Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study.
ABSTRACT The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve).
Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital.
Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.
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ABSTRACT: Transcatheter Aortic Valve Implantation [TAVI] is widespread worldwide as an alternative therapy procedure to the patients suffering from severe aortic valve stenosis. However, we shouldn't forget that the conventional surgical aortic valve replacement is still the gold standard therapy for severe aortic valve stenosis. For the patients who cannot be treated conventionally because of high risk comorbid diseases and older age, TAVI is an effective alternative therapy method. The indications should be limited, concerning the high mortality rate, 10% within 30 days of intervention. Long term efficacy data are still inadequate. Although the indications are restricted to older patients with a STS score >10 or log-Euro Score >20, age is not a definite indication for this treatment. The patients should be assessed by a heart team including a non-interventional cardiologist, interventional cardiologist, cardiac anesthesiologist and cardiac surgeon according to their general status, frailty and STS- Euro score. In other words, assessment and treatment of the patient by a heart team is the main factor besides the limited power of the scoring systems. The treatment should be applied to the patients with an aortic annulus diameter between 18-27 mm and a life expectancy of at least over 1 year. The currently ongoing investigations are focused on parameters like safety, efficiency and long term reliability of TAVI. The scientific and technical developments lead to new definitions and parameters regarding the treatment indications of severe aortic valve stenosis. In this review, we present the actual data about TAVI and also our own experiences.Balkan Journal of Medical Genetics 06/2012; 29(2):118-23. · 0.17 Impact Factor
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ABSTRACT: Transaortic valve implantation (TAVI) has a well-established position in the treatment of high-risk and inoperable patients with severe aortic stenosis (AS). The TAVI protocol requires a pre-dilatation for native valve preparation. To assess the safety and feasibility of TAVI without pre-dilatation and to compare it with the procedure with pre-dilatation. Out of 101 TAVI patients, in 10 the procedure was performed without balloon predilatation, and 8 patients were included in the analysis. The procedural, echocardiographic, and clinical outcomes were compared with a case control matched cohort (1: 2 ratio). A 12-month follow-up was done in all cases. The procedure was successfully completed in all patients in the study group (SG), but there was one procedural failure in the control group (CG). All patients received a CoreValve (Medtronic) bioprosthesis. There was a significant immediate decrease in transvalvular gradients (TG) in both study arms after the procedure (SG: mean TG: from 46.0 ±14.0 mm Hg to 10.0 ±4.8 mm Hg, p < 0.001; CG: mean TG: from 55.9 ±12.0 mm Hg to 9.9 ±2.9 mm Hg, p < 0.001). A marked increase in the effective orifice areas was observed in both cohorts (SG: 1.63 ±0.13 cm(2) and CG: 1.67 ±0.25 cm(2), p = 0.75). The periprocedural complication rate was equally distributed in both arms. The 12-month all-cause mortality was 12.5% in both groups. The direct TAVI approach seams to be safe and feasible. The clinical and echocardiographic results are not different from those achieved in patients treated with standard TAVI protocol with pre-dilatation.01/2014; 10(4):250-257.
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ABSTRACT: Background: Data are limited regarding transcatheter aortic valve replacement (TAVR)-related thrombocytopenia (TP). We sought to thoroughly characterize the presence, clinical impact, and severity of TP associated with TAVR. Methods and Results: Data were collected from 90 patients who underwent TAVR using the Edwards SAPIEN valve (59 TF, 29 TA, 2 Tao). Platelet counts were evaluated peri-procedurally and for 8 days following TAVR. Platelet levels were compared and patients were divided into a no TP (No-TP) group 1, acquired (new) TP (NTP) group 2, pre-existing (pre-TAVR) TP (PTP) group 3, and further stratified based on the severity of TP: mild (M) TP (100–149 3 10 3 cell/mL) and moderate–severe (MS) TP (<100 3 10 3 cell/mL). Pre-TAVR point prevalence and post-TAVR incidence of TP were 40% and 79%, respectively (P < 0.001); nadir plate-let count in all groups occurred day 4 post-TAVR. Baseline predictors for developing MS TP in groups 2–3 included baseline TP, leaner body mass, smaller pre-procedural aortic valve area, higher peak aortic jet velocity, and worsening baseline renal function. Development of "major" TP (nadir platelet count <100 3 103 cell/mL, !50% decrease) predicted a higher risk of major vascular complications (OR 2.78 [95% CI, 1.58–3.82]) and major bleeding (OR 3.18 [95% CI, 1.33–5.42]) in group 3. Conclusion: TAVR-related TP is predictable and classification by PTP and TP severity prior to TAVR allows for better risk stratification in predicting in-hospital clinical outcomes. Major TP in the presence of worsening TP is predictable and is associated with worse clinical out-comes. V C 2014 Wiley Periodicals, Inc.Catheterization and Cardiovascular Interventions 09/2014; · 2.51 Impact Factor