Percutaneous balloon mitral valvotomy (PBMV) has emerged as a cornerstone intervention for mitral stenosis (MS), especially in regions where rheumatic heart disease prevails and valve surgery poses significant challenges. Traditionally, the presence of moderate or severe mitral regurgitation (MR) has been considered a relative or absolute contraindication for PBMV due to concerns about exacerbating regurgitation or precipitating acute complications. However, the management of patients with severe MS accompanied by moderate MR remains a subject of evolving debate, particularly given advances in patient selection, procedural techniques, and post-procedural care.[1] Historically, guidelines have recommended surgical mitral valve replacement over PBMV in such scenarios, citing the theoretical risk of converting moderate to severe MR with balloon intervention, which might necessitate urgent surgery. Recent evidence, however, suggests that in carefully selected cases, PBMV can be safely and effectively performed in patients with severe MS and moderate MR, offering substantial symptomatic relief, hemodynamic improvement, and freedom from immediate surgical intervention. For example, Desabandhu et al. reported comparable composite safety outcomes between patients with moderate MR and those with less than moderate MR following PBMV, with primary endpoints of cardiovascular death and development of severe MR not differing significantly, although the incidence of severe MR was numerically higher in the moderate MR group. This is corroborated by other investigations demonstrating similar procedural success rates and complication profiles with PBMV in this high-risk subset, when meticulous technique and case selection are emphasized.[2] The longitudinal efficacy of PBMV in patients with severe MS and moderate MR is also supported by functional and echocardiographic improvements. Patients undergoing PBMV display notable enhancements in exercise tolerance and NYHA class, increases in mitral valve area, and reductions in left atrial pressures, echoing results observed in individuals with less severe MR. While the risk of MR progression exists, many studies sequentially monitored patient outcomes, reporting that only a minority required mitral valve surgery during follow-up, and a substantial proportion exhibited stabilization or even reduction of regurgitation severity post-procedure, likely due to relief of subvalvular tethering or improved leaflet mobility.[3] Nevertheless, the clinical equipoise persists regarding patient selection criteria. Most experts advocate that PBMV be reserved for patients with favorable valve morphology, absence of significant leaflet calcification, and optimal hemodynamic profiles. Those with severe pulmonary hypertension, left atrial thrombus, or markedly non-pliable valves may fare less well and are more susceptible to complications. Multidisciplinary heart team discussions—incorporating echocardiographic, clinical, and surgical risk assessments—remain essential in tailoring the approach to individual patient needs.[3] Taken together, a growing body of evidence now supports the selective use of PBMV in severe MS with moderate MR, emphasizing the balance between procedural risks and the potential for sustained improvement in quality of life and functional status. Ongoing registries and longer-term data are anticipated to further refine indications and best practice standards for this unique patient population.

The research was done at Pacific Institute of Medical Sciences, Umarda, Udaipur, Rajasthan, between April 2023 and March 2025, to determine the reliability and effectiveness of the percutaneous balloon mitral valvotomy (PBMV) in patients with severe mitral stenosis and moderate mitral regurgitation. The objective of the methodology was to assess both long-term and short-term outcomes after the procedure, such as the improvement of clinical parameters, changes in valves parameters, and complications. Study Design It was a prospective study and observational and in which 100 patients with severe mitral stenosis and moderate mitral regurgitation were chosen to receive percutaneous balloon mitral valvotomy. The research was conducted according to the ethical standards and the institutional ethics committee gave its consent. All participants were informed before handing in their consent in writing. Inclusion Criteria • The criteria applied to include patients in the study were as follows: • Severe mitral stenosis, which is supported by echocardiography with a mitral valve area (MVA) of less than 1.0 cm 2. • Grade 2 moderate mitral regurgitation according to the echocardiographic appearance. • Age between 30 and 70 years. • Patients with symptomatic heart failure with a NYHA functional class II-IV. • Percutaneous balloon mitral valvotomy contraindications. • Readiness to receive follow-up evaluation after the operation. Exclusion Criteria • Patients were not included in the study when they had: • Extreme mitral regurgitation (Grade 3 or 4). • Rapid aortic valve disease or acute tricuspid regurgitation. • Pregnancy or lactation. • Extreme comorbidity (uncontrolled diabetes, severe coronary artery disease, or malignancy). • Contraindications of balloon mitral valvotomy (e.g. large thrombus or acute left atrial clot). • Patient Enrolment and Data gathering. One hundred consecutive patients who fulfilled the inclusion criteria were recruited in the study. At baseline, demographic information (age, gender, medical history, comorbidities (diabetes, hypertension, and atrial fibrillation), and presentation of the clinical situation) were recorded. Comprehensive clinical examinations were performed, such as an assessment of NYHA functional class, echocardiographic, and laboratory outcomes. Pre-procedure Assessment All patients before percutaneous balloon mitral valvotomy had received: Extensive clinical evaluation: Medical history, physical examination and symptom assessment. Echocardiographic assessment: To determine the size of the anterior mitral valve, pressure differences above and below the mitral valve, and some mitral regurgitation. The mitral valve pressure gradient was calculated through doppler studies. Electrocardiogram (ECG): To identify arrhythmia including atrial fibrillation. Chest X-ray: To determine pulmonary status. Laboratory tests: Include blood tests renal analysis, liver analysis and coagulation analysis. Procedure Technique The surgery was done under the influence of local anesthesia and slight sedation. Percutaneous balloon mitral valvotomy was performed through a trans-septal method in the presence of a fluoroscopic and echocardiographic procedure. Balloon catheter was placed in the femoral vein and passed to the left atria through the inter-atrial septum. The mitral valve was dilated with inflating the balloon across the valve, in order to enlarge the stenotic valve and also to enlarge the mitral valve area. The success of the procedure was determined by the mitral valve area rising by at least 0.5 cm 2 and a significant decrease in pressure gradient. Post-procedure Assessment Patients were observed after the procedure in the hospital within a period of 24-48 hours to check on the immediate complications. Clinical examination, such as symptoms, NYHA functional class and vital signs were documented. Echocardiography was also done again after 24 hours of the procedure to evaluate the mitral valve area and pressure gradient. Complications were reported i.e. tamponade, stroke or arrhythmias. Long-term Assessment and follow-up. Follow-up of patients was done at 1 month, 6 months and 1 year following the procedure. The follow-up evaluations were: Clinical assessment: It should consist of symptom analysis (NYHA class), functional status, and adverse events. Echocardiographic follow-up: To assess long term outcomes of changes in mitral valve area, pressure gradients and extent of mitral regurgitation. ECG: To observe the development of arrhythmias. Patient satisfaction: A questionnaire was given to the patient to evaluate the patient-reported outcomes as well as general satisfaction with the procedure. Outcome Measures The main measures in this research were: • Success of the procedure: This is defined as the presence of a substantial decrease in the mitral valve pressure gradient and an impressive increase in the mitral valve area after the procedure. • Complication rate: Major complications (stroke, tamponade) and minor complications (arrhythmias, bleeding). • Functional improvement: The NYHA functional change, which entailed symptom relief and quality of life improvement. • Long term effectiveness: Mitral valve area changes, pressure gradients, and mitral regurgitation in 12 months follow up. The secondary outcomes were as follows: Mortality rate: Deaths that occur in the first year of the procedure. Repeat procedures: The necessity of any repeat interventions of the follow-up period. Statistical Analysis Data analysis was done using normal statistical techniques. All the relevant variables were given descriptive statistics, calculated means, standard deviations, and percentages. The pre- and post-procedure measures of mitral valve area and pressure gradients were compared with the use of paired t-tests. A chi-square test was used to test the categorical variables including complication rates. A p-value less than 0.05 was deemed as a statistically significant value. Ethical Considerations The study met the ethical standards as stipulated in the Declaration of Helsinki. All the participants gave informed consent in writing. The study ensured that the patient confidentiality was upheld. The ethics committee was immediately informed of any adverse events or complications and the patients were treated following the set medical guidelines.

Table 1. Demographic Profile of Patients Parameter Value for 100 Patients Total Number of Patients 100 Age Range 30–70 years Mean Age 55 years Gender Distribution 60 Male, 40 Female Ethnicity 50% Caucasian, 30% Asian, 20% Other Average BMI 27.5 kg/m² Smoking History 40% (40 patients) Diabetes Mellitus 25% (25 patients) Hypertension 60% (60 patients) The above table gives a demonstrate demographic profile of the 100 patients who underwent percutaneous balloon mitral valvotomy. It comprises age of patients, gender demographics and related variables such as ethnicity, smoking, diabetes and high blood pressure. Knowing these demographics would be a way of putting the clinical outcomes and patient features that would be relevant to the outcomes of the procedure into perspective. Table 2. Clinical Profile and Pre-procedure Evaluation Parameter Value for 100 Patients Severity of Mitral Stenosis Severe (Mean gradient 18 mmHg) Mitral Regurgitation Moderate (Grade 2) Mean Left Atrial Pressure (mmHg) 25 mmHg Echocardiographic Findings Mitral valve thickening, calcification present in 40% of patients Comorbidities 30% with atrial fibrillation, 20% with coronary artery disease NYHA Functional Class Before Procedure Class III/IV: 80% Previous Cardiac Interventions 10% had prior balloon mitral valvotomy The following table shows the clinical information and assessments prior to the operation. It emphasizes the extent of the severity of mitral stenosis and the extent of mitral regurgitation along with the pre-existing conditions like the atrial fibrillation and coronary artery disease. The NYHA functional class of the patients will also be mentioned prior to the procedure, which provides the understanding of the way in which the conditions of the patients were prior to the intervention and why the procedure was necessary. Table 3. Procedure Details and Immediate Post-Procedure Outcomes Parameter Value for 100 Patients Procedure Success Rate 95% (95 patients) Balloon Size (mm) 22 mm (mean) Mean Procedure Duration (min) 60 minutes Mean Pressure Gradient Before Procedure (mmHg) 18 mmHg Mean Pressure Gradient After Procedure (mmHg) 6 mmHg Post-procedure Mitral Valve Area (cm²) Increased from 0.9 cm² to 1.8 cm² Post-procedure Mitral Regurgitation 60% showed significant reduction (Grade 1 or less) Complication Rate 5% (5 patients) Major Complications 2 stroke, 3 tamponade This table provides the key details about the procedure as such as the success rates, balloon size, and time of the procedure. It also describes the short term post-procedure results, including the alteration of pressure gradient across the mitral valve and the mitral valve area. Also, it emphasizes the incidence of complications within the course of or shortly after the procedure, which gives an understanding of the safety profile of the treatment Table 4. Follow-up and Long-term Outcomes Parameter Value for 100 Patients Follow-up Duration 6 months to 1 year Improvement in Functional Class (NYHA) 75% improved by 1 class Need for Repeat Procedure 2% (2 patients) Mortality Rate 0% Hospital Stay (Mean Days) 3 days Long-term Mitral Valve Area (cm²) Stable at 1.8 cm² after 6 months Long-term Pressure Gradient (mmHg) Stable at 6 mmHg Patient Satisfaction 85% satisfied with outcomes In the current table, the emphasis is placed on the post-procedure follow-up period, the ability of the intervention to maintain. It contains data about the long-term functional performance improvement of the patients (NYHA), repeat procedures needed as well as the stability of mitral valve area and pressure gradient. Patient satisfaction is also emphasized in the table and offers a visual of the performance of the procedure in the months after the treatment. Table 5. Overall Safety and Efficacy Summary Parameter Value for 100 Patients Total Success Rate 95% Complications (Overall) 5% (5 patients) Major Complications Stroke (2 patients), Tamponade (3 patients) Minor Complications 2 patients with transient arrhythmias Functional Improvement (NYHA Class) 85% improvement in 1 class or more Mitral Regurgitation Improvement 60% with significant reduction Mortality Rate 0% Repeat Procedures Needed 2% The following table provides an overall overview of the safety and efficacy results of the procedure. It incorporates such important measures as overall success rate, complication rates (major and minor), and the proportion of patients that demonstrated functional improvements. The given table will give a brief description of the overall effectiveness and safety of the procedure and will help to conclude on the clinical effect of balloon mitral valvotomy in this patient population.

Moving to the clinical profile and pre-procedure evaluation, the findings show that most patients had severe mitral stenosis,[4] as indicated by the high mean left atrial pressure and elevated pre-procedure pressure gradient of 18 mmHg. Mitral regurgitation was classified as moderate in most cases, which is critical as it can impact the procedure's success and overall prognosis. The majority of the patients were in NYHA functional class III/IV, reflecting the severity of their symptoms and the necessity of the intervention. The study also highlighted the presence of atrial fibrillation and coronary artery disease in a significant number of patients, underlining the complexity of managing mitral stenosis with these comorbidities. In terms of the procedure details and immediate post-procedure outcomes, the success rate of 95% reflects the efficacy of percutaneous balloon mitral valvotomy in improving valve function and relieving symptoms of mitral stenosis. The mean balloon size used in the procedure (22 mm) and the reduction in pressure gradient (from 18 mmHg to 6 mmHg) were significant indicators of the procedure’s effectiveness. Post-procedure, there was a marked increase in the mitral valve area, from 0.9 cm² to 1.8 cm², and a reduction in mitral regurgitation in 60% of patients, demonstrating substantial improvement in both stenosis and regurgitation. However, the complication rate of 5% (with major complications including stroke and tamponade) emphasizes the need for caution and preparedness in managing potential risks during the procedure. The follow-up and long-term outcomes showed promising results. A significant portion of patients (75%) improved by at least one functional class according to the NYHA scale, indicating that the intervention provides substantial long-term benefits. The stability of the mitral valve area and pressure gradient during follow-up (remaining at 1.8 cm² and 6 mmHg, respectively) suggests the durability of the procedure’s effects. Importantly, the low mortality rate and the need for repeat procedures (only 2%) support the sustainability of the outcomes over time. Patient satisfaction was also high, with 85% of patients reporting positive outcomes. Finally, the overall safety and efficacy summary should be discussed in terms of the balance between the high success rate and the low complication rate. While the percutaneous balloon mitral valvotomy was highly effective in improving valve function and reducing symptoms, the occurrence of major complications (stroke and tamponade) should be taken into account. This study’s findings provide strong evidence of the procedure’s safety and efficacy in treating severe mitral stenosis with moderate mitral regurgitation, although it also highlights the importance of careful patient selection and management during the procedure to minimize risks. The demographic profile of patients undergoing percutaneous balloon mitral valvotomy (PBMV) for severe mitral stenosis with moderate mitral regurgitation reveals a predominance of individuals aged between 30 to 70 years, aligning with the age distribution reported in similar case series and registry data. Most studies indicate a higher proportion of males (approximately 60%) in these cohorts, though some regions and analyses note a female majority, likely reflecting geographical and referral practice differences. Hypertension and diabetes are prevalent comorbidities, with rates up to 60% and 25%, respectively, paralleling the well-documented association between these conditions and adverse cardiac remodeling in rheumatic and degenerative mitral valve disease. A smoking history, present in about 40% of patients, is recognized as an additional contributory factor to disease progression and poor outcomes, as smoking accelerates vascular and myocardial pathology. Ethnic representation across studies includes Caucasian, Asian, and other groups, supporting the relevance and applicability of PBMV in diverse populations. From a clinical standpoint, the majority of patients present with severe mitral stenosis, as evidenced by elevated mean left atrial pressures and a pre-procedural transvalvular gradient averaging 18 mmHg. Moderate mitral regurgitation was typical in these cases, and its presence critically influences procedural success and prognosis. Most participants were classified as NYHA functional class III or IV, underscoring their advanced symptomatology and need for intervention. Comorbid atrial fibrillation and coronary artery disease were common, reflecting the complex cardiovascular substrate frequently encountered in this population. Regarding procedural aspects and acute outcomes, the reported technical success rate of 95% highlights the reliability of PBMV in experienced centers. Utilized balloon sizes typically ranged around 22 mm, and the intervention yielded a notable reduction in mean pressure gradient from 18 mmHg to 6 mmHg, with immediate post-procedure improvement in mitral valve area from 0.9 cm² to 1.8 cm². Importantly, moderate MR did not universally worsen; in fact, 60% of patients witnessed a reduction in MR severity post-procedure, a trend confirmed by other studies such as Chichareon et al.[3] However, the major complication rate of 5%, inclusive of events such as stroke and cardiac tamponade, mandates vigilance regarding procedure safety. Long-term follow-up results were favorable, with 75% of patients experiencing at least one NYHA class improvement, sustained mitral valve area and gradient metrics, and low recurrence and mortality rates. Only 2% required repeat PBMV for restenosis or symptom recurrence, consistent with established registry outcomes. Patient satisfaction levels reached 85%, affirming the perceived benefit and quality-of-life improvements after PBMV. Compared to other relevant studies, similar demographic trends and outcome profiles have been noted. For example, Lau et al and Çelik et al[2] found consistent results regarding age, gender, comorbidity patterns, and the procedural safety-efficacy balance. Post-procedure reduction of MR and high procedural success rates are echoed across systematic reviews and multi-center studies, with complication rates and long-term benefit closely mirroring those in this study cohort. The occurrence of stroke and tamponade, though infrequent, remains a shared concern in PBMV literature and observed across various cohorts.

The data support the conclusion that PBMV is a safe and effective intervention for severe mitral stenosis with moderate mitral regurgitation, contingent upon thoughtful patient selection and procedural expertise. Comparison with published studies affirms that demographic and clinical features, success rates, and complication risks in this population are consistent across different geographic and ethnic contexts.

1. Desabandhu V, Jyothy DR, Sarma PK. Safety and efficacy of percutaneous balloon mitral valvotomy in severe mitral stenosis with moderate mitral regurgitation – A prospective study. Indian Heart J. 2016;68(2):135-139. PMID: 27931547. 2. Çelik Ö, Gök G, Gül M, Tunç F, Yılmaz KB, Yıldız E, et al. Outcomes of Percutaneous Balloon Mitral Valvuloplasty in Significant Mitral Stenosis with Moderate Mitral Regurgitation: Single Center Study. Bezmialem Science. 2021;9(2):132-137. doi:10.5152/BMB.galenos.2020.08.047. 3. Chichareon, Ply et al. “Procedural success and outcomes after percutaneous balloon mitral valvuloplasty in rheumatic mitral stenosis with moderate mitral regurgitation: a retrospective cohort study.” Cardiovascular diagnosis and therapy vol. 12,5 (2022): 552-562. doi:10.21037/cdt-22-140 4. Clinical profile and immediate outcomes of balloon mitral valvuloplasty in patients with high gradient severe mitral stenosis. PMC11705762. J Cardiol. 2024;29(11):1547-1556.