2011年 · 第124卷第06期

Primary percutaneous coronary intervention (PPCI) is the cornerstone of treatment to reduce infarct size and improve outcomes in patients with ST-elevation myocardial infarction (STEMI).1 The optimal site for initiation of reperfusion strategies is the patient's home or place where the infarction occurs。

Abstract：Background Primary percutaneous coronary intervention (PCI) has been clearly identified as the first therapeutic option for patients with acute ST-segment elevation myocardial infarction (STEMI). The importance of reducing door-to-balloon (D2B) time has gained increased recognition. This study aimed to assess the feasibility, safety and efficacy of the strategy of direct ambulance transportation of patients with acute STEMI to catheterization lab to receive primary PCI.Methods The study population included 141 consecutive patients with chest pain and ST-segment elevation who were admitted to the catheterization laboratory directly by the ambulance and underwent primary PCI (DIRECT group).Another 145 patients with STEMI randomly selected from the PCI database, were served as control group (conventional group); they were transported to catheterization laboratory from emergency room (ER). The primary endpoint of D2B time,and secondary endpoint of in-hospital and 30-day major adverse cardiac events (MACE, including death, non-fatal reinfarction, and target vessel revascularization) were compared.Results Baseline and procedural characteristics between the two groups were comparable, except more patients in the DIRECT group presented TIMI 0-1 flow in culprit vessel at initial angiogram (80.1% and 73.8%, P=0.04). Comparing to conventional group, the primary endpoint of D2B time was reduced ((54±18) minutes and (112±55) minutes, P ＜0.0001)and the percentage of patients with D2B ＜90 minutes was increased in the DIRECT group (96.9% and 27.0%, P＜0.0001).The success rate of primary PCI with stent implantation with final Thrombolysis in Myocardial Infarction (TIMI) 3 flow was significantly higher in the DIRECT group (93.8% and 85.2%, P=0.03). Although no significant difference was found at 30-day MACE free survival rate between the two groups (95.0% and 89.0%, P=0.06), a trend in improving survival status in the DIRECT group was demonstrated by Kaplan-Meier analysis.Conclusion Direct ambulance transport of STEMI patients to the catheterization laboratory could significantly reduce D2B time and improve success rate of primary PCI and 30-day clinical outcomes。

Abstract：Background Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently,investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.Methods A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group:156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤40 mm,reference vessel diameter 2.25-4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years,including major adverse cardiac events (cardiac death,myocardial infarction, or target-lesion revascularization) and stent thrombosis.Results Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25±0.33) mm vs. (0.57±0.55) mm, diff (95% CI)-0.23 (-0.32, -0.14), P ＜0.0001; in-segment (0.25±-0.33) mm vs. (0.42±-0.55) mm, diff (95% CI) -0.13 (-0.23, -0.02),P=0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P=0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P=0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P=0.1630).Conclusions TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years.The MACE rate at 2 years was comparable in both groups。

Abstract：Background Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.Methods The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.Results Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up,including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21±0.40) mm in-segment and (0.23±0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.Conclusions The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)

Abstract：Background Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aimed to investigate the impact of DES, in comparison with BMS, on the 2-year clinical outcomes in patients with ST-elevation myocardial infarction (STEMI).Methods From January 2002 to December 2008, a total of 1301 consecutive STEMI patients treated with coronary stenting in Shenyang Northern Hospital were prospectively registered. Patients received BMS (n=868) or DES (n=435) implantation in the infarction related artery according to physician's discretion. A propensity score analysis was performed and two well matched subgroups were selected (BMS, n=288; DES, n=288) to evaluate the 2-year clinical outcomes. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, myocardial infarction (MI), or target vessel revascularization (TVR).Results Survival salvage analysis showed that 2-year cumulative hazards were not significantly different between the two groups with respect to TVR (2.8% vs. 3.1%, log-rank P=0.780), stent thrombosis (1.7% vs. 4.2%, log-rank P=0.079) and MACE (8% vs. 10.8%, log-rank P=0.236). Multivariate analysis showed that DES was an independent protective factor of MI (HR: 0.211, 95% CI: 0.049 to 0.908) and stent thrombosis (HR: 0.327, 95% CI: 0.107 to 0.994).Conclusion DES was associated with similar 2-year clinical outcomes to those of BMS for the treatment of STEMI in daily practice。

Abstract：Background The Firebird 2TM sirolimus-eluting stent (Firebird 2 stent) is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2TM cObalt-Chromium alloy sirolimus-elUting Stent registry (FOCUS registry) aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.Methods The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry.Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.Results Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events (MACE) was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction (MI), and 6 target vessel revascularization (TVR). At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis (ST) occurred in 0.43% (22/5058) of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.Conclusion The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases。

Abstract：Background The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent (BSES) in vivo remained unclear.Methods Forty-one patients were enrolled in this study and virtual histology intravascular ultrasound (VH-IVUS) was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES (DSES) during long-term follow-up (median: 8 months). The incidence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss (0.15 mm (0.06-0.30 mm) vs. 0.19 mm (0.03-0.30 mm), P=0.772), the overall incidence of necrotic core abutting to the lumen was significantly less in BSES group than in DSES group (44% vs.63%, P ＜0.05) (proximal 18%, stented site 14% and distal 12% in BSES group, proximal 19%, stented site 28% and distal 16% in DSES group). The DSES-treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts (73% vs. 36%, P ＜0.01). In addition, more multiple necrotic core abutting to the lumen was observed in DSES group (overall: 63% vs. 36%, P ＜0.05). Furthermore, when the stented segments with necrotic core abutting to the lumen had been taken into account only, DSES-treated lesions tended to contain more multiple necrotic core abutting to the lumen through the stent struts than BSES-treated lesions (74% vs. 33%), although there was no statistically significant difference between them (P=0.06).Conclusions By VH-IVUS analysis at follow-up, a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs. The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on DES surface biodegraded as time went by。

Abstract：Background The role of plasma high sensitivity C-reactive protein (hs-CRP) in in-stent restenosis (ISR) remains controversial. We investigated plasma hs-CRP level at both admission and follow-up in patients with stable angina (SA)after successful coronary stenting in order to clarify the predictive value of hs-CRP for ISR.Methods We summarized 303 consecutive chronic SA patients with coronary drug-eluting stent (DES) implantation.The ISR was analyzed by quantitative coronary analysis (QCA) at a mean follow-up of 8 months, and the patients were divided into two groups according to the detected ISR as ISR group (n=48) and non-ISR group (n=255). Plasma hs-CRP was examined at both admission and 8-month follow-up in all patients, standard medication continued throughout the investigation period.Results QCA presented that 48 patients (15.8%) suffered from ISR at follow-up. The basic clinical characteristics were similar between the two groups, while plasma hs-CRP was higher in ISR group than that in non-ISR group at both admission and follow-up, P ＜0.001 respectively. Multivariate regression analysis indicated that plasma hs-CRP level at either admission or follow-up could independently predict ISR occurrence (OR=5.581, 95% Cl 2.532-12.302, P＜0.001and OR=6.299, 95% CI 2.722-14.577, P ＜0.001, respectively).Conclusions Our data indicate that plasma hs-CRP level may independently predict ISR at both admission and follow-up in SA patients with coronary DES implantation, which implies that a chronic, sustained systemic inflammatory response might be involved in ISR pathogenesis。

Abstract：Background The conventional thoracic endovascular aortic repair (TEVAR) involves groin incisions under general or epidural anesthesia. As technology moves towards less invasive procedures, a total percutaneous approach is desirable.In this study, we describe a Preclosing technique and investigate its safety and efficacy for femoral access sites management, and evaluate its advantages as compared to those of traditional surgical cutdown approaches.Methods The Preclosing technique involves two or multiple 6 F Perclose Proglide devices deployed in the femoral artery before upsizing to a 20-25 F sheath. The sutures were secured to close the arteriotomy at the end of the procedure. The medical records of patients who underwent thoracic endovascular aortic repairs using the Preclosing technique between December 2009 and November 2010 (group A) were compared with those using surgical femoral cutdown from January 2008 to November 2009 (group B). Outcome measures included rates of technical success, early complications, anesthesia method, procedure time, cardiac care unit (CCU) stay, time from procedure to discharge,hospital stay, procedure expense, hospital cost.Results Between the two groups, there were no significant differences in baseline characteristics, in the endograft models or profiles. The technical success rate was 100.0% (85/85) in group A vs. 97.4% (147/151) in group B (P ＜0.05).There was no access-related mortality in both groups. Compared with group B, the incidence of early complications were fewer in group A, 9.4% (8/85) vs. 22.5% (34/151) (P ＜0.01). Local anesthesia with conscious sedation was used more often in group A, 68.2% (58/85) vs. 51.7% (78/151) in group B (P＜0.01). The procedure duration was shorter, (96±33)minutes in group Avs. (127±41) minutes in group B (P＜0.01). The length of the CCU stay, the duration from procedure to discharge, and the hospital stay were both reduced in group A, (117.3±88.3) hours, (7.5±5.3) days and (15.3±6.8) days vs. (132.7±115.5) hours, (10.5±5.0) days and (19.5±7.8) days in group B (P＜0.01). The procedure cost was RMB (109 000±30 000) Yuan in group A vs. RMB (108 000±25 000) Yuan in group B (P=NS). The hospital cost was RMB (130 000±35 000) Yuan in group A vs. RMB (128 000±33 000) Yuan in group B (P=NS).Conclusions Total percutaneous TEAVR with the Preclosing technique is safe and effective with meticulous technique and appropriate patient selection. The Preclosing technique decreases access-related complications, depends less on general anesthesia and the surgeon's cooperation, saves procedure time and shortens the CCU/hospital stay. With these advantages, the use of two percutaneous closure devices increases the hospital cost only slightly。

Abstract：Background Omeprazole, usually used in the antiplatelet therapy during percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS), has been reported to increase ischemic events in retrospective studies. However, other clinical trials gave paradoxical results. The aim of this study was to assess the effects of omeprazole on clopidogrel efficacy and clinical events.Methods All patients (n=172) received aspirin (loading dose 300 mg and maintenance dose 100 mg/d) and clopidogrel (loading dose 600 mg and maintenance dose 75 mg/d) during the therapy. They were randomized to receive omeprazole (20 mg/d) or placebo for 30 days. Residual platelet activities in the adenosine 5'-diphosphate (ADP) pathway were detected on the fifth day after PCI with thrombelastography (TEG)-mapping. The clinical events were recorded after one month.Results According to the five levels of platelet activities, the frequency distributions of the inhibition rates were significantly different (P=0.0062). However, no significant change was seen in the distribution among the highest or the lowest inhibiting levels (＞95% and ＜30% inhibition rate). And there were no significant differences (P ＞0.05) in events incidence, while gastra-intesternal bleeding decreased in co-administration of omeprazole.Conclusions Omeprazole significantly blunts clopidogreal efficacy while not exacerbates ischimic events in ACS undergoing PCI. Omeprazaole even can decrease gastra-intestinal bleeding in those patients。

Abstract：Background Prior studies have demonstrated worse results of women in both hospital and short-term outcomes post-percutaneous coronary intervention. However, with advanced devices like drug-eluting stents (DESs) available,there are no consistent data revealing gender impact in outcome. This study examined whether gender affected hospital outcome and showed one-year single-center patient results of coronary stenting.Methods The study group included 969 consecutive patients (250 women and 719 men) undergoing coronary stenting for stable or unstable angina. Clinical events were assessed for at least 1 year post-procedure.Results Compared to men, women were older, presented more often with diabetes, hypertension, dyslipidemia, and lower creatinine clearance rate (Ccr); they had less percutaneous transluminal coronary angioplasty (PTCA) history,smaller vessel size, and shorter lesions. The hospital major adverse cardiovascular event (MACE) rate was 2.8% of women and 0.97% of men (P=0.037). The one-year MACE rate was 10.0% of women and 10.4% of men (P=0.874). After adjusting other covariates, women still had significantly higher hospital MACE rates (P=0.034) and odds ratios (0.18;95% confidence interval: 0.036-0.874). In women (n=250), there was no statistically significant difference in hospital or one-year MACE between bare metal stent (BMS) and DES groups. Meanwhile, in men (n=719), DES had a significant one-year improvement of MACE compared to BMS (P=0.004). The female hospital MACE rate was five times greater than male results. However, there were similar one-year outcomes between women and men. DES currently have an advantage in long-term outcome.Conclusions Currently, with the use of BMS and DES, adverse hospital post-procedure cardiovascular event rate has occurred more often in women than in men. However, the MACE rate differences between women and men resolved with one year follow-up。

Abstract：Marfan syndrome is a systemic disorder of connective tissue, caused by mutations in the FBN1, TGFBR1 or TGFBR2 genes. This syndrome is characterized by involvement of three major systems, skeletal, ocular, and cardiovascular. The continuing improvements in molecular biology and increasing availability of molecular diagnosis in clinical practice allow recognition of Marfan syndrome in patients with incomplete phenotypes. Additionally, molecular analyses could also be used for preimplantation genetic diagnosis. The identification of a mutation allows for early diagnosis, prognosis, genetic counseling, preventive management of carriers and reassurance for unaffected relatives. The importance of knowing in advance the location of the putative family mutation is highlighted by its straightforward application to prenatal and postnatal screening。

Abstract：Up till 2000 when Edmonton group introduced islet transplant procedure in conjunction with a novel glucocorticoid-free immunosuppressive regimen rendering 100％ (n=7) of patients with type 1 diabetes insulin-independent for at least 1 year, islet transplant was taken into the clinic. Although significant progress in clinical islet transplant has occurred during recent years, challenges remain, including shortage of available donor organs, technical aspects of islet preparation and transplantation, immunological rejection post-transplant, unclear long-term outcomes of islet transplantation. Special attention is given to current limitation in islet transplantation together with new possible strategies that raise expectations for the widespread use of islet transplantation in the future。

Abstract：Background StentBoost (SB) is a novel angiographic technique which can enhance stent visualization and improve detection of inadequate stent expansion. Studies of SB that compare it with intravascular ultrasound (IVUS), which is the current gold standard for detection of stent underexpansion, remain inadequate. This study aimed to test the correlation of IVUS and SB, and to evaluate the effect of SB guiding the stent postdilatation.Methods From March 2009 to June 2010, 52 patients were analyzed using quantitative coronary angiography (QCA),IVUS, and SB. They included 37 patients (54 stents) with postdilatation and 15 patients (21 stents) without postdilatation.Correlations of stent diameter between the three modalities were determined.Results The minimum diameter, maximum diameter and average diameter of postdilatation obtained by QCA, IVUS,SB were significantly larger than that of poststenting, and the ratio (maximum stent diameter (MaxLD)-minimum stent diameter (MinLD))/MaxLD of postdilatation was smaller. Correlations of MinLD were the highest between IVUS and SB (r=0.979, P ＜0.0001) when compared with QCA and SB (r=0.973, P ＜0.0001), and QCA and IVUS (r=0.964, P ＜0.0001).Conclusions SB has superior correlations for stent expansion measured by IVUS when compared with QCA. In addition, there is an important advantage for SB in guiding the stent postdilatation。

Abstract：Background Balloon dilatation angioplasty is a minimally invasive surgery for treating benign ureteral stricture. The aim of this study was to investigate the effect of placing double J (D-J) stents using high-pressure balloon angioplasty in treating benign ureteral stricture.Methods A total of 42 patients (48 cases) with benign ureteral stricture (42 had benign ureteral stricture) were investigated by inserting dual D-J stents using high-pressure balloon angioplasty. The control group contained 50 patients (57 cases) employing the conventional balloon angioplasty with a single D-J stent inserted for comparison.Results The overall effective rate of the treated and control groups was 87.8％ (36/41) and 62.7％ (32/51), respectively (P ＜0.05).Conclusion This new approach produces a better curative effect than the conventional balloon angioplasty with a single D-J stent insertion in treating benign ureteral stricture。

Abstract：This study is designed to serve as a reference for the establishment of health security systems for children's critical diseases. Through analysis of the operation of Shanghai Children Hospital Care Aid (SCHCA), this study explored the financing model and management of a children's critical disease healthcare system and analyzed the possibility of expanding this system to other areas. It is found that a premium as Iow as RMB 7 per capita per year under SCHCA can provide high-level security for children's critical diseases. With the good experience in Shanghai and based on the current basic medical insurance system for urban residents and the new rural cooperative medical scheme (NRCMS), it is necessary and feasible to build a health security system for children's critical diseases at the national level。

Abstract：A 10-year-old boy who had previously undergone surgical correction for tetralogy of Fallot was referred for cardiac catheterization because of recurrent symptomatic postoperative heart failure owing to major aortopulmonary collateral arteries (MAPCAs). A successful occlusion of these MAPCAs was achieved percutaneously using the Amplatzer vascular plug and a detachable coil. Transcatheter occlusion of MAPCAs after surgical correction is an effective method for treatment of post-operative heart failure。

Abstract：Technologies associated with cardiac resynchronization therapy (CRT) devices and lead systems have progressed.However, dislocation after coronary sinus (CS) lead placement continues to be a problem. We reported on the patient treated with CRT, in whom dislocation of CS lead occurred. In the case, we tried to reposition the CS lead without the left heart delivery system only using pre-shaped stylet and guidewire, and the dislocated CS lead could be successfully repositioned by the method. The method of only using a pre-shaped stylet and guidewire is easier than the conventional way, and it can shorten procedure duration and fluoroscopy time, as well as reduce the cost of treatment, but it is not always feasible。

Abstract：This case report we presented is that the anomalous left main coronary artery (LMCA) originates from the proximal segment of right coronary artery. In order to confirm the origin and course of the anomalous LMCA, a multi-slice computed tomography (MSCT) of the heart was performed on a 64-slice machine (Philips 64 Slice, Philips, USA) after 6 months of coronary angiography operation. The results showed that the anomalous LMCA originates from the proximal segment of right coronary artery, lies posteriorly to the aorta before taking acute sharply to go between the aorta and left atrium. It was classified as R-Ⅱ P subtype according to Lipton's classification. It is a rare case in the clinical practice。

Abstract：Severe tricuspid regurgitation with permanent pacemaker wire passing through the orifice of bioprosthetic tricuspid valve is extremely rare. We present a case of such kind of patient and redid bioprosthetic tricuspid valve replacement. A hawk mouth forceps for bone surgery was used to cut off the mental ring of ruined bioprosthetic tricuspid valve and the ruined valve was removed. A new bioprosthetic tricuspid valve was implanted and the wire of permanent pacemaker was left outside the ring of bioprosthetic tricuspid valve. This method may be helpful for such kind of patient。