Comparison of efficacy of pharmacological cardioversion with antazoline and propafenone versus electrical cardioversion in atrial fibrillation during cryoablation.

Introduction: Antazoline with propafenone may be an alternative to electrical cardioversion (ECV) in restoring sinus rhythm in patients with atrial fibrillation (AF), including during balloon cryoablation. Aim: To compare the efficacy of antazoline with propafenone and ECV in restoring and maintaining sinus rhythm at discharge in patients with AF during cryoablation with special regard to type of AF. Material and methods: The study retrospectively analyzed 196 patients who underwent elective cryoablation. Eighty-nine patients who developed AF in the perioperative period were selected as the study group (32 women and 57 men). The study group was divided into two groups - 46 (51.7%) patients were given pharmacological cardioversion with 70 mg of propafenone and 100 or 200 mg of antazoline, whereas the other 43 (48.3%) patients underwent ECV. Results: There were no statistically significant differences between the groups regarding: left atrial area, left atrium diameter, right atrial area and right atrium diameter. In the overall population, ECV was more effective than antazoline with propafenone therapy (31 [72.1%] vs. 20 [43.5%]; p = 0.01). A similar relationship was demonstrated in patients with persistent AF (13 [59.1%] vs. 3 [12.5%]; p = 0.002). There was no significant difference in the group of patients with paroxysmal AF (18 (85.6%) vs. 17 (77.3%); p = 0.7). Conclusions: In AF during the cryoablation procedure ECV appears to be more effective in restoring and maintaining sinus rhythm at discharge than antazoline with propafenone in the general AF patient population, especially in patients with persistent AF.

Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial.

BACKGROUND: Renal denervation (RDN) has demonstrated clinically relevant reductions in blood pressure (BP) among individuals with uncontrolled hypertension despite lifestyle intervention and medications. The safety and effectiveness of alcohol-mediated RDN have not been formally studied in this indication. METHODS: TARGET BP I is a prospective, international, sham-controlled, randomized, patient- and assessor-blinded trial investigating the safety and efficacy of alcohol-mediated RDN. Patients with office systolic BP (SBP) ≥150 and ≤180 mm Hg, office diastolic BP ≥90 mm Hg, and mean 24-hour ambulatory SBP ≥135 and ≤170 mm Hg despite prescription of 2 to 5 antihypertensive medications were enrolled. The primary end point was the baseline-adjusted change in mean 24-hour ambulatory SBP 3 months after the procedure. Secondary end points included mean between-group differences in office and ambulatory BP at additional time points. RESULTS: Among 301 patients randomized 1:1 to RDN or sham control, RDN was associated with a significant reduction in 24-hour ambulatory SBP at 3 months (mean±SD, -10.0±14.2 mm Hg versus -6.8±12.1 mm Hg; treatment difference, -3.2 mm Hg [95% CI, -6.3 to 0.0]; P=0.0487). Subgroup analysis of the primary end point revealed no significant interaction across predefined subgroups. At 3 months, the mean change in office SBP was -12.7±18.3 and -9.7±17.3 mm Hg (difference, -3.0 [95% CI, -7.0 to 1.0]; P=0.173) for RDN and sham, respectively. No significant differences in ambulatory or office diastolic BP were observed. Adverse safety events through 6 months were uncommon, with one instance of accessory renal artery dissection in the RDN group (0.7%). No significant between-group differences in medication changes or patient adherence were identified. CONCLUSIONS: Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory SBP compared with sham control. No significant differences between groups in office BP or 6-month major adverse events were observed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02910414.

Firibastat Versus Ramipril After Acute Mechanical Reperfusion of Anterior Myocardial Infarction: A Phase 2 Study.

BACKGROUND: Preclinical data suggest that central renin-angiotensin system blockade by the brain aminopeptidase-A inhibitor firibastat can improve left ventricular ejection fraction (LVEF) after myocardial infarction (MI). OBJECTIVES: This study aimed to compare the effect of firibastat versus ramipril on post-MI LVEF. METHODS: In this phase 2, randomized, double-blind trial, patients selected within 24 h of first acute anterior MI treated by primary percutaneous coronary intervention were randomly assigned (1:1:1) to firibastat 100 mg, firibastat 500 mg or ramipril 5 mg, each twice daily for 12 weeks. The primary endpoint was change in LVEF on cardiac magnetic resonance imaging (cMRI) from baseline to day 84 in the modified intent-to-treat (mITT) population (at least one dose received and one follow-up cMRI available) for each treatment group. RESULTS: From June 4, 2019 to April 12, 2021, 294 patients were randomized and 229 were evaluable for the mITT analysis. After 12 weeks, mean ± standard deviation (SD) percent change in LVEF was 5.6 ± 1.2 with firibastat 100 mg, 5.3 ± 1.1 with firibastat 500 mg and 5.7 ± 1.1 with ramipril. The absolute ± SE adjusted difference in LVEF change from baseline between firibastat 500 mg and ramipril was - 0.36 ± 1.32% (p = 0.79). Occurrence of treatment-related adverse events was similar in the three groups. CONCLUSIONS: Firibastat was not superior to ramipril for prevention of left ventricular dysfunction after first acute anterior MI, and their safety profiles were similar. REGISTRATION: ClinicalTrials.gov identifier NCT03715998.

Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy.

INTRODUCTION: Resistant hypertension (HTN), despite the tremendous advances in pharmacotherapy, is a major global problem. Transcatheter renal denervation (RDN) could be a pertinent strategy for resistant HTN and patients with poor pharmacotherapy adherence. Nonetheless, the adoption of energy-based RDN in clinical practice is slow and alternative approaches are needed. AREAS COVERED: The review focuses on the assessment of the Peregrine System Infusion Catheters. The system is designed for chemically mediated transcatheter RDN by the infusion publications on the Peregrine system. The theoretical assumptions for chemically mediated RDN, design of the system, data from preclinical and clinical studies, and further perspectives are discussed. EXPERT OPINION: Peregrine System Infusion Catheters are the only catheter on the market designed for chemically mediated RDN by the infusion of the neurolytic agent. Chemical neurolysis more efficiently destroys nerves around the renal artery in comparison to energy-based catheters, due to deeper tissue penetration and circumferential distribution resulting in a wider range of effective nerve injury. Chemically mediated RDN by the infusion of the neurolytic agent (alcohol) has an excellent safety profile as confirmed in initial clinical trials which also suggested high efficacy. Currently, there is an ongoing phase III sham-control study. Other possible applications of this technology include clinical settings like heart failure or atrial fibrillation.

Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry.

Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5−69.7) vs. 11.4% (5.8−20.7), p < 0.001, and the stenotic area 82.6% (72.4−90.8) vs. 21.5% (11.1−37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0−66.0) to 86.0% (69.2−90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5−77.2) to 89.0% (85.0−92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.

Comparison of Safety and Efficiency between Tiger-2 Catheter with Right Radial Artery Access and Judkins Catheter with Left Radial Artery Access.

We sought to compare the safety and efficiency of Tiger-2 in the right radial and Judkins catheter in the left radial access. We retrospectively collected data of 487 patients, involving 172 patients after coronary angiography with Judkins on the left radial artery and 315 patients with Tiger-2 on the right radial artery access. There were no differences in baseline characteristics, except for hypertension ratio and mean age. There was a difference in pulse absence on the radial artery. The volume of contrast used was higher in the Judkins group. Both groups differed in the amount of drugs administered (NTG and heparin). Fluorescence times were comparable between groups. Radiation dosage and AK was significantly greater in the Tiger-2 group. The Tiger-2 catheters were significantly more often changed to another type of catheter (100 changes) than the Judkins (12 changes). However, there was no statistical difference in access site change. Judkins with left radial access seems to be a safer option because of the lower radiation exposure and less incidence of complications than Tiger-2 with right radial access, however, it requires a higher volume of contrast.

Neointimal hyperplasia of ultra-thin stents with microcrystalline sirolimus or durable polymer everolimus-eluting stents: 6- and 24-month results of the DESSOLVE III OCT study.

AIMS: The DESSOLVE III OCT substudy aimed to compare serially neointimal hyperplasia volume obstruction (%VO) between the thin-strut MiStent with early polymer elimination and nine-month sustained drug release from microcrystalline sirolimus and the durable polymer-coated everolimus-eluting XIENCE stent at six and 24 months after implantation. METHODS AND RESULTS: The efficacy endpoint was %VO, calculated as abluminal neointimal volume/stent volume. Thirty-six patients (MiStent 16 patients, 16 lesions; XIENCE 20 patients, 22 lesions) underwent serial OCT evaluation at both six and 24 months. At six months, mean abluminal %VO was significantly lower in the MiStent group than in the XIENCE group (14.54±3.70% vs 19.11±6.70%; p=0.011), whereas the difference in %VO between the two groups decreased at 24 months (20.88±5.72% vs 23.50±7.33%; p=0.24). There was no significant difference in percentage malapposed struts and percentage uncovered struts between the two groups at both time points. CONCLUSIONS: In the serial comparative OCT analysis of the MiStent versus the XIENCE, the MiStent showed a more favourable efficacy for preventing neointimal formation with comparable strut tissue coverage, as compared with the XIENCE at six months, but this difference in %VO decreased at 24 months so that the difference in neointima at 24 months was no longer significant.

Evaluation of Transcatheter Alcohol-Mediated Perivascular Renal Denervation to Treat Resistant Hypertension.

Catheter-based renal denervation (RDN) has been investigated for hypertension (HTN) treatment with variable success. One of the novel approaches to RDN is the delivery of micro-doses of dehydrated alcohol to the adventitial space of the renal artery to perform perivascular ablation of the sympathetic nerves. We sought to assess the safety and efficiency of transcatheter alcohol-mediated perivascular renal denervation in patients with resistant hypertension. Fifty adult patients who had been referred for resistant HTN were screened. To qualify for the study, the patients had to have a mean 24 h systolic pressure ≥ 135 mmHg based upon ambulatory blood pressure monitoring (ABPM) and acceptable renal artery anatomy confirmed by the contrast computer tomography (AngioCT) and nephrologist consultation. Ten patients were eligible for chemical RND. There were no safety issues throughout the 24 months of follow-ups. The mean decrease in the office BP (OBP) was significant during 24 months of follow-up (p < 0.01). The difference in the BP in the ABPM was statistically significant in the 1st, 3rd and 12th months (p < 0.01), whereas during the 3-month follow-up, a trend was observed. The modifications of anti-hypertension drugs throughout the follow-up period were minimal. This study has shown that transcatheter alcohol-mediated renal denervation in patients with resistant hypertension is feasible and safe. Nevertheless, it is a hypothesis-generating study.

Influence of heart rate on FFR measurements: An experimental and clinical validation study.

BACKGROUND: Functional lesion assessment in stable coronary disease is considered the gold standard. The result of fractional flow reserve (FFR) in stable coronary disease is often a decision-maker for patient qualification. Taking into account the paramount position of FFR, it is crucial to acknowledge and reduce all potential bias. AIMS: In the present study, we quantified the influence of elevated HR on FFR results using a preclinical model and then validated the results in a clinical setting. METHODS AND RESULTS: The relationship between FFR and HR was first explored experimentally in a porcine model. A clinical validation study was conducted in patients with isolated moderate lesions in the left anterior descending artery (LAD) or right coronary artery (RCA). In both the experimental and clinical arms, FFR was measured at resting HR and with pacing at 100, 130, 160, and 180 (for pigs) beats per minute. In the porcine model and in the clinical settings, a significant correlation between FFR and HR was confirmed in the LAD (r = 0.89, p < .0001; r = 0.53, p = .00002), but not in the RCA (r = -0.19, p = .5; r = 0.14, p = .3). Post hoc analyses revealed that the FFR values in the LAD at 130/min and above tended to be significantly different from the baseline HR. CONCLUSIONS: The results of this study indicate that in an experimental setting, tachycardia might be responsible for an overestimation of FFR results in LAD lesions.

Comparison of long-term outcomes after directional versus rotational atherectomy in peripheral artery disease.

INTRODUCTION: The rate of atherectomy utilization in peripheral artery diseases (PAD) is growing. The two atherectomy devices available on the market and used most frequently are the directional and rotational ones. Nonetheless, there is a lack of direct comparison between these two types of atherectomy in PAD. AIM: To compare the long-term outcomes after PAD endovascular revascularization with two types of atherectomies: rotational (AR) (Phoenix Philips) and directional (AD) (SilverHawk Medtronic). MATERIAL AND METHODS: This was a single-center, retrospective study of obstructive and symptomatic PAD patients who underwent revascularization with atherectomy. The endpoints were considered as target lesion revascularization (TLR), death, amputations and bailout stenting (BS). RESULTS: The AR group consisted of 97 patients, while the AD group consisted of 85 individuals. There were no significant differences between the groups in terms of baseline characteristics except for an increased critical limb ischemia (CLI) prevalence in the AR group. The mean follow-up for AD and AR was 282.6 ±147.4 and 255.7 ±186.1 days, respectively (p = 0.44). There were no significant differences in the death rate (AD: 1 (1.7%) vs. AR: 5 (5.7%); p = 0.54), amputations (AD: 2 (2.3%) vs. AR: 5 (5.7%); p = 0.45) or bailout stenting (AD: 2 (2.3%) vs. AR: 3 (3.2%); p = 0.74), whereas TLR was more frequent in the AD group (AD: 25 (29%) vs. AR: 15 (15.9%; p = 0.03). The Kaplan-Meier analysis showed no significant differences between the groups in time to TLR, amputation or death. CONCLUSIONS: In this hypothesis-generating study the AR had a lower rate of TLR when compared to the AD. Nevertheless, this should be confirmed in further controlled randomized trials.

Long term outcomes in diabetic patients treated with atherectomy for peripheral artery disease.

BACKGROUND: The prevalence of diabetes has increased significantly in well-developed countries during the last decade and it continues to grow. Diabetes increases the risk of restenosis in patients treated percutaneously for peripheral artery disease. The present study sought to compare outcomes of atherectomy treatment in diabetic (DM) vs. non-diabetic (nDM) patients suffering from peripheral artery disease. METHOD: Between 2008 and 2012, 204 revascularization atherectomy procedures were performed on arteries of the lower extremities. The endpoints included target lesion revascularization (TLR), amputation and death. The type of atherectomy (excisional-soft plaque, orbital-calcified plaque, with active aspiration - with a thrombus) was left to operator discretion. RESULTS: This study contains 132 DM (66% male, age 68 ± 11.2 years) and 72 nDM (63% male, age 75 ± 11.3 years) subjects. DM were younger but had a higher prevalence of coronary artery disease (DM: 91% vs. nDM: 62%, p < 0.0001) and end-stage renal disease (DM: 22% vs. nDM: 2.5%, p < 0.0001). There were no differences in critical limb ischemia between the groups (DM: 21% vs. nDM: 12%, p = = 0.13). Mean time of follow-up was 384 and 411 days in DM and nDM, respectively (p = 0.43). There were no significant differences in TLR (DM: 15.2% vs. nDM: 22.2%, p = 0.249), amputations (DM: 3.0% vs. nDM: 1.5%, p = NS) or death rates (DM: 2.2% vs. nDM: 2.7%, p = NS). Kaplan-Mayer analysis showed no significant differences between the groups in the time to TLR, amputation or death. CONCLUSIONS: Plaque modification with adjusted atherectomy appears to have similar outcomes in diabetic as well as in non-diabetic patients. Nonetheless, a randomized study would be warranted to confirm the findings of the current study.

Spatio-temporal image correlation (STIC) in evaluation of advanced neuroendocrine tumours.

INTRODUCTION: 4D Ultrasound technology merging the Power Doppler option called High-Definition Flow (HDF) with Spatio-Temporal Image Correlation (STIC) is used in gynaecology and obstetrics. It seems to be a promising tool in assessing tissue vascularisation. The aim of the paper was to assess whether HDF STIC technique could be a useful tool for the evaluation of gastro-entero-pancreatic neuroendocrine neoplasm (GEP-NEN) advancement. MATERIAL AND METHODS: Forty-eight patients [mean age 57.7 ± 10.3 years; male 40.9% (n = 18)] diagnosed with metastatic GEP-NENs were included in the analysis. All subjects were enrolled in the Department of Endocrinology and Neuroendocrine Tumours, Medical University of Silesia, Katowice. We analysed liver metastases. Patients with G3 grading or faintly vascularised lesions were excluded. HDF STIC volumes were acquired during USG examination. 4D indices [volumetric pulsatility index (vPI) and volumetric systolic/diastolic index (vS/D)] were calculated using dedicated software. RESULTS: There were no correlations between vS/D and Ki-67 [p = 0.67; r = -0.19; (-0.28-0.19)], CgA [p = 0.47; r = -0.11; (-0.38-0,19)], 5-HIAA [p = 0.52; r = -0.09 (-0.37-0.2)], serotonin [p = 0.83; r = -0.03 (-0.32-0.26)], and VCAM-1 (p = 0.62; r = 0.09 (-03-0.47)]. The were no correlations between vPI and Ki-67 [p = 0.29; r = -0.16 (-0.45-0.14)], CgA (p = 0.46; r = -0.11 (-0.39-0.19)], 5-HIAA [p = 0.52; r = -0.09 (-0.37-0.2)], serotonin [p = 0.82; r = -0.03 (-0.32-0.26)], and VCAM-1 (p = 0.62; r = -0.09 (-03-0.47)]. There was no significant difference between carcinoid versus non-carcinoid patients if compared by vS/D and vPI (p = 0.62, p = 0.61, respectively). CONCLUSIONS: HDF STIC seems not to be an efficient marker to assess advancement of NENs, due to lack of correlation with widely used and approved markers of progression.

Five-year outcomes after revascularization of superficial femoral artery occlusion using Ocelot catheter.

INTRODUCTION: The population of patients with lower limb atherosclerosis includes a considerable proportion of individuals with long superficial femoral artery (SFA) lesions. Chronic total occlusions (CTOs) represent the "last frontier" of percutaneous interventions. While open strategies are considered earlier as standard management for these lesions, the results of a number of trials indicate that endovascular management might become an effective alternative to surgery. MATERIAL AND METHODS: This paper presents 5-year outcomes of a first-in-man (FIM) study (before CE mark) and the registry of OCT Guided Ocelot Catheter (Avinger) for chronic total occlusions of the superficial femoral artery. The study group comprised 10 patients with Rutherford 3 lower limb ischemia including nine men and one woman. RESULTS: The efficacy of the primary intervention was 90%. Angiography performed at 6 months of the procedure, according to the study protocol, revealed 3 and 1 cases of restenosis and reocclusion, respectively, repaired using PTA and open common and deep femoral artery patch plasty. Doppler ultrasound performed at 1, 2 and 5 years after the primary intervention did not reveal significant target vessel restenosis. The primary and primary-assisted patency was 89%. During a 5-year follow-up, four peripheral percutaneous interventions and one femoropopliteal bypass surgery were performed in non-target limbs. There were no cardiovascular deaths, myocardial infarction or stroke and no amputation was required. CONCLUSIONS: This is a first-in-man study reporting long-term follow-up after SFA CTO revascularization using the Ocelot catheter. The catheter proved to have a satisfactory safety profile and a high proportion of CTO crossings. A 5-year follow-up revealed high primary and primary-assisted patency rates.

The use of modern telemedicine technologies in an innovative optimal cardiac rehabilitation program for patients after myocardial revascularization: Concept and design of RESTORE, a randomized clinical trial.

Despite proven efficacy of cardiac rehabilitation (CR) in reducing the all-cause mortality in patients after myocardial revascularization, the penetration of CR, due to patient-related factors and referral rates remains limited. To improve the outcomes, home-based tele-rehabilitation (TR) has been proposed recently. In theory TR enhances the effects of standard CR procedures due to implementation of an intelligent monitoring system designed to ensure optimal training through on-demand transmission of vital signs, aimed at motivating the patients through daily schedule reminders, setting daily goals and creating a platform for mutual feedback. Several meta-analyses assessing various studies comparing these two methods (CR and TR) have proven that they are at least equally effective, with some of the research showing superiority of TR. Although there was a small sample size, lack of long-term follow-up, reporting effects of TR itself, no integration with tools designed for coaching, motivating and promoting a healthy lifestyle constitutes an important limitation. The latter carries a hopeful prognosis for improvement when utilizing a broad-spectrum approach, especially with use of dedicated technological solutions exploiting the fact of a large and yet rapidly increasing penetration of smartphones, mobile PCs and tablets in the population. The above-mentioned findings worked as the basis and rationale for commencing the RESTORE project aimed at developing and delivering state-of-the-art, comprehensive TR for patients after myocardial revascularization and evaluating its molecular aspect in view of how it influences the atherosclerosis progression attenuation. This paper presents the current state and rationale behind the project based on up-to-date TR efficacy data.

Safety and feasibility of same-day early discharge after endovascular revascularization of lower extremities in elderly. SENIOR-ER registry.

OBJECTIVE: The aim of the study was to assess safety and feasibility of one-day early discharge (ODD) after endovascular revascularization (ER) of lower extremities in elderly. BACKGROUND: Safety and feasibility of ODD after ER have never been investigated in the elderly, despite the PAD rate has been rising in well-developed countries as their populations are getting older. METHODS: The consecutive data of 477 patients after ER who were intended to ODD were reviewed. The ER procedure (balloon angioplasty, atherectomy, stenting) was performed due to significant, angiographically confirmed arterial stenosis with at least Rutheford III claudication. The population was divided into two groups: ≥70 years old (y. o.) in which were 235 patients and 220 patients <70 y. o., the younger control cohort. The follow-up was performed 24 hr after (24FU) the procedure and 30 days (30FU) after discharge. RESULTS: There were no differences between the groups in the ratio of same-day discharge (99% vs 99.5%, P = 0.6) and the mean time to ambulation was 287.4 ± 43.4 min versus 285.8 ± 45.7 min (P = 0.603). The ODD was not applied in 2 patients ≥70 y. o. due to two pseudoaneurysms requiring surgical repairs and in one from the control group due to retroperitoneal bleeding. There was no MACE or creatinine increase at 24 hr in both groups. At 30 days, there was no incidence of MACE in the ≥70 y. o. group while 3 MACE occurred in the control. The ratio of access site complications was comparable between the groups. CONCLUSION: The study allows for a hypothesis that the advantages of ODD could be safely extended to the patients ≥70 y. o.

Temporal healing patterns and coverage dynamics after new Polish transcatheter PFO occluder implantation in a swine.

BACKGROUND: Although currently used devices for interventional closure of patent foramen ovale (PFO) are widely used due to the minimally invasive nature of this technique and high success rate, there is still a need to look for new materials and designs in order to improve the treatment outcomes. AIM: To evaluate the safety, biocompatibility, temporal healing patterns, and coverage dynamics of the new Polish PFO occluder (Balton, Warsaw, Poland) in a swine model - an observation that may assist the decision with regard to its first-in-human use and duration of anticoagulation therapy. METHODS: In total, 12 pigs were scheduled for 28-day (n = 6) and 90-day follow-up (n = 6). In each animal, using a standard femoral venous approach, one PFO occluder was implanted and subsequently, in order to verify device position stability, the Minnesota manoeuvre was performed. At follow-up, all devices underwent a comprehensive evaluation with the use of high-resolution radiography (Faxitron MX-20 system), scanning electron microscopy (SEM), and standard histopathological techniques. RESULTS: All PFO occluders were implanted successfully with no complications. The Faxitron revealed that all nitinol portions of the frame appeared intact and breaks were not detected at both studied time points. Overall, the device appeared to be well deployed in the atrial septum. At 28 days the average neointimal coverage of the right side of the PFO occluder by SEM was 92%; while in contrast the left side had less coverage, at 63%. At 90 days, the coverage of the right side of the occluder was 96.8%, while the left side of the PFO occluder improved and had similar coverage of 93.3%. By histology the endothelialisation process was virtually complete at 90 days. At the early time-point the overall inflammatory infiltrate was moderate and subsequently it diminished and was only mild or occasionally moderate at 90-day follow-up. At both time points the inflammatory reaction was limited to the neointimal tissue surrounding the device. CONCLUSIONS: Our study confirmed safety and good overall biocompatibility of the new Polish PFO occluder, which is comparable to other devices available on the market - an observation that supports the decision with regard to its first-in-human application. Neoendothelialisation was virtually completed at 90 days, suggesting that similarly to other widely used devices a minimum of three to six months of anticoagulation therapy should be recommended.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty　- Propensity Score-Matched Registry.

BACKGROUND: The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. CONCLUSIONS: AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge.

BACKGROUND: This was the first prospective study to assess the safety and efficiency of MynxGrip vascular closure device (VCD) in peripheral interventions with antegrade access. METHODS AND RESULTS: We enrolled 66 consecutive patients from 1 center. All patients were discharged home on the day of procedure and were observed for adverse events at 1 and 30 days of follow-up. No major complications were observed. The rate of minor complications (conversion to manual or mechanical compression) was 7.6%. Postdischarge, 3% of patients experienced minor complications-small abscess, ipsilateral deep vein thrombosis. In 1 patient, a second VCD was deployed after device failure. The derived device failure rate was 5.9%. No patients required hospitalization. No late bleeding and no hematomas >6 cm were noted. The mean time to discharge was 4 hours and 5 minutes. CONCLUSION: The MynxGrip was safe and effective in sealing access sites after antegrade femoral artery puncture with same-day discharge.

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model.

BACKGROUND: Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model. METHODS: A total of 40 stents were implanted with 120% overstretch in coronaries of 17 domestic swine: 16 BP-SES, 16 EES and 8 bare metal controls (BMS). Following 28 and 90 days, coronary angiography and optical coherence tomography (OCT) was performed, animals sacrificed and stented segments harvested for pathological evaluation. RESULTS: At 28 days neointimal thickness in OCT was lowest in the BP-SES when compared to EES and BMS (0.18 ± 0.1 vs. 0.39 ± 0.1 vs. 0.34 ± 0.2 mm, respectively; p = 0.04). There was no difference in the proportion of malapposed or uncovered struts, although protruding covered struts were more common in BP-SES (14.8 ± 10% vs. 4.1 ± 4% vs. 3.7 ± 6%; p = 0.03). In pathology, the lowest neointimal thickness was confirmed in BP-SES (p < 0.05). The inflammation score was significantly lower in BP-SES and EES when compared to BMS (0.24 ± 0.1 vs. 0.4 ± 0.1 vs. 0.77 ± 0.4; p < 0.01) whilst EES and BP-SES had higher fibrin scores than BMS (1.2 ± 0.4 vs. 1.3 ± 0.3 vs. 0.17 ± 0.2; p < 0.01). At 90 days neointimal coverage and thickness in OCT was comparable between groups and healing in histopathology was complete. CONCLUSIONS: New generation, BP-SES show similar vascular healing and biocompatibility profile with marginally higher degree of restenosis inhibition, when compared to fluoropolymer EES in the porcine coronary restenosis model.

Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial.

OBJECTIVES: This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. BACKGROUND: The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. METHODS: In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. RESULTS: At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). CONCLUSIONS: In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.