Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive ...dysfunction.
The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients.
Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data.
Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat ITT population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval CI: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm
. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion.
The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).
Abstract Objectives This study sought to evaluate the proportion of patients with intermediate coronary stenosis diagnosed on computed tomography angiography (CTA), which may be saved from any ...further testing due to use of CTA-based fractional flow reserve (FFR). Background Coronary CTA often results in diagnosis of intermediate stenosis, triggering further physiological testing. CTA-based FFR (CTA-FFR) is a promising diagnostic tool, which may obviate the need for further testing. However, the specific thresholds for CTA-FFR values predicting ischemic versus nonischemic FFR with acceptable confidence are unknown, obscuring clinical utility of the diagnostic strategy using CTA-FFR. Methods We analyzed 96 lesions (mean CTA stenosis: 69.7 ± 11.7%) in 90 patients (63.4 ± 8.2 years, 32% were men) who underwent CTA for suspected CAD and were diagnosed with at least 1 intermediate coronary stenosis (50% to 90%) scheduled for further physiological testing. All patients underwent routine invasive FFR and CTA-FFR evaluation. The objective was to determine the proportion of patients falling between the lower and upper CTA-FFR thresholds that predict ischemic and nonischemic stenosis, respectively (on the basis of an invasive FFR cutpoint of ≤0.80), with ≥90% accuracy. Results The invasive FFR ≤0.8 was observed in 41 of 96 lesions (42.7%). According to Bland-Altman analysis, the CTA-FFR underestimated FFR by 0.01 and the 95% limits of agreement were ±0.19. Receiver-operating characteristic area under the curve was significantly higher for CTA-FFR than that for CTA (per lesion 0.835 vs. 0.660, respectively; p = 0.007). The CTA-FFR thresholds for which the positive and negative predictive values were each ≥90% (corresponding to an FFR of ≤0.80) were >0.87 or <0.74, respectively, encompassing 49 lesions (51%) and 45 of 90 patients. Conclusions In around one-half of the patients diagnosed with intermediate stenosis, coronary CTA-based FFR may confidently discriminate between ischemic versus nonischemic stenoses. Our findings require validation in an independent cohort.
Although coronary computed tomographic angiography has the ability to depict potentially malignant features of anomalous coronary artery originating from the opposite sinus of Valsalva (ACAOS), there ...are limited data on the significance of ACAOS in the computed tomography population. The aims of this study were to assess the prevalence of ACAOS and to correlate its anatomic features with patients' symptoms among 8,522 consecutive subjects who underwent coronary computed tomographic angiography from February 2008 to May 2012. The ACAOS proximal course was classified into anterior, interarterial, septal, and retroaortic subtypes. Malignant ACAOS was recorded if a slitlike ostium, an acute angle of takeoff, an intramural course, and significant compression between the aorta and pulmonary trunk were present simultaneously. The prevalence of ACAOS was 0.84% (72 of 8,522), including right-sided origins of the left main coronary artery (n = 11), left anterior descending coronary artery (n = 9), and left circumflex coronary artery (n = 33) and left-sided origin of the right coronary artery (n = 20). Of the 24 ACAOS (0.28%) with an interarterial course, 12 (0.14%) showed significant vessel compression, of which 6 (0.07%) were classified as malignant. The presence of significant interarterial compression and malignant ACAOS type were observed in left-sided right coronary arteries only, and interarterial compression correlated with patients' symptoms at a median of 15-month follow-up. In conclusion, the computed tomographic prevalence of ACAOS seems to be comparable with that of previous angiographic studies. The malignant features of ACAOS in the adult computed tomography population might be exclusively associated with left-sided right coronary arteries.
Summary Background Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical ...arterial properties and reduce blood pressure in patients with uncontrolled hypertension. Methods We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov , number NCT01642498. Findings 83 (43%) of 195 patients screened were assigned arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the arteriovenous coupler group (p<0·0001) and by 3·7 (21·2) mm Hg in the control group (p=0·31). Mean systolic 24 h ambulatory blood pressure reduced by 13·5 (18·8) mm Hg (p<0·0001) in arteriovenous coupler recipients and by 0·5 (15·8) mm Hg (p=0·86) in controls. Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 (29%) of 42 patients and was treatable with venoplasty or stenting. Interpretation Arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension. Funding ROX Medical.
Background We aimed to compare statin monotherapy and upfront combination therapy of statin and ezetimibe in patients with acute coronary syndromes (ACSs). Methods and Results The study included ...consecutive patients with ACS included in the PL‐ACS (Polish Registry of Acute Coronary Syndromes), which is a national, multicenter, ongoing, prospective observational registry that is mandatory for patients with ACS hospitalized in Poland. Data were matched using the Mahalanobis distance within propensity score matching calipers. Multivariable stepwise logistic regression analysis, including all variables, was next used in propensity score matching analysis. Finally, 38 023 consecutive patients with ACS who were discharged alive were included in the analysis. After propensity score matching, 2 groups were analyzed: statin monotherapy (atorvastatin or rosuvastatin; n=768) and upfront combination therapy of statin and ezetimibe (n=768 patients). The difference in mortality between groups was significant during the follow‐up and was present at 1 (5.9% versus 3.5%; P =0.041), 2 (7.8% versus 4.3%; P =0.019), and 3 (10.2% versus 5.5%; P =0.024) years of follow‐up in favor of the upfront combination therapy, as well as for the overall period. For the treatment, rosuvastatin significantly improved prognosis compared with atorvastatin (odds ratio OR, 0.790 95% CI, 0.732–0.853). Upfront combination therapy was associated with a significant reduction of all‐cause mortality in comparison with statin monotherapy (OR, 0.526 95% CI, 0.378–0.733), with absolute risk reduction of 4.7% after 3 years (number needed to treat=21). Conclusions The upfront combination lipid‐lowering therapy is superior to statin monotherapy for all‐cause mortality in patients with ACS. These results suggest that in high‐risk patients, such an approach, rather than a stepwise therapy approach, should be recommended.
Objectives This study sought to evaluate which specific calcium characteristics impact diagnostic accuracy of coronary computed tomography angiography (CTA). Background Coronary calcifications ...comprise one of the most significant factors interfering with diagnostic accuracy of coronary CTA. Despite this fact, there is paucity of data regarding this phenomenon. Methods A total of 525 coronary lesions (252 calcified and 273 reference noncalcified lesions) within 97 arteries of 60 patients (19 women, age 63 ± 10 years) underwent assessment with both 2 × 64-slice computed tomography and intravascular ultrasound (IVUS). Nineteen calcium characteristics were determined. The main outcome was coronary CTA inaccuracy defined as the deviation of minimum lumen area within the calcification measured with coronary CTA from that measured with IVUS, in both absolute (mm2 ) and relative (%) terms. Results Presence of calcification was found to be independently correlated to coronary CTA inaccuracy in both absolute and relative terms (p < 0.001 for both). The relative (%) inaccuracy of coronary CTA was independently correlated to total calcium length (p = 0.004), total calcium volume (p = 0.008), cross section calcium thickness (p = 0.023), cross section calcium area (p = 0.023), and cross section lumen area (p = 0.001). The absolute inaccuracy of CTA was correlated to calcium length (p = 0.010), calcium volume (p = 0.017), and cross section calcium area (p < 0.001). The presence of both total calcium arc ≥47° and mean lumen diameter of ≤2.8 mm provided the best predictive accuracy for detection of excessive lumen underestimation by CTA. The best accuracy for prediction of excessive lumen overestimation provided combination of 2 of 3 features: maximum calcium density <869 HU, OR whole calcium length <2.4 mm, OR total calcium volume <6.4 mm3. Conclusions Our results indicate which specific calcium characteristics impact accuracy of coronary CTA in lumen assessment within calcified lesions. This may provide practical assistance in predicting coronary lumen underestimation or overestimation by coronary CTA, therefore mitigating risk of diagnostic errors in clinical practice.
Desde a primeira descrição da tetralogia de Fallot (ToF) em 1671 por Niels Stensen e em 1888 por Étienne-Louis Arthur Fallot, vários trabalhos relataram essa anomalia juntamente com suas variantes e ...anomalias cardiovasculares concomitantes. A artéria subclávia direita aberrante (ASDA) é a anomalia do arco aórtico mais comum. Diferentemente da artéria subclávia esquerda aberrante, a ocorrência de ASDA em pacientes com ToF só foi relatada casuisticamente. Apresentamos dois pacientes de ToF com ASDA. É importante notar que o conhecimento da coexistência das duas anomalias tem pontos muito práticos durante correções endovasculares ou cirúrgicas de defeitos cardíacos congênitos (inclusive ToF).
Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for ...reduction in IS in anterior STEMI.
We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest.
Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001).
There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group.
The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.
The aim of the study was to evaluate the transcatheter aortic valve replacement (TAVR) in high-risk patients with severe bicuspid aortic valve (BAV) stenosis and to compare the outcomes with a ...matched group of patients with tricuspid aortic valve. TAVR became an alternative treatment method in high-risk patients with symptomatic aortic stenosis; however, BAV stenosis is regarded as a relative contraindication to TAVR. The study population comprised 28 patients with BAV who underwent TAVR. BAV was diagnosed based on a transesophageal echocardiography. CoreValve and Edwards SAPIEN prostheses were implanted. The control group consisted of 84 patients (3:1 matching) with significant tricuspid aortic valve stenosis treated with TAVR. There were no significant differences between patients with and without BAV in device success (93% vs 93%, p = 1.0), risk of annulus rupture (0% in both groups), or conversion to cardiosurgery (4% vs 0%, respectively, p = 0.25). The postprocedural mean pressure gradient (11.5 ± 6.4 vs 10.4 ± 4.5 mm Hg, p = 0.33), aortic regurgitation grade ≥2 of 4 (32% vs 23%, p = 0.45), 30-day mortality (4% vs 7%, p = 0.68), and 1-year all-cause mortality (19% vs 18%, p = 1.00) did not differ between the groups. Echocardiography showed well-functioning valve prosthesis with a mean prosthetic valve area of 1.6 ± 0.4 cm2 versus 1.7 ± 0.3 cm2 (p = 0.73), a mean pressure gradient of 10.3 ± 5.4 versus 9.8 ± 2.8 mm Hg (p = 0.64), and aortic regurgitation grade ≥2 of 4 (22% vs 22%, p = 1.00) for the 2 groups. In conclusion, selected high-risk patients with BAV can be successfully treated with TAVR, and their outcomes are similar to those reported in patients without BAV.
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