Vertebral artery stenosis in the Basilar Artery International Cooperation Study (BASICS): prevalence and outcome

We assessed the prevalence of vertebral artery (VA) stenosis or occlusion and its influence on outcome in patients with acute basilar artery occlusion (BAO). We studied 141 patients with acute BAO enrolled in the Basilar Artery International Cooperation Study (BASICS) registry of whom baseline CT angiography (CTA) of the intracranial VAs was available. In 72 patients an additional CTA of the extracranial VAs was available. Adjusted risk ratios (aRRs) for death and poor outcome, defined as a modified Rankin Scale score ≥4, were calculated with Poisson regression in relation to VA occlusion, VA occlusion or stenosis ≥50 %, and bilateral VA occlusion. Sixty-six of 141 (47 %) patients had uni- or bilateral intracranial VA occlusion or stenosis ≥50 %. Of the 72 patients with intra- and extracranial CTA, 46 (64 %) had uni- or bilateral VA occlusion or stenosis ≥50 % and 9 (12 %) had bilateral VA occlusion. Overall, VA occlusion or stenosis ≥50 % was not associated with the risk of poor outcome. Patients with intra- and extracranial CTA and bilateral VA occlusion had a higher risk of poor outcome than patients without bilateral VA occlusion (aRR, 1.23; 95 % CI 1.02-1.50). The risk of death did not depend on the presence of unilateral or bilateral VA occlusion or stenosis ≥50 %. In conclusion, in patients with acute BAO, unilateral VA occlusion or stenosis ≥50 % is frequent, but not associated with an increased risk of poor outcome or death. Patients with BAO and bilateral VA occlusion have a slightly increased risk of poor outcome.

Effect of Pulmonary Hypertension Hemodynamic Presentation on Clinical Outcomes in Patients With Severe Symptomatic Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation: Insights From the New Proposed Pulmonary Hypertension Classification.

BACKGROUND Pulmonary hypertension (PH) frequently coexists with severe aortic stenosis, and PH severity has been shown to predict outcomes after transcatheter aortic valve implantation (TAVI). The effect of PH hemodynamic presentation on clinical outcomes after TAVI is unknown. METHODS AND RESULTS Of 606 consecutive patients undergoing TAVI, 433 (71.4%) patients with severe aortic stenosis and a preprocedural right heart catheterization were assessed. Patients were dichotomized according to whether PH was present (mean pulmonary artery pressure, ≥25 mm Hg; n=325) or not (n=108). Patients with PH were further dichotomized by left ventricular end-diastolic pressure into postcapillary (left ventricular end-diastolic pressure, >15 mm Hg; n=269) and precapillary groups (left ventricular end-diastolic pressure, ≤15 mm Hg; n=56). Finally, patients with postcapillary PH were divided into isolated (n=220) and combined (n=49) subgroups according to whether the diastolic pressure difference (diastolic pulmonary artery pressure-left ventricular end-diastolic pressure) was normal (<7 mm Hg) or elevated (≥7 mm Hg). Primary end point was mortality at 1 year. PH was present in 325 of 433 (75%) patients and was predominantly postcapillary (n=269/325; 82%). Compared with baseline, systolic pulmonary artery pressure immediately improved after TAVI in patients with postcapillary combined (57.8±14.1 versus 50.4±17.3 mm Hg; P=0.015) but not in those with precapillary (49.0±12.6 versus 51.6±14.3; P=0.36). When compared with no PH, a higher 1-year mortality rate was observed in both precapillary (hazard ratio, 2.30; 95% confidence interval, 1.02-5.22; P=0.046) and combined (hazard ratio, 3.15; 95% confidence interval, 1.43-6.93; P=0.004) but not isolated PH patients (P=0.11). After adjustment, combined PH remained a strong predictor of 1-year mortality after TAVI (hazard ratio, 3.28; P=0.005). CONCLUSIONS Invasive stratification of PH according to hemodynamic presentation predicts acute response to treatment and 1-year mortality after TAVI.

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions. METHODS AND RESULTS Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern-TAVI-Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870). CONCLUSIONS The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.

Clinical outcomes and revascularization strategies in patients with low-flow, low-gradient severe aortic valve stenosis according to the assigned treatment modality

OBJECTIVES This study compared clinical outcomes and revascularization strategies among patients presenting with low ejection fraction, low-gradient (LEF-LG) severe aortic stenosis (AS) according to the assigned treatment modality. BACKGROUND The optimal treatment modality for patients with LEF-LG severe AS and concomitant coronary artery disease (CAD) requiring revascularization is unknown. METHODS Of 1,551 patients, 204 with LEF-LG severe AS (aortic valve area <1.0 cm(2), ejection fraction <50%, and mean gradient <40 mm Hg) were allocated to medical therapy (MT) (n = 44), surgical aortic valve replacement (SAVR) (n = 52), or transcatheter aortic valve replacement (TAVR) (n = 108). CAD complexity was assessed using the SYNTAX score (SS) in 187 of 204 patients (92%). The primary endpoint was mortality at 1 year. RESULTS LEF-LG severe AS patients undergoing SAVR were more likely to undergo complete revascularization (17 of 52, 35%) compared with TAVR (8 of 108, 8%) and MT (0 of 44, 0%) patients (p < 0.001). Compared with MT, both SAVR (adjusted hazard ratio [adj HR]: 0.16; 95% confidence interval [CI]: 0.07 to 0.38; p < 0.001) and TAVR (adj HR: 0.30; 95% CI: 0.18 to 0.52; p < 0.001) improved survival at 1 year. In TAVR and SAVR patients, CAD severity was associated with higher rates of cardiovascular death (no CAD: 12.2% vs. low SS [0 to 22], 15.3% vs. high SS [>22], 31.5%; p = 0.037) at 1 year. Compared with no CAD/complete revascularization, TAVR and SAVR patients undergoing incomplete revascularization had significantly higher 1-year cardiovascular death rates (adj HR: 2.80; 95% CI: 1.07 to 7.36; p = 0.037). CONCLUSIONS Among LEF-LG severe AS patients, SAVR and TAVR improved survival compared with MT. CAD severity was associated with worse outcomes and incomplete revascularization predicted 1-year cardiovascular mortality among TAVR and SAVR patients.

Cognitive improvement in patients with carotid stenosis is independent of treatment type

Treatment of carotid artery stenosis decreases the long-term risk of stroke and may enhance cerebral blood flow. It is therefore expected to have the potential to prevent cognitive decline or even improve cognition over the long-term. However, intervention itself can cause peri-interventional cerebral infarcts, possibly resulting in a decline of cognitive performance, at least for a short time. We investigated the long-term effects of three treatment methods on cognition and the emotional state one year after intervention. In this prospective observational cohort study, 58 patients with extracranial carotid artery stenosis (≥70%) underwent magnetic resonance imaging and assessment of cognition, mood and motor speed before carotid endarterectomy (n = 20), carotid stenting (n = 10) or best medical treatment (n = 28) (i.e., time-point 1 [TP1]), and at one-year follow-up (TP2). Gain scores, reflecting cognitive change after treatment, were built according to performance as (TP2 -TP1)/TP1. Independent of the treatment type, significant improvement in frontal lobe functions, visual memory and motor speed was found. Performance level, motor speed and mood at TP1 were negatively correlated with gain scores, with greater improvement in patients with low performance before treatment. Active therapy, whether conservative or interventional, produces significant improvement of frontal lobe functions and memory in patients with carotid artery disease, independent of treatment type. This effect was particularly pronounced in patients with low cognitive performance prior to treatment.

Changes in Left Ventricular Torsion Early Postoperatively After Aortic Valve Replacement and at Long-Term Follow-up.

OBJECTIVE In patients with aortic stenosis, left ventricular systolic torsion (pT) is increased to overcome excessive afterload. This study assessed left ventricular torsion before and immediately after surgical valve replacement and tested the instant effect of fluid loading. DESIGN Prospective, clinical single-center study. SETTING Intensive care unit of a university hospital. PARTICIPANTS 12 patients undergoing elective aortic valve replacement for aortic stenosis. INTERVENTIONS Echocardiography was performed on the day before surgery, within 18 hours after surgery including a fluid challenge, and after 2.5 years. MEASUREMENTS AND MAIN RESULTS pT decreased early postoperatively by 21.2% (23.4° ± 5.6° to 18.4° ± 6.9°; p = 0.012) and reached preoperative values at 2.5 years follow-up (24 ± 7). Peak diastolic untwisting velocity occurred later early postoperatively (13% ± 8% to 21% ± 9.4%; p = 0.019) and returned toward preoperative values at follow-up (10.2 ± 4.7°). The fluid challenge increased central venous pressure (8 ± 4 mmHg to 11 ± 4 mmHg; p = 0.003) and reduced peak systolic torsion velocity (138.7 ± 37.6/s to 121.3 ± 32/s; p = 0.032). pT decreased in 3 and increased in 8 patients after fluid loading. Patients whose pT increased had higher early mitral inflow velocity postoperatively (p = 0.04) than those with decreasing pT. Patients with reduced pT after fluid loading received more fluids (p = 0.04) and had a higher positive fluid balance during the intensive care unit stay (p = 0.03). Torsion after fluid loading correlated with total fluid input (p = 0.001) and cumulative fluid balance (p = 0.002). CONCLUSIONS pT decreased early after aortic valve replacement but remained elevated despite elimination of aortic stenosis. After 2.5 years, torsion had returned to preoperative levels.

New Self-Expanding Transcatheter Valve for Off-Pump Transatrial Mitral Valve-In-Ring Implantation.

OBJECTIVES To validate a self-expanding transcatheter valve for off-pump transatrial mitral valve-in-ring (VIR) implantation via a left thoracotomy. METHODS Mitral valve annuloplasty was performed via sternotomy during cardiopulmonary bypass on 9 pigs. After successful weaning from extracorporal circulation, the custom-made, self-expanding transcatheter VIR device was deployed under fluoroscopic guidance within the annuloplasty ring via a left thoracotomy. Hemodynamic data before and after the implantation were recorded. Mitral annulus diameter and valve area were measured by echocardiography. Transvalvular and left-ventricular outflow-tract pressure gradient were measured invasively. RESULTS Eight successful implantations were performed. Implantation failed in 1 pig because of difficulty with technical delivery of the sheath. Mean transatrial procedure time was 12.6 ± 1.7 min. Hemodynamic status during transatrial implantation was stable, and differences were not statistically significant. Mean mitral annulus diameter and mean mitral orifice area were 2.32 ± 0.2 and 3.84 ± 0.55 cm2, respectively. Mild regurgitation was detected in 7 animals and moderate regurgitation in 1. Mean gradients were 6.1 ± 5.0 mm Hg across the device. Postmortem examination confirmed adequate positioning of devices within the annuloplasty ring. CONCLUSIONS This custom-made transcatheter device allows for safe and reproducible off-pump transatrial mitral VIR implantations. Transatrial access is a promising route to facilitate VIR implantations. Our custom-made stent-valve may be suitable for VIR procedures.

Expanding Indications of Transcatheter Heart Valve Interventions.

Transcatheter aortic valve replacement (TAVR) has been established as a less invasive alternative to open-heart surgery in inoperable or high-risk patients presenting with symptomatic severe aortic valve stenosis. The feasibility and efficacy of valve-in-valve implantation in degenerated surgical aortic bioprostheses have also been described and can currently be considered a valuable treatment option in patients deemed unsuitable for repeat cardiac surgery. However, the clinical use of TAVR devices is not limited to the treatment of the tricuspid stenotic aortic valve. Several additional indications including treatment of the bicuspid stenotic aortic valve, aortic regurgitation, and valve-in-valve or valve-in-ring implantation in the mitral or tricuspid position as well as treatment of pure mitral, tricuspid, or pulmonary regurgitation have been described. The purpose of the present review is to summarize the available evidence concerning the emerging off-label use of TAVR devices in current clinical practice. Case examples have been selected to highlight the main procedural steps of each particular intervention.

Development of post-pump syndrome in a sheep after mitral valve stenting

A one-year-old healthy sheep received an implant stenting the mural ('posterior') leaflet of the mitral valve. The experiment was authorized by the Cantonal Ethical Committee. The surgery was performed on the open, beating heart during cardiopulmonary bypass (CPB). Management of anaesthesia was based on isoflurane with mechanical intermittent positive pressure ventilation (IPPV) of the lungs, combined with intercostal nerve blocks and intravenous fentanyl and lidocaine. Marked cardiovascular depression occurred towards the end of CPB time and required high doses of dopamine, dobutamine, lidocaine and ephedrine to allow for weaning off the CPB pump. Moreover, severe pulmonary dysfunction developed when IPPV was re-initiated after CPB. Hypoxaemia persisted throughout the recovery from general anaesthesia. Multiple organ failure developed gradually during the three postoperative days, leading to euthanasia of the animal. As described in this case, marked lung injury associated with some degree of failure of other vital organs may occur in sheep after CPB. Intraoperative cardiorespiratory complications when weaning-off may indicate the development of 'post-pump syndrome'.

Quantitative multi-slice computed tomography assessment of the mitral valvular complex for transcatheter mitral valve interventions part 1: systematic measurement methodology and inter-observer variability

AIMS Transcatheter mitral valve replacement (TMVR) is an emerging technology with the potential to treat patients with severe mitral regurgitation at excessive risk for surgical mitral valve surgery. Multimodal imaging of the mitral valvular complex and surrounding structures will be an important component for patient selection for TMVR. Our aim was to describe and evaluate a systematic multi-slice computed tomography (MSCT) image analysis methodology that provides measurements relevant for transcatheter mitral valve replacement. METHODS AND RESULTS A systematic step-by-step measurement methodology is described for structures of the mitral valvular complex including: the mitral valve annulus, left ventricle, left atrium, papillary muscles and left ventricular outflow tract. To evaluate reproducibility, two observers applied this methodology to a retrospective series of 49 cardiac MSCT scans in patients with heart failure and significant mitral regurgitation. For each of 25 geometrical metrics, we evaluated inter-observer difference and intra-class correlation. The inter-observer difference was below 10% and the intra-class correlation was above 0.81 for measurements of critical importance in the sizing of TMVR devices: the mitral valve annulus diameters, area, perimeter, the inter-trigone distance, and the aorto-mitral angle. CONCLUSIONS MSCT can provide measurements that are important for patient selection and sizing of TMVR devices. These measurements have excellent inter-observer reproducibility in patients with functional mitral regurgitation.

European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry

OBJECTIVES The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting. BACKGROUND Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath. METHODS The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure. RESULTS The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. CONCLUSIONS The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497).

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.