Effects of intracoronary low-dose prourokinase administration on ST-segment elevation in patients with myocardial infarction and a high thrombus burden: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of low-dose prourokinase (pro-UK) administration during primary percutaneous coronary intervention (PCI) for the treatment of acute ST-segment elevation myocardial infarction (STEMI) in patients with a high thrombus burden. METHODS: A prospective, randomized controlled trial was conducted at the Inner Mongolia People's Hospital, China. Patients with STEMI and a high thrombus burden who underwent thrombus aspiration and primary PCI were randomly allocated to pro-UK administration or control groups. The primary endpoint was corrected thrombolysis in myocardial infarction (TIMI) frame count (CTFC). RESULTS: There were no significant differences in the baseline demographics or clinical characteristics of the two groups. The CTFC, tissue myocardial perfusion grade, ST-segment resolution, and myocardial blush grade of the pro-UK group were significantly better than those of the control group. In addition, after 30 days of follow-up, the pro-UK group had better cardiac function and perfusion than the control group. There were no differences in the clinical outcomes or incidence of hemorrhage. CONCLUSIONS: Intracoronary low-dose pro-UK improves myocardial perfusion and cardiac function in patients with a high thrombus burden. Major hemorrhages still occur in patients administered pro-UK, but are no more frequent.Study registration: Chinese Clinical Trial Registry (ChiCTR1900022290).

ECG-guided PICC insertion using a new silicon catheter with a conductive tip: A retrospective clinical study.

OBJECTIVE: Safety and efficacy of ECG-guided PICC insertion using a new silicon catheter with a conductive tip was evaluated in daily practice. METHODS: A retrospective study was conducted on 1659 patients who accepted successful tip-conductive PICC placement and clinically followed-up until the catheter removal between January 2018 and April 2019. Baseline of patient characteristics, catheter placement characteristics, date of dressing changes as well as records of catheter-related complications were extracted from a special designed mobile APP. RESULTS: The first-attempt success (success of placing catheter tip to the ideal position by primary indwelling operation) rate of PICC placement was 99.3%. The average duration of PICC placement was 128.7 ± 39.5 days and 1535 patients (92.5%) reached the therapy end-point without any complications and removed the catheter normally. The cumulative rates of total complications were 7.5%, including exit site infection (2.5%), phlebitis (0.9%), DVT (1.0%), catheter malposition (1.1%), catheter breakage (0.1%), and liquid extravasation (1.8%). In multivariable logistic regression analyses, hyperlipidemia, diabetes mellitus, lung cancer, stomach cancer, and lymphoma were significantly associated with increased risk of complications, as the independent risk factors. CONCLUSIONS: This retrospective clinical study demonstrates that ECG-guided insertion of a new tip-conductive PICC is associated with a high rate of first-attempt success and low rate of catheter related complications.

New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction　- A Prospective Randomized Trial.

BACKGROUND: Application of drug-coated balloons (DCBs) is popular for the treatment of percutaneous coronary intervention (PCI). A new DCB has been designed as ultrasound-controlled paclitaxel releasing. This study was conducted to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary ST-elevation myocardial infarction (STEMI) patients, as well as determine the efficiency and safety of this new DCB.Methods and Results:Overall, 184 pretreated STEMI patients were randomized into DCB and DES groups with a 1:1 allocation. The main study end-point was late lumen loss (LLL) during the 9 months after PCI. Late lumen loss was reported to be 0.24±0.39 mm in the DCB group and 0.31±0.38 mm in the DES group (P=0.215). Diameter stenosis was 28.27±15.35% in the DCB group and 25.73±15.41% in the DES group (P=0.312). Major adverse cardiovascular events (MACEs) were reported in 3 patients (3.4%) in the DCB group and 4 patients (4.7%) in the DES group (P=0.718). TLR and TVR in the DCB group was 2.3%, 3.4% and 2.4%, 3.5% in the DES group (P=1.000), respectively. No cardiac death and stent thrombosis (ST) was found in the DCB group at 12 months clinical follow up. CONCLUSIONS: The DCB-only strategy showed good angiographic and clinical outcomes in the 9- and 12-month follow-up periods, respectively. The VasoguardTM DCB is safe and feasible to treat STEMI patients.

Randomized multicenter study on long-term complications of peripherally inserted central catheters positioned by electrocardiographic technique.

BACKGROUND: The intracavitary electrocardiogram (IC-ECG) method has been used for the tip location of central venous access devices for the advantage of being safe, accurate and highly cost effective. However, long-term follow-up is rare. This randomized clinical trial aimed to evaluate the long-term complications of peripherally inserted central catheters (PICCs) positioned by the IC-ECG method. METHODS: We randomized 2250 patients who needed PICC placement to either a landmark length estimation supplemented by IC-ECG positioned group (ECG group) or the traditional landmark length estimation alone group (control group) in a 2:1 allocation. Post-procedural chest X-rays were applied to confirm tip position. Follow-up was performed monthly to six months. Standard statistics analyses were performed with the SAS 9.13 software, and p < 0.05 was considered significant. RESULTS: As evaluated by post-procedural chest X-ray, tip location in the ECG group had a first-attempt success (catheter tip located at optimal position) of 91.7% (95% confidence interval (CI): 90.3%-93.1%), significantly higher than 78.9% (95% CI: 76.0%-81.9%) observed in the control group (p < 0.001). At six-month follow-up, in the control group, frequency of total complications was 9.5%, including the exit site infection (4.0%), phlebitis (1.3%), deep venous thrombosis (1.5%), liquid extravasation (2.9%) and mechanical failure (1.9%). The IC-ECG group had significantly lower rates of complications (6.4%, p < 0.001), including the exit site infection (2.7%, p > 0.05), phlebitis (1.1%, p > 0.05), deep venous thrombosis (1.2%, p > 0.05), liquid extravasation (2.4%, p > 0.05) and mechanical failure (1.2%, p > 0.05). In the univariable logistic regression analysis, ECG method, other diseases and upper arms were the independent protective factors, and the number of adjustment procedures (n ≥ 2) were the independent risk factors of the complications. CONCLUSIONS: The intra-procedural tip location by IC-ECG is more safe and accurate than the traditional method of verifying tip location only post-procedurally, by chest X-ray.

Safety and efficacy of leadless pacemaker retrieval.

BACKGROUND AND OBJECTIVES: The success rate of leadless cardiac pacemaker (LP) retrieval remains a major concern for this disruptive technology. The present paper performed a systematic review of the safety and feasibility of the retrieval of LPs. METHODS: Primary publications that performed LP retrieval were collected and included five animal experiments and two worldwide retrieval experiences in human. The procedural details, such as indication, days post implantation, extraction success rate, and complications, were described. The present paper analyzed factors affecting the retrieval and management of the nonfunctional devices. RESULTS: Retrieval animal models was possible at least up to 2.5 years post implantation, and data from humans suggest that removal of a device that was implanted longer (eg, 4 years and 9 months for Nanostim; 4 years for Micra) could be performed within a reasonable safety profile. The fixed mechanism, implant site, and encapsulation of the LP systems may affect the retrieval process. CONCLUSIONS: A high success rate in the relatively chronic retrieval of LPs was demonstrated, which promotes the extensive use of these devices in the treatment arrhythmia in the future.

Radiofrequency Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation: Meta-analysis of Safety and Efficacy.

BACKGROUND: Radiofrequency ablation (RFA) and antiarrhythmic drugs (AADs) are the main treatments used for atrial fibrillation (AF). In recent years, a number of articles comparing the 2 treatments have begun to emerge. Though, the influence of follow-up time in the meta-analysis was not considered in these articles. However, more recently, large-scale clinical trial articles have included follow-up with the patients up to 5 years after treatment. Therefore, the aim of this study was to assess the impact of variable follow-up times on the recurrence of AF by observing both the short-term and long-term efficacy and safety of catheter ablation and AADs for the treatment of AF. METHODS AND RESULTS: The primary investigators of eligible randomized controlled trials were invited to contribute standardized outcome data. Random effect summary estimates were calculated as standardized mean differences and odds ratios with 95% confidence intervals for continuous and binary outcomes. In this study, 9 randomized controlled trials (n = 1542 patients) were included. The rate of recurrence of AF with no limit on follow-up time, >12 months, >18 months, >24 months, >30 months, and approximately 36 months was compared. Furthermore, the gap between the RFA and AAD groups in the recurrence rate of AF was found to decrease inversely to follow-up time. When the follow-up time reached 24 months, the difference between RFA and AAD was relatively stable with an odds ratio of 0.45 (95% confidence interval: 0.32-0.62). Overall, RFA decreased adverse events in the remaining trials; however, AAD performed better in terms of safety and had fewer adverse events with RFA usually causing more serious complications. CONCLUSION: RFA is more advantageous in terms of recurrence rate of AF than drug therapy. In addition, the analysis suggests that this effect persists during long-term follow-up; however, these benefits appear to decrease with longer follow-up time. Finally, AAD performed better in terms of safety and had fewer adverse events.

Meta-analysis of the incidence of lead dislodgement with conventional and leadless pacemaker systems.

INTRODUCTION: Leadless cardiac pacemaker (LCP) implantation using a transcatheter was recently developed to avoid pocket- and lead-related complications. Although a LCP has an active fixation mechanism using tines or a helix, LCP and lead dislodgement issues remain a major safety concern for patients. This article reviews the literature to determine the incidence of lead and LCP dislodgement. METHODS AND RESULTS: A total of 18 studies which included 17,321 patients undergoing conventional single- or dual-chamber pacemaker implantation and three studies which included 2,116 patients undergoing LCP device implantation were reviewed. The incidence of lead dislodgement ranged from 1% to 2.69% in individual studies with a mean of 1.63%, weighted mean of 1.71%, and median of 1.60 %. There was a relatively higher lead dislodgement rate between atrial and ventricular electrodes (odds ratio [OR], 3.56; 95% confidence interval [CI], 1.9-6.70; P  =  0.6; I2   =  0%), and between magnetic resonance imaging conditional and conventional leads (OR, 2.79; 95% CI, 1.30-5.99; P  =  0.16; I2   =  46%). The use of active fixation leads (OR, 1.06; 95% CI, 0.66-1.70; P  =  0.29; I2   =  20%) showed no significant difference in dislodgement risk compared to passive fixation leads. The incidence of LCP device dislodgement was 0%, 0.13%, and 1% in three leadless pacemaker studies. CONCLUSIONS: The incidence rates of conventional pacemaker lead dislodgement vary in individual studies with an overall high incidence. Use of the currently available LCP systems appears to result in a lower rate of device dislodgement. This may reflect the effectiveness of this novel technology and the fixation design of LCP devices.