Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
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Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




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It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




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Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : June | Volume : 16 | Issue : 6 | Page : OC30 - OC34 Full Version

Percutaneous Pulmonary Valvuloplasty by JOMIVA Balloon in Adults: Long Term Retrospective Study from a Tertiary Care Hospital of Eastern India


Published: June 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/53367.16526
Chandrakanta Mishra, Archana Mishra, Satyanarayan Routray

1. Associate Professor, Department of Cardiology, SCB Medical College, Cuttack, Odisha, India. 2. Associate Professor, Department of Physiology, SJ Medical College, Puri, Odisha, India. 3. Professor Department of Cardiology, SCB Medical College, Cuttack, Odisha, India.

Correspondence Address :
Chandrakanta Mishra,
Friends Colony, Buxibazar, Cuttack, Odisha, India.
E-mail: drckmishra@gmail.com

Abstract

Introduction: Isolated pulmonary valve stenosis with intact ventricular septum constitutes the third most common congenital heart disease apart from Ventricular Septal Defect (VSD) and Atrial Septal Defect (ASD). Percutaneous balloon pulmonary valvuloplasty is an effective therapeutic alternative procedure of choice in severe valvular PS. Conventionally, the Mansfield balloon is being used worldwide for pulmonary valvuloplasty. Joseph Mitral Valvuloplasty (JOMIVA) balloon offers advantages of longer size, lower cost and its familiarity to use this balloon for mitral valvuloplasty in this institution since long.

Aim: To assess the immediate and long-term results of Joseph Mitral Valvuloplasty (JOMIVA)balloon for Pulmonary valvuloplasty in isolated severe Pulmonary Stenosis (PS).

Materials and Methods: This was a long term retrospective study conducted at the Cardiology Department of SCB Medical college and Hospital, Cuttack, Odisha, India, where pulmonary valvuloplasty was performed using single JOMIVA balloon in 21 adults and adolescent patients. Clinical and Echocardiography (Echo) Doppler evaluation for restenosis and Pulmonary Regurgitation (PR) were assessed. All the cases were followed-up serially in Outpatient Department (OPD) for 12 years in retrospect manner.

Results: Data of total 21 participants (15 males and 6 females; mean age was 18.3±6.8 years) were analysed in the study. After pulmonary valvuloplasty, the median transvalvular gradient significantly decreased from 115 mmHg (interquartile range (IQR) 101-128 mmHg) to 46 mmHg (IQR 37-51 mmHg) (p-value<0.0001). Also, the right ventricular systolic pressure reduced significantly from 136 mmHg (IQR 122-148 mmHg) to 67 mmHg (IQR 57-71 mmHg) (p-value<0.0001). Catheterization Laboratory (Cath Lab) complications were transient and self-limiting. Mild to moderate (PR) was noted in all cases i.e., Grade I in 12 cases (57.1%) and Grade II in 9 cases (42.8%) which showed evidence of regression on follow-up. Neither significant restenosis nor significant PR (Grade III /IV) was observed during follow-up period of 12 years.

Conclusion: Percutaneous valvuloplasty using JOMIVA Balloon, in case of severe valvular PS in adults, is a cost-effective procedure. It has excellent immediate results, and long-term incremental benefits was observed in this 12-year follow-up study.

Keywords

Immediate results, Joseph mitral valvuloplasty, Long-term outcomes, Pulmonary regurgitation, Pulmonary stenosis, Pulmonary valve balloon dilatation

Congenital isolated pulmonary valve stenosis (PS) with intact ventricular septum, constitutes the third most common and comprises 8% to 10% (1) of all congenital heart diseases and can also occur in up to 50% (2) of patients with other congenital cardiac defects. This condition may be broadly divided in to three categories i.e., neonatal critical stenosis, dome-shaped and dysplastic (10%-15% of cases) (2) stenosis. Now a days, percutaneous balloon pulmonary valvuloplasty is an effective and well-established therapeutic procedure of choice in dome-shaped severe valvular pulmonary stenosis in neonates and adults (2). In case of dome-shaped pulmonary valvular stenosis, the commissures are fused with the three resultant fibrous raphes extending from the level of sino-tubular junction, over the surface of valve to a central orifice, where valvular tissue is not thickened, the arterial walls are normal, and pulmonary annulus is usually within normal size. Splitting of commissural fusion is the mechanism involved in balloon dilatation in case of dome-shaped severe pulmonary stenosis. Even in critical neonatal pulmonary stenosis, a simple efficacious balloon dilation by experienced interventionalist, can provide a definite solution and avoid the need for future medical intervention. However, in dysplastic valve which commonly associated with genetic anomaly like Noonan’s syndrome has unsatisfactory and variable results from balloon valvuloplasty because of its severely thickened myxomatous valve leaflets with “cauliflower” like changes affecting the distal tips and hypoplastic annulus (2).

This procedure has been extensively reported in a wide range of patients (3 months to 56 years) (3),(4),(5) and even in a neonate (6) with satisfactory immediate (7),(8) and long-term results (9),(10) using a single balloon (Inoue) (11) and double balloon (12) techniques. Need for re-intervention (surgical or transcatheter) for residual or recurrent pulmonary valvular stenosis is about 5% -10% of patients within 10 years of the initial intervention (13).

Conventionally, the Mansfield balloon is being used worldwide as the percutaneous procedure to relieve obstruction in the case of PS (14). Joseph Mitral Valvuloplasty (JOMIVA) balloon (Table/Fig 1) was used for mitral valvuloplasty (15) in this institution since long. As the JOMIVA balloon offers advantages of longer size, lower cost and its user-friendly characterstics, this study was planned to evaluate its utility in severe PS. The primary objective was to assess the Immediate and long-term results of JOMIVA balloon for pulmonary valvuloplasty in case of isolated severe PS. Secondary objectives were changes in relation to the New York Heart Association (NYHA) class (16), transvalvular gradient, restenosis, reintervention, and pulmonary regurgitation following procedure.

Material and Methods

It was a retrospective record-based study, at the Cardiology Department of SCB Medical college and Hospital at Cuttack in Odisha, India, on patients underwent pulmonary valvuloplasty using JOMIVA balloon. The follow-up effects on the patients were recorded. All patients that underwent the procedure at the Department of Cardiology, between December 2002 and June 2006, and were followed up serially in the OPD were included in this study. The last follow up visit was documented in June 2018. The record room and the records of the Cardiology Department are in the custody of office of the Professor and Head of Department of Cardiology. Necessary permission for performing the record-based study (and perusing the records) were obtained from the office of the HOD Cardiology by November 2019 and the analysis of collected data was done from November 2020-April 2021. ICMR’s National Ethical Guidelines for Biomedical and Health Research involving Human participants were followed.

Data extraction: The relevant patient records were retrieved from the filing unit of the Department and perused for this study. All patient identifiers were removed during data extraction to maintain patient confidentiality and data handling was done as per the National Ethical Guidelines for Biomedical and Health Research involving Human participants of Indian Council for Medical Research (ICMR).

Inclusion criteria: Patients with isolated severe valvular pulmonary stenosis admitted to this tertiary care hospital for pulmonary valvuloplasty, Peak Transvalvular Gradient (TVG) of 64 mmHg or more across pulmonary valve, by echo Doppler study, irrespective of symptoms.

Exclusion criteria: Patients associated with Atrial Septal Defect(ASD),Ventricular Septal Defect(VSD), tetralogy physiology, sub and supra-valvular PS and mild to moderate PS were excluded.

Procedure

Twenty-three consecutive cases which met the inclusion and exclusion criteria were subjected for pulmonary valvuloplasty procedure. In two patients, neither wire nor catheter could cross the pulmonary valve and the procedure were abandoned, hence these two patients were excluded from the analysis. Rest 21 patients underwent pulmonary valvuloplasty using JOMIVA balloon (Table/Fig 1) that were included for analysis. Procedural success was defined as a 50% deduction in the transvalvular gradient across pulmonary valve following valvuloplasty.

After right heart catheterization, an Right Ventricular (RV) angiogram was performed either in the left lateral view (Table/Fig 2)a or Antero-posterior (AP) view with cranial angulation for the creation of a reference image and measurement of the pulmonary valve annulus. An exchange stiff guide wire (0.035) was placed distally either in the pulmonary artery or mostly on the distal left lower lobe pulmonary artery.

After proper sizing of JOMIVA balloon i.e., 20% to 40% higher than annulus, a deflated balloon was inserted through a short 14-F sheath over exchange wire and positioned across the Pulmonary Valve (PV), so that waist remains at the center of the balloon. The balloon was fully inflated until the complete disappearance of waist (Table/Fig 2)b and then quickly deflated in 20 sec. If required, subsequent two or more re-dilatations were undertaken to achieve satisfactory results. The balloon was advanced to the Pulmonary Artery (PA) and pulled back to measure RV pressure and transvalvular gradient across pulmonary valve. All these 21 study subjects were followed-up for immediate hemodynamic parameters and subsequent evaluation of symptoms related to restenosis along with Echocardiography (Echo) doppler evaluation of transvalvular pulmonary gradient and Pulmonary Regurgitation (PR) at discharge, at 1 year, 3 yearly thereafter till 12 years. The degree of PR was semi quantitated by the criteria adopted by Cooper J et al., (17).

Statistical Analysis

Statistical Package for Social Sciences (SPSS) version 21.0 was used to test the hypothesis for comparing the distribution of variables among different follow-ups using medians, Interquartile Range (IQR), and Friedman test. The comparison between pair-wise follow up was done by the Wilcoxon Signed ranks test. Box plot has been used to see the comparison of the distribution of pressure gradient over different follow-ups. The cut-off for p-value was 0.05.

Results

Out of 21 study subjects, 15 were males (71.4%), age of patients varied from 12-29 years, and the mean age was 18.3 ± 6.8 years. The most common symptoms were Shortness of Breath (SOB) class II/III (18, 85.7%). Peak Transvalvular Gradient (TVG) across pulmonary valve was in the range of 76-126 mmHg with mean 102.6±15.8 mmHg as per echocardiography. TR was found in two-thirds of cases and only one case had a dysplastic valve and another one was associated with right pulmonary artery branch stenosis (PAS). The main pulmonary artery (MPA) was dilated in 20 cases (95.3%). The median annular size was 20 mm (IQR,18-21 mm). The median balloon size was 24 mm (IQR,23-26). The median balloon to annulus ratio was 1.3 (IQR,1.2-1.3) (Table/Fig 3).

Immediate results: Procedural success was achieved in 19 cases (90.4%) with significant reduction of median peak TVG from 115 mmHg (IQR,101-128 mmHg) to 46 mmHg (IQR,37-51 mmHg) p-value<0.001. Similarly, median RVSP significantly reduced from 136 mmHg (IQR, 122-148 mmHg) to 66 mmHg (IQR, 57-71 mmHg) p-value<0.001 (Table/Fig 4). In one patient with dysplastic valve, there was also a non-significant reduction of TVG from 110 mmHg to 78 mmHg, and Right Ventricular Systolic Pressure (RVSP) from 130 mmHg to 96 mmHg even though it does not meet the criteria of procedural success.

Repeated dilatation i.e., two and more times were required in the majority of the Patients (20 cases, 95%) to achieve procedural success, of which 10 patients required two times (46.6%), 9 patients required three times (43%), and 1 required four times (4%) i.e., in dysplastic valve (Table/Fig 3).

Long-term results: The comparison of pressure gradient for pair-wise follow-ups at different intervals revealed that at every follow up there was a significant reduction in pressure gradient p-value <0.05 (Table/Fig 5). But there was no significant difference between 9-year and 12-year follow-ups as seen in the box plot in (Table/Fig 6). This showed the reduction in the central value(median) and variation (IQR) of pressure gradient over the follow-ups until 9 years and maintained for 12 years. Seven patients had high immediate postoperative residual gradient of more than 50 mmHg of which, the mean pressure gradient reduced from 55.4 mmHg to 31.1 mmHg, at the end of 12 years. There was one patient (dysplastic valve) with a higher-pressure gradient at post-intervention and different follow-ups (Table/Fig 6). Nevertheless, this patient was maintained at around 60 mmHg from 1 year to 12 years follow up.

(Table/Fig 7) depicts the percentage reduction in pressure gradient over different follow-up. At immediate postoperative, 12 out of 21 patients had reduction of 60-70% and 7 had reduction of 50-60%. In subsequent follow-up, a higher range of reduction in pressure gradient was observed i.e., 5 patients had 80-90% reduction, 15 had 70-80% reduction at the end of 12 years. This shows high stability of pressure gradient following pulmonary valvuloplasty in long-term follow-up.

Complications: Transient bradycardia and hypotension during balloon dilatation was seen in all patients (Table/Fig 8). Benign ventricular arrhythmia such as multiple Ventricular Premature Complexes (VPC), Non-sustained Ventricular Tachycardia (NSVT) were seen in 19 patients (90.4%), which were self-limiting. No death was observed during valvuloplasty or follow-up period. Vascular complications like groin hematoma seen in 3 (14.3%), that recovered with a pressure bandage. The patient with dysplastic value had prolonged VT with convulsion, and recovered with Direct Current (DC) shock. Only minor grades (Grade I & II) of pulmonary regurgitation (PR) were observed in all patients, following valvuloplasty of which Grade I, were 12 cases and Grade II, 9 cases which showed significant reduction over different follow-up periods. At 12 years, there were only 9 patients (42%) of Grade I pulmonary regurgitation (Table/Fig 9).

Discussion

Percutaneous balloon valvuloplasty, after Kan’s (14) report in 1982, has been so successful that in recent years it has largely replaced surgical valvotomy except in patients with dysplastic valve (18).

Present study represents one of the largest series of pulmonary valvuloplasty with the JOMIVA balloon in adults and adolescents. It was found effective procedure irrespective of age and sex, as with earlier reports using Mansfield balloon or Inoue balloon (11) in severe PS. Procedural success in this series was achieved in 90.4% of cases with excellent hemodynamic and symptomatic improvement, which is comparable with the previous series
(Table/Fig 10), even though there were higher initial transvalvular gradient and supra systemic RV pressure in our series i.e. median value were 115 mmHg and 136 mmHg respectively. However repeated dilatation (>2 times) was required in the majority of cases to achieve good results because of the cylindrical shape of the balloon without a pre-defined waist, liable for slippage during inflation. One case of the dysplastic valve had also shown significant reduction of gradient following balloon dilatation with development of grade-II PR and it did not show significant reduction of gradient on subsequent follow-up. This lesser reduction of gradient could be due to its dysplastic nature, immobility of valve without commissural fusion. Its success rate varies from 0% to 75% in different series (18),(19).

It was noted that even significant immediate post-intervention residual gradient could resolve spontaneously on follow-up. Assessing sub-valvular pressure gradient after valvuloplasty is often technically difficult (20). Infundibular obstruction is dynamic and it occurs at the end of systole & is the result of forceful contraction of crista supraventricularis, septal, parietal muscle bands, and ventricular walls (21). In the present series, seven patients had a high immediate post-op residual gradient of which, the mean pressure gradient was significantly reduced from 50.5 mmHg to 21.1 mmHg at the end of 12 years follow-up. This could be due to regression of sub-valvular hypertrophy and obstruction, as observed in Kaul UA et.al., (22). Hence, an apparently poor immediate result from balloon pulmonary valvuloplasty doesn’t preclude a good result latter.

Procedural complications (Table/Fig 8) observed in this series were transient, and self-limiting, without much alteration of cardiac hemodynamics, which amounting to safe procedure and better immediate results. In the patient with dysplastic valve, the convulsion could be due to anoxic encephalopathy following prolonged and repeated dilatation. However, the patient recovered completely without any residual neurological deficit. Ventricular arrhythmia i.e., multiple VPC, NSVT, were observed in almost all cases related to catheter manipulation in RV and RVOT, but were self-limiting. Neither restenosis nor reintervention was observed on follow-up. Significant PR (Grade III&IV), causing hemodynamic alteration, was not observed, in contrast to surgical valvotomy. Both residual transvalvular gradient (TVG) and non-significant PR (Grade I & II) following pulmonary valvuloplasty showed a gradual reduction in a mean follow-up 12 years (Table/Fig 5), (Table/Fig 9), (Table/Fig 6). This could be due to regression of infundibular hypertrophy and obstructions, as observed by Fawzy ME et.al., (23) It suggests that gradient immediately after valvuloplasty probably underestimates the long-term efficacy of balloon dilatation.

Limitation(s)

The study was conducted in a single center and the sample was small. The study did not compare the results with other balloons, and therefore it is difficult to provide comparable results. The study highlights JOMIVA balloon may still be useful in resource-limited settings. Also, we did not identify the characteristics of patients where the procedure was failed and thus selection bias can’t be ruled out.

Conclusion

To the best of our knowledge, this is the first study to describe the use of JOMIVA balloon in pulmonary valvuloplasty. Pulmonary valvuloplasty using JOMIVA balloon is an effective technique for severe valvular PS in adults and adolescents. It is associated with excellent immediate results with long-term incremental benefits in the terms of regression of infundibular hypertrophy and narrowing was observed in this longest follow-up period of 12 years. Using JOMIVA balloon in severe pulmonary stenosis offers a cost-effective approach in developing countries like India. However, a prospective study with a larger sample involving a wide range of age groups is required to validate these findings.

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DOI and Others

DOI: 10.7860/JCDR/2022/53367.16526

Date of Submission: Nov 19, 2021
Date of Peer Review: Feb 25, 2022
Date of Acceptance: Apr 20, 2022
Date of Publishing: Jun 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? NA
• Was informed consent obtained from the subjects involved in the study? NA
• For any images presented appropriate consent has been obtained from the subjects. NA

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