Major Procedural Complications Research Articles

Abstract 4135984: Comparison of Immediate and Staged Complete Revascularization in STEMI Patients with Multivessel Disease: Meta-Analysis of Randomized Controlled Trial

Background: Patients diagnosed with ST-segment elevation myocardial infarction (STEMI) frequently present with multivessel coronary artery disease (CAD) at the time of primary percutaneous coronary intervention (PCI). The optimal timing of complete revascularization (CR) in these cases remains a subject of ongoing debate. Objective: To assess major cardiovascular outcomes and procedural complications in STEMI patients with multivessel CAD undergoing immediate versus staged CR post index procedure. Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing immediate to staged CR in STEMI and multivessel CAD. Trials were identified via a systematic search of MEDLINE, Embase, and Cochrane Libraries from database inception to March 6, 2024. The data were analyzed using RevMan software. Results: Among five RCTs (n=1,415) the majority of participants were male, the weighted mean follow-up duration across studies was 15.6 months. Immediate versus staged CR showed no significant differences in MACE (13.3% vs 9.8%; RR: 1.07, 95% CI [0.62, 1.83]), all-cause mortality (3% vs 4.55%; RR: 0.70, 95% CI [0.41, 1.21]), or MI (4.5% vs 2.6%; RR: 1.43, 95% CI [0.58, 3.55]). However, the staged group had higher unplanned revascularization incidence (8.6% vs 4.4%; RR: 1.92, 95% CI [1.21, 3.04]). Conclusion: Staged revascularization in STEMI patients with multivessel CAD demonstrates comparable effectiveness to immediate revascularization but leads to a greater number of unplanned revascularization procedures, likely due to delayed intervention. The early implementation of staged PCI during the initial hospitalization phase may provide equivalent efficacy to immediate complete revascularization. Nonetheless, further research is necessary to corroborate these findings.

Left Atrial Appendage Closure in Atrial Fibrillation Patients with Cancer.

Background: There are limited data about left atrial appendage closure (LAAC) in patients with cancer. We therefore sought to compare the outcome after LAAC in patients with vs. without cancer in a multicentre registry. Methods: In this sub-analysis of the prospective Austrian LAAC Registry, we analysed consecutive patients undergoing LAAC to assess the relationship between baseline characteristics and outcome in patients with vs. without cancer. Inverse probability weighting was performed to adjust for differences in baseline characteristics. Results: A total of 486 consecutive patients from 9 centres with a median age of 75 years (IQR 70-79 years; 35.8% female) were included. Fifty-seven patients (11.7%) had a history of cancer. The median CHA2DS2-VASc and HAS-BLED scores were similar in both groups (median [IQR], 4 [4-6] vs. 5 [3-5], p = 0.415; 4 [3-4] vs. 3 [3-4], p = 0.428 in cancer vs. other patients). Cancer patients were significantly older, and anaemia and gastrointestinal bleeding were significantly more common. Major procedural complications occurred in 5.3% vs. 7.0% (p = 0.276) of patients. The cumulative five-year survival rates were 80.7% and 84.8% in cancer vs. other patients (adjusted hazard ratio for death 1.29 [95% CI 0.67-2.48], p = 0.443). There were also no differences in one-year survival (96.1% vs. 94.0%, p = 0.582) and five-year event-free survival (64.9% vs. 74.4%, p = 0.124). Conclusions: In daily clinical practice, LAAC has already been accepted as a treatment option in patients with cancer. This retrospective analysis shows that short-term and adjusted long-term complications are similar in patients with vs. without cancer undergoing LAAC.

Survival in very elderly patients with severe aortic stenosis submitted to TAVI compared to the general population

Abstract Introduction Severe aortic stenosis (AS) is the most common acquired valvular heart disease. Transcatheter aortic valve implantation (TAVI) is indicated as an alternative to surgery in patients (pts) with severe AS above 75 years old (yo) regardless of surgical risk. The prevalence of severe AS increases with age. In the very elderly, i.e. > 85yo, the presence of severe AS is often accompanied with important comorbidities and frailty. To improve pts assessment in the heart team, it is essential to characterize the outcomes of previous interventions in this challenging group of patients and that was the goal of the present study. Methods Single-center retrospective analysis, on prospectively collected data, of consecutive patients ≥85yo undergoing TAVI between 2015 to 2021. Successful TAVI, major procedural complications and 1-year mortality rates were defined according to the VARC-3 definition. Observed survival was compared to an age-matched population using life expectancy tables available at the portuguese National Statistics Institute. Simulated survival curves for an age-matched population were performed using an expected hazard rate of 0.14. This was a conservative approach assuming that mortality rate remained constant in the population during follow-up. Results A total of 767 pts underwent TAVI during the study period. Of these, 349 pts were ≥85yo and were included in our study. Median age was 87yo [IQR 86-89], 60% female (n = 211) with a median Euroscore II of 5% [IQR 4-7]. A total of 98 pts (28%) had previous coronary artery disease, 300 pts (85%) had chronic kidney disease and 22 pts (6%) had a previous stroke. Median mean aortic valve gradient was 49mmHg [IQR 42-60] and left ventricle ejection fraction was 55% [IQR 50-56]. 268 pts (77%) underwent an elective TAVI and the remaining 23% were urgent procedures after hospital admission. The transfemoral approach was used in 334 pts (96%) and 258 pts (74%) implanted a self-expanding valve. Median in-hospital time was 6 days [IQR 4-11] and most common complications were permanent pacemaker implantation (n=59, 17%) and major access-related complications (n=17, 5%). All-cause mortality at 30 days and 1 year were 2.1% (n=7) and 13.1% (n=46), respectively. This compares similarly to the group of younger pts (<85yo) which presented a 30 day and 1 year mortality of 2.8% and 12.8%, respectively. Among very-elderly, 35 pts (10%) were readmitted in the first-year post TAVI. The mean survival time in our cohort was 4.9 years compared to expected 6.2 years (figure, log-rank < 0.01). The mortality rate at one year was 13% (n = 46) in our cohort compared to expected mortality of 14% (n = 50), not statistically significant. Conclusion In this study, very old patients submitted to TAVI had a 1-year mortality rate similar to age-matched population and a mean survival time of more than 4 years, albeit inferior to an age-matched population.

Ablation outcome in patients with atrial fibrillation undergoing ICE-guided pulsed-field ablation

Abstract Background Prior experiences from preclinical studies indicate the critical need of catheter-tissue- contact for creation of consistent transmural lesions in pulsed-field ablation (PFA). Intracardiac echocardiography (ICE) not only provide real-time visualization of cardiac structures, but also ensure adequate contact with the tissue. Objective We evaluated ablation outcome and reconnection rate following ICE-guided PFA procedure in patients with atrial fibrillation (AF). Methods Consecutive patients receiving ICE-guided PFA procedure were included in this multi-center analysis. All patients received isolation of PVs (PVI). Additional ablation of left atrial posterior wall (LAPW) was decided based on operator’s discretion. Concentric overlapping lesions were placed in the LAPW. Number of applications were determined on a case-by-case basis. ICE and fluoroscopy were used to optimize contact between the PFA catheter and the targeted tissue. All procedures were performed under uninterrupted anticoagulation. Mapping was done before and after ablation to confirm electrical isolation. Arrhythmia-monitoring was done for 1-year with periodic clinic visits, event recorders and 7-day Holter monitoring. Results A total of 372 patients [age: 62.69 ± 10.41 years, male: 201 (71.3%), paroxysmal AF: 67 (18%)] were included in this analysis of which 48 (12.9%) underwent PVI-only and the remaining subjects received additional ablation of LAPW. Mean number of applications were 34.67 ± 8.88 and 73.65 ± 37.21 for PVI-only and PVI+LAPWI cohorts respectively (p<0.001). No major procedural complications such as esophageal injury, atrio-esophageal fistula, pericardial effusion requiring drainage or cerebrovascular accidents were reported. During 1-year follow-up, 38 (10.2%) patients underwent repeat procedure for recurrence. Reconnection of PV and LAPW were found in only 2 (5.2%) patients. In all 38 patients, new triggers initiating AF were detected to be originating from interatrial septum: 25 (65.8%), superior vena cava: 9 (23.7%), coronary sinus: 7 (18.4%) and left atrial appendage: 6 (15.8%). Conclusion ICE-guided PFA procedures are safe and produce durable lesions leading to very low reconnection rate. The recurrence was mostly due to new triggers initiating AF.

Left atrial appendage closure guided by fusion of 3D computational modelling on real-time fluoroscopy: A multicenter experience

BackgroundPatient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported. ObjectivesTo assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective. MethodsWe included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization. ResultsA total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device SINGLE-deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired. ConclusionsFusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Percutaneous Repair of Chronic Aortic Pseudoaneurysm: A Single-Center Experience

BackgroundAortic pseudoaneurysm (AP) is a late complication of aortic repair that, without intervention, carries a high mortality rate. Surgical repair has significant in-hospital mortality and high health care costs. Endovascular stent grafting use is currently limited to branch-free aortic segments or the use of complex fenestrated devices. Our objective was to review the literature and share our institution’s experience with AP percutaneous closure by vascular plugs and occluder technology. MethodsWe retrospectively reviewed percutaneous AP closure cases published in the literature (2005-2016) and from our institution (2017-2019). The follow-up strategy in our institution group was up to the discretion of the performing physician. We measured the procedure’s safety, complications, and follow-up outcomes. ResultsWe found 40 cases in the literature and 10 at our institution. The procedural success rate was 90% in the literature and 100% in our group. Our group’s average length of stay was 1.9 days with no observed major procedural complications. The literature’s follow-up was generally limited to the hospitalization period. Our patients had a median follow-up time of 12 months (range 3-47 months). Late follow-up of AP demonstrated that sac size remained stable or reduced in 6 patients, but a size increase was observed in 4 patients requiring surgical intervention. Death from nonprocedure-related complications occurred in 40% of our patients. The cost per procedure was hypothetically less than for performing open surgical repair. ConclusionsOur experience shows a viable option for percutaneous AP repair, given its initial safety and cost-effectiveness. Our experience highlights the critical role of follow-up imaging in identifying AP expansion and the need for further intervention. The high nonaorta-related mortality seen in follow-up emphasizes the high-risk nature of the population due to comorbidities.

Effects of a prior failed attempt on the outcomes of subsequent chronic total occlusion‐percutaneous coronary intervention

AbstractObjectivesPatients undergoing a prior failed attempt of chronic total occlusion‐percutaneous coronary intervention (CTO‐PCI) represent a challenging subgroup across all patients undergoing CTO‐PCI. There are limited data on the effects of a prior failed attempt on the outcomes of subsequent CTO‐PCI. We aimed to compare the procedural results and 24‐month outcomes of prior‐failed‐attempt CTO‐PCI with those of initial‐attempt CTO‐PCI.MethodsPatients who underwent attempted CTO‐PCI between January 2017 and December 2019 were prospectively enrolled. We analyzed the procedural results and 24‐month major adverse cardiac events (MACE) between patients who underwent prior‐failed‐attempt and initial‐attempt CTO‐PCI. MACE was defined as a composite of cardiac death, target vessel‐related myocardial infarction, and ischemia‐driven target vessel revascularization (TVR) during follow‐up.ResultsIn total, 484 patients who underwent CTO‐PCI (prior‐failed‐attempt, n = 49; initial‐attempt, n = 435) were enrolled during the study period. After propensity score matching (1:3), 147 patients were included in the initial‐attempt group. The proportion of the Japanese‐CTO (J‐CTO) score ≥2 was higher in the patients who underwent prior failed attempt than in those who underwent initial attempt (77.5% vs. 38.8%, p < 0.001). The retrograde approach was more often adopted in the prior‐failed‐attempt group than in the initial‐attempt group (32.7% vs. 3.4%, [P< 0.001). Successful CTO revascularization rates were significantly lower in the prior‐failed attempt‐group than in the initial attempt group (53.1% vs. 83.3%, P < 0.001). The multivariate analysis revealed that J‐CTO score ≥2 [odds ratio (OR), 0.359; 95% confidence interval (CI), 0.159–0.812; P = 0.014], intravascular ultrasound procedure (OR, 4.640; 95% CI, 1.380–15.603; P = 0.013), and prior failed attempt (OR, 0.285; 95% CI, 0.125–0.648; P = 0.003) were the independent predictors for successful CTO revascularization. There were no significant differences in major procedural complications (2.0% vs. 0.7%, p = 0.438) and MACE rates (4.1% vs. 8.8%, p = 0.438) between the groups, mainly due to the TVR rate (4.1% vs. 8.2%, P = 0.522).ConclusionsCompared with initial‐attempt CTO‐PCI, prior‐failed‐attempt CTO‐PCI deserves more attention, since it is associated with a lower successful CTO revascularization rate. Prior failed attempt, J‐CTO score ≥2, and IVUS procedure are the determining factors for predicting successful CTO revascularization. There are no significantly different unfavorable outcomes between patients who undergo prior‐failed‐attempt and initial‐attempt CTO‐PCI.

Failure to Rescue After Percutaneous Coronary Intervention: Insights From the National Cardiovascular Data Registry.

Failure to rescue (FTR) describes in-hospital mortality following a procedural complication and has been adopted as a quality metric in multiple specialties. However, FTR has not been studied for percutaneous coronary intervention (PCI) complications. This is a retrospective study of patients undergoing PCI from the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry between April 1, 2018, and June 30, 2021. PCI complications evaluated were significant coronary dissection, coronary artery perforation, vascular complication, significant bleeding within 48 hours, new cardiogenic shock, and tamponade. Secular trends for FTR were evaluated with descriptive analysis, and hospital-level variation and clinical predictors were analyzed with logistic regression. Among 2 196 661 patients undergoing PCI at 1483 hospitals, 3.5% had at least 1 PCI complication. In-hospital mortality occurred more frequently following a complication compared with cases without a complication (19.7% versus 1.3%). FTR increased during the study period from 17.1% to 20.1% (P<0.001). The median odds ratio for FTR was 1.48 (95% CI, 1.44-1.53) indicating significant hospital-level variation. Spearman rank correlation demonstrated the modest correlation between FTR and in-hospital mortality, 0.525 (P<0.001). Major procedural complications during PCI are infrequent, but FTR occurs in roughly 1 in 5 patients following a PCI procedural complication with significant hospital-level variation. Improved understanding of practices associated with low FTR could meaningfully improve patient outcomes following a PCI complication.

Initial real-world data on catheter ablation in patients with persistent atrial fibrillation using the novel lattice-tip focal pulsed-field ablation catheter.

Technological advancements have contributed to the enhanced precision and lesion flexibility in pulsed-field ablation (PFA) by integrating a three-dimensional mapping system combined with a point-by-point ablation strategy. Data regarding the feasibility of this technology remain limited to some clinical trials. This study aims to elucidate initial real-world data on catheter ablation utilizing a lattice-tip focal PFA/radiofrequency ablation (RFA) catheter in patients with persistent atrial fibrillation (AF). Consecutive patients who underwent catheter ablation for persistent AF via the lattice-tip PFA/RFA catheter were enrolled. We evaluated acute procedural data including periprocedural data as well as the clinical follow-up within a 90-day blanking period. In total, 28 patients with persistent AF underwent AF ablation either under general anaesthesia (n = 6) or deep sedation (n = 22). In all patients, pulmonary vein isolation was successfully achieved. Additional linear ablations were conducted in 21 patients (78%) with a combination of successful anterior line (n = 13, 46%) and roof line (n = 19, 68%). The median procedural and fluoroscopic times were 97 (interquartile range, IQR: 80-114) min and 8.5 (IQR: 7.2-9.5) min, respectively. A total of 27 patients (96%) were interviewed during the follow-up within the blanking period, and early recurrent AF was documented in four patients (15%) including one case of recurrent AF during the hospital stay. Neither major nor minor procedural complication occurred. In terms of real-world data, our data confirmed AF ablation feasibility utilizing the lattice-tip focal PFA/RFA catheter in patients with persistent AF.

Effects of hemodynamic support on arrhythmia-free survival following catheter ablation of ventricular arrhythmias

Abstract Background Radiofrequency-guided catheter ablation is an established therapy for ventricular tachycardia (VA). Hemodynamic support (HS) is often required for patients suffering from incessant VA to guide ablation. Data on the outcome of patients receiving HS during VA ablation procedures are lacking. Purpose The aim of this observational study was to analyze the acute procedural success as well as long-term 36-month-VA-recurrence rates and mortality in patients requiring HS during VA ablation procedures. Methods Data from consecutive patients receiving HS during VA ablation procedures between 2015-2023 were analyzed. HS was defined as the use of an Impella, an extracorporeal membrane oxygenation (ECMO) or a left ventricular assist device (LVAD). HS-group patients were compared to patients that underwent VA ablation procedures without HS. All patients were continuously followed up in our outpatient clinic. Data on procedural parameters, acute success and complications as well as long-term VA-free survival and mortality were analyzed. Results A total of 95 consecutive patients (mean age 60.9 ± 11.0 years, 15% female) were included. 62 patients (65%, mean age 60.4±9.4 years, 16% female) receiving HS (ECMO or Impella: n=26, 42%; ECMO+Impella: n=7, 11%; LVAD: n=29, 47%) were compared to those without (mean age 61.7±13.5 years, 12 % female). In the HS-cohort a significantly lower left ventricular ejection fraction (LVEF) (p&amp;lt;0.001), a higher New York Heart Association (NYHA) functional class (p=0.013) and a more frequent antiarrhythmic drug use (p=0.045) was documented. Fluoroscopy times were significantly longer in the HS-group (HS: 10:22 ± 07:04 vs. no HS: 05:52 ± 02:50 minutes, p&amp;lt;0.001). Acute procedural success (HS: n=59, 95% vs. no HS: n=33, 100%, p=0.549) and major procedure complications (HS: n=4. 6% vs. no HS: n=4. 6%, p=1.000) were comparable between the two groups. Nevertheless, patients receiving HS had a significantly higher in-hospital mortality (HS: n=20, 32 % vs. no HS: n=2, 6%, p=0.004). The estimated 36-month-VA-free survival was comparable between the groups (Log-rank p=0.114). But Kaplan-Meier-plot analyses revealed a significantly higher estimated mortality in patients receiving HS (Log-rank p=0.002) (Figure 1). Between the subgroups (ECMO or Impella vs. LVAD) no statistically relevant differences were observed (Log-rank p=0.466). Multivariate analyses revealed HS as an independent predictor for mortality (Hazard ratio (HR) 3.259, Confidence Interval (CI) 1.060-10.015, p=0.039), but not for VA-recurrence. Conclusion In the specific cohort of patients receiving HS, VA ablation procedures seem to be safe and effective with comparable acute and long-term success- and complication-rates. The need for HS seems to be associated with an increased risk for mortality. Further studies are required to validate our initial observations.Kaplan-Meier-plot on 36-month survival

Pulsed-field ablation using a lattice-tip catheter without general anesthesia is feasible for atrial fibrillation ablation

Abstract Background General anesthesia (GA) was employed to titrate lesion formations for a pulsed-field ablation (PFA) using a lattice-tip catheter. The evidence using a lattice-tip catheter without the use of GA is limited. Purpose We conducted a series of exploratory evaluation of a lattice-tip PFA catheter ablation without GA. Methods Patients undergoing their first atrial fibrillation (AF) ablation procedures using a lattice-tip catheter were enrolled in the study. To assess acute outcomes and safety, the patients were divided into two groups: one undergoing the procedure with GA and the other without GA. Procedural characteristics were collected. Results In total, 20 patients (6 with GA, 14 without GA) were enrolled in the current study. One patient in non-GA group needed a larynx mask due to apnea from anesthesia. The pre-ablation 3D mapping time was equivalent between the two group (with GA versus without GA: 17±7 versus 16±5; P=0.762). All first-pass isolations of the pulmonary veins (PV) were successfully achieved, and there was no difference in the number of applications between the right and left PV (with GA versus without GA: 45±8 versus 53±12; P=0.206 and 47±14 versus 49±9; P=0.792). Linear lesions including anterior linear ablation (33% with GA and 36% without GA: P=1.000), roof linear ablation (67% with GA and 71% without GA: P=1.000) and cavo-tricuspid isthmus ablation (0% with GA and 7% without GA: P=1.000) were performed. The ablation, laboratory stay and fluoroscopy times were equivalent between the two group (with GA versus without GA:88±22 versus 97±20; P=0.483, 128±25 versus 111±18; P=0.216 and 9±4 versus 10±2; P=0.902), while the pre-ablation preparation times were shorter in the group without GA (with GA versus without GA:40±17 versus 14±4; P&amp;lt;0.01). There was no major and minor procedural complication in both groups. Conclusions The use of a lattice-tip catheter for ablation without GA has a potential to shorten the whole procedural work-flow including preparing time while maintaining comparable safety and lesion formation to cases where GA is utilized.

Midterm Experience with the Self-Expandable Venus P-Valve™ for Percutaneous Pulmonary Valve Replacement in Large Right Ventricular Outflow Tracts

Background. Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes with the Venus P-Valve™. Methods. Twenty patients who underwent Venus P-Valve™ implantation in our institution were included in this retrospective study. Procedural data and clinical, imaging, and hemodynamic data at baseline and last follow-up were recorded and analyzed. Results. Mean patient age was 35.0 ± 16.8 years, and five patients were &lt;18 years of age. Procedural success was 100%, and there was no major valve-related procedural complication. At last follow-up (median 0.5 (range 0.1–6.6) years), valve function was excellent in all patients. Two patients had mild regurgitation after 6.2 and 6.6 years, respectively, while all other patients had no or only trace regurgitation. Flow was unobstructed with a mean gradient estimated by echocardiography of 12 ± 4 mmHg. NYHA functional class improved significantly (p=0.009), and right ventricular dimensions significantly decreased (right ventricular end-diastolic diameter 56±9 mm vs. 44±8 mm) (p&lt;0.001). Transient benign ventricular arrhythmias were frequent. One patient experienced a severe arrhythmia with sustained ventricular tachycardia during follow-up. Conclusions. Early and midterm results with the Venus P-Valve™ are excellent. It considerably extends the interventional options and offers a safe and effective alternative to surgery in patients with large right ventricular outflow tracts. Larger multi-institutional studies with longer follow-up duration are required to reliably assess the long-term performance and possible long-term complications of the Venus P-Valve™.

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193.

Percutaneous balloon mitral valvuloplasty with shockwave lithotripsy for the treatment of calcific mitral valve stenosis.

Calcific mitral stenosis (calcific MS) presents a challenge for surgical treatment and is a contraindication for most contemporary transcatheter mitral valve replacement devices (TMVR), rendering patients with very limited therapeutic options. This study aims to assess the clinical and hemodynamic follow-up after mitral valve lithotripsy (MVL). All consecutive patients who underwent MVL to treat symptomatic calcific MS at St Michael's Hospital, Toronto, Canada, were included. Patients were deemed unsuitable for mitral surgery or TMVR after heart team assessment. Patients with rheumatic MS or ≥moderate mitral regurgitation (MR) were excluded. The primary endpoint was a reduction in the invasive mitral gradient by ≥50% without significant (≥moderate) MR. Fifteen patients underwent MVL between 2021 and 2023 with a mean age of 74 ± 9 years; 53% were female, with a mean STS score of 10% ± 0.1%. Following MVL, there was a reduction in the invasively measured mean trans-mitral gradient compared to baseline (14 mmHg vs. 6 mmHg; p < 0.05). The primary endpoint was achieved in 8 patients (53%) with no major procedural complications. At follow-up (median 90 days, IQR 58-115 days), 14 (93%) patients reported improved symptoms from New York Heart Association (NYHA) Class III-IV to NYHA Class I-II (p < 0.01) with stable echo-derived mean gradient (7.7 mmHg ± 2 mmHg vs. 8.4 mmHg ± 2.9 mmHg (p = 0.7). In selected patients with symptomatic inoperable calcific MS, MVL was safe and associated with significant short-term clinical and hemodynamic improvement. MVL may represent a new compassionate therapy for this challenging cohort. Further studies are needed to determine the long-term outcomes and help define the role of IVL technology in treating calcific valvular conditions.

ASSESSMENT OF SAFETY AND FEASIBILITY OF ROTATIONAL ATHERECTOMY (RA) VERSUS CONVENTIONAL STENTING IN PATIENTS WITH CHRONIC TOTAL OCCLUSION (CTO) LESIONS

Chronic total occlusion (CTO) sores in coronary arteries present a challenge in percutaneous coronary intervention (PCI) because of their complex anatomy and high rates of procedural failure. Objectives: In this comparative study, we aim to investigate the safety and feasibility of rotational atherectomy (RA) versus conventional stenting in patients with chronic total occlusion (CTO) lesions. Methods: This comparative study was conducted at Ayub teaching hospital from September 2023 to December 2023. Data was collected from 110 patients from both genders. Patients aged &gt; 18 years and diagnosed with chronic total occlusion (CTO) lesions in coronary arteries confirmed by coronary angiography were included in the study. Baseline demographic and clinical data, including age, gender, comorbidities, and angiographic characteristics, were collected for each participant. Additionally, procedural details such as the type of intervention, rotational atherectomy, conventional stenting, procedural time, fluoroscopy time, contrast volume, and any adverse events encountered during the procedure were recorded. Results: Data were collected from 110 patients from both genders. The mean age of participants in the Rotational Atherectomy (RA) group was 62.4 ± 7.3 years, while in the Conventional Stenting group, it was 61.8 ± 6.9 years. There were 40 males and 15 females in the RA group, compared to 38 males and 17 females in the Conventional Stenting group. The prevalence of diabetes mellitus was 42.0% in the RA group and 45.5% in the Conventional Stenting group. Left ventricular ejection fraction (LVEF) was 53.7 ± 4.2% in the RA group and 54.1 ± 4.5% in the Conventional Stenting group. The RA group showed a success rate of 81.8%, and the conventional stenting group achieved a success rate of 90.9%. However, the RA group experienced slightly higher rates of major procedural complications (9.1% vs. 5.5%) and minor procedural complications (12.7% vs. 10.9%) than the conventional stenting group. Conventional stenting group, the mean change was -1.2 ± 0.7. Additionally, the incidence of target lesion revascularisation (TLR) was observed in 8 patients (14.5%) in the RA group and 12 patients (21.8%) in the conventional stenting group. Furthermore, major adverse cardiovascular events (MACE) occurred in 9 patients (16.4%) in the RA group and 11 patients (20.0%) in the conventional stenting group. Conclusion: It is concluded that both rotational atherectomy (RA) and conventional stenting are effective and safe treatment options for patients with chronic total occlusion (CTO) lesions. Our findings suggest that both strategies yield comparable procedural success rates, complication rates, and efficacy outcomes, including myocardial infarction frequency, troponin levels, and left ventricular ejection fraction changes.

Safety and efficacy of coated flow diverters in the treatment of ruptured intracranial aneurysms: a retrospective multicenter study

BackgroundThis multicenter study evaluated the safety and efficacy of coated flow diverters (cFDs) for the treatment of ruptured intracranial aneurysms.MethodsConsecutive patients treated with different cFDs for ruptured aneurysms under tirofiban...

Safety, Efficacy and Outcome of Rotational Thrombectomy assisted Endovascular Revascularisation of the Superior Mesenteric Artery in Acute Thromboembolic Mesenteric Ischaemia.

To evaluate the efficacy and safety of percutaneous rotational thrombectomy-assisted endovascular revascularization of acute thromboembolic superior mesenteric artery occlusions in acute mesenteric ischemia. Fifteen cases of percutaneous rotational thrombectomy- assisted (Rotarex S, BD, USA) revascularization were retrospectively analyzed. The etiology was embolic in 40 % of cases and thrombotic in 60 %. A "Thrombectomy in Visceral Ischemia" (TIVI) 5-point score determined vessel patency at presentation, after percutaneous rotational thrombectomy, and after adjunctive technologies. TIVI 3 indicated nearly complete revascularization (minimal residual side branch thrombus). TIVI 4 indicated complete revascularization. Technical success was defined as successful device application and a final TIVI score of 3/4 after adjunctive technologies. Safety and outcome were also analyzed. Device application via femoral access was feasible in 100 % of cases and improved flow in 86.7 % of cases (1 × TIVI 0→1, 11 × TIVI 0→2, 1 × TIVI 1→2). There was no change in 13.3 % of cases (2 × TIVI 2→2). Additional devices resulted in further flow improvement in 93.3 % of cases (8 × TIVI 3, 6 × TIVI 4). One recanalization failed (TIVI 2→2→2). After adjunctive technologies (10 × manual aspiration, 11 × angioplasty, 9 × stenting), the technical success rate was 93.3 %. The mean procedure time was 40.5(± 14) minutes for embolism and 72.1(± 20) minutes for thrombosis. There was one device-related major complication (catheter tip fracture) resulting in a device-related safety rate of 93.3 %. The overall major complication rate was 20 %. Surgical exploration (13 ×), bowel resection (9 ×) and Fogarty embolectomy/bypass (3 ×) were also performed. The 30-day mortality rate was 40 %. Percutaneous rotational thrombectomy is an effective adjunct for rapid endovascular recanalization of acute thromboembolic superior mesenteric artery occlusions with an acceptable rate of major procedural complications. · Percutaneous rotational thrombectomy-assisted superior mesenteric artery revascularization in acute occlusive mesenteric ischemia is feasible and effective.. · Percutaneous rotational thrombectomy facilitates rapid flow restoration in native and stented superior mesenteric artery segments.. · Brachial access should be considered in the case of steep take-off angles of the superior mesenteric artery..

Treatment of atrial fibrillation with second-generation cryoballoon followed by contact-sensing radiofrequency catheter ablation for arrhythmia recurrences-results of a 5-year follow-up.

The aim of this study was to report the long-term follow-up results of cryoballoon (CB) ablation in patients with atrial fibrillation. All consecutive patients who underwent second-generation CB ablation from February 2015 to December 2017 were included in our study. In all procedures, we used a 28-mm CB placed via a single transseptal puncture guided by intracardiac ultrasound. A 20-mm octapolar intraluminal circular catheter was used for intracardiac recordings. A single 180-s freeze strategy was employed. Repeated procedures were performed with a 3D mapping system and radiofrequency catheters. A total of 126 patients (69.8% male, mean age 57 ± 11years), of which 77.0% had paroxysmal atrial fibrillation (PAF), were included in the study. After a 5-year period, 52.4% of patients were in sinus rhythm without AF recurrence, off antiarrhythmic drugs. A total of 61.9% of patients were free of AF recurrence when redo PVI procedures were performed. When accounting for redo pulmonary vein isolation and antiarrhythmic drugs, a total of 73.8% of the patients were without AF recurrence in long-term follow-up. The patients who underwent redo pulmonary vein isolation procedures had statistically significant lower rates of AF recurrence (p = 0.006). In patients with PAF, long-term success rates improved from 62.9 to 79.4% for patients who underwent the redo procedure (p = 0.020). In patients with persistent atrial fibrillation (PersAF), success rates went up from 41.4 to 55.1% for patients with single or repeated PVI procedure (p = 0.071). In the whole cohort, a total of 3 (2.4%) procedure-related major complications occurred which included persistent PNP, arterial pseudoaneurysm, and arteriovenous fistula. Our data suggest a favorable long-term safety and efficacy profile of second-generation CB ablation. In the mixed paroxysmal and persistent population, up to 73.8% of patients remained free of AF recurrence in the 5-year follow-up, when accounting for redo procedures and AADs. Only 2.4% of patients experienced major complications of the ablation procedure, none with permanent sequelae.

Retrograde distal access versus femoral access for below the knee angioplasty.

The prevalence of peripheral artery disease (PAD) in the general population is about 12% to 14% and it increases with age. PAD increased from 164 million people in 2000 to 202 million people in 2010. More than two-thirds of people with PAD are based in low- or middle-income countries. Critical limb ischaemia (CLI) occurs in 1% to 2% of people with intermittent claudication over five years. One third of people with CLI have isolated below the knee (BTK) lesions. CLI and isolated BTK lesions are associated with a higher incidence of limb loss when compared with people with multilevel arterial disease. Endovascular procedures such as angioplasty (with or without stenting) are widely used to treat isolated BTK lesions, aiming to improve blood flow and limb salvage. The technical success of any angioplasty procedure depends on the ability to cross the target lesion. Failed attempts are underestimated in the literature and failures in the real world appear to be higher than reported. People with isolated BTK lesions undergoing angioplasty by conventional femoral access present a high failure rate to cross these lesions. Retrograde distal access may provide some advantages that can lead to successful crossing of the target lesion. To evaluate the benefits and harms of retrograde distal access versus conventional femoral access for people undergoing below the knee angioplasty. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 26 September 2022. We planned to include randomised or quasi-randomised controlled trials comparing people undergoing retrograde distal access versus people undergoing conventional femoral access (ipsilateral antegrade or contralateral retrograde) for BTK angioplasty. Two review authors independently assessed identified studies for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions. Our primary outcomes were technical success of angioplasty procedure and major procedural complications. Our secondary outcomes were mortality rate, amputation-free survival, primary patency, minor procedural complications and wound healing. We planned to use GRADE to assess the certainty of the evidence for each outcome. We identified no randomised or quasi-randomised controlled trials that met the inclusion criteria. We identified no randomised or quasi-randomised controlled trials that compared retrograde distal access versus femoral access for BTK angioplasty. High-quality studies that compare retrograde distal access versus conventional femoral access for BTK angioplasty are needed.

The safety and efficacy of endoscopic ultrasound-guided portal pressure gradient measurement with concomitant endoscopic ultrasound-guided liver biopsy: a systematic review

IntroductionPortal hypertension (PH) is a complication of advanced liver disease. Traditionally, PH has been quantified using hepatic venous pressure gradient (HVPG) through an indirect transjugular approach requiring ionizing radiation exposure. Endoscopic ultrasound-guided porto-systemic pressure gradient (EUS-PPG) measurement is an emerging alternative, minimally invasive technique that provides direct portal pressure measurement. The aim of this systematic review is to evaluate the safety and efficacy of EUS-PPG measurement and concomitant EUS-guided liver biopsy (EUS-LB) in patients with chronic liver disease.MethodsThe preferred reporting items for systematic reviews and meta-analyses method was used. A PubMed, Medline, Web of Science, Google Scholar, and CINAHL search for terms “endoscopic ultrasound,” “EUS,” and “portal pressure gradient” was used to identify qualifying studies. Eligible studies included those which were published before 2022, reporting outcomes of EUS-PPG measurement, simultaneous EUS-LB if applicable, and adverse events rate. Risk of bias was assessed by Egger’s test. Results were synthesized using I2 to test heterogeneity.ResultsFour published studies including 147 patients met inclusion criteria, with mean age 59.6 years, 59% male. Indications for EUS-PPG measurement were history of chronic liver disease or suspected cirrhosis, viral hepatitis, alcohol associated liver disease, hepatic sinusoidal obstruction or Budd Chiari syndrome. The pooled technical success rate of EUS-PPG measurements was 98.61% with 95% confidence interval of 95.20% - 99.82%. A 25-gauge needle was used in 92% (135/147) of patients. EUS-PPG measurement was performed through a transgastric approach in all 147 (100%) patients using a compact manometer with pressure transducer and non-compressible tubing. The mean PPG was 10.07 (range 6.44 – 13.70) mmHg. Ninety-five patients underwent simultaneous EUS-LB using 19G needle with wet suction technique. Technical success rate of EUS-LB was 100% and specimen was adequate in 99% (94/95) patients to establish histological diagnosis. There were no major life-threatening complications of the EUS-PPG procedure. Predominant adverse events were abdominal pain 6.1% (9/147) and sore throat 5.4% (8/147).ConclusionEUS-PPG measurement is safe and useful in providing an assessment of portal pressure in patients with chronic liver disease. Future studies are needed to evaluate whether there is consistent correlation between EUS-PPG measurements and histologic fibrosis stage by liver biopsy.