In a randomized trial, 1845 patients undergoing PCI were assigned to receive either everolimus-eluting bioresorbable vascular scaffolds or everolimus-eluting metallic stents. The incidence of device ...thrombosis was higher with the bioresorbable scaffold than with the metallic stent.
Drug-eluting stents are the standard of care in percutaneous coronary intervention (PCI).
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Nevertheless, their rigid metallic cages hamper vasomotion, and they are associated with the development of neoatherosclerosis, which results in an ongoing risk of stent thrombosis (rate of 0.1 to 0.2% per year) and repeat revascularization (rate of 2 to 3% per year).
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Bioresorbable vascular scaffolds theoretically leave no permanent implant and allow for restoration of vessel function.
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The ABSORB III trial showed the noninferiority of the bioresorbable vascular scaffold (Absorb, Abbott Vascular) to the cobalt–chromium everolimus-eluting metallic stent (Xience, Abbott Vascular) with respect to target-lesion failure . . .
Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve ...hemodynamic conditions.
The aim of this study was to determine whether a new percutaneous mechanical circulatory support (pMCS) device (Impella CP, Abiomed, Danvers, Massachusetts) decreases 30-day mortality when compared with an intra-aortic balloon pump (IABP) in patients with severe shock complicating AMI.
In a randomized, prospective, open-label, multicenter trial, 48 patients with severe CS complicating AMI were assigned to pMCS (n = 24) or IABP (n = 24). Severe CS was defined as systolic blood pressure <90 mm Hg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality.
At 30 days, mortality in patients treated with either IABP or pMCS was similar (50% and 46%, respectively; hazard ratio with pMCS: 0.96; 95% confidence interval: 0.42 to 2.18; p = 0.92). At 6 months, mortality rates for both pMCS and IABP were 50% (hazard ratio: 1.04; 95% confidence interval: 0.47 to 2.32; p = 0.923).
In this explorative randomized controlled trial involving mechanically ventilated patients with CS after AMI, routine treatment with pMCS was not associated with reduced 30-day mortality compared with IABP. (IMPRESS in Severe Shock; NTR3450)
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Objectives The aim of the present analysis was to compare 1-year mortality prediction of Bleeding Academic Research Consortium (BARC)-defined bleeding complications with existing bleeding definitions ...in patients with ST-segment elevation myocardial infarction (STEMI) and to investigate the prognostic value of the individual data elements of the bleeding classifications for 1-year mortality. Background BARC recently proposed a novel standardized bleeding definition. Methods The in-hospital occurrence of bleeding defined according to the BARC, TIMI (Thrombolysis In Myocardial Infarction), GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries), and ISTH (International Society on Thrombosis and Haemostasis) bleeding classifications was assessed in 2,002 STEMI patients undergoing primary percutaneous coronary intervention between January 1, 2003, and July 31, 2008. Results BARC types 2, 3, 4, and 5 bleeding occurred in 4.4%, 14.2%, 1.4%, and 0.3% of patients, respectively. By multivariable analysis, GUSTO- and ISTH-defined bleeding was not significantly associated with 1-year mortality, whereas TIMI major and BARC type 3b or 3c bleeding conferred a 2-fold higher risk of 1-year mortality (hazard ratios HRs: 2.00 95% confidence interval (CI): 1.32 to 3.01 and 1.84 95% CI: 1.23 to 2.77, respectively). Data elements most strongly associated with mortality were a hemoglobin decrease ≥5 g/dl (HR: 1.94 95% CI: 1.26 to 2.98), the use of vasoactive agents for bleeding (HR: 2.01 95% CI: 0.91 to 4.44), cardiac tamponade (HR: 2.38 95% CI: 0.56 to 10.1), and intracranial hemorrhage (HRs for 1-year mortality were not computable because there was only 1 patient with intracranial bleeding). Conclusions Both the BARC and TIMI bleeding classification identified STEMI patients at risk of 1-year mortality.
Abstract
Aims
The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. ...self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking.
Methods and results
In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% interquartile range (IQR) 4.0–13.0%. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7–1.0, P = 0.10. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5–1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3–0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6–3.3, P < 0.001).
Conclusion
In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.
Background
Transcatheter aortic valve implantation (TAVI) with the Medtronic‐CoreValve bioprosthesis (CoreValve Inc., Irvine, CA, USA) is associated with a high incidence of new‐onset left bundle ...branch block (LBBB) and cardiac conduction disorders (CCDs) requiring permanent pacemaker (PPM) implantation. Our objective was to investigate the predictors and permanency of CCDs after TAVI and specifically to evaluate the necessity for pacing.
Methods
In this single‐center study, we included patients who underwent TAVI with the Medtronic‐CoreValve bioprosthesis. Electrocardiographic evaluation was performed pre‐ and post‐TAVI and at follow‐up. Pacemaker follow‐up data were obtained and analyzed.
Results
We included 121 patients (age 81 ± 8 years). LBBB developed in 47 patients, for which prosthesis size (26 mm; odds ratio OR: 4.1, 95% confidence interval CI: 1.32–12.34, P = 0.01) and prosthesis depth (OR: 1.3, 95% CI: 1.09–1.57, P = 0.004) were independent predictors. In 19%, this new‐onset LBBB was temporary. Requirement for a PPM occurred in 23 patients, for which mitral annular calcification (MAC; OR: 1.3, 95% CI: 1.05–1.56, P = 0.02) and preexisting right bundle branch block (RBBB; OR: 8.5, 95%CI: 1.61–44.91, P = 0.01) were independent predictors. At follow‐up, 52% of the patients were continuously paced, but 22% of the patients had adequate atrioventricular conduction without the necessity for pacing. In the other 26% of the patients there was intermittent pacing.
Conclusion
There is a high incidence of new‐onset LBBB and PPM implantation following TAVI with a Medtronic‐CoreValve bioprosthesis. Prosthesis depth and size were predictors for new LBBB, while MAC and preexistent RBBB were predictors for PPM implantation. In approximately one fifth of the patients, new‐onset LBBB and the necessity for pacing are only temporary.
Transcatheter aortic valve implantation (TAVI) is a novel therapy for treatment of severe aortic stenosis. Although 30% to 50% of patients develop new left bundle-branch block (LBBB), its effect on ...clinical outcome is unclear.
Data were collected in a multicenter registry encompassing TAVI patients from 2005 until 2010. The all-cause mortality rate at follow-up was compared between patients who did and did not develop new LBBB. Of 679 patients analyzed, 387 (57.0%) underwent TAVI with the Medtronic CoreValve System and 292 (43.0%) with the Edwards SAPIEN valve. A total of 233 patients (34.3%) developed new LBBB. Median follow-up was 449.5 (interquartile range, 174-834) days in patients with and 450 (interquartile range, 253-725) days in patients without LBBB (P=0.90). All-cause mortality was 37.8% (n=88) in patients with LBBB and 24.0% (n=107) in patients without LBBB (P=0.002). By multivariate regression analysis, independent predictors of all-cause mortality were TAVI-induced LBBB (hazard ratio HR, 1.54; confidence interval CI, 1.12-2.10), chronic obstructive lung disease (HR, 1.56; CI, 1.15-2.10), female sex (HR, 1.39; CI, 1.04-1.85), left ventricular ejection fraction ≤50% (HR, 1.38; CI, 1.02-1.86), and baseline creatinine (HR, 1.32; CI, 1.19-1.43). LBBB was more frequent after implantation of the Medtronic CoreValve System than after Edwards SAPIEN implantation (51.1% and 12.0%, respectively; P<0.001), but device type did not influence the mortality risk of TAVI-induced LBBB.
All-cause mortality after TAVI is higher in patients who develop LBBB than in patients who do not. TAVI-induced LBBB is an independent predictor of mortality.
Background As younger patients are being considered for transcatheter aortic valve implantation (TAVI), the assessment and treatment of concomitant coronary artery disease is taking on increased ...importance. Methods and Results Thirteen contemporary lower-risk patients with TAVI with severe aortic stenosis (AS) and moderate-severe coronary lesions were included. Patients underwent assessment of coronary hemodynamics in the presence of severe AS (pre-TAVI), in the absence of severe AS (immediately post-TAVI), and at longer-term follow-up (6 months post-TAVI). Fractional flow reserve decreased from 0.85 (0.76-0.88) pre-TAVI to 0.79 (0.74-0.83) post-TAVI, and then to 0.71 (0.65-0.77) at 6-month follow-up (
<0.001 for all comparisons). Conversely, instantaneous wave-free ratio was not significantly different: 0.82 (0.80-0.90) pre-TAVI, 0.83 (0.77-0.88) post-TAVI, and 0.83 (0.73-0.89) at 6 months (
=0.735). These changes are explained by the underlying coronary flow. Hyperemic whole-cycle coronary flow (fractional flow reserve flow) increased from 26.36 cm/s (23.82-31.82 cm/s) pre-TAVI to 30.78 cm/s (29.70-34.68 cm/s) post-TAVI (
=0.012), to 40.20 cm/s (32.14-50.00 cm/s) at 6-month follow-up (
<0.001 for both comparisons). Resting flow during the wave-free period of diastole was not significantly different: 25.48 cm/s (21.12-33.65 cm/s) pre-TAVI, 24.54 cm/s (20.74-27.88 cm/s) post-TAVI, and 25.89 cm/s (22.57-28.96 cm/s) at 6 months (
=0.500). Conclusions TAVI acutely improves whole-cycle hyperemic coronary flow, with ongoing sustained improvements at longer-term follow-up. This enhanced response to hyperemic stimuli appears to make fractional flow reserve assessment less suitable for patients with severe AS. Conversely, resting diastolic flow is not significantly influenced by the presence of severe AS. Resting indices of coronary stenosis severity, therefore, appear to be more appropriate for this patient population, although large-scale prospective randomized trials will be required to determine the role of coronary physiology in patients with severe AS.
Background The Absorb everolimus-eluting bioresorbable vascular scaffold (AbsorbBVS) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents, providing ...temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease. Methods The objective of the AIDA trial is to evaluate the efficacy and performance in an contemporary all-comer population of the AbsorbBVS strategy vs the XIENCE family everolimus-eluting metallic coronary stent system in the treatment of coronary lesions. The AIDA trial is a prospective, randomized (1:1), active-control, single-blinded, all-comer, noninferiority trial. A total of 2,690 subjects will be enrolled with broad inclusion and limited exclusion criteria according to the “Instructions for Use” of the AbsorbBVS strategy. The study population includes both simple and complex lesions, in patients with stable and acute coronary syndrome. The follow-up continues for 5 years. The primary end point of the trial is target vessel failure, defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization, at 2 years. This study is registered on ClinicalTrials.gov with number NCT01858077. Conclusion The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice.
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