| Background and Objective:Coronary heart disease (CHD) is the main cause of death in western countries, which caused 0.49 million deaths in the United States in 2001. According to the World Health Organization (WHO) MONICA research report, over the past decade, the highest average incidence of CHD was male in Finlandt, women in UK, and the lowest average incidence of CHD was male in China, women in Spain. With the acceleration of globalization, the improvement of people’s living condition, physical activity, weight gain and high fat diet increases, the incidence of coronary heart disease also increases gradually in our country.Coronary artery chronic occlusion lesions (CTO) is a kind of clinical common complex coronary artery lesions, which defined as complete obstruction of a native coronary artery with TIMI flow grade 0 and more than 3 months duration of coronary occlusion, estimated from clinical events including myocardial infarction (MI), sudden onset or worsening of the symptoms, or proved by previous angiography. Despite the expertise of the operator and the development of novel interventional devices, chronic total occlusion (CTO) remains the most challenging lesion subset in percutaneous coronary intervention (PCI). Failure to cross with a wire is the most common mode of CTO PCI failure, but inability of a balloon across even after successful wire passing accounts for 10%-15% of all procedure failures. Successful CTO PCI is associated with improved cardiac symptoms, exercise tolerance, survival, and reduced major adverse cardiac events (MACEs) compared with unsuccessful CTO PCI.The Crusade catheter (Kaneka) is a double-lumen multifunctional probing microcatheter, which was initially designed with the major purpose of managing bifurcation lesions. The guidewire in the monorail lumen protruding from the end helps to stabilize the microcatheter, while the guidewire in the over-the-wire (OTW) lumen protruding from the side hole can be directed toward the ostium of the intended branch. Thus, this device provides adjunctive support in getting catheters into the desired position. However, considering the possible role in CTO PCI, we evaluate the efficacy of Crusade in patients with CTO and summarize our experience in this study.Subjects and Methods:1. Patients PopulationWe have initiated this novel guidewire approach for handling CTO lesion with Crusade since November 1,2013. Consecutive patients in Bethune international peace hospital who underwent PCI for at least one CTO lesion with Crusade between November 1,2013 and October 31,2014 were enrolled in this retrospective cohort study. The same numbers of consecutive patients who underwent PCI for CTO with conventional guidewire approach before November 1,2013 were enrolled as the control cohort.2. Inclusion and exclusion criteriaThe patients enrolled in our study must fulfill the following inclusion criteria:(1) A diagnosis of CTO, which defined as complete obstruction of a native coronary artery with TIMI flow grade 0 and more than 3 months duration of coronary occlusion, estimated from clinical events including myocardial infarction (MI), sudden onset or worsening of the symptoms, or proved by previous angiography; (2) undergoing PCI with Crusade or conventional approach; and (3) were continuously enrolled. Moreover, those CTO lesions revealed by angiography without PCI attempts were excluded. For all patients, informed written consent was obtained from their parents or relatives before the procedure.3. Procedure and Outcome MeasurementsWhen guidewire technique with conventional microcatheter failed to cross the CTO lesion or an available smallest profile balloon (1.20mm in balloon diameter) failed to cross the CTO lesion after successfully delivered by guidewire, the Crusade microcatheter could be used for further attempt in Crusade cohort; the guidewire in the monorail lumen protruding from the end could facilitate stabilizing the microcatheter, while the guidewire in the OTW lumen protruding from the side hole could be tried to cross the lesion or crush the plaque inside the occluded segment, and then the CTO lesion was loosened and the gap was made by the microcatheter, so that the smallest balloon could cross the lesion successfully.The primary endpoint in this study was success of the procedure defined as recanalization of the artery (percutaneous transluminal coronary angioplasty, PTCA or stents implantation). Data were collected regarding patients’baseline characteristics and comorbid conditions (age, sex, admission diagnosis, cardiac function, diabetes and hypertension, etc), angiography characteristics (included J-CTO score) and procedure characteristics.4. Statistical AnalysisDescriptive statistics were generated including the outcome rates in Crusade study cohort and control cohort, and distributions of baseline characteristics. Baseline characteristics were compared between the two cohorts by Student t test or Wilcoxon rank sum test as appropriate for continuous variables, and chi-square test or Fisher’s exact test as appropriate for categorical variables. Statistical analyses were performed using SPSS for Windows, version 16.0 (Statistical Package for the Social Science Inc., Chicago, II, USA). In all analyses, p values were considered statistically significant at<0.05 level.Result:1. Patients and Procedural CharacteristicsWe identified a study cohort of consecutive 120 patients who underwent PCI for at least one CTO lesion with Crusade and a control cohort of consecutive 120 patients who underwent PCI for CTO with conventional guidewire approach at our institution. The mean age of the cohort was 61.75 years (standard deviation [SD] 9.96), and 179 (74.58%) were male. There were no statistically significant differences in baseline characteristics between the two cohorts. Most of all included patients had tough CTO defined as difficult with J-CTO score≥2 (86.7% in Crusade study cohort and 85.8% in control cohort, respectively). The average of J-CTO score is 2.53±0.94 in Crusade study cohort and 2.52±0.99 in control cohort, respectively. Antegrade approach (90.83% in Crusade study cohort and 95.00% in control cohort, respectively) was often performed in this study.2. Procedural success rate analysisProcedural success for CTO PCI was achieved in 111 of 120 (92.50%) patients representing 131 CTO lesions in Crusade study cohort and 99 of 120 (82.50%) patients representing 132 CTO lesions in control cohort, respectively. In patients where>1 CTO lesion was attempted, procedural success was defined as the successful treatment of at least 1 CTO lesion. Success rate of Crusade study cohort were much more than that of control cohort (OR:2.33,95% CI 1.05 to 5.20). In Crusade study cohort, there were 5 cases that an available smallest profile balloon failed to cross the CTO lesion after successfully delivered by guidewire, but success was achieved in all of these cases at last by Crusade assisted parallel wire plaque crushing. Duration of the procedures in Crusade study cohort was shorter than that in control cohort (74.38±32.20min vs.89.97±55.34min, p=0.008), and radiation exposure in Crusade study cohort was also less than that in control cohort (2603.10±1127.04mGy vs.3148.80±1936.73mGy, p=0.008). No coronary perforation and pericardial tamponade occurred during PCI procedure in the two cohorts.Subgroup analyses were performed according to some mixed factors. Patients who were female, with a history of previous PCI or previous MI seemed to be more successful (OR:6.67,95% CI 1.32 to 33.69, OR:5.29,95% CI 0.56 to 50.08 and OR: 3.57,95% CI 1.27 to 9.92, respectively).Conclusion:The guidewire approach with Crusade has a higher success rate in CTO PCI without increases in procedural complications and radiation exposure. |
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