Management of Transcatheter Aortic Valve Implantation and Complex Aorta Anatomy: The Importance of Pre-Procedural Planning.

Aortic stenosis is the most common primary valve lesion requiring surgery or, especially for older patients, transcatheter intervention (TAVI). We showcase a successful transfemoral TAVI procedure in a very high-risk patient and an extremely tortuous S-shaped descending aorta, characterized by heavy calcifications and multiple strong resistance points. We demonstrated that transfemoral TAVI using the "buddy stiff guidewire" technique could be a feasible, simple, quick, and easy procedure able to straighten an extremely abdominal aorta tortuosity. With all techniques available and careful pre-procedural planning, and thanks to the flexibility of new generation TAVI delivery systems, it is possible to safely perform the procedure even in the most challenging patients.

Long-term results of the randomized comparison of everolimus-eluting stents and sirolimus-eluting stent in patients with ST elevation myocardial infarction (RACES-MI trial).

BACKGROUND: Several concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES), especially in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). New generation DES have demonstrated reduction in ST at mid-term follow-up, however no data are available on long-term follow-up. Therefore, the aim of this study was to report long-term results of the RACES-MI trial conducted to compare Everolimus-Eluting Stent (EES) vs Sirolimus-Eluting Stent (SES) in patients undergoing primary PCI. METHODS: The RACES-MI trial enrolled consecutive STEMI patients admitted within 12h of symptom onset, undergoing primary PCI with stent implantation at a tertiary center with 24-hour primary PCI capability, who were randomly assigned to SES or EES. Primary endpoint of this analysis is major adverse cardiac events (MACE) at long-term follow-up. Secondary endpoints are 1) death; 2) reinfarction; 3) definite or probable ST; 4) target-vessel revascularization (TVR) at long-term follow-up. RESULTS: From April 2007 to May 2009 500 patients with STEMI were randomized to EES (n=250) or SES (n=250). No difference was observed between the groups either in baseline clinical characteristics, in the number of implanted stent or total stent length per patient. However, a larger reference diameter was observed with SES (3.35±0.51 mm vs 3.25±0.51 mm, p=0.001), whereas patients randomized to EES received Gp IIb-IIIa inhibitors more often (54.4% vs 42.4%, p=0.006). At long-term follow-up (2132±528 days), EES was associated with a significant reduction in MACE (23.8 vs 34.1%, adjusted p=0.028), ST (2.5% vs 7.7%, adjusted p=0.009), without any difference in death (8.7% vs 11.4%, adjusted p=0.47), reMI (9.3% vs 13.1%; adjusted p=0.18) and TVR (8.6% vs 12.3%, adjusted p=0.31). CONCLUSIONS: This study shows that among STEMI patients undergoing primary PCI EES, as compared to SES, is associated with significant reduction in MACE and ST at long-term follow-up.

Impact of diabetes on the benefits from everolimus-eluting stent as compared to first-generation drug-eluting stent in patients with ST elevation myocardial infarction.

BACKGROUND: Drug-eluting stent has been shown to reduce the risk of repeated revascularization. However, as shown for first-generation drug-eluting stent, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction patients. In addition, diabetes has been shown to be an independent predictor of poor survival and repeated target vessel revascularization. No data have been reported so far on the long-term benefits and safety of new-generation drug-eluting stent in ST-segment elevation myocardial infarction according to diabetes. Therefore, the aim of this study was to evaluate whether diabetes may impact on the benefits from everolimus-eluting stent versus first-generation drug-eluting stent in patients undergoing primary angioplasty. METHODS: We combined data from two randomized trials (PaclitAxel or Sirolimus-Eluting Stent vs Bare-Metal Stent in Primary Angioplasty and randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction) including consecutive ST-segment elevation myocardial infarction patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation at a tertiary centre with 24-h primary percutaneous coronary intervention capability. Primary endpoint of this study was major adverse cardiac events at 3-year follow-up. Secondary endpoints were as follows: (1) death, (2) reinfarction, (3) definite or probable ST and (4) target vessel revascularization at 3-year follow-up. No patient was lost to follow-up. RESULTS: Our population is represented by 680 ST-segment elevation myocardial infarction patients treated with drug-eluting stent (180 enrolled in the PaclitAxel or Sirolimus-Eluting Stent vs Bare-Metal Stent in Primary Angioplasty trial, treated with first-generation drug-eluting stent, and 500 patients in the randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction, randomized to everolimus-eluting stent or sirolimus-eluting stent). Diabetes was observed in a total of 178 patients (26.1%) and associated with higher major adverse cardiac events, mortality, reinfarction, stent thrombosis and target vessel revascularization. Similar outcome was observed in terms of overall major adverse cardiac events, mortality, recurrent myocardial infarction, target vessel revascularization, with everolimus-eluting stent as compared to first-generation drug-eluting stent in both diabetic and non-diabetic patients, whereas everolimus-eluting stent was associated with a significantly lower rate of stent thrombosis only in diabetic patients (1.6% vs 9.6%, hazard ratio (95% confidence interval) = 0.15 (0.02-0.98), p = 0.04) whereas no difference was observed in non-diabetic patients. CONCLUSION: This study shows that among ST-segment elevation myocardial infarction patients undergoing primary angioplasty, diabetes is associated with a significantly worse outcome at 3-year follow-up. A similar outcome was observed between everolimus-eluting stent and first-generation drug-eluting stent in non-diabetic patients, whereas among diabetic patients everolimus-eluting stent was associated with a significant reduction in stent thrombosis.

Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial.

OBJECTIVES: The aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty. BACKGROUND: Drug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI. METHODS: Consecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up. RESULTS: From April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035). CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982).

Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome.

Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an "off-label" use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.

"Tako-tsubo" cardiomyopathy and duloxetine use.

We report the case of a 68-year-old woman in whom the use of duloxetine, a potent serotonin and norepinephrine reuptake inhibitor, was associated with "tako-tsubo" cardiomyopathy (TTC). Although several pathophysiological mechanisms for TTC have been proposed, available evidence suggests that an excess of catecholamines may play a major role. Our patient had a history of myocardial infarction with normal coronary arteries, probably the first manifestation of TTC. We speculate that duloxetine may have precipitated TTC by increasing plasma catecholamine concentration in a predisposed patient.

Impact of diabetes on long-term outcome in STEMI patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors and BMS or DES.

Diabetes has been shown to be associated with worse survival and repeat revascularization (TVR) after primary angioplasty. Drug-eluting stent (DES) may offer benefits in terms of TVR, that may be counterbalanced by an higher risk of stent thrombosis, especially among STEMI patients. Aim of the current study was to evaluate the impact of diabetes on 5-year outcome in patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors in the era of DES. Our population is represented by STEMI patients undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary PCI capability within 12 h of symptom onset. All patients received glycoprotein IIb-IIIa inhibitors. No patient was lost to follow up. From 2003 to 2005, 270 STEMI patients were treated with DES (n = 180), or BMS (n = 90). A total of 69 patients had history of diabetes at admission (25.5%). At a follow-up of 1510 +/- 406 days, diabetes was associated with a higher rate of death (29.5 vs. 5.1%, P < 0.0001), reinfarction (24.1 vs. 9.1%, P < 0.0001), TVR (19.1 vs. 13.1%, P = 0.052), IST (17.2 vs. 6.8%, P < 0.001) and MACE (51.9 vs. 25.1%, P < 0.001). These results were confirmed in both patients receiving BMS or DES, except for TVR, where no difference was observed between diabetic and non-diabetic patients. This study shows that among STEMI patients undergoing primary angioplasty with Gp IIb-IIIa inhibitors, diabetes is associated with worse long-term mortality, reinfarction, and IST, even with DES implantation, that, however, were able to equalize the outcome in terms of TVR as compared to non diabetic patients.

Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial.

BACKGROUND: Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty. METHODS AND RESULTS: Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization. CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.

Valve surgery in octogenarians: in-hospital and long-term outcomes.

BACKGROUND: Global population aging and greater age-related incidence of ischemic, degenerative and calcific valve disease have led to an increasing number of very elderly patients being referred for valve surgery. However, their preoperative risk factors, and in-hospital and long-term outcomes have not been thoroughly investigated. METHODS: Three hundred seven consecutive patients 80 years and older (60% female; mean age 83+/-2.4 years) attending three major Italian cardiac centres to undergo valve surgery were evaluated. Seventy-nine patients underwent mitral valve surgery (isolated n=30, combined n=49) and 228 underwent aortic valve surgery (isolated n=134, combined n=94). RESULTS: The most frequent in-hospital complications were atrial arrhythmias, need for inotropic support for more than 48 h, renal insufficiency, congestive heart failure, respiratory failure, and stroke or transient ischemic attack. The in-hospital mortality rate was 9.7% (30 of 307). Multivariate logistic regression identified the following clinical variables as predictors of in-hospital death: New York Heart Association functional class IV, diabetes, hypertension, renal insufficiency at presentation, rheumatic etiology and left ventricular ejection fraction of less than 45%. Late mortality occurred in 45 of 277 patients (16.2%), but there was a substantial improvement in the New York Heart Association functional class of the 232 long-term survivors (from 3.0+/-0.7 to 1.7+/-0.6; P<0.0001). CONCLUSIONS: Surgery seems to be an effective therapeutic option for selected symptomatic octogenarians with valve disease, associated with good long-term survival and an improved functional class. Operative mortality is related more to patients' preoperative clinical status and increased comorbidity than the type of surgery per se.

Axillary artery access for interventional procedures.

PURPOSE: To evaluate axillary artery access for the interventional treatment of carotid or splanchnic arteries that have angulated takeoff or complex anatomy when larger catheters (up to 9 F) are needed. TECHNIQUE: The axillary artery approach was used to treat the left internal carotid artery (ICA) in 3 patients (2 angulated takeoffs and 1 bovine arch) and a celiac axis aneurysm. An 8-F, 45-cm-long introducer sheath was inserted for the carotid procedures, whereas a 9-F, 90-cm sheath was chosen for the celiac aneurysm. Cerebral protection and stenting were successfully performed in all carotid patients; an 8x40-mm stent-graft was implanted to exclude the celiac artery aneurysm. An 8-F vascular closure device was used in the axillary arteries; hemostasis was immediate, and no hematoma or other complications were recorded in follow-up. CONCLUSIONS: This preliminary experience revisits the axillary approach as an alternative access route for interventional procedures. In association with a vascular closure device, this approach should be considered as a useful and safe option for those interventional procedures in which larger sheaths or catheters are required to cope with difficult arterial anatomies.

[Unstable carotid plaque: biochemical and cellular marker of vulnerability]. / La placca carotidea instabile: marker bioumorali e cellulari di vulnerabilità.

Stroke is the second most common cause of death in developed countries. Carotid plaque disruption and distal embolization of atheromatous debris are the most common pathogenic mechanisms for cerebral ischemia from carotid atherosclerotic disease. Morphologic composition of the atherosclerotic plaque, rather than the stenotic severity, appears to be central in determining the risk of both plaque rupture and subsequent thrombosis. Histologic features of vulnerable plaques include a large lipid core, a thin fibrous cap, intraplaque hemorrhage, and an increased number of inflammatory cells, mostly monocyte-macrophages. Due to the catastrophic implications of thrombus formation and embolization on the arterial plaque, detection before major neurologic events occur is now a major goal of cardiovascular clinicians and researchers. New detection imaging techniques such as intravascular thermography, optical coherence tomography, photonic spectroscopy, and elastography have been developed in order to document atherosclerotic lesion composition. This review will focus on the new possibilities under investigation for vulnerable atherosclerotic carotid plaque detection by means of the serologic markers of plaque instability. New markers, such as pregnancy-associated protein A, P-selectin, interleukin-6 and interleukin-12, metalloproteinases, lipoprotein(a), and oxidation products have been reviewed. Most of the promising serologic markers in this article are still in a nascent phase of development and remain to be validated in clinical settings. However, these biohumoral markers, and their potential combination of techniques, may hold promise for the future characterization of the vulnerable plaque and moreover of the vulnerable patient.

Echocardiographic assessment of overt or latent unexplained pulmonary hypertension.

Primary (idiopathic or unexplained) pulmonary hypertension is a rare disease of the pulmonary vasculature characterized by sustained elevation of pulmonary artery pressure, normal pulmonary artery wedge pressure and absence of secondary causes. Because of the nonspecific nature of early symptoms and physical findings, the diagnosis, essentially one of exclusion, is often made in the later stages of primary pulmonary hypertension. Echocardiography, providing an accurate noninvasive estimate of pulmonary pressure at rest and during exercise, is an essential component in the initial assessment and serial evaluation of patients with primary pulmonary hypertension. Furthermore, it is important to monitor the efficacy of specific therapeutic interventions, to estimate the prognosis and to detect preclinical stages of this disease.