Background The SHAM-PVI (A Randomized Sham-Controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation) trial demonstrated that pulmonary vein isolation (PVI) reduces atrial fibrillation (AF) burden and enhances quality of life (QoL). However, the relationship between QoL improvements and actual reductions in AF burden remains insufficiently studied, particularly with regard to the potential influence of the placebo effect. Objectives This study sought to investigate the relationship between AF burden and patient-reported QoL outcomes in the context of a sham-controlled, double-blind trial comparing PVI to a sham procedure. Methods This is a secondary analysis of the SHAM-PVI trial involving 126 patients with symptomatic paroxysmal or persistent AF. Participants were randomized to cryoballoon PVI or a sham procedure, with AF burden measured continuously via an implantable loop recorder. QoL was assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT), Mayo AF-Specific Symptom Inventory (MAFSI), and 36-Item Short Form Health Survey (SF-36) instruments. Associations between AF burden and QoL were analyzed using regression models, including interaction terms for treatment group. Results Reduction in geometric mean AF burden was statistically significantly associated with improvements in overall AFEQT score (estimate 0.971; 95% CI: 0.962 to 0.981; P < 0.0001), MAFSI symptom severity and frequency, and multiple SF-36 subdomains. The relationship between the geometric mean AF burden and QoL outcomes was constant between the 2 groups. Symptom-specific analysis highlighted stronger associations between AF burden and palpitations, dizziness, shortness of breath, tiredness, unable to exercise, and weakness. Conclusions In this secondary analysis of the SHAM-PVI trial, there was a statistically significant relationship observed between AF burden reduction and QoL improvements. The study provides robust evidence for the use of AF burden as a marker of success and further reinforces that PVI exhibits no placebo effect.
Our objective was to compare the efficacy of atrial fibrillation (AF) ablation versus permanent pacemaker (PPM) with atrioventricular node ablation (AVNA) versus direct current cardioversion (DCCV) for persistent AF in patients ≥65 years old. Seventy-seven patients (aged 66-86, mean 75.4 years) with persistent AF were randomised (1:1:1) to AF ablation + amiodarone (± DCCV), PPM with AVNA (+DCCV) or DCCV + amiodarone. The primary end point was persistent AF recurrence, measured with an implanted cardiac monitor or PPM. Cardiopulmonary exercise testing (CPET) was performed at baseline and six months. Symptom questionnaires were completed monthly. Follow-up was 12 months. The primary end point occurred in fewer patients following AF ablation + amiodarone than DCCV + amiodarone (seven patients, 28% vs. 15 patients, 60%; hazard ratio [HR] 0.559, 95% confidence interval [CI] 0.293 to 1.065, p=0.073) with no differences between DCCV + amiodarone and PPM with AVNA (HR 0.990, 95%CI 0.539 to 1.818, p=0.973). AF ablation + amiodarone resulted in a lower AF burden at 12 months compared with DCCV + amiodarone (17.0 ± 37.9% vs. 61.7 ± 48.6%, p<0.0001). Modified European Heart Rhythm Association (EHRA) symptom class improved in all patients (baseline 2.4 ± 0.495 vs. 12-month follow-up 1.84 ± 0.081, p=0.00001). Six-month CPET demonstrated a higher VO2 peak in sinus rhythm (SR) compared with baseline in AF (12.1 ± 4.2 ml/kg/min at baseline to 15.3 ± 4.2 ml/kg/min at six months, p=0.013). In conclusion, in older patients with persistent AF, ablation + amiodarone resulted in a lower AF burden at 12 months than DCCV + amiodarone. There was a non-significant trend toward reduced recurrence of devicedetected persistent AF episodes. All therapies improved symptoms despite DCCV restoring SR in <50% of patients at 12 months. CPET demonstrated improved VO2 peak with SR restoration.
Catheter ablation is superior to pharmacological therapy in controlling atrial fibrillation (AF). There are few data on the long-term outcome of AF ablation in octogenarian patients. This analysis aims to evaluate the outcome of AF ablation in octogenarians vs. younger patients. In this retrospective study in 13 centres in the UK, France, and Switzerland, the long-term outcomes of 473 consecutive octogenarian patients undergoing ablation for AF were compared to 473 matched younger controls (median age 81.3 [80.0, 83.0] vs. 64.4 [56.5, 70.7] years, 54.3
Importance There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted. Objective To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation. Design, Setting, and Participants Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%. Intervention Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62). Main Outcomes and Measures The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder. Results A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points). Conclusions and Relevance Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.
Importance:There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted. Objective:To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation. Design, Setting, and Participants:Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%. Intervention:Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62). Main Outcomes and Measures:The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder. Results:A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points). Conclusions and Relevance:Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure. Trial Registration:ClinicalTrials.gov Identifier: NCT04272762.
INTRODUCTION:Catheter ablation for atrial fibrillation (AF) reduces symptoms and improves the quality of life compared with medical treatment. It is unclear if frailty impacts on the outcome of catheter ablation in patients with symptomatic AF. We sought to evaluate the association between frailty as measured by the validated NHS electronic Frailty Index (eFI) and outcomes post-AF ablation. METHODS:Two hundred forty eight patients who had undergone AF ablation with a mean age of 72.9 ± 5.16 were included in the study retrospectively. The primary endpoint for success was defined as freedom from atrial arrhythmia lasting >30 s beyond the 3-month blanking periods. Frailty was based on the eFI, and the cohort split into four groups: fit (no frailty), mild, moderate and severe frailty. RESULTS:Frailty was categorized as fit (118/248; 47.6%), mild (66/248; 26.6%), moderate (54/248; 21.8%), and severe (10/248; 4.0%). Freedom from arrhythmia occurred in 167 of 248 (67.3%) patients after a mean follow-up of 25.8 +/- 17.3 months. Fit patients had significantly greater freedom from arrhythmia (92/118; 78%) compared to mild frailty (40/66; 60.6%, p-value = .020), moderate frailty (31/54; 57.4%, p-value = .006), or severe frailty (4/10; 40.0%, p-value < .001). There was also a significant difference in arrhythmia occurrence between patients with mild frailty and severe frailty (p-value = .044). CONCLUSION:Frailty is associated with poorer outcomes in patients undergoing AF ablation. The eFI may be used in the prognostic evaluation of AF ablation outcomes. Further studies are essential to confirm the findings of this study.
Introduction: Atrial fibrillation (AF) is suspected as the main cause of stroke in the majority of patients presenting with cryptogenic stroke (CS). Implantable loop recorders (ILR's) are indicated for detecting AF in these patients. The short term (<1 month) and long-term AF detection rates in patients inserted with an ILR immediately after CS is reported. Secondly, we compare the safety of nurse led vs physician led ILR implantation in these patients. Methods: This is a ret-rospective review of all patients who underwent inpatient ILR implantation (Med-tronic Linq) between May 2020 and May 2022 at East Sussex Healthcare NHS trust. All patients were remotely monitored via the FOCUSONTM monitoring and triage service. Results: A total of 186 subjects were included in the study and were fol-lowed up for a mean period of 363.0 +/-222.6 days. The mean time between stroke and ILR was 7.0 +/-5.5 days. The mean time between referral and ILR was 1.0 +/-2.0 days. AF was detected in 25 (13.4%) patients. During the first 30 days of monitoring, AF was detected in 9 (4.8%) patients. The number of ILR implants performed by the specialist nurse was 107 (57.5%). There was no significant difference in the major complication rate (requiring device removal) between nurse and physician led implant (1 (0.95%) vs 0 (0%), p value = 0.389). Conclusion: Inpatient ILR for cryptogenic stroke is feasible. The rate of AF detection in the first month post CS is 4.8% however, more AF was detected up to one year post implant, suggesting rationale for proceeding directly to ILR implant in these patients before discharge to not delay treatment. A nurse led ser-vice is also viable with no significant difference in the major complication rate com-pared to physician led implants.
AbstractAimsThere is rising healthcare utilization related to the increasing incidence and prevalence of atrial fibrillation (AF) worldwide. Simplifying therapy and reducing hospital episodes would be a valuable development. The efficacy of a streamlined AF ablation approach was compared to drug therapy and a conventional catheter ablation technique for symptom control in paroxysmal AF.Methods and resultsWe recruited 321 patients with symptomatic paroxysmal AF to a prospective randomized, multi-centre, open label trial at 13 UK hospitals. Patients were randomized 1:1:1 to cryo-balloon ablation without electrical mapping with patients discharged same day [Ablation Versus Anti-arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent (AVATAR) protocol]; optimization of drug therapy; or cryo-balloon ablation with confirmation of pulmonary vein isolation and overnight hospitalization. The primary endpoint was time to any hospital episode related to treatment for atrial arrhythmia. Secondary endpoints included complications of treatment and quality-of-life measures. The hazard ratio (HR) for a primary endpoint event occurring when comparing AVATAR protocol arm to drug therapy was 0.156 (95% CI, 0.097–0.250; P < 0.0001 by Cox regression). Twenty-three patients (21%) recorded an endpoint event in the AVATAR arm compared to 76 patients (74%) within the drug therapy arm. Comparing AVATAR and conventional ablation arms resulted in a non-significant HR of 1.173 (95% CI, 0.639–2.154; P = 0.61 by Cox regression) with 23 patients (21%) and 19 patients (18%), respectively, recording primary endpoint events (P = 0.61 by log-rank test).ConclusionThe AVATAR protocol was superior to drug therapy for avoiding hospital episodes related to AF treatment, but conventional cryoablation was not superior to the AVATAR protocol. This could have wide-ranging implications on how demand for AF symptom control is met.Trial registrationClinical Trials Registration: NCT02459574.
BACKGROUND:Catheter ablation of the atrioventricular node (AVN) is an effective treatment for patients with symptomatic atrial fibrillation. This study compares the success rate, procedure time, radiation time, and complication rates of retrograde left-sided (LSA) and anterograde right-sided (RSA) AVN ablation in a randomised controlled trial.METHODS:Thirty-one patients undergoing AVN ablation were randomized to either LSA (15 patients) or RSA (16 patients). Crossover occurred after six unsuccessful radiofrequency (RF) applications.RESULTS:The LSA cohort had a mean age of 77.00 ± 5.17 and the RSA cohort was 79.44 ± 6.08 (p = .0240). There were five crossovers from LSA to RSA and there was one crossover from RSA to LSA. There was no significant difference in ablation time between LSA and RSA (210.40 ± 179.77 vs. 192.19 ± 130.29 seconds, p = .748). There was no significant difference in procedure time, fluoroscopy time, radiation dose, or number of RF applications between the two groups. There was 1 (6.67%) serious adverse event in the LSA group and 1 (6.25%) in the RSA group due to femoral hematomas requiring blood transfusion or intervention. There was no significant difference in patient-reported discomfort between LSA and RSA (16.43 ± 20.67 vs. 17.87 ± 28.08, p = .877). The study was stopped before full recruitment due to futility.CONCLUSIONS:Retrograde LSA of the AVN does not reduce RF applications, procedure time, or radiation exposure compared with conventional RSA and cannot be recommended as a first-line clinical approach.
Aims Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI.Methods and results Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 +/- 7.6 degrees C, temperature at 30 s of -38.6 +/- 7.2 degrees C, time to -40 degrees C of 34.1 +/- 13.7 s, and time to isolation of 49.8 +/- 33.2 s. Independent predictors for achieving PVI included time to reach -40 degrees C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of <= 34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of <=-54.0 degrees C (AUC 0.71; P < 0.001), respectively.Conclusions This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.
Introduction The rate of pacemaker implantation over the last two decades has risen and will continue to rise as the population becomes more elderly. As such, the number of pacemaker generator changes performed in nonagenarians will also increase. There is little data regarding the risks associated with routine generator changes in this patient cohort. This is important as this cohort of patients are generally more frail and have more co-morbidities, potentially increasing the risks associated with generator change. We retrospectively analysed data on pacemaker generator changes in nonagenarians from a single high volume centre over 10 years. Methods Electronic health record data were reviewed for all patients aged >90 undergoing pacemaker generator change between October 2010 and December 2021. 207 records were identified which met the inclusion criteria. 7 were excluded from the analysis as duplicate entries or occasions where the procedure was not begun due to patient factors such as advanced dementia or acute sickness. The primary outcome was any procedural-related complication occurring in the first year post generator change. Results The mean age was 93 ± 2.34 years. 94 (47%) patients were male. 200 procedures were performed, of which 50 (25%) patients had a single-chamber pacemaker as their original device, 138 (69%) patients had a dual–chamber pacemaker, and 9 (4.5%) patients had a CRT-P device. 1 (0.5%) patient had a CRT-D device in situ, 1 (0.5%) patient had a single-chamber ICD, and 1 (0.5%) patient had a dual-chamber ICD. Twenty-two patients (11%) had a lead capped to convert dual-chamber pacemakers to single-chamber pacemakers. The average procedural time was 40 ± 16 minutes. Complications occurred in 13 patients (6.5%), of which 12 (6%) were classified as “minor”. The most common complication was poor lead performance requiring adjustment of thresholds at follow-up. This was seen in 7 patients (3.5%). The next most common complication was wound haematoma requiring conservative management, seen in 4 patients (2.0%). 1 patient had a minor wound infection, requiring further antibiotic treatment (0.5%). The only major complication seen was threatened erosion of the device, requiring re-siting, which occurred in 1 patient (0.5%). Following generator replacement, mean time to death was 895 ± 718 days. 2 patients died within 30 days of generator change. Conclusion Complication rates during and post generator replacement in nonagenarians are low, with very low rates of serious complications requiring revision. The rates seen in this study are in keeping with previous analyses of generator replacement across patients of all ages, and do not suggest a significantly increased risk of complication amongst patients greater than 90 years old. Conflict of Interest None
INTRODUCTION:Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS & METHODS:The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. RESULTS:Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. CONCLUSION:This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.
Introduction: There is limited data using continuous monitoring to assess outcomes of atrial fibrillation (AF) ablation. This study assessed long-term outcomes of AF ablation in patients with implantable cardiac devices. Methods: 207 patients (mean age 68.1 +/- 9.5, 50.3% men) undergoing ablation for symptomatic AF were followed up for a mean period of 924.5 +/- 636.7 days. Techniques included The Pulmonary Vein Ablation Catheter (PVAC) (59.4%), cryoablation (17.4%), point by point (14.0%) and The Novel Irrigated Multipolar Radiofrequency Ablation Catheter (nMARQ) (9.2%). Results: 130 (62.8%) patients had paroxysmal AF (PAF) and 77 (37.2%) persistent AF. First ablation and repeat ablation reduced AF burden significantly (relative risk 0.91, [95% CI 0.89 to 0.94]; P <0.0001 and 0.90, [95% CI, 0.86-0.94]; P <0.0001). Median AF burden in PAF patients reduced from 1.05% (interquartile range [IQR], 0.1%-8.70%) to 0.10% ([IQR], 0%-2.28%) at one year and this was maintained out to four-years. Persistent AF burden reduced from 99.9% ([IQR], 51.53%-100%) to 0.30% ([IQR], 0%-77.25%) at one year increasing to 87.3% ([IQR], 4.25%-100%) after four years. If a second ablation was required, point-by-point ablation achieved greater reduction in AF burden (relative risk, 0.77 [95% CI, 0.65-0.91]; P <0.01). Conclusion: Ablation reduces AF burden both acutely and in the long-term. If a second ablation was required the point-by-point technique achieved greater reductions in AF burden than "single-shot" technologies. Persistent AF burden increased to near pre ablation levels by year 4 suggesting a different mechanism from PAF patients where this increase did not occur.
BACKGROUND:Second-generation cryoballoon ablation is safe and effective in patients with paroxysmal (PAF) and persistent atrial fibrillation (AF).OBJECTIVE:This study aimed to assess the long-term clinical outcomes and freedom from AF in patients undergoing thermal-guided cryoablation without the use of an electrical mapping catheter.METHODS:All patients who had undergone thermal-guided second-generation cryoablation without electrical mapping between January 2015 and April 2018 at Eastbourne District General Hospital were retrospectively analysed. Success was defined as freedom from atrial arrhythmia lasting >30 s during the follow up period.RESULTS:The study included 234 patients with a mean age of 65.3 ± 10.6 years. There were 134 (57.0%) and 100 (42.7%) patients who had PAF and persistent AF respectively. Arrhythmia recurrence occurred in 38 of 134 (28.4%) PAF and 42 of 100 (42.0%) persistent AF patients after mean follow up of 40 ± 9.2 months. The patients with PAF had a significantly greater freedom from arrhythmia than patients with persistent AF (p = .040). The mean procedure time was 55.5 ± 12.2 min and the mean fluoroscopy time was 10.9 ± 4.8 min 73.5% of patients were discharged on the same day.CONCLUSION:Thermal-guided cryoablation is feasible, safe and results in freedom from arrhythmia in the majority of paroxysmal and persistent AF patients in the long term. Randomised controlled trials are required to confirm the findings of this study.
OBJECTIVES This multicenter registry aimed to assess the reproducibility and safety of intentional coronary vein exit and carbon dioxide insufflation to facilitate subxiphoid epicardiat access in the setting of ventricular tachycardia ablation. BACKGROUND Epicardial ablation for ventricular tachycardia is not a widespread technique due to the significant potential complications associated with subxiphoid puncture. The first experience in 12 patients showed that intentional coronary vein exit and carbon dioxide insufflation was technically feasible. METHODS A branch of the coronary sinus was cannutated by means of a diagnostic JR4 coronary catheter. Intentional perforation at the distal portion of that branch was performed with a high tip toad 0.014-inch angioplasty wire. A microcatheter was advanced over the wire into the pericardial space. Carbon dioxide was then insufflated into the pericardial space, allowing direct visualization of the anterior pericardial space to facilitate subxiphoid puncture. RESULTS Intentional coronary vein exit was attempted in 102 consecutive patients in 16 different centers and successfully completed in 101 patients. Significant pericardial adhesions were confirmed in 3 patients, preventing carbon dioxide insufflation and epicardial ablation. None of the punctures were complicated with inadvertent right ventricular puncture or damage to a coronary artery. Significant bleeding (>80 ml) due to coronary vein exit occurred in 5 patients, without hemodynamic compromise. None of the patients required surgery. CONCLUSIONS Coronary vein exit and carbon dioxide insufflation can be safely and reproducibly achieved to facilitate subxiphoid pericardial access in the setting of ventricular tachycardia ablation. (C) 2021 by the American College of Cardiology Foundation.
INTRODUCTION:Current UK and international guidelines advocate the need for multidisciplinary team (MDT) discussion of selected patients undergoing either percutaneous or surgical cardiac procedures to decide the optimal treatment strategy. To date, it is unknown if using videoconference facilities is cost-effective. Therefore, we performed a cost analysis of using a high-speed internet video conferencing system compared with conventional face-to-face MDT meetings.METHODS:Costs of running a conventional MDT meeting vs a video conferencing MDT were modelled and compared over a 2-year period. Participants were also surveyed on the overall effectiveness of conducting remote MDTs.RESULTS:The set-up and maintenance cost of the video conferencing system over 2 years was £30 400. The staff costs of running the face-to-face MDT were £95 970 and the video conferencing MDT was £23 992.50. The total travel costs of the conventional face-to-face MDTs were £10 555.34. In total, the cost of the conventional face-to-face MDT was £106 525.34 and the video conferencing MDT was £54 392.50 representing a cost saving of 48.9%. Participants rated the effectiveness of conducing a remote MDT and the ease of technology use as very good.CONCLUSIONS:Video conferencing systems provide a highly cost-effective method of facilitating MDT meetings between cardiologists and cardiac surgeons at remote centres.
The COVID-19 pandemic has significantly altered working practices within hospitals. This includes surgical theatres and cardiac catheter laboratories. Here we describe how we have harnessed the use of video technology to improve the running of the cardiac catheter lab in our institution, reducing the exposure of staff members to COVID-19, reducing the need for personal protective equipment (PPE) and maintaining and enhancing educational and teaching opportunities for trainees.
Figure 1 as originally published is incorrect. On the published Fig. 1 it reads 3 patients Medtronic Sensia and 3 patients Medtronic Advisa. This should read 1 patient Medtronic Sensia and 1 patient Medtronic Advisa. Figure 1 has been corrected below.
BACKGROUND:Increasing evidence exists suggesting that cardiac contractility modulation therapy (CCM) improves symptoms in heart failure patients if various selection criteria are fulfilled. The aim of this study is to analyse an unselected sample of heart failure patients to establish what percentage of patients would meet the current criteria for CCM therapy.METHODS:All patients admitted to two district general hospitals in the UK in 2018 with a diagnosis of heart failure were audited for eligibility for CCM therapy. The selection criteria were (a) ejection fraction (EF) 25%-45%, (b) QRS duration less than 130 ms, (c) New York Heart Association (NYHA) class 3-4 and (d) treated for heart failure for at least 90 days and on stable medications. Exclusion criteria included: (a) significant valvular disease, (b) permanent or persistent atrial fibrillation, (c) biventricular pacing system implanted or QRS duration more than 130 ms and (4) patients not suitable for device therapy as a result of palliative treatment intent.RESULTS:A total of 475 patients were admitted with heart failure during the study period. From this group, 24 (5.1%) patients fulfilled the criteria for CCM therapy. The mean age and ejection fraction were 70.8 ± 10.2 and 32.5% ± 7.4%. The majority of patients were men (71%) and had an ischaemic cardiomyopathy (75%). If patients with atrial fibrillation were included, an additional 18 (3.8%) patients potentially may be eligible for CCM.CONCLUSION:Only 5.1% of all patients presenting with heart failure might benefit from cardiac CCM. This is a small proportion of the overall heart failure population. However, this population has no other current option for device therapy of their condition.
Introduction Implanting of cardiac implantable electrical devices (CIEDs) has become routine practice in the majority of acute hospitals. The numbers of patients receiving CIEDs are increasing rapidly due to a growing elderly population and adherence to NICE guidance. CIEDs have been subject to safety advisories potentially resulting in intensive patient follow up. Recent experience indicates that the number of advisories we deal with is increasing. We sought to quantify the additional burden this has placed on the cardiac device clinic and patients. Methods A retrospective review was undertaken on all advisories & recalls issued by device company field safety notices and the MHRA website from 2008 to 2018. We assessed 24 hardware and 13 software advisories Then the number of patients affected by each at Eastbourne District General Hospital (EDGH) were recorded (n=1720), and the impact on the device clinic (additional hours) was calculated. Results 5188 patients in total were seen in our device clinic over 10 years. 1720 patients were found to be subject to an advisory. Of these patients, 1234 were software advisories and 486 mechanical advisories. This resulted in 1237 patients requiring device follow up to be intensified. One hour of additional support was calculated per patient advisory. This was made up of 20 minutes for the initial interrogation and 40 minutes for extra administration and subsequent follow up if required. An average of 1720 hours was spent on patient advisories over a 10-year period resulting in one extra clinic session per week.Abstract 27 Figure 1 This chart illustrates the breakdown of mechanical issues versus software issues for each of the major manufacturers. The left side of the donut graph shows the percentage of mechanical problems which include lead, device battery and circuitry.The predominant issue in more recent years are as a result of software. Half of software updates related to pacemakers including CRTP.Battery issues accounted for the largest proportion of mechanical malfunctions, 60% due to ICD battery technology. Conclusion We calculated that 33% of all patients seen in clinic in the last 10 years have been subject to an advisory. On average over the ten year period this has required an additional 1720 hours per patient advisory resulting in an extra whole physiology clinic session per week. This represents a significant challenge to the Pacing workforce. Our data shows that there are more software related advisories than hardware advisories. Software solutions resolve the issue but are often delayed. Device advisories have now become a major complication in pacemaker implantation with a significantly higher frequency than procedural complications. One could consider adding this finding to the discussion with the patient prior to device implant. Conflict of Interest None at time of writing