Regional Disparities in Transvenous Lead Extraction for Cardiac Implantable Electronic Device Infection in Japan　- A Descriptive Study Using the National Database Open Data.

BACKGROUND: Because the penetration of transvenous lead extraction (TLE) for cardiac implantable electronic device (CIED) infection has not been investigated in Japan, we conducted a population-based, retrospective, descriptive study to evaluate regional disparities in the use of TLE for CIED infection and the potential undertreatment of CIED infection using a nationwide insurance claims database.Methods and Results: Patients who underwent CIED implantation or generator exchange and TLE between April 2018 and March 2020 were identified. Moreover, the penetration ratio of TLE for CIED infection in each prefecture was estimated. CIED implantation and TLE were most prevalent in the age categories of 80-89 years (40.3%) and 80-89 years (36.9%), respectively. There was no correlation between the number of CIED implantations and that of TLE (rho=-0.087, 95% confidence interval -0.374 to 0.211, P=0.56). The median penetration ratio was 0.00 (interquartile range 0.00-1.29). Of the 47 prefectures, 6, comprising Okinawa, Miyagi, Okayama, Fukuoka, Tokyo, and Osaka, showed a penetration ratio ≥2.00. CONCLUSIONS: Our study data indicated great regional disparities in the penetration of TLE and potential undertreatment of CIED infection in Japan. Additional measures are needed to address these issues.

Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices.

A Glidesheath slender (Terumo, Tokyo, Japan) and a sheathless Eaucath guiding catheter (Asahi Intecc, Nagoya, Japan) are two major slender devices utilized in percutaneous coronary intervention (PCI). This study aimed to investigate the differences in access-site complications between these devices in PCI for acute coronary syndrome (ACS). A total of 1108 consecutive patients who underwent transradial PCI for ACS were enrolled. Transradial PCI was performed using either a 7-Fr Glidesheath slender/7-Fr guiding catheter combination (Glidesheath group) or a 7.5-Fr sheathless guiding catheter (Sheathless group); 1 : 1 propensity score matching was performed, and 728 patients (364 in each group) were included in the propensity-matched population. In the matched patients, univariate analysis revealed that the Glidesheath group had less radial artery occlusion (RAO) at 30 days (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) = 0.33, 95% confidence interval (CI) = 0.12-0.91, p=0.039), whereas no significant between-group differences were observed in severe radial spasm (Glidesheath: 1.4% vs. Sheathless: 1.9%, OR = 0.71, 95% CI = 0.23-2.22, p=0.58) or access-site major bleeding (Glidesheath: 1.4% vs. Sheathless: 1.6%, OR = 0.83, 95% CI = 0.26-2.71, p=1.00). Multivariate analysis revealed that the choice for Glidesheath was significantly associated with less RAO (OR = 0.32, 95% CI = 0.11-0.93, p=0.036). In conclusion, 7-Fr Glidesheath slender/7-Fr guiding catheter combination is obviously more advantageous than 7.5-Fr sheathless guiding catheters for decreased risk of RAO. The potential low risk of RAO in our findings supports the adoption of the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter combination in transradial PCI for ACS.

Erratum to "Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices".

[This corrects the article DOI: 10.1155/2020/8216831.].

Sheathless guide catheter in transradial percutaneous coronary intervention for ST-segment elevation myocardial infarction.

OBJECTIVES: The aim of this study was to assess the safety and efficacy of sheathless guide catheters in transradial percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Transradial PCI for STEMI offers significant clinical benefits, including a reduced incidence of vascular complications. As the size of the radial artery is small, the radial artery is frequently damaged in this procedure using large-bore catheters. A sheathless guide catheter offers a solution to this problem as it does not require an introducer sheath. However, the efficacy and safety of sheathless guide catheters remain to be fully determined in emergent transradial PCI for STEMI. METHODS: Data on consecutive STEMI patients undergoing primary PCI at the Sendai Kousei Hospital between September 2010 and May 2013 were analyzed. The primary endpoint was the rate of acute procedural success without access site crossover. Secondary endpoints included door-to-balloon time, fluoroscopy time, volume of contrast, and radial artery stenosis or occlusion rate. RESULTS: We conducted transradial PCI for 478 patients with STEMI using a sheathless guide catheter. Acute procedural success was achieved in 466 patients (97.5%). The median door-to-balloon time was 45 min (range, 15-317 min). The median fluoroscopy time was 16.4 min (range, 10-90 min). The median volume of contrast was 134 mL (range, 31-431 mL). Radial stenosis or occlusion developed in 14 (3.8%) of the 370 evaluable patients. CONCLUSIONS: This study showed that use of a sheathless guide catheter taking a transradial approach was effective and safe in primary PCI for STEMI. © 2015 Wiley Periodicals, Inc.

Associated factors and outcomes of crossover from a laser sheath to a bidirectional rotational mechanical sheath during transvenous lead extraction.

Background: During transvenous lead extraction (TLE), a GlideLight laser sheath (Philips) cannot always be advanced over the lead, and crossover to the Evolution system (i.e., an Evolution RL sheath or Evolution Shortie RL sheath [Cook Medical]) is required. We aimed to determine the associated factors and outcomes of such device crossover. Methods: This observational study included 112 patients who underwent TLE. The patients were divided into crossover and non-crossover groups. Outcomes and associated factors of crossover were evaluated. Results: Overall, 57 (50.9%) patients required crossover to the Evolution system (crossover group), whereas 55 (49.1%) patients did not require crossover (non-crossover group). Clinical success rate was similar between the two groups (98.3% vs. 100%; p = 1.00). No major intraprocedural complications related to powered sheaths occurred. Multivariate logistic regression analysis results showed that dwell time of the oldest extracted lead (per year) (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.36; p = .026), number of leads extracted per procedure (OR: 7.23, 95% CI: 1.74-29.99; p = .007), and use of a femoral approach (OR: 21.09, 95% CI: 2.33-190.67; p = .007) were associated factors of crossover. The cutoff for crossover was 7.7 years from the implant (sensitivity 90.5%, specificity 64.9%, area under the curve 0.80). Conclusions: Both groups showed a high rate of clinical success. Switching to the Evolution system may facilitate a safe and effective TLE when a laser sheath does not advance despite laser activation.

Clinical Factors Associated with Severity of Colonic Diverticular Bleeding and Impact of Bleeding Site.

Factors associated with serious colonic diverticular bleeding (CDB) are unclear, although the incidence of CDB has increased. We carried out this study to clarify factors associated with serious CDB and rebleeding. Subjects included 329 consecutive patients hospitalized for confirmed or suspected CDB between 2004 and 2021. Patients were surveyed regarding backgrounds, treatment, and clinical course. Of 152 with confirmed CDB, 112 showed bleeding from the right colon, and 40 did from the left colon. Patients received red blood cell transfusions in 157 (47.7%), interventional radiology in 13 (4.0%), and surgery in 6 (1.8%) cases. Early rebleeding within one month occurred in 75 (22.8%) patients, and late rebleeding within one year occurred in 62 (18.8%). Factors associated with red blood cell transfusion included confirmed CDB, anticoagulants, and high shock index. The only factor related to interventional radiology or surgery was confirmed CDB, which was also associated with early rebleeding. Late rebleeding was associated with hypertension, chronic kidney disease and past CDB. Right CDB showed higher rates of transfusion and invasive treatment than left CDB. Confirmed CDB had high frequencies of transfusion, invasive treatment, and early rebleeding. Right CDB seemed to be a risk for serious disease. Factors related to late rebleeding were different from those related to early rebleeding of CDB.

Risk Factors for Elevated D-Dimer Levels in Patients with Gastrointestinal Tumors Treated with Endoscopic Submucosal Dissection.

Endoscopic submucosal dissection (ESD) is almost always performed with a sedative because of the longer procedure times involved. The risk of post-ESD deep vein thrombosis (DVT) has been reported as relatively high, and D-dimer levels are sometimes elevated after ESD. This retrospective study evaluated factors affecting changes in D-dimer levels from before to after ESD to identify causes of elevated D-dimer levels after ESD. This retrospective analysis included 117 patients with gastrointestinal tumors resected using ESD. After excluding eight patients with pre-ESD levels of D-dimer >1.5 µg/mL, factors correlating with changes in D-dimer from before to after ESD were analyzed using logistic regression analysis in 109 patients. Sedation was accomplished primarily using midazolam, but, because the sedative effect of midazolam shows marked inter-individual variability, a "corrected midazolam dose" was determined by dividing the total midazolam dose by the initial dose to correct for inter-individual differences in the sedative effect of midazolam. This value was used as one potential explanatory variable in the subgroup analysis of the 103 patients who received midazolam. In the subgroup analysis using the corrected midazolam dose as an explanatory variable, only the corrected midazolam dose correlated with a change in D-dimer ≥1.0 µg/mL in multivariate analysis (odds ratio (OR) = 1.5, 95% confidence interval (CI) 0.43-0.95; p = 0.030). The corrected midazolam dose correlated with increases in post-ESD D-dimer levels. This potential relationship indicates that patients undergoing ESD and requiring extended sedation may be at increased risk of DVT.

A steerable introducer-assisted wire-loop snare technique: A bailout for unsuccessful lead extraction by a Needle's Eye Snare.

The Needle's Eye Snare (Cook Medical) is an effective tool for extracting leads via a femoral vein. However, it sometimes fails to grasp the lead. We describe an alternative method of successfully grasping a lead by creating a wire-loop around the lead with the help of a steerable introducer.

Gastrointestinal Bleeding During Direct Oral Anticoagulant Therapy in Patients With Nonvalvular Atrial Fibrillation and Risk of Polypharmacy.

Although concomitant medications have been raised as a factor affecting hemorrhage during direct oral anticoagulant (DOAC) therapy, details remain unelucidated. This study was conducted to clarify the relationship between concomitant medications with possible pharmacokinetic interactions and number of concomitant medications, and bleeding and embolism in patients with nonvalvular atrial fibrillation on DOACs. The subjects were 1010 patients prescribed DOACs from a single-center at the Teikyo University Hospital between April 2011 and June 2018. This study was an exploratory analysis and investigated their course between the first prescription and December 2018, including the presence or absence of clinically relevant bleeding, gastrointestinal bleeding, and major cardiovascular and cerebrovascular events. Impacts of medications were evaluated by the general linear model with inverse probability-weighted propensity score. The observation period was 2272 patient-years. The rate of bleeding was 4.7%/year, gastrointestinal bleeding was 2.8%/year, and major cardiovascular and cerebrovascular events were 2.0%/year. Taking 10 or more oral medications concurrently was a significant risk for gastrointestinal bleeding (hazard ratio, 2.046 [95%CI, 1.188-3.526]; P = .010). Nonsteroidal anti-inflammatory drugs were the only significant risk for gastrointestinal bleeding. Clinicians should be aware of gastrointestinal bleeding when using DOACs with patients taking more than 10 medications and/or nonsteroidal anti-inflammatory drugs.

Atrial septal perforation with Needle's Eye Snare during transvenous lead extraction.

Although the Needle's Eye Snare (Cook Medical) has been considered useful for lead extraction, serious complications can occur. We presented a case of atrial septal perforation associated with the Needle's Eye Snare. Our case highlights the importance of not persisting with the Needle's Eye Snare to prevent atrial damage.

Thrombotic events and rebleeding after hemorrhage in patients taking direct oral anticoagulants for non-valvular atrial fibrillation.

Several direct oral anticoagulants have been developed to prevent cardiogenic thrombosis in patients with atrial fibrillation, on the other hand, have the complication of bleeding. Since clinical course after bleeding with direct oral anticoagulant remains unclear, the present retrospective cohort study was to clarify the course after hemorrhage among patients receiving direct oral anticoagulants. Among all 2005 patients prescribed dabigatran, rivaroxaban, apixaban, or edoxaban between April 2011 and June 2017, subjects comprised 96 patients with non-valvular atrial fibrillation who experienced relevant bleeding during direct oral anticoagulant therapy (Bleeding Academic Research Consortium type 2 or above). The clinical course after hemorrhage was reviewed to examine whether rebleeding or thrombotic events occurred up to the end of December 2019. Gastrointestinal bleeding was the most frequent cause of initial bleeding (57 patients, 59%). Rebleeding occurred in 11 patients (4.5%/year), with gastrointestinal bleeding in 10 and subarachnoid hemorrhage in 1. All rebleeding occurred in patients who resumed anticoagulation therapy. Another significant factor related with rebleeding included past history of gastrointestinal bleeding. On the other hand, major adverse cardiac and cerebrovascular events occurred in 6 patients older than 75 years old or more (2.5%/year), with systemic thrombosis in 4 and cardiac death in 2. All 4 patients with systemic thrombosis withheld anticoagulants after index bleeding, although only 10 patients withheld anticoagulation therapy. Rebleeding should be taken care of when anticoagulants are resumed after bleeding, particularly among patients who initially experienced gastrointestinal bleeding. Systemic thrombosis occurred at a high rate when anticoagulant therapy was withheld after bleeding.

Predictors of the need for supportive femoral approach during transvenous extraction of pacemaker and defibrillator leads in Japanese patients.

BACKGROUND: Studies on femoral approach during transvenous lead extraction (TLE) are limited. METHODS: We retrospectively evaluated 75 patients undergoing TLE from September 2014 through November 2019 via supportive femoral approach (Femoral/Superior group; n = 22) and superior approach alone (Superior group; n = 53). RESULTS: No significant between-group differences were observed regarding patients' baseline characteristics except for a higher incidence of access vein occlusion in the Femoral/Superior group (59.1% vs. 31.4%; P = .037). The Femoral/Superior group exhibited significantly longer dwell times of the oldest extracted lead (median: 13.4 years; interquartile range [IQR]: 8.8-21.2 years vs. median, 7.2 years; IQR: 3.7-10.8 years; P < .001) and a higher incidence of passive fixation ventricular pacemaker lead (81.8% vs. 39.6%; P = .001). Multivariate logistic analysis showed that access vein occlusion (odds ratio [OR]: 4.07, 95% confidence interval [CI]: 1.08-15.3; P < .001) and dwell time of the oldest extracted lead (per year) (OR: 1.22, 95% CI: 1.09-1.37; P = .038) were predictors of the need for supportive femoral approach. Receiver operating characteristic curve analysis revealed that 11.8 years from implant was the cutoff for the need for supportive femoral approach (sensitivity 68.2%, specificity of 81.1%, area under the curve 0.81). CONCLUSIONS: Access vein occlusion and long dwell time of the oldest extracted lead predict a high probability of the need for supportive femoral approach. Supportive femoral approach may be necessary in patients with leads that are implanted for >11.8 years and whose access veins are occluded.

A prospective interventional registry of short-term dual-antiplatelet treatment after implantation of drug-eluting stents in patients with atrial fibrillation requiring oral anticoagulation therapy.

There are limited data regarding the use of antithrombotic therapy in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES). In this prospective interventional study, we evaluated the feasibility of short-term dual-antiplatelet therapy (DAPT) after DES implantation in AF patients treated with oral anticoagulation (OAC). The antithrombotic regimen in the present study was 1-month DAPT, followed by single-antiplatelet therapy with OAC. A total of 285 consecutive patients were enrolled between 2015 and 2017. The mean CHA2DS2-VASc score was 3.91 ± 1.51. The duration of DAPT was 28.5 ± 11.5 days. At 1-year follow-up, serious bleeding complications, defined as Bleeding Academic Research Consortium type ≥ 2, were observed in 27 patients (9.5%). Multivariate analysis showed that previous history of bleeding episodes (P = 0.009) and continuation of aspirin (P = 0.003) were independent predictors for the serious bleeding complications. High ORBIT (P = 0.008) and PRECISE-DAPT (P = 0.002) scores were associated with the bleeding complications, and the cut-off values were 5.00 and 49.0, respectively. No definite stent thrombosis occurred in any of the patients. Short-term DAPT is feasible in AF patients treated with OAC after undergoing PCI with DES. The previous history of bleeding episodes and long-term aspirin use were associated with their 1-year serious bleeding events.

Three-dimensional relationship between the conus branch and the precordial leads confirmed by 64-multidetector-row computed tomography.

A 65-year-old man with effort angina pectoris underwent percutaneous coronary intervention of the proximal right coronary artery. The lesion was dilated with a bare-metal stent under wire protection of the conus branch (CB). However, the jailed CB was occluded. Electrocardiogram with conventional precordial leads (V(1) through V(6)) accompanied with the supplementary leads (V(1) through V(6)) positioned 1 intercostal space higher showed marked ST elevation in V(1) through V(3) that was more prominent in V(1) through V(3). The 64-multidetector-row computed tomographic coronary angiography showed recanalization of the CB located just in the center of the V(1), V(2), V(1), and V(2) electrodes.

A randomised comparison of incidence of radial artery occlusion and symptomatic radial artery spasm associated with elective transradial coronary intervention using 6.5 Fr SheathLess Eaucath Guiding Catheter vs. 6.0 Fr Glidesheath Slender.

AIMS: The aim of this study was to compare incidences of radial artery occlusion (RAO) and spasm (RAS) associated with transradial coronary intervention (TRI) using a 6.5 Fr SheathLess hydrophilic-coated guide catheter (SH-GC) vs. a 6.0 Fr Glidesheath Slender (GSS). METHODS AND RESULTS: We conducted an open-label, single-centre, randomised study to compare radial complications in 600 consecutive patients undergoing elective TRI using 6.5 Fr SH-GC (n=300) or 6.0 Fr GSS (n=300) between 2015 and 2016. The primary endpoint was a composite of RAO evaluated by sonography and symptomatic RAS. The mean diameter of radial arteries was 2.20 mm in both groups; however, the sheath/radial artery diameter (S/RA) ratio was significantly smaller in the SH-GC group (1.03 vs. 1.17, p<0.001). SH-GC was associated with a higher rate of system crossover (1.7% vs. 0.7%, p=0.450) and coronary ostial dissection (1.0% vs. 0.3%, p=0.624), although there were no statistically significant differences. The incidence of major adverse cardiac events was comparable. A lower incidence of RAO and access-site crossover owing to RAS was significantly associated with SH-GC (0.0% vs. 2.0%, p=0.031). Multivariate analysis revealed that a larger S/RA ratio predicted RAO and RAS independently (p=0.007). CONCLUSIONS: The 6.5 Fr SH-GC offers a promising alternative to conventional TRI and is associated with fewer radial complications than the 6.0 Fr GSS.

Transradial Intervention in Patients With Non-ST Elevation Acute Coronary Syndrome Using One 4.0 Fr Sheath and One Sheathless Guide Catheter Via a Single Puncture Site: The 1-1-1 Strategy.

OBJECTIVES: The optimal primary transradial intervention (TRI) technique has not been established in non-ST segment elevation acute coronary syndrome (NSTEACS) patients, because they often, but not always, undergo immediate revascularization after coronary angiography (CAG). Moreover, TRI failure has been reported in 5%-10% of cases. We investigated whether a newly designed strategy of immediate TRI using one sheathless hydrophilic-coated guiding catheter (SH-GC) after diagnostic CAG with one 4.0 Fr sheath via a single access site (the 1-1-1 strategy) could be beneficial for NSTEACS patients. METHODS: We performed immediate TRI prospectively using SH-GC in consecutive NSTEACS patients in our hospital and compared the procedural success rate with that of conventional TRI performed before this study. RESULTS: Between 2015 and 2017, immediate TRI using SH-GC was performed in 330 consecutive NSTEACS patients after CAG using a 4.0 Fr sheath. Compared with the conventional TRI group (n = 330), the procedural success rate was significantly higher in the SH-GC group (P<.01), as SH-GC prevented TRI failure due to radial spasm (P<.01). SH-GC use was also significantly associated with completion of both diagnostic CAG and immediate TRI using only one sheath (P<.001) and one guiding catheter (P=.02). Multivariate analysis revealed that SH-GC use was an independent predictor of successful TRI (P<.01). The rates of major adverse cardiac events were comparable; however, rates of major access-site bleeding (P<.01) and blood transfusion (P=.02) were significantly lower in the SH-GC group. CONCLUSIONS: The 1-1-1 strategy using SH-GC may offer better TRI treatment than conventional systems for NSTEACS patients and simultaneously prevent access-site bleeding.

"Spaghetti twisting" technique: a novel method of catching pacemaker leads using a needle's eye snare.

The needle's eye snare has become an indispensable tool in contemporary pacemaker lead extraction techniques. Here, we present a modified method of using the needle's eye snare, named "spaghetti twisting" technique, to catch and secure pacemaker leads, which would help operators catch and secure leads much easily.