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Objective: To assess the effects on haemodynamic function and symptoms of percutaneous balloon dilatation of mitral stenosis in patients unable to undergo surgical treatment because of associated medical/cardiac problems., Design: A review of clinical outcome in 28 patients (of 108 undergoing balloon dilatation of the mitral valve) who were unsuitable for surgery., Setting: A tertiary cardiac referral centre: some patients referred were from other cardiac centres in Scotland., Patients: 28 patients judged by cardiac surgeons to be unsuitable for valve replacement or valvotomy because of respiratory disease (15 patients), nonmitral cardiac disease (6), multi-organ impairment (5), psychiatric problems (1) or dense intrathoracic adhesions (1)., Interventions: Percutaneous anterograde balloon dilatation of the mitral valve with polyethylene/polyvinyl balloons in 20 patients and the Inoue balloon in eight patients., Main Outcome Measures: Haemodynamic variables were measured before and immediately after mitral valve dilatation. Patient survival and symptom class (New York Heart Association) were followed for a year after the procedure., Results: Dilatation at the mitral orifice was achieved in all cases. The mean (SD) pressure drop across the valve fell from 13.9 (5.3) to 5.6 (2.5) mm Hg, cardiac output rose from 3.18 (1.02) to 3.96 (2.5) l/min, and valve area increased from 0.78 (0.32) to 1.58 (0.56) cm2. The procedure was well tolerated by most patients, even those with metabolic/electrolyte disturbance, severe obstructive airways disease, myocardial impairment, and coronary disease. In three patients a small shunt developed at the atrial level: none developed severe mitral reflux. The two patients who required assisted ventilation died soon after the procedure and in one patient with severe coronary artery disease myocardial infarction developed and she died in cardiogenic shock. Early symptomatic improvement was reported by 23 of the 25 survivors, though the increase in exercise capacity was often limited by their non-mitral disease. At one year follow up a further 6 patients had died because of their additional disease: 15 continued to show symptomatic improvement., Conclusions: Percutaneous balloon dilatation of the mitral valve is a useful new option in patients who are too ill to undergo cardiac surgery; but longer term benefit can be limited by the associated disease.