Pulmonary vein isolation by visually guided laser balloon ablation: single-center 5-year follow-up results.

BACKGROUND: Visually guided laser balloon (VGLB) ablation is a balloon-based treatment for atrial fibrillation (AF) that uses a titratable laser energy source to perform pulmonary vein isolation (PVI), allowing for real-time visualization of target tissue and ablation lesions through an endoscopic camera. Few long-term data on this technique are currently available. This report presents acute efficacy, procedural data, complication rates, and long-term AF-free survival up to 5 years post-ablation. METHODS: In this single-center, retrospective, observational report, 152 patients (72.4% male, mean age 60.6 ± 9.7 years, 62.5% paroxysmal AF, 598 pulmonary veins in total) treated with the first-generation VGLB system between 2014 and 2016 were included for analysis. AF ablation consisted of PVI only. RESULTS: Acute PVI was achieved in 98.2% of veins, with first-pass isolation in 92.5%. Procedure duration of 129 min [IQR 113-150], fluoroscopy time of 15 min [IQR 11-20], and dose area product of 5016 mGy·cm2 [IQR 3603-8711] were recorded. During a median follow-up of 51 months [IQR 45-57], 74.3% of patients remained free of AF (78.8% for paroxysmal and 65.3% for persistent AF, p = 0.108). Freedom of AF at 1, 2, 3, and 4 years follow-up was 88.2%, 82.2%, 78.9%, and 74.8%, respectively. PV reconnections were identified in only 46.9% of redo procedures. The median number of PV reconnections during redo procedures was 0 [IQR 0-2]. Anti-arrhythmic drug use was significantly reduced after ablation (p < 0.001). The most commonly reported complications were minor vascular complications (4.6%) and transient phrenic nerve paralysis (3.3%). CONCLUSIONS: First-generation VGLB ablation demonstrated high acute isolation rates, reasonable procedure times and low complication rates. Long-term freedom from AF was 78.8% for paroxysmal AF and 65.3% for persistent AF, performing PVI only.

Damage to the left descending coronary artery due to radiofrequency ablation in the right ventricular outflow tract: Clinical case series and anatomical considerations.

The purpose of this paper was to highlight the importance of the anatomy of the right ventricular outflow tract (RVOT) and the proximity of the mid segment of the left anterior descending coronary artery (LAD) to the RVOT in the setting of ablation of ventricular arrhythmias in the RVOT. During the period from 2014 till 2017, five patients with injury to the LAD during ablation within RVOT were identified in three centers, in Belgium, Germany and Israel. The clinical characteristics, procedural data and follow up data, where available, are reported. The literature review over coronary artery damage during radiofrequency ablation procedures is provided and the anatomy of the RVOT and the neighboring vascular structures is discussed. We present five patients who underwent radiofrequency ablation of ventricular arrhythmias mapped to the inferior and anterior part of the RVOT, at the insertion of the right ventricular wall to the septum, whereby ablation resulted in occlusion in four and severe stenosis in one, of the mid segment of the LAD coronary artery. All patients underwent percutaneous coronary intervention and stenting, four of them immediately during the same procedure and one 3 days later because of lack of signs and symptoms of acute coronary occlusion. In conclusion, the mid segment of the LAD at the level of the second septal perforator/second diagonal branch runs in very close proximity to the endocardial aspect of the lower part of the RVOT and care should be taken during ablation of ventricular arrhythmias in this region. Additional imaging such as intracardiac echocardiography and coronary angiography may be helpful in avoiding complications.

Comparison of de novo versus upgrade cardiac resynchronisation therapy on clinical effect and long-term outcome.

BACKGROUND: The benefit of de novo cardiac resynchronisation therapy (CRT) implantation in selected patients with heart failure is well known. The number of upgrade procedures is increasing but data on clinical response and outcome are less well documented as compared to de novo implantation. OBJECTIVES: To investigate the efficacy and outcome of CRT upgrade procedures in patients with existing cardiac implantable electronic devices (CIEDs). METHODS: Baseline characteristics, change in New York Heart Association (NYHA) functional class, echocardiographic parameters, life-threatening ventricular tachyarrhythmias, all-cause mortality and mode of death were evaluated in CRT patients with the comparison between de novo and upgrade CRT procedures. RESULTS: About 410 patients (CRT upgrade/de novo CRT, n = 97/313) were followed for 63.5 ± 38.1 months. Upgrade patients were older (75.5 ± 8.1 vs 69.9 ± 10.7 years; p < 0.001), had more often an ischaemic cause of heart failure (58.8% vs 45.4%; p = 0.021), a higher NYHA functional class (p = 0.004) and a higher comorbidity burden. Improvement in left ventricular ejection fraction (LVEF) was higher in the de novo CRT group (8.4 ± 9.9 vs 11.0 ± 10.3%; p = 0.035). Clinical response was similar between both groups (60.5 vs 62.5%; p = 0.793), as was mortality at 1 year (8.2 vs 5.8%; p = 0.351) and at last follow-up (33.0 vs 28.8%; p = 0.447). The proportion of cardiovascular related deaths was similar between both groups (46.9% vs 38.9%; p = 0.531). CONCLUSIONS: Patients with CRT upgrade procedures have similar symptomatic improvements, as well as 1 year and long-term outcome as compared to patients with de novo CRT implantation.

Effect of reinforced, targeted in-person education using the Jessa Atrial fibrillation Knowledge Questionnaire in patients with atrial fibrillation: A randomized controlled trial.

BACKGROUND: The knowledge level of atrial fibrillation patients about their arrhythmia, its consequences and treatment is poor. The best strategy to provide education is unknown. AIM: To investigate the effect of reinforced targeted in-person education using the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ). METHODS: Sixty-seven atrial fibrillation patients were randomized to standard care (including brochures) or targeted education. Follow-up visits were scheduled after one, three, six and 12 months. Targeted education during each visit focused on the knowledge gaps revealed by the JAKQ. Patients completed two questionnaires to assess their quality of life and symptom profile. Adherence to non-vitamin K antagonist oral anticoagulants was measured using electronic monitoring. RESULTS: Sixty-two patients (31 education; 31 standard care) completed follow-up. Median baseline score on the JAKQ was similar in education (62.5%) and standard care group (56.3%; p=0.815). The intervention group scored significantly better over time (one month: 75.0%, 12 months: 87.5%; p<0.001) whereas there was no significant improvement in the control group (one month: 62.5%, 12 months: 62.5%; p=0.085). Providing targeted education after completion of the JAKQ required on average 6.9±4.6 min. Some improvements in quality of life, symptom burden and adherence were shown, without significant differences between the two groups ( p-values between 0.282 and 0.677). CONCLUSION: The JAKQ is an effective tool for providing individualized education. A first targeted educational session significantly improved patients' knowledge level. Additional educational sessions maintained and strengthened this effect. A larger scale study is warranted to evaluate the impact on adherence and outcome measures.

Corrigendum and Editorial Warning Regarding Use of the MMAS-8 Scale (The Health Buddies App as a Novel Tool to Improve Adherence and Knowledge in Atrial Fibrillation Patients: A Pilot Study).

[This corrects the article DOI: 10.2196/mhealth.7420.].

Effectiveness and usability of an online tailored education platform for atrial fibrillation patients undergoing a direct current cardioversion or pulmonary vein isolation.

BACKGROUND: Atrial fibrillation (AF) care should strive for more informed, involved and empowered patients. However, few effective educational programs are available. The aim of this study was to evaluate the effectiveness of an online tailored education platform to inform AF patients undergoing a direct current cardioversion (DCC) or a pulmonary vein isolation (PVI). METHODS: 120 AF patients requiring DCC or PVI were allocated to an online education group (n = 35), a standard care group despite having online access (n = 36; randomized with group 1), and a group without a computer/tablet/smartphone receiving standard care (n = 49). The Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ), supplemented with procedure-specific questions, had to be completed 1-3 weeks before hospitalization, at hospitalization, and 6 and/or 12 weeks post-procedurally. RESULTS: Major AF-related and procedure-related knowledge gaps were shown. The online tailored education group scored significantly better at hospitalization compared to baseline (P = 0.001). This knowledge increase was retained after 6 (P = 0.010) and 12 (P < 0.001) weeks. In the online standard care group there was no change in knowledge from planning till hospitalization (P = 1.000), although knowledge was improved 6 weeks post-procedurally (P = 0.010). Knowledge did not improve in the group without computer/tablet/smartphone at any time (P = 0.248). Most patients indicated that the platform was easy to use (87.9%), understandable (97.0%), and 72.7% indicated that an online platform was their preferred way to receive future AF-related information. CONCLUSIONS: Tailored online education is an effective strategy to improve AF- and procedure-related knowledge with lasting effects up to 12 weeks post-procedurally. The platform was positively evaluated by patients.

Telemonitoring-based feedback improves adherence to non-vitamin K antagonist oral anticoagulants intake in patients with atrial fibrillation.

Aims: To evaluate the effect of telemonitoring on adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients. Methods and results: A randomized, single-blind, crossover, controlled trial in 48 AF patients on once or twice daily (OD or BID) NOAC. The Medication Event Monitoring System tracked NOAC intake during three phases of 3 months each: daily telemonitoring, telemonitoring with immediate telephone feedback in case of intake errors, and an observation phase without daily transmissions. Unprotected days were defined as ≥ 3 or ≥ 1 consecutively missed doses for a BID or OD NOAC, respectively, or excess dose intake. Cost-effectiveness was calculated based on anticipated stroke reduction derived from patients' risk profile and measured intake. Persistence over the entire study was 98%. Telemonitoring-only already led to very high taking and regimen adherence (97.4% respectively 93.8%). Nevertheless, direct feedback further improved both to 99.0% and 96.8%, respectively (P < 0.001 respectively P = 0.002). Observation without daily monitoring resulted in a significant waning of taking adherence (94.3%; P = 0.049). Taking adherence was significantly higher for OD compared to BID NOAC, although unprotected days were similar. Feedback intervention had an incremental cost of €344 289 to prevent one stroke, but this could be as low as €15 488 in high-risk patients with low adherence and optimized technology. Conclusion: Telemonitoring resulted in high NOAC adherence due to the notion of being watched, as evidenced by the rapid decline during the observation period. Feedback further optimized adherence. Telemonitoring with or without feedback may be a cost-effective approach in high-risk patients deemed poorly adherent.

The Health Buddies App as a Novel Tool to Improve Adherence and Knowledge in Atrial Fibrillation Patients: A Pilot Study.

BACKGROUND: Atrial fibrillation (AF) constitutes an important risk for stroke, especially in an ageing population. A new app (Health Buddies) was developed as a tool to improve adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in an elderly AF population by providing a virtual contract with their grandchildren, spelling out daily challenges for both. OBJECTIVE: The aim of this pilot study was to assess the feasibility and usability of the Health Buddies app in AF patients. METHODS: Two workshops were conducted to steer app development and to test a first prototype. The feasibility of the finalized app was investigated by assessing the number of eligible AF patients (based on current prescription of NOACs, the presence of grandchildren between 5 and 15 years old, availability of a mobile phone, computer, or tablet), and the proportion of those who were willing to participate. Participants had to use the app for 3 months. The motivation of the patients to use the app was assessed based on the number of logins to the app. Their perception of its usefulness was examined by specific questionnaires. Additionally, the effects on knowledge level about AF and its treatment, and adherence to NOAC intake were investigated. RESULTS: Out of 830 screened AF patients, 410 were taking NOACs and 114 were eligible for inclusion. However, only 3.7% (15/410) of the total NOAC population or 13.2% of the eligible patients (15/114) were willing to participate. The main reasons for not participating were no interest to participate in general or in the concept in particular (29/99, 29%), not feeling comfortable using technology (22/99, 22%), no interest by the grandchildren or their parents (20/99, 20%), or too busy a lifestyle (12/99, 12%). App use significantly decreased towards the end of the study period in both patients (P=.009) and grandchildren (P<.001). NOAC adherence showed a taking adherence and regimen adherence of 88.6% (SD 15.4) and 81.8% (SD 18.7), respectively. Knowledge level increased from 64.6% (SD 14.7) to 70.4% (SD 10.4) after 3 months (P=.09). The app scored positively on clarity, novelty, stimulation, and attractiveness as measured with the user experience questionnaire. Patients evaluated the educational aspect of this app as a capital gain. CONCLUSIONS: Only a small proportion of the current AF population seems eligible for the innovative Health Buddies app in its current form. Although the app was positively rated by its users, a large subset of patients was not willing to participate in this study or to use the app. Efforts have to be made to expand the target group in the future.

Performance of handheld electrocardiogram devices to detect atrial fibrillation in a cardiology and geriatric ward setting.

AIMS: To determine the usability, accuracy, and cost-effectiveness of two handheld single-lead electrocardiogram (ECG) devices for atrial fibrillation (AF) screening in a hospital population with an increased risk for AF. METHODS AND RESULTS: Hospitalized patients (n = 445) at cardiological or geriatric wards were screened for AF by two handheld ECG devices (MyDiagnostick and AliveCor). The performance of the automated algorithm of each device was evaluated against a full 12-lead or 6-lead ECG recording. All ECGs and monitor tracings were also independently reviewed in a blinded fashion by two electrophysiologists. Time investments by nurses and physicians were tracked and used to estimate cost-effectiveness of different screening strategies. Handheld recordings were not possible in 7 and 21.4% of cardiology and geriatric patients, respectively, because they were not able to hold the devices properly. Even after the exclusion of patients with an implanted device, sensitivity and specificity of the automated algorithms were suboptimal (Cardiology: 81.8 and 94.2%, respectively, for MyDiagnostick; 54.5 and 97.5%, respectively, for AliveCor; Geriatrics: 89.5 and 95.7%, respectively, for MyDiagnostick; 78.9 and 97.9%, respectively, for AliveCor). A scenario based on automated AliveCor evaluation in patients without AF history and without an implanted device proved to be the most cost-effective method, with a provider cost to identify one new AF patient of €193 and €82 at cardiology and geriatrics, respectively. The cost to detect one preventable stroke per year would be €7535 and €1916, respectively (based on average CHA2DS2-VASc of 3.9 ± 2.0 and 5.0 ± 1.5, respectively). Manual interpretation increases sensitivity, but decreases specificity, doubling the cost per detected patient, but remains cheaper than sole 12-lead ECG screening. CONCLUSION: Using AliveCor or MyDiagnostick handheld recorders requires a structured screening strategy to be effective and cost-effective in a hospital setting. It must exclude patients with implanted devices and known AF, and requires targeted additional 12-lead ECGs to optimize specificity. Under these circumstances, the expenses per diagnosed new AF patient and preventable stroke are reasonable.

Knowledge gaps in patients with atrial fibrillation revealed by a new validated knowledge questionnaire.

OBJECTIVE: The aim of this study was to develop and validate a new questionnaire, the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ), to test the knowledge of patients with atrial fibrillation (AF) about the arrhythmia, its treatment and their ability for self-management. METHODS: The JAKQ was developed based on other questionnaires, two educational checklists and patient information support websites. The JAKQ was validated based on content validity, face validity, response process, discriminatory potential and sensitivity of the questionnaire, construct validity and reliability. It was presented to both outpatients and hospitalised patients. RESULTS: A total of 466 AF patients completed the JAKQ. The final 16-item JAKQ consists of 8 questions about AF in general, 5 questions about oral anticoagulation (OAC) therapy and either 3 questions about vitamin K antagonists (VKA) or non-vitamin K antagonist oral anticoagulants (NOAC). The questionnaire is completed in 6.5±2.4min. The mean score on the JAKQ is 55.8±18.6% with a wide discriminatory span of scores. The JAKQ reveals important knowledge gaps, like 28.8% of the patients not being aware of their medical condition named 'atrial fibrillation', 33.7% being unaware that AF can cause thromboembolism and stroke, and 78.6% of the patients taking VKA and 57.0% of the patients on NOACs not knowing what to do when missing an OAC dose. CONCLUSIONS: The JAKQ is a brief, complete and valid AF-specific knowledge questionnaire that can be used in daily practice to assess patients' insight into their condition. It could be used as a tool for individually tailored patient education.

Recurrent pulmonary edema in a patient with a prosthetic mitral valve.

Prosthetic heart valve obstruction is a severe and potentially fatal complication. We present a patient with a Bjork-Shiley prosthetic mitral and aortic valve implantation and recurrent pulmonary edema. Echocardiogram showed a rate-dependent "obstruction alternans" of the prosthetic mitral valve due to pannus formation.