Natural language processing chatbots (NLPC) can be used to gather information for medical content. However, these tools contain a potential risk of misinformation. This study aims to evaluate ...different aspects of responses given by different NLPCs on questions about atrial fibrillation (AF) and clinical implantable electronic devices (CIED).
Questions were entered into three different NLPC interfaces. Responses were evaluated with regard to appropriateness, comprehensibility, appearance of confabulation, absence of relevant content, and recommendations given for clinically relevant decisions. Moreover, readability was assessed by calculating word count and Flesch Reading Ease score. 52, 60, and 84% of responses on AF and 16, 72, and 88% on CIEDs were evaluated to be appropriate for all responses given by Google Bard, (GB) Bing Chat (BC) and ChatGPT Plus (CGP), respectively. Assessment of comprehensibility showed that 96, 88, and 92% of responses on AF and 92 and 88%, and 100% on CIEDs were comprehensible for all responses created by GB, BC, and CGP, respectively. Readability varied between different NLPCs. Relevant aspects were missing in 52% (GB), 60% (BC), and 24% (CGP) for AF, and in 92% (GB), 88% (BC), and 52% (CGP) for CIEDs.
Responses generated by an NLPC are mostly easy to understand with varying readability between the different NLPCs. The appropriateness of responses is limited and varies between different NLPCs. Important aspects are often missed to be mentioned. Thus, chatbots should be used with caution to gather medical information about cardiac arrhythmias and devices.
Aims
Catheter ablation of ventricular arrhythmias (VA) has proven to be an effective therapeutic option for secondary arrhythmia prophylaxis. We sought to assess the procedural efficacy, safety and ...in-hospital mortality of a large patient cohort with and without structural heart disease undergoing VA ablation.
Methods
A total of 1417 patients (804 patients with structural heart disease) undergoing 1792 endo- and epicardial procedures were analyzed. Multivariable risk factor analysis for occurrence of major complications and intrahospital mortality was obtained and a score to allow preprocedural risk assessment for patients undergoing VA ablation procedures was established.
Results
Major complication occurred in 4.4% of all procedures and significantly more often in patients with structural heart disease than in structurally normal hearts (6.0 vs. 1.8%). The frequency of these periprocedural complications was significantly different between procedures with sole right ventricular and a combination of RV and LV access (0.5 vs. 3.1%). The most common complication was cardiac tamponade in 46 cases (3.0%). Intrahospital death was observed in 32 patients (1.8%). Logistic regression model revealed presence of ischemic heart disease, epicardial ablation, presence of oral anticoagulation or dual antiplatelet therapy as independent risk factors for the occurrence of complications or intrahospital death, while a history of previous heart surgery was an independent predictor with a decreased risk. Based on this analysis a risk score incorporating 5 standard variables was established to predict the occurrence of complications and intrahospital mortality.
Conclusions
Safety of VA catheter ablation mainly relies on patient baseline characteristics and the type of access into the ventricles or epicardial space.
Introduction
Pericardial access for ablation of ventricular arrhythmias (VA) can be gained either by an anterior-oriented or inferior-oriented epicardial puncture under fluoroscopical guidance. We ...retrospectively sought to assess the safety of these two puncture techniques and the incidence of epicardial adhesions and introduce our algorithm for management of pericardial tamponade.
Methods and results
In 211 patients (61.4 ± 15.6 years, 179 males; 84.8%) 271 epicardial ablation procedures of VA were performed using either an anterior- or inferior-oriented approach for epicardial access. Puncture-related complications were systematically analyzed. Furthermore, the incidence of adhesions was evaluated during first and repeated procedures.
A total of 34/271 (12.5%) major complications occurred and 23/271 (8.5%) were directly related to epicardial puncture. The incidence of puncture-related major complications in the anterior and inferior group was 4/82 (4.9%) and 19/189 (10.1%), respectively. Pericardial tamponade was the most common major complication (15/271; 5.5%). Collateral damages of adjacent structures such as liver, colon, gastric vessels and coronary arteries occurred in 6/189 (3.2%) patients and only within the inferior epicardial access group. Adhesions were documented in 19/211 (9%) patients during the first procedure and in 47.1% if patients had 2 or more procedures involving epicardial access.
Conclusion
Anterior-oriented epicardial puncture shows an observed association to a reduced incidence of pericardial tamponades and overall puncture-related complications in epicardial ablation of VA. In cases of repeated epicardial access adhesions increase significantly and may lead to ablation failure.
Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure ...(LAP) monitoring system in patients with HF.
The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.
To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076).
The V-LAP left atrium monitoring system appears to be safe and accurate.
Aims Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self‐management (PSM) of haemodynamics in HF has the potential to ...personalize treatment, increase adherence, and reduce the risk of worsening HF, while lowering clinicians' burden. Methods and results The VECTOR‐HF I and IIa studies are prospective, single‐arm, open‐label clinical trials assessing safety, usability and performance of left atrial pressure (LAP)‐guided HF management using PSM in New York Heart Association class II and III HF patients. Physician‐prescribed LAP thresholds trigger patient self‐adjustment of diuretics. Primary endpoints include the ability to perform LAP measurements and transmit data to the healthcare provider (HCP) interface and the patient guidance application, and safety outcomes. This is an interim analysis of 13 patients using the PSM approach. Over 12 months, no procedure‐ or device‐related major adverse cardiovascular or neurological events were observed, and there were no failures to obtain measurements from the sensor and transmit the data to the HCP interface and the patient guidance application. Patient adherence was 91.4%. Using PSM, annualized HF hospitalization rate significantly decreased compared to a similar period prior to PSM utilization (0 admissions vs. 0.69 admissions over 11.84 months, p = 0.004). At 6 months, 6‐min walk test distance and the Kansas City Cardiomyopathy Questionnaire overall summary score demonstrated significant improvement. Conclusions Interim findings suggest that PSM using a LAP monitoring system is feasible and safe. PSM is associated with high patient adherence, potentially improving HF patients' functional status, quality of life, and limiting HF hospitalizations.
Aims
In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left‐sided ...haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients.
Methods and results
The VECTOR‐HF study (NCT03775161) was a first‐in‐human, prospective, multicentre, single‐arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short‐term MACNE was 97%. Agreement between sensor‐calculated LAP and PCWP was consistent, with a mean difference of −0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582–0.886), respectively. Preliminary experience with V‐LAP‐based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6‐min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05).
Conclusion
The V‐LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms.
VECTOR‐HF trial highlights. 6MWT, 6‐min walk test; FUP, follow‐up; HF, heart failure; LAP, left atrial pressure; LVEF, left ventricular ejection fraction; M, months; MACNE, major adverse cardiac and neurological event; (NT‐pro‐)BNP, (N‐terminal pro‐)B‐type natriuretic peptide; NYHA, New York Heart Association; PCWP, pulmonary capillary wedge pressure; RHC, right heart catheterization.
Atrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator ...(CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome.
The German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR).
A total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 interquartile range (IQR), 66-77
66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2%
61.0%; P<0.001), peripheral artery disease (4.5%
2.7%; P=0.002), diabetes (33.6%
25.5%; P<0.001), hypertension (58.4%
51.1%; P<0.001) and renal failure (22.6%
15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25%
15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2%
7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation.
Our clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.