Interventional Ductus closure with a new device: Clinical study at 3600m

  • Dr Alexandra Heath, Kradiozentrum, La Paz, Bolivia
  • Dr Franz Freudenthal, PFM-Bolivia, Bolivia
  • Dr Rainer Kozlik, Klinikum Großhadern, LMU München, Germany
  • Dr Jorge Villanueva, Kardiozentrum; La Paz, Bolivia
  • Dr Joaquin Navarro, CMQBB, Cochabamba, Bolivia
  • Dr Leonardo Romero, Hospital Calvo Malena, Santiago, Chile,, Chile
  • Dr Miguel Ronderos, Fundacion Cardioinfantil, Bogota, Colombia
  • Dr Miguel Granja, Hospital italiano, Bs. Aires, Argentina

    • Objective: To present results of our clinical study in gigant ductus with a brand new PDA closure device (Nitocclud PDA® – pfm Bolivia) at more than 3600 m.

    Methods: Patients: From October 2006 to October 2008 we studied 50 patients (32 female-18 male), 8 P. w/T21, range 7 months to 30 years (10, median 10±6.54 years), weight 5,2 Kg to 60 Kg (36,median 29 ± 16.59 Kg). The PDA-MD range 2,0 mm to 8,38 mm (median 4,59 mm). Device: The new device is manufactured with nitinol in one piece with integrated polyester membranes. The distal ring will be coupled physiologically to the aortic ampoule at the time of intervention. The cylinder expands to the PDA walls.

    Results: 54% had a big PDA-MD > 4 mm (similar series: 17%), Mild 2,5 a 4 mm: 33 %, slight ≤ 2 mm:13 %.
    Rate of closure was immediate 55%, 1st day 65%, 1st month 69%, 3rd month 79%, 6th month 83%, 1st year 95%.
    The PSP ranged from 21 mmHg to 94 mmHg (median 49,6 mmHg). After the sealing the PSP sank to 16 to 75 mmHg (median 39 mmHg).
    2 early embolizations in descending aorta, recovered with loop. Temporally occlusion of femoral artery, fully recuperated. Severe complication or deaths were one year after implantation, not observed.

    Conclusion: Nitocclud PDA device is easy to use; the closure rate is for big ductus satisfactory, controlled by echocardiography, absence of haemolysis, No flow alteration in pulmonary or aorta arteries. Satisfactory decrease of the PP.