1. Lee R, Kalman J, Fitzpatrick A, Epstein L, Fisher W, Olgin J, Lesh M,Scheinman M. Radiofrequency catheter modification of the sinus node for “in-appropriate” sinus tachycardia.Circulation 1995;92:2919–2928.2. Leonelli F, Richey M, Beheiry S, Rajkovich K, Natale A. Tridimensionalmapping: guided modification of the sinus node.J Cardiovasc Electrophysiol1998;9:1214–1217.3. Yee R, Guiraudon G, Gardner M, Gulamhusein S, Klein G. Refractoryparoxysmal sinus tachycardia: management by subtotal right atrial exclusion.J Am Coll Cardiol1984;3:400–404.4. Seward J, Khandheria B, Oh J, Abel M, Hughes R, Edwards W, Nichols B,Freeman W. Transesophageal echocardiography. Technique, anatomic correla-tions, implementation, and clinical applications.Mayo Clin Proc1988;63:649–680.5. Groute J, Lufft V, Nikutta P, Lieth H, Bahlmann J, Daniel W. Transesophagealechocardiographic assessment of vena cava thrombosis in patients with long-termcentral venous hemodialysis catheters.Clin Nephrol1994;42:183–188.

6. Ayala K, Chandrasekaran K, Karalis D, Parris T, Ross J. Diagnosis of superiorvena caval obstruction by transesophageal echocardiography.Chest1992;101:874–876.7. Kastner R, Fisher W, Blacky A, Bacon M. Pacemaker-induced superior venacava syndrome with successful treatment by balloon venoplasty.Am J Cardiol1996;77:789–790.8. Sunder S, Ekong E, Sivalingam K, Kumar A. Superior vena cava thrombosisdue to pacing electrodes: successful treatment with combined thrombolysis andangioplasty.Am Heart J1992;123:790–792.9. Francis C, Starkey I, Errington M, Gillespie I. Venous stenting as treatment forpacemaker-induced superior vena cava syndrome.Am Heart J1995;129:836–837.10. Goudevenos J, Reid P, Adams P, Holden M, Williams D. Pacemaker-inducedsuperior vena cava syndrome. Report of four cases and review of the literature.PACE1989;12:1890–1895.

Acute Complications of Permanent PacemakerImplantation: Their Financial Implication and Relation

to Volume and Operator ExperienceKenneth Tobin, DO, James Stewart, MD, Douglas Westveer, MD, and

Howard Frumin, MD

In an effort to assess permanent pacemaker surgicalcomplication rates and the financial implications,

all pacemaker surgeries at our institution were ana-lyzed over a 30-month period. Pacemaker implanta-tions were evaluated for acute complications, adverseclinical events after implantation, total cost of com-plicated and uncomplicated care, and the incrementalcost of complicated care.

• • •All permanent pacemaker placements (n5 1,332)

between January 1, 1994 and June 30, 1996 at WilliamBeaumont Hospital, a 932-bed hospital in Royal Oak,Michigan, were prospectively entered in an electro-physiologic database. The charts of those patients withacute complications related to pacemaker implantationor adverse clinical events during the remainder of theirhospitalization were reviewed.

Acute complications were defined as atrial and/orventricular lead displacement requiring repositioning,infection, pneumothorax requiring chest tube place-ment or prolonged hospitalization, hemothorax, car-diac tamponade, acute myocardial infarction, anddeath. Adverse clinical events were defined as thoseprovoked by pacing rather than the implantation pro-cedure or occurring.48 hours after pacemaker im-plantation. Data were accumulated for the entire co-hort and subdivided by physician operator.

Cost analysis was performed by review of thebilling records of all patients with pacemaker implan-tation-related complications. The cost of 25 randomlyselected uncomplicated cases was used as a reference.

Hospital charges used for all calculations were refer-enced to 1996 values. A cost analysis of the adverseclinical events was not performed.

Physicians and/or research nurses who wereblinded to the technicians performing the procedurecollected the data. In situations where the connectionbetween pacemaker implantation and an adverse clin-ical event was unclear, the physician director of thecardiac pacemaker program at William BeaumontHospital reviewed the charts and rendered judgment.

All pacemakers were implanted by board certifiedcardiologists (n5 8) in a dedicated electrophysiologiclaboratory. Subclavian vena puncture was used in.95% of cases. Dual chamber pacemakers were im-planted in 70% of patients. The overall complicationrate for pacemaker implantation during the study pe-riod was 4.2% (n5 56). Within the study populationthere was a 2.4% (n5 32) incidence of lead displace-ment (combined atrial and/or ventricular), a 1.5%(n 5 20) incidence of pneumothorax requiring chesttube or prolonged hospitalization (,10% pneumotho-rax with no radiographic change over 24 hours wereexcluded), a 0.2% (n5 3) incidence of pericardialtamponade, and a 0.08% (n5 1) incidence of hemo-thorax and death (Table I).

A reverse correlation was noted between the com-plication rate and operator activity (cases per year) orexperience (years implanting) (r5 20.90, p5 0.002and r5 20.81, p5 0.016, respectively). The likeli-hood of ventricular lead dislodgement was inverselyrelated to operator activity (r5 2075, p5 0.03) butnot with operator experience (r5 0.36, p5 0.38). Apneumothorax that required a chest tube showed aslight correlation with operator experience (r5 0.66,p 5 0.08) but this did not reach statistical significance.The fewest complications occurred with operatorswho performed.40 cases/year and/or had.10 yearsexperience. The lowest complication rate was ob-

From the Northern California Cardiology Associates, Sacramento,California; and Division of Cardiology, Department of Medicine,William Beaumont Hospital, Royal Oak, Michigan. Dr. Frumin’s ad-dress is: William Beaumont Hospital, Division of Cardiology, 3601W. 13 Mile Road, Royal Oak, Michigan 48073. Manuscript re-ceived June 14, 1999; revised manuscript received and acceptedOctober 12, 1999.

774 ©2000 by Excerpta Medica, Inc. All rights reserved. 0002-9149/00/$–see front matterThe American Journal of Cardiology Vol. 85 March 15, 2000 PII S0002-9149(99)00861-9

served at the hands of those operators with experienceusing the cephalic vein cutdown technique.

There were a total of 7 adverse clinical events thatwere not classified as acute complications (4 cases ofcongestive heart failure, 2 cases of angina pectoris,and 1 cerebral vascular accident). In 3 of the 7 cases(1 congestive heart failure and 2 angina), the eventwas determined to be the consequence of cardiacpacing and was reversed by pacemaker reprogram-ming. In 4 of these cases the event was temporallyunrelated to pacemaker implantation and believed tobe an incidental occurrence.

The cost of all acute complications was equal to5.1% of the total pacemaker budget. The costs ofuncomplicated pacemaker surgery was $11,637 (6$2,087). The average cost of complicated pace-maker implantation was $25,722 (6 $21,588). Theincremental cost for each complication was deter-mined by subtracting the cost of uncomplicatedimplantation from the average cost of each compli-cation type. The average and incremental costs ofcomplicated implantation were: lead dislodgement,

$27,184 (6 $25,925), incremental cost$14,547; pneumothorax $21,687 (6$9,224), incremental cost $10,052;tamponade $44,109 (6 $27,925), in-cremental costs$32,472; and hemo-thorax $30,094, incremental costs$18,466. (Table I).

• • •There are nearly 150,000 pace-

makers inserted per year in theUnited States.1 Acute complicationsafter pacemaker implantation are notrare, ranging from 4% to 7%.2–13Ourexperience revealed an overall rateof 4.2%. A large series by Parsonnetet al,2 reported a 5.7% overall com-plication rate and is often quoted asan industry standard. This study dif-fered from ours in that there weresmaller institutional and clinical vol-umes and a larger number of primaryoperators. The complication defini-tions were similar. A more recentstudy by Link and colleagues3 re-ported a 6.1% overall complicationrate. Their population differed in thatall patients were.65 years of ageand received dual-chamber devices.A higher percentage of dual-chamberdevices would be expected to in-crease procedural complication rates.Cephalic vein access was used in23% of their patients, which shouldhave had the reverse effect.4

A recent study by Chauhan et al,5

analyzed 2,119 new pacemaker im-plantations between 1987 and 1993at a large medical center. They ob-served a 3.8% overall acute compli-cation rate and 1.6% lead displace-

ment. The lower incidence of pneumothorax (0.6% vs1.5%) could be explained by that most operators (16of 23, 70%) had accumulative experience of.100 ofpacemaker implantations. The remaining 7 implanterswere closely supervised during the study and averaged50 to 100 pacemaker surgeries per year.

Previous investigators have stated that the relationbetween operator experience and complication rates islinear.2 We analyzed our findings and indeed found alinear reverse correlation between the total complica-tion rate and operator activity or experience. Thelowest percentage of complications occurred with op-erators performing.40 cases/year and having.10years experience. In our series, all operators perform-ing .40 cases per year had.10 years experience andvisa versa; therefore, activity and experience could notbe separated as individual predictors. We also notedthe lowest complication rates at the hands of thoseoperators employing the cephalic vein cutdown tech-nique. Because the numbers of cephalic vein cut-downs were small, it was unclear whether this re-

FIGURE 1. The relation between operator activity (procedures/implanter/year) andthe occurrence of complications. Data collected from Parsonnet et al2 are comparedwith William Beaumont Hospital data. A striking overlap is noted. Adapted with per-mission from Parsonnet et al.2

TABLE I Incidence of Cost of Complications

Complication n % Incidence Average CostIncremental

Cost*

Atrial lead displacement 16 1.2 $ 27,184 $14,547(6$25,925)

Ventricular lead displacement 16 1.2 $ 27,184 $14,547(6$25,925)

Pneumothorax with chest tube 20 1.5 $ 21,687 $10,052(6$ 9,224)

Hemothorax 1 0.08 $ 30,094 $18,466Pericardial tamponade 3 0.2 $ 44,109 $32,472

(6$27,975)Death 1 0.08 $ 30,094 $18,466Total 56 4.26 $ 25,722

(6$21,588)

*Incremental cost 5 (the average cost of complication 2 cost of uncomplicated care [$11,637]).

BRIEF REPORTS 775

flected a direct effect or was an indirect reflection ofgeneral surgical capability. We graphed our findingsof individual complication rates versus operator activ-ity alongside the data of Parsonnet et al, and found astriking similarity (Figure 1).2 Our findings supportthose of Parsonnet et al, suggesting a minimumthreshold of activity and/or experience, to producelower than average complication rates; however, thesmall number of operators in our study do not allowdetermination of a precise breakpoint. The reproduc-ibility of these findings suggest they may be extrapo-lated and useful in the certification process. Hospitalstruly striving for cost efficiency and medical excel-lence may well consider extending the period of train-ing or supervision to ensure all operators have suffi-cient opportunity to produce lower than average com-plication rates.

There were 7 adverse clinical events (4 congestiveheart failure, 2 angina, and 2 cerebral vascular acci-dents) that occurred in the study population after pace-maker implantation and before hospital discharge.Three of these events were believed to be related topacing.14,15 A thorough chart review of the other 4cases did not reveal any evidence that the pacemakerimplantation surgery itself was responsible for theadverse clinical event. These were considered to becoincidental (e.g., cerebral vascular accident severaldays after pacemaker implantation with no identifiedantecedent arrhythmia cardiac event or cardiac shunt).

We assessed the financial impact of acute pace-maker complications and discovered that our 4.2%complication rate produced a 5.1% increase in thetotal pacemaker budget. The cost of complicationswere related to consumption of hospital resources, notmedical severity. The incremental cost of lead dis-lodgement was greater than that of pneumothorax.Although the latter represents a greater potential foracute morbidity, the former requires a second labora-tory procedure, and thus, results in higher hospitalcharges. The cost of hemothorax was less than that ofpericardial tamponade.

Acute complications after pacemaker surgeryare neither rare nor inexpensive. The likelihood of

complication declines with increasing operator ac-tivity, experience, and use of the cephalic vein cut-down technique. The incremental cost of care forpatients with surgical complications are related tothe use of hospital resources and do not parallelmedical severity.

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