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European Journal of Heart Failure 2006 8(6):609-614; doi:10.1016/j.ejheart.2005.11.009
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© 2005 European Society of Cardiology

Optimization of right ventricular lead position in cardiac resynchronisation therapy{star}

Lucie Riedlbauchová1, Robert Cihaák, Jan Bytesník, Vlastimil Vancura, Petr Frídl, Lenka Hoskovaá and Josef Kautzner*

Department of Cardiology, Institute for Clinical and Experimental Medicine Vídeòská 1958/9, 140 21 Praha 4, Prague, Czech Republic

* Corresponding author. Tel.: +42 26108 2353; fax: +42 24172 8225. E-mail address:josef.kautzner{at}medicon.cz (J. Kautzner)


   Abstract
Top
 Notes
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Study limitations
 6. Conclusions
 References
 
Background: The benefit of biventricular pacing (BiV) may be substantially affected by optimal lead placement.

Aim: To evaluate the importance of right ventricular (RV) lead positioning on clinical outcome of BiV.

Methods and results: A total of 99 patients with symptomatic heart failure and implantation of BiV system were included. Position of the left-ventricular (LV) lead was selected based on timing of local endocardial signal within the terminal portion of the QRS complex. RV lead was preferably positioned at the midseptum (n = 74, RVS group) where the earliest RV endocardial signal was recorded. A subgroup of patients had RV lead placed in the apex (n = 25, RVA group). NYHA class, maximum oxygen-uptake (VO2max), LV end-diastolic diameter (LVEDD, mm) and ejection fraction were assessed every third month.

A trend towards greater improvement in NYHA class and significant increase in VO2max was present in the RVS group. Moreover, a significant decrease in LVEDD ({Delta}LVEDD) was observed in the RVS group only (– 3.4 ± 6.5 mm versus + 1.7 ± 6.4 mm in RVA group at 12 months, p = 0.004). No significant correlation between the degree of {Delta}LVEDD and QRS narrowing induced by BiV was found. LVEDD reduction was predominantly present in dilated cardiomyopathy.

Conclusions: Midseptal positioning of the RV lead appears to promote reverse LV remodelling during cardiac resynchronisation therapy.

Key Words: Cardiac pacing • Lead position • Left ventricle • Cardiac resynchronisation therapy • Chronic heart failure • Remodelling

Received January 28, 2005; Revised September 2, 2005; Accepted November 17, 2005


   1. Introduction
Top
 Notes
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Study limitations
 6. Conclusions
 References
 
Multiple studies, both randomised and non-randomised, have demonstrated beneficial acute and long-term haemodynamic effects of biventricular (BiV) pacing in patients with chronic heart failure and ventricular dyssynchrony [1-3]. However, clinical outcome of BiV pacing can be influenced by multiple factors. Optimal lead positioning seems to be one of the most important. In this context, several studies have evaluated the role of left-ventricular (LV) lead placement [4-6]. Maximum benefit, both acute and mid-term, has been observed in patients paced at the most delayed LV site [7,8]. On the other hand, data regarding the influence of the right-ventricular (RV) lead positioning in BiV pacing are scarce [9-11].

The aim of this study was, therefore, to analyze feasibility and safety of alternative RV lead site in BiV pacing and to assess the importance of RV lead position in BiV pacing in terms of the clinical improvement and reduction of LV end-diastolic diameter (LVEDD) as a sign of LV reverse remodelling during the follow-up. In addition, this study evaluated whether the more pronounced QRS narrowing, influenced by position of both RV and LV lead, results in more significant clinical improvement long-term.


   2. Methods
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Study limitations
 6. Conclusions
 References
 
2.1. Patient characteristics
A total of 99 consecutive patients (20 women, mean age 61±8.5 years) with chronic symptomatic heart failure (NYHA III-IV) despite optimized medical therapy (including ACE inhibitors, beta blockers and diuretics) were included in this retrospective study (Table 1). Idiopathic dilated cardiomyopathy (DCM) was present in 40, coronary artery disease (CAD) in 54, and coexistent CAD and surgically corrected valvular heart disease in the remaining 5 cases. All patients presented with significant LV systolic dilatation and dysfunction (LVEDD 74.5±8.9 mm, LV ejection fraction (LVEF) 21.6±2.9%). All patients were in sinus rhythm and had intraventricular conduction disturbances with QRS duration ≥150 ms (mean 186±20 ms), predominantly of left bundle branch block (LBBB) morphology. Patients with chronic atrial fibrillation and/or those with a previously implanted pacemaker were excluded from the study. In addition, patients with severe heart failure requiring catecholamine support and/or those with a recent history of acute coronary syndrome or cardiac surgery (<6 months) were excluded. The study was approved by the local ethics committee and all patients gave their informed consent.


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  		Table 1 Baseline characteristics of the study population

 
2.2. Implant procedures
All procedures were performed in our department between February 2000 and November 2003. All leads were inserted transvenously via the subclavian vein. The LV lead was placed in the lateral or posterolateral vein in the majority of cases, depending on individual coronary venous anatomy (Figs. 1, 2Go) and attempting to optimize lead position by recording of the endocardial signal within the terminal portion of the QRS complex (Fig. 3). The RV lead was implanted preferably at the midseptal region of the RV (RVS group, n=74). The lead was introduced into the RV outflow tract and then pulled down along the septum to record the earliest RV electrogram corresponding with the very beginning of the QRS complex and providing largest interval between RV and LV electrograms (Fig. 3). Positioning of the RV lead in the septal region was guided by both X-ray imaging and endocardial signal recording. At least, three different X-ray views were used for the verification of the RV lead placement (anteroposterior, right and left anterior oblique 30-40° view, respectively) (Fig. 1). On average, 3 different RVS positions were examined per patient. However, some patients had the RV lead placed in the apical region (RVA group, n=25). These patients were recruited mostly (but not exclusively) from the early implant period. The atrial lead was placed in the high right atrium using active fixation.


Figure 1
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  		Fig. 1 X-ray images in 2 different views showing final lead placement after implantation of BiV pacing system: LAO-left anterior oblique 40° view, AP-anteroposterior view. RV lead was inserted at the midseptal region, LV lead was implanted via lateral vein, atrial lead was placed in the high right atrium.

 


Figure 2
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  		Fig. 2 The distribution of final lead positions in the RV (A) and LV (B) in the study cohort. A — Interventricular septum divided into 3 regions virtually: RVA — RV apex, RVS — RV midseptum, RVOT— RV outflow tract. The grey area depicts most common region of the RV lead insertion in RVS group. B — Schematic drawn of the LV free wall demonstrating number of patients with the LV lead inserted in the appropriate LV segment in RVS and RVA group separately (both absolutely (top) and relatively (bottom)). Ant — anterior, Lat—lateral, Post—posterior, Bas — basal, Mid — middle segments, and Apex — apical segments.

 


Figure 3
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  		Fig. 3 Relationship between QRS complex and intracardiac signal (ICS) of the RV lead inserted at the midseptum (A) and in the RV apex (B). Note sharp signal that precedes beginning of the QRS complex in case A as compared with biphasic signal that is relatively late in case B. An example of RV-LV interval (C) — RV component is located at the beginning of the QRS complex (RV lead positioned at midseptum) whereas LV signal coincides with terminal portion of the QRS complex (LV lead located posterolaterally in the region of the latest ventricular activation in this particular case).

 
2.3. Measured parameters
The following parameters recorded during the implant procedure were analyzed: pacing threshold, sensing and impedance in all relevant leads; QRS basal: QRS duration in spontaneous rhythm; QRS-LV and QRS-RV: QRS duration during single-site LV and RV pacing at the site of final lead placement; RV-LV interval: interventricular conduction time measured as the distance between RV and LV local endocardial signals during spontaneous rhythm at the site of final lead placement (Fig. 3C), QRS-BiV: QRS duration during BiV pacing from the same lead positions; and finally, {Delta}QRS that reflects the degree of QRS narrowing during BiV pacing (calculated as QRS-basal minus QRS-BiV). The 12-channel standard ECG recording at a speed of 100 mm/s (GE Prucka CardioLab 7000, version 5.1D, Milwaukee, USA) was used for precise QRS duration assessment.

2.4. Follow up
The above pacing and ECG parameters along with NYHA functional class, maximum oxygen uptake and echocardiographic parameters were evaluated every 3 months after implantation. Standard echocardiographic measurements were used for LVEF and LVEDD estimation (Simpson formula for LVEF and M-mode for LVEDD measurement). In addition, the difference between LVEDD before implantation and at 6 and 12 months of pacing ({Delta}LVEDD) was calculated with negative values indicating reduction of LVEDD. LV end-systolic diameter was not evaluated, since the presence of paradoxical septal movement in LBBB and subsequent change due to pacing makes this parameter unreliable.

2.5. Statistical analysis
Continuous data are expressed as the mean±SD and compared using the Student's t test for paired and unpaired data sets. Chi-square test and two-sample t-test were used to assess differences between groups, when appropriate. Stepwise multivariant analysis was used to identify independent variables. Correlation between various parameters was evaluated using Pearson's correlation coefficients. For all tests, a p value <0.05 was considered significant.


   3. Results
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Study limitations
 6. Conclusions
 References
 
Basic characteristics of the study population and the subgroups are summarized in Table 1. There was a significant difference in age before the implant between the study sub-groups (RVS and RVA). The other basic characteristics did not exhibit any important differences between the groups, including proportion of DCM and CAD cases and distribution of LV pacing sites (Table 1, Fig. 2). Although the difference in LVEDD before the implant procedure was not significant between both groups, it was apparent that a substantial proportion of patients in the RVS group presented with more advanced LV dilatation.

Both single-site LV and RV pacing resulted in QRS widening in all but 4 and 14 cases, respectively. For single-site RV pacing, a trend towards shorter ventricular activation (expressed as the QRS duration) was observed in RVS group (Table 2). However, the RV-LV interval was similar in both groups. BiV pacing significantly reduced QRS duration in all but 4 cases. Importantly, more pronounced QRS narrowing was observed in RVS group, despite comparable QRS width between the groups at baseline (Table 2). The most expressed narrowing of the QRS complex was noticed when combining RVS pacing with pacing from the LV lateral or posterolateral wall site.


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  		Table 2 Parameters measured during the implant procedure (ms)

 
Pacing parameters measured both at the time of implant and during the follow-up are summarized in Table 3. No significant difference was observed between the study groups. The RV lead could not be implanted in the RVS position in one subject. The following complications were observed with respect to the RV lead insertion: intermittent AVB III during manipulation with the RV lead in 3 patients in each group, RV lead dislodgement during long-term follow-up in 3 patients from the RVS group that required revision and lead repositioning.


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  		Table 3 Pacing parameters of both groups measured at the time of implant and during long-term follow-up (2, 6 and 12 months after the implantation)

 
Pharmacological treatment in the RVS and RVA groups is summarized in Table 1. Medication was stable and no significant differences in the daily doses were found both in the course of the 12 month follow-up period in each group and between the RVS and RVA groups during the follow-up.

Clinically, patients from both groups showed a similar improvement in functional NYHA class, although there was a trend towards a greater improvement in the RVS group during follow-up. Similarly, LVEF increased to the same extent in the groups during the 12 month follow-up period. However, patients in both groups differed in maximum oxygen uptake after 12 months (Table 4). The most important difference between the study groups was observed in LVEDD and {Delta}LVEDD parameters, from the third month after the implant. Patients in the RVS group presented with a significant reduction in LVEDD as compared with the RVA group in which no important decrease in LVEDD was seen during the first 12 months (Fig. 4). In addition, 96% of patients exhibiting LVEDD reduction ≥4 mm after 12 months of BiV pacing were in the RVS group. Interestingly, a trend towards LVEDD reduction was observed even in the RVA group after 24-36 months.


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  		Table 4 Clinical improvement observed after 12 months of biventricular pacing was comparable between both groups

 


Figure 4
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  		Fig. 4 Comparison of LVEDD reduction ({Delta}LVEDD, mm) after 6 and 12 months of BiV pacing between RVS and RVA group. Negative values mark reduction of LVEDD whereas positive values further dilatation of the LV during long-term pacing.

 
{Delta}LVEDD correlated with the degree of LVEF improvement ({Delta}LVEF) calculated at 12 months of follow-up (r=0.436, p<0.001). Otherwise, no significant correlation between {Delta}LVEDD and electrocardiographic parameters such as QRS-BiV, {Delta}QRS, QRS-RV was found. Stepwise discriminant analysis did not reveal any other parameter beyond RV lead position to predict LVEDD reduction and/or clinical improvement.


   4. Discussion
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Study limitations
 6. Conclusions
 References
 
To our knowledge, this is the first study evaluating the impact of RV lead positioning on long-term outcome of BiV pacing in patients with chronic heart failure. Its major results suggest that midseptal positioning of the RV lead is both safe and easily accessible, and leads to a more significant reduction in LVEDD as a sign of LV reverse remodelling as compared with positioning in the RV apex.

Data about the importance of RV lead positioning in BiV pacing are scarce [9-11]. The only available studies have evaluated acute haemodynamic changes and/or QRS duration in relation to site of placement of the RV lead. Leclercq et al. [9] defined optimal BiV pacing mode by the degree of QRS narrowing and found that BiV pacing with the RV lead inserted in the RV outflow tract was superior in 11 patients (61%) and in RV apex in the remaining 7 (39%) patients. However, some studies [12,13] have indicated that the degree of QRS narrowing seems to be a controversial predictor of clinical improvement and invasive haemodynamic assessment appears to be more relevant in this context. In an animal model, Frias et al. [11] observed an increase in contractility when both RV and LV leads were placed apically. Interestingly, a combination of RV outflow tract and LV base produced only slightly worse results. In this context, it is possible that the failing heart responds differently to the structurally intact one, however, this hypothesis needs to be confirmed.

The rationale for using the midseptal region for RV lead placement during BiV pacing is based on observations of previous studies that explored alternative pacing sites (the RV outflow tract or His-bundle area) for single-site RV pacing [14-17]. Besides faster ventricular activation, single-site RV outflow tract and/or septal pacing have been associated with acute haemodynamic improvement [14,15] as well as with reduced myocardial perfusion defects and wall motion abnormalities during long-term [16] as compared with single-site RVA pacing. Moreover, septal pacing results in a lesser degree of histopatological changes in the myocardium long-term, namely of the myofibrillar arrangement [17]. On the other hand, superiority of alternative pacing sites during single-site RV pacing has not been demonstrated in all studies [18,19]. Such contradicting results could be explained by 1) different positions of the RV lead at the interventricular septum, and 2) by variable duration of follow-up. The fact that there is no standardization in RV outflow tract position has been discussed by Buckingham et al. [18]. The time factor has been emphasized by Tse et al. [16] who demonstrated that pacing-induced regional wall motion abnormalities are more advanced during RVA pacing as compared with stimulation of the interventricular septum within the RV outflow tract after only 18 months. No such a difference was observed at 6 months of pacing.

In a relatively large cohort of patients, we have demonstrated that more pronounced electrical resynchronisation (as reflected in QRS duration) was present in the RVS group during both RV and BiV pacing. Some studies [20,21] have described a correlation between the shortening of the QRS duration and a more pronounced increase in VO2max and clinical improvement. In accordance with other studies, however, we did not show a correlation between clinical improvement and the degree of QRS narrowing during BiV pacing. In fact, only a few studies have described such a relationship [20,21]. Others [12,13] have suggested that the more advanced QRS narrowing does not necessarily guarantee more pronounced ventricular resynchronisation. It appears that QRS duration reflects duration of electrical activation or temporal synchrony of activation rather than the spatial synchrony of LV contraction which is more important with regard to CRT [22].

Based on our results, we suggest that the non-physiologic pattern of ventricular activation and wall motion abnormalities associated with single-site RVA pacing may counterbalance the benefit of cardiac resynchronisation therapy. This could be a possible reason for the lack of significant LV reverse remodelling in the RVA group in our study, which focused primarily on evaluation of RV lead positioning during cardiac resynchronisation. The consistency of our findings long-term suggests that the difference between the study groups is not due to the limited number of patients in the RVA group. To our surprise, the position of the RV lead is not specified exactly in the major clinical trials evaluating the impact of cardiac resynchronisation therapy. Therefore, the degree of reverse remodelling in these studies may be influenced (at least partially) by individually different RV pacing sites.


   5. Study limitations
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Study limitations
6. Conclusions
 References
 
The observational and non-randomised design is a limitation of this study. However, the results suggest that there is urgent need for a randomised comparison of both RV lead positions during cardiac resynchronisation therapy, together with detailed evaluation of wall motion abnormalities and spatial synchrony before and after implantation of the BiV pacing system. The use of LVEDD and LVEF as the only markers of reverse remodelling may be seen as another limitation of the study. However, LVEDD assessment is a standardized measurement that provides reproducible data as compared with volumetry, especially in patients with heart failure who present with paradoxical movement of the interventricular septum. The difference between accuracy of LVEDD and volumetry could also explain the observation that a trend towards the increase in LVEF in our RVA group was not associated with a significant decrease in LVEDD.

Although the smaller size of the RVA group as compared to the RVS group represents a limitation, we assume that the comparison of both groups in terms of long-term outcome is possible. The reason for it is that the groups only differed in RV pacing site, age and number of included patients only. All the other important factors (distribution of the LV pacing site, basic characteristics and proportion of CAD patients) were not significantly different between the groups.


   6. Conclusions
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Study limitations
 6. Conclusions
References
 
Midseptal positioning of the RV lead during cardiac resynchronisation therapy results in a significant reduction in LVEDD over 12 months of follow-up. This suggests that additional clinical benefit of cardiac resynchronisation therapy can be achieved through proper placement of the RV lead.


   Notes
Top
 Notes
Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Study limitations
 6. Conclusions
 References
 
{star} This study was supported by the Research Grant 8541-3/2005 of the Internal Grant Agency of the Ministry of Health of the Czech Republic. Back

1 Riedlbauchová, RV lead positioning during CRT. Back


   References
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Study limitations
 6. Conclusions
 References
 

  1. Linde C., Leclercq C., Rex S., et al. Long-term benefits of biventricular pacing in congestive heart failure: results from the Multisite Stimulation In Cardiomyopathies (MUSTIC) Study. J Am Coll Cardiol (2002) 40:111–118.[Abstract/Free Full Text]
  2. Auricchio A., Stellbrink C., Sack S., et alforthe PATH-CHF study group. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am Coll Cardiol (2002) 39:2026–2033.[Abstract/Free Full Text]
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  7. Blanc J.J., Bertault-Valls V., Fatemi M., et al. Midterm benefits of left univentricular pacing in patients with congestive heart failure. Circulation (2004) 109(14):1741–1744.[Abstract/Free Full Text]
  8. Auricchio A., Stellbrink C., Butter C., et al. Clinical efficacy of cardiac resynchronization therapy using left ventricular pacing in heart failure patients stratified by severity of ventricular conduction delay. J Am Coll Cardiol (2003) 42(12):2109–2116.[Abstract/Free Full Text]
  9. Leclercq C., Cazeau S., Le Breton H., et al. Acute hemodynamic effects of biventricular DDD pacing in patients with end-stage heart failure. J Am Coll Cardiol (1998) 32:1825–1831.[Abstract/Free Full Text]
  10. Nadurata V., Hamer A., Kertes P., et al. Optimizing the site of the right ventricular lead in cardiac resynchronization devices. Heart Lung Circ (2004) 13S2:S5. [abstract No.12].
  11. Frias P.A., Corvera J.S., Schmarkey L., et al. Evaluation of myocardial performance with conventional single-site ventricular pacing and biventricular pacing in a canine model of atrioventricular block. J Cardiovasc Electrophysiol (2003) 14:996–1000.[CrossRef][Medline]
  12. Nelson G.S., Curry C.W., Wyman B.T., et al. Predictors of systolic augmentation from left ventricular preexcitation in patients with dilated cardiomyopathy and intraventricular conduction delay. Circulation (2000) 101:2703–2709.[Abstract/Free Full Text]
  13. Ansalone G., Giannantoni P., Ricci R., et al. Doppler myocardial imaging in patients with heart failure receiving biventricular pacing treatment. Am Heart J (2001) 142(5):881–896.[CrossRef][Web of Science][Medline]
  14. Schwaab B., Frohlich G., Alexander C., et al. Influence of right ventricular stimulation site on left ventricular function in atrial synchronous ventricular pacing. J Am Coll Cardiol (1999) 33:317–323.[Abstract/Free Full Text]
  15. Giudici M.C., Thornburg G.A., Buck A., et al. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol (1997) 79:209–212.[CrossRef][Web of Science][Medline]
  16. Tse H., Yu C., Wong K.K., et al. Functional abnormalities in patients with permanent right ventricular pacing. J Am Coll Cardiol (2002) 40:1451–1458.[Abstract/Free Full Text]
  17. Karpawich P.P., Justice C.D., Chang C.H., et al. Septal ventricular pacing in the immature canine heart: a new prospective study. Am Heart J (1991) 121:827.[CrossRef][Web of Science][Medline]
  18. Buckingham T.A., Candinas R., Attenhofer C., et al. Systolic and diastolic function with alternate and combined site pacing in the right ventricle. PACE (1998) 21:1077–1084.[Medline]
  19. Victor F., Leclercq C., Mabo P., et al. Optimal right ventricular pacing site in chronically implanted patients. J Am Coll Cardiol (1999) 33:311–316.[Abstract/Free Full Text]
  20. Vogt J., Krahnefeld O., Lamp B., et al. Electrocardiographic remodeling in patients paced for heart failure. Am J Cardiol (2000) 86(9 Suppl 1):K152–K156.[CrossRef][Web of Science][Medline]
  21. Alonso C., Leclercq C., Victor F., et al. Electrocardiographic predictive factors of long-term clinical improvement with multisite biventricular pacing in advanced heart failure. Am J Cardiol (1999) 84(12):1417–1421.[CrossRef][Web of Science][Medline]
  22. Wyman B.T., Hunter W., Prinzen F.W., et al. Effects of single- and biventricular pacing on temporal and spatial dynamics of ventricular contraction. Am J Physiol Heart Circ Physiol (2002) 282:H372–H379.[Abstract/Free Full Text]

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