Percutaneous Balloon Valvuloplasty Compared with Open Surgical Commissurotomy for Mitral Stenosis
Vincent P. Reyes, B. Soma Raju, Joshua Wynne, Larry W. Stephenson, Raghava Raju, Barbara S. Fromm, P. Rajagopal, Prabodh Mehta, Shailender Singh, D. Prasada Rao, P.V. Satyanarayana, and Zoltan G. Turi
Background Percutaneous balloon mitral valvuloplasty has beenproposed as an alternative to open surgical commissurotomy forthe treatment of rheumatic mitral-valve stenosis.
Methods We enrolled 60 patients with severe mitral stenosisand favorable valvular anatomy in a prospective, randomizedtrial comparing the two procedures. All patients underwent cardiaccatheterization before the procedure and one week, six months,and three years thereafter. Hemodynamic data were analyzed byinvestigators who were blinded to the patients' treatment assignments.
Results Mitral-valve areas improved initially in both groups,from a mean (±SD) of 0.9 ±0.3 cm2 to 2.1 ±0.6cm2 in the balloon-valvuloplasty group (30 patients; P<0.01)and from 0.9 ±0.3 cm2 to 2.0 ±0.6 cm2 in the surgicalgroup (30 patients; P<0.001). Although improvement was maintainedin both groups, mitral-valve areas were greater in the patientsin the balloon-valvuloplasty group at three years (2.4 ±0.6cm2, vs. 1.8 ±0.4 cm2 in the surgery group; P<0.001).Restenosis occurred in three patients in the balloon-valvuloplastygroup and four in the surgery group. One patient in the balloon-valvuloplastygroup died of an apparent stroke after 2.5 years; four patientsin the balloon-valvuloplasty group had residual atrial septaldefects, and three patients (two in the balloon-valvuloplastygroup and one in the surgery group) were judged to have severemitral regurgitation. Seventy-two percent of the patients whounderwent balloon valvuloplasty and 57 percent of the surgicallytreated patients were in New York Heart Association functionalclass I (i.e., they had no cardiovascular symptoms) at threeyears. No patient was lost to follow-up.
Conclusions In the treatment of mitral stenosis, balloon valvuloplastyand open surgical commissurotomy have comparable initial resultsand low rates of restenosis, and both produce good functionalcapacity for at least three years. The potential complicationsassociated with balloon valvuloplasty should be noted. The betterhemodynamic results at three years, lower cost, and eliminationof the need for thoracotomy suggest that balloon valvuloplastyshould be considered for all patients with favorable mitral-valveanatomy.
Percutaneous balloon mitral commissurotomy (valvuloplasty),first described in 1984,1 has had good short- and intermediate-termresults2,3,4,5,6. In a randomized trial in patients with favorableanatomical features,7 we reported that the outcome of balloonvalvuloplasty was similar to that of closed surgical commissurotomy.Although the superiority of open over closed commissurotomyin patients with ideal valvular anatomy remains controversial,8open commissurotomy (which allows the inspection of the valveand the separation of fused chordae under direct vision) isthe preferred treatment for severe mitral stenosis in most industrializednations9. We therefore compared the results of percutaneousballoon mitral valvuloplasty with those of open mitral commissurotomyin a randomized, prospective trial, with serial invasive andnoninvasive testing of all patients through three years of follow-up.
Methods
Study Design
All the patients were enrolled during a three-week period inAugust and September 1989. Patients with severe rheumatic mitral-valvestenosis were screened in the clinics of the Nizam's Instituteof Medical Sciences, Hyderabad, India, and referred for enrollmentif they were 15 through 75 years of age and had no history ofother cardiac disease or stroke, were in sinus rhythm, and hadno severe subvalvular disease, calcification, or more than mildmitral regurgitation. A history was obtained from all patients,who also underwent physical examination, two-dimensional echocardiographyand color Doppler study, exercise testing, chest radiography,and quality-of-life evaluation. A mitral-valve echocardiographicscore was derived according to the criteria of Wilkins and colleagues,10in which a maximum of 4 points was assigned according to theseverity of each of four characteristics: mitral-valve-leafletcalcification, impaired mobility, thickening of the valve, andsubvalvular disease (0 indicates normal and 4 the most severeabnormality); the four separate scores were totaled to givethe overall echocardiographic score. A committee of cardiologistsand a committee of cardiac surgeons screened each patient; bothgroups had to agree that the patient was a suitable candidatefor their procedures. The protocol was approved by the institutionalreview board of the Wayne State University School of Medicineand the Human Investigation Committee of the Nizam's Instituteof Medical Sciences. Informed consent was obtained from allpatients, and the study was conducted in accordance with theguidelines of the 1975 Helsinki Declaration on the Rights ofHuman Subjects Enrolled in Medical Research.
Cardiac catheterization was performed at base line and one week,six months, and three years after the procedure. Cardiac outputwas determined by the Fick technique; the Flamm correction wasapplied if the oxygen saturation in the pulmony artery was morethan 6 percent higher than that in the superior vena cava11.All cardiac-catheterization data were photocopied, coded withuse of random numbers to mask the patient's identity, the groupassignment, and the time at which data were obtained and wereanalyzed by an investigator remote from the study site.
We assessed functional capacity by treadmill exercise testingaccording to a modified Naughton protocol and by the interview-basedDuke Activity Status Index,12 generating a score based on thepercentage of activities (related to personal care, ambulation,household tasks, sexual function, and recreation) that individualpatients could perform without substantial limitation.
The patients were randomly assigned to treatment groups afterall base-line data were obtained. Those assigned to balloonvalvuloplasty underwent the procedure after initial catheterization;for this procedure we used a modified version13 of the techniqueof Al Zaibag and colleagues14. After a single atrial transseptalpuncture, an 8-French Mullins sheath (USCI, Billerica, Mass.)was advanced to the left atrium. A balloon flotation catheterwas used to cross the mitral valve, after which two 0.035-in.(0.9-mm) Extra Stiff guidewires (Cook, Bloomington, Ind.) wereplaced in the apex of the left ventricle. An 8-mm septostomyballoon was used to dilate the septum (PE Plus II, USCI), afterwhich two valvuloplasty balloons, 5.5 cm long (Boston Scientific,Watertown, Mass.), were inflated simultaneously across the mitralvalve (20 mm and 15 mm in 26 patients; 18 mm and 15 mm in 4patients). The therapeutic end point was nearly complete eliminationof the mitral-valve gradient without a substantial increasein mitral regurgitation.
The patients randomly assigned to open surgical commissurotomyunderwent a midline sternotomy, cannulation of the inferiorand superior vena cava through the right atrium, and cardiopulmonarybypass (with use of a bubble oxygenator) and moderate systemichypothermia15. After the aorta was cross-clamped, approximately1 liter of a cold crystalloid-potassium cardioplegia solutionwas used to arrest the heart. The mitral valve was approachedthrough a left atriotomy; if fused chordae were noted underthe leaflets during commissurotomy, an attempt was made to separatethe area of abnormal fusion.
Patients were discharged from the hospital after echocardiographyand cardiac catheterization were performed one week after theprocedure. The investigators made extensive efforts to maintaincommunication with patients, whose homes were scattered overa wide geographic area. Patients received laminated identificationcards noting their participation in the study and were photographedfor identification purposes. Six-month and three-year follow-upexaminations were performed during two-week periods in February1990 and September 1992, with the majority of the investigatorspresent, including cardiologists from both the U.S. and Indianteams and the study statistician.
Statistical Analysis
The prospectively determined primary end point was the mitral-valvearea one week, six months, and three years after the procedures.Power calculations were based on data from our previous study7;we estimated that the enrollment of 28 patients in each treatmentgroup would give the study 80 percent power to detect a differenceof at least 25 percent in mitral-valve area between the groups.Intraobserver variability was tested and found to be reproduciblewithin a mean (±SD) of 1.2 ±1.8 mm Hg for thepulmonary wedge pressure or the left atrial pressure, 0.02 ±0.03second for the diastolic filling period, 2.3 ±3.1 beatsper minute for the heart rate, and 0.5 ±0.6 mm Hg forthe mitral-valve gradient. Because the original formula of Gorlinand Gorlin for calculating the areas of the stenotic mitralvalve and other cardiac valves was derived from a group of patientswith small valve areas16 and therefore tends to overestimatevalve area in high-flow states,17 valve areas greater than 3.0cm2 were considered to be 3.0 cm2 (all valve areas derived fromthe formula of Gorlin and Gorlin without truncation are shownin Figure 2). Repeated-measures analysis of variance was performedfor continuous variables to assess change over time and theeffect of treatment18; between-group and within-group pairwisecomparisons were made with the use of the least-squares means.Categorical variables were compared by chi-square analysis.No adjustment was made for multiple comparisons, and all testsof the hypothesis were two-tailed. The results are reportedas means ±SD.
Figure 2. Cumulative Frequency Distribution of Mitral-Valve Areas in Patients Who Underwent Balloon Valvuloplasty (Open Symbols) or Open Surgical Commissurotomy (Solid Symbols).
The vertical axis shows the percentage of patients whose mitral-valve area was less than the area on the horizontal axis.
Results
Study Population
Of the initial 82 patients who underwent cardiac catheterization,22 were excluded from randomization because of the presenceof coexisting myocardial or other valvular disease (7 patients),noncritical mitral stenosis (6), severe pulmonary hypertension(3), low body weight (2), severe subvalvular disease (1), Lutembacher'ssyndrome (1), the patient's decision not to undergo randomization(1), or left atrial thrombus demonstrated by echocardiography(1). By means of sealed envelopes, the remaining 60 patientswere randomly assigned to percutaneous balloon mitral valvuloplasty(n = 30) or open surgical commissurotomy (n = 30) and underwentthe assigned procedures within the next several days.
Base-line demographic, hemodynamic, and echocardiographic characteristicsand functional-activity ratings are shown in Table 1. The patientsin the two groups were similar in age, New York Heart Association(NYHA) functional class, hemodynamic variables, and echocardiographicscores at study entry. There were more men (P = 0.01) and exercisetimes were longer (P = 0.03) in the surgery group than in theballoon-valvuloplasty group.
Table 1. Base-Line Characteristics of Patients Who Underwent Balloon Valvuloplasty or Open Surgical Commissurotomy.
Outcome of the Procedures
All 60 patients underwent their assigned procedures. Cardiaccatheterization, echocardiography, exercise testing, and quality-of-lifeevaluation were performed as scheduled for every patient, exceptfor the 3-year study in the patient who died at 2.5 years; nopatient was lost to follow-up. Hemodynamic measurements in thetwo groups are presented in Figure 1. The initial improvementin pulmonary-artery wedge pressure, mitral-valve gradient, andmitral-valve area was sustained throughout the three years offollow-up (P<0.001 for the comparison with the base-linevalues). In both groups, pulmonary-artery wedge pressures werefurther improved at three years as compared with the valuesat the one-week or six-month evaluation (P<0.001). Both themitral-valve gradient and the pulmonary-wedge pressure werelower in the balloon-valvuloplasty group than in the surgerygroup throughout follow-up, but these differences were not statisticallysignificant. The difference in mitral-valve area between theballoon-valvuloplasty group and the surgery group became significantat three years (P<0.001). The exclusion of patients withevidence of left-to-right shunting on oxymetry or color Dopplerechocardiography did not change the above findings. Pulmonaryhypertension resolved more slowly in the surgery group; a continuingdecrease in pulmonary-artery pressures was noted at six monthsand at three years.
Figure 1. Hemodynamic Variables at Base Line and One Week, Six Months, and Three Years after Balloon Mitral Valvuloplasty or Open Surgical Commissurotomy.
The asterisk indicates P<0.001 for the comparison with the base-line value in all panels. The dagger (in Panel A) indicates P<0.001 for the comparison with the values at base line, at one week, and at six months. The double dagger (in Panel B) indicates P = 0.002 for the comparison with the balloon-valvuloplasty group and P = 0.16 (not significant) for the comparison with the base-line value. The section mark in Panel D indicates P<0.001 for the comparison with the surgery group. The bars indicate the standard errors.
Figure 2 shows the mitral-valve area for each patient plottedagainst the cumulative percentile distribution of valve areasin each group at base line and at each follow-up evaluation.The balloon-valvuloplasty and surgery groups overlap closelyat base line; the curve for the balloon-valvuloplasty groupshifts to the right of that for the surgery group at all threefollow-ups, demonstrating that the valve areas were consistentlylarger after balloon valvuloplasty than after surgical commissurotomy.
Functional Capacity
The majority of patients enrolled in this study engaged in atleast moderate physical activity despite having severe mitralstenosis at base line. By six months after the procedure, approximately80 percent were in NYHA functional class I (23 patients in thealloon-valvuloplasty group and 24 in the surgery group), indicatingthat they had no symptoms; at three years, 21 patients in theballoon-valvuloplasty group and 17 in the surgery group remainedin class I. We also compared hemodynamic variables during exerciseat three years in the two groups: although the duration of exerciseand the exercise gradient were essentially the same, the meanwedge pressure during exercise was significantly greater (P= 0.03) in the patients who underwent surgery (Figure 3).
Figure 3. Pulmonary-Artery Wedge Pressure and Mitral-Valve Gradient during Exercise and Duration of Exercise at the Three-Year Follow-up Examination.
The bars indicate the standard errors.
The scores on the Duke Activity Status Index were similar atbase line (Table 1), and improvement persisted through threeyears (at six months and three years, P<0.001 for the comparisonwith the base-line values in both groups). The six-month scorewas higher in the balloon-valvuloplasty group (activities performedeasily, 82 percent vs. 72 percent; P = 0.01), but the scoreswere similar by three years (96 percent vs. 90 percent, P =0.09).
Complications
No patient had a serious complication during the initial hospitalization.Complications during three years of follow-up are listed inTable 2. One patient in the balloon-valvuloplasty group diedapproximately 2.5 years after valvuloplasty; this patient, a52-year-old woman, had a valve area of 2.6 cm2 immediately afterthe procedure; at the 6-month follow-up examination, she hada residual atrial septal defect with a ratio of pulmonary tosystemic flow of 2.6. The information provided by her son afterher death was consistent with a diagnosis of left hemisphericstroke, dehydration, and subsequent death. One week after theprocedure, 13 patients in the balloon-valvuloplasty group and5 in the surgery group had moderate or severe mitral regurgitation(P = 0.03); mitral insufficiency was classified as severe in2 who underwent balloon valvuloplasty and none who underwentsurgical commissurotomy. At three years, mitral regurgitationwas mild or absent in 25 patients in the balloon-valvuloplastygroup and 27 in the surgery group; 3 patients had severe mitralregurgitation (2 in the balloon-valvuloplasty group and 1 inthe surgery group). No patient had left ventricular dilatationor dysfunction. There were four patients with a pulmonary-to-systemicflow ratio of more than 1.5 at three years, all of whom hadundergone atrial septostomy for balloon valvuloplasty. All patientsremained in sinus rhythm at the three-year follow-up.
Table 2. Complications of Percutaneous Balloon Valvuloplasty and Open Mitral Commissurotomy through Three Years of Follow-up.
By definition, restenosis was indicated by a mitral-valve areaof less than 1.5 cm2 and a loss of more than 50 percent of theinitial gain after the procedure19,20; three patients in theballoon-valvuloplasty group and four in the surgery group fitthese criteria and were scheduled for balloon valvuloplasty.
Cost
We calculated the charges for hospitalization and physicians'fees for the two groups of patients. With accounting for thereuse of disposable balloons in India, the cost of surgery wasat least twice that of balloon valvuloplasty; in the UnitedStates, on the basis of Medicare reimbursement at Harper Hospitalin Detroit, this ratio was nearly three to one.
Discussion
In our patients with severe mitral stenosis, both balloon valvuloplastyand open surgical commissurotomy resulted in sustained improvementthrough three years of follow-up. Our initial prediction, thatthe advantages of surgery under direct vision, including controlledseparation of fused commissures, would result in a larger mitral-valvearea21 and less mitral regurgitation, was not borne out. Inaddition to the larger mitral-valve areas in the balloon-valvuloplastygroup, the preponderance of evidence based on other measurements(mitral-valve gradient, pulmonary-artery wedge pressure, pulmonary-arterypressure, and hemodynamic measurements during exercise) showedtrends indicating the superiority of balloon valvuloplasty oversurgery.
The occurrence of atrial septal defect in over 10 percent ofpatients who underwent balloon valvuloplasty is in keeping withpublished data22 and may reflect two aspects of the techniqueused in India at that time: the reuse of balloons, a practicethat tends to result in a higher profile during withdrawal acrossthe septum, and the use of relatively large, 8-mm septostomyballoons, which were standard at that time. Since the reuseof disposable equipment to limit costs is a standard practicein most parts of the world where mitral stenosis is prevalent,we believe that our results are typical for the double-balloontechnique.
Although some increase in mitral regurgitation has been reportedto be common during follow-up, severe mitral regurgitation isless common23,24,25; two patients in the balloon-valvuloplastygroup and one in the surgery group were judged to have severemitral incompetence at three years. Although improvement inthe degree of postprocedural mitral regurgitation over timehas been reported,26 in our study regurgitation was predominantlymild one week after the procedure. All three patients who hadsevere mitral regurgitation at three years had at least moderatemitral regurgitation at one week.
It has been postulated that what is labeled restenosis may merelyreflect poor initial results. In the seven patients who metthe criteria for restenosis, the mean valve area one week afterballoon valvuloplasty or surgical commissurotomy was 2.4 ±0.9cm2, narrowing to 1.4 ±0.1 cm2 at three years, thus representingtrue restenosis. Although this 12 percent rate of restenosisis in the middle of the 4-to-27-percent range reported in previousstudies,20,27,28,29 earlier reports relied at least in parton clinical criteria, did not include routine follow-up catheterization,and did not approach our 100 percent follow-up. Furthermore,three of our seven patients who had restenosis were in NYHAclass I (i.e., they had no cardiac symptoms) despite hemodynamicevidence of severe recurrent mitral stenosis; thus, they wouldnot have been described as having restenosis according to thecriteria used by most previous investigators30,31.
In order to minimize the effect of the experience and skillsof individual physicians on the results of this study, balloonvalvuloplasty was performed by a team of interventional cardiologistsfrom the United States and India who had two years of experienceworking together, had previously conducted a comparative studyof balloon valvuloplasty and surgery (closed commissurotomy),7and had performed several hundred balloon-valvuloplasty proceduresbefore this study. Similarly, open commissurotomy was performedby an experienced team of cardiac surgeons from India, the UnitedStates, and the United Kingdom, with extensive experience inopen mitral commissurotomy. As was the case for the balloon-valvuloplastyprocedures, the 30 open commissurotomies were performed duringa two-week period; the members of the surgical team who participatedin the various operations overlapped, and attempts were madeto maintain uniform operative technique.
Limitations of the Study
The patients in this study had characteristics that made themideal candidates for balloon valvuloplasty and surgical commissurotomy,including an absence of factors known to increase the risk andlimit the success of both procedures. However, a substantialnumber of our patients had characteristics associated with highrisk during and after commissurotomy,32 including critical mitralstenosis with mitral-valve areas of 0.7 cm2 (23 percent) andmoderately severe or severe pulmonary hypertension (42 percenthad a mean pulmonary-artery pressure >40 mm Hg). Despiteour favorable results, caution should be exercised in extrapolatingour findings to older patients with high echocardiographic scores,severe subvalvular disease, or thickened, poorly mobile, calcifiedleaflets or to patients in atrial fibrillation. Studies in less-than-idealpatient groups, especially studies including procedures performedwhile physicians gained experience,33 have reported higher morbidityand mortality31.
The sex imbalance between the groups does not account for thesuperior results in the balloon-valvuloplasty group. The mitral-valveareas in the 47 women were identical at base line (0.9 ±0.3cm2 in both groups), but at the three-year follow-up the valvearea was 2.4 ±0.6 cm2 in the women in the balloon-valvuloplastygroup and 1.9 ±0.5 cm2 in those who underwent surgery(P = 0.005).
Our study did not compare the double-balloon with the Inouesingle-balloon technique, since the latter was not availableto the investigators at the beginning of the study. Comparisonsof the two techniques have thus far failed to demonstrate acompelling difference in hemodynamic results34,35,36,37 or left-to-rightshunting38,39. The ability of either technique to open valvesin these nearly ideal candidates for the procedure makes itunlikely that our overall findings would have been affectedby the choice of valvuloplasty technique40.
Our results suggest that balloon valvuloplasty should be consideredfor patients with uncomplicated mitral-valve stenosis. Opensurgical commissurotomy will continue to be useful for patientswith severe subvalvular disease, calcification, or thrombuswho are judged to be candidates for plastic procedures ratherthan mitral-valve replacement. Because mitral commissurotomyis a palliative procedure, the likelihood that thoracotomy willbe needed at some point later in the course of the disease issubstantial. By avoiding a heart operation early, these patientswill avoid the higher rate of complications associated witha second thoracotomy.
The prevalence of rheumatic mitral stenosis in developing countries,where health care funds are limited, will dictate the routineuse of balloon valvuloplasty, as long as disposable equipmentcan be reused safely. In industrialized nations, cost factorsalso favor balloon valvuloplasty, even without such reuse. Theimprovement in mitral-valve area after balloon valvuloplastyneeds to be considered in the light of the one late death fromcardiovascular causes in our study, the four patients with persistentatrial septal defects, and the one additional case of severemitral regurgitation. A longer follow-up period will be important(follow-up of seven years is planned). Nevertheless, the shorterhospital stays, avoidance of the discomfort and other problemsassociated with thoracotomy, and superior hemodynamic resultsof balloon valvuloplasty dictate that this procedure be consideredfor all patients with severe mitral stenosis in whom the anatomicalfeatures of the valve are favorable.
Supported in part by a grant from the General Electric Company.
We are indebted to the directors of the Nizam's Institute ofMedical Sciences for their generosity in making available theirfacilities and personnel; to Dr. Peter Farkas for analyzinghemodynamic data; to Dr. David Anderson (Guy's Hospital, London)for participating in the open-heart-surgery team; to Drs. D.N.Kumar, N. Krishna Reddy, P. Kishore, Padma Kumar, N.V. Rayadu,Prasad Reddy, M.S. Rao, Sunil Kapoor, B.K.S. Sastry, S. Srinivas,Syamasundera Zampani, Susan Farkas, and Shukri David and SisterMercy Augustine for assistance in patient care and the collectionof clinical data; to Mr. Michael Andersen (deceased), Mr. P.Appaya, Ms. Debbie Boldea, Ms. Priscilla Peters, and the techniciansand nurses of the cardiac catheterization laboratory of theNizam's Institute of Medical Sciences; to the C.R. Bard, BostonScientific, Namic, Cordis, and Winthrop-Sanofi corporationsfor generously providing supplies; and to the health ministersof the state of Andhra Pradesh for their continuing supportof this work.
Source Information
From the Divisions of Cardiology (V.P.R., J.W., B.S.F., P.M., Z.G.T.) and Cardiothoracic Surgery (L.W.S.), Departments of Internal Medicine and Surgery, Harper Hospital, Wayne State University School of Medicine, Detroit; and the Departments of Cardiology (B.S.R., R.R., S.S.) and Cardiac Surgery (P.R., D.P.R., P.V.S.), the Nizam's Institute of Medical Sciences and MediCiti, Hyderabad, India. Presented in part in abstract form at the 63rd and 66th Scientific Sessions of the American Heart Association, Dallas, November 14, 1990, and Atlanta, November 9, 1993.
Address reprint requests to Dr. Turi at Wayne State University School of Medicine, Harper Hospital, 3990 John R., Detroit, MI 48201.
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