Background: The implantable cardioverter defibrillators (ICDs) are increasingly being used as a treatment modality for life threatening tachyarrhythmia. The purpose of this study was to compare the frequency of complications and mortality between single-chamber and dual-chamber ICD implantation in Shahid Rajaie cardiovascular center.

Methods and results: Between January 2000 and December 2004, 234 patients received ICD by a percutaneous transvenous approach and were followed for 33 ± 23 months. The cumulative incidence of complications was 9.4% over the follow-up period. There was no significant difference in overall complication rate between single chamber (VR) and dual chamber (DR) ICD groups in the follow-up period (P= 0.11). The risk of complications did not have any statistically significant difference in secondary versus primary prevention groups (P=0.06). The complications were not associated with the severity of left ventricular systolic dysfunction (P=0.16).The frequency of lead-related complications was higher in dual chamber ICDs in comparison with single chamber ICDs (P=0.02). There was no significant difference in mortality between different sex groups (P=0.37), different indications for ICD implantation (P=0.43) or between VR and DR ICD groups (P= 0.55). Predictors of mortality were NYHA class III or more (P<0.001), age >65 years (P=0.011) and LVEF<30% (P<0.001). The mortality in patients with CAD and DCM were significantly higher than those with other structural heart diseases (P=0.001).

Conclusions: Close monitoring of patients during the first 2 month after ICD implantation is recommended because the majority of complications occur early after the procedure

Alizadeh, Abolfath

Bagherzadeh, Ataallah

Emkanjoo, Zahra

Farahani, Maryam Moshkani

Haghjoo, Majid

Sadr-Ameli, Mohammad Ali

English

PubMed

Background: The implantable cardioverter defibrillators (ICDs) are increasingly being used as a treatment modality for life threatening tachyarrhythmia. The purpose of this study was to compare the frequency of complications and mortality between single-chamber and dual-chamber ICD implantation in Shahid Rajaie cardiovascular center.  Methods and results: Between January 2000 and December 2004, 234 patients received ICD by a percutaneous transvenous approach and were followed for 33 ± 23 months. The cumulative incidence of complications was 9.4% over the follow-up period. There was no significant difference in overall complication rate between single chamber (VR) and dual chamber (DR) ICD groups in the follow-up period (P= 0.11). The risk of complications did not have any statistically significant difference in secondary versus primary prevention groups (P=0.06). The complications were not associated with the severity of left ventricular systolic dysfunction (P=0.16).The frequency of lead-related complications was higher in dual chamber ICDs in comparison with single chamber ICDs (P=0.02). There was no significant difference in mortality between different sex groups (P=0.37), different indications for ICD implantation (P=0.43) or between VR and DR ICD groups (P= 0.55). Predictors of mortality were NYHA class III or more (P65 years (P=0.011) and LVEF<30% (P<0.001). The mortality in patients with CAD and DCM were significantly higher than those with other structural heart diseases (P=0.001).  Conclusions: Close monitoring of patients during the first 2 month after ICD implantation is recommended because the majority of complications occur early after the procedure

Ataallah Bagherzadeh

Zahra Emkanjoo

Majid Haghjoo

Maryam Moshkani Farahani

Abolfath Alizadeh

Mohammad Ali Sadr-Ameli

Directory of Open Access Journals

Indian Pacing and Electrophysiology Journal

Complications and Mortality of Single Versus Dual Chamber Implantable Cardioverter Defibrillators

Cognitive Sciences ePrint Archive

 
www.ipej.org 75
Original Article
Complications  and  Mortality  of  Single  Versus  Dual 
Chamber Implantable Cardioverter Defibrillators
Ataallah Bagherzadeh, M.D., Zahra Emkanjoo, M.D., Majid Haghjoo, M.D., Maryam Moshkani 
Farahani,  M.D.,  Abolfath  Alizadeh,  M.D.  and  Mohammad  Ali  Sadr-Ameli,  M.D.  
Department of Pacemaker and Electrophysiology, Rajaie Cardiovascular Medical and Research 
Center, Iran University of Medical Sciences, Mellat Park, Vali-e-Asr Avenue, Tehran, Iran.
Address  for  correspondence: Ataallah  Bagherzadeh,  M.D.,  Department  of  Pacemaker  and 
Electrophysiology,  Rajaie  Cardiovascular  Medical  and  Research  Center,  Iran  University  of 
Medical Sciences, Mellat Park, Vali-e-Asr Avenue, Tehran 1996911151 Iran, P.O.Box: 15745-
1341.  E–mail: atabzd@gmail.com
Abstract  
Background: The implantable cardioverter defibrillators (ICDs) are increasingly being used as a 
treatment  modality  for  life  threatening  tachyarrhythmia.  The  purpose  of  this  study  was  to 
compare  the  frequency  of  complications  and  mortality  between  single-chamber  and  dual-
chamber ICD implantation in Shahid Rajaie cardiovascular center.
Methods and results: Between January 2000 and December 2004, 234 patients received ICD by 
a percutaneous transvenous approach and were followed for 33 ± 23 months. The cumulative 
incidence  of  complications  was  9.4%  over  the  follow-up  period.  There  was  no  significant 
difference in overall complication rate between single chamber (VR) and dual chamber (DR) 
ICD groups in  the  follow-up period  (P= 0.11).  The risk  of  complications  did  not  have  any 
statistically significant difference in secondary versus primary prevention groups (P=0.06). The 
complications  were  not  associated  with  the  severity  of  left  ventricular  systolic  dysfunction 
(P=0.16).The  frequency  of  lead-related  complications  was  higher  in  dual  chamber  ICDs  in 
comparison with single chamber ICDs (P=0.02). There was no significant difference in mortality 
between different sex groups (P=0.37), different indications for ICD implantation (P=0.43) or 
between VR and DR ICD groups (P= 0.55). Predictors of mortality were NYHA class III or more 
(P<0.001), age >65 years (P=0.011) and LVEF<30% (P<0.001). The mortality in patients with 
CAD  and  DCM  were  significantly  higher  than  those  with  other  structural  heart  diseases 
(P=0.001).
Conclusions: Close monitoring of patients during the first 2 month after ICD implantation is 
recommended  because  the  majority  of  complications  occur  early  after  the  procedure.
Key Words: implantable cardioverter-defibrillator; complication; mortality 
Introduction
            The  implantable  cardioverter  defibrillators  (ICDs)  are  increasingly  being  used  as  a 
treatment   modality   for   high   risk  s urvivors   of   life-threatening  tachyarrhythmia.1,2  Major 
Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)
Ataallah Bagherzadeh, Zahra Emkanjoo, Majid Haghjoo, Maryam Moshkani Farahani, 76 
Abolfath Alizadeh, and Mohammad Ali Sadr-Ameli, “Complications and Mortality of Single  
Versus Dual Chamber Implantable Cardioverter Defibrillators”  
technological advances like the introduction of transvenous defibrillation leads and "active can" 
concept  have  simplified  the  implantation  of  ICDs  and  have  reduced  implantation-related 
complications  but  still  there  are  considerable  rate  of  complications  in  most  of  the 
electrophysiologic centers.3,4
            The purpose of the current  study was to identify  and characterize prospectively the 
frequency of lead and implant-related complications and also mortality in patients with single-
chamber versus dual-chamber ICD implantation.
Methods
Patients:  
            Between January, 2000 and December, 2004, 234 patients received ICDs in our center. 
All of them included in the study and were followed for 33 ±23 months. The primary end point 
of  the  study  was  actuarial  survival.  The  secondary  end  point  was  nonfatal  complications, 
including inappropriate ICD therapy, lead-related and implant-related complications. The study 
was approved by local Ethics Committee and written informed consent was obtained from all the 
patients.
Implanted ICDs and programming:
            ICD system manufacturers  included Medtronic  and  St  Jude  systems in  160 and 75 
patients respectively. Atrial leads included 1688 T or 1642T for St Jude and 5076 for Medtronic 
systems. Ventricular leads included 1570,1572,1571,1580 and 1581 for St Jude and 6944, 6947 
and 6948 for Medtronic systems. All of the ventricular leads were bipolar. In implanted devices 
all the detection and discrimination criteria were activated with the nominal values. In all the 
devices we defined ventricular fibrillation zone (300ms) plus one VT zone (400 ms).  If  the 
patient had an episode of spontaneous or induced sustained monomorphic VT slower than 370 
ms we extended the VT zone to VT cycle length plus 40ms. In the VT detection zone the first 
therapy was three antitachycardia burst pacing. We used the nominal values of the ICDs for the 
duration and tachyarrhythmia detection criteria. Antibradycardia pacing was programmed in VVI 
mode with pacing rate of 40 beats per minute in all VR and DR ICDs, unless the patients needed 
dual  chamber  pacing,  those  with  long  QT  syndrome  and  hypertrophic  obstructive 
cardiomyopathy.
Implantation techniques:
            The  implantation  routes  were  either  subclavian  or  Axillary  veins  percutaneously  in 
electrophysiology laboratory by an electrophysiologist.
Follow-up protocol:
            The patients were followed after 1 month postoperatively and every 3 months thereafter 
and upon receiving high voltage therapy in our outpatient ICD clinic. ICD evaluations during 
follow-up visits included routine clinically appropriate measurements including interrogation of 
the device for tachyarrhythmia episodes, evaluation of sensing and pacing thresholds and lead 
impedance. Floppy diskettes were used to retrieve all episodes of ICD therapy. All the episodes 
resulted  in  ICD  therapy,  studied  independently  by  two  electrophysiologists  to  define  the 
diagnosis.  All  the  episodes  were  categorized  as  appropriate  or  inappropriate.  ICD-related 
Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)
Ataallah Bagherzadeh, Zahra Emkanjoo, Majid Haghjoo, Maryam Moshkani Farahani, 77 
Abolfath Alizadeh, and Mohammad Ali Sadr-Ameli, “Complications and Mortality of Single  
Versus Dual Chamber Implantable Cardioverter Defibrillators”  
complications were documented, as were mortality and cause of death. Chest radiography (CXR) 
was  obtained  before  hospital  discharge  and  every  6  months  to  confirm  radiographic  lead 
integrity.  Clinical  evaluation  of  patients  included  history  and  physical  examination  of  the 
implantation site. Complications were defined as unexpected adverse events that were felt to be 
related to the implant procedure or to the ICD lead and generator system.
Statistical analysis:
            Baseline  characteristics  and  complications  were  summarized  as  the  mean ±  SD for 
continuous variables and otherwise as percentage. SPSS 13 software (SPSS Inc., Chicago, IL, 
USA) was used for data storage and analysis. Qualitative characteristics were compared using the 
Pearson’s chi square and Fischer exact tests. Kaplan-Meyer survival curves were calculated. Log 
rank statistics  were used to  compare the distribution of  time to  complications  and mortality 
between different  ICD groups.  Two-tailed  P <  0.05  were  considered  significant.  Regression 
analysis  was  performed  to  evaluate  the  effect  of  variables  on  mortality  and  complications.
Results
Baseline characteristics:
            Baseline characteristics of the patients are summarized in Table 1. Table 2 compares the 
baseline characteristics of the patients in VR and DR ICD groups.
Table1: Baseline characteristics of patients
CAD= Coronary artery disease, DCM= Dilated cardiomyopathy,
HCM= Hypertrophic cardiomyopathy, NYHA= New York Heart Association
Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)
Ataallah Bagherzadeh, Zahra Emkanjoo, Majid Haghjoo, Maryam Moshkani Farahani, 78 
Abolfath Alizadeh, and Mohammad Ali Sadr-Ameli, “Complications and Mortality of Single  
Versus Dual Chamber Implantable Cardioverter Defibrillators”  
Table2: Comparison of baseline characteristics between single and dual chamber devices.
ICD-VR= Single chamber implantable cardioverter-defibrillator, ICD-DR=Dual 
chamber implantable  cardioverter-defibrillator,  LVEDd= Left  ventricular  end 
diastolic diameter, LVESd= Left ventricular end systolic diameter, LVEF= Left 
ventricular  ejection  fraction,  NYHA=  New  York  Heart  Association,  CAD= 
Coronary artery disease, DCM= Dilated cardiomyopathy, HCM= Hypertrophic 
cardiomyopathy.
Mortality:
            Three patients (1.2%) died during the first  month after ICD implantation because of 
multi-organ  failure,  massive  pulmonary  emboli  and  acute  coronary  syndrome.  The  1-year 
survival rate was 94.9% and 94.1% for VR and DR ICDs respectively. The overall survival rate 
during  follow-up  was  90.6%  and  88.9%  for  VR and  DR ICDs  respectively.  There  was  no 
significant difference in mortality between different sex groups (P=0.37), different indications 
for  ICD implantation  (P=0.43)  or  between  VR and  DR ICD groups  (P=  0.55)  (Figure 1). 
Univariate  regression  analysis  showed  predictors  of  mortality  as  NYHA  class  III  or  more 
Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)


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Clinical experience with the extrathoracic introducer insertion technique.

Clinical results with nonthoracotomy ICD systems.

Complications associated with pectoral implantation of Cardioverter Defibrillators.

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Background: The implantable cardioverter defibrillators (ICDs) are increasingly being used as a treatment modality for life threatening tachyarrhythmia. The purpose of this study was to compare the frequency of complications and mortality between single-chamber and dual-chamber ICD implantation in Shahid Rajaie cardiovascular center. Methods and results: Between January 2000 and December 2004, 234 patients received ICD by a percutaneous transvenous approach and were followed for 33 Â± 23 months. The cumulative incidence of complications was 9.4 over the follow-up period. There was no significant difference in overall complication rate between single chamber (VR) and dual chamber (DR) ICD groups in the follow-up period (P=0.11). The risk of complications did not have any statistically significant difference in secondary versus primary prevention groups (P=0.06). The complications were not associated with the severity of left ventricular systolic dysfunction (P=0.16). The frequency of lead-related complications was higher in dual chamber ICDs in comparison with single chamber ICDs (P=0.02). There was no significant difference in mortality between different sex groups (P=0.37), different indications for ICD implantation (P=0.43) or between VR and DR ICD groups (P=0.55). Predictors of mortality were NYHA class III or more (P65 years (P=0.011) and LVEF<30 (P<0.001). The mortality in patients with CAD and DCM were significantly higher than those with other structural heart diseases (P=0.001). Conclusions: Close monitoring of patients during the first 2 month after ICD implantation is recommended because the majority of complications occur early after the procedure

Bagherzadeh, A.

Emkanjoo, Z.

Haghjoo, M.

Farahani, M.M.

Alizadeh, A.

Sadr-Ameli, M.A.

eprints Iran University of Medical Sciences

 www.ipej.org 75Original ArticleComplications  and  Mortality  of  Single  Versus  Dual Chamber Implantable Cardioverter DefibrillatorsAtaallah Bagherzadeh, M.D., Zahra Emkanjoo, M.D., Majid Haghjoo, M.D., Maryam Moshkani Farahani,  M.D.,  Abolfath  Alizadeh,  M.D.  and  Mohammad  Ali  Sadr-Ameli,  M.D.  Department of Pacemaker and Electrophysiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Mellat Park, Vali-e-Asr Avenue, Tehran, Iran.Address  for  correspondence: Ataallah  Bagherzadeh,  M.D.,  Department  of  Pacemaker  and Electrophysiology,  Rajaie  Cardiovascular  Medical  and  Research  Center,  Iran  University  of Medical Sciences, Mellat Park, Vali-e-Asr Avenue, Tehran 1996911151 Iran, P.O.Box: 15745-1341.  E–mail: atabzd@gmail.comAbstract  Background: The implantable cardioverter defibrillators (ICDs) are increasingly being used as a treatment  modality  for  life  threatening  tachyarrhythmia.  The  purpose  of  this  study  was  to compare  the  frequency  of  complications  and  mortality  between  single-chamber  and  dual-chamber ICD implantation in Shahid Rajaie cardiovascular center.Methods and results: Between January 2000 and December 2004, 234 patients received ICD by a percutaneous transvenous approach and were followed for 33 ± 23 months. The cumulative incidence  of  complications  was  9.4%  over  the  follow-up  period.  There  was  no  significant difference in overall complication rate between single chamber (VR) and dual chamber (DR) ICD groups in  the  follow-up period  (P= 0.11).  The risk  of  complications  did  not  have  any statistically significant difference in secondary versus primary prevention groups (P=0.06). The complications  were  not  associated  with  the  severity  of  left  ventricular  systolic  dysfunction (P=0.16).The  frequency  of  lead-related  complications  was  higher  in  dual  chamber  ICDs  in comparison with single chamber ICDs (P=0.02). There was no significant difference in mortality between different sex groups (P=0.37), different indications for ICD implantation (P=0.43) or between VR and DR ICD groups (P= 0.55). Predictors of mortality were NYHA class III or more (P<0.001), age >65 years (P=0.011) and LVEF<30% (P<0.001). The mortality in patients with CAD  and  DCM  were  significantly  higher  than  those  with  other  structural  heart  diseases (P=0.001).Conclusions: Close monitoring of patients during the first 2 month after ICD implantation is recommended  because  the  majority  of  complications  occur  early  after  the  procedure.Key Words: implantable cardioverter-defibrillator; complication; mortality Introduction            The  implantable  cardioverter  defibrillators  (ICDs)  are  increasingly  being  used  as  a treatment   modality   for   high   risk  s urvivors   of   life-threatening  tachyarrhythmia.1,2  Major Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)Ataallah Bagherzadeh, Zahra Emkanjoo, Majid Haghjoo, Maryam Moshkani Farahani, 76 Abolfath Alizadeh, and Mohammad Ali Sadr-Ameli, “Complications and Mortality of Single  Versus Dual Chamber Implantable Cardioverter Defibrillators”  technological advances like the introduction of transvenous defibrillation leads and "active can" concept  have  simplified  the  implantation  of  ICDs  and  have  reduced  implantation-related complications  but  still  there  are  considerable  rate  of  complications  in  most  of  the electrophysiologic centers.3,4            The purpose of the current  study was to identify  and characterize prospectively the frequency of lead and implant-related complications and also mortality in patients with single-chamber versus dual-chamber ICD implantation.MethodsPatients:              Between January, 2000 and December, 2004, 234 patients received ICDs in our center. All of them included in the study and were followed for 33 ±23 months. The primary end point of  the  study  was  actuarial  survival.  The  secondary  end  point  was  nonfatal  complications, including inappropriate ICD therapy, lead-related and implant-related complications. The study was approved by local Ethics Committee and written informed consent was obtained from all the patients.Implanted ICDs and programming:            ICD system manufacturers  included Medtronic  and  St  Jude  systems in  160 and 75 patients respectively. Atrial leads included 1688 T or 1642T for St Jude and 5076 for Medtronic systems. Ventricular leads included 1570,1572,1571,1580 and 1581 for St Jude and 6944, 6947 and 6948 for Medtronic systems. All of the ventricular leads were bipolar. In implanted devices all the detection and discrimination criteria were activated with the nominal values. In all the devices we defined ventricular fibrillation zone (300ms) plus one VT zone (400 ms).  If  the patient had an episode of spontaneous or induced sustained monomorphic VT slower than 370 ms we extended the VT zone to VT cycle length plus 40ms. In the VT detection zone the first therapy was three antitachycardia burst pacing. We used the nominal values of the ICDs for the duration and tachyarrhythmia detection criteria. Antibradycardia pacing was programmed in VVI mode with pacing rate of 40 beats per minute in all VR and DR ICDs, unless the patients needed dual  chamber  pacing,  those  with  long  QT  syndrome  and  hypertrophic  obstructive cardiomyopathy.Implantation techniques:            The  implantation  routes  were  either  subclavian  or  Axillary  veins  percutaneously  in electrophysiology laboratory by an electrophysiologist.Follow-up protocol:            The patients were followed after 1 month postoperatively and every 3 months thereafter and upon receiving high voltage therapy in our outpatient ICD clinic. ICD evaluations during follow-up visits included routine clinically appropriate measurements including interrogation of the device for tachyarrhythmia episodes, evaluation of sensing and pacing thresholds and lead impedance. Floppy diskettes were used to retrieve all episodes of ICD therapy. All the episodes resulted  in  ICD  therapy,  studied  independently  by  two  electrophysiologists  to  define  the diagnosis.  All  the  episodes  were  categorized  as  appropriate  or  inappropriate.  ICD-related Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)Ataallah Bagherzadeh, Zahra Emkanjoo, Majid Haghjoo, Maryam Moshkani Farahani, 77 Abolfath Alizadeh, and Mohammad Ali Sadr-Ameli, “Complications and Mortality of Single  Versus Dual Chamber Implantable Cardioverter Defibrillators”  complications were documented, as were mortality and cause of death. Chest radiography (CXR) was  obtained  before  hospital  discharge  and  every  6  months  to  confirm  radiographic  lead integrity.  Clinical  evaluation  of  patients  included  history  and  physical  examination  of  the implantation site. Complications were defined as unexpected adverse events that were felt to be related to the implant procedure or to the ICD lead and generator system.Statistical analysis:            Baseline  characteristics  and  complications  were  summarized  as  the  mean ±  SD for continuous variables and otherwise as percentage. SPSS 13 software (SPSS Inc., Chicago, IL, USA) was used for data storage and analysis. Qualitative characteristics were compared using the Pearson’s chi square and Fischer exact tests. Kaplan-Meyer survival curves were calculated. Log rank statistics  were used to  compare the distribution of  time to  complications  and mortality between different  ICD groups.  Two-tailed  P <  0.05  were  considered  significant.  Regression analysis  was  performed  to  evaluate  the  effect  of  variables  on  mortality  and  complications.ResultsBaseline characteristics:            Baseline characteristics of the patients are summarized in Table 1. Table 2 compares the baseline characteristics of the patients in VR and DR ICD groups.Table1: Baseline characteristics of patientsCAD= Coronary artery disease, DCM= Dilated cardiomyopathy,HCM= Hypertrophic cardiomyopathy, NYHA= New York Heart AssociationIndian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)Ataallah Bagherzadeh, Zahra Emkanjoo, Majid Haghjoo, Maryam Moshkani Farahani, 78 Abolfath Alizadeh, and Mohammad Ali Sadr-Ameli, “Complications and Mortality of Single  Versus Dual Chamber Implantable Cardioverter Defibrillators”  Table2: Comparison of baseline characteristics between single and dual chamber devices.ICD-VR= Single chamber implantable cardioverter-defibrillator, ICD-DR=Dual chamber implantable  cardioverter-defibrillator,  LVEDd= Left  ventricular  end diastolic diameter, LVESd= Left ventricular end systolic diameter, LVEF= Left ventricular  ejection  fraction,  NYHA=  New  York  Heart  Association,  CAD= Coronary artery disease, DCM= Dilated cardiomyopathy, HCM= Hypertrophic cardiomyopathy.Mortality:            Three patients (1.2%) died during the first  month after ICD implantation because of multi-organ  failure,  massive  pulmonary  emboli  and  acute  coronary  syndrome.  The  1-year survival rate was 94.9% and 94.1% for VR and DR ICDs respectively. The overall survival rate during  follow-up  was  90.6%  and  88.9%  for  VR and  DR ICDs  respectively.  There  was  no significant difference in mortality between different sex groups (P=0.37), different indications for  ICD implantation  (P=0.43)  or  between  VR and  DR ICD groups  (P=  0.55)  (Figure 1). Univariate  regression  analysis  showed  predictors  of  mortality  as  NYHA  class  III  or  more Indian Pacing and Electrophysiology Journal (ISSN 0972-6292), 6(2): 75-83 (2006)

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Complications and Mortality of Single Versus Dual Chamber Implantable Cardioverter Defibrillators

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