Europace Advance Access originally published online on December 12, 2007
Europace 2008 10(1):48-52; doi:10.1093/europace/eum259
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CARDIAC RESYNCHRONISATION THERAPY
Upgrading to biventricular pacing/defibrillation systems in right ventricular paced congestive heart failure patients: prospective assessment of procedural parameters and response rate
Section Clinical Electrophysiology, Division of Cardiology, Department of Medicine, J.W. Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt a. M., Germany
Manuscript submitted 26 July 2007. Accepted after revision 5 November 2007.
*Corresponding author. Tel.: +49 69 6301 7404; fax: +49 6173 950290. E-mail address: hohnloser{at}em.uni-frankfurt.de
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Abstract |
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Aims: Cardiac resynchronization therapy (CRT) is indicated in patients with heart failure and bundle branch block. It is less clear whether this includes patients with pre-existing right ventricular pacemaker/defibrillator systems, particularly with respect to implantation success and clinical benefit.
Methods and results: In consecutive patients scheduled for CRT, we prospectively compared implantation success, procedural parameters, and clinical response in ‘de novo’ vs. upgrade procedures of previously implanted right ventricular systems. CRT implantation was attempted in 79 consecutive patients (64 ± 11 years, 63 male, 38 ischaemic, 41 non-ischaemic cardiomyopathy). De novo implantation was performed in 61 patients, upgrade procedures in 18 patients. Implant success (92 vs. 94%, P = 1.00), procedure duration (153 ± 43 vs. 164 ± 65 min, P = 0.51), fluoroscopy time (25 ± 18 vs. 32 ± 22 min, P = 0.18) or dose (40 ± 31 vs. 52 ± 49 Gy/cm2, P = 0.35), and response rate (66 vs. 59%, P = 0.5) were comparable for both groups.
Conclusion: Procedural aspects, implantation success, and clinical response to CRT were comparable for patients undergoing de-novo vs. upgrade procedures. Accordingly, patient selection for upgrading should be the same as for new CRT implantation.
Key Words: Cardiac resynchronization therapy, Biventricular pacing, Implantation, Complications, Response, Implantable cardioverter defibrillator
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Introduction |
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Cardiac resynchronization therapy (CRT) has been shown to improve quality of life, exercise capacity, and outcome in patients with heart failure of NYHA functional class III–IV, a left ventricular ejection fraction (LVEF)
0.35, and a QRS duration
120 ms. The indication for CRT therapy has been constantly widened following publication of randomized prospective clinical trials.1
–4 However, among other important unanswered questions regarding CRT, it has not been prospectively assessed whether patients with previously implanted right ventricular pacemakers or cardioverter defibrillator (ICD) systems derive similar benefit from resynchronization therapy compared with patients undergoing de novo CRT implantation. Important clinical issues related to upgrading pre-existing non-CRT devices to CRT concern the complexity and possible technical difficulties during implantation (e.g. venous obstruction, passage of ingrown old leads, coronary sinus canulation from the right subclavian vein), and clinical response to CRT in this particular patient group. Accordingly, the purpose of this prospective observational study was to examine the feasibility and outcome of upgrading preexisting pacemaker/ICD systems to CRT devices when compared with de-novo CRT implantation.
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Methods |
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Patients
Implantation and follow-up data were collected from consecutive patients who underwent CRT implantation (new or upgrade) between March 2005 and January 2007 at the J.W. Goethe University, Frankfurt, Germany. Patients were considered for CRT if they had heart failure of NYHA functional class III or IV or a history of heart failure decompensation within the last 3 months and were in NYHA class II at the time of presentation. Furthermore, an LVEF
35% and a QRS width >120 ms were required. In patients with a previously implanted pacemaker or ICD and continuous ventricular pacing, paced QRS width had to be 200 ms.1 All implanted devices were ICDs according to present indications for primary or secondary prophylaxis of sudden cardiac death.5
Device implantation
CRT de-novo implantations and upgrades were performed according to current standard procedures. Coronary sinus guiding sheaths and left ventricular pacing leads of different manufacturers were used. Left ventricular leads were implanted transvenously after obtaining an occlusive coronary sinus venogram at the time of implantation. The best available coronary sinus side-branch was selected for implantation, preferably the posterolateral vein or a side-branch in close proximity to the posterolateral area. Pacing threshold and phrenic nerve stimulation were tested. If applicable, right ventricular and atrial leads were implanted conventionally preferably using the cephalic vein. All lead measurements (old and new implanted leads) were repeated before final lead fixation and connection to the device. Since all devices were ICDs, shock testing (twice successful termination of induced ventricular fibrillation with an energy more than 10 J below maximum device energy) was performed in all patients.
Follow-up
Patients were followed in the ICD outpatient clinic at 1 and 6 months after ICD implantation and whenever clinical circumstances called for unscheduled visits. At each visit, functional heart failure status (NYHA class), serum NT-pro-BNP level, and at the 6 months visit the LVEF were determined. Concomitant medication was adjusted according to the clinical status of the patient.
Definition of response to cardiac resynchronization therapy
Patients were considered responders to CRT if they survived to the 6 months follow-up and showed significant improvement in two out of three of the following criteria: Improved clinical status, i.e. improvement of at least 1 NYHA functional class; echocardiographic improvement measured by an absolute increase in LVEF of at least 5%; or neurohormonal evidence of improvement of heart failure, expressed as a decrease in the NT-pro-BNP level of at least 30%.6,7
Statistical analysis
Patients were divided into two groups: patients with de novo CRT implantation (Group 1) and patients with a pre-existing right ventricular device undergoing upgrade to CRT (Group 2). Outcome parameters were (1) procedural characteristics (implantation time, fluoroscopy time, fluoroscopy dose), (2) implantation success rate (defined as successful implantation of all leads with capture at output levels <2.5 V and lack of phrenic nerve stimulation at 5 V), (3) implantation complications, (4) 6 months response to CRT. Baseline variables, implantation success rate, procedure and fluoroscopy time, X-ray dose, and response rates were compared using the 
2 test, Fischer's exact test, or the Student t-test whichever applied. A two-sided value of P0.05 was considered significant.
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Results |
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Patient characteristics
This report is based on data obtained from 79 consecutive CRT recipients. Of this patient cohort, 18 patients (23%) had a previously implanted right ventricular device (three pacemaker; 15 ICD) and underwent an upgrade to CRT-ICD system. In eight of 18 patients (44%) right ventricular pacing was present for more than 50% of the time including four patients with permanent complete AV block. Five of 18 patients (28%) had permanent atrial fibrillation. Baseline characteristics of the two groups are shown in Table 1. Medical therapy was optimized in all patients.
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Procedural data
Implantation was successful in 56 of 61 de novo implantations (92%) and 17 of 18 upgrade procedures (94%, P = 1.0). Preexistent devices were single chamber ICD in 13 patients, dual chamber ICD in two patients, and dual chamber pacemaker in three patients. The previous device was implanted submuscularly in 12 and subcutaneously in six patients. In addition to the left ventricular lead, a right atrial lead had to be implanted in 12, a right ventricular ICD lead in three, and an additional vena cava superior shock-coil in one patient. Causes of unsuccessful implantations were: Coronary sinus not accessible (two patients); electrode instability in the single accessible vein (one patient); high pacing threshold in
2 different veins (one patient); high pacing threshold+electrode instability+phrenic stimulation in two different veins (two patients). In two patients, the CRT upgrade procedure was complicated by an occlusion of the left subclavian vein. In both cases, successful venous recanalization could be accomplished. In one additional upgrade patient there was a large subclavian vein aneurysm which could be passed using a long sheath. Procedural data comparing the de novo and upgrade implantations are shown in Tables 2 and 3. There were no significant differences between the two groups in any of the relevant parameters.
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Response to cardiac resynchronization therapy
During the 6 months after device implantation, six patients died (four after de-novo implantations, two following upgrade procedures). The cause of death was intractable ventricular arrhythmias in one patient, progressive heart failure in three, and septicaemia in two patients. According to the predefined criteria, 37/56 de-novo implanted patients (66%) and 10/17 upgraded patients (59%) were considered responders to CRT (P = 0.80). As part of the combined definition, the NYHA functional class, the LVEF, and the NT-proBNP level showed significant improvement in the responders compared with the non-responder patients, as follows. NYHA functional class changed from 2.8 ± 0.7 to 1.7 ± 0.7 (P<0.0001) in responders while it remained unchanged in non-responders (2.8 ± 0.6 to 2.7 ± 0.5, P = n.s.). LVEF remained in the same range for non-responders (24 ± 8 to 28 ± 10%; P = n.s.) and increased in responders (23 ± 8 to 33 ± 10%; P<0.001). The NT-proBNP level decreased in responders (3598 ± 5241 to 1721 ± 2753 pg/mL; P<0.001) and increased in non-responders (2120 ± 1282 to 3641 ± 2211 pg/mL; P = 0.002). Two of the six patients (33%) with unsuccessful CRT implantation died within the first 6 months compared with four of 73 patients (6%) with successful device implantation (P = 0.063).
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Discussion |
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This prospectively designed observational study demonstrates that upgrading existing right ventricular pacing systems to CRT can be safely carried out with similar implantation success, procedural times, and complication rates as de novo CRT implantation. During the 6 months follow-up six of the 79 patients died (7.6%). At 6 months, the response rate to CRT was similar in both patients groups.
Feasibility and safety of cardiac resynchronization therapy upgrade procedures
There are only sparse data comparing success rates, implantation/fluoroscopy time, and complications in de novo CRT implantations to CRT upgrade procedures. In recent, controlled clinical studies, CRT de novo implantation was generally successful in 
90–95% of patients.3,4,8,9 In contrast, a study in 56 patients with CRT upgrade procedures reported implantation success in only 82% of attempts.10 Almost all other studies on CRT upgrade procedures were retrospective in nature and included only patients with successful implantation or did not report success or failure rates.11–16 Of note, there is no prospective observational comparison regarding success in upgrade vs. de novo implantations. Our study demonstrates that CRT upgrade can be achieved with similar success as de novo implantations. Problems such as a more difficult access to the coronary sinus from the right side, passage of preexistent chronically implanted leads which may have grown into the venous wall or may obstruct the subclavian or caval veins, or may be attached to the tricuspid valve prohibiting canulation of the coronary sinus ostium, should be anticipated in upgrade procedures.17 It may therefore be prudent to perform an angiography of the subclavian vein before planning an upgrade procedure to CRT, especially in patients having already multiple transvenous leads, to exlude a complete obstruction of the subclavian or brachiocephalic veins.17 Our study also indicates that implantation and fluoroscopy times are similar in upgrade compared with new implantations. Finally, there were no significant differences in CRT-related complications in both patient groups. Of note, serious complications such as cardiac tamponade (reported in 0.5–1% in COMPANION4 and the Italian InSync Registry18), infection and explantation (1.3% in MIRACLE,2 1% in CARE-HF3), or peri-procedural mortality (0.8% in COMPANION4) were not observed in our patients. A dissection between the wall of the vena cava superior and ingrown old ICD leads occurred in a patient undergoing CRT upgrade but remained without clinical sequelae, and did not prevent continuation of the procedure and successful CRT implantation.
Previous studies on upgrading pacemaker/implantable cardioverter-defibrillator systems to cardiac resynchronization therapy
There are only a few studies which have examined procedural aspects and clinical outcome in patients with preexisting right ventricular pacemaker or ICD undergoing upgrade to CRT.11,13,16,19 In one of these previous studies, a highly selected small group of 20 patients after AV nodal ablation and chronic heart failure was studied.11 Results from these observations cannot be generalized to heart failure patients with intact AV node conduction and/or undergoing ICD implantation.
From the remaining three studies, one was retrospective in nature13 and comprised 32 patients with upgrade procedures and 39 with de novo CRT implantations. Only one follow-up visit at 3 months was evaluated, at which time similar improvements in LV function and symptoms were found for both patient groups.13 From the other two studies, one did not include a control group, and was therefore purely descriptive in nature.18 Marai et al. compared 25 patients with upgrade procedure with 73 patients with de novo CRT implantations.16 They reported similar changes in echocardiographic parameters, NYHA functional status, and 6 min walking test. However, in this study no established response criteria to CRT had been prospectively applied; thus, individual response rates are lacking for both patient groups.
Accordingly, our prospective observational study not only confirms these previous observations but extends those findings. In essence, our patients undergoing upgrade procedures responded in 59% of cases compared with 66% in our de novo CRT patients, the difference being not significant. All patients received optimized pharmacological heart failure treatment according to contemporary guidelines.
During the 6 months follow-up, six of the 79 patients died (7.6%). According to the mortality figures for the CRT patients reported in the Care-HF3 and Companion4 studies one would predict a 1 year all-cause mortality rate in our patient cohort of 10–12%. Accordingly, the observed mortality rate in our study is within expected ranges.
Implications
Results from the present study suggest that CRT upgrade procedures may be more complex in some patients than CRT de novo implantations but are not associated with a higher incidence of complications. Importantly, clinical response to CRT in patients undergoing upgrade procedures is as good as in patients with de novo CRT implantations. Accordingly, patient selection for upgrading should be the same as for conventional new CRT implantation.
Conflict of interest: Dr S.H.H. is a consultant to and investigator of St. Jude medical and Sanofi Aventis.
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There was no external financial support for this study.
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