High Procedural Success Rate Research Articles

The relationship between the S-wave in lead 1 and recurrence of RVOT PVC ablation

BackgroundRadiofrequency catheter ablation (CA) is a common non-pharmacological treatment option for ventricular premature contractions (PVCs) originating from right ventricular outflow tract (RVOT). In this study, we aimed to investigate the relationship between recurrence after CA for RVOT-PVC and S-wave in lead 1 that was shown to be associated with RVOT depolarization. MethodologyA total of 104 patients who were referred to our clinic for CA for idiopathic RVOT-PVC between 2012 and 2015years were enrolled. All ECG parameters were measured before and after the ablation procedure. ResultsAblation was successful in 100 patients (96,1%). These patients with successful ablation were followed for a mean duration of 1078days. 13 patients (13%) had recurrence. Univariate logistic regression analysis revealed age (odds ratio: 1.916, p:0,012), presence of post-procedural S1 (odds ratio:1.040 p:0,028), post-procedural S1 area (oddsratio:1.023 p:0,041), ΔS1 area (odds ratio:1.242 p:0,004) as predictors for recurrence. Multivariate logistic regression analysis detected age (odds ratio:1.053 p:0,032) and ΔS1 area (odds ratio:0.701 p:0,009) as predictors for recurrence. ConclusionRadiofrequency CA for RVOT-PVC can be performed with high procedural success and low complication rates. Age and ΔS1 area might be helpful for prediction of recurrence after CA.

Everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the German-Austrian ABSORB RegIstRy (GABI-R).

The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R). A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients. GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

Assessing the landscape of percutaneous coronary chronic total occlusion treatment in Belgium and Luxembourg: the Belgian Working Group on Chronic Total Occlusions (BWGCTO) registry

Background: Important developments in materials, devices, and techniques have improved outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), and resulted in a growing interest in CTO-PCI. The Belgian Working Group on Chronic Total Occlusions (BWGCTO) working group aims to assess the evolution within the CTO-PCI landscape over the next years. Methods: From May 2016 onwards, patients undergoing CTO-PCI were included in the BWGCTO registry by 15 centres in Belgium and Luxemburg. Baseline, angiographic, and procedural data were collected. Here, we report on the one-year in-hospital outcomes. Results: Over the course of one year, 411 procedures in 388 patients were included with a mean age of 64 ± 11 years. The majority were male (81%). Relatively complex CTOs were treated (Japanese CTO score =2.2 ± 1.2) with a high procedure success rate (82%). Patient- and lesion-wise success rates were 83 and 85%, respectively. Major adverse in-hospital events were acceptably low (3.4%). Antegrade wire escalation technique was applied most frequently (82%). On the other hand, antegrade dissection and re-entry and retrograde strategies were more frequently applied in higher volume centres and successful for lesions with higher complexity. Conclusion: Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass

The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Interventional closure of patent foramen ovale with Nit-occlud® device in prevention of recurrent neurologic events-Long-term results.

Patent foramen ovale (PFO) was found to be associated with the increased risk of recurrent strokes or transient ischemic attacks (TIA) and there is a need of secondary prevention. Numerous devices have been developed and used for treatment. The aim of the study was to evaluate the safety and effectiveness of a new PFO occluder Nit-Occlud PFO Occlusion Device (PFM medical, Germany). Between January 2012 and August 2016, 151 patients (mean age 41 ± 11 years) who had suffered from a cryptogenic thromboembolic event underwent transcatheter PFO closure with the PFM Nit-Occlud PFO device. The procedure was successful in 150 patients (99.3%). Mean clinical follow-up time was 24.4 ± 16.1 months. Echocardiographic follow-up was done at 6 weeks and 6 months post intervention by transesophageal contrast echocardiography in 90 (60%) of patients. Clinical end-point was death, non-fatal stroke, or TIA. No major periprocedural or in-hospital complications occurred. Stroke or TIA reoccurred generally in 5 (3.3%) patients (2 strokes and 3 TIA's). In one patient (0.7%) device, thrombosis was observed. Closure was sufficient with only minimal right-to-left residual shunt in seventeen cases of 90 examined patients (19%) after 6 weeks and in one patient (1.1%) 6 months post implantation. The Nit-Occlud PFO device and its delivery system are safe and provides sufficient closure of PFO in patients who suffered from cryptogenic stroke, TIA or paradoxical peripheral embolism. It is associated with high procedural success and favorable rates of complete closure.

Progress in Endovascular Aortic Repair for Women.

The diagnosed prevalence of abdominal aortic aneurysm (AAA) in women is approximately 20% of that in men.1–3 Therefore, women are underrepresented in epidemiologic studies and trials in which screening and therapeutic methods are evaluated. Consequently, central issues related to AAA in women have not been fully investigated.First, screening recommendations provide inadequate guidance for women. The United States Preventive Services Task Force has concluded that insufficient evidence exists for screening women with a history of smoking and has advised against screening women who have never smoked.4 The only prospective studies of ultrasound screening in women yielded no difference in mortality rates at 10 years.3,5 Subsequent efforts to identify women at high risk of AAA have been more promising.6,7Female sex is associated with a more rapid aneurysmal growth rate and earlier rupture.8,9 These findings suggest that women might benefit more from earlier AAA repair than do men. In addition, AAAs in women are more likely to have complex features.10 The median infrarenal aortic neck length in women is 12 mm, compared with 16 mm in men. The degree of neck angulation is greater in women (45° vs 36°), and iliac vessel caliber is smaller (11 vs 14 mm). Thus, approximately 60% of women are not eligible for endovascular aortic repair (EVAR) with use of conventional devices.11Recent advances in device design, including smaller delivery systems and modifications to accommodate shorter neck lengths and greater angulation, can be expected to increase EVAR eligibility in women. For instance, the Endurant® II AAA Stent Graft System (Medtronic, Inc.; Minneapolis, Minn) and the TriVascular Ovation Prime® device (TriVascular, an Endologix company; Santa Rosa, Calif) can accommodate neck lengths as short as 10 mm and 7 mm, respectively. The Zenith® Fenestrated AAA Endovascular Graft (Cook Medical Inc.; Bloomington, Ind), which is uniquely manufactured to conform to patients' aortic anatomy, can be used in necks as short as 4 mm. Extreme neck angulation is accommodated by the Aorfix™ Endovascular Stent Graft (Lombard Medical, Inc.; Irvine, Calif). These devices can also be used in patients who have iliac vessel diameters as narrow as 8 mm and as wide as 25 mm. The TriVascular Ovation® provides the lowest-profile delivery system at 14F.The ongoing LIFE Study seeks to show benefits associated with the low-profile TriVascular Ovation Prime device in conjunction with the Fast-Track EVAR Protocol, which includes percutaneous access, conscious sedation, and next-day discharge from the hospital.12 Thirty-day results include low rates of adverse events, high procedural success rates, freedom from endoleak, and hospital readmission rates 5 times lower than those in contemporary EVAR reports (1.6% vs 8.2%).13 Patients assigned to the fast-track approach showed a trend toward more greatly improved quality of life. Whether the predicted benefits of the Ovation Prime device will specifically translate into improved outcomes in female patients will be determined in the forthcoming LUCY Study.14The underrepresentation of women in clinical trials related to AAA has resulted in a lack of guidance for patients and physicians in the central issues of natural history, screening, and treatment threshold. Technical advances in stent-grafts, which are now lower-profile and more compatible with complex aneurysmal features, are likely to increase eligibility for EVAR in women. In addition to procedural advances, future study should focus on improved screening algorithms and defining the optimal treatment threshold in women.

Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy - J2T Multicenter Registry.

Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.Methods and Results:This multi-center registry assessed the characteristics and outcomes of patients treated by RA for calcified coronary lesions between 2004 and 2015. Among 1,090 registered patients, mean age was 70±10 years and 815 (75%) were male. Sixty percent of patients had diabetes mellitus and 27.7% were receiving hemodialysis. The procedure was successful in 96.2%. In-hospital death occurred in 33 patients (3.0%), and 14 patients (1.3%) developed definite/probable stent thrombosis. During the median follow-up period of 3.8 years, the incidence of major adverse cardiac events (MACE), defined as all-cause death, acute coronary syndrome, stent thrombosis, target vessel revascularization and stroke, was 46.7%. On multivariable Cox hazard analysis, hemodialysis (HR, 2.08; 95% CI: 1.53-2.86; P<0.0001) and age (HR, 1.03; 95% CI: 1.01-1.04; P<0.0001) were strong independent predictors of MACE. Conversely, statin treatment was associated with lower incidence of MACE (P=0.035). This study has provided the largest Japanese dataset for long-term follow-up of RA. Although RA in calcified lesions appears feasible with a high rate of procedural success, a high incidence of MACE was observed.

A dedicated lumbar puncture clinic: performance and short-term patient outcomes.

The purpose of the study was to evaluate patient outcomes, including success rates, factors associated with unsuccessful procedures and frequency of post-lumbar puncture headaches (PLPH), at a dedicated academic outpatient lumbar puncture (LP) clinic. All patients referred to our LP clinic between June 1, 2014 and May 31, 2015 were included in this consecutive observational series. We collected information about patient characteristics, operational parameters of the procedure, and complications. We also recorded rates of participation in biomedical research involving use of cerebrospinal fluid. Univariate analysis used Student's t test and Fisher's exact test. Logistic regression was used to determine independent risk factors associated with unsuccessful LP and PLPH. The mean age of patients referred to our LP clinic was 46±17years. Of the 307 referrals, 281 patients (92%) started the procedure, with successful acquisition of CSF in 267 (95%). Factors contributing to unsuccessful procedures included higher body mass index [odds ratio (OR) 1.8], older age (OR 1.9), and female sex (OR 10.3). The rate of PLPH was 5.7%. Younger age (OR 0.5), female sex (OR 6.9), high mean arterial pressure (OR 2.2), and a traumatic LP (OR 10.0) were identified as risk factors for PLPH. Notably, 202 patients (72%) consented to biomedical research. A standardized approach to outpatient LP demonstrates high procedural success rate, low PLPH rate, and high participation in biomedical research. Awareness of a group of patients at higher risk for complications including procedure failure or PLPH provides guidance for decision-making regarding referral to the outpatient LP clinic.

Safety and efficacy of MitraClip™ therapy in patients with severely impaired left ventricular ejection fraction: results from the German transcatheter mitral valve interventions (TRAMI) registry.

The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function. Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients. In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.

Does Test-enhanced Learning Improve Success Rates of Ultrasound-guided Peripheral Intravenous Insertion? A Randomized Controlled Trial.

Teaching procedural skills in medicine is time- and resource-intensive, and it is therefore important to determine which educational strategies are most effective. Test-enhanced learning (TEL) has been demonstrated to be effective in improving learner retention; however, there is little research evaluating the testing effect on the acquisition of procedural skills in medicine. The objective of this study was to examine the impact of TEL on learning ultrasound-guided intravenous (USG IV) insertion on a simulated model. We conducted a prospective randomized controlled trial of medical students at a single tertiary care academic hospital. Participants were randomized to either the TEL group (TEG) or control group (CG). Each group received an USG peripheral IV teaching session that included a didactic portion and hands-on skills training. The training sessions were identical except that the TEG was informed at the outset that there would be an assessment at the end of the session. The TEG then received a formal assessment of the skill during the last 15 minutes of the session, whereas the CG had continued practice time. Subjects in both groups were evaluated 10-14 days later to compare skill performance using a simulation-based assessment tool consisting of a global rating scale (GRS) and checklist items. Thirty medical students completed the study, 15 in the TEG and 15 in the CG. There were no significant differences between the two groups at baseline based on year of medical training or prior IV or ultrasound experience. The overall procedural success rate was 93.3% (95% CI= 79.0%-100.0%) in the TEG and 80.0% (95% CI= 57.1%-100%) in the CG (p=0.60). The first-attempt failure rate was 13.3% (95% CI= 0.0%-32.8%) in the TEG and 33.3% (95% CI= 6.3%-60.4%) in the CG (p=0.39). There were no statistically significant differences between the means of the GRS (TEG=4.7, CG=4.2; p=0.53, r=0.11) or checklist scores (TEG=78.6%, CG=75.3%; p=0.20, r=0.24). In this study of novice learners, both TEL with structured practice and structured practice alone lead to high success rates performing USG IV insertion on a simulated model. While we noted a trend toward higher procedural success rates and lower first-attempt failure rates in the TEG, these did not meet statistical significance. Further studies with larger sample sizes are required to determine whether the beneficial effects of TEL can be transferred to procedural skills teaching.

Single-centre experience of STENTYS Xposition S in treatment of left main stem lesions

ABSTRACTBackground: The second generation STENTYS Xposition S self-expanding stent with a novel balloon delivery system was launched in May 2015. The stents unique properties are well suited for the treatment of left main stem disease where large diameters, coverage of diameter differences and precise positioning are required. We report the first consecutive experience of using this device in the treatment of left main stem lesions.Methods: 20 consecutive patients with a mean age of 73.9±10.1 years were treated over a period of 8 months at our institution and were assessed on the parameters of technical, angiographic and procedural success.Results: Technical success was achieved in 95% of cases and angiographic success in 80% of cases. There was no incidence of geographical miss. Side branch access was straightforward, with no failure to recross stent struts, dilate or deploy a second stent if required. In this unselected clinical cohort, 2 critically ill patients with cardiogenic shock on presentation died despite successful revascularisation. There was no incidence of early stent related complications up to 30-day follow up.Conclusion: This first consecutive series of left main lesions treated with STENTYS Xposition S documents high acute technical and procedural success rates.

Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry.

Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. NCT01991431.

Acute and midterm results following perventricular device closure of muscular ventricular septal defects: A multicenter PICES investigation.

To describe acute and mid-term results of hybrid perventricular device closure of muscular ventricular septal defects (mVSDs). Perventricular device closure of mVSDs can mitigate technical limitations of percutaneous closure and need for cardiopulmonary bypass or ventriculotomy with a surgical approach. This is a multicenter retrospective cohort study of patients undergoing hybrid perventricular mVSD device closure from 1/2004 to 1/2014. Procedural details, adverse events, outcomes, and follow-up data were collected. Patients were divided into two groups: (1) simple (mVSD closure alone) and (2) complex (mVSD closure with concomitant cardiac surgery). Forty-seven patients (60% female) underwent perventricular mVSD device closure at a median age of 5.2 months (IQR 1.8-8.9) and weight of 5.1 kg (IQR 4.0-6.9). Procedural success was 91% [100% (n = 22) simple and 84% (n = 21/25) complex]. Adverse events occurred in 19% (9/47) [9% (2/22) simple and 28% (7/25) complex]. Hospital length of stay (LOS) was shorter in the simple vs. complex group (4 vs. 14 days, P < 0.01). At mid-term follow-up of 19.2 months (IQR 2.3-43) 90% of pts had complete mVSD closure; none developed late heart block, increased atrioventricular (AV) valve insufficiency or ventricular dysfunction. Perventricular device closure of simple mVSD was associated with a high rate of procedural success, few adverse events, and short hospital LOS. Procedural adverse events were associated with the presence of concomitant complex surgery. Residual mVSD, AV valve insufficiency, or ventricular dysfunction were uncommon at mid-term follow-up. © 2017 Wiley Periodicals, Inc.

Procedural success and intra-hospital outcome related to left atrial appendage morphology in patients that receive an interventional left atrial appendage closure.

The interventional left atrial appendage (LAA) closure represents an emerging alternative to oral anticoagulation for stroke prevention in certain atrial fibrillation patients. Preliminary results have suggested high procedural success rates and fewer peri-interventional complications; however, there persists an insufficient understanding of the role of many underlying confounding variables (e.g., anatomical characteristics). It was investigated whether varying LAA morphologies influence procedural success as well as in-hospital outcome. Sixty-seven patients ineligible for long-term oral anticoagulation were included in this single-center, prospective, observational registry spanning from the years 2014 to 2016. Interventions were performed with the Watchman occluder (Boston Scientific, Natick, MA) or the Amplatzer Amulet (St. Jude Medical, St. Paul, MN), at the operator's discretion. Results derived from the data describing procedural success, fluoroscopy, and peri-interventional safety events were classified according to the presenting LAA morphology (cauliflower, cactus, windsock, and chicken wing). Rates of successful implantation were high across all groups (≥98%; P = 0.326). Surrogate parameters underlining procedural complexity like median total duration (P = 0.415), median fluoroscopy time (P = 0.459), median dose area product (P = 0.698), and the median amount of contrast agent (P = 0.076) demonstrated similar results across all groups. Likewise, the periprocedural complication rate was not significantly different and was mainly restricted to minor bleeding events. Irrespective of the varying morphological presentation of the LAA, the procedural success rates, interventional characteristics, and safety events did not significantly differ among patients receiving an interventional LAA closure.

Ticagrelor versus clopidogrel in real-world patients with ST elevation myocardial infarction: 1-year results by propensity score analysis

BackgroundEuropean guidelines recommend the use of ticagrelor versus clopidogrel in patients with ST elevation myocardial infarction (STEMI). This recommendation is based on inconclusive results and subanalyses from clinical trials. Few data are available on the effects of ticagrelor in a real-world population.MethodsTo compare the effects of ticagrelor and clopidogrel in a real-world STEMI population, we conducted a pre-post case-control study examining all patients with STEMI included in the Cardio-STEMI Sanremo registry between February 2011 and June 2013. Cases and controls were defined according to P2Y12 inhibitors, correcting the bias due to lack of randomization by propensity score analysis. Ticagrelor was introduced in 2012 in both in-hospital and pre-hospital settings independently of this study.ResultsOf the 416 patients enrolled in the Cardio-STEMI registry, 401 with a definite diagnosis of STEMI were included in this study. One hundred forty-two patients received ticagrelor and 259 received clopidogrel. Regarding clinical presentation and procedural data, those in the ticagrelor group had lower CRUSADE scores (23 [14–36] vs 27 [18–38]; p = 0.015] but a higher proportion of radial access (33% vs 14%; p < 0.001), percutaneous coronary intervention (PCI; 92% vs 81 %; p = 0.002) and primary PCI ≤ 12 h (82% vs 66%; p = 0.001). The patients in the ticagrelor group had a higher procedural success rate (100% vs. 96%; p = 0.044). There was no difference in Bleeding Academic Research Consortium bleeding and in unadjusted incidence of hospital major adverse cardiovascular events (MACE; cardiac death, myocardial infarction, or stroke) but there was a significant reduction in unadjusted cardiac hospital death in the ticagrelor group (0.7% vs 5.4%; p = 0.024). After correcting for propensity score, hospital death (p = 0.22) and hospital MACE (p = 0.96) did not differ in both groups. The unadjusted survival at 1 year after STEMI was higher in the ticagrelor group (97.8% vs 87.8%; p = 0.024), and this result was confirmed by propensity score analysis (hazard ratio = 0.29 [0.08–0.99]; p = 0.048).ConclusionsIn this real-word propensity score analysis, ticagrelor did not affect the risk of MACE during the hospital phase, or the incidence of hospital bleeding in patients with STEMI. However, in this mono-centric experience, ticagrelor resulted in improved 1-year survival, even after correction by propensity score.

A single-center retrospective analysis of patency rates of intraluminal versus subintimal endovascular revascularization of long femoropopliteal occlusions.

The evaluation of patency rates of intraluminal versus subintimal endovascular revascularization of long femoropopliteal (FP) lesions. Chronic total occlusions (CTO) of the FP artery in peripheral interventions are crossed either with a support catheter-guidewire based technique or subintimal dissection and re-entry device assisted approach. Both techniques have a high procedural success rate, but their long term patency is not well studied. There is also lack of comparative data addressing the patency of long non-CTO vs. CTO occlusions. We performed a single center retrospective analysis, studying the patency rates in 215 patients (254 limbs) with TASC C and D FP lesions treated with stents. There were 3 patient groups: without CTO (non-CTO); CTO crossed using support catheter and guide-wire (CTO-SW) and CTO crossed with a re-entry device (CTO-RE). There were 155 limbs in CTO-SW group; 50 in CTO-RE group and 49 in non-CTO. Lesion length (mean±SD) was 251.81±7.48mm in CTO-SW group; 280±13.18mm in CTO-RE group and 248.77±13.31 in non-CTO group (p=non-significant). In-stent restenosis (ISR) at a mean follow-up of 19.26±16.14months did not differ between groups occurring in 23 (47%) limbs in non-CTO; 66 (42%) in CTO-SW; and 24 (48%) in CTO-RE. Smoking and stent fracture were predictors of ISR by multivariate analysis. In patients with long FP lesions, ISR rates were similar between patients with and without CTO. In the CTO group mid-term vessel patency was not affected by the crossing technique utilized.

Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study.

The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO. This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up. This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.

Self-expanding STENTYS stents in daily routine use.

In the era of modern interventional cardiology, implantation of a balloon expandable stent is the finishing touch of almost every coronary angioplasty. However, sometimes we face a clinical situation in which the decision regarding the stent diameter is complicated, especially in the ectatic part of arteries, in situations when the artery lumen is obscured with the thrombus, or when the reference diameter of the proximal and distal part of the lesion vary greatly. That is why the idea of a self-apposing stent similar to the one used in peripheral vascular interventions was adopted into cardiology. The aim of this study was to present a single-centre registry of STENTYS® stent implantation in 40 selected patients with acute coronary syndromes (ACS) or with stable angina (coronary artery disease [CAD]) treated with this self-expandable stent. The device was successfully implanted in all patients. During in-hospital observation and 30-day follow-up there were two cases of death, but none of the patients had acute stent thrombosis or ACS ST elevation myocardial infarction. In one case ACS type 4b was diagnosed. In all patients the stent was delivered in the target lesion. In two cases the procedure was performed in patients with multivessel CAD extending into the left main stem in a state of cardiogenic shock. These patients died immediately after the procedure. There were two procedure complications: in one case dissection after post dilatation occurred distally to the stent, and in one patient the calcified proximal part of the left anterior descending artery was dissected with system passage. Thirty-eight patients survived the 12-month follow-up period, and three (7.8%) patients underwent repeated target-lesion revascularisation. In the presented single-centre registry the STENTYS® stent was used with a high delivery and procedural success rate. Satisfactory clinical long-term outcome both in stable patients and ACS patients with a repeated revascularisation ratio of 7.8% was observed. The stent design allowed successful treatment of bifurcation lesions.

Recanalization of peripheral chronic total occlusions: ‘no fancy devices, just a crossing catheter’

ABSTRACTBackground: Chronic total occlusions (CTOs) are challenging to treat endovascularly. Classic subintimal approach is offering only moderate success rates mainly due of the lack of dedicated crossing catheters. Purpose of this study is to assess the acute procedural success of the use of a novel hydrophilic crossing catheter in the recanalization of peripheral CTOs.Materials and methods: This is a retrospective, single-centre study of patients with femoropopliteal CTOs. Revascularization was performed with the use of the NaviCross®- crossing catheter (Terumo Europe). Technical, procedural success and complications were assessed.Results: Thirty-two patients were included in the study. Mean age was 65.9 (46–85) years; Critical limb ischemia was the indication for the procedure in 26 (81%). Target vessels included 12 superficial femoral arteries, 9 popliteal, and 11 femoropopliteal segment lesions. Mean length was 85 (50–350) mm; 21(65.6%) lesions were heavily calcified. In all cases a sub-intimal approach was used; in 21 cases the procedure was performed as a day case. Technical success was achieved in 31 (96.8%) cases. Recanalization was achieved with a guidewire in 22 (71%) lesions and with the catheter alone in 9 (29%) cases. Procedural success was achieved in all lesions. No major adverse events occurred.Conclusion: The use of the NaviCross®- crossing catheter showed high rate of technical and procedural success in challenging femoropopliteal CTOs without significant complications. The use of this catheter needs to be considered as the first approach for CTOs prior to the use of any other more complex re-entry device.

Further validation of the hybrid algorithm for CTO PCI; difficult lesions, same success.

To evaluate the success rates and outcome of the hybrid algorithm for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) by a single operator in two different clinical settings. We compared 279 consecutive CTO PCIs performed by a single, high-volume operator using the hybrid algorithm in two different clinical settings. Data were collected through the PROGRESS CTO Registry. We compared 145 interventions performed in a community program (cohort A) with 134 interventions performed in a referral center (cohort B). Patient in cohort B had more complex lesions with higher J-CTO (3.0 vs. 3.41; p<0.001) and Progress CTO (1.5 vs.1.8, P=0.003) scores, more moderate to severe tortuosity (38% vs. 64%; p<0.001), longer total occlusion length (25 vs. 40mm; p<0.001) and higher prevalence of prior failed CTO PCI attempts (15% vs. 35%; p=0.001). Both technical (95% vs. 91%; p=0.266) and procedural (94% vs. 88%; p=0.088) success rates were similar between the two cohorts despite significantly different lesion complexity. Overall major adverse cardiovascular events were higher in cohort B (1.4% vs. 7.8%; p=0.012) without any significant difference in mortality (0.7% vs. 2.3%, p=0.351). In spite of higher lesion complexity in the setting of a quaternary-care referral center, use of the hybrid algorithm for CTO PCI enabled similarly high technical and procedural success rates as compared with those previously achieved by the same operator in a community-based program at the expense of a higher rate of MACE.