Background Whether to perform valve replacement in patientswith asymptomatic but severe aortic stenosis is controversial.Therefore, we studied the natural history of this conditionto identify predictors of outcome.
Methods During 1994, we identified 128 consecutive patientswith asymptomatic, severe aortic stenosis (59 women and 69 men;mean [±SD] age, 60±18 years; aortic-jet velocity,5.0±0.6 m per second). The patients were prospectivelyfollowed until 1998.
Results Follow-up information was available for 126 patients(98 percent) for a mean of 22±18 months. Event-free survival,with the end point defined as death (8 patients) or valve replacementnecessitated by the development of symptoms (59 patients), was67±5 percent at one year, 56±5 percent at twoyears, and 33±5 percent at four years. Five of the sixdeaths from cardiac disease were preceded by symptoms. Accordingto multivariate analysis, only the extent of aortic-valve calcificationwas an independent predictor of outcome, whereas age, sex, andthe presence or absence of coronary artery disease, hypertension,diabetes, and hypercholesterolemia were not. Event-free survivalfor patients with no or mild valvular calcification was 92±5percent at one year, 84±8 percent at two years, and 75±9percent at four years, as compared with 60±6 percent,47±6 percent, and 20±5 percent, respectively,for those with moderate or severe calcification. The rate ofprogression of stenosis, as reflected by the aortic-jet velocity,was significantly higher in patients who had cardiac events(0.45±0.38 m per second per year) than those who didnot have cardiac events (0.14±0.18 m per second per year,P<0.001), and the rate of progression of stenosis provideduseful prognostic information. Of the patients with moderatelyor severely calcified aortic valves whose aortic-jet velocityincreased by 0.3 m per second or more within one year, 79 percentunderwent surgery or died within two years of the observed increase.
Conclusions In asymptomatic patients with aortic stenosis, itappears to be relatively safe to delay surgery until symptomsdevelop. However, outcomes vary widely. The presence of moderateor severe valvular calcification, together with a rapid increasein aortic-jet velocity, identifies patients with a very poorprognosis. These patients should be considered for early valvereplacement rather than have surgery delayed until symptomsdevelop.
The poor outcome of patients with symptomatic aortic stenosishas been well documented.1,2,3,4,5,6,7,8,9,10 In view of theexcellent results of aortic-valve replacement,2,11,12,13,14,15,16surgery is strongly recommended for these patients.17 In contrast,the management of asymptomatic aortic stenosis remains controversial.17The occurrence of sudden death without preceding symptoms1,4,18and the potential risk of irreversible myocardial damage14,19argue for early elective surgery. However, prospective studiessuggest that, in the absence of preceding symptoms, sudden deathmay be uncommon.20,21 Nevertheless, in 1997, Otto et al. reportedrapid progression and poor outcomes among patients with asymptomaticaortic stenosis,22 again raising the question of early electivesurgery.23 Considering the wide variation in individual outcomes,the potential risk of complications related to the prostheticvalve,17,24,25,26,27,28,29,30 and the risk of valve surgeryitself, the decision whether to operate on an asymptomatic patientremains difficult. The identification of predictors of outcomethat could help in the selection of patients who are likelyto benefit from early surgery would be highly desirable. Wetherefore prospectively studied a large cohort of patients withasymptomatic, severe aortic stenosis to identify clinical orechocardiographic predictors of outcome.
Methods
Patients
All patients who were studied in our echocardiography laboratorybetween January 1 and December 31, 1994, and who were foundto have a stenotic native aortic valve with a peak aortic-jetvelocity of at least 4 m per second were included in the studyif they had no additional hemodynamically significant valvularlesions and if they presented without symptoms. As in previousstudies,20 patients who had mild fatigue or mild dyspnea duringmaximal exercise were not excluded, because of the lack of specificityof these symptoms. Written informed consent was obtained fromthe patients for all procedures that were performed.
One hundred twenty-eight patients (mean [±SD] age, 60±18years; 59 women and 69 men; mean aortic-jet velocity, 5.0±0.6m per second) were identified by these criteria. All patientshad normal left ventricular function, except for two with coronaryartery disease. In these two patients, wall-motion abnormalitieswere regional rather than global and apparently were relatedto coronary artery disease, as demonstrated by coronary angiography.According to color Doppler ultrasonography, additional mildaortic regurgitation was present in 70 patients and mild-to-moderateor moderate aortic regurgitation in 33. The valve area of these33 patients was 0.8 cm2 or less, and none had signs of leftventricular volume overload or clinical signs of hemodynamicallyrelevant aortic regurgitation. Eighty-four patients had mildmitral regurgitation, and 61 had mild tricuspid regurgitation;8 patients also had mild mitral stenosis.
Echocardiography
Echocardiographic data were obtained with the use of commerciallyavailable ultrasound systems. All patients underwent a comprehensiveexamination, including M-mode echocardiography, two-dimensionalechocardiography, and conventional and color Doppler ultrasonography,conducted by an experienced echocardiographer. Valve stenosiswas defined as congenital if there was clear identificationof two cusps in systole and systolic cusp doming or highly asymmetricthickening or both; it was defined as rheumatic if there wascommissural fusion and mitral-valve involvement; and it wasdefined as degenerative if there was thickening and increasedechogenicity of the cusps (excluding the free edges), with reducedsystolic opening. The degree of calcification of the aorticvalve was scored as follows: 1, no calcification; 2, mildlycalcified (small isolated spots); 3, moderately calcified (multiplelarger spots); and 4, heavily calcified (extensive thickeningand calcification of all cusps). Mitral annular calcificationwas defined as a dense, highly reflective area at the base ofthe mitral-valve leaflets. For all patients for whom at leasttwo echocardiographic studies, separated by at least six months,were available, the mean increase in aortic-jet velocity (inmeters per second per year) was calculated by dividing the differencebetween the velocities measured at the first and last examinationsby the time between examinations.
Follow-Up
The patients were followed prospectively, beginning with thevisit in 1994. Follow-up information was obtained from interviewswith the patients, their relatives, and their physicians. Wecollected information regarding the development of cardiac symptoms,eventual aortic-valve replacement, and mortality.
For the assessment of outcome, the end point was death or aortic-valvereplacement necessitated by the development of symptoms. Deathswere classified as due or not due to cardiac causes on the basisof discussion with the primary care physician (two deaths),review of medical records (two deaths), or review of medicalrecords including autopsy records (four deaths). Deaths dueto cardiac causes were further classified as directly relatedto aortic stenosis (sudden death or death from congestive heartfailure) or as related to other cardiac conditions. To evaluatethe overall outcome of patients treated according to a "waitfor symptoms" strategy, we also followed patients who underwentsurgery because of the development of symptoms until 1998 andobtained information regarding perioperative and late mortality.
Statistical Analysis
The results are given as means ±SD, except for Kaplan–Meierestimates, for which the standard error is given. Base-linedifferences between the groups undergoing and not undergoingsurgery were analyzed by a two-sample t-test or a chi-squaretest for equality of proportions, when appropriate. Data onevent-free survival were analyzed by the Kaplan–Meiermethod.
Data on overall survival, as determined at the last follow-upin 1998 (taking into account perioperative deaths and postoperativefollow-up for patients who required surgery because of the developmentof symptoms), were also analyzed and compared with control dataon survival among persons of the same age and sex. The controldata were obtained from Austrian life tables for 1992, whichwere provided by the Austrian Statistical Institute and representthe survival of the general Austrian population.
The effects of clinical variables (age, sex, and presence orabsence of coronary artery disease, hypertension, diabetes,and hypercholesterolemia) and echocardiographic variables (degreeof aortic-valve calcification, cause of stenosis, and aortic-jetvelocity) were analyzed by the Kaplan–Meier method. Statisticalsignificance was determined by the log-rank test. For multivariateanalysis, a Cox proportional-hazards model was used. A P valueof less than 0.05 was considered to indicate statistical significance.
Results
Of the total study group, 22 patients, although remaining asymptomatic,underwent aortic-valve replacement within three months afterexamination at the discretion of their referring cardiologist(the surgical group). The remaining 106 patients (the nonsurgicalgroup) were followed for 27±17 months. In this group,surgery was delayed until symptoms developed. The characteristicsof the patients in the surgical and nonsurgical groups are shownin Table 1. On average, the patients in the nonsurgical groupwere younger and had a lower aortic-jet velocity. However, theages and velocities in the surgical group were well representedin the nonsurgical group.
Table 1. Characteristics of 128 Patients with Asymptomatic Aortic Stenosis According to Whether They Underwent Aortic-Valve Replacement within Three Months after Examination.
Outcome for the Total Study Group
Follow-up information was available for 126 patients (98 percent).Data on the 22 patients in the surgical group were censoredat the time of valve replacement.
Event-Free Survival
During a mean follow-up period of 22±18 months (range,0 to 54), 67 end points were observed, including 8 deaths and59 valve replacements performed because of the development ofsymptoms. Event-free survival was 67±5 percent at oneyear, 56±5 percent at two years, and 33±5 percentat four years.
Deaths
Six of the eight deaths were due to cardiac causes (four tocongestive heart failure, one to endocarditis, and one suddendeath). All deaths from cardiac causes were presumed to be relatedto aortic stenosis. Except for the one sudden death, they wereall preceded by the development of symptoms. Aortic-valve replacementwas not performed in these patients for the following reasons:three patients refused to have surgery, one had advanced prostaticcancer, and one died awaiting surgery. Of the two deaths fromother causes, one was due to pulmonary embolism and the otherto acute myeloid leukemia.
Surgery
Fifty-nine patients underwent aortic-valve replacement becausesymptoms developed. These patients were followed postoperativelyfor 28±15 months. Of the five deaths among these patients,four occurred perioperatively and one was not due to cardiaccauses. The remaining 54 patients were alive at the end of thestudy in 1998.
Overall Survival
The overall actuarial probability of survival (±SE) atthe end of the study in 1998 was 93±2 percent at oneyear, 91±3 percent at two years, and 87±3 percentat four years (Figure 1). Survival was slightly worse than thatof an age- and sex-matched population, but the difference wasnot significant.
Figure 1. Kaplan–Meier Analysis of Overall Survival among 126 Patients with Asymptomatic but Severe Aortic Stenosis, as Compared with Age- and Sex-Matched Persons in the General Population.
This analysis included perioperative and postoperative deaths among patients who required valve replacement during follow-up. The vertical bars indicate standard errors.
Predictors of Outcome
According to univariate analysis, an age of more than 50 years,diabetes mellitus, and coronary artery disease were predictorsof subsequent cardiac events, whereas the effects of femalesex, hypertension, and hypercholesterolemia did not reach statisticalsignificance (Table 2). When only clinical data were considered,an older age remained the only significant predictor of outcomeaccording to the multivariate analysis. Event-free survivalfor patients 50 years of age or younger was 85±6 percentat one year, 69±8 percent at two years, and 59±9percent at four years. In comparison, the event-free survivalrates for patients older than 50 years were 59±6 percent,49±6 percent, and 21±5 percent at one, two, andfour years, respectively (Figure 2).
Figure 2. Kaplan–Meier Analysis of Event-free Survival among 33 Patients 50 Years of Age or Younger, as Compared with 93 Patients over 50 Years of Age.
The vertical bars indicate standard errors.
The extent of aortic-valve calcification was a strong predictorof subsequent events (P<0.001). Event-free survival for patientswith no or mild calcification was 92±5 percent at oneyear, 84±8 percent at two years, and 75±9 percentat four years, as compared with 60±6 percent, 47±6percent, and 20±5 percent, respectively, for those withmoderate or severe calcification (Figure 3). The outcome wasalmost identical for patients with moderate calcification andfor those with severe calcification. All deaths occurred amongthese patients. The best outcome was found for patients withoutcalcification; among 11 such patients, no event occurred duringa mean follow-up of 38±16 months. Of the 25 patientswith no or only mild calcification, 21 had congenital diseaseand 4 had rheumatic disease. However, the cause of stenosiswas difficult to assess in the presence of moderate or severecalcification and therefore frequently remained uncertain. Thus,the assessment of the cause of stenosis did not provide usefulprognostic information.
Figure 3. Kaplan–Meier Analysis of Event-free Survival among 25 Patients with No or Mild Aortic-Valve Calcification, as Compared with 101 Patients with Moderate or Severe Calcification.
The vertical bars indicate standard errors.
On average, the aortic-jet velocity was only slightly higherin patients who had cardiac events during follow-up than inthose who did not (4.66±0.62 vs. 4.41±0.38 m persecond). This difference was statistically significant (P=0.03).Nevertheless, the aortic-jet velocity was not a significantpredictor of subsequent cardiac events. However, the rate ofprogression of aortic-jet velocity was significantly higherin patients who had cardiac events than in those who did nothave such events (0.45±0.38 vs. 0.14±0.18 m persecond per year, P<0.001) (Figure 4).
Figure 4. Mean Rate of Progression of Aortic-Jet Velocity among 41 Patients Who Had Cardiac Events and 29 Who Did Not.
The bars represent means ±SD.
When clinical and echocardiographic data were considered togetherin a multivariate analysis, the extent of valvular calcificationwas the only independent predictor of outcome. Ninety of the93 patients over 50 years of age (97 percent) presented withmoderate or severe aortic-valve calcification. Although themajority of patients 50 years of age or younger had less calcifiedvalves, 33 percent of them presented with moderate or severecalcification. These patients had event-free survival very similarto that among patients over 50 years of age who had moderatelyor severely calcified valves. The rate of progression of aortic-jetvelocity added useful prognostic information to the classificationbased on the degree of calcification. The combination of calcificationand a rapid increase in aortic-jet velocity identified a high-riskgroup. Of the patients with moderately or severely calcifiedvalves who had an increase of 0.3 m per second or more withinone year, 79 percent underwent surgery because of new symptomsor died within two years (Figure 5). In this analysis, follow-upstarted at the time of the visit at which this rapid increasein velocity was recognized in an otherwise asymptomatic patient.
Figure 5. Kaplan–Meier Analysis of Event-free Survival among 34 Patients with Moderate or Severe Calcification of the Aortic Valve and a Rapid Increase in Aortic-Jet Velocity (at Least 0.3 m per Second within One Year).
In this analysis, follow-up started with the visit at which the rapid increase was identified. The vertical bars indicate standard errors.
Discussion
Many physicians are reluctant to refer patients with severeaortic stenosis for valve replacement as long as they remainasymptomatic.23 However, there remains concern about the riskof irreversible myocardial damage14,19 or sudden death amongsuch patients who do not undergo surgery. In contrast to patientswith valvular regurgitation, patients with severe aortic stenosiswho are still asymptomatic but already have impaired left ventricularfunction are very rare. Nevertheless, myocardial fibrosis orsevere hypertrophy may not be reversible after delayed surgeryand may preclude an optimal postoperative outcome. However,the outcome after valve replacement is excellent in patientswith normal preoperative left ventricular function.2,11,12,13,14,15,16Therefore, the potential benefit of preventing myocardial fibrosisand severe hypertrophy by early intervention is unlikely tooutweigh the risk of perioperative and late complications ofvalve replacement in asymptomatic patients.
Sudden death in patients with aortic stenosis is an issue ofconcern. Prospective data on sudden death are limited. Ottoet al.22 followed 123 patients for an average of 30 months andreported no sudden deaths, but the majority of these patientsdid not have severe aortic stenosis. In two small series6,21with follow-up periods of 1.5 and 2.0 years, there were alsono sudden deaths without preceding symptoms, but again, a considerablepercentage of patients did not have severe stenosis. The onlystudy that followed a larger cohort of patients with severestenosis was conducted by Pellikka et al.20 During a mean follow-upof 20 months, there were two sudden deaths, but symptoms haddeveloped in both patients at least 3 months before death. Inour series of 126 patients with slightly higher aortic-jet velocitiesand a longer follow-up (27 months), one sudden death occurred,which was not preceded by any symptoms. Thus, our study supportsthe idea that sudden death may occur even in the absence ofpreceding symptoms in patients with aortic stenosis, but thatit appears to be uncommon, with an incidence of probably lessthan 1 percent per year.17
Although Pellikka et al.20 reported no deaths related to aorticstenosis without preceding symptoms, 3 of 113 patients eventuallydied of aortic stenosis during a mean follow-up of 20 months.It is possible that these patients did not promptly report thedevelopment of symptoms or that they died while waiting forsurgery, as was the case in one patient in the present study.According to another report,31 7 of 99 patients with severeaortic stenosis who were scheduled for surgery died during anaverage waiting period of six months. In addition, patientswith severe symptoms have been found to have significantly higheroperative mortality than those with no symptoms or only mildones, and surgery performed as an urgent procedure carries ahigher risk than elective surgery.32
Thus, the possibility that patients may not report symptomspromptly and that logistic problems may delay surgery, as wellas the higher operative mortality for patients with symptomsand those undergoing urgent surgery, makes it highly desirableto identify patients in whom symptoms are likely to developand who require surgery within a very short period, since suchpatients would benefit from early elective aortic-valve replacement.In the study by Pellikka et al.,20 only aortic-jet velocityand ejection fraction were independent predictors of the riskof subsequent cardiac events, whereas age, sex, and the presenceor absence of hypertension, diabetes mellitus, left ventricularhypertrophy, electrocardiographic strain pattern, ventricularectopic activity, and coronary artery disease, smoking status,and the use or nonuse of digoxin or diuretic drugs were not.In the study by Otto et al.,22 the only predictors of outcomewere aortic-jet velocity, the rate of change in this velocity,and functional status, but not age, sex, cause of aortic stenosis,left ventricular mass, or ejection fraction. Neither of thesestudies allowed any conclusions to be drawn about how to selecthigh-risk patients who might benefit from early elective surgery.
In the present study, in agreement with previous reports,20,22we did not identify any clinical variable as an independentpredictor of subsequent cardiac events. However, the extentof valvular calcification was found to be a strong independentpredictor of outcome. As in previous reports, aortic-jet velocitywas significantly higher in patients who had cardiac events,but the difference was small, and the marked overlap precludesdrawing any conclusions about outcome for an individual patient.However, our results suggest that assessment of the rate ofprogression of aortic-jet velocity by serial echocardiographicexamination may yield important prognostic information in additionto the degree of calcification. Thus, although not generallyrecommended in the recently published practice guidelines,17annual echocardiographic studies may play an important partin the management of asymptomatic aortic stenosis.
A limitation of our study is that 22 patients underwent surgerywithin three months after examination, although they were stillasymptomatic. It may be almost impossible, however, to studythe outcome of a large cohort of patients with severe but asymptomaticaortic stenosis without encountering this problem.20,22 Althoughcurrent practice guidelines17 do not recommend surgery for asymptomaticpatients with severe aortic stenosis, their optimal treatmentremains controversial, and some physicians decide to refer theirpatients for valve replacement despite the lack of data to supportthis strategy. Although the patients in the nonsurgical groupwere, on average, younger and had, on average, lower aortic-jetvelocities, the ages and velocities in the surgical group werewell represented in the nonsurgical group. The groups did notdiffer in any other respect.
In conclusion, our study confirms that in patients with hemodynamicallysignificant aortic stenosis, it is relatively safe to delaysurgery until symptoms develop. However, sudden death can occureven without preceding symptoms, although this is rare. Deathmay also occur in newly symptomatic patients who do not promptlyreport symptoms or who are awaiting surgery. In addition, therisk entailed by surgery is higher in symptomatic than in asymptomaticpatients. Echocardiography appears helpful in the managementof asymptomatic aortic stenosis, since it permits the earlyidentification of patients at risk.
Patients with no or only mild calcification of their stenoticaortic valves represent a low-risk subgroup. They may remainasymptomatic for many years, and early elective surgery is definitelynot justified. Follow-up visits at annual intervals and instructionto report the development of symptoms promptly appear to beappropriate for these patients. In contrast, patients with severe,asymptomatic aortic stenosis and moderately or severely calcifiedvalves represent a subgroup of patients with a poorer prognosis.Rapid progression of the disease can be expected, and approximately80 percent of these patients will require valve replacementor die within four years. Thus, such patients must be followedwith special care. Even in this group, however, individual outcomesvary widely, and elective surgery cannot be generally recommended.
In patients with moderately or severely calcified valves inwhom serial echocardiographic testing reveals a marked increasein aortic-jet velocity, the outcome is significantly worse,and an 80 percent event rate at two years can be expected. Becausepatients do not always report symptoms promptly, and in considerationof the elevated risk of death while patients await surgery,as well as the higher operative risk in symptomatic patientsand those undergoing urgent surgery, it may be worthwhile toconsider early elective valve replacement instead of waitingfor symptoms to develop in this high-risk group.
Source Information
From the Department of Cardiology, Vienna General Hospital (R.R., T.B., G.P., I.L., G.C., G.M., H.B.) and the Ludwig Boltzmann Institute for Cardiovascular Research (R.R., T.B., G.P., I.L., G.C., G.M., H.B.); and the Department of Medical Computer Sciences (M.S.), University of Vienna — all in Vienna, Austria.
Address reprint requests to Dr. Baumgartner at the Department of Cardiology, Vienna General Hospital, University of Vienna, Währinger Gürtel 18–20, A-1090 Vienna, Austria, or at helmut.baumgartner{at}akh-wien.ac.at.
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