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Objectives The goal of this study was to test whether continuous automatic remote patient monitoring (RPM) linked to centralized analytics reduces nonactionable in-person patient evaluatio...

Aim The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims. Methods and results Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P, Graphical Abstract

Background: An estimated 1 million patients require cardiac implantable electronic devices (CIEDs) but go without annually. This disparity exists in low-to-middle-income nations largely owing to the cost of CIED hardware. Humanitarian reuse of CIEDs has been shown to be safe and feasible. However, recent publications have raised concern that promotion of CIED reuse may foster a CIED “black market,” to the dismay of manufacturers, regulators, and clinicians alike. Objective: To determine if unregulated CIED sales for potential human use is a real issue by investigating unregulated public online CIED sale listings in the United States of America. Methods: An observational study was undertaken over 6 months using multiple internet search engines from May 1 to November 1, 2019. We cataloged usable CIEDs (still in packaging, manufactured

Background Transvenous lead extractions (TLEs) have increased in number due to an increased prevalence of cardiac implantable devices. Bleeding complications associated with TLEs can be catastrophic, and many institutions order blood components to be available in the procedure room. There are few studies supporting or refuting this practice. We evaluated transfusion rates for TLEs at a single, high-volume center to assess the need for having blood in the procedure room. Study design and methods Patients undergoing TLEs from April 2010 to February 2019 were identified from our institutional database. The percentage of patients transfused intraoperatively, the number of units transfused, and the reasons for transfusion were determined from the database and by manual chart review. Results A total of 473 patients underwent a TLE during this time frame. Of these, only 17 patients (3.6%) received a red blood cell (RBC) transfusion. Ten of the 17 patients received RBCs secondary to preoperative anemia. Of the remaining seven patients, only four patients received more than 2 RBC units, and only one received more than 10 RBC units. No patient received more than 2 RBC units or any plasma or platelets in the past 4 years. Conclusion Due to improvements in procedural techniques, advent of accessible remote blood allocation systems, and changes in transfusion practice (e.g., electronic crossmatch), routinely having blood components in the procedure room for every TLE may be an outdated practice for high-volume centers.

Guidelines exist for monitoring to diagnose and manage patients with several different conditions. Although there have been recent updates to the guidelines, the constantly evolving and advancing nature of the technologies creates a gap at times between the newest monitors, the indications for their use, and the reimbursement by the payers. The key element to the choice of the modality of monitoring remains matching the correct technology to the type, severity, frequency, and duration of the patient's symptoms.

BACKGROUND Transvenous lead extraction (TLE) is an important part of comprehensive lead management. The selection of tools available has expanded in recent years but data on their efficacy is limited. OBJECTIVE To evaluate outcomes using the TightRail™ mechanical rotating mechanical dilator sheath in comparison to excimer laser sheaths and describe factors predictive of successful extraction. METHODS Patients undergoing TLE at a single tertiary center (2013-2019) were included in a prospective registry. Leads targeted for extraction with either an SLS II/Glidelight™ or TightRail™ sheath were included. Outcomes were analyzed on a per-lead basis. Generalized estimating equation (GEE) models were used to assess differences in lead extraction success by extraction tool used while adjusting for nonindependence of multiple leads extracted from the same patient. Covariates included patient comorbidities, lead characteristics, and sheath size. RESULTS A total of 575 leads extracted from 372 patients were included. Overall success rate was 97%. TightRail™ was the first tool used in 180 (31.3%) leads with success rate of 61.7%; laser sheaths were the first tool in 395 leads (68.7%) with success rate of 67.8%. Predictors of successful extraction included lead age, lead type, and sheath sizing. Extraction success did not differ based on whether a laser or TightRail™ sheath was used (adjusted odds ratio = 0.94; 95% confidence interval = 0.59-1.50). CONCLUSION The TightRail™ sheath is an effective tool for TLE. Lead age, lead type, and sheath sizing were predictive of successful extraction but sheath type was not. These findings are hypothesis generating and warrant further investigation in a prospective, randomized study.

Background To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT–) have been reported. Objective The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT– patients. Methods Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT– patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. Results Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT–) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT–; P = .404) as well as for ineffective shocks (5 DT– vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339–11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752–76.203; P = .003). Conclusion In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.

Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion.The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort.Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P.001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors.The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

Contains fulltext : 238765.pdf (Publisher’s version ) (Closed access) With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.

Background: Left ventricular (LV) epicardial pacing results in slowly propagating paced wavefronts. We postulated that this effect might limit cardiac resynchronization therapy efficacy in patients with LV enlargement using conventional biventricular pacing with single-site LV pacing, but be mitigated by LV stimulation from 2 widely spaced sites using MultiPoint pacing with wide anatomic separation (MPP-AS: ≥30 mm). We tested this hypothesis in the multicenter randomized MPP investigational device exemption trial. Methods: Following implant, quadripolar biventricular single-site pacing was activated in all patients (n=506). From 3 to 9 months postimplant, among patients with available baseline LV end-diastolic volume (LVEDV) measures, 188 received biventricular single-site pacing and 43 received MPP-AS. Patients were dichotomized by median baseline LVEDV indexed to height (LVEDVI Median ). Outcomes were measured by the clinical composite score (primary efficacy end point), quality of life, LV structural remodeling (↑EF >5% and ↓ESV 10%) and heart failure event/cardiovascular death. Results: LVEDVI Median was 1.1 mL/cm. Baseline characteristics differed in patients with LVEDVI >Median versus LVEDVI ≤Median . Among patients with LVEDVI >Median , biventricular single-site pacing was less efficacious compared to patients with LVEDVI ≤Median (clinical composite score, 65% versus 79%). In contrast, MPP-AS programming generated greater clinical composite score response (92% versus 65%, P =0.023) and improved quality of life (−31.0±29.7 versus −15.7±22.1, P =0.038) versus biventricular single-site pacing in patients with LVEDVI >Median . Reverse remodeling trended better with MPP-AS programming. In patients with LVEDVI >Median , heart failure event rate increased following the 3-month randomization point with biventricular single-site pacing (0.0150±0.1725 in LVEDVI >Median versus −0.0190±0.0808 in LVEDVI ≤Median , P =0.012), but no heart failure event occurred in patients with MPP-AS programming between 3 and 9 months in LVEDVI >Median . All measured outcomes did not differ in patients receiving MPP-AS and biventricular single-site pacing with LVEDVI ≤Median . Conclusions: Conventional biventricular single-site pacing, even with a quadripolar lead, has reduced efficacy in patients with LV enlargement. However, the greatest response rate in patients with larger hearts was observed when programmed to MPP-AS pacing.

The goal of this study was to test whether continuous automatic remote patient monitoring (RPM) linked to centralized analytics reduces nonactionable in-person patient evaluation (IPE) but maintains detection of at-risk patients and provides actionable notifications.Conventional ambulatory care requires frequent IPEs. Many encounters are nonactionable, and additional unscheduled IPEs occur.Patients receiving implantable cardioverter-defibrillators for Class I/IIa indications were randomized (2:1) to RPM or conventional follow-up, and they were followed up for 15 months. IPEs were conducted every 3 months in the conventional care group but at 3 and 15 months with RPM. Groups were compared for patient retention, nonactionable IPEs, and discovery of at-risk patients during 1 year of exclusive RPM. Frequency and value of RPM alerts were assessed.Patients enrolled (mean age 63.5 ± 12.8 years; male 71.9%; left ventricular ejection fraction 29.0 ± 10.7%; primary prevention 72.3%; n = 1450) were similar between groups (977 RPM vs. 473 conventional care). Mean follow-up durations were 407 ± 103 days for the RPM group versus 399 ± 111 days for the conventional care group (p = 0.165). Patient attrition to follow-up was 42% greater with conventional care (20.1% [87 of 431]) versus RPM (14.2% [129 of 908]; p = 0.007). Nonactionable IPEs were reduced 81% by RPM (0.7 per patient year) compared with conventional care (3.6 per patient year; p 0.001) but event discoveries remained similar (2.9 per patient year). In RPM, alert rate was median 1 per patient (interquartile range: 0 to 3) with50% actionability, indicating low volume but high clinical value. Unscheduled IPE was the basis for discovery of 100% of intercurrent problems in RPM and also 75% in conventional care, indicating limited value of appointment-based follow-up for problem discovery. The number of IPEs needed to discover an actionable event was 8.2 in Conventional, 4.9 in RPM, and 2.1 when alert driven (p 0.001).RPM transformed ambulatory care to IPE directed to those patients with clinically actionable events when required. Filtering patient information by digitally driven remote monitoring expends fewer clinic resources while providing a greater yield of actionable interventions. (Lumos-T Safely Reduces Routine Office Device Follow-up [TRUST]; NCT00336284).

We present a case report of severed epicardial atrial lead salvage using an IS-1 lead extender. A 37-year-old male with single ventricle physiology, Fontan palliation, sinus node dysfunction, recurrent atrial tachycardias, and atrial fibrillation resulting in failing Fontan physiology presented with failure of the atrial pacing lead. The patient was initially paced with an epicardial system that had to be removed due to pocket infection, and the epicardial leads were cut and abandoned. Given his significant sinus node dysfunction he required atrial pacing to allow for rhythm control. The failing Fontan physiology of the patient precluded him from undergoing surgery for epicardial lead placement or a complex intravascular lead placement procedure (although anatomically feasible). We considered the option of salvaging the existing epicardial atrial leads to provide atrial pacing, allowing for rhythm control and improvement of his failing Fontan physiology as a bridge to a more permanent pacing solution. This case report is important because it demonstrates how a lead extender can be used to salvage a severed pacemaker lead. This may be useful for patients in whom implantation of new leads is not promptly feasible due to patient anatomy and/or clinical status.

Funding Acknowledgements This work was supported by Medtronic Background/Introduction: The increasing number of cardiac implantable electronic device (CIED) infections has led to increased interest in the identification of patients who may benefit from additional infection prevention measures. Purpose The purpose of this evaluation was to validate the predictive value of the Prevention of Arrhythmia Device Infection Trial (PADIT) risk score to identify patients at increased risk of CIED infection using a U.S. health claims data set. Methods A retrospective analysis using the Optum® Clinformatics® claims database was conducted to create a dataset of index procedures which either did or did not result in an infection. The study population included both commercial and Medicare Advantage patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014. Major CIED infections, defined as an infection associated with system removal, invasive procedure without system removal, or death attributable to infection, were identified through diagnosis and procedure codes. The dataset was randomized (stratified by PADIT score, which included prior procedures, age, depressed renal function, immunocompromised, and procedure type) into a Development Dataset (60%) and a Validation dataset (40%). A frailty model allowing multiple procedures per patient was fit using the Development Dataset, with PADIT score as the only predictor, excluding patients with prior infection. Prior CIED infection, which was not available in the original PADIT data, was examined for additional predictive value. Results The data extraction resulted in a dataset of 53,554 index procedures among 51,583 patients, with 30,950 patients randomized to the Development Dataset. The distribution of procedures was pacemakers (52%), ICD (20%), CRT (12%), and Revision/Upgrade (16%), while prior procedures were none (62%), 1 (37%), and 2 (1%). Among patients with no history of prior CIED infection, the frailty model showed that a 1 unit increase in the PADIT score predicts higher infection risk (20%) in the U.S. claims data set (Table 1). Prior CIED infection was associated with strong additional predictive value (HR 4.77, p Conclusion In the largest external validation of a CIED risk score, the PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that can benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection brings additional predictive value to the PADIT score.

Our world is faced with a global pandemic that threatens to overwhelm many national health care systems for a prolonged period. Consequently, the elective long-term cardiac implantable electronic device (CIED) management of millions of patients is potentially compromised, raising the likelihood of patients experiencing major adverse events owing to loss of CIED therapy. This review gives practical guidance to health care providers to help promptly recognize the requirement for expert consultation for urgent interrogation and/or surgery in CIED patients.

Transseptal puncture is a critical procedural step in pursuing left-sided catheter ablations. Most centers use either fluoroscopic and/or intracardiac echocardiographic (ICE) guidance.1, 2 However, not uncommonly, these routinely used approaches may not be sufficient to repeatedly obtain transseptal access in a safe manner.3 We present a recently described novel approach to transseptal puncture using a concomitant ablation catheter in the left atrium (LA) in 2 challenging cases.

Although definitive therapy for infected cardiac implantable electronic device systems requires removal of all hardware in the infected areas with extraction of intravascular components as well, there are situations where extraction is not available or appropriate. Palliative procedures and chronic suppressive antibiotics may be used in these cases. There are also options that may in some cases result in long-term freedom from infection.

BACKGROUND Pacemaker patients experience battery depletion that activates pacemaker's alert for replacement notification. Automatic reprogramming at replacement notification can result in loss of rate response and atrioventricular (AV) synchrony. OBJECTIVE To determine if relevant symptoms or clinical events may be associated with automatic reprogramming at replacement notification. METHODS Electronic medical record review was undertaken for 298 patients referred for pacemaker generator replacement. Primary endpoints were symptoms or clinical events during replacement notification period. RESULTS Following elimination of duplicate pacemaker replacements (n = 12), "near-replacement notification" or "recalled" (n = 15) and pacemakers at "end of life" (n = 5), 266 subjects were included. Three distinct reprogramming cohorts were identified; those with no change (control) in pacing mode (n = 46), those with loss of rate response (n = 154), and those with loss of AV synchrony ± rate response (n = 66). In total, 83 subjects (31.2%) had symptoms with significant differences seen between groups (control = 4.3%, loss of rate response = 26.0%, loss of AV synchrony ± rate response = 62.1%, P

Background Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices. Objective We sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices. Methods We searched online indexing sites to identify recent studies. Peer-reviewed manuscripts reporting infection, malfunction, premature battery depletion, and device-related death with reused devices were included. The primary study outcome was the composite risk of infection, malfunction, premature battery depletion, and death. Secondary outcomes were the individual risks. Results Nine observational studies (published 2009-2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in meta-analysis (2,114 devices; 1,258 new vs 856 reused). All device reuse protocols employed interrogation to confirm longevity and functionality, disinfectant therapy, and, usually, additional biocidal agents, packaging, and ethylene oxide gas sterilization. Demographic characteristics, indications for pacing, and median follow-up were similar. There were no device-related deaths reported and no statistically significant difference in risk between new versus reused devices for the primary outcome (2.23% vs 3.86% respectively, P = 0.807, odds ratio = 0.76). There were no significant differences seen in the secondary outcomes for the individual risks of infection, malfunction, and premature battery depletion. Conclusions Device reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or device-related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial.

Management of patients with cardiac implantable electronic devices (CIEDs) has become complex given the complications that can occur with implanted lead systems. Clinical problems such as infection, lead failure, and occluded vessels create situations that demand intervention to remove leads. Due to adhesions that occur in the venous system and at the endomyocardial attachment site, simple traction to remove a lead is often not sufficient. Infection is a mandatory reason to remove the entire CIED system. Tools and techniques are now available that enable a skilled operator to extract leads with a great deal of efficacy and safety.

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Objectives The MultiPoint Pacing (MPP) trial assessed the safety and efficacy of pacing 2 left ventricular sites with a quadripolar lead in patients with heart failure indicated for a CRT-D device. Background Cardiac resynchronization therapy nonresponse is a complex problem where stimulation of multiple left ventricular sites may be a solution. Methods Enrolled patients were indicated for a CRT-D system. Bi-ventricular (Bi-V) pacing was activated at implant. Three months later, clinical response was assessed and the patient was randomized (1:1) to receive Bi-V pacing or MPP. Patients were followed for 6 months post-randomization and clinical response was again assessed. Results The CRT-D system was successfully implanted in 455 of 469 attempted implants (97%). A total of 381 patients were randomized to Bi-V or MPP at 3 months. The primary safety endpoint was met with freedom from system-related complications of 93.2%. The primary efficacy endpoint of the noninferiority comparison of nonresponder rates between the 2 arms was met. Patients randomized to MPP arm and programmed to pace from anatomically distant poles (MPP-AS) responded to therapy at significantly higher rates than MPP-other programmed settings (MPP-Other). Within this group, 87% were responders at 9 months, 100% designated as nonresponders at 3 months converted to responders at 9 months, and 54% experienced an incremental response compared to MPP-Other. Also within MPP-AS, 92% of patients with de novo CRT-D implant were classified as responders compared with patients with MPP-Other. Conclusions MPP is safe and effective for treating heart failure. The study met the pre-specified hypothesis that response to MPP is noninferior to Bi-V pacing with a quadripolar left ventricular lead. (MultiPoint Pacing IDE Study [MPP IDE]; NCT01786993)

The need to add a new lead to a CIED system is not uncommon, either due to lead malfunction or system “upgrade”. Occlusion of the subclavian and/or superior vena cava may cause significant difficulty for the implanter by blocking access to the heart. Lead extraction provides the ability to create a new conduit, and thereby prevent the need for performing an epicardial lead placement or risking bilateral venous occlusions. This case discusses a patient with bilateral subclavian vein occlusions and need for a new dual chamber pacing system.

Infection of a CIED is not always immediately obvious. Differential diagnosis in the early post procedural time includes pocket hematoma, and it may be difficult to determine whether an intervention is needed. Several options are discussed to assist in making the decision. Once infection is diagnosed, it is critical that early system removal with lead extraction be performed. Delay in definitive treatment is associated with longer and more expensive hospital stays, as well as higher morbidity and mortality.

A patient with old, but normally functioning pacing leads and a battery at replacement time will need MRI scans in the future. A lead management decision as to reusing, abandoning or extracting and replacing the leads is needed. Informed involvement of the patient to form the best management plan is the best approach.

BACKGROUND The Biotronik DX lead is an attractive option due to its floating atrial bipole and its noninferiority compared to dual-chamber defibrillators. METHODS We describe the case of atrial undersensing by the DX lead resulting in failure of the device to appropriately treat a slow ventricular tachycardia. CONCLUSION This case underlies the importance of understanding the limitations to each lead technology as well as the underlying assumptions inherent to detection enhancement algorithms.

BACKGROUND Pacemaker battery depletion triggers alert for replacement notification and results in automatic reprogramming, which has been shown to be associated with relevant cardiorespiratory symptoms and adverse clinical events. OBJECTIVE Determine if electrocardiogram (ECG) pacing features may be predictive of pacemaker battery depletion and clinical risk. METHODS This is an ECG substudy of a cohort analysis of 298 subjects referred for pacemaker generator replacement from 2006 to 2017. Electronic medical record review was performed; clinical, ECG, and pacemaker characteristics were abstracted. We applied two ECG prediction rules for pacemaker battery depletion that are relevant to all major pacemaker manufacturers except Boston Scientific and MicroPort: (1) atrial pacing not at a multiple of 10 and (2) nonsynchronous ventricular pacing not at a multiple of 10, to determine diagnostic sensitivity, specificity, and risk in applicable ECG subjects. RESULTS We excluded 32 subjects not at replacement notification or duplicate surgeries. Overall, 176 of 266 subjects (66.2%) demonstrated atrial pacing or nonsynchronous ventricular pacing on preoperative ECG. When utilizing both rules, 139 of 176 preoperative ECGs and 12 of 163 postoperative ECGs met criteria for battery depletion yielding reasonable sensitivity (79.0%), high specificity (92.6%), and a positive likelihood ratio of 11.6:1. These rules were associated with significant increase in cardiorespiratory symptoms (P

BACKGROUND An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs). OBJECTIVE To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high-volume center. METHODS A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into "High" and "Low" risk for occurrence of MACEs. High-risk LEs included dual-coil defibrillator lead (≥3 years), pacemaker and single-coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, "High-risk" LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. "Low-risk" LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre-RISE) and postintervention (post-RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared. RESULTS Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04). CONCLUSION RISE identified a low-risk group where minimal resources are needed and allowed for rapid intervention in the high-risk group that reduced the consequences of MACEs.

Background Studies have shown that magnetic resonance imaging (MRI) conditional pacemakers experience no significant effect from MRI on device function, sensing, or pacing. More recently, similar safety outcomes were demonstrated with MRI conditional defibrillators (implantable cardioverter-defibrillator [ICD]), but the impact on ventricular arrhythmias has not been assessed. Objective The purpose of this study was to assess the effect of MRI on ICD sensing and treatment of ventricular tachyarrhythmias. Methods The Evera MRI Study was a worldwide trial of 156 patients implanted with an ICD designed to be MRI conditional. Device-detected spontaneous and induced ventricular tachycardia/ventricular fibrillation (VT/VF) episodes occurring before and after whole body MRI were evaluated by a blinded episode review committee. Detection delay was computed as the sum of RR intervals of undersensed beats. A ≥5-second delay in detection due to undersensing was prospectively defined as clinically significant. Results Post-MRI, there were 22 polymorphic VT/VF episodes in 21 patients, with 16 of these patients having 17 VT/VF episodes pre-MRI. Therapy was successful for all episodes, with no failures to treat or terminate arrhythmias. The mean detection delay due to undersensing pre- and post-MRI was 0.60 ± 0.59 and 0.33 ± 0.63 seconds, respectively (P = .17). The maximum detection delay was 2.19 seconds pre-MRI and 2.87 seconds post-MRI. Of the 17 pre-MRI episodes, 14 (82%) had some detection delay as compared with 11 of 22 (50%) post-MRI episodes (P = .03); no detection delay was clinically significant. Conclusion Detection and treatment of VT/VF was excellent, with no detection delays or significant impact of MRI observed.

Automatic Remote Monitoring of ICD Follow-Up Introduction The incidence of unscheduled encounters and problem occurrence between ICD implant and first in-person evaluation (IPE) recommended at 12 weeks is unknown. Automatic remote home monitoring (HM) may be useful in this potentially unstable period. Methods and Results ICD patients were randomized 2:1 to HM enabled post-implant (n = 908) or to conventional monitoring (CM; n = 431). Groups were compared between implant and prior to first scheduled IPE for IPE incidence, causes, and actionability (reprogramming, system revision, medication changes) and event detection time. HM and CM patients were similar (mean age 63 years, 72% male, LVEF 29%, primary prevention 73%, DDD 57%). In the post-implant interval assessed (HM 100 ± 21.3 days vs. CM 101 ± 20.8 days, P = 0.54), 85.4% (776/908) HM patients and 87.7% CM (378/431) patients had no cause for IPE (P = 0.31). When IPE occurred, actionability in HM (64/177 [36.2%]) was greater versus CM (15/62 [24.2%], P = 0.12). Actionable items were discovered sooner with HM (P = 0.025). Device reprogramming or lead revision was triggered following 53/177 (29.9%) IPEs in HM versus 9/62 (14.5%) in CM (P = 0.018). Arrhythmia detection was enhanced by HM: 276 atrial and ventricular episodes were detected in 135 follow-ups in contrast to CM (65 episodes at 17 IPEs). More silent arrhythmic episodes were discovered by HM (7.2% vs. 1.5% [P = 0.15]). Since 27/42 (64.3%) IPEs driven by HM alerts were actionable, event notification was a valuable method for problem detection. Importantly, HM did not increase incidence of non-actionable IPEs (P = 0.72). Conclusion Activation of automatic remote monitoring should be encouraged soon post-ICD implant.

Background Current lead extraction (LE) devices can harm the blood vessel endothelium, increasing the risk of perforation. Objective Proof of concept for using a solid-state pulsed laser at 355 nm with a hybrid catheter in LE. Methods A hybrid catheter was used comprising optical fibers for the delivery of 355 nm laser pulses at 30 Hz and 6 J/cm2 combined with a blunt mechanical blade. Specific parameters were chosen to enable selectivity in ablation, thereby reducing the risk of blood vessel perforation. The design exploits differences in the mechanical properties of the fibrotic tissue and the normal blood vessel. Ex vivo ablation was performed to evaluate a hybrid catheter operation on various tissues. Two ex/in vivo pig studies used a free-floating electrode to which three bovine tendon pieces were glued. Finally, two in vivo dog model studies were performed on specimens with 4-5-year-old pacing lead implants, followed by a histopathology study. Results Catheter penetration rate in the ex vivo experiments was 0.1 mm/seconds for bovine tendon, 0.025 mm/seconds for porcine superior vena cava and 0.033 mm/seconds for porcine aorta. In the ex/in vivo pig study, the three tissue blocks were successfully dissected. In the in vivo dog study, the two leads were successfully extracted. In all in vivo tests, hemodynamic stability was maintained. Gross histopathology did not reveal any injury. Conclusions Ablation using 355 nm laser pulses in combination with a mechanical blunt blade may potentially constitute a viable alternative for LE. Lasers Surg. Med. © 2015 Wiley Periodicals, Inc.

See Article by Barakat et al The implantation of cardiac implantable electronic devices (CIED) for the treatment of bradyarrhythmia and tachyarrhythmia has increased significantly during the past 30 years.1,2 Along with the increase in CIED implantation has been a steady and at times disproportional rise in device-related infections.3,4 Among Medicare beneficiaries between 1990 and 1999, there has been an increase in CIED-related infections from 0.94 to 2.11 per 1000,5 which has been validated in other cohorts.6,7 On the basis of the National Hospital Discharge Survey between 2004 and 2006, there was a 57% increase in CIED infections along with a steady rise in the prevalence of patients undergoing CIED implantation who have end-organ failure and diabetes mellitus.4 Known risk factors for CIED infection have been well established in multiple studies to include diabetes mellitus, generator replacement, anticoagulation use, multiple lead insertion, and renal dysfunction. The latter have been found to be one of the strongest risk factors (odds ratio 4.8).8,9 Among CIED patients with bacteremia, the most common organism is Staphylococcus aureus ,10 …

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE.

Background Experience with retrieval of the Micra transcatheter pacing system (TPS) is limited because of its relatively newer technology. Although abandonment of the TPS at end of life is recommended, certain situations such as endovascular infection or device embolization warrant retrieval. Objective The purpose of this study was to report the worldwide experience with successful retrieval of the Micra TPS. Methods A list of all successful retrievals of the currently available leadless pacemakers (LPs) was obtained from the manufacturer of Micra TPS. Pertinent details of retrieval, such as indication, days postimplantation, equipment used, complications, and postretrieval management, were obtained from the database collected by the manufacturer. Other procedural details were obtained directly from the operators at each participating site. Results Data from the manufacturer consisted of 40 successful retrievals of the Micra TPS. Operators for 29 retrievals (73%) provided the consent and procedural details. Of the 29 retrievals, 11 patients underwent retrieval during the initial procedure (immediate retrieval); the other 18 patients underwent retrieval during a separate procedure (delayed retrieval). Median duration before delayed retrieval was 46 days (range 1–95 days). The most common reason for immediate retrieval was elevated pacing threshold after tether removal. The most common reasons for delayed retrieval included elevated pacing threshold at follow-up, endovascular infection, and need for transvenous device. Mean procedure duration was 63.11 ± 56 minutes. All retrievals involved snaring via a Micra TPS delivery catheter or steerable sheath. No serious complications occurred during the reported retrievals. Conclusion Early retrieval of the Micra TPS is feasible and safe.

The design of pacemaker leads has continued to evolve; ease of lead handling, improved electrical performance, and magnetic resonance imaging (MRI) conditional aspects have become more important, while safety remains critical. The INGEVITY™ family leads was designed to provide MRI conditional aspects, decreased diameter, and improved performance of pacemaker leads. The INGEVITY study is an investigational device exemption trial evaluating the acute and chronic safety and effectiveness of these leads.Consecutive patients were included in 77 institutions worldwide, where 1,657 leads (846 right ventricular active fixation leads, 213 right ventricular passive fixation leads, 121 right atrial passive fixation preformed J-leads, and 477 right atrial active fixation leads) were implanted or attempted in 1,060 subjects.At 3-month follow-up, the electrical performance were: mean pacing threshold 0.67 V at 0.5-ms pulse width, pacing impedance 773 ohms, mean P-wave amplitude 4.8 mV, and R-wave amplitude 16.5 ± 6.5 mV. Over a median follow-up of 31 months, 93 subjects died and 33 subjects reported lead-related complications. Lead-related complication-free rate from 0 to 3 months and 3 to 12 months for all leads was 98.4% and 99.7%, respectively. The hazard of lead-related complications was observed to be decelerating over the course of follow-up (Weibull shape = 0.23). The overall lead dislodgment rate observed in the study was 1.3%, the perforation rate was 0.0%, and the pericardial effusion rate was 0.3%.The clinical performance of the INGEVITY lead demonstrated a high lead-related complication-free rate over 12 months of follow-up and excellent electrical characteristics.

In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial.Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited.We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers.Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%).Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

QT prolongation is a risk factor for proarrhythmia when beginning antiarrhythmic drug therapy (AAD). However, there are no data regarding monitoring repolarization changes during a ventricular paced (VP) rhythm.The purpose of this study was to compare serial changes in corrected QT and JT intervals, during native conduction (NC) and VP rhythms when initiating Class III AADs.Twenty-two patients (73% men; mean age 65 ± 11 years) with an implantable device and with10% VP were monitored during AAD initiation (16 sotalol, 6 dofetilide). QTc and JTc were measured from ECGs obtained during NC and VP at baseline (pre-AAD) and then after each AAD dose.During AAD loading, mean QTc increased significantly during NC (431 ± 28 ms to 463 ± 33 ms, P = .002) but not with VP (520 ± 48 ms to 538 ± 45 ms, P = .07). Mean percent increase in peak QTc during NC was significantly greater than during VP (12% vs 7%, P = .003). In contrast, peak JTc during AAD loading was not significantly different between NC and VP (P = .67).When initiating AAD, the change in QTc during VP does not correlate with the change in QTc during NC; thus, the VP QTc is inadequate for monitoring repolarization changes. However, VP JTc correlates well with JTc during NC. When initiating Class III AADs in patients with VP rhythms, the JTc, and not the QTc, interval is the useful marker for assessing repolarization.

Background— For ablation of atrial fibrillation, it is unclear how baseline international normalized ratio (INR) affects the dosing of unfractionated heparin (UFH). Methods and Results— A retrospective review of 170 consecutive patients undergoing atrial fibrillation ablation with baseline activated clotting time (ACT) and INR values was performed. Patients were grouped according to INR P P =0.0001). Baseline INR, ACT, and weight were predictors of the UFH dosage to achieve an ACT ≥300 seconds. An equation derived to achieve an ACT ≥300 seconds after a single bolus of UFH met this end point in 160 of 168 patients (95%). Conclusions— Baseline INR and ACT, in addition to weight, are the only predictors of UFH dosage needed to achieve an ACT ≥300 seconds. A derived equation predicted the UFH dosage to achieve an ACT ≥300 seconds.