Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review.

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.

Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies.

BACKGROUND: The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques. METHODS AND RESULTS: Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64+/-10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (>50% narrowing in both vessels). In the simple group (n=250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting. In the complex group (n=250), 89% of culotte (n=75) and 72% of crush (n=169) cases were completed successfully with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction, and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02, 95% confidence interval 1.17 to 3.47, P=0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively (P=0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P=0.002), respectively. Procedure duration and x-ray dose favored the simple approach. CONCLUSIONS: When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain the preferred strategy in the majority of cases. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.

Usage patterns and 1-year outcomes with the TAXUS Liberté stent: results of the TAXUS OLYMPIA registry.

OBJECTIVES: The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice. BACKGROUND: The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. METHODS: Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. RESULTS: Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year. CONCLUSIONS: Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting.

Quadripolar left ventricular lead implantation through the anchor struts of a mitral valve annuloplasty device.

We describe cardiac resynchronization therapy in a patient with a mitral valve annuloplasty device in situ for functional mitral regurgitation. We successfully implanted a left ventricular lead through a mitral valve annuloplasty device anchor into the coronary sinus and then through the struts of the device's proximal anchor.

Transcatheter aortic valve implantation for severe aortic stenosis-a new paradigm for multidisciplinary intervention: a prospective cohort study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an alternative treatment option for patients with aortic stenosis deemed high risk or unsuitable for aortic valve replacement. The aim of this study was to assess the feasibility of TAVI in elderly patients, the delivery of this technology with a multidisciplinary approach, and the use of traditional surgical scoring systems. METHODS: One hundred fifty-one consecutive patients (mean age 82.6 +/- 7.3 years) with severe aortic stenosis underwent TAVI with the Edwards Lifesciences (Irvine, CA) Sapien bioprosthesis using the transapical (n = 84; 56%) or transfemoral (n = 67; 44%) approach from August 2007 to September 2009 at King's Health Partners, London, United Kingdom. We analyzed procedural outcome, complications, functional status, and midterm outcome of patients. RESULTS: The multidisciplinary team comprised interventional cardiologists, cardiothoracic surgeons, imaging specialists, cardiac anesthetists, and specialist nurses. Seventy percent of patients were in New York Heart Association class III/IV, and logistic EuroSCORE was 21.6 +/- 11.9. Procedural success was achieved in 98%. Postoperative complications included stroke (6%), complete atrioventricular block (5.3%), renal failure requiring hemofiltration (9.3%), and vascular injury (8.6%). Overall 30-day mortality was 9.9% (n = 15). The logistic EuroSCORE was a predictor of short-term mortality (logistic regression model, P < .05). Thirty-day mortality post-TAVI for patients with logistic EuroSCORE <20, 20 to 40, and >40 was 5.4%, 13.2%, and 22.2%, respectively. CONCLUSIONS: Transcatheter aortic valve implantation is a feasible treatment option in this patient group with promising short/medium-term results. Renal failure is the commonest short-term complication, and the incidence of vascular complications remains high. Risk prediction/case selection remains challenging, and a multidisciplinary team approach appears to be helpful in appropriate patient selection.

Implementation and consistency of Heart Team decision-making in complex coronary revascularisation.

BACKGROUND: A multidisciplinary team (MDT) approach for decision-making in patients with complex coronary artery disease (CAD) is now a class IC recommendation in the European and American guidelines for myocardial revascularisation. The aim of this study was to evaluate the implementation and consistency of Heart Team HT decision-making in complex coronary revascularisation. METHODS: We prospectively evaluated the data of 399 patients derived from 51 consecutive MDT meetings held in a tertiary cardiac centre. A subset of cases was randomly selected and re-presented with the same clinical data to a panel blinded to the initial outcome, at least 6 months after the initial discussion, in order to evaluate the reproducibility of decision-making. RESULTS: The most common decisions included continued medical management (30%), coronary artery bypass grafting (CABG) (26%) and percutaneous coronary intervention (PCI) (17%). Other decisions, such as further assessment of symptoms or evaluation with further invasive or non-invasive tests were made in 25% of the cases. Decisions were implemented in 93% of the cases. On re-discussion of the same data (n=40) within a median period of 9 months 80% of the initial HT recommendations were successfully reproduced. CONCLUSIONS: The Heart Team is a robust process in the management of patient with complex CAD and decisions are largely reproducible. Although outcomes are successfully implemented in the majority of the cases, it is important that all clinical information is available during discussion and patient preference is taken into account.

The clinical relevance of raised cardiac troponin I in the absence of significant angiographic coronary artery disease.

OBJECTIVES: Cardiac troponins are highly sensitive and specific markers of myocardial cell injury. We wished to determine the clinical relevance of raised troponins in the absence of significant angiographic coronary artery disease. DESIGN AND METHODS: We assessed patients admitted to our hospital over the past 3 years with troponin-positive chest pain and no angiographically significant coronary disease. RESULTS: The study included 67 patients, all of whom had symptoms of "chest pain" and elevated (>0.2 microg/L) troponin I on admission. Thirty-four (51%) patients had alternative causes for myocyte injury other than coronary ischaemia. In the remaining 33 (49%) patients we could find no other associated features or diagnoses. Follow up was obtained in 29 (88%) of these 33 patients (mean follow up 58+/-13 weeks, range 17-156 weeks). During the follow up period, three (4.5%) patients were readmitted with further ischaemic events. CONCLUSIONS: Myocardial damage can occur in the absence of significant angiographic coronary disease and other causes of raised troponins should be considered according to the clinical presentation. Troponin-positive cases with angiographically "normal" coronary arteries can re-present with future cardiac events and should still be considered for aggressive risk management.

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.

AIMS: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population. METHODS AND RESULTS: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent. CONCLUSIONS: In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.

Cardiac troponin T and I and creatine kinase-MB as markers of myocardial injury and predictors of outcome following percutaneous coronary intervention.

AIMS: This study was performed to determine the most sensitive biochemical marker for the detection of cardiac myocyte damage potentially sustained during percutaneous coronary intervention (PCI) and to assess whether such a marker can be used to identify patients at increased risk of poor subsequent clinical outcome. METHODS AND RESULTS: We studied 109 consecutive patients presenting with clinical stable and unstable angina and undergoing PCI at our institution. Blood was sampled for creatine kinase-MB (CK-MB), cardiac Troponin T (cTnT) and I (cTnI) immediately before and at 6, 14 and 24 h post-PCI. Five patients with raised cardiac markers pre-PCI were excluded from further analysis. The occurrence of major adverse cardiac events (MACE) was documented in-hospital, at 30 days and at long-term clinical follow up of up to 20 months. MACE occurred in 26/109 (24%) patients: death=1, QWMI=4, NQWMI=5, repeat PCI=16 (nine target vessel revascularisations and seven de-novo lesions), CABG=5. cTnI had the highest detection rate for myocardial damage, with 58 cTnI-positive patients, 38 cTnT-positive patients and 28 CK-MB-positive patients in the 24 h following PCI (Pearson's Chi square test, P<0.01). The type of interventional strategy per se was not significantly associated with post-procedural cardiac marker concentrations (Kruskal-Wallis ANOVA, P>0.05). There was a significant association between post-procedural cardiac marker concentrations of CK-MB, cTnT and cTnI and the occurrence of procedural angiographic complications (P=0.0003, 0.0002, 0.001, respectively). All three markers, at each sampling time point between 6 and 24 h post-PCI, showed a significant predictive relationship with MACE in-hospital and at long-term follow up (ROC curve AUC analysis, P<0.05). All three markers provided equally predictive information at each of the three post-procedural sampling time points between 6 and 24 h following PCI. All levels of cardiac marker elevation above the clinically discriminant cut-off values were significantly predictive of outcome at long-term follow up. CONCLUSIONS: cTnI proved to be the most sensitive marker in detecting myocardial necrosis following PCI. CK-MB, cTnT and cTnI all provided similarly reliable prognostic information, with cTnT and cTnI being marginally superior in predicting MACE at follow up.

Direct stenting may limit myocardial injury during percutaneous coronary intervention.

BACKGROUND: Direct coronary stenting has been shown to be safe and feasible, with a demonstrable reduction in cost, procedural time and radiation exposure. Direct stenting may limit distal embolization of atherosclerotic plaque and consequently reduce myocardial cell injury following percutaneous coronary intervention, which may have important prognostic implications. METHODS AND RESULTS: We assessed cardiac troponin I (cTnI) release in the 24 hours following direct coronary stenting (DS) as compared to stenting with balloon predilatation (PD) in a total of 311 patients and 440 vessels/lesions (vessel to lesion ratio = 1:1) (DS: n = 107 patients and 149 vessels/lesions; PD: n = 204 patients and 291 vessels/lesions). The 2 groups were well matched except for a greater proportion of diabetic patients in the PD group (21%) compared to the DS group (11%) (p < 0.05). There were no significant differences in the distribution of target lesion site or angiographic complexity between the 2 groups. Primary angiographic success was achieved in 97% of vessels in the DS group and 98% of vessels in the PD group (p = NS). DS failed in 7/114 patients (6%) deemed suitable for DS by the operator, but all stents were subsequently successfully deployed following balloon predilatation. Abciximab (ReoPro , Eli Lilly Company, Indianapolis, Indiana) was used in 11 patients (10%) in the DS group and 24 patients (12%) in the PD group ( p = 0.68). The post-procedural median (IQR) peak cTnI concentrations were 0.2 0.1 g/L in the DS group and 0.5 0.3 g/L in the PD group (p = 0.02). Post-procedural cTnI concentrations were > 0.2 g/L in 11 patients (10%) in the DS group and in 53 patients (26%) in the PD group (X2 = 58.6; p < 0.0001). The rate of major adverse cardiac events at 6 18 month follow-up was 8% in the DS group and 15% in the PD group (X2 = 38.5; p = 0.02). CONCLUSION: Direct stenting without balloon predilatation is associated with lower post-procedural cTnI concentrations and lower incidence of major adverse events compared to traditional stenting with predilatation.

European experience and perspectives on transcatheter aortic valve replacement.

It could be argued that the European experience with transcatheter aortic valve replacement (TAVR) has been central to the success of this novel technology. After all, Europe provided the birthplace for the first clinical TAVR and allowed commercial approval of the early devices long before they were widely available elsewhere. Many of the largest registries are also European, helping to formulate contemporaneous guidelines with the backing of the influential cardiology and cardiothoracic societies. Despite the significant economic downturn that coincided with the availability of transcatheter technology, funding has been largely forthcoming and is increasing year on year. As we await the results of the randomised controlled trials examining TAVR in a lower risk cohort, the European adoption of the TAVR technology appears set to continue.

Direct TAVI using a balloon-expandable system: a novel technique to eliminate pre-deployment balloon aortic valvuloplasty.

AIMS: Transcatheter aortic valve implantation (TAVI) is now the therapy of choice for those patients with severe symptomatic aortic stenosis who are considered to be at too high risk for conventional surgery. Balloon aortic valvuloplasty (BAV) is routinely performed to allow placement of the balloon-expandable valve during the procedure. Instrumentation of the valve has been linked to procedural stroke risk, with the associated runs of rapid pacing risking haemodynamic compromise. We outline a novel technique to eliminate BAV prior to transcatheter valve placement. METHODS AND RESULTS: We illustrate a clinical case that outlines the problems encountered in transcatheter valve placement despite a prior BAV. The solution used in this case involved the partial inflation of the distal section of the balloon allowing easy passage of the SAPIEN XT valve from the transaortic route. After bench testing, we report a series of patients who have undergone this "direct TAVI" procedure from both the transaortic and the transfemoral routes. CONCLUSIONS: In a limited series within a single centre, "direct TAVI" has been shown to be effective in allowing accurate placement of a balloon-expandable device without the need for prior BAV.

Real-time three-dimensional transesophageal echocardiography adds value to transcatheter aortic valve implantation.

BACKGROUND: Successful transcatheter aortic valve implantation (TAVI) mandates comprehensive, accurate multimodality imaging. Echocardiography is involved at all key stages and, with the advent of real-time three-dimensional (3D) transesophageal echocardiography, is uniquely placed to enable periprocedural monitoring. The investigators describe a comprehensive two-dimensional (2D) and 3D echocardiographic protocol, and the additional benefits of 3D TEE, within a high-volume TAVI program. METHODS: TAVI was performed with 2D and 3D transesophageal echocardiographic and fluoroscopic guidance in consecutive high-risk patients with symptomatic severe aortic stenosis. The role of TEE, including the additive value of 3D TEE, was examined, and procedural and echocardiographic outcomes were evaluated. A 3D sizing transcatheter heart valve (THV) strategy was used, except as mandated by study protocol. RESULTS: Procedural success was achieved in 99% of 256 patients (mean age, 82.9 ± 7.1 years, mean logistic European System for Cardiac Operative Risk Evaluation score, 21.6 ± 11.2%; mean aortic valve area, 0.63 ± 0.19 cm(2)), with no procedural deaths. Acceptable 2D and 3D transesophageal echocardiographic images were achieved in all patients. Aortic valve annular dimensions by 2D transthoracic echocardiography, 2D TEE, and 3D TEE were 21.6 ± 1.9 mm, 22.5 ± 2.2 mm (P < .001), and 23.0 ± 2.0 mm (P = .004 vs 2D TEE), respectively. The 2D THV sizing strategy would have changed THV selection in 23% of patients, downsizing in most. Three-dimensional TEE provided superior spatial visualization and anatomic orientation and optimized procedural performance. Postprocedural mild, moderate, and severe paravalvular aortic regurgitation was observed in 24%, 3%, and 0% of patients, respectively, with no or trace transvalvular aortic regurgitation in 95%. A second valve was successfully deployed in five patients, and TEE detected five other periprocedural complications. CONCLUSIONS: A systematic, comprehensive echocardiographic protocol, incorporating the additional benefits of 3D TEE, has a vital role within a TAVI program and, combined with a 3D THV sizing strategy, contributes to excellent outcomes.

Echocardiographic evaluation of patent foramen ovale prior to device closure.

High-quality imaging of the atrial septum has never been so relevant to the adult cardiologist. This article focuses on the role of echocardiography in the evaluation of patent foramen ovale for closure. It provides a systematic and comprehensive approach to transesophageal echocardiographic study in such a patient. The salient information required for planning the device and equipment needed for the closure procedure are discussed.

Successful nonsurgical treatment of left main stem perforation by sacrifice of the LAD.

We report two cases of coronary artery disease treated percutaneously and including rotational atherectomy, in which the interventional procedure was complicated by left main coronary artery perforation. The management and outcome of this potentially fatal complication are discussed.

A simple thermodilution technique to assess coronary endothelium-dependent microvascular function in humans: validation and comparison with coronary flow reserve.

AIMS: To validate a novel method for assessment of coronary endothelium-dependent microvascular function and compare this index with the adenosine-derived coronary flow reserve (CFR). METHODS AND RESULTS: We validated use of intra-coronary pressure wire-derived thermodilution to assess changes in coronary flow compared to Doppler flow-wire/quantitative coronary angiography- (QCA) derived data in response to the endothelial agonist substance-P (endothelium-dependent response). There was a close correlation between Doppler/QCA- and thermodilution-derived assessment of endothelium-dependent microvascular function (r = 0.76; P < 0.001). Next, pressure wire-based thermodilution was employed to sequentially compare CFR (hyperaemia achieved with adenosine-140 microg/kg/mL) with changes in coronary flow in response to substance-P (20 pmol/min intra-coronary infusion; 2 min) in 65 unobstructed coronary arteries. There was no correlation between CFR and coronary endothelium-dependent microvascular response (r = 0.08; P = 0.50). Both indices were in turn compared with clinical markers of endothelial dysfunction, namely Framingham risk score (FRS-a marker for cardiovascular risk factor clustering, hence an indirect clinical measure of endothelial dysfunction) and presence/absence of diabetes. Patient's FRS correlated with coronary endothelium-dependent microvascular response (r = -0.48; P < 0.001), but not with CFR (r = 0.14; P = 0.25). Diabetic patients had greater endothelial dysfunction than non-diabetics (P < 0.001) whereas CFR was not influenced by diabetes (P = 0.10). CONCLUSION: A simple pressure wire-based thermodilution technique can be used to assess coronary endothelium-dependent microvascular function. Adenosine-derived CFR does not adequately interrogate the endothelium-dependent component of coronary microvascular function.