LEAD dysfunction is one of the major problems/complications of permanent

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1 Right Ventricular and Tricuspid Valve Function in Patients With Two Ventricular Pacemaker Leads Cengiz ÇELIKER, 1 MD, M. SERDAR KÜÇÜKOGLU, 1 MD, Alev ARAT-ÖZKAN, 1 MD, Nuran YAZICIOGLU, 1 MD, and Sinan ÜNER, 1 MD ˆ ˆ SUMMARY Existing data on the effect of retained pacemaker leads on right ventricular (RV) and tricuspid valve function is limited. Objective: In this echocardiographic study we investigated the long-term effect of retained ventricular leads on RV and tricuspid valve function in patients with permanent pacemakers. Forty patients, 18 with two (group I) and 22 with one (group II) ventricular lead were assessed echocardiographically at an average of 39 months after the second lead implantation in group I and 80 months after the lead implantation in group II. The sum of the lead body diameter in group I was significantly greater than the body diameter in group II (P < 0.000). There was no significant difference between the groups with respect to chamber diameters and ventricular or valvular functions. The distributions of the different tricuspid regurgitation (TR) grades were similar, with the majority of patients in both groups having mild TR. Retained second pacemaker leads do not have an additional negative effect on right ventricular and tricuspid valve function. (Jpn Heart J 2004; 45: ) Key words: leads Permanent pacemaker, Tricuspid regurgitation, Echocardiography, Retained LEAD dysfunction is one of the major problems/complications of permanent pacemaker therapy. Dysfunction due to mechanical or infective problems or electrical failure leads to replacement. Although lead extraction is done effectively and safely using the new extraction devices in many centers, there still exists a serious complication risk if it is done by inexperienced operators. 1,2) Some of the functionless leads can not be removed safely and are left in situ if an absolute indication for extraction does not exist. It has been shown that the retained functionless pacemaker leads in the cardiovascular system are well tolerated unless they are infected and carry a very low complication rate. 3,4) Other possible com- From the 1 Institute of Cardiology, Istanbul University, Istanbul, Turkey. Address for correspondance: Alev Arat-Özkan, MD, Institute of Cardiology, Istanbul University, Kuskonmaz sok 5/8, Yesilyurt, Istanbul, Turkey. Part of this study was presented at the XIII World Congress of Cardiology, Rio de Janeiro, Brazil, April 26-30, 1998, and at the 11 th International Congress Cardiostim 98, Nice, France, June 17-20, Received for publication May 28, Revised and accepted August 28,

2 104 ÇELIKER, ET AL Jpn Heart J January 2004 plications associated with retained pacemaker leads are lead migration and thrombosis. Theoretically, tricuspid regurgitation (TR) is another potential complication of permanent electrode implantation. 5) Existing data on the influence of ventricular leads on TR is controversial and the effect of retained leads on right ventricular (RV) and tricuspid valve function has not been extensively investigated. In this echocardiographic study, we investigated the long-term effect of the number of ventricular leads on RV and tricuspid valve function in patients with permanent pacemakers. METHODS The study population consisted of consecutive patients referred to the pacemaker department of our institute. Patients with known heart valve disease and receiving a medication with an effect on cardiac hemodynamics were excluded from the study. A total of 40 patients, 18 with two leads in RV (group I) and 22 with one ventricular lead (group II) were included in the study. One of the two leads in all patients in group I was an abandoned noninfected lead. Echocardiography: All patients underwent standard 2-D and Doppler echocardiographic studies (Acuson 128XP, 3.5 MHz transducer) with detailed evaluation of the tricuspid valve (TV). All echocardiographic examinations were conducted by an experienced physician at an average of 39 months after the second and 111 months after the first lead implantation in group I and 80 months after the lead placement in group II. RV, left ventricular (LV), and left atrial (LA) dimensions, diastolic and systolic volumes of RV and LV, and ejection fractions (EF) were recorded as well as 2-D and Doppler evaluation of all heart valves with special attention paid to the tricuspid valve. LA, LV, and RV dimensions were recorded from the parasternal long-axis view at end-diastole. Left and right ventricular EFs and ventricular volumes were calculated from the apical four chamber view with Simpson's formula and "Area-length method". The tricuspid valve mean gradient (TVMG) and tricuspid valve velocity time integral (TVVTI) were recorded from the apical four chamber view with sample volume placed proximal to the valve annulus. TR was evaluated with pulsed Doppler and confirmed with color Doppler generally from the apical four chamber view. Color gain was set in all patients by adjusting to the point at which background noise disappeared. The amount of TR was assessed as normal, trivial, mild, moderate, and severe according to the ratio of TR jet size to right atrial size. Jet length, jet eccentricity, and proximal jet width were also taken into account when assessing the degree of TR. All recordings were reviewed by two experienced physicians. Statistics: The clinical and echocardiographical findings of the groups were compared. The values are expressed as the mean ± SD. The differences between

3 Vol 45 No 1 RETAINED PACEMAKER LEADS 105 the groups were analyzed by Students' t-test. Categorical data were compared 2 using χ analysis. A P value less than 0.05 was considered statistically significant. RESULTS The mean age, gender distribution, and incidence of atrial fibrillation in both groups were similar (Table I). The mean of the sum of the body diameters of the two leads in group I was significantly greater than the mean of the body diameters in group II (3.9 mm vs 2.1 mm, P < 0.000) as expected. There were no significant differences between the groups with respect to RV, LV, and LA dimensions; thickness of the interventricular septum and posterior wall, systolic and diastolic volumes and ejection fractions of the RV and LV, and the frequency of normal mitral or aortic valve and mild mitral or aortic regurgitation (Tables II and III). The distributions of the different TR grades were also found similar in the two groups (Table III). The majority of the patients in the two groups had mild TR. None of Table I. Patient Characteristics Group Age (years) Sex (F/M) Atrial Fibrillation Lead body diameter (mm) Group I (No = 18) 67 ± 14 10/8 6 (33%) 3.98 ± 0.5* Group II (No = 22) 69 ± 12 10/12 8 (36%) 2.12 ± 0.3 P < = not significant; Group I: patients with two leads; Group II: patients with one lead. *The mean of the sum of the body diameters of the two leads. Table II. Echocardiographic Findings (part I) Group I Group II P LA (cm) LVd (cm) RV (cm) IVS (cm) PW (cm) LVSV (cm 3 ) LVDV (cm 3 ) LVEF (%) RVSV (cm 3 ) RVDV (cm 3 ) RVEF (%) 3.8 ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± 9 IVS = interventricular septum thickness; LA = left atrial dimension; LVd = left ventricular diastolic dimension; PW = posterior wall thickness; RV=right ventricular dimension; DV = diastolic volume; EF = ejection fraction; LV = left ventricular; RV = right ventricular; SV = systolic volume; = not significant.

4 106 ÇELIKER, ET AL Jpn Heart J January 2004 Table III. Echocardiographic Findings (Part II) Group I Group II P Normal MV Mild MR Normal AV Mild AR TR (-) TR (mild) TR (moderate) TVMG (mmhg) TVVTI (m/sec) 12 (66.7%) 6 (33.3%) 15 (83.3%) 3 (16.7%) 3 (16.7%) 11 (61.1%) 4 (22.2%) 3.2 ± ± (72.7%) 6 (27.3%) 18 (81.8%) 4 (18.2 %) 5 (22.7%) 13 (59.1%) 4 (18.2%) 1.1 ± ± 0.1 AR = aortic regurgitation; AV = aortic valve; MR = mitral regurgitation; MV = mitral valve; MG = mean gradient; TR = tricuspid regurgitation; TV = tricuspid valve; VTI = velocity time integral; = not significant. the study patients had severe TR. There were only insignificant increases in tricuspid valve mean gradient and velocity time integral in group I. None of the patients had symptoms or signs of TR. No complications occurred during the follow-up period. DISCUSSION Mild to moderate TR is often missed on physical examination. Doppler echocardiography has a higher sensitivity for detecting TR. 6-8) The prevalance of TR detected by pulsed Doppler in normal subjects has been variously reported as 10-50%, increasing with age. 9-12) Data on patients with transvenous pacemaker leads are controversial. 5,13-17) In their retrospective case control study, Paniagua, et al. noted an increased prevalance (52.9%) of moderate to severe TR in patients with transvenous pacemakers as compared to age- and sex-matched controls. 15) On the contrary, Leibowitz, et al showed in a prospective study that the permanent right-sided electrodes were not associated with an acute increase in tricuspid regurgitation. 16) The overall prevalances of TR prior to and after the lead placement were 58% and 63%, respectively. In our study, mild/moderate TR was present in 77.3% of the patients with one PM lead. No significant TR was detected. In the literature, there is only one report concerning the effect of two ventricular leads on right ventricular and tricuspid valve function. 17) Postacl, et al reported in their retrospective study that the incidence of TR was more frequent and of a higher degree in patients with two leads. The overall incidence of Grade II and III TR according to Miyatake, et al in their study in patients with a single lead in the right ventricle was 52.1%, which is significantly lower compared to

5 Vol 45 No 1 RETAINED PACEMAKER LEADS 107 the group with two leads in the right ventricle (88.9%). In our study, the overall incidences of mild to moderate TR showed no significant difference between the groups (83% vs 77%) although they were generally higher than that reported in other series. Compared to the report of Postacl, et al, in the double lead group TR was less frequent and of a lower degree. No significant TR was detected in either group. Similar to the findings of Postacl, et al, we did not find any significant difference in right ventricular function. There was only an insignificant increase in mean tricuspid gradient and velocity time integral in group I, indicating mild flow obstruction due to increased lead body diameter, as expected. The major limitation of the present study is the semiquantitative assessment of the TR degree. However, the comparison of color Doppler jet size to right atrial area is a widely used and accepted method for evaluating the severity of TR. 18) Another critical point may be the absence of baseline/preprocedural echocardiographic data, especially for TR in the study population, which made an indirect comparison with reports on TR data in normal subjects necessary. At this point, it should be emphasized that the major aim of the study was to evaluate the effect of the second/additional lead on tricuspid valve and right heart function. In conclusion, our results indicate that in-situ left second pacemaker leads do not have an additional negative effect on right ventricular and tricuspid valve functions. REFERENCES 1. Frank G., Tyers O. Similar indications but different methods: Should there be a concensus on optimal lead extraction techniques? (editorial) PACE 2002; 25: Bongiorni MG, Arena G, Soldati E, Mariani M. Transvenous leads removal can be effectively and safely performed in cathetes laboratory. (abstract) PACE 1997; 20: Marti V, Gurgui M, Padro JM, Oter R, Rodriguez O. Complications associated with nonfunctioning pacemaker electrodes retained within the cardiovascular system. Rev Esp Cardiol 1994; 47: Furman S, Behrens M, Andrews C, Klementowicz P. Retained pacemaker leads. J Thorac Cardiovasc Surg 1987; 94: Morgan DE, Norman R, West RO, Burggraf G. Echocardiographic assessment of tricuspid regurgitation during ventricular demand pacing. Am J Cardiol 1986; 58: Nishimura RA, Miller FA Jr, Callahan MJ, Benassi RC, Seward JB, Tajik AJ. Doppler echocardiography: theory, instrumentation, technique and application. Mayo Clin Proc 1985; 60: DePace NL, Ross J, Iskandrian AS, et al. Tricuspid regurgitation: noninvasive techniques for determining causes and severity. J Am Coll Cardiol 1984; 3: Curtius JM, Thyssen M, Breuer HM, Loogen F. Doppler versus contrast echocardiography for diagnosis of tricuspid regurgitation. Am J Cardiol 1985; 56: Come PC, Riley MF, Carl LV, Nakao S. Pulsed Doppler echocardiographic evaluation of valvular regurgitation in patients with mitral valve prolapse: comparison with normal subjects. J Am Coll Cardiol 1986; 8: Tei C, Kisanuki A, Minagoe S, et al. Incidence of tricuspid regurgitation in normal subjects according to a new Doppler echographic criterion. J Cardiol 1987; 17: Berger M, Hecht SR, Van Tosh A, Lingam U. Pulsed and continuous wave Doppler echocardiographic assessment of valvular regurgitation in normal subjects. J Am Coll Cardiol 1989; 13:

6 108 ÇELIKER, ET AL Jpn Heart J January Akasaka T, Yoshikawa J, Yoshida K, et al. Age-related valvular regurgitation: a study by pulsed Doppler echocardiography. Circulation 1987; 76: Gibson TC, Davidson RC, DeSilvey DL. Presumptive tricuspid valve malfunction induced by a pacemaker lead: a case report and review of the literature. PACE 1980; 3: Kikuchi Y, Shiraishi H, Igarashi H, Yanagisawa M. Insertion of a pacing lead via the tricuspid valve does not affect cardiac function and tricuspid valve regurgitation in young dogs. Acta Paediatr Jpn 1996; 38: Paniagua D, Aldrich HR, Lieberman EH, Lamas GA, Agatston AS. Increased prevalence of significant tricuspid regurgitation in patients with transvenous pacemaker leads. Am J Cardiol 1998; 82: Leibowitz DW, Rosenheck S, Pollack A, Geist M, Gilon D. Transvenous pacemaker leads do not worsen tricuspid regurgitation: A prospective echocardiographic study. Cardiology 2000; 93: Postaci N, Eksi K, Bayata S, Yesil M. Effect of the number of ventricular leads on right ventricular hemodynamics in patients with permanent pacemaker. Angiology 1995; 46: Cooper JW, Nanda NC, Philpot E, Fan P. Evaluation of valvular regurgitation by color Doppler. J Am Soc Echocardiogr 1989; 2: