Procedure-related Complications Research Articles

Dry Medical Thoracoscopy with Artificial Pneumothorax Induction Using Veress Needle.

In the absence of, or minimal-volume pleural effusion, conventional medical thoracoscopy (MT) is often precluded by the risk of lung injury. Dry medical thoracoscopy (dry MT) aims to ameliorate these dangers by inducing an artificial pneumothorax via needle insufflation or blunt dissection. Veress needle is a device used by surgeons to induce pneumoperitoneum before laparoscopic surgeries, but is not commonly reported in dry MT. We present data from a series of 31 patients in which dry MT with artificial pneumothorax induction using Veress needle were performed under thoracic ultrasonography (TUS) guidance. Procedures were deemed technically successful if all the following criteria were met: (i) successful pneumothorax induction, allowing smooth insertion of semi-rigid thoracoscope during the procedure; (ii) no immediate significant procedural-related complications; and (iii) no delayed complications such as persistent air leak, defined as leakage lasting more than 5 days necessitating prolonged chest tube placement. Complete pneumothorax induction was successful in 25 cases (80.6% technical success rate); nevertheless, biopsies were successfully performed in all cases. The most common histopathological diagnosis was malignancy (n=9, 29.0%), followed by inflammatory pleuritis (n=8, 25.8%) and tuberculosis (n=8, 25.8%). No complications were reported secondary to the procedure. These findings suggest that TUS-guided dry MT with a Veress needle is technically feasible and safe in the hands of experienced MT performers who are competent in TUS.

BN SO15 - Post Cholecystectomy Syndrome: Definition, Aetiology, Investigation & Management – A Systematic Review

Abstract Background Post-cholecystectomy syndrome (PCS) is a term commonly used to refer to the persistence of abdominal symptoms following cholecystectomy, or de-novo symptoms that develop post operatively. Despite the common use of the term, there is no widely agreed upon consensus definition. PCS is reported to affect between 5-40% of patients that undergo cholecystectomy representing a large populational burden. Despite this, there are no guidelines or protocols in place for the routine investigation and management of this large heterogenous patient group. In this study we systematically review the literature describing definition, aetiology, investigation and up-to-date management of PCS. Method An updated systematic search of the Medline, EMBASE and Cochrane databases was undertaken to identify studies where patients underwent cholecystectomy and subsequently were diagnosed with PCS. Included papers were published between 2016-2024, had a minimum of 10 cases of PCS following laparoscopic or open cholecystectomy. Excluded studies were case reports, narrative and systematic reviews, paediatric patient population or papers unavailable in the English language. Paper characteristics were extracted and where present, the definition of PCS, aetiology, investigations and management of these patients was both extracted and analysed. Results 145 papers were identified of which 13 were included after title, abstract and full text screening. Definition of PCS, where present, was highly heterogenous between papers. Aetiology was often divided into biliary and non-biliary causes, with some papers claiming early-PCS and late-PCS as distinct clinical phenomena. In such papers, early-PCS was most commonly attributed to gastro-oesophageal pathologies and late-PCS to biliary pathologies. Investigation strategy is sparingly reported and without guideline or protocol. Most frequently used tests include LFTs, USS, MRCP, CT, ERCP and OGD. Some studies also used 99m Tc-Mebrofenin Hepatobiliary Scintigraphy, sphincter manometry and colonoscopy. Conclusion PCS has a widely reported prevalence in the published literature. This is potentially due to the heterogeneity of definitions used to cover the syndrome. The effective management of such patients depends on both the accurate diagnosis of the underlying cause, as well as exclusion of procedure related complications. There are currently no guidelines or protocols available for the investigation and management of patients presenting with symptoms post cholecystectomy despite the large populational burden. Further studies should aim to provide a consensus definition of PCS, and work towards guidelines for the investigation and management of this patient group.

Abstract 4118804: Use and Clinical Outcomes Associated with Urgent versus Elective Catheter Ablation of Atrial Fibrillation in the United States

Introduction: Catheter ablation of atrial fibrillation (AF) is an increasingly important evidence-based treatment option for select patients. Although typically performed as an outpatient elective procedure, the use and clinical outcomes of AF ablation pursued urgently among inpatients have not been adequately characterized. Hypothesis: Rate of urgent AF ablation, defined as an AF ablation procedure pursued among inpatients hospitalized for a non-procedural indication, has increased over time, and may be associated with worse outcomes. Aims: To describe the use and outcomes of urgent versus elective AF ablation. Methods: Using the NCDR AFib Ablation Registry, patients who underwent AF ablation from 1/1/2016 to 6/30/2023 were stratified according to whether AF ablation was urgent or elective. Logistic regression models were fitted to determine patient and hospital-level factors associated with use of urgent AF ablation. Cochrane-Armitage tests were used to test for trends over time. Unadjusted and adjusted in-hospital event rates were reported. Results: Among 140,051 patients, 2,714 (1.9%) underwent urgent inpatient AF ablation and 137,337 (98.1%) elective ablation. Compared with the elective cohort, those undergoing urgent ablation had higher rates of co-morbid conditions including: diabetes (30.6% vs. 20.4%, P<0.0001), coronary artery disease (30.8% vs. 22.7%, P<0.0001), and heart failure (47.1% vs 20.8%, P<0.0001). Urgent AF ablation was more often used among patients of Black race (OR 1.68; 95% CI: 1.41 – 2.0) and those with AF at the time of the procedure (OR 1.73; 95% CI: 1.36 – 2.20). Higher hospital procedural volume of AF ablations ([per 100 cases] OR 1.22; 95% CI: 1.20 – 1.25) was also associated with higher odds of urgent AF ablation. The use of urgent AF ablation increased from 0.5% in 2016, to 2.0% in 2023 (P<0.0001). Unadjusted event rates for AF-related complications were significantly higher for the urgent cohort (Figure). The adjusted rate of any procedure-related complication was significantly higher in the urgent cohort (urgent 4.9% vs. elective 2.4%, P<0.0001). Conclusions: The rate of urgent inpatient AF ablation has increased over time. Compared with elective AF ablation, after adjustment for patient risk factors, urgent AF ablation is associated with significantly higher rates of procedural complications. Use of urgent, inpatient AF ablation should be carefully considered within clinical contexts and offered to select patients.

Safety of abdominal paracentesis in hospitalised patients receiving uninterrupted therapeutic or prophylactic anticoagulants.

Abdominal paracentesis is a frequently performed procedure in hospitalised patients with ascites. Concurrently, most hospitalised adult patients receive pharmacologic anticoagulation, either for therapeutic purposes or prophylactically to prevent venous thromboembolism. Despite this, minimal evidence exists to guide management of anticoagulant therapy pre- and post-paracentesis. The authors aimed to investigate the safety of abdominal paracentesis in hospitalised patients receiving therapeutic or prophylactic anticoagulation, including in patients for whom these medications were withheld periprocedurally. TriNetX, an electronic health record data set, was queried to identify patients between the ages of 18 and 80 years who received an abdominal paracentesis while hospitalised at the authors' institution between September 2017 and June 2022. Patients receiving prophylactic anticoagulation (137), therapeutic anticoagulation (74) and no anticoagulation because of coagulopathy or thrombocytopenia (15) were compared. Rates of withholding anticoagulation, performing service, pre- and post-paracentesis haemoglobin, bleeding complications, thrombotic complications and need for red blood cell transfusion were analysed. Procedure-related bleeding complications occurred in two (1.4%) patients in the prophylactic group and 0 (0%) patients in the therapeutic group (P = 0.54). No thrombotic complications occurred. Rates of red blood cell transfusions post-paracentesis were similar between groups. Analysis of secondary end-points identified significant differences in rates of withholding anticoagulation and mean change in haemoglobin between performing services. Performance of abdominal paracentesis in patients receiving therapeutic or prophylactic anticoagulation appears to be safe regardless of whether anticoagulation was interrupted periprocedurally, with low rates of bleeding complications, thrombotic complications or need for red blood cell transfusions post-paracentesis.

Left bundle branch area pacing versus endocardial resynchronization in patients with heart failure.

Left bundle branch area pacing (LBBAP) and endocardial resynchronization (Endo-CRT) are alternatives to biventricular pacing for cardiac resynchronization therapy (CRT). To compare the outcomes of LBBAP versus Endo-CRT using conventional pacing leads. Patients with heart failure (HF) undergoing CRT with LBBAP or Endo-CRT were included. The primary efficacy outcome was a composite of HF-related hospitalization and all-cause mortality. The primary safety outcome was any procedure-related complication. Secondary outcomes included procedural characteristics, electrocardiographic, and echocardiographic parameters. A total of 223 patients (LBBAP n = 197, Endo-CRT n = 26; mean age 69 ± 10.3 years, 32.3% female) were included. Patients in the LBBAP group had lower NYHA class, shorter preprocedural QRS durations (161 [142-183] vs. 180 [170-203] msec, p < .001), and a lower preprocedural spironolactone use (57.4% vs. 84.6%, p = .009) than patients in the Endo-CRT group. Fluoroscopy time was significantly shorter in patients undergoing LBBAP (11.4 [7.2-20] vs. 23 [14.2-34.5] min; p < .001). There was no significant difference in the primary efficacy outcome between both groups (Cox proportional HR 1.21, 95% CI 0.635-2.31; p = .56). During follow-up, patients undergoing LBBAP had a lower incidence of stroke than patients in the Endo-CRT group (0% vs. 11.5%, p = .001). Postprocedural LVEF (35% [25-45] vs. 40% [20-55]; p = .307) and change in LVEF (7% [0-20] vs. 11% [2-18]; p = .384) were similar between the LBBAP and the Endo-CRT groups, respectively. LBBAP and Endo-CRT using conventional leads are associated with similar mortality and HF-related hospitalization, as well as improvements in LVEF. Endo-CRT is associated with longer fluoroscopy times and a higher risk of stroke.

Cost-effectiveness of ultrahigh-resolution photon-counting detector coronary CT angiography for the evaluation of stable chest pain

BackgroundThe increased specificity of ultrahigh-resolution (UHR) photon-counting detector (PCD)-CT over energy-integrating detector (EID)-CT for coronary CT angiography (CCTA) could defer unwarranted downstream tests. The objective of the study was to simulate the cost-effectiveness of UHR CCTA in stable chest pain patients with coronary calcifications. MethodsA decision and simulation model was developed using Monte Carlo simulations with 1000 bootstrap resamples to estimate the costs associated with PCD-CT in lieu of EID-CT for CCTA and the referral for subsequent testing. The model was constructed using the diagnostic accuracy metrics of 55 coronary lesions in patients who underwent CCTA on both CT systems and subsequent invasive coronary angiography (ICA). Sensitivity and specificity were defined for each Coronary Artery Disease Reporting and Data System category. The aggregate healthcare expenditures were derived from the hospital billing system. ResultsAssuming a projected cohort of 15,000 patients over the lifetime of the PCD-CT, its implementation resulted in a 18.9 ​% reduction in the number of functional follow-up tests (6330.3 ​± ​59.5 vs. 5135.7 ​± ​60.6, p ​< ​0.001), a 6.0 ​% reduction in performed ICAs (1447.7 ​± ​36.2 vs. 1360.2 ​± ​34.7, p ​< ​0.001), and a 9.4 ​% decrease in major procedure-related complications. Over a 10-year expected life expectancy, PCD-CT led to an average cost saving of $794.50 ​± ​18.50 per patient and an overall cost difference of $11,917,500 ​± ​4,350,169. ConclusionsPCD-CT has the potential to reduce the financial burden on healthcare systems and procedure-related complications for stable chest pain patients with coronary calcification when compared to EID-CT.

Bilateral Anti VEGF on Same Day-Investigation on Safety in Retinopathy of Prematurity (BASISROP)- A Multicenter retrospective study

PurposeTo report incidence of procedure related complications in preterm infants with ROP treated with intravitreal anti vascular endothelial growth factors (anti VEGF) injection in both eyes on same day DesignRetrospective, multicenter case series SubjectsPreterm infants with ROP treated with anti VEGF bilaterally on same day MethodsIntervention: All included infants underwent intravitreal anti VEGF injection in both eyes under aseptic precautions in ophthalmic operation theatre (OT) or neonatal intensive care unit (NICU). Postoperative examination was performed to look for procedure related complications Main Outcome MeasuresIncidence of procedure related complication (Presumed endophthalmitis, intraocular inflammation, lens injury, vitreous hemorrhage, retinal tear) in the study cohort. To study association of indication, type of anti VEGF, type of needle used, setting of procedure, site of injection (distance from limbus) and experience of the treating ophthalmologist with the complications. Results9984 eyes of 4992 infants were analysed. The procedure was most commonly performed in ophthalmic OT (8258, 82.7%) using 29G (4514, 45.2%) needle between 1-1.5 mm (9984, 100%) from limbus. Aggressive retinopathy of prematurity was the most common indication for anti VEGF use (4866, 48.7%) while Bevacizumab was the most commonly used anti VEGF agent (8642, 86.6%). Overall, 26 eyes (0.3%) had procedure related complications. Lens injury (15, 0.15%) and presumed endophthalmitis (7, 0.07%) were most common complications. One eye had culture proven endophthalmitis with Pseudomonas aeruginosa. No case of bilateral endophthalmitis was noted. Endophthalmitis was not associated with setting of procedure or type of anti VEGF used, while risk of lens injury was seven times higher when performed in NICU and 30 times higher when performed by an ophthalmologist with < 1year of experience in injecting anti VEGF in preterm infants. ConclusionsThe incidence of presumed endophthalmitis after bilateral same day anti VEGF in infants with ROP is 0.07%. These infants can be treated in both eyes on same day with the anti VEGFs and needles (29-32G) evaluated in this study, with emphasis on the direction of needle parallel to visual axis. Extra precaution is advocated if the procedure is planned in NICU or by an ophthalmologist with limited experience.

Presence of Patent Foramen Ovale Does Not Increase Cerebrovascular Event Rates in Patients with Atrial Fibrillation Following Left Atrial Appendage Closure

ObjectiveBoth atrial fibrillation (AF) and patent foramen ovale (PFO) has been associated with occurrences of ischemic stroke. The aim of this study was to investigate whether patients with concomitant AF and PFO were at an increased risk of stroke, and whether PFO closure was necessary for the prevention of stroke in AF patients who underwent left atrial appendage closure (LAAC). MethodWe retrospectively analyzed 614 patients who underwent LAAC at Wuhan Asia Heart Hospital from May 2014 to April 2021. We compared the baseline clinical characteristics and ischemic stroke rates before LAAC, major adverse cardiovascular events (MACEs) and other long-term outcomes between AF patients with and without PFO after LAAC. The predictor for ischemic stroke or TIA after LAAC was analyzed with univariate and multivariable Cox regression, and the long-term cumulative survival rates of AF patients with PFO compared to those without PFO after LAAC were analyzed with the Kaplan–Meier graph. ResultsA total of 614 patients who underwent LAAC and had completed follow-up data were included in our study. Among them, 74 patients were diagnosed with AF with PFO, and 540 with AF without PFO. There was no significant difference between their baseline clinical data, including ischemic stroke rates (p = 0.961). Patients with and without PFO had similar device implantation success rates (98.6% vs 99.4%, P=0.403) and procedure-related complications. During follow-up (medium follow-up period 36.9 months), no significant difference was observed in the incidence of MACEs (8.1% in PFO group vs 5.7% in non-PFO group, P=0.432) or the cumulative ischemic stroke/TIA rates (5.4% in PFO group vs 4.3% in non-PFO group, P = 0.554). The Cox multivariable regression analysis indicated that the presence of PFO in patients with AF had no correlation with ischemic stroke or TIA after LAAC implantation (HR 1.685, 95% CI 0.570-4.978, P = 0.345). The only predictor for ischemic stroke/TIA events after LAAC was major leakage (>5mm) seen on transesophageal echocardiography (TEE) or left atrial CTA at the 45-day follow-up (HR 10.352, 95% CI 1.221-87.736, P = 0.032). ConclusionAF patients with PFO are not at increased risk for ischemic stroke or TIA before LAAC. The presence of PFO in AF patients did not affect the success rate and safety of LAAC. The presence of mild PFO is not a viable predictor of stroke events in AF patients who underwent LAAC during long-term follow-up. Major leakage (>5 mm) is associated with a higher ischemic stroke/TIA rate in AF patients who underwent LAAC.

Ultrasound-Guided Axillary Access Using a Micropuncture Needle Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices: A Single-Center Randomized Trial

(1) Background: Ultrasound-guided axillary (USAX) vein puncture is a relatively new method to obtain venous access for the implantation of cardiac implantable electronic devices (CIED). However, its use is limited as most of the operators are not familiar with this technique. Our aim was to investigate the safety and efficacy of the USAX compared with the traditional cephalic vein dissection for venous access in CIED implantation. (2) Methods: This was a single-center, randomized, controlled, superiority trial. A total of 114 patients were randomized (1:1 ratio) to either USAX (u/s axillary group; 59 patients) or cephalic vein access (cephalic group; 55 patients). The primary study endpoint was defined as successful placement of all leads via the chosen access. Secondary study endpoints included time from local anesthetic injection to lead advancement in the SVC, total procedure time (skin to skin), procedure-related complications and pain perception. (3) Results: USAX was superior to cephalic access in terms of primary endpoint (OR: 4.3, 95% CI: 1.3, 14.0; p = 0.012). Total procedure duration was higher in the cephalic group (55.15 ± 16.62 vs. 48.35 ± 12.81 min, p = 0.017) but there was neither a significant difference in fluoroscopy time (p = 0.872) nor in total radiation dose (p = 0.815). The level of pain was higher in the cephalic group (p = 0.016), while the rates of complications were similar in both groups (p &gt; 0.05). (4) Conclusion: USAX was superior to cephalic access regarding success rate, total procedure duration and level of pain, while having no difference in complication rates.

Fluoroscopy-Guided Percutaneous Transthoracic Needle Lung Biopsy with the Aid of Planning Cone-Beam CT: Diagnostic Accuracy and Complications.

Background: Fluoroscopy-guided PTNB for fluoroscopy-identifiable lung lesions has been suggested as a useful method for the pathological diagnosis of lung lesions; however, it is lacking in accuracy and safety compared to CT-guided PTNB. Thus, we aimed to investigate the diagnostic accuracy and complications of fluoroscopy-guided percutaneous transthoracic needle biopsy (PTNB) with the aid of pre-procedural planning cone-beam computed tomography (CBCT) in order to take advantage of their respective strengths. Methods: A total of 255 fluoroscopy-guided PTNBs with the aid of planning CBCT were performed. Pre-procedural planning CBCT was conducted to calculate the shortest length from the skin puncture site to the margin of the target lesion for the needle trajectory. No intra-procedural CBCT was performed. The diagnostic performance of fluoroscopy-guided PTNB with the aid of planning CBCT was calculated. The prognostic factors for diagnostic failures and complications were evaluated using logistic regression analysis. Results: The accuracy, sensitivity, specificity, PPV, and NPV were 97.3%, 88.0%, 90.9%, 100%, and 62.5%, respectively. There were 29 diagnostic failures (11.8%), and the multivariable analysis showed that a longer lesion depth on CBCT and a shorter specimen length were each associated with diagnostic failure (p = 0.010 and 0.012, respectively). Complications occurred in 34 PTNBs (13.3%). The multivariable analysis showed that an increased total number of biopsies per lesion, a longer length of lung aeration via needle insertion, a smaller lesion size on CT imaging (≤20 mm), and the presence of an air bronchogram were associated with the occurrence of complications (p = 0.027, <0.001, 0.003, and 0.020, respectively). Conclusions: Excellent diagnostic accuracy was obtained by fluoroscopy-guided PTNB with the aid of planning CBCT. Compared to that of CT- or CBCT-guided PTNB, the procedure-related complication rate was acceptably low, but the radiation dose to patients could be potentially reduced.

Efficacy and safety of the needle rendezvous technique for infrainguinal arterial calcified lesions

BackgroundLower extremity artery disease is increasingly prevalent, and complex lesions such as calcified chronic total occlusions pose significant challenges during endovascular therapy. The needle rendezvous technique, which involves puncturing a needle toward the guidewire within the lesion or lumen and advancing the guidewire into the needle lumen to achieve guidewire externalization, offers a potential solution. If device passage remains challenging, the Rendezvous-PIERCE technique can be subsequently employed by advancing the needle over the externalized guidewire to modify the lesion directly. This study aimed to evaluate the procedural outcomes of needle rendezvous in infrainguinal arterial occlusive lesions.MethodsThis single-center, retrospective, single-arm study included patients treated with needle rendezvous between August 2020 and March 2024. The primary outcome was technical success rate, defined as the device passage following guidewire externalization using needle rendezvous. Secondary outcomes included the rates of procedural success, complications, and 30-day clinical-driven target lesion revascularization (CDTLR).ResultsTwenty-five patients (25 limbs) with 52% on hemodialysis and 80% having chronic limb-threatening ischemia in 52% and 80% were enrolled. All cases involved bilateral calcified occlusions, and 72% targeted the infrapopliteal artery segment. The average needle rendezvous time was 3.7 ± 2.0 min. Rendezvous-PIERCE was performed in 28% of cases. All cases achieved 100% technical and procedural success, with no procedure-related complications. The 30-day CDTLR rate was 8%, limited to below-the-knee lesions.ConclusionsNeedle rendezvous is a safe and effective technique for treating complex infrainguinal arterial occlusions, providing a viable alternative when conventional methods fail.

Risk factors for procedure-related complications in very elderly patients undergoing atrial fibrillation ablation: analysis from the Japan Ablation Registry

Abstract Background As atrial fibrillation (AF) ablation procedures become increasingly prevalent, understanding the risks of procedure-related complications is crucial, particularly in the very elderly population, defined in this context as patients aged 80 years and above. This study aimed to identify risk factors for complications in this demographic. Methods We conducted a prospective analysis of 170,017 AF ablation procedures from the Japan Ablation Registry, covering 482 facilities between 2017 and 2020. The analysis focused on patients aged 80 or older (very elderly group, n=14,389). Multivariate analysis was employed to identify risk factors for procedure-related complications in the very elderly, incorporating factors that showed a p-value of less than 0.1 in univariate analysis. Results Procedure-related complications were observed in 3.62% of the very elderly group. The multivariate analysis (Model 1) identified significant risk factors were the initial procedure (OR 1.30, 95% CI 1.01-1.67, p=0.041), type of AF (OR 1.34, 95% CI 1.03-1.74), and body weight (OR 0.99, 95% CI 0.98-1.00, p=0.082). For further analysis, the type of AF was categorized into paroxysmal AF (PAF), persistent AF (PeAF) and long-standing PeAF. We included these categories, along with the initial procedure and body weight, into further multivariate analysis (Model 2), which revealed that long-standing PeAF (OR 1.34, 95% CI 1.03-1.74, p=0.032), initial ablation (OR 1.30, 95% CI 1.01-1.67, p=0.042) and body weight (OR 0.99, 95% CI 0.98-0.99, p=0.001) were independently and significantly associated with complications. Conclusion This study identifies initial procedures, low body weight, and long-standing PeAF as significant risk factors for procedure-related complications in very elderly patients undergoing AF ablation. These findings highlight the importance of careful patient selection and tailored procedure planning for these subgroups in the very elderly population.

Long-term efficacy and safety of ablation for atrial fibrillation in patients with hypertrophic cardiomyopathy

Abstract Background Hypertrophic cardiomyopathy (HCM) is often accompanied by atrial fibrillation (AF) but data on safety and long-term outcomes after catheter ablation for AF in HCM are scarce. Purpose To investigate safety, long-term efficacy and clinical outcomes following AF ablation in patients with HCM and in matched controls. Methods Patients with HCM (n=76) undergoing a first catheter ablation for AF or atrial flutter between 1999 and 2022 at a University Hospital in Sweden were included (age 64±12 years, 43% female). Diagnosis of HCM was based on the European Society of Cardiology definition (left ventricular wall thickness ≥15 mm or ≥13 mm not solely explained by abnormal loading conditions, and combined with family history, genetic components and/or electrocardiogram abnormalities). Patients with HCM were matched with controls (n=152) based on age, gender, ablation type and intervention-year. Patients were followed for a mean of 5 years and study endpoints included heart failure hospitalization (HFH), stroke and mortality. Cox regression analyses were performed for the association between HCM and the endpoints. Results Among the overall population, 121 (53%) underwent pulmonary vein isolation (PVI), 62 (27%) isthmus ablation and 45 (20%) His-Bundle ablation. Patients with HCM had a shorter mean duration of AF before ablation (48 months vs. 66 months; p=0.047) and more severe symptoms as indicated by a higher EHRA class (EHRA class IV: 30% vs. 10%; p&amp;lt;0.01). Procedural success rate of PVI and isthmus ablation was lower in patients with versus without HCM (88% vs. 97%; p=0.02). Procedure related complications (vascular complications, tamponade) were overall similar in both groups (9% in HCM vs. 5% in controls, p=0.17) except for higher rates of pulmonary oedema in patients with HCM (7% vs 1%, p=0.03). There was a nearly two-fold increase in risk of AF recurrence after PVI or isthmus ablation in patients with HCM compared to controls (OR 1.95; 95% CI 1.06-3.58; p=0.03). During follow-up, patients with HCM had an increased risk of HFH (HR 2.55, 95% CI 1.21-5.36, p=0.01) but not of stroke or mortality (Figure 1). Conclusion AF ablation was overall safe in patients with HCM but less effective. Patients with HCM had an increased risk of the individual endpoint of HFH after AF ablation but not stroke or mortality during long-term follow-up.

Sex differences in outcomes among patients undergoing transcatheter atrial septal defect closure: Do they benefit equally?

Abstract Background Although sex differences in congenital heart disease are prevalent and relevant, there is limited research on their role in atrial septal defect (ASD) closure. We aimed to investigate sex differences in baseline characteristics, procedural and long-term outcomes of patients with transcatheter ASD closure. Methods Data from adult patients undergoing ASD closure between 2005-2016 were retrospectively analyzed. Results Of the 853 patients included, 281 (32.9%) were male and 572 (67.1%) were female. Females were more symptomatic at presentation than males (p &amp;lt; 0.001). Males had a higher frequency of cardiovascular comorbidities than females (p &amp;lt; 0.001). Although echocardiographic right ventricular (RV) diameter relative to body surface area was equal in males and females (2.49 cm/m2 versus 2.57 cm/m2; p = 0.072), males had more RV dysfunction (12.1% versus 7.6%; p = 0.028). In contrast, females had higher RV systolic pressures (39.71 mmHg versus 37.23 mmHg; p = 0.025), and were more likely to have moderate to severe tricuspid regurgitation (15.4% versus 8.9%; p = 0.007). Males had larger defects with use of larger implants (p &amp;lt; 0.05). Procedure-related complications were rare and did not differ by sex. At 12-month follow-up, both male and females showed comparable decreases in RV diameter (-0.57 cm versus -0.59 cm; p = 0.751), RV systolic pressure (-4.57 mmHg versus -6.31 mmHg; p = 0.094), and severity of tricuspid regurgitation (p = 0.173; Figure). After a mean follow-up of 3 years (SD = 5), no significant differences were observed in the incidence of death (incidence rate ratio (IRR) = 0.49 [95% CI 0.27-0.83]; p = 0.402), new onset atrial fibrillation (IRR = 3.22 [95% CI 2.57-3.99]; 0.063), cardioversion or ablation (IRR = 0.40 [95% CI 0.20-0.71], p = 0.335), stroke/TIA (IRR = 0.29 [95% CI 0.12-0.56]; p = 0.745), and pacemaker implantation (IRR = 0.29 [95% CI 0.12-0.57], p = 0.728). Conclusions Although patient profiles differed by sex, procedural and long-term outcomes were comparable, suggesting that transcatheter ASD closure can be safely performed in both males and females.Figure.Sankey Plot

Penumbra Indigo® system to safely remove intracardiac thrombus in a 7-month-old infant with severe immunodeficiency disorder.

We report on a 7-month-old boy (4.2 kg/60 cm) with severe immunodeficiency disorder and bacterial septicaemia who was referred for an infected atrial thrombus secondary to a jugular central line. The echocardiogram showed a teardrop-shaped thrombus with a wide base adherent to the interatrial wall and a flimsy tail moving freely in the right atrium. Chest CT scan showed multiple lesions in both lungs consistent with infected micro-thrombi. The thrombus increased in size despite 2 weeks of antibiotics and anticoagulation. We applied the Indigo® Lightning® 7 aspiration system from Penumbra® (Alameda, USA) and removed percutaneously the thrombus under transoesophageal ultrasound and biplane fluoroscopic guidance. At 6 weeks of follow-up, the patient is alive, under enoxaparin with no procedure-related complication.

Leadless pacemaker - lead parameters stability and battery longevity in the mid-term follow-up

Abstract Background A leadless pacemaker (L-PM) has been designed to avoid the need for a pacemaker pocket and transvenous lead. Long-term safety will largely depend on the need for replacements, mainly due to battery depletion (end-of-life). While the mean L-PM battery longevity predicted by the manufacturer is 12 years, real-world longevity data are still scarce. We aimed to describe L-PM parameters’ stability and battery longevity during the mid-term follow-up. Methods Single-center registry of consecutive patients undergoing L-PM implantation from May 2015 to November 2023. Procedural characteristics, lead parameters and battery longevity were collected immediately after implantation and during the most recent follow-up visit. Results Overall, 261 consecutive patients had a transcatheter L-PM implanted through a femoral vein (mean age 78±10 years; 66% male). Mean procedural duration was 44±28min and fluoroscopy time was 4,4±3,9min. The device was successfully implanted in all but one patient. The main indications for permanent pacing were high-degree atrioventricular block [N=130 (50%)], atrial fibrillation with pauses [N=78 (30%)], and sinus node disease [N=28 (11%)]. Immediately after implantation, three cases (1,2%) of pericardial effusion (one with tamponade) were reported. In one case (0,4%), a conventional pacemaker was implanted due to L-PM acute dysfunction. No other procedure-related complications, including dislodgment, were reported at discharge. After a mean follow-up of 2,8±1,7years, the pacing threshold and R-wave amplitude remained stable [0,67mV vs. 0,62mV (p=0,9); and 10,3mV vs. 16,1mV (p&amp;lt;0,001), respectively] and mean ventricular pacing was 54±38%. Expected battery longevity was &amp;gt;8 years (maximum value) in 84% of the patients. In the subgroup of patients with &amp;gt;5 years of follow-up (N=20; mean follow up of 6,3±1,8years), the expected battery longevity was &amp;gt;8 years in 85% (N=17) of the patients. In three cases, the L-PM was upgraded to cardiac resynchronization therapy or left bundle branch area pacing due to pacing-induced left ventricular dysfunction. There was one case of L-PM end-of-life 6 years after implant (pacing threshold 0,5mV; ventricular pacing 100%), in which a second L-PM was successfully implanted. Overall, 78 (31%) patients died, a mean of 2,2±1,9 years after L-PM implantation, none related to the device. Conclusion In this real-world cohort, L-PM maintained stable pacing parameters and, in the mid-term follow-up, only one battery depletion was observed while expected longevity remained above 8 years in the large majority of patients. Longer follow up will allow better understanding of both technical and clinical aspects relevant to manage end-of-life devices.Table 1Figure 1

Safety profile, electrical performances and clinical outcomes of a novel leadless pacemaker; first results from real-world clinical practice in Saudi Arabia

Abstract Introduction Leadless pacemakers (LP) are emerging as an effective and safe alternative to transvenous pacemakers to reduce lead-related and pocket-related complications and to improve patient experience. A new LP system, the Aveir VR, has been approved in 2022 for US and other countries, and in 2023 for Europe, and features innovative characteristics such as the active fixation helix mechanism and the possibility to measure sensing/pacing parameters before LP deployment. Purpose Evaluate safety, electrical performances and clinical outcomes associated with the first Aveir VR LP implants in 2 Hospitals in Saudi Arabia. Methods We performed a prospective evaluation of all-comer patients who received Aveir VR LP. Decision for LP implant was based on conditions such as cardiac pacing indication, lack of upper extremity venous access, risk of device infection, and life expectancy, and using shared decision-making. Clinical and electrical data were collected at implant and at 1st and 6th month visits. Results A total of 54 patients (25 female, mean age 69 years) were included between December 2022 and October 2023. Pacemaker implant indication was AV block in 25 (46%) patients, sinus node disease in 19 (35%) patients, atrial fibrillation and slow ventricular response in 9 (17%) patients and left bundle branch block in 1 (2%) patient. Implant was successful in all attempted cases. Final device position was lower septum in 51/54 (94.4%) patients and mid-septum in 3/54 (5.6%) patients. Mean procedure time was 48±22 minutes and showed a decreasing trend as a function of operator experience with a mean of 55, 50 and 36 minutes in the first, second and third group of consecutive implants, respectively. Mean fluoroscopic time was 11±8 minutes and showed a decreasing trend as a function of operator experience with a mean of 13, 13 and 6 minutes in the first, second and third group of consecutive implants, respectively. Final device position was achieved at first attempt in 42/54 (77.8%) cases and at first or second attempt in 51/54 (94.4%) cases. At implant mean R wave sensing was 7.6±3.7 mV, mean impedance was 724±335 Ohm, mean threshold was 1.0±0.6 V at 0.4 ms. During implant there was one patient with pericardial effusion treated with pericardiocentesis. In a mean follow-up of 73 days there were no procedure-related or device-related complications, electrical parameters showed acceptable values, and all implanted devices performed as expected. Median longevity, estimated at last follow-up visit, was 19 years (interquartile range: 12-20 years). Conclusion First real-world cases of use of a novel leadless pacemaker in Saudi Arabia show optimal feasibility and good safety profile and electrical performances. Procedure and fluoroscopic times were acceptable and decreased as a function of operator experience. Longevity estimations predict very long service life-times.

Empiric embolization by vasospasm therapy for acute lower gastrointestinal bleeding: a preliminary report

To report the preliminary result of empiric embolization for angiographycally-negative lower gastrointestinal bleeding (LGIB) by using the pharmaco-induced vasospasm technique with or without the adjunctive use of intra-arterial multi-detector computed tomography (MDCT). 23 LGIB patients with positive MDCT findings but negative angiographic results underwent empiric pharmaco-induced vasospasm therapy. The presumed bleeding artery was semi-selectively catheterized, and a segment of bowel was temporarily spasmed with bolus injection of epinephrine and immediately followed by 4-h’ vasopressin infusion. The rebleeding, primary and overall clinical success rates were reported. MDCT showed 19 bleeders in the SMA territory and 4 bleeders in the IMA territory. Early rebleeding was found in 6 patients (26.1%): 2 local rebleeding, 3 from new-foci bleeding and 1 uncertain. Of the 10 small bowel bleeding patients, only 1 out of the 7 who underwent intra-arterial MDCT showed rebleeding, whereas 2 out of the 3 without intra-arterial MDCT rebled. No patients exhibited procedure-related major complications, including bowel ischemia and cardiopulmonary distress. The overall clinical success rate was 91.3% (21/23) with a 30-day mortality rate of 26.1% (2 of the 6 patients had early rebleeding). Empiric pharmaco-induced vasospasm therapy, when localized with/without adjunctive intra-arterial MDCT, seems to be a safe and effective method to treat angiographically-negative LGIB patients.

Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.

Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence. Data from patients undergoing PFO closure between 2010 and 2015 was collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up. 330 patients were included, mean age was 49 (±12) years and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p=0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p=0.042), and a history of prior neurological events (adjHR: 9.94; p<0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes. In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.

Efficacy of endoscopic interventions versus surgery for pain management in patients with chronic calcific pancreatitis: a systematic review and meta-analysis.

Chronic calcific pancreatitis (CCP) is a debilitating inflammatory condition characterized by the accumulation of calcific deposits in the pancreatic tissue, leading to chronic abdominal pain and functional insufficiencies. This study aims to systematically review and meta-analyse comparative studies assessing the efficacy of endotherapy versus surgery in managing CCP-related pain. MEDLINE, EMBASE, and Cochrane library (CENTRAL and CDSR), from inception to October 2023, were searched. The inclusion criteria encompassed randomized controlled trials (RCTs) and non-randomized controlled trials (NRS), and cohort studies comparing endoscopic interventions to surgery for pain management in patients with CCP. Pain relief, procedural technical success, and procedural-related complications were the outcomes of interest. Two review authors (CN, KK) independently assessed study eligibility criteria and performed data extraction. Using a random-effects model, pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated. The level of certainty of the evidence was assessed using the GRADE approach. Five studies were included. For the outcome of pain relief, a meta-analysis of five studies (3 RCTs and 2 cohort studies) demonstrated a significant therapeutic effect in favour of surgery with an OR of 2.36 (95% CI: 1.12 to 5.00, I2 = 41.70), with moderate level of certainty of evidence. In the analysis of five studies (3 RCTs, 1 NRS and 2 cohort studies), procedural technical success was comparable between the two groups (OR of 3.02, 95% CI: 0.47 to 19.59, I2 = 79.27%) as were adverse events (OR 1.31, 95% CI: 0.47 to 3.70, I2 = 50.93%). In conclusion, this systematic review and meta-analysis suggest that surgery may be more effective in relieving pain in patients with CCP compared to endoscopic interventions. Disease stage may be important to determine the appropriateness of each procedure. PROSPERO (CRD42023476153).