Safety and efficacy of e-cigarettes in those with atherosclerotic disease: a review.

Smoking cessation is the most effective intervention to reduce mortality in patients with established atherosclerotic cardiovascular disease (ASCVD), with 'e-cigarettes' becoming an increasingly used intervention to achieve smoking cessation. The current review aims to summarise the current evidence base for their efficacy and safety in the ASCVD cohort. A search of the PUBMED and MEDLINE databases using the terms 'e-cigarette', 'cessation', 'safety' and 'efficacy' since 2012 yielded 706 results. Both observational and experimental studies were included, while those with an unavailable full text, non-English or duplicates were excluded, yielding 78 relevant articles, with 13 subsequent additional articles included from a search of reference lists, for a total of 91 included papers. E-cigarette vapour contains many known pro-atherosclerotic substances and has been demonstrated to potentiate traditional atherosclerotic mechanisms. While e-cigarettes may be more effective in promoting smoking cessation in the general population over a medium term (>6 months), when compared with nicotine replacement therapy (NRT), few studies specifically examined those with ASCVD, despite the latter having a higher baseline quit rate (52% vs 2%). Most studies compare e-cigarettes with NRT alone and do not include pharmacotherapy, which may be more effective in the ASCVD cohort. The single randomised controlled trial addressing the research question favoured traditional methods. Those that successfully quit smoking using e-cigarettes are more likely to continue to use the intervention at 1 year (90% vs 9%). Conflicting advice exists regarding the utilisation of e-cigarettes for smoking cessation. E-cigarettes may be inferior to standard care for smoking cessation in those with ASCVD, and their use is likely to promote the key drivers of the atherosclerotic process already active in this cohort.

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.

OBJECTIVES: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes. BACKGROUND: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population. METHODS: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up. RESULTS: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis. CONCLUSIONS: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System.

OBJECTIVES: The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system. BACKGROUND: Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair. METHODS: Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria. RESULTS: Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%). CONCLUSIONS: This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.

Single-center prospective study examining use of the Wattson temporary pacing guidewire for transcatheter aortic valve replacement.

OBJECTIVES: To assess the safety and efficacy of the Wattson temporary pacing guidewire. BACKGROUND: Transcatheter aortic valve replacement (TAVR) requires a guidewire for device delivery and generally requires temporary pacing wire for burst and back-up pacing. The Wattson wire provides concomitant support and bipolar pacing without the need to place a temporary venous pacemaker (TVP). METHODS: This was a single-center nonrandomized prospective clinical trial enrolling 20 patients. The primary endpoint was defined as successful rapid pacing and transcatheter heart valve (THV) delivery with no loss of capture. Safety, qualitative and quantitative secondary outcomes were also analyzed. RESULTS: Mean age was 77.4 ± 9.0 years. Mean Society of Thoracic Surgery (STS) score was 3.0 ± 1.5%. All patients received a balloon-expandable valve via a transfemoral approach. All patients met the primary end-point. One patient (5%) had balloon predilatation and six patients (30%) had postdilatation, all using the wire. Mean pacing threshold was 2.2 ± 1.2 mA that was evaluated prior to placing an insulating catheter over the wire. One patient required TVP placement and subsequent permanent pacemaker implantation due to complete heart block post THV deployment. There were no incidences of cardiac perforation or tamponade. One patient required valve reintervention, which was not related to the device. CONCLUSIONS: The Wattson wire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe THV delivery in this patient cohort. It has the potential to make TAVR a safer and more efficient procedure.

Percutaneous Transcatheter Mitral Valve Replacement: First-in-Human Experience With a New Transseptal System.

BACKGROUND: Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option. OBJECTIVES: The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system. METHODS: This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days. RESULTS: Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died. CONCLUSIONS: Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted.

A Review of the Anatomical and Histological Attributes of the Left Atrial Appendage with Descriptive Pathological Examination of Morphology and Histology.

The left atrial appendage (LAA) has a key role in the embolic complications of atrial fibrillation (AF). It has been studied extensively, from recent interest in the thrombotic implications of various LAA morphologies to LAA occlusion and ablation. We collected eleven post-mortem LAA samples for visual analysis, two were not included due to poor sample quality. On examination of the nine remaining samples, several common patterns of pectinate muscle orientation were noted. The LAA samples were noted to have a smooth circumferential neck of muscular tissue giving rise to a dominant singular smooth trunk of papillary muscle in 6 cases and two trunks in 3 cases. These trunks were either shallow (5 samples) or more muscular and raised (4 samples). Shallow trunks tended to be wider than the raised trunks and may even be circumferential (2 samples). The main trunk arborized to give off papillary muscle branches down to third or fourth order branches. The samples were visually assessed for the percentage of smooth papillary muscle versus non-papillary recesses and were found to have ≤50% smooth muscle in 3 samples, 50-75% in 3 samples and >75% in 3 samples. We performed histological analysis of further LAA samples collected during cardiac surgery in a parallel study. We identified a distinct pattern of myocyte orientation from the neck, mid-section and apical section of the LAA demonstrating arborization of myocyte fibers with minimal communication in distal segments of the LAA. We feel that this information may help understanding of the issues surrounding LAA ablation strategies.

Accuracy in precordial ECG lead placement: Improving performance through a peer-led educational intervention.

BACKGROUND AND OBJECTIVES: Inaccurate electrocardiography (ECG) lead placement may lead to erroneous diagnoses, such as poor R wave progression. We sought to assess the accuracy of precordial ECG lead placement amongst hospital staff members, and to re-evaluate performance after an educational intervention. METHODS AND RESULTS: 100 randomly selected eligible staff members placed sticker dots on a mannequin, their positions were recorded on a radar plot and compared to the correct precordial lead positions. The commonest errors were placing V1 and V2 leads too superiorly, and V5 and V6 leads too medially.Following an educational intervention with the aid of moderated poster presentations and volunteer patients, the study was repeated six months later. 60 subjects correctly placed all leads, compared to 10 in the pre-intervention cohort (P<0.0001) with the proportion achieving correct placement of any lead rising from 0.34 to 0.83, (p<0.0001 for all leads). CONCLUSION: Incorrect ECG lead placement is common. This may be addressed through regular training incorporated into annual induction processes for relevant health care professionals.

Clinical outcome when left atrial posterior wall box isolation is included as a catheter ablation strategy in patients with persistent atrial fibrillation.

PURPOSE: Isolation of the pulmonary veins alone (PVI) is associated with a 50 to 70 % success rate in paroxysmal atrial fibrillation (AF) but is significantly lower for persistent AF. We sought to evaluate patient outcomes in terms of safety and efficacy when posterior left atrial box isolation is included as a catheter ablation strategy in patients with mainly persistent AF. METHODS: We performed an audit of 100 patients undergoing left atrial (LA) box isolation. Recurrence of arrhythmia was detected by evaluating symptoms and continuous 24 h ECG monitoring at 2, 6 and 12 months post procedure. RESULTS: Seventy-two patients had persistent AF prior to procedure. Average duration of AF was 5.4 ± 5.2 years. All patients underwent circumferential PVI plus linear posterior LA lines to complete box isolation. At a mean follow-up of 12.5 ± 4.2 months, 75 patients were free from atrial fibrillation, 50.6 % of these were taking no antiarrhythmic medication. Twenty-five patients had recurrence of AF, 84 % of whom had previous persistent AF. The average time to recurrence post procedure was 5.9 ± 4.4 months. Thirteen patients underwent repeat procedures for recurrent AF. There were no adverse events relating to the procedure. CONCLUSION: These results suggest that the strategy of left atrial box isolation is safe and effective, worthy of further evaluation in a multicentre registry.