Cost-effectiveness of the coronary sinus Reducer and its impact on the healthcare burden of refractory angina patients.

AIMS: The coronary sinus Reducer is a percutaneous device proven to improve angina symptoms in refractory angina (RA). We evaluated its potential cost-effectiveness and impact on the healthcare resource use. METHODS AND RESULTS: Angina-related healthcare resource usage and quality-of-life data were collected for 215 consecutive RA patients undergoing Reducer implantation in Belgium, the Netherlands, and Italy. Costs were assessed from each country's healthcare system perspective. Data from the date of RA diagnosis to Reducer implantation [Standard-of-Care (SoC)-period] and from Reducer implantation to follow-up (Reducer-period) were compared: during Reducer-period, a significant reduction in angina-driven hospitalizations, outpatient visits, coronary angiograms, and percutaneous coronary interventions per patient-year was observed, translating into significantly reduced costs per patient-year. To assess cost-effectiveness, costs and utilities of 1-year SoC were compared with those of 1-year Reducer-period. Assumptions on Reducer efficacy duration were further explored with modelled projections. Reducer was associated with higher quality-adjusted life years (QALYs: 0.665 vs. 0.580, P < 0.001) and incremental costs, yielding incremental cost-effectiveness ratios (ICERs) of 53 197, 34 948, 63 146 €/QALY gained in Belgium, the Netherlands, and Italy, respectively. Under both the assumptions of 2 and 3 years Reducer effect duration with a 30%-year efficacy decrease, the device yielded ICERs in the range of 1977-20 796 €/QALY gained. CONCLUSION: In patients with RA, Reducer device decreases healthcare resource use and related costs. In a limited 1-year timeframe, Reducer is consistently cost-effective according to a range of cost-effectiveness thresholds. Under the explored assumptions, the device yields cost-effectiveness ratios suggesting high value from all the considered perspectives.

Evaluation of Chronic Total Occlusion Recanalization: A Physiologic Assessment Perspective by Dynamic Exercise Tests.

Chronic total occlusion (CTO) recanalization and its effects on left ventricular function and patient outcomes has intrigued the interventional community over the last several years. Now that there is plenty of knowledge and experience on "how to treat" the lesion, another scientific effort should focus on "when to treat" the lesion. Physiologic assessment has altered the way we treat coronary artery stenosis to improve cardiovascular outcomes. We tend to assess the effects of CTO recanalization by evaluating resting parameters, although the effects of ischemia and concomitant left ventricular dysfunction manifest mainly during exercise. Physiologic assessment in CTOs by implementation of cardiopulmonary exercise testing, in order to indirectly assess the physiological effect of exercise-induced left ventricular dysfunction, could represent a novel approach to monitor the effects of CTO recanalization and hopefully to identify the responders after recanalization.

Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk.

BACKGROUND: Balancing ischemic and bleeding risk is an evolving framework. METHODS AND RESULTS: Our objectives were to simulate changes in risks for adverse events and event-driven costs with use of ticagrelor or prasugrel versus clopidogrel according to varying levels of ischemic and bleeding risk. Using the validated PARIS risk functions, we estimated 1-year ischemic (myocardial infarction or stent thrombosis) and bleeding (Bleeding Academic Research Consortium types 3 or 5) event rates among PARIS study participants who underwent percutaneous coronary intervention with drug-eluting stent implantation for an acute coronary syndrome and were discharged with aspirin and clopidogrel (n=1497). Simulated changes in adverse events with ticagrelor or prasugrel were calculated by applying treatment effects from randomized trials for a 1-year time horizon. Event costs were estimated using National Inpatient Sample data. Net costs were calculated between antiplatelet therapy groups according to level of ischemic and bleeding risk. After weighting events for quality-of-life impact, we calculated event rates and costs for risk-tailored treatment versus clopidogrel under multiple drug pricing assumptions. One-year rates (per 1000 person-years) for ischemic events were 12.6, 24.1, and 66.1, respectively, among those at low (n=630), intermediate (n=536), and high (n=331) ischemic risk. Analogous bleeding rates were 11.0, 23.9, and 66.2, respectively, among low (n=728), intermediate (n=634), and high (n=135) bleeding risk patients. Mean per event costs were $22 174 (ischemic) and $12 203 (bleeding). When risks for ischemia matched or exceeded bleeding, simulated utility-weighted event rates favored ticagrelor/prasugrel, whereas clopidogrel reduced utility-weighted events when bleeding exceeded ischemic risk. One-year costs were sensitive to drug pricing assumptions, and risk-tailored treatment with either agent progressed from cost incurring to cost saving with increasing generic market share. CONCLUSIONS: Tailoring antiplatelet therapy intensity to patient risk may improve health utility and could produce cost savings in the first year after percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00998127.

Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC).

Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

Cardiovascular disease burden among human immunodeficiency virus-infected individuals.

Human Immunodeficiency Virus (HIV) infection affects 36.7 million people worldwide, it accounted for 1.1 million deaths in 2015. The advent of combined antiretroviral therapy (cART) has been associated with a decrease in HIV-related morbidity and mortality. However, there are increasing concerns about long-lasting effects of chronic inflammation and immune activation, leading to premature aging and HIV-related mortality. Cardiovascular diseases, especially coronary artery disease, are among the leading causes of death in HIV-infected patients, accounting for up to 15% of total deaths in high income countries. Furthermore, as cART availability expands to low-income countries, the burden of cardiovascular related mortality is likely to rise. Hence, over the next decade HIV-associated cardiovascular disease burden is expected to increase globally. In this review, we summarize our understanding of the pathogenesis and risk factors associated with HIV infection and cardiovascular disease, in particular coronary artery disease.

Incidence and Management of Restenosis After Treatment of Unprotected Left Main Disease With Second-Generation Drug-Eluting Stents (from Failure in Left Main Study With 2nd Generation Stents-Cardiogroup III Study).

Incidence, predictors, and impact on prognosis of target lesion revascularization (TLR) for patients treated with second-generation drug-eluting stents (DESs) on unprotected left main (ULM) remain to be defined. The present study is a multicenter study including patients treated with a second-generation DES on ULM from June 2007 to January 2015. Rate of TLR was the primary end point. All cause death, myocardial infarction, target vessel revascularization, and stent thrombosis were the secondary end points. A total of 1,270 patients were enrolled: after a follow-up of 650 days (230 to 1,170), 47 (3.7%) of them underwent a re-percutaneous coronary intervention TLR on the left main, 22 during a planned angiographic follow-up. Extent of coronary artery disease was similar among groups (median value of Syntax of 27 ± 10 vs 26 ± 9, p = 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM, 56% presented with a focal restenosis, 33% diffuse and 10% proliferative. At multivariate analysis, insulin-dependent diabetes mellitus increased risk of TLR (hazard ratio [HR] 2.0: 1.1 to 3.6, p = 0.04), whereas use of intravascular ultrasound resulted protective (HR 0.5: 0.3 to 0.9, p = 0.02). At follow-up, rates of cardiovascular death did not differ among the 2 groups (4% vs 4%, p = 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1 to 1.6, p = 0.22), whereas cardiogenic shock and III tertile of Syntax portended a worse prognosis (HR 4.5: 2.1 to 10.2, p = 0.01 and HR 1.4: 1.1 to 1.6, p = 0.03, respectively). In conclusion, repeated revascularization after implantation of second-generation DES on ULM represents an unfrequent event, being increased in insulin-dependent patients and reduced by intravascular ultrasound. Impact on prognosis remains neutral, being related to clinical presentation and extent of coronary artery disease.

Radiation Exposure and Contrast Agent Reduction During Transcatheter Aortic Valve Implantation: An Ongoing Experience.

OBJECTIVES: To determine the patient radiation exposure and contrast agent variation during transcatheter aortic valve implantation (TAVI) procedures resulting from technological improvements. METHODS: TAVI procedures from January 2008 to July 2015 were analyzed in three different time periods: 1st period, when the angiography was equipped with an image intensifier technology; 2nd period, starting with the installation of a new angiography system with flat-panel detector (FPD) technology; and 3rd period, starting with the systematic use of preprocedural multidetector computed tomography (MDCT) to individualize optimal fluoroscopic projections for the aortic prosthesis implantation. RESULTS: Significant differences were found in contrast volume (198 ± 99 mL vs 139 ± 74 mL; P<.001), kerma area product (211 ± 135 Gy•cm² vs 147 ± 120 Gy•cm²; P<.001) and effective dose (42 ± 27 mSv vs 29 ± 24 mSv; P<.001) between the 1st and 2nd periods, respectively. The reduction continued between the 2nd and 3rd periods for contrast volume (139 ± 74 mL vs 110 ± 61 mL; P<.001), kerma area product (147 ± 120 Gy•cm² vs 111 ± 69 Gy•cm²; P<.001), and effective dose (29 ± 24 mSv vs 22 ± 11 mSv; P<.001), respectively. CONCLUSIONS: The present study suggests that the appropriate use of FPD technology and preprocedural MDCT to individualize fluoroscopic implant projections for TAVI temporally reduced the amount of radiation and contrast agent administered over time.

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Is it time to simplify the TAVI procedure? "Make it simple but not too simple".

As transcatheter aortic valve implantation (TAVI) becomes a standardised procedure with reproducible and excellent periprocedural, early and medium-term outcomes, it is opportune to question whether the time has come to simplify the TAVI procedure. In some centres, a minimalist approach to TAVI is already the standard of care. In this perspective, we share our experience and opinions on how and when we can simplify the TAVI procedure.

The role of intravascular ultrasound and quantitative angiography in the functional assessment of intermediate coronary lesions: correlation with fractional flow reserve.

BACKGROUND: The correlation between fractional flow reserve (FFR) and intravascular ultrasound (IVUS) metrics including minimal lumen area (MLA), plaque burden and morphology remain a matter of debate. METHODS: Between June 2008 and May 2013, 132 intermediate stenoses in 109 patients were assessed by FFR, IVUS and quantitative angiography. Receiver-operating characteristic (ROC) curve analyses were used to identify MLA/lesion length/plaque burden cut-off values predictive of FFR <0.80. RESULTS: FFR <0.80 was observed in 39 lesions. In the entire cohort, MLA value <2.70mm(2) had 79.5% sensitivity, 76.3% specificity, 0.822 area under curve (AUC), 58.5% positive predictive value, 89.9% negative predictive value and 77.3% accuracy in predicting a positive FFR. In lesions with reference diameter vessel (RVD) ≥3.0mm, the MLA cut-off value was 2.84mm(2) (sensitivity 72.2%, specificity 83.0%, AUC 0.842) whereas in lesions with RVD <3.0mm, 2.59mm(2) (sensitivity 90.5%, specificity 69.6%, AUC 0.823). A moderate correlation was observed between MLA and FFR (r=0.429, p<0.001). The cut-off lesion length predictive of FFR <0.80 was 11.0mm with a weak correlation between the two (r=-0.348, p<0.001). Plaque morphology did not significantly affect FFR (p=0.485). On multivariable analysis, MLA (OR: 0.15; 95% CI: 0.05-0.40; p<0.001) and plaque burden (OR: 1.11; 95% CI: 1.04-1.20; p<0.003) were independent predictors of FFR <0.80. CONCLUSION: A modest, yet significant correlation was observed between MLA and FFR. The high negative predictive value of large MLAs (using afore-mentioned cut-off values) may provide some degree of confidence that the lesion in question is not functionally significant.

[SICI-GISE position paper on drug-coated balloon use in the coronary district]. / Documento di posizione SICI-GISE sul corretto utilizzo del pallone a rilascio di farmaco nel distretto coronarico.

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogeneous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjunctive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. At present, a variety of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian Society of Interventional Cardiology (SICI-GISE) decided to coordinate the efforts of a group of renowned experts in this field, in order to produce a position paper on the correct use of drug-coated balloons in all settings of coronary artery disease, giving a class of indication to each one, based on clinical evidence. This position paper represents a quick reference for operators, investigators and manufacturers to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

Assessment of efficacy and safety of combining "paclitaxel" eluting balloon and "limus" eluting stent in the same lesion.

OBJECTIVES: To assess the safety and efficacy of combining drug-eluting balloon (DEB) and drug-eluting stents (DES) in the same coronary lesion. BACKGROUND: Use of DEB may not always produce optimal results or even result in dissection, compelling the operators to consider bailout stenting with bare metal stents (BMS). However, BMS may not be ideal in patients who have significant risk-profile for restenosis. We have opted for DES over BMS in such situations and present our follow-up data. METHODS: Between 2009 and 2011, 46 patients (57 lesions) requiring bailout stenting following DEB use were treated with second-generation DES. All patients had at-least one or more risk-factors that made them vulnerable for restenosis (diabetes, chronic kidney disease, previous in-stent restenosis [ISR], and/or long diffuse lesions ≥ 30 mm). RESULTS: Of the 57 lesions, 34 (60%) were previous ISR. The mean length of the DEB was: 36.2 ± 5.6 mm. All patients had TIMI-3 flow post PCI with no in-lab complications. At median follow-up of 12.3 months (interquartile range [IQR]: 7.5-18.1), the rates target lesion revascularization (TLR) and target vessel revascularization (TVR) were 3 (5.3%) and 4 (7%), respectively. One patient had died 3 months following treatment. There were no episodes of myocardial infarction, definite or probable stent thrombosis. The major adverse cardiovascular events (MACE) rate defined as cardiac-death, MI, and TVR occurred in 11% of patients. CONCLUSION: The results from this novel strategy of combining "Paclitaxel" eluting balloon and "Limus" eluting stent in a same lesion are encouraging. Dual drug-elution acting on two different pathways may provide potential synergy that may explain the favorable outcome.

Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study.

OBJECTIVES: The aim of this study was to explore the incidence, causes, and outcomes of cardiac tamponade in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Use of TAVI is increasing, but the procedure is vulnerable to complications, given the cohort of patients. Cardiac tamponade is a possible complication, and there is a scarcity of data on the incidence and outcomes of cardiac tamponade during TAVI. METHODS: All patients who sustained cardiac tamponade during or post-TAVI between 2007 and 2012 were included in the study. RESULTS: Of 389 patients who underwent TAVI, 17 (4.3%) had cardiac tamponade. The mean age was 82.3 ± 3.7 years, and most were women (n = 12, 70.6%). Causes of cardiac tamponade were right ventricular perforation by temporary pacemaker (9 patients, 52.9%), annular rupture or aortic dissection (4 patients, 23.5%), and tear in the left ventricular free wall caused by Amplatz stiff wire or catheters (4 patients, 23.5%). Mortality occurred in 4 patients (23.5%), and all had tamponade caused by injury to the high-pressured left-sided circulation (left ventricle and aorta). Most patients (n = 14, 82.4%) sustained cardiac tamponade during the procedure-2 patients (11.7%) within 24 h, and 1 patient after 24 h. CONCLUSIONS: Cardiac tamponade during TAVI is not frequent but is associated with high mortality rates especially when left-sided structures are involved. Meticulous handling of the equipment and improvements in the safety of currently used devices could further reduce the occurrence of this complication.

Dynamic assessment of 'valvular reserve capacity' in patients with rheumatic mitral stenosis.

AIMS: Mitral stenosis (MS) may exhibit a dynamic valvular reserve. When resting gradients and systolic pulmonary pressure (sPAP) do not reflect the real severity of the disease, a dynamic evaluation becomes necessary. The aim of the study was to assess the clinical utility of exercise echocardiography in symptomatic patients with apparently subcritical MS. METHODS AND RESULTS: One hundred and thirty consecutive patients were referred for symptomatic MS. Patients with unimpressive resting MVA (>1-1.5 cm(2)) and mean PG (≥5-9 mmHg) underwent exercise echocardiography. Cardiac performance and mitral indices (MVA, peak/mean PG, sPAP) were measured. Exhaustion of valvular reserve capacity under exercise was defined as appearance of symptoms and sPAP > 60 mmHg. Forty-six patients (35%) (age: 53 ± 10 years; 74%, female) with resting MVA (1.2 ± 0.36 cm(2)), mean PG (6.8 ± 2.7 mmHg), and sPAP (38 ± 7 mmHg) inconsistent with symptoms underwent stress echocardiography. Exercise was stopped for dyspnoea (76%) or fatigue (24%). At peak workloads (57.2 ± 21.8 Watts), increased mean PG (17.2 ± 4.8 mmHg, P< 0.001) and sPAP (67.4 ± 11.4 mmHg; P< 0.0001) were observed, without change in MVA (1.25 ± 0.4 cm(2); P= n.s.). At univariate analysis, predictors of adaptation to exercise were age (-0.345; P = 0.024), mean PG (0.339; P= 0.023), and sPAP (0.354; P= 0.024); at multivariate analysis, best predictor was resting mean PG, although correlation was poor (-0.339; P= 0.015). CONCLUSION: In MS with limiting symptoms despite unimpressive findings at rest, valvular capacity exhaustion should be tested on a dynamic background, as no single resting index can predict potential haemodynamic adaptation to exercise. In such context, the contribution of exercise echocardiography remains extremely valuable.

Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforation.

OBJECTIVES: The aim of this study was to evaluate the incidence, predictors, management, and clinical outcomes in patients with grade III coronary perforation during percutaneous coronary intervention. BACKGROUND: Grade III coronary perforation is a rare but recognized complication associated with high morbidity and mortality. METHODS: From 24,465 patients undergoing percutaneous coronary intervention from May 1993 to December 2009, 56 patients had grade III coronary perforation. RESULTS: Most lesions were complex: 44.6% type B2, 51.8% type C, and 28.6% chronic total occlusions, and within a small vessel (≤ 2.5 mm) in 32.1%. Glycoprotein IIb/IIIa inhibitors were administered in 17.9% of patients. The device causing perforation was intracoronary balloon in 50%: 53.6% compliant, 46.4% noncompliant; intracoronary guidewire in 17.9%; rotablation in 3.6%; and directional atherectomy in 3.6%. Following perforation, immediate treatment and success rates, respectively, were prolonged balloon inflation 58.9%, 54.5%; covered stent implantation 46.4%, 84.6%; coronary artery bypass graft surgery (CABG) and surgical repair 16.0%, 44.4%; and coil embolization 1.8%, 100%. Multiple methods were required in 39.3%. During the procedure (n = 56), 19.6% required cardiopulmonary resuscitation and 3.6% died. In-hospital (n = 54), 3.7% required CABG, 14.8% died. The combined procedural and in-hospital myocardial infarction rate was 42.9%, and major adverse cardiac event rate was 55.4%. At clinical follow-up (n = 46) (median: 38.1 months, range 7.6 to 122.8), 4.3% had a myocardial infarction, 4.3% required CABG, and 15.2% died. The target lesion revascularization rate was 13%, with target vessel revascularization in 19.6%, and major adverse cardiac events in 41.3%. CONCLUSIONS: Grade III coronary perforation is associated with complex lesions and high acute and long-term major adverse cardiac event rates.

Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents 70 restenotic cases from a cohort of 718 patients: FAILS (Failure in Left Main Study).

OBJECTIVES: This study sought to retrospectively appraise the incidence and management of restenosis after drug-eluting stent (DES) implantation for unprotected left main (ULM) disease. BACKGROUND: The promising role of DES for ULM has been reported. However, no detailed data are available on subsequent restenosis. METHODS: From the total sample of patients with ULM treated with DES, we identified those presenting with angiographic ULM restenosis. The primary end point was the long-term rate of major adverse cardiac events (MACE), that is, death, myocardial infarction (MI), or target lesion revascularization (TLR). We also adjudicated stent thrombosis according to the Academic Research Consortium. RESULTS: Post-DES restenosis in ULM occurred in 70 of 718 patients (9.7%). Of these, 59 (84.3%) were treated percutaneously (34 [48.6%] with additional DES, 22 [31.4%] with standard or cutting balloons, 2 [2.9%] with rotational atherectomy, and 1 [1.4%] with a bare-metal stent), whereas 7 (10%) patients underwent bypass surgery and 4 (5.7%) were treated medically. In-hospital MACE included no periprocedural MI and only 1 (1.4%) death. After 27.2 +/- 15.4 months, MACE occurred cumulatively in 18 (25.7%) patients, with death in 4 (5.7%), MI in 2 (2.9%), and TLR in 15 (21.4%). Patients treated with medical, interventional, and surgical therapy had the following MACE rates, respectively: 50%, 25.4%, and 14.3%. Definite, probable, and possible stent thrombosis occurred in 0 (0%), 1 (1.4%), and 1 (1.4%) patient, respectively. CONCLUSIONS: DES restenosis in the ULM artery can be managed in most cases with a minimally invasive approach, achieving favorable early and late results.

Assessment of the SYNTAX score in the Syntax study.

AIMS: The SYNTAX score has been designed to better anticipate the risks of percutaneous or surgical revascularisation, taking into account the functional impact of the coronary circulation with all its anatomic components including the presence of bifurcations, total occlusions, thrombus, calcification, and small vessels. The purpose of this paper is to describe the baseline assessment of the SYNTAX score in the Syntax randomised trial, the corelab reproducibility, the potential difference in score assessment between the investigator and the corelab, and to ascertain the impact on one-year outcome after either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) in patients with complex coronary artery disease. METHODS AND RESULTS: To assess the reliability of Syntax scoring, 100 diagnostic angiograms from the Syntax trial were randomly selected and assessed independently by two observers. Intra-observer variability was assessed by analysing 91 sets of angiograms after an interval of at least eight weeks by one of the observers. Clinical outcomes in the randomised cohort of the Syntax trial up to one year are presented with stratification by tertile group of the SYNTAX score. The weighted kappa value for the inter-observer reproducibility on the global score was 0.45, while the intra-observer weighted kappa value was 0.59. The SYNTAX score as calculated by investigators consistently underscored the corelab score by 3.4 points. When the Syntax randomised cohort was stratified by tertiles of the SYNTAX score, there were similar or non-significantly different MACCE rates in those with low or intermediate scores; however in the top tertile the MACCE rate was greater in those receiving PCI compared to CABG. CONCLUSIONS: The SYNTAX score is a visual coronary score with an acceptable corelab reproducibility that has an impact on the one-year outcome of those having PCI, whereas it has no effect on the one-year outcome following surgical revascularisation. The SYNTAX score tool is likely to be useful in a wide range of patients with complex coronary disease.

Annular-to-leaflet mismatch and the need for reductive annuloplasty in patients undergoing mitral repair for chronic mitral regurgitation due to mitral valve prolapse.

Annular dilation is a common feature of chronic degenerative mitral regurgitation caused by leaflet prolapse. Accordingly, patients undergoing surgical repair usually undergo concomitant reductive annuloplasty to restore a normal annular-to-leaflet relation. With the evolution of transcatheter valve repair technologies, patient selection criteria for those who do not require annuloplasty are needed. A series of patients undergoing mitral repair was analyzed, and the role of annular-to-leaflet mismatch in identifying patients requiring reductive annuloplasty was explored. Preoperative data for 82 patients undergoing mitral repair with annuloplasty for degenerative mitral regurgitation were prospectively collected, including annular intercommissural (IC) and septolateral (SL) dimensions and heights of anterior (ALH) and posterior leaflets. An SL/ALH ratio >1.4 was used to define annular-to-leaflet mismatch. After mitral repair, the ratio between preoperative IC distance and the size of the implanted annular prosthesis (Seguin ring [SR], IC/SR <1.2) was used to identify patients for whom annuloplasty was nonreductive. All patients underwent successful mitral repair. Mean preoperative IC was 46 +/- 6 mm, SL was 42 +/- 5 mm, and ALH was 31 +/- 5 mm. Mean SR was 34 +/- 3 mm, with a mean IC/SR ratio of 1.34 +/- 0.14. Sixteen patients (19%) had an IC/SR ratio <1.2. IC/SR ratio <1.2 was predicted by a SL/ALH ratio < or =1.4 (p = 0.009). In conclusion, annular dilation is negligible in <20% of surgical candidates. In this subgroup, an isolated leaflet repair may be indicated. SL/ALH ratio is a good indicator of annular-to-leaflet mismatch and could be used as an adjunct to other methods of annular function assessment to select patients for ringless mitral repair.

[Drug-eluting stents: from the results of clinical studies to economic simulation models in the Italian reality]. / Stent a rilascio di farmaco: dai risultati degli studi clinici ai modelli di impatto economico-sanitario nella realtà italiana.

Several studies with drug-eluting stents (DES) have demonstrated dramatic reductions in restenosis rates compared with bare metal stents (BMS). Although the clinical benefits of DES are increasingly evident, important concerns about their costs have been raised. Most data regarding the impact of restenosis on long-term costs after percutaneous coronary intervention (PCI) are derived from clinical trials. These studies demonstrate that there is no single cost or economic burden of restenosis; these values vary substantially according to the specific patient population under investigation and to the healthcare system reality where they are applied. In the present study we propose an economic interactive decision model which was applied to the Italian healthcare system, considering the different reimbursement rates of the Italian regions for DES and for both PCI and coronary artery bypass surgical interventions (CABG). The aim of this model was to simulate the impact of DES introduction after potential complete reimbursement by the national healthcare system, hypothesizing the usage of 1.4 stent per patient in case of single vessel disease and 2.4 stents in case of multivessel disease, and utilizing the TAXUS IV rate of revascularization for reintervention costs calculation and the ARTS-I study for CABG costs. For a low risk patients' population, the mean cost of a procedure with DES was 6% greater than utilizing BMS (xi 8125 for DES vs xi 7651 for BMS). However, this percentage was reduced in case of diabetic patients (+4%), long lesions (+2%) and was favourable for small vessels (-3%). In addition, in case of multivessel disease with conversion from CABG to DES, the 12 months cost per patients was reduced of around 30% (xi 10 170 for PCI vs xi 14 584 for CABG). This model suggests that national healthcare system may save 2.1% of the total costs (xi 18.60 millions) if 60% of revascularization procedures converts to total DES utilization and 15% from CABG to PCI with DES.