Device Upgrade Research Articles

Is Venoplasty an Alternative to Lead Extraction for Patients With Venous Obstruction?

Indications for cardiovascular implantable electronic devices (CIEDs) have increased over time. Patients may require lead replacement or implantation due to lead failure or need for device upgrade. Venous obstruction is a common finding in these patients and often poses difficulties for operators. Venoplasty as an alternative to lead extraction emerges as an important intervention in the treatment of selected patients, particularly with a view to minimising procedural risk. Nine (9) patients with CIED related venous occlusion were treated with venoplasty at our institution between April 2006 and October 2019. Six (6) of nine patients were initially referred to our institution for consideration of transvenous lead extraction in the setting of venous occlusion. These patients are the subjects of the case series. Patient demographics, indication for venoplasty and procedural outcomes were examined. We present a series of six patients in whom venoplasty has been performed at our centre as an alternative to lead extraction. Device and patient characteristics have been examined as well as radiation exposure and fluoroscopy time. The median age of our cohort was 64.5 years (range: 37-81 years) and 67% were female. Luminal calibre was improved in all patients allowing lead replacement, device upgrade or relief of symptoms. Procedural complications were not observed, and all patients remained free of symptoms related to venous occlusion at 3-month follow-up. We present venoplasty as a viable alternative to lead extraction in high risk patients or in those who favour a less invasive approach.

The role of an antibiotic envelope in the prevention of major cardiac implantable electronic device infections: A systematic review and meta-analysis.

Background:Over the past decade, rates of cardiac implantable electronic device (CIED) related infections have increased and been associated with increased morbidity, mortality and financial burden on healthcare systems.Methods:To examine the effect of an antibacterial envelope in reducing major CIED related infections, we performed a systematic review and meta-analysis by searching PubMed/MEDLINE, CENTRAL, Google scholar and Clinicaltrials.gov for studies that examined the effect of an antibiotic envelope in reducing major related CIED infections, comprising of device-related endocarditis, systemic infection requiring systemic antibiotics and or device extraction, compared to control up till February 15th, 2020. A random-effects meta-analysis was conducted by calculating risk ratios (RR) and respective 95% confidence intervals (CI).Results:We include 6 studies that comprise of 11,897 patients, of which 5844 received an antibiotic envelope and 6053 did not. Compared with control, utilization of an antibiotic envelope at the time of procedure was associated with a significant 74% relative risk reduction in major CIED related infections among patients at high risk for infection (RR: 0.26 [95% CI, 0.08–0.85]; P = .03), while no significant reduction was observed among patients enrolled from studies with any risk for infection (RR: 0.53 [95% CI, 0.06–4.52]; P = .56). Additionally, no reduction in mortality among patients that received an envelope compared to control was observed (RR: 1.15 [95% CI, 0.53–2.50]; P = .72).Conclusion:The utilization of an antibiotic envelope at the time of device implantation or upgrade reduces major CIED infections, especially if used in patients perceived to be at higher risk for infection.

P1147Complications in young ICD patients - a retrospective analysis

Abstract Introduction In specific situations implantable cardioverter defibrillator (ICD) therapy is recommended for patients under the age of 40 years. Due to the active lifestyle of this patient population, complication rates in devices with conventional transvenous electrodes may be higher than for the remaining population. Methods The ICD-YOUNG study is a retrospective analysis of consecutive patients ≤ 40 years undergoing transvenous or subcutaneous ICD (s-ICD) implantation, device change or lead revision at our centre between July 2006 and December 2017. Rehospitalization for lead failure or device battery depletion was documented. Results Out of 586 patients undergoing ICD implantation, 35 patients (6.0%) were ≤ 40 years. Mean age was 30.0 ± 7.2 years, 48.6% were female, 37.1% received ICD therapy for primary prevention and 11.4% primarily received s-ICD. Median follow up was 7.3 (interquartile range, 1.8-12.0) years, with a lower follow up duration in s-ICD patients than conventional ICD patients (median, 2.9 vs. 9.0 years). Over the course of follow-up, 37.1% received successful anti-tachycardia therapy. 19.4% of patients in the conventional ICD group had right ventricular lead problems requiring intervention, while none of the s-ICD patients had to be revised. Time to first device change due to battery depletion and/or device upgrade was similar in young and remaining patients (median 5.4 vs 6.0 years, p = 0.23). Discussion Young patients requiring ICD have a high rate of lead problems. In most young patients, s-ICD therapy is an encouraging alternative to conventional ICD therapy with a lower lead failure rate.

Wire countertraction for sheath placement through stenotic and tortuous veins: The "body flossing" technique.

BackgroundInnominate vein stenosis and venous tortuosity are common findings during cardiac implantable electronic device upgrades or replacements and present a challenge to the implanting physician. Various techniques have been described to facilitate lead placement, including serial dilation, balloon venoplasty, and percutaneous access medial to the stenosis, each with its own benefits and risks.ObjectiveThe purpose of this study was to assess the feasibility, safety, and efficacy of the wire countertraction (“body flossing”) technique to facilitate sheath placement through tortuous and stenotic vessels.MethodsPatients undergoing cardiac implantable electronic device procedures requiring the body flossing technique due to inability to place vascular sheaths over the wire through stenoses or tortuosity were retrospectively analyzed. Clinical characteristics, procedural equipment, and outcomes were analyzed.ResultsSimultaneous countertraction was successful in all attempted cases, including 8 patients with stenoses and 2 with tortuosity. In 2 of the stenosis cases, venoplasty had previously failed. No complications occurred.ConclusionSimultaneous countertraction (body flossing) is an effective tool to overcome venous stenosis and tortuosity that are amenable to wire advancement but not to vascular sheaths. It seems to be a safe and effective alternative to other techniques used in these scenarios.

Peri-procedural use of direct anticoagulation agents during cardiac device implantation: vitamin K antagonists vs direct oral anticoagulants.

Warfarin is deemed safe compared to bridging with heparin in the peri-procedure setting while implanting cardiac devices. The timing of discontinuation and re-initiation of direct anticoagulant agents (DOACs) such as dabigatran, apixaban, and rivaroxaban in the peri-procedural setting in comparison to warfarin is not well studied. We wanted to compare three DOAC agents with warfarin during cardiac device implantation. Consecutive patients on treatment with dabigatran, rivaroxaban, or apixaban (group A) undergoing a cardiac device generator change, upgrade, or new implantation procedure were compared to those on warfarin (group B). Incidence of hematoma, infection, effusion, stroke, and other complications were noted at 1 day, 1 week, and 3 months. A total of 311 patients in group A underwent the above procedures with 73 patients on dabigatran, 153 on rivaroxaban, and 85 on apixaban. There were 467 patients on warfarin in group B. Mean age of the total population was 68 ± 12 years with 67% males and > 80% Caucasians. The last dose of the DOAC was the night prior to the procedure and resumed the night of the procedure (single dose interruption for apixaban and dabigatran and no un-interruption for rivaroxaban). There was no difference noted in the incidence of minor or major hematoma (9% vs 8.5%, p = 0.7). No stroke occurred in either group. Use of DOAC agents with transient interruption of one dose is as safe as warfarin in the peri-procedural setting during implantation of cardiac devices.

Microengineered biosynthesized cellulose as anti-fibrotic in vivo protection for cardiac implantable electronic devices

Upon cardiac implantable electronic device (CIED) exchange, upgrade, or revision surgery patients are exposed to a considerable risk of adverse events. The presence of firm fibrotic tissue endangers these procedures. Leads can be damaged in the attempt of freeing them from fibrotic tissue. Hematoma can form as result of capsulectomy, pocket debridement and leads dissection. Due to the increasing number of CIED exchange, upgrade and revision surgeries, the incidence of related complications is expected to rise in the near future.The aim of the study was to evaluate the feasibility, safety, and performance of a rationally micro-engineered non-resorbable biosynthesized cellulose (BC) membrane as conformal wrapping protection around CIED implants. Protective membranes were generated by means of a recently established method to transfer on-demand microscale geometries onto the surface of BC. A chronic minipig animal model was selected to investigate the performance of the BC anti-fibrotic protection, directly measured as reduction of fibrotic tissue formation. Sixteen (n = 16) animals received each one BC coated pacemaker (PMC) and one native pacemaker (BI) at equivalent anatomical sites. BC protective layers were juxtaposed around pacemakers through a fast and well-repeatable procedure. Explants were performed at 3 and 12 months after implantation. Endpoint analysis showed that the BC protective layers were 100% integer, with no sign of chemical or mechanical degradation and appeared as a thin layer of white-tan material, adherent to the surrounding thin fibrous capsule, from which it could be peeled off by gently pulling with forceps. The protective effect of micro-engineered BC yielded an average thickness reduction of 66% of the fibrotic tissue thickness generated around PMC, as compared to that measured around the naked counterpart (i.e. the BI). When protected by in BC, both the generator and the proximal parts of the leads were completely free from fibrotic tissue. The insertion of an anti-adhesive, non-resorbable and well-tolerated BC interface between the implant and the surrounding tissue in the surgical pocket significantly reduced the formation of fibrotic tissue, ensuring an easy access to the device pocket, and thus creating the conditions for simplified CIED revision surgeries.

Postoperative opioid prescription patterns and new opioid refills following cardiac implantable electronic device procedures

Prescription opioids are a major cause of the opioid epidemic. Despite the invasive nature of cardiac implantable electronic device (CIED) procedures, data on opioid prescription patterns after CIED procedures are lacking. The purpose of this study was to assess opioid prescribing patterns and the rates of new opioid refills (refills in previously opioid naïve patients) among patients undergoing CIED procedures. We performed a retrospective analysis of all patients undergoing CIED procedures from January 1, 2010, to March 30, 2018, at the Mayo Clinic (Minnesota, Arizona, and Florida). Procedures were categorized into new implant, generator change, device upgrade, lead revision or replacement, and subcutaneous implantable cardiac defibrillator (S-ICD) procedures. The rates of postoperative opioid prescription and new opioid refills were analyzed. Wilcoxon rank sum and χ2 tests assessed variations. A total of 16,517 patients (mean age 70 ± 15; 36% female) underwent CIED procedures. Opioids were prescribed to 20.2% of the patients, among whom 80% were opioid naïve. Among opioid naïve patients who received opioids, 9.4% (95% confidence interval [CI] 8.3%-10.5%) had subsequent opioid refills. The percentage of patients who received more than 200 oral morphine equivalents of prescription was 38.8% (95% CI 37.2%-40.5%). Temporal trends revealed increasing rates of any opioid prescription, peaking in 2015 at 25.9%, with subsequent downtrend to 14.6% in 2018 (P <.001). Postoperative opioid prescription rate after CIED procedures was 20.2%, with most patients being opioid naïve. Among opioid naïve patients who received opioids, 9.4% had subsequent opioid refills. This finding suggests that perioperative pain management in CIED procedures warrants meticulous attention.

P5238Rate, cause and costs of Heart Failure hospitalizations following ICD/CRT-D replacement: preliminary data from an Italian multicenter registry

Abstract Background Heart failure hospitalizations (HFHs) likely represent the main health care expenditure also in implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) recipients yet the event rate of HFH and the associated costs after device replacement or upgrade are unknown. Purpose To report HFH rates and associated costs within 12 months following ICD/CRT-D device replacement or upgrade procedure from ICD to CRT-D. Methods The DEtect long-term COmplications after icD rEplacement (DECODE) was a prospective, single-arm, multicenter cohort study exploring complications in ICD/CRT-D recipients undergoing device replacement or upgrade from ICD to CRT-D. All clinical and survival data of these patients at 12-month follow-up were prospectively analyzed. For each adjudicated HFH, the admission and discharge date were recorded, and ICD-9-CM diagnoses and procedure codes were obtained. The estimated reimbursement for each hospitalization was calculated according to the 2012 Italian national reimbursement rates. Results Between 2013 and 2015, 983 patients (mean age = 71 years, mean LVEF = 35%, NYHA class I/II = 75.6%) were enrolled: 900 (91.6%) patients underwent device replacement (446 ICD/454 CRT-D) and 83 (8.4%) upgrade from ICD to CRT-D. After 12 months, 66 (6.7%) patients died, 40 (60.6%) for cardiovascular reasons. Fifty-five (5.6%) patients experienced at least 1 HFH. Overall, 91 HFH (9.6% event rate 95% CI, 7.7–11.7) occurred. Among the variables tested at univariate analysis, only LVEF ≤35%, AF history and renal disease were confirmed as HFH predictors at multivariate analysis. HFH rate was significantly higher following upgrade procedures and occurrence of HFH was associated with an eleven-fold increased mortality risk (95% CI: 5.9 to 20.5; p&lt;0.0001). The cumulative cost associated with HFHs incurred over the 12 months follow-up was 515305 €. The mean cost per HFH was 5662±9497 € [ranging from 3144 € to 64479 €] while the mean cost per patient with events was 9369±12687 €. Conclusion Underlying cardiac disease and renal failure are the main drivers of HFH and mortality, and of higher healthcare expenditures in ICD/CRT-D recipients following device replacement or upgrade. Accurate clinical assessment is needed to support the decision-maker at the time of ICD replacement to take an appropriate clinical and economic sustainable decision. Acknowledgement/Funding None

P3138Age based outcomes after implantable cardioverter-defibrillator extraction

Abstract Background There are growing numbers of defibrillator implantations for prevention of sudden cardiac death. As such, there has been a concomitant need for lead extraction. This procedure is often indicated in the setting of device or systemic infection, device upgrade, lead malfunction or elective extraction in cases of abandoned leads. Lead Extraction is associated with increased morbidity and mortality. The comparative safety and effectiveness of lead extraction in various age groups has not been well evaluated. Purpose The average age of patients undergoing lead extraction in our single center database is (65.5±15.9). There are lack of studies on age associated outcomes with lead extraction. We intend to evaluate differences in major in minor adverse outcomes in patients undergoing lead extraction stratified by age. Methods We identified 1,297 patients who underwent lead extraction between January 2003 and April 2016 at a major metropolitan center and evaluated procedural outcomes stratified by age. Age groups were stratified as &lt;55, 55–64, 65–74, 75–84, and &gt;85 years old. Baseline characteristics including history of coronary artery bypass graft (CABG), hypertension (HTN), congestive heart failure (CHF), hyperlipidemia (HLD), diabetes mellitus (DM) and coronary artery disease (CAD) were evaluated using chi-squared analysis. Adverse events were identified as major complications (death, cardiac arrest, cardiac perforation, coronary venous dissection, pericardial tamponade, or urgent cardiac surgery), and minor complications (coronary sinus dissection, pneumothorax, pocket bleeding requiring drainage, worsening tricuspid valve function, vegetation embolization, venous thrombosis, requirement of blood transfusion or lead migration). Subgroups for age were also analyzed using chi squared analysis to prevent type 1 error. Results There was no statistically significant difference in overall major and minor complications amongst different age groups (P&gt;0.05). An overall statistically significant difference was noted in baseline characteristics of CABG, HTN, HLD, DM, and CAD (P&lt;0.05). Within each age subgroup, no statistically significant difference was noted for major or minor complications post lead extraction (P&gt;0.05). Conclusion This study shows lead extraction can be performed safely in patients of all age groups without significant overall risk of major or minor complications. Acknowledgement/Funding None

Safety and efficacy of transvenous lead extractions for noninfectious superfluous leads in a Japanese population: A single-center experience.

A challenging decision exists as whether to abandon or remove noninfectious superfluous leads during lead revisions or cardiac implantable electronic device (CIED) upgrades. There is insufficient data in the Asian population to guide decision making. This study investigated the safety and efficacy of transvenous lead extractions (TLEs) in a high-volume Japanese center. Among a total of 341 patients who underwent lead revisions or CIED upgrades between 2008 and 2018, 53 patients (16%) who underwent TLEs to remove the superfluous leads were analyzed. Indications for TLE were vascular issues (60%), recalled leads (21%), growth of the body size (6%), abandoned leads in young patients (6%), switch to a subcutaneous implanted cardiac defibrillator (4%), need for an MRI conditional CIED (2%), and risks of vascular injury (2%). The population included 29 patients (55%) with nonfunctional leads and 24 (45%) with functional abandoned leads. A total of 74 target leads (mean 1.4 leads/person, median lead age 6.7 years) were extracted with a complete removal achieved in 98%. All coexisting leads, intended for continued use, were not damaged. All new leads (mean 1.4 leads/person) that had been simultaneously implanted during the TLE procedures were successfully implanted. There was one minor complication (2%) involving a pericardial effusion but it did not affect the hemodynamics. In this Japanese single center experience, the removal of noninfectious superfluous leads with TLEs seemed to be a safe and effective therapeutic option.

A Strategy of Lead Abandonment in a Large Cohort of Patients With Sprint Fidelis Leads

This study sought to examine outcomes of our approach to managing a large cohort of patients with Sprint Fidelis (Medtronic, Minneapolis, Minnesota) leads. The optimal management approach for patients with leads under advisory is unknown. Concerns regarding the risk of device infection and complications associated with delaying lead extraction have recently been suggested to argue against abandoning leads under advisory. All patients with a Sprint Fidelis lead implanted at our institute were included. Lead management options were discussed with patients who presented for device surgery at the time of device upgrade, lead fracture, or elective replacement indicator. Implantation of a new lead with abandonment of the Sprint Fidelis lead was the recommended strategy. Patients were subsequently followed at the device clinic at 6-month intervals and were enrolled prospectively in a longitudinal registry. A total of 520 patients had Sprint Fidelis leads implanted between December 2003 and October 2007 at the study center; 217 patients underwent lead replacement (213 underwent a lead abandonment strategy and 4 underwent a lead extraction strategy). Mean follow-up after lead replacement was 55 ± 33months. In patients undergoing lead abandonment, 10 of 213 (4.7%) had a procedural complication and 3 of 213 (1.4%) developed subsequent device infection requiring system extraction. In patients with a Sprint Fidelis lead, implanting a new lead without prophylactic extraction may beafeasible and safe strategy but requires longer follow-up.

Bundled skin antiseptic preparation for complex cardiac implantable electronic device infection: a propensity-score matching cohort study

Cardiac implantable electronic device (CIED) infection, a major complication of a CIED implant procedure, can prolong hospitalization and cause mortality. To evaluate the efficacy of a bundled skin antiseptic preparation for preventing infection after implantation of a complex CIED. This study analysed 1163 consecutive patients who had received a bundled skin antiseptic preparation before CIED implantation from July 2012 to December 2017. According to the complexity of the CIED implant procedure, the patients were divided into a complex CIED group (N= 370) and a non-complex CIED group (N= 793). A complex procedure was defined as a pacemaker replacement, implantation of implantable cardioverter defibrillator and cardiac resynchronization therapy, device upgrade, or lead revision. During a mean follow-up of 2.9 ± 1.7 years, CIED infection developed in 15 patients (1.3%), and the incidence of minor and major infection was 1.1% and 0.2%, respectively. The incidence of CIED infection did not significantly differ between the complex CIED group and the non-complex CIED group (1.1% vs 1.4%, respectively; non-significant). Multivariate analysis indicated that procedural complexity was not an independent predictor of CIED infection. After 2:1 propensity score matching, the matched non-complex CIED group and the matched complex CIED group still showed no significant difference in the incidence of CIED infection. Bundled skin antiseptic preparation is an effective and widely applicable strategy for decreasing infection risk after a complex CIED implantation.

Feasibility of Revision Cochlear Implant Surgery for Better Speech Comprehension.

Background and ObjectivesThe purpose of this study was to evaluate the efficacy of revision cochlear implant (CI) surgery for better speech comprehension targeting patients with low satisfaction after first CI surgery.Subjects and MethodsEight patients who could not upgrade speech processors because of an too early CI model and who wanted to change the whole system were included. After revision CI surgery, we compared speech comprehension before and after revision CI surgery. Categoies of Auditory Performance (CAP) score, vowel and consonant confusion test, Ling 6 sounds, word and sentence identification test were done.ResultsThe interval between surgeries ranged from eight years to 19 years. Same manufacturer’s latest product was used for revision surgery in six cases of eight cases. Full insertion of electrode was possible in most of cases (seven of eight). CAP score (p-value=0.01), vowel confusion test (p-value=0.041), one syllable word identification test (p-value=0.026), two syllable identification test (p-value=0.028), sentence identification test (pvalue=0.028) had significant improvement. Consonant confusion test (p-value=0.063), Ling 6 sound test (p-value=0.066) had improvement but it is not significant.ConclusionsAlthough there are some limitations of our study design, we could identify the effect of revision (upgrade) CI surgery indirectly. So we concluded that if patient complain low functional gain or low satisfaction after first CI surgery, revision (device upgrade) CI surgery is meaningful even if there is no device failure.

Contemporary management of cardiac implantable electronic device infection

### Learning objectives As our population ages with the increasing prevalence of comorbidities, and indication for cardiac implantable electronic devices (CIED) expand for treatment of heart failure, bradyarrhythmias and sudden...

Long term follow-up of patients with ventricular high rate events detected on remote monitoring of pacemakers

AimsPrevious data suggest ventricular high rate episodes (VHREs) on pacemakers are frequent and not associated with overall mortality on short term follow up. We sought to determine whether VHREs are associated with mortality, device upgrade, or change in ejection fraction on long term follow up. MethodsA single center, retrospective study was performed on 542 patients with permanent pacemakers followed between 2011 and 2013. Follow-up was extended to 2017 for determination of long term outcomes. “True” VHREs were defined as episodes adjudicated to be due to non-sustained ventricular tachycardia on review of electrograms and “false” VHREs were defined as supraventricular arrhythmias or noise. ResultsVHRE occurred in 202(37.2%)/542 included patients. True VHRE was detected in 148(27.3%) while 54(10%) had false VHRE. The mean age of the population was 72 ± 15 years and 46% were women. Mean follow-up was 3.3 ± 1.4 years. The baseline characteristics of the true, false and no VHRE patients were similar. There was no difference in all-cause mortality between groups (27% mortality in true VHRE, 33% in false VHRE and 29% in no VHRE). Furthermore, there was no difference between groups with regards to any device upgrade (5% any upgrades in the VHRE, 9% in false VHRE and 5% in no VHRE.) On follow up, EF declined in all groups: −4% vs −2.4% vs −3.5% for true, false and no VHRE. ConclusionVHRE are frequently encountered on remote monitoring of pacemakers and not associated with increased risk of mortality or need for downstream device upgrade.

Predictors of venous stenosis or occlusion following first transvenous cardiac device implantation: Prospective observational study

Introduction:Venous stenosis or occlusion related to an intracardiac device is a well-known complication of that procedure. There are numerous studies tried to determine predictors of venous stenosis or occlusion; however, most of them investigate the venous system prior to device upgrade, generator replacement, or transvenous lead extraction. Therefore, we aimed to assess the prevalence and determine the predictors of venous stenosis or occlusion following first transevnous cardiac device implantation.Methods:Observational, prospective study included 71 consecutive patients admitted for first transvenous cardiac device implantation. All patients were followed up for 6 months after operation.Results:Implanted device systems comprised cardioverter defibrillator (n = 26), single-chamber or dual-chamber pacemakers (n = 34), and biventricular pacemakers (n = 11); 88.5% of implantable cardioverter defibrillator leads were single-coils and 11.5% were dual-coils. The incidence of venous stenosis or occlusion within 6-month follow-up was 21.1%. Multivariate logistic regression showed that only diabetes or prediabetes (p = 0.033, odds ratio: 0.17, 95% confidence interval: 0.04–0.87), prolonged procedure time (p = 0.046, odds ratio: 4.54, 95% confidence interval: 1.01–20.12), and perioperative complications (p = 0.021, odds ratio: 7.04, 95% confidence interval: 1.35–36.85) were predictors of venous stenosis or occlusion.Conclusion:Prolonged implantation time (>60 min) and perioperative complications are associated with an increased risk of venous stenosis or occlusion, whereas diabetes and prediabetes significantly reduce the risk of venous stenosis or occlusion.

Cardiac resynchronisation therapy: current benefits and pitfalls.

Cardiac resynchronisation therapy (CRT) has been shown to reduce all-cause mortality, heart failure events, and symptoms while improving exercise capacity and quality of life. Nevertheless, despite a large number of multicentre randomised trials and clear evidence confirming the above, there is still a higher number of patients who fail to develop reverse remodelling. In order to select the optimal patient population, the current European Society of Cardiology guidelines recommend a simultaneous evaluation of QRS morphology and width. However, based on recent data, QRS width itself is a less accurate parameter in the prediction of the outcome, as compared to QRS morphology. Furthermore, the baseline left ventricular (LV) ejection fraction (LVEF), which is also an known criterion for selecting CRT candidates (partly applied due to cost-benefit reasons), can be misleading. Data showed that patients with LVEF > 35% might also benefit from this type of treatment. Thus, LVEF should be evaluated less rigorously when screening patients for resynchronisation therapy. While the subsequent beneficial response to CRT is multifactorial, procedure-related parameters, such as LV lead position, are also crucial. The first data released recently confirmed the previous empiric clinical experience indicating that the LV lead should be implanted into the lateral or posterior coronary sinus side branch. This location was associated with a better long-term clinical outcome in terms of death and heart failure events. Some issues related to CRT are awaiting further clarification, such as the choice of the type of the implanted device (pacemaker or defibrillator) or the decision about CRT device upgrade. This review discusses the current evidence regarding the above, focusing on the questions that should be handled with caution or require clarification.

5305Heart failure-related hospitalizations in ICD/CRT-D recipients following device replacement or upgrade: insights from the DECODE registry

5305Heart failure-related hospitalizations in ICD/CRT-D recipients following device replacement or upgrade: insights from the DECODE registry

Real-worldgeographic variations in the use of cardiac implantable electronic devices-The PANORAMA 2 observational cohort study.

Currently, several geographies around the world remain underrepresented in medical device trials. The PANORAMA 2 study was designed to assess contemporary region-specific differences in clinical practice patterns of patients with cardiac implantable electronic devices (CIEDs). In this prospective, multicenter, observational, multinational study, baseline and implant data of 4,706 patients receiving Medtronic CIEDs (Medtronic plc, Minneapolis, MN, USA; either de novo device implants, replacements, or upgrades) were analyzed, consisting of: 54% implantable pulse generators (IPGs), 20.3% implantable cardiac defibrillators (ICDs), 15% cardiac resynchronization therapy -defibrillators, and 5.1% cardiac resynchronization therapy -pacemakers, from 117 hospitals in 23 countries across four geographical regions between 2012 and 2016. For all device types, in all regions, there were fewer females than males enrolled, and women were less likely to have ischemic cardiomyopathy. Implant procedure duration differed significantly across the geographies for all device types. Subjects from emerging countries, women, and older patients were less likely to receive a magnetic resonance imaging-compatible device. Defibrillation testing differed significantly between the regions. European patients had the highest rates of atrial fibrillation (AF), and the lowest number of implanted single-chamber IPGs. Evaluation of stroke history suggested that the general embolic risk is more strongly associated with stroke than AF. We provide comprehensive descriptive data on patients receiving Medtronic CIEDs from several geographies, some of which are understudied in randomized controlled trials. We found significant variations in patient characteristics. Several medical decisions appear to be affected by socioeconomic factors. Long-term follow-up data will help evaluate if these variations require adjustments to outcome expectations.

Comparing Traffic Speed Deflectometer and Falling Weight Deflectometer Data

In recent years the pavement engineering community has shown increasing interest in shifting from a stationary falling weight deflectometer (FWD) to moving testing platforms such as the traffic speed deflectometer (TSD). This paper dealt with comparing TSD measurements against FWD measurements; it focused on the comparison methodology, utilizing experimental data for demonstration. To better account for differences in loading conditions between the two devices a new FWD deflection index was formulated first. This index served as reference/benchmark for assessing the corresponding TSD measurements. Next, a Taylor diagram was proposed for visualizing several comparison statistics. Finally, a modern agreement metric was identified and applied for ranking comparison results across different datasets. Overall, the suggested methodology is deemed generic and highly applicable to future situations, especially for assessing the worth of emerging device upgrades or improved interpretation schemes (or both).