Factors Associated with Implantation-Related Complications MALTE MEESMANN From the Medizinische Universitatsklinik Wurzburg, Wurzburg, Germany
The implantable cardioverter defibrillator (ICD) increasingly is being used as a treatment modality for life-threatening, otherwise refractory ventricular tachyarrhythmias. Before it can be regarded as the "treatment of choice,"^ one has to consider its potential shortcomings and risks. In this article, factors associated virith, perioperative complications are reviewed. Magnitude of Perioperative Mortality Although one of the largest series from the United States reported a perioperative mortality as low as 1.5%,^'^ some recent reports disclose inhospital mortality rates as high as 8% to 9%.^"'' A detailed listing of perioperative or in-hospital mortality rates is given in Table I. Of note is the high divergence of mortality rates between centers despite very similar mean left ventricular ejection fractions.^'* ICD implantation at a perioperative mortality rate of 6% and more will reduce significantly the overall benefit of this treatment modality in patients at high risk for sudden cardiac death. Transvenous electrode systems show a reduced complication rate,^^'^^ although this approach is not without problems (Table I). Refractory arrhythmias, pump failure, and sepsis due to device infection were reported as frequent causes of perioperative death during ICD implantation. Complications reported at ICD implantation are listed in Table II. It is remarkable that the most frequent cause for perioperative mortality is arrhythmias. In a large series reported from the Cleveland Clinic,^" this was 58.4% of all perioperative deaths. So patients often die of the very disease for which they are undergoing operation. This
Address for reprints: Dr. M. Meesmann, Medizinische Universitatsklinik, Josef-Schneider-Str. 2, W-8700 Wurzburg, Germany. Fax: (49) 931 201-3453.
PACE, Vol. 15
has to be taken into account during postoperative management, especially since antiarrhythmic drugs often are withdrawn for the operation. Following is a discussion of factors that might contribute to a poor perioperative outcome. Patient Selection In general, the more advanced the clinical state of heart failure and the lower the left ventricular ejection fraction, the higher the perioperative risk. In a recent report,* an in-hospital mortality of 42% (5 out of 12) in patients with Class IV heart failure was reported. In addition, the prolongation of survival usually is small,* rendering this form of therapy not suitable for patients in Class IV heart failure. Thus, careful patient selection is a decisive step for a successful ICD implantation. Left Ventricular Ejection Fraction. A left ventricular ejection fraction of :^30% is associated with an increased mortality. Thus in a report from the Cleveland Clinic,^° 10 out of 134 (7.5%) patients with an ejection fraction (EF) of 30% (P = 0.015,^). This is in contrast to the findings reported in the PCD™trial where the patients who died had a mean EF of 34% whereas the total cohort had a mean EF of 34.8%^ The type of anesthesia used may have a significant influence on the operative outcome. However, this has not received much attention so far. Concomitant Surgery Additional cardiac surgery such as coronary artery bypass grafting or valve replacement in conjunction with ICD implantation poses an additional risk. This is illustrated by the results from
April 1992, Part III
649
MEESMANN
Table 1. In-hospital Mortality AT ICD-lmplantation Percentage (»/'") 7.4 1.4 3.2 1.5 4.4 9.6 1.65 0 9.8 8.3 4.8 2.5 8 0 3 4.2
(2)
(1) (2) (2)
Total Number 27 70 94 270 271 218 555 20 122 109 210 120 80 19 70 24
Author
Year
Marchlinski et al.^ Tchou et al.^ Kelly et al.« Winkle et al.^ Gohn et al.^° Levine et al." Winkle et al.^ McCowan et al.^^ CPI^ Lindemans et al.* Hannover^^ Hamburg^^ Munster^" Block et al.^* Munster^" Wurzburg
1986 1988 1988 1989 1991 1991 1991 1991 1989 1991 10/91 10/91 10/91 1991 10/91 10/91
EF
36 33 34 ? 35 33 29 35 35
(1) epicardial patch electrodes (2) transvenous electrodes
Table II. Perioperative Complications Refractory ventricular arrhythmias Pump failure Atrial arrhythmias Electrode/patch dislocation Electrode disconnection Pocket seroma/hematoma Infection/sepsis Pneumonia/respiratory failure Pleural effusion Pneumothorax Stroke Erosion of coronary artery/vein or aorta Constrictive pericarditis Bleeding (subclavian vein) Thrombosis (subclavian vein) Pulmonary embolism
650
Hannover where 8 of the 10 patients who died following ICD implantation had concomitant surgery^^ With increasing availability of transvenous electrode systems, it seems logical to plan a twostage procedure with transvenous placement of electrodes 2 weeks following the primary operation.^^ Infection Intraoperative infection poses a significant problem since an established infection usually can be treated only by surgical removal of the complete system.^'' Most centers now give antibiotics on a prophylactic basis. At our institution, we follow the practice of Winkle et al.^ and give cephalosporin and vancomycin beginning on the day of operation (first dose immediately prior to operation) and continuing for 5 days. Most infections have been due to StaphyJococcus aureus or epidermidis. Of course, a short operating time and avoidance of tissue trauma with its secondary interference with microcirculation are fundamental to prevention of infection. Furthermore, during the operation all the implantable components are kept in their sterile boxes for as long as possible, and the pulse generator is covered with sponges soaked with ciprofloxacin.^^ Before closure, all operative sites are rinsed with a solution of ciprofloxacin. Planning the implantation as the first procedure in an operating room as opposed to the third of a day and restricting the number of attending persons to an absolute minimum further helps to diminish the risks of infection. Although these details seem simple and straightforward, meticulous attention to these factors will help to prevent infection. Following these guidelines, we have observed no infection at 21 first implants and 6 generator replacement operations, except for one patient. This patient developed a systemic infection 5 months following generator replacement, requiring removal of the complete system. Especially worrisome is the infection rate at generator replacement operations. Looking again at the data from Hannover, the largest group of ICD patients in Europe, Klein and associates report an infection rate of 5.9% (5 out of 85) for generator replacement operation.^^ This figure is very similar to the 7.1% reported from the Cleveland Clinic.^^ This prob-
April 1992, Part III
PACE, Vol. 15
COMPLICATIONS AT ICD IMPLANTATION
lem highlights the need for generators with greater longevity. Formation of fibrous tissues around the generator with decreased circulation has been considered as a factor for the increased infection rate.^^ In our opinion, the consideration of creating a new pocket at generator replacement operation deserves some consideration. Intraoperative Testing for Defibrillation Threshold Repeated inductions of ventricular fibrillation (VF) are required in order to establish a meaningful defibrillation threshold. In our opinion this testing should be performed as restrictively as possible for the following reasons: (a) since the electric field at defibrillation usually is not homogeneous, there are some areas in the heart that are exposed to excessively high currents.^" Thus, with each defibrillation shock at least some areas in the heart are damaged (e.g., increased membrane leakage). Apart from possibly worsening pump function, the heart as a electrophysiological substrate is changed and the meaning of unsuccessful shocks after a series of previous shocks is questionable; (b) extensive testing prolongs operating time and thus increases the risk for infection. If a satisfactory defibrillation threshold cannot be achieved within a few (6 to 8) shocks, further testing should be performed at a later time.^^ Elevated defibrillation thresholds are to be expected in patients with decreased left ventricular ejection fraction.^^ Amiodarone has been associated with increased defibrillation thresholds.^^ To date, it is not clear whether amiodarone itself is responsible for the increase in defibrillation threshold or that amiodarone treatment simply reflects more advanced disease of the ventricles.^^ Furthermore, using the transvenous approach, defibrillation thresholds may be higher^^'^^'^' This is problematic if external defibrillation is not effective since the heart is not exposed for immediate direct cardiac massage and institution of cardiopulmonary bypass is more difficult. Arrhythmias Prolonged Ventricular Fibrillation During Testing Several cases of prolonged VF have been reported (Table III). In the cases reported by Winkle,
PACE, Vol. 15
Table III. Prolonged Ventricular Fibrillation at ICD Implantation Author
Remark
Disease
Hannover 1991^^
DCM
advanced disease. first induction of
Winkle 1987^"
HCM
Winkle 1987^"
CAD
Meesman et al.
CAD
fourth induced episode of VT/VF concomitant bypass surgery well-preserved ejection fraction transvenous approach cardiac massage for 3 minutes
VF
1991^6
Hannover 1991^^
DCM
Block etal. 1991 15
?
HCM = hypertrophic cardiomyopathy; CAD = coronary artery disease; DCM = dilative cardiomyopathy.
maximum efforts including cardiopulmonary bypass could not stabilize the patient. One patient from the Hannover series with advanced dilative cardiomyopathy developed refractory VF after the first induction of VF. In a second case from Hannover, following transvenous placement of electrodes and induction of VF, the patient could not be defibrillated and after emergency sternotomy and subsequent cardiac massage, fatal rupture of the right ventricle occurred. In Wurzburg, we observed an almost fatal episode of prolonged VF in a patient with a well-preserved EF. Following a successful first defibrillation with 20 Joules, a second episode of induced VF could only be terminated after 20 minutes.^'* Each center should make a detailed plan of how to act in emergencies like these, and the intravenous administration of amiodarone should be considered in these circumstances. Management of Arrhythmias in Tbe Postoperative Phase Following ICD implantation, a patient is at high risk for developing serious arrhythmias. Since currently implanted devices are programmable, it is our policy to activate the defibrillator
April 1992, Part III
651
MEESMANN
immediately following surgery. For the postoperative period, the device is programmed to a fairly high cutoff rate (taking into consideration ventricular rates during previous episodes of atrial fibrillation) and basically used as a one-zone device against VF. Adverse effects, i.e., induction of VF by shocks given during atrial fibrillation have been reported,^^ but we think that the immediate defibrillation by the device outweighs these risks. Should atrial fibrillation with a rapid ventricular response develop, the device can be deactivated immediately by a magnet. In order to facilitate this procedure for physicians less experienced with defibrillators, we indicate the appropriate position for the magnet on the body by a red circle. Similarly, we indicate where external defibrillator paddles should be placed in case external defibrillation has to be performed. This is especially important in patients with two large epicardial patch electrodes that may interfere with external defibrillation.
that experienced teams of nurses and cardiologists are readily available around the clock. This may be difficult during weekends or at the time of large scientific meetings.
Conclusions
General Postoperative Care
Perioperative mortality is a significant problem in some institutions and requires meticulous attention to all details to achieve or maintain good results. We have learned that it is often small details that cause big problems. It is hoped that with transvenous systems, a lower perioperative complication rate can be achieved. In order to shorten everybody's "learning curve," detailed reporting of implantation methods and handling of problems should be encouraged. Because severe complication can occur, ICD implantation should not be performed in centers without cardiac surgery. Despite all these possible complications at implantation, the overall benefit of ICD therapy has been reported in several papers,^"^'^'^ although randomized studies in this respect have not yet been published.
Since many of the implantees have serious medical illnesses, it is our policy to transfer the patient to the medical intensive care unit immediately post operation. Since it is often small details that trigger serious complications, it is necessary
AcknovvJedgmenfs: The author wishes to thank Drs. M. Block (Miinster), H. Klein (Hannover), and K.-H. Kuck (Hamburg) for sharing their data on perioperative complications. Dr H. Hopp's cooperation at the ICD implant procedures in Wurzburg is deeply appreciated.
References 1. Lehmann MH, Steinman RT, Schuger CD, et al. The automatic implantable cardioverter defibrillator as antiarrhythmic treatment modality of choice for survivors of cardiac arrest unrelated to acute myocardial infarction. Am J Cardiol 1988; 62:803-805. 2. Winkle RA, Mead H, Ruder MA, et al: Long-term outcome with the automatic implantahle cardioverter defibrillator. J Am Coll Cardiol 1989; 13:1353-1361. 3. Winkle RA, Mead RW, Ruder MA, et al. Ten year experience with implantable defihrillators. (ahstract) Circulation 1991; 84(Suppl II): 426. 4. Levine JH, Mellits ED, Baumgardner RA, et al: Predictors of first discharge and subsequent survival in patients with automatic implantable cardioverter defihrillators. Circulation 1991; 84:558-566. 5. Lindemans EW, van Berlo AMW, Bourgeois IM. Summary of PCD clinical study results. In FW Lindemans, IR Rankin, J Vegter (eds.): Symposium on PCD™ Clinical Results. Proceedings. Bakken Research Center; Maastricht, The Netherlands, 1991, pp. 111-119.
652
6. Ventak P Investigator Meeting. Cardiac Pacemaker, Inc. Ciessen, 1989. 7. Marchlinski FE, Flores BT, Buxton AE,, et al. The automatic implantable cardioverter defibrillator: Efficacy, complications, and device failures. Ann Intern Med 1986; 104:481-488. 8. Tchou PJ, Kadri N, Anderson J, et al. Automatic implantable cardioverter defibrillators and survival of patients with left ventricular dysfunction and malignant ventricular arrh3rthmias. Ann Intern Med 1988; 109:529-534. 9. Kelly PA, Cannom DS, Caran H, et al. The automatic implantable cardioverter defibrillator: Efficacy, complications and survival in patients with malignant ventricular arrhythmias. J Am Coll Cardiol 1988; 11:1278-1286. 10. Cohn D, Edel T, Pollard C, et al. Determinants of operative mortality in implantable cardioverter defihrillators. (abstract] J Am Coll Cardiol 1991; 17:86A. 11. McCowanR,MaloneyJ,WilkoffB, etal. Automatic
April 1992, Part III
PACE, Vol. 15
COMPLICATIONS AT ICD IMPLANTATION
12. 13. 14. 15.
16. 17. 18. 19. 20.
implantable cardioverter defibrillator implantation without thoracotomy using an endocardial and submuscular patch system. J Am Coll Cardiol 1991; 17:415-421. Klein H. October 14,1991, personal communication. Kuck K-H. October 14,1991, personal communication. Block M. October 14,1991, personal communication. Block M, Hammel D, Borggrefe M, et al. Erste klinische Erfahrungen mit einem transvenos-subkutanem Defibrillations system. Z Kardiol 1991; 80:657-664. Epstein AE. Invited letter concerning: Automatic implantable cardioverter defibrillator. J Thorac Cardiovasc Surg 1991; 102:160-161. Wunderly D, Maloney J, Edel T, et al. Infections in implantable cardioverter defibrillator patients. PACE 1990; 13:1360-1364. Siclari F, Klein H, Troster J. Intraventricular migration of an ICD patch. PACE 1990; 13:1356-1359. Furman S. Implantable cardioverter defibrillator infection. Editorial. PACE 1990; 13:1351. Chen P-S, Wolf PD, Claydon FJ, et al. The potential gradient field created by epicardial defibrillation electrodes in dogs. Circulation 1986; 74:626-636.
PACE, Vol. 15
21.
Grubb BP, Mancini M, Temesy-Armos P, et al. Resolution of high initial epicardial patch defibrillation threshold following chronic implantation. PACE 1991; 14:149-151. 22. Cobn D, Edel T, Moore S, et al. High defibrillation thresholds: Univariant and multivariant analysis, (abstract) J Am Coll Cardiol 1991: 86A. 23. Cuarnieri T, Cannom DS, Chapman PD, et al. Multicenter experience: Transvenous implantable cardioverter defibrillator lead system, (abstract) Circulation 1991; 84(Suppl II), 428. 24. Winkle RA, Thomas A. The automatic implantable cardioverter defibrillator: U.S. experience. In P Brugada, HJ) Wellens (eds.): Cardiac Arrhythmias: Where To Go from Here? New York, Futura Publishing, 1987, pp. 663-680. 25. Meesmann M, Hopp H, Langenfeld H, et al. Prolongiertes Kammer-flimmern als Komplikation bei der Implantation eines Cardioverters-Defibrillators-ein Fallbericht. (abstract) Kliniscbe Wochenscbrift 1991; 69(Suppl XXIII):149. 26. Manz M, Gerckens U, Luderitz B. Erroneous "discharge from an.implanted automatic defibrillator during supraventricular tacbyarrhytbmia induced ventricular fibrillation. Am J Cardiol 1986; 57:343-344.
April 1992, Part III
653
The implantable cardioverter defibrillator (ICD) increasingly is being used as a treatment modality for life-threatening, otherwise refractory ventricular tachyarrhythmias. Before it can be regarded as the "treatment of choice,"^ one has to consider its potential shortcomings and risks. In this article, factors associated virith, perioperative complications are reviewed. Magnitude of Perioperative Mortality Although one of the largest series from the United States reported a perioperative mortality as low as 1.5%,^'^ some recent reports disclose inhospital mortality rates as high as 8% to 9%.^"'' A detailed listing of perioperative or in-hospital mortality rates is given in Table I. Of note is the high divergence of mortality rates between centers despite very similar mean left ventricular ejection fractions.^'* ICD implantation at a perioperative mortality rate of 6% and more will reduce significantly the overall benefit of this treatment modality in patients at high risk for sudden cardiac death. Transvenous electrode systems show a reduced complication rate,^^'^^ although this approach is not without problems (Table I). Refractory arrhythmias, pump failure, and sepsis due to device infection were reported as frequent causes of perioperative death during ICD implantation. Complications reported at ICD implantation are listed in Table II. It is remarkable that the most frequent cause for perioperative mortality is arrhythmias. In a large series reported from the Cleveland Clinic,^" this was 58.4% of all perioperative deaths. So patients often die of the very disease for which they are undergoing operation. This
Address for reprints: Dr. M. Meesmann, Medizinische Universitatsklinik, Josef-Schneider-Str. 2, W-8700 Wurzburg, Germany. Fax: (49) 931 201-3453.
PACE, Vol. 15
has to be taken into account during postoperative management, especially since antiarrhythmic drugs often are withdrawn for the operation. Following is a discussion of factors that might contribute to a poor perioperative outcome. Patient Selection In general, the more advanced the clinical state of heart failure and the lower the left ventricular ejection fraction, the higher the perioperative risk. In a recent report,* an in-hospital mortality of 42% (5 out of 12) in patients with Class IV heart failure was reported. In addition, the prolongation of survival usually is small,* rendering this form of therapy not suitable for patients in Class IV heart failure. Thus, careful patient selection is a decisive step for a successful ICD implantation. Left Ventricular Ejection Fraction. A left ventricular ejection fraction of :^30% is associated with an increased mortality. Thus in a report from the Cleveland Clinic,^° 10 out of 134 (7.5%) patients with an ejection fraction (EF) of 30% (P = 0.015,^). This is in contrast to the findings reported in the PCD™trial where the patients who died had a mean EF of 34% whereas the total cohort had a mean EF of 34.8%^ The type of anesthesia used may have a significant influence on the operative outcome. However, this has not received much attention so far. Concomitant Surgery Additional cardiac surgery such as coronary artery bypass grafting or valve replacement in conjunction with ICD implantation poses an additional risk. This is illustrated by the results from
April 1992, Part III
649
MEESMANN
Table 1. In-hospital Mortality AT ICD-lmplantation Percentage (»/'") 7.4 1.4 3.2 1.5 4.4 9.6 1.65 0 9.8 8.3 4.8 2.5 8 0 3 4.2
(2)
(1) (2) (2)
Total Number 27 70 94 270 271 218 555 20 122 109 210 120 80 19 70 24
Author
Year
Marchlinski et al.^ Tchou et al.^ Kelly et al.« Winkle et al.^ Gohn et al.^° Levine et al." Winkle et al.^ McCowan et al.^^ CPI^ Lindemans et al.* Hannover^^ Hamburg^^ Munster^" Block et al.^* Munster^" Wurzburg
1986 1988 1988 1989 1991 1991 1991 1991 1989 1991 10/91 10/91 10/91 1991 10/91 10/91
EF
36 33 34 ? 35 33 29 35 35
(1) epicardial patch electrodes (2) transvenous electrodes
Table II. Perioperative Complications Refractory ventricular arrhythmias Pump failure Atrial arrhythmias Electrode/patch dislocation Electrode disconnection Pocket seroma/hematoma Infection/sepsis Pneumonia/respiratory failure Pleural effusion Pneumothorax Stroke Erosion of coronary artery/vein or aorta Constrictive pericarditis Bleeding (subclavian vein) Thrombosis (subclavian vein) Pulmonary embolism
650
Hannover where 8 of the 10 patients who died following ICD implantation had concomitant surgery^^ With increasing availability of transvenous electrode systems, it seems logical to plan a twostage procedure with transvenous placement of electrodes 2 weeks following the primary operation.^^ Infection Intraoperative infection poses a significant problem since an established infection usually can be treated only by surgical removal of the complete system.^'' Most centers now give antibiotics on a prophylactic basis. At our institution, we follow the practice of Winkle et al.^ and give cephalosporin and vancomycin beginning on the day of operation (first dose immediately prior to operation) and continuing for 5 days. Most infections have been due to StaphyJococcus aureus or epidermidis. Of course, a short operating time and avoidance of tissue trauma with its secondary interference with microcirculation are fundamental to prevention of infection. Furthermore, during the operation all the implantable components are kept in their sterile boxes for as long as possible, and the pulse generator is covered with sponges soaked with ciprofloxacin.^^ Before closure, all operative sites are rinsed with a solution of ciprofloxacin. Planning the implantation as the first procedure in an operating room as opposed to the third of a day and restricting the number of attending persons to an absolute minimum further helps to diminish the risks of infection. Although these details seem simple and straightforward, meticulous attention to these factors will help to prevent infection. Following these guidelines, we have observed no infection at 21 first implants and 6 generator replacement operations, except for one patient. This patient developed a systemic infection 5 months following generator replacement, requiring removal of the complete system. Especially worrisome is the infection rate at generator replacement operations. Looking again at the data from Hannover, the largest group of ICD patients in Europe, Klein and associates report an infection rate of 5.9% (5 out of 85) for generator replacement operation.^^ This figure is very similar to the 7.1% reported from the Cleveland Clinic.^^ This prob-
April 1992, Part III
PACE, Vol. 15
COMPLICATIONS AT ICD IMPLANTATION
lem highlights the need for generators with greater longevity. Formation of fibrous tissues around the generator with decreased circulation has been considered as a factor for the increased infection rate.^^ In our opinion, the consideration of creating a new pocket at generator replacement operation deserves some consideration. Intraoperative Testing for Defibrillation Threshold Repeated inductions of ventricular fibrillation (VF) are required in order to establish a meaningful defibrillation threshold. In our opinion this testing should be performed as restrictively as possible for the following reasons: (a) since the electric field at defibrillation usually is not homogeneous, there are some areas in the heart that are exposed to excessively high currents.^" Thus, with each defibrillation shock at least some areas in the heart are damaged (e.g., increased membrane leakage). Apart from possibly worsening pump function, the heart as a electrophysiological substrate is changed and the meaning of unsuccessful shocks after a series of previous shocks is questionable; (b) extensive testing prolongs operating time and thus increases the risk for infection. If a satisfactory defibrillation threshold cannot be achieved within a few (6 to 8) shocks, further testing should be performed at a later time.^^ Elevated defibrillation thresholds are to be expected in patients with decreased left ventricular ejection fraction.^^ Amiodarone has been associated with increased defibrillation thresholds.^^ To date, it is not clear whether amiodarone itself is responsible for the increase in defibrillation threshold or that amiodarone treatment simply reflects more advanced disease of the ventricles.^^ Furthermore, using the transvenous approach, defibrillation thresholds may be higher^^'^^'^' This is problematic if external defibrillation is not effective since the heart is not exposed for immediate direct cardiac massage and institution of cardiopulmonary bypass is more difficult. Arrhythmias Prolonged Ventricular Fibrillation During Testing Several cases of prolonged VF have been reported (Table III). In the cases reported by Winkle,
PACE, Vol. 15
Table III. Prolonged Ventricular Fibrillation at ICD Implantation Author
Remark
Disease
Hannover 1991^^
DCM
advanced disease. first induction of
Winkle 1987^"
HCM
Winkle 1987^"
CAD
Meesman et al.
CAD
fourth induced episode of VT/VF concomitant bypass surgery well-preserved ejection fraction transvenous approach cardiac massage for 3 minutes
VF
1991^6
Hannover 1991^^
DCM
Block etal. 1991 15
?
HCM = hypertrophic cardiomyopathy; CAD = coronary artery disease; DCM = dilative cardiomyopathy.
maximum efforts including cardiopulmonary bypass could not stabilize the patient. One patient from the Hannover series with advanced dilative cardiomyopathy developed refractory VF after the first induction of VF. In a second case from Hannover, following transvenous placement of electrodes and induction of VF, the patient could not be defibrillated and after emergency sternotomy and subsequent cardiac massage, fatal rupture of the right ventricle occurred. In Wurzburg, we observed an almost fatal episode of prolonged VF in a patient with a well-preserved EF. Following a successful first defibrillation with 20 Joules, a second episode of induced VF could only be terminated after 20 minutes.^'* Each center should make a detailed plan of how to act in emergencies like these, and the intravenous administration of amiodarone should be considered in these circumstances. Management of Arrhythmias in Tbe Postoperative Phase Following ICD implantation, a patient is at high risk for developing serious arrhythmias. Since currently implanted devices are programmable, it is our policy to activate the defibrillator
April 1992, Part III
651
MEESMANN
immediately following surgery. For the postoperative period, the device is programmed to a fairly high cutoff rate (taking into consideration ventricular rates during previous episodes of atrial fibrillation) and basically used as a one-zone device against VF. Adverse effects, i.e., induction of VF by shocks given during atrial fibrillation have been reported,^^ but we think that the immediate defibrillation by the device outweighs these risks. Should atrial fibrillation with a rapid ventricular response develop, the device can be deactivated immediately by a magnet. In order to facilitate this procedure for physicians less experienced with defibrillators, we indicate the appropriate position for the magnet on the body by a red circle. Similarly, we indicate where external defibrillator paddles should be placed in case external defibrillation has to be performed. This is especially important in patients with two large epicardial patch electrodes that may interfere with external defibrillation.
that experienced teams of nurses and cardiologists are readily available around the clock. This may be difficult during weekends or at the time of large scientific meetings.
Conclusions
General Postoperative Care
Perioperative mortality is a significant problem in some institutions and requires meticulous attention to all details to achieve or maintain good results. We have learned that it is often small details that cause big problems. It is hoped that with transvenous systems, a lower perioperative complication rate can be achieved. In order to shorten everybody's "learning curve," detailed reporting of implantation methods and handling of problems should be encouraged. Because severe complication can occur, ICD implantation should not be performed in centers without cardiac surgery. Despite all these possible complications at implantation, the overall benefit of ICD therapy has been reported in several papers,^"^'^'^ although randomized studies in this respect have not yet been published.
Since many of the implantees have serious medical illnesses, it is our policy to transfer the patient to the medical intensive care unit immediately post operation. Since it is often small details that trigger serious complications, it is necessary
AcknovvJedgmenfs: The author wishes to thank Drs. M. Block (Miinster), H. Klein (Hannover), and K.-H. Kuck (Hamburg) for sharing their data on perioperative complications. Dr H. Hopp's cooperation at the ICD implant procedures in Wurzburg is deeply appreciated.
References 1. Lehmann MH, Steinman RT, Schuger CD, et al. The automatic implantable cardioverter defibrillator as antiarrhythmic treatment modality of choice for survivors of cardiac arrest unrelated to acute myocardial infarction. Am J Cardiol 1988; 62:803-805. 2. Winkle RA, Mead H, Ruder MA, et al: Long-term outcome with the automatic implantahle cardioverter defibrillator. J Am Coll Cardiol 1989; 13:1353-1361. 3. Winkle RA, Mead RW, Ruder MA, et al. Ten year experience with implantable defihrillators. (ahstract) Circulation 1991; 84(Suppl II): 426. 4. Levine JH, Mellits ED, Baumgardner RA, et al: Predictors of first discharge and subsequent survival in patients with automatic implantable cardioverter defihrillators. Circulation 1991; 84:558-566. 5. Lindemans EW, van Berlo AMW, Bourgeois IM. Summary of PCD clinical study results. In FW Lindemans, IR Rankin, J Vegter (eds.): Symposium on PCD™ Clinical Results. Proceedings. Bakken Research Center; Maastricht, The Netherlands, 1991, pp. 111-119.
652
6. Ventak P Investigator Meeting. Cardiac Pacemaker, Inc. Ciessen, 1989. 7. Marchlinski FE, Flores BT, Buxton AE,, et al. The automatic implantable cardioverter defibrillator: Efficacy, complications, and device failures. Ann Intern Med 1986; 104:481-488. 8. Tchou PJ, Kadri N, Anderson J, et al. Automatic implantable cardioverter defibrillators and survival of patients with left ventricular dysfunction and malignant ventricular arrh3rthmias. Ann Intern Med 1988; 109:529-534. 9. Kelly PA, Cannom DS, Caran H, et al. The automatic implantable cardioverter defibrillator: Efficacy, complications and survival in patients with malignant ventricular arrhythmias. J Am Coll Cardiol 1988; 11:1278-1286. 10. Cohn D, Edel T, Pollard C, et al. Determinants of operative mortality in implantable cardioverter defihrillators. (abstract] J Am Coll Cardiol 1991; 17:86A. 11. McCowanR,MaloneyJ,WilkoffB, etal. Automatic
April 1992, Part III
PACE, Vol. 15
COMPLICATIONS AT ICD IMPLANTATION
12. 13. 14. 15.
16. 17. 18. 19. 20.
implantable cardioverter defibrillator implantation without thoracotomy using an endocardial and submuscular patch system. J Am Coll Cardiol 1991; 17:415-421. Klein H. October 14,1991, personal communication. Kuck K-H. October 14,1991, personal communication. Block M. October 14,1991, personal communication. Block M, Hammel D, Borggrefe M, et al. Erste klinische Erfahrungen mit einem transvenos-subkutanem Defibrillations system. Z Kardiol 1991; 80:657-664. Epstein AE. Invited letter concerning: Automatic implantable cardioverter defibrillator. J Thorac Cardiovasc Surg 1991; 102:160-161. Wunderly D, Maloney J, Edel T, et al. Infections in implantable cardioverter defibrillator patients. PACE 1990; 13:1360-1364. Siclari F, Klein H, Troster J. Intraventricular migration of an ICD patch. PACE 1990; 13:1356-1359. Furman S. Implantable cardioverter defibrillator infection. Editorial. PACE 1990; 13:1351. Chen P-S, Wolf PD, Claydon FJ, et al. The potential gradient field created by epicardial defibrillation electrodes in dogs. Circulation 1986; 74:626-636.
PACE, Vol. 15
21.
Grubb BP, Mancini M, Temesy-Armos P, et al. Resolution of high initial epicardial patch defibrillation threshold following chronic implantation. PACE 1991; 14:149-151. 22. Cobn D, Edel T, Moore S, et al. High defibrillation thresholds: Univariant and multivariant analysis, (abstract) J Am Coll Cardiol 1991: 86A. 23. Cuarnieri T, Cannom DS, Chapman PD, et al. Multicenter experience: Transvenous implantable cardioverter defibrillator lead system, (abstract) Circulation 1991; 84(Suppl II), 428. 24. Winkle RA, Thomas A. The automatic implantable cardioverter defibrillator: U.S. experience. In P Brugada, HJ) Wellens (eds.): Cardiac Arrhythmias: Where To Go from Here? New York, Futura Publishing, 1987, pp. 663-680. 25. Meesmann M, Hopp H, Langenfeld H, et al. Prolongiertes Kammer-flimmern als Komplikation bei der Implantation eines Cardioverters-Defibrillators-ein Fallbericht. (abstract) Kliniscbe Wochenscbrift 1991; 69(Suppl XXIII):149. 26. Manz M, Gerckens U, Luderitz B. Erroneous "discharge from an.implanted automatic defibrillator during supraventricular tacbyarrhytbmia induced ventricular fibrillation. Am J Cardiol 1986; 57:343-344.
April 1992, Part III
653
