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The historical restriction of magnetic resonance imaging (MRI) for patients with cardiac implantable electronic devices (CIEDs) has been lifted by certified MRI-conditional systems in recent years. Mixed-brand CIED systems consisting of a generator from one manufacturer and at least one lead from another manufacturer are not certified for MRI. We evaluated the temporal trend in the prevalence of mixed-brand systems in the era of MRI-conditional systems. Data were analyzed on 5853 CIEDs implanted de novo between 2012 and 2022 in 81 Italian centers linked to the nationwide Home Monitoring Expert Alliance network. The percentage of mixed-brand implants was calculated by device type (pacemaker, implantable cardioverter-defibrillator [ICD], cardiac resynchronization therapy [CRT] device) and over time. A mixed-brand system was implanted in 4.1% (95% CI, 3.6-4.6%) of analyzed patients or, by device type, in 4.5% (3.5-5.7%) of pacemaker patients, 1.1% (0.7-1.7%) of ICD patients, and 6.8% (5.7-7.9%) of CRT pacemaker/defibrillator patients (p < 0.001). Prevalence of mixed-brand implants exhibited significant temporal fluctuations, first declining from 6.6% (2012-2014) to 1.3% (2019), and then increasing to 5.1% (2022). Temporal changes were statistically significant for pacemakers (p < 0.001) and CRT devices (p = 0.001), but not for ICDs (p = 0.438). In the decade between 2012 and 2022, mixed-brand CIED systems were more prevalent in patients treated with pacemakers and CRT devices than in ICD recipients. A decline in the prevalence of mixed-brand systems was observed after the introduction of MRI-conditional systems, reaching a minimum in 2019, followed by a progressive increase in the subsequent years., (© 2024. The Author(s).)

Introduction: Data on implants of cardiac pacing systems in Spain in 2023 are presented., Methods: The registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers., Results: In 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately., Conclusions: In 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Prior analyses of the relationship between insurance status and receipt of tests and procedures have yielded conflicting findings and have focused on outpatient care. We sought to characterize the relationship between primary payer and diagnostic and procedural intensity, comparing rates of cardiac tests and procedures in matched hospitalized Medicaid and commercially insured patients., Methods and Results: We created a propensity score-matched sample of Medicaid and commercially insured adults hospitalized at all acute care hospitals in Kentucky, Maryland, New Jersey, and North Carolina from 2016 to 2018. The main outcome was receipt of a cardiac test or procedure: echocardiogram, stress test, cardiac catheterization (elective, in acute coronary syndrome, in ST-segment-elevation myocardial infarction), and pacemaker and subcutaneous cardiac rhythm monitor implantation. Generalized linear models with a hospital-specific indicator variable were estimated to calculate the adjusted odds of a commercially insured patient receiving a given test or procedure relative to a Medicaid patient. Models controlled for race, ethnicity, and zip code income quartile. Commercially insured patients were more likely to receive each cardiac test or procedure, with adjusted odds ratios ranging from 1.16 (95% CI, 1.00-1.34) for cardiac catheterization in ST-segment-elevation myocardial infarction to 1.40 (95% CI, 1.27-1.54) for pacemaker implantation., Conclusions: Hospitalized commercially insured patients were more likely to undergo a range of cardiac tests and procedures, some of which may represent low-value care. This may be driven by a combination of physician and patient preference, financial incentives, and social determinants of health. Our findings support the need for hospital payment models focused on increasing value and reducing inequities.

Objectives: The threshold to perform concomitant tricuspid valve (TV) repair during primary mitral valve (MV) surgery has decreased, based on recent randomized evidence. Based on these developments, the indication for TV repair during MV surgery is expected to increase further. However, concerns have been raised regarding the risk of permanent pacemaker implantation (PPI) during a concomitant procedure. Therefore, we aim to assess the incidence of PPI in combined MV and TV surgery in a nationwide registry., Methods: The current study uniquely cross-linked the Cardiothoracic and Pacemaker/ICD registry of the Netherlands Heart Registration. Patients undergoing primary MV and TV surgery (± atrial septal defect closure, rhythm surgery, coronary artery bypass grafting) between 1 January and 31 December2021 were included. The primary outcome was PPI within 30 days after surgery. Subgroup analyses were performed for isolated MV and TV surgery and MV repair. The association between concomitant TV surgery and PPI was assessed using multivariable binary logistic regression analyses., Results: A total of 1060 patients (n = 833 MV, n = 227 MV + TV) were included. The overall incidence of PPI was 4.3%. No significant difference in PPI between MV and MV + TV surgery were found (3.7% vs 6.6%, P = 0.06). Concomitant TV surgery was not an independent risk factor for PPI after surgery after adjustment for covariates. These results were robust after sensitivity analyses., Conclusions: The current study was not able to find a statistical difference between the PPI rate in MV surgery patients and MV + TV surgery patients. Extension of the waiting period prior to PPI, may result in decreased PPI rates., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Device-related infective endocarditis (IE) is associated with high mortality, resulting in a growing emphasis on identifying and managing comorbidities that increase the risk of IE in these patients. Psoriasis is increasingly being recognized as having multiple cardiovascular manifestations. However, little is known about the impact of psoriasis on IE risk in patients with permanent pacemakers (PPM). Our study aimed to assess whether psoriasis is associated with an increased risk of developing IE in patients with PPM., Methods: The National Inpatient Sample database was utilized to extract patients with PPM. The presence of psoriasis stratified patients. Demographic and comorbidity data were collected. 1:10,000 propensity matching for IE risk factors was performed to examine independent associations between psoriasis and IE., Results: Of 437,793 patients, 45 had psoriasis. Psoriasis patients had higher IE rates (4.4% vs. 0.6%; P < 0.01). On multivariate analysis, psoriasis was associated with a 7.2-fold high IE risk (OR: 7.2 [1.7-30.2]; P < 0.01). Post-match analysis showed an 8.3-fold IE risk in psoriasis patients (OR: 8.3 [2.0-34.4]; P < 0.001)., Conclusion: Psoriasis was independently associated with elevated IE risk in patients with PPM. Further studies are required to corroborate these findings, which will have implications for IE prophylaxis., (© 2024 the International Society of Dermatology.)

Pacemakers (PM) and implantable cardioverter-defibrillators are vital devices in contemporary clinical practice, but their growing adoption poses challenges. Complications, including lead migration, infections, and post-implantation venous thrombosis, underscore the importance of comprehensive investigation. This retrospective observational study enrolled patients diagnosed with upper limb deep vein thrombosis (DVT) secondary to intracardiac devices at a tertiary hospital from 2015 to 2022. The aim of the study was to determine the incidence and long-term outcomes (bleeding, DVT recurrence and sequelae) in these patients. Across the study period, 2681 intracardiac devices were implanted, with 12 cases of upper limb DVT documented. The majority of patients were male (91.7%), with a mean age of 63.92 years. DVT occurred in patients with PM (50%), implantable cardioverter-defibrillators (25%) and implantable cardioverter-defibrillators with Cardiac Resynchronization Therapy (25%). Treatment encompassed low-molecular-weight heparin (91.7%) during the acute episode and long-term anticoagulation with direct oral anticoagulants (75%) or vitamin K antagonists (25%). Over a mean follow-up period of 33.17 months, half of the patients exhibited long-term sequelae, notably collateral circulation (66.7%). Remarkably, no thrombosis recurrences were observed during follow-up. However, one patient (8.3%) experienced a major bleeding event during treatment, and one patient (8.3%) required device removal (PM) due to persistent symptoms. This study revealed upper limb DVT occurred in 0.45% of patients after intracardiac device implantation. Rate of thrombosis recurrence was low during follow-up. Although half of the patients developed long-term sequelae, the need for prolonged anticoagulant therapy in these cases remains uncertain., (© 2024. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)

Aims: Cardiac implantable electronic device (CIED) infections are a burden to hospitals and costly for healthcare systems. Chronic kidney disease (CKD) increases the risk of CIED infections, but its differential impact on healthcare utilization, costs, and outcomes is not known., Methods and Results: This retrospective analysis used de-identified Medicare Fee-for-Service claims to identify patients implanted with a CIED from July 2016 to December 2020. Outcomes were defined as hospital days and costs within 12 months post-implant, post-infection CKD progression, and mortality. Generalized linear models were used to calculate results by CKD and infection status while controlling for other comorbidities, with differences between cohorts representing the incremental effect associated with CKD. A total of 584 543 patients had a CIED implant, of which 26% had CKD and 1.4% had a device infection. The average total days in hospital for infected patients was 23.5 days with CKD vs. 14.5 days (P < 0.001) without. The average cost of infection was $121 756 with CKD vs. $55 366 without (P < 0.001), leading to an incremental cost associated with CKD of $66 390. Infected patients with CKD were more likely to have septicaemia or severe sepsis than those without CKD (11.0 vs. 4.6%, P < 0.001). After infection, CKD patients were more likely to experience CKD progression (hazard ratio 1.26, P < 0.001) and mortality (hazard ratio 1.89, P < 0.001)., Conclusion: Cardiac implantable electronic device infection in patients with CKD was associated with more healthcare utilization, higher cost, greater disease progression, and greater mortality compared to patients without CKD., Competing Interests: Conflict of interest: D.J.W. has received research grants and consultancy fees from Medtronic and Boston Scientific and educational fees from Abbot. M.E.T. has received speaker’s fees from Abbot, Biotronik, Boston Scientific, Medtronic, and Microport CRM. J.Z., C.W., R.H., and J.M. are employees of Medtronic, Inc. M.F.E.-C. has received consultant fees from Medtronic and Boston Scientific., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: The objective of this study was to evaluate the association between comprehensive cardiac rehabilitation (CCR) completion and long-term clinical outcomes in patients with cardiac implantable electronic devices (CIED)., Methods: This retrospective cohort study included 834 patients with CIED who participated in CCR, which included a cardiopulmonary exercise test or 6-min walk test. Patients with a left ventricular ejection fraction ≤40%, predicted peak oxygen uptake ≤80%, or B-type natriuretic peptide level ≥80 pg/mL were eligible. The primary outcome was all-cause mortality., Results: After excluding 241 patients with duplicate records and 69 who underwent CCR in the outpatient department, the data of 524 patients were analyzed. Mean age was 64 ± 15 yr, 389 (74%) patients were men, left ventricular ejection fraction was 31 ± 15%, and 282 (54%) patients had a history of hospitalization for worsening heart failure. Of the patients referred for CCR, 294 (56%) completed the program, and an additional 230 patients started but did not complete CCR. Over a 3.7-yr median follow-up period, all-cause mortality occurred in 156 (30%) patients. Completers had lower all-cause mortality rates than non-completers (log-rank 15.77, P < .001). After adjusting for prognostic baseline characteristics, completers had 58% lower all-cause mortality risks than non-completers (HR = 0.42; 95% CI, 0.27-0.64, P < .001)., Conclusions: Three-mo CCR program completion was associated with lower mortality risks in patients with CIED. New programs or management methods are needed to decrease mortality risks, especially for those who cannot complete CCR programs., Competing Interests: Kengo Kusano: Speaker honoraria from Medtronic Japan and recipient of research grants from Medtronic Japan and Boston Scientific. Nobuhiko Ueda and Kouhei Ishibashi: Speaker honoraria from Medtronic Japan. The other authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To quantify the rate of cardiac implantable electronic device (CIED)-related infections and to identify risk factors for such infections., Design: Retrospective cohort study; analysis of linked hospital admissions and mortality data., Setting, Participants: All adults who underwent CIED procedures in New South Wales between 1 January 2016 and 30 June 2021 (public hospitals) or 30 June 2020 (private hospitals)., Main Outcome Measures: Proportions of patients hospitalised with CIED-related infections (identified by hospital record diagnosis codes); risk of CIED-related infection by patient, device, and procedural factors., Results: Of 37 675 CIED procedures (23 194 men, 63.5%), 500 were followed by CIED-related infections (median follow-up, 24.9 months; interquartile range, 11.2-40.8 months), including 397 people (1.1%) within twelve months of their procedures, and 186 of 10 540 people (2.5%) at high risk of such infections (replacement or upgrade procedures; new cardiac resynchronisation therapy with defibrillator, CRT-D). The overall infection rate was 0.50 (95% confidence interval [CI], 0.45-0.54) per 1000 person-months; it was highest during the first month after the procedure (5.60 [95% CI, 4.89-6.42] per 1000 person-months). The risk of CIED-related infection was greater for people under 65 years of age than for those aged 65-74 years (adjusted hazard ratio [aHR], 1.71; 95% CI, 1.32-2.23), for people with CRT-D devices than for those with permanent pacemakers (aHR, 1.46; 95% CI, 1.02-2.08), for people who had previously undergone CIED procedures (two or more v none: aHR, 1.51; 95% CI, 1.02-2.25) or had CIED-related infections (aHR, 11.4; 95% CI, 8.34-15.7), or had undergone concomitant cardiac surgery (aHR, 1.62; 95% CI, 1.10-2.39), and for people with atrial fibrillation (aHR, 1.33; 95% CI, 1.11-1.60), chronic kidney disease (aHR, 1.54; 95% CI, 1.27-1.87), chronic obstructive pulmonary disease (aHR, 1.37; 95% CI, 1.10-1.69), or cardiomyopathy (aHR 1.60; 95% CI, 1.25-2.05)., Conclusions: Knowledge of risk factors for CIED-related infections can help clinicians discuss them with their patients, identify people at particular risk, and inform decisions about device type, upgrades and replacements, and prophylactic interventions., (© 2024 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.)

Background: Comorbid cardiovascular diseases have been associated with poor outcomes in total knee arthroplasty (TKA); however, our understanding of TKA with prior cardiac treatment procedures has largely been undocumented. In this study, we examined TKA patients who had undergone different cardiac interventions that addressed their condition. The purpose was to characterize and compare outcomes for a growing patient population not yet analyzed., Materials and Methods: The 2016-2019 Nationwide Inpatient Sample database was queried for 558,256 patients who had TKA (ICD-10CM). Backgrounds significant for pacemaker [PM] (n = 8025), coronary artery bypass [CABG] (n = 12,683), heart valve surgery [HV] (n = 4125), or coronary stent [CS] (n = 19,483) were compared against those without, across demographics, admission information, and various complications., Results: Cardiac interventions were associated with increased age, male gender, length of stay, and cost of care. CABG, and Stent groups had more diabetics, but HV had significantly fewer (p = 0.008). PM and HV had significantly less tobacco use and, in addition to CABG, less obesity. Postoperatively, mortality was elevated in the PM [Odds ratio (OR) 2.89, p = 0.008], CABG (OR 2.53, p = 0.006) and CS group (OR 1.94, p = 0.018), but not HV. Myocardial infarctions were elevated in the CABG (OR 3.874) and CS group (OR 5.11) (p < 0.001). PM, HV, and CS had increased odds of periprosthetic fracture by 2.15-fold (p < 0.001), 2.09-fold (p < 0.001), 1.29-fold (p = 0.011) respectively. HV saw increased periprosthetic mechanical complications (OR 1.48, p = 0.006). CABG increased the odds of deep surgical site infection 14.23-fold and CS 9.22-fold (p < 0.001). Postoperative pneumonia was increased in PM, CABG, and CS groups (OR 2.15,), (OR 2.21,), (OR 1.64,) (p < 0.001)., Conclusions: Patients who have undergone cardiac intervention are generally at risk for adverse stays. Furthermore, risk factors and complications vary between the groups. Our analysis emphasizes the importance of individualized medical care and as a basis for electing and informing patients for TKA., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Previous registries have shown a younger average age at presentation with cardiovascular diseases in the Middle East (ME), but no study has examined atrioventricular block (AVB). Moreover, these comparisons are confounded by younger populations in the ME. We sought to describe the average age at presentation with AVB in ME and quantify the effect of being from ME, adjusted for the overall younger population., Methodology: This was a retrospective analysis of PANORAMA registries, which collected data on patients who underwent cardiac rhythm device placement worldwide. Countries with a median population age of ≤30 were considered 'young countries'. Multivariate linear regression was performed to assess the effect of being from ME, adjusted for being from a 'young country', on age at presentation with AVB., Results: The study included 5,259 AVB patients, with 640 (8.2%) from the ME. Mean age at presentation was seven years younger in ME than in other regions (62.9 ± 17.8 vs. 70 ± 14.1, P < 0.001). Being from a 'young country' was associated with 5.6 years younger age at presentation (95%CI -6.5--4.6), whereas being from ME was associated with 3.1 years younger age at presentation (95%CI -4.5--1.8), (P < 0.001 for both)., Conclusion: The average age at presentation with AVB in the ME is seven years younger than in other regions. While this is mostly driven by the overall younger population, being from the ME appears to be independently associated with younger age. Determinants of the earlier presentation in ME need to be assessed, and care should be taken when applying international recommendations., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2024 The Author(s).)

We evaluated predictors of permanent pacemaker implantation (PPI) following self-expanding transcatheter aortic valve replacement (TAVR), examined site-to-site variability of PPI rates, and explored the relationship of implantation methods on the need for PPI. Despite the benefits of TAVR compared to surgical aortic valve replacement, increased PPI remains a limitation. A total of 699 patients without baseline PPI were included in the study. Clinical, echocardiographic, and procedural characteristics were compared in patient with and without new PPI. Clinical outcomes were assessed at 30 days and 1 year. Funnel plots were constructed to display site-to- site variability and identify outliers in PPI. Clinical outcomes were similar in patients with and without PPI. Predictors of a new PPI within 7 days included a baseline right bundle branch block (p < 0.001) and not using general anesthesia (p = 0.003). There was substantial site to site variability in the rate of PPI. Patients at sites with a lower PPI rate had shallower implantation depth at the non-coronary (p < 0.001) and the left coronary sinus (p < 0.001), and fewer patients with an implantation depth > 5 mm below the annulus (p = 0.004). In low-risk patients undergoing TAVR with Evolut valves, baseline conduction disorders and implant depth were important predictors of PPI. Implantation method may have contributed to this variability in PPI rates across clinical sites., Competing Interests: Declaration of competing interest Hemal Gada reports financial support, administrative support, statistical analysis, and writing assistance were provided by Medtronic. Hemal Gada reports a relationship with Abbott Cardiovascular Structural Heart Division that includes: consulting or advisory. Hemal Gada reports a relationship with C R Bard Inc. that includes: consulting or advisory. Hemal Gada reports a relationship with Boston Scientific Corp that includes: consulting or advisory. Hemal Gada reports a relationship with Edwards Lifesciences Corp that includes: consulting or advisory. Hemal Gada reports a relationship with Medtronic that includes: consulting or advisory. Amit Vora reports a relationship with Medtronic Inc. that includes: consulting or advisory. Gilbert Tang reports a relationship with Abbott Cardiovascular Structural Heart Division that includes: consulting or advisory and speaking and lecture fees. Gilbert Tang reports a relationship with WL Gore and Associates that includes: consulting or advisory. Mubashir Mumtaz reports a relationship with Edwards Lifesciences Corp that includes: consulting or advisory and funding grants. Mubashir Mumtaz reports a relationship with Japanese Organization for Medical Device Development that includes: consulting or advisory and funding grants. Mubashir Mumtaz reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Mubashir Mumtaz reports a relationship with Z-Medical that includes: consulting or advisory and funding grants. John Forrest reports a relationship with Edwards Lifesciences Corp that includes: consulting or advisory, funding grants, and speaking and lecture fees. John Forrest reports a relationship with Medtronic that includes: consulting or advisory, funding grants, and speaking and lecture fees. Roger Laham reports a relationship with Medtronic that includes: funding grants. Roger Laham reports a relationship with Abbott Vascular Redwood City that includes: funding grants. Roger Laham reports a relationship with Boston Scientific Corp that includes: funding grants. Jian Huang reports a relationship with Medtronic that includes: employment. Michael Reardon reports a relationship with Medtronic that includes: consulting or advisory., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: Our goal was to compare pacemaker rate usage following two different operating techniques for implanting the Perceval aortic valve replacement., Methods: In this retrospective, single-centre study, we studied patients with isolated or concomitant Perceval aortic valve replacement operated on first between April 2013 and January 2016, following traditional operating techniques, with patients operated on between January 2016 and December 2020, after the adoption of a modified protocol based on different annulus sizing, higher positioning of the valve and no ballooning after valve deployment was adopted. The operations were performed by 2 surgeons, and patients were followed-up for a period of 30 days., Results: A total of 286 patients, with a mean age of 77 (4.9) years, had Perceval valves implanted during the study period, of which 79% were isolated aortic valve procedures. Most patients (66.8%) underwent minimally invasive procedures. Cross-clamp time was 55.1 (17.6) min. The overall postoperative pacemaker insertion rate was 8.4%, which decreased decisively after the 2016 change in the implant protocol (16% vs 5.6%; P = 0.005), adjusted odds ratio of 0.31 (95% confidence interval: 0.13-0.74, P = 0.012). Univariable and multivariable analysis showed that larger valve size (P = 0.01) and ballooning (P = 0.002) were associated with higher risk of implanting a pacemaker. Postoperative 30-day mortality was of 4.5%., Conclusions: Improvement in the operating techniques for implanting the Perceval valve may decrease the rate of pacemakers implanted postoperatively. Although further studies are needed to confirm these results, such a risk reduction may lead to wider use of Perceval valves in the future, potentially benefiting patients who are suitable candidates for minimally invasive surgery., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown., Objective: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey., Methods: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure., Results: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe., Conclusion: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients., (Copyright © 2021 Heart Rhythm Society. All rights reserved.)

Aims: The coronavirus disease-19 (COVID-19) outbreak has been recently associated with lower hospitalization rates for acute coronary syndromes. Aim of the study was to investigate whether a similar behaviour is observed in admissions for urgent pacemaker implant., Methods: This retrospective study included 1315 patients from 18 hospitals in Northern Italy with a high number of COVID-19 cases. Hospitalization rates for urgent pacemaker implant were compared between the following periods: 20 February to 20 April 2020 (case period); from 1 January to 19 February 2020 (intra-year control period); from 20 February to 20 April 2019 (inter-year control period)., Results: The incidence rate of urgent implants was 5.0/day in the case period, 6.0/day in the intra-year control period and 5.8/day in the inter-year control period. Incidence rate in the case period was significantly lower than both the intra-year [incidence rate ratio (IRR): 0.81, 95% CI 0.67-0.99, P = 0.040] and inter-year control periods (IRR: 0.79, 95% CI 0.66-0.95, P = 0.012); this reduction was highest after the national lockdown (IRR 0.68, 95% CI 0.52-0.91, P = 0.009). The prevalence of residents in rural areas undergoing urgent pacemaker implant was lower in the case period (36%) than in both the intra-year (47%, P = 0.03) and inter-year control periods (51%, P = 0.002). Elective pacemaker implants also decreased in the case period, with the incidence rate here being 3.5/day vs. 6.4/day in the intra-year (-45%) and 6.9/day in the inter-year period (-49%)., Conclusion: Despite severe clinical patterns, the COVID-19 outbreak has negatively affected the population presentation to Emergency Departments for bradyarrhythmias requiring urgent pacemaker implant in Northern Italy. This mainly occurred after the national lockdown and concerned patients living in rural areas., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Leadless pacemakers (LPs) have proven safe and effective, but device revisions remain necessary. Either replacing the LP or implanting a new adjacent LP is feasible. Replacement seems more appealing, but encapsulation and tissue adhesions may hamper the safety and efficacy of LP retrieval., Objective: We determined the incidence and cellular characteristics of tissue adherent to retrieved LPs and the potential implications for end-of-life strategy., Methods: All 15 consecutive successful Nanostim LP retrievals in a tertiary center were included. We assessed the histopathology of adherent tissue and obtained clinical characteristics., Results: Adherent tissue was present in 14 of 15 retrievals (93%; median implantation duration 36 months; range 0-96 months). The tissue consisted of fibrosis (n = 2), fibrosis and thrombus (n = 9), or thrombus only (n = 3). In short-term retrievals (<1 year), mostly fresh thrombi without fibrosis were seen. In later retrievals, the tissue consisted of fibrosis often with organizing or lytic thrombi. Fibrosis showed different stages of organization, notably early fibrocellular and later fibrosclerotic tissue. Inflammatory cells were seen (n = 4) without signs of infection. Tricuspid valve material was retrieved in 1 patient after 36 months, resulting in increased tricuspid regurgitation., Conclusion: Our results suggest that fibrosis and thrombus adherent to LPs are common and encapsulate the LP as seen in transvenous pacemakers. LPs may adhere to the tricuspid valve or subvalvular apparatus affecting retrieval safety. The end-of-life strategy should be optimized by incorporating risk stratification for excessive fibrotic encapsulation and adhesions., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Abstract: Very elderly people (over 80 years) with cardiac implantable electronic devices (CIEDs) indications often have a higher prevalence of aging comorbidity, among which cognitive impairment is not uncommon. This study aimed to investigate periprocedural complications of CIED implantation among very elderly patients with and without cognitive impairment. One hundred eighty patients ≥80 years of age indicated for CIED implantation were included in our study. During hospitalization, the cognitive evaluation was performed according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). According to the cognitive test results, patients were divided into 2 groups (90 patients with normal cognitive function and 90 patients with cognitive impairment). Meanwhile, their physical parameters and laboratory measurements were completed. The procedural data and periprocedural complications were collected from both groups. The association between cognitive impairment and periprocedural complications was analyzed using univariate and multiple logistic regression analyses. During a one-month follow-up, the most frequent periprocedural complications in very elderly patients were pocket hematoma and thrombosis events. Cognitively impaired patients had a higher incidence of complications than normal cognitive patients. Multivariate regression analysis showed that cognitive impairment was positively correlated with periprocedural complications in very elderly patients. Cognitive impairment is associated with increased periprocedural complications of CIED implantation in very elderly patients., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Importance: Prior studies investigating the long-term clinical outcomes of patients who have undergone permanent pacemaker implantation after aortic valve replacement reported conflicting results., Objective: To investigate long-term outcomes after primary surgical aortic valve replacement among patients who underwent postoperative permanent pacemaker implantation., Design, Setting, and Participants: This cohort study included all patients who underwent surgical aortic valve replacement in Sweden from 1997 to 2018. All patients who underwent primary surgical aortic valve replacement in Sweden and survived the first 30 days after surgical treatment were included. Patients who underwent preoperative permanent pacemaker implantation, concomitant surgical treatment for another valve, or emergency surgical treatment were excluded. Patients who underwent concomitant coronary artery bypass grafting or surgical treatment of the ascending aorta were included. Follow-up data were complete for all patients. Data were analyzed from October through December 2020., Exposures: Patients underwent implantation of a permanent pacemaker or implantable cardioverter defibrillator within 30 days after aortic valve replacement., Main Outcomes and Measures: The primary outcome was all-cause mortality., Results: Among 24 983 patients who underwent surgical aortic valve replacement, 849 patients (3.4%) underwent permanent pacemaker implantation within 30 days after surgical treatment and 24 134 patients (96.6%) did not receive pacemakers in that time. The mean (SD) age of the total study population was 69.7 (10.8) years, and 9209 patients were women (36.9%). The mean (SD) and maximum follow-up periods were 7.3 (5.0) years and 22.0 years, respectively. At 10 years and 20 years after surgical treatment, the Kaplan-Meier estimated survival rates were 52.8% and 18.0% in the pacemaker group, respectively, and 57.5% and 19.6% in the nonpacemaker group, respectively. All-cause mortality was statistically significantly increased in the pacemaker group compared with the nonpacemaker group (hazard ratio [HR], 1.14; 95% CI, 1.01-1.29; P = .03), and so was risk of heart failure hospitalization (HR, 1.58; 95% CI, 1.31-1.89; P < .001). No statistically significant increase was found in the risk of endocarditis in the pacemaker group., Conclusions and Relevance: This study found that there were increased risks of all-cause mortality and heart failure hospitalization among patients who underwent permanent pacemaker implantation after surgical aortic valve replacement, suggesting that these risks are important considerations, especially in an era when transcatheter aortic valve replacement is used in younger patients at lower risk of adverse surgical outcomes. These findings further suggest that future research should investigate how to avoid permanent pacemaker dependency after surgical and transcatheter aortic valve replacement.

Right ventricular (RV) septum is an alternate site for the placement of RV lead tip instead of RV apex. Recent studies have demonstrated that less than half of the RV leads targeted for septal implantation are placed on the RV septum using a conventional stylet system; new guiding catheter systems have become available for RV lead placement. This study aimed to investigate the usefulness of the delivery catheter system in lead placement on the RV septum when compared with the stylet system. We retrospectively evaluated 198 patients who underwent fluoroscopically guided pacemaker implantation with RV leads targeted to be placed in the RV septum and in whom computed tomography was incidentally and subsequently performed. A delivery catheter was used in 16 patients, and a stylet in 182 patients. The primary endpoint of this study was the success rate of RV lead placement on the RV septum. The proportion of RV lead placement on the RV septum was higher in the delivery catheter group than in the stylet group (100% vs. 44%; p < 0.001). In the stylet group, the lead tips were placed at the hinge in 92 cases (51%) and on the free wall in 9 cases (5%). Paced QRS duration was narrower in the delivery catheter group than in the stylet group (128 ± 16 vs. 150 ± 21 ms, p < 0.01). The delivery catheter system designated for pacing leads may aid in selecting RV septal sites and achieve good physiologic ventricular activation.

Abstract: Transcatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients' electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3-7) days, whereas pacemakers were implanted after a median interval of 13 (8-28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure., Competing Interests: The authors have no funding and conflicts of interests to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Methods and Results: We retrospectively compared 257 consecutive patients undergoing TAVR with self-expandable valves using either CON ( n  = 101) or COVL ( n  = 156) in four intermediate/low volume centers. There were no significant differences in baseline characteristics between the groups. The 30-day incidence of new-onset LBBB (12.9% vs. 5.8%; p =0.05) and PPMI rate (17.8% vs. 6.4%; p =0.004) was significantly lower when using the COVL implantation view. There was no difference between the CON and COVL groups in 30-day incidence of death (4.9% vs. 2.6%), any stroke (0% vs. 0.6%), and the need for surgical aortic valve replacement (0% for both groups)., Conclusion: Using the COVL view for implantation, we achieved a significant reduction of the LBBB and PPMI rate after TAVR in comparison with the traditional CON view, without compromising the TAVR outcomes when using self-expandable prostheses., Competing Interests: Oscar A. Mendiz, MD, is a physician proctor for Medtronic and Boston Scientific and speaker for Philips. Matias Stefjman, MD, is a physician proctor for Medtronic and Boston Scientific. Hemal Gada, MD, is a consultant for Abbott Vascular, Bard Medical, Boston Scientific, Medtronic. Gilbert H. L. Tang, MD, is a physician proctor for Medtronic and a consultant for Medtronic, Abbott Structural Heart, and W. L. Gore & Associates. All the other authors do not have any conflicts of interest., (Copyright © 2021 Oscar A. Mendiz et al.)

Background Limited clinical evidence and literature are available about the potential impact of sex on permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). The aim of this work was to evaluate the relationship between sexes and atrioventricular conduction disturbances requiring PPI after TAVI. Methods and Results Data were obtained from 46 studies from PubMed reporting information about the impact of patient sex on PPI after TAVI. Total proportions with 95% Cls were reported. Funnel plot and Egger test were used for estimation of publication bias. The primary end point was 30-day or in-hospital PPI after TAVI, with odds ratios and 95% CIs extracted. A total of 70 313 patients were included, with a cumulative proportion of 51.5% of women (35 691 patients; 95% CI, 50.2-52.7). The proportion of women undergoing TAVI dropped significantly over time ( P <0.0001). The cumulative PPI rate was 15.6% (95% CI, 13.3-18.3). The cumulative rate of PPI in women was 14.9% (95% CI, 12.6-17.6), lower than in men (16.6%; 95% CI, 14.2-19.4). The risk for post-TAVI PPI was lower in women (odds ratio, 0.90; 95% CI, 0.84-0.96 [ P =0.0022]). By meta-regression analysis, age ( P =0.874) and ventricular function ( P =0.302) were not significantly associated with PPI among the sexes. Balloon-expandable TAVI significantly decrease the advantage of women for PPI, approaching the same rate as in men ( P =0.0061). Conclusions Female sex is associated with a reduced rate of PPI after TAVI, without influence of age or ventricular function. Balloon-expandable devices attenuate this advantage in favor of women. Additional investigations are warranted to elucidate sex-based differences in developing conduction disturbances after TAVI.

Kidney transplant recipients (KTRs) are considered high-risk patients for surgical interventions. Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS) at high operative risk. However, the outcomes of TAVI compared with SAVR KTRs have not been well-studied in nationally representative data. Patients with prior history of functioning kidney transplant who were hospitalized for TAVI and SAVR between January 2012 and December 2017 were identified retrospectively in the Nationwide Readmissions Database. Our study included 762 TAVI and 1,278 SAVR KTRs. Compared with SAVR, TAVI patients generally had higher rates of co-morbidities with lower risk of in-hospital mortality (3.1% vs 6.3, p = 0.002), blood transfusion (11.5% vs 38.6%, p <0.001), acute myocardial infarction (3.9% vs 6.5%, p = 0.16), acute kidney injury (24.5% vs 42.1%, p <0.001), sepsis (3.9% vs 9.5%, p <0.001) and discharge with disability (42.6% vs 68.4%, p <0.001). However, the rate of permanent pacemaker implantation was significantly higher in TAVI group (11.4% vs 3.9%, p <0.001). Of note, in-hospital stroke and 30-day readmission were comparable between both groups. These findings were confirmed after adjusting for other co-morbidities. TAVI is growing as a valid and safe alternative for KTRs with severe AS., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this study., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: We compared early and 2-year clinical outcomes of sutureless aortic valve replacement (SAVR) with conventional aortic valve replacement (CAVR) in a nationwide study based on claims data., Methods: From December 2016 to November 2018, 3,173 patients underwent bioprosthetic aortic valve replacements. SAVR and CAVR were performed in 641 and 2,532 patients, respectively. Propensity score-matched analysis was performed in 640 patient pairs., Results: Operative mortality rate was 2.8% without significant differences between the SAVR (3.4%) and CAVR (2.3%) groups ( P = 0.324). There were no significant differences in postoperative morbidities between the groups except for permanent pacemaker (PPM) implantation. PPM implantation rate was significantly higher in the SAVR (3.8%) than in the CAVR group (0.9%) ( P < 0.001). One- and two-year overall survival was 89.1% and 87.5%, respectively, without significant differences between the groups (SAVR group vs. CAVR grou P = 89.9% and 90.5% vs. 87.2% and 88.7%, respectively; P = 0.475). There were no significant differences in the cumulative incidence of cardiac death, stroke, aortic valve reoperation and infective endocarditis between the groups. Cumulative PPM implantation incidence at 6 months in the CAVR was 1.1%, and no patient required PPM implantation after 6 months. In the SAVR, the cumulative PPM implantation incidence at 0.5, one, and two years was 3.9%, 5.0% and 5.6%, respectively. The cumulative PPM implantation rate was higher in the SAVR group than in the CAVR group ( P < 0.001)., Conclusion: Early and 2-year clinical outcomes between SAVR and CAVR were not different except for a high rate of permanent pacemaker implantation in the SAVR group., Competing Interests: The authors have no potential conflicts of interest to disclose., (© 2021 The Korean Academy of Medical Sciences.)

Objective: To characterize contemporary pacemaker procedure trends., Methods: Nationwide analysis of pacemaker procedures and costs between 2008 and 2017 in Australia. The main outcome measures were total, age- and gender-specific implant, replacement, and complication rates, and costs., Results: Pacemaker implants increased from 12,153 to 17,862. Implantation rates rose from 55.3 to 72.6 per 100,000, a 2.8% annual increase (incidence rate ratio [IRR] 1.028; 95% CI, 1.02-1.04; p < .001). Pacemaker implants in the 80+ age group were 17.37-times higher than the < 50 group (95% CI 16.24-18.59; p < .001), and in males were 1.48-times higher than in females (95% CI 1.42-1.55; p < .001). However, there were similar increases according to age (p = .10) and gender (p = .68) over the study period. Left ventricular lead rates were stable (IRR 0.995; 95% CI 0.98-1.01; p = .53). Generator replacements decreased from 20.5 to 18.3 per 100,000 (IRR 0.975; 95% CI 0.97-0.98; p < .001). Although procedures for generator-related complications were stable (IRR 0.995; 95% CI 0.98-1.01; p = .54), those for lead-related complications decreased (IRR 0.985; 95% CI 0.98-0.99; p < .001). Rates for all pacemaker procedures were consistently greater in males (p < .001). Although annual costs of all pacemaker procedures increased from $178 million to $329 million, inflation-adjusted costs were more stable, rising from $294 million to $329 million., Conclusions: Increasing demand for pacemaker implants is driven by the ageing population and rising rates across all ages, while replacement and complication procedure rates appeared more stable. Males have consistently greater pacemaker procedure rates than females. Our findings have significant clinical and public health implications for healthcare resource planning., (© 2021 Wiley Periodicals LLC.)

Tricuspid valve (TV) surgery is associated with a high risk of postoperative pacemaker requirement. We set out to identify the incidence of atrioventricular block (AVB) after TV surgery and determine whether atrioventricular conduction recovers within time.We investigated pre/intra- and postoperative predictors of AVB in patients who underwent tricuspid valve surgery (not only isolated TV surgery) at our institution between 2004 and 2017. Patients who had pacemakers prior to surgery were excluded.One year after surgery, 5.8% of the surviving cohort had received a pacemaker due to AVB. In the complete follow-up time, 33 out of 505 patients required pacemaker implantation because of AVB. Of the 37 patients who presented to the intensive care unit postoperatively with AVB III, 14 (38%) underwent pacemaker implantation for AVB, and 20 (54%) did not require a pacemaker. AVB III at ICU admission was identified as a predictor of pacemaker implantation (OR: 9.7, CI: 3.8-24.5, P < 0.001). TV endocarditis was also identified as a predictor (OR: 12.4, CI: 3.3-46.3, P < 0.001). Eleven out of 32 patients (34%) with tricuspid endocarditis required a pacemaker for AVB. The mean ventricular pacing burden within the first 5 years after pacemaker implantation was 79%.The issue of AVB after TV surgery is significant. Both the initial rhythm after surgery and etiology of the tricuspid disease can help predict pacemaker requirement. Within the first 5 years after surgery, the ventricular pacing burden remains high without relevant rhythm recovery.

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions., Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs)., Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year., Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm 2 vs. 1.37 ± 0.5 cm 2 ; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003)., Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality., Competing Interests: Author Disclosures Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Kim has received proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr. Barbanti is a consultant for Edwards; and is an Advisory Board member for Biotronik. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Redwood is a proctor for and has received lecture fees from Edwards. Dr. Hamm is an Advisory Board member for Medtronic. Dr. Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Wood is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr. Sathananthan is a consultant to Edwards Lifesciences. Dr. Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr. Leipsic is a consultant to Circle CVI and Edwards Lifesciences; and provides institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Andreas is a proctor for Edwards and Abbott; and is an Advisory Board member for Medtronic. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Castriota is a proctor for Medtronic and Boston Scientific. Dr. Kodali has received research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences; has received personal fees from and holds equity in Admedus; and holds equity in Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve. Dr. Conradi is a consultant to Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Neovasc, and JenaValve. Dr. Nazif has received consulting fees or honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and has received consulting fees from and holds equity in Venus Medtech. Dr. Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr. Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi-Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr. Latib has received institutional research or grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr. Hildick-Smith is a proctor and adviser to Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is limited evidence on the influence of sex on the decision to implant a cardiac resynchronization therapy device with pacemaker (CRT-P) or defibrillator (CRT-D) and the existence of sex-dependent differences in complications that may affect this decision., Methods: All patients undergoing de novo CRT implantation (2004-2014) in the United States National Inpatient Sample were included and stratified by device type (CRT-P and CRT-D). Multivariable logistic regression models were conducted to assess the association of female sex with receipt of CRT-D and periprocedural complications., Results: Out of 400,823 weighted CRT procedural records, the overall percentages of women undergoing CRT-P and CRT-D implantations were 41.5% and 27.8%, respectively, and these percentages increased compared with men over the study period. Women were less likely to receive CRT-D (odds ratio 0.66, 95% confidence interval 0.64-0.67), and this trend remained stable throughout the study period (P = 0.06). Furthermore, compared with men, women were associated with increased odds of procedure-related complications (bleeding, thoracic, and cardiac) in the CRT-D group but not in the CRT-P group. Factors such as atrial fibrillation, malignancies, renal failure, advanced age (> 60 years), and admission to nonurban/small hospitals favoured the receipt of CRT-P over CRT-D, whereas history of ischemic heart disease, cardiac arrest ,or ventricular arrhythmias favoured the receipt of CRT-D over CRT-P., Conclusions: Women were associated with persistently reduced odds of receipt of CRT-D compared with men over an 11-year period. This study identifies important factors that predict the choice of CRT device offered to patients in the United States., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Introduction: The number of patients who have a cardiac implantable electronic device (CIEDs) that undergo a course of radiotherapy is increasing due to the ageing population. The majority of clinical studies only evaluate any CIED malfunction at the end of a course of irradiation or in a case of there being symptoms of possible malfunction. As a result, little data has been collected on CIED status acquired during an active course of irradiation., Material and Methods: We aimed to evaluate the correct functioning of a CIED during a course of radiotherapy. So, a retrospective analysis was made of all patients having CIEDS in a single institution during their course of radiotherapy. All CIEDs were systematically checked before and during the course of radiotherapy according to the risk of device failure and patient dependence., Results: Data was analysed from 56 patients (43 men, 13 women) with a mean age of 78.2 years, of whom 87.5% of the patients carried a pacemaker (PM), the 39% of the patients were PM dependent, and the remaining patients carried an implantable cardioverter-defibrillator (ICD). An observable dose of irradiation was evident in only 10 cases. 69.1% of the CIEDs were checked daily and the remainder were checked weekly. During the radiotherapy course, 82% of the patients did not complain of any cardiological event. The CIED of five patients experienced an increase in the threshold and, in another case, a sudden reduction in the duration of the battery was reported. Another patient with a CIED experienced a cardiac insufficiency episode triggered by a ventricular tachycardia., Conclusion: In conclusions, although adverse clinical events from exposure of a CIED to irradiation are rare, they can appear in any group of risk. No dose-dependency was observed on the malfunction of the CIED.

Background: The purpose of this study was to identify predictors of mortality and potentially modifiable factors related to arrhythmias in patients that undergo transcatheter aortic valve replacement (TAVR). Patients that undergo TAVR are at risk for complete heart block requiring pacemaker implant. Additionally, other arrhythmias, specifically atrial fibrillation (AF), are common in this population. It is unclear how arrhythmias and their management contribute to mortality risk., Methods: The study analyzed 176 patients who underwent TAVR at a single center. Factors associated with pacemaker implantation within 30 days were analyzed by logistic regression. Factors associated with mortality were analyzed by Kaplan-Meier and Cox regression analyses., Results: Mean age was 80 ± 8.5 years. AF was present in 69 patients, and 39 received anticoagulation. Post-TAVR, a pacemaker was implanted in 25 patients within 30 days. Over a follow up of 566 ± 496 days, 49 patients died. In multivariable analysis, right bundle branch block remained significant (odds ratio 4.212, P = 0.012) for pacemaker implant within 30 days. The AF (hazard ratio [HR] 3.905, P = 0.001), albumin level (HR 0.316, P = 0.034), and diabetes (HR 2.323, P = 0.027) were predictors of death in a multivariate analysis, while pacemaker implant within 30 days was not. Patients with AF who were anticoagulated had improved survival in a stratified Kaplan-Meier analysis compared with those who were not anticoagulated (P = 0.0001)., Conclusion: AF, diabetes, and low albumin levels are independently associated with mortality after TAVR. In particular, patients with AF who are not anticoagulated are at highest risk for death. Efforts to identify AF and consider anticoagulation should be emphasized., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Nationwide studies documenting temporal trends in permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) are limited. Methods and Results We selected patients who underwent TAVR between 2012 and 2017 in the National Readmission Database. The primary end point was the 6-year trend in post-TAVR PPMI at index hospitalization and at 30, 90, and 180 days after discharge. The secondary end point was the association between PPMI and in-hospital mortality, stroke, cost, length of stay, and disposition. Among the 89 202 patients who underwent TAVR, 77 405 (86.8%) with no prior pacemaker or defibrillator were included. Patients who required PPMI had a higher prevalence of atrial fibrillation (43.6% versus 38.7%, P <0.001) and conduction abnormalities (28.4% versus 15.3%, P <0.001). The incidence of PPMI during index admission increased from 8.7% in 2012 to 13.2% in 2015, and then decreased to 9.6% in 2017. The incidence of inpatient PPMI within 30 days after discharge increased from 0.5% in 2012 to 1.25% in 2017 ( P trend <0.001). Inpatient PPMI beyond 30 days remained rare (<0.5%) during the study period. After risk adjustment, PPMI was not associated with in-hospital mortality or stroke but was associated with increased nonhome discharge, longer hospitalization, and higher cost. The incremental expenditure associated with post-TAVR PPMI during index admission increased from $9.6 million to $72.2 million between 2012 and 2017. Conclusions After an upward trend, rates of PPMI after TAVR in the United States stabilized at ~10% in 2016 to 2017, but there was a notable increase in PPMI within 30 days after the index admission. PPMI was not associated with increased in-hospital morbidity or mortality but led to longer hospitalization, higher cost, and more nonhome discharges.

Importance: Health care-associated infections (HAIs) are preventable, harmful, and costly; however, few resources are dedicated to infection surveillance of nonsurgical procedures, particularly cardiovascular implantable electronic device (CIED) procedures., Objective: To develop a method that includes text mining of electronic clinical notes to reliably and efficiently measure HAIs for CIED procedures., Design, Setting, and Participants: In this multicenter, national cohort study using electronic medical record data for patients undergoing CIED procedures in Veterans Health Administration (VA) facilities for fiscal years (FYs) 2016 and 2017, an algorithm to flag cases with a true CIED-related infection based on structured (eg, microbiology orders, vital signs) and free text diagnostic and therapeutic data (eg, procedure notes, discharge summaries, microbiology results) was developed and validated. Procedure data were divided into development and validation data sets. Criterion validity (ie, positive predictive validity [PPV], sensitivity, and specificity) was assessed via criterion-standard manual medical record review., Exposures: CIED procedure., Main Outcomes and Measures: The concordance between medical record review and the study algorithm with respect to the presence or absence of a CIED infection. CIED infection in the algorithm included 90-day mortality, congestive heart failure and nonmetastatic tumor comorbidities, CIED or surgical site infection International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes, antibiotic treatment of Staphylococci, a microbiology test of a cardiac specimen, and text documentation of infection in specific clinical notes (eg, cardiology, infectious diseases, inpatient discharge summaries)., Results: The algorithm sample consisted of 19 212 CIED procedures; 15 077 patients (78.5%) were White individuals, 1487 (15.5%) were African American; 18 766 (97.7%) were men. The mean (SD) age in our sample was 71.8 (10.6) years. The infection detection threshold of predicted probability was set to greater than 0.10 and the algorithm flagged 276 of 9606 (2.9%) cases in the development data set (9606 procedures); PPV in this group was 41.4% (95% CI, 31.6%-51.8%). In the validation set (9606 procedures), at predicted probability 0.10 or more the algorithm PPV was 43.5% (95% CI, 37.1%-50.2%), and overall sensitivity and specificity were 94.4% (95% CI, 88.2%-97.9%) and 48.8% (95% CI, 42.6%-55.1%), respectively., Conclusions and Relevance: The findings of this study suggest that the method of combining structured and text data in VA electronic medical records can be used to expand infection surveillance beyond traditional boundaries to include outpatient and procedural areas.

Background Myotonic dystrophy type 1 involves cardiac conduction disorders. Cardiac conduction disease can cause fatal arrhythmias or sudden death in patients with myotonic dystrophy type 1. Methods and Results This study enrolled 506 patients with myotonic dystrophy type 1 (aged ≥15 years; >50 cytosine-thymine-guanine repeats) and was treated in 9 Japanese hospitals for neuromuscular diseases from January 2006 to August 2016. We investigated genetic and clinical backgrounds including health care, activities of daily living, dietary intake, cardiac involvement, and respiratory involvement during follow-up. The cause of death or the occurrence of composite cardiac events (ie, ventricular arrhythmias, advanced atrioventricular blocks, and device implantations) were evaluated as significant outcomes. During a median follow-up period of 87 months (Q1-Q3, 37-138 months), 71 patients expired. In the univariate analysis, pacemaker implantations (hazard ratio [HR], 4.35; 95% CI, 1.22-15.50) were associated with sudden death. In contrast, PQ interval ≥240 ms, QRS duration ≥120 ms, nutrition, or respiratory failure were not associated with the incidence of sudden death. The multivariable analysis revealed that a PQ interval ≥240 ms (HR, 2.79; 95% CI, 1.9-7.19, P <0.05) or QRS duration ≥120 ms (HR, 9.41; 95% CI, 2.62-33.77, P < 0.01) were independent factors associated with a higher occurrence of cardiac events than those observed with a PQ interval <240 ms or QRS duration <120 ms; these cardiac conduction parameters were not related to sudden death. Conclusions Cardiac conduction disorders are independent markers associated with cardiac events. Further investigation on the prediction of occurrence of sudden death is warranted.

There are two commercially available transcatheter heart valve systems: balloon expandable valves (BEV) and self-expanding valves (SEV). However, there is a paucity of randomized trials comparing both systems. Electronic databases (Medline, the Cochrane Library, Web of Science, and clinicaltrials.gov) and major conference proceedings were searched for randomized trials of patients with symptomatic severe aortic stenosis and received transcatheter aortic valve implantation (TAVI) with a SEV or BEV or surgical aortic valve replacement. The main efficacy outcomes were all-cause mortality and stroke at the longest available follow-up. The main analysis was performed using a random-effects network meta-analysis complemented by several subgroup and sensitivity analyses. Ten trials with 9,439 patients (mostly undergoing transfemoral TAVI) were included. At a median of 27 months, there was no difference between BEV and SEV valves in terms of all-cause mortality (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.79 to 1.42). The incidence of any stroke was higher with BEV (OR 1.51, 95% CI 1.01 to 2.26), but there was no difference in the incidence of disabling stroke. At 30-days, BEV valves were associated with lower incidence of new permanent pacemaker placement (OR 0.50, 95% CI 0.32 to 0.79) and moderate/severe paravalvular regurgitation (OR 0.39, 95% CI 0.22 to 0.68). In conclusion, in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI, SEV and BEV were associated with similar all-cause mortality. BEV were associated with a higher incidence of any stroke driven by nondisabling strokes, but lower incidence of new permanent pacemaker placement and moderate/severe paravalvular regurgitation compared with SEV., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Implantation of the subcutaneous implantable cardioverter-defibrillator (S-ICD) is spreading and has been shown to be safe and effective; however, it does not provide brady-pacing. Currently, data on the need for brady-pacing and cardiac resynchronization therapy (CRT) implantation in patients with ICD indication are limited., Methods: The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II enrolled post-MI patients with reduced ejection fraction (EF ≤ 35%), randomized to either an implantable cardioverter-defibrillator (ICD) or conventional medical therapy. Kaplan-Meier analyses and multivariate Cox models were performed to assess the incidence and predictors of pacemaker (PM), or CRT implantation in the conventional arm of MADIT-II, after excluding 32 patients (6.5%) with a previously implanted PM., Results: During the median follow-up of 20 months, 24 of 458 patients (5.2%) were implanted with a PM or a CRT (19 PM, 5 CRT). Symptomatic sinus bradycardia was the primary indication for PM implantation (n = 9, 37%), followed by AV block (n = 5, 21%), tachy-brady syndrome (n = 4, 17%), and carotid sinus hypersensitivity (n = 1, 4%). Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation. Patients with PM/CRT implantation had a significantly higher risk for heart failure (HR = 2.67, 95% CI = 1.38-5.14, p = .003), but no increased mortality risk (HR = 1.06, 95% CI = 0.46-2.46, p = .89)., Conclusion: The short-term need for ventricular pacing or CRT implantation in patients with MADIT-II ICD indication was low, especially in those with a normal baseline PR interval, and such patients are appropriate candidates for the subcutaneous ICD., (© 2020 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals, Inc.)

Recent positive results of transcatheter aortic valve replacement (TAVI) in clinical trials have sparked debate on whether TAVI should be first line for all patients with aortic stenosis. However, limited evidence exists on the clinical impact of TAVI on a national level. Using the national inpatient sample (NIS) of hospital discharges in the United States from 2001 to 2016, we evaluated the rate of AVR and associated in-hospital outcomes in pre-TAVI and TAVI era. Hierarchical mixed effect modeling was used to assess for trend and calculate risk adjusted estimates. Annual volume of AVR increased from 49,357 in 2001 to 100,050 in 2016 (103% increase). Compared with the pre-TAVI era, mean annual change in volume of AVR was higher in the TAVI era (+2.9% vs +9.4%, respectively, p <0.001). In contrast, rate of in-hospital mortality decreased from 5.4% in 2001 to 2.7% in 2016 (50% decrease). Compared with the pre-TAVI era, magnitude of mean annual change in mortality was higher in TAVI era (-4.0% vs -6.7%, respectively, p = 0.04). Unlike SAVR for which risk-adjusted rate for most outcomes seems to have plateaued, TAVI demonstrated significant improvement from 2012 to 2016 for mortality (4.6% to 1.8%), acute kidney injury (15.1% to 2.6%) and nonroutine home discharge (63.6% to 44.6%). However, no significant change in the rate of stroke (2.4% to 2.1%) and pacemaker implantation remained high (8.1% to 9.4%). Lastly, median length of stay was shorter for TAVI compared with isolated SAVR (3 vs 8 days, respectively). In conclusion, the adoption of TAVI has led to increase in volume of AVR for severe aortic stenosis in the United States with favorable short-term outcome., Competing Interests: Conflict of interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this study., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). There is limited data exploring differences in outcomes post-TAVI SEV vs. BEV. This study compared procedural success and 30-d clinical outcomes self-expandable valves (SEV), vs. balloon-expandable valves (BEV) for patients with severe AS. Methods: Retrospective analysis was undertaken of patients receiving TAVI at St Vincent's Hospital, Melbourne between August 2009 and May 2018. The primary endpoints included procedural success, clinical outcomes and complication rates at 30-d. Results: Out of 151 patients undergoing TAVI, 70 received (46.3%) SEV (Medtronic CoreValve & Evolut-R) and 81 (53.6%) BEV (Edwards SAPIEN-XT & S3). The mean Society of Thoracic Surgery (STS) risk score did not differ between the groups, SEV (83.6 ± 4.9 years, STS 4.4 ± 3.8) compared to BEV (82.3 ± 5.8 years, STS 4.9 ± 4.9). Procedural success was similar SEV 67 (95.7%) vs. BEV 78 (96.3%). Rates of ≥ moderate paravalvular aortic regurgitation (PAR) at 30-d were significantly higher in SEV compared to BEV (6.7 vs. 0.0%; p =  .02). SEV patients had higher rates of pacemaker insertion (36.4 vs. 9.5%; p =  .001) and stroke rates (12.4 vs. 1.4%; p =  .04) compared to BEV patients. The difference in 30-d mortality between the two groups was similar (SEV 4.6% vs. BEV 1.3%; p  = .23). Conclusions: This real-world retrospective analysis demonstrates higher rates of ≥ moderate PAR, stroke and pacemaker insertion with SEV compared to BEV at 30 d post-TAVI for severe symptomatic AS.

Background: Transcatheter aortic valve-in-valve (VIV) procedure is a safe alternative to conventional reoperation for bioprosthetic dysfunction. Balloon-expandable valve (BEV) and self-expanding valve (SEV) are the 2 major types of devices used. Evidence regarding the comparison of the 2 valves remains scarce., Methods: A systematic review and meta-analysis was conducted to compare the outcomes of BEV and SEV in transcatheter VIV for aortic bioprostheses dysfunction. A computerized search of Medline, PubMed, Embase, and Cochrane databases was performed. English-language journal articles reporting SEV or BEV outcomes of at least 10 patients were included., Results: In total, 27 studies were included, with 2,269 and 1,671 patients in the BEV and SEV groups, respectively. Rates of 30-day mortality and stroke did not differ significantly between the 2 groups. However, BEV was associated with significantly lower rates of postprocedural permanent pacemaker implantation (3.8% vs. 12%; P < 0.001). Regarding echocardiographic parameters, SEV was associated with larger postprocedural effective orifice area at 30 days (1.53 cm2 vs. 1.23 cm2; P < 0.001) and 1 year (1.55 cm2 vs. 1.22 cm2; P < 0.001)., Conclusions: For patients who underwent transcatheter aortic VIV, SEV was associated with larger postprocedural effective orifice area but higher rates of permanent pacemaker implantation. These findings provide valuable information for optimizing device selection for transcatheter aortic VIV., Competing Interests: The authors have declared that no competing interests exist.

Objective: Patients undergoing single-ventricle palliation have experienced significant improvement in survival in the recent era. However, a substantial proportion of these patients undergo reoperations. We performed a review of the Australia and New Zealand (ANZ) Fontan Registry to determine the overall reintervention and reoperative burden in these patients., Methods: A retrospective longitudinal cohort study was performed using data from patients who underwent a Fontan operation between 1975 and 2016 from the ANZ Fontan Registry. The data obtained included Fontan operation, reinterventions and most recent follow-up status. We examined the type and timing of reinterventions and survival., Results: Of the 1428 patients identified, 435 (30%) underwent at least one reintervention after the Fontan operation: 110 patients underwent early reintervention and 413 underwent late reinterventions. Excluding Fontan conversion and transplantation, 220 patients underwent at least one interventional procedure and 209 patients underwent at least one reoperation. Fenestration closure and pacemaker-related procedures were the most common catheter and surgical interventions, respectively. The cumulative incidence of reintervention following Fontan was 23%, 37% and 55% at 10, 20 and 30 years, respectively. Survival and freedom from failure were worse in patients requiring later reintervention after Fontan surgery (51% vs 83% and 42% vs 69%, respectively at 30 years, p<0.001). This difference persisted after excluding pacemaker-related procedures (p<0.001). Operative mortality for non-pacemaker late reoperations after Fontan was 6%., Conclusions: A substantial proportion of Fontan patients require further intervention to maintain effective single-ventricle circulation. Patients undergoing reoperation after Fontan have higher rates of mortality and failure, despite intervention., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The aim of this study was to develop and validate a risk prediction model for high-grade atrioventricular block requiring cardiac implantable electronic device (CIED) implantation after transcatheter aortic valve replacement (TAVR)., Background: High-grade atrioventricular block requiring CIED remains a significant sequelae following TAVR. Although several pre-operative characteristics have been associated with the risk of post-operative CIED implantation, an accurate and validated risk prediction model is not established yet., Methods: This was a single center, retrospective study of consecutive patients who underwent TAVR from March 10, 2011, to October 8, 2018. This cohort sample was randomly divided into a derivation cohort (group A) and a validation cohort (group B). A scoring system for risk prediction of post-TAVR CIED implantation was devised using logistic regression estimates in group A and the calibration and validation were done in group B., Results: A total of 1,071 patients underwent TAVR during the study period. After excluding pre-existing CIED, a total of 888 cases were analyzed (group A: 507 and group B: 381). Independent predictive variables were as follows: self-expanding valve (1 point), hypertension (1 point), pre-existing first-degree atrioventricular block (1 point), and right bundle branch block (2 points). The resulting score was calculated from the total points. The internal validation in group B showed an ideal linear relationship in calibration plot (R 2  = 0.933) and a good predictive accuracy (area under the curve: 0.693; 95% confidence interval: 0.627 to 0.759)., Conclusions: This prediction model accurately predicts post-operative risk of CIED implantation with simple pre-operative parameters., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated the performance of Temporary Pacing via an Externalized Active-Fixation (TPEAF) lead., Background: The incidence of cardiac implantable electronic device infections is increasing, which necessitates the need for transvenous lead extraction (TLE). Pacemaker-dependent patients require temporary pacing during the guideline-recommended waiting period before reimplantation. Data regarding safety and efficacy of TPEAF leads are very limited., Methods: We evaluated patients implanted with TPEAF leads post-TLE at our center between April 2004 and December 2017., Results: TPEAF leads were placed in 158 patients. The mean age was 74 ± 11 years. The median duration of the temporary lead was 6 days (range 1 to 29). There were 4 procedural complications (2.5% incidence): 1 patient had cardiac arrest from hyperkalemia, 2 developed cardiac tamponade, and 1 had profuse bleeding from the entry point of the leads. There were 13 complications post-implantation (8.2% incidence): 8 lead dislodgments, 1 elevated pacing threshold, 2 vegetations on the temporary lead, 1 pneumothorax, and 1 loss of capture due to the generator "safety switch." All dislodgements occurred within 24 h, except 1 on day 3. Sixteen patients died during the hospital stay: 10 due to septic shock, 2 due to hyperkalemic cardiac arrest, 3 due to ventricular tachycardia, and 1 due to a massive cerebrovascular accident., Conclusions: The use of TPEAF leads is safe and efficacious in pacemaker-dependent patients post-TLE. Dislodgement can occur within the first 24 h. The presence of persistent fever and positive blood cultures should raise concern for vegetation on the temporary lead., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: The management of patients bearing a cardiac implantable electronic device and needing a radiotherapy treatment is an important clinical scenario. The aim of this survey was to evaluate the level of awareness within the Italian Radiation Oncologist community on this topic., Materials and Methods: A survey was promoted by the Young Group of Italian Association of Radiotherapy and Clinical Oncology (AIRO) with a questionnaire made up of 22 questions allowing for multiple answers, which was administered, both online and on paper version. It was addressed to Radiation Oncologists, AIRO members, participating in the National Congress held in 2015., Results: A total of 113 questionnaires were collected back and analyzed (survey online: 50 respondents; paper version: 63). The answers showed a good level of awareness on the issue, but with a nonhomogeneous adherence to the different published guidelines (GL). There is a general low rate of referral for a preliminary cardiological evaluation in patients bearing PM/ICDs, in line with some published surveys; nevertheless, a focused attention to certain specific treatment factors and patient-centered point of view emerged., Conclusions: A generally good awareness of this topic was shown but homogeneous application of GL was not observed, possibly due to the multiplicity of available GL. A prospective data collection could help to better clarify the shadows on this topics.

Aim: With increasing lifespans, patients requiring a pacemaker are older than they were in the past. Data regarding all-cause mortality in older patients implanted with a pacemaker are scarce. As physical activity is associated with a decrease in all-cause mortality, we investigated whether daily physical activity time, expressed as the activity rate determined by pacemakers, can predict all-cause mortality in older patients (aged ≥75 years) with a pacemaker., Methods: We retrospectively investigated the baseline characteristics, echocardiographic indices, laboratory data and pacemaker parameters of 107 consecutive older patients with a newly implanted pacemaker at our hospital (age 83.8 ± 5.0 years; 54.2% men). The study end-point was all-cause mortality., Results: During the follow-up period (mean 3.0 years), 21 cases of all-cause death were reported. The area under the receiver operating characteristic curve for activity rate to predict all-cause mortality was 0.82 (95% confidence interval 0.72-0.92, P < 0.001). An activity rate of 3.4% (50 min/day) had a sensitivity of 86.0% and a specificity of 66.7% for predicting all-cause mortality. The survival rate was significantly higher among patients with an activity rate ≥3.4% than among those with an activity rate <3.4% (log-rank, P < 0.001). A multivariate Cox regression analysis identified low activity rates as a predictor of all-cause mortality (hazard ratio 15.0, 95% confidence interval 4.29-52.6; P < 0.001)., Conclusions: Low activity rates appear to be a strong predictor of all-cause mortality in older patients with a pacemaker. Geriatr Gerontol Int 2020; 20: 106-111., (© 2019 Japan Geriatrics Society.)

Background: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2018 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards., Results: PM Registry: data about 23 912 PM implantations were collected (20 084 first implants and 3828 replacements). The number of collaborating centers was 180. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 34.5% of first PM implants, sick sinus syndrome in 18.3%, atrial fibrillation plus bradycardia in 13.0%, other in 34.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (19.2% of first implants). Use of single-chamber PMs was reported in 24.9% of first implants, of dual-chamber PMs in 67.6%, of PMs with cardiac resynchronization therapy (CRT) in 1.6%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 5.9%. ICD Registry: data about 18 353 ICD implantations were collected (13 944 first implants and 4359 replacements). The number of collaborating centers was 433. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 84.3% of first implants, secondary prevention in 15.7% (cardiac arrest in 5.3%). A single-chamber ICD was used in 27.9% of first implants, dual-chamber ICD in 31.9% and biventricular ICD in 40.2%., Conclusions: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

Introduction: The aim of our study was to perform an economic assessment in order to check whether or not telemonitoring of users with pacemakers offers a cost-effective alternative to traditional follow-up in outpatient clinics., Methods: We used effectiveness and cost data from the NORDLAND trial, which is a controlled, randomized, non-masked clinical trial. Fifty patients were assigned to receive either telemonitoring (TM; n = 25) or conventional monitoring (CM; n = 25) and were followed up for 12 months after the implantation. A cost-utility analysis was performed in terms of additional costs per additional Quality-Adjusted Life Year (QALY) attained from the perspectives of the Norwegian National Healthcare System and patients and their caregivers., Results: Effectiveness was similar between alternatives (TM: 0.7804 [CI: 0.6864 to 0.8745] vs. CM: 0.7465 [CI: 0.6543 to 0.8387]), while cost per patient was higher in the RM group, both from the Norwegian NHS perspective (TM: €2,079.84 [CI: 0.00 to 4,610.58] vs. €271.97 [CI: 158.18 to 385.76]; p = 0.147) and including the patient/family perspective (TM: €2,295.91 [CI: 0.00 to 4,843.28] vs. CM: €430.39 [CI: 0.00 to 4,841.48]), although these large differences-mainly due to a few patients being hospitalized in the TM group, as opposed to none in the CM group-did not reach statistical significance. The Incremental Cost-Effectiveness Ratio (ICER) from the Norwegian NHS perspective (€53,345.27/QALY) and including the patient/caregiver perspective (€55,046.40/QALY), as well as the Incremental Net Benefit (INB), favors the CM alternative, albeit with very broad 95%CIs. The probabilistic analysis confirmed inconclusive results due to the wide CIs even suggesting that TM was not cost-effective in this study. Supplemental analysis excluding the hospitalization costs shows positive INBs, whereby suggesting a discrete superiority of the RM alternative if hospitalization costs were not considered, albeit also with broad CIs., Conclusions: Cost-utility analysis of TM vs. CM shows inconclusive results because of broad confidence intervals with ICER and INB figures ranging from potential savings to high costs for an additional QALY, with the majority of ICERs being above the usual NHS thresholds for coverage decisions., Trial Registration: ClinicalTrials.gov NCT02237404., Competing Interests: The authors have declared that no competing interests exist.

Aims: Permanent pacemaker (PPM) implantation is one of the most common complications after transcatheter aortic valve replacement (TAVR). We studied the incidence of PPM implantation and identified the predictors in patients who underwent TAVR in a Chinese population., Methods and Results: A total of 256 patients who underwent TAVR with self-expandable valves were included. The incidence of PPM implantation in our study population was 14.8%. In patients who received PPM implantation, the proportion of bicuspid aortic valve (BAV) patients was much lower compared to tricuspid aortic valve (TAV) patients (18.4 vs. 81.6%, p < 0.05). Patients with BAV were associated with a significantly lower PPM implantation rate and shallower implantation depth compared to patients with TAV (6.4 vs. 21.7% and 4.2 ± 4.4 vs. 6.2 ± 5.0 mm, respectively, p < 0.05 for both). In the multivariable logistic regression analysis, prior right bundle branch block (RBBB; OR 8.3, 95% CI 2.2-32.1, p < 0.05), implantation depth (OR 1.3, 95% CI 1.1-1.5, p = 0.01), and TAV (OR 4.7, 95% CI 1.5-14.4, p < 0.05) were independent predictors of PPM implantation after TAVR. There was no difference in 30-day and 1-year all-cause mortality between the 2 groups., Conclusions: The incidence of PPM implantation in patients with self-expandable valves after TAVR was 14.8% in our cohort study. Independent predictors of PPM implantation included prior RBBB, TAV, and implantation depth at the noncoronary sinus side. TAVR in BAV with a supra-annular structure-based sizing strategy might decrease the risk of PPM implantation., (© 2019 S. Karger AG, Basel.)