Klaudija Bijuklic

The PROFI Study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting) : A Prospective Randomized Trial

OBJECTIVES The objective of this study was to compare the cerebral embolic load of filter-protected versus proximal balloon-protected carotid artery stenting (CAS). BACKGROUND Randomized trials comparing filter-protected CAS with carotid endarterectomy revealed a higher periprocedural stroke rate after CAS. Proximal balloon occlusion may be more effective in preventing cerebral embolization during CAS than filters. METHODS Patients undergoing CAS with cerebral embolic protection for internal carotid artery stenosis were randomly assigned to proximal balloon occlusion or filter protection. The primary endpoint was the incidence of new cerebral ischemic lesions assessed by diffusion-weighted magnetic resonance imaging. Secondary endpoints were the number and volume of new ischemic lesions and major adverse cardiovascular and cerebral events (MACCE). RESULTS Sixty-two consecutive patients (mean age: 71.7 years, 76.4% male) were randomized. Compared with filter protection (n = 31), proximal balloon occlusion (n = 31) resulted in a significant reduction in the incidence of new cerebral ischemic lesions (45.2% vs. 87.1%, p = 0.001). The number (median [range]: 2 [0 to 13] vs. 0 [0 to 4], p = 0.0001) and the volume (0.47 [0 to 2.4] cm(3) vs. 0 [0 to 0.84] cm(3), p = 0.0001) of new cerebral ischemic lesions were significantly reduced by proximal balloon occlusion. Lesions in the contralateral hemisphere were found in 29.0% and 6.5% of patients (filter vs. balloon occlusion, respectively, p = 0.047). The 30-day MACCE rate was 3.2% and 0% for filter versus balloon occlusion, respectively (p = NS). CONCLUSIONS In this randomized trial of patients undergoing CAS, proximal balloon occlusion as compared with filter protection significantly reduced the embolic load to the brain.

Direct Percutaneous Access Technique for Transaxillary Transcatheter Aortic Valve Implantation: “The Hamburg Sankt Georg Approach”

OBJECTIVES This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices. BACKGROUND Transaxillary TAVI is gaining increasing acceptance as an alternative to the transfemoral route; however, the access has always been done via surgical cutdown so far. METHODS Between August 2010 and September 2011, a total of 24 high-risk patients with severe aortic valvular stenosis underwent a percutaneous TAVI procedure by direct puncture of the axillary artery without surgical cutdown. For safety reasons and as a target for the puncture, a wire was advanced via the ipsilateral brachial artery. Moreover, a balloon was placed into the subclavian artery via the femoral artery for temporary vessel blockade before percutaneous vessel closure. Vascular closure was performed using either the ProStar XL system (Abbott Vascular Devices, Redwood City, California) or 2 ProGlide systems (Abbott Vascular Devices). RESULTS The true percutaneous approach was successfully completed in all patients (14 left and 8 right axillary artery cases). Overall mortality at 30 days was 8.3%. Acute vascular closure device success was achieved in 17 patients (71%). Vascular closure device success rate was 100% for the ProGlide device and 37% for the ProStar device, respectively. Seven patients (29%) with failing closure devices were treated by endovascular stent graft implantation without the need for surgical repair. For the last 12 treated patients, direct closure was achieved in 11 patients. CONCLUSIONS Direct puncture of the axillary artery for TAVI is feasible and safe if a wire is placed into the subclavian artery via the ipsilateral brachial artery.

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet).

OBJECTIVES This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting. BACKGROUND The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period. METHODS A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland. RESULTS The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm(3). The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm(3)) lesion in relation to the 48-h scan. CONCLUSIONS The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period.

Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study

Background— Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve. Methods and Results— Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm2 at baseline to 1.47±0.35 cm2 at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR. Conclusions— In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.

OBJECTIVES The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. BACKGROUND The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. METHODS A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. RESULTS Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2). CONCLUSIONS At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

Transfemoral Tricuspid Valve Repair Using a Percutaneous Mitral Valve Repair System.

There is increasing evidence that severe tricuspid regurgitation (TR) is associated with a poor prognosis. Recently, less invasive transcatheter tricuspid repair technologies are emerging as alternative therapeutic options for high surgical risk patients. One percutaneous mitral valve repair system

Impact of Asymptomatic Cerebral Lesions in Diffusion-Weighted Magnetic Resonance Imaging After Carotid Artery Stenting

OBJECTIVES This study sought to analyze the impact of new asymptomatic cerebral ischemic lesions, found in diffusion-weighted magnetic resonance imaging (DW-MRI) after carotid artery stenting (CAS) in relation to other risk factors for major adverse cerebral and cardiovascular events (MACCE) defined as death, stroke, and myocardial infarction. BACKGROUND After CAS, new cerebral lesions have been reported in up to 70% of patients. The impact of asymptomatic lesions on prognosis after CAS has not been studied. METHODS Eight hundred thirty-seven consecutive patients underwent CAS with cerebral embolic protection. In 728 patients (86.9%), a pre- and post-procedural DW-MRI was available; these patients were included in the analyses. Multivariate Cox regression analysis and Kaplan-Meier estimates were performed to identify independent risk factors for MACCE at follow-up. Clinical, procedural, and lesion characteristics and DW-MRI findings were included in the analyses. RESULTS Post-procedure new cerebral ischemic lesions were detected in 32.8% (n = 241) of patients. Fifteen patients (1.79%) had a periprocedural MACCE and were therefore excluded from the analysis. At a mean follow-up of 766.8 ± 513.4 days (range 30 to 2,577 days), MACCE occurred in 45 patients (6.2%). Cox regression analysis and Kaplan-Meier estimates both identified diabetes as the only significant independent risk factor of MACCE. Asymptomatic cerebral lesions after CAS were not associated with MACCE. CONCLUSIONS Beyond 30 days, diabetes is the only risk factor of MACCE at follow-up. Asymptomatic cerebral embolic events after CAS had no prognostic impact.

Risk Factors for Cerebral Embolization After Carotid Artery Stenting With Embolic Protection A Diffusion-Weighted Magnetic Resonance Imaging Study in 837 Consecutive Patients

Background—Meta-analyses of randomized trials have shown an increased risk of periprocedural stroke after carotid artery stenting (CAS) compared with carotid endarterectomy, which may differ in specific patient subgroups. Knowledge of risk factors for cerebral embolic lesions during CAS may impact treatment decisions for the individual patient, but these factors have not been extensively studied. We aimed to identify factors predictive for cerebral ischemic lesions during embolic protected CAS. Methods and Results—Preprocedural and postprocedural diffusion-weighted magnetic resonance imaging was performed for evaluation of new cerebral ischemic lesions in 728 (86.9%) of 837 consecutive patients undergoing CAS with cerebral embolic protection. Multivariable logistic regression analyses were performed to identify factors predictive for embolic lesions. New ischemic lesions were found in 32.8% of patients. Age, hypertension, lesion length, lesion eccentricity, and aortic arch type III were significantly associated with new ischemic lesions; calcified lesions were negatively associated. In 25% of these patients embolic lesions were also found in the contralateral hemisphere. Predictive factors for contralateral lesions were age, >50% stenosis of the contralateral internal carotid artery, and an aortic arch type II, with a trend for aortic arch type III. Conclusions—Age, hypertension, lesion morphology, and aortic arch type were predictive for procedural-related cerebral embolic lesions during embolic protected CAS. Age, significant contralateral carotid stenosis, and complex aortic arch type were predictive for bilateral ischemic lesions. The clinical implications of ischemic lesions are not yet fully understood.

Direct Flow Medical valve.

AIMS To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. METHODS AND RESULTS The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. CONCLUSIONS The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

Carotid artery stenting, what can be learned after more than 1,000 patients: a single centre single operator experience

AIMS The aim of the present study was to evaluate the outcome of carotid artery stenting (CAS) in a single, high-volume centre of a single operator and to analyse the circumstances under which complications occur. Recent trials comparing CAS with carotid endarterectomy demonstrated controversial results. The low experience of interventionists in performing CAS was a major limitation of these studies. The number of procedures needed to achieve optimal skills is unknown. METHODS AND RESULTS From May 1997 until April 2010, 1,004 patients with symptomatic or asymptomatic carotid artery stenosis underwent CAS by a single operator. A cerebral protection device was in mandatory use since 2000. In-hospital complication rates were defined as the cumulative rate of death, myocardial infarction or stroke. Procedural success was achieved in 97.77% of patients. The perioperative complication rate was 1.69% including 0.2% deaths, 1.1% patients with minor stroke, 0.4% patients with major stroke. In 88% (15 out of 17) of the patients with complications, unfavourable anatomical or procedural factors could be identified. After the first 100 CAS performed,the complication rate was at 3% and significantly decreased to 1% after more than 500 procedures. Patients ≥80 years had a significantly higher complication rate. CONCLUSIONS In a high-volume experienced centre, the in-hospital complication rate is low. Complications occurred almost exclusively in patients with unfavourable anatomical or procedural characteristics and seem to be avoidable in most patients. A learning curve was observed up to 500 procedures. Elderly patients have a higher complication rate.