The Removal, Excision, Sterilization, and Quarantine (RESQ) Method is a Feasible Alternative Treatment for Cardiac Implantable Electronic Device Infections.

Background: Current guidelines recommend that all infected cardiac implantable electronic devices (CIEDs) should be removed. However, financial or anatomical concerns can lead to management of infection with simple debridement, as opposed to complete removal. In this observational study, we report the outcomes of our modified procedure for this real-world dilemma. Methods and Results: The Quarantine (RESQ) method is characterized as follows: the removal (R) of all non-essential foreign materials, including old sutures and leads; the excision (E) of all non-viable, chronically inflamed, granulation, or scar tissue; the sterilization (S) of the remaining generator; and the quarantine (Q) of a new pocket in the sub-muscular layer for reimplantation. From a review of electronic medical records, 30 patients were selected and divided into three groups according to the intervention used: RESQ (n = 9) in group A, simple debridement (n = 16) in group B, and guideline-recommended replacement (n = 5) in group C. Patient baseline characteristics were similar between the groups. After analyzing the proportion of patients that were free from infection one year following their respective interventions, we found that group A performed better than group B (100% and 31.2% infection-free, respectively, p = 0.001), and was comparable to group C (both 100% infection-free, p = not applicable). Conclusions: The RESQ method is a feasible and beneficial alternative for selected patients with CIED infections who are unable to receive a generator replacement according to the recommended guideline.

Safety and Efficacy of Submuscular Implantation With Resterilized Cardiac Implantable Electronic Device in Patients With Device Infection: A Retrospective Observational Study in Taiwan.

Background: Reuse of cardiac implantable electronic devices (CIEDs) can reduce the cost of using these expensive devices. However, whether resterilized CIEDs will increase the risk of reinfection in patients with previous device infection remains unknown. The aim of the present study is to compare the reinfection rates in patients who had initial CIED infection and underwent reimplantation of resterilized CIEDs or new devices. Methods: Data from patients with initial CIED infection who received debridement of the infected pocket and underwent reimplantation of new or resterilized CIEDs at MacKay Memorial Hospital, Taipei, Taiwan, between January 2014 and June 2019 were retrospectively analyzed. Patient characteristics, relapse rates of infection, and potential contributing factors to the infection risk were examined. Results: Twenty-seven patients with initial CIED infection and reimplanted new CIEDs (n = 11) or resterilized CIEDs (n = 16) were included. During the 2-year follow-up, there were 1 (9.1%) and 2 (12.5%) infection relapses in the new and resterilized CIED groups, respectively. No relapse occurred for either group if the lead was completely removed or cut short. The median duration between debridement and device reimplantation in patients with infection relapse vs patients without relapse was 97 vs 4.5 days for all included patients, and 97 vs 2 days and 50.5 vs 5.5 days for the new and resterilized CIED groups, respectively. Conclusions: Subpectoral reimplanting of resterilized CIEDs in patients with previous device infection is safe and efficacious. With delicate debridement and complete extraction of the leads, the CIED pocket infection relapse risk can be greatly decreased.

Rhythm control without catheter ablation may have benefits beyond stroke prevention in rivaroxaban-treated non-permanent atrial fibrillation.

The current treatment paradigm for atrial fibrillation (AF) prioritizes rate control over rhythm control; however, rhythm control has shown benefits over other AF strategies. This study compares the outcomes of rivaroxaban with and without concomitant antiarrhythmic drugs (AADs), using propensity score matching to correct for statistical effects of baseline discrepancies. This multi-center retrospective study included 1,477 patients with non-permanent AF who took rivaroxaban for at least one month between 2011 and 2016 and had not received catheter ablation. Concomitant AAD use was compared against clinical outcome endpoints for effectiveness, safety, and major adverse cardiac events (MACE). Associations with concomitant AAD use were evaluated using multivariate Cox proportional hazard analyses. Patients were divided into two matched groups: rivaroxaban alone (n = 739) and with concomitant AADs (n = 738). The cumulative incidences of safety (p = 0.308), effectiveness (p = 0.583), and MACE (p = 0.754) were similar between the two groups, and multivariate analysis showed no significant differences. The new thromboembolism and all-cause death rates were higher in rivaroxaban alone (2.7% vs 0.8%, p = 0.005; and 10% vs. 6.9%, p = 0.032, respectively). The heart failure readmission rate was higher in the concomitant-AAD group (8.4% vs. 13.3%, p = 0.003). The concomitant use of rivaroxaban with AADs appears to be well-tolerated, with lower rates of thromboembolism and all-cause death, but is associated with more occurrences of congestive heart failure.

Exploratory Evaluation of Rhythm Control by Dronedarone in Combination With Low-Dose Rivaroxaban, Warfarin, Antiplatelet, or None of the Antithrombotic Therapy in High-Risk Patients With Non-Permanent Atrial Fibrillation: A Retrospective Cohort Study.

The emerging data supports rhythm control to prevent major adverse cardiac events (MACE) in high-risk patients with atrial fibrillation (AF). Limited data demonstrated rivaroxaban 10 mg combining dronedarone seemed feasible. This study aimed at investigating clinical events in a dronedarone-treated cohort. This exploratory, retrospective chart review was conducted in nonpermanent AF patients receiving dronedarone for ≥ 3 months between 2009/1 and 2016/2. In Taiwan, dronedarone's labeled indication was strict to age ≥ 70 or 65 to 70 years with either hypertension, diabetes, prior stroke, or left atrium >50 mm. We divided all into 4 groups using antithrombotic strategies to evaluate the safety, effectiveness, and MACE endpoints. A total of 689 patients (mean CHA2DS2-VASc score 3.8 ± 1.4) were analyzed: rivaroxaban 10 mg (n = 93, 13.5%), warfarin (n = 89, 12.9%), antiplatelet (n = 331, 48.0%), and none (n = 176, 25.5%). During the follow-up period (mean 946 ± 493.8 days), the rivaroxaban group did not report any stroke or thromboembolism (ishcmeic stroke rate: antiplatelet [0.6%], none [1.1%]; hemorrahgic stroke rate: warfarin [2.2%]; thromboembolism rate: warfarin [2.2%]). There was no significant difference in safety, effectiveness, and MACE endpoints between groups. Also, >104 weeks of dronedarone use was the independent predictor for MACE after adjusting the strategy and other covariates (hazard ratio 0.14 [95% confidence interval 0.04-0.44], P = .001). Our findings warrant concomitant rivaroxaban 10 mg and dronedarone for further investigation. Regardless of antithrombotic strategies, a more extended persistence of dronedarone was associated with fewer MACE.

Effect of Reducing Heart Rate on Outcomes in Patients With Reduced Ejection Fraction.

Since 1953, sinus tachycardia has been defined as a heart rate (HR) in sinus rhythm of >100 beats per minute (bpm). However, this number has never been formally evaluated, and no established threshold values for special groups, such as those with heart failure (HF) accompanied by a reduced ejection fraction (HFrEF). Herein, we provided evidence that lowering the HR of patients with HFrEF to <70 bpm with medications such as ivabradine improves outcomes. Numerous large-scale trials and smaller clinical studies have shown that reducing the HR in patients with HFrEF improves cardiovascular and overall outcomes. Evidence suggests that a HR of <70 bpm is appropriate for patients with HFrEF. Examination of HF registries indicates that in a large proportion of these patients the HR exceeds 80 bpm, and no consideration is given to lowering the HR, due in large part to lack of physician awareness of the benefits of a lower HR. Evidence indicates that the first-line medication for lowering HR in patients with HFrEF is ivabradine. In conclusion, the improved prognosis following appropriate HR management in patients with HFrEF suggest that the cut-off value for sinus tachycardia in these patients should be redefined as 75 bpm. Maintaining a HR of <70 bpm in patients with HFrEF is associated with improved cardiovascular and overall outcomes.

Safety and Effectiveness of Rivaroxaban in Combination with Various Antiarrhythmic Drugs in Patients with Non-Permanent Atrial Fibrillation.

INTRODUCTION: Rivaroxaban reduces the risk of thromboembolism in atrial fibrillation (AF) patients, who often also receive antiarrhythmic drugs (AADs) to maintain sinus rhythm. Current guidelines contraindicate concomitant use of rivaroxaban with the popular AAD dronedarone, despite little data demonstrating interactions with AADs. This study investigates the outcomes of concomitant rivaroxaban and AAD drug use in a real-world cohort. METHODS: This retrospective study included 1777 non-permanent AF patients taking rivaroxaban for ≥ 1 month between 2011 and 2016 from a multicenter cohort in Taiwan, and compared concomitant AAD use against clinical outcome endpoints for safety, effectiveness, and major adverse cardiac events (MACE). Multivariate Cox proportional hazard analyses were used to evaluate the association between concomitant AAD use and outcomes. RESULTS: Patients were divided into rivaroxaban alone (n = 1205) and with concomitant amiodarone (n = 177), dronedarone (n = 231), or propafenone (n = 164) groups. The proportion of patients using rivaroxaban 10 mg was highest in the concomitant dronedarone group: rivaroxaban alone, 53.6%; with amiodarone, 57.6%; with dronedarone, 77.1%; and with propafenone, 46.3% (p < 0.001). The cumulative incidences of safety (p = 0.892), effectiveness (p = 0.336), and MACE (p = 0.674) were similar between the four groups; however, there were significantly fewer new systemic thromboembolisms in the dronedarone group: rivaroxaban alone, 2.5%; with amiodarone, 0.6%; with dronedarone, 0%; and with propafenone, 1.2% (p = 0.029). The all-cause death rate was also lowest in the dronedarone group: rivaroxaban alone, 9.0%; with amiodarone, 9.6%; with dronedarone, 3.0%; and with propafenone: 6.1% (p = 0.013). After covariate adjustment, there were no differences in the safety, effectiveness, and MACE endpoints between patients receiving or not receiving AADs. CONCLUSION: Concomitant use of rivaroxaban with AADs appears to be well tolerated, warranting further investigation into the apparent benefits of a reduced dose of rivaroxaban combined with dronedarone.

The Use and Clinical Outcomes of Single-Burr Rotational Atherectomy: The Experience of a Local Hospital in Taiwan.

BACKGROUND: Treating heavily calcified lesions is a challenge and is associated with high re-stenosis and target lesion revascularization (TLR). Before stent implantation, lesions must be adequately prepared using rotational atherectomy (RA), which has shown favorable results. The study aims to report our hospital's clinical outcomes when using rotational atherectomy on complex and heavily calcified coronary lesions with a single-burr strategy. METHODS: We retrospectively analyzed 58 patients who underwent percutaneous coronary interventions with RA at our center between December 2006 and April 2017. Data on immediate post-procedural events and major adverse cardiovascular events were collected during follow-up, including cardiovascular death, myocardial infarction, TLR, target vessel revascularization (TVR) and stroke. RESULTS: Of the 58 patients and 90 lesions treated over 10 years, 88 lesions (97.8%) used only one burr. The intervention procedure success rate was 100%. During a mean follow-up of 41.2 months, 6 patients experienced acute coronary syndrome, 12 required TLR, 2 needed TVR, and 6 died due to a cardiovascular event. We divided lesions into 5 categories. The prevalence of lesions and the burr size most commonly used were: category 1 (ostial lesion, 8.9%, 1.75 mm), category 2 (focal lesion, 20%, 1.75 mm), category 3 (intermediate lesion, 13.3%, 1.5 mm), category 4a (long, looser lesion, 26.7%, 1.5 mm), and category 4b (long, rigid lesion, 31.1%, 1.25 mm). CONCLUSIONS: Rather than a routine step-by-step strategy for RA, this study shows convincing evidence supporting the use of this device to treat complex calcified coronary lesions using a single-burr strategy.

Effectiveness of a Non-Taped Compression Dress in Patients Receiving Cardiac Implantable Electronic Devices.

BACKGROUND: Hematoma and skin damage are not uncommon after cardiac implantable electronic device (CIED) placement. The use of conventional hemostatic gauze and tape seems to be suboptimal in controlling these complications. This study aimed to evaluate the impact of a novel compression dress with a special pad and elastic bands for postoperative care. METHODS: A total of 175 CIED recipients were randomly divided into two groups: an experimental group with 85 patients who used a non-taped compression dress and a control group with 90 patients who used conventional gauze ball and elastic tapes. Skin integrity, hematoma, and oozing were compared between these two groups within 7 days after surgery. RESULTS: The mean age of the patients was 71.2 ± 13.3 years, and 83 (47.4%) were male. The results of the experimental vs. control group were as follows: skin integrity - 96.5% vs. 86.7% (p < 0.05); hematoma - 0% vs. 7.8% (p < 0.05); and oozing - 1.2% vs. 7.8% (p < 0.05). All observed endpoints were better in the experimental group. CONCLUSIONS: The use of a non-taped compression dress was associated with less unfavorable outcomes in terms of skin integrity and hemostasis.

Effect of Radiofrequency-Based Renal Denervation: The Impact of Unplanned Medication Change from a Systematic Review and Meta-Analysis.

BACKGROUND: Catheter-based renal denervation (RDN) has emerged as a promising treatment option for hypertension. However, randomized controlled trials (RCTs) have reported conflicting results on blood pressure (BP) reduction. Patient- and procedure-related confounders have been implied as the potential sources of inconsistent BP responses. We aimed to investigated whether unplanned and frequent medication changes in RDN studies affected the BP response to RDN by conducting sensitivity and subgroup analyses, according to antihypertensive medication change rates in a meta-analysis of RCTs. METHODS: We searched the PUBMED, EMBASE, and COCHRANE databases up to May 2018. RCTs that studied the effects of RDN on hypertensive patients were included. A meta-analysis was carried out using RevMan 5.3. RESULTS: A total of 12 studies were included, of which four fulfilled the inclusion criteria of < 10% medication change rate in our review. Subgroup meta-analyses of the four RCTs with < 10% medication change rates showed statistically significant reductions of 6.07 mmHg and 7.12 mmHg in 24-hour and office systolic BP, respectively. The 24-hour and office diastolic BP were also reduced (mean difference = -3.89 mmHg and -4.27 mmHg, respectively). These subgroup analyses had no heterogeneity (I2 = 0%). In contrast, the pooled analysis of the 12 studies and the subgroup analysis of eight studies with > 10% medication change rates both had a high level of heterogeneity and no significant BP reduction. CONCLUSIONS: The effectiveness of RDN was demonstrated across a broad range of antihypertensive medications used at baseline after removing the confounder of unplanned medication changes.

Relations between baseline burden, maximum duration, and relative reduction of atrial fibrillation: Insights from continuous monitoring in rhythm control.

INTRODUCTION: Cardiac implantable electronic devices (CIEDs) can measure atrial fibrillation (AF) early; however, the timing for administering antiarrhythmic drugs (AADs) to suppress AF remains unclear. This study aimed to investigate the association between baseline values and changes after AAD in terms of relative reduction of AF burden (RRAB) and maximum AF duration (RRMD). METHODS: This multicenter retrospective study screened all patients with nonpermanent AF who had dual-chamber pacemakers and only enrolled those receiving a naive AAD between September 2009 and December 2014. AF burden and maximum duration were calculated using CIED at 0 and 3 to 6 months after starting rhythm control. All the enrolled patients were divided into four groups according to baseline AF burden. RRAB and RRMD were monitored using CIEDs. RESULTS: Overall, 145 eligible subjects received a naive AAD for nonpermanent AF. The mean RRAB in the four groups (AF burden <1%, 1%-4%, 4%-18%, and ≥18%) were -65.3%, -46.4%, -34.7%, and -27.9% (P = 0.005), respectively. Mean RRMD were -26.8%, -12.4%, 4.2%, and 6.0%, respectively ( P = 0.006). Multivariate analysis revealed that the lowest baseline AF burden (<1%) was significantly associated with greater RRAB, which was not observed in the RRMD model. CONCLUSIONS: Lower baseline AF burden was associated with greater RRAB by AADs. Our finding suggests that rhythm control should be started in the early stage to achieve better responses to AADs.

Is endotracheal intubation a non-beneficial treatment in patients with respiratory failure due to paraquat poisoning?

INTRODUCTION: Paraquat poisoning can result in dysfunction of multiple organs, and pulmonary fibrosis with respiratory failure is the major cause of mortality. For terminally ill patients, some life-prolonging treatments can be non-beneficial treatments (NBT). The objective of this study was to determine if intubation is a NBT for patients with respiratory failure due to paraquat poisoning. METHODS: The study included 68 patients with respiratory failure due to paraquat poisoning. Patients were hospitalized at MacKay Memorial Hospital, Taitung Branch, Taiwan, between 2005 to April 2016. Composite outcomes of intra-hospital mortality, the rate of do-not-resuscitate (DNR) orders, prescribed medications, length of stay, and medical costs were recorded and compared between the do-not-intubate (DNI) group and endotracheal intubation (EI) group. RESULTS: Intra-hospital mortality rate for the entire population was 100%. There were significantly more patients with DNR orders in the DNI group (P = 0.007). There were no differences in the length of hospital stay. However, patients in DNI group had significantly less vasopressor use and more morphine use, shorter time in the intensive care unit, and fewer medical costs. CONCLUSION: The procedure of intubation in patients with respiratory failure due to paraquat poisoning can be considered inappropriate life-prolonging treatment.

Circumferential ablation at the base of the left ventricular papillary muscles: A highly effective approach for ventricular arrhythmias originating from the papillary muscles.

BACKGROUND: Radiofrequency catheter ablation (RFCA) of ventricular arrhythmias (VAs) originating from the left ventricular (LV) papillary muscles (PMs) is challenging. METHODS: We enrolled 16 consecutive patients who received RFCA for VAs from LV PMs. Three-dimensional electroanatomical mapping was used to construct activation and/or pace maps. RFCA was performed first at the earliest activation site or at the best matched site in the pace maps. When an acceleration or reduction in the incidence of VAs was observed during the first few seconds of the application, the ablation energy was delivered continuously for 60-120s. Additional ablation was then circumferentially delivered at the base of the PMs. RESULTS: RFCA was successfully performed in all 16 patients with no cases of recurrence of VAs after a mean follow-up of 20±12months. VAs originated from the anterior (n=8) and posterior (n=8) PMs. Purkinje potentials were identified at the target sites in seven patients. All VAs were temporarily suppressed by one to two long-duration shots of RFCA at the initial targeted site, but recurrence was subsequently noted. In six patients, the QRS morphologies of the VAs changed after the initial RFCA. A subsequent circumferential approach with multiple ablations applied to the base of the PMs completely eliminated all VAs. In all but one patient, successful RFCA was achieved using an open-irrigated ablation catheter. CONCLUSIONS: Circumferential RFCA at the base of the PMs overcame anatomical limitations, leading to a high success rate of RFCA for VAs from LV PMs.