Dobrin Vassiliev

First‐in‐Man Study of Dedicated Bifurcation Sirolimus‐eluting Stent: 12‐month Results of BiOSS LIM® Registry

OBJECTIVES The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry. BACKGROUND The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions. METHODS This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months. RESULTS A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm. CONCLUSION Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.

Five‐year Follow‐up of Intracardiac Echocardiography‐assisted Transcatheter Closure of Complex Ostium Secundum Atrial Septal Defect

OBJECTIVE We sought to prospectively evaluate long-term follow-up results of intracardiac echocardiography-aided transcatheter closure of complex atrial septal defects (ASD) in the adults. DESIGN AND SETTINGS Prospective multicenter registry in tertiary care hospitals. PATIENTS AND INTERVENTIONS Over a 5-year period, we prospectively enrolled 56 patients (mean age 49 ± 16.7 years, 24 females) who have been referred to our center for catheter-based closure of complex secundum ASD (> 25 mm diameter, deficiency of ≥ 1 rim, multiple secundum ASD, multiperforated ASD, associated incomplete floor of the fossa ovalis with or without aneurysm, embryonic remnants of incomplete atrial septation). All patients were screened by means of transesophageal echocardiography before the operation. Eligible patients underwent intracardiac echocardiography study and closure attempt. RESULTS Forty patients underwent a transcatheter closure attempt: transesophageal echocardiography-planned device type and size were modified in 32 patients (64%). Rates of procedural success, predischarge occlusion, and major complications rate were 100%, 90%, and 2%, respectively. On mean follow-up of 5.4 ± 1.8 years, the follow-up occlusion rate was 98%. During follow-up, only one case of permanent atrial fibrillation was observed. There were no cases of aortic/atrial erosion, device thrombosis, or new atrioventricular valve dysfunction. CONCLUSIONS Intracardiac echocardiography-guided complex secundum ASD transcatheter closure is safe and effective and appears to have excellent long-term results, thus minimizing potential complications resulting from the complex anatomy.

Complex coronary bifurcation revascularization by means of very minimal crushing and ultrathin biodegradable polymer DES: Feasibility and 1-year outcomes of the “Nano-crush” technique

AIM To assess feasibility and 1-year outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (nano-crush technique) in a series of patients with large (≥2.5mm) complex coronary bifurcation. METHODS From January 2015 to June 2016, patients referred for large (≥2.5mm) complex coronary bifurcation percutaneous coronary interventions (PCI) were enrolled to receive Orsiro (Biotronik Inc., Bulack, Switzerland) double stenting using a very minimal crush technique (nano-crush). Per our institutional protocol, follow-up was conducted by physical examination at 1, 6, 12month and yearly whereas angiographic control was eventually scheduled at 6-8months on the basis of symptoms recurrence or/and positive induced ischemia tests. RESULTS Fifty-two patients (15 females mean age 77.2±6.2years) were enrolled. Mean angles between main branch and side branch were 63.6±21.3°. The mean diameter and length of implanted stents were 3.8±0.4mm and 27.1±8.7mm in main branch and 2.8±0.3mm and 22.1±.7.1mm in side branch. Immediate success was 100%. Clinical follow-up was available for 100% of patients: at a mean follow-up of 12.0±2.6months, no patient death, or acute myocardial infarction or target vessel revascularization were observed. Angiographic follow-up was available in 25/52 patients (48%) at a mean time from the procedure of 7.2±0.5months and showed no significant angiographic restenosis. CONCLUSIONS The revascularization of complex large (≥2.5mm) coronary bifurcation disease using the nano-crush technique and the ultrathin polymer biodegradable stent appeared feasible in our small study with promising 1year outcomes.

ICE-classification of interatrial septum anatomy in patients with R → L shunt.

Right-to-left (R-to-L) shunt caused by patent foramen ovale (PFO) is a dark field for interventionalists, particularly after the conflicting results from the most recent trials regarding PFO transcatheter closure. It seems that the confusing results (negative in the Closure I [Closure or Medical

Strategies to Overcome Hostile Subclavian Anatomy during Transradial Coronary Angiography and Interventions: Impact on Fluoroscopy, Procedural Time, Complications, and Radial Patency

BACKGROUND Hostile anatomy of the subclavian artery (severe tortuosity and/or heavy calcification) remains a significant obstacle for the transradial approach during coronary angiography and interventions. OBJECTIVE To assess impacts on fluoroscopy and procedural times, complications, and radial artery patency in patients with hostile subclavian anatomy by using multiple catheter-guide techniques. METHODS We retrospectively reviewed the medical and equipment data of 4,580 consecutive patients (mean age 74.4 ± 26.7 years, 49.5% females) who have been referred for transradial coronary angiography and/or interventions within the last 3 years (September 2010-September 2013). In order to overcome the strangling hold of a hostile subclavian artery, 2 techniques have been used: (1) for a coronary angiography-only procedure, a double mother and child technique; (2) for percutaneous coronary intervention, a triple mother and child technique. RESULTS Ninety-five patients (2.1%) from the entire study population exhibited a hostile subclavian artery. Fifty-two patients (1.1%) underwent coronary angiography only and 43 patients (1%) underwent interventions requiring the use of the above double or triple mother and child techniques, respectively. The 2 techniques were successful in 94.7% of patients (90/95 patients). The procedural time was significantly longer in the patients with hostile subclavian artery while there were no differences in the fluoroscopy time. The radial artery was patent at 30 days in 92.6% of patients (88/95 patients). CONCLUSION Our data showed that in the presence of hostile subclavian anatomy, the mother and child techniques appeared safe and effective, allowing for the completion of the intended procedure.

TIMI Risk Index as a Predictor of 30-Day Outcomes in Patients with Acute Pulmonary Embolism

BACKGROUND Available studies have already identified age, heart rate (HR) and systolic blood pressure (SBP) as strong predictors of early mortality in acute pulmonary embolism (PE). MATERIAL AND METHODS One-hundred-seventy patients, with acute PE confirmed on computed tomography angiography (CTA) were enrolled. Thrombolysis In Myocardial Infarction (TIMI) risk index (TRI) was calculated using the formula [heart rate (HR) x (AGE/102)/ systolic blood pressure (SBP)]. Study outcomes were 30-day mortality and/or clinical deterioration. RESULTS Receiver operating characteristics (ROC) curve revealed that a TRI ≥45 was highly specific for both outcomes (AUC 0.91, 95% CI 0.83-0.98, p<0.0001) with a positive predictive value (PPV) and negative predictive value (NPV) of 8.3 and 96% for 30-day mortality while PPV and NPV for 30-day mortality and/or clinical deterioration were 21.1 and 98.2%, respectively. Multivariate regression analysis showed that TRI ≥45 was an independent predictor of 30-day mortality (O.R. 22.24, 95% CI 2.54-194.10, p=0.005) independently from positive cTnI and RVD (O.R. 9.57, 95% CI 1.88-48.78, p=0.007; OR 24.99, 95% CI 2.84-219.48, p=0.004). Similarly, 30-day mortality and/or clinical deterioration was predicted by TRI ≥45 (O.R. 11.57, 95% CI 2.36-56.63, p=0.003) and thrombolysis (3.83, 95% CI 1.04-14.09, p=0.043), independently from age, RVD and positive cTnI. Cox regression analysis confirmed the role of TRI as independent predictor for both outcomes. Mantel-Cox analysis showed that after 30-day follow-up there was a statistically significant difference in the distribution of survival between patients with and without TRI ≥45 [log rank (Mantel-Cox) chi-square 17.04, p<0.0001]. CONCLUSIONS Thrombolysis In Myocardial Infarction (TIMI) risk index (TRI) predicted both 30-days mortality (all-causes) and/or clinical deterioration in patients with acute PE.

Revascularization of TASCC/D Iliac Occlusion Extendedto Common/SuperficialFemoral Artery using a MixedEndoluminal and SubintimalTechnique through the RadioBrachialAccess

Revascularization of TASC C/D Iliac Occlusion Extended to Common/Superficial Femoral Artery using a Mixed Endoluminal and Subintimal Technique through the RadioBrachial Access Background: Patients with Trans-Atlantic Inter Society Consensus (TASC) C and D iliac lesions extended to common and/or superficial femoral artery are a very challenging subset of patients. Objective: The aim of this study is to discuss the technical implication and short-term outcome of endovascular revascularization through the radio-brachial access using a mixed endoluminal and subintimal recanalization using a Mmxed endoluminal and subintimal technique. Methods: From January 2010 to Jannuary 2015 We prospectively enrolled 33 consecutive patients (mean age 79 ± 12.5 years) , with long (>80 mm) TASC C and TASC D symptomatic chronic iliac arteries occlusion extended to the common/superficial femoral artery, judged not candidates for surgery. Procedure was attempted through the left radial or brachial artery by means of a mixed endoluminal and subintimal recanalization technique using coronary and peripheral dedicated guidewires. Results: The procedure was successful in all but one case (96.9%), mean length and diameter of implanted stents were 160.4 ± 30.2 mm and 8.6 ± 1.4 mm (Everflex EV3 in 20 patients, Pulsar in 3 patients, Smart Flex in 10 patients) , respectively. The procedure was successful in 32/33 patients (96.9%): mean length and diameter of implanted stents were 160.4 ± 30.2 mm and 8.6 ± 1.4 mm (Everflex EV3 in 20 patients, Pulsar in 2 patients, Smart Flex in 10 patients) , respectively. Complications rate was 9.1% including two vessel ruptures and one distal embolization. Death rate was 3%. At a mean follow up of 18.1 ± 11.2 montshs, the primary and secondary patency rates were 90.1 and 96.9%, respectively with a significant improvement of ABI (0.29 ± 0.6 versus 0.88 ± 0.3, p<00.1) and Rutherford class (5.3 ± 0.8 versus 0.7 ± 1.9, P <0.01) compared to baseline. Conclusion: The described technique appeared to be effective and safe allowing for recanalization of long iliac occlusion extended to common/superficial femoral artery.