Cardiac Rhythm Devices Research Articles

Direct oral anticoagulants for stroke prevention in patients with device-detected atrial fibrillation: assessing net clinical benefit.

Subclinical, device-detected atrial fibrillation (AF) is frequently recorded by pacemakers and other implanted cardiac rhythm devices. Patients with device-detected AF have an elevated risk of stroke, but a lower risk of stroke than similar patients with clinical AF captured with surface electrocardiogram. Two randomized clinical trials (NOAH-AFNET 6 and ARTESiA) have tested a direct oral anticoagulant (DOAC) against aspirin or placebo. A study-level meta-analysis of the two trials found that treatment with a DOAC resulted in a 32% reduction in ischaemic stroke and a 62% increase in major bleeding; the results of the two trials were consistent. The annualized rate of stroke in the control arms was ∼1%. Several factors point towards overall net benefit from DOAC treatment for patients with device-detected AF. Strokes in ARTESiA were frequently fatal or disabling and bleeds were rarely lethal. The higher absolute rates of major bleeding compared with ischaemic stroke while on treatment with a DOAC in the two trials are consistent with the ratio of bleeds to strokes seen in the pivotal DOAC vs. warfarin trials in patients with clinical AF. Prior research has concluded that patients place a higher emphasis on stroke prevention than on bleeding. Further research is needed to identify the characteristics that will help identify patients with device-detected AF who will receive the greatest benefit from DOAC treatment.

The Average Age of Atrioventricular Block Onset in Middle Eastern Patients with Cardiac Rhythm Devices Adjusted for the Overall Young Population: Insights from a Multicenter International Registry.

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. 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. 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). 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.

Long-term outcome and cardiac function after anatomic repair of congenitally corrected transposition.

There is limited information on long-term outcomes and trajectories of ventricular and valvular functions in patients with congenitally corrected transposition of the great arteries after anatomic repair according to the operative strategy with a median follow-up period of more than 10 years. Twenty-nine patients who underwent anatomic repair in Okayama University Hospital between January 1994 and December 2020 were reviewed. Outcomes were compared between patients who underwent a double switch operation (DS group) and patients with an atrial switch with a Rastelli operation (Rastelli-Senning/Mustard group). Fifteen (52%) were in the DS group and 14 (48%) were in the Rastelli-Senning/Mustard group. The median follow-up period after anatomic repair was 12.7 (interquartile range 4.2-18.8) years. There were 3 (10%) early deaths and 3 (10%) late deaths. Survival rates for the entire cohort at 10 and 20 years were 86% and 71%, respectively, and were not different between the 2 groups. Using competing risk analysis, risks of heart failure, cardiac rhythm device implantation and atrial arrhythmia showed no significant differences between the 2 groups, whereas risk of reoperation was higher in the Rastelli-Senning/Mustard group than that in the DS group. Four patients after a DS operation and 1 patient after a Rastelli technique developed more than moderate aortic regurgitation. During a median follow-up period of more than 10 years, mortality rate and ventricular and valvular functions after anatomic repair were acceptable, though the incidences of late complications were relatively high, especially in the Rastelli-Senning/Mustard group.

Site of left axillary vein crossing the clavicle: an analysis with computed tomography venography as a guide for vein puncture for device implantation.

Blind axillary venous access is a convenient but technically difficult approach for cardiac rhythm device lead implantation. We try to explore whether there are rules on the axillary vein course to facilitate blind venous cannulation. In a single-center, retrospective study, we included 155 patients who underwent computed tomography venography (CTV) examination of left axillary vein. All scans were reviewed for the relationship between left axillary vein and clavicle, vein steepness, and depth. Factors probably affecting above indicators were analyzed. The location of left axillary vein crossing the clavicle was mainly concentrated around the medial 1/3 of clavicle, with mean crossing location of the medial 1/3 of clavicle, which was not correlated with sex, age, abdominal subcutaneous fat thickness, upper thoracic kyphosis angle, or the angle between clavicle and anterior midline (P < 0.05). The average angle between axillary vein and horizontal line was 31.57 ± 11.72°, which was positively associated with age, whereas inversely associated with the angle between clavicle and anterior midline (P < 0.05). The proximal axillary vein ran more and more shallow until becoming the subclavian vein (P < 0.01); and it had a mean depth of 3cm, which was significantly associated with abdominal subcutaneous fat thickness (P < 0.05). The left axillary vein and clavicle had a relatively fixed relationship that axillary vein commonly crossed the medial 1/3 of clavicle. The average angle between axillary vein and horizontal line was 31.57 ± 11.72°, associated with age and the clavicle course. The mean depth of proximal axillary vein was 3cm, and patients with larger weight had a deeper position of axillary vein.

Anticoagulant therapy during cardiovascular implantable electronic device procedures.

The objective of the study is to systematically evaluate the safety and efficacy of peri-procedural utilization of anticoagulation therapy during cardiovascular implantable electronic device procedures. The review materials were based on comprehensive retrieval of randomized controlled trials and observational studies published until April 2023. Studies which compared different management strategies of long-term anticoagulation therapy during peri-procedural cardiac rhythm device implantation and compared the complications of bleeding and/or thromboembolic events were selected and reviewed. Studies analysing non-vitamin K oral anticoagulants interruption versus continuation during peri-procedural implantable cardiac device surgery found no statistically significant difference in bleeding or thromboembolic complications between these strategies. Studies comparing non-vitamin K oral anticoagulants with vitamin K antagonists also showed no statistically significant difference. One study comparing uninterrupted warfarin with interrupted warfarin with heparin bridging reported a reduced incidence of clinically significant device pocket haematoma in patients with continued warfarin treatment (relative risk = 0.19; 95% confidence interval: 0.10 to 0.36; p < 0.001). A sub-analysis of one study comparing dabigatran versus warfarin with heparin bridging and without bridging reported a lower risk of pocket haematoma with dabigatran when compared to warfarin with heparin bridging (risk difference: -8.62%, 95% confidence interval: -24.15 to -0.51%; p = 0.034). Both bleeding and thromboembolic complications were rare. The traditional method of vitamin K antagonists interruption with heparin bridging is less safe than continuing vitamin K antagonists at therapeutic levels. Both continuation and interruption strategies of non-vitamin K anticoagulants during cardiac device surgery seem to be safe and appropriate.

Surgical Implications of Implanted Cardiac Rhythm Devices.

Surgical Implications of Implanted Cardiac Rhythm Devices.

Abstract 13109: Pacemaker Mediated Contact Allergy to Thiuram and Paraphenylenediamine

Introduction: Allergic contact dermatitis to cardiac rhythm devices (CRD) has been reported sporadically from the early 1980s to present. Most of these cases involve allergic reactions to direct contact agents such as nickel, silicone, titanium, cobalt, epoxy resin, mercury, polysulfone, polyurethane and polychloroparaxylene. Our case is unique in that the strongest allergic reaction was with thiuram and P-phenylenediamine (PPD), which has only been documented once since the advent of permanent pacemakers (PPM) Case: 58-year old male with history of hypertension and coronary artery disease presented with palpitations and fatigue. Holter monitoring demonstrated tachybrady syndrome and he underwent dual chamber PPM implantation (L331 Accolade TM MRI - Boston Scientific Inc). Eight weeks later he presented with new onset rash around his neck and the surgical site. PPM allergy was suspected, as patient did not respond to empiric antibiotics. He underwent PPM and lead extraction. Decision was made to observe patient without immediate re-implantation of PPM. Skin patch testing was strongly positive to thiuram and PPD. Final diagnosis of allergic contact dermatitis was made and patient’s condition improved. Discussion: Thiuram and PPD, the raw materials used in the production of silicone rubber, encase pacemaker headers and leads. Individuals typically get sensitized to PPD by using hair dyes or temporary henna tattooing. The device used in our patient contained the same compounds. No studies to date document the true incidence and/or prevalence of allergic reactions to pacemaker components. One non-randomized retrospective trial reported benefits of skin patch testing before CRD implantation in patients who had a history of allergy to metals. Future trials are warranted to further evaluate the efficacy and benefits of pre-implantation skin testing and if it would benefit the population as a whole.

Central Vein Stenosis in Patients with Central Vein Manipulation: A Single Center Experience

Introduction: Central vein catheterization (CVC) is one of the main risk factors for central vein stenosis (CVS) occurrence in the hemodialysis population. In this work we aimed to evaluate previous central venous manipulation, clinical presentation, and complications in hemodialysis patients with proved CVS. Material and Methods: We retrospectively reviewed all venous angiographies in patients attending our public hospital center for hemodialysis treatment from 2013 to 2018 (n=209). In patients with confirmed CVS (n=29, 14%), we evaluated history of prior CVC and cardiac rhythm devices (CDR), as well as demographics and cardiovascular risk factors. Results: We identified 31 CVS in 29 patients who underwent venous angiography. Most of these patients, 75.9% (n=22), had at least one CVC (ipsilateral or not); at least one previous ipsilateral short-term CVC was found in 34.4% (n=10) of patients and at least one previous ipsilateral long-term CVC was found in 41.4% (n=12) of patients. All patients who had a prior CRD (n=4, 13.8%), had developed an ipsilateral CVS. Conclusion: Prevalence of detected CVS in our population was significant and is likely underestimated. A high percentage of patients with CVS had an history of previous ipsilateral CVC. The number of patients with previous short-term CVC was similar to that of previous long-term CVC, hinting an important role of short-term CVC as a risk factor do CVS.

Quantifying the Impact of COVID-19 “Lockdown” on Physical Activity in Children and Adults with Implanted Cardiac Rhythm Devices: A Single Center Experience Using Cardiac Rhythm Device Accelerometer Data

Background: In response to the COVID-19 pandemic, the US states of New York and New Jersey instituted a “lockdown” that closed schools and most businesses except for essential services. The public was urged to remain at home. The 78-day lockdown period extended from 22 March 2020 to 6 June 2020. We sought to evaluate the impact of COVID-19 lockdown on continuously recorded physical activity in our patients with congenital heart disease with implanted cardiac rhythm management (CRM) devices—pacemakers (PPM), defibrillators (ICD) and implantable loop recorders (ILR) enabled with accelerometers that translate motion into a measure of active hours/day. Methods: All patients from our congenital CRM database with accelerometer-enabled devices who had stable cardiac status residing in NY and NJ were included. Forty-one patients met the inclusion criteria; the median age was 29.6 years (range 7–60); 54% female; 23 ICD, 15 PPM and 3 ILR. The patient activity was averaged for the 2 months prior to lockdown, during the lockdown, and the 2 months afterward. Paired t-tests were used to compare activity before and during lockdown, and before and after lockdown. Each patient served as his/her own control. Results: Active hours/day decreased by a mean of 32% (±27%) from baseline (p &lt; 0.001). A total of 32 patients experienced a decline, 6 had no change and 3 had an increase. Active hours rebounded after lockdown and were unchanged compared to pre-lockdown levels. Conclusions: The COVID-19 lockdown in NY/NJ during the Spring of 2020 resulted in a significant drop in active hours/day in children and adults with congenital heart disease. Active hours/day rebounded to baseline after restrictions were lifted.

Trends in Utilization of Magnetic Resonance Imaging for Stroke Patients With Cardiac Rhythm Devices.

Magnetic resonance imaging (MRI) is safe for most patients with cardiovascular implantable electronic devices (CIEDs). However, patients presenting with acute ischemic stroke or transient ischemic attack (AIS/TIA) who have CIEDs may undergo MRI less frequently than patients without devices. We assessed contemporary use of MRI for patients with AIS/TIA and the effect of a recent coverage revision by the Center for Medicare and Medicaid Services (CMS) on MRI utilization. Using Optum® claims data from January 2012 to June 2019, we performed an interrupted time series analysis of MRI utilization during AIS/TIA hospitalizations with the April 2018 CMS coverage revision serving as the intervention. For patients treated after the coverage revision, we used multivariable logistic regression to determine the association between lack of CIED and MRI utilization for AIS/TIA. We identified 417,899 patient hospitalizations for AIS/TIA, of which 30,425 (7%) had a CIED present (CIED vs non-CIED patients: age 77.6 ± 9.8 vs 72.7 ± 12.3 years; 45.5% vs 54.3% female). From 2012 to 2019, annual MRI utilization increased from 3% to 20% for CIED patients and 58% to 66% for non-CIED patients. The CMS coverage revision was associated with a 4.2% absolute additional increase in MRI utilization for CIED patients. Non-CIED patients treated after the CMS coverage revision were substantially more likely than CIED patients to undergo MRI (adjusted OR 6.7, 95% CI: 6.3-7.1, P<.001). MRI utilization has increased for stroke patients with CIEDs but remains far lower than in similar patients without devices.

Risk of infective endocarditis associated with invasive dental procedures in patients with cardiac rhythm devices.

The incidence of infective endocarditis related to cardiac implantable electronic devices (CIEDs) has gradually increased. The risk associated with dental procedures in patients with CIED implantation and the need for prevention of infective endocarditis remain unclear. The present study investigated the incidence and risk of infective endocarditis associated with invasive dental procedures in patients with CIEDs. We analysed a nationwide population-based cohort of patients with CIEDs who underwent dental procedures. We performed a self-controlled case series analysis and evaluated the incidence rate ratio of infective endocarditis 3 months after dental procedures. Of a total of 62 019 patients who underwent CIED implantation, 32 536 patients underwent at least one dental procedure during follow-up, and the mean number of dental procedures was 3.4 per patient. They were 152 infections with an incidence of 445 per 100 000 person-years in the dental procedure period and 500 events at an incidence of 255 per 100 000 person-years in the non-dental procedure period. The CIED-related infective endocarditis in the dental procedure period occurred significantly more frequently than during non-dental procedure periods (odds ratio, 1.75; 95% confidence interval, 1.48-2.05; P < 0.001). The mean time interval from dental procedure to infective endocarditis was 59.6 ± 47.3 days. Invasive dental procedures are associated with an increased risk of infective endocarditis in those who underwent CIED implantation. Appropriate preventive therapy might be needed in these patients.

Commentary: Why “tri” to repair the valve if it will just “lead” to recurrent regurgitation?

Life-threatening arrhythmias after congenital heart surgery that require cardiac rhythm devices remain a challenging management problem for many patients. In this report from Huang and colleagues,1 the authors examine mid-term results of the surgical management of transvenous lead-induced tricuspid regurgitation. The authors determine that there are similar rates of survival and reintervention on the tricuspid valve between the valve repair and valve replacement cohorts during their follow-up period.

Cardiac rhythm devices in pediatric patients: Impact on family functioning and parent's health-related quality of life.

This study compares the impact of children's cardiac rhythm devices and health status on their parents with that of healthy controls. Furthermore, it aims to ascertain whether sociodemographic characteristics and medical data are associated with parent-reported impacts. This cross-sectional study is part of a comprehensive single-center study of long-term psychosocial outcomes in pediatric patients with pacemakers and implantable cardioverter defibrillators. The study includes 69 patients with their parents: 69 mothers and 57 fathers. Parents responded to the Pediatric Quality of Life Inventory Family Impact Module and to open-ended questions assessing impact on family life and treatment satisfaction. Parents reported more negative impact on family life than healthy controls in all three summary scores. Among fathers, presence of a child's congenital heart disease and female sex is associated with lower family function. No group differences emerged regarding device type. Positive and negative cognitive aspects predominated for patients' mothers and fathers. However, one substantial difference is that mothers reported more positive and negative emotional impact than fathers. We conclude that parents' well-being should be addressed in clinical contexts, especially through emotional and practical support and open communication focused on parents' worries and concerns.

Anaesthesia for extraction of long-term cardiac device leads

Cardiac rhythm devices, cardiac resynchronisation therapy and implantable cardioverter defibrillators are being placed in increasing numbers of patients. These devices can become infected, defective or recalled, necessitating their removal. In the 12-month period from April 2019 to March 2020, the National Audit of Cardiac Rhythm Management reported that more than 40,000 devices were implanted in the UK.1 Based on a 4% prevalence of extraction, this amount equates to 1,600 extractions per year.2

Influence of peri-procedural management of direct oral anticoagulants on the incidence of pocket hematoma in patients undergoing cardiac rhythm device implantation – The StimAOD study

Direct oral anticoagulants (DOAC) are commonly used in patients undergoing rhythm device implantation, exposing to an increased risk of pocket hematoma. However, the optimal perioperative strategy for DOAC management remains unclear. We performed a multicentre prospective observational study of patients receiving DOAC and undergoing pacemaker or defibrillator implantation. The primary endpoint was clinically relevant hematoma (CRH) within 30 ± 5 days after implantation. Any hematoma included CRH and non-clinically relevant hematoma. We aimed to describe practices, assess the impact of DOAC interruption before and after the procedure and identify predictors of CRH. In total, 789 patients were included, median age 80 [30–102], 36.4% women. CHA 2 DS 2 -VASc score was 4 [0–8] and 16.5% had a history of stroke. Defibrillators were implanted in one fifth. Antiplatelet therapy accounted for 18.5%. Overall DOAC were interrupted 40.8 ± 45.3 h prior the procedure and resumed 38.8 ± 40.3 h later. Pre- and post-procedural heparin bridging were observed in 8.2% and 3.9%, and shortened anticoagulation interruption (32.1 ± 48.8 vs. 55.8 ± 45.5 h, P < 0.001 and 22 ± 26.2 vs. 39.5 ± 40.6 h, P < 0.001, respectively). Postoperative bridging increased by 4.1 the risk of any hematoma up to 5.9 when associated with preoperative bridging. CRH occurred in 3.3%. In multivariate analysis dual antiplatelet therapy, defibrillator implantation and CHA 2 DS 2 -VASc score 0-1 were strong predictors of CRH ( Table 1 ). Among CHA 2 DS 2 -VASc score 0-1, postoperative anticoagulation was resumed earlier in those with a hematoma (29.6 ± 15.1 vs. 65.7 ± 70.5 hours, P = 0.007). Finally, thromboembolic events were low (0.63%). Dual antiplatelet therapy, defibrillator and CHA 2 DS 2 -VASc score 0-1 majored the risk of CRH. Timing of DOAC interruption and resumption were not predictive of CHR, however postoperative period seemed to be at high-risk of hematoma especially when bridging is performed. These findings have strong impact for clinical practice.

Three-Dimensional Reconstruction of Pacemaker Lead Trajectory From Orthogonal Chest X-Rays: A Proof of Concept

Understanding the lead trajectory is important in preventing complications after cardiac rhythm device implantation. In this report, we sought to reconstruct the three-dimensional (3D) shape of a pacing lead from radiographs taken at 90-degree angles. All image data were obtained from a 65-year-old male patient, who underwent pacemaker implantation at our hospital due to third-degree atrioventricular block in 2016. Both frontal and lateral chest X-rays were taken just after the device implantation (supine position) and on the post-procedural day 1 (upright position), respectively. Fluorine-18-fluorodeoxyglucose positron emission tomography/CT was performed 75 days after the pacemaker implantation for the diagnosis of cardiac sarcoidosis. Contours of the ventricular leads were manually traced in each X-ray image and saved as Scalable Vector Format (SVG) files using the GNU Image Manipulation Program (GIMP). The 3D reconstruction was performed on Blender 2.93, which is an open-source computer graphics software. The lead trajectory could be reconstructed from bidirectional radiographs, which may allow for further investigation of the 3D shape change of the pacemaker leads.

525 Incidence and possible determinants of device-pocket haematoma after cardiac implantable electronic devices in patients treated with a pressure dressing

Abstract Aims Device-pocket haematoma (DPH) occurs in 2–15% of the implantations of cardiac rhythm devices. Major bleedings occur in 0.2–2% of the cases. The present study aims to evaluate the incidence of DPH in patients treated with a pressure dressing after implantation of a pacemaker and to investigate the impact of antiplatelet and anticoagulant therapy on DPH in the same cohort. Methods and results A retrospective evaluation on 446 consecutive patients who underwent implantation or replacement of pacemaker/ICD between 2017 and 2018 was performed. Cardiovascular risk factors, clinical parameters, medical history of the patients, as well as their drug history were collected. The presence or absence of perioperative DPH was investigated. All patients were treated with a pressure dressing immediately after the procedure and for the first 24 h. The preliminary results obtained after reviewing the medical records of the 446 patients (age 76.8 ± 10.4 years; 67% males; left ventricular ejection fraction 47.3 ± 12.2%) show an incidence of DPH of 8.1% (n = 36). 332 (74%) of the patients had documented hypertension, 131 (29%) diabetes, 213 (48%) were taking antiplatelet medications, and 150 (34%) were taking anticoagulants. No significant differences were found directly comparing the main variables under study between patients who experienced DPH and those who did not. However, at binomial logistic regression analysis, performed including antithrombotic therapies, sex, and age, a tendency of patients treated with warfarin to experience DPH emerged (OR : 3.25, 95% CI : 1.00–10.50; P = 0.049). Conclusions The preliminary results of the present study show an incidence of DPH of 8.1% in patients treated with a pressure dressing after pacemaker implantation. Between antithrombotic therapies, sex and age, anticoagulation therapy with warfarin appeared to be correlated with an increased risk of DPH.

Safety and feasibility of a telemonitoring-guided exercise program in patients receiving cardiac resynchronization therapy.

BackgroundTelerehabilitation is an alternative clinic‐based rehabilitation. A remote monitoring (RM) system attached to a cardiac rhythm device can collect physiological data and the device function. This study aimed to evaluate the safety and feasibility of telerehabilitation supervised by an RM in patients receiving cardiac resynchronization therapy (CRT).MethodsA single group pre–post exercise program was implemented for 3 months in 18 CRT recipients. The exercise regimen consisted of walking a prescribed number of steps based on a 6‐min walk distance (6MWD) achieved at baseline. The patients were asked to exercise 3 to 5 times per week for up to 30 min per session, wearing an accelerometer to document the number of steps taken. The safety was assessed by the heart failure hospitalizations and all‐cause death. The feasibility was measured by the improvement in the quality of life (QOL) using the EuroQol 5 dimensions, and daily active time measured by the CRT, 6MWD, B‐type natriuretic peptide (BNP) level, and left ventricular ejection fraction (LVEF).ResultsNo patients had heart failure hospitalizations or died. No patients had any ventricular tachyarrhythmias. One patient needed to suspend the exercise due to signs of exacerbated heart failure by the RM. Compared to baseline, there were significant improvements in the QOL (−0.037, p < .05), active time (1.12%/day, p < .05), and 6MWD (11 m, p < .001), but not the BNP (–32.4 pg/ml, p = .07) or LVEF (0.28%, p = .55).ConclusionsThree months of RM‐guided walking exercise in patients with CRT significantly increased the QOL, active time, and exercise capacity without any adverse effects.

Abstract 11645: Use of an Electronic Health Record to Identify Implantable Cardiac Rhythm Device Lead Failure

Introduction: Electronic health records (EHR) offer the potential to facilitate research examining the real-world effectiveness and safety of medical interventions. However, few studies have used EHR data to evaluate medical devices. This study sought to devise a method using current procedural terminology (CPT) and international classification of disease (ICD) codes captured in EHR data to identify patients with implantable cardiac rhythm device lead failures. Hypothesis: CPT and ICD diagnosis codes within an EHR can be used to correctly identify implantable cardiac rhythm device lead failures. Methods: Study data were extracted from the EHR of a large North Carolina health system. Patients who had implantable cardiac rhythm devices implanted during January 2013 to December 2018 were identified using predetermined CPT codes. Patients were followed longitudinally to identify those undergoing subsequent lead insertions or removals through December 2019. Medical records were reviewed to determine reasons for the re-insertion or removal and identify true lead failures. Random forest modeling was used to develop an algorithm for predicting true lead failure using CPT and ICD codes for mechanical breakdown or cardiac device complication. Patients with potential lead failure were split into two cohorts: 60% for model training and 40% for testing. Results: A total of 4,148 encounters with billed CPT codes for implantable cardiac rhythm devices were initially identified. After applying study exclusion criteria, 2,390 patients met study inclusion criteria. Of those, 175 patients had a subsequent insertion indicating a potential lead failure. A total of 31 patients were found to have true lead failures. A random forest algorithm predicted true lead failures with good discrimination, achieving an AUROC (area under receiver operating curve) of 0.908. The model accurately detected 66% of true lead failure cases in the testing dataset. Conclusions: Applying a specific combination of CPT and diagnosis codes to a cohort of patients undergoing subsequent implantable cardiac rhythm device procedures following an index insertion can correctly identify patients with lead failure with strong accuracy and moderate sensitivity.

Assessment of the effects of cardiac rhythm device implantation on right sided heart function and tricuspid valve

Abstract Objective To assess the effects of trans-tricuspid placement of permanent pacemaker (PPM), on the right-sided heart function and tricuspid valve function. Background Over the last decade there has been a significant increase in the number of cardiac device implantation as permanent pacemakers (PPM) worldwide in patients with cardiac rhythm disorders. Tricuspid regurgitation (TR) due to the endocardial lead is a known complication of this procedure, however the incidence of new or worsening TR had not been well studied. Patients and Methods We reviewed patients who underwent permanent pacemaker implantation in our cardiology department in Ain Shams University. Patients who had pacemaker implantation less than one year ago, had severe tricuspid regurgitation before implantation or had previous tricuspid valve repair were excluded. A total of one hundred patients with an echocardiographic study before and another echocardiographic study at least one year after device implantation were included in our study. TR severity was graded as (0 none/trace, 1 mild, 2 moderate, 3 severe). Results Of the 100 patients (Mean age: 53.10 ± 16.04, 50% of patients were males) 65 had DDD and 35 had VVI. Before implantation 25 patient had trace TR (grade 0) vs. 6 patients after, 75 patients had mild TR (grade 1) vs. 82 after, with no patient had moderate TR (grade 2) vs. 12 patients after. TR worsened by one grade in 25 patients, (16 patients from grade 0 to grade 1 and 9 patients from grade 1 to grade 2) and by 2 grades in 3 patients (from grade 0 to grade 2), Pvalue &amp;lt; 0.01. TR jet area size (Mean ± SD: 2.80 ± 0.77 before vs. 4.15 ± 1.29 after, P-value &amp;lt; 0.01). Also, 99 patients had normal RV size and one had dilated RV before implantation vs. 95 patient had normal RV and 5 had dilated RV (p-value= 0.097). RV size, LVEF (Mean ± SD: 56.41% ± 7.52 before vs. 55.77% ± 8.00 after), RV function by TASPE (Mean ± SD: 19.15 ± 1.00 before vs. 18.96 ± 0.96 after), RVSP (Mean ± SD: 29.48mmHg ± 5.54 before vs. 29.81 ± 5.09 after) and diastolic function by E/A ratio (Mean ± SD: 1.60 ± 0.39 before vs. 1.57 ± 0.38 after implantation) did not show significant change. Conclusion Permanent pacemaker (PPM) implantation is associated with worsening of tricuspid regurgitation. Echocardiography plays an important role in assessing and grading this condition. Further studies are needed in order to illustrate the effects of these finding on patients outcomes.