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ournal of Cardiology Cases (2010) 1, e176—e179

avai lab le at www.sc iencedi rec t .com

journa l homepage: www.e lsev ier .com/ locate / j ccase

ase report

nitial Japanese experience and long-term follow-upith a new active fixation coronary sinus lead,

he StarFix 4195

akayuki Nagai (MD)a,∗, Hideki Okayama (MD, FJCC)a,azuhisa Nishimura (MD)a, Katsuji Inoue (MD)a, Jun Suzuki (MD)a,kiyoshi Ogimoto (MD)a, Tomoaki Ohtsuka (MD)a, Go Hiasa (MD)b,akumi Sumimoto (MD, FJCC)b, Jun-ichi Funada (MD)c,itsuo Higaki (MD, FJCC)a

Division of Cardiology, Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine,hitsukawa, Toon, Ehime 791-0295, JapanDepartment of Cardiology, Kitaishikai Hospital, Ozu, Ehime, JapanDepartment of Cardiology, Ehime National Hospital, Toon, Ehime, Japan

eceived 28 October 2009; received in revised form 14 December 2009; accepted 15 December 2009

KEYWORDSActive fixationcoronary sinus lead;Cardiacresynchronizationtherapy;Pacemaker lead

Summary Technologies associated with cardiac resynchronization therapy (CRT) devices andlead systems have progressed. However, dislocation after coronary sinus (CS) lead placementcontinues to be a problem. Furthermore, CS lead positioning at the site of the ventricular latestactivation (detected by echocardiography) is often problematic due to large vessel size leadingto the lead placement (wedge site) near the apical site. The newly available active fixationCS lead (StarFix 4195) enabled us to anchor the CS lead at the target site regardless of vesselsize and availability of a wedge site. We report on seven patients who had previously failed

dislocation conventional CS lead positioning due to large vessel size and a low phrenic nerve stimulationthreshold at the optimal site and lack of stabilization followed by dislocation at the targetvein. We attempted to replace the original lead with the StarFix 4195. All patients successfullyunderwent StarFix 4195 lead replacement at the target site and responded to CRT in the long-

term follow-up period. © 2010 Japanese College of Car

∗ Corresponding author. Tel.: +81 89 960 5302;ax: +81 89 960 5306.

E-mail address: nagait@m.ehime-u.ac.jp (T. Nagai).

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878-5409/$ — see front matter © 2010 Japanese College of Cardiology.oi:10.1016/j.jccase.2009.12.007

diology. Published by Elsevier Ireland Ltd. All rights reserved.

ntroduction

he newly available active fixation coronary sinus (CS) leadStarFix 4195TM, Medtronic Inc., Minneapolis, MN, USA) is anipolar, steroid eluting, over the wire left ventricular (LV)

Published by Elsevier Ireland Ltd. All rights reserved.

New CS lead for CRT e177

Table 1 Details of seven patients who underwent StarFix 4195 lead replacement.

Patient Age Sex NYHA class Diagnosis Cause of StarFix use Effect of CRT

1 69 M III CHF after DDD pacing Dislocation of Attain 4194 Responder2 80 M III—IV DCM Dislocation of Attain 4193 Responder3 36 M III Corrected TGA PN stimulation at the optimal site Responder4 78 M III—IV CHF after DDD pacing PN stimulation at the optimal site Responder5 72 M III OMI PN stimulation at the optimal site Responder6 71 M III DCM Dislocation of Attain 4194 Responder7 77 F III—IV Cardiac sarcoidosis Dislocation of Attain 4194 Responder

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CHF, congestive heart failure; CRT, cardiac resynchronization theraOMI, old myocardial infarction; PN, phrenic nerve; TGA, transposi

pacing lead characterized by three deployable lobes whichcan be deployed by advancing the outer pushing tube ofthe proximal catheter. The StarFix 4195 lead has enabledus to anchor the CS lead at the target site regardless ofvessel size and availability of a wedge site, and decreasedthe rate of lead dislocation which might be followed by LV

capture threshold rise and/or appearance of phrenic nervestimulation. We report the first experience of cardiac resyn-chronization therapy (CRT) using the StarFix 4195 CS leadsystem in Japan.

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Figure 1 Representative case. (A) Coronary venography (right antetarget lateral vein, which was relatively straight and lacked vessel bravessel. Of note, the posterior vein was not suitable for coronary sinudistance between the CS and the right ventricular lead tips, possibtherapy. (B) Final CS lead position (Medtronic Attain 4194) in the laoperation. Note the tip of CS lead was wedged at a more apical portcatheter was removed. (D) During the second operation, the StarFix 4of the lateral coronary vein. (E) The CS lead maintained a stablebetween the indicator rings is reduced indicating that all the three lacceptable.

CM, dilated cardiomyopathy; NYHA, New York Heart Association;of the great arteries.

ase report

rom November, 2007 through March, 2009, seven patientssix males and one female; median age 69 years; range6—80 years) experienced failure of CS lead placement andherefore underwent active fixation within the target coro-

ary vein using the StarFix 4195 lead. All patients hadeverely decreased LV ejection fraction (<35%) and weren New York Heart Association functional class III or IVespite optimal drug therapy. Etiologies of heart failure in

rior oblique view) of patient 1 (upgrade from DDD) showing thenches of appropriate size for wedging at the mid-portion of thes (CS) lead placement because that resulted in an insufficient

ly leading to unfavorable effects of cardiac resynchronizationteral vein with guidewire protruding at the time of the initialion. (C) The Attain 4194 lead dislocated soon after the guiding195 CS lead was used for active fixation within the mid-portionposition after the guiding catheter was removed. The spaceobes were deployed. Pacing and sensing performance were all

e178 T. Nagai et al.

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igure 2 Changes in left ventricular end-systolic volume (LVESificantly improved during long-term follow-up after cardiac resrom baseline to follow-up were compared using Student’s pair

he seven patients are shown in Table 1. CRT pacemakersr CRT defibrillators were implanted with standard tech-iques using an endovascular approach via a left axillaryein. Target coronary vein branch for the optimal CS leadositioning (according to findings of echocardiography) wasetermined after CS venogram. The conventional CS leadystems (Attain 4193 and 4194) were used for LV pacingn all patients. We used the StarFix 4195 only in patientsho had failed conventional CS lead positioning due to lackf ‘‘wedge position’’ because of large vessel size, a lowhrenic nerve stimulation threshold at the optimal site, andislocation at the target vein even after successfully posi-ioned at the ‘‘wedge position’’. Because the StarFix 4195ead had not been approved for clinical use in Japan (beforepril 2009), the medical ethics committee at Ehime Uni-ersity Hospital approved the individual import and usagef the lead. All patients gave written informed consent.ll patients were followed up and echocardiographic dataere obtained every 3 months. CRT responder status wasefined by a decrease in LV end-systolic volume of ≥15%sing the modified biplane Simpson’s method at follow-upchocardiography.

Clinical data for the seven patients are shown in Table 1.he StarFix 4195 was used because of a low phrenic nervetimulation threshold at the ‘‘wedge position’’ in threeatients, and a lack of stabilization followed by disloca-ion when the tip of the pacing lead was inserted at the‘wedge position’’ in four patients. All patients successfullynderwent StarFix 4195 lead replacement at the target veinfully deployed within lateral or posterolateral branch ofhe coronary vein) without complications. The parametersor sensing (R wave of 11 ± 7 mV) and pacing (threshold at.4 ms pulse width of 1.4 ± 1.3 V) were all acceptable. A

epresentative case is shown in Fig. 1. After a follow-uperiod of 12 ± 6 months, none of the leads have dislodged.esults have been completely satisfactory, with adequateensing and pacing function. As compared with baseline,V ejection fraction and LV end-systolic volume improved

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d left ventricular ejection fraction (LVEF). Both parameters sig-ronization therapy. The changes in echocardiographic variablestest. A level of statistical significance was set as p < 0.05.

ignificantly after long-term follow-up (Fig. 2). All patientsere considered responders to CRT by echocardiography.hus, the StarFix 4195 is a useful device for reducinghe frequency of CS lead failure during and after CRTevice implantation and thereby maximizing the efficacyf CRT.

iscussion

RT is widely recognized as a treatment for chronic heartailure in patients with severely impaired LV systolic func-ion combined with dyssynchrony [1,2]. Although the mostelayed electromechanical activation site should be pacedo maximize the effect of CRT [3—6], standard transvenousS lead placement at the site of the ventricular latest acti-ation (detected by echocardiography) is often challengingecause of anatomic conditions such as a lack of adequateranches of coronary veins, low phrenic nerve stimulationhresholds, and high LV capture thresholds. Even when suchroblems are not encountered, CS lead stabilization at theptimal site can become impossible if a ‘‘wedge position’’s not available due to large vessel size. Furthermore, dislo-ation after successful CS lead placement at the target veinemains an issue.

CS lead dislocation occurs in 8—11% of patients whondergo CRT device implantation without active fixationf the CS lead [7] and it is one of the critical problemsffecting patients who undergo CRT device implantation.islocation is associated with LV capture loss and phrenicerve stimulation, which might result in repositioning ofhe CS lead after the initial procedure. In order to avoidS lead dislocation, the pacing lead should be inserted

t the ‘‘wedge position’’. However, that position is oftenocated near the apical site, resulting in a decreased dis-ance from the right ventricular pacing lead positioned athe apex. This may lead to a decrease in the CRT respon-er rate [8]. Even when the CS lead is positioned at the

[10] Hansky B, Vogt J, Gueldner H, Schulte-Eistrup S, Lamp B,

New CS lead for CRT

‘‘wedge position’’, dislocation of the lead can still occur.Previous reports have suggested the usefulness of other CSlead stabilization techniques such as stenting [9] or activefixation using a screw-in lead [10]. However, CS lead place-ment using the StarFix 4195 lead is safer than the othermethods in terms of a reduced risk of perforation and insu-lation defects of the pacing lead. A major limitation of theStarFix 4195 lead placement is extractability after long-term implantation, particularly in cases of lead infection.Because there are no published data regarding any type ofCS lead extraction, additional studies in a larger patientpopulation are needed. Nonetheless, taking the poor prog-nosis of drug refractory heart failure into consideration, wethink the CS lead positioning at the optimal site is a firstpriority.

Conclusion

Despite limited data, our results indicate that the newlyavailable StarFix 4195 CS lead reduces the frequency of leaddislocation and maximizes the efficacy of CRT.

References

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[2] Takamatsu H, Tada H, Okaniwa H, Toide H, Maruyama H, HiguchiR, Kaseno K, Naito S, Kurabayashi M, Oshima S, Taniguchi K.Right bundle branch block and impaired left ventricular func-tion as evidence of a left ventricular conduction delay. Circ J2008;72:120—6.

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[8] Heist EK, Fan D, Mela T, Arzola-Castaner D, Reddy VY, Man-sour M, Picard MH, Ruskin JN, Singh JP. Radiographic leftventricular-right ventricular interlead distance predicts theacute hemodynamic response to cardiac resynchronizationtherapy. Am J Cardiol 2005;96:685—90.

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Heintze J, Horstkotte D, Koerfer R. Implantation of activefixation leads in coronary veins for left ventricular stimula-tion: report of five cases. Pacing Clin Electrophysiol 2007;30:44—9.