title: Comparative study on safety, efficacy, and midterm results of balloon mitral valvotomy performed with triple lumen and double lumen mitral valvotomy catheters.
abstract: BACKGROUND
  The triple lumen Inoue balloon is routinely used for balloon mitral valvotomy (BMV) in India. Its major limitation is the high cost. The double lumen Accura balloon is less expensive, making it an attractive alternative in the developing countries. The study was meant to assess the safety, efficacy and midterm results of Accura balloon with respect to the Inoue balloon.
  
  
  METHODS
  816 consecutive patients, who underwent elective BMV in this Institute from 1997 to 2003, were included in the study. The data of 487 patients who underwent BMV with Accura balloon was compared with 329 patients who underwent BMV with Inoue balloon. The clinical, echocardiographic, and hemodynamic data of these patients were analyzed retrospectively to assess the safety and efficacy of Accura balloon with respect to the Inoue balloon.
  
  
  RESULTS
  Immediate procedural success (93.9% in Inoue group and 91.6% in Accura group p. NS) and complications (6.6% in Inoue group and 5.6% in Accura group p. NS) were comparable between the study groups. The two study population had similar restenosis rate and events at 1 year after BMV. Both balloons could be reused multiple times without compromising on the safety and effectiveness. Accura balloons were less costly than Inoue balloon. The reusability with Accura was slightly more and found to be more cost-effective.
  
  
  CONCLUSIONS
  Both Accura and Inoue balloon mitral valvotomy balloons are effective in providing relief from hemodynamically significant mitral stenosis in terms of gain in valve area and reduction in trans mitral gradient. Both groups have similar procedural success and complication rates, restenosis, and follow-up events at 1 year. Both balloons could be reused multiple times and Accura balloon is found to be more cost effective.
authors.affiliation: Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.
authors.forename: Krishna Kumar Mohanan
authors.initials: KK
authors.lastname: Nair
authors.forename: Harikrishnan Sivadasan
authors.initials: HS
authors.lastname: Pillai
authors.forename: Anees
authors.initials: A
authors.lastname: Thajudeen
authors.forename: Jaganmohan
authors.initials: J
authors.lastname: Tharakan
authors.forename: Thomas
authors.initials: T
authors.lastname: Titus
authors.forename: Ajitkumar
authors.initials: A
authors.lastname: Valaparambil
authors.forename: Sivasankaran
authors.initials: S
authors.lastname: Sivasubramonian
authors.forename: Krishnamoorthy Kavassery
authors.initials: KK
authors.lastname: Mahadevan
authors.forename: Narayanan
authors.initials: N
authors.lastname: Namboodiri
authors.forename: Bijulal
authors.initials: B
authors.lastname: Sasidharan
authors.forename: Sanjay
authors.initials: S
authors.lastname: Ganapathi
mesh_terms: D000328:Adult; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D062906:Cardiac Catheters / Q000191:economics; D016009:Chi-Square Distribution; D017046:Cost Savings; D015150:Echocardiography, Doppler; D004867:Equipment Design; D017743:Equipment Reuse; D005260:Female; D006439:Hemodynamics; D017721:Hospital Costs; D006801:Humans; D007194:India; D008297:Male; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D008946:Mitral Valve Stenosis / Q000000981:diagnostic imaging / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D012008:Recurrence; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult