.9 percent) required re-operation and included two deaths, and 14 patients (3.1 percent) experienced minor complications.

For more information:

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init