Assessment of quality of life before and after successful percutaneous transvenous mitral commissurotomy in patients with severe mitral stenosis.

BACKGROUND: Rheumatic mitral stenosis (MS) is a significant cause of morbidity and mortality in India. Percutaneous transvenous mitral commissurotomy (PTMC) has become the procedure of choice for severe MS with pliable leaflets. Despite a wealth of literature on the technical aspects of PTMC, there is a dearth of literature addressing the impact of PTMC on the quality of life (QOL). AIM: The aim of the study is to assess the impact of PTMC on clinical status and QOL of patients with severe MS.
MATERIALS AND METHODS: Twenty-five consecutive patients with severe MS undergoing PTMC were included in the study with their informed consent. All patients were subjected to routine blood tests, electrocardiogram, chest X-ray, two-dimensional and color echocardiography, treadmill test (TMT), and World Health Organization (WHO) QOL scale. The echocardiography, TMT, and WHOQOL scale were repeated after the procedure.
RESULTS: The procedural success was 98%. The mean (range) mitral valve area preprocedure was 0.82 (0.59-0.92) cm2 and postprocedure was 1.61 (1.51-1.76) cm2. The difference was statistically significant (t = 5.02; P < 0.01). The mean (range) of TMT preprocedure was 4.05 (3.0-7.0) METS and postprocedure was 8.52 (6-12) METS. The difference was statistically significant (T = 3.08; P < 0.01). The mean (range) of QOL assessment pre- and post-procedure on physical domain was 8.83 (8.3-10.1) which increased to 11.11 (10-12.7); on social relationship domain from 9.17 (7.5-12.4) to 11.37 (9.4-12.0); on personal relationship from 11.6 (11-13) to 12.52 (12-13); on environment domain from 10.78 (10.2-11.7) to 11.56 (10.8-12); and on level of independence from 9.02 (8-10) to 12.29 (11.0-13.6). All the differences were statistically significant (Wilcoxon signed-rank test z = -4.376; -4.379; -4.234; -4.200; -4.375; respectively, all P < 0.001 highly significant).
CONCLUSIONS: PTMC resulted in a significant improvement in the QOL of patients with severe MS. The significant improvement in QOL post-PTMC may be an indication for offering PTMC at an earlier stage to those patients whose QOL is severely compromised. Copyright:

According to the World Health Organization (WHO), quality of life (QOL) is defined as “the individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals.”[1] “The degree of need and satisfaction within the physical, psychological, social, activity, material, and structural area;” “…the individuals' perception of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns;” and “…a state of well-being which is a composite of two components: the ability to perform everyday activities which reflects physical, psychological, and social well-being and patient satisfaction with levels of functioning and the control of disease- and/or treatment-related symptoms.” QOL is the general well-being of individuals and societies. It encompasses life satisfaction, physical health, family, education, employment, wealth, religious beliefs, finance, and the environment.[2] It gives an idea about how the individual's well-being may be influenced over time by a disease, disability, or disorder. The current concept of QOL in health care needs the individuals to put their actual situation in relation to their personal expectation.[3] The understanding of QOL is an important health-care topic because the relationship between cost and value raises complex problems, often with high emotional attachment because of the potential impact on human life. It can be used as a key performance metric when designing and implementing organizational change initiatives.[4]

Rheumatic mitral stenosis (MS) continues to be a significant cause of morbidity and mortality in our country.[5] It is a major burden in developing countries where it causes most of the cardiovascular morbidity and mortality in young people, leading to about 250,000 deaths/year worldwide.[6] The lesion if left untreated imposes a significant burden on the individual and the society in terms of both health and finances. MS is the prototype of rheumatic heart disease. In the West, it usually takes decades from the onset of rheumatic valvulitis until significant symptomatic obstruction occurs. This period is considerably shortened in the tropical countries. In developing countries, the latent period has been reported to be as short as 3 years.[78] The symptoms of MS are mainly due to the effect of the stenosis on the left atrial pressure and size. Increased left atrial pressures lead to elevation of pulmonary venous pressure, and this causes exertional dyspnea in patients. Further, progression of disease and elevation of pressure lead to paroxysmal nocturnal dyspnea and orthopnea. The increase in the left atrial size causes pressure symptoms at times in the form of hoarseness of voice; more commonly, it causes atrial fibrillation and consequence thereof. The disease once symptomatic has a steady progressive curve, which can be controlled in the initial stages by drugs. The relentless progression of the disease, however, soon renders drug therapy ineffective and one has to intervene to mechanically increase the valve area, thereby abrogating the elevated left atrial pressure.

Surgical mitral commissurotomy was the treatment of choice for severe MS till 1984 when Inou et al. first described percutaneous transvenous mitral commissurotomy (PTMC).[9] Since then, PTMC has shown excellent results.[1011] The options available for the treatment of severe MS at present are closed mitral valvutomy, open mitral valvutomy, and percutaneous mitral commissurotomy (PTMC). The first procedure entails a thoracotomy, the second an open heart surgery, whereas the third can be done under local anesthesia. The operation mortality of surgery is 4.7% and that of PTMC is <1%. PTMC is a procedure that involves passing a balloon catheter from the right atrium through the intra-arterial septum into the left atrium and then across the stenotic mitral valve into the left ventricle. This procedure which is performed under local anesthesia produces immediate hemodynamic improvement and relieves congestive symptoms. It has become the procedure of choice for MS in symptomatic patients with optimum valve morphology.[12] The patient has to be is symptomatic prior to being considered for PTMC on ordinary physical activity (Class II New York Heart Association [NYHA]).

The disease symptoms can be a nightmare literally and figuratively and the apprehension increases as time passes by. The recurrence of symptoms imposes a significant impact on the QOL of the individual and the family. Although rheumatic MS is more common in females, it usually impacts the whole family, especially if the lady of the house is affected. There is plenty of literature on the technical aspects of PTMC in terms of hemodynamics, valve areas, and objective symptomatic relief, but there is a paucity of studies addressing the impact of PTMC on QOL. In view of the lack of studies in this area, the present work was undertaken to assess the impact of PTMC on the QOL of patients with MS.

MATERIALS AND METHODS

This prospective, longitudinal, hospital-based study was undertaken in the Department of Cardiology, Military Hospital (Cardiothoracic Centre) and Armed Forces Medical College, Pune. The project was approved by the institutional ethical committee and all the participants gave written informed consent.

Study sample

The sample for the study consisted of consecutive patients with severe MS with a mitral valve surface area of equal to or <1 cm2 and pliable valves meeting the following exclusion criteria were included in the study with their consent.

Exclusion criteria for percutaneous transvenous mitral commissurotomy were

Grade III or Grade IV mitral regurgitation

Wilkin score of >8

Presence of a left atrial thrombosis

Significant aortic valve disease

Not giving consent for taking part in the study.

Tools used

World Health Organization quality of life

The WHOQOL was developed collaboratively in 15 culturally diverse field centers around the world. It is used to measure the perception of an individual of their position in life in the context of the culture and value systems in which they live. It has been rigorously tested to assess its validity and reliability. The WHOQOL produces a multidimensional profile of scores across six domains – Physical, Psychological, Level of Independence, Social Relationships, Environment, Spirituality, and 24 subdomains of QOL.[1314]

Study procedure

Functional status of the patients was assessed by the NYHA criteria. All patients were subjected to routine blood tests, which included blood hemoglobin, total leukocyte count, differential leukocyte count, bleeding time, clotting time, serum glucose, blood urea, serum creatinine, and liver function tests. A 12-lead electrocardiogram, chest X-ray posteroanterior view, and echocardiography (two-dimensional and color) were done. Patients were also subjected to an objective assessment of their physical performance on the treadmill using the Bruce protocol. The echocardiography and treadmill test (TMT) were repeated after PTMC. PTMC was performed using an anterograde approach from the femoral vein. The transseptal puncture was done by the Brockenborough needle, and the Inoue balloon was positioned across the mitral valve. The balloon inflation was done in this position valvotomy was done. Successful PTMC was defined as a postprocedural mitral valve area (MVA) of 1.5 cm2 or more or percentage increase in MVA of ≥50% in the absence of major complications, including death, systemic embolism, and cardiac tamponade. Procedural mortality was defined as death within 24 h of PTMC.

All patients also underwent an evaluation of QOL using the WHOQOL questionnaire 1 day before and after the procedure.

Statistical analyses

The collected data were analyzed using the Statistical Package for the Social Sciences version 16.0 (IBM, USA). For comparison of data, appropriate statistical tests (Independent sample t-test, Wilcoxon signed rank test, and Pearson's correlation) were used. Statistical analyses were performed with a significance level of <0.05 and a confidence level of 95%.

RESULTS

The total number of patients who underwent PTMC during the study period was 25, which included 8 male and 17 female patients. The mean (± standard deviation) age of the patients was 26.2 (+ 11.2) years. The NYHA status of the patients was as follows: Class II – 3 (12.0%), Class III – 19.0 (76.0%), and Class IV – 3 (12.0%). The procedural success was 98%. The MVA preprocedure ranged from 0.59 to 0.92 cm2 and postprocedure was 1.51–1.76 cm2. The treadmill performed preprocedure ranged from 3.0 to 7.0 METS and postprocedure was 6–12 METS. The procedural results in terms of MVA and performance on treadmill before and after PTMC are given in Table 1 and Figure 1. Table 2 shows changes in mean MVA pre- and post-procedure of the present study along with few earlier studies.

Table 1

Mitral valve area and performance on treadmill before and after percutaneous transvenous mitral commissurotomy

	Pre-PTMC	Post-PTMC	t-test	P
Mitral valve area (cm2)
Mean±SD	0.83±0.08	1.61±0.07	34.8	<0.0001
Range	0.59-0.92	1.51-1.76
Performance on treadmill (METS)
Mean±SD	4.06±1.62	8.52±1.54	9.94	<0.0001
Range	3-9	5.5-12

SD – Standard deviation; PTMC – Percutaneous mitral commissurotomy

Figure 1

Mitral valve area and treadmill test results before and after percutaneous transvenous mitral commissurotomy

Table 2

Mean mitral valve area pre- and post-percutaneous transvenous mitral commissurotomy procedure of the present study and few earlier studies

Study	MVA, mean±SD (cm2)		P (<0.001)	Procedural success rate (%)
	Pre-PTMC	Post-PTMC
Arora et al. 2002	0.7±0.2	1.9±0.3	<0.0001	99.8
Yonga et al. 2003	0.6±0.19	10.9±0.19	<0.0001	100
Kothari et al. 2006*	0.70	1.53	-	100
Shresta et al. 2013	0.7±0.15	1.5±0.32	<0.001	94
Wilson et al. 2014*	0.9	1.7	<0.05	100
Adhikari et al. 2015	0.8±0.1	1.6±0.2	<0.006	87.7
Ali et al. 2016	0.684±0.12	1.533±0.28	<0.0001	95.9
Khan et al. 2017	0.84±0.13	1.83±0.49	<0.001	71.4
Munir et al. 2018	0.92±0.39	1.48±0.29	<0.001
Present study	0.83±0.08	1.61±0.07	<0.0001	98

*Median values. SD – Standard deviation; PTMC – Percutaneous mitral commissurotomy; MVA – Mitral valve area

The QOL assessment on the physical domain preprocedure was 8.3–10.1, which increased to 10–12.7 postprocedure. The social relationship domain score increased from 7.5–12.4 preprocedure to 9.4–12.0 postPTMC. The personal relationship score was 11–13 and 12–13 pre- and post-PTMC, respectively. The environment domain was 10.2–11.7 preprocedure to 10.8–12 postprocedure. The level of independence ranged from 8–10 pre-PTMC to 11.0–13.6 post-PTMC. The results of WHOQOL assessment domain scores before and after PTMC are given in Table 3. Correlations of WHOQOL domain scores with MVA and TMT scores after PTMC are given in Tables 4 and 5, respectively.

Table 3

Results of the World Health Organization quality of life domain scores of the patients before and after percutaneous transvenous mitral commissurotomy

Quality of life domains	Pre/post PTMC	Mean±SD	Range	Percentiles			Wilcoxon signed-rank test	P
				25th	50th	75th
Physical	Pre-PTMC	8.83±0.52	8-10	8.4	8.8	9.1	−4.38	<0.001
	Post-PTMC	11.11±0.75	10-12.7	10.5	11.0	11.9
Social	Pre-PTMC	9.17±1.78	7.2-12.4	7.6	8.3	10.6	−4.739	<0.001
	Post-PTMC	11.37±1.44	9.4-13.6	9.8	11.8	12.5
Personal	Pre-PTMC	11.60±0.65	11-13	11	12	12	−4.234	<0.001
	Post-PTMC	12.52±0.51	12-13	12	13	13
Environmental	Pre-PTMC	10.39±1.91	1.5-11.7	10.4	10.6	11.1	−4.202	<0.001
	Post-PTMC	11.56±0.61	10.4-12.6	11.0	11.8	12.0
Level of independence	Pre-PTMC	9.02±0.86	8.0-11.2	8.3	9.0	9.55	−4.374	<0.001
	Post-PTMC	12.38±0.91	11.0-13.9	11.55	12.4	13.15
Spirituality	Pre-PTMC	9.08±0.64	8.10-10.4	8.6	9.0	9.6	−4.375	<0.001
	Post-PTMC	11.42±0.74	10.20-12.8	11.0	11.20	12.0

SD – Standard deviation; PTMC – Percutaneous mitral commissurotomy

Table 4

Correlations of mitral valve area with World Health Organization quality of life domain scores after percutaneous transvenous mitral commissurotomy

	MVA	Physical	Social	Personal	Environmental	Independence	Spiritual
MVA
Correlation	1	−0.056	−0.281	0.292	0.068	0.359*	0.373*
Significant		0.395	0.087	0.078	0.374	0.039	0.033
Physical
Correlation	−0.056	1	−0.234	0.284	−0.410*	0.196	0.002
Significant	0.395		0.130	0.084	0.021	0.174	0.496
Social
Correlation	−0.281	−0.234	1	−0.072	−0.116	−0.261	−0.310
Significant	0.087	0.130		0.365	0.290	0.104	0.066
Personal
Correlation	0.292	0.284	−0.072	1	−0.237	0.181	0.400*
Significant	0.078	0.084	0.365		0.127	0.193	0.024
Environmental
Correlation	0.068	−0.410*	−0.116	−0.237	1	0.222	−0.024
Significant	0.374	0.021	0.290	0.127		0.143	0.454
Independence
Correlation	0.359*	0.196	−0.261	0.181	0.222	1	0.372*
Significant	0.039	0.174	0.104	0.193	0.143		0.033
Spiritual
Correlation	0.373*	0.002	−0.310	0.400*	−0.024	0.372*	1
Significant	0.033	0.496	0.066	0.024	0.454	0.033

*Correlation is significant at the 0.05 level (one-tailed). MVA – Mitral valve area

Table 5

Correlations of treadmill test results with World Health Organization Quality Of Life domain scores after percutaneous transvenous mitral commissurotomy

	TMT	Physical	Social	Personal	Environmental	Independence	Spiritual
TMT
Correlation	1	−0.060	−0.148	0.474**	−0.165	0.152	0.068
Significant		0.387	0.241	0.008	0.216	0.234	0.373
Physical
Correlation	−0.060	1	−0.234	0.284	−0.410*	0.196	0.002
Significant	0.387		0.130	0.084	0.021	0.174	0.496
Social
Correlation	−0.148	−0.234	1	−0.072	−0.116	−0.261	−0.310
Significant	0.241	0.130		0.365	0.290	0.104	0.066
Personal
Correlation	0.474**	0.284	−0.072	1	−0.237	0.181	0.400*
Significant	0.008	0.084	0.365		0.127	0.193	0.024
Environmental
Correlation	−0.165	−0.410*	−0.116	−0.237	1	0.222	−0.024
Significant	0.216	0.021	0.290	0.127		0.143	0.454
Independence
Correlation	0.152	0.196	−0.261	0.181	0.222	1	0.372*
Significant	0.234	0.174	0.104	0.193	0.143		0.033
Spiritual
Correlation	0.068	0.002	−0.310	0.400*	−0.024	0.372*	1
Significant	0.373	0.496	0.066	0.024	0.454	0.033

**Correlation is significant at the 0.01 level (one-tailed), *Correlation is significant at the 0.05 level (one-tailed). TMT – Treadmill test

DISCUSSION

It is obvious from the literature that in developing countries like India, MS predominantly affects a younger population and the majority of symptomatic MS patients usually present before the age of 30 years and our findings are in agreement with these studies.[151617181920212223] On the other hand, in Western countries, the disease primarily involves the older population as shown in a series of PTMC reported from developed countries.[24] In addition, reports indicate that the progression of symptoms of rheumatic MS in this part of the world is very rapid. In an earlier study, >85% of the patients were in functional Class III/IV at the time of presentation. The age distribution and female preponderance of our patients were similar to other studies from developing countries.[2526]

PTMC using the Inoue technique was first reported by Inoue et al. in 1984.[9] Since then, it has evolved and rapidly became the standard technique for the management of MS with pliable valves. The results of PTMC in adults are similar to that of open commissurotomy and better than that of closed commissurotomy.[2728] Studies have found that PTMC with use of simple height-based balloon sizing method in the step-wise Inoue balloon approach is associated with excellent short-term and long-term efficacy rates and a low risk of creating severe mitral regurgitation.[29]

The present study reported statistically significant difference between pre- and post-procedure MVA (cm2) after PTMC (0.83 ± 0.08 vs. 1.61 ± 0.07). According to Munir et al.,[21] Adhikari et al.,[18] Ali et al.,[19] and Sharma et al.,[29] PTMC significantly directly increases the rate of perioperative MVA (cm2) as 0.92 ± 0.39 vs. 1.48 ± 0.29, 0.8 ± 0.1 vs. 1.6 ± 0.2, 0.684 ± 0.1226 vs. 1.533 ± 0.281, and 0.87 ± 0.13 vs. 1.63 ± 0.19, respectively. The results of the present study are similar to the above results. In accordance with the above, the patients in the study cohort had a demonstrable increase in their performance on the treadmill after PTMC. This was not uniformly correlated to the valve area but was related to pre-PTMC physical statistics and the well-known variable hemodynamic effects of flow and valve area.

Many patients of MS present with respiratory symptoms. The chronic changes in the pulmonary circulation are secondary to increased pulmonary venous pressure and reflex pulmonary artery vasoconstriction. Accumulation of water, proteins, and proteoglycans in the interstitium of the lungs are the basis of the clinical manifestations of MS and can be detected by pulmonary function tests also the residual volume function may be altered due to an increase in the left atrial pressure. Few recent studies have shown that successful PTMC immediately improves cardiac and pulmonary function along with the clinical status of patients with MS.[3031]

Despite the availability of standardized scales for assessment of QOL the literature on the assessment of QOL in patients with rheumatic MS is rare, and no study has assessed the effects of PTMC on QOL. Chronic rheumatic disease is associated with increased physical and psychosocial impairments including pain, fatigue, and difficulties with activities of daily living, ranging from basic household chores to more complex tasks such as employment and social roles, e.g., childbearing. Moreover, chronic rheumatic disease requires long-term prophylactic treatment, including painful administration of intramuscular medication. Due to these reasons, it causes stress and anxiety in patients resulting in impaired QOL. In addition, rheumatic MS may cause functional and psychosocial limitations that contribute to further deteriorate the patient's QOL.[323334]

The impact of PTMC on the QOL of patients with severe MS in this study was remarkable as seen by significant correlation of MVA and TMT scores postprocedure with WHOQOL domain scores [Tables 4 and 5] and the significant improvement of all WHOQOL domain scores after the procedure compared to the preprocedure scores [Table 3]. The maximum impact was seen only in the physical and level of independence domain and less on social personal and environment domains. The reason for this is probably because the relief of physical symptoms occurs immediately after PTMC, while the social changes are likely to occur after discharge from the hospital. Since the post-PTMC assessment was done prior to discharge from the hospital only, the changes in physical and level of independence domain of QOL were evident. However, even this improvement in the physical and level of independence domain has an important effect in improving the QOL, personal confidence, and ability of the patients. Being a pioneering study measuring the QOL of patients before and after PTMS, comparison of the findings of the present study with other studies is not possible.

Limitations

The present study has certain limitations. The sample size was rather small and no follow-up could be done due to the limitation of time for our study. Hence, future studies with larger sample and longer follow-up are suggested.

CONCLUSIONS AND RECOMMENDATIONS

PTMC has a very significant impact on the QOL of patients most so in the physical and level of independence domains. This quality enhances the confidence, self-esteem, and mood of the patient. Hence, for a better QOL, this procedure should be advised in patients with MS. It is recommended that the assessment of QOL should be carried out routinely in all cases of severe MS. The significant improvement in QOL post-PTMC may be an indication for offering PTMC at an earlier stage to those patients whose QOL is severely compromised.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.