Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

AIMS: While numerous studies have demonstrated favourable safety and efficacy of the excimer laser sheath for transvenous lead extraction (TLE) in smaller cohorts, comprehensive large-scale investigations with contemporary data remain scarce. This study aims to evaluate the safety and performance of laser-assisted TLE through a meta-analysis of contemporary data. METHODS AND RESULTS: A systematic literature search was conducted to identify articles that assessed the safety and performance of the spectranetics laser sheath (SLS) II and GlideLight Excimer laser sheaths in TLE procedures between 1 April 2016 and 31 March 2021. Safety outcomes included procedure-related death and major/minor complications. Performance outcomes included procedural and clinical success rates. A random-effects, inverse-variance-weighting meta-analysis was performed to obtain the weighted average of the evaluated outcomes. In total, 17 articles were identified and evaluated, including 1729 patients with 2887 leads. Each patient, on average, had 2.3 ± 0.3 leads with a dwell time of 7.9 ± 3.0 years. The TLE procedural successes rate was 96.8% [1440/1505; 95% CI: (94.9-98.2%)] per patient and 96.3% [1447/1501; 95% CI: (94.8-97.4%)] per lead, and the clinical success rate per patient was 98.3% [989/1010, 95% CI: (97.4-99.0%)]. The procedure-related death rate was 0.08% [7/1729, 95% CI: (0.00%, 0.34%)], with major and minor complication rates of 1.9% [41/1729; 95% CI: (1.2-2.8%)] and 1.9% [58/1729; 95% CI: (0.8-3.6%)], respectively. CONCLUSION: This meta-analysis demonstrated that excimer laser sheath-assisted TLE has high success and low procedural mortality rates. It provides clinicians with a reliable and valuable resource for extracting indwelling cardiac leads which require advanced extraction techniques.

European experience with a first totally leadless cardiac resynchronization therapy pacemaker system.

AIMS: Totally leadless cardiac resynchronization therapy (CRT) can be delivered with a combination of Micra and WiSE-CRT systems. We describe the technical feasibility and first insights into the safety and efficacy of this combination in European experience. METHODS AND RESULTS: Patients enrolled had indication for both Micra and WiSE-CRT systems because of heart failure related to high burden of pacing by a Micra necessitating system upgrade or inability to implant a conventional CRT system because of infectious or anatomical conditions. The endpoints of the study were technical success of WiSE-CRT implantation with right ventricle-synchonized CRT delivery, acute QRS duration reduction, and freedom from procedure-related major adverse events. All eight WiSE-CRT devices were able to detect the Micra pacing output and to be trained to deliver synchronous LV endocardial pacing. Acute QRS reduction following WiSE-CRT implantation was observed in all eight patients (mean QRS 204.38 ± 30.26 vs. 137.5 ± 24.75 mS, P = 0.012). Seven patients reached 6 months of follow-up. At 6 months after WiSE-CRT implantation, there was a significant increase in LV ejection fraction (28.43 ± 8.01% vs. 39.71 ± 11.89%; P = 0.018) but no evidence of LV reverse remodelling or improvement in New York Heart Association class. CONCLUSION: The Micra and the WiSE-CRT systems can successfully operate together to deliver total leadless CRT to a patient. Moreover, the WiSE-CRT system provides the only means to upgrade the large population of Micra patients to CRT capability without replacing the Micra. The range of application of this combination could broaden in the future with the upcoming developments of leadless cardiac pacing.

Ventricular tachycardia secondary to leadless pacemaker implantation in the setting of myocardial ischaemia.

Leadless pacemakers are increasingly part of the electrophysiology practice and offer an interesting pacing alternative for patients who have a history of CIED infection. We present the case of a patient who developed life-threatening ventricular arrythmias after a leadless pacemaker implant, in the context of previously unrecognised coronary artery disease.

The Emerging Role of Cardiac Magnetic Resonance Imaging in the Evaluation of Patients with HFpEF.

PURPOSE OF REVIEW: To give an update on the emerging role of cardiac magnetic resonance imaging in the evaluation of patients with heart failure with preserved ejection fraction (HFpEF). This is important as the diagnosis of HFpEF remains challenging and cardiac imaging is pivotal in establishing the function of the heart and whether there is evidence of structural heart disease or diastolic dysfunction. Echocardiography is widely available, although the gold standard in quantifying heart function is cardiac magnetic resonance (CMR) imaging. RECENT FINDINGS: This review includes the recently updated 2016 European Society of Cardiology guidelines on diagnosing HFpEF that define the central role of imaging in identifying patients with HFpEF. Moreover, it includes the pathophysiology in HFpEF, how CMR works, and details current CMR techniques used to assess structural heart disease and diastolic function. Furthermore, it highlights promising research techniques that over the next few years may become more used in identifying these patients. CMR has an emerging role in establishing the diagnosis of HFpEF by measuring the left ventricular ejection fraction (LVEF) and evidence of structural heart disease and diastolic dysfunction.

Biophysical Modeling to Determine the Optimization of Left Ventricular Pacing Site and AV/VV Delays in the Acute and Chronic Phase of Cardiac Resynchronization Therapy.

BACKGROUND: Cardiac anatomy and function adapt in response to chronic cardiac resynchronization therapy (CRT). The effects of these changes on the optimal left ventricle (LV) lead location and timing delay settings have yet to be fully explored. OBJECTIVE: To predict the effects of chronic CRT on the optimal LV lead location and device timing settings over time. METHODS: Biophysical computational cardiac models were generated for 3 patients, immediately post-implant (ACUTE) and after at least 6 months of CRT (CHRONIC). Optimal LV pacing area and device settings were predicted by pacing the ACUTE and CHRONIC models across the LV epicardium (49 sites each) with a range of 9 pacing settings and simulating the acute hemodynamic response (AHR) of the heart. RESULTS: There were statistically significant differences between the distribution of the AHR in the ACUTE and CHRONIC models (P < 0.0005 in all cases). The site delivering the maximal AHR shifted location between the ACUTE and CHRONIC models but provided a negligible improvement (<2%). The majority of the acute optimal LV pacing regions (76-100%) and device settings (76-91%) remained optimal chronically. CONCLUSION: Optimization of the LV pacing location and device settings were important at the time of implant, with a reduced benefit over time, where the majority of the acute optimal LV pacing region and device settings remained optimal with chronic CRT.

Substrate-dependent risk stratification for implantable cardioverter defibrillator therapies using cardiac magnetic resonance imaging: The importance of T1 mapping in nonischemic patients.

INTRODUCTION: The role of implantable cardioverter defibrillators (ICDs) in nonischemic cardiomyopathy is unclear and better risk-stratification is required. We sought to determine if T1 mapping predicts appropriate defibrillator therapy in patients with nonischemic cardiomyopathy. We studied a mixed cohort of ischemic and nonischemic patients to determine whether different cardiac magnetic resonance (CMR) applications (T1 mapping, late gadolinium enhancement, and Grayzone) were selectively predictive of therapies for the different arrhythmic substrates. METHODS AND RESULTS: We undertook a prospective longitudinal study of consecutive patients receiving defibrillators in a tertiary cardiac center. Participants underwent CMR myocardial tissue characterization using T1 mapping and conventional CMR scar assessment before device implantation. QRS duration and fragmentation on the surface electrocardiogram were also assessed. The primary endpoint was appropriate defibrillator therapy. One-hundred thirty patients were followed up for a median of 31 months (IQR ± 9 months). In nonischemic patients, T1_native was the sole predictor of the primary endpoint (hazard ratio [HR] 1.12 per 10 millisecond increment in value [95% confidence interval [CI] 1.04-1.21; P ≤ 0.01]). In ischemic patients, Grayzone_2SD-3SD was the strongest predictor of appropriate therapy (HR 1.34 per 1% left ventricular increment in value [95% CI 1.03-1.76; P = 0.03]). QRS fragmentation correlated well with myocardial scar core (receiver operating characteristic area under the curve [ROC AUC] 0.64; P = 0.02) but poorly with T1_native (ROC AUC 0.4) and did not predict appropriate therapy. CONCLUSIONS: In the medium-long term, T1_native mapping was the only independent predictor of therapy in nonischemic patients, whereas Grayzone was a better predictor in ischemic patients. These findings suggest a potential role for T1_native mapping in the selection of patients for ICDs in a nonischemic population.

Updates in Cardiac Resynchronization Therapy for Chronic Heart Failure: Review of Multisite Pacing.

PURPOSE OF REVIEW: Cardiac resynchronization therapy (CRT) reduces the morbidity and mortality of patients with left ventricular (LV) systolic dysfunction and intra-ventricular conduction delay. However, its clinical outcomes are heterogeneous and not all patients show a beneficial response. Multisite pacing (MSP), by stimulating the myocardium from more than one locations, is a potential therapeutic option in patients requiring CRT. This article provides a current update in the methods and outcomes of MSP, as well as in challenges in this field and opportunities for further research and development. RECENT FINDINGS: MSP can be delivered either with multiple leads or with quadripolar LV leads which can stimulate the LV from two separate sites. Initial results are promising but not always consistent across studies. Larger patient subgroups and longer follow-up duration are required for more conclusive evaluation of MSP. Routine use of MSP in clinical practice cannot be advocated at present. In selected patient subgroups, however, MSP could be considered. Newer devices and expanding knowledge are expected to facilitate the more widespread implementation of MSP and the assessment of its effects in the clinical outcomes of CRT.

Biophysical Modeling Predicts Ventricular Tachycardia Inducibility and Circuit Morphology: A Combined Clinical Validation and Computer Modeling Approach.

INTRODUCTION: Computational modeling of cardiac arrhythmogenesis and arrhythmia maintenance has made a significant contribution to the understanding of the underlying mechanisms of arrhythmia. We hypothesized that a cardiac model using personalized electro-anatomical parameters could define the underlying ventricular tachycardia (VT) substrate and predict reentrant VT circuits. We used a combined modeling and clinical approach in order to validate the concept. METHODS AND RESULTS: Non-contact electroanatomic mapping studies were performed in 7 patients (5 ischemics, 2 non-ischemics). Three ischemic cardiomyopathy patients underwent a clinical VT stimulation study. Anatomical information was obtained from cardiac magnetic resonance imaging (CMR) including high-resolution scar imaging. A simplified biophysical mono-domain action potential model personalized with the patients' anatomical and electrical information was used to perform in silico VT stimulation studies for comparison. The personalized in silico VT stimulations were able to predict VT inducibility as well as the macroscopic characteristics of the VT circuits in patients who had clinical VT stimulation studies. The patients with positive clinical VT stimulation studies had wider distribution of action potential duration restitution curve (APD-RC) slopes and APDs than the patient with a negative VT stimulation study. The exit points of reentrant VT circuits encompassed a higher percentage of the maximum APD-RC slope compared to the scar and non-scar areas, 32%, 4%, and 0.2%, respectively. CONCLUSIONS: VT stimulation studies can be simulated in silico using a personalized biophysical cardiac model. Myocardial spatial heterogeneity of APD restitution properties and conductivity may help predict the location of crucial entry/exit points of reentrant VT circuits.

Multisite Pacing for Cardiac Resynchronization Therapy: Promise and Pitfalls.

Cardiac resynchronization therapy (CRT) reduces the morbidity and mortality of patients with symptomatic heart failure and intraventricular conduction delay. However, its clinical outcomes are non-uniform and up to one third of treated patients are subsequently classified as non-responders. Multisite pacing (MSP), i.e. stimulating the myocardium from multiple locations, has emerged as a potential therapeutic option in patients requiring CRT. The rationale for MSP is based on the hypothesis that increasing the pacing locations in the left ventricle results in a more physiologic and coordinated myocardial systole. MSP can be achieved by additional leads in the right or left ventricle but this can lead to high battery drain and more frequent generator replacements. Multipolar left ventricular leads can deliver pacing at multiple sites, and therefore, a single lead can be used for MSP. However, the optimal programming settings and the outcomes of this approach remain yet to be determined.

Cardiac Resynchronization Therapy Delivered Via a Multipolar Left Ventricular Lead is Associated with Reduced Mortality and Elimination of Phrenic Nerve Stimulation: Long-Term Follow-Up from a Multicenter Registry.

INTRODUCTION: Cardiac resynchronization therapy (CRT) using quadripolar left ventricular (LV) leads provides more pacing vectors compared to bipolar leads. This may avoid phrenic nerve stimulation (PNS) and allow optimal lead placement to maximize biventricular pacing. However, a long-term improvement in patient outcome has yet to be demonstrated. METHODS: A total of 721 consecutive patients with conventional CRTD criteria implanted with quadripolar (n = 357) or bipolar (n = 364) LV leads were enrolled into a registry at 3 UK centers. Lead performance and mortality was analyzed over a 5-year period. RESULTS: Patients receiving a quadripolar lead were of similar age and sex to those receiving a bipolar lead, although a lower proportion had ischemic heart disease (62.6% vs. 54.1%, P = 0.02). Both groups had similar rates of procedural success, although lead threshold, impedance, and procedural radiation dose were significantly lower in those receiving a quadripolar lead. PNS was more common in those with quadripolar leads (16.0% vs. 11.6%, P = 0.08), but was eliminated by switching pacing vector in all cases compared with 60% in the bipolar group (P < 0.001). Furthermore, LV lead displacement (1.7% vs. 4.6%, P = 0.03) and repositioning (2.0% vs. 5.2%, P = 0.03) occurred significantly less often in those with a quadripolar lead. All-cause mortality was also significantly lower in the quadripolar compared to bipolar lead group in univariate and multivariate analysis (13.2% vs. 22.5%, P < 0.001). CONCLUSIONS: In a large, multicenter experience, the use of quadripolar LV leads for CRT was associated with elimination of PNS and lower overall mortality. This has important implications for LV pacing lead choice.

A review of multisite pacing to achieve cardiac resynchronization therapy.

Non-response to cardiac resynchronization therapy remains a significant problem in up to 30% of patients. Multisite stimulation has emerged as a way of potentially overcoming non-response. This may be achieved by the use of multiple leads placed within the coronary sinus and its tributaries (dual-vein pacing) or more recently by the use of multipolar (quadripolar) left ventricular pacing leads which can deliver pacing stimuli at multiple sites within the same vein. This review covers the role of multisite pacing including the interaction with the underlying pathophysiology, the current and planned studies, and the potential pitfalls of this technology.

A prospective evaluation of cardiovascular magnetic resonance measures of dyssynchrony in the prediction of response to cardiac resynchronization therapy.

BACKGROUND: Many patients with electrical dyssynchrony who undergo cardiac resynchronization therapy (CRT) do not obtain substantial benefit. Assessing mechanical dyssynchrony may improve patient selection. Results from studies using echocardiographic imaging to measure dyssynchrony have ultimately proved disappointing. We sought to evaluate cardiac motion in patients with heart failure and electrical dyssynchrony using cardiovascular magnetic resonance (CMR). We developed a framework for comparing measures of myocardial mechanics and evaluated how well they predicted response to CRT. METHODS: CMR was performed at 1.5 Tesla prior to CRT. Steady-state free precession (SSFP) cine images and complementary modulation of magnetization (CSPAMM) tagged cine images were acquired. Images were processed using a novel framework to extract regional ventricular volume-change, thickening and deformation fields (strain). A systolic dyssynchrony index (SDI) for all parameters within a 16-segment model of the ventricle was computed with high SDI denoting more dyssynchrony. Once identified, the optimal measure was applied to a second patient population to determine its utility as a predictor of CRT response compared to current accepted predictors (QRS duration, LBBB morphology and scar burden). RESULTS: Forty-four patients were recruited in the first phase (91% male, 63.3 ± 14.1 years; 80% NYHA class III) with mean QRSd 154 ± 24 ms. Twenty-one out of 44 (48%) patients showed reverse remodelling (RR) with a decrease in end systolic volume (ESV) ≥ 15% at 6 months. Volume-change SDI was the strongest predictor of RR (PR 5.67; 95% CI 1.95-16.5; P = 0.003). SDI derived from myocardial strain was least predictive. Volume-change SDI was applied as a predictor of RR to a second population of 50 patients (70% male, mean age 68.6 ± 12.2 years, 76% NYHA class III) with mean QRSd 146 ± 21 ms. When compared to QRSd, LBBB morphology and scar burden, volume-change SDI was the only statistically significant predictor of RR in this group. CONCLUSION: A systolic dyssynchrony index derived from volume-change is a highly reproducible measurement that can be derived from routinely acquired SSFP cine images and predicts RR following CRT whilst an SDI of regional strain does not.

Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction.

AIMS: The number of procedures involving upgrade or revision of cardiac implantable electronic devices (CIEDs) is increasing and the risks of adding additional leads are significant. Central venous occlusion in patients with pre-existing devices is often asymptomatic and optimal management of such patients in need of device revision/upgrade is not clear. We sought to assess our use of laser lead extraction in overcoming venous obstruction. METHODS AND RESULTS: Patients in need of device upgrade/revision underwent pre-procedure venography to assess venous patency. In patients with venous occlusion or stenosis severe enough to preclude passage of a hydrophilic guide wire, laser lead extraction with retention of the outer sheath in the vasculature was performed with the aim of maintaining a patent channel through which new leads could be implanted. Data were recorded on a dedicated database and patient outcomes were assessed. Between July 2004 and April 2012, laser lead extractions were performed in 71 patients scheduled for device upgrade/revision who had occluded or functionally obstructed venous anatomy. New leads were successfully implanted across the obstruction in 67 (94%) cases. There were two major complications (infection) and four minor complications with no peri-procedural mortality. Device follow-up was satisfactory in 65 (92%) cases with mean follow-up up to 26 ± 19 months. CONCLUSION: Laser lead extraction is a safe and effective option when managing patients with central venous obstruction in need of CIED revision or upgrade.

An anthropomorphic phantom for atrial transseptal puncture simulation training.

BACKGROUND: Transseptal puncture (TSP) is a critical prerequisite for left-sided cardiac interventions, such as atrial fibrillation (AF) ablation and left atrial appendage closure. Despite its routine nature, TSP can be technically demanding and carries a risk of complications. This study presents a novel, patient-specific, anthropomorphic phantom for TSP simulation training that can be used with X-ray fluoroscopy and ultrasound imaging. METHODS: The TSP phantom was developed using additive manufacturing techniques and features a replaceable fossa ovalis (FO) component to allow for multiple punctures without replacing the entire model. Four cardiologists and one cardiology trainee performed TSP on the simulator, and their performance was assessed using four metrics: global isotropy index, distance from the centroid, time taken to perform TSP, and a set of 5-point Likert scale questions to evaluate the clinicians' perception of the phantom's realism and utility. RESULTS: The results demonstrate the simulator's potential as a training tool for interventional cardiology, providing a realistic and controllable environment for clinicians to refine their TSP skills. Experienced cardiologists tended to cluster their puncture points closer to regions of the FO associated with higher global isotropy index scores, indicating a relationship between experience and optimal puncture localization. The questionnaire analysis revealed that participants generally agreed on the phantom's realistic anatomical representation and ability to accurately visualize the TSP site under fluoroscopic guidance. CONCLUSIONS: The TSP simulator can be incorporated into training programs, offering trainees the opportunity to improve tool handling, spatial coordination, and manual dexterity prior to performing the procedure on patients. Further studies with larger sample sizes and longitudinal assessments are needed to establish the simulator's impact on TSP performance and patient outcomes.

The current practice and perception of cardiac implantable electronic device transvenous lead extraction in the UK.

AIMS: The number of patients requiring an extraction of cardiac implantable electronic devices (CIEDs) is rising. Lead extraction of chronically implanted leads is a highly specialized procedure and the Heart Rhythm Society published a consensus document outlining best practice. We sought to ascertain the current practice and perception of lead extraction in the UK. METHODS AND RESULTS: A prospective e-mail survey consisting of 21 questions was sent to members of Heart Rhythm UK. Key areas for exploration included case volume, settings for extraction procedures, levels of surgical support, preferred techniques, and the perceptions of difficulty, risk, morbidity, and mortality associated with lead extraction. Thirty responses were received giving a response rate of 9.3%. Eighty-three per cent of responders performed extractions regularly and of these 92% were electrophysiologists. Median number of cases performed per year was 13 (interquartile range 6-26). Fifty-six per cent performed <20 procedures per year. Eighty per cent of procedures were performed in the electrophysiology (EP) laboratory and of these 50% had no identifiable surgeon or operating theatre on standby. Mechanical dissection sheaths were the most widely used method of extraction after failure of manual traction (63%). The risk of minor complications was perceived to be 4% or less by the majority of respondents across the device range. The same measure for major complications and death was 2 and 1%, respectively. CONCLUSION: Increased operator caseload and closer links between EP extractors and surgeons should be seen as achievable goals.

Leadless Cardiac Pacing: New Horizons.

Since the introduction of transvenous cardiac pacing leads, pacemaker system design has remained similar for several decades. Progressive miniaturisation of electronic circuitry and batteries has enabled a smaller, single pacing unit comprising the intracardiac electrodes, generator and computer. This review explores the development of leadless pacing, the clinical trials comparing leadless to transvenous pacing in addition to the future developments of multi-chamber leadless pacing.

Percutaneous closure and "push-pull" technique to repair arterial lead and sheath placement complicating cardiac resynchronization therapy.

We present a case of inadvertent subclavian arterial puncture and lead placement to the left ventricle in a patient undergoing cardiac resynchronization therapy. We describe the use of a "push-pull" technique within an arterial setting to allow removal of the lead, while maintaining access through the same puncture to allow an arterial-closure device to then seal the artery at this site. As a result of this percutaneous approach, the patient avoided the need for a vascular surgical procedure.