Clinical Outcomes in Patients with Deferred Coronary Lesions according to Disease Severity Assessed by Fractional Flow Reserve

Data on the clinical outcomes in deferred coronary lesions according to functional severity have been limited. This study evaluated the clinical outcomes of deferred lesions according to fractional flow reserve (FFR) grade using Korean FFR registry data. Among 1,294 patients and 1,628 lesions in Korean FFR registry, 665 patients with 781 deferred lesions were included in this study. All participants were consecutively categorized into 4 groups according to FFR: group 1: >/= 0.96 (n = 56), group 2: 0.86-0.95 (n = 330), group 3: 0.81-0.85 (n = 170), and group 4: /= 0.81) deferred coronary lesions. Compared to subjects with ischemic deferred lesions, clinical outcomes in subjects with non-ischemic deferred lesions according to functional severity are favorable. However, longer-term follow-up may be necessary

Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893].

BACKGROUND: Extended systemic lymphadenectomy (D2) is standard procedure for surgical treatment of advanced gastric cancer (AGC) although less extensive lymphadenectomy (D1) can be applied to early gastric cancer. Complete D2 lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC. However, the actual extent of D2 lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station. This study is aimed to develop a consensus for D2 lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D2 gastrectomy. METHODS/DESIGN: This (KLASS-02-QC) is a prospective, observational, multicenter study to qualify the surgeons that will participate in the KLASS-02-RCT, which is a prospective, randomized, clinical trial comparing laparoscopic and open gastrectomy for AGC. Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training, and the gastrectomy metrics of their primary hospitals. All surgeons must submit three laparoscopic and three open D2 gastrectomy videos, respectively. Each video will be allocated to five peer reviewers; thus each surgeon's operations will be assessed by a total of 30 reviews. Based on blinded assessment of unedited videos by experts' review, a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-02-RCT. The primary outcome measure is each surgeon's proficiency, as assessed by the reviewers based on evaluation criteria for completeness of D2 lymphadenectomy. DISCUSSION: We believe that our study for standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC) will guarantee successful implementation of the subsequent KLASS-02-RCT study. After making consensus on D2 lymphadenectomy, we developed evaluation criteria for completeness of D2 lymphadenectomy. We also developed a unique surgical standardization and quality control system that consists of recording unedited surgical videos, and expert review according to evaluation criteria for completeness of D2 lymphadenectomy. We hope our systematic approach will set a milestone in surgical standardization that is essential for surgical clinical trials. Additionally, our methods will serve as a novel system for educating surgeons and assessing surgical proficiency. TRIAL REGISTRATION: NCT01283893

Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes.

Patients still present with drug-eluting stent (DES) failure despite an angiographically successful implantation. The aim of the present study was to investigate the relation between the fractional flow reserve (FFR) measured after DES implantation and the clinical outcomes at 1 year. A total of 80 patients (mean age 62 years, 74% men, 99 DESs) underwent coronary pressure measurement at maximum hyperemia after successful DES implantation. The composite of major adverse cardiac events (MACE), including death, myocardial infarction, and ischemia-driven target vessel revascularization was evaluated at 1 year. The patients were divided into 2 groups (low-FFR group, FFR ≤0.90 and high-FFR group, FFR >0.90) according to the median FFR. The mean poststent percent diameter stenosis was 11 ± 5% in the low-FFR group and 12 ± 3% in the high-FFR group (p = 0.31). Left anterior descending coronary artery lesions were more frequent in the low-FFR group than in the high-FFR group (82% vs 55%, p = 0.02). The mean stent length was greater in the low-FFR group than in the high-FFR group (38 ± 18 vs 28 ± 13 mm, p = 0.01). Six cases (7.5%) of MACE occurred during the 1-year follow-up. The rate of MACE was 12.5% in the low-FFR group and 2.5% in the high-FFR group (p <0.01). Receiver operating characteristic curves revealed 0.90 as the best cutoff of FFR after DES implantation for the prediction of 1-year MACE. In conclusion, a poststent FFR of ≤0.90 correlated with a greater adverse event rate at 1 year