Background The surgical closure of an atrial septal defect isfrequently recommended for patients over 40 years of age. However,the prognosis for such patients with unrepaired defects is largelyunknown, and the outcome for patients operated on after thefourth decade of life has not yet been compared with that formedically treated patients in a controlled follow-up study.
Methods In a retrospective study, we examined the clinical courseof 179 consecutive patients with isolated atrial septal defectsdiagnosed after the age of 40. The 84 patients (47 percent)who underwent surgical repair were compared with the 95 patients(53 percent) who were treated medically. The mean (±SD)follow-up period was 8.9±5.2 years (range, 1 to 26).
Results Multivariate analysis revealed that surgical closureof the defect significantly reduced mortality from all causes(relative risk, 0.31; 95 percent confidence interval, 0.11 to0.85). The adjusted 10-year survival rate of surgically treatedpatients was 95 percent, as compared with 84 percent for themedically treated patients. In addition, surgical treatmentprevented functional deterioration, as measured by the New YorkHeart Association class (relative risk, 0.21; 95 percent confidenceinterval, 0.08 to 0.55). However, the incidence of new atrialarrhythmias or of cerebrovascular insults in the two groupswas not significantly different.
Conclusions The surgical repair of an atrial septal defect inpatients over 40 years of age, as compared with medical therapy,increases long-term survival and limits the deterioration offunction due to heart failure. However, surgically treated patientsshould be followed closely for the onset of atrial arrhythmiasso as to reduce the risk of thromboembolic complications.
Patients with isolated atrial septal defects may have a benignclinical course. Most of them have minimal, if any, functionallimitation during childhood and adolescence.1 Patients oftensurvive to an advanced age.2,3,4 Nevertheless, the life expectancyof patients with unrepaired atrial septal defects is generallythought to be shortened. According to a commonly cited observationalreport, less than 50 percent of these patients survive beyondthe age of 40 years, and only 10 percent reach the age of 60.5However, the clinical series that formed the basis for thisestimate included only small numbers of middle-aged and elderlypatients, and these either were examined on only one occasion6or were followed for a mean period that did not exceed fiveyears.2 Furthermore, although the surgical closure of an atrialseptal defect is performed frequently in patients over 40,7,8there is a lack of controlled follow-up studies comparing thelong-term outcome for such patients with that of a medicallytreated population with unrepaired defects. The data availablein the literature cannot be considered sufficient to demonstratewhether surgical closure or medical treatment is preferablefor middle-aged and elderly patients with atrial septal defects.9
In the present study, we followed the clinical course of 179consecutive patients with isolated atrial septal defects diagnosedafter the age of 40. The outcome of the 84 patients who wereoperated on was compared with that of the remaining 95 patients,who were treated medically throughout the follow-up period.The aim of the study was to examine the effect of surgery onlong-term survival as well as on the incidence of cardiovascularevents during follow-up.
Methods
Study Population
Between November 1966 and July 1991, 179 patients over 40 yearsof age were given a diagnosis of atrial septal defect at theUniversitätsklinik Freiburg or the Herzzentrum Bad Krozingen.There were 125 women (70 percent) and 54 men (30 percent), witha mean (±SD) age of 56±9 years (range, 41 to 79).Of these patients, 3 (2 percent) had ostium primum defects,13 (7 percent) had sinus venosus defects of the superior venacaval type, and the remaining 163 (91 percent) had ostium secundumdefects. All the patients underwent right heart catheterization,and the ratio of pulmonary to systemic blood flow (Qp:Qs) wasdetermined by oximetry. The study patients had predominant left-to-rightinteratrial shunt with a Qp:Qs of at least 1.5:1. We excludedfrom the study patients who had been referred for reoperationof previously repaired atrial septal defects (i.e., those repairedbefore the age of 40), as well as those with complex congenitalcardiac malformations. Patients with angiographically confirmedcoronary artery disease or severe mitral regurgitation werealso excluded.
Treatment of the Atrial Septal Defect
Surgically Treated Patients
Surgical closure of the defect was performed in 84 patients(47 percent). The mean age at the time of operation was 56±7years. Surgical closure of the defect was combined with repairof partial anomalous pulmonary venous drainage in three patients(4 percent) and tricuspid-valve annuloplasty in four (5 percent).Sixty-seven of the 84 patients (80 percent) were referred forsurgery within 12 months of confirmation of the diagnosis bycardiac catheterization. The remaining 17 patients in this group(20 percent) were initially treated medically and underwentsurgery after a period ranging from 2 to 16 years (mean, 7±4years), either at the discretion of the physicians caring forthem or because of the initial reluctance of the patients toundergo surgery. A complete clinical and hemodynamic follow-upevaluation, including right and left heart catheterization aswell as coronary angiography, was performed in all patientsbefore surgery.
Medically Treated Patients
In our study group, 95 patients (53 percent) were given onlymedical treatment (digitalis, diuretics, or nitrates), whichextended throughout the follow-up period; the decision not tooperate was based on the judgment of the cardiologists and cardiacsurgeons involved in each case. All patients who were not referredfor surgical closure of the defect after diagnosis were advisedto appear for follow-up examinations at 12-month intervals oras soon as they noticed the onset of new symptoms or the worseningof existing symptoms.
Follow-Up Evaluation
The mean follow-up period was 8.9±5.2 years (range, 1to 26). The current status of all patients was assessed by meansof a standardized questionnaire addressed to the referring physicianor by direct telephone contact with the patient or a first-degreerelative. Complete clinical data included the patient's NewYork Heart Association (NYHA) functional class, cardiac rhythm(in particular, atrial fibrillation or flutter), specific cardiacsymptoms, current medication, and information on the occurrenceof cardiovascular events. A cardiovascular event was definedas death due to cardiovascular causes (congestive heart failure,sudden death, massive pulmonary embolism, or stroke), transientischemic attack or nonfatal stroke, peripheral arterial embolization,a new instance of atrial fibrillation or flutter (whether sustainedor paroxysmal), or the need for implantation of a permanentpacemaker. Postoperative cardiovascular events were furtherclassified as early or late, depending on whether they occurredwithin 30 days of surgery or after this period. Finally, theprogression to congestive heart failure was clinically definedas a change in the patient's NYHA ranking to class III or IV,which reflected either the death of the patient due to heartfailure or severe functional limitation at the end of the follow-upperiod.
Death certificates as well as autopsy reports were obtainedfor all patients who died. Causes of death were classified aseither cardiovascular, according to the above definition, ornoncardiovascular. In addition, for patients who underwent surgicalrepair of the defect, perioperative mortality was defined asdeath within 30 days after the operation.
Statistical Analysis
In the statistical description of the patients, absolute andrelative frequencies were calculated for discrete variables;means (±SD) were determined for continuous variables.Differences between the characteristics of the two patient groups— medical and surgical — were tested for significancewith Fisher's exact test, for discrete variables, and with thetwo-sample Wilcoxon rank-sum test, for continuous variables.10
Overall survival time for all patients started at the date ofright heart catheterization. To avoid waiting-time bias, surgicallytreated patients were counted as belonging to the medicallytreated group until the date of closure of the defect.11 Forthe surgically treated patients, survival time free of cardiovascularevents started at the date of operation. A Cox proportional-hazardsmodel12 was used to investigate the independent prognostic effectof base-line characteristics on the patients' total and event-freesurvival. Base-line continuous variables were prospectivelydichotomized at clinically relevant cutoff points. The resultsare presented as estimates of relative risk, with corresponding95 percent confidence intervals and P values calculated withWald's test. Because of the high number of cardiovascular eventsoccurring shortly after surgical repair, the corresponding relativerisk for surgically treated, as opposed to medically treated,patients is not constant over time and must be interpreted asan average risk during the whole follow-up period. For purposesof graphic presentation, estimates of the probability of overallsurvival according to treatment group were calculated on thebasis of the Cox model.13 Multiple logistic regression was usedto investigate the independent effect of base-line characteristicson the functional deterioration of patients, defined as a changein the patient's status to NYHA class III or IV — severefunctional limitation or death due to heart failure —by the end of the follow-up period. The results are presentedas odds-ratio estimates with corresponding 95 percent confidenceintervals and P values calculated with Wald's test.
All tests of significance were two-tailed, with P values ofless than 0.05 assumed to indicate significance.
Results
Clinical and Hemodynamic Characteristics at Diagnosis
The symptoms and clinical characteristics of the medically andsurgically treated patients at the time of diagnosis are presentedin Table 1. The mean age of the patients who subsequently underwentclosure of the defect was 54±7 years, whereas the ageof those who were treated medically was 57±10 years (P= 0.01). There was no significant difference between the twogroups with regard to other clinical characteristics. Overall,168 patients in the study population (94 percent) reported cardiacsymptoms at presentation.
Table 1. Clinical Characteristics of 179 Consecutive Patients Who Presented with Atrial Septal Defect.
Table 2 shows the hemodynamic characteristics of the study groupat the time of initial cardiac catheterization. Comparison ofpulmonary-artery pressures — systolic, diastolic, andmean — revealed no appreciable difference between themedical and surgical groups. Overall, 121 patients (68 percent)had systolic pulmonary-artery pressures of less than 40 mm Hg,46 patients (26 percent) had systolic pressures of 40 to 60mm Hg, and 12 patients (7 percent) had severe pulmonary hypertensionwith systolic pressures exceeding 60 mm Hg. Surgically treatedpatients had lower values for pulmonary vascular resistance(Table 2). However, markedly elevated pulmonary vascular resistance— defined as a value higher than 400 dyn · sec· cm-5 — indicating severe pulmonary vascular obstructivedisease14 was present in only four patients (2 percent of thestudy population), two in each group.
Table 2. Hemodynamic Characteristics at the Time of Diagnosis.
Multivariate Analysis of Factors Affecting Mortality
Cox proportional-hazards analysis revealed a significant decreasein overall mortality after surgical closure of an atrial septaldefect. After adjustment for the covariates listed in Table 3,the relative risk of death was 0.31 for patients who underwentsurgical closure, as compared with the patients treated medically(P = 0.02). The estimated probability of survival was 98 percentat 5 years after catheterization and 95 percent at 10 yearsfor surgically treated patients, as compared with 93 and 84percent, respectively, for those treated medically (Figure 1).Among the clinical and hemodynamic variables, NYHA class IIIor IV, a systolic pulmonary pressure of 40 mm Hg or more, anda Qp:Qs ratio of more than 2.5:1 at the time of diagnosis werefound to be significant independent predictors of death in thestudy population (Table 3).
Figure 1. Estimated Probability of Survival for 179 Patients with Isolated Atrial Septal Defects.
The mean follow-up time was 8.9±5.2 years. Survival data have been adjusted for all important prognostic variables. The adjusted relative risk of death was 0.31 for surgically treated patients as compared with medically treated patients (95 percent confidence interval, 0.11 to 0.85; P = 0.02).
There were no perioperative deaths among the patients who underwentsurgical closure of the defect. After discharge from the hospital,the 84 patients in this group were followed for a mean of 9.1±5.0years. Six patients died during the follow-up period. Therewere three deaths from cardiovascular causes; two of these weredue to congestive heart failure. In the third patient, who diedsuddenly, 24-hour Holter monitoring had indicated the presenceof complex ventricular arrhythmias. Two patients died from noncardiovascularcauses, one of a metastatic colonic tumor and one of an ovariantumor. The cause of death of one patient remained unknown.
Medically treated patients were followed for 8.8±5.3years after diagnosis of the defect. During this period, 23patients died. Of 21 deaths due to cardiovascular causes inthis group, 15 were due to congestive heart failure; 1 was dueto massive pulmonary embolism; and 2 were the result of stroke.In the remaining three patients, who died suddenly of unspecifiedcardiac disease, an arrhythmogenic cause of death was consideredprobable on the basis of a history of ventricular arrhythmia.One medically treated patient died of an unknown cause and anotherpatient, who had recurrent respiratory infections, died of pneumonia.
Incidence of Cardiovascular Events
Cardiovascular events occurred in nine (11 percent) of the surgicallytreated patients during the early postoperative phase, two ofwhom required implantation of a pacemaker (Table 4). After dischargefrom the hospital, another 25 patients from this group (30 percent)had late complications. Of the nine patients who had a latetransient ischemic attack or stroke, six (67 percent) had atrialfibrillation, which was of new (postoperative) onset in twocases. Only two of the six patients with atrial fibrillationwere receiving anticoagulant therapy at the time of the event.In the medically treated group cardiovascular complicationsoccurred in 37 (39 percent) of the patients during long-termfollow-up (Table 4). Six medically treated patients had a transientischemic attack or stroke during this period, but only two ofthese patients had a history of permanent or paroxysmal atrialfibrillation.
Multivariate analysis showed no independent favorable effectof surgery on the overall incidence of cardiovascular eventsduring follow-up (Table 3). This finding is explained by thelower average duration of event-free survival in the surgicallytreated group, which was due to the increased incidence of nonfatalcardiovascular complications in the early postoperative period.
The functional status of the surgically and medically treatedpatients at presentation and at the end of the follow-up periodis presented in Figure 2A and Figure 2B. Overall, function,as measured by the NYHA scale, improved in 27 of the surgicallytreated patients (32 percent) and deteriorated in only 9 patients(11 percent). The favorable effect of surgical treatment wasmost prominent in the subgroup of patients with severe preoperativeheart failure (NYHA class III or IV), since 69 percent of thosepatients had a long-term improvement in NYHA functional classafter defect closure.
Figure 2. New York Heart Association (NYHA) Functional Class of Patients at the Time of Diagnosis (Gray Bars) and at the End of the Follow-up Period (Black Bars).
Panel A shows patients in the surgical group and Panel B those in the medical group. The numbers above the bars are percentages of patients.
In the medically treated group, a deterioration in NYHA classwas observed in 32 of the 95 patients (34 percent); only 3 patients(3 percent) had a long-term lessening of the severity of heartfailure with medical treatment. Logistic-regression analysisconfirmed that the surgical repair of atrial septal defectsresulted in a considerable reduction in the risk of functionaldeterioration (P = 0.002) (Table 3).
Discussion
The surgical repair of atrial septal defects has been performedfor approximately 40 years.15 During this time, several investigatorshave reported on the clinical course of patients who were operatedon after the age of 40.7,8,16,17,18,19 However, none of thesestudies compared the outcome of surgical treatment with thatof medical treatment in an age-matched control group with unrepaireddefects. In addition, Murphy et al. recently pointed out thatpatients who undergo surgery after the age of 40 are at increasedrisk for postoperative cardiovascular complications, whereassurgically treated children and young adults have an excellentprognosis.20 In accord with these findings, we found no favorableeffect of operation on the survival of elderly patients withatrial septal defects and concomitant cardiac diseases, suchas coronary atherosclerosis or mitral regurgitation.21 In thelight of such findings, the traditional recommendation of routinesurgical treatment for middle-aged and elderly patients withatrial septal defects and substantial left-to-right shunts7,22has recently been called into question.9
In our present study the clinical course of 179 consecutivepatients with isolated atrial septal defects diagnosed afterthe age of 40 was followed over a mean period of 8.9±5.2years. Nearly half the patients (47 percent) underwent surgicalrepair of the defect, whereas the remaining patients receivedonly medical treatment, which extended throughout the follow-upperiod. Multivariate analysis showed a significant reductionin overall mortality after surgical closure of the defect. Forthe surgical group as compared with the medically treated group,the relative risk of death during the follow-up period was 0.31.Our results suggest that the surgical repair of atrial septaldefects substantially increases the long-term survival of middle-agedand elderly patients. There were no perioperative deaths inour study group, and the estimated 10-year survival rate aftersurgery was 95 percent, as compared with a rate of 84 percentfor medically treated patients.
These results are similar to the excellent survival rates reportedby Horvath et al.8 in a group of patients who were younger thanour study population and also had less severe symptoms at thetime of operation. On the other hand, our findings do not agreewith a recent study that found that the closure of an atrialseptal defect in adult life does not significantly alter thepatient's prognosis.23 However, as noted by its authors, thatstudy included only patients who had minimal, if any, cardiacsymptoms at presentation, as well as normal pulmonary-arterypressures. It is therefore not possible to extrapolate thoseresults to an unselected adult population with unrepaired defects.
In contrast to the clear long-term survival benefit of surgicaltreatment, the incidence of nonfatal cardiovascular complicationsduring the follow-up period was not reduced by surgical closureof the defect. This was mostly a result of the occurrence ofearly postoperative complications in nine (11 percent) of thepatients who underwent surgery. During long-term follow-up,atrial fibrillation or flutter developed in 15 percent of thesurgically treated patients, an incidence similar to that observedin the medically treated group (17 percent). Furthermore, paroxysmalor permanent atrial fibrillation was present in the majorityof the patients — six of nine — who had a transientischemic attack or stroke during the late postoperative phase.Thus, our observations are consistent with the conclusions reachedby other researchers that the repair of atrial septal defectslate in life does not significantly reduce the development ofatrial fibrillation or the morbidity associated with thromboemboliccomplications.20,23
The functional status (NYHA class) of the patients followedin our study improved dramatically after surgical, as comparedwith medical, treatment of the defect. Of the surgically treatedpatients, 32 percent reported a long-term reduction in the severityof symptoms related to heart failure, as opposed to only 3 percentof those treated medically. Of even greater clinical importanceis the fact that there was functional improvement in 69 percentof the patients who had had severe heart failure (NYHA classIII or IV) before surgery.
A limitation of this study is the retrospective, nonrandomizedassignment of patients to the two treatment groups. With suchan observational design, selection bias cannot be excluded.In the present study, we observed three variables that wereunequally distributed between the surgically and medically treatedgroups: age, pulmonary vascular resistance, and the Qp:Qs ratio.Surgically treated patients were younger and had lower valuesfor pulmonary vascular resistance than those treated medically;on the other hand, the group that underwent surgery had greaterleft-to-right shunts. When these differences are taken together,they do not indicate a more favorable prognosis for one groupover the other. Nevertheless, in order to adjust for the biasingeffects of any measured confounding factors, all our analyseswere based on multivariate regression models that took intoaccount all important prognostic factors. In addition, patientswith either concomitant coronary artery disease or severe mitralregurgitation that required surgical treatment were excludedfrom the study.
The results of the present study indicate that the surgicalrepair of atrial septal defects in middle-aged and elderly patientsis superior to medical treatment as regards both long-term survivaland the lessening of functional limitation due to heart failure.However, the risk of atrial arrhythmia is not reduced by closureof the defect, and surgically treated patients should be followedclosely for the onset of atrial fibrillation or flutter in orderto prevent or reduce morbidity resulting from cerebral thromboembolism.
We are indebted to Dr. E. Braunwald for a thorough review ofthe manuscript.
Source Information
From the Abteilung Innere Medizin III–Kardiologie (S.K., A.G., H.J.), Abteilung Herz und Gefässchirurgie (G.S.), and Abteilung Medizinische Biometrie und Informatik (M.O.), Universitätsklinik Freiburg, Freiburg; the Herzzentrum Bad Krozingen, Bad Krozingen (L.G., H.R.); and the St. Josef Hospital, Wiesbaden (W.K.) — all in Germany.
Address reprint requests to Dr. Geibel at the Universitätsklinik Freiburg, Innere Medizin III–Kardiologie, Hugstetter Str. 55, D-79106 Freiburg, Germany.
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Atrial Septal Defect
Ward C., Henderson R.A., Sanderson J. E., Fung W.H., Cox J. L., Jaquiss R. D.B., Konstantinides S., Geibel A.
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N Engl J Med 1996;
334:56-57, Jan 4, 1996.
Correspondence
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