doi:10.1136/hrt.2007.132753 2009;95;259-264 Heart

  Kim Rajappan  

part IPermanent pacemaker implantation technique:

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ARRHYTHMIAS

Permanent pacemaker implantationtechnique: part IKim Rajappan

c Supplemental video footage isavailable online only at http://heart.bmj.com/content/vol95/issue3

Correspondence to:Dr Kim Rajappan, CardiacDepartment, John RadcliffeHospital, Headley Way,Headington, Oxford OX3 9DU,UK; kim.rajappan@orh.nhs.uk

Although device therapy is increasingly a subspeci-alty in its own right, permanent pacemaker (PPM)implantation remains one of the core skills ofcardiologists. Most trainees will require at leastbasic skills in PPM implantation and the aim of thisarticle (in two parts) is to provide a guide to thesteps involved, and some of the fundamentals oftechnique. No article on this subject can be totallycomprehensive and cover all the subtle nuances oftechnique used by different operators.Furthermore, like any practical skill it is onlypossible to give a flavour of the methodology inwriting, and nothing can replace the practicaltuition of an experienced implanter in the pacingtheatre during a number of PPM implants. Thathaving been said, before outlining some of thepractical aspects of PPM implantation, the firststep is to identify whether a patient needs a PPM.This may be straightforward, but there can besome complex cases. For this information thereader is referred to the various guidelines widelyavailable.1–3 When it comes to the actual implantthe following provides a step-by-step account.

PATIENT PREPARATIONFor any patient undergoing PPM implantation,appropriate informed consent should first beobtained. This includes the indication for implan-tation (often to prevent syncope secondary tobradycardia) and the risks associated with theprocedure (table 1), which may be tailored to one’sown practice/institutional figures; also it is increas-ingly important to document other important

information given to the patient—for example,rules regarding driving.4 Placement of an intra-venous cannula is routine for administration ofprophylactic antibiotics, administration of intra-venous analgesia/sedation, and potentially to per-form venography (see section on central venousaccess techniques). For this latter reason it is theauthor’s practice to make this at least a 20 Gcannula in the left antecubital fossa (assuming aleft sided implant) to allow adequate contrast flowto visualise the venous anatomy. Pre-proceduresedation may be given before the patient is movedto the operating theatre, but if sedation is used atall, it is often simply given in the theatre itself.Most PPMs are implanted on the left side. This isbecause it is more natural for right handedoperators and it is easier to position the leads(especially the atrial lead). There may be goodreason to implant on the right side—for example,the patient recently had an infected systemremoved from the left—but handedness is not adetermining factor (although 90% of patients areright handed anyway).

The choice of sedation and antibiotic prophy-laxis will often be determined by local guidelines/practice. It is of interest (and will no doubt berecognised by all implanters) that there is a distinctlack of either national or international guidance inthis latter area. This mainly stems from theconflicting evidence regarding its use; however,meta-analysis does suggest a benefit from pre-procedure intravenous antibiotics.5 In generalprotection against staphylococcal organisms isrequired whichever antibiotic is used, and localmicrobiological advice is often helpful to ensureadequate cover against identified pathogens. Inmost cases this will be either a single dose of apenicillin-type antibiotic—for example, flucloxacil-lin 1–2 g or a cephalosporin given within 2 h beforethe implant itself—but vancomycin and gentami-cin are increasingly used in cases that are deemedto be higher risk—for example, in patients with arecent, unrelated infective illness.

Preparing the procedure field is also crucial tominimising complications. Sterility is obviously ofparamount importance, and the technique for thisis best learnt from an experienced scrub nurse. Ofnote, some units will use disposable drapes that arepre-fashioned, while others retain conventional re-usable drapes. Whichever is being used, theoperator needs to ensure that these are placed ina position that enables them to access all parts of

Table 1 Risks associated with permanent pacemaker implantation

Superficial bruising: common and of no clinical significance unless it leads to pocket haematoma

Pocket haematoma: often managed conservatively, but may need intervention depending on size,concomitant anticoagulation, and/or tension on incision

Pneumothorax: risk depends on access route (table 2), but consent for 1% on average

Lead displacement: early and late displacements may be up to 4% in total

Cardiac perforation/tamponade: uncommon with current lead designs (,0.2%)

Infection: may be ,1% overall but recognised factors affect the risk* as below

Risk factor for infection OR (95% CI)

Fever within 24 h before device implantation 5.83 (2.00 to 16.98)

Use of temporary pacing wire before implantation 2.46 (1.09 to 5.13)

Pre-discharge re-intervention (eg, for clot evacuation, lead dislodgement) 15.04 (6.7 to 33.73)

De novo device implantation 0.46 (0.24 to 0.87)

Antibiotic prophylaxis 0.40 (0.18 to 0.86)

CI, confidence interval; OR, odds ratio.*Adapted from Klug D, et al for the PEOPLE Study Group. Risk factors related to infections of implantedpacemakers and cardioverter-defibrillators. Results of a large prospective study. Circulation 2007;116:1349–55.

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the field that they desire (fig 1). Movement ofthese drapes during the procedure should be keptto an absolute minimum, and if possible avoidedaltogether. Some operators will use a transparentadhesive dressing over the operation field to assistin holding the drapes in position, as well asmaintaining skin tension.

EQUIPMENTApart from the fluoroscopy equipment and vitalobservation monitors—for example, automated

blood pressure cuff and oxygen saturationprobe—there are a number of sterile surgicalinstruments and equipment that are needed.Figure 2 shows a standard PPM trolley set up forimplantation. The quality of the instruments isimportant in determining the ease and speed of theprocedure, and where necessary inadequate equip-ment should be replaced.

INCISIONThere are at least three different recognisedincisions that are used for PPM implantation(fig 1). Most operators will develop a preferencefor one of these or a slight variation on them. Eachof them has advantages and disadvantages (shownin fig 1) and the way in which the incision is madecan again determine the ease of implant. A poorlymade incision can hamper access to the vein, makefashioning the pocket problematic, and potentiallylead to a poor cosmetic result. For the ‘‘deltopec-toral’’ incision, the incision is made from approxi-mately 1 cm below the clavicle, in the delto-pectoral groove (indentation between the clavicu-lar head of the pectoralis major medially and thedeltoid laterally). For the ‘‘horizontal’’ incision thecut is made starting approximately 1–2 cm belowthe junction of the middle and lateral thirds of theclavicle and extending directly laterally to cross thedeltopectoral groove by approximately 1 cm. The‘‘oblique’’ incision is made running parallel to andapproximately 1–2 cm below the lateral third ofthe clavicle. The total length of the incision(commonly 4–5 cm) will vary according to: (1)the size of the device; and (2) the thickness of thesubcutaneous layer (a longer incision is required ifthicker tissue is present). Before performing theincision, local anaesthetic is infiltrated along thelength of the intended incision as well as moredeeply and slightly medially in preparation for thePPM pocket formation. Although guidelines sug-gest a maximum 3 mg/kg of 1% lignocaine (so in a50 kg person this is only 15 ml), more may need tobe used to achieve adequate anaesthesia.

POCKET FORMATIONAlthough the pocket may be formed in the axilla(in children in particular) or in the abdomen (forepicardial or femoral systems), the most commonsite is the pectoral region. Debate exists aboutsome aspects of PPM pocket formation. The first iswhether to fashion a subcutaneous pocket (at thelevel of the prepectoral fascia), or submuscularpocket (this could be either an intramuscularpocket between the pectoralis major and minor,or a subpectoral pocket below both the pectoralismajor and minor and above the ribcage). Thesubcutaneous pocket is the easiest and least painfulto form, although it is imperative to get into thecorrect plane of prepectoral fascial tissue. Once inthe correct plane, the pocket is made simply byusing one or two fingers to gently spread thetissues apart slightly medially and caudally, afterinfiltration of local anaesthetic; note that in a

Figure 1 In panel A the position of three common incisions are shown in relation to theclavicle and humeral head. Deltopectoral (DP) incision—ease of access to the cephalicvein but may limit access to the subclavian vein. The operator needs to ensure the pocketis made medially to the incision; it may be more difficult to make a subpectoral pocketwith this incision. Horizontal (H) incision—ease of access to both the cephalic andsubclavian veins with this incision, although not as easy for the cephalic vein as thedeltopectoral incision. It can be used for either subcutaneous or subpectoral pocketformation. Oblique (O) incision—similar to the horizontal incision but parallel to Langer’slines. It can make access to the cephalic vein more difficult. Incisions parallel to theselines may cause less scarring and give a better cosmetic result. In panel B the steriledrapes are in place, and the locations of the three incisions are shown again.

Figure 2 Pacing trolley laid out with instruments andequipment before permanent pacemaker implantation.These include: (A) a selection of scissors, (B) selfretainers, (C) sterile cover for image intensifier, (D) sterilepots for cleaning solution, saline, (E) gauze, (F) selectionof sutures, (G) lead testing cables, (H) toothed and non-toothed forceps, (I) skin preparation swabs, (J) selectionof clips, and (K) suture holder.

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young, muscular patient this tissue plane may stillbe fairly tight and require some effort to separatethe layers, whereas in a more elderly patient itoften spreads apart with minimal pressure. Thesubmuscular pockets are formed by a shallowincision in the pectoralis major muscle and thenblunt dissection, either through both muscle layers(subpectoral) or just down to the pectoralis minor(intramuscular, although this plane can be quitedifficult to identify). This is more painful thansubcutaneous pocket formation, but can be donewith conscious sedation.6

With the size of current devices the subcuta-neous pocket is sufficient for the vast majority ofpeople undergoing PPM implantation; however, forthose with little adipose tissue the submuscularpocket offers increased protection against deviceerosion. Other perceived advantages of a subcuta-neous pocket are that generator changes are easierand there is less risk of neurovascular damagewhen forming the pocket than if one dissectsthrough the muscle, while submuscular pocketsgive a better cosmetic result and reduce the risk ofmigration. In reality, there are little definitive datato support any of these suggestions and ultimatelythe choice of pocket will lie with the operator, or in

some cases with the patient (either through patientchoice or because of the body habitus).

The pocket may be fashioned at the start of theprocedure before any lead placement, or at the endonce the leads are secured (see section on leadplacement techniques in part II). There are somespecific reasons why the pocket may be made laterin the procedure. If an axillary or submuscularpocket is being used it may be easier to gauge thefinal optimal position of the pocket after securingthe leads. In routine practice the advantage ofmaking the pocket (particularly a subcutaneousone) early in the procedure is that there is lesschance of inadvertently displacing the leads oncethey are in place. The disadvantage is that there is asmall chance that venous access will be impossibleon the ipsilateral side and a redundant pocket thenexists. However, this finding is relatively rare andtherefore most operators will make the pocketearly in the procedure.

CENTRAL VENOUS ACCESS TECHNIQUESThis fundamental step can be broadly divided intothose techniques involving direct visualisation ofthe target vein by a cut down technique (mostcommonly the cephalic vein), or those involvingneedle puncture of the vein.7 Advantages anddisadvantages of each are shown in table 2.

Cephalic vein cut downThe usual course of the cephalic vein is in thedelto-pectoral groove, penetrating the clavi-pec-toral fascia to join the axillary vein medial to thepectoralis minor muscle. An occasional variantruns over the superficial surface of the clavicle tojoin the external jugular vein. When dissecting inthe groove towards the lateral border of thepectoral muscle it is common to see an area ofadipose tissue caudal to the lateral end of theclavicle. Dissection through this tissue, betweenthe pectoralis major muscle on the medial side andthe deltoid muscle on the lateral side, may revealthe cephalic vein at the bottom. It is worth notingthat sometimes it lies just under the edge of themuscle so it is important to explore the marginscarefully. Once the vein has been identified it isfreed from the surrounding tissue by carefuldissection. Ideally a 1–2 cm length of vein needsto be freed. An accompanying arteriole is commonand one should be alert to this, carefully dissectingthe vein away and ensuring cannulation of thecorrect vessel. Also, there may be a plexus of veinsrather than a single vein. In this case it may bepossible to cannulate the largest branch, but if theyare all of similar small calibre it may be better notto attempt this route. The vein may lie deep, andthe difficulty this creates may again mean that theoperator does not pursue this access route,particularly in patients with a large body habitus.Once the vein is freed it is tied off at the distal end(farther away from the patient and closer to theoperator). Care needs to be taken not to twist thevein as this is done because this makes venotomy

Table 2 Advantages and disadvantages of different venous access routes

Cephalic veinSubclavianvein

Extrathoracicsubclavian/axillary vein

Surgical skill required Most skill needed Average Average

Pneumothorax risk ,0.1% 1–2% ,0.1%

Risk of lead crush Very low Highest Low

Amount of fluoroscopy required to gainaccess

Minimal Minimal More than other 2methods

Ease of passage of multiple leads May be difficult Easier Easiest

Ease of extraction if required May be difficult Easier Easier

Figure 3 In panel A the cephalic vein has been isolated with silk ties at either end, andis lifted up by a clip to demonstrate it more clearly. The location of the deltopectoralgroove in relation to this has been marked. In panel B, after an incision was made withiris scissors, the vein lifter (inset) has been used to open the cephalic vein lumen and apacemaker lead has been inserted.

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and passage of a guide wire or lead more difficult. Aloose tie is left on the cephalic vein proximal towhere the venotomy incision is made. Sharp, finescissors should be used for the venotomy (irisscissors). The vein is then entered using a vein lifter(fig 3). The lead(s) may be directly passed throughthe cephalic vein or guidewires can be introducedand sheaths used. When passing a guidewire it maytrack into the axillary vein (down the arm) ratherthan the subclavian. If this happens, pull back theguidewire to the entry point of the cephalic veininto the axillary vein and manipulate it directlyinto the subclavian vein under fluoroscopy.Traction on the patient’s ipsilateral arm maylessen the angle of entry and facilitate this process.Where valves obstruct passage of the lead itself astandard guidewire, or a hydrophilic guide wire (forexample, Terumo), may help. Tortuosity of thecephalic vein can normally be negotiated by the useof one or more of these techniques.

Subclavian vein punctureThis route is the first choice access for someoperators, particularly if an extrathoracic approachis used. For the conventional percutaneous sub-clavian puncture to insert a central access catheter,for example, the landmark for entry through theskin is the junction between the medial and middlethird of the clavicle. When performing a subclavianpuncture during PPM insertion it needs to be noted

that puncture is no longer being made through theskin and subcutaneous tissue but now directlythrough the muscle. This means that although theentry point through the muscle is similar, the angleof the needle to the chest wall has to be reduced—that is, the needle is less steep to allow for the factthat entry is up to several centimetres below theskin surface in some individuals. Once the muscleis pierced the needle is advanced from a lateral tomedial direction aiming for the medial head of theclavicle. Some operators describe ‘‘walking under’’the clavicle—this means that the needle is kepthorizontal and when advancing the needle theclavicle is hit and then the needle is retractedslightly, the angle of the needle slightly steepenedand the needle advanced again. This process isrepeated until the needle just passes under theclavicle. This reduces the risk of inadvertent lungpuncture but may increase the risk of damage tothe inserted pacemaker lead from pressure of theclavicle (‘‘subclavian crush’’).

Although some operators perform this puncturewithout any form of extra imaging, the fact thatthe subclavian often runs under the medial head ofthe clavicle means that fluoroscopy can be used tohelp guide the needle (fig 4). An extrathoracicsubclavian vein puncture is performed over thefirst rib. The puncture through the muscle is madeslightly more medially than the conventionalsubclavian puncture, but importantly the angle ofthe needle is much steeper (in some cases almost90u) and it is advanced in a superficial-to-deep andanterior-to-posterior direction. This is done underfluoroscopy and it is important that the needlealways remains over the first rib in the standardpostero-anterior (PA) projection, and specificallynever passes medial to the rib (fig 4). The needle isadvanced (gently aspirating on an attached syringeas with any other indirect puncture), aiming forthe space below the clavicle and over the first ribuntil either the vein is cannulated or the rib isstruck (supplemental video 1). If the rib is struckthe needle should be gently withdrawn 1–2 cmwhile still aspirating and, if there is still noflashback of blood, the caudo-cephalad angle ofthe needle is changed to aim for either a slightlymore cephalic or caudal position on the first rib andthe same process repeated. The steep angle of theneedle may mean the vein collapses on the needle,making passage of the guidewire difficult.

Other access sitesAxillary vein puncture is performed by cannulatingthe vein over the second rib. Usually a venogram isperformed to help guide puncture as the course ofthe axillary vein is more variable than thesubclavian vein (fig 4, supplemental video 2).This technique is described in more detail else-where.8 The internal jugular vein and femoral veinmay also be used in certain circumstances, butneither of these is used routinely as the first choicefor lead implantation and is reserved for caseswhere the other access sites are not possible.

Figure 4 A venogram has been performed from the left antecubital fossa (top panel).This shows the drainage into the cephalic vein, axillary vein, running over the first rib, andthen into the subclavian vein. A schematic is shown in the lower panel outlining theimportant structures and landmarks for an extrathoracic subclavian/axillary vein puncture.The area in red represents the target area for puncture of the vein in an extrathoracicposition, theoretically making the risk of a pneumothorax almost zero.

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Troubleshooting difficult central accessAs with axillary vein puncture, where it is provingdifficult to cannulate the subclavian vein it is oftenworth performing a venogram from the ipsilateralarm (usually through a cannula in the antecubitalfossa) to delineate the exact course of the vein overthe first rib and under the clavicle (fig 4, supple-mental video 2). Also, with patients in a sedated stateand having often been left relatively dehydratedbefore the implant procedure, it may be worth givingfluid intravenously to increase central venous filling,and using a wedge under the legs as well as head-down tilt to increase venous return. Where there isdifficulty in passing the guidewire from the sub-clavian into the superior vena cava (SCV), it ispossible to place the dilator from the introducersheath into the subclavian and inject contrast tovisualise this area clearly and look for obstruction/stenosis, particularly where there are leads already inthe vein. If bleeding from the puncture site into thepocket is a problem after the leads have beenpositioned, a purse string suture around the leadsinto the muscle and pocket can help.

Multiple lead accessWhere access is required for more than a singlepacemaker lead, the operator has to make adecision how to best achieve this. With thecephalic vein, for example, it is theoretically

possible to provide unlimited venous accessthrough the venotomy. However, the size of thevessel will limit this to some extent. Where the sizeof the vein allows, some operators will simply passtwo (or more) leads via the cephalic vein withoutany guidewires or sheaths. Alternatively twoguidewires may be positioned through the cephalicvein into the subclavian vein. This is achieved bypassing an introducer sheath down the first guide-wire, taking out the dilator from the sheath whileretaining the guidewire in the sheath, passing anextra guidewire next to the existing one down theintroducer sheath, and then taking out theintroducer sheath without removing any of theguidewires. Introducer sheaths are then used foreach lead in turn. With a dual chamber pacemakerthe right ventricular lead is conventionally posi-tioned first, and then the right atrial lead. Frictionbetween adjacent leads can hamper manipulationin this situation, causing inadvertent lead dislodge-ment. To minimise interaction of the two leads,while positioning the second lead the introducersheath may be left in situ until both leads are in asatisfactory position. Where multiple access isthrough a subclavian or axillary vein puncture asimilar ‘‘double wiring’’ technique may be used,particularly if the puncture has been difficult andthe risk of a pneumothorax may be increased bymultiple attempts. However, there may be aslightly increased risk of bleeding from the largerhole created, so if the puncture is straightforward,a second puncture should be performed, which alsomakes individual lead manipulation easier.

This concludes the first part of this two partarticle. In part II further aspects of the implantprocess including lead placement techniques will beconsidered.

Competing interests: In compliance with EBAC/EACCME guide-lines, all authors participating in Education in Heart have disclosedpotential conflicts of interest that might cause a bias in the article.The author has no competing interests.

REFERENCES1. British Pacing and Electrophysiology Group. Recommendations

for pacemaker prescription for symptomatic bradycardia. Report of aworking party of the British Pacing and Electrophysiology Group. BrHeart J 1991;66:185–91.

2. European Society of Cardiology, European Heart RhythmAssociation. The Task Force for Cardiac Pacing and CardiacResynchronization Therapy of the European Society of Cardiology.Developed in Collaboration with the European Heart RhythmAssociation. Guidelines for cardiac pacing and cardiacresynchronization therapy. Eur Heart J 2007;28:2256–95.

3. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008guidelines for device-based therapy of cardiac rhythm abnormalities.J Am Coll Cardiol 2008;51:1–62.

c The most recent guidelines on selection of patients for PPMimplantation. Importantly, these now emphasise the needfor the implanter to think carefully about each individualpatient’s case and the device used.

4. Driver and Vehicle Licensing Agency. For medical practitioners.At a glance guide to the current medical standards of fitness to drive.p19 http://www.dvla.gov.uk/media/pdf/medical/aagv1.pdf.

c Helpful information to give to patients, and should bedocumented when given.

5. Da Costa A, Kirkorian G, Cucherat M, et al. Antibiotic prophylaxisfor permanent pacemaker implantation: a meta-analysis. Circulation1998;97:1796–801.

c Meta-analysis of the limited number of randomised trials toevaluate the effectiveness of antibiotic prophylaxis to

Permanent pacemaker implantation I: key points

c Documentation of consent and any advice given to the patient beforepermanent pacemaker implantation is essential.

c Be meticulous over aseptic technique from start to finish.c A poorly made incision can affect the entire procedure.c Where access is proving difficult, perform a venogram and consider

manoeuvres to increase venous filling.

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reduce infection rates after PPM implantation, which,despite the limitations of some of the studies included,demonstrated a benefit in the use of pre-procedureparenteral antibiotics to prevent short term pocketinfection, skin erosion or septicaemia.

6. Lipscomb KJ, Linker NJ, Fitzpatrick AP. Subpectoral implantationof a cardioverter defibrillator under local anaesthesia. Heart1998;79:253–5.

7. Lau EW. Upper body venous access for transvenous leadplacement – review of existent techniques. Pacing ClinElectrophysiol 2007;30:901–9.

c Comprehensive yet brief review of the techniques available.8. Burri H, Sunthorn H, Dorsaz PA, et al. Prospective study of axillary

vein puncture with or without contrast venography for pacemakerand defibrillator lead implantation. Pacing Clin Electrophysiol2005;28:S280–3.

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