Quantitative Determinants of the Outcome of Asymptomatic Mitral Regurgitation
Maurice Enriquez-Sarano, M.D., Jean-François Avierinos, M.D., David Messika-Zeitoun, M.D., Delphine Detaint, M.D., Maryann Capps, R.D.C.S., Vuyisile Nkomo, M.D., Christopher Scott, M.S., Hartzell V. Schaff, M.D., and A. Jamil Tajik, M.D.
Background The clinical outcome of asymptomatic mitral regurgitationis poorly defined, and the treatment is uncertain. We studiedthe effect on the outcome of quantifying mitral regurgitationaccording to recent guidelines.
Methods We prospectively enrolled 456 patients (mean [±SD]age, 63±14 years; 63 percent men; ejection fraction,70±8 percent) with asymptomatic organic mitral regurgitation,quantified according to current recommendations (regurgitantvolume, 66±40 ml per beat; effective regurgitant orifice,40±27 mm2).
Results The estimated five-year rates (±SE) of deathfrom any cause, death from cardiac causes, and cardiac events(death from cardiac causes, heart failure, or new atrial fibrillation)with medical management were 22±3 percent, 14±3percent, and 33±3 percent, respectively. Independentdeterminants of survival were increasing age, the presence ofdiabetes, and increasing effective regurgitant orifice (adjustedrisk ratio per 10-mm2 increment, 1.18; 95 percent confidenceinterval, 1.06 to 1.30; P<0.01), the predictive power ofwhich superseded all other qualitative and quantitative measuresof regurgitation. Patients with an effective regurgitant orificeof at least 40 mm2 had a five-year survival rate that was lowerthan expected on the basis of U.S. Census data (58±9percent vs. 78 percent, P=0.03). As compared with patients witha regurgitant orifice of less than 20 mm2, those with an orificeof at least 40 mm2 had an increased risk of death from any cause(adjusted risk ratio, 2.90; 95 percent confidence interval,1.33 to 6.32; P<0.01), death from cardiac causes (adjustedrisk ratio, 5.21; 95 percent confidence interval, 1.98 to 14.40;P<0.01), and cardiac events (adjusted risk ratio, 5.66; 95percent confidence interval, 3.07 to 10.56; P<0.01). Cardiacsurgery was ultimately performed in 232 patients and was independentlyassociated with improved survival (adjusted risk ratio, 0.28;95 percent confidence interval, 0.14 to 0.55; P<0.01).
Conclusions Quantitative grading of mitral regurgitation isa powerful predictor of the clinical outcome of asymptomaticmitral regurgitation. Patients with an effective regurgitantorifice of at least 40 mm2 should promptly be considered forcardiac surgery.
Mitral-valve regurgitation is common,1 and its prevalence increaseswith age.1 The management of mitral regurgitation and indicationsfor surgery are controversial.2 Previous outcome studies showedthat patients with organic mitral regurgitation who have symptomsor a reduced ejection fraction are at high risk,3,4 warrantingmitral surgery.2 Conversely, the clinical outcome among patientswith asymptomatic mitral regurgitation is poorly defined, andcriteria defining high-risk subgroups are uncertain.2 Such subgroupsare important to identify as technical improvements in surgery5,6— decreased operative mortality7 and increased repairrates8 — allow the restoration of patients' life expectancy.9Thus, surgery may be warranted in high-risk patients with asymptomaticmitral regurgitation under medical management.
Patients with mitral-valve prolapse and higher degrees of regurgitationhave been considered to be at higher risk than those with lowerdegrees of regurgitation,4 suggesting that the severity of regurgitationmay provide important information on the outcome. However, standardqualitative assessment of mitral regurgitation is fraught withproblems,10 and recently, American and European cardiac societiesissued joint guidelines advocating the use of quantitative methodsinvolving Doppler echocardiography and determining thresholdsof severity.11 However, it is not yet clear whether this approachprovides meaningful information on outcomes. Thus, we designeda prospective study, enrolling patients with organic mitralregurgitation who were monitored by their independent personalphysicians, to test our hypothesis that quantitative classificationof regurgitation according to the regurgitant volume and effectiveregurgitant orifice independently predicts the outcome.
Methods
Study Population
Between 1991 and 2000, we prospectively enrolled patients whohad at least mild holosystolic mitral regurgitation on color-flowimaging,12 which was due to organic mitral-valve disease identifiedby two-dimensional echocardiography, isolated (without aortic-valvedisease) and pure (without stenosis), quantitatively assessedby the authors using at least two Doppler echocardiographicmethods, and asymptomatic at diagnosis. Patients were excludedif they had mitral regurgitation due to ischemic heart diseaseor cardiomyopathy, minimal or early or late systolic regurgitation,structurally normal valves, associated mitral stenosis thatwas more than trivial, associated organic aortic or tricuspiddisease, a history of valve repair or replacement, congenitalor pericardial heart disease, or an ejection fraction below50 percent.4 Age, sex, and the type of cardiac rhythm were notconsidered in the eligibility criteria. The study was approvedby our institutional review board. Because the protocol wasjudged to pose a low risk, oral informed consent was recommendedand obtained.
Clinical Assessment and Management
Each patient's history and the results of a clinical examinationwere recorded at baseline by his or her personal physician atour institution. Coexisting conditions were evaluated by meansof the Charlson index.13 Congestive heart failure was diagnosedduring follow-up on the basis of criteria from the FraminghamHeart Study.14 Clinical management was determined independentlyby the patient's personal physician using all information available.Follow-up information was collected in 2002 after enrollmentended and all baseline data had been obtained.
Echocardiographic Measurements
Complete Doppler echocardiography was performed. Quantitativedata were promptly obtained, stored in a database, and not alteredthroughout the study.
Quantitation of Mitral Regurgitation
Mitral regurgitation was quantified by at least two of threevalidated methods, and the results were averaged to calculatethe regurgitant volume per beat and the area of the effectiveregurgitant orifice. Quantitative Doppler echocardiography isbased on the measurement of mitral and aortic stroke volumes.15,16,17Quantitative two-dimensional echocardiography is based on themeasurement of left ventricular volume.17,18 The proximal isovelocitysurface area is determined by measuring proximal-flow convergence.19,20According to published guidelines, mild, moderate, and severemitral regurgitation correspond to a regurgitant volume of lessthan 30, 30 to 59, and at least 60 ml per beat, respectively,and an effective regurgitant orifice of less than 20, 20 to39, and 40 mm2 or more, respectively.11,21
Other Echocardiographic Measurements
Left ventricular diameters, volumes, ejection fraction, andmass were measured as recommended.22 Left atrial volume wasmeasured by means of an area–length method.23 Planimetrywas used to measure the mitral regurgitant jet on color-flowimaging in two planes,12 and the ratio of the mitral regurgitantjet to the left atrial area was calculated.24 The severity ofmitral regurgitation was also qualitatively classified in grades(1/4 to 4/4).25
Statistical Analysis
Unless otherwise specified, data are presented as means ±SDor percentages. Comparisons between groups were performed withuse of analysis of variance, Student's t-test, or the chi-squaretest, as appropriate. End points were death from any cause,death from cardiac causes, and cardiac events (defined as deathfrom cardiac causes, congestive heart failure, or new atrialfibrillation). New atrial fibrillation was diagnosed only inpatients who were in sinus rhythm at baseline. These end pointswere ascertained while the patients were under medical management(from diagnosis to surgery or death), and data were censoredat the time of cardiac surgery if it was performed. Event rates(±SE) were calculated according to the Kaplan–Meiermethod and compared by means of the log-rank test.
We compared the observed mortality rates with the expected mortalityrates using U.S. Census Bureau national life-tables and thelog-rank test. Univariate and multivariate analyses of the timeto events were performed with use of Cox proportional-hazardsmodels with the effective regurgitant orifice and regurgitantvolume as independent variables in continuous and categoricalformats. The effect of surgery on the outcome was analyzed asa time-dependent variable with the use of proportional-hazardsmodeling and data from the entire follow-up period (medicaland postoperative). All P values were two-sided, and valuesof less than 0.05 were considered to indicate statistical significance.
All authors participated in designing the study, collectingand analyzing data, and drafting and revising the manuscript.
Results
Baseline Characteristics and Management
Table 1 shows the baseline characteristics of the 456 patientsenrolled, both overall and according to the effective regurgitantorifice. The majority of patients were in their 60s, were men,and had mitral-valve prolapse as the mechanism of regurgitation.The effective regurgitant orifice was determined on the basisof an average of two methods in 85 patients and three methodsin 371 patients and was classified as less than 20 mm2 in 28percent of patients, 20 to 39 mm2 in 28 percent, and at least40 mm2 in 43 percent, with a qualitative grade of 1/4 in 70patients, 2/4 in 49, 3/4 in 93, and 4/4 in 244 (15, 11, 20,and 54 percent, respectively).
Table 1. Baseline Clinical, Left Ventricular, and Hemodynamic Characteristics of Patients with Asymptomatic Mitral Regurgitation.
When the patients were stratified according to the effectiveregurgitant orifice, there were significant differences in jetsize, regurgitant volume, and ventricular and atrial dilatation(Table 1). As expected, a significantly higher percentage ofpatients with severe regurgitation were men and had mitral-valveprolapse,7 whereas there was no significant difference in theCharlson comorbidity index among the three groups. Clinicalmanagement after diagnosis was solely medical in 224 patients(49 percent) and was medical followed by surgery (mean, 1.2±2.0years later) in 232 patients: 11 patients with an effectiveregurgitant orifice of less than 20 mm2 (9 percent of this group),58 with an effective regurgitant orifice of 20 to 39 mm2 (45percent), and 163 with an effective regurgitant orifice of atleast 40 mm2 (82 percent). Follow-up lasted up to 11.7 years,but the mean duration of follow-up after diagnosis was 2.7±2.9years under medical management and 5.1±2.9 years undermedical and surgical management.
Survival
There were 56 deaths among the patients whose mitral regurgitationwas managed medically, with survival rates of 96±1 percentat one year and 78±3 percent at five years. In univariateanalysis, the degree of mitral regurgitation strongly predictedthe likelihood of survival, with a risk ratio for death fromany cause of 1.21 for each 10-mm2 increment in the effectiveregurgitant orifice (95 percent confidence interval, 1.10 to1.32; P<0.01) (Table 2) and of 1.11 for each increment of10 ml per beat in the regurgitant volume (95 percent confidenceinterval, 1.03 to 1.19; P<0.01). Among the patients withmedically managed mitral regurgitation, the five-year survivalrate was highest among those with an effective regurgitant orificeof less than 20 mm2 (91±3 percent), intermediate amongthose with an effective regurgitant orifice of 20 to 39 mm2(66±6 percent), and lowest among those with an effectiveregurgitant orifice of at least 40 mm2 (58±9 percent,P<0.01) (Figure 1).
Table 2. Risk of Death from Any Cause, Death from Cardiac Causes, and Cardiac Events among Patients with Asymptomatic Mitral Regurgitation under Medical Management.
Figure 1. Kaplan–Meier Estimates of the Mean (±SE) Rates of Overall Survival among Patients with Asymptomatic Mitral Regurgitation under Medical Management, According to the Effective Regurgitant Orifice (ERO).
Values in parentheses are survival rates at five years.
The observed five-year survival rates did not differ significantlyfrom expected survival rates in the overall population (78±3percent vs. 84 percent, P=0.21) or in the group with an effectiveregurgitant orifice of less than 20 mm2 (91±3 percentvs. 86 percent, P=0.12). However, the actual survival rateswere significantly lower than the expected rates in the groupwith an effective regurgitant orifice of 20 to 39 mm2 (66±6vs. 84 percent, P=0.04) and the group with an effective regurgitantorifice of at least 40 mm2 (58±9 vs. 78 percent, P=0.03).
In multivariate analysis, survival was independently predictedby increasing age (P<0.01), the presence of diabetes (P<0.01),and a greater effective regurgitant orifice (adjusted risk ratioper 10-mm2 increment, 1.18; 95 percent confidence interval,1.06 to 1.30; P<0.01). After adjustment for age, sex, thepresence or absence of diabetes and atrial fibrillation at baseline,and the ejection fraction (and even the Charlson comorbidityindex), the effective regurgitant orifice independently predictedsurvival, with an adjusted risk ratio for death from any causeof 1.20 for each 10-mm2 increment (95 percent confidence interval,1.07 to 1.34; P<0.01) and of 2.90 for an effective regurgitantorifice of at least 40 mm2, as compared with one of less than20 mm2 (95 percent confidence interval, 1.33 to 6.32) (Table 2).
Regurgitant volume was less strongly predictive of survivalafter adjustment for age and the presence or absence of diabetes(P=0.04) and even less so after adjustment for age, sex, thepresence or absence of diabetes and atrial fibrillation, andthe ejection fraction (P=0.06). The qualitative grade of mitralregurgitation, jet area, and ratio of the jet to the left atrialarea were predictive of survival on univariate analysis (allP0.05) but not on multivariate analysis (all P>0.30). Furthermore,nested models showed that quantitative classification basedon the effective regurgitant orifice significantly increasedthe predictive value of models that used qualitative gradingor jet measures (all P<0.01).
Among the patients with medically managed mitral regurgitation,35 died of cardiac causes, with a five-year mortality rate of14±3 percent overall and 3±2 percent among thosewith an effective regurgitant orifice of less than 20 mm2, 20±6percent among those with an effective regurgitant orifice of20 to 39 mm2, and 36±9 percent among those with an effectiveregurgitant orifice of at least 40 mm2 (P<0.01) (Figure 2).In multivariate analysis, the effective regurgitant orificepredicted the adjusted risk of death from cardiac causes (Table 2).Regurgitant volume also predicted the risk of death fromcardiac causes (adjusted risk ratio per increment of 10 ml perbeat, 1.17; 95 percent confidence interval, 1.05 to 1.30; P<0.01)but with a slightly lower 2 (52 vs. 57). In nested models includingthe qualitative or jet-related grade of mitral regurgitation,the quantitative classification of the effective regurgitantorifice had superior predictive power (all P<0.01).
Figure 2. Kaplan–Meier Estimates of the Mean (±SE) Rates of Death from Cardiac Causes among Patients with Asymptomatic Mitral Regurgitation under Medical Management, According to the Effective Regurgitant Orifice (ERO).
Values in parentheses are survival rates at five years.
Seventy-four patients died during the follow-up period (medicaland postoperative). The five-year survival rate was 85±2percent overall and did not differ significantly from the rateexpected in the general population among those with an effectiveregurgitant orifice of less than 20 mm2 (91±3 percentvs. 86 percent, P=0.19), those with an effective regurgitantorifice of 20 to 39 mm2 (81±4 percent vs. 85 percent,P=0.61), or those with an effective regurgitant orifice of atleast 40 mm2 (85±3 percent vs. 86 percent, P=0.80), reflectingnormalization of the life expectancy among the groups with aneffective regurgitant orifice of 20 mm2 or more after accountingfor postoperative survival rates.
Cardiac Events
During medical follow-up, 91 patients had a cardiac event (deathfrom cardiac causes, congestive heart failure, or new atrialfibrillation), with one-year and five-year rates of 7±1percent and 33±3 percent, respectively. The five-yearrates of cardiac events differed significantly according toboth the effective regurgitant orifice (15±4 percentamong those with an effective regurgitant orifice of less than20 mm2, 40±7 percent among those with an effective regurgitantorifice of 20 to 39 mm2, and 62±8 percent among thosewith an effective regurgitant orifice of at least 40 mm2; P<0.01)(Figure 3) and the regurgitant volume (17±4 percent amongthose with a regurgitant volume of less than 30 ml per beat,32±6 percent among those with a volume of 30 to 59 mlper beat, and 55±7 percent among those with a volumeof at least 60 ml per beat; P<0.01). The effective regurgitantorifice was a powerful predictor of the risk of cardiac eventson univariate analysis (risk ratio per 10-mm2 increment, 1.22;95 percent confidence interval, 1.13 to 1.30; P<0.01) andalong with age (P<0.01), the presence of diabetes (P<0.01),and the presence of atrial fibrillation (P=0.05), was an independentpredictor of risk.
Figure 3. Kaplan–Meier Estimates of the Mean (±SE) Rates of Cardiac Events among Patients with Asymptomatic Mitral Regurgitation under Medical Management, According to the Effective Regurgitant Orifice (ERO).
Cardiac events were defined as death from cardiac causes, congestive heart failure, or new atrial fibrillation. Values in parentheses are survival rates at five years.
After adjustment for age, sex, the presence or absence of diabetesand atrial fibrillation, and the ejection fraction, the effectiveregurgitant orifice remained independently predictive of therisk of cardiac events (Table 2). Similarly, the regurgitantvolume predicted the risk of cardiac events (unadjusted riskratio per increment of 10 ml per beat, 1.15; 95 percent confidenceinterval, 1.09 to 1.21; P<0.01; adjusted risk ratio per incrementof 10 ml per beat, 1.18; 95 percent confidence interval, 1.10to 1.25; P<0.01; and adjusted risk ratio for a volume ofat least 60 ml per beat as compared with a volume of less than30 ml per beat, 4.50; 95 percent confidence interval, 2.40 to8.60; P<0.01). The moderate range of regurgitant volume (30to 59 ml per beat) showed borderline significance (risk ratiofor the comparison with a volume of less than 30 ml per beat,1.80; 95 percent confidence interval, 0.97 to 3.30; P=0.06).The qualitative grade and jet area were predictive of the riskof cardiac events on univariate analysis (both P<0.01) butnot on multivariate analysis (both P>0.25). In nested models,the predictive power of the quantitative classification of theeffective regurgitant orifice was superior to that affordedby the qualitative grade or jet area (both P<0.01).
Surgery and Clinical Outcome
Among the 232 patients who underwent cardiac surgery, 2 underwentisolated coronary bypass and 230 underwent mitral surgery (valverepairs in 209 and valve replacements in 21, with 38 associatedcoronary-bypass graft procedures). The appearance of symptomswas the indication for surgery in 94 patients. In 91 other patients,the presence of marked left ventricular dilatation (end-systolicdiameter of at least 40 mm, end-diastolic diameter of at least65 mm, or both), atrial dilatation (volume of at least 100 ml),or both contributed to the indication for surgery. Thus, physicians'and patients' preference led to surgery in only 47 patients.The Charlson comorbidity index was similar in patients who underwentsurgery and those who did not (P=0.51).
The five-year rates of freedom from surgery and from death orcardiac surgery were 46±3 percent and 36±3 percent,respectively. Excluding patients who underwent cardiac surgerywithin 90 days after the diagnosis of mitral regurgitation,the 5-year rates of freedom from surgery and from death or cardiacsurgery were 63±3 percent and 49±3 percent, respectively.These rates were 94±3 percent and 86±4 percent,respectively, among those with an effective regurgitant orificeof less than 20 mm2; 55±6 percent and 36±6 percent,respectively, among those with an effective regurgitant orificeof 20 to 39 mm2; and 27±6 percent and 16±4 percent,respectively, among those with an effective regurgitant orificeof at least 40 mm2 (P<0.01).
Eighteen patients died after surgery, two during the 30-daypostoperative period (1 percent). Cox proportional-hazards analysiswith surgery as the time-dependent variable showed that surgerywas associated with a decreased subsequent risk of death onunivariate analysis (risk ratio, 0.32; 95 percent confidenceinterval, 0.18 to 0.54; P<0.01); in a multivariate analysiswith adjustment for age, sex, the presence or absence of diabetesand atrial fibrillation, the effective regurgitant orifice,and the ejection fraction (risk ratio, 0.28; 95 percent confidenceinterval, 0.14 to 0.55; P<0.01); and after additional adjustmentfor the Charlson comorbidity index (risk ratio, 0.35; 95 percentconfidence interval, 0.18 to 0.68; P<0.01).
Mitral regurgitation enlarges the left atrium,23 which increasesatrial compliance enough to normalize left atrial pressure,even in the presence of severe regurgitation.26 Therefore, mostpatients are asymptomatic at diagnosis,3 a circumstance thatled to the belief that asymptomatic mitral regurgitation isbenign.27 More recent natural-history studies raised the possibilitythat the clinical course of initially asymptomatic organic mitralregurgitation may be more complicated than once thought.3,28,29Hence, clinical management is difficult and subject to controversy.2,30Delaying surgical correction until symptoms appear is problematic,since the outcome may be suboptimal at that stage,9 with anexcess risk of postoperative mortality and left ventriculardysfunction.31 Hence, it has been suggested that surgery fororganic mitral regurgitation should be considered while patientsare asymptomatic.7,32 This approach is supported by the highfeasibility,33 low risk,8 and excellent long-term results5,6of valve repair, but it requires the identification of subgroupsof patients with mitral regurgitation who are at high risk undermedical management.30 In previous studies,3 patients with symptomsor a reduced ejection fraction had a poor outcome. However,the approach to risk stratification for the majority of patientswho did not have these characteristics is uncertain.28
Recently, American and European cardiac societies have emphasizedthe value of a quantitative assessment of mitral regurgitation,11on the basis of previous validation studies.15,16,17,18,19,20Recommendations describe methods of measuring the regurgitantorifice and volume and propose a grading scheme,11 but therehave been no data on whether these measures influence outcomeand may be used for risk stratification among patients withasymptomatic mitral regurgitation.
The identification of severe mitral regurgitation was previouslybased on physiological17 and angiographic21 data. Our data clearlyshow that patients with a regurgitant volume of at least 60ml per beat or an effective regurgitant orifice of at least40 mm2 have a poor outcome with medical management alone andshould be considered to have severe mitral regurgitation.
The effective regurgitant orifice is a major determinant ofsurvival after diagnosis and, therefore, must be determinedat diagnosis.11 Patients with an effective regurgitant orificeof at least 40 mm2 had considerable rates of complications anddeath with the use of medical management in our study and representa high-risk group despite the absence of symptoms and the ostensiblybenign presentation. These patients should mainly be the oneswho are considered for prompt surgery, especially if valve repairappears feasible. Conversely, patients with an effective regurgitantorifice of 20 to 39 mm2 have a low risk of death and cardiacevents within the first few years after diagnosis and may initiallybe followed medically. The rates of cardiac complications subsequentlyincrease, possibly because of progression of regurgitation,36and such patients require careful follow-up and repeated quantitativeassessment of the degree of regurgitation.
Mitral surgery is associated with a considerably decreased subsequentrisk of mortality and heart failure.37 The reduction in therisk of death associated with surgery is greater among patientswith a larger effective regurgitant orifice than among thosewith a smaller effective orifice and results in normalizationof the life expectancy.9 These data provide a firm basis forconsidering surgery in patients with asymptomatic mitral regurgitationwho have an effective regurgitant orifice of at least 40 mm2.However, since the risk of atrial fibrillation increased aftersurgery, a clinical trial of surgery in such patients is essential.
Supported in part by grants from the National Institutes ofHealth (HL 64928) and the American Heart Association (MA 840-140).
Source Information
From the Divisions of Cardiovascular Diseases and Internal Medicine (M.E.-S., J.-F.A., D.M.-Z., D.D., M.C., V.N., A.J.T.) and Cardiac Surgery (H.V.S.) and the Section of Biostatistics (C.S.), Mayo Clinic, Rochester, Minn.
Address reprint requests to Dr. Enriquez-Sarano at the Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, or at sarano.maurice{at}mayo.edu.
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0.05) but not on multivariate analysis (all P>0.30). Furthermore, nested models showed that quantitative classification based on the effective regurgitant orifice significantly increased the predictive value of models that used qualitative grading or jet measures (all P<0.01). 
2 (52 vs. 57). In nested models including the qualitative or jet-related grade of mitral regurgitation, the quantitative classification of the effective regurgitant orifice had superior predictive power (all P<0.01). 
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