The Japanese lead extraction registry (J-LEX): Annual report 2020.

The Japanese Heart Rhythm Society established a nationwide, mandatory, multi-center, prospective, observational registry of transvenous lead extraction (TLE) named the Japanese lead extraction registry (J-LEX) in 2018. We have published the first annual report of J-LEX with 661 cases from 42 hospitals. The second annual report of J-LEX in 2020 enrolled increased numbers of 785 cases from 75 hospitals. TLE procedure was attempted on patients with an average age of 71.7 years old, male in 72.5% in the hybrid operating room in 57.9%, and in standard OR with a C-arm fluoroscope in 18.7%. The indication of TLE was an infection in 62.8% and the guideline classification was class-I in 67.4% and class-IIa in 23.8%. The average implantation duration of target leads was 7.9 years. Complete removal was achieved in 96.6% of the target leads and clinical success in 98.1% of the patients. Perioperative complications were observed in 7.1% of the patients. One patient died during a TLE operation and the other three patients died in-hospital (cardiac death in one patient and non-cardiac in two patients). Although the annual J-LEX report in 2020 demonstrated an increased number of TLE procedures despite the first pandemic year of coronavirus disease-2019 (COVID-19), perioperative complications increased a little in comparison with J-LEX 2019.

Japanese Lead EXtraction (J-LEX) registry: Annual report 2019.

Along with the incremental cases of cardiac implantable electronic devices implantation or upgrade, the lead-related complications are also in rise year after year. The most common and serious lead-related complication is infection that needs a transvenous lead extraction (TLE) as the first-line therapy. TLE is also performed for abandoned leads in case of lead failure or device upgrade, and for lead-related trouble such as pain, vessel stenosis or occlusion, too many leads, tricuspid valve regurgitation, and difficulty of radiation therapy. This registration has been performed by the Japanese Heart Rhythm Society and started in July 2018. The first reported data of the Japanese Lead Extraction (J-LEX) from July 2018 to December 2019 were underestimated since the number of patients and hospitals increased gradually because of the approval process of each hospital's IRB. The TLE procedure was attempted to 1253 leads among 661 patients. Complete removal was achieved in 96.7% of the target leads and the clinical success was obtained in 98.9% of the patients. Perioperative complications were observed in 4.1% of the patients. The annual J-LEX report reflects a real-world TLE medicine in Japan and demonstrates that the clinical outcome is similar to former reports from high-volume centers in North America and European countries.

Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

BACKGROUND: Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real-world setting. METHODS: The Japanese Lead EXtraction (J-LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500-1000 per year. We will also compare the results with other registries in foreign countries. RESULT: The results of this study are currently under investigation. CONCLUSION: The J-LEX registry will provide real-world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan.

Lifestyle Modification or Medication to Improve Condition of Patients With Asymptomatic Heart Failure　- Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization II (MOMOTARO II) Study.

BACKGROUND: In heart failure (HF) patients implanted with high-energy devices, worsening of HF can be diagnosed from intrathoracic impedance (ITI) before symptoms appear. Early therapeutic intervention can prevent HF worsening, but the optimal intervention remains unknown. This study aimed to examine which lifestyle modifications or medications can improve HF indicators in asymptomatic HF patients diagnosed from ITI.Methods and Results:This multicenter, prospective, randomized study included patients with high-energy devices, left ventricular ejection fraction <40%, or with a history of HF hospitalization. After the OptiVol alert was evoked by decreased ITI, patients underwent examinations. If they were diagnosed with HF, they were randomly assigned to 3 groups: lifestyle modification, diuretic, or nitrate. After 1 week, they underwent the same examinations. The primary endpoint was change in ITI and serum B-type natriuretic peptide (BNP). Totally, 57 patients were randomized. In all 3 groups, ITI was significantly increased post-intervention compared with pre-intervention. In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group. CONCLUSIONS: Compared with lifestyle modifications, diuretic and nitrate therapy for 1 week may be more effective management of HF detected by decreased ITI. However, lifestyle modification may have the additional benefits of reducing the workload or cost.

An improved algorithm calculated from intrathoracic impedance can precisely diagnose preclinical heart failure events: Sub-analysis of a multicenter MOMOTARO (Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization) trial study.

BACKGROUND: Ambulatory measurement of intrathoracic impedance (ITI) with an implanted device has potential to assess fluid accumulation in patients with heart failure (HF), but it has failed to reduce HF-related hospitalization because of a high false-positive rate. OBJECTIVE: We aimed to examine whether a modified algorithm (OptiVol 2.0) could reduce false-positive HF events documented in our multicenter trial (MOMOTARO). METHODS: The MOMOTARO trial assessed the potential that fluid index could predict fluid accumulation and therefore HF. The MOMOTARO trial assessed whether HF events could be detected based on fluid accumulation as assessed by fluid index. We re-analyzed raw data of ITI trends of the threshold-crossing events with the modified algorithm. RESULTS: The study consisted of 195 patients who had been implanted with a high-energy device. During a mean follow-up period of 658±165 days, there were 154 primary HF events detected by the previous algorithm (OptiVol 1.0). With the previous algorithm, there was no significant difference in log concentration of brain natriuretic peptide (BNP) between baseline and alert (p=0.21). Among 150 alerts of the previous algorithm, only 37 reached the threshold by the modified algorithm, and log BNP was significantly higher in these 37 events compared with the baseline value (2.40±0.46 vs. 2.27±0.52, p<0.01). CONCLUSION: Our simulation study demonstrates that fluid index calculated with the modified algorithm reduces the number of false-positive threshold-crossing HF events and is promising for accurate diagnosis of fluid accumulation in patients.

Decreased Intrathoracic Impedance Associated With OptiVol Alert Can Diagnose Increased B-Type Natriuretic Peptide - MOMOTARO (Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization) Study - .

BACKGROUND: Ambulatory measurement of intrathoracic impedance (ITI) with an implanted device may detect increases in pulmonary fluid retention early, but the clinical utility of this method is not well established. The goal of this study was to test whether conventional ITI-derived parameters can diagnose fluid retention that may cause early stage heart failure (HF). METHODS AND RESULTS: HF patients implanted with high-energy devices with OptiVol (Medtronic) monitoring were enrolled in this study. Patients were monitored remotely. At both baseline and OptiVol alert, patients were assessed on standard examinations, including analysis of serum brain natriuretic peptide (BNP). From April 2010 to August 2011, 195 patients from 12 institutes were enrolled. There were 154 primary OptiVol alert events. BNP level at the alerts was not significantly different from that at baseline. Given that ITI was inversely correlated with log BNP, we added a criterion specifying that the OptiVol alert is triggered only when ITI decreases by ≥4% from baseline. This change improved the diagnostic potential of increase in BNP at OptiVol alert (sensitivity, 75%; specificity, 88%). CONCLUSIONS: BNP increase could not be identified based on OptiVol alert. Decrease in ITI ≥4% compared with baseline, in addition to the alert, however, may be a useful marker for the likelihood of HF (Clinical trial info: UMIN000003351).

Radiographic and electrocardiography-gated noncontrast cardiac CT assessment of lead perforation: modality comparison and interobserver agreement.

BACKGROUND: Pacemaker or implantable cardioverter-defibrillator lead extraction may be required because of infection, malfunction, or breakage. The preprocedural identification of lead tip position may help ensure safe performance of the procedure. OBJECTIVE: To analyze the ability of chest radiography and CT imaging to characterize lead tip position and identify perforation in a population of patients who underwent lead extraction. METHODS: Among patients who underwent lead extraction between November 2008 and April 2011, a nonrandom subset of 50 patients with 116 leads was selected for retrospective analysis. All patients had undergone chest radiography and thin-section electrocardiography-gated noncontrast cardiac CT. Two radiologists independently evaluated the imaging studies, using oblique multiplanar image reconstruction techniques for the CT examinations. Beam hardening artifacts were graded (0-3). Likelihood of perforation on each imaging study was graded on a 5-point scale. RESULTS: Among 116 leads, 17 were identified as perforated on CT, 12 leads were equivocal, and 87 were not perforated. Interobserver agreement for CT perforation vs nonperforation was good (κ = 0.71); weighted kappa for the entire 5-point scale was moderate (κ = 0.54). Beam hardening artifacts were common, with a mean value of 2.1. The 2 observers identified perforation on chest radiography with an average sensitivity of 15% compared with CT. The 2 observers did not agree on any cases of chest radiographic perforation (κ = -0.1). CONCLUSION: Electrocardiography-gated noncontrast cardiac CT imaging with oblique multiplanar analysis can identify potential lead perforation with a moderate-to-good level of interobserver agreement. Chest radiography demonstrates poor sensitivity and interobserver agreement compared with CT.

Serial clinical and angiographic follow-up after phosphorylcholine-coated stent implantation.

The efficacy of drug-eluting stents (DES) has been proven, but concerns about late complications after DES have been raised. Polymers that do not increase inflammatory or hypersensitivity reactions which may contribute to late complications are needed for new generation DES. To evaluate the safety and efficacy of phosphorylcholine-polymer coating, we investigated serial clinical and angiographic outcomes after phosphorylcholine-coated stent placement. Seventy-five consecutive patients treated with a BiodivYsio phosphorylcholine-coated stent for de novo lesions at our institute between October 2001 and August 2002 were enrolled. Six-month follow-up angiography was performed in 71 lesions (94.7%), and angiographic restenosis was found in 19 lesions (26.8%). Target lesion revascularization (TLR) was performed in 10 lesions (14.1%). Eighteen-month follow-up angiography was performed in 58 (95.1%) of the remaining 61 lesions (excluding TLR lesions), and angiographic restenosis was found in only 3 lesions. The cumulative MACE-free survival rate was 86.3%, 83.6%, and 78.6% at 6-month, 18-month, and 8-year follow-up, respectively. There were no episodes of stent thrombosis. Late loss decreased significantly from 0.74 ± 0.40 mm (6-months) to 0.51 ± 0.46 mm (18-months) (P < 0.0001). Phosphorylcholine-coated stent implantation was associated with acceptable clinical and angiographic results. Phosphorylcholine-coating may be an ideal polymer for new generation DESs.

Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis.

OBJECTIVES: The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis. BACKGROUND: Because drug-eluting stents (DES) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is unknown. METHODS: This study was a prospective single-blind randomized trial conducted in 50 patients with SES restenosis. Patients were randomly assigned to a PEB group (n = 25) or a conventional balloon angioplasty (BA) group (n = 25). The primary end point was late lumen loss at 6-month follow-up. Secondary end points included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up. RESULTS: At 6-month angiographic follow-up (follow-up rate: 94%), in-segment late lumen loss was lower in the PEB group than in the BA group (0.18 ± 0.45 mm vs. 0.72 ± 0.55 mm; p = 0.001). The incidence of recurrent restenosis (8.7% vs. 62.5%; p = 0.0001) and target lesion revascularization (4.3% vs. 41.7%; p = 0.003) was also lower in the PEB group than in the BA group. The cumulative MACE-free survival was significantly better in the PEB group than in the BA group (96% vs. 60%; p = 0.005). CONCLUSIONS: In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional BA.