Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey.

BACKGROUND: Valvular heart disease (VHD) is an important cause of mortality and morbidity and has been subject to important changes in management. The VHD II survey was designed by the EURObservational Research Programme of the European Society of Cardiology to analyze actual management of VHD and to compare practice with guidelines. METHODS: Patients with severe native VHD or previous valvular intervention were enrolled prospectively across 28 countries over a 3-month period in 2017. Indications for intervention were considered concordant if the intervention was performed or scheduled in symptomatic patients, corresponding to Class I recommendations specified in the 2012 European Society of Cardiology and in the 2014 American Heart Association/American College of Cardiology VHD guidelines. RESULTS: A total of 7247 patients (4483 hospitalized, 2764 outpatients) were included in 222 centers. Median age was 71 years (interquartile range, 62-80 years); 1917 patients (26.5%) were ≥80 years; and 3416 were female (47.1%). Severe native VHD was present in 5219 patients (72.0%): aortic stenosis in 2152 (41.2% of native VHD), aortic regurgitation in 279 (5.3%), mitral stenosis in 234 (4.5%), mitral regurgitation in 1114 (21.3%; primary in 746 and secondary in 368), multiple left-sided VHD in 1297 (24.9%), and right-sided VHD in 143 (2.7%). Two thousand twenty-eight patients (28.0%) had undergone previous valvular intervention. Intervention was performed in 37.0% and scheduled in 26.8% of patients with native VHD. The decision for intervention was concordant with Class I recommendations in symptomatic patients with severe single left-sided native VHD in 79.4% (95% CI, 77.1-81.6) for aortic stenosis, 77.6% (95% CI, 69.9-84.0) for aortic regurgitation, 68.5% (95% CI, 60.8-75.4) for mitral stenosis, and 71.0% (95% CI, 66.4-75.3) for primary mitral regurgitation. Valvular interventions were performed in 2150 patients during the survey; of them, 47.8% of patients with single left-sided native VHD were in New York Heart Association class III or IV. Transcatheter procedures were performed in 38.7% of patients with aortic stenosis and 16.7% of those with mitral regurgitation. CONCLUSIONS: Despite good concordance between Class I recommendations and practice in patients with aortic VHD, the suboptimal number in mitral VHD and late referral for valvular interventions suggest the need to improve further guideline implementation.

The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: insights from the first-in-man ABSORB Cohort B and SPIRIT II trials.

AIMS: To assess serially the edge vascular response (EVR) of a bioresorbable vascular scaffold (BVS) compared to a metallic everolimus-eluting stent (EES). METHODS AND RESULTS: Non-serial evaluations of the Absorb BVS at one year have previously demonstrated proximal edge constrictive remodelling and distal edge changes in plaque composition with increase of the percent fibro-fatty (FF) tissue component. The 5 mm proximal and distal segments adjacent to the implanted devices were investigated serially with intravascular ultrasound (IVUS), post procedure, at six months and at two years, from the ABSORB Cohort B1 (n=45) and the SPIRIT II (n=113) trials. Twenty-two proximal and twenty-four distal edge segments were available for analysis in the ABSORB Cohort B1 trial. In the SPIRIT II trial, thirty-three proximal and forty-six distal edge segments were analysed. At the 5-mm proximal edge, the vessels treated with an Absorb BVS from post procedure to two years demonstrated a lumen loss (LL) of 6.68% (-17.33; 2.08) (p=0.027) with a trend toward plaque area increase of 7.55% (-4.68; 27.11) (p=0.06). At the 5-mm distal edge no major changes were evident at either time point. At the 5-mm proximal edge the vessels treated with a XIENCE V EES from post procedure to two years did not show any signs of LL, only plaque area decrease of 6.90% (-17.86; 4.23) (p=0.035). At the distal edge no major changes were evident with regard to either lumen area or vessel remodelling at the same time point. CONCLUSIONS: The IVUS-based serial evaluation of the EVR up to two years following implantation of a bioresorbable everolimus-eluting scaffold shows a statistically significant proximal edge LL; however, this finding did not seem to have any clinical implications in the serial assessment. The upcoming imaging follow-up of the Absorb BVS at three years is anticipated to provide further information regarding the vessel wall behaviour at the edges.

Vascular response of the segments adjacent to the proximal and distal edges of the ABSORB everolimus-eluting bioresorbable vascular scaffold: 6-month and 1-year follow-up assessment: a virtual histology intravascular ultrasound study from the first-in-man ABSORB cohort B trial.

OBJECTIVES: This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS). BACKGROUND: The edge vascular response after implantation of the BVS has not been previously investigated. METHODS: The ABSORB Cohort B trial enrolled 101 patients and was divided into B(1) (n = 45) and B(2) (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B(1)) or 1 year (B(2)) with virtual histology intravascular ultrasound (VH-IVUS) imaging. RESULTS: At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: -1.80% [-3.18; 1.30], p < 0.05), with a tendency to regress at 1 year (Δ vessel cross-sectional area: -1.53% [-7.74; 2.48], p = 0.06). The relative change of the fibrotic and fibrofatty (FF) tissue areas at this segment were not statistically significant at either time point. At the 5-mm distal edge, a significant increase in the FF tissue of 43.32% [-19.90; 244.28], (p < 0.05) 1-year post-implantation was evident. The changes in dense calcium need to be interpreted with caution since the polymeric struts are detected as "pseudo" dense calcium structures with the VH-IVUS imaging modality. CONCLUSIONS: The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.

Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: an ABSORB cohort B trial sub-study.

AIMS: Bioresorbable vascular scaffolds (BVS) present different mechanical properties as compared to metallic platform stents. Therefore, the standard procedural technique to achieve appropriate deployment may differ. METHODS AND RESULTS: Fifty-two lesions treated with a 3 x 18 mm BVS were imaged with optical coherence tomography (OCT) post-implantation and screened for parameters suggesting non-optimal deployment. These included minimal scaffold area (minSA)<5 mm², residual area stenosis (RAS)>20%, edge dissections, incomplete scaffold/strut apposition (ISA)>5% and scaffold pattern irregularities. The angiographic proximal and distal maximal lumen diameters (DMAX) were measured by quantitative coronary angiography. Based on the DMAX values, the population was divided into three groups: DMAX <2.5 mm (n=13), DMAX between 2.5-3.3 mm (n=30) and DMAX >3.3 mm (n=9). All three groups presented with similar pre-implantation angiographic characteristics except for the vessel size and were treated with similar balloon/artery ratios. The group with a DMAX <2.5 mm presented with a higher percentage of lesions with minSA <5 mm² (30.8% vs. 10.0% vs. 0%; p=0.08) and edge dissections (61.5% vs. 33.3% vs. 11.1%; p=0.05). Lesions with >5% of ISA were significantly higher in the group with DMAX >3.3 mm (7.7% vs. 36.7% vs. 66.7%; p=0.02). RAS >20% was similar between all groups (46.2 vs. 53.3 vs. 77.8%; p=0.47) and scaffold pattern irregularities were only documented in three cases. CONCLUSIONS: BVS implantation guided with quantitative angiography may improve the OCT findings of optimal deployment. The clinical significance of these angiographic and OCT findings warranted long term follow-up of larger cohort of patients.

Risk of target lesion failure in relationship to vessel angiographic geometry and stent conformability using the second generation of drug-eluting stents.

BACKGROUND: Vessel angulation and large changes in vessel geometry after stent implantation have been associated with an increased risk of target lesion failure (TLF) using bare-metal stents. Second-generation drug-eluting stents (DES)offer superior conformability and inhibition of neointima. The aim of the study is to investigate the relationship between pre and post-implant vessel geometry and the occurrence of TLF at 1 year after treatment with second-generation DES; and to compare the conformability of Resolute and Xience stents. METHODS: The RESOLUTE All-Comers trial randomized 2292 patients (3366 lesions) to Resolute zotarolimus-DES (Medtronic CardioVascular) or Xience everolimus-DES (Abbott Vascular). At 1 year, 176 lesions (121 patients)presented with TLF; a composite of cardiac death, acute myocardial infarction (AMI) and target lesion revascularization (TLR). Lesions with TLF were matched with 176 lesions (168 patients) without TLF adjusting for clinical and procedural characteristics. The number of bends, vessel curvature and angulation were assessed with quantitative coronary angiography pre and post-implantation. The absolute difference post minus pre-implantation was used as a surrogate of stent conformability. RESULTS: At pre-implantation, lesions without and with TLF had similar numbers of bends/lesion (1.81 vs 1.74; P = .35), vessel curvature (0.295 cm(-1) vs 0.363 cm(-1); P = .13) and vessel angulation (46.3° vs 43.5°; P = .80), respectively. Lesions without and with TLR also had similar numbers of bends/lesion (1.39 vs 1.39; P = .83), vessel curvature (0.368 cm(-1) vs 0.325 cm(-1); P = .33) and angulation (40.2° vs 37.2°; P = .19). Lesions without and with in-hospital AMI also presented with similar number of bends/lesion (1.69 vs 1.81; P = .48), vessel curvature (0.349 cm(-1) vs 0.345 cm(-1); P = .91) and vessel angulation (43.53° vs 48.45°; P = .38). The absolute difference post- - pre-implantation was similar in lesions without and with TLF, TLR and In-hospital AMI. The absolute difference post- - pre-implantation was similar with both Resolute and Xience in vessel curvature (-0.046 cm(-1) vs -0.047 cm(-1); P = .66) and was smaller in number of bends/lesion (-0.08 vs -0.16; P = .13) and in vessel angulation (-6.0° vs -10.1°; P = .03) with the Resolute. CONCLUSIONS: Bended, curved, and angulated lesions and changes in the number of bends/lesion, vessel curvature, and angulation from pre to post-implantation have no relation with TLF and TLR at 1 year and have no relation with In-hospital AMI using second-generation of DES. Resolute appears to be more conformable than Xience.

A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents.

OBJECTIVES: The aim of this study was to assess the differences in terms of curvature and angulation of the treated vessel after the deployment of either a metallic stent or a polymeric scaffold device. BACKGROUND: Conformability of metallic platform stents (MPS) is the major determinant of geometric changes in coronary arteries caused by the stent deployment. It is not known how bioresorbable polymeric devices perform in this setting. METHODS: This retrospective study compares 102 patients who received an MPS (Multi-link Vision or Xience V, Abbott Vascular, Santa Clara, California) in the SPIRIT FIRST and II trials with 89 patients treated with the Revision 1.1 everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) from cohort B of the ABSORB (A bioabsorbable everolimus-eluting coronary stent system) trial. All patients were treated with a single 3 × 18 mm device. Curvature and angulation were measured with dedicated software by angiography. RESULTS: Both the MPS and BVS groups had significant changes in relative region curvature (MPS vs. BVS: 28.7% vs. 7.5%) and angulation (MPS vs. BVS: 25.4% vs. 13.4%) after deployment. The unadjusted comparisons between the 2 groups showed for BVS a nonsignificant trend for less change in region curvature after deployment (MPS vs. BVS: 0.085 cm(-1) vs. 0.056 cm(-1), p = 0.06) and a significantly lower modification of angulation (MPS vs. BVS 6.4° vs. 4.3°, p = 0.03). By multivariate regression analysis, the independent predictors of changes in curvature and angulation were the pre-treatment region curvature, the pre-treatment region angulation, and the used device. CONCLUSIONS: Bioresorbable vascular scaffolds have better conformability than conventional MPS. The clinical significance of the observed differences will require further investigation.

3-Dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds: a proposal for classification.

OBJECTIVES: The purpose of this study is to assess jailing of side branches (SB) by the everolimus-eluting, bioresorbable vascular scaffold (BVS) with 3-dimensional (3D) optical coherence tomography (OCT) reconstruction. BACKGROUND: Because BVS struts at the SB orifice are suspected of being bioresorbed and/or forming a neointimal bridge, OCT has been used to evaluate the struts in detail at that particular site. Our understanding of the 3D relationship of the strut and the SB orifice is limited by the use of 2-dimensional OCT images. Fourier-domain OCT enables reliable 3D reconstruction of coronary vessels. METHODS: The ABSORB Cohort B (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trial is a multicenter single-arm trial to assess the safety and performance of the BVS. Fourier-domain OCT pullbacks (C7-XR system, LightLab Imaging Inc., Westford, Massachusetts) are obtained at pullback speed of 20 mm/s and 3D renderings are performed. The orifices of the SB are assessed visually. The area of SB orifice and the number of strut-free compartments delineated by the BVS struts are evaluated. RESULTS: Fifty-one OCT pullbacks were acquired: 33 pullbacks were imaged with Fourier-domain OCT and 27 treated segments had 46 side branches. Three-dimensional assessment was feasible in 87% (40 of 46) of pullbacks. The mean area of the SB orifice was 1.16 +/- 1.02 mm(2). The mean number of strut-free compartments was 2.0 +/- 1.1. The classification of the overhanging struts is proposed. CONCLUSIONS: This study demonstrates that 3D OCT reconstruction is feasible to evaluate the orifices of SB jailed with BVS. (ABSORB Clinical Investigation, Cohort B; NCT00856856).

Risk of acute kidney injury in patients with severe aortic valve stenosis undergoing transcatheter valve replacement.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for high-risk and inoperable patients with severe aortic stenosis is an emerging procedure in cardiovascular medicine. Little is known of the impact of TAVI on renal function. METHODS: We analysed retrospectively renal baseline characteristics and outcome in 58 patients including 2 patients on chronic haemodialysis undergoing TAVI at our institution. Acute kidney injury (AKI) was defined according to the RIFLE classification. RESULTS: Fifty-eight patients with severe symptomatic aortic stenosis not considered suitable for conventional surgical valve replacement with a mean age of 83 +/- 5 years underwent TAVI. Two patients died during transfemoral valve implantation and two patients in the first month after TAVI resulting in a 30-day mortality of 6.9%. Vascular access was transfemoral in 46 patients and transapical in 12. Estimated glomerular filtration rate (eGFR) increased in 30 patients (56%). Fifteen patients (28%) developed AKI, of which four patients had to be dialyzed temporarily and one remained on chronic renal replacement therapy. Risk factors for AKI comprised, among others, transapical access, number of blood transfusions, postinterventional thrombocytopaenia and severe inflammatory response syndrome (SIRS). CONCLUSIONS: TAVI is feasible in patients with a high burden of comorbidities and in patients with pre-existing end-stage renal disease who would be otherwise not considered as candidates for conventional aortic valve replacement. Although GFR improved in more than half of the patients, this benefit was associated with a risk of postinterventional AKI. Future investigations should define preventive measures of peri-procedural kidney injury.

Pitfalls and key lessons with the symmetry proximal anastomotic device in coronary artery bypass surgery.

BACKGROUND: Increasing practice of less-invasive coronary artery bypass surgery has generated a revival of automated methods to facilitate the creation of vascular connections during coronary artery bypass grafting procedures. METHODS: We have reviewed our clinical experience with 107 patients who received at least one proximal Symmetry aortic connector from St. Jude Medical Anastomotic Technology Group (St. Paul, MN) to connect a saphenous vein graft to the ascending aorta, in whom the minimal follow-up is 6 months. Seventy-five patients were part of an observational study, and 32 patients were enrolled in a prospective randomized study to compare the anastomotic device with the conventional suture technique. Key lessons and pitfalls observed during loading and deployment as well angiographic findings are presented. RESULTS: Hospital mortality was 0.9% (1/107); a 76-year-old woman suffered from cerebral complications and died after combined coronary artery bypass grafting and aortic valve replacement. Two connectors had to be removed because of leakage and one because of incomplete deployment. The residual 104 grafts connected to the ascending aorta were patent at the end of the operation (mean flow, 72 +/- 29 mL/min). Fourteen patients from the prospective study have received 6 months of angiographic assessment so far. Forty-two grafts have been evaluated: all IMA grafts (n = 14) are patent. Four radial artery grafts have been studied: three are patent and one is occluded. Twenty-four vein grafts have been assessed: 11 were hand-sewn and 13 were connected to the aorta with the proximal connector system. Patency rate is not different between the two techniques, but there is an incidence of 38% (5/13) stenosis in the proximal vein graft segment in those patients with a proximal connector. No proximal hand-sewn anastomosis shows any significant stenosis. CONCLUSIONS: The use of proximal devices allows ultrafast connection of a bypass graft to the aorta. The handling of this device is simple, manipulations on the ascending aorta are minimized, and hemostasis is perfect. However, because stenoses have been observed in the vein graft close to the connector site, mid- and long-term patency rates have to be assessed in large prospective trials.