Incidence, course and risk factors of head injury: a retrospective cohort study.

OBJECTIVES: To assess the incidence of head injury and predictors of complication across the care continuum. DESIGN: Retrospective cohort study using data from a research network. We calculated the incidence of overall head injury in a longitudinal cohort covering 1-year interval (31 369 patient-years), and the incidence of complicated head injury in a longitudinal cohort covering 10 years interval (220 352 patient-ears). Incidence rates were calculated per 1000 patient-years with 95% CI using the Mid-P exact test. We calculated ORs to assess potential risk factors for a complicated head injury. SETTING: A practice-based research network covering a population of >30 000 patients. PARTICIPANTS: All patients listed in practices within the research network during the years 2005-2014. MAIN OUTCOME MEASURES: Incidence of (complicated) head injury and predictors for clinical complications. RESULTS: The incidence of overall head injury was 22.1 per 1000 person-years and the incidence of a complicated course following head injury was 0.16 per 1000 person-years. The following determinants were risk factors for a complicated course: high energy trauma, bicycle accident, traffic accident in general, use of anticoagulants, alcohol intoxication, age above 60 years and low Glasgow Coma Scale at initial presentation. A complicated course was very unlikely when the patients' first encounter with a healthcare professional was in primary care (OR 0.03, 95% CI 0.01 to 0.07). CONCLUSIONS: Complication after head injury are rarely seen in general practice. Patients who do experience complications are often easily identifiable as requiring specialist care. A more reserved referral policy for general practice may be desirable, suggesting that current guidelines are too defensive.

TriGuard™ HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

OBJECTIVES: This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events. METHODS: This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI. RESULTS: Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049]. CONCLUSION: This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc.

Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis.

BACKGROUND/OBJECTIVES: Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment. METHODS: In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis. RESULTS: Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (-0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006). CONCLUSIONS: The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective.

Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial.

OBJECTIVE: To evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial. BACKGROUND: DEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis. METHODS: This study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization). RESULTS: Forty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.51 ± 0.59 mm as compared to 0.74 ± 0.57 mm in BMS (P = 0.44), 0.64 ± 0.56 mm in DEB+BMS (P = 0.88) and 0.21 ± 0.32 mm in PES (P < 0.01); in-balloon/stent binary restenosis rates were 22.2%, 23.8% (P = 0.67), 28.6% (P = 0.97), and 4.5% (P = 0.07), respectively; and MACE rates were 17.5%, 23.5% (P = 0.20), 20.0% (P = 0.26), and 4.1% (P = 0.90), respectively. No acute or late thrombotic events occurred in the DEB-only group. CONCLUSIONS: PPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents.

Silent ischemic brain lesions after transcatheter aortic valve replacement: lesion distribution and predictors.

AIMS: Silent ischemic brain lesions and ischemic stroke are known complications of transcatheter aortic valve replacement (TAVR). We aimed to investigate the occurrence and distribution of TAVR-related silent ischemic brain lesions using diffusion-weighted magnetic resonance imaging (DWI). METHODS: Consecutive patients with severe aortic valve stenosis treated with TAVR underwent cerebral DWI within 5 days after the index procedure. DWI scans were analyzed for the occurrence and distribution of new ischemic lesions post-TAVR. RESULTS: Forty-two patients were enrolled in this study. After TAVR, a total of 276 new cerebral ischemic lesions were detected in 38 (90 %) patients, with a median of 4.5 (interquartile range 2.0-7.0) lesions per patient. A total of 129 (47 %) lesions were detected in the cortical regions, 97 (35 %) in the subcortical regions, and 50 (18 %) in the cerebellum or brainstem. The median lesion volume was 20.2 µl (10.0, 42.7) and the total ischemic lesion volume was 132.3 µl (42.8, 336.9). The new ischemic brain lesions were clinically silent in 37 (97 %) patients; the other patient had a transient ischemic attack. Age (B = 0.528, p = 0.015), hyperlipidaemia (B = 5.809, p = 0.028) and post-dilatation of the implanted prosthesis (B = 7.196, p = 0.029) were independently associated with the number of post-TAVR cerebral DWI lesions. In addition, peak transaortic gradient was independently associated with post-procedural total infarct volume. CONCLUSION: Clinically silent cerebral infarcts occurred in 90 % of patients following TAVR, most of which were small (<20 µl) and located in the cortical regions of the cerebral hemispheres. An independent association was found between age, hyperlipidaemia and balloon post-dilatation and the number of post-TAVR ischemic brain lesions. Only peak transaortic gradient was independently associated with post-procedural total infarct volume.

Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

AIMS: To compare the extent of cerebral ischemic injury after transcatheter aortic valve replacement (TAVR) with the use of an Embrella Embolic Deflector System versus unprotected TAVR. METHODS: Fifteen patients with severe symptomatic aortic stenosis underwent TAVR with use of the Embrella Embolic Deflector System for cerebral protection. Cerebral diffusion-weighted magnetic resonance imaging (DWI) was performed in all patients at day 4 after the procedure and images were retrospectively compared to 37 patients who had previously undergone TAVR without a protection device (TAVR-only group). RESULTS: Successful placement of the Embrella device was achieved in all patients. DWI revealed an increase in the number of ischemic lesions in the Embrella group compared with the TAVR-only group (9.0 vs 5.0, P = .044). The use of the Embrella device was however associated with a significant reduction in single-lesion volume: 9.7 µL [5.8, 18.4] versus 17.8 µL [9.5, 38.7] (P < .001). Moreover, total infarct volumes of more than 1000 µL were only seen in the TAVR-only group. More lesions occurred in the right side of the brain in the Embrella group, whereas in the TAVR-only group lesions were distributed equally between left and right. One patient in the TAVR-only group suffered from a transient ischemic attack. Postoperative evaluation was clinically uneventful in the Embrella group. CONCLUSIONS: The use of the Embrella device during TAVR increased the number of cerebral ischemic lesions on postprocedural brain imaging. This increase in number was however accompanied by a significant reduction in single-lesion volume and the absence of large total infarct volumes.

Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.

OBJECTIVES: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. METHODS: Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. RESULTS: Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P < .01). The rate of new pacemaker implantations was 41.7%. CONCLUSIONS: In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.

Same wrist intervention via the cubital (ulnar) artery in case of radial puncture failure for percutaneous cardiac catheterization or intervention: the multicenter SWITCH registry.

AIMS: The radial approach is safer than the femoral for percutaneous coronary procedures. However its feasibility is lower, mainly for technical issues, often related to failure to puncture or cannulate the radial artery. The ulnar approach is a valid alternative to radial. We aimed to test the incidence, feasibility and safety of a direct homolateral ulnar approach in case of failed radial sheath insertion. METHODS AND RESULTS: Five operators collected their 1-year activity (diagnostic and interventional) with focus on entry site. Entry site choice was left to operators' discretion. In case of failed radial sheath insertion, an attempt to cannulate the homolateral ulnar artery was mandated, if ulnar pulse was present. All patients in whom this attempt was performed were followed until discharge. Out of 2403 procedures (1271 interventions), the final successful entry site was radial in 66.5%, femoral in 31.0%, ulnar in 2.1% and brachial in 0.4%. Radial failure occurred in 117 patients (6.9%). In 75 patients, the radial failure was not due to sheath insertion (which was successful), but to lack of catheter support or to tortuosity of the subclavian/brachial arteries. In the remaining 42 (35.9% of all radial failures), a homolateral ulnar approach was attempted. A successful cannulation of the ulnar artery occurred in 36 patients (85.7%) with further performance of the complete procedure. Concerning local complications, 1 radial pseudo-aneurysm (treated with additional compression) occurred, while no cases of early hand ischemia were reported. CONCLUSIONS: In this multicenter registry, in case of failed radial sheath insertion, switching directly to the homolateral ulnar artery for percutaneous coronary procedures is feasible and it appears to be safe, without cases of symptomatic hand ischemia.

Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique.

AIMS: To evaluate the two-step inflation technique aimed at achieving optimal valve implantation depth (defined as 40% of prosthesis height extending below the lower sinus border on angiography) during balloon-expandable transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Between September 2010 and March 2013, 103 patients (67 females, mean age 80.9±5.6 years) were treated with the Edwards SAPIEN XT prosthesis using the two-step inflation technique. Implantation depth was measured on angiography. A historical control group (treated with Edwards SAPIEN) was used for comparison (n=20). Deviation from the defined optimum implantation depth (expressed as a percentage of stent frame height) was significantly less in the study group versus controls (7.0 [3.4-14.1]% vs. 13.9 [5.4-18.9]%; p=0.048). Valve placement was graded "as intended"/"within range"/"out of range" (defined as ≤10%, >10% but ≤20% and >20% deviation, respectively) in 66%/22%/12% of the study group and 35%/40%/25% of historical controls (p=0.02). Corrections in valve position were made in 20 procedures (20%), resulting in placement as intended in 16 cases (80%), with highest efficacy in the transapical and direct aortic approaches. CONCLUSIONS: The two-step inflation technique improves valve placement towards optimal implantation depth and may thereby prevent adverse events due to malpositioning.

Automated 3D analysis of pre-procedural MDCT to predict annulus plane angulation and C-arm positioning: benefit on procedural outcome in patients referred for TAVR.

OBJECTIVES: The aim of this study was to determine whether pre-procedural analysis of multidetector row computed tomography (MDCT) scans could accurately predict the "line of perpendicularity" (LP) of the aortic annulus and corresponding C-arm angulations required for prosthesis delivery and impact the outcome of the procedure. BACKGROUND: Optimal positioning of the transcatheter aortic prosthesis is paramount to transcatheter aortic valve replacement (TAVR) procedural success. METHODS: All patients referred for TAVR at our center underwent a routine pre-procedural MDCT scan. A 3-dimensional (3D) analysis using software dedicated to define the LP of the aortic annulus and the corresponding C-arm positioning was performed in 71 consecutive patients. In 35 patients, the results of the MDCT analysis were not available at the time of the procedure (angiography cohort). In that cohort the position of the C-arm was determined during the procedure using ad-hoc angiography. In 36 patients, the MDCT analysis was performed pre-procedure and results were available at the time of the procedure (MDCT cohort). In that cohort the position of the C-arm was derived from the MDCT analysis rather than by ad-hoc angiography. RESULTS: Intraobserver and interobserver reproducibility of MDCT analysis to predict the LP of the aortic annulus were excellent (kappa = 1 and 0.94, respectively). Patient variations of the LP ranged >70°. Compared with the angiography cohort, the MDCT cohort was associated with a significant decrease in implantation time (p = 0.0001), radiation exposure (p = 0.02), amount of contrast (p = 0.001), and risk of acute kidney injury (p = 0.03). Additionally, the combined rate of valve malposition and aortic regurgitation was also reduced (6% vs. 23%, p = 0.03). CONCLUSIONS: Automated 3D analysis of pre-implantation MDCT accurately predicts the LP of the aortic annulus and the corresponding C-arm position required for TAVR. With this approach, the implantation of the balloon-expandable prosthetic valve can be performed without an aortogram in the majority of cases and still be safe, with a low rate of valve malpositioning and regurgitation.

A prospective "oversizing" strategy of the Edwards SAPIEN bioprosthesis: results and impact on aortic regurgitation.

OBJECTIVE: Moderate to severe aortic regurgitation is occurring in 20% to 30% of cases after transcatheter aortic valve implantation. METHODS: The purpose of the study was to investigate the impact of a prospective policy of "oversizing" the Edwards SAPIEN bioprosthesis (Edwards Lifesciences LLC, Irvine, Calif) relative to the diameter of the aortic annulus on the rate and severity of aortic regurgitation in 28 consecutive patients initially considered eligible for transcatheter aortic valve implantation on the basis of angiography, multislice computed tomography, and transthoracic echocardiography. This policy included the systematic use of transesophageal echocardiography to exclude borderline patients and the modification of the procedure to use the larger device possible. The results were studied on an individual patient basis. RESULTS: Because 6 of 28 patients (21%) had an annulus diameter greater than 24 mm by transesophageal echocardiography, 22 patients underwent implantation of the Edwards SAPIEN prosthesis. In 6 of 22 patients, the procedure was adapted to follow our "oversizing" policy. As a result, the "prosthesis/annulus cover index" was 12.4% ± 4.3%. The procedure was successful in 21 of 22 patients (95%), and 18 patients were available for echocardiography at 1 month. Although a moderate to severe aortic regurgitation was observed pretreatment in 4 of 18 patients (22%), it was no longer the case at 1 month (0/18, 0%; P = .03). The improvement was secondary to a disappearance of the aortic regurgitation in all 7 patients with a significant aortic regurgitation at pretreatment, whereas the new aortic regurgitations appearing in 5 of the 11 patients with no aortic regurgitation at pretreatment were only mild aortic regurgitations. CONCLUSIONS: In patients with a successful implantation of an Edwards SAPIEN valve, a simple "oversizing" policy based on a systematic use of transesophageal echocardiography and modification of the procedure may prevent the occurrence of moderate and severe aortic regurgitations.

First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions.

AIMS: To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this. METHODS AND RESULTS: In 15 patients (mean age 79 years) with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve implantation, the SMT Embolic Deflection Device was advanced utilising the contralateral femoral artery access using a 9 Fr delivery sheath. Once deployed in the aortic arch, a porous membrane shields the supraaortic-cerebral trunks by deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. A 6 Fr pigtail catheter can be used through the same sheath throughout the whole procedure. Brain diffusion weighted (DW)-MRI was obtained in 10 patients before and at 4 days after (± 2 days) the procedure and retrospectively compared to 20 patients previously undergoing TAVI without a protection device. Successful placement of the embolic protection device was achieved in all patients. Additional procedural time due to the use of the device was 7 min (± 2 min). There were no procedural complications. No patient developed new neurological symptoms or clinical findings of stroke except one patient who suffered from a transient ischaemic attack (TIA) two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in the group without SMT filter. CONCLUSIONS: In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI.