Br Heart J 1992;67:185-9

Percutaneous transarterial balloon dilatation ofthe mitral valve: five year experience

Uros U Babic, Sreten Grujicic, Zoran Popovic, Zoran Djurisic, Petar Pejcic,Mihailo Vucinic

AbstractObjective-To examine the value of

transarterial balloon dilatation of themitral valve for treatment of patientswith mitral stenosis over a period of fiveyears.Design-Analysis of patients' func-

tional state, and haemodynamic andechocardiographic variables, before andimmediately after the procedure andduring a follow up ofup to five years.Setting--A cardiovascular centre in

Belgrade, Yugoslavia.Patients-Two hundred and ninety

four patients who underwent percutan-eous transarterial dilatation of themitral valve between February 1985 andFebruary 1990.Results-Mean mitral valve area was

enlarged by 109%. Complications in-cluded death (0 7%), severe mitral insuf-ficiency (2-3%), mild mitral insufficiency(999%), cerebral embolism (2%), andinjury to the femoral artery (2%). Twomore patients died at two and 11 monthsafter the procedure. Late cardiac sur-gery was needed in eight patients (mitralinsufficiency in three, restenosis in three,thrombus in one, and endocarditis inone. Restenosis occurred in sevenpatients. Four of these underwent repeatdilatation and three had surgery. Im-provement of symptoms was seen in 94%of patients during the follow up.Conclusion-Transarterial balloon

dilatation of the mitral valve gave goodresults with acceptable morbidity andmortality and had some advantages overthe anterograde approach.

Balloon dilatation of the mitral valve is oftenused to treat mitral valve stenosis. Theoriginal transvenous technique reported byInoue et al' has been modified by many work-

-raua ers.23 To avoid injuring the interatrial septumCentre Dedinje, with large balloon catheters and to enableBeograd, Yugoslavia better stabilisation of the balloon across theU U Babic mitral valve we started to use the transarterialS Grujicic approach in February 1985. This study des-Z PopovicZ Djurisic cribes our five year experience with this tech-P Pejcic nique in 294 patients.M Vucinic

Correspondence toDr Uros U Babic,Cardiovascular Centre -Patients and methodsDedinje, S Radica 1, Beograd PATIENTS

11000, Yugoslavia. From February 1985 to February 1990, 294

Accepted for publication1 August 1991 patients (238 (81%) women and 56 (19%)

men aged 15-76 (mean (SD) 36 (7) years)underwent transarterial balloon dilatation ofthe mitral valve. Atrial fibrillation was presentin 64% of patients. Only 35 patients (12%)had been given anticoagulants before theprocedure. Sixty one patients were in the NewYork Heart Association (NYHA) functionalclass IV, 185 in class III, 37 in class II, and 11in class I (all young women who wished tobecome pregnant). According to the echocar-diographic criteria4 171 (58%) patients had apliable mitral valve. There was calcification ofthe mitral valve or mitral apparatus or both, asverified by echocardiography and fluoroscopy,in 49 patients (16%) although 15 still had apliable valve.None of the patients had important coron-

ary artery disease, 48 had aortic valve regur-gitation of less than Sellers5 grade III, twohad considerable and four minor aortic valvestenosis. Nine patients had undergone pre-vious open or closed mitral commissurotomy.

Patients with left atrial thrombi or mitralvalve regurgitation greater than grade II andthose with a significant iliofemoral arterialdisease were excluded. All patients gave in-formed consent.

TECHNIQUEThe technique of transarterial balloon dilata-tion of the mitral valve has been reportedpreviously.67 A description of our presenttechnique is given here. The double ballooncatheter technique has not been used sincelow profile single catheter with the shaft con-nected to two balloons in parallel (twin Mans-field) became available.

Right and left catheterisations were per-formed. Cardiac output was determined bythe Fick principle based on an assumedoxygen consumption8 and by the thermodilu-tion technique. The mitral valve area wascalculated from the Gorlin formula.9 Coron-ary angiography was performed in all patientsto exclude those with coronary artery diseaseand to look for possible neovascularisation ofleft atrial thrombi.10 A Mullins 8 Frenchtrans-septal sheath was advanced from theright femoral vein trans-septally into the leftatrium. Heparin (100 units/kg) was given. A 7French retrieval catheter7 was advancedthrough a sheath from the left femoral arteryto the aortic root where its wire loop wasopened. A 7 French floating Swan-Ganz cath-eter (Vygon), which permits a 0 035 inch wireto pass through its central lumen, was ad-vanced through the Mullins sheath into theleft atrium. The Swan-Ganz floating catheter

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was inflated with carbon dioxide and advancedthrough the left ventricle into the aortic rootacross the wire loop of the retrieval catheter.A guide wire (350 cm long 0 035 inch dia-meter, with flexible J end, Cook) was advancedvia the Swan-Ganz floating catheter from theright femoral vein into the aortic root where itwas snared by the retrieval catheter andbrought out of the body through the leftfemoral artery. A F14 sheath was insertedover this wire into the left femoral artery. Aballoon catheter (twin Mansfield) was intro-duced over the wire through the F14 sheathfrom the left femoral artery to the aortic root.The floating catheter was withdrawn and a twoway Tuohy-Borst adapter was attached on theproximal hub of the Mullins sheath. Thecentral channel of the adapter secured thevenous end of the long guide wire while thesidearm served as the left atrial line for moni-toring of left atrial pressure and for simulta-neous injection of contrast medium into theleft atrium. The long guide wire was pushedfrom both sides to form a large loop within theleft ventricle. The balloon catheter was advan-ced over the loop into the left ventricle up to2-3 cm from the apex after which it wasplaced across the mitral valve by pulling thelong guide wire from the venous side whilethe arterial end of the long wire was securedto the balloon catheter shaft by a Y connector(fig 1).

After the balloon was positioned across thevalve orifice it was inflated and optimalpositioning of the balloon was controlled byinjection of contrast medium into the leftatrium (30 ml volume; 8 ml/s flow). To keepthe balloon stable, the Mullins sheath was

Figure I Diagram oftransarterial balloondilatation of the mitralvalve. Note the tip of theMullins sheath put into theleft atrium during ballooninflation. APL, arterialpressure linefrom thesidearm of the introducersheath; BC, ballooncatheter; LAL, left atrialline; LGW, longguidewire; MSH, Mullinssheath; TBA, Tuohy-Borst two-way adapter.

Figure 2 Cineangiogram showing a twin balloon(18 + 20 mm Mansfield) placed and semi-inflated acrossthe mitral valve.

pushed while the balloon catheter (secured tothe wire by Y connector) was pulled forward(fig 2). The balloon was deflated and pulledback into the aortic root.A single 25 mm balloon (Mansfield) was

used in 17 patients, two balloons (2 x 18,18 + 20, 2 x 20 mm Mansfield) in 188, and abifoil (2 x 19 Schneider) or a "twin"(18 + 20) in 89 patients.

Left atrial pressure and the mitral gradientswere recorded by advancing the Mullinssheath into the left ventricle and withdrawingit into the left atrium. When necessary, dilata-tion was repeated with the same or a largerballoon exchanged over the wire. The hae-modynamic measurements and left ven-triculography were repeated after final dilata-tion and in most patients contrast mediumwas injected into the left atrium through apigtail catheter in the Mullins sheath toexclude left-right shunting. Cephalosporinwas given intravenously one hour before andfor the first 24 hours after the procedure. Anoral antibiotic was given for the next five days.Oral anticoagulants were given to all patientsfor six months after balloon dilatation andtreatment was continued for longer in thosewith atrial fibrillation. Balloon sizes werechosen according to diastolic left ventriculardiameter, valve anatomy, and the body surfacearea.

FOLLOW UPThe patients were followed up as outpatientsone and six months after the procedure andthereafter once a year. Clinical state and chestx ray film were assessed and physical examina-tion and cross sectional and Doppler echocar-diography were performed at each visit.Repeat catheterisation was performed only inpatients with significant recurrent symptoms.

DATA ANALYSISData were expressed as a mean (SD). Thevariables were compared by Student's t test.

ResultsWithin the five year period 16 patients withmitral stenosis were found to have left atrialthrombi and were sent for surgery rather thanballoon dilatation of the valve. Transthoracicechocardiography showed atrial thrombi in 11

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Percutaneous transarterial balloon dilatation of the mitral valve:fiveyear experience

Haemodynamic results before and after percutaneous transarterial balloon dilatation ofthe mitral valve in 294 patients

Before Aftermean (SD) mean (SD) p Values

Pressures (mm Hg):.Pulmonary artery

Systolic 62 (12) 44 (8) <0-001Mean left atrial 23(6) 11(4) <0-001Mean mitral valve gradient 18 (6) 6 (3) <0001

Cardiac output (1/min) 4-1 (0-7) 4-3 (0 6) >0-05Mitral valve area (cm2) 1-1 (0-3) 2-3 (0 4) <0-001

patients, and coronary angiography detectedneovascularisation of thrombi in eight, includ-ing five in whom echocardiography had beennegative. Thrombi were found at operation inall of these patients. In four patients trans-septal catheterisation caused a haemopericar-dium and cardiac tamponade that requiredsubxiphoid pericardiocentesis with a pigtailcatheter. These patients were discharged andthe procedure was successfully repeated two tofour months later. Valve dilatation wasaccomplished in all 294 patients in whom it wasattempted. The time needed for the entireprocedure with a single balloon catheter (bifoilor twin) was less than one hour in mostpatients. In 14 patients the result was poor(enlargement of the mitral valve area was lessthan 25%).The table gives the haemodynamic indices

before and after balloon dilatation. The meanmitral valve area was enlarged by 109%. Theincrease in valve area was more prominent inyounger patients and in those with a pliablevalve (fig 3). In two patients with concomitantaortic valve stenosis, combined aortic andmitral valve balloon dilatation was performedwith the same long guide wire arrangement."The aortic valve gradients were reduced from85 to 25 mm Hg and 110 to 50 mm Hg in thesetwo patients. Aortic valve insufficiency grade IIwas produced in both.

rp30.05- | rPC0.0rr p3-o.Wos I I p34.os I-rP4.001_1 r;k.00011 rp-C0.00011 rp40.00011

vn=19

Valve PliableBefore After

Group IRange 32-37Mean 34

n=14Non-plifbBefore AfterGroup 1132-3734

n=1Opliabe

Before AfterGroup III

52-754

:7rn=10Non-PlableBefore AfterGroup IV52-57 Age (y)55

Figure 3 Individual valuesfor mitral valve area before and after dilatation in 53patients. All patients were dilated with the same 18 + 20 mm twin Mansfield balloon.Two age groups (range five years) were compared. The achieved enlargement of themitral valve area was higher in younger patients and in those with a pliable valve.

COMPLICATIONSThere were two procedural deaths. One patientdied of cerebral embolism and one of leftcoronary artery embolism. Cerebral embolismoccurred in five further patients, only one ofwhom recovered completely. In all sevenpatients with embolic complications the trans-thoracic echocardiography had given incon-clusive findings due to inadequate echogenicity,and transoesophageal echocardiography wasnot available at that time. Immediate surgerywas needed in three patients because of acutesevere mitral insufficiency, and at operation atear in the anterior mitral leaflet was found in allof them. Four patients with post proceduralgrade III mitral insufficiency were dischargedin a stable clinical condition. The left ven-tricular apex was perforated in one patientbecause the balloon was advanced too rapidlythrough the left ventricle. After pericardiocen-tesis and successful dilatation of the valve theperforation site had to be sutured surgically.Oximetry and opacification of the left atriumshowed no left to right shunting after thedilatation in any of the 294 patients.

Vascular surgical intervention on the femoralartery was needed in seven patients (femoralartery intimal flap in three, bleeding at thepuncture site in two, a clot in one, and ahaematoma in one patient). Surgical interven-tion was sucessful in all seven patients andthere were no chronic circulatory sequelae.

RESULTS AT FOLLOW UPAt one to three months after operation echocar-diography confirmed poor results in 14 patients,whose symptoms remained unchanged. Areview ofthe cineangiograms and video tapes ofthe procedures showed that in 11 of 14 patientsthe balloon had not been properly stabilisedduring inflation and the valve had not beendilated. Six of these patients underwent sur-gery. Commissural splitting was not found inany of them. In the other five patients balloondilatation was repeated. These 14 patients weretreated in the early part ofour experience whensimultaneous injection of contrast into the leftatrium was not performed.Two patients died (two and 11 months after

operation). One of these patients haddeveloped mitral regurgitation of grade IIseverity, and the other had no complicationrelated to the operation.

Elective surgery was needed in three out offour patients with grade III mitral regurgita-tion. Surgery was performed at one year, 18months, and two years after balloon dilatation.In two of these patients a tear in the anteriormitral leaflet was found and in the third themitral annulus was dilated (perhaps as a resultof overdilatation with 2 x 20 mm balloons).One patient was operated on because of a leftatrial thrombus at two years, and one becauseof mitral endocarditis three months afterballoon dilatation.

Restenosis (loss of more than 50% of theincrease in valve area), as assessed by repeatcatheterisation, was found in seven patientsbetween six months and two years of follow up.Three had surgery and four had repeat balloon

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294 184 105

294

Pro dl Imm post 1 2Years

Figure 4 Mitral valve area as determined by cross se(Pre dil) immediately after (Imm post), and one tofithe mitral valve.

dilatation of thefibrillation was co.to 15 (mean 5 (SDThe cardiothor

first six months f(p < 0-05) in 210further during folemboli occurred iiup but these hadsectional echocardof the achieved mup (fig 4). Symptoduring the five ye.tion (fig 5). By thipatients returnedtion class IV. Thrvalve replacemenvalve replacement

DiscussionThis study repor

arterial balloon d294 patients, mohad a favourabledural mortality (

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severe mitral regurgitation, and 2% incidenceofembolism-were similar figures to those repor-

2 5 ted after a transvenous approach.""'4 With the52 15 advent of transoesophageal echoradiography,

which became available in our hospital only in1991, the risk of embolism should decreasebecause of better detection of atrial thrombi.There was local injury of the femoral artery in2% of our patients. This complication isspecific to the transarterial approach and it isregarded as the major disadvantage of thistechnique.The atrial septum may be damaged after

T T - -r - I balloon dilatation of the mitral valve. Although3 4 5 there have been reports that significant left to

right shunting leads to an acquired Lutem-bacher syndrome,5 16 it is generally considered

yeional echocardiographytbefore, that these shunts are of little haemodynamicyveyears after balloon dilatation of

importance. Left to right shunting was foundin 62% of patients immediately after transven-ous balloon dilatation with two balloons and in48% of patients at six months after the

valve. In 19 patients atrial procedure.'7 After the Inoue mitral balloontnverted to sinus rhythm four procedure left to right shunting, as detected by) 4)) months after dilatation. Doppler colour flow imaging, was found in 15%acic ratio decreased after the of patients immediately after and in 4% ofFrom 0 5 (009) to 0-46 (0 1) patients one year after the procedure.'8 WithIpatients and did not change the transarterial approach the balloon does notIlow up. Peripheral systemic cross the atrial septum and damage to then four patients during follow septum is minimised. We found no evidence ofI no serious sequelae. Cross left to right shunting in any of our 294 patientsliography showed persistence by oximetry. Petrossian et al calculated theitral valve area during follow mitral valve area after transvenous balloontms improved in most patients dilatation of the mitral valve in 13 patientsar period after balloon dilata- before and after occlusion of the septal holeree years after operation four with a balloon.'9 The calculated area was largerto New York Heart Associa- before than after occlusion. Even whenree of them underwent mitral oximetry does not show important shunting theLt and one mitral and aortic calculated area after transvenous balloont. dilatation of the mitral valve may overestimate

the real area because of the atrial communica-tion. This finding may mean that some reporteddata on transvenous balloon dilatation of the

ts our experience with trans- mitral valve may not be accurate because theilatation of the mitral valve in calculation was done without the occlusion ofist of whom were young and the atrial septal hole.valve anatomy. The proce- The transarterial approach aids stabilisation

of 07%, 2-3% incidence of of the ballons at the valve orifice during dilata-tion. Also simultaneous opacification of the leftatrium monitors the events during the balloon

20 5 inflation and avoids the false impression ofvalvedilatation that may occur when a resistantorifice causes ejection of the balloons from theorifice.The major advantages of the transarterial

approach are avoidance of injury to the atrialJ Class IV septum and good positioning of the balloon at* Class Ill the orifice. The Inoue balloon dilatation sys-

M Class 11 tem, however, offers similar advantages and iseasier to perform. The Inoue procedure must

* Class I be compared with the transarterial approach tojudge which technique is better.Most of our patients experienced a symp-

tomatic improvement that was maintained overthe follow up period of up to five years. The

I I I5U results of this study support the use of balloondilatation of the mitral valve for patients withmitral stenosis and pliant valves.We thank Professor Brian C Morton MD from the University of

Ottawa Heart Institute for reviewing this paper and Ms Roxanne

Prud'Homme for secretarial assistance.

Years

Figure 5 Changes ofNew York Heart Association functional classes after balloondilatation of the mitral valve over afive year period.

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Percutaneous transarterial balloon dilatation of the mitral valve:fiveyear experience

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