Recovery rate from conduction disorders in patients with permanent pacemaker implantation after transcatheter aortic valve implantation.

BACKGROUNDS: Permanent pacemaker implantation (PPMI) is one of the greatest disadvantages of transcatheter aortic valve implantation (TAVI). To seek the predictors and clinical impacts of PPMI and investigate the recovery rate from conduction disorders. METHODS: We retrospectively analysed data from 745 consecutive patients who underwent TAVI for severe aortic stenosis from November 2013 to July 2022. The ventricular pacing (VP) rate was recorded at 1 and 6 months after PPMI and the recovery from conduction disorders was defined as the VP rate <1%. RESULTS: Postoperative PPMI was performed in 7.1% (53/745) of patients. Balloon predilatation was significantly frequent in the PPMI (-) group (52.8% (28/53) vs 80.6% (558/692); p<0.001) and the oversizing ratio was significantly greater in the PPMI (+) group (11.8%±10.1% vs 9.1%±9.7%; p=0.035). Freedom from rehospitalisation due to heart failure rate was significantly higher in the PPMI (-) group (p=0.032). In patients with postoperative PPMI, recovery from conduction disorders was observed in 17.0% and 27.9% of patients at 1 and 6 months, respectively. CONCLUSIONS: Recovery from conduction disorders occurred frequently. Avoidance of oversizing and extension of observation time may reduce the need for PPMI after TAVI.

Leadless pacemaker implantation using halo-shape technique in a severe dextroscoliosis octogenarian.

The halo-shape technique (HST) is an emerging approach for implanting a leadless pacemaker in scoliosis patients in recent years. Severe scoliosis and humpback made it challenging to push the tip of the delivery catheter towards the ventricular septum using the conventional gooseneck-shape technique. The feasibility and safety of the use of HST in an octogenarian with severe dextroscoliosis and humpback have not been well-assessed. Here, we report a case of high-degree atrioventricular block octogenarian with severe dextroscoliosis and humpback who successfully received a leadless pacemaker implantation using HST. Procedure-related complications were not observed, and the electrical parameters were stable at 6-month follow-up.

Dual-chamber vs. single-chamber pacemaker in patients in sinus rhythm with an atrioventricular block: a nationwide cohort study.

AIMS: In complete atrioventricular block (AVB) with underlying sinus rhythm, it is recommended to implant a dual-chamber pacemaker rather than a single-chamber pacemaker. However, no large-scale study has been able to demonstrate the superiority of this choice on hard clinical criteria such as morbimortality. METHODS AND RESULTS: This retrospective observational study included all patients who received a primary pacemaker implantation in the indication of complete AVB with underlying sinus rhythm in France, based on the national administrative database between January 2013 and December 2022. After propensity score matching, we obtained two groups containing 19 219 patients each. The incidence of all-cause mortality was 9.22%/year for the dual-chamber pacemaker group, compared with 11.48%/year for the single-chamber pacemaker group (hazard ratio (HR) 0.807, P < 0.0001]. Similarly, there was a lower incidence of cardiovascular mortality (HR 0.766, P < 0.0001), heart failure (HR 0.908, P < 0.0001), atrial fibrillation (HR 0.778, P < 0.0001), and ischaemic stroke (HR 0.873, P = 0.008) in the dual-chamber pacemaker group than in the single-chamber pacemaker group. Regarding re-interventions and complications, there were fewer upgrades (addition of atrial lead or left ventricular lead) in the dual-chamber group (HR 0.210, P < 0.0001), but more haematomas (HR 1.179, P = 0.006) and lead repositioning (HR 1.123, P = 0.04). CONCLUSION: In the indication of complete AVB with underlying sinus rhythm, our results are consistent with current recommendations to prefer implantation of a dual-chamber pacemaker rather than a single-chamber pacemaker for these patients. Implantation of a dual-chamber pacemaker is associated with a lower risk of mortality, heart failure, atrial fibrillation, and stroke during follow-up.

Single-chamber atrial pacing†+†Micra AV implantation: A case report.

RATIONALE: The use of transvenous pacing leads is associated with the risk of tricuspid valve dysfunction, mainly due to the continuous presence of the leads can have an impact on subsequent tricuspid function and possible operation injury of the tricuspid valve during implantation or operation. PATIENT CONCERNS: A 69-year-old female with a history of syncope for 9 months was admitted to the hospital. The electrocardiogram showed sinus bradycardia, junctional escape rhythm, and a heart rate of 44 bpm. Echocardiography suggested a downward displacement and severe insufficiency of the tricuspid valve and atrial septal defect. DIAGNOSES: The cause of syncope was considered to be sick sinus syndrome. The patient was diagnosed with Ebstein anomaly and is considered a candidate for surgical intervention. INTERVENTIONS: To avoid aggravating tricuspid insufficiency by pacing leads crossing the tricuspid valve and hindering subsequent tricuspid valve surgery, a single-chamber pacing mode with atrial pacing (AAI) lead and Micra AV was chosen for maintaining atrioventricular synchrony after multidisciplinary discussion. OUTCOMES: The patient had stable parameters and was in good general condition at 1- and 3-month outpatient follow-ups after discharge. LESSONS: This is the first case of new implantation of single-chamber atrial pacing + leadless ventricular pacing with Micra AV, an alternative strategy to epicardial or coronary sinus system for tricuspid valve displacement and severe tricuspid regurgitation.

Relationship Between Insurance Status and Receipt of Cardiac Tests and Procedures During Hospitalization: A Cross-Sectional Study.

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.

Left Ventricular Outflow Tract Morphology as a Predictor of Conductance Disturbances Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Conduction disturbances represent one of the most common complications following transcatheter aortic valve replacement (TAVR). We sought to investigate the role of left ventricular outflow tract (LVOT) morphology in the development of conduction disturbances following TAVR. METHODS AND RESULTS: Consecutive patients who underwent TAVR in our center were included. The ratio between the LVOT area and the aortic annulus area was calculated. Patients were then divided into 2 groups on the basis of this ratio: group 1, which included patients with an LVOT area/aortic annulus area ratio <0.9; and group 2, which included patients with an LVOT area/aortic annulus area ratio ≥0.9. The primary end point was to assess the relationship between LVOT shape and the rate of permanent pacemaker implantation following TAVR. A multivariable analysis was performed to identify predictors of permanent pacemaker implantation following TAVR. From January 2018 to December 2020, 276 patients were included. Ninety-one patients with tapered LVOT morphology were assigned to group 1 and the rest (n=185 patients), tubular LVOT or flared LVOT shape, to group 2. The mean age was 81.5±5.7 years and 57% were women. After adjusting by confounding factors, tapered morphology of the LVOT and prior right bundle-branch block were found to be independent predictors of permanent pacemaker implantation (hazard ratio [HR], 2.6 [95% CI, 1.2-5.7]; P=0.014; and HR: 4.3 [95% CI 2.4-7.6], P<0.001); at a median follow-up time of 15.5 (interquartile range, 15) months. CONCLUSIONS: A tapered-LVOT morphology was associated with increased risk for permanent pacemaker implantation. LVOT morphology may be an additional factor to consider when choosing prosthesis size.

3-T MR-guided focused ultrasound thalamotomy for tremor in patients with a cardiac pacemaker: case series and review of the literature.

MR-guided focused ultrasound (MRgFUS) has proven its efficacy and safety for the treatment of essential tremor (ET) and/or Parkinson's disease (PD). However, having a cardiac pacemaker has been considered an exclusion criterion for the use of MRgFUS. Only 2 patients with a cardiac pacemaker treated with MRgFUS have been previously reported, both treated using 1.5-T MRI. In this paper, the authors present their experience performing 3-T MRgFUS thalamotomy in 4 patients with an implanted cardiac pacemaker. Treatments were uneventful regarding complications or severe side effects. MRgFUS using 3-T MRI was found to be an efficient and safe treatment for ET and/or PD in patients with an MRI-compatible pacemaker.

Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial.

BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

[Diagnostics and treatment of syncope]. / Diagnostik und Therapie von Synkopen.

The 2018 guidelines of the European Society of Cardiology (ESC) provide improved algorithms for the diagnostics and treatment of syncope. New guidelines on ventricular tachycardia, on the prevention of sudden cardiac death and on cardiomyopathies and pacemakers have refined the recommendations. The detailed medical history and examination are crucial for differentiating between cardiac and noncardiac causes and determining the appropriate treatment. High-risk patients need urgent and comprehensive diagnostics. The basic diagnostics include medical history, physical examination and a 12-lead electrocardiography (ECG). Further tests, such as long-term ECG monitoring, implantable loop recorders and electrophysiological investigations are helpful in unclear cases. The treatment depends on the cause, with pacemaker implantation and implantable cardioverter defibrillators (ICD) being important for cardiac causes, while behavioral measures and medication management have priority for noncardiac syncope.

Implantation of CRT pacemaker during pregnancy: estimated fetal radiation dose.

The benefits of a cardiac resynchronization therapy (CRT) implantation are known in severe heart failure and its implantation may also be considered during pregnancy to ensure safe pregnancy and delivery for both the mother and the fetus. This study on a patient case aimed to estimate the absorbed dose (AD) to the fetus during the CRT implantation of 21st week of the pregnant woman. AD measurement was done using anthropomorphic phantom, radiophotoluminescence dosemeters and Monte Carlo simulation utilizing kerma area product (KAP) of the procedures. The measured AD for a phantom's uterus and heart was 0.116 and 14.7 mGy with total KAP of 27.9 Gycm2. The estimated actual AD to the fetus and the mother's heart was 0.004 and 1.2 mGy, with total KAP of 1.5 Gycm2. The dose to the fetus can be minimized with the optimized procedure.

Percutaneous Extraction of Transvenous Permanent Pacemaker/Defibrillator Leads-A Single-Center Experience.

Background and Objectives: The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods: We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results: Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions: Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.

Extraction of lumenless pacing leads from the His bundle and left bundle branch area: outcomes of the high-volume centre.

AIMS: The application of conduction system pacing (CSP) in clinical practice is growing, and the need for lead extraction will also increase. The data on outcomes and safety of CSP lead extraction are limited. The aim of this study was to assess procedural outcomes and safety of CSP lead removal. METHODS AND RESULTS: Forty-seven patients from the EXTRACT Registry with the indication for CSP lead removal were enrolled in the study conducted at the Department of Electrocardiology in Katowice, Poland. Extraction technique, outcomes, safety, and complication were evaluated. Forty-three (91.5%) leads were successfully removed, and 41 (87.2%) were removed with traction only. The dwelling time of 28 extracted leads was longer than 1 year, and the oldest extracted lead was implanted for 89 months. Seven (14.9%) leads were removed from the left bundle branch (LBB) area and 36 from the His bundle (HB). Transient complete atrioventricular block occurred during the procedure in two patients. In 27 out of 31 attempts (87.1%), new CSP leads were implanted: nine (33.3%) HB pacing leads and 18 (66.7%) LBB area pacing leads. CONCLUSION: The CSP lead extraction is safe and feasible with a low complication rate and high rate of CSP lead reimplantation.

Impact of comorbidity on complication rates and life expectancy in patients with a leadless pacemaker.

BACKGROUND: Knowledge about impact of age and comorbidities on outcome in patients with leadless pacemakers (LPM) is limited. OBJECTIVES: To analyse outcome in LPM patients according to age and comorbidities. METHODS: This Swiss, multi-centre, retrospective analysis includes all patients with LPM implanted between 2015 and 2022. Charlson-Comorbidity-Index (CCI) was determined and patients were divided into a low- (CCI ≤ 5) and high-comorbidity (CCI > 5) group. Peri-procedural complications, in-hospital death, and all-cause mortalities were assessed. Finally, all-cause mortality according to three groups (CCI ≤ 3, 4-5, >5) was compared to age and sex-adjusted mortality in the general Swiss population. RESULTS: 863 patients (median age 81 years, 65% male, 42% with CCI > 5) were included. Peri-procedural/long-term complication rates did not differ between the low- vs. high-comorbidity groups (2.6% vs. 1.7%, p = 0.48 and 1.2% vs. 2.8%, p = 0.12, respectively). In-hospital (3.6% vs. 0.6%, p = 0.002) and all-cause mortality (HR 2.9, 95%CI 2.2-3.8, p < 0.001) were significantly higher in the high-comorbidity group resulting in a three-year mortality of 58% (95%CI 51-65%) vs. 22% (95%CI 17-27%) in the low-comorbidity group. In patients with a CCI ≤ 3, all-cause mortality was comparable to the age- and sex-adjusted mortality of the general Swiss population. CONCLUSIONS: In elderly patients with high comorbidity, LPM implantation was not associated with increased peri-procedural/long-term complications. All-cause mortality in LPM patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. Despite a relatively high three-year mortality due to competing risk factors, LPM implantation is safe, even in elderly patients with high comorbidity. CONDENSED ABSTRACT: In this Swiss, multi-centre, retrospective cohort analysis, 863 patients implanted with a leadless pacemaker were included and divided into a high-comorbidity (with a CCI > 5) and low-comorbidity (with a CCI ≤ 5) group. There was no between group difference in terms of implantation outcomes and peri-operative or long-term complications. Furthermore, all-cause mortality during follow-up in patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. These data indicate that LPM implantation is a safe procedure, even in elderly patients with high comorbidity.

Cardiac implantable electronic device infection awareness - A European survey amongst implanting physicians.

BACKGROUND AND AIMS: Cardiac Implantable Electronic Device (CIED) infections pose significant mortality and morbidity despite optimal treatment. This survey aimed to understand whether and how the risk of CIED infection is assessed and mitigated in clinical practice in Europe, and to detect gaps with respect to EHRA recommendations. METHODS: An Expert Group of 8 European cardiologists with specific expertise across CIED therapy designed and distributed electronically a survey to a number of European Cardiologists. RESULTS: 302 physicians from 18 European countries responded to the survey. 288/302 (95%) physicians agreed that CIED-related infections represent a burden on healthcare resources and are associated with significant morbidity and mortality. 285/302 respondents (94%) primarily assess the risk of CIED infections by only evaluating the patient's clinical profile (137/302, 46%) or with the support of a risk score (148/302, 49%). Intravenous antibiotic prophylaxis is used by 282/302 (93%), followed by the implantation of the lowest number of leads possible (182/302, 60%), and by the use of an antibacterial envelope (173/302, 57%). 230/302 respondents (76%) declared that there is need for clear and concise guidelines and more sensitive risk-scores for CIED infection, to maximize the chances of preventative strategies. CONCLUSIONS: This survey demonstrates a high level of awareness about the multifaceted issue of CIED infection, however, it also highlights an incomplete penetration of scoring systems for risk stratification owing to their perceived limitations, and detects a strong commitment to increase the effectiveness of preventative strategies.

Human-heart-model for hardware-in-the-loop testing of pacemakers.

To guarantee the safety of medical devices, including embedded systems, it is essential to consider both electronic components and the natural environment during validation and verification. In contrast to prior research, we present a hardware-in-the-loop environment that connects a real medical system to a biological model in real time for validation, including the modeling of the mechanical component of the heart valves in addition to the modeling of the electrical conduction and electrical stimulation of the heart chambers. Our model accounts for the dynamic adaptation of the temporal processes in the heart chambers to the pacing frequency of the individual chambers as a function of the action potential. This study investigates two additional risk factors affecting the heart under different conditions: pacemaker syndrome and electrical stimulation during the vulnerable phase. Both can be life-threatening to the patient if left untreated. In implementing our concept on a physical pacemaker connected to our software-based model of the heart, we discovered that the test pacemaker was unable to generate the required heart rate in three of the scenarios we tested. Additionally, our tests revealed occurrences of pacemaker syndrome and stimulation in the vulnerable phase.

Observational study of left bundle branch area pacing: implantation of the solia S lead using the selectra 3D sheath at an inclined angle.

BACKGROUND: Left Bundle Branch Area Pacing (LBBaP) is a cardiac pacing technique designed to mimic the natural conduction system of the heart. Traditional right ventricular apical pacing has been associated with increased risks of heart failure and atrial fibrillation. This study investigates the stability and safety of LBBaP using the Selectra 3D sheath (Biotronik) with an inclined angle for implanting the Solia S lead (Biotronik, SE & Co, KG). METHODS: A single-center retrospective study was conducted on 25 patients who underwent LBBaP implantation using the Selectra 3D sheath at our hospital. The procedure involved inserting the Solia S lead into the interventricular septum at an inclined angle. Surgical and postoperative data were collected, including the success rate, depth and angle of electrode insertion, complications, and follow-up data. RESULTS: The success rate of LBBaP implantation was 92%. The length of electrode insertion into the interventricular septum ranged from 12 to 23.0 mm, with an average of 18.1 ± 3.08 mm. The angle formed between the electrode and the septum ranged from 0° to 57.3°, with an average of 35.14°±14.31°. During the 3-month follow-up period, pacing parameters remained stable, and no complications were reported. CONCLUSIONS: LBBaP implantation using the Selectra 3D sheath with an inclined angle for the Solia S implantation demonstrates stability and safety. The procedure boasts a high success rate and offers an effective option for LBBaP implantation.

Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve implantation.

OBJECTIVE: This study aimed to identify the incidence, risk factors, and outcomes of permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI) procedures. METHODS: A retrospective analysis was conducted on 70 patients who underwent TAVI at the Department of Cardiology, Fujian Provincial Hospital, from January 2018 to March 2022. Based on whether a new PPM was implanted after TAVI, all patients were divided into two groups: NEW PPM and NO PPM. Baseline characteristics and clinical data were compared between the two groups. Univariate analysis was used to analyze different variables between the two groups. A binary logistic regression analysis was used to evaluate independent correlates for PPM implantation after TAVI. RESULTS: The mean age of the 70 patients was 73.1 ± 8.8 years. The incidence of PPM implantation was 17.1%. Patients with diabetes and chronic kidney disease were more likely to require PPM (50% vs. 20.7%, p = 0.042, 25% vs. 5.2%, p = 0.042). Our study did not identify any significant differences in the incidence of electrocardiographic conduction disturbances except for the previous right bundle branch block (RBBB) (NO PPM 6.9% vs. NEW PPM 33.3%, p < 0.05). We found that prosthesis size, implantation depth, procedural duration, and length of hospital and intensive care unit (ICU) stays were comparable between the two groups. The leading independent predictors of PPM implantation were previous RBBB (odds ratio 10.129, p = 0.034). CONCLUSION: The previous RBBB was the leading independent predictor of PPM implantation. New PPM was not associated with significantly new-onset left BBB, extended post-procedure hospitalization, ICU stay, or procedural duration.