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Permanent transvenous pacemaking for senile heart block
Permanent Transvenous Pacemaking for Senile Heart Block NOEL H. FISHMAN, MD,* San Francisco, California JOHN C. HUTCHINSON, MD,* San Francisco, California L. HENRY EDMUNDS, Jr, MD,* San Francisco, California BENSON B. ROE, MD, San Francisco, California
l)¢rmancnl transvcnons paccmaking is the obvious al~crnativc to imphmtation of epicardial electrodes in the t~ld. ill. or debilitated patient, or whenever severe pcricardial ;~dhcsitms arc anticipated. Routine use of the tr:lnsvenous route has been difficult to justify because di.,,h~dgmcnt of the cathcter (with failure to pace) and vcntricuh~r perforation may occur. Material and Methods Since January t~65. permanent transvenous bipolar Medtronic~ pacemaker systems have been inserted in sixty patients at the University of California. San Francisco. for the trcatmem of senile heart block. The average age of these pattents was seventy-four years (range fifty-one to ctghty-six vcarsl. Although permanent pacemaking was used primarily lo prevent Stokcs-Adam~ attacks, thirteen patients required a fa~ter heart rate for relief of severe congestive failure and low output states. (Table I.) In nine i)atients the transvenous pacemakers were inserted to red,lace previously implanted pacemaker systems. "Two of these pacemaker.~ (one epicardial and one transvenous| had failed because a wire had broken. Seven lepicardial) pacemakers had to be replaced to eradicate infection in the sac which contained the pulse generator. The entire procedure is. perforlned in the operating room with the patient under general anesthesia. Whenever intravenous isoproterenol is not completely effective ~n raising the heart rate. a temporary venous pacemaker catheter is inserted preoperatively. A single subclavicular recision is used to introduce the pacemaker catheter into the cephalic vein and to create a deep axillary pocket for the pulse generator. (Figure 1.) The tip of the bipolar electrode is guided into the apex of the right ventri~:le under ttuoroscopic control. The position of the catheter ,s changed until pacing is maintained with 1.5 milliamperes ~r 'less. After the guide-wire stylet is withdrawn, the :'atheter is advanced an additional 2 to 3 em to produce ., slight forward impacting pressure and is secured within ~he vein by encircling ligatures. The connections are then completed, the rate and current controls are adjusted, and From the Departments of Surgery and ~,ledicine. University of Call. iornia. San Francisco. San Francisco. California 94122. Presented at the Forty-First Annual Meeting of the Pacific Coast Surgical Association. San Francisco. California. February 15-18. 1970, • By invitation. Volume 120, August 1970
the pulse generator is inserted into the previOusly prepared deep axiltary pocket. Prophylactic antibiotics are usually given. Hemovac~ drainage is used when fluid ~:ollections are anticipated. Postoperatively, the electr0cardiogram is monitored continuously for several days; whenever possible a recorder with a "memory loop" and alarm system is employed. When the heart fails to beat in response to even one pacemaker impulse the current output of the pulse generator is increased or the position of the catheter is adjusted within the right ventricle.
Results One hundred twenty-two operations were performed in this group of elderly patients, without hospital mortality. (Table II.) Sixteen patients died two weeks to thirty months after implantation. (Table III.) Four of these patients probably died from complications o f operation or pacemaker function. The pacemaker sac became infected two and one half months postoperatively in one patient who died from sepsis. Another patient died four months afte( operation from tricuspid valvular subacute bacterial endocarditis (Staphylococcus aureus). The transvenous catfieter in this patient had been-'used to replace infected right ventricular epicardial wires. Postmortem examination revealed a residual staphylococcal abscess in the epjcardial wire sinus tracts and myocardium near the tip of the endocardial pacemaker catheter. Two patients with fixed rate pacemakers died suddenly several months postoperatively. We presume that death resulted from arrhythmia which could have been induced by competition between the patient's own pacing mechanism and the artificial pacemaker. Twelve patients died of causes unrelated to the procedure or pacemaker. Twenty-four pulse generators have b e e n replaced for battery or circuit failure eleven to twenty-four months (average eighteen months) after implantation. The complications which occurred in this series are listed in Table IV. Minor Catheter Dislodgment. Minor dislodgment of the trl~nsvenous pacemaker catheter occurred twentynine times in twenty patients (twice in eight patients and three times in onerpatient). Although the position 187
Fishman et al TABLE i
Indications for Permanent Transvenous Pacemakers
TABLE II
Operations for Implantation and Maintenance of Permanent Transvenous Pacemakers
Number of Patients St0kes-Adams Disease
Indication Fixed third degree block Intermittent third degree block Intermittent second degree block Sinus bradycardia Sinus arrest Total
Circulatory Insufficiency
23
6
11
3
5 6 2 47
3
1 0 13
of the catheter appeared unaltered on radiologic examin.ation occasional "missed beats" were detected on the electrocardiogram, indicating marginal contact between the electrodes and the endocardial surface. Minor catheter dislodgment occurred from one to eleven days (mean 5.7 days) after implan.tation. The secondary dislodgments occurred one to forty-two days (mean 13.5 days) after the first. In two cases, recurrent dislodgment resulted in abandonment of the transvenous mode and institution of epicardial pacemaking. One patient had cardiac arrest but was resuscitated, with complete myocardial and neurologic recovery. Repositioning of the catheter was accomplished in the other patients without incident. Major catheter dislodgment, defined as displacement o f the catheter out of the cavity or through the wall of the right ventricle, did not occur in this series. Electrode Wire Breakage. Breakage of wires occurred in three patients; in each case a wire broke between the pulse generator and the entrance of the catheter into the cephalic vein. The presenting sign of a broken wire was occasional failure to pace, initiated
Operation
t~umber
Initial implant Repositioning of electrode Replacement of generator Conversion to epicardial pacemake~ Removal of pacemaker Removal of infected pacemaker Repair of broken wire Total
60 29 24 3 1 3 3 122
by a r m motion, positional change, or external m:mipulation of tile pulse generator by tt~e examining physician. In e'tch case the fractured wire was converted into an indifferent subcutaneous electrode, and the remaining endocardial electrode was used as a unipolar cathode. Injection o] /'ul.~e Generator P~'ket. The pacemaker sac became infected in three patients. Stapl'loeoccus albus was cultured from the bursa in onc of these patiems, who was operated upon catty in our experience. The infection was successfully cleared by local and systemic antibiotics (kanamycin and ampicillin), without removing the pacemaker or draining the sac. The second patient, ir~ whom a Staph aurcus infection developed around the pulse generator, was treated similarly with apparent success, but she went into shock from sepsis six weeks postoperatively, and died despite removal of the infected pacemakcr and electrode catheter. In the third patient, a postoperative wound hematoma became infected with Staph aureus. The pulse generator was externalized, and the pocket was packed for several days while mcthicillin was administered systemically, The clcctrodc catheter was left in Place to control the heart rate daring insertion of a new transvenous system through the opposite cephalic vein and was removed after closure of the fresh surgical incision. All wound sites healed wcll. TABLE III
/
Late Deaths in Sixteen Patients with Permanent Transvenous Pacemakers
Cause of Death
Related to pacemaker Septicemia ; Subacute bacterial endocarditis Sudden d e a t h Total
t
Figure 1. The patient is supine with his left aria extended. The pacemaker catheter is introduced fnto the cephalic vein and a deep axillary pocket is created through the same subclavicular incision. The course of the catheter is deep to the clavicle.
188
Unrelated to pacemaker Unrelenting congestive heart failure Unrelated infection Cancer Scleroderma Automobile accident Total
Number of Patients
Survival (me)
1
1.5
I 2
4 10. 12
6 3 1 1 1
0.5, 1.5, 2 13, 23, 26 2, 5, 11 4 10 10
4
12 The American Journal of Surgery
Transvenous Pacemaking for Senile Heart Block Comments
13ccause of the advantages of Iransvcnous pacemaking we now use it in all patients who require permanent pacing for senile heart block. Although the procedure has been performed successfully by others in the cardiac catheterization laboratory or x-ray department with the patient under local anesthesia, the possibility of contamination in these circumstances is probably greater. We performed all procedures in the operating room The facl that 122 operations were performed using general anesthesia in sixty elderly patients, with no hospital mortality, would appear to substantiate the safety of this method. The frequent minor dislodgment of the bipolar electrode w;~s clisappointing. Displacement probably rcsuhcd fr~m failure to impact the tip of the catheter tirmty enough Into the trabcculae of the right ventricle. Wc believe, however, that excessive forward pressure t~ likely to dislodge the tip of the catheter. Causing ,it to recoil out cff the right ventricle into the pulmonary ~utllow tr:lct, b:lck into the right atrium or inferior vcna ca~zl, t~r ~hrt~u~h the vcntrictdar wal] itself. (Figurc 2,) These potential complications did not occur in our series. ~md none (~f our patients has had cerebral ~r m'yt~cardial inEirction as a rcstdt of minor dislodgment t~f the c:lthcter. Interestingly, Meyer and Millar [1] recently reported that fou.~tccn right ventricular perforations c~ccurrcd in the same hospital; none of their p;~tients died. but they noted that this complication is more ct~mmon ti~zm we realize. Their review of the literature revealed that perforation of the ventricle caused fatal or life-threatening tamponade in 9 per ccm of reported cases, In addition, failure to pace, another life-threatening complication, occurred in more than half of tile cases they reviewed. Brewer [2] cstimz~tcd the incidence of electrode displacement and myocardial perforation to be 10 per cent and 8.6 per cent. respectively. Furm:m. Escher. and Solomon [3] reported seven cases of electrode "ejection" in 265 implantations: they also reported thirteen cases of catheter perforation in the same series. Parsonnet et al. [4], however, reported a reduction in their dislodgment rate from 17 per cent in forty-two patients to 2 per cent in fifty-eight patients; they attribute .this change to the use of a silicone rubber flange for fixaTABLE iV
Complications of P e r m a n e n t Transvenous Pacemakers in Sixty Patients Complication
Minor d i s l o d g m e n t of catheter Repeated d i s l o d g m e n t of catheter Breakage of electrode wire Infection in pulse generator sac Subacute bacterial endocarditis Volume 120, August 1970
Number of Pattents
Per cent
20
33
8 3 3 1
Figure 2. A, major catheter dislodgments from excessive impacting pressure. Three possibilities are 'depicted: recoil out of the ventricle, diversion into the bulmonary artery, and perforation through the r h y o c a r d i u m i b y the electrode catheter. B, minor catheter dislodgment. S l i g h t distraction of the electrode and endocardial surface is shown.
tion of the catheter to the vein. Catheter perforation was r~ot observed in their series, which suggests that proper fixation can be achieved without excessive impacting pressure. However, the effect of changing catheter design and of increasing experience are not clearly defined by the authors. Breakage of a pacemaker electrode wire occurred in t h r e e oY our patients ( 5 per cent), an incidence which is similar to that reported b y others [1-3,5]. Wire breakage occurred much more frequently with epicardial pacemakers [3]. Use of the external ~jugular vein for insertion of the catheter and failure to remove the guide-wire stylets are associated with much higher breakage rates [4,5]. Infection of the bursa of the pulse generator, which occurred in three of our patients, was slow to appear and was treated successfully in one patient by local instillation and parenteral administration of antibiotics. However, another patient died after an attempt was made to treat her bursal infection the Same way, which demonstrates how important it is to remove the pacemaker and to drain the sac at the first sign of infection. The presence of a large foreign body makes it essential to avoid bacterial contamination and fluid accumulation. It is notable that all three infections occurred in the small group of eight "patients who did not receive pi'ophylactic antibiotics during or after the surgical implantation. (Table V.) No infections occurred i n TABLT. V
Antibiotics No antibiotics
Effect of Prophylactic Antibiotics on Infections of Pulse Generator Bursa*
Number of Patients
Number of Infections
52 8
0 3
" There were three infections per sixty patients (5 per cent) or three infections per 122 operations (2.5 per cen't). 189
Fishman et al
the bursae of the s e v e n patients in whonl transvenous pacetnakers were inserted to rcphtce infected epicardial systems and w h o were protected by type-specific antibiotics and preliminary externalization of the pace"maker pulse generator. T h e c o n t a m i n a t e d wires in these patients were e x t r a c t e d after the .new incision was ,closed. T w e n t y of these patients were treated with H e m o v a c d r a i n a g e ; infections d e v e l o p e d in none of them. H o w e v e r , these patients all recievcd p r o p h y l a c t.ic o r type-specific antibiotics, which m a k e s their role in, preventing infection difficult to assess. Tht: p a c e m a k c r c a t h e t e r has been r e p o r t e d to erode the skin when the external jugular vein has been used for transvenous p a c e m a k i n g 16]. T h e superficial course of the c a t h e t e r over the clavicle makes i t , v u l n e r a b l e to exposure b y pressure necrosis of the overlying skin. W e have used only the subclavicutar r,~ute ( c e p h a l i c v e i n ) for introduction of the c a t h e t e r :or the past five years, and have not had this complication. F u r m a n ct al [3], Schwartz. C r a s t n o p o l . and H a m b v [61, and King. A r r i n g t o n . and Dalton [7] report similar experiences. Erosion of the skin over the projecting control "'nipples" threatened to occur in two of o u r patients v~,ho were quite thin-skinned. We have since o v e r c o m e this potential d a n g e r by deep axillary implantation. This position of the pulse generator is so c o m f o r t a b l e that m a n y patients have b e c o m e almost u n a w a r e of their p a c e m a k e r and engage in vigorous recreational activities without conscious e n c u m b r a n c e . H o w e v e r . this deep position m a k e s the rate and c u r r e n t controls s o m e w h a t inaccessible to p e r c u t a n e o u s adjustment. Summary and Conclusions T r a n s v e n o u s p a c e m a k i n g has p r o v e d to be a safe m e t h o d for the m a n a g e m e n t of senile heart block. T h e frequency of m i n o r c a t h e t e r d i s l o d g m e n t and need for r e o p e r a t i o n , although disturbing, has not resulted in death o r serious sequelae. C o n t i n u i n g use of this technic in all patients with S t o k e s - A d a m s attacks o r c i r c u l a t o r y insufficiency s e c o n d a r y to h e a r t b l o c k seems justified. It is postulated that with g r e a t e r e x p e r i e n c e the incidence of m i n o r d i s l o d g m e n t m a y be lowered without increasing the likelihood of m a j o r d i s l o d g m e n t o r ventricular perforation. T h e safety with which ~ransvenous p a c e m a k e r s are i m p l a n t e d a n d m a i n t a i n e d is e n h a n c e d by the u s e of the o p e r a t i n g r o o m , general anesthesia, t e m p o r a r y preliminary p a c e m a k i n g , and p o s t o p e r a t i v e e l e c t r o c a r d i o graphic m o n i t o r i n g with a " m e m o r y l o o p " recorder. P r o p h y l a c t i c antibiotics are a l s o r e c o m m e n d e d for p a c e m a k e r operations. References 1. Meyer JA, Millar K: Perforatiofi of the right ventricle by electrode catheters: a review and report of nine cases. Ann Surg 168: 1048, 1968. 190
2. Brewer LA: Discussion of Kennedy PA et al [5]. 3. Furman S, Escher DJW, Solomon N: Experiences with myocardial and transvenous implanted cardiac pacemakers. Amer J Cardiol 23: 66, 1969. 4. Porsonnet V, Zucker IR, Gilbert L, Brief DK, Alpert J: Implantable transvenous pacemakers: a two and onehalf year evaluation. Dis Chest 53: 247, 1968. 5. Kennedy PA, Shipiey RE, Pr,ozan GB, Gleckler WJ. Madding GF: Three years' experience with !ong-term endo. cardiac pacing. Amer J Surg 116: 164. ]968. 6. Schwartz EL, Crastnopol P, Hamby RI: Catheter extrusion with infection complicating permanent endocardial pacing. An unusual complication reported in three cases. Dis Chest 54: 28, 1968. 7. King SM, Arrington JO, Dalton ML: Permanent transvenOus cardiac pacing via the left cephalic vein, Ann Thorac Surg 5: 469. 1968, Discussion
BERT ~,V. N.|[cYL:R ( Los Angeles, Catif) : The management of pacemakers requires some knowledge of cardiology. some electrical "'know how." and. above all. per'severance when i~ositioning the endocardial electrode. Our experience has been similar to that presented in this paper ~ith some minor but unporlanl differences. Temporary pacing has been instituted in all patienl,, prior to permanent implantation and the pacemaker left in place several days thereafter until it is certain tha! permanent pacing ix satisfactory. This is a definite safety factor and we would not consider using general anesthc~,ia without temporary pacing as recommended. We prefer !o use 1 per cent Xylocaineg for local anesthesia with minimal or no premedication. 1 would condemn general aneslhesia as complicating a procedure that has as its main feature sire plicity. Our technics are otherwise similar. In the catherization laboratory the electrode is positioned under the image intensifier. The electrode i~ passed via the external jugular vein but occasionally the internal jugular vein is used. We have not used the cephalic v=.in, mainly because il is sometimes hard to find. It protmbly makes little difference what vein is used. Three types of pacers have been e m p l o y e d - - t h e Medtronic. Cordis. and General E!ectrlc. All are efficient, but the General Electric pacemaker does not require the messy Silastic~ gl'ue, which may be an advantage. Since the atrioventricular block may be variable and in other patients there may be reversmn to sinus rhythm after permanent pacing has been established, the stand-by demand model has been Used routinely. Our complications,! too, have been minimal and our results generally favorable. Electrode displacement with failure to pace properly has been our most common complication also. and at times has required repeated readjustment. Myocardial perforation has not been a problem. Surprisingly, serious infection has not occurred, even though the sterile technic in the catheterization laboratory leaves something to be desired. In two cases the overlying skin eroded, but eventually closed under conservative management. Prophylactic antibiotics have been used routinely. Electrode fracture has not occurred as has been the case with lhe epicordial leads. The American Journal of Surgery
Transvenous Pacemaking for Senile Heart Block To my knowledge, there have been only thr~ee deaths attributable to pacemaker failure in our series. Finally, whether transvenotls pacing should be used in all adults is questionable. The electrode seems to be well tolerated in the, heart, but thrombus formation as a result has been reported and the possibility of small repeated thronlbotic emboli to the lungs producing pulmonary hypertension must be considered. We believe that epicardial electrodes still have a place in the patient below age sixty who is in generally good health. A longer followup study may prove the approach wrong. P^ut. A. Krr~NEOY (Burlingame, Calif) : Since,-reporting to this Association two years ago the results with forty such endocardiM pacemaking systems, we have extended our experience to sixty patients and l 18 operations. We have had no operative deaths, although such have been reported by others. We have had two hospital deaths due to unrelated causes and twenty late deaths. Forty-eight patients are currently being paced for one to sixty months, Ttto of the forty pacemaking systems have been converted Io epicardial leads. The causes of death are those usually seen in this age group, although we have had two sudden unexplained deaths and accept them as due to a pacing defect, x,Ve have had one case of pulmonary thromboembolus resulting in death and there have been additional such re~x)rls in the literature. Our complications are similar to those the authors listed, although there were seven generatot failures. Supposedly a loss of power will Occur in less than I0 per cent of the pacemakers if elective generator change is made within thirty months. This has not been \
Volume 120, August 1970
our experience and we now elect to change the generator between twenty-four and tqcenty-six months to reduce this incidence. Four of six of the catheter fractures occurred early in the series when one stylet was left in place. "This pacemaking system has been satisfactory and I am sure the results will improve. However, since this procedure has an attendant significant nt'mber of electrode problems, of which loss of catheter position is the most frequent, I agree that in good risk patients thoraeotomy and the placement of myocardir.l electrodes s h o u l d be considered seriously before the endocardial approach is used• BEsso~ B. ROE (closing): I am interested to learn that other physicians have trouble with this valuable but frustrating mode of therapy. Because of the high incidence of transvenous ~leetrode dislodgme'gt, I believe that epicardial electrodes should b e applied~dn those patients who can tolerate thoracotomy without ihazard. This report, of course, was hmtted to those patmnts selected for the transvenous method. Kinking of the wire during insertion of the generator box, location of the generator, and setting adequate current output are factors in ultimate performance. As we indicated, general anesthesia has proved t o be safe and may offset the discomfort to the patient while the electrode is being positioned: Further, we are convinced that the subpectoral position o f the battery box is more comfortable and that the dissection of this deep pocket with the patient under local anesthesia may be m0re difficult, •
.
~
.
191
l)¢rmancnl transvcnons paccmaking is the obvious al~crnativc to imphmtation of epicardial electrodes in the t~ld. ill. or debilitated patient, or whenever severe pcricardial ;~dhcsitms arc anticipated. Routine use of the tr:lnsvenous route has been difficult to justify because di.,,h~dgmcnt of the cathcter (with failure to pace) and vcntricuh~r perforation may occur. Material and Methods Since January t~65. permanent transvenous bipolar Medtronic~ pacemaker systems have been inserted in sixty patients at the University of California. San Francisco. for the trcatmem of senile heart block. The average age of these pattents was seventy-four years (range fifty-one to ctghty-six vcarsl. Although permanent pacemaking was used primarily lo prevent Stokcs-Adam~ attacks, thirteen patients required a fa~ter heart rate for relief of severe congestive failure and low output states. (Table I.) In nine i)atients the transvenous pacemakers were inserted to red,lace previously implanted pacemaker systems. "Two of these pacemaker.~ (one epicardial and one transvenous| had failed because a wire had broken. Seven lepicardial) pacemakers had to be replaced to eradicate infection in the sac which contained the pulse generator. The entire procedure is. perforlned in the operating room with the patient under general anesthesia. Whenever intravenous isoproterenol is not completely effective ~n raising the heart rate. a temporary venous pacemaker catheter is inserted preoperatively. A single subclavicular recision is used to introduce the pacemaker catheter into the cephalic vein and to create a deep axillary pocket for the pulse generator. (Figure 1.) The tip of the bipolar electrode is guided into the apex of the right ventri~:le under ttuoroscopic control. The position of the catheter ,s changed until pacing is maintained with 1.5 milliamperes ~r 'less. After the guide-wire stylet is withdrawn, the :'atheter is advanced an additional 2 to 3 em to produce ., slight forward impacting pressure and is secured within ~he vein by encircling ligatures. The connections are then completed, the rate and current controls are adjusted, and From the Departments of Surgery and ~,ledicine. University of Call. iornia. San Francisco. San Francisco. California 94122. Presented at the Forty-First Annual Meeting of the Pacific Coast Surgical Association. San Francisco. California. February 15-18. 1970, • By invitation. Volume 120, August 1970
the pulse generator is inserted into the previOusly prepared deep axiltary pocket. Prophylactic antibiotics are usually given. Hemovac~ drainage is used when fluid ~:ollections are anticipated. Postoperatively, the electr0cardiogram is monitored continuously for several days; whenever possible a recorder with a "memory loop" and alarm system is employed. When the heart fails to beat in response to even one pacemaker impulse the current output of the pulse generator is increased or the position of the catheter is adjusted within the right ventricle.
Results One hundred twenty-two operations were performed in this group of elderly patients, without hospital mortality. (Table II.) Sixteen patients died two weeks to thirty months after implantation. (Table III.) Four of these patients probably died from complications o f operation or pacemaker function. The pacemaker sac became infected two and one half months postoperatively in one patient who died from sepsis. Another patient died four months afte( operation from tricuspid valvular subacute bacterial endocarditis (Staphylococcus aureus). The transvenous catfieter in this patient had been-'used to replace infected right ventricular epicardial wires. Postmortem examination revealed a residual staphylococcal abscess in the epjcardial wire sinus tracts and myocardium near the tip of the endocardial pacemaker catheter. Two patients with fixed rate pacemakers died suddenly several months postoperatively. We presume that death resulted from arrhythmia which could have been induced by competition between the patient's own pacing mechanism and the artificial pacemaker. Twelve patients died of causes unrelated to the procedure or pacemaker. Twenty-four pulse generators have b e e n replaced for battery or circuit failure eleven to twenty-four months (average eighteen months) after implantation. The complications which occurred in this series are listed in Table IV. Minor Catheter Dislodgment. Minor dislodgment of the trl~nsvenous pacemaker catheter occurred twentynine times in twenty patients (twice in eight patients and three times in onerpatient). Although the position 187
Fishman et al TABLE i
Indications for Permanent Transvenous Pacemakers
TABLE II
Operations for Implantation and Maintenance of Permanent Transvenous Pacemakers
Number of Patients St0kes-Adams Disease
Indication Fixed third degree block Intermittent third degree block Intermittent second degree block Sinus bradycardia Sinus arrest Total
Circulatory Insufficiency
23
6
11
3
5 6 2 47
3
1 0 13
of the catheter appeared unaltered on radiologic examin.ation occasional "missed beats" were detected on the electrocardiogram, indicating marginal contact between the electrodes and the endocardial surface. Minor catheter dislodgment occurred from one to eleven days (mean 5.7 days) after implan.tation. The secondary dislodgments occurred one to forty-two days (mean 13.5 days) after the first. In two cases, recurrent dislodgment resulted in abandonment of the transvenous mode and institution of epicardial pacemaking. One patient had cardiac arrest but was resuscitated, with complete myocardial and neurologic recovery. Repositioning of the catheter was accomplished in the other patients without incident. Major catheter dislodgment, defined as displacement o f the catheter out of the cavity or through the wall of the right ventricle, did not occur in this series. Electrode Wire Breakage. Breakage of wires occurred in three patients; in each case a wire broke between the pulse generator and the entrance of the catheter into the cephalic vein. The presenting sign of a broken wire was occasional failure to pace, initiated
Operation
t~umber
Initial implant Repositioning of electrode Replacement of generator Conversion to epicardial pacemake~ Removal of pacemaker Removal of infected pacemaker Repair of broken wire Total
60 29 24 3 1 3 3 122
by a r m motion, positional change, or external m:mipulation of tile pulse generator by tt~e examining physician. In e'tch case the fractured wire was converted into an indifferent subcutaneous electrode, and the remaining endocardial electrode was used as a unipolar cathode. Injection o] /'ul.~e Generator P~'ket. The pacemaker sac became infected in three patients. Stapl'loeoccus albus was cultured from the bursa in onc of these patiems, who was operated upon catty in our experience. The infection was successfully cleared by local and systemic antibiotics (kanamycin and ampicillin), without removing the pacemaker or draining the sac. The second patient, ir~ whom a Staph aurcus infection developed around the pulse generator, was treated similarly with apparent success, but she went into shock from sepsis six weeks postoperatively, and died despite removal of the infected pacemakcr and electrode catheter. In the third patient, a postoperative wound hematoma became infected with Staph aureus. The pulse generator was externalized, and the pocket was packed for several days while mcthicillin was administered systemically, The clcctrodc catheter was left in Place to control the heart rate daring insertion of a new transvenous system through the opposite cephalic vein and was removed after closure of the fresh surgical incision. All wound sites healed wcll. TABLE III
/
Late Deaths in Sixteen Patients with Permanent Transvenous Pacemakers
Cause of Death
Related to pacemaker Septicemia ; Subacute bacterial endocarditis Sudden d e a t h Total
t
Figure 1. The patient is supine with his left aria extended. The pacemaker catheter is introduced fnto the cephalic vein and a deep axillary pocket is created through the same subclavicular incision. The course of the catheter is deep to the clavicle.
188
Unrelated to pacemaker Unrelenting congestive heart failure Unrelated infection Cancer Scleroderma Automobile accident Total
Number of Patients
Survival (me)
1
1.5
I 2
4 10. 12
6 3 1 1 1
0.5, 1.5, 2 13, 23, 26 2, 5, 11 4 10 10
4
12 The American Journal of Surgery
Transvenous Pacemaking for Senile Heart Block Comments
13ccause of the advantages of Iransvcnous pacemaking we now use it in all patients who require permanent pacing for senile heart block. Although the procedure has been performed successfully by others in the cardiac catheterization laboratory or x-ray department with the patient under local anesthesia, the possibility of contamination in these circumstances is probably greater. We performed all procedures in the operating room The facl that 122 operations were performed using general anesthesia in sixty elderly patients, with no hospital mortality, would appear to substantiate the safety of this method. The frequent minor dislodgment of the bipolar electrode w;~s clisappointing. Displacement probably rcsuhcd fr~m failure to impact the tip of the catheter tirmty enough Into the trabcculae of the right ventricle. Wc believe, however, that excessive forward pressure t~ likely to dislodge the tip of the catheter. Causing ,it to recoil out cff the right ventricle into the pulmonary ~utllow tr:lct, b:lck into the right atrium or inferior vcna ca~zl, t~r ~hrt~u~h the vcntrictdar wal] itself. (Figurc 2,) These potential complications did not occur in our series. ~md none (~f our patients has had cerebral ~r m'yt~cardial inEirction as a rcstdt of minor dislodgment t~f the c:lthcter. Interestingly, Meyer and Millar [1] recently reported that fou.~tccn right ventricular perforations c~ccurrcd in the same hospital; none of their p;~tients died. but they noted that this complication is more ct~mmon ti~zm we realize. Their review of the literature revealed that perforation of the ventricle caused fatal or life-threatening tamponade in 9 per ccm of reported cases, In addition, failure to pace, another life-threatening complication, occurred in more than half of tile cases they reviewed. Brewer [2] cstimz~tcd the incidence of electrode displacement and myocardial perforation to be 10 per cent and 8.6 per cent. respectively. Furm:m. Escher. and Solomon [3] reported seven cases of electrode "ejection" in 265 implantations: they also reported thirteen cases of catheter perforation in the same series. Parsonnet et al. [4], however, reported a reduction in their dislodgment rate from 17 per cent in forty-two patients to 2 per cent in fifty-eight patients; they attribute .this change to the use of a silicone rubber flange for fixaTABLE iV
Complications of P e r m a n e n t Transvenous Pacemakers in Sixty Patients Complication
Minor d i s l o d g m e n t of catheter Repeated d i s l o d g m e n t of catheter Breakage of electrode wire Infection in pulse generator sac Subacute bacterial endocarditis Volume 120, August 1970
Number of Pattents
Per cent
20
33
8 3 3 1
Figure 2. A, major catheter dislodgments from excessive impacting pressure. Three possibilities are 'depicted: recoil out of the ventricle, diversion into the bulmonary artery, and perforation through the r h y o c a r d i u m i b y the electrode catheter. B, minor catheter dislodgment. S l i g h t distraction of the electrode and endocardial surface is shown.
tion of the catheter to the vein. Catheter perforation was r~ot observed in their series, which suggests that proper fixation can be achieved without excessive impacting pressure. However, the effect of changing catheter design and of increasing experience are not clearly defined by the authors. Breakage of a pacemaker electrode wire occurred in t h r e e oY our patients ( 5 per cent), an incidence which is similar to that reported b y others [1-3,5]. Wire breakage occurred much more frequently with epicardial pacemakers [3]. Use of the external ~jugular vein for insertion of the catheter and failure to remove the guide-wire stylets are associated with much higher breakage rates [4,5]. Infection of the bursa of the pulse generator, which occurred in three of our patients, was slow to appear and was treated successfully in one patient by local instillation and parenteral administration of antibiotics. However, another patient died after an attempt was made to treat her bursal infection the Same way, which demonstrates how important it is to remove the pacemaker and to drain the sac at the first sign of infection. The presence of a large foreign body makes it essential to avoid bacterial contamination and fluid accumulation. It is notable that all three infections occurred in the small group of eight "patients who did not receive pi'ophylactic antibiotics during or after the surgical implantation. (Table V.) No infections occurred i n TABLT. V
Antibiotics No antibiotics
Effect of Prophylactic Antibiotics on Infections of Pulse Generator Bursa*
Number of Patients
Number of Infections
52 8
0 3
" There were three infections per sixty patients (5 per cent) or three infections per 122 operations (2.5 per cen't). 189
Fishman et al
the bursae of the s e v e n patients in whonl transvenous pacetnakers were inserted to rcphtce infected epicardial systems and w h o were protected by type-specific antibiotics and preliminary externalization of the pace"maker pulse generator. T h e c o n t a m i n a t e d wires in these patients were e x t r a c t e d after the .new incision was ,closed. T w e n t y of these patients were treated with H e m o v a c d r a i n a g e ; infections d e v e l o p e d in none of them. H o w e v e r , these patients all recievcd p r o p h y l a c t.ic o r type-specific antibiotics, which m a k e s their role in, preventing infection difficult to assess. Tht: p a c e m a k c r c a t h e t e r has been r e p o r t e d to erode the skin when the external jugular vein has been used for transvenous p a c e m a k i n g 16]. T h e superficial course of the c a t h e t e r over the clavicle makes i t , v u l n e r a b l e to exposure b y pressure necrosis of the overlying skin. W e have used only the subclavicutar r,~ute ( c e p h a l i c v e i n ) for introduction of the c a t h e t e r :or the past five years, and have not had this complication. F u r m a n ct al [3], Schwartz. C r a s t n o p o l . and H a m b v [61, and King. A r r i n g t o n . and Dalton [7] report similar experiences. Erosion of the skin over the projecting control "'nipples" threatened to occur in two of o u r patients v~,ho were quite thin-skinned. We have since o v e r c o m e this potential d a n g e r by deep axillary implantation. This position of the pulse generator is so c o m f o r t a b l e that m a n y patients have b e c o m e almost u n a w a r e of their p a c e m a k e r and engage in vigorous recreational activities without conscious e n c u m b r a n c e . H o w e v e r . this deep position m a k e s the rate and c u r r e n t controls s o m e w h a t inaccessible to p e r c u t a n e o u s adjustment. Summary and Conclusions T r a n s v e n o u s p a c e m a k i n g has p r o v e d to be a safe m e t h o d for the m a n a g e m e n t of senile heart block. T h e frequency of m i n o r c a t h e t e r d i s l o d g m e n t and need for r e o p e r a t i o n , although disturbing, has not resulted in death o r serious sequelae. C o n t i n u i n g use of this technic in all patients with S t o k e s - A d a m s attacks o r c i r c u l a t o r y insufficiency s e c o n d a r y to h e a r t b l o c k seems justified. It is postulated that with g r e a t e r e x p e r i e n c e the incidence of m i n o r d i s l o d g m e n t m a y be lowered without increasing the likelihood of m a j o r d i s l o d g m e n t o r ventricular perforation. T h e safety with which ~ransvenous p a c e m a k e r s are i m p l a n t e d a n d m a i n t a i n e d is e n h a n c e d by the u s e of the o p e r a t i n g r o o m , general anesthesia, t e m p o r a r y preliminary p a c e m a k i n g , and p o s t o p e r a t i v e e l e c t r o c a r d i o graphic m o n i t o r i n g with a " m e m o r y l o o p " recorder. P r o p h y l a c t i c antibiotics are a l s o r e c o m m e n d e d for p a c e m a k e r operations. References 1. Meyer JA, Millar K: Perforatiofi of the right ventricle by electrode catheters: a review and report of nine cases. Ann Surg 168: 1048, 1968. 190
2. Brewer LA: Discussion of Kennedy PA et al [5]. 3. Furman S, Escher DJW, Solomon N: Experiences with myocardial and transvenous implanted cardiac pacemakers. Amer J Cardiol 23: 66, 1969. 4. Porsonnet V, Zucker IR, Gilbert L, Brief DK, Alpert J: Implantable transvenous pacemakers: a two and onehalf year evaluation. Dis Chest 53: 247, 1968. 5. Kennedy PA, Shipiey RE, Pr,ozan GB, Gleckler WJ. Madding GF: Three years' experience with !ong-term endo. cardiac pacing. Amer J Surg 116: 164. ]968. 6. Schwartz EL, Crastnopol P, Hamby RI: Catheter extrusion with infection complicating permanent endocardial pacing. An unusual complication reported in three cases. Dis Chest 54: 28, 1968. 7. King SM, Arrington JO, Dalton ML: Permanent transvenOus cardiac pacing via the left cephalic vein, Ann Thorac Surg 5: 469. 1968, Discussion
BERT ~,V. N.|[cYL:R ( Los Angeles, Catif) : The management of pacemakers requires some knowledge of cardiology. some electrical "'know how." and. above all. per'severance when i~ositioning the endocardial electrode. Our experience has been similar to that presented in this paper ~ith some minor but unporlanl differences. Temporary pacing has been instituted in all patienl,, prior to permanent implantation and the pacemaker left in place several days thereafter until it is certain tha! permanent pacing ix satisfactory. This is a definite safety factor and we would not consider using general anesthc~,ia without temporary pacing as recommended. We prefer !o use 1 per cent Xylocaineg for local anesthesia with minimal or no premedication. 1 would condemn general aneslhesia as complicating a procedure that has as its main feature sire plicity. Our technics are otherwise similar. In the catherization laboratory the electrode is positioned under the image intensifier. The electrode i~ passed via the external jugular vein but occasionally the internal jugular vein is used. We have not used the cephalic v=.in, mainly because il is sometimes hard to find. It protmbly makes little difference what vein is used. Three types of pacers have been e m p l o y e d - - t h e Medtronic. Cordis. and General E!ectrlc. All are efficient, but the General Electric pacemaker does not require the messy Silastic~ gl'ue, which may be an advantage. Since the atrioventricular block may be variable and in other patients there may be reversmn to sinus rhythm after permanent pacing has been established, the stand-by demand model has been Used routinely. Our complications,! too, have been minimal and our results generally favorable. Electrode displacement with failure to pace properly has been our most common complication also. and at times has required repeated readjustment. Myocardial perforation has not been a problem. Surprisingly, serious infection has not occurred, even though the sterile technic in the catheterization laboratory leaves something to be desired. In two cases the overlying skin eroded, but eventually closed under conservative management. Prophylactic antibiotics have been used routinely. Electrode fracture has not occurred as has been the case with lhe epicordial leads. The American Journal of Surgery
Transvenous Pacemaking for Senile Heart Block To my knowledge, there have been only thr~ee deaths attributable to pacemaker failure in our series. Finally, whether transvenotls pacing should be used in all adults is questionable. The electrode seems to be well tolerated in the, heart, but thrombus formation as a result has been reported and the possibility of small repeated thronlbotic emboli to the lungs producing pulmonary hypertension must be considered. We believe that epicardial electrodes still have a place in the patient below age sixty who is in generally good health. A longer followup study may prove the approach wrong. P^ut. A. Krr~NEOY (Burlingame, Calif) : Since,-reporting to this Association two years ago the results with forty such endocardiM pacemaking systems, we have extended our experience to sixty patients and l 18 operations. We have had no operative deaths, although such have been reported by others. We have had two hospital deaths due to unrelated causes and twenty late deaths. Forty-eight patients are currently being paced for one to sixty months, Ttto of the forty pacemaking systems have been converted Io epicardial leads. The causes of death are those usually seen in this age group, although we have had two sudden unexplained deaths and accept them as due to a pacing defect, x,Ve have had one case of pulmonary thromboembolus resulting in death and there have been additional such re~x)rls in the literature. Our complications are similar to those the authors listed, although there were seven generatot failures. Supposedly a loss of power will Occur in less than I0 per cent of the pacemakers if elective generator change is made within thirty months. This has not been \
Volume 120, August 1970
our experience and we now elect to change the generator between twenty-four and tqcenty-six months to reduce this incidence. Four of six of the catheter fractures occurred early in the series when one stylet was left in place. "This pacemaking system has been satisfactory and I am sure the results will improve. However, since this procedure has an attendant significant nt'mber of electrode problems, of which loss of catheter position is the most frequent, I agree that in good risk patients thoraeotomy and the placement of myocardir.l electrodes s h o u l d be considered seriously before the endocardial approach is used• BEsso~ B. ROE (closing): I am interested to learn that other physicians have trouble with this valuable but frustrating mode of therapy. Because of the high incidence of transvenous ~leetrode dislodgme'gt, I believe that epicardial electrodes should b e applied~dn those patients who can tolerate thoracotomy without ihazard. This report, of course, was hmtted to those patmnts selected for the transvenous method. Kinking of the wire during insertion of the generator box, location of the generator, and setting adequate current output are factors in ultimate performance. As we indicated, general anesthesia has proved t o be safe and may offset the discomfort to the patient while the electrode is being positioned: Further, we are convinced that the subpectoral position o f the battery box is more comfortable and that the dissection of this deep pocket with the patient under local anesthesia may be m0re difficult, •
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