Since all the studies available in the literature were conducted in North America or Europe, the results of percutaneous aortic valve replacement in Asia are unknown. We included 253 patients with severe aortic stenosis who received TAVI at 14 sites in Asia (Edwards Sapiens: 140 patients; Medtronic Core Valve: 113 patients). The success rate was...
The objective was to evaluate the safety and efficacy of the Lotus Valve System to treat patients with severe aortic stenosis and high surgical risk. The study included 60 patients who received the device and were followed during 30 days. Mortality from all causes was 1.7% and the incidence of stroke was 8.6%, with half...
Percutaneous aortic valve replacement (TAVI) is a new treatment option for patients that are inoperable or present a high surgical risk. Some studies have shown that the stroke rate may be higher with TAVI than with medical treatment or surgical replacement. Embolic protection has been used successfully for the carotids, but there is not much...
We evaluated 88 consecutive patients (at this phase) with severe aortic stenosis who received the second-generation device for transapical access. Survival at thirty days was 85.1% with a cardiovascular death rate of 4.8%. No strokes were observed during this period. Average gradient reduction was highly significant, (40.4 to 8.1 mmHg, p <0.001), as well as...
Strokes after TAVI occur in between 3.8 and 6.7% of the cases, with new MRI lesions being almost the rule. The TriGuard EDD device is a nitinol filter covering the origin of the vessels of the neck and held in place with stabilizers. It has a diameter of 9 Fr and is implanted by femoral...
The first generation of the Edwards valve was stainless steel and bovine pericardium with a profile of 22 to 24 Fr for transfemoral access and up to 33 Fr to apical access. From 2010 it became cobalt chromium bovine pericardium with a higher profile, (18-19 Fr for transfemoral and 24-26 Fr for transapical). 2,688 patients...
Lowering blood pressure with renal denervation has been demonstrated in previous studies but unfortunately there was not much data regarding the reduction of clinical events. This study will enroll patients between 40 and 55 years of age with resistant hypertension plus risk factors for major cardiovascular events. A five year follow-up has been planned. The...
This new stent is a sirolimus-eluting low-profile cobalt chrome platform (80 µm) with a rapid resorption polymer (3 months). Theoretically, it presents less risk of inflammation of the vessel due to the kinetics of drug elution and polymer degradation. The objective of this study was to test the safety and efficacy of the new device....
This study is still in progress and includes patients using SYNTAX II score based on functional invasive evaluation with iFR / FFR and performing angioplasty guided by IVUS using the biodegradable polymer everolimus eluting stent. The study seeks to prove superiority versus the first generation paclitaxel-eluting stent and non-inferiority versus surgery using historical data. We...
From the total of 1900 patients in the FREEDOM study, 1248 did not require insulin (631 received angioplasty and 617 received CABG) and 602 if required (325 received angioplasty and 277 received CABG). Insulin dependent patients were more obese, with higher glycosylated hemoglobin, increased incidence of heart failure and increased incidence of acute coronary syndromes....