Left atrial low-voltage areas, but not volume, predict the recurrence of atrial fibrillation in repeat ablation procedures.

INTRODUCTION: Left atrial (LA) low voltage areas (LVA) are a controversial target in atrial fibrillation ablation procedures. However, LVA and LA volume are good predictors of arrhythmia recurrence in ablation-naïve patients. Their predictive value in progressively diseased pre-ablated atria is uncertain. METHODS: Consecutive patients with recurrent atrial fibrillation (AF) or atrial tachycardia (AT), who were scheduled for repeat LA ablation, were enrolled in the prospective Bernau ablation registry between 2016 and 2020. All patients received a complete LA ultrahigh-density map before ablation. Maps were analyzed for LA size, LVA percentage and distribution. The predictive value of demographic, anatomic, and mapping variables on AF recurrence was analyzed. RESULTS: 160 patients (50.6% male, 1.3 pre-ablations, 60% persistent AF) with complete LA voltage maps were included. Mean follow-up time was 16 ± 11 months. Mean recorded electrograms (EGMs) per map were 9754 ± 5808, mean LA volume was 176.1 ± 35.9 ml and mean rate of LVAs <0.5 mV was 30.6% ± 23.1%. During follow-up recurrence rate of AF or AT >30 s was 55.6%. Patients with recurrence had a significant higher percentage of LVAs (40.0% vs. 18.8%, p < .001) but no relevant difference in LA volume (172 vs. 178 mL, p = .299). ROC curves revealed LVA as a good predictor for recurrence (AUC = 0.79, p < .001) and a cut-off of 22% LVAs with highest sensitivity (73.0%) and specificity (71.8%). Based on this cut off, event free survival was significantly higher in the Low LVA group (p < .01). CONCLUSION: Total LVA percentage has a good predictive power on arrhythmia recurrence in a cohort of advanced scarred left atria in repeat procedures independent of the applied ablation strategy. Left atrial volume seems to have minor impact on the rhythm outcome in our study cohort.

Outcome and microbiological findings of patients with cardiac implantable electronic device infection.

INTRODUCTION: Infections associated with cardiac implantable electronic devices (CIEDs) are a multifactorial disease that leads to increased morbidity and mortality. OBJECTIVE: The aim was to analyze patient-, disease- and treatment-related characteristics including microbiological and bacterial spectrum according to survival status and to identify risk factors for 1- and 3-year mortality in patients with local and systemic CIED infection. METHODS: In a retrospective cohort study, we analyzed data from patients with CIED-related local or systemic infection undergoing successful transvenous lead extraction (TLE). Survival status as well as incidence and cause of rehospitalization were recorded. Microbiology and antibiotics used as first-line therapy were compared according to mortality. Independent risk factors for 1- and 3-year mortality were determined. RESULTS: Data from 243 Patients were analyzed. In-hospital mortality was 2.5%. Mortality rates at 30 days, 1- and 3 years were 4.1%, 18.1% and 30%, respectively. Seventy-four (30.5%) patients had systemic bacterial infection. Independent risk factors for 1-year mortality included age (OR 1.05 [1.01-1.10], p = 0.014), NT-proBNP at admission (OR 4.18 [1.81-9.65], p = 0.001), new onset or worsened tricuspid regurgitation after TLE (OR 6.04 [1.58-23.02], p = 0.009), and systemic infection (OR 2.76 [1.08-7.03], p = 0.034), whereas systemic infection was no longer an independent risk factor for 3-year mortality. Staphylococcus aureus was found in 18.1% of patients who survived and in 25% of those who died, p = 0.092. There was a high proportion of methicillin-resistant strains among coagulase-negative staphylococci (16.5%) compared to Staphylococcus aureus (1.2%). CONCLUSIONS: Staphylococci are the most common causative germs of CIED-infection with coagulase-negative staphylococci showing higher resistance rates to antibiotics. The independent risk factors for increased long-term mortality could contribute to individual risk stratification and well-founded treatment decisions in clinical routine. Especially the role of tricuspid regurgitation as a complication after TLE should be investigated in future studies.

Laser lead extraction in octo- and nonagenarians. A subgroup analysis from the GALLERY registry.

INTRODUCTION: In an aging population with cardiac implantable electronic devices, an increasing number of octo- and even nonagenarians present for lead extraction procedures. Those patients are considered at increased risk for surgical procedures including lead extraction. Here, we investigated safety and efficacy of transvenous lead extraction in a large patient cohort of octo- and nonagenarians. METHODS AND RESULTS: A subgroup analysis of all patients aged ≥80 years (n = 499) in the German Laser Lead Extraction Registry (GALLERY) was performed. Outcomes were compared to the nonoctogenarians from the registry. Primary extraction method was Laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. An analysis of patient- and device characteristics, as well as an assessment of predictors for adverse events via multivariate analyses was conducted. Mean patients age was 84.3 ± 3.7 years in the octogenarians group and 64.1 ± 12.4 years in the nonoctogenarians group. The median lead dwell time was 118.0 months (78; 167) and 92.0 months [60; 133], p < .001 in the octogenarians and nonoctogenarians group, respectively. Clinical procedural success rate was achieved in 97.6% of the cases in octogenarians and 97.9% in nonoctogenarians (p = .70). Overall complication rate was 4.4% in octogenarians and 4.3% in nonoctogenarians (0.91). In octogenarians procedure-related mortality was 0.8% and all-cause in-hospital mortality was 5.4%, while in nonoctogenarians, procedure related and all-cause in-hospital mortality were 0.5% and 3.1%, respectively. A body mass index (BMI) <20 kg/m2 , was the only statistically significant predictor for procedure-related complications in octogenarians, while systemic infection, BMI ≤20 kg/m2 , procedural complications and chronic kidney disease were predictors for in-hospital mortality. CONCLUSIONS: Laser lead extraction in octo- and nonagenarians is safe and effective. BMI ≤20 kg/m2 was the only statistically significant predictor for procedural complications. According to our data, advanced age should not be considered as contraindication for laser lead extraction.

Transvenous lead extraction of implantable cardioverter-defibrillators: A comprehensive outcome-and risk factor analysis.

BACKGROUND: Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with transvenous implantable-cardioverter-defibrillator (ICD). OBJECTIVES: Aim of this study was to characterize the procedural outcome and risk-factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE. METHODS: We conducted a subgroup analysis of all ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed. RESULTS: We identified 842 patients with an ICD undergoing TLE with the mean age of 62.8 ± 13.8 years. A total number of 1610 leads were treated with lead dysfunction (48.5%) as leading indication for extraction, followed by device-related infection (45.4%). Lead-per-patient ratio was 1.91 ± 0.88 and 60.0% of patients had dual-coil defibrillator leads. Additional extraction tools, such as mechanical rotating dilator sheaths and snares were utilized in 6.5% of cases. Overall procedural complications occurred in 4.3% with 2.0% major complications and a procedure-related mortality of 0.8%. Clinical success rate was 97.9%. All-cause in-hospital mortality was 3.4%, with sepsis being the leading cause for mortality. Multivariate analysis revealed lead-age ≥10 years (OR:5.82, 95%CI:2.1-16.6; p = .001) as independent predictor for procedural failure. Systemic infection (OR:9.57, 95%CI:2.2-42.4; p < .001) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p < .001) were identified as risk factors for all-cause mortality. CONCLUSIONS: TLE is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE.

Selection and outcome of implantable cardioverter-defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials.

BACKGROUND: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT. METHODS: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up. RESULTS: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality. CONCLUSION: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients.

The GermAn Laser Lead Extraction RegistrY: GALLERY.

AIMS: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. METHODS AND RESULTS: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. CONCLUSION: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Incidence and risk factors for acute kidney injury in patients with cardiac implantable electronic devices undergoing transvenous lead removal.

BACKGROUND: This study aimed to investigate the incidence and potentially modifiable risk factors of acute kidney injury (AKI) in patients with cardiac implantable electronic devices (CIED) admitted for removal of infected and non-infected transvenous leads. MATERIALS AND METHODS: In this observational cohort study, data from 147 consecutive patients with CIED undergoing transvenous lead removal were analyzed. Study endpoint was AKI according to the KDIGO criteria. Multivariable logistic regression analysis was performed to identify independent risk factors for AKI. RESULTS: Lead removal was performed due to systemic infection (50.3%), isolated pocket infection (34.0%), pocket or lead perforation without infection (13.6%), and endocarditis (2.0%). Out of 147 patients, 34 (23.1%) developed AKI (82.4% stage 1, 8.8% stage 2, and 8.8% stage 3). There was no difference regarding incidence of AKI when separated by infectious vs. non-infectious lead status (25.5 vs. 25.0%) p = 0.605. Defibrillator lead type (HR 24.55, CI 2.41 - 249.97, p = 0.007), necessity to perform laser-assisted lead removal (HR 5.41, CI 1.12 - 26.13, p = 0.035), and time from initial implantation to lead removal (HR 1.01, CI 1.00 - 1.02, p = 0.013) were independent risk factors for AKI. Also, AKI was associated with in-hospital mortality (HR 8.44, CI 2.08 - 34.33, p = 0.003). CONCLUSION: Almost a quarter of patients undergoing transvenous lead removal developed AKI. Independent modifiable risk factors for AKI were identified. The role of procedure-related risk factors for AKI, such as lead type and use of laser, needs further evaluation in these patients.

Endothelialization and Inflammatory Reactions After Intracardiac Device Implantation.

BACKGROUND: Due to the advances in catheter-based interventional techniques, a wide range of heart diseases can now be treated with a purely interventional approach. Little is yet known regarding biological effects at the intracardiac implantation site or the effects on endothelialization and vascular inflammation in an in vivo environment. Detailed knowledge of ongoing vascular response, the process of endothelialization, and possible systemic inflammatory reactions after implantation is crucial for the clinical routine, since implants usually remain in the body for a lifetime. METHODS: For this narrative review, we conducted an extensive profound PubMed analysis of the current literature on the endothelialization processes of intracardially implanted devices, such as persistent foramen ovale (PFO) occluders, atrial septal defect (ASD) occluders, left atrial appendage (LAA) occluders, transcatheter aortic valve implantations (TAVIs), and leadless pacemakers. Additionally, the known biological activities of common metallic and synthetic components of intracardiac devices in an "in vivo" setting have been evaluated. RESULTS: Nitinol, an alloy of nickel and titanium, is by far the most commonly used material found in intracardiac devices. Although allergies to both components are known, implantation can be performed safely in the vast majority of patients. Depending on the device used, endothelialization can be expected within a time frame of 3-6 months. For those patients with a known allergy, gold coating may be considered as a viable alternative. CONCLUSION: Based on our analysis, we conclude that the vast majority of devices are made of a material that is both safe to implant and nontoxic in long-term treatment according to the current knowledge. The literature on the respective duration of endothelialization of individual devices however is highly divergent.

The Transcription Factor EB (TFEB) Sensitizes the Heart to Chronic Pressure Overload.

The transcription factor EB (TFEB) promotes protein degradation by the autophagy and lysosomal pathway (ALP) and overexpression of TFEB was suggested for the treatment of ALP-related diseases that often affect the heart. However, TFEB-mediated ALP induction may perturb cardiac stress response. We used adeno-associated viral vectors type 9 (AAV9) to overexpress TFEB (AAV9-Tfeb) or Luciferase-control (AAV9-Luc) in cardiomyocytes of 12-week-old male mice. Mice were subjected to transverse aortic constriction (TAC, 27G; AAV9-Luc: n = 9; AAV9-Tfeb: n = 14) or sham (AAV9-Luc: n = 9; AAV9-Tfeb: n = 9) surgery for 28 days. Heart morphology, echocardiography, gene expression, and protein levels were monitored. AAV9-Tfeb had no effect on cardiac structure and function in sham animals. TAC resulted in compensated left ventricular hypertrophy in AAV9-Luc mice. AAV9-Tfeb TAC mice showed a reduced LV ejection fraction and increased left ventricular diameters. Morphological, histological, and real-time PCR analyses showed increased heart weights, exaggerated fibrosis, and higher expression of stress markers and remodeling genes in AAV9-Tfeb TAC compared to AAV9-Luc TAC. RNA-sequencing, real-time PCR and Western Blot revealed a stronger ALP activation in the hearts of AAV9-Tfeb TAC mice. Cardiomyocyte-specific TFEB-overexpression promoted ALP gene expression during TAC, which was associated with heart failure. Treatment of ALP-related diseases by overexpression of TFEB warrants careful consideration.

Atrial Fibrillation and Transvenous Lead Extraction-A Comprehensive Subgroup Analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY).

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56−377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01−7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68−25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial.

BACKGROUND: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. METHODS: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. RESULTS: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group. CONCLUSIONS: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.

Impact of closed loop stimulation on prognostic cardiopulmonary variables in patients with chronic heart failure and severe chronotropic incompetence: a pilot, randomized, crossover study.

AIMS: Clinical effects of rate-adaptive pacing in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) remain unclear. Closed loop stimulation (CLS) is a new rate-adaptive sensor in CRT devices. We evaluated the effectiveness of CLS in CRT patients with severe CI, focusing primarily on key prognostic variables assessed by cardiopulmonary exercise (CPX) testing. METHODS AND RESULTS: In the randomized, crossover, multicentre BIO|CREATE study, 20 CRT patients with severe CI and NYHA Class II/III (60%/40%) were randomized 1:1 to the sequence DDD-40 mode to DDD-CLS mode, or the sequence DDD-CLS mode to DDD-40 mode (1 month in each mode). Patients underwent symptom-limited treadmill-based CPX test in each mode. An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS. Seventeen patients with full data sets had a mean intra-individual VE slope change of -1.8 ± 3.0 (-4.1%) with CLS (P = 0.23). Eight patients (47%) were CLS responders, with a -6.1 ± 2.7 (-16.4%) slope change (P = 0.029). Compared to non-responders, CLS responders had a higher left ventricular (LV) ejection fraction (46 ± 3 vs. 36 ± 9%; P = 0.0070), smaller end-diastolic LV volume (121 ± 34 vs. 181 ± 41 mL; P = 0.0085), smaller end-systolic LV volume (65 ± 23 vs. 114 ± 39 mL; P = 0.0076), and were predominantly in NYHA Class II (P = 0.0498). CONCLUSION: The data of the present pilot study are compatible with the notion that CLS activation may improve VE slope in CRT patients with severe CI and less advanced heart failure. Further research is needed to determine the long-term clinical outcomes of CLS.

Risk stratification of patients undergoing transvenous lead extraction with the ELECTRa Registry Outcome Score (EROS): an ESC EHRA EORP European lead extraction ConTRolled ELECTRa registry analysis.

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.

Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades.

AIMS: Cardiac resynchronization therapy (CRT) upgrades may be less likely to improve following intervention. Leadless left ventricular (LV) endocardial pacing has been used for patients with previously failed CRT or high-risk upgrades. We compared procedural and long-term outcomes in patients undergoing coronary sinus (CS) CRT upgrades with high-risk and previously failed CRT upgrades undergoing LV endocardial upgrades. METHOD AND RESULTS: Prospective consecutive CS upgrades between 2015 and 2019 were compared with those undergoing WiSE-CRT implantation. Cardiac resynchronization therapy response at 6 months was defined as improvement in clinical composite score (CCS) and a reduction in LV end-systolic volume (LVESV) ≥15%. A total of 225 patients were analysed; 121 CS and 104 endocardial upgrades. Patients receiving WiSE-CRT tended to have more comorbidities and were more likely to have previous cardiac surgery (30.9% vs. 16.5%; P = 0.012), hypertension (59.2% vs. 34.7%; P < 0.001), chronic obstructive airways disease (19.4% vs. 9.9%; P = 0.046), and chronic kidney disease (46.4% vs. 21.5%; P < 0.01) but similar LV ejection fraction (30.0 ± 8.3% vs. 29.5 ± 8.6%; P = 0.678). WiSE-CRT upgrades were successful in 97.1% with procedure-related mortality in 1.9%. Coronary sinus upgrades were successful in 97.5% of cases with a 2.5% rate of CS dissection and 5.6% lead malfunction/displacement. At 6 months, 91 WiSE-CRT upgrades and 107 CS upgrades had similar improvements in CCS (76.3% vs. 68.5%; P = 0.210) and reduction in LVESV ≥15% (54.2% vs. 56.3%; P = 0.835). CONCLUSION: Despite prior failed upgrades and high-risk patients with more comorbidities, WiSE-CRT upgrades had high rates of procedural success and similar improvements in CCS and LV remodelling with CS upgrades.

EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS).

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.

Optimal CRT Implantation-Where and How To Place the Left-Ventricular Lead?

PURPOSE OF REVIEW: Cardiac resynchronization therapy (CRT) represents a well-established and effective non-pharmaceutical heart failure (HF) treatment in selected patients. Still, a significant number of patients remain CRT non-responders. An optimal placement of the left ventricular (LV) lead appears crucial for the intended hemodynamic and hence clinical improvement. A well-localized target area and tools that help to achieve successful lead implantation seem to be of utmost importance to reach an optimal CRT effect. RECENT FINDINGS: Recent studies suggest previous multimodal imaging (CT/cMRI/ECG torso) to guide intraprocedural LV lead placement. Relevant benefit compared to empirical lead optimization is still a matter of debate. Technical improvements in leads and algorithms (e.g., multipoint pacing (MPP), adaptive algorithms) promise higher procedural success. Recently emerging alternatives for ventricular synchronization such as conduction system pacing (CSP), LV endocardial pacing, or leadless pacing challenge classical biventricular pacing. This article reviews current strategies for a successful planning, implementation, and validation of the optimal CRT implantation. Pre-implant imaging modalities offer promising assistance for complex cases; empirical lead positioning and intraoperative testing remain the cornerstone in most cases and ensure a successful CRT effect.

The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis.

AIMS: Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location. METHODS AND RESULTS: Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as <30 procedures/year, and high-volume (HiV) centres as ≥30 procedures/year. Three thousand, two hundred, and forty-nine patients underwent TLE by a primary operator cardiologist; 17.1% in LoV centres and 82.9% in HiV centres. Procedures performed by primary operator cardiologists in LoV centres were less likely to be successful (93.5% vs. 97.1%; P < 0.0001) and more likely to be complicated by procedure-related deaths (1.1% vs. 0.4%; P = 0.0417). Transvenous lead extraction undertaken by primary operator cardiologists in LoV centres were associated with increased procedure-related major complications including death (odds ratio 1.858, 95% confidence interval 1.007-3.427; P = 0.0475). Transvenous lead extraction locations varied; 52.0% operating room, 9.5% hybrid theatre and 38.5% catheterization laboratory. Rates of procedure-related major complications, including death occurring in a high-risk environment (combining operating room and hybrid theatre), were similar to those undertaken in the catheterization laboratory (1.7% vs. 1.6%; P = 0.9297). CONCLUSION: Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.

Geriatric or cardiac rehabilitation? Predictors of treatment pathways in advanced age patients after transcatheter aortic valve implantation.

BACKGROUND: Aim of the study was to find predictors of allocating patients after transcatheter aortic valve implantation (TAVI) to geriatric (GR) or cardiac rehabilitation (CR) and describe this new patient group based on a differentiated characterization. METHODS: From 10/2013 to 07/2015, 344 patients with an elective TAVI were consecutively enrolled in this prospective multicentric cohort study. Before intervention, sociodemographic parameters, echocardiographic data, comorbidities, 6-min walk distance (6MWD), quality of life and frailty (score indexing activities of daily living [ADL], cognition, nutrition and mobility) were documented. Out of these, predictors for assignment to CR or GR after TAVI were identified using a multivariable regression model. RESULTS: After TAVI, 249 patients (80.7 ± 5.1 years, 59.0% female) underwent CR (n = 198) or GR (n = 51). GR patients were older, less physically active and more often had a level of care, peripheral artery disease as well as a lower left ventricular ejection fraction. The groups also varied in 6MWD. Furthermore, individual components of frailty revealed prognostic impact: higher values in instrumental ADL reduced the probability for referral to GR (OR:0.49, p <  0.001), while an impaired mobility was positively associated with referral to GR (OR:3.97, p = 0.046). Clinical parameters like stroke (OR:0.19 of GR, p = 0.038) and the EuroSCORE (OR:1.04 of GR, p = 0.026) were also predictive. CONCLUSION: Advanced age patients after TAVI referred to CR or GR differ in several parameters and seem to be different patient groups with specific needs, e.g. regarding activities of daily living and mobility. Thus, our data prove the eligibility of both CR and GR settings.

Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy.

BACKGROUND: Endocardial pacing may be beneficial in patients who fail to improve following conventional epicardial cardiac resynchronization therapy (CRT). The potential to pace anywhere inside the left ventricle thus avoiding myocardial scar and targeting the latest activating segments may be particularly important. The WiSE-CRT system (EBR systems, Sunnyvale, CA) reliably produces wireless, endocardial left ventricular (LV) pacing. The purpose of this analysis was to determine whether this system improved symptoms or led to LV remodeling in patients who were nonresponders to conventional CRT. METHOD: An international, multicenter registry of patients who were nonresponders to conventional CRT and underwent implantation with the WiSE-CRT system was collected. RESULTS: Twenty-two patients were included; 20 patients underwent successful implantation with confirmation of endocardial biventricular pacing and in 2 patients, there was a failure of electrode capture. Eighteen patients proceeded to 6-month follow-up; endocardial pacing resulted in a significant reduction in QRS duration compared with intrinsic QRS duration (26.6 ± 24.4 ms; P = .002) and improvement in left ventricular ejection fraction (LVEF) (4.7 ± 7.9%; P = .021). The mean reduction in left ventricular end-diastolic volume was 8.3 ± 42.3 cm3 (P = .458) and left ventricular end-systolic volume (LVESV) was 13.1 ± 44.3 cm3 (P = .271), which were statistically nonsignificant. Overall, 55.6% of patients had improvement in their clinical composite score and 66.7% had a reduction in LVESV ≥15% and/or absolute improvement in LVEF ≥5%. CONCLUSION: Nonresponders to conventional CRT have few remaining treatment options. We have shown in this high-risk patient group that the WiSE-CRT system results in improvement in their clinical composite scores and leads to LV remodeling.

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.

BACKGROUND: Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population. METHODS: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed. FINDINGS: Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55-5·23) in the remote patient management group and 6·64% (6·19-7·13) in the usual care group (ratio 0·80, 95% CI 0·65-1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14-10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21-13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50-0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560). INTERPRETATION: The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality. FUNDING: German Federal Ministry of Education and Research.