Quantitative analysis reveals influencing factors to facilitate successful anodal-ring capture in left bundle branch pacing.

AIMS: Left bundle branch pacing (LBBP) maintains left ventricular synchrony but induces right ventricular conduction delay (RVCD). Although anodal-ring capture (ARC) during bipolar LBBP improves RVCD, it is not achieved in all patients receiving LBBP. This study aimed to analyze the factors influencing ARC implementation. METHODS AND RESULTS: Patients receiving LBBP with intraoperative ARC testing were enrolled. Electrocardiographic parameters were measured, including stimulus-to-QRS duration (stim-QRSd), stimulus-to-left/right ventricular activation time (stim-LVAT/RVAT), and V6-V1 interpeak interval. The distribution of lead-tip sites was described as the corrected longitudinal and lateral distance (longit-/lat-dist). Relative angles of the LBBP lead were measured. Echocardiography in short-axis view was used to measure the intraseptal lead length. Intergroup comparisons, correlation analysis, and stepwise logistic regression were performed. In total, 105 patients were included, among which 65 (62%) patients achieved ARC at a pacing output ≤ 5.0 V/0.5 ms (average 3.1 V/0.5 ms). Anodal-ring capture further shortened the stim-QRSd by 13.1 ± 7.5 ms. Better unipolar-ring (cathodal) threshold and R-wave sensing in LBBP-ARC group indicated the critical role of ring-septum contact in ARC. Longer corrected longit-dist and shorter corrected lat-dist of lead-tip sites were positively correlated with higher success likelihood of ARC, likely due to the greater relative angle in which the lead enters the septum and consequently the longer intraseptal lead length and better ring-septum contact. CONCLUSION: This study elucidated the factors affecting the success likelihood of LBBP-ARC. These findings improve the understanding of LBBP-ARC, providing references for future research and clinical practice.

Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing.

INTRODUCTION: Left bundle branch area pacing (LBBAP) is achieved by advancing the lead tip deep in the septum. Most LBBAP implants are performed using the Medtronic SelectSecure™ MRI SecureScan™ Model 3830 featuring a unique 4 Fr fixed helix lumenless design. Details of lead use conditions and long-term reliability have not been reported. This study was designed to quantify the mechanical use conditions for the 3830 lead during and after LBBAP implant, and to evaluate reliability using bench testing and simulation. METHODS: Fifty bradycardia patients with implantation of the 3830 lead for LBBAP were enrolled. Use conditions of lead deployment at implantation were collected and computed tomography (CT) scans were performed at 3-month follow-up. Curvature amplitude along the pacing lead was determined with CT images. Fatigue bending was performed using accelerated testing in a more severe environment than routine clinical use conditions. Conductor fracture rate in a simulated patient population was estimated based on clinical use conditions and fatigue test results. RESULTS: The number of attempts to place the 3830 lead for LBBAP was 2.1 ± 1.3 (range: 1-7) with 13 ± 6 lead rotations at the final attempt. Extreme implant conditions were simulated in bench testing with 5 applications of 20 turns followed by up to 400 million bending cycles. Reliability modeling predicted a 10-year fracture rate of 0.02%. CONCLUSIONS: LBBAP implants require more lead rotations than standard pacing implants and result in unique lead bending. Application of simulated LBBAP use conditions to the 3830 lead in an accelerated in-vitro model does not produce excess conductor fractures. IMAGE-LBBP Study ID of ClinicalTrial.GOV: NCT04119323.

Long-term follow-up results of patients with left bundle branch pacing and exploration for potential factors affecting cardiac function.

Background: Left bundle branch pacing (LBBP) is an alternative strategy for His bundle pacing (HBP). This study aimed to analyze the long-term performance of LBBP and the potential factors affecting long-term cardiac function. Methods: Patients with LBBP were continuously enrolled from January 2018 to August 2020. Pacing parameters, electrocardiogram (ECG), and echocardiography were collected. The anatomic position of LBBP leads was described by echocardiographic and fluoroscopic parameters. Results: A total of 91 patients with a median follow-up of 18 months were enrolled. Most patients maintained stable pacing parameters during follow-up. The intra-septal position of the 3830 lead also remained stable as the distance from the lead tip to the left surface of the ventricular septum was 0.4 (0, 1.4) mm. The overall level of left ventricular ejection fraction (LVEF) slightly increased. 59 patients had improved LVEF (∆LVEF > 0), while 28 patients had unchanged or reduced LVEF (∆LVEF ≤ 0). The declines of baseline LVEF, ∆ Paced QRSd, and corrected longitudinal distance (longit-dist) of lead-implanted site correlated with LVEF improvement, and these three factors had negative linear correlations with ∆LVEF. Patients with tricuspid valve regurgitation (TVR) deterioration had longer follow-up duration (20.5 vs. 15.0 months, p = 0.01) and shorter Lead-TVA-dist (18.6 vs. 21.6 mm, p = 0.04) than those without TVR deterioration. Conclusion: Patients with LBBP generally remained stable in pacing performance, anatomic lead positions, and cardiac function in long-term follow-up. Baseline LVEF, ∆ Paced QRSd, and corrected longit-dist might be associated with potential LVEF decrease, which required further confirmation.

Changes of repolarization parameters after left bundle branch area pacing and the association with echocardiographic response in heart failure patients.

Background: Left bundle branch area pacing (LBBAP) has become a safe and effective option for heart failure (HF) patients indicated for cardiac resynchronization therapy (CRT) and/or ventricular pacing, yet the response rate was only 70%. Repolarization parameters were demonstrated to be associated with cardiac mechanics and systolic function. This study aimed to investigate the effects of LBBAP on repolarization parameters and the potential association between those parameters and echocardiographic response. Methods and results: A total of 59 HF patients undergoing successful LBBAP were consecutively included. QTc, Tpeak-Tend (TpTe), and TpTe/QTc were measured before and after the implantation. The results turned out that the dispersion of ventricular repolarization (DVR) improved after LBBAP among the total population. Although trends of repolarization parameters varied according to different QRS configurations at baseline, the post-implant parameters showed no significant difference between groups. The association between repolarization parameters and LBBAP response was then evaluated among patients with wide QRS. Multivariate analysis demonstrated that post-implant TpTe was the independent predictor of LBBAP response (p < 0.05). Receiver operating characteristic analysis indicated an area under the curve of 0.77 (95% CI, 0.60-0.93) with a cutoff value of 81.2 ms (p < 0.01). Patients with post-implant TpTe<81.2 ms had a significantly higher rate of echocardiographic response (93.3 vs. 44.4%, p < 0.01). Further subgroup analysis indicated that the predictive value of post-implant TpTe for LBBAP response was more significant in non-left bundle branch block (LBBB) patients than in LBBB patients. Conclusion: LBBAP improved DVR significantly in HF patients. Post-implant TpTe was associated with the echocardiographic response after LBBAP among patients with wide QRS, especially for non-LBBB patients.

Computed tomography imaging-identified location and electrocardiographic characteristics of left bundle branch area pacing in bradycardia patients.

INTRODUCTION: Left bundle branch area pacing (LBBAP) is a novel physiological pacing modality. The relationship between the pacing lead tip location and paced electrocardiographic (ECG) characteristics remains unclear. The objectives are to determine the lead tip location within the interventricular septum (IVS) and assess the location-based ECG QRS duration (QRSd) and left ventricular activation time (LVAT). METHODS: This multicenter study enrolled 50 consecutive bradycardia patients who met pacemaker therapy guidelines and received LBBAP implantation via the trans-ventricular septal approach. After at least 3 months postimplant, 12-lead ECGs and pacing parameters were obtained. Cardiac computed tomography (CT) imaging was performed to assess the LBBAP lead tip distance from the LV blood pool. RESULTS: Among the 50 patients, analyzable CT images were obtained in 42. In 23 of the 42 patients, the lead tips were within 2 mm to the LV blood pool (the LV subendocardial (LVSE) group), 13 between 2 and 4 mm (the Near-LVSE group), and the remaining 6 beyond 4 mm (the Mid-LV septal (Mid-LVS) group). No significant differences in paced QRSd were found among the three groups (LVSE, 107 ± 15 ms; Near-LVSE, 106 ± 13 ms; Mid-LVS, 104 ± 15 ms; p = .87). LVAT in the LVSE (64 ± 7 ms) was significantly shorter than in the Mid-LVS (72 ± 8 ms; p < .05), but not significantly different from that in the Near-LVSE (69 ± 8 ms; p > .05). CONCLUSION: In routine LBBAP practice, paced narrow QRSd and fast LVAT, indicative of physiological pacing, were consistently achieved for lead tip location in the LV subendocardial or near LV subendocardial region.

The therapeutic effects of upgrade to cardiac resynchronization therapy in pacing-induced cardiomyopathy or chronic right ventricular pacing patients: a meta-analysis.

Pacing-induced cardiomyopathy (PICM) or heart failure accompanied with chronic right ventricular pacing (CRVP-HF) has no established treatments. We aimed to carry out a meta-analysis of published studies about the therapeutic effects of the upgrade to cardiac resynchronization therapy (CRT) in patients of PICM/CRVP-HF. The PUBMED, EMBASE, MEDLINE, OVID databases, and Cochrane Library were systemically searched for relevant publications. Data about the improvements of left ventricular ejection fraction (LVEF), NYHA functional class (NYHA-FC), and the CRT response rate was extracted and synthesized. Mean difference (MD), odds ratio, and standard mean difference (SMD) with 95% confidence interval (CI) were calculated as the effect size by both fixed and random effect models. We included sixteen studies (four about PICM and twelve about CRVP-HF). The total sample size of PICM/CRVP-HF patients was 924. Upgrade to CRT improved the LVEF by 10.87% (95%CI, 8.90 to 12.84%) and reduce the NYHA-FC by around one class (MD, -1.25; 95%CI, -1.43 to -1.06) in PICM/CRVP-HF patients overall. Upgrade to CRT seemed to improve LVEF no less than de-novo CRT (SMD 0.24; 95%CI 0.05 to 0.43; P < 0.05). This meta-analysis suggested that upgrade CRT could improve the cardiac function in PICM/CRVP-HF patients. This strategy may be considered in these patients but require more evidence about the efficacy and procedure-related complications from prospective studies or randomized controlled trials.

Quantitative distance and electrocardiographic parameters for lead-implanted site selection to enhance the success likelihood of left bundle branch pacing.

BACKGROUND: Left bundle branch pacing (LBBP) is a novel near-physiological pacing method that still lacks quantitative criteria to guide the selection of lead-implanted sites to enhance the success likelihood of lead deployments. This study aimed to quantitatively analyze the relationships of LBBP success likelihood to the distribution of lead-implanted sites and the lead-localization-pacing electrocardiographic (ECG) features. METHODS: All the lead-implanted sites in patients with finally successful LBBP were enrolled for analysis, including successful and failed sites. A novel coordinate system was invented to describe the sites' distribution as longitudinal distance (longit-dist) and lateral distance (lat-dist). Corrected distance parameters were generated to eliminate the cardiac dimension variations. The lead-localization-pacing ECG parameters were also collected, such as paced QRS duration (locat-QRSd), left ventricular activation time (locat-LVAT), LVAT/QRSd ratio (locat-LVAT/QRSd), and QRS directions. RESULTS: A total of 94 patients with 105 successful sites and 93 failed sites were enrolled. Longit-dist and corrected longit-dist of successful sites were significantly longer, while locat-QRSd and locat-LVAT were shorter and locat-LVAT/QRSd was lower than failed sites. There was a positive dose-response relationship between LBBP success likelihood and corrected longit-dist with a cut-off of 26.95 mm, whereas there were negative dose-response relationships of LBBP success likelihood to locat-QRSd, locat-LVAT, and locat-LVAT/QRSd with the cut-offs of 142 ms, 92 ms, and 64.7%, respectively. Downward QRS direction in II/III ECG leads was also associated with successful LBBP. CONCLUSION: Longit-dist, locat-QRSd, locat-LVAT, and locat-LVAT/QRSd were quantitative parameters to guide the selection of lead-implanted sites during LBBP implantation. Quantitative distance and electrocardiographic parameters for lead-implanted site selection to enhance the success likelihood of left bundle branch pacing. LBBP, left bundle branch pacing; Longit-dist, longitudinal distance; CL-apex-dist, distance from contraction line to apex; LBBB, left bundle branch block; IVCD, intraventricular conduction delay; Locat-QRSd, lead-localization-pacing QRS duration; Locat-LVAT, lead-localization-pacing left ventricular activation time; Locat-LVAT/QRSd, lead-localization-pacing LVAT/QRSd ratio.

Formaldehyde reinforces pro-inflammatory responses of macrophages through induction of glycolysis.

Formaldehyde (FA) is widely used in chemical industry, which is also known as a common indoor air pollutant. Exposure of FA has been associated with multiple detrimental health effects. Our previous study showed that FA could inhibit the development of T lymphocytes in mice, leading to impaired immune functions. Macrophages are important innate immune cells which trigger inflammatory responses in tissues. In the present study, FA exposure at 2.0 mg/m3 was found to enhance the pro-inflammatory responses of macrophages in male BALB/c mice, which was confirmed by elevated pro-inflammatory cytokine release and NO secretion in macrophages isolated from the FA-exposed mice and in vitro macrophage models upon lipopolysaccharide stimulation. Glycolysis is the key metabolic process for the classical activation of macrophages, which was found to be elevated in the in vitro macrophage models treated with FA at 50 and 100 µM concentrations for 18 h. HIF-1α and the associated proteins in its signaling cascade, which are known to mediate glycolytic metabolism and inflammatory responses, were found to be upregulated by 50 and 100 µM FA in THP-1 derived and RAW264.7 macrophage models, and the enhanced pro-inflammatory responses induced by 100 µM FA were reversed by inhibitory compounds interfering with glucose metabolism or suppressing HIF-1α activity. Collectively, the results in this study revealed that FA could enhance the pro-inflammatory responses of macrophages through the induction of glycolysis, which outlined the FA-triggered metabolic and functional alterations in immune cells.

The incidence and location of epicardial connections in the era of contact force guided ablation for pulmonary vein isolation.

BACKGROUND: The effects of epicardial connections (ECs) involving pulmonary veins (PVs) in atrial fibrillation (AF) ablation have been revealed recently. However, no systematic approaches to identify and ablate the ECs were established. METHODS: Patients with AF undergoing radiofrequency (RF) catheter ablation were retrospectively analyzed. ECs were identified when (1) PV isolation (PVI) cannot be achieved after first-pass isolation; (2) PVI was still absent although the conduction gap was detected and ablated; (3) the earliest activation area (EAA) was revealed located within the PV antrum distant from the initial ablation line using high-density mapping (HDM) technique; (4) focal ablation at the EAA was effective to achieve PVI. Relevant pacing maneuvers were performed to elucidate ECs' bidirectional conduction. RESULTS: Overall, 36 ECs were identified and ablated in 35/597 (5.86%) patients. Among the 35 patients with ECs, at least one PV insertion of ECs was located at the carina region. The most common pattern was a single breakthrough in 31 (88.6%) patients, followed by multiple breakthroughs in 3 and wide breakthroughs in 1. The median distance from EAA to the initial ablation line was 10.0 mm. The average number of RF energy delivery was 1.75 ± 1.00, and single RF delivery was adequate in 16/36 (44.4%) patients. Continuous potentials were present at the EAA in 9/34 (26.5%) patients. CONCLUSION: ECs were confirmed and ablated successfully in 5.86% (35/597) AF patients using HDM. PV insertions of ECs were mainly located at the carina region. Continuous potentials might assist in the prediction of ECs.

Relationship of paced left bundle branch pacing morphology with anatomic location and physiological outcomes.

BACKGROUND: Left bundle branch pacing (LBBP) is an emerging physiological pacing modality. However, little is known about pacing at different locations on the left bundle branch (LBB). OBJECTIVE: The purpose of this study was to explore pacing and physiological characteristics associated with different LBBP locations. METHODS: The study included 68 consecutive patients with normal unpaced QRS duration and successful LBBP implantation. Patients were divided into 3 groups according to the paced QRS complex as left bundle branch trunk pacing (LBTP), left posterior fascicular pacing (LPFP), or left anterior fascicular pacing (LAFP). Electrocardiographic (ECG) characteristics, pacing parameters, and fluoroscopic localization were collected and analyzed. RESULTS: There were 17 (25.0%), 35 (51.5%), and 16 (23.5%) patients in the LBTP, LPFP, and LAFP groups, respectively. All subgroups had relatively narrow paced QRS complex (128.6 ± 9.1 ms vs 133.7 ± 11.2 ms vs 134.8 ± 9.6 ms; P = .170), fast left ventricular activation (70.4 ± 9.0 ms vs 70.6 ± 10.2 ms vs 71.0 ± 9.0 ms; P = .986), as well as low and stable pacing thresholds. Delayed right ventricular activation and interventricular dyssynchrony were similar between groups. Fluoroscopic imaging indicated that the lead tip was located most commonly in the basal-middle region of the septum (67.7%), and this was independent of paced QRS morphology group (88.2% vs 57.1% vs 68.8%; P = .106). CONCLUSION: Pacing at different sites of the LBB resulted in similar intraventricular and interventricular electrical synchrony in patients with an intact conduction system. Fluoroscopic imaging alone could not predict specific LBBP paced ECG morphology.

Efficiency, Safety, and Efficacy of High-Power Short-Duration Radiofrequency Ablation in Patients with Atrial Fibrillation.

Pulmonary vein isolation (PVI) is the cornerstone therapy of atrial fibrillation (AF). Radiofrequency catheter ablation (RFCA) is performed using a point-by-point method to achieve durable PVI. However, this procedure remains complex and time-consuming, and the long-term clinical outcomes are still not satisfactory. Recently, there has been increasing interest in the clinical application of high-power short-duration (HPSD) approaches in the field of RFCA. HPSD ablation, distinguishing it from the conventional ablation strategy, delivers RF energy at a high power and saves the dwell time at each site. It is unknown whether the HPSD approach can bring some gratifying changes in the field of RF energy ablation. A number of experimental studies and clinical studies have been conducted regarding this topic. The review aimed to summarize the research findings and evaluate the procedural efficiency, safety, and clinical outcomes of the HPSD approach based on the evidence available to date.

Feasibility and efficacy of left bundle branch area pacing in patients indicated for cardiac resynchronization therapy.

AIMS: The present study was to evaluate the feasibility and clinical outcomes of left bundle branch area pacing (LBBAP) in cardiac resynchronization therapy (CRT)-indicated patients. METHODS AND RESULTS: LBBAP was performed via transventricular septal approach in 25 patients as a rescue strategy in 5 patients with failed left ventricular (LV) lead placement and as a primary strategy in the remaining 20 patients. Pacing parameters, procedural characteristics, electrocardiographic, and echocardiographic data were assessed at implantation and follow-up. Of 25 enrolled CRT-indicated patients, 14 had left bundle branch block (LBBB, 56.0%), 3 right bundle branch block (RBBB, 12.0%), 4 intraventricular conduction delay (IVCD, 16.0%), and 4 ventricular pacing dependence (16.0%). The QRS duration (QRSd) was significantly shortened by LBBAP (intrinsic 163.6 ± 29.4 ms vs. LBBAP 123.0 ± 10.8 ms, P < 0.001). During the mean follow-up of 9.1 months, New York Heart Association functional class was improved to 1.4 ± 0.6 from baseline 2.6 ± 0.6 (P < 0.001), left ventricular ejection fraction (LVEF) increased to 46.9 ± 10.2% from baseline 35.2 ± 7.0% (P < 0.001), and LV end-diastolic dimensions (LVEDD) decreased to 56.8 ± 9.7 mm from baseline 64.1 ± 9.9 mm (P < 0.001). There was a significant improvement (34.1 ± 7.4% vs. 50.0 ± 12.2%, P < 0.001) in LVEF in patients with LBBB. CONCLUSION: The present study demonstrates the clinical feasibility of LBBAP in CRT-indicated patients. Left bundle branch area pacing generated narrow QRSd and led to reversal remodelling of LV with improvement in cardiac function. LBBAP may be an alternative to CRT in patients with failure of LV lead placement and a first-line option in selected patients such as those with LBBB and heart failure.

Rapid rehabilitation technique with integrated traditional Chinese and Western medicine promotes postoperative gastrointestinal function recovery.

BACKGROUND: During the perioperative period, the characteristic therapy of traditional Chinese medicine is effective in improving postoperative rehabilitation. In large-scale hospitals practicing traditional Chinese medicine, there is accumulating experience related to the promotion of fast recovery in the perioperative period. AIM: To evaluate the efficacy and safety of Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique. METHODS: This prospective, multicenter, randomized, controlled study included two groups: Treatment group and control group. The patients in the treatment group and control group received Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique and routine treatment, respectively. Clinical observation regarding postoperative recovery of gastrointestinal function was performed, including the times to first passage of flatus, first defecation, and first normal bowel sounds. The comparison between groups was conducted through descriptive analysis, χ 2, t, F, and rank-sum tests. RESULTS: There was a statistically significant difference in the time to postoperative first defecation between the treatment and control group (87.16 ± 32.09 vs 109.79 ± 40.25 h, respectively; P < 0.05). Similarly, the time to initial recovery of bowel sounds in the treatment group was significantly shorter than that in the control group (61.17 ± 26.75 vs 79.19 ± 33.35 h, respectively; P < 0.05). However, there was no statistically significant difference in the time to initial exhaust between the treatment and control groups (51.54 ± 23.66 vs 62.24 ± 25.95 h, respectively; P > 0.05). The hospitalization expenses for the two groups of patients were 62283.45 ± 12413.90 and 62059.42 ± 11350.51 yuan, respectively. Although the cost of hospitalization was decreased in the control group, the difference was not statistically significant (P > 0.05). This clinical trial was safe without reports of any adverse reaction or event. CONCLUSION: The rapid rehabilitation technique with integrated traditional Chinese and Western medicine promotes the recovery of postoperative gastrointestinal function and is significantly better than standard approach for patients after colorectal surgery.

Bilateral Bundle Branch Area Pacing to Achieve Physiological Conduction System Activation.

BACKGROUND: Left bundle branch pacing (LBBP) is a technique for conduction system pacing, but it often results in right bundle branch block morphology on the ECG. This study was designed to assess simultaneous pacing of the left and right bundle branch areas to achieve more synchronous ventricular activation. METHODS: In symptomatic bradycardia patients, the distal electrode of a bipolar pacing lead was placed at the left bundle branch area via a transventricular-septal approach. This was used to pace the left bundle branch area, while the ring electrode was used to pace the right bundle branch area. Bilateral bundle branch area pacing (BBBP) was achieved by stimulating the cathode and anode in various pacing configurations. QRS duration, delayed right ventricular activation time, left ventricular activation time, and interventricular conduction delay were measured. Pacing stability and short-term safety were assessed at 3-month follow-up. RESULTS: BBBP was successfully performed in 22 of 36 patients. Compared with LBBP, BBBP resulted in greater shortening of QRS duration (109.3±7.1 versus 118.4±5.7 ms, P<0.001). LBBP resulted in a paced right bundle branch block configuration, with a delayed right ventricular activation time of 115.0±7.5 ms and interventricular conduction delay of 34.0±8.8 ms. BBBP fully resolved the right bundle branch block morphology in 18 patients. In the remaining 4 patients, BBBP partially corrected the right bundle branch block with delayed right ventricular activation time decreasing from 120.5±4.7 ms during LBBP to 106.1±4.2 ms during BBBP (P=0.005). CONCLUSIONS: LBBP results in a relatively narrow QRS complex but with an interventricular activation delay. BBBP can diminish the delayed right ventricular activation, producing more physiological ventricular activation. Graphic Abstract: A graphic abstract is available for this article.

Recovery of complete left bundle branch block following heart failure improvement by left bundle branch pacing in a patient.

A 57-year-old male presented with symptomatic systolic heart failure and complete left bundle branch block (LBBB). Left bundle branch pacing corrected LBBB at a low capture threshold (0.5V @0.4ms) with right bundle branch conduction delay and paced QRS morphology changed to near-normal by adjusting AV delay with diminished RBBD. At 1-year follow-up, the patient had a significant improvement in heart failure and LBBB automatically resolved with a rate-dependent pattern. LBBP may be an alternative to conventional cardiac resynchronization therapy with the likelihood of recovery of LBBB. More research is needed to evaluate the potential use of this pacing strategy in patients with LBBB and heart failure.

Effect of Yikou-Sizi powder hot compress on gastrointestinal functional recovery in patients after abdominal surgery: Study protocol for a randomized controlled trial.

BACKGROUND: Postoperative gastrointestinal dysfunction (PGD) is a common complication of patients who have undergone surgery. The clinical manifestations cause great discomfort to postoperative patients and can severely affect postoperative recovery. However, although various pharmacologic agents have been explored for several years, success has been limited. Because some commonly used drugs have caused adverse reactions and because abdominal surgery patients generally cannot consume food or medication during the perioperative period, we were prompted to try an external Chinese medicine treatment method. Yikou-Sizi powder hot compress is an efficient therapy in our hospital, but there is a lack of rigorous studies to certify the safety and effectiveness of its external use to improve gastrointestinal motility. This study aimed to introduce the clinical trial design and test the ability of Yikou-Sizi powder hot compress treatment to accelerate gastrointestinal functional recovery after abdominal surgery. METHODS: This study is a randomized controlled clinical trial. The participants will undergo laparoscopic colorectal cancer surgery and laparoscopic total hysterectomy. The primary outcome measure will be the gastrointestinal functional evaluation index, including the time to first passage of flatus, first defecation, first normal bowel sounds, and first consumption of liquid/semigeneral diet foods. According to good clinical practice (GCP), we will evaluate the clinical efficacy and safety of Yikou-Sizi powder hot compress and objectively study the acting mechanism of ghrelin. This pilot trial will be a standard, scientific, and clinical study designed to evaluate the effect of Yikou-Sizi powder hot compress for the recovery of gastrointestinal function after surgery and determine its overall safety. DISCUSSION: This is the first study to describe the use of Yikou-Sizi powder hot compress to accelerate the recovery of gastrointestinal function after abdominal surgery. The study is designed as a randomized, controlled, clinical, large sample size and pilot trial. Evaluation will consist of combining the primary outcome measures with secondary outcome measures to ensure the objectivity and scientific validity of the study. Due to the observational design and the limited follow-up period, it is not possible to evaluate to what extent the connection between the observed improvement and the interventions represents a causal relationship. Efficient comparison between groups will be analyzed by chi-square test.

Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial.

BACKGROUND: Most patients who undergo abdominal surgery recover bowel movements within a week; however, some suffer prolonged intestinal paralysis or postoperative ileus (POI) leading to complications, such as infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. Chinese medicine is effective for accelerating the recovery of gastrointestinal function after abdominal surgery. Xiangbin prescription (XBP) is the standard prescription for this purpose in our hospital; however, randomized controlled trials of it have not yet been conducted. METHODS/DESIGN: This double-blind, randomized controlled clinical trial aims to recruit patients who have undergone abdominal surgery and experienced postoperative dysmotility to evaluate the efficacy and safety of XBP for preventing POI and accelerating recovery. The research will tackle the common problem of slow recovery of gastrointestinal function after surgery. The participants will be patients who undergo laparoscopic radical resection of rectal carcinoma or laparoscopic panhysterectomy of a benign lesion. Primary outcome measures will be time to first flatus, defecation, normal bowel sounds, and liquid/semi-liquid/general diet. Good Clinical Practice (GCP) standards of efficacy and safety will also be evaluated, along with objective investigation of the mechanism of action of ghrelin. DISCUSSION: This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of XBP for the recovery of gastrointestinal function after surgery, and it will conform to international standards for clinical trials for the recognition of traditional Chinese medicine. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR-TRC-14004156 . Registered on 3 January 2014.

Predictive value of unipolar and bipolar electrograms in idiopathic outflow tract ventricular arrhythmia mapping and ablation.

INTRODUCTION: Radiofrequency catheter ablation is an effective therapy for focal idiopathic outflow tract ventricular arrhythmia (OTVA). However, visual inspection of the unipolar electrogram (EGM) QS morphology is subjective with a poor specificity for predicting successful ablation sites. This study aims to evaluate the predictive value of unipolar and bipolar EGMs in OTVA mapping and ablation. METHODS AND RESULTS: Twenty-two patients scheduled for idiopathic OTVA ablation were prospectively enrolled. During the procedure, unipolar and bipolar EGMs were recorded simultaneously and visually inspected by the operator to identify their values for predicting arrhythmogenic sites. Quantitative features of the unipolar EGM including the ratio of amplitude of the first positive peak versus the nadir (R-ratio), the maximum descending slope (MaxSlope), and the time interval between the initial deflection point to the MaxSlope (D-Max) were calculated for each target site in offline analysis. EGMs from 100 sites were collected in 20 patients and analyzed. The bipolar reverse polarity characteristic was not as practical for identifying successful ablation site as the unipolar QS characteristic. Successful ablation sites demonstrated smaller R-ratio and shorter D-Max than unsuccessful sites, but no significant difference in MaxSlope. A unipolar EGM-derived quantitative criterion provided significantly better specificity (0.70) than visual inspection (0.37) without compromising on the sensitivity (0.83 vs. 0.89). CONCLUSION: The bipolar reverse polarity characteristic was not a practical method for identifying target in idiopathic OTVA ablation. The unipolar EGM-derived quantitative criteria have better predictive performance than visual inspection of the QS characteristic and are likely to reduce unnecessary ablation sites.