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ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 1  |  Page : 29-34

Acute and short-term outcomes of balloon aortic valvuloplasty in patients with significant aortic stenosis: A single-center experience


1 Department of Cardiology, U. N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus, Asarwa, Ahmedabad, India
2 Gujarat, Chief Interventional Cardiologist, Global Superspeciality Hospital, Nanded, Maharashtra, India
3 Department of Research, U. N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus, Asarwa, Ahmedabad, India

Date of Submission10-Oct-2020
Date of Decision04-Jan-2021
Date of Acceptance18-Jan-2021
Date of Web Publication30-Mar-2021

Correspondence Address:
Dr. Pooja Vyas
Department of Cardiology, U. N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus, Asarwa, Ahmedabad - 380 016, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/heartindia.heartindia_46_20

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  Abstract 


Background: The optimal treatment for congenital aortic stenosis (AS) remains in debate over the past three decades of practice with both balloon aortic valvuloplasty (BAV) and surgical aortic valvotomy. BAV has been the palliative therapy with AS in most centers. The present study aimed to provide role and short-term outcomes of BAV in AS patients.
Methods: We enrolled 58 patients aged ≤20 years of AS from July 2017 to November 2019. All patients were evaluated by echocardiography at 1, 3, and 6 months.
Results: From the total of 58 patients, there were 38 male and 20 female patients. BAV could be successfully completed in 56 patients (96.5%). Pre-BAV mean left ventricle systolic pressure (LVSP) was 187.85 ± 53.75 mmHg and transaortic gradient (TAG) was 90.67 ± 42.77 mmHg. LVSP and TAG were reduced significantly (P = 0.0001) post procedure (133.85 ± 41.33 mmHg and 28.11 ± 23.22 mmHg, respectively). Echocardiographic parameters such as V max, aortic valve (AV) G max, and AV G mean were significantly decreased post procedure and AVA was increased significantly post procedure. Ten (17.86%) patients had developed significant (more than or equal to moderate) aortic regurgitation post procedure (17.24%). About 66% of our patients had no complication post procedure. At 1, 3, and 6-month follow–up, AV G max and G mean and V max increased but were not statistically significant.
Conclusion: BAV via transarterial route in pediatric population with significant AS is safe, effective palliation with good immediate and midterm follow-up results with minimum complications. We did not face any major complications except for development of variable degrees of aortic regurgitation and access site complications.

Keywords: Aortic stenosis, balloon aortic valvuloplasty, surgical aortic intervention


How to cite this article:
Prajapati J, Singh P, Vyas P, Patel I. Acute and short-term outcomes of balloon aortic valvuloplasty in patients with significant aortic stenosis: A single-center experience. Heart India 2021;9:29-34

How to cite this URL:
Prajapati J, Singh P, Vyas P, Patel I. Acute and short-term outcomes of balloon aortic valvuloplasty in patients with significant aortic stenosis: A single-center experience. Heart India [serial online] 2021 [cited 2021 Aug 1];9:29-34. Available from: https://www.heartindia.net/text.asp?2021/9/1/29/312487




  Introduction Top


The prevalence of aortic stenosis (AS) in the general population in the western Indian population is 1.9%. Aortic valve (AV) stenosis is a congenital or acquired disease that causes a decrease in AV area resulting in an impaired outflow of blood from the left ventricle (LV) into the aorta and increased end-diastolic pressure in LV.[1]

Aortic valvuloplasty (AoVP) is the therapeutic procedure of choice in most centers for the treatment of congenital AV stenosis in pediatric patients,[2],[3] even though no randomized controlled trials have been conducted to allow a valid comparison of AV surgery (surgical valvotomy, Ross operation, and mechanical AV replacement) and AoVP. Aortic balloon valvuloplasty has now become established as an alternative to surgery for the long-term palliation of congenital AS in children.[4]

In AV stenosis, onset of symptoms significantly worsens the patient's prognosis as it is related to higher mortality risk (about 50%–85% during 5 years from the onset of symptoms).[5],[6] However, residual stenosis and the occurrence of aortic regurgitation are well-known problems after balloon valvuloplasty as well as after surgery.[7]

We investigated the safety, efficacy, complications, and outcomes of balloon AoVP (BAV) via transarterial route in neonates, infants, children, and young adults with severe AS at immediate and short-term follow-up.

METHODS

All patients in present were enrolled prospectively with significant AS between July 2014 and November 2016. Demographic details, baseline vitals, history, clinical findings, anthropometry findings, electrocardiogram (ECG), and echo parameters were recorded for each patient.

Study criteria

  • All patients with age ≤20 years with significant AS with bicuspid AV and echocardiographic mean transaortic gradient more than 40 mmHg with or without ECG evidence of left ventricular hypertrophy with or without presence of symptoms were included in our study
  • Patients of severe AS with significant AV calcification and at least ≥ Grade II aortic regurgitation were excluded from our study.


Procedure protocol

Procedures were performed under local anesthesia or monitored general anesthesia care. Femoral arterial and venous access was established with 4–6-F sheaths (Cordis Corporation, Miami, USA). Heparin (100 units/kg body weight) was given. The balloon chosen was at least 1–2 mm smaller than the valve diameter measured from a cine aortogram. The AV was approached in all patients retrogradely from the femoral artery route via the descending aorta, ascending aorta, and arch of the aorta into the LV using a pigtail catheter (Cordis Corporation, Miami, USA). In one patient, antegrade approach was used through femoral vein by transseptal puncture technique. An aortic root angiogram was performed. The AV was crossed using straight tip Terumo Guide Wire or coronary guide wire. Right ventricle pacing was done to prevent balloon slippage during BAV. Balloon was passed over the wire and inflated. Hemodynamic parameters such as left ventricular systolic pressure, ascending aortic pressure, and transaortic gradient (TAG) were recorded pre- and postballoon dilation. Post-BAV aortic root angiogram was performed to assess any postprocedure aortic regurgitation. Postprocedure echocardiogram was performed and the results were recorded. Complications if any immediately post procedure were noted and managed accordingly.

Postprocedure follow-up

All patients were followed up at 1, 3, and 6 months. Echocardiography was done at each time for transaortic gradient, AV area, left ventricular function, and aortic regurgitation.

The antegrade systolic velocity across the AV was measured using continuous wave Doppler in multiple acoustic windows (apical, right parasternal/suprasternal view; rarely subcostal/supraclavicular views). AS jet velocity is defined as the highest velocity signal obtained from any window. Any complication during the follow-up has been noted.

Statistical analysis

All statistical studies were carried out using SPSS vs. 20 (IBM® SPSS Statistics®, Chicago, IL, USA.). AV area was calculated using continuity equation. Continuous variables were expressed as the mean ± standard deviation and categorical variables were expressed as percentage (%). A comparison of parametric values between the two groups was performed using the independent sample t-test. A nominal significance was taken as a two-tailed P < 0.05.


  Results Top


[Table 1] shows the baseline study characteristics. Male-to-female ratio was 1.9:1. Majority of our patients (66.8%) were in the age group of more than 1 year.
Table 1: Baseline characteristics of the populations

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In the present study, 48 (82.75%) patients had presented for the first time and were posted for primary BAV and 10 (17.25%) patients had a history of BAV in the past and were planned for redo BAV. Eight patients were posted for emergency BAV either due to hemodynamic instability or severe LV dysfunction. Fifty patients were planned for elective BAV.

In our study, 45 patients had isolated AS. Six patients had associated coarctation of the aorta, two patients had associated small atrial septal defect, two patients had small ventricular septal defect and three patients had small patent ductus arteriosus (PDA). Patients with significant coarctation were simultaneously treated with balloon dilation of coarctation. One patient with PDA underwent PDA device closure concurrent with BAV.

BAV was attempted in 58 patients in our study. It was successful in 56 patients (96.5%). The procedure could not be completed in two patients as the wire could not be negotiated across the AV in view of critical AS. These two patients were referred for surgery. In one patient, BAV was performed by antegrade route through the femoral vein via transseptal puncture, as there was a history of failed attempt of BAV in the past through a retrograde approach.

[Table 2] shows cath parameters of the study population which suggests a significant fall in TAG immediate postprocedure. Ascending aortic systolic pressure was increased from 92.79 mmHg to 105.47 mmHg at postprocedure by P = 0.01.
Table 2: Procedural parameters in the study population

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[Figure 1] presents procedural complications in the study. The procedure was uneventful in 37 patients. Nine patients developed local site complications. Six patients had transient loss of peripheral pulsations which were managed with intravenous unfractionated heparin. All these patients responded to treatment and pulsations returned within 24 h. Three patients had acute thrombotic occlusion of the common femoral artery detected by arterial Doppler study. Of these three patients, one patient underwent a femoral artery embolectomy. The other two patients were thrombolysed with injection streptokinase. All patients responded well to treatment.
Figure 1: Procedural complications

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[Table 3] shows development of aortic regurgitation immediately post procedure and on 6-month follow-up.
Table 3: Development of aortic regurgitation postprocedure

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Pre- and postprocedure characteristics on echocardiography are shown in [Table 4]. Mean AV area significantly (P ≤ 0.0001) increased from 0.67 mm2 to 1.37 mm2. AV G max (AV G max), AV G mean, and AV V max significantly (P ≤ 0.0001) decreased immediately post procedure.
Table 4: Pre and immediate postballon aortic valvotomy echocardiographic parameters

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Ten patients developed aortic regurgitation post procedure, of which 8 had moderate aortic regurgitation and 2 had severe aortic regurgitation. These two patients were referred for AV replacement in view of progressive severe aortic regurgitation.

[Table 5] presents the improved TAG at 1 month, 3 months, and 6 months. The mean aortic gradient was found to be little increased without statistical significance. AV area was increased little as compared to immediate postprocedure and the difference at 1 month, 3 month, and 6 month was nonsignificant.
Table 5: Echocardiographic parameters on follow-up

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One patient required reintervention in the form of redo BAV in view of restenosis on follow-up. There was no reported mortality either immediately post procedure or on follow-up.


  Discussion Top


BAV remains the procedure of choice in patients with congenital AS, particularly in pediatric age group. The treatment of AV stenosis in children aims to preserve left ventricular function and to prevent acute and chronic complications.[8] Even in the present era of transcatheter aortic valve implantation, BAV (balloon aortic valvotomy) remains the first line of management in pediatric population.[9] It has been shown to have promising immediate and short-term results with BAV. The risk of restenosis remains a concern over the long term.[10],[11],[12],[13] However, BAV has shown to significantly delay the need for surgical intervention and preserve left ventricular function. Even in the presence of severe LV dysfunction, BAV promising results in terms of relief of LVOT obstruction and subsequent improvement in left ventricular systolic function.[14],[15] With today's much-improved balloon profiles and use of retrograde approach via the femoral artery, the procedure can be performed safely although with risk of development of aortic regurgitation in a few cases.

The number of patients in our study was 58 which was similar to most of the previous studies of BAV. The number of patients in previous studies[10],[16],[17],[18],[19],[20] ranged from 13 to 97 except in the study by Ewert et al.[21] who performed retrospective meta-analysis of 1004 patients from data collected between 1985 and 2003. All the patients enrolled in our study had bicuspid AV morphology on echocardiography which was consistent with findings in most of the previous studies on BAV.

In our study, there was a statistically significant decline in transaortic gradients after BAV was measured either invasively or by continuous-wave Doppler method. The reduction in gradient in our patients was comparable to or greater than that in previously reported data.[22] In this study, balloon valvuloplasty directly resulted in a 28.75% reduction of peak systolic left ventricular pressure, and a 69% decrease in the transvalvular gradient measured invasively. The continuous-wave Doppler-derived maximum transaortic gradient decreased by 56.5% and the mean transaortic gradient decreased by 61% after BAV in our study. The gradient reduction (as measured with continuous-wave Doppler) was not as large as that measured invasively (56.5% vs. 69%). Selection of a moderate balloon size did not have a negative influence on gradient decrease. This is reliable with the registry study,[23] which found no correlation between the balloon to annulus ratio.

Aortic regurgitation after balloon aortic valvoplasty is of major concern. The relation between oversized balloons and an increased incidence of postinterventional aortic regurgitation[8] is well known. We used 0.9–1.0 balloons and did not find any correlation between the balloon-to-annulus ratio and aortic regurgitation in our study. Even with the use of moderate-sized balloons, the rate of aortic regurgitation immediately after balloon valvoplasty in our patients is in the same range as in other studies previously reported. If the incidence and degree of aortic regurgitation were low immediately after balloon valvoplasty, they remained so in short- and medium-term follow-ups. The early severe aortic regurgitation in our series was extremely less (3.4%); however, Witsenburg et al., employing a 0.9–1 annulus to balloon ratio, reported a 14% incidence of early severe aortic regurgitation.[24] Thus, the possible role played by different valve morphologies has to be considered for the development of AR post valvuloplasty.[25]

Indeed, we reported means of repeated Doppler measurements, which combined with color flow and pulsed wave Doppler criteria, which suggested that the course of aortic regurgitation was nonprogressive. The mixture of color flow and pulsed wave Doppler criteria was a useful tool in evaluating postinterventional aortic regurgitation. Data reported by the valvulotomy and angioplasty of congenital anomalies registry showed, in contrast, some influence of the average balloon-to-aortic annulus ratio on aortic regurgitation.[24] However, in that series of patients, the maximum balloon-to-annulus ratio was 1.5, while in our series, it was 0.9–1.

In our study, arterial complications were frequent (16%); however, only three patients required some sort of intervention: for arterial thrombosis. Two patients were thrombolysed with injection streptokinase and one patient underwent femoral artery embolectomy. In the others, medical treatment restored arterial flow with intravenous heparin infusion. One patient required blood transfusion post procedure.

There were no major life-threatening complications reported in our study. Older studies had reported complications such as perforation, cardiac tamponade, heart blocks, and requirement of pacemaker or need for emergency surgery. This has not been seen in our study. Immediate and short-term outcomes were favorable as there was only one case with significant restenosis observed. Only concerns seen were the development of moderate aortic regurgitation in 17% and local site complications in 15% of patients. However, the development of aortic regurgitation was managed conservatively with only one patient requiring surgical correction.

Balloon valvoplasty has a low procedure-related mortality.[8] Few cases of procedure-related mortality were reported in various studies. However, there was no procedure-related mortality in our study. Furthermore, there was a continued significant reduction in gradient at both early and late follow-up study, indicating the continued long-term benefits from this procedure.

BAV can thus be considered as a very useful palliative procedure with the understanding that subsequent surgery may be required in adulthood. The outcomes of our study were in consistency with the majority of studies of the past which had evaluated BAV.


  Conclusion Top


BAV via transarterial route in pediatric population with bicuspid AV with significant AS is safe, effective palliation with minimum complications. It is not associated with any major complications except for development of variable degrees of aortic regurgitation and access site complication. It has been shown to delay the need for early surgical intervention with a very low rate of short-term restenosis.

Financial support and sponsorship

This work was financially supported by U.N. Mehta Institute of Cardiology and Research Centre itself and received no specific grant from any funding agency, commercial, or not-for-profit sectors.

Conflicts of interest

There are no conflicts of interest.

Ethical approval

The study has been approved by Institutional ethics committee.

Authors' contributions

All authors have contributed to prepare this present manuscript



 
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