Single center experience with the novel rotating dilator sheath TightRailTM Sub-C in transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction has become a frequent procedure in the context of device lead management and various tools are available. The aim of this study was to investigate the efficacy and safety of the novel short rotating dilator sheath TightRailTM Sub-C (Sub-C) in transvenous lead extraction. METHODS: For this retrospective single-center analysis, we included consecutive patients undergoing transvenous lead extraction using the Sub-C from January 2018 until February 2020 at the University Heart Center Zurich. RESULTS: A total of 87 leads were extracted within 45 patients using the Sub-C extraction sheath. The mean dwell time of the leads was 112 ± 9.1 months. Complete procedural success was achieved in 95.6% (43/45) and clinical procedural success in 97.8% (44/45). Two major complications (4.4%, 2/45) occurred, but neither was directly related to the Sub-C. CONCLUSION: This retrospective single-center analysis suggests that transvenous lead extraction with a routine use of the TightRailTM Sub-C extraction sheath is a safe strategy resulting in high success rates that may offer useful theoretical benefits. Future studies are needed to evaluate the incremental benefit of a routine use of short extraction sheaths including the Sub-C during TLE procedures.

Sense-B-noise: an enigmatic cause for inappropriate shocks in subcutaneous implantable cardioverter defibrillators.

AIMS: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are well established. However, inappropriate shocks (IAS) remain a source of concern since S-ICDs offer very limited troubleshooting options. In our multicentre case series, we describe several patients who experienced IAS due to a previously unknown S-ICD system issue. METHODS AND RESULTS: We observed six patients suffering from this novel IAS entity. The IAS occurred exclusively in primary or alternate S-ICD sensing vector configuration (therefore called 'Sense-B-noise'). IAS were caused by non-physiologic oversensing episodes characterized by intermittent signal saturation, diminished QRS amplitudes, and disappearance of the artefacts after the IAS. Noise/oversensing could not be provoked by manipulation, X-ray did not show evidence for lead/header issues and impedance measurements were within normal limits. The pooled experience of our centres implies that up to ∼5% of S-ICDs may be affected. The underlying root cause was discussed extensively with the manufacturer but remains unknown and is under further investigation. CONCLUSION: Sense-B-noise is a novel cause for IAS due to non-physiologic signal oversensing, arising from a previously unknown S-ICD system issue. Sense-B-noise may be suspected if episodes of signal saturation in primary or alternate vector configuration are present, oversensing cannot be provoked, and X-ray and electrical measurements appear normal. The issue can be resolved by reprogramming the device to secondary sensing vector.

Performance and safety of temperature- and flow-controlled radiofrequency ablation for ventricular arrhythmia.

AIMS: High-power ablation is effective for ventricular arrhythmia ablation; however, it increases the risk of steam pops. The aim of this study was to define the safety and efficacy of QMODE ablation in the ventricle and the risk of steam pop. METHODS AND RESULTS: Consecutive patients undergoing ventricular ablation using QDOT were included in a prospective single-centre registry. Procedural data, complications, and follow-up were systematically analysed and compared with a historical ventricular tachycardia (VT) and premature ventricular complexes (PVC) cohort ablated using STSF. QMODE (≤50 W) ablation was performed in 107 patients [age 62 ± 13 years; 76% male; VT (n = 41); PVC (n = 66)]. A total of 2456 applications were analysed [power: 45.9 ± 5.0 W with minimal power titration (90% > 95% max power); duration 26 ± 8 s; impedance drop 9.4 ± 4.7 Ω; ablation index: 569 ± 163; mean-max temperature 44.3 ± 2.6°C]. Ventricular tachycardia ablation was associated with shorter radiofrequency (RF) time and a trend towards shorter procedure times using QDOT (QDOT vs. STSF: 20.1 ± 14.7 vs. 31 ± 17 min; P = 0.002, 151 ± 59 vs. 172 ± 48 min; P = 0.06). Complications, VT recurrence, and mortality rates were comparable (QDOT vs. STSF: 2% vs. 2%; P = 0.9, 24% vs. 27%; P = 0.82, and 2% vs. 4%; P = 0.67). Five audible steam pops (0.02%) occurred. Premature ventricular complex ablation was associated with comparable RF and procedure times (QDOT vs. STSF: 4.8 ± 4.6 vs. 3.9 ± 3.1 min; P = 0.25 and 96.1 ± 31.9 vs. 94.6 ± 24.7 min; P = 0.75). Complication and PVC recurrence were also comparable (QDOT vs. STSF: 0% vs. 3%; P = 0.17 and 19% vs. 22%; P = 0.71). CONCLUSION: Ventricular ablation using QMODE ≤ 50 W is safe and effective for both VT and PVC ablation and is associated with a low risk for steam pop.

Long-term follow-up after the use of the as low as reasonably achievable radiation protocol in patients with symptomatic supraventricular tachycardia.

INTRODUCTION: Catheter ablation is an effective treatment modality for patients with symptomatic supraventricular tachycardia (SVT), such as atrioventricular nodal re-entrant tachycardia (AVNRT) and typical atrial flutter (TAF). With increasingly invasive electrophysiological procedures and continuous development of ablation techniques, the aim is to reduce radiation doses for patients and the electrophysiological team. Modern methods that combine the "as low as reasonably achievable" (ALARA) protocol and three-dimensional mapping systems are now state-of-the-art procedures in the treatment of arrhythmia. This study aimed to compare the effectiveness and long-term success of the ALARA approach compared to those of conventional therapy, without using modern mapping systems. METHODS: Sixty-one patients with symptomatic SVT (37 with AVNRT, 19 with isthmus-dependent counter-clockwise TAF, and five with other SVTs) were randomised into two groups: the ALARA and conventional groups. All patients underwent successful SVT ablation. Clinical and remote follow-up was available for 59 patients after a mean period of 3.2 years. RESULTS: The mean fluoroscopy time was significantly shorter in the ALARA group (1.1 min vs. 8.4 min, p < 0.01). Regarding complications and recurrences, during a median follow-up period of 3.2 years, eight patients (13.5%) had recurrences, all of which occurred in the conventional group. CONCLUSION: This study confirmed a significantly lower radiation burden for patients and the entire electrophysiological team with the ALARA approach and a significantly increased risk of recurrence and complications with the conventional approach. The reduction in radiation time and high long-term success indicate the utility of the ALARA protocol in daily practice.

Cardiac resynchronisation therapy in patients with left bundle branch block with residual conduction.

AIM: To evaluate whether left bundle branch block with residual conduction (rLBBB) is associated with worse outcomes after cardiac resynchronisation therapy (CRT). METHODS: All consecutive CRT implants at our institution between 2006 and 2013 were identified from our local device registry. Pre- and post-implant patient specific data were extracted from clinical records. RESULTS: A total of 690 CRT implants were identified during the study period. Prior to CRT, 52.2% of patients had true left bundle branch block (LBBB), 19.1% a pacing-induced LBBB (pLBBB), 11.2% a rLBBB, 0.8% a right bundle branch block (RBBB), and 16.5% had a nonspecific intraventricular conduction delay (IVCD) electrocardiogram pattern. Mean age at implant was 67.5 years (standard deviation [SD] = 10.6), mean left ventricular ejection fraction (LV EF) was 25.7% (SD = 7.9%), and mean QRS duration was 158.4 ms (SD = 32 ms). After CRT, QRS duration was significantly reduced in the LBBB (p < 0.001), pLBBB (p < 0.001), rLBBB (p < 0.001), RBBB (p = 0.04), and IVCD groups (p = 0.03). LV EF significantly improved in the LBBB (p < 0.001), rLBBB (p = 0.002), and pLBBB (p < 0.001) groups, but the RBBB and IVCD groups showed no improvement. There was no significant difference in mortality between the LBBB and rLBBB groups. LV EF post-CRT, chronic kidney disease, hyperkalaemia, hypernatremia, and age at implant were significant predictors of mortality. CONCLUSION: CRT in patients with rLBBB results in improved LV EF and similar mortality rates to CRT patients with complete LBBB. Predictors of mortality post-CRT include post-CRT LV EF, presence of CKD, hyperkalaemia, hypernatremia, and older age at implant.

Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) in patients with paroxysmal atrial fibrillation (PAF) is effective but hampered by pulmonary vein reconnection due to insufficient ablation lesions. High-power delivery over a short period of time (HPSD) in RFA is stated to create more efficient lesions. The aim of this study was to compare intraprocedural safety and outcome of HPSD ablation to conventional power settings in patients undergoing PVI for PAF. METHODS AND RESULTS: We included 197 patients with PAF that were scheduled for PVI. An ablation protocol with 70 W and a duration cut-off of 7 s at the anterior left atrium (LA) and 5 s at the posterior LA (HPSD group; n = 97) was compared to a conventional power protocol with 30-40 W for 20-40 s (standard group; n = 100) in terms of periprocedural complications and a 1-year outcome. The HPSD group showed significantly less arrhythmia recurrence during 1-year follow-up with 83.1% of patients free from atrial fibrillation compared to 65.1% in the standard group (P < 0.013). No pericardial tamponade, periprocedural thromboembolic complications, or atrio-oesophageal fistula occurred in either group. Mean radiofrequency time (12.4 ± 3.4 min vs. 35.6 ± 12.1 min) and procedural time (89.5 ± 23.9 min vs. 111.15 ± 27.9 min) were significantly shorter in the HPSD group compared to the standard group (both P < 0.001). CONCLUSION: High-power short-duration ablation demonstrated a comparable safety profile to conventional ablation. High-power short-duration ablation using 70 W for 5-7 s leads to significantly less arrhythmia recurrences after 1 year. Radiofrequency and procedural time were significantly shortened.

Early recurrence after pulmonary vein isolation is associated with inferior long-term outcomes: Insights from a retrospective cohort study.

AIMS: The aim of this retrospective cohort study was to assess the influence of early recurrence (ER) after pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) on long-term outcomes and to identify clinical variables associated with ER. METHODS: We retrospectively collected clinical and procedural data from 1285 patients with paroxysmal AF who underwent PVI from 2011 to 2016. Kaplan-Meier, receiver operating characteristic (ROC) curve, logistic and Cox regression analyses were performed to analyze the influence of ER on long-term outcomes. RESULTS: ER was observed in 13% of patients. Kaplan-Meier analyses showed significantly different outcomes in 1285 patients with and without ER (49% vs 74%, log rank P < .01) and in 286 patients in the subgroup that underwent reablation (44% vs 79%, log rank P < .01). The hazard ratio (HR) of ER was 1.7 within 48 hours (5% of patients), 2.7 within 1 month (5%), 3.0 within 2 months (2%), and 6.4 within 3 months (1%) for late recurrence (LR), P < .01. ROC analysis (area under the curve [AUC] = 0.79) resulted in 70.3% sensitivity and 74.2% specificity for a 14-day blanking period, and 53.1% sensitivity and 85.5% specificity for a 30-day blanking period. Female patients (odds ratio [OR] 1.69, P < .01) and those with diabetes (OR 1.95, P = .01) were at higher risk for ER. CONCLUSIONS: ER is observed in a substantial number of patients with paroxysmal AF after PVI and has a continuous direct effect on LR according to the timing of ER. Randomized trials are required to assess the safety and effects of reablations in a shortened blanking period on long-term outcomes.

Catheter ablation of left atrial arrhythmias on uninterrupted oral anticoagulation with vitamin K antagonists: What is the relationship between international normalized ratio, activated clotting time, and procedure-related complications?

BACKGROUND: Ablation of atrial fibrillation (AF) on uninterrupted phenprocoumon reduces periprocedural thromboembolic and bleeding complications. Heparin is administered intraprocedurally to achieve activated clotting times (ACT) of 300-400 seconds. We investigated the effect of international normalized ratio (INR) on ACT and intraprocedural heparin requirements. Moreover, safety of a target ACT of 250-300 seconds was investigated. METHODS AND RESULTS: We studied 949 patients referred for AF or left atrial tachycardia ablation. Patients were divided into Group 1 (n = 249) with an INR <2 and Group 2 (n = 700) with an INR ≥2. Mean INR was 1.7 ± 0.13 in Group 1 and 2.3 ± 0.25 in Group 2. Baseline, mean, minimum and maximum ACT were significantly lower in Group 1 (138 ± 17 seconds vs. 145 ± 21 seconds; 281 ± 28 seconds vs. 288 ± 29 seconds; 251 ± 36 seconds vs. 258 ± 34 seconds; 307 ± 32 seconds vs. 316 ± 40 seconds; P <0.05). Intraprocedural heparin requirements adjusted to body weight were lower in Group 1 (127 ± 41 U/kg vs. 122 ± 40 U/kg). Weak correlations between INR and baseline, mean, minimum and maximum ACT as well as intraprocedural heparin requirements were observed. No differences regarding major or minor complications were found. INR and periprocedural anticoagulation parameters had no influence on major complications. No thromboembolic complications were observed in both groups with a target ACT value of 250-300 seconds. CONCLUSIONS: There is only a weak correlation between INR, intraprocedural ACT, and intraprocedural heparin requirements. Periprocedural target ACT of 250-300 seconds seems safe and does not increase periprocedural bleeding and thromboembolic complications in patients undergoing RF ablation on uninterrupted phenprocoumon therapy.

Predictors for long-term survival after transcatheter edge-to-edge mitral valve repair.

OBJECTIVES: To determine predictors for long-term outcome in high-risk patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for severe mitral regurgitation (MR). BACKGROUND: There is no data on predictors of long-term outcome in high-risk real-world patients. METHODS: From August 2009 to April 2011, 126 high-risk patients deemed inoperable were treated with TMVR in two high-volume university centers. RESULTS: MR could be successfully reduced to grade ≤2 in 92.1% of patients (116/126 patients). Long-term clinical follow-up up to 5 years (95.2% follow-up rate) revealed a mortality rate of 35.7% (45/126 patients). Repeat mitral valve treatment (surgery or intervention) was needed in 19 patients (15.1%). Long-term clinical improvement was demonstrated with 69% of patients being in NYHA class ≤II. In a multivariable Cox regression analysis, the post-procedural grade of MR (hazard ratio [HR] 1.55 per grade, P = 0.035), the left ventricular ejection fraction (HR 0.58 for difference between 75th and 25th percentile, P = 0.031) and the glomerular filtration rate (HR 0.33 for 75th vs 25th percentile, P < 0.001) were independent predictors for long-term mortality. Patients with primary MR and a post-procedural MR grade ≤1 had the most favorable long-term outcome. CONCLUSIONS: This study determines predictors of long-term clinical outcome after TMVR and demonstrates that the grade of residual MR determines long-term survival. Our data suggest that it might be of benefit reducing residual MR to the lowest possible MR grade using TMVR-especially in selected high-risk patients with primary MR who are not considered as candidates for surgical MVR.

Transseptal Puncture Guided by CT-Derived 3D-Augmented Fluoroscopy.

BACKGROUND: Transseptal puncture for left atrial (LA) access is still mainly performed using fluoroscopy and transesophageal or intracardiac echocardiography. We present an easily applicable approach for the guidance of transseptal puncture that uses the combination of a 3D-mapping system and CT-derived 3D-overlayed anatomy. METHODS AND RESULTS: A computer tomographic (CT) LA-angiography was performed in n = 65 patients prior to a scheduled atrial fibrillation ablation procedure. The CARTO3 (Biosense Webster, Diamond Bar, CA, USA) segmentation tool was used to create a 3D-reconstruction of cardiac anatomy and the spine. The CARTO UNIVU module was then used to overlay and register the segmented 3D-anatomy onto fluoroscopy. The 3D-reconstructed spine and cardiac anatomy were congruently aligned to their fluoroscopic counterparts in fluoroscopic views. The feasibility of the technique, its safety, and accuracy (assessed as contour offsets between 3D-overlay and angiographic LA anatomy) were evaluated. Overlay registration accuracy was analyzed by CARTO3 registration matrices. Transseptal puncture was feasible without complications in all 65 patients using the new 3D-overlay technique. Three-dimensional-overlay contour offsets were 1.6 ± 1.2 mm in left PV, 1.7 ± 1.2 mm in right PV, and 1.3 ± 1.0 mm in the LA roof region. Overlay registration accuracy was 4.9 ± 2.7 mm. The average time needed for anatomy segmentation was 204 ± 61 seconds, time needed for overlay registration was 18 ± 8 seconds. CONCLUSIONS: Three-dimensional-augmented fluoroscopy is feasible, safe, and easy to apply as guidance for transseptal puncture and demonstrates a high level of accuracy.

Electromagnetic Contact-Force Sensing Electrophysiological Catheters: How Accurate is the Technology?

BACKGROUND: Contact-force (CF) sensing catheters are increasingly used in clinical electrophysiological practice due to their efficacy and safety profile. As data about the accuracy of this technology are scarce, we sought to quantify accuracy based on in vitro experiments. METHODS AND RESULTS: A custom-made force sensor was constructed that allowed exact force reference measurements registered via a flexible membrane. A Smarttouch Surround Flow (ST SF) ablation catheter (Biosense Webster, Diamond Bar, CA, USA) was brought in contact with the membrane of the force sensor in order to compare the ST SF force measurements to force sensor reference measurements. ST SF force sensing technology is based on deflection registration between the distal and proximal catheter tip. The experiment was repeated for n = 10 ST SF catheters, which showed no significant difference in accuracy levels. A series of measurements (n = 1200) was carried out for different angles of force acting to the catheter tip (0°/perpendicular contact, 30°, 60°, 90°/parallel contact). The mean absolute differences between reference and ST SF measurements were 1.7 ± 1.8 g (0°), 1.6 ± 1.2 g (30°), 1.4 ± 1.3 g (60°), and 6.6 ± 5.9 g (90°). Measurement accuracy was significantly higher in non-parallel contact when compared with parallel contact (P < 0.01). CONCLUSIONS: Catheter force measurements using the ST SF catheters show a high level of accuracy regarding differences to reference measurements and reproducibility. The reduced accuracy in measurements of 90° acting forces (parallel contact) might be clinically important when creating, for example, linear lesions.

Evaluation of a new very low dose imaging protocol: feasibility and impact on X-ray dose levels in electrophysiology procedures.

AIMS: This study presents and evaluates the impact of a new lowest-dose fluoroscopy protocol (Siemens AG), especially designed for electrophysiology (EP) procedures, on X-ray dose levels. METHODS AND RESULTS: From October 2014 to March 2015, 140 patients underwent an EP study on an Artis zee angiography system. The standard low-dose protocol was operated at 23 nGy (fluoroscopy) and at 120 nGy (cine-loop), the new lowest-dose protocol was operated at 8 nGy (fluoroscopy) and at 36 nGy (cine-loop). Procedural data, X-ray times, and doses were analysed in 100 complex left atrial and in 40 standard EP procedures. The resulting dose-area products were 877.9 ± 624.7 µGym² (n = 50 complex procedures, standard low dose), 199 ± 159.6 µGym² (n = 50 complex procedures, lowest dose), 387.7 ± 36.0 µGym² (n = 20 standard procedures, standard low dose), and 90.7 ± 62.3 µGym² (n = 20 standard procedures, lowest dose), P < 0.01. In the low-dose and lowest-dose groups, procedure times were 132.6 ± 35.7 vs. 126.7 ± 34.7 min (P = 0.40, complex procedures) and 72.3 ± 20.9 vs. 85.2 ± 44.1 min (P = 0.24, standard procedures), radiofrequency (RF) times were 53.8 ± 26.1 vs. 50.4 ± 29.4 min (P = 0.54, complex procedures) and 10.1 ± 9.9 vs. 12.2 ± 14.7 min (P = 0.60, standard procedures). One complication occurred in the standard low-dose and lowest-dose groups (P = 1.0). CONCLUSION: The new lowest-dose imaging protocol reduces X-ray dose levels by 77% compared with the currently available standard low-dose protocol. From an operator standpoint, lowest X-ray dose levels create a different, reduced image quality. The new image quality did not significantly affect procedure or RF times and did not result in higher complication rates. Regarding radiological protection, operating at lowest-dose settings should become standard in EP procedures.

Impact of the Right Ventricular Lead Position on Clinical End Points in CRT Recipients--A Subanalysis of the Multicenter Randomized SPICE Trial.

BACKGROUND: The impact of right ventricular (RV) lead location on clinical end points in patients undergoing cardiac resynchronization therapy (CRT) is unclear. We evaluated the impact of different RV lead locations on clinical outcome in CRT patients enrolled in the Septal Positioning of ventricular implantable cardioverter-defibrillator (ICD) Electrodes (SPICE) trial, which randomized recipients of implantable cardioverter defibrillators to apical versus midseptal RV lead positioning. METHODS: Ninety-eight CRT recipients were included in the multicenter SPICE trial and followed for 12 months: Fifty-three patients were randomized to receive an apical (A) and 45 to receive a midseptal (S) lead position. We compared echocardiographical and electrocardiographical parameters and outcome. RESULTS: Echocardiographic response with respect to improvement of left ventricular ejection fraction (A: +15.8 ± 14.6%, S: +9.7 ± 12.6%, P = 0.156) and reduction of left ventricular end-diastolic diameter (A: -4.2 ± 10.7 mm, S: -7.5 ± 10.7 mm, P = 0.141) was comparable in apical and midseptal groups. Paced QRS width neither differed at prehospital discharge (A: 129 ± 21 ms, S: 135 ± 21 ms, P = 0.133) nor at 12-month follow-up (A: 131 ± 23 ms, S: 134 ± 28 ms, P = 0.620). No differences were found with respect to the risk of ventricular tachyarrhythmia or ICD therapy. Septal RV lead position, however, was associated with a significant longer time to a first heart failure event (P = 0.040) and a longer survival time (P = 0.019). CONCLUSIONS: In CRT recipients, midseptal RV lead position was not superior with respect to improvement of echocardiographic parameters or paced QRS width. It did not predispose to ventricular arrhythmias or ICD therapy. The finding that midseptal lead position was associated with a longer time to first heart failure event and a longer survival time deserves further investigation.

Sensor-Based Electromagnetic Navigation (Mediguide®): How Accurate Is It? A Phantom Model Study.

BACKGROUND: Data about localization reproducibility as well as spatial and visual accuracy of the new MediGuide® sensor-based electroanatomic navigation technology are scarce. We therefore sought to quantify these parameters based on phantom experiments. METHODS AND RESULTS: A realistic heart phantom was generated in a 3D-Printer. A CT scan was performed on the phantom. The phantom itself served as ground-truth reference to ensure exact and reproducible catheter placement. A MediGuide® catheter was repeatedly tagged at selected positions to assess accuracy of point localization. The catheter was also used to acquire a MediGuide®-scaled geometry in the EnSite Velocity® electroanatomic mapping system. The acquired geometries (MediGuide®-scaled and EnSite Velocity®-scaled) were compared to a CT segmentation of the phantom to quantify concordance. Distances between landmarks were measured in the EnSite Velocity®- and MediGuide®-scaled geometry and the CT dataset for Bland-Altman comparison. The visualization of virtual MediGuide® catheter tips was compared to their corresponding representation on fluoroscopic cine-loops. Point localization accuracy was 0.5 ± 0.3 mm for MediGuide® and 1.4 ± 0.7 mm for EnSite Velocity®. The 3D accuracy of the geometries was 1.1 ± 1.4 mm (MediGuide®-scaled) and 3.2 ± 1.6 mm (not MediGuide®-scaled). The offset between virtual MediGuide® catheter visualization and catheter representation on corresponding fluoroscopic cine-loops was 0.4 ± 0.1 mm. CONCLUSIONS: The MediGuide® system shows a very high level of accuracy regarding localization reproducibility as well as spatial and visual accuracy, which can be ascribed to the magnetic field localization technology. The observed offsets between the geometry visualization and the real phantom are below a clinically relevant threshold.

Long-term outcome of patients with severe biventricular heart failure and severe mitral regurgitation after percutaneous edge-to-edge mitral valve repair.

OBJECTIVE: To assess long-term outcome and parameters associated with poor and favorable outcome in patients with a left ventricular ejection fraction (LV-EF) ≤25% and severe mitral regurgitation (MR) after percutaneous edge-to-edge mitral valve repair (pMVR). BACKGROUND: There is no data on long-term outcome in this cohort of patients. METHODS: We analyzed all 34 patients with a LV-EF ≤25% and severe MR treated with pMVR in 2 university hospitals from 2009 to 2012. RESULTS: Mitral regurgitation could be successfully reduced to grade ≤2 in 30 patients (88%). Long-term follow-up (up to 5 years) revealed a steep decline of the survival curve reaching 50% already 8 month after pMVR. In contrast, estimated survival of the remaining patients showed a favorable long-term outcome. Patients deceased during the first year presented with higher right ventricular tricuspid pressure gradient (RVTG) (44.5 ± 8.4 mmHg vs. 35.2 ± 15.4 mmHg, P = 0.035) and worse RV-function (P = 0.014) prior to the procedure. One-year mortality of patients with pulmonary hypertension and depressed RV-function (n = 22) was very high (77%) compared to the remaining patients (n = 12, mortality rate of 0%, P = 0.0001). CONCLUSIONS: Although pMVR lead to a successful reduction of MR in patients with a LV-EF ≤25%, 1-year mortality in this cohort was very high. However, a subgroup of patients showed a favorable long-term outcome after pMVR. Especially the right ventricular parameters sustained RV-function and absence of pulmonary hypertension-easily assessed with echocardiography-might be used to identify this subgroup and encourage pMVR in these patients.

A stepwise electrocardiographic algorithm for differentiation of mid-septal vs. apical right ventricular lead positioning: the SPICE ECG substudy.

AIMS: Right ventricular (RV) septum is a non-apical site targeted during lead implantation. Electrocardiographic (ECG) recognition of mid-septal lead location is challenging. The aim of the study is to determine ECG correlates of RV mid-septal pacing. METHODS AND RESULTS: The present study is a pre-specified analysis of a prospective, multicenter study, which randomized recipients of an implantable cardioverter defibrillator to an apical vs. mid-septal RV lead positioning. Following implantation, a 12-lead ECG was recorded during intrinsic rhythm and RV pacing. In total, 227 patients, 121 in the apical group (76.9% males, 67.1 ± 11.3 years) and 106 in the mid-septal group (82.1% males, age 64.7 ± 12.7 years) were included. Apically as compared with septally paced patients had significantly longer paced QRS duration (177.0 ± 25.0 vs. 170.4 ± 21.7, respectively, P = 0.03) and significantly more leftward paced QRS axis (-71.6 ± 33.3° vs. 9.4 ± 86.5°, respectively, P < 0.001). A significantly higher proportion of patients in the mid-septal as compared with the apical group displayed predominantly positive QRS in lead V6 (62.3 vs. 4.1%, P < 0.001), predominantly positive QRS in any of the inferior leads (53.8 vs. 4.1%, P < 0.001), and a QR pattern in lead aVL (53.3 vs. 3.3%, P < 0.001). These ECG correlates were incorporated in a stepwise algorithm with total sensitivity of 87% and specificity of 90% for the identification of a mid-septal lead location. CONCLUSION: A mid-septal lead location may be identified using a simple stepwise algorithm, based on the presence of positive QRS in lead V6, positive QRS in any of the inferior leads, and a QR pattern in lead aVL.

Catheter Ablation of Ventricular Arrhythmias using a Fluoroscopy Image Integration Module.

BACKGROUND: The impact of the CartoUnivu™ technology (Biosense Webster, Diamond Bar, CA, USA) on fluoroscopy exposure compared to a conventional approach using electroanatomical mapping (Carto 3™) was evaluated in patients undergoing radiofrequency ablation for ventricular tachyarrhythmias (VT). METHODS AND RESULTS: We prospectively evaluated 23 patients undergoing VT ablation using the CartoUnivu™ technology. The CartoUnivu™ Module integrates fluoroscopic images and cine loops into the electroanatomical mapping system. As a control group, 23 out of 88 VT patients (ablated using conventional fluoroscopy supplemented by electromagnetic mapping with the Carto 3™ System) were matched for age, gender, body surface area, operator, redo-procedure, presence of coronary artery disease, and left ventricular dysfunction using propensity score matching. A significant reduction in fluoroscopy exposure was observed in the CartoUnivu™ group when compared to the conventional group (10.57 ± 7.93 minutes vs 18.52 ± 11.24 minutes, P_= 0.008; 611 cGy/cm(2) vs 1650 cGy/cm(2) , P = 0.001). In multivariate analysis, the CartoUnivu™ module was an independent predictor of reduced fluoroscopy use. CONCLUSION: This is a report on the clinical application of the CartoUnivu system for VT ablation. CartoUnivu™ markedly reduced fluoroscopy time and dose compared to conventional fluoroscopy/electroanatomical mapping.

Impact of comorbidity on complication rates and life expectancy in patients with a leadless pacemaker.

BACKGROUND: Knowledge about impact of age and comorbidities on outcome in patients with leadless pacemakers (LPM) is limited. OBJECTIVES: To analyse outcome in LPM patients according to age and comorbidities. METHODS: This Swiss, multi-centre, retrospective analysis includes all patients with LPM implanted between 2015 and 2022. Charlson-Comorbidity-Index (CCI) was determined and patients were divided into a low- (CCI ≤ 5) and high-comorbidity (CCI > 5) group. Peri-procedural complications, in-hospital death, and all-cause mortalities were assessed. Finally, all-cause mortality according to three groups (CCI ≤ 3, 4-5, >5) was compared to age and sex-adjusted mortality in the general Swiss population. RESULTS: 863 patients (median age 81 years, 65% male, 42% with CCI > 5) were included. Peri-procedural/long-term complication rates did not differ between the low- vs. high-comorbidity groups (2.6% vs. 1.7%, p = 0.48 and 1.2% vs. 2.8%, p = 0.12, respectively). In-hospital (3.6% vs. 0.6%, p = 0.002) and all-cause mortality (HR 2.9, 95%CI 2.2-3.8, p < 0.001) were significantly higher in the high-comorbidity group resulting in a three-year mortality of 58% (95%CI 51-65%) vs. 22% (95%CI 17-27%) in the low-comorbidity group. In patients with a CCI ≤ 3, all-cause mortality was comparable to the age- and sex-adjusted mortality of the general Swiss population. CONCLUSIONS: In elderly patients with high comorbidity, LPM implantation was not associated with increased peri-procedural/long-term complications. All-cause mortality in LPM patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. Despite a relatively high three-year mortality due to competing risk factors, LPM implantation is safe, even in elderly patients with high comorbidity. CONDENSED ABSTRACT: In this Swiss, multi-centre, retrospective cohort analysis, 863 patients implanted with a leadless pacemaker were included and divided into a high-comorbidity (with a CCI > 5) and low-comorbidity (with a CCI ≤ 5) group. There was no between group difference in terms of implantation outcomes and peri-operative or long-term complications. Furthermore, all-cause mortality during follow-up in patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. These data indicate that LPM implantation is a safe procedure, even in elderly patients with high comorbidity.