Outcome and Management of Pacemaker-Induced Superior Vena Cava Syndrome HAI-XIA FU, M.D.,*,† XIN-MIAO HUANG, M.D.,*,‡ LI ZHONG, M.D.,*,§ MICHAEL J. OSBORN, M.D.,* HARALDUR BJARNASON, M.D.,¶ SIVA MULPURU, M.D.,* XIAN-XIAN ZHAO, M.D.,** PAUL A. FRIEDMAN, M.D.,* and YONG-MEI CHA, M.D.* From the *Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota; †Department of Cardiovascular Diseases, Henan Provincial People’s Hospital, Henan, China; ‡Department of Cardiovascular Diseases, Changhai Hospital, Second Military Medical University, Shanghai, China; §Department of Cardiology, Southwest Hospital, Third Military Medical University, Chongqing, China; ¶Division of Cardiovascular Diseases, Department of Radiology, Mayo Clinic, Rochester, Minnesota; and **Department of Cardiovascular Diseases, Changhai Hospital, Second Military Medical University, Shanghai, China

Background: We aimed to determine the long-term outcomes of percutaneous lead extraction and stent placement in patients with pacemaker-induced superior vena cava (SVC) syndrome. Methods: The study retrospectively screened patients who underwent lead extraction followed by central vein stent implantation at Mayo Clinic (Rochester, MN, USA), from January 2005 to December 2012, to identify the patients with pacemaker-induced SVC syndrome. Demographic, clinical, and followup characteristics of those patients were collected from electronic medical records. Results: Six cases were identified. The mean (standard deviation) age was 56 (15) years (male, 67%). All patients had permanent dual-chamber pacemakers, with a mean 11-year history of pacemaker placement. The entire device system was explanted in five patients; one patient had a 21-year-old pacemaker lead that could not be removed. Eight stents were implanted in six patients: five patients had one stent, one patient had three. A new pacemaker system was reimplanted through the stented vein in five patients. Technical success was achieved in all patients, without any complication. Symptoms rapidly resolved in all patients after stent deployment. The mean follow-up duration was 48 months (range, 10–100 months). Three patients remained symptom free. Reintervention with percutaneous balloon venoplasty was successful in three patients with symptom recurrence. Conclusion: Percutaneous stent implantation after lead removal followed by reimplantation of leads is a feasible alternative therapy for pacemaker-induced SVC syndrome, although some cases may require repeat intervention. (PACE 2014; 37:1470–1476) lead extraction, pacemaker, superior vena cava syndrome, venous stenting

Introduction Lead-induced venous thrombosis occurs in approximately 30–45% of patients early or late after implantation of a transvenous pacemaker.1 Most patients are asymptomatic because they have development of adequate collateral circulation. The incidence of pacemaker-induced superior Authors Hai-Xia Fu and Xin-Miao Huang contributed equally to the manuscript. Mayo Clinic does not endorse the products mentioned in this article. Disclosures None. Address for reprints: Yong-Mei Cha, M.D., Division of Cardiovascular Diseases, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: [email protected]; Xian-xian Zhao, M.D., Department of Cardiovascular Diseases, Changhai Hospital, Second Military Medical University, Shanghai, 200433, China; e-mail: [email protected] Received December 13, 2013; revised April 15, 2014; accepted May 26, 2014. doi: 10.1111/pace.12455

vena cava (SVC) syndrome has been reported to be less than 0.1%.2 Although the SVC syndrome associated with indwelling leads is a condition with a benign origin, it is a debilitating and sometimes recalcitrant complication. There is no currently accepted standard of care.3 Endovascular procedures with angioplasty and stent placement have been established as a less invasive but equally effective alternative to open surgical treatment.4 However, treatment is associated with the potential for lead damage, with ensuing dysfunction in patients with stent placement across existing leads. Entrapment of leads by a stent would be an insolvable situation if the device gets infected. A percutaneous approach consisting of lead removal, stent implantation, and reimplantation of leads has been described with good results over the short and medium term,5 but the long-term efficacy of this approach is unknown. Moreover, the advocates of lead conservation versus the risk associated with lead explantation at the time of SVC intervention

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remains to be learned. The objective of this study was to determine long-term outcomes of percutaneous lead extraction and stent implantation in patients with pacemaker-induced SVC syndrome. Methods The study proposal was approved by the Mayo Clinic Institutional Review Board. All patients in this study consented to use of their medical records for research purposes. Study Patients All subjects who underwent lead extraction and central vein stent implantation at Mayo Clinic (Rochester, MN, USA) from January 2005 to December 2012 were identified. We screened records to identify the subset of patients with pacemaker-induced SVC syndrome. Data Collection We reviewed electronic medical records of all identified patients. Baseline demographic, clinical, and follow-up characteristics were collected. The diagnosis of pacemaker-induced SVC syndrome was based on the symptoms, physical signs, imaging tests (invasive venography or computed tomography), and history of pacemaker implantation. Culprit lesions were determined by imaging features or pressure gradients across the stenosis (or both). We used the classification scheme of Stanford and Doty6 to classify SVC obstructions into type I–IV on the basis of the severity of SVC stenosis and the extent of collateral venous circulation indicated by the venogram. Lead Extraction Percutaneous lead extraction was performed in the surgical operating room or electrophysiology laboratory with transesophageal echocardiographic monitoring and cardiovascular surgical backup. A stepwise approach was used for lead extraction, as described previously.7–9 Briefly, for an active fixation lead, manual traction with the aid of a regular stylet was performed after the helix was retracted. For a passive fixation lead, the lead body and stylet were gently pulled back with a counterclockwise rotation. If simple traction was not successful, a locking stylet and excimer laser catheter were used. Stent Deployment Venous stent deployment was performed after lead extraction. Details of stent deployment have been described previously4 and are shown in Figure 1. All patients underwent venography before the intervention. Percutaneous balloon angioplasty and stenting were performed by using a femoral vein approach. If the lesion

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could not be crossed by a wire with this approach, the right internal jugular vein was accessed and the obstructed lesion was crossed antegradely. A femoral-internal jugular wire rail was established by a pull-through technique with a femoral snare wire.10 When necessary, predilation or postdilation was performed with a balloon catheter. Technical success was defined as less than 30% residual stenosis after the intervention. Clinical success was defined as resolution of presenting clinical symptoms. New pacemaker leads, if necessary, were implanted through the stented vein on the same day or a few days later. Postprocedure Care and Follow-Up All patients had anticoagulant or antiplatelet treatment (or both) for at least 3 months. Outpatient follow-up visits were scheduled at 3–6 months for clinical evaluation and device followup, with repeat venography for patients with recurrent symptoms. Statistical Analysis Continuous variables are expressed as mean (SD) or median and interquartile ranges (IQR). Categorical variables are reported as frequency and percentages. Continuous variables were compared using a two-sample t-test. Statistical analyses were performed using JMP Pro Version 9.0 (SAS Institute, Cary, NC, USA). A P value of 90% SVC stenosis or occlusion with antegrade azygos blood flow) in one patient and type III (>90% SVC stenosis or occlusion with reversal of azygos blood flow) in four patients. Stent implantation was performed immediately after lead extraction in five cases and 4 days later in one case. Stent deployment was performed using a femoral vein approach in all patients. In two patients, a guidewire channel from the femoral vein to the SVC was established by adjuvant internal jugular vein access and use of a snare. Balloon angioplasty preceded stent placement in three cases. Eight stents were implanted in six patients: five patients had one stent and one patient had three stents. An old pacemaker lead that could not be removed was trapped by stents in one patient (patient 3). Technical success was achieved in all cases; repeat venograms after stent deployment showed excellent flow in all patients. A new pacemaker system was implanted on the same day after stent deployment in three patients, 1 day later in one patient, and 4 days later in one patient. One patient did not have a pacemaker reimplanted because the device was no longer indicated. Clinical Outcome The presenting symptoms resolved rapidly in all patients after stent deployment, and no complications occurred. The median duration of hospitalization was 1 day (IQR, 1–5.25 days). At discharge, five patients were prescribed combined anticoagulant and antiplatelet therapy, and one was prescribed dual antiplatelet therapy. All patients had follow-up at our institution. The mean follow-up duration was 48 months (range, 10–100 months). No patients had stent malposition, nor did any die during followup. All patients remained asymptomatic at 3 months. Three patients (patients 1, 2, and 6) remained symptom-free for 10, 100, and 22 months, respectively. A repeat venogram at 7 months showed a widely patent vein stent in patient 1, and a computed tomographic scan at 89 months showed a patent SVC in patient 2.

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Figure 2. Repeat interventions for in-stent stenosis (patient 3). (A) Venography 28 months after stenting showed severe in-stent stenosis in the segment near the superior vena cava–right atrial junction (arrow). (B) Stenosis (arrow) was alleviated after balloon dilation. (C) In-stent restenosis (arrow) at 16 months after the second intervention. (D) Restenosis was alleviated after balloon dilation.

Patients 3, 4, and 5 had symptom recurrence during follow-up. Patient 3 did well for about 26 months and then had recurrence of the same symptoms of SVC obstruction. The patient underwent successful balloon dilation of the instent stenosis at 28 and 44 months, respectively (Figure 2). Patient 4 had no recurrent symptoms of SVC obstruction for 8 months. Symptom severity increased by 24 months, and venograms revealed narrowing at the inferior end of the stent, at the cavoatrial junction. The restenosis was then dilated with an angioplasty balloon and the symptoms resolved after the procedure. Patient 5 had symptom relief for 4 months after stent deployment but then had recurrent obstructive symptoms. In the subsequent 80 months, the patient underwent 11 percutaneous balloon venoplasty procedures because of recurrent in-stent stenosis of the SVC. Discussion The pathogenesis of SVC syndrome after implantation of a permanent transvenous pacemaker is not well understood. Both chronic

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mechanical irritation and foreign body reactions associated with pacemaker leads may result in vessel wall fibrosis, thrombus formation, and ultimately, narrowing of the lumen.11 In our case series, half of the patients had a history of lead extraction and reimplantation before SVC syndrome developed, which suggests that the mechanical venous trauma created by lead extraction could be an important causative factor for late venous stenosis or occlusion. Although pacemaker-induced SVC syndrome is relatively benign, symptoms are often debilitating and refractory to drug therapy.12,13 Percutaneous balloon venoplasty can effectively relieve symptoms, but venous obstruction often recurs and repeat interventions are frequent.14,15 Four patients in our series had a history of multiple venous dilations, with restenosis each time. Stenting should be considered in these circumstances. Stent placement is now the firstline treatment for malignant SVC obstruction to establish long-term venous patency, and it is increasingly being used in benign SVC obstruction.16 Stent placement across existing leads in patients

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Table III. Published Cases of Percutaneous Lead Extraction and Stent Implantation in Patients with Pacemaker-Induced SVC Syndrome

Study Rosenthal et al.,199621 Chan et al., 20025 Bolad et al., 200522 Garlitski et al., 200623 Aryana et al., 200724 Klop et al., 201125

No. of Cases

Lead Re-implantation, Endocardial/Epicardial

Acute Success, Yes/No

Follow-Up, Months

Recurrence, Yes/No

1 4 2 1 1 2

0/1 3/1 2/0 1/0 1/0 2/0

1/0 4/0 2/0 1/0 1/0 2/0

0 9 (6–12) 5, 23 12 0 30, 34

NA 0/4 0/2 0/2 NA 1/1†

† Recurrent

SVC syndrome 5 months after stenting because of stent dislocation and occlusion. NA = not applicable; SVC = superior vena cava.

with pacemaker-related SVC syndrome has been described in small case series.17–19 Concerns persist over the potential risk of lead damage, with ensuing dysfunction caused by the metallic mesh of the stent. In addition, entrapment of pacemaker leads by a stent would make potential future extraction of leads (e.g., for infection) virtually impossible without a cardiac surgical procedure. The latest Heart Rhythm Society consensus statement on lead extraction recommended lead removal in patients with SVC stenosis or occlusion with limiting symptoms (class I; level of evidence, C) and in patients with planned stent deployment in a vein already containing a transvenous lead (class I; level of evidence, C).9 Lead extraction alone could lead to large intimal flaps and thrombosis, with a low likelihood of sustaining patency20 ; therefore, a reasonable treatment for pacemaker-induced SVC syndrome is lead extraction and stent implantation. Eleven cases treated in this manner have been reported previously (Table III). These preliminary studies reported excellent acute efficacy and short- and midterm primary patency rates (up to 30 months).5,21–25 The reported complications included a lead fracture and remnant associated with lead extraction21 and later stent dislocation and occlusion associated with stent deployment.25 The extraction site with venous access maintained could be used for access for the balloon and stent.5,23 In our series, stent deployment was performed using a femoral vein approach. The femoral approach allows a direct access to the SVC and avoids potential difficulty of balloon catheter going through the subclavian vein. Percutaneous lead extraction has been effectively accomplished in many centers. The procedural success rate was more than 90% with a major complication rate of 1.4–1.9% and an

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in-hospital death rate of 0.8%.26–28 The benefits of our management strategy over stenting with conserved leads should be cautioned in highrisk patients undergoing lead extraction. In these patients, it would be a reasonable option to place a stent across existing leads, and to implant new leads through the stented vein. Long-term patency is the main concern in the setting of benign SVC obstruction. In our series, all patients had rapid symptomatic relief and were symptom free at 3 months. However, during a mean follow-up of 4 years, half the patients had recurrent symptoms from in-stent stenosis that necessitated repeat interventions. This treatment strategy is challenged by its low long-term efficacy. Fortunately, stent patency can be restored by repeat intervention for most patients.29–31 Surgical treatment with venous reconstruction and implantation of an epicardial lead may be an alternative option for patients with SVC obstruction that is refractory to endovascular interventions.32 The pathogenesis of restenosis after stent deployment has not been clearly determined. Thrombosis, fibrosis, and intimal hyperplasia incited by a stent may be potential causative factors. Covered stents could be a better option than baremetal stents because they can potentially reduce the intimal hyperelastic response by using a relatively inert and stable intravascular matrix for endothelialization.33,34 Drug-eluting stents might have advantages over bare-metal stents in patients with SVC obstruction because they may help reduce intimal hyperplasia.16 Study Limitations The patients who were referred for surgical treatment or endovascular intervention without lead extraction were not included in this study.

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Decisions about the type of stents used and the antithrombotic therapies after stent placement were not standardized. Conclusion The percutaneous intervention of stent implantation after lead removal followed by reim-

plantation of leads is a feasible and safe treatment for pacemaker-induced SVC syndrome, although some cases eventually may require repeat intervention. A larger number of patients with a longer follow-up duration after the intervention are needed to define the long-term efficacy of this approach.

References 1. Spittell PC, Hayes DL. Venous complications after insertion of a transvenous pacemaker. Mayo Clin Proc 1992; 67:258–265. 2. Mazzetti H, Dussaut A, Tentori C, Dussaut E, Lazzari JO. Superior vena cava occlusion and/or syndrome related to pacemaker leads. Am Heart J 1993; 125:831–837. 3. Riley RF, Petersen SE, Ferguson JD, Bashir Y. Managing superior vena cava syndrome as a complication of pacemaker implantation: A pooled analysis of clinical practice. Pacing Clin Electrophysiol 2010; 33:420–425. 4. Rizvi AZ, Kalra M, Bjarnason H, Bower TC, Schleck C, Gloviczki P. Benign superior vena cava syndrome: Stenting is now the first line of treatment. J Vasc Surg 2008; 47:372–380. 5. Chan AW, Bhatt DL, Wilkoff BL, Roffi M, Mukherjee D, Gray BH, Baizer CT, et al. Percutaneous treatment for pacemaker-associated superior vena cava syndrome. Pacing Clin Electrophysiol 2002; 25:1628–1633. 6. Stanford W, Doty DB. The role of venography and surgery in the management of patients with superior vena cava obstruction. Ann Thorac Surg 1986; 41:158–163. 7. Lloyd MA, Hayes DL, Holmes DR Jr., Stanson AW, Espinosa RE, Osborn MJ, McGoon MD. Extraction of the telectronics accufix 330– 801 atrial lead: The Mayo Clinic experience. Mayo Clin Proc 1996; 71:230–234. 8. Hamid S, Arujuna A, Khan S, Ladwiniec A, McPhail M, Bostock J, Mobb M, et al. Extraction of chronic pacemaker and defibrillator leads from the coronary sinus: Laser infrequently used but required. Europace 2009; 11:213–215. 9. Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009; 6:1085–1104. 10. Matsushita J, Morita S, Suzuki K, Inoue H, Yokomizo H, Yoshimatsu K, Aoshima H, et al. Pull-through technique with pincer tactics for stent placement in severe superior vena cava syndrome. Ann Vasc Surg 2012; 26:421.e11.–421.e15. 11. Shimada Y, Yaku H, Kawata M, Oka K, Shuntoh K, Okano T, Takahashi A, et al. An operative case of inferior vena cava stenosis due to fibrosis around permanent pacemaker leads. Pacing Clin Electrophysiol 2002; 25:223–225. 12. Ito T, Tanouchi J, Kawabata M, Tanaka K, Miyawaki M, Kato J, Morioka T, et al. Superior vena cava syndrome due to a permanent transvenous pacing lead. Jpn Circ J 1996; 60:707–709. 13. Melzer C, Lembcke A, Ziemer S, Eddicks S, Witte J, Baumann G, Borges AC. Pacemaker-induced superior vena cava syndrome: Clinical evaluation of long-term follow-up. Pacing Clin Electrophysiol 2006; 29(12):1346–1351. 14. Asif A, Salman L, Carrillo RG, Garisto JD, Lopera G, Barakat U, Lenz O, et al. Patency rates for angioplasty in the treatment of pacemakerinduced central venous stenosis in hemodialysis patients: Results of a multi-center study. Semin Dial 2009; 22:671–676. 15. Zartner P, Toussaint-Goetz N, Wiebe W, Schneider M. Vascular interventions in young patients undergoing transvenous pacemaker revision. Catheter Cardiovasc Interv 2011; 78:920–925. 16. Warner P, Uberoi R. Superior vena cava stenting in the 21st century. Postgrad Med J 2013; 89:224–230. 17. Gilard M, P´erennes A, Mansourati J, Etienne Y, Fatemi M, Blanc JJ, Boschat J. Stent implantation for the treatment of superior vena cava syndrome related to pacemaker leads. Europace 2002; 4:155–158. 18. Teo N, Sabharwal T, Rowland E, Curry P, Adam A. Treatment of superior vena cava obstruction secondary to pacemaker wires with

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Outcome and management of pacemaker-induced superior vena cava syndrome.

We aimed to determine the long-term outcomes of percutaneous lead extraction and stent placement in patients with pacemaker-induced superior vena cava...
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