Postoperative Plain Radiographic Evaluation of Electrode Placement After Cochlear Implantation: An Observational Study From India

Abstract

Despite a rise in the number of cochlear implant (CI) surgeries, limited data is available to date in the Indian settings, on the use of postoperative imaging to confirm intracochlear position of CI electrode array. The current study aims to evaluate the incidence of post-implantation complications related to surgical placement of CI electrode array, as identified on postoperative plain radiographs (X-rays). It also compares the occurrence of such complications amongst different CI manufacturers. The retrospective, observational study incorporated 469 patients (paediatric and adult), who underwent 478 primary cochlear implantations at a tertiary- care CI centre in India, between January 2006 and December 2023. Postoperative day one X-rays were evaluated to check the post-implantation intracochlear position of CI electrode. Angular insertion depths of electrode arrays were measured. Comparison of incidence of electrode related issues was performed amongst devices from four different CI manufacturers used in the study. Postoperative day one X-rays demonstrated normal intracochlear electrode array placement in 93.7 % (448) of the cochlear implantations; whereas electrode-related issues such as kink, incomplete insertion, tip fold-over, basal fold-over, migration and misplacement were identified in 6.3% (30) of the implantations. The percentages of postoperative X-ray abnormalities identified in CI electrodes from Cochlear™ Nucleus® (10.2%) and Oticon Medical (10.5%) were significantly higher than those identified in electrodes from MED-EL (3.8%) and Advanced Bionics (3.7%, p value < 0.05). Assessment of postoperative X-ray findings following CI surgeries conducted over the past 17 years, revealed a statistically significant decline in the overall percentage of electrode-related abnormalities from 12.9% in the years before 2010 to 5.7 % in the subsequent years after 2010 (p-value < 0.05). This study conducted in a large cohort of Indian patients, reiterates that postoperative plain radiography is a simple, reliable, cost-effective imaging technique that can be employed in the Indian settings, to ascertain the post-implantation intracochlear position of CI electrode. Postoperative imaging facilitates optimisation of CI surgery outcomes and leads to timely performance of revision surgeries for correction of electrode position; wherever indicated.

Supplementary Information

The online version contains supplementary material available at 10.1007/s12070-025-05555-9.

Introduction

Hearing loss is a leading cause of disability globally, as well as in India. World Health Organization (WHO) has reported a rise in the number of Indian persons with disabling hearing loss (DHL), from 76.5 million in 2008 to 100 million in 2018 [1, 2]. The 75th National Sample Survey (NSS) (2017–2018) report on persons with disabilities in India has reported hearing disability in 0.3% of the total Indian population [3]. Early detection and timely intervention are thus imperative for managing such a high burden of hearing impairment.

Cochlear implant (CI) surgery is being increasingly performed across the world and also in India, to treat severe to profound sensorineural hearing disorders, in children as well as adults [4–9]. Appropriate placement of CI electrode array within the cochlea is crucial to achieve optimal post-cochlear implantation outcomes [4, 10–12]. Imaging and electrophysiological tests are used to determine the post-CI electrode position [10–14].

Over the past 17 years, cochlear implantation is a standard surgical procedure being performed at the CI centre of our tertiary-care hospital in Pune, Western India. Similar to many other CI centres; post-surgical CI electrode position is confirmed with plain-film radiographs, at our centre [15–18. In the Indian setting, limited data is available till date, on the use of postoperative imaging to check the electrode array position after CI surgery [19, 20]. This study conducted in a large cohort of Indian patients at our CI centre, primarily aims to evaluate the incidence of post-implantation complications related to surgical placement of CI electrode array, as delineated on postoperative plain radiographs. The secondary objective was to compare the occurrence of such complications amongst different CI manufacturers.

Materials and Methods

Subjects

In all, 631 cochlear implantation surgeries were performed at the CI centre of our tertiary-care hospital, between March 2006 and November 2023. Of these, 478 cochlear implantations in 469 patients were included in this retrospective, observational study. Patients fulfilling the following inclusion criteria were enrolled in the study: (1) paediatric and adult patients with bilateral severe to profound sensorineural hearing loss; (2) who underwent primary cochlear implant surgery; and (3) who gave informed consent for their data to be collected and used in the study. Informed consent was obtained from either the parent or the guardian of patients < 18 years of age. Patients with congenital or acquired inner ear pathologies and patients who underwent revision CI surgeries were excluded. The study was approved by the hospital Institutional Review Board.

Surgical Technique

Cochlear implantations in all the study patients were performed by three different, experienced CI surgeons. The postauricular, trans-mastoid posterior tympanotomy approach was used for all the patients. Intracochlear insertion of the electrode array was done by either a cochleostomy (CS) or round window (RW) or extended round window (ERW) technique. The anatomy and the type of electrode being inserted determined the choice of intracochlear insertion technique.

Cochlear implants from four device manufacturers were inserted: (1) Cochlear™ Nucleus^® (Cochlear Limited, NSW, Australia); (2) MED-EL (Innsbruck, Austria); (3) Advanced Bionics (AB, Valencia, CA, USA) and (4) Oticon Medical (SAS, Vallauris, France).

Postoperative Radiography

On postoperative day one, single view (either modified Stenver’s or antero-posterior (AP) transorbital view) plain radiography (X-ray) images were obtained in all the patients, on a Siemens 300 mA Digital X-ray machine, Siemens Healthcare, Erlangen, Germany. Modified Stenver’s view X-ray demonstrating the petrous temporal bone, internal auditory meatus, and bony labyrinth (Fig. 1A), was obtained in patients undergoing unilateral cochlear implantation, whereas an AP trans-orbital view X-ray (Fig. 1B) demonstrating both the cochlear implants was obtained in patients with bilateral cochlear implantations [12, 15, 21, 22].

Fig. 1.

Appropriate, normal intracochlear placement of CI electrodes (white arrows) on post-operative plain radiographs. A: Postoperative Modified Stenver’s view radiograph of the left temporal bone in a paediatric patient with left unilateral cochlear implantation. B: Postoperative AP trans-orbital view radiograph in a paediatric patient, after bilateral simultaneous cochlear implantations

The plain radiographs were subsequently uploaded to the picture archiving and communication system (PACS) for further analysis and documentation. These were retrospectively assessed by a blinded ENT surgeon, to evaluate the placement and angular insertion depth of the implanted CI electrode. Angular insertion depths of the electrodes were measured as per the method described by Marsh et al. [15]. Vestibular system was used as a zero-reference point to calculate the angular insertion depth, as the round window is not visible on a plain radiograph.

Data were collected from the medical records of the CI centre. Clinical information collected from all the study patients included: age at the time of cochlear implantation, gender, year of CI surgery, implant model and electrode type used, relevant surgical details and postoperative plain film radiography (X-ray) findings.

Statistical Analysis

The data was statistically analysed using Epi-Info software. Descriptive statistics were presented as numbers (n) and percentages (%). The quantitative continuous variables were summarized as Mean ± Standard deviation (SD). Analysis of variance (ANOVA) test was applied for comparing means among different groups. Post-hoc Bonferroni test was applied for between-group comparisons. Pearson chi square test was used to compare percentages of categorical variables (post-CI surgery X-ray abnormalities identified over the years). P-value < 0.05 was considered statistically significant for all the statistical tests.

Results

Demographic and Operative Characteristics

Of the 469 patients recruited in this retrospective, observational study; 439 (93.7%) were in the paediatric age group (aged < 18 years) and 30 (6.3%) were adults (aged ≥ 18 years) (Table 1). Amongst the patient cohort, 58% were male and the mean age at implantation of the study participants was 6.6 ± 9.2 years. Majority of the participants (96.6%) underwent unilateral CI; whereas bilateral CI was performed in 16 patients (3.4%). Data from both the cochlear implantations in 9 of the 16 patients with bilateral CI surgeries, could be incorporated in this study. Details of CI insertion technique and electrode type are listed in Table 1. Distribution of CI electrodes as per the four different CI manufacturers used in the study, is illustrated in Supplementary Fig. S1.

Table 1.

Patient characteristics, CI surgery and electrode details

Characteristic	Number (Percentage)
Age of patient (in years)
Mean ± SD; Range	6.6 ± 9.2; 1.1–74.5
Age- groups of patients (in years), at the time of CI surgery	Number of cochlear implantations (n = 478)
< 2	59 (12.4%)
2–5	254 (53.1%)
5.1–10	101 (21.1%)
10.1- <18	34 (7.1%)
≥ 18	30 (6.3%)
Gender	Number of patients (n = 469)
Male	272 (58%)
Female	197 (42%)
Type of Surgery	Number of patients (n = 469)
Unilateral CI	453 (96.6%)
Bilateral CI	16 (3.4%)
Sequential bilateral CI	11 (2.3%)
Simultaneous bilateral CI	5 (1.1%)
CI Insertion Technique	Number of cochlear implantations (n = 478)
CS	99 (20.7%)
RW	358 (74.9%)
ERW	21 (4.4%)
Type of Electrode array	Number of cochlear implantations (n = 478)
LW	420 (87.9%)
PM	49 (10.2%)
MS	9 (1.9%)

All data are expressed as numbers (percentage) or mean ± standard deviation. CI indicates cochlear implant; CS, cochleostomy; RW, round window; ERW, extended round window; LW, lateral wall; PM, perimodiolar; MS, mid scala

Postoperative Plain Radiography

The findings of postoperative plain radiographs are summarised in Supplementary Table S1. On postoperative day-one X-ray evaluation, normal, intracochlear placement of CI electrode array (Fig. 1) was seen in majority of (448, 93.7%) the cochlear implantations. Postoperative plain X-rays revealed intracochlear electrode-related issues in 6.3% (30) of the CI surgeries. Of these, kinking of electrode (Fig. 2A) was found in 15 (3.1%) CI surgeries, whereas incomplete insertion of electrode was seen in 6 (1.3%) implantations (Fig. 2B and C). Electrode tip fold-over (Fig. 2D) and basal fold-over (Fig. 2E) were identified in 2 (0.4%) and 3 (0.6%) cases; respectively. Postoperative plain radiographs detected migration of electrodes (Fig. 2F) in 2 (0.4%) and misplacement of electrodes (Fig. 2G and H) in 2 (0.4%) implantees.

Fig. 2.

Different types of Electrode-related issues identified on postoperative plain radiographs. A: Electrode kink (white arrow). B and C: Electrode kink with incomplete insertion. D: Tip fold-over (white arrow). E: Basal fold-over (white arrow). F: Electrode migration. G: Postoperative X-ray showing electrode misplacement into superior semi-circular canal (SSC, yellow arrow). H: Electrode misplacement into SSC confirmed on HRCT of the temporal bone (yellow arrow)

Comparison of incidence of post-implantation electrode-related issues detected on the postoperative X-rays, amongst different CI manufacturers; revealed abnormal placements in 17 (10.2%) electrodes from Cochlear™ Nucleus^®, 5 (3.8%) electrodes from MED-EL, 6 (3.7%) electrodes from Advanced Bionics and 2 (10.5%) electrodes from Oticon Medical (Fig. 3A and B and Supplementary Table S1). In the present study, the percentages of postoperative X-ray abnormalities identified in CI electrodes from Cochlear™ Nucleus^® and Oticon Medical were greater than those identified in CI electrodes from MED-EL and Advanced Bionics. This difference was statistically significant [chi square = 8.185, p = 0.004, effect size (Cramer’s V) was 0.131].

Fig. 3.

Postoperative plain X-ray findings amongst different CI manufacturers. A: Distribution of normal as well as abnormal electrode placements on postoperative X-rays. B: Distribution of various electrode-related issues on postoperative X-rays

Comparing Angular Insertion Depths

Table 2 and box and whisker plots in Supplementary Fig. S2a show mean angular insertion depths of the different CI electrode models included in the study. The overall mean angular insertion depth of the 476 electrode arrays implanted, was 446.82 ± 119.795. Angular insertion depth was not measured in two patients with electrode misplacement on postoperative radiographs. The electrode arrays from Cochlear™ Nucleus^® showed significantly shorter mean angular insertion depth (349.52 ± 56.834) when compared to that of electrode arrays from MED-EL (578.30 ± 115.875, p < 0.001, by ANOVA test, effect size measured by Cohen’s d, was d = 2.51, indicating a large effect size). The mean angular insertion depth was comparable between the electrode arrays from Advance Bionics and Oticon Medical (p > 0.05). Further, these two types of CI models demonstrated significantly different mean angular insertion depths when compared to those of electrode arrays from Cochlear™ Nucleus^® as well as MED-EL (p < 0.001, by Post-hoc Bonferroni Test, Cohen’s d > 0.8).

Table 2.

Measurements of angular insertion depths of the implanted CI electrodes (n = 476 CIs)

Manufacturer of CI	Angular insertion depth in degrees
	Mean ± Std. Deviation	Median
Cochlear™ Nucleus®	349.52 ± 56.834	355.00
MED-EL	578.30 ± 115.875	630.00
Advanced Bionics	440.06 ± 63.570	450.00
Oticon Medical	440.00 ± 37.118	450.00
Total	446.82 ± 119.795	425.00

Data are presented as Mean ± Standard Deviation and as Median; CI indicates Cochlear Implant

Impact of Surgical Technique and CI Electrode Type on Electrode Placement

Majority of the cochlear implantations in this study, were performed using round window (RW) approach (358, 74.9%) and lateral wall (LW) electrode type (420, 87.9%, Table 1). Out of the 99 implantations done with cochleostomy (CS) approach, 97% (96) were performed between the years 2006–2011. In the subsequent years, from 2011 onwards majority of the implants [91.3% (356/ 390)] were inserted by RW approach.

Bar charts A and B in Supplementary Fig. S2b demonstrate the distribution of electrode placements as seen on postoperative plain radiographs, amongst cochlear implantations performed using different CI insertion techniques [CS/ RW/Extended round window (ERW)] and different electrode types [LW/ Perimodiolar (PM)/ Mid-Scala (MS)]; respectively. The impact of differences in the insertion techniques and electrode types on the percentages of occurrence of various postoperative electrode-related issues, was not statistically significant.

Year-wise Occurrence of Post-CI X-ray Abnormalities

The overall percentage of post-op X-ray abnormalities seen in the cochlear implantees, decreased from 12.9% before the year 2010 to 5.7% in the subsequent years after 2010. This decline was statistically significant [Chi-square = 5.319, p-value = 0.021, effect size (Cramer’s V) was 0.105]. A decreasing trend was noted in the overall percentage of these abnormalities in the later years (from 2010 to 2014 onwards). However, no statistically significant change was observed in the percentage of electrode-related issues identified between the years 2010–2014 (4.5%), 2015–2019 (5.5%) and 2020 onwards (7.0%; Bar chart A in Supplementary Fig. S2c and Supplementary Table S2).

Year-wise comparison between the percentages of electrode-related abnormalities observed on postoperative X-rays in electrodes from different CI manufacturers; showed a trend towards reduction in the percentage of these abnormalities over time, particularly in CI electrodes from Cochlear™ Nucleus^® and MED-EL (Bar chart B in Supplementary Fig. S2c and Supplementary Table S2).

Discussion

Cochlear implantation is now an established treatment option that has transformed the management of severe to profound sensorineural hearing loss, across all age groups [4, 5, 9]. Successful outcome following cochlear implant (CI) surgery greatly depends on an optimal, atraumatic placement of the CI electrode into scala tympani (ST) compartment of the cochlea, so as to create an effective electrode–neural interface [10–12, 23–25].

Postoperative imaging by either plain radiography (X-ray), or digital volume tomography (DVT), or computed tomography (Cone-beam or Flat panel CT) is routinely employed for confirmation of post-insertion position of the CI electrode within the cochlea [4, 5, 10, 11, 17, 18, 22, 26–29]. Appropriate postoperative imaging not only documents the intracochlear position and insertion depth of the CI electrodes, but also provides a reference for the future, if electrode-related issues occur. It guides programming strategies for the CI speech processor [5].

Notwithstanding, the increased prevalence of CI surgeries in India; scant data is available till date as regards postoperative imaging and incidence of post- implantation electrode -related issues in Indian patients [2, 8, 9, 19, 20]. To the best of our knowledge, the present study is one of the first investigation into the incidence of post-implantation CI electrode-related issues identified on postoperative plain radiographs, in such a large cohort of Indian patients.

In line with the mounting scientific evidence advocating early cochlear implantation in children with profound deafness; majority (93.7%) of patients in this study belonged to the paediatric age-group [8, 30]. More than half (53.1%) of the implantations were conducted in the 2–5 years age-group, whereas 12.4% of CI surgeries were performed in patients less than 2 years of age (Table 1). Further, in this study, 29 (96.7%) out of the 30 cases of postoperative electrode -related issues were identified in paediatric patients.

Similar to the postoperative radiography techniques reported in multiple prior studies; postoperative imaging was done using Modified Stenver’s plain radiographic view in all the study patients with unilateral cochlear implantation [4, 12, 15, 31, 32]. An AP transorbital post-implantation check X-ray was performed for patients with bilateral cochlear implantations [16, 22]. Anne S et al. concluded in their study, that routine post-implantation radiographs are unnecessary in paediatric cochlear implantees; especially in clinics where intraoperative electrophysiological tests are regularly conducted [33]. However, it is standard practice at our CI centre to obtain a single-view, postoperative plain radiograph in all cochlear implantees, across all age -groups; as digital radiography involves low radiation dose exposure, well within the recommended dose limits [18, 26]. Further, in each patient, a precisely protocolled skull radiograph is obtained by an expert technician [34].

Observations from the present study reiterate that plain radiography acts as a first line investigation for evaluating the post-insertion status of CI electrodes [12, 18, 35]. In certain patients with electrode-related issues detected on plain radiographs, high resolution computed tomography (HRCT) / CBCT may be performed for scalar localization of the electrode array (Fig. 2G and H). This corroborates with the recommendations outlined in previous scientific literature [4, 18, 22, 31, 36].

The present study recorded normal, intracochlear placement of electrode arrays on postoperative X-rays in 93.7% of the cochlear implantations, whereas electrode-related issues such as kinking, incomplete insertion, tip fold-over, basal fold-over, migration and misplacement were identified in 6.3% of the CI surgeries (Figs. 2A-G). These results were better than those recorded in the retrospective review by Coombs et al.; wherein electrode-related issues were reported on postoperative plain X-rays in 12% (26) of the total study cohort of 220 adult CI patients [35]. Dirr et al. observed electrode- related issues such as tip-over, loop, kinking, scalar transition and incomplete insertion on the position check radiographs, in 5% of their study cohort (after excluding from analysis cases with inner ear dysplasia or labyrinthine ossification) [17]. Half of these abnormalities could have been overlooked if the authors had relied only on surgical conspicuities noted during electrode insertion. Of the 245 study patients evaluated by Çelik et al., electrode-related abnormalities such as partial insertion, tip fold-over and misplacement, were identified on the postoperative Stenver’s view radiographs in 2% (5) of the cases [18]. This retrospective analysis has underscored the importance of post-implantation check X-rays, as it has described a patient in whom postoperative radiograph showed early electrode migration; despite recording normal intraoperative electrophysiological tests and surgical notes. Thus, some studies have found intra-operative non-imaging investigations to be inadequate for confirming appropriate post-surgical CI electrode placement, due to their high specificity, but low sensitivity [12, 17, 18].

In the present study, selection of the electrode type and model of CI was patient-specific (Supplementary Table S1) [25, 37]. Comparison between different CI manufacturers, as regards the occurrence of post-implantation electrode-related issues; revealed significantly greater percentages of postoperative X-ray abnormalities in electrodes from Cochlear™ Nucleus^® and Oticon Medical than those identified in electrodes from MED-EL and Advanced Bionics (p = 0.004, < 0.05).

Of the 15 cases showing kinking of electrode (Fig. 2A) in our study; 14 had been implanted with straight electrode arrays (11 from Cochlear™ Nucleus^®, 2 from MED-EL and 1 from Advanced Bionics). All of the 6 cases of incomplete insertion of the electrode arrays (Fig. 2B and C) were also implanted with straight electrode arrays (3 from Cochlear™ Nucleus^® and 3 from MED-EL) (Supplementary Table S1). These findings were in agreement with the reviews presented by Risi F and Ishiyama A et al.; in which they have reported increased prevalence of kinking and incomplete electrode insertion in straight arrays [37, 38]. Electrode tip fold-over (Fig. 2D) was noted in 0.4% (2) of the cochlear implantations in our study. Prior studies have found higher incidence of tip-fold over in pre-curved, perimodiolar electrode arrays [24, 37–40]. Of the two cases of tip fold-over identified in the present study, one patient had received a Cochlear Contour Advance perimodiolar type of electrode array inserted with ERW approach. The second patient was inserted with LW Oticon Digisonic CI using RW surgical approach.

Electrode migration (Fig. 2F), defined as the detection of movement of two or more electrodes out of the cochlea after CI surgery, was seen in two of our study patients [41]. Both these cases of electrode migration confirmed to the observations of earlier studies that have found migration to be more common in LW, straight electrode arrays [37, 38, 42, 43]. Literature and case review by Shin T et al. has estimated incidence of electrode misplacement to be 0.49% and has recorded vestibular system to be the commonest (50.8%) location of misplacement [44]. The present study also recorded similar incidence (0.4%) of electrode misplacement. One of these patients showed intra-labyrinthine misplacement of electrode into the superior semi-circular canal (Fig. 2G). Both the cases of electrode misplacement in this study, involved straight electrode arrays. Revision surgeries were performed for patients with electrode migration and misplacement.

Guenette JP has proposed that angular insertion depth of CI electrode accurately indicates the position of the electrode tip within the cochlear spiral [45]. Several prior studies have demonstrated that post-insertion radiographs provide reliable measurement of angular insertion depth [15, 21, 26, 45, 46]. In our study, the post-insertion angular insertion depths of electrodes measured on the postoperative radiographs, varied according to the CI design and length selected [28]. The electrode arrays from MED-EL, therefore, showed significantly greater mean angular insertion depth when compared to those from Cochlear™ Nucleus^® (p < 0.001) (Supplementary Fig. S2a).

Data from previous studies suggest that RW and ERW surgical approaches along with LW electrode types are associated with an increased likelihood of successful intracochlear ST placement of the CI electrode; ensuring better hearing outcomes [11, 23, 24, 25]. However, in the present study the impact of differences in the CI insertion approaches and electrode types, on the overall percentage of post-implantation electrode-related issues; was found to be statistically insignificant (Supplementary Fig. S2b).

This retrospective study reviewed CI surgeries conducted over a time-span of 17 years. A trend of decreasing percentages of electrode-related abnormalities was noted in the study patients implanted with devices from Cochlear™ Nucleus^® and MED-EL, over time (Supplementary Fig. S2c and Supplementary Table S2). Analysis of the year-wise occurrence of post-CI X-ray abnormalities revealed a statistically significant decline in the overall percentage of incidence of electrode-related issues in the study patients, from 12.9% before the year 2010 to 5.7% in the subsequent years after 2010. This corroborates with the growing evidence indicating that newer electrode array designs are less prone to certain postoperative electrode- related complications [10–37]. Also, from the year 2011 onwards, majority of the implants included in this study (91.3%, 356/390) were inserted by RW approach [23–25].

Limitations

Limitations of the present study include retrospective study design and lack of correlation of the postoperative imaging findings of the patients with intra-operative surgical suspicion or electrophysiological tests. Furthermore, postoperative follow-up as regards CI performance along with hearing and speech rehabilitation of the study patients, was beyond the scope of this study.

Conclusion

In the present times; increased public awareness, broadening of indications for CI surgeries, advancements in technology, growing surgical expertise, and availability of well-equipped CI centres; have resulted in increase in the number of cochlear implantations that are being performed in Indian patients [2, 8, 9, 30, 47]. In these settings, the present study conducted in a large cohort of Indian patients; documents electrode-related issues identified through post-cochlear implantation radiographs. It reiterates that postoperative plain radiography is a simple, reliable, cost-effective imaging technique that can be routinely employed to determine the post-implantation intracochlear position of CI electrode. This facilitates optimisation of post-implantation outcomes and leads to timely performance of revision surgeries for correction of CI electrode position; wherever indicated.

Further, the study results demonstrate a decline in the overall percentage of intracochlear electrode placement related issues, with improvements in the CI electrode designs, over time.

Electronic Supplementary Material

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Author Contributions

Conceptualization: Neelam Vaid, Nikhil Gokhale and Jaxin Joy; Methodology: Neelam Vaid, Nikhil Gokhale and Ajay Kothadiya; Data curation: Jaxin Joy, Nikhil Gokhale and Aparna Chandorkar. Formal analysis and Investigation: Neelam Vaid, Nikhil Gokhale, Jaxin Joy and Ajay Kothadiya. Writing-original draft: Jaxin Joy and Aparna Chandorkar. Writing-review & editing: Neelam Vaid, Nikhil Gokhale and Ajay Kothadiya.Funding acquisition: Not applicable; Resources: Neelam Vaid. Supervision: Neelam Vaid and Ajay Kothadiya. Approval of final manuscript: Neelam Vaid, Nikhil Gokhale, Jaxin Joy, Aparna Chandorkar and Ajay Kothadiya.

Funding

This research study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data Availability

Data supporting the findings presented in this study are available on request from the first and corresponding author (NV)

Code Availability

Not applicable (no special Software used).

Declarations

Ethics Approval

This work was approved by the Hospital Ethics Committee of KEM Hospital, Pune 411011, Maharashtra, India (KEMHRC/VSP/Dir.Off/EC/2308). The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

Informed Consent

Written-Informed consent was obtained taken from all the study participants.

Conflicts of Interest

The authors have no competing interests to declare that are relevant to the content of this original article.