Safety and acute efficacy of cryoballoon ablation for atrial fibrillation at community hospitals.

AIMS: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is an established procedure for treating symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI performed at community hospitals are unknown. We aimed to determine the safety and acute efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. METHODS AND RESULTS: This registry study included 1004 consecutive patients who had PVI performed for symptomatic paroxysmal (n = 563) or persistent AF (n = 441) from January 2019 to September 2020 at 20 hospitals. Each hospital performed fewer than 100 CBA-PVI procedures/year according to local standards. Procedural data, efficacy, and complication rates were determined. The mean number of CBA procedures performed/year at each centre was 59 ± 25. The average procedure time was 90.1 ± 31.6 min and the average fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins was documented in 97.9% of patients. The most frequent reason for not achieving complete isolation was development of phrenic nerve palsy. No hospital deaths were observed. Two patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in six patients (0.6%), two of whom (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), two of whom (0.2%) required vascular surgery. Phrenic nerve palsy occurred in 48 patients (4.8%) and persisted up to hospital discharge in six patients (0.6%). CONCLUSION: Pulmonary vein isolation procedures for paroxysmal or persistent AF using CBA can be performed at community hospitals with high acute efficacy and low complication rates.

Hemodynamic monitoring by intracardiac impedance measured by cardiac resynchronization defibrillators: Evaluation in a controlled clinical setting (BIO.Detect HF II study).

BACKGROUND: In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), intracardiac impedance measured by dedicated CRT-D software may be used to monitor hemodynamic changes. We investigated the relationship of hemodynamic parameters assessed by intracardiac impedance and by echocardiography in a controlled clinical setting. METHODS: The study enrolled 68 patients (mean age, 66 ± 9 years; 74% males) at 12 investigational sites. The patients had an indication for CRT-D implantation, New York Heart Association class II/III symptoms, left ventricular ejection fraction 15%-35%, and a QRS duration ≥150 ms. Two months after a CRT-D implantation, hemodynamic changes were provoked by overdrive pacing. Intracardiac impedance was recorded at rest and at four pacing rates ranging from 10 to 40 beats/min above the resting rate. In parallel, echocardiography measurements were performed. We hypothesized that a mean intra-individual correlation coefficient (rmean) between stroke impedance (difference between end-systolic and end-diastolic intracardiac impedance) measured by CRT-D and the aortic velocity time integral (i.e., stroke volume) determined by echocardiography would be significantly larger than 0.65. RESULTS: The hypothesis was evaluated in 40 patients with complete data sets. The rmean was 0.797, with a lower confidence interval bound of 0.709. The study hypothesis was met (p = 0.007). A stepwise reduction of stroke impedance and stroke volume was observed with increasing heart rate. CONCLUSIONS: Intracardiac impedance measured by implanted CRT-Ds correlated well with the aortic velocity time integral (stroke volume) determined by echocardiography. The impedance measurements bear potential and are readily available technically, not requiring implantation of additional material beyond standard CRT-D system.

First interventional exchange of a left transvenous phrenic nerve stimulation lead from the novel remede system.

The remede system is a novel fully implantable transvenous phrenic nerve stimulation (TPNS) device developed to treat central sleep apnea. No information is published on how to explant or replace its leads. An eighty-one year-old had a fractured lead and we removed it over a wire. However, unbreachable resistances occurred with a new lead deployed over the enclosed wire and interventional endovascular techniques were performed to reimplant a new fully functioning system. This first report demonstrates TPNS lead exchange is possible but can be challenging. Interventional maneuvers and techniques, including balloon angioplasty, can facilitate this procedure.

Fracture of an S-ICD lead after two prior transvenous lead-related complications with conventional defibrillators.

Six months after subcutaneous implantable cardioverter defibrillator (S-ICD) implantation a 26-year-old Brugada patient presented because of a beeping tone emitted by his device. Chest X-ray displayed two functionless transvenous shock leads and the S-ICD system with a lead fracture. During lead revision procedure, extensive preparation of the lead from unexpectedly firm surrounding fibrous tissue encapsulating the lead was necessary before it could be removed, and a new shock lead could be implanted. This is the first report of an S-ICD lead exchange due to very early lead fracture and unexpectedly severe fibrous tissue hampering surgical lead extraction.

Interventional techniques to increase implantation success of transvenous phrenic nerve stimulation for central sleep apnea treatment.

PURPOSE: Central sleep apnea (CSA) is a highly common comorbidity in heart failure (HF) patients and is known to deteriorate quality of life and prognosis. Effective treatment options are scarce. Transvenous phrenic nerve stimulation (PNS) has been shown to be effective and safe in CSA treatment in HF. However, lead implantation may be difficult or fail due to anatomical or technical challenges. We report novel and innovative approaches applying different interventional techniques to enhance PNS implantation success, allowing otherwise missing CSA treatment. METHODS: Twenty-seven consecutive HF patients (86% male, mean age: 69 ± 11 years; reduced left ventricular ejection fraction in 16 patients (57%)) were included in this study who were unable to tolerate or had contraindications for mask-based therapy. We evaluated PNS total implantation success, procedural characteristics, and feasibility and success rates of intravascular interventions to facilitate PNS lead implantation in otherwise ineffective procedures. RESULTS: Seven lead implantation attempts (24%) required additional intravascular interventional action to facilitate successful implantation, mainly consisting of balloon angioplasties to allow optimal PNS lead placement. Two procedures remained unsuccessful and two patients underwent a second procedure due to stimulation side effects and lead fracture respectively. All over, no complications resulted from application of interventional techniques to achieve a 93% implantation success rate. CONCLUSION: Transvenous PNS lead placement for CSA treatment can be difficult and challenging. However, interventional intravascular techniques markedly increase implantation success and thereby allow application of this therapy for effective CSA treatment in most patients without additional complications.

How to implant a phrenic nerve stimulator for treatment of central sleep apnea?

BACKGROUND: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA. OBJECTIVE: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remede System, Respicardia, Inc). METHODS: The remede System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration. RESULTS: In the remede System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty-two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months. CONCLUSION: In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.

Shock efficacy of single and dual coil electrodes-new insights from the NORDIC ICD Trial.

Aims: Dual coil (DC) electrodes are preferred to single coil (SC) electrodes because of an assumed higher shock efficacy. However, DC-electrodes may be associated with an increased difficulty and risk of lead extraction. We aimed to compare SC- and DC-electrodes with respect to the first shock efficacy (FSE) after implantable cardioverter defibrillator (ICD) implantation. Methods and results: One thousand and seventy-seven patients of the NORDIC ICD trial were randomly assigned to first time ICD implantation with or without defibrillation (DF) testing. The electrode configuration was determined before randomization. One thousand and sixty-seven patients eventually received an ICD, 516 (48.4%) with a SC- and 551 (51.6%) with a DC-electrode. DC-electrodes were preferentially selected in older patients, renal failure, atrial fibrillation, dual chamber, Cardiac Resynchronization Therapy (CRT) devices, angiotensin-converting-enzyme (ACE) inhibitors/angiotensin (AT) receptor blockers and without Sotalol. However, the preference of the investigational site was dominant over clinical parameters. The DF energy at the final electrode position was higher in SC-electrodes (adjusted difference +1.15 J; P = 0.005; only patients tested). Less patients with DC-electrodes required intra-operative system reconfiguration (adjusted difference -3.9; P = 0.046; only patients tested). Using mixed logistic regression, the FSE was 92.6% in SC- and 97.8% in DC-electrodes (adjusted odds ratio 4.3 (95% confidence interval [1.9, 9.8]; P < 0.001)). Conclusion: Dual coil-electrode selection mainly depends on the preference of the investigational site and seems to be preferred in older patients, renal failure, atrial fibrillation, dual chamber, and CRT devices. Patients with DC-electrodes required less intraoperative system reconfigurations. Dual coil-electrodes provided a substantially higher FSE during follow-up. Mortality rates were not significantly different in patients with DC- and SC-electrodes.

Reduction of radiation exposure in cryoballoon ablation procedures: a single-centre study applying intracardiac echocardiography and other radioprotective measures.

AIMS: The population treated with cryoballoon (CB) ablation is relatively young, and radiation protection is of major importance. We aimed to demonstrate that radiation exposure can be markedly reduced by intracardiac echocardiography (ICE) and optimized settings of the X-ray system. METHODS AND RESULTS: We analysed 100 patients undergoing CB pulmonary vein isolation (PVI) for treatment of paroxysmal atrial fibrillation. In 50 consecutive patients (25 male, 59 ± 13 years; Group 1), we used ICE, skipped PV angiography prior to CB inflation, and avoided fluoroscopy whenever possible. Furthermore, we reduced the frame rate, minimized distance between patient and detector, and consequently applied collimation. These patients were compared with 50 similar preceding patients in Group 2 (29 male, 61 ± 12 years). Total fluoroscopy time was reduced from 18 ± 6 min in Group 2 to 12 ± 5 min in Group 1 (P < 0.001). Moreover, the dose area product was significantly lower (1555 ± 1219 vs. 4935 ± 2094 cGycm2, P < 0.001), total freezing time was significantly shortened (1855 ± 399 vs. 2121 ± 756 s, P = 0.031), and contrast media use was significantly reduced (66 ± 25 vs. 109 ± 27 mL, P < 0.001). At the same time, total procedure duration and complication rates did not differ significantly between both groups. After a 12 months follow-up, a similar percentage of patients was free from recurrences (74% in Group 1 vs. 78% in Group 2, P = 0.640). CONCLUSION: Radiation exposure in CB PVI can be markedly reduced without prolonging procedure times, affecting the outcome or complication rates. Moreover, ICE seems to shorten total freezing time.

Additional electrodes on the Quartet™ LV lead provide more programmable pacing options than bipolar and tripolar equivalents.

AIMS: The aim of this study was to evaluate any benefits to the number of viable pacing vectors and maximal spatial coverage with quadripolar left ventricular (LV) leads when compared with tripolar and bipolar equivalents in patients receiving cardiac resynchronization therapy (CRT). METHODS AND RESULTS: A meta-analysis of five previously published clinical trials involving the Quartet™ LV lead (St Jude Medical, St Paul, MN, USA) was performed to evaluate the number of viable pacing vectors defined as capture thresholds ≤2.5 V and no phrenic nerve stimulation and maximal spatial coverage of viable vectors in CRT patients at pre-discharge (n = 370) and first follow-up (n = 355). Bipolar and tripolar lead configurations were modelled by systematic elimination of two and one electrode(s), respectively, from the Quartet lead. The Quartet lead with its four pacing electrodes exhibited the greatest number of pacing vectors per patient when compared with the best bipolar and the best tripolar modelled equivalents. Similarly, the Quartet lead provided the highest spatial coverage in terms of the distance between two furthest viable pacing cathodes when compared with the best bipolar and the best tripolar configurations (P < 0.05). Among the three modelled bipolar configurations, the lead configuration with the two most distal electrodes resulted in the highest number of viable pacing vectors. Among the four modelled tripolar configurations, elimination of the second proximal electrode (M3) resulted in the highest number of viable pacing options per patient. There were no significant differences observed between pre-discharge and first follow-up analyses. CONCLUSION: The Quartet lead with its four electrodes and the capability to pace from four anatomical locations provided the highest number of viable pacing vectors at pre-discharge and first follow-up visits, providing more flexibility in device programming and enabling continuation of CRT in more patients when compared with bipolar and tripolar equivalents.

Long-Term Experience with First-Generation Implantable Neurostimulation Device in Central Sleep Apnea Treatment.

BACKGROUND: Sleep-disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) are associated with shorter survival in patients with heart failure. A novel treatment method for this patient group is unilateral phrenic nerve stimulation by the remede® system (Respicardia Inc., Minnetonka, MN, USA), a transvenously implantable neurostimulation device, which has recently been studied in a large randomized, controlled trial. Previous literature has shown efficacy and safety of the treatment with this first-generation device, but hardly any data are available on long-term clinical parameters, the remede® device's battery lifetime, device exchangeability, lead position stability, surgical accessibility, and manageability. METHODS: We performed remede® device replacements in consecutive patients for battery depletion, and documented clinical parameters, longevity, operation procedure, complications, and difficulties. RESULTS: All patients were on neurostimulation treatment by phrenic nerve neurostimulation when device replacement became necessary. Apnea-hypopnea index (from 45 ± 4/h to 9 ± 4/h), oxygen-desaturation index (from 35 ± 7/h to 7 ± 6/h), and time spent with oxygen saturation of <90% (T < 90% from 5 ± 7% to 0 ± 0%) were improved and improvements remained constant throughout the 4-year follow-up. Mean battery life was 4.2 ± 0.2 years and mean replacement procedure time was 25 ± 5.1 minutes. Apart from conventional X-ray documentation of stable lead positions in a long-term setting, no radiation or contrast dye usage was needed and no major complications occurred. In addition, clinical exercise capacity and sleepiness symptoms improved. CONCLUSIONS: Novel remede® device shows sustained therapy efficacy and safety in terms of stable lead positions over 4 years. Long-term phrenic nerve neurostimulation therapy for central SDB/CSR appears feasible in a clinical routine setting.

Left ventricular three-dimensional quadripolar lead acute clinical study: the LILAC study.

AIMS: This multicenter acute clinical study was designed to verify novel three-dimensional (3D) quadripolar lead designs that can achieve ≤2.5 V average pacing capture threshold (PCT) not only at the apex, but also at the base of the left ventricle with phrenic nerve stimulation (PNS) avoidance for cardiac resynchronization. METHODS: During the implant procedure, up to two different left ventricular investigational leads were introduced and tested in the same target coronary vein based on the coronary sinus venogram in a wedged and unwedged position. Adverse events were collected in 30 days following the procedure. RESULTS: Eighty-seven leads were tested in 50 patients. When the best performing spiral electrode was chosen from each lead testing, the average of the best PCT on spiral in a wedged position was similar to the unwedged position (1.7 ± 1.5 V vs 1.9 ± 1.5 V, P = ns) and was similar to the wedged tip electrode average PCT (1.7 ± 1.5 V vs 1.6 ± 1.6 V, P = ns). In the majority of patients (89-96%), pacing was achievable in a mid-basal ventricular location without PNS. CONCLUSIONS: This acute study demonstrated that a 3D quadripolar spiral lead design can achieve acceptable PCTs and avoid PNS without repositioning the lead at implant in the vast majority of patients. It also demonstrated that this lead design can achieve mid-basal ventricular stimulation with low PCT and good acute stability.

Treatment of Cheyne-Stokes respiration reduces arrhythmic events in chronic heart failure.

OBJECTIVE: This study aimed to investigate whether adequate treatment of Cheyne-Stokes respiration (CSR) reduces the risk of arrhythmic events in patients with chronic heart failure (CHF). METHODS: A cohort of 403 registry patients with CHF (LVEF≤45%, NYHA-class≥2) and implanted cardioverter-defibrillator devices (ICD) was studied. They underwent overnight polygraphy, with 221 having mild or no CSR (apnea-hypopnea index [AHI]<15/h), and 182 having moderate to severe CSR (AHI>15/h). Latter ones were offered therapy with adaptive servoventilation (ASV), which 96 patients accepted and 86 rejected. During follow-up (21± 15 months) defibrillator therapies were recorded in addition to clinical and physiologic measures of heart failure severity. RESULTS: Event-free survival from (a) appropriate cardioverter-defibrillator therapies and (b) appropriately monitored ventricular arrhythmias was shorter in the untreated CSR group compared to the treated CSR and the no CSR group. Stepwise Cox proportional hazard regression analysis showed untreated CSR (a: hazard ratio [HR] 1.99, 95% confidence interval [CI] 1.46-2.72, P < 0.001; b: HR 2.19, 95%CI 1.42-3.37, P < 0.001), but not treated CSR (a: HR 1.06, 95%CI 0.74-1.50; P = 0.77; b: HR 1.21, 95%CI 0.75-1.93, P = 0.43) was an independent risk factor. The treated CSR group showed improvements in cardiac function and respiratory stability compared to the untreated CSR group. CONCLUSION: This study demonstrates a decrease of appropriate defibrillator therapies by ASV treated CSR in patients with CHF and ICD. A reduced exposure to hyperventilation, hypoxia, and improvement in indices of CHF severity and neurohumoral disarrangements are potential causative mechanisms.

Acute effects of multisite left ventricular pacing on mechanical dyssynchrony in patients receiving cardiac resynchronization therapy.

BACKGROUND: A novel quadripolar left ventricular (LV) pacing lead has the ability to deliver multisite LV pacing (MSLV). We set out to characterize the safety and changes in acute mechanical dyssynchrony with MSLV in cardiac resynchronization therapy (CRT) patients. METHODS AND RESULTS: Prospective multicenter study in 52 patients receiving CRT. An acute pacing protocol comprising 8 MSLV configurations covering a range of delays was compared with conventional CRT (baseline). Transthoracic tissue Doppler imaging (TDI) was used to measure the standard deviation of time to peak contraction of 12 LV segments (Ts-SD) and delayed longitudinal contraction. No ventricular arrhythmia occurred in any of the 52 patients. Complete TDI datasets were collected in 41 patients. Compared with baseline: 1) The mean Ts-SD was significantly lower for the optimal MSLV configuration (35.3 ± 36.4 vs 50.2 ± 29.1 ms; P < .001); 2) at least 1 MSLV configuration exhibited a significant dyssynchrony improvement in 63% of patients; and 3) the mean number of LV segments with delayed longitudinal contractions was significantly reduced with the optimal MSLV configuration (0.37 ± 7.99 vs 2.20 ± 0.19; P < .001). CONCLUSIONS: Acute MSLV was acutely safe, and a proportion of MSLV vectors resulted in a significant reduction in echocardiographic dyssynchrony compared with conventional CRT.

Transvenous phrenic nerve stimulation for the treatment of central sleep apnoea in heart failure.

AIMS: Periodic breathing with central sleep apnoea (CSA) is common in heart failure patients and is associated with poor quality of life and increased risk of morbidity and mortality. We conducted a prospective, non-randomized, acute study to determine the feasibility of using unilateral transvenous phrenic nerve stimulation for the treatment of CSA in heart failure patients. METHODS AND RESULTS: Thirty-one patients from six centres underwent attempted transvenous lead placement. Of these, 16 qualified to undergo two successive nights of polysomnography-one night with and one night without phrenic nerve stimulation. Comparisons were made between the two nights using the following indices: apnoea-hypopnoea index (AHI), central apnoea index (CAI), obstructive apnoea index (OAI), hypopnoea index, arousal index, and 4% oxygen desaturation index (ODI4%). Patients underwent phrenic nerve stimulation from either the right brachiocephalic vein (n = 8) or the left brachiocephalic or pericardiophrenic vein (n = 8). Therapy period was (mean ± SD) 251 ± 71 min. Stimulation resulted in significant improvement in the AHI [median (inter-quartile range); 45 (39-59) vs. 23 (12-27) events/h, P = 0.002], CAI [27 (11-38) vs. 1 (0-5) events/h, P≤ 0.001], arousal index [32 (20-42) vs. 12 (9-27) events/h, P = 0.001], and ODI4% [31 (22-36) vs. 14 (7-20) events/h, P = 0.002]. No significant changes occurred in the OAI or hypopnoea index. Two adverse events occurred (lead thrombus and episode of ventricular tachycardia), though neither was directly related to phrenic nerve stimulation therapy. CONCLUSION: Unilateral transvenous phrenic nerve stimulation significantly reduces episodes of CSA and restores a more natural breathing pattern in patients with heart failure. This approach may represent a novel therapy for CSA and warrants further study.

Twelve-month efficacy of second-generation cryoballoon ablation for atrial fibrillation performed at community hospitals: results of the German register on cryoballoon ablation in local hospitals (regional).

BACKGROUND: The 12-month follow-up (F/U) efficacy of CBA PVI performed at community hospitals for treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF) is unknown. This study determined the 12-month efficacy of pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) performed at community hospitals with limited annual case numbers. METHODS: This registry study included 983 consecutive patients (pts) from 19 hospitals, each with an annual procedural volume of < 100 PVI procedures/year. Pts underwent CBA PVI for paroxysmal AF (n = 520), persistent AF (n = 423), or redo PVI (n = 40). The primary endpoint was frequency of documented recurrent AF, the occurrence of atrial flutter or tachycardia following a 90-day period after the index ablation and up to 12 months. The frequency of repeat ablation was determined. RESULTS: Isolation of all PVs was documented in 98% of pts at the end of the procedure. Twelve-month F/U data could be obtained in 916 pts. A 24-h ECG registration was performed in 641 pts (70.0%); in 107 pts (16.7%) of them, recurrent AF was documented. The primary endpoint was met in 193 F/U pts (21.1%). It occurred in 80/486 F/U pts with paroxysmal AF (16.4%), and in 107/390 F/U pts with persistent AF (27.4%). Redo PVI was performed in 71 pts (7.8%), and atrial flutter ablation was performed in 12 pts (1.4%). CONCLUSIONS: CBA PVI for paroxysmal or persistent AF can be performed at community hospitals with adequate rates of 12-month symptom freedom and arrhythmia recurrence. The study was registered at the German register of clinical studies (DRKS00016504).

Novel robotic catheter manipulation system integrated with remote magnetic navigation for fully remote ablation of atrial tachyarrhythmias: a two-centre evaluation.

AIMS: Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium. METHODS AND RESULTS: This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system. CONCLUSIONS: The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.

First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead.

AIMS: Cardiac resynchronization therapy (CRT) is sometimes complicated by elevated pacing thresholds and phrenic nerve stimulation (PNS), both of which may require that the coronary sinus lead be repositioned. The purpose of this study was to evaluate the performance of a novel quadripolar electrode lead and cardiac resynchronization therapy-defibrillator (CRT-D) device that enables electrical repositioning, potentially obviating a lead reposition procedure. METHODS AND RESULTS: Patients indicated for CRT were enrolled and received a quadripolar electrode lead and CRT-D device (Quartetmodel 1458Q and Promote Q; St Jude Medical, Sylmar, CA, USA). Electrical data, and the presence of PNS during pacing from each left ventricular (LV) configuration, were documented at pre-hospital discharge and at 1 month. Seventy-five patients were enrolled and 71 were successfully implanted with a Quartetlead. Electrical measurements were stable over the follow-up period. Ninety-seven per cent (64 of 66) of patients had one or more programmable configurations with a threshold < 2.5 V and no PNS vs. 86% (57 of 66) if only conventional bipolar configurations were considered. Physicians were able to use the increased programming options to manage threshold changes and PNS. CONCLUSION: The new quadripolar electrode LV lead provides more programming options to address common problems faced when managing CRT patients. Electrical measurements from new vectors are comparable with conventional configurations. Furthermore, 11% of patients in the study suffered PNS on all conventional bipolar vectors.

Three-dimensional coronary sinus reconstruction-guided left ventricular lead implantation based on intraprocedural rotational angiography: a novel imaging modality in cardiac resynchronization device implantation.

AIMS: Rotational angiography (RA) of the coronary sinus (CS) provides more anatomical insights compared with static angiographies. We evaluated intraprocedural three-dimensional (3D) CS reconstruction (RC) based on RA, using syngo(®) DynaCT Cardiac to guide CS lead implantation. METHODS AND RESULTS: In 24 patients with indication for cardiac resynchronization therapy, intraprocedural RA and 3D RC of the CS was performed. Lead placement was guided by 3D image integration into real-time fluoroscopy. Rotational angiography and 3D RCs were evaluated regarding visibility of the CS and tributaries, CS-to-target vein angles, and vessel diameters. The target vein for CS lead implantation, identified by RA, was successfully displayed by 3D RC in 20 (91%) of 22 patients with adequate RA. All lead implantations were guided successfully by 3D image integration into real-time fluoroscopy. Cranial or caudal angulations were used in 95% of the procedures without further angiographies. Rotational angiography displayed a mean of 2.9 ± 1.0 second-order side branches compared with 1.8 ± 1.1 in 3D RCs (P< 0.05). The CS-to-target vein angle estimated from static projections (right anterior oblique 20°, left anterior oblique 40°, and even optimal RA view) differed substantially from 3D RCs. Main vessel diameters did not differ significantly between both techniques. CONCLUSION: Intraprocedural 3D RC of the CS and 3D image integration-guided lead placement is feasible. Coronary sinus-to-target vein angles seemed to be misestimated even by RA views compared with 3D RC. Thus RA and 3D CS RC should be applied routinely for CS lead implantation.

Intracardiac echocardiography for registration of rotational angiography-based left atrial reconstructions: a novel approach integrating two intraprocedural three-dimensional imaging techniques in atrial fibrillation ablation.

AIMS: Image integration of three-dimensional (3D) reconstructions of left atrial (LA) and pulmonary vein (PV) anatomy into electroanatomical mapping (EAM) plays a major role in atrial fibrillation (AF) ablation. Point-by-point EAM is commonly used for registration of imported LA and PV anatomy. We aimed to assess the accuracy of intraprocedural rotational angiography-based LA imaging registered by spatial reconstruction of intracardiac echocardiography (ICE) in patients undergoing AF ablation. METHODS AND RESULTS: Twenty-two patients (11 males, 66 ± 12 years) were studied. Reconstructions of LA and PVs based on rotational angiography were registered by a second 3D reconstruction based on ICE. In a second step, EAM points were added to ICE 3D reconstructions. A 3D image of the LA and PVs was reconstructed in all patients by both imaging modalities. Rotational angiography and ICE-based LA 3D reconstructions took 11.5 ± 5.2 and 20.4 ± 11.2 min, respectively. A total of 17 ± 6 two-dimensional ICE fans were used for spatial reconstruction of ICE. The deviation between the two 3D shells was 2.6 ± 0.5 mm. Integration of 78 ± 58 EAM points into ICE 3D reconstruction did not significantly reduce the deviation to rotational angiography-based reconstructions (2.7 ± 0.6 mm). All PVs were isolated successfully. CONCLUSIONS: Intraprocedural 3D reconstruction of LA and PVs for ablation of AF is feasible based on both rotational angiography and ICE. LA reconstructions based on rotational angiography can accurately be registered using 3D ICE shells. Additional EAM does not enhance accuracy. Therefore, registration of rotational angiography-based 3D reconstructions by 3D reconstructions from ICE seems to be an alternative technique to support AF ablation.