Roger G. Carrillo

Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management: This document was endorsed by the American Heart Association (AHA)

Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, OH, Ohio State University, Division of ardiovascular Medicine, Columbus, OH, Broward General Medical Center, Fort Lauderdale, FL, University Hospital, ivision of Cardiovascular Medicine, Pisa, Italy, University of Miami, Cardiothoracic Surgery, Miami, FL, St. Thomas esearch Institute, University of Tennessee College of Medicine, Nashville, TN, Brigham and Women’s Hospital, Boston, A, **Baylor College of Medicine, Pediatrics and Texas Children’s Hospital, Houston, TX, Sahlgrenska University ospital, Gothenburg, Sweden, University of Medical Sciences, Poznan, Poland, Providence St. Joseph Medical enter, Burbank, CA, American Heart Association Representative.

Lead Extraction in the Contemporary Setting: The LExICon Study. An Observational Retrospective Study of Consecutive Laser Lead Extractions

OBJECTIVES This study sought to examine the safety and efficacy of laser-assisted lead extraction and the indications, outcomes, and risk factors in a large series of consecutive patients. BACKGROUND The need for lead extraction has been increasing in direct relationship to the increased numbers of cardiovascular implantable electronic devices. METHODS Consecutive patients undergoing transvenous laser-assisted lead extraction at 13 centers were included. RESULTS Between January 2004 and December 2007, 1,449 consecutive patients underwent laser-assisted lead extraction of 2,405 leads (20 to 270 procedures/site). Median implantation duration was 82.1 months (0.4 to 356.8 months). Leads were completely removed 96.5% of the time, with a 97.7% clinical success rate whereby clinical goals associated with the indication for lead removal were achieved. Failure to achieve clinical success was associated with body mass index <25 kg/m(2) and low extraction volume centers. Procedural failure was higher in leads implanted for >10 years and when performed in low volume centers. Major adverse events in 20 patients were directly related to the procedure (1.4%) including 4 deaths (0.28%). Major adverse effects were associated with patients with a body mass index <25 kg/m(2). Overall all-cause in-hospital mortality was 1.86%; 4.3% when associated with endocarditis, 7.9% when associated with endocarditis and diabetes, and 12.4% when associated with endocarditis and creatinine > or =2.0. Indicators of all-cause in-hospital mortality were pocket infections, device-related endocarditis, diabetes, and creatinine > or =2.0. CONCLUSIONS Lead extraction employing laser sheaths is highly successful with a low procedural complication rate. Total mortality is substantially increased with pocket infections or device-related endocarditis, particularly in the setting of diabetes, renal insufficiency, or body mass index <25 kg/m(2). Centers with smaller case volumes tended to have a lower rate of successful extraction.

Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier

To the Editor: Studies have demonstrated equivalent defibrillation efficacy and all-cause mortality in patients with single and dual coil implantable cardioverter-defibrillator (ICD) leads ([1,2][1]). Despite this equivalency, the vast majority of implanted ICD leads are dual coil ([3][2]). The

Multicenter Experience With Extraction of the Sprint Fidelis Implantable Cardioverter-Defibrillator Lead

OBJECTIVES This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. BACKGROUND The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. METHODS We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. RESULTS Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p=0.006). There were no major procedural complications or deaths. CONCLUSIONS Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.

Timing of the most recent device procedure influences the clinical outcome of lead-associated endocarditis results of the MEDIC (Multicenter Electrophysiologic Device Infection Cohort).

OBJECTIVES The purpose of this study was to determine whether the timing of the most recent cardiac implantable electronic device (CIED) procedure, either a permanent pacemaker or implantable cardioverter-defibrillator, influences the clinical presentation and outcome of lead-associated endocarditis (LAE). BACKGROUND The CIED infection rate has increased at a time of increased device use. LAE is associated with significant morbidity and mortality. METHODS The clinical presentation and course of LAE were evaluated by the MEDIC (Multicenter Electrophysiologic Device Cohort) registry, an international registry enrolling patients with CIED infection. Consecutive LAE patients enrolled in the Multicenter Electrophysiologic Device Cohort registry between January 2009 and May 2011 were analyzed. The clinical features and outcomes of 2 groups were compared based on the time from the most recent CIED procedure (early, <6 months; late, >6 months). RESULTS The Multicenter Electrophysiologic Device Cohort registry entered 145 patients with LAE (early = 43, late = 102). Early LAE patients presented with signs and symptoms of local pocket infection, whereas a remote source of bacteremia was present in 38% of patients with late LAE but only 8% of early LAE (p < 0.01). Staphylococcal species were the most frequent pathogens in both early and late LAE. Treatment consisted of removal of all hardware and intravenous administration of antibiotics. In-hospital mortality was low (early = 7%, late = 6%). CONCLUSIONS The clinical presentation of LAE is influenced by the time from the most recent CIED procedure. Although clinical manifestations of pocket infection are present in the majority of patients with early LAE, late LAE should be considered in any CIED patient who presents with fever, bloodstream infection, or signs of sepsis, even if the device pocket appears uninfected. Prompt recognition and management may improve outcomes.

New-Onset Atrial Fibrillation After Aortic Valve Replacement : Comparison of Transfemoral, Transapical, Transaortic, and Surgical Approaches

OBJECTIVES This study sought to determine the incidence of new-onset atrial fibrillation (AF) associated with different methods of isolated aortic valve replacement (AVR)-transfemoral (TF), transapical (TA), and transaortic (TAo) catheter-based valve replacement and conventional surgical approaches. BACKGROUND The relative incidences of AF associated with the various access routes for AVR have not been well characterized. METHODS In this single-center, retrospective cohort study, we evaluated a total of 231 consecutive patients who underwent AVR for degenerative aortic stenosis (AS) between March 2010 and September 2012. Patients with a history of paroxysmal, persistent, or chronic AF, with bicuspid aortic valves, and patients who died within 48 h after AVR were excluded. A total of 123 patients (53% of total group) qualified for inclusion. Data on documented episodes of new-onset AF, along with all clinical, echocardiographic, procedural, and 30-day follow-up data, were collated. RESULTS AF occurred in 52 patients (42.3%). AF incidence varied according to the procedural method. AF occurred in 60% of patients who underwent surgical AVR (SAVR), in 53% after TA-TAVR, in 33% after TAo-TAVR cases, and 14% after TF-TAVR. The episodes occurred at a median time interval of 53 (25th to 75th percentile, 41 to 87) h after completion of the procedure. Procedures without pericardiotomy had an 82% risk reduction of AF compared with those with pericardiotomy (adjusted odds ratio: 0.18; 95% confidence interval: 0.05 to 0.59). CONCLUSIONS AF was a common complication of AVR with a cumulative incidence of >40% in elderly patients with degenerative AS who underwent either SAVR or TAVR. AF was most common with SAVR and least common with TF-TAVR. Procedures without pericardiotomy were associated with a lower incidence of AF.

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

Fred M. Kusumoto, MD, FHRS, FACC, Chair, Mark H. Schoenfeld, MD, FHRS, FACC, FAHA, CCDS, Vice-Chair, Bruce L. Wilkoff, MD, FHRS, CCDS, Vice-Chair, Charles I. Berul, MD, FHRS, Ulrika M. Birgersdotter-Green, MD, FHRS, Roger Carrillo, MD, MBA, FHRS, Yong-Mei Cha, MD, Jude Clancy, MD, Jean-Claude Deharo, MD, FESC, Kenneth A. Ellenbogen, MD, FHRS, Derek Exner, MD, MPH, FHRS, Ayman A. Hussein, MD, FACC, Charles Kennergren, MD, PhD, FETCS, FHRS, Andrew Krahn, MD, FRCPC, FHRS, Richard Lee, MD, MBA, Charles J. Love, MD, CCDS, FHRS, FACC, FAHA, Ruth A. Madden, MPH, RN, Hector Alfredo Mazzetti, MD, JoEllyn Carol Moore, MD, FACC, Jeffrey Parsonnet, MD, Kristen K. Patton, MD, Marc A. Rozner, PhD, MD, CCDS, Kimberly A. Selzman, MD, MPH, FHRS, FACC, Morio Shoda, MD, PhD, Komandoor Srivathsan, MD, Neil F. Strathmore, MBBS, FHRS, Charles D. Swerdlow, MD, FHRS, Christine Tompkins, MD, Oussama Wazni, MD, MBA

Patency rates for angioplasty in the treatment of pacemaker-induced central venous stenosis in hemodialysis patients: results of a multi-center study.

While hemodialysis access ligation has been used to manage pacemaker (PM) and implantable cardioverter‐defibrillator (ICD) lead‐induced central venous stenosis (CVS), percutaneous transluminal balloon angioplasty (PTA) has also been employed to manage this complication. The advantages of PTA include minimal invasiveness and preservation of arteriovenous access for hemodialysis therapy. In this multi‐center study we report the patency rates for PTA to manage lead‐induced CVS. Consecutive PM/ICD chronic hemodialysis patients with an arteriovenous access referred for signs and symptoms of CVS due to lead‐induced CVS were included in this analysis. PTA was performed using the standard technique. Technical and clinical success was examined. Technical success was defined as the ability to successfully perform the procedure. Clinical success was defined as the ability to achieve amelioration of the signs and symptoms of CVS. Both primary and secondary patency rates were also analyzed. Twenty‐eight consecutive patients underwent PTA procedure. Technical success was 95%. Postprocedure clinical success was achieved in 100% of the cases where the procedure was successful. The primary patency rates were 18% and 9% at 6 and 12 months, respectively. The secondary patency rates were 95%, 86%, and 73% at 6, 12, and 24 months, respectively. On average, 2.1 procedures/year were required to maintain secondary patency. There were no procedure‐related complications. This study finds PTA to be a viable option in the management of PM/ICD lead‐induced CVS. Additional studies with appropriate design and sample size are required to conclusively establish the role of PTA in the management of this problem.

Management of cardiac device-related infections: A review of protocol-driven care

BACKGROUND The prevalence of cardiac device-related infections (CDIs) has mirrored the unprecedented increase in device usage. CDIs are currently one of the leading indications for extraction. Despite this, there is limited data regarding the clinical trends, management and outcomes associated with this complication. METHODS A review of a prospective registry of all patients undergoing device extraction between January 1, 2004, and June 15, 2009, at a single high-volume tertiary referral center was performed. RESULTS A total of 506 consecutive patients were identified. From these, 350 patients were identified as having a CDI (205 ICD, 145 PPM). The mean age was 69.9 ± 13.7. Although most patients presented clinically with signs of a pocket infection (PI) (42%), the most common final diagnosis was cardiac device infective endocarditis (CDIE) (57%). The two most common pathogens were methicillin-resistant Staphylococcus aureus (27%) and methicillin-resistant Staphylococcus epidermidis (23%); they accounted for 69% of all deaths. Cultures taken from pocket tissue as opposed to exudates displayed higher concordance with lead-tip cultures (56% and 31% respectively). The mean time from explantation to device reimplantation for PIs, bacteremia and CDIE was 6.7 ± 4.7, 10.25 ± 4.7 and 11.39 ± 16.6 days respectively. CONCLUSION CDIs are a serious complication associated with device usage. Diagnosis and management protocols for CDIs should feature transesophageal echocardiography; complete hardware extraction; broad-spectrum antibiotics that cover methicillin-resistant Staphylococci and cultures derived from lead-tips and preferably pocket tissue. Immediate device reimplantation is possible in noninfectious cases; several factors should be considered regarding reimplantation in cases involving CDIs.

Multicenter experience with extraction of the Riata/Riata ST ICD lead

BACKGROUND In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. OBJECTIVE Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. METHODS We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. RESULTS Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P < .0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). CONCLUSION Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.