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We report an elderly male patient with frequent episodes of dizziness due to a complete atrioventricular block who underwent temporary pacemaker insertion in a local hospital. After the implantation of a permanent pacemaker and removal of the temporary pacemaker lead, the patient developed sudden neurological symptoms, upon which an acute cerebellar infarction was diagnosed via head CT. We will discuss the adequacy of the periprocedural administration.
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OBJECTIVES: Transcutaneous cardiac pacing (TCP) is a potentially lifesaving therapy for patients who present in the prehospital setting with bradycardia that is causing hemodynamic compromise. Our objective was to examine the outcomes of patients who received prehospital TCP and identify predictors of TCP failure. METHODS: We utilized the 2018-2021 ESO Data Collaborative public use research datasets for this study. All patients without a documented TCP attempt were excluded. Mortality was derived from hospital disposition data. TCP failure was defined as initiation of CPR following the first TCP attempt among patients who did not receive CPR prior to the first TCP attempt. Multivariable logistic regression models using age and sex as covariables were used to explore the association between prehospital vital signs and TCP failure. RESULTS: During the study period, 13,270 patients received transcutaneous pacing and 2,560 of these patients had outcome data available. Overall, the mortality rate following TCP was 63.4%. Among patients who did not receive CPR prior to the first TCP attempt (n = 7,930), TCP failure (progression to cardiac arrest) occurred 20.4% of the time. Factors associated with TCP failure included increased body weight (>100 vs. 60-100 kg, aOR: 1.33 (1.15, 1.55)), a pre-pacing non-bradycardic heart rate (>50 vs. <40 bpm, aOR: 2.87 (2.39, 3.44)), and pre-TCP hypoxia (<80% vs. >90% SpO2, aOR: 6.01 (4.96, 7.29)). CONCLUSIONS: Patients who undergo prehospital TCP are at high risk of mortality. Progression to cardiac arrest is common and associated with factors including increased weight, a non-bradycardic initial heart rate and pre-TCP hypoxia.
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To compare the efficacy and safety of bedside ultrasound-guided and fluoroscopy-guided transvenous cardiac temporary pacing in the treatment of bradyarrhythmia in children. Children treated by temporary intravenous cardiac pacing from January 2016 to June 2023 in Hunan Provincial Children's Hospital were enrolled, and the characteristics and data of the cases were summarized. Patients were divided into bedside ultrasound-guided group (ultrasound group) and fluoroscopy-guided group (fluoroscopy group) according to the implantation guidance methods. The efficacy, safety, and incidence of complications in children were compared, and follow-up analysis was carried out. A total of 30 children were enrolled, including 18 males and 12 females, with a median age of 5.5 (2.9, 10.0) years and a median weight of 18.7 (12.7, 32.7) kg. The most common primary diseases were fulminant myocarditis (13/30 cases) and congenital high-grade AVB (10/30 cases). Among them, the proportion of congenital high AVB in the fluoroscopy group was significantly higher than that in the ultrasound group, and the difference was statistically significant (p = 0.007). The implantation process was successful in all 30 children. From the time of pacing decision to implantation, the median time of ultrasound group was 56 (30, 60) min and that of fluoroscopy group was 154 (78,180) min, with a statistically significant difference (P < 0.001). A total of 5 cases developed complications. There was no statistically significant difference between the two groups (P > 0.05). Compared with traditional fluoroscopic temporary pacing, bedside ultrasound-guided temporary pacing technology can effectively shorten the operation time and reduce the occurrence of complications and has become a better choice for children's emergency and critical care treatment. The right internal jugular vein is preferred for intravenous implantation.
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INTRODUCTION: While right ventricular pacing (RVP) is the conventional temporary pacing modality used for transcatheter aortic valve replacement (TAVR), this approach possesses inherent risks and procedural challenges. We aim to assess and compare the safety and efficacy of left ventricular pacing (LVP) and RVP during TAVR and balloon aortic valvuloplasty (BAV). METHODS: Following PRISMA guidelines, a comprehensive literature search was conducted in four databases from inception to December 15th, 2023. We included observational studies and clinical trials comparing LVP with RVP during TAVR and BAV procedures. Primary outcomes included short-term mortality, mortality due to cardiac tamponade, and procedural complications including bleeding, vascular complications, and cardiac tamponade. Secondary outcomes comprised procedure duration and length of hospital stay. RESULTS: Five studies involving 830 patients with RVP and 1577 with LVP were included. Short-term mortality was significantly higher in the RVP group (RR 2.32, 95% CI: [1.37-3.93], P = .002), as was the incidence of cardiac tamponade (RR 2.19, 95% CI: [1.11-4.32], P = .02). LVP demonstrated shorter hospital stays (MD = 1.34 d, 95% CI: [0.90, 1.78], P < .001) and reduced procedure duration (MD = 7.75 min, 95% CI: [5.08, 10.41], P < .00001) compared to RVP. New pacemaker implantation was higher in the RVP group (RR 2.23, 95% CI: [1.14, 4.39], P = .02). CONCLUSION: LVP during TAVR and BAV emerges a safer alternative to RVP, offering reduced mortality, hospital stays, and procedure durations.
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BACKGROUND: Extravascular and leadless pacemakers are a new class of cardiac devices that may reduce the rate of complications common to traditional cardiac pacemakers with intracardiac leads. These devices also have the potential of expanding access to cardiac pacing therapy by simplifying the complexity and cost of implantation. The objective of this study is to evaluate the implantation, chronic safety, and performance of a novel subxiphoidal pacemaker. METHODS: This study is an open-label, non-randomized, early feasibility study. Ten patients indicated for implantation of a single-chamber ventricular pacemaker will be enrolled and implanted with the investigational device. The pacemaker will be inserted underneath the ribcage and clipped to the xiphoid process, with stimulation electrodes positioned on the cardiac pericardium. Patients will be programmed to chronic pacing; pacing capture threshold, sensing amplitude, and lead impedance will be measured at implant and regularly scheduled follow-up visits. 24-h Holter ECG and cardiac troponin will also be periodically measured. Adverse events will be recorded throughout the study period. CONCLUSION: This study is designed to assess the feasibility, safety, and chronic performance of a novel extravascular pacemaker, and will provide valuable data on whether this device has the potential to be a viable alternative to conventional pacemakers.
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OBJECTIVE: To describe complications and outcomes in dogs undergoing epicardial pacemaker (EP) implantation, identify factors associated with survival, and investigate improvement in clinical signs and health-related quality of life (HRQoL) following surgery. ANIMALS: 52 client-owned dogs that underwent EP placement. METHODS: Medical records of 4 UK-based referral hospitals were searched and data reviewed retrospectively between July 2010 and December 2022. Factors contributing to outcomes after EP placement were assessed. RESULTS: The primary reasons for referral included collapsing/syncopal episodes (n = 36), exercise intolerance (15), and significant bradycardia (46). Third-degree atrioventricular block (39/52 [75%]) was the predominant indication for pacemaker placement, and common reasons for EP placement included previous transvenous pacemaker dislodgment/loss of capture (n = 12) and small body size (10). Intra- and postoperative complications were documented in 11% and 23% of dogs, respectively. Overall, 96% of dogs survived to discharge, and median follow-up time was 462 days (range, 31 to 3,139 days). Presence of coexistent myocardial or valvular disease at the time of EP implantation was associated with a reduced survival. Owners reported decreased clinical signs, increased activity levels, and improved HRQoL. CLINICAL RELEVANCE: Epicardial pacemaker implantation is a valuable option for dogs requiring artificial cardiac pacing. Complications were common but did not impact the overall outcome. Dogs with a coexisting cardiac pathology had a shorter life expectancy after EP placement, but their HRQoL appeared to be good, with an improvement in clinical signs and increased activity levels.
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His bundle pacing (HBP) and left bundle branch pacing (LBBP) are novel methods of pacing directly pacing the cardiac conduction system. HBP while developed more than two decades ago, only recently moved into the clinical mainstream. In contrast to conventional cardiac pacing, conduction system pacing including HBP and LBBP utilizes the native electrical system of the heart to rapidly disseminate the electrical impulse and generate a more synchronous ventricular contraction. Widespread adoption of conduction system pacing has resulted in a wealth of observational data, registries, and some early randomized controlled clinical trials. While much remains to be learned about conduction system pacing and its role in electrophysiology, data available thus far is very promising. In this review of conduction system pacing, the authors review the emergence of conduction system pacing and its contemporary role in patients requiring permanent cardiac pacing.
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Permanent right ventricular apical pacing deteriorates cardiac systolic function in some patients. We investigated an alternative site for permanent pacemaker (PPM) lead positioning with the goal of achieving more physiological pacing. A total of 132 patients with bradyarrhythmias underwent PPM implantation at the right ventricular outflow tract (RVOT) with conventional active-fixation leads. A real-time cross-correlation analysis (CCA) was performed using the Synchromax® software (EXO Health, Seattle, WA, USA) to determine the optimal site for ventricular lead implantation based on the cardiac synchrony index. The follow-up period ranged from 6-36 months, and the following parameters were assessed: pacing capture threshold, lead stability, and the need for lead repositioning. Adequate parameters were achieved in 129 patients (98%), and there were no procedure-related complications. At follow-up, no leads were dislodged, pacing thresholds remained stable, and no lead required repositioning. Using real-time CCA as an intraoperative parameter during PPM implantation at the septal RVOT helps to achieve cardiac synchrony in the vast majority of cases. This technique is a simple, effective, and safe way to simplify and standardize PPM implantation at the RVOT.
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BACKGROUND: Intravascular cardiac pacemakers are an established therapy for bradycardic indications. Recently, a new class of leadless pacemakers have mitigated some of the complications related to pacemaker leads. In this study, we evaluate the implantation and performance of a novel extravascular technology that delivers epicardial pacing through a subxiphoidal approach. METHODS: Fifteen patients undergoing non-emergent open-heart surgery were enrolled. A midline incision was made just below the xiphoid process, and substernal tunneling was used to create a pocket for the device and to access the anterior pericardium over the right ventricle. The test device (Calyan Technologies, Oakdale, MN) was temporarily inserted underneath the ribcage and clipped to the xiphoid process. The sensing and pacing electrode (FlexArm) was positioned on the anterior pericardium. Ventricular sensing and pacing capture thresholds were measured. RESULTS: The test device was successfully implanted in all 15 patients. There were no device or procedure-related adverse events. The first five implanted patients had no pacing capture at maximum stimulation intensity. Design changes were made to the device, including different electrode size and shape, and successful ventricular capture was achieved in 9 of the subsequent 10 patients. In these patients, pacing threshold was 3.8 ± 1.6 mA with a pulse width of 0.5 ms. All devices were successfully explanted at the end of the procedure. CONCLUSIONS: In a first-in-human experience with a novel extravascular pacemaker, this study demonstrated the feasibility of pericardial ventricular pacing via a subxiphoidal approach. Further chronic studies are required to evaluate the safety and performance of this novel pacing technology.
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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.
Subject(s)
Defibrillators, Implantable , Prosthesis-Related Infections , Humans , Male , Retrospective Studies , Female , Aged , New South Wales/epidemiology , Defibrillators, Implantable/adverse effects , Defibrillators, Implantable/statistics & numerical data , Prosthesis-Related Infections/epidemiology , Prosthesis-Related Infections/etiology , Middle Aged , Risk Factors , Aged, 80 and over , Pacemaker, Artificial/adverse effects , Pacemaker, Artificial/statistics & numerical data , Adult , Hospitalization/statistics & numerical dataABSTRACT
AIMS: Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP). METHODS: This prospective, randomized, double-blind, non-significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded. RESULTS: Ten subjects with HFpEF associated with hypertension who also had permanent dual-chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post-treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post-treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post-treadmill. CONCLUSIONS: An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross-over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer-term treatment.
Subject(s)
Blood Pressure , Cardiac Pacing, Artificial , Heart Failure , Proof of Concept Study , Humans , Male , Female , Double-Blind Method , Prospective Studies , Blood Pressure/physiology , Heart Failure/physiopathology , Heart Failure/therapy , Heart Failure/rehabilitation , Aged , Cardiac Pacing, Artificial/methods , Exercise Test , Heart Rate/physiology , Treatment Outcome , Stroke Volume/physiology , Middle Aged , Algorithms , Exercise/physiology , Heart Atria/physiopathologyABSTRACT
Guidelines are important tools to guide the diagnosis and treatment of patients to improve the decision-making process of health professionals. They are periodically updated according to new evidence. Four new Guidelines in 2021, 2022 and 2023 referred to pediatric pacing and defibrillation. There are some relevant changes in permanent pacing. In patients with atrioventricular block, the heart rate limit in which pacemaker implantation is recommended was decreased to reduce too-early device implantation. However, it was underlined that the heart rate criterion is not absolute, as signs or symptoms of hemodynamically not tolerated bradycardia may even occur at higher rates. In sinus node dysfunction, symptomatic bradycardia is the most relevant recommendation for pacing. Physiological pacing is increasingly used and recommended when the amount of ventricular pacing is presumed to be high. New recommendations suggest that loop recorders may guide the management of inherited arrhythmia syndromes and may be useful for severe but not frequent palpitations. Regarding defibrillator implantation, the main changes are in primary prevention recommendations. In hypertrophic cardiomyopathy, pediatric risk calculators have been included in the Guidelines. In dilated cardiomyopathy, due to the rarity of sudden cardiac death in pediatric age, low ejection fraction criteria were demoted to class II. In long QT syndrome, new criteria included severely prolonged QTc with different limits according to genotype, and some specific mutations. In arrhythmogenic cardiomyopathy, hemodynamically tolerated ventricular tachycardia and arrhythmic syncope were downgraded to class II recommendation. In conclusion, these new Guidelines aim to assess all aspects of cardiac implantable electronic devices and improve treatment strategies.
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There is a perceived need to express concisely the advice of guidelines in the context of consideration of invasive management of highly symptomatic vasovagal syncope. In response to this need the table is presented as a checklist and the text adds explanation and details. It is anticipated that this will prove to be of value for clinicians.
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Syncope, Vasovagal , Syncope, Vasovagal/therapy , Syncope, Vasovagal/diagnosis , Syncope, Vasovagal/physiopathology , Humans , Practice Guidelines as Topic , Treatment Failure , ChecklistABSTRACT
Background and Objectives: Atrioventricular (AV) dyssynchrony as well as atrial and ventricular pacing affect left atrial (LA) function. We conducted a study evaluating the effect of atrial and ventricular pacing on LA morphological and functional changes after dual-chamber pacemaker implantation. Materials and Methods: The study prospectively enrolled 121 subjects who had a dual-chamber pacemaker implanted due to sinus node disease (SND) or atrioventricular block (AVB). Subjects were divided into three groups based on indication and pacemaker programming: (1) SND DDDR 60; (2) AVB DDD 60 and (3) AVB DDD 40. Subjects were invited to one- and three-month follow-up visits. Three subsets based on pacing burden were analyzed: (1) high atrial (A) low ventricular (V); (2) high A, high V and (3) low A, high V. LA function was assessed from volumetric parameters and measured strains from echocardiography. Results: The high A, low V group consisted of 38 subjects; while high A, high V had 26 and low A, high V had 23. A significant decrease in reservoir and contractile LA strain parameters were only observed in the high A, low V pacing group after three months (reservoir 25.9 ± 10.3% vs. 21.1 ± 9.9%, p = 0.003, contractile -14.0 ± 9.0% vs. -11.1 ± 7.8, p = 0.018). While the re-established atrioventricular synchrony in the low A, high V group maintained reservoir LA strain at the baseline level after three months (21.4 ± 10.4% vs. 22.5 ± 10.4%, p = 0.975); in the high A, high V group, a further trend to decrease was noted (20.3 ± 8.9% vs. 18.7 ± 8.3%, p = 0.231). Conclusions: High atrial pacing burden independently of atrioventricular dyssynchrony and ventricular pacing impairs LA functional and morphological parameters. Changes appear soon after pacemaker implantation and are maintained.
Subject(s)
Atrioventricular Block , Pacemaker, Artificial , Humans , Cardiac Pacing, Artificial/adverse effects , Heart Atria , Sick Sinus Syndrome/therapy , Atrioventricular Block/therapyABSTRACT
The term non-cardiac syncope includes all forms of syncope, in which primary intrinsic cardiac mechanism and non-syncopal transient loss of consciousness can be ruled out. Reflex syncope and orthostatic hypotension are the most frequent aetiologies of non-cardiac syncope. As no specific therapy is effective for all types of non-cardiac syncope, identifying the underlying haemodynamic mechanism is the essential prerequisite for an effective personalized therapy and prevention of syncope recurrences. Indeed, choice of appropriate therapy and its efficacy are largely determined by the syncope mechanism rather than its aetiology and clinical presentation. The two main haemodynamic phenomena leading to non-cardiac syncope include either profound hypotension or extrinsic asystole/pronounced bradycardia, corresponding to two different haemodynamic syncope phenotypes, the hypotensive and bradycardic phenotypes. The choice of therapy-aimed at counteracting hypotension or bradycardia-depends on the given phenotype. Discontinuation of blood pressure-lowering drugs, elastic garments, and blood pressure-elevating agents such as fludrocortisone and midodrine are the most effective therapies in patients with hypotensive phenotype. Cardiac pacing, cardioneuroablation, and drugs preventing bradycardia such as theophylline are the most effective therapies in patients with bradycardic phenotype of extrinsic cause.
Subject(s)
Hypotension, Orthostatic , Hypotension , Syncope, Vasovagal , Humans , Bradycardia/diagnosis , Bradycardia/therapy , Bradycardia/complications , Syncope/diagnosis , Syncope/etiology , Syncope/therapy , Syncope, Vasovagal/diagnosis , Syncope, Vasovagal/therapy , Hypotension, Orthostatic/complicationsABSTRACT
BACKGROUND: Traditional cardiac pacemakers commonly have a range of complications related to the presence of intracardiac leads. A new class of extravascular and leadless pacemakers has recently emerged with the potential to mitigate these complications and expand access to cardiac pacing. The objective of this study is to evaluate the implantation, short-term chronic safety, and performance of a novel subxiphoidal extracardiac pacemaker. METHODS: Normal Yorkshire Cross swine (n = 16) were implanted with the subxiphoidal pacemaker. The pacemaker was inserted through a midline chest incision and clipped to the underside of the sternum, with the stimulation electrode placed on the anterior pericardium. Animals were chronically paced and followed for 90 days post-implant, with periodic measurement of pacing capture threshold (PCT) and electrode impedance. RESULTS: All 16 animals were successfully implanted with the study device. At implant, a consistent average PCT of 2.2 ± 0.4 V at a pulse width of 1.0 ms was observed in all animals, with an average implant impedance of 648 ± 44 Ω. Chronic pacing was programmed at a rate of 60 bpm, an amplitude of 3.4 ± 0.7 V, and a pulse width of 1.0 ms. PCT rose to 4.6 ± 0.8 V at 14 days and stabilized; at 90 days, PCT was 3.8 ± 1.2 V and electrode impedance was 533 ± 105 Ω. All implanted animals completed the study with no clinically significant findings, no clinically significant abnormalities, and with no adverse events that affected animal welfare. CONCLUSIONS: This study demonstrated the safety and feasibility of a novel subxiphoidal extracardiac pacemaker to deliver short-term chronic extravascular therapy. Further studies are required to assess the safety, feasibility, and long-term chronic pacing performance in human subjects.