Contributions of Advanced Techniques to the Success and Safety of Transvenous Leads Extraction

Purpose: We measured the proportion of intravascular leads, which can be extracted by simple traction versus with newer techniques, and examined the overall safety and success rate of lead extractions.
Methods: Between January 2005 and December 2007, 311 consecutive patients (mean age = 70 ± 14 years, 79% men) underwent extractions of 250 atrial, 318 ventricular, and 22 coronary sinus leads, in the surgical facilities of two experienced medical centers, under general anesthesia, at a mean of 7.2 ± 5.1 years (range 0.1–27.0) after lead implantation. Infection was the indication for extraction in 67.5% of cases. Complementary techniques were used when simple extraction with a locking stylet was unsuccessful.
Results: Simple traction, with or without a locking stylet, allowed the complete removal in 27.0% (95% confidence interval [CI] 22.1–31.9) of patients. A mechanical sheath, laser sheath, and/or lasso catheter were used in the remaining patients. The overall extraction success rate was 89.7% (95% CI 86.3–93.1). There was one procedure-related death (0.3%; 95% CI 0.0–1.0). Among five other deaths occurring within 10 days after the procedure, four were due to septic shock. Duration of lead implantation was the strongest independent predictor of major adverse events (P = 0.002) and incomplete lead extraction (P = 0.005).
Conclusion: In contrast with simple traction, advanced techniques allowed the complete extraction of nearly 90% of leads. In experienced hands and with surgical back-up, these techniques were safe. Patients presenting with infected implanted cardiac devices suffered a high rate of major adverse despite complete extraction of the lead(s).     

Initial Experience with Transvenous Implantable Cardioverter Defibrillator Lead Systems: Operative Morbidity and Mortality

Introduction of non-thoracotomy lead systems™ (Medtronic, Inc.) for the implantable cardioverter defibrillator (ICD) has expanded the indications for use of this mode of therapy. Patients previously considered "too ill" to undergo a thoracotomy as well as patients who are at a high risk for developing sudden death but without previous cardiac arrest, are now considered candidates. The initial experience with the non-thoracotomy lead system at our institution was analyzed for morbidity and mortality. Thirty-four patients underwent attempted intravascular lead implantation, with 30 having initial successful implantation (88.2%). There were 23 males; average ejection fraction (EF) was 38.6%. Three patients developed pulmonary edema and low output immediately after the procedure. Three patients developed electromechanical dissociation during defibrillation threshold testing. A prolonged testing time for the non-thoracotomy lead system was noted when compared to the thoracotomy system (57.39 vs 32.30 min; P < 0.0000). There were more intraoperative morbidities with the non-thoracotomy leads than with the thoracotomy system. There were no perioperative deaths. The potential consequences of prolonged anesthesia time and extensive defibrillation threshold testing should be considered when choosing the route of ICD implant, the type of anesthesia, and the intraoperative testing protocol for each patient.     

Safety of Pacemaker Implantation in Patients with Transvenous (Nonthoracotomy) Implantable Cardioverter Defibrillators

While several reports bave documented the safety of implantation of transvenous pacemakers in patients with epicardial patch-based impiantable cardioverter defibrillators (ICDs), the implantation of transvenous pacemakers in patients with transvenous (nonthoracotomy) ICDs has not been well-descrihed. We present three patients with transvenous ICDs who subsequently underwent implantation of transvenous pacemakers without complication. Technical considerations and a testing protocol for detection of pacemaker-ICD interactions are discussed.     

A Shocking End to the Defibrillator as We Know It: Unmet Needs and the Case for a Stand‐Alone Device that Uses Pacing Only to Treat the Risk of Life‐Threatening Arrhythmias

The defining feature of an ICD is its capacity to deliver a shock. However, the past decade has seen a marked de‐emphasis on the perceived value, necessity and safety of shocks. As a consumer product, it is time to reimagine the ICD, decoupling the shock feature from pacing and antitachycardia pacing.     

Permanent Pacing from the Coronary Sinus in a Patient with an Implantable Defibrillator

A woman with an ICD underwent permanent pacemaker implantation for bradycordia-tachycardia syndrome. Despite multiple right atrial positions, oversensing secondary to "double counting" was always noted. A coronary sinus pacing catheter was inserted and left atrial pacing was accomplished with acceptable pacing and sensing characteristics. The patient has since done well without further shocks.     

Retromammary Implantation of an ICD Using a Single Lead System: An Alternative Approach to Pectoral Implantation in Women

Pectoral ICD implantation, although feasible with the release of smaller devices, can be cosmetically disturbing to some patients due to the device protruding under the skin. An ICD was implanted using the retromammary approach in a 25-year-old female patient. Retromammary implantation of an ICD is feasible and offers an alternative approach in women.     

Prospective Study of Axillary Vein Puncture with or Without Contrast Venography for Pacemaker and Defibrillator Lead Implantation

Axillary vein puncture may be used to implant pacemaker (PM) or cardioverter defibrillator leads, though usually requires venography. We prospectively compared punctures guided by venography versus a new radiological landmark. In 232 patients, the puncture was guided by injecting diluted contrast material via an ipsilateral peripheral vein (group A, n = 142), or without venography using the intersection of the lateral borders of the second and third rib as a radiological landmark, followed by contrast injection in case of failure (group B, n = 90). We implantated 1–3 leads per patient. In group A, implantation was successful in 135 patients (95%) and in group B in 55 patients (61%, P < 0.001 vs group A). Subsequent contrast injection allowed successful implantations in 34 of 35 patients, with an success rate of 97% for the overall study population of 224 patients. Venous access was achieved after a mean of 10.4 ± 3.2 minutes of skin incision in group A versus 9.4 ± 3.0 minutes in group B (ns). Pneumothorax occurred in two patients (1% overall). Thus non-contrast guided puncture using a new radiological landmark was successful in a majority of patients. This technique may be useful in absence of ipsilateral peripheral vein access, or presence of contrast allergy.     

Antitachycardia Pacing in Patients with Implantable Cardioverter Defibrillators: How Many Attempts Are Useful?

The purpose of this study was to determine the termination and acceleration rates for 1 to 6 attempts of antitachycardia pacing (ATP) delivered by ICD in order to terminate spontaneously occurring VTs. Twenty-four ICD recipients with active ATP programs, including a maximum of six ATP sequences and spontaneously occurring VTs during follow-up, were investigated. During a mean follow-up of 42 ± 15 months (range, 17–63 months) 413 spontaneous VT episodes (17 ± 14; range, 1–49 per patient) resulting in appropriate ATP delivery by the ICD occurred. ATP successfully terminated 328 episodes (80 %) with a mean number of 1.6 ± 1.1 pacing sequences. Eighty episodes (19%) were accelerated by ATP and 5 (1%) were unresponsive to ATP. The ATP success decreased until the third ATP sequence (59%→ 31%→ 24%), but increased again in the fourth to sixth attempt (46%→ 46%→ 29%). The acceleration rate increased from sequence one to sequence three (8%→ 13%→ 28%), but decreased significantly in further ATP attempts (19%→ 0%→ 0%). The mean time delays until redetection or termination after 4, 5, and 6 attempts of ATP were 22 ± 5 seconds, 37 ± 2 seconds, and 41 ± 9 seconds, respectively. Nine patients (37%) used ≥3 ATP attempts during follow-up and all of them had a therapeutic benefit from it. Five out of 13 VTs (38%) treated with ≥4 attempts could ultimately be terminated by ATP. The results of this study demonstrate that the first ATP sequence is the most effective and that > 4 ATP attempts may be useful in a minority of patients. There seems to be a low risk of VT acceleration by the fourth to sixth ATP sequence. Because of the associated time delay, a high number of ATP attempts should only be programmed in patients with hemodynamically well-tolerated stable VTs.     

Improvement of Quality of Life by Means of Antitachy Pacing: From PainFREE to the ADVANCE-D Trial

Background: Implantable cardioverter-defibrillators (ICD) can terminate ventricular tachyarrhythmias with shocks (painful) or antitachycardia pacing (painless). According to the results of the Pacing Fast VT Reduces Shock ThErapies Trials, antitachycardia pacing (ATP) can avoid painful shocks and also increase device longevity. The purpose of the ADVANCE-D (Atp DeliVery for PAiNless ICD ThErapy) study is to determine the most appropriate ventricular tachycardia (VT) therapy, so as to optimize painless therapy for life-threatening arrhythmias.
Methods and Results: The ADVANCE-D is a prospective, multicenter, parallel, two-arm randomized study designed to evaluate the efficacy of two different sequences of ATP therapies (burst 15 pulses, 88%, vs burst 8 pulses, 88%), during an episode of spontaneous arrhythmia classified as fast VT (FVT) in patients with a Class I or IIA indication for ICD implantation (single and dual chamber devices). The primary endpoint is to compare the efficacy of two ATP therapies for FVT episodes. The study will enroll a minimum of 900 patients within 2 years, followed-up for 12 months. The investigation is expected to be completed in 2007.
Conclusions: The ADVANCE-D trial is the first large randomized clinical investigation aimed to evaluate optimal programming and efficacy of ATP.     

Implantation of a Cardioverter/Defibrillator in the Subpectoral Region Combined with a Nonthoracotomy Lead System

An implantable cardioverter defibrillator was placed into a sub-pectoral pocket via the incision for cephalic venotomy during implantation of a nonthoracotomy lead system. The approach obviated another incision and subcutaneous tunneling of the leads. There were no perioperative complications and after 6 months of follow-up, the patient continues to tolerate the device satisfactorily.     

Temporary Transvenous Pacing with an Active Fixation Bipolar Lead in Children:

Various techniques and electrode catheters have been developed for effective and safe temporary transvenous cardiac pacing. In neonates and children, lead dislodgment and myocardial perforation have been attendant risks with passive fixation leads. We report our experience with the recently introduced Medtronic 6416 active fixation bipolar lead in a small group of children. Between January 2000 and February 2002, 4 children (2 boys, 2 girls) underwent temporary transvenous pacing with the Medtronic 6416 lead. The median age at implantation was 4.25 years (range: 5 days–13 years), median weight was 14.5 kg (range: 2.5 kg–54 kg) and the median duration of temporary pacing was 19.5 days (range: 5–38 days). The indication for temporary pacing was AV block (n = 2), sinus arrest (n = 1) and sinus node dysfunction (n = 1). The acute pacing threshold was <1.5 mA with no significant rise in the follow-up period. The venous access for lead placement was femoral vein (n = 2), internal jugular vein (n = 1), and subclavian vein (n = 1). There were no complications related to implantation or in the follow-up period. The Medtronic 6416 lead appears to be a safe and effective tool in temporary transvenous pacing in neonates and children. (PACE 2003; 26[Pt. I]:1519–1522)     

Transvenous cardioverter defibrillator lead malfunction due to terminal connector damage in pectoral implants

Lead failure places patients with implantable cardioverter defibrillators (ICD) at risk for sudden cardiac death or results in delivery of inappropriate shocks. This study describes a mechanism of lead malfunction occurring at the junction of the terminal ring with the conductor coil of the rate sensing terminal connector in one specific model of a transvenous ICD lead. We detected the problem in a population of 179 patients with a mean age of 61 +/- 10 years and a mean lead implant duration of 16 +/- 11 months. All patients underwent pectoral ICD implantation using a submuscular approach. The implanting physician chose to place the ICD on the left side in 155 patients (87%) and on the right side in 24 patients (13%). Cephalic vein cutdown provided central venous access in 147 patients (82%), and subclavian vein puncture provided access in 32 patients (18%). Follow-up examination detected lead failure in six patients (3.5% over 31 months) due to insulation damage with or without conductor coil fracture at the junction of the terminal ring and conductor coil of the IS-1 rate sense terminal. We detected lead disruption 17 +/- 9 months (range 5-31 months) after implantation. Multiple nonsustained arrhythmia episodes exhibiting nonphysiologic intervals associated with noisy rate sensing electrograms during pocket manipulation led to discovery in three patients. The other three patients presented with inappropriate device discharges confirmed by stored high-energy lead electrograms showing normal rhythm. Pacing lead impedance abnormally dropped in two patients. Impedance remained stable in the other four patients. In conclusion, the generator pocket represents an important site of ICD transvenous lead vulnerability. Lead failure may result from conductor coil and/or insulation disruption at the interface with the rate sensing terminal connector.