Advances in Transcatheter Aortic Valve Therapy in Bicuspid Aortic Valve Disease: Insight into Patient Selection, Management, and Future Directions.

Bicuspid aortic valve (BAV) disease is the most common congenital abnormality and is characterized by a risk of premature aortic valve disease, predominantly aortic stenosis. Surgery remains the treatment of choice for patients with symptomatic BAV disease, but, in patients who are unsuitable for surgical aortic valve replacement, transcatheter aortic valve replacement (TAVR) is currently used as an alternative to surgery, although there is no official recommendation for their management, since BAV patients with severe aortic stenosis have been excluded from the major TAVR randomized clinical trials. Patients with BAV stenosis present anatomic challenges for treatment with TAVR. The BAV annulus often has an elliptical shape and is larger than the tricuspid valve, and is more likely to exhibit severe eccentric calcification. In addition, BAV is often associated with a dilated, horizontal ascending aorta, and effaced sinuses. The calcified raphe may also place differential stress on the expansion of the transcatheter valve, increasing the risk of suboptimal positioning and consequently the risk of paravalvular leakage, new pacemaker implantation, new-onset left bundle branch block, and annular rupture. Moreover, coronary obstruction may occur when leaflet fusion results in a longer leaflet. Although some of these challenges have been successfully overcome using new-generation devices, the complication rate is still relatively high and requires a deeper understanding of the patient's specific complex and variable anatomy. Selection of the type and size of the transcatheter valve according to the patient's individual anatomy is critical to achieving successful results. Therefore, given the increasing frequency of BAV stenosis in younger patients, and the worldwide expansion in the application of TAVR in younger and lower surgical-risk patients, preprocedural multimodality imaging involving CT scan and three-dimensional echocardiography is mandatory to understand the complex and variable anatomy of BAV disease and improve both procedural results and short- and long-term outcomes in these patients.

Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Educational pathway, competence, indication and quality process of the new classification of echocardiography according to the appropriateness of use and application.

In continuation of a previous publication, the present study will take into account for each application and profile the clinical use, the minimal data settings, the echo data findings, the indications, the quality process, the accreditation requirements, educational tailored pathway contents and modalities. The aim of the present document was to define the main applications of echocardiography and to tailor for each application-derived profile, according with the previous definitions, requirements that clearly identify the indication, objective, clinical situation in which echocardiography is used, educational pathway and training, quality process and accreditation.

One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry).

The aim of this study was to report on the 30-day and 1-year outcomes of percutaneous mitral valve repair with the MitraClip technique in patients with grade ≥3+ mitral regurgitation (MR) at high risk for conventional surgical therapy enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. Acute device success was defined as residual MR ≤2+ after clip implantation. The primary safety end point was the rate of major adverse events at 30 days. The primary efficacy end point was freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 30 days and 1 year. A total of 117 patients were treated. Eighty-nine patients (76%) presented with functional MR and 28 patients (24%) with organic MR. Acute device success was observed in all patients. Device implantation time significantly diminished with experience and varied significantly between cases with 1 versus ≥2 clips. No procedural mortality was recorded. Major adverse events occurred in 4 patients at 30 days (4.3%). Deterioration to MR ≥3+ was recorded in 25% of patients with degenerative MR and 7% of those with functional MR at 1 year. No surgery for mitral valve dysfunction occurred within 1 year. Freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR was 96.4% and 75.8% at 30 days and 1 year, respectively. No significant differences were noted in the primary efficacy end point between patients with degenerative MR and those with functional MR. In conclusion, percutaneous mitral valve repair with the MitraClip technique was shown to be safe and reasonably effective in 117 patients from a real-world setting.

Core Valve embolization: technical challenges and management.

Transcatheter Aortic Valve Implantation with the Core Valve self expanding prosthesis can be complicated by hemodynamic instability in cases of low deployment (implant failure). The management of a low implant may necessitate repositioning the prostheses with the help of a snare catheter. Snaring can however be complicated by embolization of the prosthesis which presents a series of technical challenges that need to be addressed. We have discussed the technical issues and the approach to address them successfully in a systematic manner to ensure optimal procedural and patient outcomes.

Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry.

AIMS: The pivotal ATLANTA first-in-man study showed the promising safety and efficacy profile of the novel Catania™ stent in a population with ~20% American College of Cardiology/American Heart Association (ACC/AHA) type C coronary lesions. The ATLANTA 2 registry was designed to evaluate the 12-month safety and efficacy of the Catania stent in a broader real world scenario. METHODS AND RESULTS: The ATLANTA 2 registry was a prospective, non-randomised, single-arm study of patients with symptomatic ischaemic heart disease and de novo lesions of native coronary arteries. A total of 300 patients (396 lesions) were recruited and 482 Catania stents were implanted. At 12 months, major adverse cardiac events were 8.8%, mainly driven by target lesion revascularisation (6.5%). Cardiac death and non-fatal myocardial infarction occurred in 2.5% and 0.7% of patients, respectively. Subacute definite or probable stent thrombosis was 0.7%. No late stent thrombosis was recorded. Compared with patients treated with drug-eluting stents or bare metal stents in the study period, those treated with Catania stents experienced similar outcomes at one year. CONCLUSIONS: The 12-month results of the ATLANTA 2 registry confirmed the positive results of the ATLANTA first-in-man trial in a more complex population. A randomised trial is needed to assess the comparative value of the Catania stent over currently-used drug-eluting stents or bare metal stents.

Global risk classification and clinical SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) score in patients undergoing percutaneous or surgical left main revascularization.

OBJECTIVES: The aim of this study was to investigate the ability to predict cardiac mortality of the Global Risk Classification (GRC) and the Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score (CSS) in left main (LM) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). BACKGROUND: There is a renewed interest in combining clinical and angiographic information to define the risk of patients undergoing LM revascularization. METHODS: The GRC and CSS were assessed in patients undergoing LM PCI (n = 400) or CABG (n = 549). Stand-alone clinical (ACEF [age, creatinine, ejection fraction]), EuroSCORE (European System for Cardiac Operative Risk Evaluation) and angiographic (SYNTAX score) risk scores were also investigated. RESULTS: The GRC (Hosmer-Lemeshow statistic 0.357, p = 0.550; area under the curve 0.743) and the ACEF (Hosmer-Lemeshow 0.426, p = 0.514; area under the curve 0.741) showed the most balanced predictive characteristics in the PCI and CABG cohorts, respectively. In PCI patients, the CSS used fewer data to achieve similar discrimination but poorer calibration than the GRC. Propensity-adjusted outcomes were comparable between PCI and CABG patients with low, intermediate, or high EuroSCORE, ACEF, GRC, and CSS and those with low or intermediate SYNTAX score. Conversely, in the group with the highest SYNTAX score, the risk of cardiac mortality was significantly higher in PCI patients (hazard ratio: 2.323, 95% confidence interval: 1.091 to 4.945, p = 0.029). CONCLUSIONS: In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease.

Procedural success and 30-day clinical outcomes after percutaneous aortic valve replacement using current third-generation self-expanding CoreValve prosthesis.

BACKGROUND: Percutaneous aortic valve replacement (PAVR) is an emerging alternative for high-risk patients with severe aortic stenosis. The aim of this study was to report acute and short-term outcomes of PAVR with the 18 Fr CoreValve Revalving System. METHODS: From January 2007 to July 2008, 69 high-risk symptomatic patients with severe aortic stenosis were screened to assess their eligibility criteria for PAVR. All candidates were evaluated by a cardiac surgeon and a cardiologist. Thirty patients (13 men, 17 women, ages 82 +/- 5 years, range 73-88 years) met all the eligibility criteria and were enrolled in the study. RESULTS: Twenty-nine patients (97%) underwent successful valve implantation by a retrograde approach, with improvement in valve area (0.61 +/- 0.18 cm(2) to 1.49 +/- 0.39 cm(2); p < 0.001) and transvalvular gradient (58.1 +/- 17.6 mmHg to 9.2 +/- 4.0; p < 0.001). Paravalvular leakages were 1+ (n = 12) and 2+ (n = 2). Procedural success was achieved in 93% of patients, with 1 case of pericardial tamponade occurred during the first 48 hours after implantation. At 30-day mortality was 7%. The mean NYHA Functional Class declined from 2.72 +/- 0.59 to 1.31 +/- 0.47 (p < 0.001). No other major adverse events occurred at a mean follow up of 4.9 +/- 4.0 months (range 1-13 months). CONCLUSIONS: Our initial experience of PAVR in a cohort of older and high-risk surgical patients has been positive, with excellent acute and encouraging short-term results in terms of safety and efficacy.

A novel approach to define risk of stent thrombosis after percutaneous coronary intervention with drug-eluting stents: the DERIVATION score.

Recent studies of drug-eluting stents (DES) use in routine clinical practice have led to concern regarding their long-term safety and to questions about the adequacy of current antiplatelet therapy guidelines. This study sought to derivate a risk score for predicting stent thrombosis after drug-eluting stenting. The large single center DES Real-world Incremental Value in the erA of percutaneous revascularizaTION (DERIVATION) database, collecting data about 1,377 patients of any age undergoing PCI with DES as treatment for symptomatic coronary artery disease, was use for this purpose. Logistic regression and bootstrap procedure were used to select correlates of stent thrombosis that were subsequently weighted and integrated into an integer scoring system. Five variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for stent thrombosis [baseline left ventricular ejection fraction <50% (4 points), angioplasty in the setting of acute coronary syndromes (3 points), bifurcation lesion (2 points), left anterior descending as target vessel (2 points), multiple stenting (2 points)]. Three strata of risk were defined (low risk, 0-2; intermediate risk, 3-6; high risk >or=7) with good prognostic accuracy for early, late and very late thrombosis (c statistic = 0.75, 0.65 and 0.73, respectively) in the derivation set. In conclusion, the DERIVATION score may be used as a simple clinical tool for the identification of a sizable cohort in whom close monitoring and aggressive therapy may be beneficial.

Real world safety and efficacy of the Janus Tacrolimus-Eluting stent: long-term clinical outcome and angiographic findings from the Tacrolimus-Eluting STent (TEST) registry.

OBJECTIVES: We sought to evaluate the safety and performance of the Janus Tacrolimus-Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria. BACKGROUND: Continued attention to the safety, efficacy, and deliverability of first-generation drug eluting stents has led to the development of new antiproliferative agents with alternative stent platforms and different drug carrier vehicles. METHODS: The TEST (Tacrolimus Eluting STent) registry is a prospective, nonrandomized single-center registry in which 140 consecutive patients who underwent single- or multi-vessel percutaneous coronary intervention between February 2005 and August 2005 were enrolled. RESULTS: The composite rate of major adverse cardiac events (MACE) at 22 months clinical follow-up was 40.9%. The rate of mortality, myocardial infarction, and target lesion revascularization (TLR) were 5.5%, 11%, and 31.5%, respectively. Angiographic follow-up at 8 months was achieved in 74% of patients; binary restenosis occurred in 39.4% of lesions. Most restenosis lesions (94.6%) had a diffuse pattern, while focal restenosis was observed in 5.4% of cases. Definite or probable stent thrombosis was observed in 2.4% of patients. CONCLUSIONS: The present prospective, nonrandomized, TEST registry indicated high MACE and restenosis rates, and thereby rather discouraging long-term outcomes with use of the Janus TES in an unselected "real world" population of patients who underwent single- or multi-vessel percutaneous coronary intervention.

Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.

Usefulness of exercise myocardial scintigraphy in multivessel coronary disease after incomplete revascularization with coronary stenting.

The aim of this prospective study was to evaluate the prognostic value of exercise myocardial scintigraphy in patients who undergo incomplete revascularization with percutaneous coronary stenting. In 322 consecutive patients (mean age 61 +/- 10 years), exercise technetium-99m-tetrofosmin single-photon emission computed tomography scintigraphy was prospectively performed 4 to 6 months after an incomplete revascularization procedure. Follow-up lasted < or = 84 months (median 33). Patients with normal findings were at low risk of cardiac events compared with patients with mildly abnormal and severely abnormal findings (yearly event rate 1.5% vs 5.1% and 8.5%, respectively, p < 0.01). A significant difference was observed in hard, soft, and composite event-free survival among patients with normal, mildly abnormal, and severely abnormal findings (p < 0.01, p < 0.03, and p < 0.01, respectively). Nuclear data provided significant incremental prognostic value for cardiac events compared with the clinical, angiographic, and exercise test findings. In conclusion, in patients with incomplete revascularization procedures, exercise myocardial scintigraphy provides significant independent information concerning the subsequent risk of cardiac events, with an annualized event rate of < 2% for patients with normal scan findings. Myocardial scintigraphy is able to provide incremental prognostic information after adjusting for clinical, angiographic, and exercise variables.