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   2021| January-June  | Volume 6 | Issue 1  
    Online since June 30, 2021

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2021 ISHNE/HRS/EHRA/APHRS Expert collaborative statement on mhealth in arrhythmia management: Digital medical tools for heart rhythm professionals: From the international society for holter and noninvasive electrocardiology/heart rhythm society/european heart rhythm association/asia-pacific heart rhythm society
Niraj Varma (ISHNE Chair), Iwona Cygankiewicz (ISHNE Vice-Chair), Mintu Turakhia (HRS Vice-Chair), Hein Heidbuchel (EHRA Vice-Chair), Yufeng Hu (APHRS Vice-Chair), Lin Yee Chen, Jean-Philippe Couderc, Edmond M Cronin, Jerry D Estep, Lars Grieten, Deirdre A Lane, Reena Mehra, Alex Page, Rod Passman, Jonathan Piccini, Ewa Piotrowicz, Ryszard Piotrowicz, Pyotr G Platonov, Antonio Luiz Ribeiro, Robert E Rich, Andrea M Russo, David Slotwiner, Jonathan S Steinberg, Emma Svennberg
January-June 2021, 6(1):2-46
This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society (HRS)/European Heart Rhythm Association/Asia-Pacific HRS describes the current status of mobile health (mHealth) technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that may be applied to and clinical decisions that may be enabled is discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.
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A prospective, multicenter, single-arm study of performance of the micra transcatheter pacemaker in chinese patients: A comparison to the global experience
Keping Chen, Shu Zhang, Liqun Wu, Xingbin Liu, Yangang Su, Yujie Zhou, Jiangang Zou, Jian-An Wang, Meixiang Xiang, Chengjun Guo, Xuejun Ren, Xiaofeng Hou, Shufeng Liu, Ming Zhang, Dedra H Fagan, Kejiang Cao
January-June 2021, 6(1):47-53
Background: We have compared the patient characteristics and safety and efficacy results of the Micra transcatheter pacemaker from the China Micra Transcatheter Pacing Study with those from the global trials. Subjects and Methods: In this prospective, multicenter, single-arm study, patients with a class I or II guideline recommendation for single-chamber pacemaker therapy were enrolled from seven centers in China between July 30, 2018, and December 12, 2018. The primary outcome measure of this study was freedom from system- or procedure-related major complications through 6 months postimplantation (prespecified performance goal 83%). Patient baseline characteristics and major complications were compared with data from the global trials. Performance after medically indicated magnetic resonance imaging (MRI) scans was characterized. The study was approved by the ethics committee at each participating center and registered with ClinicalTrials.gov (Identifier: NCT03624504). Results: Implantation was successful in 81 of 82 (98.8%) patients with a mean follow-up of 8.7 ± 1.5 months. Chinese patients who had lower body mass index were more often female, and less frequently had a pacing indication associated with atrial fibrillation (AF) compared with global patients. Through 6 months postimplantation, two major complications occurred, with a major complication-free rate of 97.6% (95% confidence interval: 90.6–99.4%), exceeding the primary endpoint performance goal (P = 0.002). The major complication rate was in line with rates from the Micra investigational trial and Post-Approval Registry (2.4% vs. 3.7% and 2.9%, respectively, P = 0.50). Among 14 patients who underwent 3T MRI scans, electrical performance was stable with mean pre- and post-MRI pacing thresholds of <0.5 V. No MRI-related device performance issues were observed. Conclusion: In the hands of new operators in China, the Micra pacemaker was implanted successfully with a very low complication rate. Although Chinese Micra patients were on average of smaller stature and the majority had a pacing indication not associated with AF, Micra performance was excellent and in line with the global trial experience.
  3,078 236 -
A prospective, multi-center, single-arm study of a novel double-disc left atrial appendage closure system: The periprocedural and mid-term outcomes (english version)
Shuang Li, Wei Chen, Mengyun Zhu, Junbo Ge, Daxin Zhou, Xiaochun Zhang, Jianan Wang, Youqi Fan, Yan Wang, Dong Chang, Yihan Chen, Fadong Chen, Hua Fu, Hongde Hu, Heng Cai, Yushun Zhang, Jing Zhou, Wei Ma, Zhongyuan Ren, Dongdong Zhao, Kai Tang, Yifan Zhao, Xiaoxin Chang, Weijing Liu, Yawei Xu
January-June 2021, 6(1):60-66
Background: Percutaneous left atrial appendage (LAA) closure has been demonstrated to be an alternative to oral anticoagulation for the prevention of ischemic stroke in nonvalvar atrial fibrillation (NVAF) patients. However, there were some designed limitations of current widely-used devices. This study was designed to evaluate the efficacy and safety of a novel double-disc LAA closure (LAAC) device, the LEFTEAR, in patients with NVAF who had contraindications of long-term oral anticoagulation or still high risks of stroke with anticoagulation treatment. Subjects and Methods: A total of 200 NVAF patients who underwent LAAC were prospectively recruited in nine participating centers in China between April 2014 and March 2019 in this prospective, multi-center, single-arm study. The study was approved by the institutional review board of each clinical center. The enrolled cases had ages ranged from 38 to 89 years (mean 68.3 ± 8.7) years. There were 112 males (56%). CHA2DS2-VASc scores were 3.5 ± 1.44, and HAS-BLED scores 2.5 ± 1.18. LAAC was conducted with the LEFTEAR occluder. Successful closure of LAA was defined as there was no or a small amount of peri-device leak (PDL ≤3 mm) of residual shunt, evaluated by transesophageal echocardiography. The composite end-point events (hemorrhagic/ischemic stroke, systemic embolism, and cardiogenic/unexplained death) within 12 months after the procedure were the main efficacy indicators. Severe adverse events (SAEs) within 12 months were safety indicators. Results: Totally 196 were implanted with an occluder, and the remaining 4 were not (1 case found with an large LAA which the ostium was great than 35 mm, the upper limit of the clinical program, 1 case gave up after failed attempt of LAAC procedure, 2 cases showed “pericardial tamponade” after AF ablation and no attempts were made to continue LAAC). Among them, the “Hybrid procedures” (LAAC combined with AF ablation) reached up to 133 cases (66.5%). Up to December 31, 2019, the mean follow-up was 6 months. There were none major composite endpoint events occurred during the perioperative and follow-up periods (0%). SAEs were recorded in 10 cases, of which 7 were “pericardial tamponades” and 3 of “occluder detachment or displacements.” All SAEs occurred in “Hybrid procedures” cases, of which 9 occurred in the perioperative period (90%). Six cases of “pericardial tamponade” were recorded in the perioperative period, but only two required emergency surgeries. The successful rate of immediate LAAC was 100%, among which 178 cases (90.8%, 178/196) had no residual shunt (PDL = 0 mm). A total of 153 cases (79.7%, 153/192) had completed at least one follow-up transoesophageal echocardiography examination, and the success of mid-term LAAC was 98.7% (151/153), with no events of device-related thrombosis. Conclusions: LAAC with a novel disc-like occlude, named LEFTEAR was generally effective and safe. The “Hybrid procedures” increased the incidence of adverse events to some extent. This study was the first-in-human trial of LEFTEAR, thus further larger sample studies are still needed to verify.
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Follow and promote the trend of mhealth in arrhythmia management: Pathways to succeed
Yi-Gang Li, Shu Zhang, Iwona Cygankiewicz, Niraj Varma
January-June 2021, 6(1):1-1
  2,491 212 -
Safety and efficacy of transvenous lead removal after cardiovascular implantable electronic device infection in the older patients: A retrospective cohort study (english version)
Jia Zheng, Yuan Gao, Rongfang Lan, Wei Xu
January-June 2021, 6(1):54-59
Background: Cardiovascular implantable electronic device (CIED) infection is a life-threatening complication following pacemaker therapy. Complete CIED removal is the first-line therapy for patients with CIED system infection. However, the safety and efficacy of transvenous lead removal of infected CIED in older patients (≥75 years of age) are unknown. Thus, our study aimed to investigate the safety and efficacy of transvenous lead removal of infected CIED in older patients. Subjects and Methods: This is a single-center retrospective cohort study in which 316 patients with transvenous lead removal after CIED infections were recruited from Nanjing Drum Tower Hospital between January 2013 and October 2019. We evaluated the safety of the CIED removal based on the rate of major complications (e.g., lead perforation, coronary sinus tear, and pericardial tamponade) and minor complications (e.g., minor pericardial effusion, venous thrombus, and minor hematoma). Procedural success rate and infection recurrence were used to evaluate the efficacy. The differences in gender, comorbidities, type of implanted devices, number and type of leads, anesthesia method, extraction strategies, complications, and complete removal rate were also analyzed. The study was approved by the Ethics Committee of Drum Tower Hospital, Nanjing University Medical School (approval No. 2019-230-01) on February 1, 2019. Results: In total, 316 patients were included, of whom 115 patients were ≥75 years old, and 79 were male. There were more defibrillation devices in the <75-year-old group (10.9% vs. 4.3%, P = 0.044). Seven cases (6.1%, 7/115) in the ≥75-year-old group had minor complications without major complications, whereas ten cases (5.0%, 10/201, P = 0.796) of <75-year-old group had minor complications with one case had major complications. 111 patients (96.5%, 111/115) in the ≥75-year-old group had complete removal of the pacing system. Four patients (3.5%, 4/115) achieved clinical success without removal failure. 191 patients (95.0%, 191/201, P = 0.933) in the <75-year-old group had complete removal of the pacing system, and nine patients (4.5%, 9/201, P = 0.776) had clinical success with 1 case (0.5%, 1/201) being failed to remove pacing system. Overall, there was no significant difference in the safety and efficacy among the two groups. Conclusions: Transvenous lead removal is safe and curative in patients ≥75 years old with CIED infections.
  2,434 176 -
A case report of ictal bradycardia and asystole: An uncommon manifestation of epilepsy
Nambirajan Jayabalan, Harshal Pamecha, Senthil Nallaswamy
January-June 2021, 6(1):73-75
The ictal bradycardia syndrome occurs when epileptic discharges disrupt normal cardiac rhythms leading to a reduction of heart rate that is more than 10 beats/min below the baseline. Mostly documented ictal bradycardias are accompanied by complex partial seizures of temporal lobe origin. Sudden unexpected death in epilepsy is often assumed to be associated with a concomitant seizure, but it is almost impossible to prove conclusively. Here, we report the case of a 52-year-old female patient admitted with the complaints of two episodes of generalized tonic–clonic seizures and vomiting followed by presyncope and syncope. The patient was admitted in a drowsy disoriented state with hypotension and electrocardiogram (ECG) illustrating sinus tachycardia. Later during admission, the patient developed complex focal seizures with secondary generalization and cardiac arrest. During video electroencephalogram/ECG, she had another similar episode and cardiac arrest. ECG showed rapid progression to asystole and ventricular pause of 25 s followed by complete heart block with ventricular escape rhythm of 17 beats/min. She was implanted with a temporary pacemaker but later during the hospitalization, sudden unexpected death in epilepsy occurred in spite of cardiac pacing and optimum antiepileptic medication. Most documented pauses are of nonlife-threatening duration (range 3–20 s) with longer pauses being observed. Cardiac pacing may help to reduce the risk of falls, but in the absence of official practice guidelines, cardiac pacing should only be considered for patients in whom conventional antiepileptic therapy has failed to prevent ictal asystole. Early diagnosis, interventions, and optimum antiepileptic dose escalation with occasional epilepsy surgery are the mainstay to prevent mortality and severe prognosis of the ictal bradycardia syndrome.
  2,110 150 -
The joint physician- and pharmacist-managed anticoagulation clinic is aiming to improve warfarin management in outpatients with atrial fibrillation in China: A prospective observational study
Zimo Sha, Youmei Shen, Duxiao Zhang, Jiaojiao Shi, Zidun Wang, Mingfang Li, Minglong Chen
January-June 2021, 6(1):67-72
Background: Anticoagulation clinic (AC) is aimed at improving anticoagulation control and outcomes in patients with atrial fibrillation (AF). There is little published data on the benefits of providing an AC in China even if Asians have a higher risk of hemorrhage and stroke when taking warfarin. This study attempts to assess the impact of the AC on warfarin management in the Chinese population. Subjects and Methods: This prospective observational study was conducted in the First Affiliated Hospital of Nanjing Medical University and consecutively enrolled 42 AF patients from the joint physician-and pharmacist-managed AC from March 2017 to April 2018. The study protocol was approved by the Institutional Review Board of the First Affiliated Hospital of Nanjing Medical University. Patients already on warfarin for at least 6 months before coming to the AC and unwilling to receive AF ablation or switch to non-Vitamin K antagonist oral anticoagulants were included. The anticoagulant activity of warfarin was monitored using the international normalized ratio (INR). The primary outcome of this study was INR control, which was defined by the time-in-therapeutic range (TTR). The TTR before and after visiting the AC was compared. Results: The mean age of the enrolled 42 patients was 68.3 ± 10.6 years and 25 (59.5%) were women. The mean CHA2DS2-VASc score and the mean HAS-BLED score were 3.43 ± 1.29 and 1.86 ± 0.80, respectively, in 28 (66.7%) patients with nonvalvular AF. The median follow-up time after visiting the AC was 298.5 days (interquartile range: 151.8–441.8 days). The TTR (% days) before and after visiting the AC was 44.1% ± 27.5% and 69.7% ± 23.3% (P < 0.001), respectively. Meanwhile, 6 (14.3%) and 25 (59.5%) patients had TTR (% days) >65% before and after visiting the AC (P = 0.001), respectively. Conclusions: TTR values were higher in AF patients taking warfarin after the AC. More patients reached satisfactory warfarin control after visiting the AC.
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