BACKGROUND Long-term outcomes are poorly understood, and data in patients undergoing transvenous lead extraction (TLE) are lacking.OBJECTIVE The purpose of this study was to evaluate factors influencing survival in patients undergoing TLE depending on extraction indication.METHODS Clinical data from consecutive patients undergoing TLE in the reference center between 2000 and 2019 were prospectively collected. The total cohort was divided into groups depending on whether there was an infective or noninfective indication for TLE. We evaluated the association of demographic, clinical, and device-related and procedure-related factors on mortality.RESULTS A total of 1151 patients were included. Mean follow-up was 66 months, and mortality was 34.2% (n 5 392). Of these patients, 632 (54.9%) and 519 (45.1%) were for infective and noninfective indications, respectively. A higher proportion in the infection group died (38.6% vs 28.5%; P ,.001). In the total cohort, multivariable analysis demonstrated increased mortality risk with age .75 years (hazard ratio [HR] 2.98; 95% confidence interval [CI] 2.35-3.78; P ,.001), estimated glomerular filtration rate ,60 mL/min/1.73 m 2 (HR 1.67; 95% CI 1.31-2.13; P ,.001), higher cumulative comorbidity (HR 1.17; 95% CI 1.09-1.26; P ,.001), reduced risk per percentage increase in left ventricular ejection fraction (HR 0.98; 95% CI 0.97-0.99; P ,.001), and near unity per year of additional lead dwell time (HR 0.98; 95% CI 0.96-1.00; P 5 .037). Kaplan-Meier survival curves demonstrated worse prognosis, with a higher number of leads extracted and increasing comorbidities.CONCLUSION Long-term mortality for patients undergoing TLE remains high. Consensus guidelines recommend evaluating risk for major complications when determining whether to proceed with TLE. This study suggests also assessing longer-term outcomes when considering TLE in those with a high risk of medium-and longterm mortality, particularly for noninfective indications.
Aims Transvenous lead extraction is associated with a significant risk of complications and identifying patients at highest risk pre-procedurally will enable interventions to be planned accordingly. We developed the ELECTRa Registry Outcome Score (EROS) and applied it to the ELECTRa registry to determine if it could appropriately risk-stratify patients. Methods and results EROS was devised to risk-stratify patients into low risk (EROS 1), intermediate risk (EROS 2), and high risk (EROS 3). This was applied to the ESC EORP European Lead Extraction ConTRolled ELECTRa registry; 57.5% EROS 1, 31.8% EROS 2, and 10.7% EROS 3. Patients with EROS 3 or 2 were significantly more likely to require powered sheaths and a femoral approach to complete procedures. Patients with EROS 3 were more likely to suffer procedure-related major complications including deaths (5.1 vs. 1.3%; P < 0.0001), both intra-procedural (3.5 vs. 0.8%; P = 0.0001) and post-procedural (1.6 vs. 0.5%; P = 0.0192). They were more likely to suffer post-procedural deaths (0.8 vs. 0.2%; P 0.0449), cardiac avulsion or tear (3.8 vs. 0.5%; P < 0.0001), and cardiovascular lesions requiring pericardiocentesis, chest tube, or surgical repair (4.6 vs. 1.0%; P < 0.0001). EROS 3 was associated with procedure-related major complications including deaths [odds ratio (OR) 3.333, 95% confidence interval (CI) 1.879–5.914; P < 0.0001] and all-cause in-hospital major complications including deaths (OR 2.339, 95% CI 1.439–3.803; P = 0.0006). Conclusion EROS successfully identified patients who were at increased risk of significant procedural complications that require urgent surgical intervention.
Background No periprocedural metric has demonstrated improved cardiac resynchronization therapy (CRT) outcomes in a multicenter setting. Objective We sought to determine if left ventricular (LV) lead placement targeted to the coronary sinus (CS) branch generating the best acute hemodynamic response (AHR) results in improved outcomes at 6 months. Methods In this multicenter randomized controlled trial, patients were randomized to guided CRT or conventional CRT. Patients in the guided arm had LV dP/dt max measured during biventricular (BIV) pacing. Target CS branches were identified and the final LV lead position was the branch with the best AHR and acceptable threshold values. The primary endpoint was the proportion of patients with a reduction in LV end-systolic volume (LVESV) of ≥15% at 6 months. Results A total of 281 patients were recruited across 12 centers. Mean age was 70.8 ± 10.9 years and 54% had ischemic etiology. Seventy-three percent of patients in the guided arm demonstrated a reduction in LVESV of ≥15% at 6 months vs 60% in the conventional arm ( P = .02). Patients with AHR ≥ 10% were more likely to demonstrate a reduction of ESV ≥ 15% (84% of patients with an AHR ≥10% vs 28% with an AHR <10%; P < 0.001). Procedure duration and fluoroscopy times were longer in the pressure wire–guided arm (104 ± 39 minutes vs 142 ± 39 minutes; P < .001 and 20 ±16 minutes vs 28 ± 15 minutes; P = .002). Conclusions AHR determined by invasively measuring LV dP/dt max during BIV pacing predicts reverse remodeling 6 months after CRT. Patients in whom LV dP/dt max was used to guide LV lead placement demonstrated better rates of reverse remodeling.
Background The value of screening sub‐clinical atherosclerosis in asymptomatic patients with type 2 diabetes mellitus (T2DM) remains controversial. Hypothesis An integrated model incorporating carotid intima‐media thickness (CIMT) and carotid plaque with traditional risk factors can be used to predict prevalence and severity of coronary artery calcification in asymptomatic T2DM patients. Methods A cohort of 262 asymptomatic T2DM patients were prospectively studied with carotid ultrasound to evaluate CIMT and carotid plaque and also a computed tomography coronary artery calcium (CT‐CAC) scan. Results Carotid plaque was detected in 124 (47%) patients and mean CIMT was 0.75±0.14 mm. Two hundred (76%) patients had a CAC score >0, of whom 57 (22%) had severe coronary atherosclerosis (>400 Au). In this group, carotid plaque was present in 40 (70%) patients (p<0.001). Univariable analysis revealed significant associations between non‐zero CAC score and age (p<0.001), hypertension (p=0.01), gender (p=0.003) and duration of diabetes (p=0.004). Carotid plaque and mean CIMT were also significantly associated with non‐zero CAC score (odds ratios [95% CI], 3.12 [1.66 ‐5.85] and 2.98 [0.24 ‐7.17], respectively). After adjusting for traditional risk factors, carotid plaque continued to be predictive of non‐zero CAC score (2.59 [1.17 ‐5.74]) and CIMT was borderline significant (p=0.05). When analysed with binary logistical regression, the prevalence of carotid plaque significantly predicted severe CAC burden (CAC >400 Au; 3.26 [2.05 ‐5.19]). Upper CIMT quartiles showed a similar association (2.55 [1.33 ‐4.87]). Conclusion Carotid plaque is more predictive of underlying silent coronary atherosclerosis prevalence, severity and extent in asymptomatic T2DM patients.
Conduction System Pacing (CSP) delivered by His Bundle Pacing (HBP) or Left Bundle Pacing (LBP) are exciting novel interventions in the field of Cardiac Resynchronization Therapy (CRT). As the evidence base for CSP grows, the volume of implants worldwide is projected to rise significantly in the coming years. As such, physicians will be confronted with increasingly prevalent and vital issues arising in long-term follow up, including the management of infected, malfunctioning, or redundant CSP leads. Transvenous lead extraction (TLE) is the first-line option for removal of pacing leads when indicated in these circumstances. The evidence base for TLE in the context of CSP is still in its infancy. In this article, we first provide a brief overview of TLE. We then examine the data on the long-term performance of HBP leads. Next, we describe the features of the Medtronic Select Secure 3,830 lead, and how experience of TLE of this lead in the paediatric population has informed our practice. Finally, we review the current evidence for TLE in HBP and LBP, and discuss how future studies can address gaps in our current knowledge.
Background Optimal positioning of the left ventricular (LV) lead is an important determinant of cardiac resynchronization therapy (CRT) response. Objective Evaluate the feasibility of intraprocedural integration of cardiac computed tomography (CT) to guide LV lead implantation for CRT upgrades. Methods Patients undergoing LV lead upgrade underwent ECG‐gated cardiac CT dyssynchrony and LV scar assessment. Target American Heart Association segment selection was determined using latest non‐scarred mechanically activating segments overlaid onto real‐time fluoroscopy with image co‐registration to guide optimal LV lead implantation. Hemodynamic validation was performed using a pressure wire in the LV cavity (dP/dtmax)). Results 18 patients (male 94%, 55.6% ischemic cardiomyopathy) with RV pacing burden 60.0 ± 43.7% and mean QRS duration 154 ± 30 ms underwent cardiac CT. 10/10 ischemic patients had CT evidence of scar and these segments were excluded as targets. Seventeen out of 18 (94%) patients underwent successful LV lead implantation with delivery to the CT target segment in 15 out of 18 (83%) of patients. Acute hemodynamic response (dP/dtmax ≥ 10%) was superior with LV stimulation in CT target versus nontarget segments (83.3% vs. 25.0%; p = .012). Reverse remodeling at 6 months (LV end‐systolic volume improvement ≥15%) occurred in 60% of subjects (4/8 [50.0%] ischemic cardiomyopathy vs. 5/7 [71.4%] nonischemic cardiomyopathy, p = .608). Conclusion Intraprocedural integration of cardiac CT to guide optimal LV lead placement is feasible with superior hemodynamics when pacing in CT target segments and favorable volumetric response rates, despite a high proportion of patients with ischemic cardiomyopathy. Multicentre, randomized controlled studies are needed to evaluate whether intraprocedural integration of cardiac CT is superior to standard care.
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