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Subclavian Balloon Venoplasty to Facilitate Lead Implant in Patient with Subclavian Venous Obstruction
Supported by multiple randomized trials demonstrating their efficacy, implantable cardioverter defibrillators (ICD) have become the cornerstone therapy in preventing sudden cardiac death (SCD) in the population at high risk.1 Cardiac resynchronization therapy (CRT) has also been an important therapeutic option for patients with congestive heart failure (CHF).1
It is common to see patients who need a device upgrade, either because they have a permanent pacemaker and they develop left ventricular systolic dysfunction or malignant ventricular arrhythmias needing an ICD for SCD prevention, or because they have an ICD and they develop interventricular conduction abnormality along with heart failure symptoms and will need CRT. Another less common reason for device upgrade could be the need to change a single-chamber ICD to a dual-chamber ICD, such as in patients with heart failure who develop sick sinus syndrome needing frequent pacing. An additional number of patients may require lead change due to lead failure.
Implanting new leads for defibrillation or pacing leads could be problematic as a result of venous obstruction. Up to 50% of patients with pacemaker/ICD leads have an asymptomatic subclavian vein obstruction.1 This lack of symptoms is due to the frequent occurrence of collaterals in chronic total occlusion. This obstruction is usually easy to overcome, but occasionally it is very challenging. One could abandon the existing lead system and implant an entirely new system on the contralateral side. Alternatively, a contralateral transvenous lead could be implanted and tunneled across the chest to the existing system, or an epicardial lead could be placed via thoracotomy and tunneled to the existing system. One possible solution could be the removal of an existing lead by simple explantation or by lead extraction using laser, telescoping sheath and locking stylets. Each of these approaches has significant drawbacks.
This report presents an alternative approach that successfully uses percutaneous subclavian balloon venoplasty (PSBV) to regain venous access and avoid the need for contralateral access, extraction and surgical intervention. PSBV typically involves the use of intravascular inflatable balloons to dilate the obstructed portion of the subclavian vein.
Case Report: Patient #1. The first patient was a 71-year-old gentleman with history of coronary artery disease, left ventricular systolic dysfunction, atrial flutter treated with radiofrequency isthmus ablation, atrial tachycardia originating from the left atrium with unsuccessful ablation attempt (failed due to inability to cross the interatrial septum), and complete heart block who had a dual-chamber permanent pacemaker implanted 15 years prior to the venoplasty. This was followed by a generator change 10 years later. He later developed persistent atrial fibrillation; at the time of this admission, he was in atrial fibrillation and was ventricular-paced 100% of the time.
An upgrade to an ICD was indicated due to worsening left ventricular systolic function. After securing a transvenous right ventricular pacing lead via right femoral vein access, we 
opened the pocket and explanted the old permanent pacemaker pulse generator. Using fluoroscopy-guided first rib approach, we obtained a single venous access to the left subclavian vein. We faced difficulty advancing the 0.035" standard J-tip wire at the subclavian-superior vena cava (SVC) junction (Figure 1). We were able to successfully negotiate that site manually with the wire; however, we could not advance the 7 French (Fr) sheath over it. The occlusion site was negotiated over the wire with the dilator of a 5 Fr sheath and the wire was exchanged for a 0.035" Superstiff Amplatz guidewire (Boston Scientific, Watertown, Massachusetts). We then advanced a 40 x 10 mm inflatable Durado percutaneous transluminal angioplasty (PTA) balloon (Bard, Tempe, Arizona). The balloon was inflated to its operational pressure of 8 atm, then deflated and exchanged for the 7 Fr sheath, which was successfully advanced over the wire to the right atrium. The procedure was then completed in the usual manner; it was tolerated well and there were no complications.
Patient #2. The second patient was a 46-year-old lady with a history of nonischemic cardiomyopathy, paroxysmal atrial fibrillation and sustained ventricular tachycardia who had a biventricular implantable cardioverter defibrillator (BiV/ICD) implanted 2 years earlier. During follow-up, her atrial lead was found to have increased pacing thresholds. She was referred to us for routine generator replacement and possible new atrial lead implant. We opened the pocket and explanted the old BiV/ICD pulse generator. We then confirmed the increased pacing threshold of the atrial lead. We noted that the old ICD lead was a single-coil lead, and it was observed to be in an unusual position in the high interventricular septum with its right ventricle (RV) coil directed to the tricuspid valve. Using fluoroscopy-guided first rib approach, we obtained a single venous access to the left subclavian vein by a standard 14 gauge needle with good blood return. However, we could 
not advance the 0.035" J-tip wire, so we obtained a venogram from the puncture needle and it showed a significant narrowing in the mid subclavian vein (Figure 2). At that point, we used a flexible tip 0.035" Glidewire (Terumo, Somerset, New Jersey) and we were able to advance it to the SVC. Over that wire, we advanced a 7 Fr dilator to the SVC. Then, we replaced the Glide wire with a 0.035" Superstiff Amplatz guidewire and advanced a long, 7 Fr sheath over it to the right atrium (RA). We used that sheath to implant a new atrial pace/sense lead and we capped and abandoned the old atrial lead. At that point, we connected a new BiV/ICD pulse generator. Our concerns about the RV lead position were valid, as the ICD failed to defibrillate the patient during defibrillation testing despite appropriate values of pacing and sensing. We concluded that the system, due to the single coil lead in a poor position, resulted in an inappropriate defibrillation vector that failed to capture a critical mass of the left ventricular myocardium and decided that it needed to be fixed.
The therapeutic options at that point were extraction and re-implantation of the ICD lead with a dual-coil ICD lead into the RV apex versus the addition of a subcutaneous coil. We discussed those options with the patient the next morning, and she preferred the first option. We stabilized the RV and the old RA leads with a standard stylet and unscrewed them from the myocardium. We then incised the insulation of the old RA lead and used it to advance a wire into the vascular space. To secure that access, we freed that wire and advanced it to the connection between the RA and the IVC. At that point, we explanted both leads with simple traction (the old RA lead and ICD lead). We faced difficulty trying to advance the 7 Fr sheath beyond the connection between the superior vena cava and the RA. A small dilator from a 5 Fr sheath was advanced into the subclavian vein and again a 0.035'' Superstiff Amplatz guidewire was advanced into the RA-IVC junction. We then exchanged the sheath with a 40 x 10 mm inflatable Durado PTA balloon. The balloon was inflated to its operational pressure of 8 atm, then deflated and exchanged for the 7 Fr sheath, which was successfully advanced over the wire to the RA. We used that sheath to implant an ICD pace/sense/defibrillator lead in the RV apex, where we were able to demonstrate appropriate defibrillation function. The procedure was then completed in the usual manner; it was tolerated well and there were no complications.
Discussion. A significant number of patients will need an implantable device.1 Of these, many will need repeated access to the subclavian vein for additional lead placement or for extraction or upgrade of existent leads.1–5
Subclavian venous obstruction could make this repeat procedure difficult or impossible. This gains particular importance, since it is usually an unexpected finding during the procedure as many patients are asymptomatic. This lack of symptoms is due to the frequent occurrence of collaterals in chronic total occlusion. About 13–35% of patients with prior leads will have an asymptomatic subclavian venous obstruction.2 Both our patients needed repeat access to their pacing systems and at the time of the procedure they had significant subclavian venous obstruction that was asymptomatic; hence, it was an unexpected finding during the procedure. In a similar situation, one could mechanically relieve the venous obstruction to allow the advancement of leads by balloon venoplasty. In our patients, we used a 40 x 10 mm inflatable Durado PTA balloon. The balloon was inflated to its operational pressure of 8 atm, then deflated and exchanged for the 7 Fr sheath, which was successfully advanced over the wire to the RA. This is similar to the previous reports mentioning this technique.1–5 Our experience was consistent with the previous reports, in that such mechanical angioplasty was safe and highly effective. Balloon rupture with contrast extravasation was reported in 3 out of 130 cases.2 This didn’t happen in any of our cases. This could be merely because we presented only 2 cases or because our use of lower inflation pressure, as we used the operational pressure and not the rated burst pressure.2
In conclusion, we presented 2 cases where subclavian balloon venoplasty was used to allow access from the subclavian vein to the superior vena cava, therefore permitting lead implantation without the need to access the internal jugular vein or the contralateral venous system. We believe this technique is safe and effective.
References
- Gula LJ, Ames A, Woodburn A, et al. Central venous occlusion is not an obstacle to device upgrade with the assistance of laser extraction. Pacing Clin Electrophysiol 2005;28:661–666.
- Worley SJ. Implant venoplasty: Dilation of subclavian and coronary veins to facilitate device implantation: Indications, frequency, methods, and complications. J Cardiovasc Electrophysiol 2008;19:1004–1007.
- Pace JN, Maquilan M, Hessen SE, et al. Extraction and replacement of permanent pacemaker leads through occluded vessels: Use of extraction sheaths as conduits — Balloon venoplasty as an adjunct. J Interv Card Electrophysiol 1997;1:271–279.
- Worley SJ, Gohn DC, Pulliam RW. Over the wire lead extraction and focused force venoplasty to regain venous access in a totally occluded subclavian vein, J Interv Card Electrophysiol 2008;23:135–137.
- McCotter CJ, Angle JF, Prudente LA, et al. Placement of transvenous pacemaker and ICD leads across total chronic occlusions. Pacing Clin Electrophysiol 2005;28:921–925.
