Clinical and neurocognitive outcomes after transcatheter aortic valve implantation (TAVI) with cerebral protection: initial experience with a novel dual-filter device in Southeast Asia.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. A novel dual-filter system to reduce cerebral embolism during TAVI recently became available. We aimed to assess the feasibility, safety, and clinical and neurocognitive outcomes of TAVI with cerebral protection in Asian patients. METHODS: 40 consecutive patients undergoing TAVI with cerebral protection were enrolled. All procedures were performed via femoral access using the self-expanding Evolut R/PRO or Portico, or the balloon-expandable SAPIEN 3 bioprostheses. Baseline characteristics, procedural and clinical outcomes were recorded. Cognition was assessed at baseline and 30 days using the abbreviated mental test (AMT). RESULTS: The mean age of the patients (75% male) was 76.4 ± 8.4 years. TAVI was uncomplicated in all patients. The filter device was successfully deployed in 38 (95.0%) patients without safety issues. There was no stroke or death at 30 days, and the survival rate at nine months was 95.0%. There was no overall cognitive change (baseline vs. 30-day AMT: 9.2 ± 1.1 vs. 9.0 ± 1.5, p = 0.12), and only 1 (2.5%) patient developed impaired cognition at 30 days. Patients with a decreased AMT score at 30 days were significantly older than those without (82.1 ± 4.5 vs. 74.4 ± 7.7 years, p = 0.019). All patients with decreased AMT scores were aged ≥ 76 years. CONCLUSION: In this early Asian experience of TAVI under cerebral protection, the filter device was successfully deployed in 95% of patients, with 100% procedural success. There were no filter-related complications and no stroke or mortality at 30 days. Overall cognition was preserved, although increased age was associated with a decline in AMT score.

New set of intravascular ultrasound-derived anatomic criteria for defining functionally significant stenoses in small coronary arteries (results from Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore [IDEAS] study).

We sought to determine the intravascular ultrasound-derived anatomic criteria for functionally significant lesions in small coronary arteries with a reference segment diameter <3 mm. A fractional flow reserve (FFR) of <0.75, as determined by pressure wire using high-dose (100 to 150 microg) intracoronary adenosine, was used as the reference standard for functional significance. For the 94 patients/lesions involved in the present study, the average reference vessel diameter was 2.72 mm. The FFR was <0.75 in 38 patients (40.4%) and > or =0.75 in 56 patients (59.6%). Logistic regression analysis identified the minimal lumen area, plaque burden, and lesion length as the 3 most important determinants of the FFR. Using classification and regression tree analysis, the best cutoff values for these determinants to discriminate a FFR of <0.75 versus > or =0.75 were a minimal lumen area of < or =2.0 mm(2) (sensitivity 82.35%, specificity 80.77%), plaque burden of > or =80% (sensitivity 87.9%, specificity 78.9%), and lesion length of > or =20 mm (sensitivity 63.6%, specificity 78.9%). A significant increase was found in the area under the receiver operating characteristic curve of the combined parameters (minimal lumen area plus plaque burden plus lesion length) compared to the plaque burden (p = 0.014) and other individual parameters (p <0.001). In conclusion, we found that intravascular ultrasound-derived anatomic criteria are able to predict the functional significance of intermediate lesions in small coronary arteries. A minimal lumen area of < or =2.0 mm(2), plaque burden of > or =80%, and lesion length of > or =20 mm predicted a FFR of <0.75 with good sensitivity and specificity.

Procedural success and 30 day outcomes between CYPHER and TAXUS stent implantation for the treatment of bifurcation lesions--a single-center experience.

BACKGROUND: There are fundamental differences between the CYPHER and TAXUS stents, including the drug coatings, polymers and stent platforms. In this registry study, we sought to investigate the procedural success and 30-day outcomes of the patients who were treated with either the CYPHER or TAXUS stents for de novo bifurcation lesions. METHODS: A total of 83 patients with 85 de novo bifurcation lesions treated with either the CYPHER or TAXUS stents from June 2002 to May 2004 were recruited for analysis. RESULTS: True bifurcation lesion, stenosis in both the main vessel and side branch, constituted 39% of the treated lesions. The procedural success was 96% and 93% in CYPHER and TAXUS groups, respectively. Bifurcation stenting was performed in 13% of the overall study population. Two patients each in the CYPHER (8%) and TAXUS (3%) groups had a slight elevation of cardiac enzymes after the procedure. At 30-day follow up, 2 patients in the TAXUS and none in the CYPHER group had subacute stent thrombosis (SAT), leading to myocardial infarction (MI). Urgent target vessel revascularization (TVR) was attempted in these 2 patients, but failed in 1 of them. A total of 6 adverse events (1 stroke, 2 MIs and 3 TVRs) from 4 patients (2 patients with 2 adverse events) in the TAXUS group, and 1 adverse event (TVR) in the CYPHER group were reported. The adverse event rate was slightly, but not significantly, higher in the TAXUS group (7% vs. 4%; p = 1.000). CONCLUSION: Our results suggest that the procedural success and 30-day outcomes were similar in patients who had been treated with either the CYPHER or TAXUS stent for de novo bifurcation lesions. The occurrence of SAT in the TAXUS but not in the CYPHER group warrants further evaluation.