The femoral route revisited: an alternative for pectoral pacing lead implantation

Abstract

We describe the implantation via the femoral vein of a dual-chamber pacing system with lumenless, catheter-delivered pacing leads in a patient in whom subclavian access on both sides was obstructed. (Neth Heart J 2010;18:42-4.)

The classical subpectoral implant sites for pacing leads may sometimes become unavailable because of venous obstruction or recent infection. We discuss a rarely used but valuable alternative for percutaneous implantation of a pacing system via the femoral vein with a novel pacing lead.

Patient

A 72-year-old female patient had a DDDR pacemaker implanted in the right subpectoral region in 1982 because of complete AV block. The generator was removed in 1987 after skin erosion and a new VVI pacing system was implanted in the left subpectoral area. The system was upgraded to a DDD system in 1996 because of pacemaker syndrome symptoms during VVI pacing.

In 2007, she experienced diminished exercise tolerance and dyspnoea. The left ventricular angiogram showed normal contractions and there were no significant stenoses observed in the coronary angiogram. Pacemaker interrogation demonstrated atrial undersensing and non-capture, effectively resulting in VVI pacing. Reprogramming to VVIR did not relieve her symptoms and restoration of DDD pacing was contemplated. However, a venous angiogram showed that both left and right subclavian and brachiocephalic veins were occluded, prohibiting normal insertion of a new atrial lead from the pectoral route. The patient was then referred to our hospital in order to restore AV synchronous pacing. Three alternative methods for lead insertion were considered and discussed with the patient: 1) recanalisation of the vein with a laser sheath, 2) surgical positioning of epicardial pacing leads and 3) a femoral endovascular approach. Recanalisation with laser was considered too dangerous given the length of the obstructed segments, and the patient refused epicardial pacing because of the morbidity accompanying surgery. Finally it was decided to implant a complete new system from the femoral route.

Procedure

A longitudinal incision was made over the femoral vein in the right groin a few centimetres below the inguinal ligament at the site of insertion of the long saphenous vein (figure 1). The latter was dissected over a short distance to allow positioning of two resorbable sutures around the vein for later haemostasis. The vein was then catheterised in between the sutures using a stepwise Seldinger technique. First, a 6 F tapered sheath originally developed for radial artery catheterisation (Cordis, Miami FL) was introduced over a 0.023” guidewire inserted through a 21G needle. Second, two 0.035” guidewires, provided together with standard 7 F peel-away sheaths (SafeSheath, Pressure Products, San Pedro CA), were inserted through the 6 F sheath and the latter removed to allow insertion of the peel-away sheath.

Figure 1.

Drawing of the location of the incision in the upper thigh to introduce the leads into the femoral vein and lower abdomen to position the generator.

A Select Secure 383069 bipolar 4 F fixed-screw pacing lead was introduced via an Attain C304-XL74 deflectable 8.4F guiding sheath (Medtronic, Minneapolis MN), the latter advanced closely to the right ventricular septum (figure 2). Adequate fixation of the lead was assessed by the current injury recorded from the right ventricular electrogram. After obtaining satisfactory sensing and pacing thresholds the guiding was split and the peel-away sheath removed. After introducing a second peel-away sheath, a second Select Secure 383069 lead was positioned in a similar fashion at the right atrial free wall. Care was taken to provide enough slack of the leads to prevent dislodgement (figure 3).

Figure 2.

Fluoroscopic image of the insertion of the ventricular lead. The Attain deflectable guiding sheath (Medtronic, Minneapolis MN) is positioned close to the ventricular wall (downward arrow) and the Select Secure lead is advanced towards the ventricular myocardium (upward arrow).

Figure 3.

X-ray of the final position of the leads. Note the slack that is provided for both leads to avoid dislocation. The atrial lead is overdrawn by the dotted line, the ventricular lead by the dashed line. The previous subpectoral pacemaker was used as back up until proven reliability of the femoral pacing system and removed a few days after the femoral implant.

The leads were fixated using the anchor sleeves at the fascia of the underlying muscle with non-resorbable sutures. A pacemaker pocket was created in the subcutaneous tissue of the abdomen via a second incision high enough above the inguinal ligament to prevent discomfort in a sitting position (figure 1). Both leads were tunnelled subcutaneously from the infra-inguinal incision to the pocket and connected to a Vitatron T70DR pulse generator (Vitatron, Arnhem, the Netherlands).

During a follow-up of six months, the pacing system is functioning satisfactorily and the patient is relieved of her symptoms without discomfort or complications at the implant site.

Discussion

Unilateral occlusion of the subclavian or brachiocephalic vein after implantation of pacemaker or defibrillator leads is not uncommon and occurs in about 10% of uncomplicated implants. When both pectoral areas have been used for implant, bilateral occlusion can sometimes be encountered.¹

Epicardial pacing is the standard alternative approach for pacing when insertion of leads via the subclavian veins is not feasible. Single-chamber epicardial ventricular pacing can be instituted through a subxiphoidal incision. However, a thoracotomy is needed to position an atrial lead if dual-chamber pacing is attempted, and atrio-ventricular synchrony was essential to ameliorate the pacemaker syndrome in our patient. Further, longevity of adequate epicardial lead function may be inferior to endocardial pacing.^2,3 As an alternative to epicardial pacing, recanalisation of an obstructed subclavian or brachiocephalic vein with a laser sheath guided over a non-functional lead may allow insertion of new leads via the classical venous route.^4,5 However, given the long trajectory of the obstruction, we considered the risk for venous perforation or avulsion too high. Further, this procedure can be quite laborious in case of long obstructed segments.

Almost 30 years ago, El Gamal and van Gelder first described an identical use of the femoral endovascular route for atrial pacing with the Helifix lead.⁶ As in the original cohort, we inserted the leads clearly below the inguinal crease: first to prevent discomfort from the scar, and second to be able to use the saphenous vein as the venous entry site. In this way we avoided direct trauma to the femoral vein and could secure haemostasis with ligatures around the saphenous vein, similarly to a cephalic vein procedure. In contrast to our approach, Ellestad et al. punctured the iliac (instead of the femoral) vein just above the inguinal ligament.⁷

We created a separate pocket in the abdominal wall to prevent discomfort from the generator in the vicinity of the inguinal crease or upper thigh. Ellestad et al. also used a separate abdominal pocket and did not encounter any local complications in 95 implants.⁷ However Mathur et al., who used one incision in the inguinal crease to introduce the leads into the femoral vein and then fashioned the pocket cranial from within this incision, reported skin erosion in two out of 27 patients.⁸ Some operators position the generator in a pocket in the upper thigh, but the subcutaneous tissue there is relatively thin and this position may also be more prone to discomfort.⁹

An increased incidence of lead fractures might be expected given the need to U-turn the leads from the venous entry site to the generator pocket, but this is not an issue mentioned in the literature. The groin is probably a much less mobile region than the subpectoral area, especially in elderly patients, and does not have an equivalent for the clavicle to inflict crush injuries.

Dislodgement of atrial leads is, however, a real concern. Ellestad et al. and Mathur et al. respectively reported a 21 and 20% dislodgement rate, even with the use of active fixation leads.^7,8 Gravity may play an important role in this: the whole length of the lead is suspended from its anchor point in the myocardium, in contrast to leads inserted from the pectoral area. The choice for the lightweight and more floppy 4 F Select Secure was also inspired by this consideration. Establishing adequate fixation of the screw-in leads and providing ample slack is important as well. Active fixation leads should not be considered securely attached without a proper current of injury.¹⁰

In conclusion, the femoral route constitutes a good alternative when the standard pectoral implant route is unavailable. It has a low morbidity and is easy to implement compared with other alternative implant techniques.