Steven P. Kutalek

Intravascular Extraction of Problematic or Infected Permanent Pacemaker Leads: 1994–1996

Of the 400,000–500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5‐year period (1989–1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix® or Encor® leads (46%), or other causes (2%). Patients were 64 ± 17 years of age (range 5–96); 59% were men, 41% women. Leads were implanted 47 ± 41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P < 0.0001), less experienced physicians (P < 0.0001), ventricular leads (P < 0.005), noninfected patients (P < 0.0005), and younger patients (P < 0.0001). Major complications were reported for 1.4% of patients (< 1% at centers with > 300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P < 0.005) and with less experienced physicians (P < 0.005); risk of major complications was higher for women (P < 0.01). Given physician experience, appropriate precautions, and appropriate patient selection, contemporary lead removal techniques allow success with low complication rates.

Percutaneous pacemaker and implantable cardioverter-defibrillator lead extraction in 100 patients with intracardiac vegetations defined by transesophageal echocardiogram.

OBJECTIVESnWe describe the feasibility, safety, and clinical outcomes of percutaneous lead extraction in patients at a tertiary care center who had intracardiac vegetations identified by transesophageal echocardiogram.nnnBACKGROUNDnInfection in the presence of intracardiac devices is a problem of considerable morbidity and mortality. Patients with intracardiac vegetations are at high risk for complications related to extraction and protracted clinical courses. Historically, lead extraction in this cohort has been managed by surgical thoracotomy.nnnMETHODSnWe analyzed percutaneous lead extractions performed from January 1991 to September 2007 in infected patients with echocardiographic evidence of intracardiac vegetations, followed by a descriptive and statistical analysis.nnnRESULTSnA total of 984 patients underwent extraction of 1,838 leads; local or systemic infection occurred in 480 patients. One hundred patients had intracardiac vegetations identified by transesophageal echocardiogram, and all underwent percutaneous lead extraction (215 leads). Mean age was 67 years. Median extraction time was 3 min per lead; median implant duration was 34 months. During the index hospitalization, a new device was implanted in 54 patients at a median of 7 days after extraction. Post-operative 30-day mortality was 10%; no deaths were related directly to the extraction procedure.nnnCONCLUSIONSnPatients with intracardiac vegetations identified on transesophageal echocardiogram can safely undergo complete device extraction using standard percutaneous lead extraction techniques. Permanent devices can safely be reimplanted provided blood cultures remain sterile. The presence of intracardiac vegetations identifies a subset of patients at increased risk for complications and early mortality from systemic infection despite device extraction and appropriate antimicrobial therapy.

Proarrhythmic effects of adenosine: One decade of clinical data

In 1989, adenosine was introduced into the American clinical setting as an antiarrhythmic drug for the acute management of reentrant supraventricular tachycardia involving the atrioventricular node. During this decade of use, evidence for proarrhythmic effects of the drug have been documented. In addition to the mostly benign transient episodes of atrial fibrillation, several cases of life-threatening ventricular arrhythmias induced by adenosine have been reported. This article summarizes the proarrhythmic effects of adenosine as they were reported in the literature as well as data from the manufacturer files. The causes of these adverse effects of adenosine are analyzed, and factors to be considered before using the drug are discussed.

Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results

BACKGROUNDnThe subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to reduce short- and long-term complications associated with transvenous ICD leads. Early multicenter studies included younger patients with less left ventricular systolic dysfunction and fewer comorbidities than cohorts with traditional ICD.nnnOBJECTIVEnThe purpose of this study was to characterize patient selection and the acute performance of the S-ICD in a contemporary real-world setting.nnnMETHODSnThe S-ICD Post-Approval Study is a prospective registry involving 86 US centers. Patients were enrolled if they met criteria for S-ICD implantation, passed an electrocardiogram screening test, and had a life expectancy of >1 year. Analyses of descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed.nnnRESULTSnThe study includes 1637 patients who underwent S-ICD implantation. The cohort included 68.6% (1123/1637) male patients, and 13.4% (220/1636) were receiving dialysis for end-stage renal disease. The mean age was 52 ± 15 years, with a mean left ventricular ejection fraction of 32.0% ± 14.6%. Electrocardiogram screening was successful for at least 1, 2, or 3 vectors in 100%, 93.8%, and 51.4% of patients, respectively. Medical imaging (65.1%, 1065/1636) and general anesthesia (64.1%, 1048/16) were used in a majority of patients, and 52.2% (855/1637) were implanted with the 2-incision technique. Induced ventricular tachycardia/ventricular tachycardia was successfully converted in 98.7% (1394/1412) of patients. The 30-day complication-free rate was 96.2%. Predictors of complications included diabetes, younger age, and higher body mass index.nnnCONCLUSIONnContemporary US patients with S-ICD have more comorbidities than do previous cohorts with S-ICD, but they are younger with more end-stage renal disease than do patients with transvenous ICD. Implantation success is high, and short-term complication rates are acceptable.

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

BACKGROUNDnIn 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.nnnOBJECTIVEnData regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited.nnnMETHODSnWe performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers.nnnRESULTSnBetween 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%).nnnCONCLUSIONnExtraction 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.

Intrinsic conduction maximizes cardiopulmonary performance in patients with dual chamber pacemakers

Dual chamber pacemaker programmability allows the possibility of atriallytracked ventricular pacing in patients who would otherwise have intrinsic atrioventricular (AV) conduction. Thirteen patients with permanent AV sequential pacemakers (ages 50–79) were evaluated with paired exercise tests to determine the Cardiopulmonary effects of pacemaker induced right ventricular activation compared with normal AV and intraventricular conduction. Peak oxygen uptake (VO2), oxygen pulse (O2P), respiratory rate (RR), and respiratory exchange ratio (RER) were determined using breath by‐breath analysis of expired gases. Patients exercised to fatigue and exercise tests were performed in random sequence. For patients with intrinsic AV conduction (group I, n = 8) the AV delay was programmed to preserve intrinsic conduction during one study; the alternate test used AV delay programming to produce ventricular pacing. Five patients with chronic AV block (group II) acted as a control for the effects of a rate adaptive AV delay compared to a fixed AV delay. Paired t‐testing showed a significantly lower peak VO2 (P < 0.015) and O2P (P < 0.01) in patients with atrially‐tracked ventricular pacing compared to intrinsic conduction. In contrast, group II showed a significant improvement in peak VO2 with rate adaptive AV delay compared to fixed AV delay programming (P < 0.05). In conclusion, intrinsic conduction should be preserved in patients with dual chamber pacemakers whenever possible.

Axillary subpectoral approach for pacemaker or defibrillator implantation in patients with ipsilateral prepectoral infection and limited venous access

PurposeThe prepectoral approach is the procedure of choice for pacemaker or defibrillator (device) implantation. Epicardial or transiliac approaches are reserved for patients in whom the pectoral approach is not feasible. We studied the viability of the axillary subpectoral approach for implanting devices in patients in whom the standard prepectoral approach was not feasible.MethodsDevices and leads were extracted from 16 patients with infected devices in the prepectoral position. The contralateral site was unsuitable for reimplantation because of infection or inadequate venous access. On the side ipsilateral to that with prior prepectoral device infection, we made an incision on the anterior axillary line along the border of the pectoralis major; dissection was continued below the muscle to create a pocket for generator implantation. Axillary venous puncture was performed from the axillary incision and beneath the pectoralis major muscle using a long 14-gauge needle. Long guidewires and peel-away sheaths were used for positioning the lead. The generator was placed in the subpectoral pocket; the wound was closed with absorbable sutures.ResultsOne patient developed a pocket hematoma; one developed a pneumothorax; no other surgical complication, lead malfunction, or recurrence of infection was observed.ConclusionThe axillary subpectoral approach is an acceptable, technically feasible method for reimplantation for patients with pectoral device infection and limited venous access options. It offers the advantage of a new sterile fascial plane ipsilateral to the site of prepectoral device infection.

Outcomes of subcutaneous implantable cardioverter-defibrillator implantation in patients on hemodialysis

BackgroundSubcutaneous implantable cardioverter-defibrillator (S-ICD) provides potential benefits in patients on hemodialysis (HD) by reducing the risk of blood stream infection and preserving vascular access sites. We evaluated the safety and efficacy of S-ICD in patients with end-stage renal disease (ESRD) on HD.MethodsAll consecutive patients implanted with S-ICD between October 2012 and April 2015 at our high-volume center were included in this retrospective, single-center study. Baseline demographics, procedural details, and short- as well as long-term outcomes were compared between patients on HD and not on HD.ResultsA total of 86 S-ICDs were implanted at our institution during the study period. Eighteen (21xa0%) patients were on HD at the time of implant. HD patients were more likely to be implanted for secondary prevention. There was no statistically significant difference in procedural complications between the two groups. HD patients had a longer duration hospital stay after implant (3.6u2009±u20095.14 vs. 1.69u2009±u20092.29xa0days, pu2009=u20090.021). During a mean follow-up of 205u2009±u2009208xa0days in the HD cohort and 242u2009±u2009238xa0days in the non-HD cohort (pu2009=u20090.268), there was no device or blood stream infection in the HD group, compared with five device infections in the non-HD group. The incidence of inappropriate shocks was similar in both groups. All appropriate shocks were successful in terminating ventricular tachyarrhythmias in both groups. Patients on hemodialysis had worse inpatient as well as long-term mortality after S-ICD implant, compared with non-HD patients.ConclusionsOur study demonstrates the safety and efficacy of S-ICD in patients on HD. Despite representing a sicker patient population, HD patients implanted with S-ICD had similar procedural outcomes and inappropriate shocks. There was no device or blood stream-related infection in HD patients. All appropriate shocks for ventricular arrhythmias in HD patients were successful.

Device interaction--antitachycardia pacemakers and defibrillators for sustained ventricular tachycardia.

We evaluated the combined use of permanent automatic antitachycardia pacemakers and implanted defibrillators in fen patients with recurrent monomorphic sustained ventricular tachycardia (VT). Pacemaker programming was VVI‐T automatic burst in eight patients, VVI‐T magnet mode in one patient, and VVI in one patient. Device interactions occurred in four patients, requiring changes in pacemaker programming. These included defibrillator multiple counting during pacing, in‐appropriate pacemaker bursts initiating VT, inappropriate reset of the pacemaker antitachycardia mode by defibrillation, defibrillator discharge after pacemaker VT termination, and defibrillator VT reinitiation. Two patients required pacemaker programming out of the antitachycardia mode, and two required a change in antitachycardia pacing parameters. Seven patients remain in automatic VVI‐T and three in VVI modes. Mean follow‐up is 13 months and all patients are alive. Thus, although pacemaker/ defibrillafor combinations function well for patients with more than one VT rate, device interactions occur frequently and may require pacemaker reprogramming or elimination of the overdrive mode. Combined use of these devices should be cautiously considered when single device therapy is unsatisfactory. Devices that combine both pacing and defibrillation features may reduce adverse interaction.

Incidence and Timing of Activity Parameter Changes in Activity Responsive Pacing Systems

AHERN, T., et al.: Incidence and Timing of Activity Parameter Changes in Activity Responsive Pacing Systems. The incidence and timing of rate response parameter reprogramming in activity responsive pacing systems during the year after implantation was evaluated in two groups of patients: 24 patients in whom a VVI, R system was implanted (Activitrax, Medtronic, Inc.), and 21 patients in whom a DDD, R system was implanted (Synchrony, Siemens Pacesetter, Inc.). Activity parameter changes in Activitrax patients were made based on the presence of symptoms, while in Synchrony patients, changes were based on objective data obtained using a sensor indicated rate histogram with a slow and fast walk protocol. No significant difference in the incidence of activity parameter reprogramming was noted at various time intervals during the first year in Activitrax patients; in Synchrony patients a greater incidence of reprogramming changes was noted at the 1‐month follow‐up visit compared to later follow‐up visits (P < 0.02). Further, the incidence of changes at 1 month was greater for Synchrony compared to Activitrax patients (P < 0.001), while no difference was detected between groups at subsequent follow‐up intervals. Use of the slow and fast walk protocol, by permitting serial evaluation of sensor response, demonstrated alterations in sensor drive rates with similar levels of activity over the initial 4 to 6 postimplant weeks. This may result from postoperative changes at the pacemaker insertion site. Based on this experience, predischarge programming may not predict long‐term rate response requirements. We recommend evaluation of sensor function using an exercise protocol performed at 4 to 6 postimplant weeks in all rate responsive pacing systems that utilize a piezoelectric crystal.