Proper management of post-interventional pain relieves unwarranted patient distress and enhances patient satisfaction. There have been only a limited number of investigations into patient discomfort following electrophysiological interventions. This study aims to quantify pain after interventional procedures, including ablation of atrial fibrillation (AF) or ventricular tachycardia (VT), as well as implant or explant of pacemakers or implantable cardioverter defibrillators. One-hundred and two consecutive patients (mean age 66 years, 70 men) were asked to quantify post-interventional pain on a numeric rating scale (NRS 0–10) every 2 h during a period of 24 h after their intervention (49 ablations in deep propofol sedation, 53 device surgeries in local anaesthesia with mepivacaine 1%) and to specify the type of pain. Pain was classified as moderate to severe in case of NRS > 3. Post-operative pain medication included non-opioid and opioid analgesics as per the treating physicians' discretion. Sixty-one patients (60%) suffered from moderate-to-severe pain within the first 24 h after the procedure, despite the use of analgesics in 47 patients (46%). Pain was present in an early period (0–6 h) in 54% and in a late period (8–24 h) in 40% of patients. Patients complained of back pain (44%), pain at the site of the device pocket (39%), pain at the groin after puncture (7%), and pericarditic pain (5%). Multivariate analysis identified female gender (P = 0.046) associated with early post-interventional pain while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain. The findings highlight the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures, despite the use of peri-interventional analgesics. These findings highlight the need for more careful pain assessment and management programmes.

Aims: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients’ comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. Methods and results: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. Conclusion: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) investigated the efficacy and safety of the subcutaneous implantable cardioverter defibrillator (S-ICD) compared with a transvenous ICD (TV-ICD) and showed noninferiority of the S-ICD with regard to the composite end point of device-related complications and inappropriate shocks after 49.1 months. Complications associated with transvenous leads are expected to occur after longer follow-up. The PRAETORIAN-XL trial aims to investigate whether the S-ICD is superior to the TV-ICD with respect to device-related complications at 8-year follow-up. METHODS: The PRAETORIAN trial randomized patients with a class I or IIa indication for ICD therapy without the need for pacing to either S-ICD or TV-ICD among 39 centers in the United States and Europe between March 2011 and January 2017. The follow-up was extended after 49.1 months by an additional 4 years for the PRAETORIAN-XL trial. The primary end point was the composite of all device-related complications. Complications could be related or unrelated to the lead and minor or major, with major complications being those requiring an invasive intervention. End points were analyzed according to the modified intention-to-treat principle using a Fine-Gray subdistribution hazards model to account for competing risks. An as-treated analysis was performed using a Cox proportional hazards model with device type as time-dependent variable. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). Twenty-one percent of the S-ICD group versus 18% of the TV-ICD group were women. The median age at implantation was 63 (interquartile range, 54–69) years for the S-ICD and 64 (interquartile range, 56–69) years for the TV-ICD. After a median follow-up of 87.5 months, all device-related complications (major and minor combined) were not significantly different in the modified intention-to-treat analysis (subdistribution hazard ratio, 0.73 [95% CI, 0.48–1.12]); P =0.15). However, TV-ICD patients more often had a major complication or lead-related complication ( P =0.03 and P <0.001, respectively). Moreover, the as-treated analysis showed significantly more complications in patients with a TV-ICD compared with an S-ICD (hazard ratio, 0.64 [95% CI, 0.41–0.99]; P =0.047). CONCLUSIONS: The PRAETORIAN-XL trial demonstrated that there was no significant difference between the S-ICD and TV-ICD in all device-related complications during long-term follow-up. However, the TV-ICD carries a higher risk of major and lead-related complications compared with S-ICD therapy. The S-ICD should therefore be considered for all patients without a pacing indication who are evaluated for ICD therapy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01296022.

Aims: Data on safety and efficacy of a non-fasting strategy in minimal invasive cardiac procedures are lacking. We assessed a non-fasting strategy compared with a fasting strategy regarding patient’s well-being and safety in elective cardiac implantable electronic device (CIED) procedures. Methods and results: In this randomized, single-blinded clinical trial, 201 patients (non-fasting = 100, fasting = 101) with a mean age of 72.0 ± 11.6 years (66.7% male) were assigned to a non-fasting strategy (solids/fluids allowed up to 1 h) or a fasting strategy (at least 6 h no solids and 2 h no fluids) before the procedure and analysed on an intention-to-treat basis. The co-primary outcomes were patients’ well-being scores (based on numeric rating scale, 0–10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration, and emergency intubation. Renal, haematological, and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients’ well-being score was significantly lower in the non-fasting group [non-fasting: 13.1 ± 9.6 vs. fasting: 16.5 ± 11.4, 95% confidence interval (CI) of mean difference (MD) −6.35 to −0.46, P = 0.029], which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (non-fasting vs. fasting; hunger: 0.9 ± 1.9 vs. 3.1 ± 3.2, 95% CI of MD −2.86 to −1.42, P < 0.001; tiredness: 1.6 ± 2.3 vs. 2.6 ± 2.7, 95% CI of MD −1.68 to −0.29, P = 0.023). No intra-procedural food-related adverse events were observed. Relevant blood parameters and 30-day follow-up did not show significant differences. Conclusion: These results showed that a non-fasting strategy is beneficial to a fasting one regarding patient’s well-being and comparable in terms of safety for CIED procedures (NCT04389697).

Ablation of atrial fibrillation (AF) is recommended in the guidelines as a Class Ia/IIa indication. However, associated complications should not be dismissed; specifically, inguinal vascular complications (IVC). Although IVCs are generally considered trivial, they represent an economic burden for the procedure-performing hospital and the patient. Therefore, the ability to monitor and ultimately minimize potential complications is of considerable interest. An economic model was developed to calculate the economic impact for certain IVC-types from a large German single-centre perspective in 2015 and 2016. Twenty-nine of 1040 (2.79%) and 48 of 1152 (4.17%) AF-ablation patients had documented IVC in 2015 and 2016 (P = 0.08), respectively. Inguinal vascular complications that required invasive treatment (thrombin, intervention, surgery) occurred in 0.58% of the 2015 and in 0.87% of the 2016 AF-ablation cases. The expected excess costs (incorporating direct costs, benefit lost adjusted for reimbursement) per patient treated with AF-ablation were 139.54€ and 153.31€ in 2015 and 2016, respectively. This was mostly driven by opportunity costs, which could reach 15 544.71€ for certain IVC. Sensitivity analysis revealed the probability of occurrence, length of stay of certain IVC types, and the revenue per day influenced the expected costs per AF-ablation patient. Even relatively benign complications such as IVC can result in considerable cost increases. Therefore, measures to reduce them should be established and implemented.