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CLINICAL EVENTS CALENDAR

  • Saturday, November 8, 2008 - 15:00
    The American Heart Association Scientific Sessions
    http://www.scientificsessions.org
  • Wednesday, November 19, 2008 - 00:00
    Brisbane, Australia
    http://www.aameda.org
  • Friday, November 21, 2008 - 00:00
    EnSite 3D Mapping System Workshop
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  • Thursday, November 27, 2008 - 15:00
    1st Asia-Pacific Heart Rhythm Society Scientific Session (APHRS 2008)
    http://www.aphrs2008.com


practical EP

Bipolar Leads: New Options for CRT Implants

VOLUME: 5 PUBLICATION DATE: Feb 01 2005

Guidant CRT-D Systems and Leads

Indications
Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF £ 35%) and QRS duration >= 120 ms. The Guidant EASYTRAK coronary venous, steroid-eluting, single electrode (EASYTRAK) or dual electrode (EASYTRAK 2 and 3) pace/sense leads are transvenous leads intended for chronic LV pacing and sensing via the coronary veins when used in conjunction with a compatible Guidant CRT device that accepts the LV-1 or IS-1 connector.

Contraindications
There are no contraindications for the CRT-D device. Use of the coronary venous lead is contraindicated in patients with a hypersensitivity to a nominal single dose of 0.7 mg (EASYTRAK and EASYTRAK 2) or 1.0 mg (EASYTRAK 3) of dexamethasone acetate drug.

Warnings
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in injury to, or death of, the patient. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator paddles or an equivalent (eg, R2 pads) immediately available during conversion testing. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient’s death. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not subject a patient with an activated implanted pulse generator to diathermy since diathermy may damage the pulse generator. Do not use atrial-tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. Do not use atrial only modes in patients with heart failure because such modes do not provide CRT. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. Do not use defibrillation patch leads with the CRT-D system, or injury to the patient may occur. Do not use the CRT-D with a separate pacemaker system. This combination could result in CRT-D/pacemaker interaction. The emulator is not intended for use as a permanent lead electrode and must be removed from the patient. It is for one-time use only. Do not resterilize. When using a RV pace/sense lead in conjunction with an EASYTRAK lead, it is recommended that a polyurethane-insulated lead be used. Failure to observe this warning could result in insulation damage of the RV lead, which can cause a periodic or continual loss of pacing, sensing or both. Lead fracture, dislodgment, abrasion or an incomplete connection can cause a periodic or continual loss of pacing, sensing or both. The use of battery-powered equipment is recommended during lead implantation and testing to protect against fibrillation that might be caused by leakage currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. The lead connector must be insulated from any leakage currents that could arise from line-powered equipment. The lead is not designed to tolerate excessive flexing, bending or tension. This could cause structural weakness, conductor discontinuity or lead dislodgment. Use the corresponding finishing wire model for the lead length. If the wrong length finishing wire is used, the finishing wire tip may extend out of the distal end of the lead or not stabilize the lead properly.

Precautions
For information on precautions, read the following sections of the PG product labeling: sterilization, storage and handling, implantation and device programming, follow-up testing, pulse generator explant and disposal, environmental and medical therapy hazards; home and occupational environments; and following sections of the lead product labeling: sterilization and handling, an lead evaluation and implantation. Failure to observe these cautions could resulting incorrect lead implantation, lead damage/dislodgment, or harm to the patient. Advise patients to avoid lingering near anti-theft devices (electronic article surveillance [EAS]). Advise patients to hold cellular phones to the ear opposite the side of the implanted device. Patients should not carry a cellular phone in a breast pocket or on a belt over or within 6 inches (15 cm) of the implanted devices since some cellular phones may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone acetate apply to the use of the low concentration, highly localized, controlled-release device. For a listing of potentially adverse effects refer to the Physician’s Desk Reference.

Potential Adverse Events
Potential adverse events from implantation of the Guidant CRT-D system include, but are not limited to, the following: allergic/physical reaction, death, erosion/migration, fibrillation or other arrhythmias, fracture/insulation break (lead or accessory), hematoma/seroma, inappropriate therapy, infection, lead tip deformation and/or breakage, procedure related, psychologic intolerance to an ICD system – patients susceptible to frequent shocks despite antiarrhythmic medical management, random component failure.
Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events.

article_reference: 
Issue Number: 
2 (Feb 2005)
author: 

Tracy Webster, RN, BSN, Mayo Clinic, Amy Beeman, RN, BSN, Mayo Clinic, Douglas Beinborn, RN, BSN, MA, Mayo Clinic, Keith L. Herrmann, PhD, Mary Jane Rasmussen, RN, Guidant Corporation

Cardiac resynchronization therapy (CRT), also known as biventricular pacing, provides symptomatic relief, clinical improvement, prolonged survival, and a better quality of life for many heart failure patients. CRT defibrillators (CRT-D) also provide potentially life-saving tachyarrhythmia therapies for these patients. Many of the challenges that occur during the implantation of CRT devices are due not only to venous anatomy, but to diaphragmatic stimulation and/or high left ventricular (LV) thresholds while positioning the LV lead.
In August 2004, the FDA approved EASYTRAK ® 2 and EASYTRAK 3, the first bipolar LV leads in the United States. These leads, manufactured by Guidant Corporation, now give the physicians the ability to program around diaphragmatic stimulation and elevated thresholds. The testing and programming can be done either during implantation or post procedure. If the patient develops stimulation or elevated thresholds days, weeks, or even months post-implant, the vectors can be reprogrammed at that time as well.
With older unipolar technology, the pacing vector for CRT therapy utilizes the tip of the LV lead along with the right ventricular (RV) lead coil. This is called the extended bipolar configuration. The advanced technology of Guidant Corporation s devices, programmers, and bipolar leads provide new options for physicians. Electronic Repositioning enables physicians to program around diaphragmatic stimulation and elevated thresholds without physically moving the LV lead. With Electronic Repositioning, there are now four pacing vector options for CRT-D (Figures 1-4) and six pacing vectors for CRT-P implants.

These two new bipolar leads capable of providing Electronic Repositioning were recently introduced at the Mayo Clinic. Having a family of EASYTRAK leads gives the implanter the opportunity to inject contrast dye for a venogram, which allows lead selection based on the patient s anatomy (Figure 5).

The new bipolar lead design and handling are similar to the original unipolar EASYTRAK lead. All of the leads are steroid-eluting and have a combination of polyurethane for abrasion resistance and silicone rubber for flexibility. The EASYTRAK 2 (Figure 7) is similar in shape to the EASYTRAK (Figure 6). The EASYTRAK 3 has a flexible fixation and is designed to provide stability in large branch veins and to allow repositioning within the same vein. The fluoroscopic marker assists in the correct placement within the vessel (Figure 8).

The first challenge in the LV lead implant procedure is the cannulation of the coronary sinus (CS) ostium. The shape of the guide catheter plays a key role in the cannulation of the CS. Guidant s new RAPIDO ® ADVANCE guide catheter derives support from the superior vena cava (SVC) instead of the wall and floor of the often-dilated right atrium. The new guide catheter also has more support in the mid-shaft section for pushability, and softer distal segments to enhance access and tracking into coronary branch veins. The new 8 French (Fr) guide catheter works in concert with a 6 Fr inner catheter. This RAPIDO dual-catheter system has the ability to sit in a stable position and selectively deliver contrast medium, guidewires and a LV lead directly into a branch vein (Figures 9-10).

Optimal LV lead location is important for maximizing CRT benefit. The implant challenge of getting into a tortuous branch is simplified by branch vein cannulation and Direct Delivery. RAPIDO ADVANCE, with its longer length, enables deeper fixation in the vessel, and enables Direct Delivery of the LV lead into the target vein. All of these improvements can help physicians achieve the goal of fast, predictable LV lead implants. In addition, Guidant provides guide catheters specifically designed for right-sided implants (Figure 11).

The Mayo Clinic recently has had several clinical experiences with this new technology. The following case scenario demonstrates the application of this new technology. The benefits of this new technology extend beyond the implant by allowing programmable pacing vector options during patient follow-up.
Mr. Smith is an 82-year-old male with a history of ischemic cardiomyopathy status post out-of-hospital cardiac arrest (OHCA). At that time, he received a Guidant 1831 DR ICD. His past medical history is significant for myocardial infarction and coronary artery bypass grafting.
In the past year, Mr. Smith was hospitalized for congestive heart failure with complaints of fatigue. During hospitalization, his medical therapy was optimized. In November, Mr. Smith s ICD reached ERI. At that time, he was considered for CRT-D. His underlying rhythm showed atrial flutter with LBBB with a QRS duration of 146 msec. His ejection fraction was 15-20%, with associated Class III NYHA heart failure symptoms. The decision was made to proceed with upgrade to CRT-D.
At the time of procedure, accessing the CS proved to be quite difficult. Once access to the CS was obtained, initial attempts at LV lead placement were unsuccessful. Balloon angiography was performed and showed scant tributaries in the distal CS with a large branch that tracked to the postero-lateral wall. The lead was ultimately placed in this large branch.
Initial threshold via the analyzer using the bipolar Tip to Ring configuration was 0.5 msec/2.3 volts; the lead impedance was 1,097 ohms. However, thresholds through the device were elevated at 0.5 msec/3.5 volts in the same configuration. Since we were using Guidant s EASYTRAK 2 lead, we were able to utilize Electronic Repositioning. Through the device, the following thresholds were obtained using each of the four programmable pacing vector options:
Tip to Ring: 0.5 msec/3.5 volts
Ring to Tip: 0.5 msec/2.8 volts
Tip to Coil: 0.5 msec/2.2 volts
Ring to Coil: 0.5 msec/1.8 volts

Based on the above thresholds, the final programmed pacing vector was Ring to Coil. As this case demonstrates, the technology of the Guidant EASYTRAK 2 bipolar LV lead allows physicians the option of Electronic Repositioning, which in this case resulted in a shorter procedure time benefiting both the patient and the practitioner.

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