Use of an Active-Fixation Coronary Sinus Lead to Implant a Biventricular Pacemaker via the Femoral Vein

Abstract

Cardiac resynchronization therapy, which involves the placement of a pacing lead in the right atrium and in each ventricle, is effective in treating heart failure that is caused by left bundle branch block and cardiomyopathy. The left ventricular lead is usually placed into a lateral branch of the coronary sinus via the subclavian route. When the subclavian route is unavailable, insertion of a standard, passive-fixation coronary sinus lead via the femoral approach is feasible; however, the likelihood of subsequent dislodgment is high. Herein, we describe the placement of a novel, self-retaining, active-fixation coronary sinus lead—the Attain StarFix® Model 4195 OTW Lead—in an elderly heart-failure patient, via the femoral approach. We believe that this is the 1st report of this procedure.

In cardiac resynchronization therapy, coronary sinus (CS) lead placement is required for the implantation of an endocardial biventricular pacemaker. The insertion of passive-fixation CS leads via the femoral vein¹ is typically avoided because of the high likelihood of lead dislodgment, although this route remains useful when subclavian venous access is unattainable. Here, we describe our use of the femoral approach in combination with an active-fixation CS lead to place a biventricular lead system and pacemaker in an elderly patient.

Case Report

An 81-year-old woman with nonischemic cardiomyopathy (left ventricular ejection fraction [LVEF], 0.30) experienced recurrent episodes of congestive heart failure, which had resulted in frequent hospitalizations and marked debility. Her medical history included pulmonary hypertension, emphysema, and bilateral radical mastectomy with radiation for breast cancer in 1975. Physical examination revealed a cachectic woman (weight, 92 lb) who had minimal subcutaneous and muscle tissue on both sides of the anterior chest. The prior radiation had left the skin brawny and indurated. Due to the recurrent congestive heart failure, low LVEF, and left bundle branch block with a QRS duration of 160 ms, she was scheduled for atriobiventricular pacemaker implantation—a resynchronization method that has proved effective in the treatment of heart failure that involves cardiomyopathy and left bundle branch block.² Her previously irradiated chest wall and cachexia prompted concern regarding adequate tissue healing after the device was placed. Therefore, after consulting plastic and thoracic surgeons, we decided upon the femoral venous route for pacemaker implantation.

A novel, self-retaining, active-fixation CS lead—the Attain StarFix® Model 4195 OTW Lead (Medtronic, Inc.; Minneapolis, Minn)—was available for implantation under an approved research protocol. The patient signed separate consents for the clinical procedure and for the implantation of the investigational lead.

Equipment Design and Function

The Attain StarFix Model 4195 is a 5F, steroid-eluting, unipolar, polyurethane-insulated cardiac-vein lead (Fig. 1). Its unique design includes distal incisions that are cut into a surrounding polyurethane lead sheath. Upon being slid over the lead body, the proximal sheathing is compressed, and it progressively buckles tangentially and outward. Deployable orthogonal strips or “lobes” of sheath form on the slotted distal end of the lead. Traction on the lead results in deployment of self-retaining protuberances. The terminal lobes are buttressed against the internal venous surface (up to a 24F diameter). Of note, when the lobes are deployed in vivo, they cannot be seen by radiographic means; however, movement of the radiopaque markers closer together is a surrogate marker of deployment.

Fig. 1 Photograph shows progressive lobe deployment in the terminal section of the Attain StarFix® Model 4195 OTW Lead (Medtronic, Inc.).

The design of the Attain StarFix lowers the risk of dislodgment that typically accompanies the placement of passive-fixation CS leads; furthermore, the device can be repeatedly deployed for acute repositioning of the leads. After deployment, the apparatus somewhat resembles a Chinese lantern.

Technique and Results

The technique described by Ellestad and colleagues^1,3 was chosen in order to attain femoral access, place the right atrial and right ventricular leads, and form the abdominal pacemaker pocket. Placement of the CS lead was attempted first, because failure would necessitate aborting the entire procedure. After femoral venous access was attained, a long, peel-away SafeSheath® (Pressure Products, Inc.; San Pedro, Calif) was placed so that the sheath tip entered the CS. This sheath was the temporary conduit for venography and the CS lead. Coronary sinus venography was performed with use of a balloon-tipped catheter, and a lateral branch of the CS was identified. Standard over-the-wire techniques were used to place the CS lead in the lateral cardiac vein. Traction was applied to the lead sheath, and the lead was fixed in the mid-lateral cardiac vein. Upon testing, the pacing threshold (0.4 V at 0.5 ms), the sensing threshold (20 mV), and the impedance (1,243 ohms) were all acceptable. No diaphragmatic stimulation was noted at an output of 5 V. At this point, the SafeSheath was peeled away and removed. The right atrial and right ventricular leads were then inserted (Figs. 2 and 3). All 3 implanted leads were tunneled to the pacemaker pocket on the rectus fascia. Finally, the pulse-generator was connected and inserted into the abdominal pocket.

Fig. 2 Fluoroscopic image (45° left anterior oblique view) shows the 3 intracardiac leads emanating from the inferior vena cava. The atrial lead tip is superior and to the left, the right ventricular lead tip is inferior, and the coronary sinus lead (right) travels posteriorly in the sinus; its lead tip terminates in a lateral branch. The transesophageal probe is at the top.

Fig. 3 Fluoroscopic image (30° right anterior oblique view) shows the 3 intracardiac leads. The coronary sinus lead is in the middle. Close approximation of all of the distal radiopaque markers suggests full lobe deployment.

The patient was monitored overnight and was discharged from the hospital the next day, after chest and abdominal radiographs showed good lead placement. At her 2-year follow-up examination, the patient's CS pacing threshold was 1 V at 0.5 ms, and the R wave was >22.4 mV. Upon echocardiography, the LVEF had improved to 0.55 from the previous 0.30. Cardiac nuclear testing revealed a LVEF of 0.61. In addition, during the 2-year postprocedural period, the patient's weight had increased from 92 to 122 lb.

Discussion

In 1980, Ellestad and coworkers described pacemaker placement via the femoral venous route.¹ Although this is a safe approach without risk of pneumothorax, it is infrequently used because of potential lead dislodgment. Active-fixation leads have reduced the prevalence of this complication. Leads currently are also thinner and lighter; however, their dislodgment has still been noted—with a 21% incidence, according to a follow-up study by Ellestad and French³; and with a 20% incidence in a more recent study.⁴ Other concerns that surround the femoral implantation route include a higher rate of infection and femoral vein thrombosis, although neither of these complications was reported by Mathur and associates in 2001.⁴ Situations in which it is impossible or risky to use the subclavian approach for pacemaker placement include problems pertaining to skin infections or skin healing at the entry site, and abnormalities or thrombosis of the subclavian vein. After seeking cross--disciplinary opinions, we concluded that it was prudent to use the femoral route in our patient. Because of her general medical condition, a pacemaker rather than a defibrillator was placed, although implantation of a defibrillator is feasible via the femoral approach.⁵

In 2006, Yousef and co-authors⁶ described the placement of a biventricular system via the femoral vein. A passive-fixation CS lead was used. Although this procedure was successful in that single case, we considered the subsequent dislodgment of passive-fixation CS leads to be probable, and therefore too risky, in our patient or any other. Accordingly, we used an active-fixation over-the-wire lead that was designed to prevent lead migration and to reduce the chance that diaphragmatic stimulation and threshold changes would occur.

We believe that this is the 1st report of the successful placement of an active-fixation CS lead via the femoral venous approach.

Acknowledgments

We thank Melanie Edwards for editorial assistance and Ken Leblanc for assistance with graphics.