Prospective randomized controlled trial of simulator-based versus traditional in-surgery laparoscopic camera navigation training

Background: Surgical residents often use a laparoscopic camera in minimally invasive surgery for the first time in the operating room (OR) with no previous education or experience. Computer-based simulator training is increasingly used in residency programs. However, no randomized controlled study has compared the effect of simulator-based versus the traditional OR-based training of camera navigation skills. Methods: This prospective randomized controlled study included 24 pregraduation medical students without any experience in camera navigation or simulators. After a baseline camera navigation test in the OR, participants were randomized to six structured simulator-based training sessions in the skills lab (SL group) or to the traditional training in the OR navigating the camera during six laparoscopic interventions (OR group). After training, the camera test was repeated. Videos of all tests (including of 14 experts) were rated by five blinded, independent experts according to a structured protocol. Results: The groups were well randomized and comparable. Both training groups significantly improved their camera navigational skills in regard to time to completion of the camera test (SL P=0.049; OR P=0.02) and correct organ visualization (P=0.04; P=0.03). Horizon alignment improved without reaching statistical significance (P=0.20; P=0.09). Although both groups spent an equal amount of actual time on camera navigation training (217 vs. 272min, P=0.20), the SL group spent significantly less overall time in the skill lab than the OR group spent in the operating room (302 vs. 1002min, P<0.01). Conclusion: This is the first prospective randomized controlled study indicating that simulator-based training of camera navigation can be transferred to the OR using the traditional hands-on training as controls. In addition, simulator camera navigation training for laparoscopic surgery is as effective but more time efficient than traditional teachin

Unexpected high failure rate of a specific MicroPort/LivaNova/Sorin pacing lead.

BACKGROUND Pacing leads are the Achilles heel of pacemakers. Most manufacturers report a 3-year survival rate of >99% of their leads. We observed several failures of the Beflex/Vega leads (MicroPort, Shanghai, China; formerly Sorin/LivaNova). OBJECTIVE The purpose of this study was to investigate failure rates of Beflex/Vega leads. METHODS We analyzed the performance of Beflex/Vega leads implanted at our tertiary referral center. All-cause lead failures (any issues requiring reinterventions such as lead dislocations, cardiac perforations, and electrical abnormalities) were identified during follow-up. The Beflex/Vega lead was compared with a reference lead (CapSureFix Novus 5076, Medtronic, Minneapolis, MN) implanted within the same period and by the same operators. RESULTS A total of 585 leads were analyzed (382 Beflex/Vega and 203 CapSureFix Novus 5076 leads). Cumulative failure rate estimates were 5.2%, 6.3%, and 12.4% after 1, 2, and 3 years for the Beflex/Vega lead. This was worse compared to the reference lead (1.5%, 1.5%, 3.7% after 1, 2, and 3 years; P = .001). Early failure manifestations up to 3 months occurred at a similar rate (Beflex/Vega vs CapSureFix Novus 5076 lead: 1.3% vs 0.5% for dislocations; 1.3% vs 1.0% for perforations). During follow-up, electrical abnormalities such as noise oversensing (P = .013) and increased pacing thresholds (P = .003) became more frequent in the Beflex/Vega group. Electrical abnormalities were the most common failure manifestation 3 years after implantation in this group (9.4% vs 2.2% for the CapSureFix Novus 5076). CONCLUSION The failure rate of the Beflex/Vega lead of >10% after 3 years was higher than that of a competitor lead. This gives rise to concern since >135,000 such leads are active worldwide

Validation of a multipolar pulsed-field ablation catheter for endpoint assessment in pulmonary vein isolation procedures.

AIMS To validate the performance of a multipolar pulsed-field ablation (PFA) catheter compared to a standard pentaspline 3D-mapping catheter for endpoint assessment of pulmonary vein isolation (PVI). PFA for PVI using single-shot devices combines the benefits of high procedural efficacy and safety. A newly available multipolar PFA catheter allows real-time recording of pulmonary vein (PV) signals during PVI. METHODS AND RESULTS Patients undergoing first PVI using PFA with the standard ablation protocol (eight applications per PV) were studied. Entrance and exit block (10 V/2 ms) were assessed using the PFA catheter. Subsequently, a high-density 3D electroanatomical bipolar voltage map (3D-EAM) was constructed using a standard pentaspline 3D-mapping catheter. Additional PFA applications were delivered only after confirmation of residual PV connection by 3D-EAM. In 56 patients, 213 PVs were targeted for ablation. Acute PVI was achieved in 100% of PVs: in 199/213 (93%) PVs with the standard ablation protocol alone and in the remaining 14 PVs after additional PFA applications. The accuracy of PV assessment with the PFA catheter after the standard ablation protocol was 91% (194/213 veins). In 5/213 (2.3%) PVs, the PFA catheter incorrectly indicated PV-isolation. In 14/213 (6.6%), the PFA catheter incorrectly indicated residual PV-conduction due to high-output pace-capture. Lowering the output to 5 V/1 ms reduced this observation to 0.9% (2/213) and increased the overall accuracy to 97% (206/213). CONCLUSION A novel multipolar PFA catheter allows reliable endpoint assessment for PVI. Due to its design, far-field sensing and high-output pace-capture can occur. Lowering the pacing output increases the accuracy from 91 to 97%

Acute and Long-term Outcomes of quadripolar IS-4 versus bipolar IS-1 Left Ventricular Leads in Cardiac Resynchronization Therapy: A Retrospective Registry Study.

BACKGROUND The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary. METHODS In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint. RESULTS Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03±1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = 0.002). The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs 22.4%; p = 0.003; 4.5% vs. 17.9%; p = 0.015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = 0.029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = 0.036). CONCLUSION In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU. This article is protected by copyright. All rights reserved

Efficacy and safety of ethanol infusion into the vein of Marshall for mitral isthmus ablation.

INTRODUCTION Chemical ablation by retrograde infusion of ethanol into the vein of Marshall (VOM-EI) can facilitate the achievement of mitral isthmus block. This study sought to describe the efficacy and safety of this technique. METHODS AND RESULTS Twenty-two consecutive patients (14 males, median age 71 years) with attempted VOM-EI for mitral isthmus ablation were included in the study. VOM-EI was successfully performed with a median of 4 ml of 96% ethanol in 19 patients (86%) and the mitral isthmus was successfully blocked in all (100%). Touch up endocardial and/or epicardial ablation after VOM-EI was necessary for 12 patients (63%). Perimitral flutter was present in 12 patients (63%) during VOM-EI and terminated or slowed by VOM-EI in 4 and 3 patients, respectively. The low-voltage area of the mitral isthmus region increased from 3.1 cm2 (interquartile range [IQR] 0-7.9) before to 13.2 cm2 (IQR: 8.2-15.0) after VOM-EI and correlated significantly with the volume of ethanol injected (p = .03). Median high-sensitive cardiac troponin-T increased significantly from 330 ng/L (IQR: 221-516) the evening of the procedure to 598 ng/L (IQR: 382-769; p = .02) the following morning. A small pericardial effusion occurred in three patients (16%), mild pericarditis in one (5%), and uneventful VOM dissection in two (11%). After a median follow-up of 3.5 months (IQR: 3.0-11.0), 10 of 18 patients (56%) with VOM-EI and available follow-up had arrhythmia recurrence. Repeat ablation was performed in five patients (50%) and peri-mitral flutter diagnosed in three (60%). CONCLUSION VOM-EI is feasible, safe, and effective to achieve acute mitral isthmus block

Efficacy and safety of ethanol infusion into the vein of Marshall for mitral isthmus ablation

INTRODUCTION Chemical ablation by retrograde infusion of ethanol into the vein of Marshall (VOM-EI) can facilitate the achievement of mitral isthmus block. This study sought to describe the efficacy and safety of this technique. METHODS AND RESULTS Twenty-two consecutive patients (14 males, median age 71 years) with attempted VOM-EI for mitral isthmus ablation were included in the study. VOM-EI was successfully performed with a median of 4 ml of 96% ethanol in 19 patients (86%) and the mitral isthmus was successfully blocked in all (100%). Touch up endocardial and/or epicardial ablation after VOM-EI was necessary for 12 patients (63%). Perimitral flutter was present in 12 patients (63%) during VOM-EI and terminated or slowed by VOM-EI in 4 and 3 patients, respectively. The low-voltage area of the mitral isthmus region increased from 3.1 cm2 (interquartile range [IQR] 0-7.9) before to 13.2 cm2 (IQR: 8.2-15.0) after VOM-EI and correlated significantly with the volume of ethanol injected (p = .03). Median high-sensitive cardiac troponin-T increased significantly from 330 ng/L (IQR: 221-516) the evening of the procedure to 598 ng/L (IQR: 382-769; p = .02) the following morning. A small pericardial effusion occurred in three patients (16%), mild pericarditis in one (5%), and uneventful VOM dissection in two (11%). After a median follow-up of 3.5 months (IQR: 3.0-11.0), 10 of 18 patients (56%) with VOM-EI and available follow-up had arrhythmia recurrence. Repeat ablation was performed in five patients (50%) and peri-mitral flutter diagnosed in three (60%). CONCLUSION VOM-EI is feasible, safe, and effective to achieve acute mitral isthmus block