Day Case Permanent Pacing

GUY A. HAYWOOD, SUE M. JONES, A. JOHN CAMM, and DAVID E. WARD

From St. Ceorge's Hospital, London. United Kingdom

HAYWOOD, G.A., ET AL.: Day Case Permanent Pacing. We have previously reported our preliminaryexperience of day-case permanent pacing in the United Kingdom. The study has now been extended to50 patients with/oJJou'-up o/22 ± 4 months. During the study period, all palients referred/or permanenfpacing, either to the senior author, or as in-hospi(ai transfers, were considered for the study. Forfy Iwopercent of patients considered fulfiiied inclusion and exclusion criteria, resulting in a (otaJ of 50 patientsbeing randomized either to day case or convenlionai in-patienf management. In (he first month postim-pJantation, one patient in each group developed a complication requiring revision of system. Oniy onefurther pacing related complication occurred over the foJlow-up period, percutaneous extrusion of afixation sleeve with spontaneously healing of the tvound. This was in a day-case palient. Mean durationof in-patient stay was 5.7 hours in day-case palients, compared with 70.0 hours in those managedconventionally. Postimplantation local physician consultation rates were equal in both groups. Ques-tionnaires were used to determine the relative acceptability to patients of the two management protocols;on a ten point score of acceptability, the mean score for both groups was 8.8. The difference in cost perpatient using day-case management was approximately £430 {$817}. We conclude that day-case per-manent pacing in the United Kingdom is feasible, acceptable to patients, and has considerable economicbenefits. (PACE, Vol. 14, May, Part I 1991J

day case, pacing, cost

IntroductionThere are 62 pacing centres in Britain each

providing a service for an average of 900.000 peo-ple.' This represents a considerable pressure onacute cardiology services both economically andin terms of bed occupancy. Ambulatory pacing,(same day discharge following permanent pacing)has been reported in the United States^ and WestGermany * and its safety demonstrated in these set-tings. Recent reviews in the United Kingdom have,however, suggested that patients should remain inhospital for 24 hours after the procedure." Wehave previously reported our preliminary expe-rience of day-case permanent pacing in the UnitedKingdom.^ The study has now been extended to50 patients with follow-up of 22 ± 4 months. Our

Address for reprint.?: Dr. D.E. Ward. Dept. of Cardiology, St.George's Hospital, Blackshaw Road, London SWl7 OQT,United Kingdom. Fax: 44-81-7677141.

Received November 30, 1990; revision [anuary 23. 1991; ac-cepted January 24, 1991.

aims were to investigate the feasibility and ac-ceptability to patients of day-case management bya randomized, controlled study in a United King-dom pacing centre, to determine what percentageof pacing referrals had suitable home circum-stances for a day-case management protocol, tocompare the work load imposed on local physi-cians in the first month following day case or con-ventional management, and to assess the likelycost and waiting list benefits of introducing day-case permanent pacing.

Methods

Patients accepted for pacing were assessed ac-cording to the criteria in Table I. If suitable, thenature of the study was explained to the patients,who were then randomized to either day case orconventional management. No patients objectedto randomization. Conventional management re-quired at least one night as an in-patient followingpacing. The intended schedule for conventionalmanagement was admission on day one, implan-

PACE, Vol. 14 May 1991, Part I 773

HAYWOOD, ET AL.

Table I.

Inclusion Criteria Exclusion Criteria

1) Over 18 years of age.2) Requiring elective

pacemaker insertionor generator change,

3) At home, or residenton a general hospitalward prior to admis-sion.

1) Elective revision pro-cedures.

2) Infected permanentor infected temporarysystems.

3) Presence of anothermedical problem re-quiring in-patientcare.

4) Inability to walk fromroom to room.

5) Lack of a telephoneat home,

6) Lack of someone tostay with the patienton the first night fol-lowing pacing.

7) Inability to arrangeday-case transport.

tation on day two and discharge on the morningof day three. Day-case patients were admitted onthe morning of implantation, the procedure car-ried out on the morning list, and the patients weredischarged by early evening on the same day. Day-case patients were accompanied home by a friendor relative who had agreed in advance to stay withthem during the first night postimplantation. Pa-tients were asked to starve for 4 hours prior to theprocedure. Consent was obtained and standardmethods followed for implantation or generator

change. No patients received sedatives or generalanaesthesia. A pressure dressing was applied be-fore leaving the catheter laboratory. Patients re-turned to the day ward, cardiac or general medicalwards according to availability. Day-case patientshad a chest x-ray and pacing check during the af-ternoon following pacing; these procedures wereperformed the following day in the conventionalmanagement group. At discharge, patients weregiven a brief explanatory letter to pass to theirlocal physicians.

At 1 month patients were reviewed in the pac-ing clinic, an initial follow-up assessment made(Table II), and a questionnaire requesting detailsof physician consultations in the month followingpacing sent to the patients' local physician. Pa-tients continued to be followed at either our ownpacing clinic or, in the case of patients moving outof our area, through the cooperation of other pac-ing clinics in the United Kingdom.

Statistical Analysis

Results from the day case and conventionalgroups were compared using the two-tailed Mann-Whitney U test.

Results

Fifty patients entered the study, 32 males and18 females. These represented 42% of those con-sidered lor inclusion. The reasons for exclusionof the remaining 58% are shown in Figure 1.Twenty-six were randomized to day case and 24to conventional management. The characteristicsof the study groups are shown in Table III. Onlythree patients underwent generator changes, allthese were randomly allocated to conventional ad-

Table II.

One Month Follow-Up Assessment

1) History from the patient of any symptoms or prob-lems over the preceding month.

2) Examination of pacing site.3) Standard pacing check of threshold and sensitivity.4) Completion of acceptability questionnaire.5) Dispatch of a letter to the GP requesting details of

any consultations made by the patient-

aEanD•

Riiamr\<i for Fxdiision

Revision of SysieniOther IrjalOlhet Medical ProblemNo phoneHIS Buridle AblationNo RelaiivB ! • AccompanyInfected Temp. Wire

(58%)

(30%)

( 5%)(35%)

( 2%)( 4%)(30%)< 4%)

Figure 1. Patients excluded from the study, with per-centagi! frequency of exclusion criteria.

774 May 1991, Part I PACE, Vol. 14

DAY CASE PERMANENT PACING

Table III.

Characteristics of the Study Groups

%Management Mean % Generator

Protocol Number Age Males Changes

Day-caseConventional

2624

73.773.2

7354

012.5

mission; two were VVI systems and one a DDD.The other 47 procedures were all new implanta-tions. Subclavian vein puncture was performed in48% of the implants in the day-case group and44% in the conventional management group. Inthe remainder, the cephalic vein was used. Therelative proportions of tho different pacing modesin the day case and conventional managementgroups are similar to the overall implantation ratesat our centre taken from a 3-month sample duringthe course of the trial (Fig. 2]

Two patients in the day-case group were keptin overnight, one because of the developmentwithin 1 hour of implantation of a significant he-matoma, and the other because of the refusal ofthe patient's family to accept her home on the dayof pacing (despite prior agreement).

Duration of Stay

In the day-case group, the mean length of staywas 7.6 hours; this fell to 5.7 hours if the two pa-tients who could not he discharged on the day ofpacing were excluded. Mean stay in the conven-tional group was 70.0 hours.

100 -I

a.oO

(0a>c•5.0

20

Pacing Systems ImplantedDay-case v. Conventional

• Day-Case0 Conventional• Overall Nov-Feb 1988

VVIR DDD/R AAI/R

Pacing Mode

VVI

Figure 2. Percentages of patients in different pacingmodes in day-case and conventional groups, and in allpalients paced at our cenfre over a 3-month period dur-ing the study.

FoUow-Up

No patients were lost to follow-up. Mean du-ration of follow-up was 22 ± 4 months.

Complications

One early complication (< 1 month postim-plantation) requiring revision of system occurredin each group (Tahle IV). A further patient in theconventional group required repositioning of anatrial electrode on the day following implantation.The only late pacing-related complication oc-curred in a patient who had undergone day-casemanagement, in whom the pacing lead fixationsleeve migrated and discharged itself through the

Management Protocol

Day-case (total 26)

Conventional (total 24)

Table IV.

Complications in First Month Postimplantation

Electrode Problem Pneumothorax

Electrode dislodged (1)High threshold at one

month (1)'Atrial Electrode dis-

lodgment (1)

0

1

InfectionRequiring

Re-Do

0

r

SignificantHematoma

1

0

* same patient

PACE, Vol. 14 May 1991, Part t 775

HAYWOOD, ET AL.

skin. The wound rehealed spontaneously withoutintervention. Four patients died during the fol-low-up period, one in the day-case group andthree in the conventional management group. Theday-case death was in an 89- year-old lady follow-ing worsening congestive cardiac failure with nor-mal pacing function. In the conventional groupthere was one death from congestive cardiac fail-ure unrelated to pacing, one following a severestroke and one ruptured aortic aneurysm.

Local Physician Consultations

There was an 80% response rate to the letterrequesting information from the patients' localphysicians. There were 11 local physician con-sultations in each group in the month followingpacing, hi the day-case group night (73%) of thesewere related to the pacing procedure, but only twowere associated with a problem: minor discomfortin one and inflammation at tho pacing site in theother. In the conventional group five consulta-tions (45%) were related to the pacemaker, Ofthese, four were associated with problems, anxietyover hematoma in two, inflammation in two, anddiscomfort at the site in one.

Acceptability to Patients

At 1 month follow-up, on a ten-point scoringsystem relating to how acceptable they found theexperience as a whole (0 = maximally unaccept-able, 10 = maximally acceptable), both groupsgave a mean score of 8.8 ± 1.9. In reply to whetherpatients felt ready to go home at the time of dis-charge, four (15%) patients in the day-case groupsaid they had not felt ready, compared with two(9%) in the conventional group. In reply towhether, if they were to 're-live' the experience,they would prefer to stay in overnight or go home

following pacing, most patients appeared to optfor a repetition of the management protocol theyhad already experienced; however, 5 (23%) of theconventional management group felt they wouldhave preferred to have gone home on the day ofpacing and 7 (19%) of the day-case group wouldhave preferred to stay. In order to assess whetherday-case patients experienced more anxiety on re-turning home following pacing, they were askedto grade the degree of anxiety they felt they hadexperienced; (a) while awaiting admission, (b)during the pacing admission and (c) on returninghome following pacing. The mean values for thedegrees of anxiety that patients stated they hadexperienced were low throughout with no signif-icant differences between day case and conven-tional groups (Table V).

Statistical Results

There were no statistically significant differ-ences in the frequency of local physician consul-tations in the first month following pacing, or inthe three sections of the acceptability question-naire between the two groups. The numbers in-volved in the study are too small to determinewhether any statistically significant difference ex-ists in the frequency of electrode dislodgment be-tween the two management groups, however, thenumbers that would be required to achieve thisare too large to make such a study feasible. Meanreported figures, for the frequency of electrode dis-lodgment suggest this to be approximately 2%^'using conventional management. A sample sizecalculation shows tbat the number of patients thatwould have to be studied for a 90% probability ofrevealing a doubling of this frequency of electrodedislodgment with day-case management is 2,500,using a one-tailed test at the 5% level.

ManagementProtocol

Day-case (26)Conventional (22)

Table V.

Level of Anxiety

Prepacing

2.7 ± 3.42.7 ± 3.1

(Min = 0

During

1.7 ±2.4 ±

, Max =

Pacing

: 2 2: 2.8

10)

Postpacing

0.9 ± 2.3 (0-9)0.7 ± 1.5 (0-5)

776 May 1991, Part I PACE, Vol. 14

DAY CASE PERMANENT PACING

Discussion

Of the patients randomized to day-case man-agement, 24 (92%) successfully underwent themanagement protocol and were discharged homeon the same day. This demonstrates that, withsuitable screening of referrals, day-case perma-nent pacing is feasihle in the United Kingdom pac-ing centres. In our population, we considered 42%of patients requiring permanent pacing proce-dures were eligible for day-case management. Thetwo most frequent reasons for exclusion from thestudy: lack of someone to accompany the patienton the first night following discharge and othermedical prohlems necessitating further in-patientcare, probably reflects the large number of elderlypatients requiring pacing. Sixty percent of pa-tients paced at our centre, during 1988, were over75. These patients frequently live alone, and havea higher prevalence of multiple medical problems.

For the reasons of sample size stated, a sta-tistically sound assessment of the relative fre-quency of complication rates comparing the twomanagement protocols would require a large mul-ticentre study; however, there was no obvious dif-ference in complication rates arising from thisstudy. One potential weakness in applying the re-sults from this study to centres where dual cham-ber pacing is predominant is the high percentageof patients in our own centre who received VVIsystems at the time of the implantation phase ofthis study. However, since the completion of re-cruitment into this study, we have continued toimplant dual chamher systems using day-casemanagement and have not noted any increase inthe complication rates in these patients.

In terms of patient acceptability, there is noevidence that superior results are obtained by useof an overnight-stay management protocol. Thereis also no evidence that earlier discharge imposesa greater burden on local physicians in the firstmonth following discharge.

The cost per patient-day in the cardiothoracicunit of our hospital, excluding costs arising frominterventional procedures and investigations, is£160 ($304). This includes in-patient and day-casebeds. The cost per patient hour is, therefore, £6.68($12.69). Comparing the mean durations of stayfor the two groups, the difference in cost per pa-tient between day-case and conventional manage-ment is, therefore, [£B.68 x 70) - (£6.68 x 5.7)

= £429.50 ($816). These figures derive from ourown centre and while in similar centres in theUnited Kingdom equivalent proportional savingsmight be expected, the impact on costs in pacingcentres in other countries may differ. We shouldalso point out that the difference in costs betweenday case and conventional management wouldhave been lower if it had heen possible to adhereto the planned 48-hour management protocol in-tended in the 'conventional' group. Implantationwas postponed following admission in several pa-tients due to pressure on time available in thecatheter laboratory. In day-case patients, the op-tion to postpone implantation and allow other pa-tients to take priority was not available.

Day-ward facilities are being expanded inmany hospitals in the United Kingdom, however,sufficient places available for the total number ofpatients who could undergo day-case pacing is un-likely. Although the availability of day beds maylimit the potential increase in through put thatcould be achieved by use of day-case management,beds on general wards could be turned to this use.Centers with a similar rate of eligibility in the pop-ulation requiring pacing, might expect to be ableto double through-put without increasing the totalnumber of beds used for pacing. This wouldclearly have a major impact on waiting lists forpermanent pacing procedures in the United King-dom and in other countries where there is a rela-tive shortage of cardiothoracic beds.

Acknowledgments: We thank Dr. |.D. Poloniecki lur as-sistance in the statistical deKigii and analysis of Ihis study andto our colleagues Dr. C.W. Humphrey and Dr. D. Rtjcivvood forenabling us to involve their patients in the trial.

References

1. Rickards AF. Where's the block? Br Med I 1984;288:737-738.

2. Belott PH. Outpatient pacemaker procedures. Int Jcardio! 1987; 17:169-176.

3. Zegelman M, Kreuzer I, Wagner R. Ambulatorypacemaker surgery-Medical and economical ad-vantages. PACE 1986; 9:1299-1303.

4. Bloomfield P, Miller HC. Permanent pacing. Br MedI 1987; 295: 741-744.

5. Haywnod GA, Camm A|, Ward DE. Insertion of per-manent pacemakers as day c:ase procedure. Br Med) 1989; 299:1139.

6. Ohm J, Breivik K. Pacing leads. In Perez-Gomez F(ed.): Cardiac Pacing, Electrophysiology, Tachyar-rhythmias, Editorial Crouz, Madrid. 1985: p. 971.

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