Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents.

BACKGROUND: The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid. METHODS AND RESULTS: Between September 1998 and April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121 ± 17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change. CONCLUSION: Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.

Long-term use of carvedilol in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

BACKGROUND: Despite its recommendation by the current guidelines, the role of long-term oral beta-blocker therapy has never been evaluated by randomized trials in uncomplicated ST-segment elevation myocardial infarction (STEMI) patients without heart failure, left ventricular dysfunction or ventricular arrhythmia who underwent primary percutaneous coronary intervention (PCI). METHODS AND RESULTS: In a multi-center, open-label, randomized controlled trial, STEMI patients with successful primary PCI within 24 hours from the onset and with left ventricular ejection fraction (LVEF) ≥40% were randomly assigned in a 1-to-1 fashion either to the carvedilol group or to the no beta-blocker group within 7 days after primary PCI. The primary endpoint is a composite of all-cause death, myocardial infarction, hospitalization for heart failure, and hospitalization for acute coronary syndrome. Between August 2010 and May 2014, 801 patients were randomly assigned to the carvedilol group (N = 399) or the no beta-blocker group (N = 402) at 67 centers in Japan. The carvedilol dose was up-titrated from 3.4±2.1 mg at baseline to 6.3±4.3 mg at 1-year. During median follow-up of 3.9 years with 96.4% follow-up, the cumulative 3-year incidences of both the primary endpoint and any coronary revascularization were not significantly different between the carvedilol and no beta-blocker groups (6.8% and 7.9%, P = 0.20, and 20.3% and 17.7%, P = 0.65, respectively). There also was no significant difference in LVEF at 1-year between the 2 groups (60.9±8.4% and 59.6±8.8%, P = 0.06). CONCLUSION: Long-term carvedilol therapy added on the contemporary evidence-based medications did not seem beneficial in selected STEMI patients treated with primary PCI. TRIAL REGISTRATION: CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT 01155635.

Risk stratification for major adverse cardiac events and ventricular tachyarrhythmias by cardiac MRI in patients with cardiac sarcoidosis.

BACKGROUND: The presence of myocardial fibrosis by cardiac MRI has prognostic value in cardiac sarcoidosis, and localisation may be equally relevant to clinical outcomes. OBJECTIVE: We aimed to analyse cardiac damage and function in detail and explore the relationship with clinical outcomes in patients with cardiac sarcoidosis using cardiac MRI. METHODS: We included 81 consecutive patients with cardiac sarcoidosis undergoing cardiac MR. Left ventricular mass and fibrosis mass were calculated, and localisation was analysed using a 17-segment model. Participants underwent follow-up through 2015, and the development of major adverse cardiac events including ventricular tachyarrhythmias was recorded. RESULTS: Increased left ventricular fibrosis mass was associated with increased prevalence of ventricular tachyarrhythmias (p<0.001). When localisation was defined as the sum of late gadolinium enhancement in the left ventricular basal anterior and basal anteroseptal areas, or the right ventricular area, it was associated with ventricular tachyarrhythmias (p<0.001). Kaplan-Meier analysis during a median follow-up of 22.1 months showed that both the mass and localisation groupings for fibrosis were significantly associated with major adverse cardiac events or ventricular tachyarrhythmias and that when combined, the risk stratification was better than for each variable alone (p<0.001, respectively). By Cox-proportional hazard risk analysis, the localisation grouping was an independent predictor for the both. CONCLUSIONS: In patients with cardiac sarcoidosis, both fibrosis mass and its localisation to the basal anterior/anteroseptal left ventricle, or right ventricle was associated with the development of major adverse cardiac events or ventricular tachyarrhythmias. Cardiac MR with late gadolinium enhancement may be useful for improving risk stratification in patients with cardiac sarcoidosis.

Novel use of postpacing interval mapping to guide radiofrequency ablation of focal atrial tachycardia with long intra-atrial conduction time.

If the intra-atrial conduction time of a focal tachycardia is prolonged and exceeds the tachycardia cycle length, isochronal electroanatomical maps may be confusing by not showing the classical centrifugal pattern of focal activation. In addressing the hypothesis that by mapping post pacing intervals (PPI), the shortest PPI (ideally identical to tachycardia cycle length) would clearly display the site of origin of a focal tachycardia; this technique was used successfully to identify the origin and ablate the atrial tachycardia of a patient with previously corrected Tetralogy of Fallot.

Bare metal stent implantation in large-sized unprotected left main coronary artery stenosis in the drug-eluting stent era.

Recently, drug-eluting stent (DES) has been recommended as the first choice in those patients who need stent implantation in unprotected left main coronary artery (ULMCA) stenosis. However, the long-term safety and efficacy of this procedure is still controversial. The objective of this study was to evaluate the safety and efficacy of bare metal stent (BMS) implantation in ULMCA stenting in the DES era. We implanted BMS (mainly 4 mm-diameter) in large-sized ULMCA after December 2004 when DES became available. The results of BMS implantation (n = 19) were compared with those of DES implantation (n = 39). There was no significant difference between the 2 groups regarding age, gender and coronary risk factors. Emergency procedures were more frequently performed in the BMS group than in the DES group (53% vs. 26%, p = 0.08). The initial mortality was 10.5% (n = 2) in the BMS group and 2.6% (n = 1) in the DES group (p = 0.25). There was no stent thrombosis, Q-wave myocardial infarction or emergent bypass surgery in either group during their hospital stay. The restenosis rate was 0% (n = 45) in both groups, and the target vessel revascularization rate was 5.9% in the BMS group (1/17) and 2.6% (1/38) in the DES group (p = 0.53). Therefore, there were no statistically significant differences in outcomes between the two study groups. These results indicate that BMS implantation in a large-sized ULMCA may be a safe and effective treatment even in the DES era.

Histopathological findings of new in-stent lesions developed beyond five years.

We analyzed 14 cases of new lesions inside implanted bare-metal stents. In every case, there was no angiographic restenosis within 3 years, but a new lesion was observed inside a stented segment at long-term follow-up (>5 years). Fourteen cases were evaluated: 9 with Wiktor stents, 2 with Palmaz-Schatz stents, and 3 with ACS Multilink stents. The interval from stent implantation to follow-up angiography was 63-147 months (89 +/- 23). Thirteen lesions were treated by percutaneous coronary intervention (PCI) and stenotic tissue was obtained by directional coronary atherectomy (DCA) in 10 cases. All retrieved samples were composed of newly developed atherosclerosis facing the healed neointimal layer, and four samples showed histopathological findings of acute coronary syndrome. Stent struts were retrieved in four cases and no inflammation was observed surrounding them. Qualitative and quantitative analysis of stent struts was performed in two cases that showed no metal corrosion. These findings suggest that new atherosclerotic progression occurred inside the implanted stent without peristrut inflammation.

Successful radiofrequency current catheter ablation of accessory atrioventricular pathway in Ebstein's anomaly using electroanatomic mapping.

Ebstein's anomaly is highly associated with atrioventricular reciprocating tachycardia (AVRT) due to an atrioventricular accessory pathway (AP). This case report describes a case of a 30-year-old man with Ebstein's anomaly who had been suffering from recurrent palpitation caused by AVRT due to the right-sided AP. Conventional mapping technique failed to ablate his AP successfully. In baseline electrophysiological study, orthodromic AVRT with a right posterior AP were induced. The AP was mapped using an electroanatomic mapping system. RF current was successfully delivered at the posterior site. RFCA using an electroanatomic mapping system seems to be useful for A VRT patients in Ebstein's anomaly.