Jamil Bashir

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.

Complications Associated With Revision of Sprint Fidelis Leads Report From the Canadian Heart Rhythm Society Device Advisory Committee

Background— It has been observed that replacement of an implantable cardioverter-defibrillator generator in response to a device advisory may be associated with a substantial rate of complications, including death. The risk of lead revision in response to a lead advisory has not been determined previously. Methods and Results— Twenty-five implantable cardioverter-defibrillator implantation and follow-up centers from the Canadian Heart Rhythm Society Device Advisory Committee were surveyed to assess complication rates as a result of lead revisions due to the Sprint Fidelis advisory issued in October 2007. As of June 1, 2009, there had been 310 lead failures found in 6237 Sprint Fidelis leads in Canada (4.97%) over a follow-up of 40 months. There were 469 leads to be revised, 66% for confirmed fracture. Of the patients who underwent revision, 95% had a new lead inserted, whereas 4% had a pace/sense lead added. The lead was removed in 248 cases (53%), by simple traction in 61% and by laser lead extraction in 33%. Complications were encountered in 14.5% of the lead revisions; 7.25% of these were major, whereas 7.25% were minor. There were 2 deaths (0.43%). The overall risk of complications (19.8%) was greater in those who underwent lead removal at the time of revision than in those whose leads were abandoned (8.6%; P=0.0008). Conclusions— The overall rate of major complications that arose from lead revision due to the Sprint Fidelis advisory was significant. This must be taken into account when lead revision is planned in those patients who have not yet demonstrated an abnormality in lead performance.

Off-Pump Implantation of the HeartWare HVAD Left Ventricular Assist Device Through Minimally Invasive Incisions

Implantation of left ventricular assist devices through small incisions, avoiding cardiopulmonary bypass, may decrease the activation of the inflammatory and coagulation cascades and decrease bleeding and vasoplegia. One patient with severe, inotrope-dependant cardiomyopathy received the HeartWare left ventricular assist device (HeartWare Inc, Framingham, MA) through an upper ministernotomy and left minithoracotomy. The outflow graft was connected to the ascending aorta, and the inflow of the left ventricular assist device was attached through to the apex of the heart. The apical puncture was performed under rapid ventricular pacing, followed by insertion of the inflow of the pump. The patient was extubated rapidly and discharged home 14 days later.

Coronary Sinus Lead Extraction

TYERS, G.F.O., et al.: Coronary Sinus Lead Extraction. Complications are reported more frequently with the implantation of coronary sinus (CS) than other types of leads, and attempts to extract CS leads may also be associated with increased risks. The authors have performed nonthoracotomy lead extraction (LE) since 1981 and maintained a detailed database. By November 2001, 796 leads had been removed from 401 patients. We undertook review of our CS‐LE experience to evaluate prevalence, safety, and efficacy. Of 14 patients referred for CS‐LE, 7 were treated in the last year. In six the lead had been placed in the CS intentionally, and in eight inadvertently. One recent patient treated with biventricular pacing was septic and died before LE was undertaken. In nine men and four women (mean age 66 years) had one each CS lead and a total of 34 LEs (2.6/patient). Four CS leads had been in place for <6 months (mean 1.5 month), whereas nine had been in place for between 6 months and 27 years. Several LE methods were used, from simple traction to the use of intraluminal locking stylets and powered sheaths. Complete removal of all leads was achieved in all patients. CS‐LE required a mean of 13 minutes, including 1.8 minutes of fluoroscopy. There were no serious complications during the procedures, and the mean hospital stay was 4 days. (PACE 2003; 26[Pt. II]:524–526)

Successful Weaning and Explantation of the Heartmate II Left Ventricular Assist Device

BACKGROUND Ventricular assist devices (VADs) are used in cases of heart failure refractory to medical therapy. Most VADs are used as a bridge to heart transplantation; however, in certain cases, myocardial function recovers and VADs can be explanted after the patient is weaned. The objectives of this study were to describe patients who required Heartmate II VAD insertion, followed by myocardial recovery and explanation in a quaternary heart centre. METHODS Patients who had a VAD explanted were identified in the mechanical support institutional database and their outcomes were analyzed. Clinical examinations, biochemical markers, and serial echocardiograms were used to demonstrate myocardial recovery. RESULTS Seventeen patients had a Heartmate II VAD inserted between 2008 and 2010. Four patients underwent successful weaning and subsequent VAD explantation. Etiology of decompensated heart failure was idiopathic dilated cardiomyopathy (n = 1), ischemic (n = 1), or myocarditis (n = 2). Mean age was 35.3 years. Patients were supported for 213 days (range 70-293 days) and were in New York Heart Association class I in the community before explantation. The devices were explanted via a minimally invasive approach, without cardiopulmonary bypass. All patients survived explantation and were discharged alive from hospital after an average of 5.7 ± 1.5 days post pump explantation. No adverse events were reported after explantation. Only one patient required allogenic blood transfusion after the procedure. CONCLUSIONS Patients requiring VAD support for myocardial failure can undergo significant reverse remodelling. Explantation can lead to optimal outcome with minimal morbidity. Methods for assessment of reverse remodelling, weaning protocol, and optimal timing of explantation remain under evaluation.

Combined Use of Transesophageal ECHO and Fluoroscopy for the Placement of Left Ventricular Pacing Leads via the Coronary Sinus

Biventricular pacing is an emerging technology for treatment of congestive heart failure. Left ventricular leads are most commonly placed through the coronary sinus (CS) into an epicardial coronary vein. Cannulation of the CS can be difficult and standard guiding catheters have a tendency to displace during lead advancement. This study found that transesophageal echocardiography facilitated CS cannulation in complex cases requiring antecedent lead extraction. (PACE 2003; 26:1951–1954)

Minimally invasive, off-pump explant of a continuous-flow left ventricular assist device.

The left ventricular assist device (LVAD) has been used successfully for bridge to transplant and destination therapy. In some cases, myocardial recovery is possible and allows LVAD explantation. We describe a novel explant technique for the HeartMate II LVAD using small incisions on a beating heart, without cardiopulmonary bypass.

Early Failure of the Biotronik Linox Implantable Cardioverter Defibrillator Lead

The Linox and Durata implantable cardioverter defibrillator (ICD) leads were introduced to British Columbia (BC) in 2008. We determined their performance and the potential risk factors for lead failure in a large population‐based patient registry.

Thrombosis and failure of a HeartMate II Device in the absence of alarms

Next-generation left ventricular assist devices such as the HeartMate II (Thoratec Corporation, Pleasanton, CA) have significantly improved patient outcomes. In particular, the incidence of thromboembolic events appears to be significantly reduced. Pump thrombosis has occurred, however, and is well reported in the literature. The thromboses reported with next-generation devices have generally been partial thromboses associated with significant abnormalities in the system performance data as displayed on the system monitor. We describe a case of complete thrombosis of a HeartMate II axial-flow pump resulting in cardiac arrest but in the absence of alarms or significant aberrations in the performance data.

Preventing cardiac implantable electronic device infections

Cardiac implantable electronic devices (CIEDs) have dramatically improved clinical outcomes in patients with heart disease, and the number of CIED-related procedures being performed continues to grow. Unfortunately, the rate of device-related infection (DRI) is increasing disproportionately to the rate of implantation, with DRI rates of >2% in many series. This increase in DRI is a consequence of the increased number of patients with a higher burden of comorbidities, who are more susceptible to infection and are undergoing more complex device procedures. Identification of high-risk patients is an important component of procedural planning, and targeted therapy and surveillance may be beneficial in certain groups. An understanding of the pathophysiology of DRI has facilitated more effective and widespread use of prophylactic antibiotics; however, current guidelines for antibiotic prophylaxis are based on a relatively small evidence base. Clinical equipoise remains regarding the optimal prophylactic regimen, and we are continuing to learn how best to manage these patients. In this review, we discuss the epidemiology and pathophysiology of DRI and its clinical presentation, the risk factors for DRI, and the existing and emerging evidence supporting strategies to prevent DRI.