Extraction of a 6-year-old leadless pacemaker (MICRA transcatheter pacing system) using commercially available removal tools: A case report.

INTRODUCTION: Leadless pacemakers are associated with a low risk of infection, so indications for their removal are rare. One can expect that the dwell time of the device correlates with a more difficult removal, but it has not been proved so far. METHODS AND RESULTS: We present a case of a patient in whom MICRA transcatheter pacing system was successfully removed with nondedicated commercially available tools, 70 months after implantation. CONCLUSION: A successful removal of the MICRA leadless pacemaker is possible, and may be safe even many years after the device implantation, despite a lack of dedicated tools. Due to the potential risk of complications, the benefits and risks of the procedure should be weighted before making a final decision.

Recall devices: Defects at initial visit and during remote monitoring supported follow-up.

BACKGROUND: In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter-defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM-supported follow-up. METHODS: Single-center observational study. RESULTS: Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow-up. CONCLUSIONS: The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.

Predictors of Long-Term Infections After Cardiac Implantable Electronic Device Surgery　- Utility of Novel PADIT and PACE DRAP Scores.

BACKGROUND: Cardiac implantable electronic device-related infections (CDI) are of increasing importance and involve substantial healthcare resources. This study aimed to evaluate potential CDI risk factors and the utility of the novel PADIT and PACE DRAP scores to predict CDI.Methods and Results:The study group included 1,000 consecutive patients undergoing implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) surgery. Patients' and procedural characteristics were collected. CDI occurrence was assessed during 1-year follow-up. Moreover, if periprocedural significant pocket hematoma (SPH) occurred, the maximal volume was calculated based on ultrasonographic measurements and ABC/2 formula. The overall incidence of CDI was 1.8%. In the multivariable regression analysis independent CDI risk factors were: age >75 years (odds ratio [OR]: 5.93; 95% confidence interval [CI]: 1.77-19.84), system upgrade procedure (OR: 6.46; CI: 1.94-21.44), procedure duration >1 h (OR: 13.96; CI: 4.40-44.25), presence of SPH (OR: 4.95; CI: 1.62-15.13) and reintervention within 1 month (OR: 16.29; CI: 3.14-84.50). The PACE DRAP score had higher discrimination of CDI incidence (area under curve [AUC] 0.72) as compared with the PADIT score (AUC 0.63). CONCLUSIONS: We identified 5 independent risk factors of CDI development. Our study also showed that the PACE DRAP score was better able to identify patients at high risk of CDI than the PADIT score.

Validation of the Polish version of the Beck Depression Inventory in patients with epilepsy.

BACKGROUND: Despite the fact that depressive disorders are the most common comorbidities among patients with epilepsy (PWE), such disorders often go unrecognized and untreated. In addition, the availability of validated screening instruments to detect depression in PWE is limited. The aim of the present study was thus to validate the Polish version of the Beck Depression Inventory (BDI) in adult PWE. METHODS: A group of 118 outpatient PWE were invited to participate in the study. Ninety-six patients meeting the inclusion criteria completed the Polish Version of Beck Depression Inventory-I (BDI-I) and were examined by a trained psychiatrist using the Structured Clinical Interview (SICD-I) for Diagnostic and statistical manual of mental disorders - fourth edition (Text revision) (DSM-IV-TR). Receiver operating characteristic (ROC) curves were used to determine the optimal threshold scores for BDI. RESULTS: Receiver operating characteristic analysis showed the area under the curve to be approximately 84%. For major depressive disorder (MDD) diagnosis, the BDI demonstrated the best psychometric properties for a cut-off score to be 18, with a sensitivity of 90.5%, specificity of 70.7%, positive predictive value (PPV) of 46.3%, and negative predictive value (NPV) of 96.4%. For the 'any depressive disorder' group, the BDI optimum cut-off score was 11, with a sensitivity of 82.5%, specificity of 73.2%, PPV of 68.8%, and NPV of 85.4%. CONCLUSIONS: The BDI score is a valid psychometric indicator for depressive disorders in PWE maintaining adequate sensitivity and specificity, high NPV, and acceptable PPV with an optimum cut-off score of 18 for MDD diagnosis.

Acalculous cholecystitis in a female with cardiac device-related infective endocarditis.

Acute acalculous cholecystitis (AAC) is a necroinflammatory disease of the gallbladder with no gallstones present. ACC is known to be a serious, even potentially lethal complication observed mainly in patients with various severe underlying conditions including trauma, burn and sepsis. Infection of cardiac implantable electronic devices may lead to cardiac device-related infective endocarditis (CDRIE). The authors describe a case of a 55-year-old female with a history of advanced heart failure and implantation/reimplantation of biventricular pacemaker/defibrillator (CRT-D) for cardiac resynchronization therapy. She was admitted presently due to the symptoms of septicemia. Echocardiography revealed CDRIE with mobile vegetations on pacemaker leads; chest computed tomography showed pulmonary infarctions. Staphylococcus aureus was cultured from the blood. Antibiotics were applied in accordance with antimicrobial susceptibility and were continued after percutaneous leads extraction and pacemaker explantation. After 6 weeks of hospitalization, nonspecific abdominal symptoms developed, ultrasonography and computed tomography confirmed AAC diagnosis. Laparoscopic cholecystectomy was performed. To the best of the authors' knowledge, the case presented is the first report of ACC in a patient with CDRIE due to infection of pacemaker leads.

Validation of the Polish Version of the Hamilton Rating Scale for Depression in patients with epilepsy.

OBJECTIVE: Depressive disorders are the most common comorbidities among patients with epilepsy (PWE). The availability of standardized clinical instruments for PWE is limited with scarce validation studies available so far. The aim of the study was to validate the Polish Version of the Hamilton Rating Scale for Depression (HRSD) in adult PWE. METHODS: A group of 96 outpatient PWE were examined by a trained psychiatrist using the Structured Clinical Interview (SCID-I) for DSM-IV-TR and the 17-item Polish Version of HRSD (HRSD-17). Receiver operating characteristic (ROC) curves were used to determine the optimal threshold scores. RESULTS: The ROC analyses showed areas under the curve approximately 0.9. For diagnoses of MDD, HRSD-17 demonstrated the best psychometric properties for a cutoff score of 11 with sensitivity of 100%, specificity of 89.3%, positive predictive value of 72.4%, and negative predictive value of 100%. CONCLUSIONS: The 17-item Polish Version of HRSD proved to be reliable and valid in the epilepsy setting with a cutoff score of 11 points.

Validation of the Hospital Anxiety and Depression Scale in patients with epilepsy.

OBJECTIVE: Despite the fact that depressive disorders are the most common comorbidities among patients with epilepsy (PWEs), they often go unrecognized and untreated. The availability of validated screening instruments to detect depression in PWEs is limited. The aim of the present study was to validate the Hospital Anxiety and Depression Scale (HADS) in adult PWEs. METHODS: A consecutive group of 118 outpatient PWEs was invited to participate in the study. Ninety-six patients met inclusion criteria, completed HADS, and were examined by a trained psychiatrist using Structured Clinical Interview (SCID-I) for DSM-IV-TR. Receiver operating characteristic (ROC) curves were used to determine the optimal threshold scores for the HADS depression subscale (HADS-D). RESULTS: Receiver operating characteristic analyses showed areas under the curve at approximately 84%. For diagnoses of MDD, the HADS-D demonstrated the best psychometric properties for a cutoff score ≥7 with sensitivity of 90.5%, specificity of 70.7%, positive predictive value of 46.3%, and negative predictive value of 96.4%. In the case of the group with 'any depressive disorder', the HADS-D optimum cutoff score was ≥6 with sensitivity of 82.5%, specificity of 73.2%, positive predictive value of 68.8%, and negative predictive value of 85.4%. CONCLUSIONS: The HADS-D proved to be a valid and reliable psychometric instrument in terms of screening for depressive disorders in PWEs. In the epilepsy setting, HADS-D maintains adequate sensitivity, acceptable specificity, and high NPV but low PPV for diagnosing MDD with an optimum cutoff score ≥7.

Reevaluating the prevalence and diagnostic subtypes of depressive disorders in epilepsy.

OBJECTIVE: Depressive disorders are common among patients with epilepsy (PWE). The aim of this study was to estimate the prevalence of different forms of depressive disorders among PWE treated in the outpatient setting. METHODS: A group of consecutive PWE that visited the epilepsy outpatient clinic was invited to participate in the study. Ninety-six patients met inclusion criteria and were examined by a trained psychiatrist using standardized measures. RESULTS: A diagnosis of a current major depression was established in 21 (22.3%) out of 96 participants. Furthermore, almost 20% of the study group fulfilled criteria for mood disorder categories other than MDD, adding up to over 40% of PWE suffering from any mood disorder category. Older age and later age at seizure onset, as well as unemployment, were associated with an increase in the odds of MDD diagnosis. STUDY LIMITATIONS: A number of limitations are to be considered: the sample size is relatively small, and the findings may not be representative of PWE in general because our population represents a sample coming from a single outpatient clinic with a higher ratio of drug-resistant epilepsy. CONCLUSIONS: Major depression as well as other forms of depressive disorders are common among PWE. Unemployment, age, and age at seizure onset are important factors associated with major depression among PWE.

Symptom Frequency Characteristics of the Hamilton Depression Rating Scale of Major Depressive Disorder in Epilepsy.

BACKGROUND: Depressive disorders are common among patients with epilepsy (PWE). The aim of this study was to explore symptom frequencies of 17-item Hamilton Depression Rating Scale (HDRS-17) and recognize the clinical characteristics of Major Depressive Disorder in PWE. SUBJECTS AND METHODS: A sample of 40 adults outpatients with epilepsy and depression was diagnosed using SCID-I for DSM-IV-TR and HDRS-17. The total HDRS-17 score was analysed followed by the exploratory analysis based on the hierarchical model. RESULTS: The frequencies of HDRS-17 items varied widely in this study. Insomnia related items and general somatic symptoms items as well as insomnia and somatic factors exhibited constant and higher frequency. Feeling guilty, suicide, psychomotor retardation and depressed mood showed relatively lower frequencies. Other symptoms had variable frequencies across the study population. CONCLUSIONS: Depressive disorders are common among PWE. In the study group insomnia and somatic symptoms displayed highest values which could represent atypical clinical features of mood disorders in PWE. There is a need for more studies with a use of standardized approach to the problem.

Follow-up and characteristics of recipients of cardiac resynchronization therapy with and without a defibrillator.

BACKGROUND: Cardiac resynchronization therapy defibrillator (CRT-D) and pacemaker (CRT-P) are treatment options for patients with advanced heart failure and electrical dyssynchrony. Current guidelines provide only factors favoring, not specific recommendations as to implant CRT-D or CRT-P. This analysis aimed to compare and contrast populations of CRT-D and CRT-P recipients. METHODS: Retrospective data were collected from medical records, including 231 patients treated with either CRT-D or CRT-P between 2015 and 2019. Following data were analyzed demographics, co-morbidities, pharmacotherapy, laboratory tests, and data related to the procedure of implantation. The primary endpoint of the study was all-cause mortality. RESULTS: A total of 231 patients were included (mean age [standard deviation, SD], 64.1 [12.3] years, 76% male), of these, 13.6% (n = 32) with CRT-P and 86.4% (n = 199) with CRT-D. Mean New York Heart Association (NYHA) class did not differ between the groups: 2.23 (0.9) in CRT-P and 2.35 (0.6) in CRT-D group (P = 0.42). Mean left ventricular ejection fraction was lower in patients eligible for CRT-D: 27.1% vs. 38% (P < 0.001). Patients were followed for a median (interquartile range [IQR]) of 29 (13-44) months and survival in the CRT-P group was 84%, in CRT-D - 82% (P = 0.74). Patients in the CRT-P group were older, and more often after atrioventricular node ablation. The CRT-P group had tendency towards higher Charlton Comorbidity Index, reaching a mean of 4.66 (1.5) points vs. 3.96 (1.5) points in CRT-D (P = 0.06). CONCLUSIONS: Populations with CRT-P and CRT-D differ in terms of comorbidities; however, they have similar survival. Further studies are required to identify a group of patients, who derive a benefit from adding a defibrillator.

Complications of cardiac resynchronization therapy implantation: De novo implants versus upgrades.

BACKGROUND: Cardiac resynchronization therapy (CRT) is a well-established treatment of patients with advanced heart failure and electrical dyssynchrony. Implantation of those devices is in some cases associated with intervention on a formerly implanted system. The aim of this analysis was to compare the rate and type of complications of de novo implants and upgrades to CRT-D. METHODS: Retrospective data were collected from medical records, including 326 patients treated with CRT-D between 2015 and 2020. The following data were analyzed: procedure data including complications, demographics, co-morbidities, pharmacotherapy, and laboratory tests. The primary endpoint of the study was all-cause mortality. RESULTS: A total of 326 procedure were included, of which 53% (n = 172) were de novo implants and 47% (n = 154) were upgrades. The groups did not differ in the incidence of complications: in the de novo group: 25.5% (n = 44); in the upgrade group: 30.5% (n = 47), p = 0.78. The incidence of complications was also similar in respect of the following: early (p = 0.98) and late (p = 0.45), infectious (p = 0.38) and non-infectious (p = 0.82), surgical (p = 0.38) and device or lead related (p = 0.6). The most common complication in the upgrade group was pocket hematoma (n = 9, 5.8%) and in the de novo group pneumothorax (n = 8, 4.7%). CONCLUSIONS: Upgrade procedures of are not associated with a higher percentage of complications than de novo implantations of CRT-D. Previously implanted cardiac implantable electronic device should not limit the implantation of CRT-Ds.

Patient perspective and safety of remote monitoring of implantable cardioverter-defibrillators in the Polish Nationwide Multicenter Registry: the Medtronic CareLink network evaluation.

BACKGROUND: Remote monitoring of cardiovascular implantable electronic devices allows the assessment of system effectiveness, arrhythmia occurrence, and indirectly, clinical changes. Medical interventions can be performed earlier because of a faster transfer of information to the monitoring site, even in the case of asymptomatic arrhythmias or abnormalities in the operation of the system. AIMS: The aim of the study was to assess the effectiveness of remote monitoring of implantable cardioverter-defibrillators and evaluation in an outpatient setting during 12-month follow -up. METHODS: We analyzed 176 patients at 10 sites (men, 84.1%). The mean (SD) age of the patients was 60.7 (12.5) years (range, 20-86 years), and mean (SD) follow -up period was 405 (70) days (range, 131-723 days). RESULTS: A total of 354 outpatient and 514 remote follow -up visits were conducted. Episodes of arrhythmias and device malfunctions were detected with similar frequency in outpatient visits and in remote visits. During the study period, patient sense of safety increased. More patients preferred joined remote and outpatient visits as the optimal healthcare model. As the patient survey showed, the greatest benefit of the CareLink network was fast intervention and an increased sense of safety. CONCLUSIONS: The strategy of remote monitoring appeared to be feasible, safe, and patient friendly, demonstrating that the majority of patients do not require an additional in -person visit within 1 year from the device implantation just to confirm the proper functioning of the implantable cardioverter--defibrillators.

PACE DRAP: a simple score for predicting significant bleeding complications after cardiac implantable electronic device surgery.

INTRODUCTION: Currently, no risk score for predicting significant bleeding complications (SBCs) after cardiac implantable electronic device (CIED) surgery is available. OBJECTIVES: We aimed to develop a new scoring system for predicting SBCs aft er CIED surgery. PATIENTS AND METHODS: The incidence of SBCs was 4.5%. Based on multivariable analyses, the following predictors of SBCs were identified: age ≥75 years (odds ratio [OR], 8.10; 95% CI, 3.54-18.54); cardiac resynchronization therapy or implantable cardioverter-defibrillator surgery (OR, 5.96; 95% CI, 2.48-14.32); upgrade procedure (OR, 10.22; 95% CI, 4.05-25.78); uncontrolled arterial hypertension (OR, 4.82; 95% CI, 1.78-13.06); presence of valvular prosthesis (OR, 7.85; 95% CI, 3.15-19.58); current malignancy (OR, 6.11; 95% CI, 1.81-20.66); renal failure (OR, 4.28; 95% CI, 1.86-9.87); and the use of antiplatelet drugs (clopidogrel [OR, 6.69; 95% CI, 2.48-18.04] or ticagrelor [OR, 22.25; 95% CI, 4.56-108.46]). The score was created using the weighted points proportional to the ß regression coefficient of each predictor rounded to the nearest integer, and the acronym PACE DRAP corresponds to the predictor's first letter. The cutoff point for the high risk of SBCs was 6 points with a sensitivity of 88.24% and a specificity of 87.23%. The PACE DRAP showed good predictive ability (area under the curve, 0.95 ; P <0.001). CONCLUSIONS: The PACE DRAP score is useful in identifying patients at high risk for SBCs after CIED surgery.

Cardiac resynchronization in Poland - comparable procedural routines? Insights from CRT Survey II.

INTRODUCTION: CRT Survey II was initiated by the European Heart Rhythm Association and the Heart Failure Association, to explore everyday implantation practice of cardiac resynchronization therapy (CRT) devices in a broad spectrum of hospitals in European Society of Cardiology (ESC) member countries. AIM: To compare Polish and European procedural practice. MATERIAL AND METHODS: Procedural details of Polish patients collected in 37 Polish centres (n = 1241 - Poland group) were compared to the patients enrolled throughout Europe (n = 9847 - CRT II Survey group). RESULTS: There were significant differences in: successful implantation (96.1% vs. 97.4%), type of device implanted (for CRT-D: 87% vs. 67.6%), implanting physician subspecialty (for electrophysiologist: 69.2% vs. 79.8%), type of location of procedure (for operating room: 19.4% vs. 8.9%), duration of procedure (117.8 ±44 vs. 97.5 ±46.1 min), left ventricle lead type (for multipolar lead: 50% vs. 57.9%), coronary sinus venogram with occlusion rate (41.4% vs. 47.9%) and peri-procedural complication rate (7.5% vs. 5.3%) between Poland and CRT II Survey groups, respectively. CONCLUSIONS: This study provides important information describing current differences in Polish procedural routines in relation to ESC member countries. Heterogeneous CRT implantation practices across European countries still exist. However, it may be related to different clinical profile of patients qualified for CRT implantation in Poland as well as organization of care.