Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study.

BACKGROUND: The optimal right ventricular pacing site for patients requiring pacemaker implantation for permanent atrioventricular block is a matter of debate. Long-term right ventricular apical pacing has been associated with left ventricular ejection fraction impairment and heart failure. Right ventricular septal pacing has been proposed as an alternative. AIM: The aim of this randomized prospective multicentre trial was to compare left ventricular remodelling and outcomes between right ventricular apical and septal pacing after mid-term follow-up. METHODS: Patients requiring pacemaker implantation for high-degree atrioventricular block were enrolled and randomized in a 1:1 fashion to receive a right ventricular apical or septal lead. RESULTS: A total of 141 patients were included, 69 in the septal group and 72 in the apical group. Both groups exhibited similar left ventricular ejection fractions after 18 months of follow-up (septal 57.1±11.9% vs. apical 57.4±13.4%), and left ventricular ejection fraction variation was similar in the two groups at the end of follow-up (septal -1.5±13.2% vs. apical 0.3±13.3%). Additionally, left ventricular volume, quality of life and 6-minute walk distance were similar in the two groups. However, patients in the septal group were more likely to be asymptomatic, with a significantly lower concentration of N-terminal prohormone of brain natriuretic peptide. Lastly, lead position did not impact 18-month survival. CONCLUSION: Pacing from the right ventricular apex does not have any detrimental effect on left ventricular systolic function compared with septal pacing over an 18-month period.

His bundle pacing: A promising alternative strategy for anti-bradycardic pacing - report of a single-center experience.

His bundle pacing (HBP) is proven to be a safe and effective alternative pacing modality that, in addition, avoids pacemaker-induced cardiomyopathy (PICM) by achieving a "physiological" ventricular stimulation, via the native conduction system. Indications include various causes of bradycardia requiring anti-bradycardic pacing, inadequately controlled atrial fibrillation requiring AV node ablation and established PICM. In addition, HBP may also be used as an alternative therapy for patients with heart failure (HF) and an indication for cardiac resynchronization therapy (CRT). Available data show several advantages of HBP with regard to preservation or restoration of intra- and inter-ventricular synchronization; improvement in left ventricular ejection fraction, functional status and quality of life; decrease in atrial fibrillation incidence and improvement in HF hospitalization rates, compared with conventional pacing. Nevertheless, superiority in terms of mortality rates has not been consistently demonstrated, and the long-term efficacy and safety of HBP remain to be proven. In the present manuscript, we review the status of HBP and present our current experience with this novel pacing modality.

Treatment of atypical pacemaker-mediated tachycardia with ablation of the retrograde atrioventricular nodal pathway.

A 25-year-old runner received a single-lead, VDD pacemaker after ablation of AV nodal reentrant tachycardia complicated by intermittent AV block. The rate-adaptive AV delay algorithm (RAAV), which shortens the sensed AV interval (SAV) at faster atrial rates, was programmed to provide a physiologic SAV with exercise. She developed repetitive, atypical, long-RP pacemaker-mediated tachycardia (PMT) because the RAAV shortened the antegrade SAV and retrograde conduction occurred over the slow AV nodal pathway. PMT was refractory to usual programming solutions. Using high-density electroanatomic mapping, we were able to ablate the retrograde limb of PMT without further damaging AV conduction.

Electrogram-only guided approach to His bundle pacing with minimal fluoroscopy: A single-center experience.

INTRODUCTION: His bundle pacing (HBP) is the most physiological pacing. The standard technique based on fluoroscopic approach might be challenging and fluoro consuming. Targeting the His guided exclusively by the electrical signals could enable a precise lead implant, thus reducing fluoroscopy time (FT) and X-ray dose, desirable both for patients and operators. The aim of the study is to evaluate the feasibility, efficacy, and safety both acutely and at 30 days of the electrogram (EGM)-guided HBP with minimal or no fluoroscopy. METHODS AND RESULTS: Between October and December 2018, 41 consecutive patients underwent EGM-guided HBP. Successful HBP was obtained in 39 (95%) patients, (30 males, 78 ± 10 years). Selective HBP (S-HBP) was achieved in 23 (59%), nonselective HBP (NS-HBP) in 16 (41%) patients. The final HBP lead position was reached in 31 (79.4%) patients without fluoroscopy, only guided by electrical signals. In eight patients a minimal fluoroscopy (mean, 8 seconds) has been required. The sheath's cutting and the slack of the lead were routinely performed under fluoroscopy. No difference was observed in FT for HBP lead placement in S-HBP and NS-HBP (mean, 8.1 ± 25 vs 7.5 ± 20 seconds, P = .8; median value 0 vs 0 seconds). No differences were observed in FT for the entire procedure, total dose area product and total procedural time in S-HBP and NS-HBP. Lead dislodgement occurred in one (2.6%) patient 1 day after the procedure. CONCLUSIONS: HBP could be performed safely and efficiently using the EGMs, with minimal or no fluoroscopy. Fluoroscopy was required during sheath removal and atrial lead placement.

Quality of life of patients undergoing conventional vs leadless pacemaker implantation: A multicenter observational study.

BACKGROUND: Leadless pacemakers (L-PM) are an emerging effective and safe technology that offer an alternative to conventional pacemakers (C-PM) for right ventricular stimulation. However, there is little information about their potential benefits for quality of life (QoL) in patients with L-PM. We compared QoL between patients with L-PM and C-PM. METHODS: The study population comprised patients undergoing single chamber pacemaker implantation from December 2016 to March 2018. The SF-36 questionnaire was used to evaluate QoL at baseline and at 6 months of followup. We also used a questionnaire consisted of 10 specific questions related to the implant procedure. RESULTS: A total of 106 patients (64 C-PM; 42 L-PM) were included. There were no differences in baseline characteristics between the groups (C-PM vs L-PM), except for age (81.5 vs 77.3 years; P = .012) and diabetes (38% vs 17%; P = .021). Baseline SF-36 scores did not differ between the groups. At 6 months followup, patients in the L-PM group scored significantly higher on physical function (63 vs 42; P < .001), physical role (64 vs 36; P = .004), and mental health (75 vs 65; P = .017), even after adjusting for covariates. Pacemaker-related discomfort and physical restrictions were significantly lower for the L-PM group. CONCLUSION: L-PM is associated with better QoL than C-PM in both physical and mental health. Patients undergoing L-PM implantation reported less procedure-related discomfort, physical restriction, and preoccupation.

Left bundle branch pacing utilizing three dimensional mapping.

INTRODUCTION: Permanent His bundle pacing is feasible and effective in patients with atrioventricular block or left bundle branch block. However, pacing thresholds to capture the distal His bundle is often higher. Recently left bundle branch area pacing (LBBP) has been shown to be feasible by advancing the lead transvenously, deep into the interventricular septum to reach the left ventricular endocardial surface. In this article we describe the utility of three dimensional (3D) mapping to achieve LBBP. METHODS: Ensite Precision (Abbott) mapping system was used to perform LBBP. A decapolar catheter was used to create 3D map of right atrium and right ventricle (RV). Regions of interest (His bundle, potential LBBP sites of interest in RV) were tagged in the 3D map. The LBBP lead was implanted utilizing the 3D map. The lead depth in the septum was assessed in the 3D map. RESULTS: LBBP was performed in three patients: chronic LBBB and intermittent 2:1 atrioventricular block; atrioventricular (AV) node ablation and conduction system pacing; and bifascicular block and intermittent AV block in a patient with severe left ventricular hypertrophy. LBBP was successful in all three patients. The lead depth in the interventricular septum was 12, 11, and 21 mm, respectively as assessed by 3D mapping. CONCLUSIONS: Three-dimensional mapping was helpful in achieving LBBP in patients with LBBB, severe left ventricular hypertrophy or during AV node ablation. 3D mapping also facilitated easy assessment of lead depth during and after lead fixation. 3D mapping techniques may be a valuable tool to reduce the learning curve of implanters with minimal experience in LBBP.

Safety and compatibility of smart device heart rhythm monitoring in patients with cardiovascular implantable electronic devices.

INTRODUCTION: Emerging medical technology has allowed for monitoring of heart rhythm abnormalities using smartphone compatible devices. The safety and utility of such devices have not been established in patients with cardiac implantable electronic devices (CIEDs). We sought to assess the safety and compatibility of the Food and Drug Administration-approved AliveCor Kardia device in patients with CIEDs. METHODS AND RESULTS: We prospectively recruited patients with CIED for a Kardia recording during their routine device interrogation. A recording was obtained in paced and nonpaced states. Adverse clinical events were noted at the time of recording. Electrograms (EGMs) from the cardiac device were obtained at the time of recording to assess for any electromagnetic interference (EMI) introduced by Kardia. Recordings were analyzed for quality and given a score of 3 (interpretable rhythm, no noise), 2 (interpretable rhythm, significant noise) or 1 (uninterpretable). A total of 251 patients were recruited (59% with a pacemaker and 41% with ICD). There were no adverse clinical events noted at the time of recording and no changes to CIED settings. Review of all EGMs revealed no EMI introduced by Kardia. Recordings were correctly interpreted in 90% of paced recordings (183 had a score of 3, 43 of 2, and 25 of 1) and 94.7% of nonpaced recordings (147 of 3, 15 of 2, and 9 of 1). CONCLUSION: The AliveCor Kardia device has an excellent safety profile when used in conjunction with most CIEDs. The quality of recordings was preserved in this population. The device, therefore, can be considered for heart rhythm monitoring in patients with CIEDs.

Deep Negative Deflection in Unipolar His-Bundle Electrogram as a Predictor of Excellent His-Bundle Pacing Threshold Postimplant.

Background His-bundle pacing (HBP) is a physiological form of pacing. Although high capture thresholds are common, few predictors of low HBP threshold have been determined. We aimed to identify electrophysiological predictors. Methods Fifty-one patients (53% with atrioventricular block) underwent HBP for bradycardia with an intrinsic QRS duration of <120 ms. Attempts to anchor the HBP lead were guided by unipolar His-bundle electrograms (HB EGMs) recorded with an electrophysiology recording system. Patients were followed-up for >6 months. Results In total, 153 attempts at anchoring the HBP lead were made, of which, 45 achieved acceptable HBP thresholds (≤2.5 V at 1 ms). The amplitude of negative deflection in HB EGM and the selective HBP form at fixation were independently associated with achieving an acceptable threshold. A negative amplitude of ≥0.060 mV in HB EGM was determined as the optimal value for identifying the acceptable threshold. This deep negative HB EGM was recorded with an HBP threshold of 1.4±1.3 V (in 34 attempts), significantly lower than that of positive HB EGM without deep negative deflection (2.8±1.3 V, in 31 trials; or >5 V, in 38 trials). The permanent HBP lead remained with deep negative (≥0.060 mV) or positive HB EGMs in 28 and 14 patients, respectively, and with positive or negative HB injury current in 19 and 23 patients, respectively. During follow-up, increased HBP threshold of >1 V was significantly more prevalent in the positive HB EGM group. The HBP thresholds of deep negative HB EGM and HB injury current, but not of the selective HBP group, were significantly lower than the other subgroups during follow-up. Conclusions Deep negative HB EGM at fixation was associated with an excellent short-term HBP threshold, similar to HB injury current. Analysis of unipolar HB EGM postfixation may enable prediction of permanent HBP threshold.

Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping: A Feasibility Study.

BACKGROUND: Conventional permanent His Bundle pacing (PHBP) can be challenging and associated with high fluoroscopy exposure. The aim of this study was to assess the feasibility and safety of performing low fluoroscopy PHBP using 3-dimensional electroanatomic mapping and comparing outcomes with conventional fluoroscopy guided PHBP implants. METHODS: PHBP was performed at 2 centers using electroanatomic mapping-guided low fluoroscopy implantation in 10 patients using a novel protocol (group 1) and conventional fluoroscopy guided implantation in 20 patients (group 2). The primary end point was feasibility of achieving PHBP with low/zero fluoroscopy and safety end points included total radiation exposure (fluoroscopy time and dose area product), procedure-related complications associated with lead implantation or need for lead revisions. RESULTS: PHBP was successful in 9 of 10 patients (90%) in group 1 and 100% successful in the group 2 patients. The mean His lead fluoroscopy time was significantly lower in group 1 (0.2±0.2 minutes) compared with 8±7 minutes in group 2 ( P=0.002) as was the total fluoroscopy time (0.8±0.3 versus 13±8 minutes, P=0.003) and the dose area product (96±83 versus 1531±923 microGy/m2, P=0.003). The HB capture threshold was lower in group 1 (0.7±0.4 at 1 ms) compared with patients in group 2 (1.15±0.7 at 1 ms) P=0.04. There were no procedure-related complications or lead dislodgements in either group. There was an increase in HB capture threshold in 1 patient (5%) in group 2 at 1-month follow-up. CONCLUSIONS: Electroanatomic mapping-guided PHBP is feasible can be performed safely and results in a significant reduction in fluoroscopy duration and exposure.

Cardiac implantable electronic device and vascular access: Strategies to overcome problems.

For arrhythmia treatment or sudden cardiac death prevention in hemodialysis patients, there is a frequent need for placement of a cardiac implantable electronic device (pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization device). Leads from a cardiac implantable electronic device can cause central vein stenosis and carry the risk of tricuspid regurgitation or contribute to infective endocarditis. In patients with end-stage kidney disease requiring vascular access and cardiac implantable electronic device, the best strategy is to create an arteriovenous fistula on the contralateral upper limb for a cardiac implantable electronic device and avoidance of central vein catheter. Fortunately, cardiac electrotherapy is moving toward miniaturization and less transvenous wires. Whenever feasible, one should avoid transvenous leads and choose alternative options such as subcutaneous implantable cardioverter defibrillator, epicardial leads, and leadless pacemaker. Based on recent reports on the leadless pacemaker/implantable cardioverter defibrillator effectiveness, in patients with rapid progression of chronic kidney disease (high risk of renal failure) or glomerular filtration rate <20 mL/min/1.73 m2, this option should be considered by the implanting cardiologist for future access protection.

Analysis of arrhythmic events is useful to detect lead failure earlier in patients followed by remote monitoring.

BACKGROUND: Remote monitoring (RM) has been advocated as the new standard of care for patients with cardiovascular implantable electronic devices (CIEDs). RM has allowed the early detection of adverse clinical events, such as arrhythmia, lead failure, and battery depletion. However, lead failure was often identified only by arrhythmic events, but not impedance abnormalities. OBJECTIVE: To compare the usefulness of arrhythmic events with conventional impedance abnormalities for identifying lead failure in CIED patients followed by RM. METHODS: CIED patients in 12 hospitals have been followed by the RM center in Okayama University Hospital. All transmitted data have been analyzed and summarized. RESULTS: From April 2009 to March 2016, 1,873 patients have been followed by the RM center. During the mean follow-up period of 775 days, 42 lead failure events (atrial lead 22, right ventricular pacemaker lead 5, implantable cardioverter defibrillator [ICD] lead 15) were detected. The proportion of lead failures detected only by arrhythmic events, which were not detected by conventional impedance abnormalities, was significantly higher than that detected by impedance abnormalities (arrhythmic event 76.2%, 95% CI: 60.5-87.9%; impedance abnormalities 23.8%, 95% CI: 12.1-39.5%). Twenty-seven events (64.7%) were detected without any alert. Of 15 patients with ICD lead failure, none has experienced inappropriate therapy. CONCLUSIONS: RM can detect lead failure earlier, before clinical adverse events. However, CIEDs often diagnose lead failure as just arrhythmic events without any warning. Thus, to detect lead failure earlier, careful human analysis of arrhythmic events is useful.

Atrioventricular node ablation and His bundle pacing.

AIMS: Atrioventricular node ablation (AVNA) and right ventricular pacing (RVP) are effective therapies for patients with atrial fibrillation (AF) and rapid ventricular rates. His bundle pacing (HBP) is a physiologic alternative to RVP. The aim of our study is to assess the feasibility and safety of HBP in patients undergoing AVNA and its effect on left ventricular (LV) function. METHODS AND RESULTS: Permanent HBP is the preferred form of ventricular pacing at our institute. Atrioventricular node ablation and HBP were performed in patients with AF and difficulty in rate control. His bundle pacing implant characteristics and thresholds were recorded. Fluoroscopic relationship of AVNA site to HBP lead electrodes was documented. Left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) functional class at baseline and during follow-up were assessed. Forty-two patients underwent HBP and AVNA: age 74 ± 11 years; men 45%; HTN 64%; DM 19%; CAD 36%; permanent AF 40%; cardiomyopathy 55%. His bundle pacing was successful in 40 of 42 patients (95%). Successful AVNA site was at or below the ring electrode in 22 (no acute change in HBP threshold); above the ring electrode in 13 and left side in 2 pts (acute increase in HBP threshold in 7 of 15 pts). Final HBP threshold at implant was 1 ± 0.8 V@1 ms and increased to 1.6 ± 1.2 V@1 ms during a mean follow-up of 19 ± 14 months. Left ventricular ejection fraction increased from 43 ± 13% to 50 ± 11% (P = 0.01). New York Heart Association functional status improved from 2.5 ± 0.5 to 1.9 ± 0.5 (P = 0.04). CONCLUSION: Atrioventricular node ablation and HBP were successful in 95% of patients. His bundle pacing lead characteristics remained relatively stable. Left ventricular ejection fraction improved significantly during follow-up. His bundle pacing is feasible, safe and effective in pts undergoing AVNA.

A devices' game of thrones: cardiac resynchronization therapy vs. pacemaker.

AIMS: Oversensing can interfere with biventricular pacing. Cardiac Resynchronization Therapy (CRT) output inhibition due to automatic brady mode change from a sensing to a pacing mode of a previously implanted pacemaker as it reached battery capacity depleted indicator has not been previously published in the medical literature. METHODS AND RESULTS: We report the first case of CRT output inhibition in a pacemaker dependent patient due to electrical stimuli from a previously right-sided implanted pacemaker, after unaware reversion of OVO mode (O = no chambers paced; V = ventricular sensing; O = no response to sensing) to backup VVI (V = ventricular pacing; V = ventricular sensing; I = inhibitory response to sensing) when it reached the elective replacement interval. CONCLUSION: This paper emphasizes the importance of knowing the distinct pacemaker brady mode behaviours after battery capacity depleted indicator has been reached, according to the pacemakers' manufacturer, including the possibility of automatic brady mode change from sensing to pacing mode. It also highlights the potential for severe bradycardia or asystole of this automatic brady mode change from a previously implanted pacemaker in pacemaker dependent patients submitted to CRT upgrade.

Postoperative atrial fibrillation: The role of the inflammatory response.

OBJECTIVE: Abnormal atrial conduction has been shown to be a substrate for postoperative atrial fibrillation (POAF). This study aimed to determine the relationship between the location of the atrial reentry responsible for POAF, and degree of atrial inflammation. METHODS: Normal mongrel dogs (n = 18) were divided into 3 groups: anesthesia alone (anesthesia), lateral right atriotomy (atriotomy), and lateral right atriotomy with anti-inflammatory therapy (steroid). Conduction properties of the right and left atria (RA and LA) were examined 3 days postoperatively by mapping. Activation was observed during burst pacing-induced AF. The RA and LA myeloperoxidase activity was measured to quantitate the degree of inflammation. RESULTS: Sustained AF (>2 minutes) was induced in 5 of 6 animals in the atriotomy group, but in none in the anesthesia or steroid groups. All sustained AF originated from around the RA incision. Three of these animals had an incisional reentrant tachycardia around the right atriotomy and 2 had a focal activation arising from the RA during AF. The LA activations in these animals were passive from the RA activation. The RA activation of the atriotomy group was more inhomogeneous than that of the anesthesia group (inhomogeneity index: 2.0 ± 0.2 vs 1.0 ± 0.1, P < .01). Steroid therapy significantly normalized the RA activation after the atriotomy (1.2 ± 0.1, P < .01). The inhomogeneity of the atrial conduction correlated with the myeloperoxidase activity (r = 0.774, P < .001). CONCLUSIONS: Reentrant circuits responsible for POAF are dependent on the degree of inflammation and rotate around the atriotomy. Anti-inflammatory therapy decreased the risk of postoperative AF.

Assessment of the Extravascular Implantable Defibrillator: Feasibility of Substernal Ventricular Pacing.

INTRODUCTION: The objective of this study was to assess feasibility of ventricular pacing and thresholds from within the substernal space to examine a new extravascular ICD configuration with pacing capabilities. METHODS: In patients undergoing midline sternotomy, a duodecapolar diagnostic pacing catheter was positioned in the substernal space anterior to the pericardium, and a cutaneous patch in left lateral position. Different unipolar and bipolar pacing configurations were assessed. Strength-duration curves were performed to identify the optimal output, starting at 25 mA with a pulse width of 10 milliseconds. RESULTS: Eight patients with mean age 69 ± 9 years were included. In 5, ventricular capture was achieved in ≥1 configuration. The mean bipolar pacing thresholds at PW 10, 5, 3, 1 milliseconds were 12.4 ± 3.7 mA (5 patients), 13.3 ± 5.8 mA (3 patients), 18.3 ± 5.7 mA (3 patients), and 25 ± 0 mA (2 patients), respectively. The 60-mm electrode spacing was the most successful bipolar configuration. Unipolar pacing was successful in 3 out of 4 patients with mean thresholds of 10 ± 0 mA at 10 milliseconds (3 patients), 15 ± 0 mA at 5 milliseconds (3 patients), 16.7 ± 2.9 mA at 3 milliseconds (3 patients), and 20 ± 7.1 mA at 1 milliseconds (2 patients). CONCLUSION: Ventricular pacing from the substernal space in patients with midline sternotomy is feasible. Closed sternum studies are needed to determine pacing thresholds more accurately.

Prolonged Ventricular Conduction and Repolarization During Right Ventricular Stimulation Predicts Ventricular Arrhythmias and Death in Patients With Cardiomyopathy.

OBJECTIVES: The goal of this study was to evaluate whether prolonged ventricular conduction (paced QRS) and repolarization (paced QTc) times observed during ventricular stimulation predict ventricular arrhythmic events and death. BACKGROUND: Abnormal ventricular conduction and repolarization can predispose patients to ventricular arrhythmias. METHODS: Consecutive patients with left ventricular dysfunction (ejection fraction <50%) undergoing electrophysiology studies from January 2002 until May 2014 were identified at Mayo Clinic (Rochester, Minnesota). Patients were followed up until December 2014 for occurrence of ventricular arrhythmias and death. RESULTS: Among the 501 patients included (mean age 65 years; mean left ventricular ejection fraction 33.1%), longer paced ventricular conduction was associated with longer baseline QRS duration, longer QT interval, and lower ejection fraction. On multivariable analysis, longer paced QRS duration was associated with higher risk of ventricular arrhythmia (hazard ratio [HR]: 1.11 per 10-ms increase; 95% confidence interval [CI]: 1.07 to 1.16; p < 0.001) and all-cause death or arrhythmia (HR: 1.09; 95% CI: 1.09 to 1.13; p < 0.001). A paced QRS duration >190 ms was associated with a 3.6 times higher risk of ventricular arrhythmia (HR: 3.6; 95% CI: 2.35 to 5.53; p < 0.001) and a 2.1 times higher risk of death or arrhythmia (HR: 2.12; 95% CI: 1.53 to 2.95; p < 0.001), independent of left ventricular function or baseline QRS duration. Longer QTc interval during ventricular pacing was associated with a higher risk of ventricular arrhythmia (HR: 1.03 per 10-ms increase; 95% CI: 1.02 to 1.12; p < 0.001) independent of paced QRS duration. CONCLUSIONS: Longer paced QRS duration and paced QTc interval predict ventricular arrhythmias in patients with cardiomyopathy. Ventricular conduction and repolarization prolongation during right ventricular pacing can determine the risk of ventricular arrhythmias.