Long-Term Mortality, Cause of Death, and Temporal Trends in Complications after Percutaneous Aortic Balloon Valvuloplasty for Calcific Aortic Stenosis
ABSTRACT We sought to assess survival, predictors of adverse outcomes, and complication rates in a more recent series of adults undergoing percutaneous aortic balloon valvuloplasty (PABV) for symptomatic calcific aortic stenosis. While aortic valve replacement is the treatment of choice for adults with symptomatic calcific aortic stenosis, PABV has been used in selected patients who are not good surgical candidates. Registries of patients who underwent PABV over 15 years ago have shown poor long-term survival and high procedural complication rates. This single-center cohort study enrolled consecutive adults undergoing PABV between 1989 and 2005 for calcific aortic stenosis. Demographic, hemodynamic, and procedural data, as well as vital status, were collected by chart review and query of the National Death Index. The study included 78 patients: mean age 78 +/- 11 years, 51% female, 90% heart failure, 61% coronary disease, and 8% end-stage renal disease. While 22% had a major procedural complication, this rate tended to decrease over time (P=0.068). In the cohort, 87% died with a median survival of 6.6 months. According to NDI records, the primary cause of death was cardiac in 54% of deaths. Survival was significantly higher in patients <or=70 years and those bridged to aortic valve replacement. PABV in patients who are elderly and not candidates for bridge to aortic valve replacement is associated with poor long-term survival. The decrease in the complication rate over the past 15 years has important implications regarding the morbidity associated with percutaneous aortic valve replacement techniques.
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ABSTRACT: Interventional Therapy of Aortic Stenosis - an Option for all Patients? Calci- fied aortic stenosis is the predominant valve dis- ease in the western world. Especially elderly patients with significant stenosis and certain comorbidities are not referred for surgery due to high operative mortality. Percutaneous aortic
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ABSTRACT: Balloon aortic valvuloplasty (BAV), introduced since almost 20 years, has experienced a revival for its use in the treatment of elderly patients with severe calcified aortic stenosis that are associated with high operative risk and co-morbidities. This is due to the introduction of new balloon catheters and techniques. This study reports about 75 such cases performed within the past 28 months. The mean age of our patient group was 78 +/- 7 years (median = 80 years). Risk calculation with the EuroSCORE demonstrated an average value of 24.4 +/- 19.5%. BAV was performed along with burst pacing to reduce transvalvular blood flow for stabilization of the balloon catheter until blood pressure dropped to less than 50 mmHg. BAV was performed in 72 patients with a procedural success rate of 73%. There was a decrease of 31 mmHg peak-to-peak gradient across the aortic valve from 63 +/- 35 to 32 +/- 22 mmHg (P < 0.0001). Mean gradient was reduced from 51 +/- 24 to 27 +/- 15 mmHg (P < 0.0001). Aortic valve area increased by 49% from 0.84 +/- 0.33 to 1.25 +/- 0.45 cm(2) (P < 0.0001). Serious adverse events (SAE) occurred in 17% of the 75 BAV procedures. Follow-up revealed a significant improvement in 6-month and 1-year survival. The improved technology of BAV makes this technique attractive for elderly patients who are at high operative risk or in cases where valve replacement was refused for any reason.Clinical Research in Cardiology 05/2008; 97(5):288-97. DOI:10.1007/s00392-008-0650-0 · 4.17 Impact Factor
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ABSTRACT: Restenosis occurs invariably within 1 year following balloon valvulopasty in aortic valve stenosis. The mechanism of restenosis seems to involve a dynamic cellular component that could be a target for drug inhibition. We investigated the feasibility of local drug delivery at the aortic valve tissues of healthy pigs with a paclitaxel-eluting balloon. Aortic valvuloplasty was performed in eight anesthetized domestic pigs using paclitaxel-eluting balloons (3 micro2) balloon surface area). They were assigned to two or four times 15-second balloon inflations and were sacrificed 30 minutes after final balloon inflation. The aortic annulus to balloon diameter ratio was 1.15 +/- 0.07. The mean paclitaxel concentration in the aortic valve leaflets was 0.91 +/- 1.36 micro (0.34 +/- 0.05 micro in the two-inflation group, 1.48 +/- 1.86 micro in the four-inflation group, P = 0.23). The percentage of the total paclitaxel dose recovered in the aortic valve leaflets was 18 +/- 11(-6)% (13 +/- 6(-6)% and 25 +/- 14(-6)% in the two- and four-inflation group, P = 0.16). Local drug delivery at the aortic valve leaflets of healthy pigs with a paclitaxel-eluting balloon is feasible and concentrations within the therapeutic window are detected 30 minutes after the procedure. The antirestenotic potential of this treatment should be studied.Journal of Interventional Cardiology 04/2009; 22(3):291-8. DOI:10.1111/j.1540-8183.2009.00447.x · 1.32 Impact Factor