Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertension, severe...

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INVITED ARTICLE Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertension, severe tricuspid regurgitation, atrial fibrillation, left atrial size, left ventricular function Mohamed Eid Fawzy October 6 University Medical School, Cairo, Egypt Received 29 October 2013; accepted 19 November 2013 KEYWORDS Mitral valve; Mitral stenosis; Valvotomy Abstract Percutaneous mitral balloon valvotomy (MBV) was introduced in 1984 by Inoue who developed the procedure as a logical extension of surgical closed commissurotomy. Since then, MBV has emerged as the treatment of choice for severe pliable rheumatic mitral stenosis (MS). With increasing experience and better selection of patient, the immediate results of the procedure have improved and the rate of complications declined. When the reported complications of MBV are viewed in aggregate, complications occur at approximately the following rates: mortality (0–0.5%), cerebral accident (1–2%), mitral regurgitation (MR) requiring surgery (0.9–2%). These complication rates compare favorably to those reported after surgical commissurotomy. Several randomized trials reported similar hemodynamic results with MBV and surgical commissurotomy. Restenosis after MBV ranges from 4% to 70% depending on the patient selection, valve morphol- ogy, and duration of follow-up. Restenosis was encountered in 31% of the author’s series at mean follow-up of 9 ± 5.2 years (range 1.5–19 years) and the 10, 15, and 19 years restenosis-free survival rates were (78 ± 2%) (52 ± 3%) and (26 ± 4%), respectively, and were significantly higher for patients with favorable mitral morphology (MES 6 8) at 88 ± 2%, 67 ± 4% and 40 ± 6%, respec- tively (P < 0.0001). The 10, 15, and 19 years event-free survival rates were 88 ± 2%, 60 ± 4% and 28 ± 7%, respectively, and were significantly higher for patients with favorable mitral morphology 92 ± 2%, 70 ± 4% and 42 ± 7%, respectively (P < 0.0001). The effect of MBV on severe pul- monary hypertension, concomitant severe tricuspid regurgitation, left ventricular function, left atrial size, and atrial fibrillation is addressed in this review. ª 2013 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Cardiology. 1. Introduction Mitral stenosis is a progressive disease that leads to heart failure and is finally fatal unless mechanical intervention enlarges the E-mail address: [email protected] Peer review under responsibility of Egyptian Society of Cardiology. Production and hosting by Elsevier The Egyptian Heart Journal (2013) xxx, xxxxxx Egyptian Society of Cardiology The Egyptian Heart Journal www.elsevier.com/locate/ehj www.sciencedirect.com 1110-2608 ª 2013 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Cardiology. http://dx.doi.org/10.1016/j.ehj.2013.11.002 Please cite this article in press as: Fawzy ME Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertension, severe tricuspid regurgitation, atrial fibrillation, left atrial size, left ventricular function, The Egypt Heart J (2013), http://dx.doi.org/ 10.1016/j.ehj.2013.11.002

Transcript of Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertension, severe...

The Egyptian Heart Journal (2013) xxx, xxx–xxx

Egyptian Society of Cardiology

The Egyptian Heart Journal

www.elsevier.com/locate/ehjwww.sciencedirect.com

INVITED ARTICLE

Mitral balloon valvotomy, long-term results, its

impact on severe pulmonary hypertension, severe

tricuspid regurgitation, atrial fibrillation,

left atrial size, left ventricular function

E-mail address: [email protected]

Peer review under responsibility of Egyptian Society of Cardiology.

Production and hosting by Elsevier

1110-2608 ª 2013 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Cardiology.

http://dx.doi.org/10.1016/j.ehj.2013.11.002

Please cite this article in press as: Fawzy ME Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertsevere tricuspid regurgitation, atrial fibrillation, left atrial size, left ventricular function, The Egypt Heart J (2013), http://dx.d10.1016/j.ehj.2013.11.002

Mohamed Eid Fawzy

October 6 University Medical School, Cairo, Egypt

Received 29 October 2013; accepted 19 November 2013

KEYWORDS

Mitral valve;

Mitral stenosis;

Valvotomy

Abstract Percutaneous mitral balloon valvotomy (MBV) was introduced in 1984 by Inoue who

developed the procedure as a logical extension of surgical closed commissurotomy. Since then,

MBV has emerged as the treatment of choice for severe pliable rheumatic mitral stenosis (MS).

With increasing experience and better selection of patient, the immediate results of the procedure

have improved and the rate of complications declined. When the reported complications of MBV

are viewed in aggregate, complications occur at approximately the following rates: mortality

(0–0.5%), cerebral accident (1–2%), mitral regurgitation (MR) requiring surgery (0.9–2%). These

complication rates compare favorably to those reported after surgical commissurotomy. Several

randomized trials reported similar hemodynamic results with MBV and surgical commissurotomy.

Restenosis after MBV ranges from 4% to 70% depending on the patient selection, valve morphol-

ogy, and duration of follow-up. Restenosis was encountered in 31% of the author’s series at mean

follow-up of 9 ± 5.2 years (range 1.5–19 years) and the 10, 15, and 19 years restenosis-free survival

rates were (78 ± 2%) (52 ± 3%) and (26 ± 4%), respectively, and were significantly higher for

patients with favorable mitral morphology (MES 6 8) at 88 ± 2%, 67 ± 4% and 40 ± 6%, respec-

tively (P < 0.0001). The 10, 15, and 19 years event-free survival rates were 88 ± 2%, 60 ± 4% and

28 ± 7%, respectively, and were significantly higher for patients with favorable mitral morphology

92 ± 2%, 70 ± 4% and 42 ± 7%, respectively (P < 0.0001). The effect of MBV on severe pul-

monary hypertension, concomitant severe tricuspid regurgitation, left ventricular function, left

atrial size, and atrial fibrillation is addressed in this review.ª 2013 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Cardiology.

1. Introduction

Mitral stenosis is a progressive disease that leads to heart failure

and is finally fatal unless mechanical intervention enlarges the

ension,oi.org/

2 M.E. Fawzy

mitral valve orifice to permit adequate cardiac output at a toler-able left atrial pressure. Starting over 50 years ago a variety ofsurgical techniques were developed; first closed commissurot-

omy followed by open commissurotomy after the introductionof the cardiopulmonary bypass.1,2 Mitral balloon valvotomywas introduced in 1984 by the Japanese surgeon Inoue, who

developed the procedure as a logical extension of surgical closedcommissurotomy.3 Since then, MBV has emerged as the treat-ment of choice for severe pliable rheumatic mitral stenosis.

The mechanism by which both procedures reduce stenosis isthe same and involves mechanical dilatation of fusedcommissures.4 Several randomized trials reported similarhemodynamic results with balloon valvotomy and surgical

commissurotomy. However, periprocedural complications insurgical patients were somewhat higher.5–8 Both forms of com-missurotomy eliminate the risks common to prosthetic valves,

which include primary valve failure, thromboembolism, andendocarditis. The purpose of this review is to summarize theimmediate and long-term results up to 19 years of MBV, its

complications, and elucidate the effect of MBV on severe pul-monary hypertension, concomitant severe tricuspid regurgita-tion, left ventricular function, left atrial size, and atrial

fibrillation.

2. Techniques

The transseptal technique is the most common technique usedto perform MBV. The technique consists of advancing a cath-eter over the wire across the interatrial septum after transseptalpuncture, enlarging the opening and advancing one large bal-

loon (Inoue balloon) or two smaller balloons (double-balloontechnique) across the mitral orifice and inflating them withinthe orifice. Although acute and short-term outcomes differ lit-

tle between these two techniques,9,10 complications such asdeath, left ventricular perforation, and stroke appear to be lesscommon with the Inoue balloon. The multiple advantages of

the Inoue balloon, include low profile of the device, the elimi-nation of the stiff guide wire (minimizing the risk of LV perfo-ration), easy maneuverability, and the stepwise dilation

(gradual increase of balloon size on sequential inflations).11

3. Echocardiographic evaluation

Echocardiography is the mainstay of the noninvasive evalua-tion of mitral stenosis. The transthoracic echocardiographyprovides an evaluation of the valvular apparatus, mitral valvearea (MVA), left atria dimension, and associated valve lesions.

Doppler echo provides hemodynamic evaluation includingmean mitral gradient, MVA, assessment of concomitant tricus-pid regurgitation (TR) and estimation of pulmonary artery

pressure. The morphologic evaluation of the mitral valve issemiquantilated using echocardiographic score (echo score).The scoring system evaluates leaflet thickening, mobility,

calcification, and subvalvular involvement on a scale of 0–4,as described by Wilkins et al.12 The mitral valve morphologyis considered favorable if the mitral echocardiographic score

(MES) is 68. Transesophageal (TEE) echo should be per-formed before MBV for patients with atrial fibrillation or priorhistory of systemic embolism or very obese patient where theleft atrium was not properly visualized. We do not recommend

TEE as a routine procedure before MBV.13

Please cite this article in press as: Fawzy ME Mitral balloon valvotomsevere tricuspid regurgitation, atrial fibrillation, left atrial size, left v10.1016/j.ehj.2013.11.002

4. Results

4.1. Immediate hemodynamic results

The left atrial pressure, mean mitral gradient, and pulmonary arterysystolic pressure decreased significantly after MBV with a corre-

sponding increase inMVA. In theNationalHeart, LungBlood Insti-tute Balloon Valvotomy Registry of 736 patients,14 the MVA byechocardiographic assessmentwas 1.09± 0.29 cm2before the proce-

dure and increased to 1.8± 0.15 cm2 after the procedure. In theauthor’s series, 547 consecutive patients13 the echocardiographicMVA was 0.92 ± 0.17 cm2 before the procedure, and in-creased to 1.95 ± 0.29 cm2 after the procedure. A significant

inverse relationship was found between the echo score andpost-procedure MVA where mitral valve morphology wasfound to be a strong predictor of post-procedure mitral open-

ing.12,15 However, good results could also be obtained in caseswith relatively high echo score.

4.2. Complications of balloon mitral valvotomy

In general, MBV is a safe procedure with high success rate,particularly if the patients chosen have optimal valve morphol-

ogy as determined by echo score. When the reported rates ofcomplications of MBV are viewed in aggregate, complicationsappear to occur at approximately the following rates: mortal-ity (0–0.5%), cerebrovascular accident (CVA) (0.5–2%), car-

diac tamponade (0.7–1%), mitral regurgitation requiringsurgery (0.9–2%), mitral regurgitation of some degree (15%),and atrial septal defect detected by color Doppler (20–23%)

which, however, closes or decreases in size in mostpatients.11,16,17

4.3. Long-term follow-up and predictors of restenosis and event-free survival

4.3.1. Mitral restenosis

The restenosis rate after MBV has been reported as 39% at7 years18 and was lower (31%) at 19 years in our younger pop-ulation (mean age 31.5 ± 11 years)19 and was 20% in sub-

group of patients with MES 6 8. The actuarial freedom fromrestenosis rates for this population were 78 ± 2% at 10 years,52 ± 3% at 15 years, and 26 ± 5% at 19 years and were sig-

nificantly higher for patients with optimal morphology echoscore 6 8, namely 88 ± 2% at 10 years, 67 ± 4% at 15 years,40 ± 6% at 19 years (Fig. 1) . The predictors of being free

from restenosis were a low echo score (P < 0.0001) andpost-procedure MVA P 2.0 cm2.19–21

4.3.2. Event-free survival

Iung et al. reported an event-free survival (survival with free-dom from redo MBV, MVR, cardiac death, NYHA functionalclass III or IV) rate of 61% at 10 years in 528 patients with suc-

cessful PMBV (mean age, 49 years).21 Palacios et al. (879 pa-tients with successful MBV mean age, 55 years) reported arate of 38% at 12 years for patients with echo score 68 and22% for patients with echo score >8.22 Event-free survival

rates at 10, 15, and 19 years were 88%, 60%, and 28%, respec-tively, in our relatively younger patients and were significantly

y, long-term results, its impact on severe pulmonary hypertension,entricular function, The Egypt Heart J (2013), http://dx.doi.org/

Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertension 3

higher for patients with MES 6 8 (92%, 70%, 42%, respec-tively; P < 0.0001). The predictors of event-free survival werelow echo score and baseline A.F (P < 0.0001 and P = 0.014,

respectively)19 (Fig. 2).

4.3.3. Regression of severe pulmonary hypertension

Pulmonary hypertension frequently complicates mitral stenosis

and may significantly influence the clinical findings and prog-nosis of this condition. The increase in pulmonary arterialpressure is often out of proportion to the degree of left atrial

hypertension, reflecting a major increase in pulmonary vascu-lar resistance.23,24 To elucidate the effect of MBV on severepulmonary hypertension, the author studied 559 consecutive

patients with severe MS undergoing successful MBV. Patientswere allocated to three groups on the basis of their pulmonaryartery systolic pressure (PASP) at cardiac catheterization prior

to MBV; group A (n = 345; 62%) had mild pulmonary hyper-tension (PASP < 50 mmHg); group B (n= 183; 33%) hadmoderate pulmonary hypertension (PASP 50–79 mmHg);and group C (n= 31; 5%) had severe pulmonary hypertension

(PASP P 80 mmHg). Immediately following valvotomy, thePASP normalized in group A, in group B and C, pulmonaryhypertension decreased slightly with further substantial regres-

sion occurring overtime (Fig. 3) and severe pulmonary hyper-tension normalized over 6–12 months in patients withsuccessful PMBV and follow-up MVA P 2.0 cm2.25,26

4.3.4. Regression of significant tricuspid regurgitation

Significant tricuspid valve regurgitation (TR) is a commonfinding in patients with severe MS and in the majority of cases,

it is functional, resulting from right ventricular and tricuspidannular dilation caused by long standing pulmonary hyperten-sion. Although earlier reports suggested that TR can resolve

once the diseased mitral valve is replaced,27,28 the results of la-ter studies are contradictory.29,30 We and other investigators

Figure 1 Freedom from restenosis by Kaplan–Meier estimates for al

represent patients alive and uncensored at each year of follow-up.

Please cite this article in press as: Fawzy ME Mitral balloon valvotomsevere tricuspid regurgitation, atrial fibrillation, left atrial size, left v10.1016/j.ehj.2013.11.002

demonstrated regression of significant TR after successfulMBV in relatively young patients (mean age 25 ± 10 years)with severe MS and concomitant significant pulmonary hyper-

tension (70 ± 22 mmHg).31,32 On the other hand, Sagie et al.33

reported no regression of TR in relatively older patients (meanage 57 ± 15 years) with severe MS and mild pulmonary hyper-

tension (46 ± 15 mmHg). We demonstrated that severe pul-monary hypertension is a strong predictor of regression ofsevere TR after MBV.31

4.3.5. Effect of mitral valvotomy on left ventricular function

In most cases of mitral stenosis, the left ventricular contractil-ity is normal. However, in about one third of patients with mi-

tral stenosis left ventricular systolic function is reduced.Preload reduction – caused by limited mitral inflow – and in-creased afterload – precipitated by reflex vasoconstriction sec-

ondary to decreased cardiac output, act in concert to reduceejection performance.34 We have demonstrated normalizationof impaired LV systolic function after successful MBV in pa-tients with severe MS.35

4.3.6. Effect of MBV on left atrial size

Significant reduction of LA size following successful mitral

Valvotomy was demonstrated by several investigators.36–38

To demonstrate the effect of MBV on left atrial size, 205 con-secutive patients (mean age 31 ± 11 years) were studied by theauthor. LA size at baseline and at mean follow-up of

31 ± 21 months after successful MBV (post-procedureMVA P 1.5 cm2, MR 6 214) was analyzed. LA anteroposte-rior dimension decreased in 87% of the patients (from

48.7 ± 7 to 42 ± 6.6 mm; P < 0.0001) whereas in 13%, it re-mained unchanged or even increased. Similarly, LA volumewas decreased in 93.5% of patients (from 92 ± 29 to

61 ± 24 cm3; P < 0.0001) whereas in the remaining 6.5% ofpatients it remained unchanged or even increased. LA antero-

l patients and for patients with MES 6 8. Numbers at the bottom

y, long-term results, its impact on severe pulmonary hypertension,entricular function, The Egypt Heart J (2013), http://dx.doi.org/

Figure 2 Kaplan–Meier event-free survival estimates (alive and free of redo MBV, MVR, NYHA III or IV) for all patients and for

patients with MES 6 8. Numbers at the bottom represent patients alive and uncensored at each year of follow-up.

Figure 3 Mean pulmonary artery systolic pressure estimated by Doppler echocardiography for groups A–C at baseline and at follow-up

over 12 months.

4 M.E. Fawzy

posterior dimension returned to normal in 29.2% of patients insinus rhythm and in none of the patients with AF. Multiple lin-

ear stepwise regression analysis was used to identify predictorsof regression of LA size after MBV. The variables included inthe analysis were gender, age, baseline anteroposterior LA

dimension, baseline and post-procedure echo MVA, echoscore, and baseline AF. Only two of these variables (baselineanteroposterior LA dimension and baseline AF) were shown

to be predictors of regression of LA dimension (P < 0.001).37

Please cite this article in press as: Fawzy ME Mitral balloon valvotomsevere tricuspid regurgitation, atrial fibrillation, left atrial size, left v10.1016/j.ehj.2013.11.002

4.3.7. Effect of MBV on the incidence of atrial fibrillation

We demonstrated a favorable effect of MBV on the long-

term incidence of chronic AF (8.9%) in patients with severe

MS39 in comparison with the historical controls (29%) of

patients with severe MS and similar baseline characteristicswho were not submitted to intervention.40 The predictors ofAF were age, large LA> 40 mm, small MVA (61.5 cm2) at

follow-up.39

y, long-term results, its impact on severe pulmonary hypertension,entricular function, The Egypt Heart J (2013), http://dx.doi.org/

Mitral balloon valvotomy, long-term results, its impact on severe pulmonary hypertension 5

4.3.8. Comparison of mitral balloon valvotomy with surgical

commissurotomy

MBV is associated with less morbidity, shorter hospital stay,avoidance of the discomfort and other problems associatedwith thoracotomy, while the cost of surgery is at least twice

that of balloon Valvotomy in the United States.41 The imme-diate results appear to be very similar to closed and open sur-gical commissurotomy6,8 while operative mortality from closed

commissurotomy was 2.97%42 which was higher than that re-ported after MBV (0–0.5%).14 The only long-term, though rel-atively small (30 patients in each group), randomized studycomparing surgical closed, open, or percutaneous commissur-

otomy, has been reported by Farahat et al. in young popula-tion with pliable, noncalcified valves. The 7-year results werebetter for open and percutaneous procedures than for closed

commissurotomy as assessed by a higher event-free survival(93%, 90%, and 50%, respectively), better follow-up MVA(1.8, 1.8, and 1.3 cm2) and lower restenosis rate (6%, 6%,

and 37%).8 In long-term surgical series Hickey et al. reportedon 103 patients with closed commissurotomy (mean age38 years) event-free rate from mitral valve replacement of

78% at 10 years and 47% at 20 years.43 Rihal et al. reportedon 267 patients’ (mean age 43 years) event-free rate fromMVR 57% at 10 years and 24% at 20 years.44 In our series,the combined event-free rates after MBV are 88% at 10 years,

60% at 15 years, and 28% at 19 years which were not worsethan those of surgical series.19

5. Conclusions

Mitral balloon valvuloplasty, which is the procedure of choicein the treatment of rheumatic mitral stenosis, has excellent

immediate and long-term results in patients with favorable mi-tral valve morphology but those with less favorable anatomymay still have reasonably good hemodynamic and symptom-

atic relief. This technique is associated with less morbidityand long-term results are better than the historical reportedsurgical results. The long-term outcome can be predicted from

baseline clinical and valvular characteristics. MBV is safe andeffective when treating patients with MS and severe pulmonaryhypertension, the latter condition being normalized over6–12 months after successful MBV. Severe TR regresses after

successful MBV in the presence of severe pulmonary hyperten-sion. Severely impaired LV systolic function normalized aftersuccessful MBV.

Conflict of interest statement

The author of the manuscript claims no conflict of interest.

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