High Procedural Success Rate Research Articles

P110 INTRAVASCULAR LITHOTRIPSY FOR THE TREATMENT OF SEVERELY CALCIFIED LEFT MAIN CORONARY STENOSIS

Abstract Background Even if pilot studies have been conducted to validate Intravascular Lithotripsy, most challenging cases were excluded, including unprotected Left Main (LM) coronary stenosis. Methods We retrospectively enrolled patients treated with IVL in a real–world multicenter registry from 21 centers among Italy and Spain from January 2020 to November 2021. The primary safety endpoint was freedom from major adverse cardiovascular events (cardiac death, target vessel revascularization, stent thrombosis) at 30 days. The primary effectiveness endpoint was procedural success (defined as stent delivery with a residual stenosis <20% and without intra–procedural MACE). Secondary endpoint were 6–months and 12–months MACE rates. Results From a total amount of 470 patients enrolled in our registry, 41 underwent IVL to LM stenosis. Most of them were males (78.0%). The clinical presentation was acute coronary syndrome (ACS) in 41.4% of cases. Mechanical circulatory support was necessary in 4 cases (9.7%). IVL before stent implantation was planned in 90% of cases. The primary safety endpoint occurred in 97.6%. of patients. The primary effectiveness endpoint was achieved in 97.6% of cases. Interestingly, at 6 months and 12 months, no MACE was recorded. Conclusions Intravascular lithotripsy for the treatment of severely calcified Left Main stenosis seems to be a safe and effective option with very high procedural success rate and low MACE rate at follow–up.

C54 ACUTE AND LONG TERM PERFORMANCE OF MAGMARIS BIORESORBABLE SCAFFOLD IMPLANTATION IN SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD): THE EXPERIENCE OF THE COORDINATOR CENTER OF THE INTERNATIONAL MULTICENTER REGISTRY DISCO

Abstract Background Spontaneous Coronary Artery Dissection (SCAD) is a challenging clinical scenario and represents an increasingly studied cause of acute coronary syndrome (ACS). An interventional strategy in these cases remains controversial since it may require an extensive permanent metallic stenting of vessel to seal the dissection with a non negligible rate of complications. Moreover, SCAD patients are usually young women with non–calcified disease where Bioresorbable Scaffolds (BrS) may be an intriguing option. Methods DISCO IT/SPA is a International observational registry which retrospectively enrolled patients admitted with a diagnosis of SCAD across 26 Italian and Spanish centers. Baseline, procedural characteristics, in–hospital management and outcomes of 369 SCAD patients were collected, of these 12 patients were treated with PCI with BrS MAGMARIS at the coordinator center of Rivoli and Orbassano. Major cardiovascular events (MACEs) were defined as the composite of cardiovascular death, non–fatal Myocardial infarction (MIs) and any PCI performed. Results In our cohort of SCAD patients treated with BrS there was a slight prevalence of women (n=7, 58,3%) with an average age of 50,9±7,4 years. NSTE–ACS was the most common clinical presentation (83,3%), followed by STEMI (16,7%). In 7 patients the first treatment choice for SCAD was PCI with BrS deployment, in 5 patients BrS were deployed during hospitalization for unplanned PCIs (four of them) and after one month for a MI due to SCAD recurrence in the last patient. Multivessel disease was present only in one case and LAD–DG was the main vessel affected (n=10, 83,3%). SCAD type 2A was the most frequent (41,7%). Intravascular imaging was performed in 10 cases (83,3%) and procedural success was achieved in all cases. Angiographic follow–up was obtained in 9 patients (75%), through coronary angiogram (n=8) or CT scan (n=1), at a mean length of 5,2±5,6 months. In–hospital MACE were 5 (23,8%) but none of them occurred after BrS deployment. The only MACE reported after BrS deployment was an unplanned PCI for SCAD progression. Conclusions In SCAD bioresorbable scaffolds represent an excellent option to preserve the natural physiology of the coronary vessels. Notably, in our cohort we reported a very high procedural success rate in PCI assisted in large part by intracoronary imaging. Further studies with larger numerosity are needed to demonstrate the advantages of this type of scaffold in these patients.

Letter: Transradial Flow-Diverting Stent Placement Through an Arteria Lusoria: 2-Dimensional Operative Video.

To the Editor: We read with great interest the article “Transradial Flow-Diverting Stent Placement Through an Arteria Lusoria: 2-Dimensional Operative Video” by Hackett et al.1 The authors present a case of a patient with an arteria lusoria who received effective flow-diverting stent therapy for a large left internal carotid artery (ICA) aneurysm using a large bore guide catheter through right transradial access (TRA). Diagnostic angiography showed that the left ICA could be accessed through the right TRA. A 6F radial sheath was introduced into the right radial artery, and the sheath was then exchanged over a 0.035″ guidewire for an 8F 90-cm guide catheter (Infinity; Stryker Neurovascular). After navigating a 5F 130-cm Simmons catheter into the left common carotid artery through the arteria lusoria, the 8F guide catheter was delivered into the left ICA using the telescoping technique. The large left ICA-ophthalmic artery aneurysm was successfully treated with a pipeline embolization device (Medtronic). The importance of evaluating transradial diagnostic angiography to determine whether a catheter system can safely track into the target supra-aortic vessels is critical for successful transradial neurointervention in patients with arteria lusoria, and we wholeheartedly concur with the authors' conclusion on this point. Cannulation into the supra-aortic vessels through right TRA can be extremely challenging in patients with arteria lusoria because of unfavorable catheter trajectory.2 In addition, the right TRA can cause fatal arteria lusoria dissection.3 Therefore, transfemoral access is frequently employed as first-line access if neurointerventionalists encounter arteria lusoria.2 Previous study reported that left TRA is a technically feasible alternative in neurointerventions for patients with arteria lusoria.4 Nevertheless, a guide catheter may result in a failed TRA that necessitates a crossover to transfemoral access because of a failed cannulation, a kinked catheter, or an unstable system. We have used transradial access as the first-line access for neurointerventions.5-18 The first-line TRA using a 6F preshaped Simmons guiding sheath (outer diameter, 2.70 mm; inner diameter, 0.088″; usable length, 90 cm; 6F Axcelguide Stiff-J; Medikit) offers a large bore working channel and a high procedural success rate without catheter kinking or system instability even in patients with an unfavorable steep supra-aortic take-off.5-7,13 The 6F Simmons guiding sheath is fully engaged into the target common carotid artery with a pull-back maneuver (the pull-back technique) after reforming the Simmons curve within the ascending aorta. The Simmons curve can be reformed by anchoring the 6F Simmons guiding sheath to the descending aorta (the descending aorta anchoring technique) or contralateral subclavian artery (the subclavian artery anchoring technique) through the left TRA. Transradial carotid cannulation with the pull-back technique is technically simple and promising. As a result, left TRA with the 6F Simmons guiding sheath can be a beneficial treatment choice for performing anterior circulation procedures in patients with arteria lusoria. Finally, we would like to express our appreciation to the authors for their interesting article that advances the transradial neurointerventional method.

Efficacy of Primary Percutaneous Coronary Intervention (PCI) Performed Through a Transradial Approach in Patients with ST- Segment Elevation Myocardial Infarction (STEMI) at a Tertiary Care Cardiac Center

Objective of Study: The study aimed to evaluate the clinical outcomes, safety, and efficacy of primary percutaneous coronary intervention (PCI) performed through a transradial approach in patients with ST- Segment elevation myocardial infarction (STEMI) at a tertiary care cardiac center. Place of Study: The study was conducted at the National Institute of Cardiovascular Diseases, Karachi, Pakistan Duration of Study: The study was conducted over a period of six months, from April, 2022 to September, 2022. Methods: A total of 250 consecutive patients who underwent primary PCI through a transradial approach were included in the study. Demographic, clinical, procedural, and angiographic data were collected. The primary outcome measure was the incidence of major adverse cardiovascular events (MACE), including death, myocardial infarction, target vessel revascularization, and stroke at 30 days and six months' post-procedure. Secondary outcomes included procedural success, access site complications, and door-to-balloon time. Results: The mean age of participants was 58.7 ± 10.2 years, with 72.8% being male. The procedural success rate was 96.4%. The incidence of MACE at 30 days and six months was 5.6% and 8.8%, respectively. Access site complications were observed in 2.8% of patients, and the mean door-to-balloon time was 81.3 ± 25.6 minutes. Multivariate analysis identified diabetes mellitus and triple-vessel disease as independent predictors of MACE. Conclusion: Primary PCI through a transradial approach at a tertiary care cardiac center in Karachi, Pakistan, demonstrated high procedural success rates, favorable clinical outcomes, and a low incidence of access site complications. This approach may be considered a safe and effective treatment option for patients with acute coronary syndromes. Keywords: primary percutaneous coronary intervention, transradial approach, ST- segment elevation myocardial infarction, major adverse cardiovascular events, tertiary care cardiac center, access site complications, door-to-balloon time

Outcomes After Left Main Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock (from the German ALKK PCI Registry)

Early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcomes in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte-PCI registry were centrally collected and analyzed. Patients were divided into 4 groups with PCI for left main (LM), 1-vessel, 2-vessel, and 3-vessel diseases. Patients' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared between the 4 groups. Between 2010 and 2015 a total of 2,348 consecutive patients with AMI and CS were treated by PCI in 51 hospitals, 295 for LM (15 for protected, 280 for unprotected) and single-vessel (n=491), 2-vessel (n=524), and 3-vessel disease (n=1,038). Thrombolysis in myocardial infarction 3 patency of the culprit lesion after PCI was 84.3%, 84.0%, 80.8%, and 84.6% in single-vessel, 2-vessel, 3-vessel disease, and LM PCI, respectively, whereas in-hospital mortality was 27.9%, 33.9%, 46.5%, and 55.9%. Bleeding rates were low (2.0%-2.3 %) and not different between groups. In a multivariate analysis a higher age, thrombolysis in myocardial infarction flow <3 after PCI, 3-vessel disease, and LM PCI were independent predictors of mortality. In conclusion, PCI of the LM is performed in about 12.5% of patients with AMI and CS and was associated with a high procedural success rate, whereas mortality is increased with LM PCI.

PO-04-069 OUTCOME AND SAFETY OF PULSED FIELD ABLATION FOR ATRIAL FIBRILLATION

Pulsed field ablation (PFA) has recently been introduced as a novel ablation technology for atrial fibrillation (AF). However, data on long-term procedural outcome are sparse. To investigate acute and chronic procedural success and safety in patients undergoing PFA for the treatment of AF. Consecutive paroxysmal and persistent AF patients underwent PFA-based catheter ablation using a multi-spline catheter. PFA-based ablation procedures, including first and repeat ablation procedures, were performed with additional 3D electroanatomical mapping. Procedural parameters, acute success, safety and long-term outcome were assessed. Follow up was conducted by telephone interview, routine Holter-ECGs and control of implantable cardiac devices, if applicable. A total of 101 patients undergoing PFA from May 2021 until November 2022 in one German center were included in the study. Patients suffered from paroxysmal AF (n= 38; 38%), persistent AF (n=36; 36%) and consecutive atrial tachycardias (AT) due to previous catheter ablation (n=27; 26%). Mean age was 67 ± 14 years, median CHA2DS2-VASc Score was 2 (Q1-Q3: 1-3), mean left atrial diameter was 44 ± 9 mm and 83 of 101 (82%) patients had a normal left ventricular ejection fraction. Of all PFA procedures, 61 (60%) were index ablation procedures and 40 (40%) were repeat procedures (including re-pulmonary vein isolation and/or left posterior wall isolation and/or conduction of roof, anterior and/or mitral isthmus lines). The median total procedure and left atrial (LA) PFA times were 98 (Q1-Q3: 61-121) and 34 (Q1-Q3: 24-47) minutes, respectively. Mean total fluoroscopy and LA PFA fluoroscopy times were 14 ± 7 and 9 ± 5 minutes. Successful PFA lesions were created in 100/101 patients (99%). In one patient, the use of radiofrequency ablation in the coronary sinus was needed to block the mitral isthmus line. Total complication rate was 7.9% (8/101) including only one major complication (n=1 pericardial tamponade; 0,99%). Minor complications were found in 7 patients (1 coronary spasm without sequela, 2 minor groin AV fistulas, 1 cardiac decompensation, 1 transient intra-procedural AV-block, 1 aspiration, 1 macro hematuria). Preliminary follow up of 264 ± 138 days including 63 patients showed 83% freedom from arrhythmias (52/63 patients without recurrence). In this initial experience, PFA applied in patients with atrial fibrillation demonstrates high chronic procedural success rates and a favorable safety profile.

Outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature.

Endoscopic placement of a self-expandable metal stent (SEMS) is a minimally invasive treatment for use in malignant and benign colonic obstruction. However, their widespread use is still limited with a nationwide analysis showing only 5.4% of patients with colon obstruction undergoing stent placement. This underutilization could be due to perceived increase risk of complications with stent placement. To review long- and short-term clinical success of SEMS use for colonic obstruction at our center. We retrospectively reviewed all the patients who underwent colonic SEMS placement over a eighteen year period (August 2004 through August 2022) at our academic center. Demographics including age, gender, indication (malignant and benign), technical success, clinical success, complications (perforation, stent migration), mortality, and outcomes were recorded. Sixty three patients underwent colon SEMS over an 18-year period. Fifty-five cases were for malignant indications, 8 were for benign conditions. The benign strictures included diverticular disease stricturing (n = 4), fistula closure (n = 2), extrinsic fibroid compression (n = 1), and ischemic stricture (n = 1). Forty-three of the malignant cases were due to intrinsic obstruction from primary or recurrent colon cancer; 12 were from extrinsic compression. Fifty-four strictures occurred on the left side, 3 occurred on the right and the rest in transverse colon. The total malignant case (n = 55) procedural success rate was 95% vs 100% for benign cases (P = 1.0, NS). Overall complication rate was significantly higher for benign group: Four complications were observed in the malignant group (stent migration, restenosis) vs 2 of 8 (25%) for benign obstruction (1-perforation, 1-stent migration) (P = 0.02). When stratifying complications of perforation and stent migration there was no significant difference between the two groups (P = 0.14, NS). Colon SEMS remains a worthwhile option for colonic obstruction related to malignancy and has a high procedural and clinical success rate. Benign indications for SEMS placement appear to have similar success to malignant. While there appears to be a higher overall complication rate in benign cases, our study is limited by sample size. When evaluating for perforation alone there does not appear to be any significant difference between the two groups. SEMS placement may be a practical option for indications other that malignant obstruction. Interventional endoscopists should be aware and discuss the risk for complications in setting of benign conditions. Indications in these cases should be discussed in a multi-disciplinary fashion with colorectal surgery.

Midterm results on a new self-expandable covered stent combined with branched stent grafts: Insights from a multicenter Italian registry

ObjectiveTo investigate the technical periprocedural and midterm outcomes of endovascular repairs with multibranched endovascular repair or iliac branch devices combined with a new self-expanding covered stent. MethodsThe COvera in BRAnch registry is a physician-initiated, multicenter, ambispective, observational registry (ClinicalTrials.gov Identifier: NCT04598802) enrolling patients receiving a multibranched endovascular repair or iliac branch devices procedure mated with Bard Covera Plus (Tempe, AZ) covered stent, designed to evaluate the outcomes of the covered stent mated with patient-specific and off-the-shelf branched stent graft. Primary end points were technical success, branch instability, and freedom from aortic and branch-related reintervention within 30 days and at follow-up. Preoperative characteristics, comorbidities, and outcomes definitions were graded according to the Society for Vascular Surgery reporting standards. ResultsTwo hundred eighty-four patients (76 years; range, 70-80 years; 79% males) in 24 centers were enrolled for a total of 708 target vessels treated. The covered stents were mated with an off-the-shelf graft in 556 vessels (79%) and a custom-made graft in 152 (21%). Three hundred seven adjunctive relining stents in 277 vessels (39%) were deployed, of which 116 (38%) were proximal, 66 (21%) intrastent, and 125 (41%) distal. Adjunctive relining stent placement was more frequent when landing in a vessel branch instead of the main trunk (59% vs 39%; P = .031), performing a percutaneous access (49% vs 35%; P < .001), using a stent with a diameter of 8 mm or greater (44% vs 36%; P = .032) and a length of 80 mm or greater (65% vs 55%; P = .005), when a post-dilatation was not performed (45% vs 29%; P < .001) and when an inner branch configuration was used (55% vs 35%; P < .001). Perioperative technical bridging success was 98%. Eight patients (3%) died in the perioperative period. Two deaths (1%) were associated with renal branch occlusion followed by acute kidney injury and paraplegia. Follow-up data were available for 638 vessels (90%) at a median of 32 months (Q1, Q3, 21, 46). Branch instability was reported in 1% of branches. Forty-six patients (17%) died during follow-up, nine (3%) of them owing to aortic-related causes. Primary patency rates at 1, 2, and 3 years were 99% (581/587), 99% (404/411), and 97% (272/279), respectively. Branch instability was associated with patient-specific devices (9% vs 4%; P = .014) and intrastent adjunctive stent placement (12% vs 2%; P = .003), especially when a bare metal balloon-expandable stent was used (25% vs 3%; P < .001). ConclusionsThe use of this new self-expanding covered stent mated with branched endografts proved to be safe and feasible with high technical procedural success rates. Low rates of branch instability were observed at midterm follow-up. Comparative studies with other commercially available covered stents are warranted.

Triple-compartment strategy for abdominal sacral colpopexy using PVDF mesh: one-year report of anatomical and subjective outcomes.

Abdominal Sacral Colpopexy (ASC) is one of the best surgical methods to repair apical or uterine prolapse. We aimed to evaluate the short-term results of a triple-compartment open ASC strategy using polyvinylidene fluoride (PVDF) mesh in the treatment of patients with severe apical or uterine prolapse. Women with high-grade uterine or apical prolapse with or without cysto-rectocele were prospectively enrolled in the study from April 2015 to June 2021. We performed all-compartment repair using a tailored PVDF mesh for ASC. We assessed the severity of pelvic organ prolapse (POP) using the Pelvic Organ Prolapse Quantification (POP-Q) system at baseline and 12 months after the operation. The patients completed the International Continence Society Questionnaire Vaginal Symptom (ICIQ-VS) questionnaire at baseline, 3, 6, and 12 months postoperatively. Thirty-five women with a mean age of 59.8±10.0 years were included in the final analysis. Stage III and stage IV prolapse was evident in 12 and 25 patients, respectively. After 12 months, the median POP-Q stage was significantly lower compared to the baseline (4 vs 0, p=<0.0001). Vaginal symptoms score was also reduced significantly at 3-month (7.5±3.5), 6-month (7.3±3.6), and 12-month (7.2±3.1) compared to the baseline (39.5±6.7) (p values < 0.0001). We did not observe any mesh extrusion or high-grade complications. Six (16.7%) patients had cystocele recurrence during the 12-month follow-up, and two of them needed reoperation. Our short-term follow-up showed that using an open ASC technique with PVDF mesh in treating high-grade apical or uterine prolapse is associated with a high rate of procedural success and low rates of complication.

Percutaneous endoscopic gastrostomy in amyotrophic lateral sclerosis: outcomes of a dedicated anesthesia and surgery protocol.

Patients requiring percutaneous endoscopic gastrostomy (PEG) for amyotrophic lateral sclerosis (ALS) related dysphagia represent a clinical challenge. Diminished pulmonary function and aspiration risks can lead to anesthesia-related complications, and gastric displacement from hemidiaphragm elevation may preclude safe gastric access. This study reports the efficacy and outcomes of a dedicated anesthesia/surgery management protocol for ALS patients undergoing PEG. In 2013, a PEG placement protocol for ALS patients was developed emphasizing efficient pre-operative evaluation, rapidly metabolized anesthetic agents, and minimization of opioid use. Outcomes were analyzed retrospectively. Preoperative weight loss, pulmonary function tests, total analgesia, procedural time, and 90-day morbidity and mortality were recorded. From 2013-2019, 67 ALS patients (mean age 65.3years, 52.2% female) received a PEG under the protocol. Mean percentage weight loss 6months before PEG was 9.3 ± 5.1% with 38.8% of patients meeting criteria for severe malnutrition. Mean anesthesia time (propofol induction to anesthesia emergence) was 34.5 ± 10.8min and mean operative time (endoscope insertion to dressing placement) was 16.4 ± 8.2min. Regional anesthesia with liposomal bupivacaine was performed in 76.1%. All attempts at PEG placement were successful. With a mean follow-up of 6.1 ± 6.8months, all PEGs were functional and there were no surgical site complications. Thirty-day readmission rate was 7.0% and 90-day mortality was 22.4% (46.7% occurring within 30days). Mean time from surgery to death was 8.8 ± 7.8months. Protocols for optimizing PEG may help overcome challenges present in the ALS patient population. Despite patient comorbidities, protocol implementation and dedicated team members resulted in a high procedural success rate and low complication rate. Further study is warranted to optimize the timing of PEG placement in relation to ALS disease progression and determine the utility of regional anesthesia during PEG placement.

Atypical atrial flutter catheter ablation in the era of high-density mapping.

Mapping and ablating atypical atrial flutters (AAFLs) have evolved greatly with advances in high-density 3D mapping systems over the last years. The objectives are to evaluate the feasibility of AAFL catheter ablation based on high-density mapping and minimizing entrainment and to better characterize AAFL circuits. Consecutive patients who underwent AAFL ablation using the EnSite Precision™ system and HD Grid™ mapping catheter (Abbott, Chicago, IL) between 06/2018 and 1/2022 were included. Mitral isthmus-dependent and roof-dependent AAFLs were classified as conventional circuits. All other AAFL circuits were classified as non-conventional circuits and were defined based on the location of the critical isthmus. Sixty-two patients underwent AAFL ablation (mean age 68±11 years). A total of 95 AAFLs were mapped and 92 (97%) were successfully ablated. Fifty-three (85%) patients had a previous AF/AFL ablation. Forty-four (46%) AAFL circuits were classified as conventional and 51 (54%) as non-conventional. Conventional AAFL circuits had longer critical isthmuses (19.0±9.0 vs 10.8±6.3mm, p<0.001), a lower prevalence of slow conduction at the critical isthmus (59% vs 86%, p=0.005), and a longer radiofrequency time to AAFL termination (117±119 vs 51±66 s, p=0.002). Entrainment was attempted in 19 (20%) flutters and its use declined significantly over the study period. Procedural success rates remained high whether entrainment was used or not. Freedom of any atrial tachycardia was 65% over a follow-up of 13.8±9.0 months. AAFL catheter ablation can be achieved with high procedural success rate using a contemporary strategy based on high-density mapping alone. Non-conventional circuits are frequent and present unique electrophysiological characteristics.

Intravascular lithotripsy in the treatment of coronary artery calcification in a high-risk real world population.

The DISRUPT-CAD study series demonstrated feasibility and safety of intravascular lithotripsy (IVL) in selected patients, but applicability across a broad range of clinical scenarios remains unclear. This study aims to evaluate the procedural and clinical outcomes of IVL in a high-risk real-world cohort, compared to a regulatory approval cohort. Consecutive patients treated with IVL and percutaneous coronary interventionat our center from May 2016 to April 2020 were included. Comparison was made between those enrolled in the DISRUPT-CAD series of studies to those with calcified lesions but an exclusion criteria. Among 177 patients treated with IVL, 142 were excluded from regulatory trials due to acute coronary syndrome presentation (47.2%), left ventricular ejection fraction <40% (22.5%), chronic renal failure (12.0%), or use of mechanical circulatory support (8.5%). This clinical cohort had a higher SYNTAX score (22.6 ± 12.1 vs. 17.4 ± 9.9, p = 0.019), and more treated ACC/AHA C lesions (56.3% vs. 37.1%, p = 0.042). Rates of device success (93.7% vs. 100.0%, p = 0.208), procedural success (96.5% vs. 100.0%, p = 0.585), and minimal lumen areagain (221.2 ± 93.7% vs. 198.6 ± 152.0%, p = 0.807) were similar in both groups. The DISRUPT-CAD cohort had no in-hospital mortality, 30-day major adverse cardiac events (MACE), or 30-day target vessel revascularization (TVR). The clinical cohort had an in-hospital mortality of 4.2%, 30-day MACE of 7.8%, and 30-day TVR of 1.5%. There was no difference in 12-month TVR (2.9% vs. 2.2%; p = 0.825). Twelve-month MACE was higher in the clinical cohort (21.1% vs. 8.6%, p = 0.03). IVL use remains associated with high clinical efficacy, procedural success, and low complication rates in a real-world population previously excluded from regulatory approving trials.

A Systematic Review of Total Endovascular Aortic Arch Repair: A Promising Technology.

Total endovascular aortic arch repair (TEAAR) represents an emerging alternative for the treatment of aortic arch disease in patients at prohibitive risk for open surgery. A systematic review of TEAAR was performed to delineate early outcomes with this new technology. All studies (excluding single-patient case reports) of CE-certified "custom made" or "off-the-shelf" zone 0 stent graft deployments were included. The primary search of Medline, Embase, CINAHL, and the Cochrane CENTRAL registry was supplemented with searches of Web of Science, ClinicalTrials.gov, and conference abstracts (within last 3 years), and a hand search of citations within relevant articles. Articles underwent 2-stage screening by 2 independent reviewers before inclusion. Fifteen relevant investigations were identified. Indications for TEAAR were chronic arch dissection with degenerative aneurysmal disease (54%, 148/273), pure arch aneurysm (41%, 112/273), penetrating atherosclerotic ulcer (2%, 5/273), and type IA endoleak from a zone 2 thoracic endograft (1%, 3/273). Double-branch (70%, 192/273), triple-branch (19%, 53/273), and single-branch (into innominate artery; 10%, 28/273) devices were used. Adjunct left carotid-subclavian bypass occurred in 90% of double- and single-branch procedures. Procedural success with TEAAR was 93% (95% CI 85.8%-96.3%). The proportion of all-cause mortality was 16% (95% CI 8%-26%), stroke 14% (8%-24%), peripheral vascular events 7% (1%-33%), and myocardial infarction 4% (2%-7%). Endoleaks were identified in 13% (7%-25%) of the study population. TEAAR represents an emerging option for the management of aortic arch disease wth high procedural success rates and acceptable early outcomes in a high-risk patient population.

Clinical Characteristics, Procedural Details, and Outcomes of Patients Who Underwent Percutaneous Coronary Intervention in Real-world Practice at a Tertiary Care Center in Sri Lanka

Introduction: Outcomes of percutaneous coronary intervention (PCI) vary across different regions of the world. Despite a substantial increase in the demand for PCI in recent years, there is a lack of comprehensive data on PCI in Sri Lanka. Objective: The objective of this study was to investigate the pattern of PCI procedures in real-world practice in Sri Lanka over a period of time. Methods: This prospective descriptive study included all patients who underwent PCI at one unit of a tertiary care cardiac center in Colombo, Sri Lanka, between March 2022 and December 2022. Patients’ baseline clinical characteristics, procedural details, equipment usage, and complications were analyzed and followed up for 6 months. Results: Among 317 patients included in the analysis, 89.9% were ≥40 years old, with a mean age of 54.7 years (standard deviation: 11), and 73.5% were male. The most common presentation was chronic coronary syndrome, 65.9%, with 6.9% chronic total occlusion (CTO) cases. Within acute coronary syndrome cases, the highest percentage (27.1%) was attributed to ST-elevation myocardial infarction (MI), with 18.3% being anterior MI, suggesting that the left anterior descending artery was most commonly affected. Approximately 86.1% had single-vessel PCI, whereas 2.8% underwent left main PCI. Transradial access was obtained in 87.4%. Despite a 6.9% CTO, a high procedural success rate of 94.3% was observed. The inhospital mortality rate was low at 0.3%, and the 6-month mortality rate was 0.9%. Conclusions: Despite the limited sample size, our study provides valuable insights into the current practices and outcomes of PCI in Sri Lanka. Despite the constraints of limited resources, we observed a high success rate and minimal complications.

Long-Term Outcomes after Rotational Atherectomy for Calcified Chronic Total Occlusion versus Nonchronic Total Occlusion Coronary Lesions.

The role of rotational atherectomy (RA) in contemporary percutaneous coronary intervention (PCI) is expanding to include certain chronic total occlusion (CTO) lesions. However, the long-term outcome of RA in CTOs is still unclear. To investigate in-hospital and long-term outcomes after RA for CTO compared to non-CTO calcified lesions. Moreover, this report evaluates the role of the elective RA approach in calcified CTOs. This study enrolled 812 patients (869 lesions; CTO, n = 80 versus non-CTO, n = 789). The mean age of the study population was 73.1 ± 8.6 years, the baseline characteristics were comparable in both groups. Balloon-resistant CTO lesions represented the main indication for RA in CTO patients (61.2%). The mean J-CTO score was 2.42 ± 0.95. The angiographic success rate was lower in CTO patients (88.8% vs 94.9%; p = 0.022). In-hospital major adverse cardiac events (MACE) rate was comparable in both groups (CTO 8.8% vs 7.0% in non-CTO;p = 0.557). At two-year follow-up, a higher target lesion failure (TLF) was observed in CTO group (25.5% vs 15.1%, log rank p = 0.041), driven by higher cardiac mortality while the clinically driven target lesion revascularisation (TLR) was comparable between the study groups. Elective RA for CTO had a shorter procedural time and lower rate of dissection (7.5% vs 25%; p = 0.030) compared to bail-out RA with similar long-term outcomes. Compared to non-CTO, RA for CTO can be performed with a high procedural success rate and comparable in-hospital outcomes. Apart from higher cardiac mortality in the CTO group, the long-term outcomes are comparable in both groups. Elective RA is a feasible and beneficial approach to be used in CTO intervention.

A novel anatomic classification to guide transcatheter aortic valve replacement for pure aortic regurgitation.

The success of transcatheter aortic valve replacement (TAVR) in native aortic regurgitation (AR) is limited by the absence of calcified anchoring structures. We sought to evaluate transfemoral TAVR in patients with native AR using a novel aortic root imaging classification. From March to November 2021, 81 patients with severe AR were prospectively enrolled in 2 cardiac centers in China. All were evaluated using multidetector computed tomography (MDCT) and classified into 4 anatomic types in reference to transcatheter heart valve (THV) anchoring: Type 1: anchoring at the left ventricular outflow tract (LVOT), annulus, and ascending aorta (AA); Type 2: anchoring at the annulus and AA; Type 3: anchoring at the annulus and LVOT; and Type 4: anchoring at only 1 level or none at all. Based on the dual-anchoring strategy, patients with Types 1-3 were considered TAVR candidates. Procedural and 30-day outcomes were assessed according to Valve Academic Research Consortium-3 definitions. TAVR was performed in 32 (39.5%) patients (71.9±8.0 years of age, 71.9% were male) using 2 self-expanding THVs. Types 1, 2, and 3 comprised 13 (40.6%), 11 (34.4%), and 8 (25.0%) cases, respectively. The procedural and device success rates were 100% and 93.8%, respectively, with 2 THV migration. Eight patients (25.0%) required a permanent pacemaker, and 2 (6.3%) developed moderate paravalvular leaks. No deaths or other major complications occurred during the study. The novel anatomic classification and dual-anchoring strategy were associated with a high procedural success rate with favorable short-term safety and clinical outcomes.

Abstract 9556: From Low Volume to High Volume: Successful Reduction in Major Complications While Building Transvenous Lead Extraction Center Volume

Introduction: Transvenous lead extraction (TLE) is associated with better outcomes in high-volume (HiV, &gt;30 TLE/year) than low-volume centers. Little data exist regarding transitioning to a HiV TLE center. We examined the impact of strategic interventions at a tertiary care center transitioning to a HiV TLE center. Hypothesis: Systematic interventions to increase TLE volume and quality are expected to decrease the rate of major complications without adversely affecting procedural success rates. Methods: Consecutive patients undergoing TLE with leads &gt;1 year post implantation from 2012-2021 were reviewed. The primary endpoints were TLE success and major complications including TLE-related mortality, vascular laceration, pericardial effusion, and emergent cardiothoracic surgery. Outcomes were compared between TLE completed in 2012-2018 prior to the intervention (n=125) and TLE after intervention 2019-2021 (n=127). Results: There were 252 consecutive TLE procedures included involving 398 leads. Strategic interventions were implemented in 2018 (Figure). Annual mean TLE volume increased from 19.5 TLE (29.7 leads) to 42.4 TLE (69.7 leads). Baseline characteristics including age (62.4±14.7 vs. 61.9±17.4), gender (52.4% vs. 47.7% male), and infectious indications (33.6% vs. 35.4%) were similar (P&gt;0.05 for all). With the transition to a HiV center, there was no significant change in complete procedural success (84.0% vs. 85.8%, P=0.73) and clinical success (94.4% vs. 96.1%, P=0.57). Major complications significantly decreased from 10/125 (8.0%) to 3/127 (2.4%) after the interventions in 2018 (P=0.049). Conclusions: Multidisciplinary improvements in pre-procedural risk stratification, scheduling, and technique resulted in a successful transition to a HiV TLE center with a reduction in major complications and a high procedural success rate.

Safety and feasibility of a 7F thin-walled sheath via distal transradial artery access for complex coronary intervention

BackgroundCompared with traditional trans-radial artery access (TRA), there are limited data that can confirm the efficacy and safety of a 7F thin-walled sheath placed via distal TRA (dTRA) for percutaneous coronary intervention (PCI).ObjectiveThis study aims to analyze the safety and efficacy of the placement of a 7F thin-walled sheath via dTRA for PCI.MethodsThis was a single-center retrospective observational study in which 102 patients who received complex PCIs with a 7F thin-walled sheath placed via dTRA in the catheter room of our hospital from May 2020 to October 2021 were included. The basic information, puncture success rate, radial artery occlusion (RAO) rate, radial artery lumen diameter and area, surgical data, pain score, and complication rate were observed and recorded.ResultsThe puncture success rate was 90.2% in the 102 patients, and the success rate of the operation was 97.8% among 92 patients with a successful puncture. The PCIs for patients included emergency PCIs and all types of complex PCIs. Color Doppler ultrasound performed at 1 and 30 d after the procedure showed that the RAO rate was 2.2%, the distal RAO rate was 3.3%, the postoperative average pain score was 2.2 points, and there were five patients (5.4%) with local hematoma, all of which were grade 1–2. Radial artery spasm and nervous injury occurred in two patients (2.2%), and arteriovenous fistula occurred in one patient (1.1%). Radial artery perforation, radial artery dissection, pseudoaneurysm, and sheath kinking did not occur.ConclusionThe placement of a 7F thin-walled sheath via dTRA for PCI showed a high puncture and procedural success rate, a low postoperative RAO rate, and a low incidence of local hematoma and other complications. The placement of a 7F Glidesheath Slender® via dTRA for PCI is safe and feasible.

Three-year outcomes following transcatheter tricuspid valve edge-to-edge repair

Abstract Background Tricuspid regurgitation (TR) has long been neglected due to limited therapeutic options. Within the past five years, transcatheter tricuspid valve edge-to-edge repair (T-TEER) has become a valuable tool in the treatment of TR besides diuretic medical therapy and valve surgery. Owing its novelty, data on long-term survival after T-TEER for relevant TR are sparse. Beyond that, there is uncertainty on the impact of TR reduction on outcomes after successful T-TEER. Purpose This study sought to investigate long-term survival outcome after T-TEER for relevant symptomatic TR. We evaluated the impact of TR reduction on outcome in patients with successful T-TEER. Methods Consecutive patients who underwent successful isolated T-TEER for relevant TR from 2016 until 2022 at a high-volume university center were included in the study. Procedural success was defined as at least one degree TR reduction. Long-term survival endpoint was three-year all-cause mortality. Survival follow-up was completed via phone calls with the patients themselves, the next of kin, local practitioners and using the German national population registry. Post-procedural TR was assessed by interventionalist and echocardiographer at the end of the T-TEER procedure. Results A total of 244 patients who underwent successful T-TEER in the study period were included in the present analysis (mean age 77.7±8.7 years; 50.8% female). Patients were highly symptomatic as represented by New York Heart Association functional class ≥ III in 95.9% of cases. TR was 4+ in 128 patients (52.2%), 3+ in 106 patients (43.4%) and 2+ in 10 patients (6.1%). The etiology of TR was predominately functional (88.5%), while 5.4% presented with degenerative TR and 6.1% with TR of mixed etiology. Median time to last contact or death was 365 days (interquartile range 166–809 days). Three-year follow-up was available in 98% of eligible patients. T-TEER was performed using a mean number of 2.0±0.6 devices (Mitra-/TriClip 53%; PASCAL 47%). Post-procedural TR was 1+ in 126 patients (51.6%), 2+ in 101 patients (41.4%) and 3+ in 17 patients (7.0%). Survival rates at one, two and three years were 76%, 68% and 56%. Among patients with procedural success (at least 1° TR reduction), a higher degree in post-procedural TR was associated with a trend towards reduced postinterventional survival (Figure 1). The absolute degree of TR reduction did not impact survival rates in patients with procedural success (Figure 2). Conclusion T-TEER effectively reduces TR severity and shows high rates of procedural success. While the extent of TR reduction did not yield prognostic value in terms of long-term survival, the degree of post-procedural TR showed a trend regarding survival outcome. These results indicate that procedural techniques and strategies should be refined to achieve TR1+ at the end of the procedure. Funding Acknowledgement Type of funding sources: None.

Pulsed field ablation for atrial fibrillation: acute procedural efficacy and safety of an initial German multicenter experience

Abstract Background Pulsed field ablation (PFA) is a novel non-thermal energy source to conduct catheter ablation of atrial fibrillation (AF). However, real-world multi-center data regarding acute procedural efficacy and safety is sparse. Purpose To study acute procedural success and safety in patients undergoing PFA for catheter ablation of AF in a multicenter registry. Methods Consecutive paroxysmal and persistent AF patients undergoing PFA-based catheter ablation using a multispline catheter were enrolled. The cohort included first and repeat ablation procedures. Procedural parameters, acute success and in-hospital safety were evaluated. A follow-up of all patients was conducted. Results Five German centers enrolled a total of 154 patients undergoing PFA in this study. Mean age was 68±12 years, median CHA2DS2-VASc Score was 3 (Q1-Q3: 2–4). Patients suffered from paroxysmal AF (n=55; 36%), persistent AF (n=93; 60%) and consecutive atrial tachycardias (AT) due to previous CA (n=6; 4%). The median left atrial (LA) PFA and total procedure times were 33 (Q1-Q3: 24–53) and 90 (Q1-Q3: 73–116) minutes, respectively. Mean LA PFA fluoroscopy and total fluoroscopy times were 12.1±5.5 and 20.2±8.7 minutes. Of all 154 procedures, 130 (84%) were index ablation procedures with isolation of pulmonary veins (PVI) only and 24 (16%) were repeat procedures (including re-PVI and ablation of consecutive AT). Acute PV reconnection following primary PVI and the initial set of PFA-applications was found in 20/130 (15%) patients, necessitating additional PFA ablation. Finally, successful PFA-guided PVI was achieved in all patients. Additional PFA lesion sets (including LA posterior wall isolation, anterior ablation, mitral isthmus ablation) were applied in 17/154 (11%) patients. Complications occurred in a total of 6/154 (3.8%) patients (including three groin site complications, two pericardial tamponades, one transient coronary spasm without sequela). The follow up data is still being assessed and will be provided by the time of the ESC 2022 meeting. Conclusion PFA performed in patients with atrial fibrillation demonstrates high acute procedural success rates and a favorable safety profile in this first real-world multicenter registry. Funding Acknowledgement Type of funding sources: None.