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European Heart Journal Advance Access originally published online on January 25, 2007
European Heart Journal 2007 28(4):450-456; doi:10.1093/eurheartj/ehl469
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Cardiac resynchronization therapy: predictive factors of unsuccessful left ventricular lead implant

Alfonso Macías1, Ignacio García-Bolao2, Ernesto Díaz-Infante1, Jose María Tolosana1, Bárbara Vidal1, Juan José Gavira2, Antonio Berruezo1, Josep Brugada1 and Lluis Mont1,*

1 Thorax Institute, Hospital Clinic Universitari de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), Barcelona, Spain
2 Department of Cardiology and Cardiovascular Surgery, Clinica Universitaria, Universidad de Navarra, Pamplona, Spain

Received 7 February 2006; revised 18 December 2006; accepted 21 December 2006; online publish-ahead-of-print 25 January 2007.

* Corresponding author. Tel: +34 932275551; Fax: +34 934513045. E-mail address: lmont{at}clinic.ub.es


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
 Acknowledgements
 References
 
Aims Cardiac resynchronization therapy is an established therapy for advanced heart failure. However, coronary sinus access and pacing is not achieved in about 5–10% of patients. The aim of this study was to identify predictive factors for failure of left ventricular (LV) lead transvenous implant.

Methods and results We evaluated 212 consecutive patients who received a cardiac resynchronization system. In 26 patients (12.3%), the attempt to pace the LV was unsuccessful. At univariate analysis, in patients with an unsuccessful implant a higher proportion of permanent atrial fibrillation (AF), valvular heart disease, and previous heart surgery were observed. Anteroposterior, longitudinal, and transversal left atrium diameters (LAD) were also larger among patients with an unsuccessful implant. The anteroposterior LAD (APLAD) with an optimal value to predict implant failure was 48.5 mm. At logistic regression analysis, the presence of permanent AF and APLAD were independent predictors of failed implant (OR 7.7, 95% CI 2.5–23.9, P = 0.002 and OR 11.7, 95% CI 3.1–37.6, P < 0.001, respectively).

Conclusion The presence of permanent AF and APLAD are factors that predict unsuccessful pacing from the LV.

Key Words: Heart failure • Resynchronization therapy • Coronary sinus • Unsuccessful implant


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Study limitations
 Conclusions
 Acknowledgements
 References
 
Cardiac resynchronization therapy (CRT) is a new therapy for patients with advanced heart failure and ventricular conduction delay. Several studies have shown a chronic functional improvement due to reverse remodelling of the left ventricle (LV), with a subsequent reduction of hospitalizations and a decrease in mortality.1–7

The implantation of a CRT device requires LV stimulation, achieved usually by a transvenous approach through the venous branches of the coronary sinus (CS). Alternatively, a direct epicardial placement through a lateral thoracotomy can be used. Although the implant technique and the tools are improving, there are still some implant failures. Failure of implantation of a transvenous LV lead occurs in about 5–10% of cases.8,9

The aim of this retrospective study was to identify predictive factors for the failure of LV lead transvenous implant.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Study limitations
 Conclusions
 Acknowledgements
 References
 
Study population
The investigators included all the consecutive CRT implants from their earlier experience (January 2000) until May 2005. All patients had New York Heart Association (NYHA) functional class II, III, or IV heart failure despite optimized pharmacological treatment, LV ejection fraction (EF) <35%, and QRS duration >120 ms or >200 ms in patients previously paced in the right ventricle. The study population was divided into two groups based on the outcome of the procedure (success vs. unsuccessful implant). None of these patients have been included in previous studies. The study protocol has been approved by the University's Ethics Committee, and written informed consent was obtained from all patients. We only included in the analysis the first attempt to implant a biventricular device.

Before the implant procedure, patients underwent the following evaluations: clinical history, NYHA functional class assessment, 12-lead ECG, performance on the 6-min walk test, and echocardiography study.

Patients received either a pacemaker or an implantable cardioverter defibrillator (ICD) device according to the current clinical indications.

Device implantation
Implantation was performed in two electrophysiology laboratories. The implant was performed following the usual steps, namely placement of standard right chamber leads, cannulation of the CS with a guiding sheath, CS angiography, placement of a pacing lead in the coronary vein branch, removal of the guiding sheath, and attachment of the leads to the generator. In cases where the guide catheter alone failed to enter the CS, intracardiac electrograms and deflectable tip electrophysiological catheters were used to provide access into the CS. Conventional stylet-guided pacing leads or over the wire approaches were used depending on the CS branches anatomy and the operator's choice.

The leads were placed through the subclavian or cephalic vein and the left subclavian approach was preferred. The LV lead was implanted in the lateral region, and an anterior branch was chosen only as a last resort if lateral implantation was not possible. Anterior zone was defined as the zone lying between 10 and 1 o'clock and lateral zone as the zone lying between 2 and 5 o'clock in the 45° left anterior oblique projection.

Total implant procedure duration, CS cannulation time, LV lead implantation time, fluoroscopy time, and pacemaker and lead related data (threshold, impedance, and R wave amplitude) were recorded, as well as the complications during the procedure and the post-operative period.

All patients received a biventricular DDD-R device when sinus rhythm was present and a VVI-R device when permanent atrial fibrillation (AF) was present.

Echocardiographic evaluation
Before implant, a transthoracic, two-dimensional echocardiogram was performed in all patients using a Sonos 5500 ultrasound system (Philips). The examination included M-mode, two-dimensional, and Doppler data. The following parameters were measured using the different axis: LV end-diastolic diameter (LVEDD), LV end-systolic diameter, LVEF, amount of mitral regurgitation, and several left (anteroposterior, longitudinal, and transversal) and right (transversal and longitudinal) atrial diameters.

Statistical analysis
Unless otherwise specified, data are presented as the mean value ± SD. Comparison of quantitative variables was performed using the Student's t-test for paired and unpaired data when appropriate. Dichotomous or categorical variables were assessed with the {chi}2 test.

The receiver-operating characteristic (ROC) curve was used to determine a cut-off point for categorical risk stratification of unsuccessful implant. The variables that were significant in the univariate analysis were used in logistic regression analysis to determine independent predictors of failed implant. The accuracy of the model was verified with the Hosmer–Lemeshow goodness-of-fit test. ‘Learning curve’ was defined as the first 100 implants and was assessed in the model as a continuous variable (procedure date).

A P-value < 0.05 was considered statistically significant. All test that we performed were two-sided and no correction of type I error was done for multiple test. All statistical tests were performed with the SPSS 12.0.1 statistical package (SPSS Inc., Chicago, IL, USA).


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Study limitations
 Conclusions
 Acknowledgements
 References
 
Patient population
The baseline characteristics of the 212 consecutive patients receiving a CRT system are depicted in Table 1. There was a male predominance and a similar proportion of patients with ischaemic and dilated cardiomyopathy. Previous open heart surgery was present in 8% and permanent AF in 18%. Most patients were in NYHA functional class III or IV (76.8%). All patients in NYHA functional class II walked <450 m in the 6-min walking test and had an indication for ICD implantation. LVEF was severely depressed and LV was severely dilated. Left bundle branch block (LBBB) was present in the majority of patients with a severely prolonged QRS interval (mean 172.7 ± 19.9 ms). Exercise performance and quality-of-life (QoL) score (measured by the Minnesota Living with Heart Failure questionnaire) were also severely diminished. Learning curve was defined as the first 100 implants.


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  		Table 1 Baseline clinical characteristics

 
Implantation and technical aspects
Transvenous LV lead implantation was unsuccessful in 26 (12.3%) patients due to several causes. Overall, 56.7% of patients received a CRT-ICD and 43.3% received a CRT-pacemaker. Median total time procedure (‘skin-to-skin’) was 120.0 (102.5–150.0) min (Table 2), and median fluoroscopy time was 28.0 (17.25–41.75) min. Mean total time procedure was 124 ± 30 min in patients with a successful implant and 131 ± 43 min in patients with an unsuccessful implant (P = 0.409). The final LV lead position include 108 patients (58.0%) in the lateral vein, 47 (25.2%) in the posterior–lateral vein, 13 (6.9%) in the anterior–lateral vein and 18 (9.9%) in the anterior vein. Mean pacing threshold was 1.57 V to 0.5 ms, with an impedance of 950 ± 379 ohm and an R wave amplitude of 12.2 ± 7.3 mV. In Table 3, we compared several parameters between the first 100 implants and the last 112. The majority of patients (n = 206) were implanted with an over the wire approach and in only six patients (one failed implant) conventional stylet-guided implant were chosen. Therefore, a direct statistical comparison was not assessed.


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  		Table 2 Technical characteristics

 

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  		Table 3 Comparison of technical parameters in the first implants vs. the last implants

 
Successful vs. unsuccessful implant
In 26 patients (12.3%), the attempt to pace from the LV was unsuccessful. At univariate analysis (Table 4), in patients with an unsuccessful implant a higher proportion of permanent AF (53.8 vs. 12.9%, P < 0.001), valvular heart disease (38.3 vs. 9.6%, P = 0.023), and previous open heart surgery (25.7 vs. 6.0%, P = 0.001) were observed. Anteroposterior, longitudinal, and transversal left atrium diameters (APLAD, LLAD, and TLAD, respectively) measured by echocardiography were also larger among patients with an unsuccessful implant.


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  		Table 4 Comparison of clinical and echocardiographic variables in successful vs. unsuccessful implants

 
Receiver-operating characteristics (ROC) curves showed the overall performance of APLAD, LLAD, and TLAD for predicting an unsuccessful implant (Figure 1). The area under the ROC curve was larger (P < 0.01) for APLAD (0.801) than for TLAD (0.526) and LLAD (0.489). Only the area under the ROC curve for APLAD was higher (P < 0.001) than 0.50. We observed that a cut-off value of APLAD of 48.5 mm provided 75.7% sensitivity and 70.0% specificity for predicting a failed implant (OR 15.4, 95% CI 3.2–84.7; P < 0.001).


Figure 1
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  		Figure 1 ROC curves for LADs for determining an unsuccessful implant of LV lead.

 
APLAD, LLAD, and TLAD were considered as continuous variables and included in the logistic regression analysis with a 5 mm step (Table 5). The presence of permanent AF and the enlargement of APLAD were the only independent predictors of failed implant (OR 7.7, 95% CI 2.5–23.9; P = 0.002 and OR 11.7, 95% CI 3.1–37.6; P < 0.001, respectively). The accuracy of the model was confirmed by the non-significant Hosmer–Lemeshow goodness-of-fit test (P = 0.576). These predictors did not differ when we analysed them in the first 100 implants or in the last 112 implants.


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  		Table 5 Results of multivariable logistic regression analysis

 
At logistic regression analysis, the learning curve variable was not an independent predictor of failed implant (OR 1.3, 95% CI 0.3–8.1; P = 0.488).

Implant failure and complications
Of the 212 patients, 186 (87.7%) were successfully implanted. Twenty six patients (12.3%) could not be implanted due to several reasons detailed in Table 6: failure to cannulate the CS (12 patients) (Figure 2), CS dissection (four patients), high threshold to chronic pacing (six patients), and impossibility to obtain a stable lead placement (four patients).


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  		Table 6 Aetiology of unsuccessful implant and complications

 

Figure 2
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  		Figure 2 CS angiography in two patients undergoing implantation of a biventricular pacemaker and a biventricular defibrillator. In both cases, once CS were located by different techniques, it remained impossible to advance the guiding catheter because of extreme angulations.

 
The implant procedure (successful and unsuccessful) produced 25 significant complications (11.8%). Nine (4.2%) were lead-related complication due to lead dislodgement, all of which were successfully re-implanted. CS dissection (Figure 3) was observed in six patients (2.8%), two were implanted in the same procedure and four were implanted later (two weeks). No acute perforation was reported. Another two patients (0.94%) had phrenic nerve stimulation, both requiring lead repositioning.


Figure 3
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  		Figure 3 (A) A CS angiography in a patient with a previous anterolateral myocardial infarction where great cardiac vein is absent (*) and there is an important stenosis in the lateral vein (white arrow). (B) A dissection of the proximal CS (*), as indicated by the persistent contrast staining.

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Study limitations
 Conclusions
 Acknowledgements
 References
 
The major finding of the current study is the identification of two clinical and echocardiographic parameters that are able to predict a lower probability of a successful CS lead implant: permanent AF and APLAD higher than 48.5 mm measured by echocardiography.

Stable LV pacing was achieved in 87.7% of cases and a targeted lateral or posterolateral vein was reached in 83.8%. In the first 100 procedures the success rate was 82%, compared as the 93% of the last 112, with a higher total procedure and fluoroscopy times in the first 100 implants, showing evidence of the learning curve and introduction of better implantation tools. This implantation success rate was similar to majority of studies. For instance, in the MUSTIC study,2 the success rate was 92% (80% in lateral vein), in the MIRACLE study,3 an implant success rate of 93% was reported, and in CONTAK-CD10 the success rate was very similar (91%). In a recent study of Lecoq et al.,11 including the learning curve, the implantation success rate was 88% and increased from the first case (61–98%).

Therefore, failure to pacing the LV through the CS is still a limitation of the technique that occurs between 5 and 10% of cases.12–14 The main difficulty is the impossibility to locate and cannulate the CS. In the present study, this fact occurred in 12 patients (5.5%). Major CS abnormalities were found in 2.9% of patients with supraventricular tachycardias and normal structural heart in previous studies.15,16 In another series of patients without heart failure, the success rate of CS cannulation was 94.4%.17 Meisel et al.18 evaluated the anatomy of CS in 129 patients undergoing cardioverter-defibrillator implantation by malignant ventricular tachycardias and in 4% of patients the cannulation of CS was not feasible. Moreover, the dimensions of the CS and its tributaries are affected by the heart dimensions and may differ between patients with cardiomyopathy according to severity, evolution, and aetiology. Also, enlargement of the right and left atrium may cause the distortion of the CS ostium anatomy, increasing the number of failed implants.19 In fact, in our study, the main determinant of a failed implant was the APLAD. On the other hand, LV diameter and right atrium diameters (RAD) were not associated with a failed implant. Not surprisingly, permanent AF was also associated with failed implant. It is well known that permanent AF occurs in dilated atria and induces further atrial enlargement. This might contribute to further distortion of CS anatomy.

At times, once the CS has been cannulated, it remains difficult to advance the guiding catheter because of acute angulations, stenosis, or intravenous valves (Thebesian and Vieussens valves),20 or previous CS cannulations for administrating retrograde cardioplegia solutions during cardiac surgery. In our study, the rate of unsuccessful implant was higher in patients with previous cardiac surgery, however, in the multivariate analysis model, this variable was not an independent predictor of failed implant.

In the present study, 11.8% of 212 patients had complications. This complication rate was similar to that reported in some reference resynchronization studies such as the MIRACLE3 (13%) or the COMPANION trial5 (9.9%). CS lead dislodgement is reported to be one of the most common complication of biventricular pacing.21,22 In the present study, this complication occurred in nine patients (4.2%). In other trials, the rate of CS lead dislodgement was in consonance with our data: 5.8% in CONTAK-CD trial,10 4.4% in InSync trial,23 and 12.5% in MUSTIC trial.2 With the present technology and growing experience, the guiding catheter is usually removed without dislocation of the CS lead.

Another significant complication in our study was the CS dissection (six patients, 2.8%). The incidence of reported CS dissection in several studies is ~1.5–5%.24,25 Generally, CS dissection is caused by the advancement of the guiding catheter into the vessel or by injection of the contrast media through an angiography catheter with its tip impacted against the CS wall. The rate of this complication can be decreased with softer tips of the guiding catheters and handling carefully the angiography catheter.

Two patients (1%) had phrenic nerve stimulation that could not be changed with device reprogramming, both requiring repositioning one day later of implant. According to previously reported data,22 phrenic nerve stimulation was more common in the lateral (posterolateral) region than in the anterior (anterolateral) region (11.4 vs. 4.2%, respectively), but only 3/120 (2.5%) patients needed a reintervention for this complication. With the possibility of programming several pacing configurations (i.e. bipolar or pseudobipolar), the need of repositioning the CS lead has decreased dramatically. Finally, one patient had an acute renal failure during the post-operative period, requiring transient haemodialysis to restore renal function. Its a rare but severe complication, and should be assessed when a high amount of contrast media is used during the procedure.


   Study limitations
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
Conclusions
 Acknowledgements
 References
 
The statistical analysis has considered ‘failure to pace from CS’ as the dependent variable. All causes of CS pacing failure were considered together. Since the majority of failures were due to inability to cannulate the CS, the predictive variables for CS pacing failure are probably predicting the impossibility to cannulate the CS, but not necessarily are predicting the failure to achieve a good threshold or the occurrence of dissection of the CS. A study with a larger population might allow a separate analysis for the diverse causes of CS pacing failure.

The reported data include the learning curve of the implanting centres and the old design of guiding catheters and leads. Therefore, a higher proportion of success in CS lead implant should be expected at the present time with state-of-the-art technology. However, this limitation does not invalidate the results of the study, since probably large atrium and permanent AF poses additional difficulties to the procedure.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
Acknowledgements
 References
 
The present study indicates that the presence of permanent AF and APLAD are factors that predict unsuccessful pacing from the CS. Stable chronic CS lead pacing was achieved in more than 85% of cases and was associated with a relatively low rate of complications.


   Acknowledgements
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
 Acknowledgements
References
 
A.M. was supported by a grant from the Fundació Clinic per la Recerca Biomedica.

Conflict of interest: none declared.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
 Acknowledgements
 References
 

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A. Macias, J.-J. Gavira, S. Castano, E. Alegria, and I. Garcia-Bolao
Left ventricular pacing site in cardiac resynchronization therapy: Clinical follow-up and predictors of failed lateral implant
Eur J Heart Fail, April 1, 2008; 10(4): 421 - 427.
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