High-volume Centers Research Articles

Venoarterial extracorporeal membrane oxygenation: from evidence to clinical practice

Mortality for cardiogenic shock is still high despite optimal pharmacological therapy. Therefore, active mechanical circulatory support devices are increasingly used; venoarterial extracorporeal membrane oxygenation (VA-ECMO) enables full circulatory and respiratory support. However, recent data show that in patients with infarct-related shock unselected early use of VA-ECMO does not improve survival and is associated with major bleeding and peripheral ischemic complications. Nowadays, waiting for the results of definitive randomized controlled trials, the main indication for ECMO utilization is in selected patients with cardiac arrest, in those with shock for advanced heart failure refractory to conventional therapy, in those with fulminant myocarditis, in patients candidate for heart transplant or ventricular assistance, especially in presence of respiratory insufficiency and severe biventricular dysfunction. An important recommendation is its utilization in specialized, high-volume centers in the setting of hub and spoke hospitals.

Diagnosis and Management of Desmoid Fibromatosis of the Breast.

Desmoid fibromatosis of the breast (also known as desmoid tumor of the breast) is a rare entity infrequently encountered by oncologists and surgeons caring for patients with breast disease. The current body of literature is highly reliant on case series and extrapolations from other sites of desmoid tumor-related disease. Much remains unclear regarding the pathological origins, natural history, and response to treatment of this condition. Traditional treatment strategies have centered on surgical resection, which may result in significantly disfiguring cosmetic and functional outcomes, frequent need for re-operation, and associated morbidity. There are limited data to support the superiority of upfront surgical resection when compared to medical therapy or watchful waiting strategies. Current treatment guidelines for desmoid tumors do not focus on the breast as a site of disease and are purposefully ambiguous due to the paucity of evidence available. We aim to review the literature concerning desmoid fibromatosis of the breast and propose an algorithm for current evidence-based management of this rare disease in the context of our experience with this pathology at a high-volume quaternary referral center.

Risk factor analysis and optimal cutoff value selection of PSAD for diagnosing clinically significant prostate cancer in patients with negative mpMRI: results from a high-volume center in Southeast China

BackgroundMulti-parametric magnetic resonance imaging (mpMRI) is a diagnostic tool used for screening, localizing, and staging prostate cancer. Patients with Prostate Imaging Reporting and Data System (PI-RADS) score of 1 and 2 are considered negative mpMRI, with a lower likelihood of detecting clinically significant prostate cancer (csPCa). However, relying solely on mpMRI is insufficient to completely exclude csPCa, necessitating further stratification of csPCa patients using biomarkers.MethodsA retrospective study was conducted on mpMRI-negative patients who underwent prostate biopsy at the First Affiliated Hospital of Zhejiang University from January 2022 to June 2023. A total of 607 patients were included based on inclusion and exclusion criteria. Univariate and multivariate logistic regression analysis were performed to identify risk factors for diagnosing csPCa in patients with negative mpMRI. Receiver Operating Characteristic (ROC) curves were plotted to compare the discriminatory ability of different Prostate-Specific Antigen Density (PSAD) cutoff values for csPCa.ResultsAmong the 607 patients with negative mpMRI, 73 patients were diagnosed with csPCa. In univariate logistic regression analysis, age, PSA, f/tPSA, prostate volume, and PSAD were all associated with diagnosing csPCa in patients with negative mpMRI (P < 0.05), with PSAD being the most accurate predictor. In multivariate logistic regression analysis, f/tPSA, age, and PSAD were independent predictors of csPCa (P < 0.05). PSAD cutoff value of 0.20 ng/ml/ml has better discriminatory ability for predicting csPCa and is a significant risk factor for csPCa in multivariate analysis.ConclusionAge, f/tPSA, and PSAD are independent predictors of diagnosing csPCa in patients with negative mpMRI. It is suggested that patients with negative mpMRI and PSAD less than 0.20 ng/ml/ml could avoid prostate biopsy, as a PSAD cutoff value of 0.20 ng/ml/ml has better diagnostic performance than the traditional cutoff value of 0.15 ng/ml/ml.

Current Management of Acute Severe Ulcerative Colitis: New Insights on the Surgical Approaches

Acute severe ulcerative colitis (ASUC) is a life-threatening medical emergency with considerable morbidity. Despite recent advances in medical IBD therapy, colectomy rates for ASUC remain high. A scoping review of published articles on ASUC was performed. We collected data, such as general information of the disease, diagnosis and initial assessment, and available medical and surgical treatments focusing on technical aspects of surgical approaches. The most relevant articles were considered in this scoping review. The management of ASUC is challenging; currently, personalized treatment for it is unavailable. Sequential medical therapy should be administrated, preferably in high-volume IBD centers with close patient monitoring and indication for surgery in those cases with persistent symptoms despite medical treatment, complications, and clinical worsening. A total colectomy with end ileostomy is typically performed in the acute setting. Managing rectal stump is challenging, and all individual and technical aspects should be considered. Conversely, when performing elective colectomy for ASUC, a staged surgical procedure is usually preferred, thus optimizing the patients’ status preoperatively and minimizing postoperative complications. The minimally invasive approach should be selected whenever technically feasible. Robotic versus laparoscopic ileal pouch–anal anastomosis (IPAA) has shown similar outcomes in terms of safety and postoperative morbidity. The transanal approach to ileal pouch–anal anastomosis (Ta-IPAA) is a recent technique for creating an ileal pouch–anal anastomosis via a transanal route. Early experiences suggest comparable short- and medium-term functional results of the transanal technique to those of traditional approaches. However, there is a need for additional comparative outcomes data and a better understanding of the ideal training and implementation pathways for this procedure. This manuscript predominantly explores the surgical treatment of ASUC. Additionally, it provides an overview of currently available medical treatment options that the surgeon should reasonably consider in a multidisciplinary setting.

Recurrence of rectal cancer on the pelvic sidewall after lateral lymph node dissection

PurposeAlthough lateral lymph node dissection has been performed to prevent lateral pelvic recurrence in locally advanced lower rectal cancer, the incidence of lateral pelvic recurrence after this procedure has not been investigated. Therefore, this study aimed to investigate the long-term outcomes of patients who underwent lateral pelvic lymph node dissection, with a particular focus on recurrence patterns.MethodsThis was a retrospective study conducted at a single high-volume cancer center in Japan. A total of 493 consecutive patients with stage II-III rectal cancer who underwent lateral lymph node dissection between January 2005 and August 2022 were included. The primary outcome measures included patterns of recurrence, overall survival, and relapse-free survival. Patterns of recurrence were categorized as lateral or central pelvic.ResultsAmong patients who underwent lateral lymph node dissection, 18.1% had pathologically positive lateral lymph node metastasis. Lateral pelvic recurrence occurred in 5.5% of patients after surgery. Multivariate analysis identified age > 75 years, lateral lymph node metastasis, and adjuvant chemotherapy as independent risk factors for lateral pelvic recurrence. Evaluation of the recurrence rate by dissection area revealed approximately 1% of recurrences in each area after dissection.ConclusionWe demonstrated the prognostic outcome and limitations of lateral lymph node dissection for patients with advanced lower rectal cancer, focusing on the incidence of recurrence in the lateral area after the dissection. Our study emphasizes the clinical importance of lateral lymph node dissection, which is an essential technique that surgeons should acquire.

Is mechanical bowel preparation necessary to reduce surgical site infection following colon surgery? Protocol for a multicentre Canadian randomized controlled trial.

There is significant practice variation with respect to the use of bowel preparation to reduce surgical site infection (SSI) following colon surgery. Although intravenous antibiotics + mechanical bowel preparation + oral antibiotics (IVA + MBP + OA) has been shown to be superior to IVA + MBP and IVA, there are insufficient high-quality data from randomized controlled trails (RCTs) that directly compare these options. This is an important question, because if IVA + OA has similar effectiveness to IVA + MBP + OA, mechanical bowel preparation can be safely omitted, and the associated side effects avoided. The aim of this work is to compare rates of SSI following IVA + OA + MBP (MBP) versus IVA + OA (OA) for elective colon surgery. This is a multicentre, parallel, two-arm, noninferiority RCT comparing IVA + OA + MBP versus IVA + OA. The primary outcome is the overall rate of SSI 30 days following surgery. Secondary outcomes are length of stay and 30-day emergency room visit and readmission rates. The planned sample size is 1062 subjects with four participating high-volume centres. Overall SSI rates 30 days following surgery between the treatment groups will be compared using a general linear model. Secondary outcomes will be analysed with linear regression for continuous outcomes, logistic regression for binary outcomes and modified Poisson regression for count data. It is expected that IVA + OA will work similarly to IVA + MBP + OA and that this work will provide definitive evidence showing that MBP is not necessary to reduce SSI. This is highly relevant to both patients and physicians as it will have the potential to significantly change practice and outcomes following colon surgery in Canada and beyond.

The Short-Term and Long-Term Outcomes of Laparoscopy-Assisted Proximal Gastrectomy with Double-Tract Reconstruction versus Laparoscopy-Assisted Total Gastrectomy with Roux-en-Y Reconstruction for Adenocarcinoma of the Esophagogastric Junction: A Multicenter Study Based on Propensity Score Matching Analysis

Purpose. To compare the antireflux effect, long-term nutritional levels, and quality of life (QoL) between laparoscopy-assisted proximal gastrectomy with double-tract reconstruction (LPG-DTR) and laparoscopy-assisted total gastrectomy with Roux-en-Y reconstruction (LTG-RY) for adenocarcinoma of the esophagogastric junction (AEG). Methods. This multicenter retrospective cohort study collected clinicopathological and follow-up data of AEG patients from January 2016 to January 2021 at five high-volume surgery centers. The study included patients who underwent digestive tract reconstruction with LPG-DTR or LTG-RY after tumor resection. Propensity score matching (PSM) was utilized to minimize confounding factors. The comparison after PSM included postoperative complications, reflux esophagitis, long-term nutritional levels, and QoL. Results. A total of 151 consecutive patients underwent either LPG-DTR or LTG-RY. After PSM, 50 patients from each group were included in the analysis. The frequency of reflux esophagitis and Clavien–Dindo classification did not significantly differ between the two groups (P&gt;0.05). At 1 year after surgery, the LPG-DTR group showed significantly higher weight and hemoglobin levels than the LTG-RY group (P&lt;0.05). The overall postoperative Visick grade differed significantly between the groups (P&lt;0.05), but there was no significant difference in the proportion of patients with Visick≥III (P&gt;0.05). Conclusion. Both LPG-DTR and LTG-RY are safe and feasible methods for digestive tract reconstruction in patients with AEG. Both methods have similar antireflux effects and postoperative QoL. However, LPG-DTR resulted in superior nutritional levels compared to LTG-RY. Therefore, LPG-DTR is considered a relatively effective method for digestive tract reconstruction in AEG patients.

Postoperative Delirium Screening Characteristics in Pediatric Intestinal, Liver, and Renal Transplant Recipients: Single-Center Retrospective Cohort Study.

To describe and compare the results of delirium screening in the immediate post-transplant PICU admission for pediatric intestinal, liver, and renal transplant recipients. We also examined associations with known and suspected risk factors for pediatric delirium (PD). Retrospective analysis of a single-center cohort, 2016-2022. Twenty-four-bed PICU in a high-volume transplant center. All intestinal, liver, and renal transplant recipients under 23 years old admitted between July 2016 and August 2022. We identified 211 pediatric transplant recipients: intestinal (n = 36), liver (n = 78), and renal (n = 97). Results of the Cornell Assessment for PD during the immediate post-transplant PICU admission were reviewed and patients were categorized into screen positive, screen negative, and unscreened. Corresponding data on known and suspected risk factors for PD were also collected. Data on delirium subtypes were not collected. Screens were available for 156 of 211 patients (74%) who were included in the final analysis. The prevalence of a positive screen by transplant category was: intestine 80% (24/30), liver 75% (47/63), and renal 14% (9/63). A positive screen was associated with younger age, greater duration of mechanical ventilation, and greater PICU length of stay (LOS) in bivariate analysis. In multivariable analysis, age and PICU LOS remained strongly correlated with a positive screen (p < 0.05). Deep sedation and agitation as categorized by the State Behavioral Scale was associated with a positive screen, as was significant iatrogenic withdrawal symptoms (p < 0.05). Most patients screened positive by post-transplant days 2 and 3 (58/80 [72%] and 64/80 [80%], respectively). In our 2016 to 2022 experience, we found a high prevalence of positive PD screens in pediatric intestinal and liver transplant recipients in the immediate post-transplant PICU admission. A positive screen was associated with younger age and greater PICU LOS.

Indications and results of right-lobe living donor liver transplantation.

The shortage of deceased liver donor organs over the years has always posed the need to expand the donor pool. A viable alternative to deceased donors is that of the living donor. Indeed, the living donor in liver transplantation, initially in pediatric transplantation, but for several years now also in adult transplantation, is a more than viable alternative to deceased liver donation. In fact, right liver lobe donation has proven to be a surgical procedure with low impact on the donor's life in terms of morbidity and mortality, with excellent results in recipients of such organs. In recent years, an increasing number of studies have been published that show excellent results in right-lobe living donor liver transplantation, encouraging this practice not only in countries that have historically had a shortage of deceased donor organs, such as Asian countries, but making it a practice of increasing use in Western countries as well. In addition, thanks to improvements in surgical technique and the experience of high-volume centers, this surgery has also begun to be performed using minimally invasive surgical techniques, allowing us to envision ever better outcomes for both donor and recipient in the coming years.

Radiomics of Intrahepatic Cholangiocarcinoma and Peritumoral Tissue Predicts Postoperative Survival: Development of a CT-Based Clinical-Radiomic Model.

For many tumors, radiomics provided a relevant prognostic contribution. This study tested whether the computed tomography (CT)-based textural features of intrahepatic cholangiocarcinoma (ICC) and peritumoral tissue improve the prediction of survival after resection compared with the standard clinical indices. All consecutive patients affected by ICC who underwent hepatectomy at six high-volume centers (2009-2019) were considered for the study. The arterial and portal phases of CT performed fewer than 60days before surgery were analyzed. A manual segmentation of the tumor was performed (Tumor-VOI). A 5-mm volume expansion then was applied to identify the peritumoral tissue (Margin-VOI). The study enrolled 215 patients. After a median follow-up period of 28months, the overall survival (OS) rate was 57.0%, and the progression-free survival (PFS) rate was 34.9% at 3years. The clinical predictive model of OS had a C-index of 0.681. The addition of radiomic features led to a progressive improvement of performances (C-index of 0.71, including the portal Tumor-VOI, C-index of 0.752 including the portal Tumor- and Margin-VOI, C-index of 0.764, including all VOIs of the portal and arterial phases). The latter model combined clinical variables (CA19-9 and tumor pattern), tumor indices (density, homogeneity), margin data (kurtosis, compacity, shape), and GLRLM indices. The model had performance equivalent to that of the postoperative clinical model including the pathology data (C-index of 0.765). The same results were observed for PFS. The radiomics of ICC and peritumoral tissue extracted from preoperative CT improves the prediction of survival. Both the portal and arterial phases should be considered. Radiomic and clinical data are complementary and achieve a preoperative estimation of prognosis equivalent to that achieved in the postoperative setting.

Slow pathway ablation in pediatric patients: long-term outcomes in a high-volume center according to baseline electrophysiologic characteristics

Abstract Background Slow pathway ablation (SPA) in pediatric patients with documented paroxysmal supraventricular tachycardia (PSVT) has been proven safe and effective. Arrhythmia induction is often difficult in the pediatric population. Accordingly, empirical SPA is frequently adopted in this population. Real-world data about long-term outcomes of slow pathway ablation (SPA) in relation to tachycardia inducibility and electrophysiologic characteristics in pediatric patients with PSVT in a high-volume center are lacking. Purpose To compare long-term clinical outcomes of SPA in pediatric patients with and without intraprocedural documentation of DAVP and AV nodal reentrant tachycardia induction. Methods In this retrospective sigle-center study, all SPA procedures performed on pediatric patients (under 18 years) at our Institution since 2016 were considered. All patients had documented PSVT with short RP interval, no evidet ventricular pre-excitatio on surface ECG and normal echocardiography. Baseline EPS was performed to exclude the presence of concealed accessory pathway and isoproterenol infusion was used to exclude focal atrial tachycardias. According to intraprocedural EP characteristics, three group of patients were identified: Group 1 with AVNRT induction; Group 2 with dual atrioventricular nodal physiology (DAVP) and no tachycardia induction; Group 3 without DAVP. According to previous documentation of a short RP PSVT and after discussion with patients’ families, SPA was performed in all patients. The endpoint of the ablation was to eliminate slow pathway conduction and AV node re-entrant beat. Follow up visits were scheduled three and twelve months after ablation for all patients. Results 1734 patients underwent SPA since 2016 at our Institution. 1092 patients (73.4%) showed AVNRT induction during EPS (Group 1). 433 patients (14.2%) showed DAVP without tachycardia induction (Group 2). 209 patients (12.4%) didn’t show DAVP at EPS (Group 3). Age and gender were similar among the three groups. SPA was performed with acute procedural success in all patients. After 36-month median follow-up, freedom from palpitations was 98.5% in Group 1, 97.1% in Group 2 and 92.3% in Group 3. A survival analysis showed the best outcomes in group 1 and no significant difference in recurrence rate among the groups 2 and 3 (Figure 1). No permanent heart blocks, neither other major complication was observed. Conclusions When performed by experienced operators and in high-volume centers, SPA is a safe and effective procedure in pediatric patients with documented short RP PSVT. Success rate is highest with AVNRT induction and good without AVNRT induction, regardless of AV node dual conduction at baseline EPS. Such high success rate depends on careful exclusion of others arrhythmia mechanisms (i.e., focal atrial tachycardias, AV re-entrant tachycardias) that, although infrequent in children, are the main determinants of arrhythmia recurrences.

Trends in adoption of extravascular cardiac implantable electronic devices: the Dutch cohort

Abstract Introduction Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of mainly pocket- and lead-related complications. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on the actual adoption of EVDs for patient or center characteristics is lacking. Purpose To assess real-world nationwide trends in adoption of EVDs in the Netherlands. Methods Using the Netherlands Heart Registration, all consecutive patients with a de novo S-ICD or conventional single-chamber ICD implantation between 2012-2020, or with a de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption of EVDs are described for different patient and hospital characteristics (tertiles of device-implanting volume and whether cardiothoracic surgery back-up was available). Differences between patients with EVDs and non-EVDs and differences between implanting centers of EVDs and non-EVDs were tested for by Student’s T-test, Chi-square and Fisher’s exact test. Trends in adoption over time were calculated with linear and logistic regression analysis. Results From 2012-2020, 2190 S-ICDs and 10683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11103 conventional pacemakers were implanted. The general adoption of both increased (S-ICDs, 8% to 21%; LPs, 1% to 8%), but the increase seems to reach a plateau (Fig. 1). S-ICD recipients were younger than conventional ICD recipients (p&amp;lt;0.001) and more likely to be female (p&amp;lt;0.001); LP recipients were younger than conventional pacemaker recipients (p&amp;lt;0.001) and more likely to be male (p=0.03). Both S-ICDs and LPs were mainly implanted in high-volume centers with thoracic surgery on-site (Fig. 2). Conclusions In this nationwide study we observed a relative quick adoption of innovative EVDs with a plateau after approximately 4 years. The relative adoption of S-ICDs is especially high in younger patients. EVDs are overall mainly implanted in high-volume centers with cardiothoracic surgery available. As LPs can only be implanted in centers with cardiothoracic surgery in the Netherlands, this may have limited its adoption.

Predictive machine learning model for mechanical dilatation in transvenous lead extraction procedures

Abstract Background Transvenous lead extraction (TLE) remains a procedure that requires a high level of expertise, with a doubled risk of death and clinical failure when performed in low-volume centers compared to high-volume ones (1). Purpose The aim of this study was to create a machine learning (ML)-based risk stratification system for predicting the need for mechanical dilatation in patients undergoing TLE due to infection. Methods We designed a ML-based risk stratification system trained with data from our registry to predict the need for mechanical dilatation in patients undergoing TLE for infection. An extensive evaluation of 5 different ML models (k-nearest neighbors, support vector machine, decision tree, and decision tree ensembles, such as random forest and gradient boosting machine) was conducted to identify a classifier with the highest potential to correctly predict previously unseen patients. Results Data to train the model was extracted from our 25-year registry of patients undergoing TLE (June 1998 – March 2023), for a total of 491 patients (77.8% male; age 69.7 ± 12.8 years) and 938 leads (ICD 21.2%; pacing 78.8%; indwelling time 61 ± 60 months) removed with success in 100% of cases. Each patient was represented by a set of 21 attributes (14 clinical, 7 device-related). Manual traction (MT) was used in 27.5% of cases, and mechanical dilatation (MD) was employed in the remaining 72.5% of cases. 5-fold nested cross validation was used to estimate performances: in turn, 393 patients were used for training and model selection, and 98 patients were used for independent testing. According to the evaluation, Gradient Boosting Machine performed best, achieving test accuracy of 89% (+/- 2% std. dev.), test sensitivity of 95% (+/- 3% std. dev.), test specificity of 73% (+/- 8% std. dev.), test AUROC of 92% (+/- 1% std. dev.). A further interpretability analysis on the best performing decision tree was conducted, showing remarkable adherence between the internal decisions taken by the model to make predictions and the current clinical practice for TLE. Conclusion ML models have enhanced the prediction of MD requirements in TLE procedures. This data may support the referral of patients to specialized and high-volume centers, thereby improving preoperative risk assessment.Feature importanceROC Curves

Characterization and clinical significance of hemolysis after pulsed-field ablation for atrial fibrillation: insights from a multicentric analysis

Abstract Background Pulsed-field ablation is a novel non-thermal ablation modality which is being increasingly used in clinical practice for the treatment of atrial fibrillation (AF). While the susceptibility of erythrocytes to electroporation is well-established, the effect of cardiac PFA technologies on erythrocyte destruction has not been described so far. Purpose The aim of this study was to investigate whether PFA induces clinically significant hemolysis. Methods We included 187 patients undergoing AF catheter ablation with either PFA (n=145) or RFA (n=42) at four high-volume centers. PFA was performed using a pentaspline catheter (biphasic, bipolar pulses of 2kV) and RFA with a 3.5 mm irrigated-tip catheter (40-60 W). The lesion set comprised pulmonary vein isolation (PVI) for paroxysmal AF and PVI ± additional lesions/lines for persistent AF. Established biomarkers of hemolysis, anemia and renal function were analyzed in blood samples obtained at baseline (T1), at the end of ablation (T2) and 24 hours after the procedure (T3). Results Baseline characteristics were well-balanced between groups (65.5 ± 9.6 years, 72.7% male, p&amp;gt;0.05). The ablation procedures comprised a mean of 61.4 ± 27.2 deliveries (PFA group) and a mean RF duration of 31.0 ± 16.3 min (RFA group). Atrial ablation in addition to PVI was performed in 55.2% vs. 61.9% patients, respectively (p=0.469). The direct hemolysis marker free plasma hemoglobin was significantly higher with PFA (592.8 ± 330.6 mg/dl) than with RFA (186.6 ± 215.8 mg/dl, p&amp;lt;0.001) at the end of ablation. A strong correlation was found between free plasma hemoglobin and PFA deliveries (Pearson r=0.615, p&amp;lt;0.001). PFA was further associated with a 2.2-fold increase in bilirubin (21.3 ± 11.3 vs. 9.6 ± 4.7 µmol/l), a 2.4-fold decrease in haptoglobin (0.5 ± 0.4 vs. 1.2 ± 0.4 g/l) and a 1.8-fold increase in LDH (352.7 ± 115.7 vs. 192.2 ± 51.6 U/l, T3 vs. T1, all p&amp;lt;0.001). There were no significant changes in bilirubin and haptoglobin in the RFA group (p&amp;gt;0.05). A slight decrease in red blood cells, hemoglobin and hematocrit was detected after both PFA and RFA (Abstract Figure), with no significant differences between groups (all p&amp;gt;0.05). While mean creatinine levels and glomerular filtration rates did not significantly change after ablation in either group, acute kidney injury occurred in 4/124 (3.2%) with PFA vs. 0/32 (0%) with RFA (p=0.303). Conclusion Intravascular hemolysis is a frequent finding after PFA for AF and increases with the number of PFA deliveries. While PFA was not associated with clinically significant anemia, the incidence of acute kidney injury in the present study warrants future large-scale investigations assessing the biological impact and nephrotoxicity of PFA-induced hemolysis.Abstract Figure

Feasibility and efficacy of single-shot PFA technology for redo procedures after a previous atrial fibrillation ablation procedure

Abstract Introduction Despite significant technological advancements and a better understanding of atrial tachyarrhythmia pathophysiology, a non-negligible percentage of atrial fibrillation (AF) patients undergoing catheter ablation experiences arrhythmia relapse. Repeat procedures have been traditionally performed via thermal energy systems, which carry a certain risk of collateral damage to adjacent tissues. Pulsed Field Ablation (PFA) has emerged as an alternative non-thermal energy source for cardiac ablation. The main advantage is its selectivity to cardiac tissue. FarapulseTM is the first PFA technology to have received regulatory approval and includes a pentaspline PFA catheter. Although designed for pulmonary vein isolation, its use for extrapulmonary vein site ablation has been previously documented. Purpose To evaluate the feasibility and efficacy of the pentaspline FarawaveTM for redo procedures. Methods Patients referred for a redo procedure using FarapulseTM system were enrolled in 3 high-volume European centers. A workflow (Figure 1.A) was established based on rhythm at presentation (Group 1: sinus rhythm; Group 2: AFL; Group 3: AF). Results A total of 117 patients were included (64 in Group 1, 18 in Group 2, and 35 in Group 3). The mean number of previous procedures was 1.26, and 23 patients (19.66%) had already undergone ≥2 procedures. Previous ablation targets included PVI, either alone (46.15%) or in combination with other targets, including posterior mitral line (39.32%), posterior wall (6.84%), or anterior mitral line (2.56%). Electroanatomical mapping (EAM) was adopted in 15.38% of the cases. Specifically, in 27.78% (n=5) of group 2, 15.63% (n=10) of group 1 and 8.57% (n= 3) of group 3 cases. Additional focal radiofrequency ablation was required in 4 patients for CTI line ablation. Lesion sets are depicted in Figure 2. Mean procedural and LA dwelling time were 95.2 ± 38.0 and 50.7 ± 36.7 minutes, respectively. There was a total of one major complication (intracranial haemorrhage) and 5 minor complications (two vascular site related, and three reversible ST segment changes, related to applications on the mitral annulus area). A total of 100 patients completed at least 3 months of follow-up (FU), with a median FU time was 7.55 months (IQR 5.18 – 11.85). The total number of recurrences was 20, including 2 during the blanking period. Survival function (excluding blanking period) was 88.6 (95% CI 79.7 – 93.8) at 6 months and 80.0% (95% CI 67.3 – 88.3) 12 months. Atrial arrhythmia free-survival was higher in patients presenting in sinus rhythm, compared to the other two groups (p = 0.0135), as displayed in Figure 1.B. Conclusion The proposed stepwise approach to repeat AF ablation procedures based on the use of the single-shot PFA system (with or without EAM) was feasible, safe, fast and effective at one year follow-up.Flow chart and Kaplan Meier curveLesion sets

Coexistence of cardiac sarcoidosis and genetic cardiomyopathies: a conundrum

Abstract Introduction Cardiac sarcoidosis (CS) is a chronic inflammatory disease characterized histologically by the formation of non-caseating granuloma in the myocardium, however, causes remain largely unknown. Genetic arrhythmogenic cardiomyopathy (ACM) is an important differential diagnosis of CS. Until now, few data are available about the coexistence of CS in a patient with genetic ACM harboring a desmoglein-2 (DSG2) variant. Purpose We report a case series of patients who demonstrate coexistence of histologically proven CS and genetic ACM. Methods This is a multicentric study, which included patients from four high-volume cardiology referral centres for heart failure and ACM in Switzerland, Italy, and Austria. Patients with both a biopsy-proven diagnosis of sarcoidosis with cardiac involvement (according to the 2014 HRS criteria) also harboring a pathogenic/likely pathogenic (P/LP) variant for cardiomyopathy-associated genes were 1:1 matched for age, gender and genetic variant with patients with genetic ACM without CS (Gen-only). Clinical and imaging data (echocardiography (TTE), cardiac magnetic resonance (CMR) and positron-emission tomography (18FFDG-PET/CT) were collected. Results Each group included 5 patients (Gen+CS: age 48 ± 11 years, Gen only: age 52 ± 13.7 years, n=3 (60%) female in both groups). For each group, the following genes with P/LP variants were found: PKP2: n=2 (40%), DSG2: n=1 (20%), DSP: n=1 (20%), TTN: n=1 (20%). In patients with Gen+CS, atrio-ventricular block (AVB) I° (80% vs 20%, p=0.05) and paroxysmal atrial fibrillation (80% vs 0%, p=0.004) were more frequent, and median NT-proBNP levels (1346ng/l, IQR:103-4276 vs. 214ng/l, IQR:131-326, p=0.046), as well as high-sensitive C-reactive protein levels were higher (3.1g/dl, IQR:1.1-24.2 vs. 0.7g/dl, IQR:0.3-0.95, p=0.016). On imaging, Gen+CS patients were more likely to have septal involvement (60% vs 0%, p=0.021), as highlighted by positive late-gadolinium enhancement on CMR, metabolic activity on PET, or focal wall motion anomalies on TTE. Conclusions CS and genetic ACM can coexist. Hence, detection of a P/LP genetic variant associated with ACM should not lead to exclusion of CS, which more frequently presents with AVB, septal involvement, heart failure, and metabolic activity on imaging. On the contrary, CS can be associated with genetic variants in cardiomyopathy-associated genes.FDG-PET/CT

Radiofrequency balloon ablation: 1-year outcomes of the AURORA registry

Abstract Background and Objectives A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into 3D mapping system was recently launched. Methods Patients ablated for paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (persAF) at two German high-volume electrophysiology centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180 and 360 days following ablation including 24h Holter ECGs. Results A total of 101 patients were enrolled (50 from centre A, 51 from centre B) and 86 patients (48% male, 65 ± 11 years, 55% PAF, 59 ± 7% left ventricular ejection fraction (LVEF)) completed the follow-up. Mean ablation and procedure times were 26 ± 13 min and 71 ± 20 min, respectively. Dose area product was 1501 ± 1634 mGycm2. Acute PVI was achieved in 100%. Atrial fibrillation (AF) free survival after a mean FU of 361 (219-375) days was 78.4% for PAF and 75.4% for persAF. (p= 0.828). A multiple regression analysis did not reveal any clinical or procedural predictors of AF recurrence among sex, age, BMI, left atrial diameter, LVEF, ablation time, procedure time and single shot PVI. However, early recurrence of atrial tachyarrhythmia (ERAT) was an independent predictor for AF recurrence at 1-year (Hazard Ratio [HR]: 3.198; 95% confidence interval [95% CI]: 1.036 - 10.32, p value = 0.0433). Primary adverse events occurred in 3.5% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke or phrenic nerve paralysis were observed. Conclusions RFB-based PVI is clinically effective and safe. ERAT at the first follow-up visit is an independent predictor of late AF recurrence.

Procedural and outcome impact of body mass index on pulsed field ablation of atrial fibrillation: insights from the EU-PORIA Registry

Abstract Introduction Pulsed field ablation (PFA) is a "single-shot" non thermal ablation modality for atrial fibrillation (AF). In general, obesity is associated with increased risk of AF recurrence after catheter ablation with thermal energy sources. Purpose We aimed to assess the impact of body mass index (BMI) on procedural characteristics, safety, acute efficacy and long-term outcomes of PFA for symptomatic AF. Methods Of 1233 subjects enrolled in the EU-PORIA registry, in our subanalysis we included 1055 patients undergoing de novo pulmonary vein isolation (PVI)-only ablation procedure for symptomatic AF using the pentaspline PFA catheter from March 2021 until May 2022 at seven high-volume European centers. Patients were divided into two groups based on BMI: normal weight (nW, &amp;lt; 25 kg/m2) and overweight (oW, ≥ 25 kg/m2). Overweight patients were further categorized into three subgroups: pre-obesity (pOb, 25-29.9 kg/m2), obesity (Ob, 30-34.9 kg/m2) and severe obesity (sOb, ≥ 35 kg/m2). Clinical and procedural characteristics, complications and follow up data were collected. Results A total of 1055 patients (39% female, mean age 65,7±10,9 years, 65% paroxysmal AF) were enrolled. 32% of patients were normal weight (nW) and 68% overweight (oW). Among oW group, 438 subjects (41%) were assigned to pOb group, 204 (19%) to Ob, and 71 (7%) to sOb. Acute PVI was achieved in 100% of cases. The median skin-to-skin procedure and the median fluoroscopy time were similar between nW and oW and in all investigational subgroups, but radiation exposure increased in line with BMI (p&amp;lt;0.001). Periprocedural complications were 5% in nW, 1.6% in pOb, 3.9% in Ob, and 2.8% in sOb (p=0.06). The Kaplan-Meier estimate of arrhythmia-free survival was 80.2% in nW and 71.9% in oW (p=0.017). Each unit increment in BMI was associated with 4.2% increase in risk of AF/AT recurrence. Severe obese patients presented the highest 1-year AT/AF recurrence rate (37.2%). In the sOb group the rate of recurrence was not influenced by the type of AF (PAF 65.7% vs. pers AF 59.4%; p=0.484). Conclusion Overweight patients seem to experience more AF recurrences even after PFA PVI, mainly driven by a higher recurrence rate for BMI ≥ 35 kg/m2. Weight reduction programs remain crucial, nevertheless, reduced procedural times, good safety profile and acceptable 1-year observed AF/AT freedom make PFA a feasible strategy for AF rhythm control in patients with BMI ≥ 25 kg/m2.Freedom from AF/AT recurrence

Long-term outcome after catheter ablation for fascicular ventricular tachycardia in a single high-volume center in Germany

Abstract Background Idiopathic Fascicular Ventricular Tachycardia (IFVT) accounts for less than 10% of all VTs and represents the most common idiopathic ventricular tachycardia of the left ventricle. This study reports on clinical and procedural characteristics and the long-term outcome of patients undergoing catheter ablation of premature ventricular complexes (PVC) and ventricular tachycardias (VTs) arising in proximity of the left ventricular conduction system. Methods and results This study includes 27 patients (17 male, 45 ± 17 years; 10 females, 50 ± 11 years) who underwent electrophysiological examinations at a tertiary ablation center over a period of 14 years (2009 to 2022). Follow-up was performed via regular Holter-ECGs and clinical evaluations, or via structured follow-up within the prospective TRUST registry. In 21/27 patients (77.8%), the left posterior fascicle (LPF) was involved in the IFVT. In 4 (14.8%) the left anterior fascicle (LAF) was involved and in 2 (7.4%) patients an origin in the upper septal (US) area was demonstrated. 22/27 (81.5%) patients had a preserved left ventricular ejection fraction (LVEF) and only 5 (18.5%) patients had a LVEF less than 50% at the time of presentation. 14/27 (51.9%) patients presented with PVC or non-sustained VTs with the following distribution: 10 (71.4%) originating from the LPF, 3 (21.4%) from the LAF and 1 (7.1%) from the US. 21/27 (77.8%) patients presented with sustained VTs: 16 (76.2%) arising from the LPF, 4 (19%) from the LAF and 1 (4.8%) from the US. However, only 2 (7.4%) patients presented in sustained VT at the beginning of the EP procedure. In 16 (59.3%) patients a sustained VT was induced during the EP study via isoprenaline and/or programmed ventricular stimulation. Mean QRS duration of the VT was 124.5 ± 14.6 msec. In 21 (77.7%) patients only a retrograde approach was used, in 3 (11.1%) patients a retrograde and an additional transeptal approach and in only 3 (11.1%) patients solely a transeptal approach. Mean number of radiofrequency applications was 11.8 ± 12.6 (30 to 40 Watts, 27545.6 ± 30524.4 Joules). FVT ablation was acutely successful in 24 patients (88.9%). In 2 patients (7.4%) no ablation was performed due to inability to induce VT under sedation. 3/27 patients (11.1%) underwent re-ablation due to FVT recurrence after previous ablation procedures. Moreover, 3 (11.1%) additional patients underwent repeated VT ablations during follow-up, but the arrhythmia originated from a different LV area. No procedure-related complication occurred. In 4 patients (14.8%) left fascicular posterior block was caused by ablation and in 3 (11.1%) patients a complete left bundle block. Mean procedure time was 130 ± 48.9 minutes. Conclusion Ablation of FVT in a tertiary ablation center is associated with a high single procedural success rate of 88.9% during long-term follow-up, with a mild risk of fascicular injury. 11.1% of patients underwent re-ablation due to FVT recurrence.

Role of mechanical circulatory support in VT ablation procedures: data from the German PROTECT VT registry

Abstract Introduction Ventricular tachycardia (VT) ablation in patients with progressed heart failure (HF) is known to be complex and associated with a high periprocedural risk and mortality, in part due due to hemodynamic instability during ongoingVTs. Use of mechanical circulatory support (MCS) systems has been already implemented in complex high-risk percutaneous coronary intervention (CHIP-PCI) workflows. Use and benefit of MCS in VT ablation is still under debate. MCS protected VT ablation (proVT-A) might be associated with improved clinical outcomebut potentially comes along with an increased risk of periprocedural complications. Based on data of four German high-volume centers we aimed to analyze retrospective data on patient characteristics and impact of proVT-A with respect to safety and mid-term efficacy. Methods All patients undergoing proVT-A as a primary approach from four German EP centers were included in the analysis. Use of MCS in bailout scenariosin VT ablation were not included. Patient characteristics, procedural parameters and clinical outcome were evaluated. The primary endpoint was a combined endpoint of VT/VF recurrence and all-cause death. Results 41 patients who underwent proVT-A were included. Mean age was 64±11a, 92% of patients were male (38/41), 65% (27/41) suffered from ischemic cardiomyopathy, mean left ventricular ejection fraction was 33±13%,76% (31/41) of patients presented with a documented hemodynamically not tolerated VT, mean PAAIN-ESD score was 13±7, and 46% (19/41) had a history of a previous VT ablation w/o MCS. During proVT-A procedure at least one VT was inducible and mappable in 35 patients (85%). Acute procedural success was 85%, with only n=6 patients remaining inducible for VT. Mean procedure duration was 245±46min. With respect to periprocedural safety (30days)a total of n=12 relevant procedural complications were reported in 8 patients. This included n=5 vascular access complications, of which n=3 requiring transfusion or surgery. One case of periprocedural death was reported 6h post proVT-A due to PEA. Three patients developed pericardial effusion, one requiring drainage. Freedom from VT/VF was 78% (n=9 VT/VF recurrences) after a mean follow-up (FU) of 15±14 months (figure 1A). Death of any cause occurred in n=9 patients (figure 1B). In summary, after a mean FU of 15±14 months n=16 patients (39%) met the combined endpoint of VT/VF recurrence and all-cause death (figure 1C). Conclusion Patients enrolled in the German PROTECT VT Registry had significant cardiovascular comorbidities and therefore represent a high-risk population for VT ablation. Use of MCS was feasible, comparably safe, associated with high procedural and promising long-term success rate. These results highlight the need for larger registries and future prospective trials evaluating the potential benefit of proVT-A in selected patients. Further, it should be aimed for optimization of periprocedural vascular access site management.