Left ventricular reverse remodeling after transcatheter aortic valve implantation: a cardiovascular magnetic resonance study.

BACKGROUND: In patients with severe aortic stenosis, left ventricular hypertrophy is associated with increased myocardial stiffness and dysfunction linked to cardiac morbidity and mortality. We aimed at systematically investigating the degree of left ventricular mass regression and changes in left ventricular function six months after transcatheter aortic valve implantation (TAVI) by cardiovascular magnetic resonance (CMR). METHODS: Left ventricular mass indexed to body surface area (LVMi), end diastolic volume indexed to body surface area (LVEDVi), left ventricular ejection fraction (LVEF) and stroke volume (SV) were investigated by CMR before and six months after TAVI in patients with severe aortic stenosis and contraindications for surgical aortic valve replacement. RESULTS: Twenty-sevent patients had paired CMR at baseline and at 6-month follow-up (N=27), with a mean age of 80.7±5.2 years. LVMi decreased from 84.5±25.2 g/m2 at baseline to 69.4±18.4 g/m2 at six months follow-up (P<0.001). LVEDVi (87.2±30.1 ml /m2vs 86.4±22.3 ml/m2; P=0.84), LVEF (61.5±14.5% vs 65.1±7.2%, P=0.08) and SV (89.2±22 ml vs 94.7±26.5 ml; P=0.25) did not change significantly. CONCLUSIONS: Based on CMR, significant left ventricular reverse remodeling occurs six months after TAVI.

Isolated bicuspid pulmonary valve in adult diagnosed by three-dimensional transthoracic echocardiography.

Isolated bicuspid pulmonary valve is a rare arterial valve anomaly with very few reports in the literature, which regard overall cases of postmortem diagnosis. However, the true incidence of bicuspid pulmonary valve could be underestimated because of the difficulty in imaging pulmonary valve morphology with conventional two-dimensional transthoracic echocardiography (TTE). We report a case of isolated bicuspid pulmonary valve in an adult diagnosed by three-dimensional TTE. Off line multidimensional analysis of full-volume 3D allowed to obtain a short axis view of pulmonary valve showing a bicuspid valve characterized by an anterior and a posterior cups, normally thickened and with preserved systolic opening.

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.

Cardiovascular magnetic resonance for the assessment of patients undergoing transcatheter aortic valve implantation: a pilot study.

BACKGROUND: Before trans-catheter aortic valve implantation (TAVI), assessment of cardiac function and accurate measurement of the aortic root are key to determine the correct size and type of the prosthesis. The aim of this study was to compare cardiovascular magnetic resonance (CMR) and trans-thoracic echocardiography (TTE) for the assessment of aortic valve measurements and left ventricular function in high-risk elderly patients submitted to TAVI. METHODS: Consecutive patients with severe aortic stenosis and contraindications for surgical aortic valve replacement were screened from April 2009 to January 2011 and imaged with TTE and CMR. RESULTS: Patients who underwent both TTE and CMR (n = 49) had a mean age of 80.8 ± 4.8 years and a mean logistic EuroSCORE of 14.9 ± 9.3%. There was a good correlation between TTE and CMR in terms of annulus size (R2 = 0.48, p < 0.001), left ventricular outflow tract (LVOT) diameter (R2 = 0.62, p < 0.001) and left ventricular ejection fraction (LVEF) (R2 = 0.47, p < 0.001) and a moderate correlation in terms of aortic valve area (AVA) (R2 = 0.24, p < 0.001). CMR generally tended to report larger values than TTE for all measurements. The Bland-Altman test indicated that the 95% limits of agreement between TTE and CMR ranged from -5.6 mm to + 1.0 mm for annulus size, from -0.45 mm to + 0.25 mm for LVOT, from -0.45 mm2 to + 0.25 mm2 for AVA and from -29.2% to 13.2% for LVEF. CONCLUSIONS: In elderly patients candidates to TAVI, CMR represents a viable complement to transthoracic echocardiography.

Impact of diabetes mellitus on long-term follow-up of percutaneous coronary intervention based on clinical presentation of coronary artery disease.

AIMS: In the drug-eluting stent (DES) era, diabetes mellitus is still associated with poor clinical and angiographic outcome after PCI. Whether this phenomenon is exacerbated in the setting of acute coronary syndromes (ACS) is unclear. We investigated the long-term interaction of diabetes mellitus and clinical presentation in patients treated with percutaneous coronary intervention (PCI). METHODS: Consecutive patients undergoing PCI and DES implantation were retrospectively analyzed. The 3-year composite of death, non-fatal myocardial infarction (MI) or target vessel revascularization (TVR) was assessed. RESULTS: Four subgroups of patients were identified: diabetes mellitus and ACS (n = 302); diabetes mellitus and no-ACS (n = 191); no-diabetes mellitus and ACS (n = 573); no-diabetes mellitus and no-ACS (n = 396). Compared to non-diabetes mellitus, diabetes mellitus patients experienced higher 3-year rates of death, non-fatal MI or TVR (32.3 vs. 21.9%, P < 0.001). Diabetes mellitus was significantly associated with the composite of death, non-fatal MI or TVR in the no-ACS group [adjusted hazard ratio (AHR) 1.307, 95% confidence interval (CI) 1.090-1.566, P = 0.004] and, albeit to a lesser extent, in the ACS group (AHR 1.177, 95% CI 1.006-1.377, P = 0.041). No statistically significant interaction was observed between diabetes mellitus and clinical presentation (P for interaction = 0.802). CONCLUSIONS: No significant interaction between diabetes mellitus and clinical presentation was noted in this study. The high rates of cardiac events observed in diabetes mellitus patients despite recent advances in interventional techniques outline the need for a multidisciplinary approach in the management of diabetes mellitus patients, including optimization of glycemic control, aggressive medical therapy and more complete coronary revascularization.

Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient.

OBJECTIVES: Strut coverage represents the most powerful morphometric predictor of stent thrombosis and the best surrogate indicator of endothelization. The aim of this study was to get new insights on temporal patterns of vessel healing after stenting with different types of stent. METHODS: Optical coherence tomography (OCT) was used to investigate the early strut coverage of lesions treated with CATANIA (CAT) stent, drug-eluting stent (DES) or cobalt-chromium bare metal stent (BMS). Two cohorts of 10 and 24 patients underwent OCT follow-up at 7-10 and 28-32 days after stenting, respectively. In each cohort, patients were randomly assigned to receive a CAT stent in one lesion and a BMS or a DES in a separate lesion. RESULTS: A total of 7975 and 8406 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 7-10 days, respectively. A total of 21 123 and 25 069 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 28-32 days, respectively. At 7-10 days, the CAT stent showed higher coverage rates compared with DES (90.0 vs. 85.9%, P < 0.0001) and BMS (90.2 vs. 83.6%, P < 0.0001). Similarly, at 28-32 days, the coverage rate was higher with CAT stent compared with DES (97.7 vs. 90.5%, P < 0.0001) and BMS (97.2 vs. 96.5%, P < 0.0001). CONCLUSION: The CAT stent yields quicker and more complete strut coverage than DES and BMS in the early phases of vessel healing following stent implantation.

Long-term outcomes after drug-eluting stent for the treatment of ostial left anterior descending coronary artery lesions.

BACKGROUND: Although drug-eluting stents (DES) have reduced restenosis in a broad range of lesions, there is limited data, from relatively small studies, on the safety and efficacy of DES for isolated ostial left anterior descending (LAD) stenoses. In addition, in the setting of these high-risk lesions, there is the issue of the potential involvement of the left main (LM) bifurcation, requiring subsequent revascularization for a lesion involving this critical location. METHODS: Patients with a de novo isolated unprotected ostial LAD stenoses treated with DES were included. Evaluated end points were cardiac death, nonfatal myocardial infarction, overall target lesion revascularization (TLR), and the reintervention for a restenotic lesion located at the LM segment adjacent to the stent (TLR-LM). RESULTS: A total of 162 patients were included: 95 underwent focal ostial LAD stenting and 67 stenting from the distal LM into the LAD ostium. The 2-year Kaplan-Meier estimates of cardiac death, nonfatal myocardial infarction, overall TLR, and TLR-LM were 2.6%, 2.1%, 8.3%, and 4.7%, respectively. Overall TLR and TLR-LM rates were higher in the focal ostial LAD stenting group. There was a trend toward an independent increased risk of TLR associated with focal ostial stenting. In addition, final minimal luminal diameter trended to be independently associated with TLR. CONCLUSION: The present study showed that DES for isolated ostial LAD lesions is a feasible, safe, and effective treatment strategy. In addition, this study suggested the hypothesis that a default distal LM-LAD stenting, rather than focal ostial stenting, might provide more favorable outcomes. Nevertheless, larger specifically designed studies are needed.

Plaque distribution patterns in distal left main coronary artery to predict outcomes after stent implantation.

OBJECTIVES: The aim of this study was to investigate the association between plaque distribution at left main (LM) bifurcation and target lesion revascularization (TLR) after stenting. BACKGROUND: Despite favorable reported mid- and long-term results, stent implantation on LM bifurcation remains challenging. The role of atherosclerotic plaque distribution in affecting LM bifurcation stenting outcomes has not been explored. METHODS: A total of 329 patients undergoing LM bifurcation stenting in 2 centers were included. A method based on different plaque locations within the bifurcation area was applied. The overall population was divided in 2 groups according to the presence of a specific pattern characterized by plaque occupying (n = 145) or not occupying (n = 184) the whole bifurcation (WB) area. RESULTS: Baseline clinical, angiographic, and procedural characteristics were well-balanced between the 2 groups. The WB group showed a significantly higher risk of 3-year TLR compared with the non-WB group (24.9% vs. 8.3%; unadjusted hazard ratio: 3.12; 95% confidence interval: 1.59 to 6.11; p = 0.001; adjusted hazard ratio: 2.84; 95% confidence interval: 1.43 to 5.64; p = 0.003). The 3-year TLR rate was not significantly different between patients treated with 1-or 2-stent techniques either in the WB or non-WB groups. In the WB group, TLR was similar between patients with lesions classified as 1,1,1 and non-1,1,1 by the Medina classification (20.7% vs. 26.8%, p = 0.57, respectively). CONCLUSIONS: The WB pattern is associated with enhanced TLR risk, regardless of stent technique and plaque severity. This could impact the treatment strategy of high-risk lesions involving the whole bifurcation area.

Sirolimus versus paclitaxel-eluting stents in small coronary vessels: long-term outcomes from a single-center registry.

OBJECTIVE: Several studies showed that small vessel diameter is a determinant of increased risk of adverse events after stenting. The efficacy of different drug-eluting stent types implanted in small vessels has still not been established. The aim of the present observational study was to compare long-term clinical outcomes after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation in lesions located in small coronary vessels. METHODS: For the purpose of this analysis patients undergoing SES or PES implantation in vessels with diameter 2.5 mm or less, from May 2002 to December 2006, were included. Long-term rates of major adverse cardiac events were evaluated and compared between the two groups. Independent predictors of major adverse cardiac events were also investigated. RESULTS: A total of 336 patients were included, 225 were treated only with SES and 111 only with PES. During a mean follow-up of 23.3 +/- 12.1 months the major adverse cardiac events rates were 12.8 versus 13.6%, P = 0.98 in SES versus PES groups, respectively. The rates of target lesion revascularization (8.0 versus 6.3%, P = 0.75), mortality (3.5 versus 4.5%, P = 0.88) and myocardial infarction (2.6 versus 4.5%, P = 0.41) were similar between SES and PES, respectively. The overall thrombosis rate was also not significantly different in SES and PES groups (1.3% SES versus 4.5% PES, P = 0.12). CONCLUSION: In this study SES and PES provided similar long-term results after treatment of lesions in small vessels. Nevertheless, larger randomized studies are needed to confirm these findings.

EuroSCORE refines the predictive ability of SYNTAX score in patients undergoing left main percutaneous coronary intervention.

BACKGROUND: Whether SYNTAX score should be used as a stand-alone tool or whether its performance may be improved by the parallel use of clinical scores focusing on comorbidities, such as EuroSCORE, is a matter of debate. METHODS: A combined risk model including both clinical and angiographic information was developed, and its performance tested on a contemporary population of 255 patients with left main disease undergoing percutaneous coronary intervention (PCI). A global risk classification (GRC) system was created by combination of SYNTAX score and EuroSCORE strata, and new classes of risk were defined. RESULTS: When EuroSCORE was fitted into the SYNTAX score model, c-statistic increased from 0.681 to 0.732 for the prediction of cardiac mortality. The likelihood ratio test for the significance of adding the EuroSCORE term to the model was chi(2) = 4.109 (P = .043) with a net reclassification improvement of 26% (P = .002). GRC showed the best prediction and discriminative ability in terms of two-year cardiac mortality (HR 3.40, 95% CI 1.79-6.43, P < .001; c-statistic 0.756) as compared with SYNTAX score (HR 2.87, 95% CI 1.35-6.10, P = .006; c-statistic 0.747) and EuroSCORE (HR 3.04, 95% CI 1.41-6.57, P = .005; c-statistic 0.708) alone. CONCLUSIONS: We found a significant improvement in the prediction of cardiac mortality with the inclusion of EuroSCORE in a SYNTAX score-based model. The degree of reclassification between treatment threshold categories indicates that clinical and angiographic information are both important for assessing individual risk of patients undergoing left main PCI.

Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial: rationale, objectives and design.

BACKGROUND: Novel approaches to modify stents have been developed to address the limitations of bare-metal stents (BMS) and drug-eluting stent (DES), aiming for ideal features, such as decreased restenosis rates with decreased thrombogenicity and without the need for long-term dual antiplatelet therapy. RATIONALE: The Assessment of The LAtest Non-Thrombogenic Angioplasty Stent (ATLANTA) trial was the first-in-man study to show the safety and efficacy of the Polyzene-F coated CATANIA stent (CeloNova BioSciences, Newnan, Georgia, USA) as an alternative to both BMS and DES. The stent was found to be associated with a good clinical outcome with no vessel thrombosis and a modest growth of late neointima. A subgroup undergoing optical coherence tomography late assessment showed almost complete stent strut coverage at 6 months. However, whether the CATANIA stent is superior in promoting a greater stent strut coverage rate both at 7 and 30 days with respect to DES and BMS is unknown. METHODS: The Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial will be a prospective, randomized study providing new evidence on early vessel healing and thrombus development after stenting with different stent types. Optical coherence tomography examination at 7-10 days or 28-32 days after implantation will evaluate strut coverage and vessel healing. The primary endpoint will be a comparison of the percentage of 'healed stent struts' at 28-32 days, identified by the presence of an evenly apposed rim of tissue on stent struts, and without apposition of thrombotic material, on the total amount of analyzed struts for the stent groups.

Early and mid-term clinical outcomes with the CATANIA coronary stent system vs. bare metal stents in patients with coronary artery disease.

BACKGROUND: The potential for the CATANIA (CAT) stent to be an alternative to both bare-metal stents (BMS) and drug-eluting stents (DES) has been recently demonstrated in the Assessment of The LAtest Non-Thrombogenic Angioplasty stent (ATLANTA) first-in-human study. The aim of the present study was to compare short-term outcomes of patients treated with the CAT stent with those treated with BMS. METHODS: Based on an internal registry, the 30-day and 6-month risk-adjusted outcomes for patients who received the CAT stent (n=254) were compared against outcomes of a historical cohort of patients who received BMS (n=552) between January 2001 and December 2001. RESULTS: At 30 days, use of BMS vs. the CAT stent resulted in borderline significant differences with respect to major adverse cardiac and cerebrovascular events (MACCE) and cardiac death or myocardial infarction. At 6 months, BMS showed a statistically significant higher adjusted risk of MACCE (HR 2.79, 95% CIs 1.20-6.48, P=.017) and no differences with respect to the subcomponent end points. The cumulative incidence of definite stent thrombosis (Academic Research Consortium defined) at 6 months was 0.39% for the CAT stent and 2.35% for the BMS. CONCLUSIONS: This study confirms the favorable early and mid-term safety profile and the high-level efficacy of the CAT stent in the treatment of de novo coronary lesions seen in the ATLANTA trial. The use of stents with a nanothin Polyzene-F surface treatment provided improved results with respect to BMS and lower risk of acute and subacute stent thrombosis.

Long-term outcomes comparison of different types of DES in elderly patients from a real-world experience.

OBJECTIVE: We sought to evaluate the impact on long-term clinical outcomes of different types of drug-eluting stents (DES) in elderly patients. BACKGROUND: Elderly patients constitute a fast-growing portion of cardiovascular patients, however, they are not adequately represented in clinical trials. Moreover, few data comparing different type of DES in elderly patients are available. METHODS: From a total of 2,330 consecutive patients treated at our institution with DES, we selected 207 elderly patients (> or = 75 years of age) who underwent, from May 2002 to December 2006, sirolimus-eluting stent (SES group, 116 patients [pts], 56%) or paclitaxel-eluting stent (PES group, 91 pts, 43.9%) implantation. We evaluated the 24-month incidence of major adverse cardiac events (MACE). RESULTS: Higher rates of hypertension (78.4% vs. 90.1%; p = 0.01), diabetes (37.9 vs. 45.1; p = 0.01) and previous coronary artery bypass grafts (10.3% vs. 19.4%; p = 0.04) in the PES group were observed, whereas in the SES group, there were more smokers (26.6% vs. 12.1%; p = 0.007) and a higher incidence of previous myocardial infarction (MI) (50% vs. 35.2%; p = 0.02). Procedural success and in-hospital MACE were similar in both groups. At follow up, there was a higher incidence of MACE (22.4% vs. 10.9%; p = 0.04) and target lesion revascularization (7.1% vs. 3.0%; p = 0.02) in the SES group compared to the PES group. The incidence of cardiac death and MI were comparable between the two groups, as well as the rate of stent thrombosis. After adjustment for clinical and angiographic characteristics, no significant differences in outcomes were observed between SES and PES. CONCLUSIONS: In this real-word experience, no significant differences were found in the safety and efficacy profiles between SES and PES use in elderly patients.

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.