Fluoroscopically Guided Axillary Vein Puncture 543 Conclusions : The fluoroscopically guided axillary venous approach for implanting permanent pacemakers is equivalent to the traditional anatomic landmark – guided intrathoracic subclavian approach and has fewer complications and shorter procedural t

Background: The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. We describe an alternative technique for obtaining venous access for pacemaker implantation through axillary vein under fluoroscopic guidance and compare it with the conventional, subclavian approach. Methods: We conducted a single-centre, prospective, nonrandomized study. All adult patients with indication for permanent pacing who consented were recruited during a 3-year period. To access the axillary vein, we used the alternative technique with a new fluoroscopic landmark. The subclavian access was obtained as per the usual approach. Results: We studied 478 lead placements during 3 years; 315 lead placements through axillary venous technique (group 1) were compared with 163 lead placements through subclavian venous technique (group 2). Both routes had a high and comparable success rate, 98.09% in group 1 and 96.93% in group 2. The axillary approach was successful at the first attempt in 194 punctures (61.6%), as vs 60 in group 2 (36.8%) P 0.0001. The average number of attempts in group 1 was 2.06 per patient and 2.56 in group 2 (P 0.001). There were 3 (2.94%) pneumothoraxes in group 2 and none in group 1. During a mean follow-up period of 3.2 months in group1 and 3.7 months in group 2, 1 patient in group 2 had a lead fracture. See page 545 for disclosure information. 0828-282X/$ – see front matter © 2012 Canadian Cardiovascular Society. Published http://dx.doi.org/10.1016/j.cjca.2012.02.019 RÉSUMÉ Introduction : L’implantation d’un stimulateur cardiaque intrathoracique par la technique de la veine sous-clavière peut être associée à des complications sérieuses. Nous décrivons une technique de substitution pour obtenir l’accès veineux à l’implantation du stimulateur cardiaque par la veine axillaire à l’aide du guidage fluoroscopique et la comparons à l’approche sous-clavière classique. Méthodes : Nous avons mené une étude non aléatoire prospective unicentrique. Tous les patients adultes consentants pour qui une stimulation cardiaque permanente était indiquée ont été recrutés durant 3 ans. Pour accéder à la veine axillaire, nous avons utilisé la technique de substitution à l’aide d’un nouveau repère fluoroscopique. L’accès à la veine sous-clavière a été obtenu selon l’approche habituelle. Résultats : Nous avons étudié 478 poses de cathéter durant 3 ans; 315 poses de cathéter par la technique de la veine axillaire (groupe 1) ont été comparées aux 163 poses de cathéter par la technique de la veine sous-clavière (groupe 2). Les deux voies ont obtenu un taux de succès élevé et comparable, 98,09 % dans le groupe 1 et 96,93 % dans le groupe 2. L’approche axillaire a été réussie à la première tentative dans 194 ponctions (61,6 %), par rapport à 60 dans le groupe 2 (36,8 %), P 0,0001. Le nombre moyen de tentatives dans le groupe 1 a été de 2,06 par patient et dans le groupe 2, de 2,56 Obtaining venous access for lead placement can sometimes be a major stumbling block in the implantation of permanent pacemakers and implantable defibrillators. Multiple venous access techniques have been proposed by various operators, the most frequently used being anatomically guided intrathoracic Received for publication August 22, 2011. Accepted February 21, 2012. Corresponding author: Dr Gautam Sharma, Department of Cardiology, Cardiothoracic Centre, All India Institute of Medical Sciences, New Delhi-29, India. E-mail: drsharmagautam@gmail.com subclavian vein (ISV) puncture technique introduced by Littleford in 1979. Though it is relatively easy to learn, it may be associated with some serious complications, including pneumothorax, hemopneumothorax , brachial plexus injury, subclavian crush syndrome, lead fracture, and loss of lead insulation. Alternative techniques of venous access include the cephalic venous approach, which is safe but has a failure rate of 15% to 45%. The contrast venography–guided extrathoracic subclavian approach, which is effective in more than 90% of patients, has the drawback of needing contrast medium use and requires patent ipsilateral forearm veins. Anatomically guided extrathoracic subclavian puncture, as originally deby Elsevier Inc. All rights reserved. Sharma et al. Fluoroscopically Guided Axillary Vein Puncture 543 Conclusions: The fluoroscopically guided axillary venous approach for implanting permanent pacemakers is equivalent to the traditional anatomic landmark–guided intrathoracic subclavian approach and has fewer complications and shorter procedural time to access the vein. (P 0,001). Il y a eu 3 (2,94 %) pneumothorax dans le groupe 2 et aucun, dans le groupe 1. Durant une période de suivi moyenne de 3,2 mois dans le groupe 1 et 3,7 mois dans le groupe 2, 1 patient dans le groupe 2 a eu une fracture du cathéter. Conclusions : L’implantation d’un stimulateur cardiaque permanent par l’approche veineuse axillaire guidée par la fluoroscopie est équivalente à l’implantation par l’approche sous-clavière intrathoracique guidée par le repère anatomique traditionnel, et présente moins de complications et un temps d’intervention plus court pour accéder à la veine. scribed by Magney and colleagues and subsequently modified by Gardini and Benedini, is promising but has a steep learning curve. We describe an alternative technique of axillary venous puncture and prospectively compared it with the traditional ISV puncture technique. Our aim was to compare the feasibility, efficacy, safety, and complication rates of intrathoracic subclavian vs fluoroscopically guided axillary puncture for venous access in lead implantation for permanent pacemakers. Methods Consecutive patients undergoing pacemaker implantation at the Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India, were prospectively subjected to fluoroscopically guided, axillary venous puncture (group 1) or anatomically guided ISV (group 2) puncture for lead implantation. The choice of approach in a given patient was operator dependent. Informed written consent was obtained from all participants. The study was approved by the institute ethics committee. Consecutive patients aged 18 years or older undergoing permanent pacemaker implantation for any indication were potentially eligible participants. Patients undergoing lead replacement and those unable to provide informed consent were excluded from the study. Technique of venous puncture An incision was made in the deltopectoral groove, below which a pacemaker pocket was created. The point of entry of the puncture needle is the point where the second rib meets the thoracic cage in the fluoroscopic image of the chest (Fig. 1, A and B) with the patient’s hand resting by the side of the thorax and the head turned 45° to the contralateral side. The needle is pointed and subsequently advanced toward the area of interest, which is the intersection between the outer border of the first rib and the clavicle. An angle of about 60° (depending on the body habitus) between the needle and the horizontal plane was maintained while the needle was being introduced. In case the vein is not entered in the first attempt, a medial trajectory is taken. Care is taken to avoid going medial to the outer border of the first rib (Fig. 1, A and C). A maximum of 5 attempts were allowed per patient as part of the study protocol, and it was strictly followed in all the patients. If venous access could not be obtained after a maximum of 5 attempts, the operator could opt to change to another approach, of the operator’s choice; attempt access from the contralateral side; or perform a contrast-guided venipuncture. This course was considered a failed attempt with the technique used. While defining the landmark of axillary vein fluoroscopically, an initial 10 venipunctures were done with the help of a guidewire introduced into the subclavian vein through the ipsilateral brachial vein. Patients whose venipunctures were done during the first 3 months after introduction of the new fluoroscopic landmark were not part of the study. ISV was punctured with the help of conventional anatomic landmarks, as described by Littleford et al. The number of attempts needed and the time taken to obtain venous access were observed in all patients. In addition, complications while obtaining venous access and any complication during the index hospitalization deemed to be due to the venous access were noted. We classified the complications related to the procedure into acute and chronic. Acute complications included pneumothorax, hemopneumothorax, and hematoma that required surgical interventions. Chronic complications included crush injury to the lead, shoulder pain, and any residual complications related to the acute complications. All the procedures were done by experienced operators in this field. All participants were followed up in a dedicated arrhythmia and devices clinic a week after the procedure and at 3-month intervals later. Statistical analysis The Wilcoxon rank sum test was used to compare the differences between the 2 groups at baseline and after intervention. A P value 0.05 was considered to be significant. All analysis was done on STATA (version 9.2; College Station, TX). Results A total of 300 patients were enrolled into the study. In group 1, 315 lead placements were attempted in 202 patients (some of the patients had more than 1 lead placed as they were undergoing implantation of dual-chamber pacemakers), and 163 lead placements were attempted in 98 patients in group 2. There were significantly more men in group 2 (73.5% vs 63.86% in group 1). The age distributions of the patients were comparable in both groups (Table 1). Axillary venous puncture was successful in 309 out of the 315 lead implantations attempted (98.09%), as compared with the subclavian approach, which was successful in 158 out of 163 lead implantations (96.93%; P NS for axillary vs subclavian approach). In 194 cases,

[1]  E. Lau Upper Body Venous Access for Transvenous Lead Placement—Review of Existent Techniques , 2007, Pacing and clinical electrophysiology : PACE.

[2]  P. Belott How to access the axillary vein. , 2006, Heart rhythm.

[3]  H. Burri,et al.  Complete section of pacemaker lead due to subclavian crush , 2005, The Medical journal of Australia.

[4]  D. Shah,et al.  Prospective Study of Axillary Vein Puncture with or Without Contrast Venography for Pacemaker and Defibrillator Lead Implantation , 2005, Pacing and clinical electrophysiology : PACE.

[5]  J. Tharakan,et al.  Venogram-guided extrathoracic subclavian vein puncture. , 2003, Indian heart journal.

[6]  D. Roy,et al.  Extrathoracic subclavian venepuncture for pacemaker implantation. , 2001, Indian heart journal.

[7]  H. Halperin,et al.  Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach , 2001, Pacing and clinical electrophysiology : PACE.

[8]  V. Parsonnet,et al.  The Cephalic Vein Cutdown Versus Subclavian Puncture for Pacemaker/ICD Lead Implantation , 1999, Pacing and clinical electrophysiology : PACE.

[9]  S. Furman,et al.  Insulation Lead Failure: Is it a Matter of Insulation Coating, Venous Approach, or Both? , 1998, Pacing and clinical electrophysiology : PACE.

[10]  S. Clinic Blind Extrathoracic Subclavian Venipuncture for Pacemaker Implant: A 3-Year Experience in 250 Patients , 1998 .

[11]  J. Ball,et al.  Early complications of permanent pacemaker implantation: no difference between dual and single chamber systems. , 1995, British heart journal.

[12]  D. Flynn,et al.  A New Approach to Percutaneous Subclavian Venipuncture to Avoid Lead Fracture or Central Venous Catheter Occlusion , 1993, Pacing and clinical electrophysiology : PACE.

[13]  M. Bubrick,et al.  Anatomical and Morphological Evaluation of Pacemaker Lead Compression , 1993, Pacing and clinical electrophysiology : PACE.

[14]  F. E. Fyke,et al.  Infraclavicular Lead Failure: Tarnish on a Golden Route , 1993, Pacing and clinical electrophysiology : PACE.

[15]  A. Markewitz Safe introducer technique for pacemaker lead implantation. , 1992, Pacing and clinical electrophysiology : PACE.

[16]  E. Alt,et al.  Lead Fracture in Pacemaker Patients , 1987, The Thoracic and cardiovascular surgeon.

[17]  V. Parsonnet,et al.  Method for the rapid and atraumatic insertion of permanent endocardial pacemaker electrodes through the subclavian vein. , 1979, The American journal of cardiology.