A Pilot Trial to Compare the Long-Term Efficacy of Pulmonary Vein Isolation with High-Power Short-Duration Radiofrequency Versus Laser Energy with Rapid Ablation Mode

Background: Pulmonary vein (PV) reconnection is the major cause of atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI). The probability of reconnection is higher if the primary lesion is not sufficiently effective, which can be unmasked with an adenosine provocation test (APT). High-power short-duration radiofrequency energy (HPSD) guided with ablation index (AI) and the third generation of the visually guided laser balloon (VGLB) are new methods for PVI. Methods: A total of 70 participants (35 in each group) who underwent a PVI with either AI-guided HPSD (50 W; AI 500 for the anterior and 400 for the posterior wall, respectively) or VGLB ablation were included in this observational pilot trial. Twenty minutes after each PVI, an APT was performed. The primary endpoint was the event-free survival from AF after three years. Results: A total of 137 (100%) PVs in the HPSD arm and 131 PVs (98.5%) in the VGLB arm were initially successfully isolated (p = 0.24). The overall procedure duration was similar in both arms (155 ± 39 in HPSD vs. 175 ± 58 min in VGLB, p = 0.191). Fluoroscopy time, left atrial dwelling time and duration from the first to the last ablation were longer in the VGLB arm (23 ± 8 vs. 12 ± 3 min, p < 0.001; 157 (111–185) vs. 134 (104–154) min, p = 0.049; 92(59–108) vs. 72 (43–85) min, p = 0.010). A total of 127 (93%) in the HPSD arm and 126 (95%) PVs in the VGLB arm remained isolated after APT (p = 0.34). The primary endpoint was met 1107 ± 68 days after ablation in 71% vs. 66% in the VGLB and HPSD arms, respectively (p = 0.65). Conclusions: HPSD and VGLB did not differ with respect to long-term outcome of PVI. A large, randomized study should be conducted to compare clinical outcomes with respect to these new ablation techniques

Cardiac MRI Based Left Ventricular Global Function Index: Association with Disease Severity in Patients with ICD for Secondary Prevention

Left ventricular (LV) ejection fraction (LVEF) is the most widely used prognostic marker in cardiovascular diseases. LV global function index (LVGFI) is a novel marker which incorporates the total LV structure in the assessment of LV cardiac performance. We evaluated the prognostic significance of LVGFI, measured by cardiovascular magnetic resonance (CMR), in predicting mortality and ICD therapies in a real-world (ICD) population with secondary ICD prevention indication, to detect a high-risk group among these patients. In total, 105 patients with cardiac MRI prior to the ICD implantation were included (mean age 56 ± 16 years old; 76% male). Using the MRI data for each patient LVGFI was determined and a cut-off for the LVGFI value was calculated. Patients were followed up every four to six months in our or clinics in proximity. Data on the occurrence of heart failure symptoms and or mortality, as well as device therapies and other vital parameters, were collected. Follow up duration was 37 months in median. The mean LVGFI was 24.5%, the cut off value for LVGFI 13.5%. According to the LVGFI Index patient were divided into 2 groups, 86 patients in the group with the higher LVGFI und 19 patients in the lower group. The LVGFI correlates significantly with the LVEF (r = 0.642, p I, the initial device or a medication (each p = n.s.). Further, in Kaplan–Meier analysis no association was evident between the LVGFI and adequate ICD therapy (p = n.s.). In secondary prevention ICD patients reduced LVGFI was shown as an independent predictor for mortality and rehospitalization, but not for ICD therapies. We were able to identify a high-risk collective among these patients, but further investigation is needed to evaluate LVGFI compared to ejection fraction, especially in patients with an elevated risk for adverse cardiac events

Demaskierung der verborgenen Pulmonalvenen-Überleitung mit Adenosin-Gabe nach Pulmonalvenen-Isolation mit Laserenergie

Ziel der Studie: Die elektrische Isolation der Pulmonalvenen (PV) ist das primäre Ziel bei einer Vorhofflimmerablation, welches mit den aktuellen Katheterablationsmethoden in fast allen Fällen erreicht werden kann. Jedoch die elektrische Rekonnektion der PV ist die häufigste Ursache für das Wiederauftreten des Vorhofflimmerns. Endoskopie geführte Laser-Ballon Ablation ist ein innovatives System, welches laut der bisherigen Studien ermöglicht, dass die Mehrheit der primär isolierten PV nach 3 Monaten weiterhin elektrisch diskonnektiert bleiben. Die akute Effektivität der durch die Laser-Energie hervorgerufenen Ablationsläsion ist nicht bekannt. Daher haben wir eine hypothesengenerierende Studie aufgestellt, in der die akute Effektivität der PVI mit Laserenergie mittels Adenosin-Test überprüft wurde. Methode: 26 Patienten (19 Männer; mittleres Alter 64±9 Jahre) mit paroxysmalem Vorhofflimmern wurden konsekutiv eingeschlossen. Bei allen Patienten wurde eine PVI mit Endoskopie-gesteuertem Laser-Ballon durchgeführt. Jede PV wurde mindestens 20 Minuten nach erfolgreicher Isolation mittels Adenosin-Gabe (18 mg i.v.) auf eine Rekonnektion hin überprüft. Ergebnisse: Insgesamt wurden in 26 Patienten 104 PV mittels Laserenergie angegangen. Bei zwei PV waren aufgrund einer schwierigen Ballonplatzierung keine Ablationsläsionen mittels Laserenergie möglich. Von den 102 PV konnten drei nicht erfolgreich isoliert werden (Erfolgsrate der PVI 97%). Bei 95 erfolgreich isolierten PV in 25 Patienten wurde für jede PV ein Adenosin-Test durchgeführt (im Durchschnitt 31 min nach der PVI). Nur 6 PV (6,3%) bei insgesamt 5 Patienten (20%) zeigten eine passagere Rekonnektion der PV-Überleitung während der Adenosin-Gabe. Bei diesen PV wurden signifikant häufiger suboptimale Okklusionsraten der PV mit dem Laser-Ballon festgestellt. Außerdem wurde eine signifikant höhere Dauer der Laser-Applikationen, durchschnittliche Leistung der Laser-Applikation und Anzahl der niedrig dosierten Laser-Applikationen als bei den PV ohne Rekonnektion unter Adenosin-Gabe beobachtet. Schlussfolgerung PVI mit Endoskopie-gesteuertem Laserballon-Ablationskatheter ist eine innovative Ablationstechnik mit einer sehr niedrigen akuten Rekonnektionsrate nach Adenosin-Gabe. Es sollte untersucht werden, ob dieser Unterschied im Sinne eines Vorhofflimmerrezidivs auch klinisch bedeutsam ist

High Predictive Value of Adenosine Provocation in Predicting Atrial Fibrillation Recurrence After Pulmonary Vein Isolation With Visually Guided Laser Balloon Compared With Radiofrequency Ablation

Background: We recently demonstrated that the acute reconnection rate detected with adenosine provocation test (APT) was significantly lower after pulmonary vein isolation (PVI) with visually guided laser balloon ablation (VGLB) than with RF ablation (RF). We evaluated the recurrence rate of atrial arrhythmias at 12 months after VGLB vs. RF and the significance of APT results for the outcome. Methods and Results: Fifty patients with paroxysmal AF were randomized to either RF or VGLB ablation in a 1 : 1 fashion. After PVI each PV underwent an APT. All patients underwent a 3-day Holter and clinical follow-up every 3 months. Significantly less PVs reconnected during APT in the VGLB-arm (10 PV (10.8%) vs. 29 PV (30.9%); P=0.001). Significantly less patients had a recurrence of atrial arrhythmia in the VGLB-arm (3 vs. 9; P=0.047). In the VGLB-arm no recurrence was seen in those patients with a negative APT (negative predictive value (NPV)=100%). Only 3 of the 8 patients with a positive APT in the VGLB-arm had a recurrence (positive PV (PPV)=37%). Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%). Conclusions: There was significantly less recurrence of atrial arrhythmias at 12 months after PVI with VGLB. A negative APT after PVI with VGBL predicted freedom from AF with a very high NPV meaning that the high acute efficiency of the VGLB persisted long term