Primary Effectiveness Endpoint Research Articles

Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial.

Evidence from clinical trials of early pulsed field ablation (PFA) systems in treating atrial fibrillation has demonstrated their promising potential to reduce complications associated with conventional thermal modalities while maintaining efficacy. However, the lack of a fully integrated mapping system, a staple technology of most modern electrophysiology procedures, poses limitations in lesion creation and workflow options. A novel variable-loop PFA catheter integrated with an electroanatomic mapping system has been developed that allows for real-time nonfluoroscopic procedural guidance and lesion indexing as well as feedback of tissue-to-catheter proximity. AdmIRE (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Bosense-Webster Irreversible Electroporation Ablation System), a multicenter, single-arm, Food and Drug Administration investigational device exemption study, evaluated the long-term safety and effectiveness of this integrated PFA system in a large United States-based drug-refractory symptomatic paroxysmal atrial fibrillation patient population. Using the PFA catheter with a compatible electroanatomic mapping system, patients with drug-refractory symptomatic paroxysmal atrial fibrillation underwent pulmonary vein isolation. The primary safety end point was primary adverse event within 7 days of ablation. The primary effectiveness end point was a composite end point that included 12-month freedom from documented atrial tachyarrhythmia (ie, atrial fibrillation, atrial tachycardia, atrial flutter) episodes, failure to achieve pulmonary vein isolation, use of a nonstudy catheter for pulmonary vein isolation, repeat procedure (except for one redo during blanking), taking a new or previously failed class I or III antiarrhythmic drug at higher dose after blanking, or direct current cardioversion after blanking. At 30 centers, 277 patients with paroxysmal atrial fibrillation (61.5±10.3 years of age; 64.3% male) in the pivotal cohort underwent PFA. More than 25% of the procedures were performed without fluoroscopy. Median (Q1, Q3) pulmonary vein isolation procedure, fluoroscopy, and transpired PFA application times were 81.0 (61.0, 112.0), 7.1 (0.00, 14.3), and 31.0 (24.8, 40.9) minutes, respectively. The primary adverse event rate was 2.9% (8 of 272), with the most common complication being pericardial tamponade. The 12-month primary effectiveness end point was 74.6%. The 1-year freedom from atrial fibrillation, atrial tachycardia, or atrial flutter recurrence rate after blanking was 75.4%. Substantial improvements in quality of life were observed as early as 3 months after the procedure, concurrent with a reduction in multiple health care use measures. AdmIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure. URL: https://www.clinicaltrials.gov; Unique identifier: NCT05293639.

Effectiveness and safety of a novel crosslinked hyaluronate canalicular gel occlusive device for dry eye.

To evaluate the effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared with a commercially available hydrogel canalicular plug (Form Fit). 5 sites in the United States. Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug). Adults (≥22 years) with the Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was noninferiority of the mean within subject change from baseline to month 3 in Schirmer score for patients receiving filler compared with plugs. The key secondary effectiveness endpoint was noninferiority of the proportion of patients with filler achieving improvement from baseline to month 3 in OSDI by a minimal clinically important difference. Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear breakup time, and safety. 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was noninferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI. Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

A prospective, randomized, controlled, interventional clinical trial to evaluate the safety and efficacy of the medical monopoint reperfusion system for aspiration thrombectomy in acute ischemic stroke patients (SUMMIT MAX): Trial rationale and design.

Treatment of large vessel occlusion (LVO) using mechanical thrombectomy with or without intravenous thrombolysis has demonstrated better outcomes compared to medical treatment alone. Large-bore aspiration catheters have been recently introduced. Their effectiveness and safety have not been demonstrated in a randomized trial. The SUMMIT MAX study is designed to address this question. SUMMIT MAX is a randomized controlled trial where the effectiveness and safety of the large-bore Monopoint Reperfusion system (Route 92 Medical, San Mateo, CA), will be compared to the currently largest available FDA-cleared aspiration thrombectomy device the AXS Vecta Aspiration system (Stryker Neurovascular, Fremont, CA). The study is a multi-center, prospective, randomized, controlled, interventional, open label clinical trial. The hypothesis is that the effectiveness measured by the recanalization rate (modified thrombolysis in cerebrovascular infarction - mTICI) and safety measured by symptomatic intracranial hemorrhage rate (sICH) of the medical monopoint reperfusion system is non-inferior to the AXS Vecta Aspiration system. Up to 250 subjects are enrolled with at least 50% of subjects enrolled by US sites. The primary effectiveness endpoint is successful arterial revascularization defined as an mTICI score ≥ 2b after use of the assigned device adjudicated by an independent core lab. The primary safety endpoint is defined as sICH within 24 h (-8/+24) post-procedure. Secondary endpoints include successful arterial revascularization defined as a mTICI score ≥ 2b after use of the assigned device with or without adjunctive therapy; device-related serious adverse events; all asymptomatic hemorrhages; time from groin puncture to final angiogram; and rate of first pass effect defined as mTICI 2b after first pass with the assigned device stratified by age (≤85, ≥ 86). SUMMIT MAX is a randomized controlled trial comparing the effectiveness and safety of a new large bore class of aspiration devices to the currently largest FDA-cleared aspiration device available.

Early Results From the Pivotal Trial Substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in Angulated Necks

Objective or BackgroundTo report the investigational device exemption (IDE) study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAA). MethodsThis study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety endpoints included blood loss >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness endpoints included technical success, absence from Type I and III endoleak, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair. ResultsBetween January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years old. The mean infrarenal proximal aortic neck angle was 71.6° and mean AAA size was 62.9 mm. Overall technical success was achieved in 93 (97.9%) patients. Freedom from a primary safety endpoint through 30 days was 96.7%; 3 (3.3%) patients had blood loss >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four (4.3%) patients had Type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 (39.7%) patients experienced a Type II endoleak and 1 (1.3%) patient experienced AAA sac expansion ≥5mm. Through 12 months, 1 (1.3%) patient had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months. ConclusionsThe IDE study demonstrates safety and effectiveness of the EXCC device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Lip Augmentation With Saypha LIPS Lidocaine: A Postmarket, Prospective, Open-Label, Randomized Clinical Study To Evaluate Its Efficacy and Short- and Long-term Safety.

Versatility, biocompatibility, and reversibility make hyaluronic acid fillers the backbone of minimally invasive lip augmentation procedures. The aim of this study was to assess the effectiveness and short- and long-term safety of Saypha LIPS Lidocaine (Croma Pharma, Leobendorf, Austria) for lip augmentation to correct moderate to severe lip volume deficiency (grade 1-3 lip fullness score [LFS]). In this postmarket, prospective, open-label, multicenter, randomized clinical study, 114 patients were initially treated (with optional touch-up treatment at Week 3). Retrograde and bolus techniques were employed with defined needles or cannula. The primary effectiveness endpoint was the proportion of patients with lip volume improvement of LFS ≥ 1 grade vs baseline at Week 6 (ie, responders); with follow-up (FU) for secondary effectiveness at Months 6, 12, and 18. Evaluation scores included the LFS, Global Aesthetic Improvement Scale (investigator and patient), patient satisfaction questionnaire FACE-Q, and a numerical pain rating scale. At Week 6, >90% of the patients were responders (lower-lip: 95% CI, 92.24-99.43, P = .0071; upper-lip: 95% CI, 90.95-99.00, P = .0234), with post hoc analyses showing the outcome was influenced by the initial volume deficiency and total volume injected, but not by touch-up treatment. At Month 6, 90% of the patients were responders; at Month 12, 70%; and at Month 18, >40% still had a visible effect. Adverse events were mostly procedural, mild, and temporary. Pain perception was significantly reduced 15 minutes after the procedure. Aesthetic improvement and patient satisfaction were rated as high at all time points. Saypha LIPS Lidocaine for lip augmentation showed long-term aesthetic improvement and safety.

Impact of aspirin dose according to race in secondary prevention of atherosclerotic cardiovascular disease: a secondary analysis of the ADAPTABLE randomised controlled trial

ObjectivesTo evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD).DesignA...

One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study

BackgroundA stent with characteristics of a hybrid design may have advantages in improving the patency of symptomatic iliofemoral vein obstruction. This study assessed the safety and effectiveness of the V-Mixtent Venous Stent in treating symptomatic iliofemoral outflow obstruction.MethodsEligible patients had a Clinical-Etiologic-Anatomic-Physiologic (CEAP) C classification of ≥ 3 or a Venous Clinical Severity Score (VCSS) pain score of ≥ 2. The primary safety endpoint was the rate of major adverse events within 30 days. The primary effectiveness endpoint was the 12-month primary patency rate. Secondary endpoints included changes in VCSS from baseline to 6 and 12 months, alterations in CEAP C classification, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) scores at 12 months, and stent durability measures.ResultsBetween December 2020 and November 2021, 171 patients were enrolled across 15 institutions. A total of 185 endovenous stents were placed, with 91.81% of subjects receiving one stent and 8.19% receiving 2 stents. Within 30 days, only two major adverse events occurred (1.17%; 95% confidence interval [CI], 0.14–4.16%), below the literature-defined performance goal of 11% (P < .001). The 12-month primary patency rate (91.36%; 95% CI, 85.93–95.19%; P < .001) exceeded the literature-defined performance goal. VCSS changes from baseline demonstrated clinical improvement at 6 months (− 4.30 ± 3.66) and 12 months (− 4.98 ± 3.67) (P < .001). Significant reduction in symptoms, as measured by CEAP C classification and CIVIQ-14, was observed from pre-procedure to 12 months (P < .001).ConclusionsThe 12-month outcomes confirm the safety and effectiveness of the V-Mixtent Venous Stent in managing symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to before treatment.

Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial

Introduction and HypothesisThe objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery.MethodsA multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months.ResultsA total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher’s test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related.ConclusionsThe pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.

Seated Pulmonary Artery Pressure Monitoring in Patients With HeartFailure: Results of the PROACTIVE-HF Trial.

Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients. The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF. Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6months were freedom from device- or system-related complications or pressure sensor failure. Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95%CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P< 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6months. Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure-guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059).

Intracardiac vs transesophageal echocardiography for left atrial appendage occlusion: An updated systematic review and meta-analysis

BackgroundMultiple studies continue to evaluate the use of intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) for guiding left atrial appendage occlusion (LAAO). ObjectiveThe purpose of this study was to conduct an updated meta-analysis comparing the effectiveness and safety outcomes of both imaging modalities. MethodsPubMed, Cochrane, and Embase were searched for studies comparing ICE vs TEE to guide LAAO. Odds ratios (ORs) with 95% confidence intervals (CIs) were pooled using a random-effects model. The primary effectiveness endpoint was procedural success. The primary safety endpoint included the overall complications rate. Additional safety outcomes were assessed as secondary endpoints. Subgroup analysis of primary endpoints was conducted according to device type (Amulet, LAmbre, Watchman, Watchman FLX) and study region (American, Asia, Europe). R Version 4.3.1 was used for all statistical analyses. ResultsOur meta-analysis included 19 observational studies encompassing 42,474 patients, of whom 4415 (10.4%) underwent ICE-guided LAAO. Compared with TEE, ICE was associated with a marginally higher procedural success (OR 1.33; 95% CI 1.01–1.76; P = .04; I2 = 0%). There was no significant difference in the overall complications rate (OR 1.02; 95% CI 0.77–1.36; P = .89; I2 = 5%). However, ICE showed higher rates of pericardial effusion (OR 2.11; 95% CI 1.47–3.03; P <.001; I2 = 0%) and residual iatrogenic atrial septal defect (iASD) (OR 1.52; 95% CI 1.15–2.03; P <.004; I2 = 0%). Subgroup analysis revealed variations in procedural success within the ICE group across study regions (P = .02). ConclusionIn this updated meta-analysis, the increasing adoption of ICE-guided LAAO demonstrated higher procedural success rates compared to TEE, although with limited statistical significance. Overall complication rates were similar; however, ICE showed higher rates of pericardial effusion and residual iASD.

Retrospective, Real Life Study on the Effectiveness and Safety of a Depigmented-Polymerized Subcutaneous Vaccine Containing a Mixture of Grasses and Olea europaea

Introduction: Allergen immunotherapy is the only modifying treatment of the natural course of respiratory allergic diseases; however, the lack of evidence leads to little inconclusive results. Real life studies are on the rise and are becoming a valuable tool to confirm and complement findings from clinical trials. The objective of this study was to evaluate the effectiveness and safety of a depigmented-polymerized undiluted subcutaneous extract of grass and olive pollen, under routine clinical practice conditions. Methods: This was an observational, retrospective, longitudinal, single-center study on the use of a 2-pollen (grass mix and Olea europaea) undiluted subcutaneous extract over at least 3 consecutive years. Data were collected from 76 patients (n = 44 female; median age: 12.5 years old) diagnosed with allergic rhinoconjunctivitis with/without allergic asthma due to sensitization to both grasses and O. europaea. Primary and secondary effectiveness endpoints were symptom severity, concomitant medication, and immunological profile before and after completing the immunotherapy. A 2-year follow-up of patients’ symptoms and medication history after completing the subcutaneous immunotherapy (SCIT) was performed. Results: There was a significant improvement of symptoms and medication consumption after 3 years of SCIT treatment, and a significant decrease in specific IgE levels for grasses and O. europaea was observed after finishing the treatment. Conclusion: Three years treatment of allergic patients using an undiluted mixture of two allergen extracts was shown to be safe and effective for rhinitis and asthma, with efficacy maintained for at least 2 years after finishing SCIT. These results reinforce the importance of real life clinical data in addition to those from clinical trials, helping to individualize allergic treatments.

Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Male and Female Patients

Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in the US. Although aspirin is recommended for secondary prevention of ASCVD, there was no difference in safety and effectiveness of aspirin dosed daily at 81 mg or 325 mg in the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) randomized clinical trial. However, it is unknown whether differences by sex exist in the safety and effectiveness of the different aspirin doses. To evaluate sex-specific differences in the safety and effectiveness of 2 aspirin doses in the ADAPTAPLE trial. The ADAPTABLE study was an open-label, pragmatic, randomized clinical trial that randomly assigned participants with chronic, stable ASCVD to 81 mg vs 325 mg of aspirin daily. Using Cox proportional-hazard models, male and female participants were compared for outcomes. In addition, it was assessed whether sex was an effect modifier in the association between aspirin dose and outcomes. The ADAPTABLE trial was conducted at 40 medical centers and 1 health plan. Eligible patients were 18 years and older and had established ASCVD. Study data were analyzed from December 2021 to March 2024. Patients received 81 mg or 325 mg of aspirin daily for the secondary prevention of ASCVD. The primary effectiveness outcomes included all-cause death and hospitalization for myocardial infarction (MI) or stroke. The primary safety outcome was hospitalization for major bleeding requiring transfusion. A total of 15 076 patients (median [IQR] age, 67.6 [60.7-73.6] years; 10 352 male [68.7%]) were followed up for a median (IQR) of 26.2 (19.0-34.9) months. Overall, 4724 (31.3%) were female, and 2307 of the female participants (48.8%) received aspirin 81 mg. Compared with males, female participants were younger (median [IQR] age, 66.3 [59.4-72.6] years vs 68.2 (61.4-73.9) years, less likely to self-report White race (3426 [72.5%] vs 8564 [82.7%]), more likely to smoke (564 [12.9%] vs 818 [8.4%]), and more likely to have a history of peripheral arterial disease (1179 [25.7%] vs 2314 [23.0%]). The primary effectiveness outcome of all-cause death and hospitalization for MI or stroke occurred in 379 female participants (8.1%) and 780 male participants (7.1%). There was no significant interaction by sex for the primary effectiveness end point between the 2 aspirin doses (female adjusted hazard ratio [aHR], 1.01; 95% CI, 0.82-1.26 and male aHR, 1.06; 95% CI, 0.91-1.23; P interaction term for sex = .74). During the trial, female participants had fewer revascularization procedures (237 [5.0%] vs 680 [6.6%]; aHR, 0.79; 95% CI, 0.68-0.92; P = .002) but had a higher risk of hospitalization for stroke (aHR, 1.72; 95% CI, 1.27-2.33; P < .001). Among female participants, there was a slightly higher rate of bleeding in the 81-mg aspirin cohort compared with the 325-mg cohort (20 [0.83%] vs 13 [0.52%]; aHR, 2.21; 95% CI, 1.04-4.70; P interaction term for sex = .07). There were no significant differences between female and male participants regarding aspirin dose adherence. In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events. ClinicalTrials.gov Identifier: NCT02697916.

Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial

To study the effectiveness of a new intrauterine degradable polymer film (Womed Leaf®) in the management of moderate to severe IUA. PREG2 study was a multi-centre, double-blind, randomised, controlled, stratified, two-arm superiority clinical trial conducted in 16 centres in 7 countries. Patients ≥18 years scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (according to American fertility society (AFS) IUA score) were considered eligible for the study. Following adhesiolysis, patients were randomised at a 1:1 ratio to either have a Womed Leaf film inserted (intervention group) or not (control group). The primary effectiveness endpoint of the study was the change in AFS IUA score on second-look hysteroscopy (SLH), assessed by an independent evaluator, compared to baseline. Information on rate of no IUA and responder rate were collected as secondary effectiveness outcomes, and reported adverse events and patient reported outcomes as safety and tolerability measures. Between October 26, 2021, and September 28, 2023, a total of 160 women were randomised (Womed Leaf: n=75 and controls: n=85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared to the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device. Womed Leaf is effective and safe in the management of symptomatic severe or moderate intrauterine adhesions.

Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms.

The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms. Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10mm, aortic aneurysm sack enlargement >5mm, and aortic aneurysm rupture or open conversion. Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5mm; range, 49-124mm), proximal seal zone length (mean, 41.6mm; range, 18.9-92.9mm), graft modification time (mean, 48.7min), procedure time (mean, 137.7min), fluoroscopy time (mean, 33.8min), contrast material use (mean, 93.0mL), estimated blood loss (mean, 118.8mL), length of hospital stay (mean, 3.7d), and intensive care unit length of stay (mean, 1.6d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%. PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.

Optimized workflow for pulmonary vein isolation using very high power short duration radiofrequency ablation

Abstract Background Point-by-point radiofrequency ablation is the most used invasive treatment of atrial fibrillation (AF). However, single-shot technologies are largely widespread due to their proved safety and efficacy. QDOT MICRO (QDM) is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency (RF) ablation that allows to maintain target temperature during 90 W ablations for ≤4 seconds. Purpose This study evaluates procedural safety and effectiveness as well as long-term effects of an optimized procedural workflow using QDM catheter to perform wide atrial circumferential ablation in patients with paroxysmal AF. Methods Consecutive patients referred for paroxysmal AF first ablation through pulmonary vein isolation (PVI) were prospectively enrolled. Every procedure was performed in general anesthesia by using CARTO3 Electroanatomical Mapping System BiosenseWebster QDM catheter and Deflectable Sheet VIZIGO as single sheet in left atrium. VHPSD was performed to encircling the posterior wall, while conventional-power temperature-controlled (CPTC) mode was used to encircling the anterior wall. The primary safety endpoint was incidence of primary adverse events within ≤7 days of ablation. The primary effectiveness endpoint was freedom from documented atrial tachyarrhythmia recurrence and acute procedural, repeat ablation, and antiarrhythmic drug failure. Results 120 enrolled participants (61 ± 12 years, 45% female) met eligibility criteria. Median procedural skin-to-skin time and RF application for ablating PVs were 56 and 17 minutes, respectively. Median ablation time was 22 minutes. First-pass isolation (entrance and exit block validation) was obtained in 98 % and inter-lesion distance was 4,8 ± 0,8 mm. In 100% of patients PVI was obtained without adverse events. The Kaplan-Meier estimated 12-month rate for clinical success (freedom from symptomatic recurrence of AF) was 93%, freedom from AF was 89% Conclusions PVI performed with point by point optimized workflow using VHPSD RF catheter in combination with steerable sheet is highly efficient and effective without compromising safety.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure

BackgroundAtrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). ObjectivesThis study sought to assess the outcomes of pulsed field ablation (PFA) in HF. MethodsMANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. ResultsOf the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P > 0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). ConclusionsPFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

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.

Result of the left bundle branch area pacing data collection registry, an international multicenter study of conduction system pacing with a Tendril STS 2088 stylet-driven lead.

Left bundle branch area (LBBA) pacing (LBBAP) has been proposed as an alternative therapy option in patients indicated for cardiac pacing to treat bradycardia or heart failure. The aim of the study was to evaluate the safety and effectiveness of LBBAP in patients implanted with a Tendril 2088 stylet-driven lead. The international retrospective data collection registry included 11 sites from 5 countries globally. Patients with attempted implants of the Tendril lead in the LBBA were followed for at least 6 months post the implant attempt. The primary safety and efficacy endpoints were freedom from LBBAP lead-related serious adverse events and the composite of LBBA capture threshold of ≤2.0 V and R-wave amplitudes ≥5 mV (or ≥value at implant), respectively. Of 221 patients with attempted implants of the Tendril 2088 lead in the LBBA, 91.4% (202/221) had successful implants for LBBAP. Regardless of the LBBAP implant success, all patients were followed for at least 6 months (8.7 ± 7.3 months). Baseline characteristics: 44% female, 84% ≥65 years old, 34% coronary artery disease, and 86% of primary indications for pacemaker implant. Both primary safety and effectiveness endpoints were met (freedom from LBBAP lead-related serious adverse device effects of 99.5% and electrical performance composite success rate of 93%). The capture thresholds in LBBAP at implant and 6 months were 0.8 ± 0.3 V@0.4 ± 0.1 ms and 0.8 ± 0.3 V@0.4 ± 0.1 ms. The rate of patients with capture threshold rise ≥1 V was 1.5% through 6 months. The R-wave amplitudes in LBBAP at implant and 6 months were 9.3 ± 3.2 mV and 10.6 ± 3.0 mV. This large multicenter study demonstrates that the stylet-driven Tendril™STS 2088 lead is safe and effective for LBBAP with high success and low complication rates.

SHOULD WE BE CONCERNED ABOUT USING INTRAVASCULAR LITHOTRIPSY ON THE LEFT MAIN? INSIGHT FROM ROLLING STONE RETROSPECTIVE REGISTRY

Abstract Background The use of rotational atherectomy is currently prevalent in the treatment of left main coronary artery lesions. However, it often necessitates the use of a large burr to achieve adequate debulking, which, in turn, demands highly experienced operators. Intravascular lithotripsy (IVL) is a promising, user–friendly and increasingly employed technique for calcific plaque modification before percutaneous coronary intervention. Although in many cath labs it is now routinely used to treat lesions of the three main coronary arteries, there are still concerns regarding its use in the left main, primarily due to prolonged inflations required for its optimal efficacy. Methods We conducted a retrospective analysis using data from the multicenter retrospective Rolling Stone registry. The analysis involved data from 474 patients, with a stratification between IVL procedures involving left main coronary artery (46 patients) and those that did not (428 patients). The primary effectiveness endpoint was procedural success (defined as achieving residual stenosis &amp;lt; 20% with TIMI III flow); secondary endpoints included the rate of procedural related adverse events, in hospital adverse events and MACE rate at 30 days and 6 months. Results Between April 2018 and January 2023, a total of 474 underwent IVL procedures. Most patients presented with calcific lesion requiring lithotripsy in non–left main segments, while IVL was performed on the left main artery in 46 patients. No significative differences were found on baseline characteristics between LM and non–LM groups. Treatment of IVL–LM lesion was marked by a high procedural success rate (97.8%) and a low incidence of procedural and peri–procedural complications. However, there was a higher rate of contrast–induced acute kidney injury in patients treated in LM (6.5% vs. 1.6%, p=0.030), although no other differences for in–hospital outcomes were observed. Furthermore, there were no differences in 30–day and 6–month follow–up outcomes between the two groups. Conclusions This study suggests that employing intravascular lithotripsy in the left main coronary artery is not only a safe procedure but also produces excellent results comparable to its application in other coronary branches. This provides a substantial level of confidence in the safety and effectiveness of IVL when used in this specific context.

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.