Giovanni Schiavoni

Long-Term Results of the Radial Artery Used for Myocardial Revascularization

Background—No information is available on the long-term results of radial artery (RA) grafts used as coronary artery bypass conduits. Methods and Results—In this report, we describe the long-term (105±9 months) angiographic results of a series of 90 consecutive patients in whom the RA was used as a coronary artery bypass conduit directly anastomosed to the ascending aorta. The long-term patency and perfect patency rates of the RA were 91.6% and 88%, respectively, versus 97.5% and 96.3% for internal thoracic artery grafts. The severity of stenosis of the target vessel clearly influenced long-term RA patency, whereas location of the target vessel and long-term use of calcium channel blockers did not influence angiographic results. Preserved endothelial function and absence of flow-limiting, fibrous, intimal hyperplasia were also documented. Conclusions—Ten years after surgery, RA grafts have excellent patency and perfect patency rates. Appropriate surgical technique and correct indication are the key factors for long-term RA patency.

EuroSCORE as predictor of in-hospital mortality after percutaneous coronary intervention

Objective: To date, no common risk stratification system is available to predict the risk of surgical or percutaneous myocardial revascularisation in patients with coronary artery disease (CAD). Thus, we sought to assess the European System for Cardiac Operative Risk Evaluation (EuroSCORE) validity to predict in-hospital mortality after percutaneous coronary intervention (PCI). Design, setting and participants: EuroSCORE was prospectively and systematically assessed in 1173 consecutive patients undergoing PCI in a high-volume single centre between April 2005 and October 2006. Main outcome measure: The receiver-operating characteristics (ROC) curve was used to describe performance and accuracy of the EuroSCORE risk model for the prediction of in-hospital mortality after PCI. Results: The EuroSCORE model demonstrated an overall relation between EuroSCORE rank and the incidence of in-hospital mortality, showing consistency in predicting patient risk across many subgroups and levels of global risk. At multivariable logistic regression analysis the EuroSCORE value was an independent in-hospital mortality predictor (p = 0.002) together with left main disease (p = 0.005), procedural urgency (p = 0.001), ACC/AHA C type lesion (p = 0.02) and PCI failure (p = 0.01). The area under the ROC curve for the EuroSCORE system was 0.91 (95% CI 0.86 to 0.97), indicating a good ability of the model to discriminate patients at risk of dying during the index hospitalisation. Conclusion: The EuroSCORE risk model, already extensively validated for the prediction of early mortality following open-heart surgery, can also be efficiently utilised in the setting of PCI. The introduction of the EuroSCORE assessment in patients with documented CAD may help to improve the revascularisation strategy decision-making process.

Prospective Randomized Comparison of Sirolimus- or Everolimus-Eluting Stent to Treat Bifurcated Lesions by Provisional Approach

OBJECTIVES This study sought to compare the procedural performance and the acute angiographic result on side-branch ostium obtained using 2 different drug-eluting stents (DES) to treat patients with bifurcated coronary lesions. BACKGROUND Drug-eluting stents are routinely used in percutaneous coronary interventions (PCI) of bifurcated coronary lesions. Different DES types have major technical differences that may influence the procedural and clinical performance in bifurcation PCI. METHODS Consecutive patients with bifurcated lesions undergoing DES implantation using a systematic provisional-stenting strategy were randomized to sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) before intervention. The procedural details for PCI were prospectively recorded to assess the occurrence of any trouble in the side-branch (SB) management (primary end point). Post-PCI angiographic result (primary end point: minimal lumen diameter at SB ostium) was evaluated offline by 3-dimensional reconstruction and quantitative coronary analysis. Clinical outcome was prospectively recorded up to 18 months to assess the occurrence of target bifurcation failure. RESULTS A total of 150 patients were enrolled in the study (29% diabetics, 17% unprotected left main). The stent was successfully implanted according to randomization in all cases. Procedural performance was not significantly different between the 2 kinds of DES. Three-dimensional reconstruction and quantitative coronary analysis showed similar post-PCI results in the main vessel and better results in the SB with EES than with SES (minimal lumen diameter at SB ostium: 1.94 ± 0.72 mm vs. 1.64 ± 0.62 mm; p = 0.013). At 18 months, target bifurcation failure occurred in 7 (9.0%) of SES-treated patients versus 8 (10.7%) of EES patients (p = 0.57). CONCLUSIONS In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3-dimensional reconstruction and quantitative coronary analysis result in the SB. Both DES are associated with low rates of major adverse events and angiographic failure. (Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical Significance of Residual Side-Branch Stenosis [SEA-SIDE]; NCT00697372).

Relation Between Platelet Response to Exercise and Coronary Angiographic Findings in Patients With Effort Angina

Background—Platelet reactivity is increased by exercise in patients with obstructive coronary artery disease (CAD) but not in patients with syndrome X. In this study, we prospectively investigated whether the platelet response to exercise might help distinguish, among patients with angina, those with obstructive CAD from those with normal coronary arteries (NCAs). Methods and Results—Venous blood samples were collected before and 5 minutes after exercise from 194 consecutive patients with stable angina. Platelet reactivity was measured by the platelet function analyzer (PFA)-100 system as the time for flowing whole blood to occlude a collagen-adenosine diphosphate ring (closure time). Coronary angiography showed CAD in 163 patients (84%) and NCA in 31 patients (16%). Baseline closure time was shorter in NCA patients (78.0±16 versus 95.5±23 seconds, P <0.0001). With exercise, closure time decreased in CAD patients (−15.5 seconds; 95% confidence limits [CL], −13.0 to −18.0 seconds;P <0.0001), but increased in NCA patients (12.5 seconds; 95% CL, 7.4 to 17.7 seconds;P =0.0004). An increase in closure time with exercise ≥10 seconds had 100% specificity and positive predictive value for NCAs. Similarly, a decrease ≥10 seconds had 100% specificity and positive predictive value for CAD. A closure time change (increase or decrease) ≥10 seconds allowed a correct classification of 55% of all patients. Conclusions—Among patients with stable angina, the response of platelet reactivity to exercise was predictive of normal or stenosed coronary arteries at angiography. Specifically, an increase in closure time with exercise ≥10 seconds was invariably associated with the presence of NCA.

Arterial Versus Venous Bypass Grafts in Patients With In-Stent Restenosis

Background—In patients who develop in-stent restenosis, successful revascularization can be difficult to achieve using percutaneous methods. This study was designed to verify the surgical results in this setting and to evaluate the potential beneficial role of arterial bypass conduits. Methods and Results—Sixty consecutive coronary artery bypass patients with previous in-stent restenosis and 60 control cases were randomly assigned to receive an arterial conduit (either right internal thoracic or radial artery; study group) or a great saphenous vein graft (control group) on the first obtuse marginal artery to complete the surgical revascularization procedure. At a mean follow-up of 52±11 months, patients were reassessed clinically and by angiography. Freedom from clinical and instrumental evidence of ischemia recurrence was found in 19 of 60 subjects in the study group versus 45 of 60 in the control series (P=0.01). The results of the arterial grafts were excellent in both the study and control groups (right internal thoracic artery patency rate, 19 of 20 for both, and radial artery patency rate, 20 of 20 versus 19 of 20; P=0.99). Saphenous vein grafts showed lower patency rate than arterial grafts in both series and had extremely high failure rate in the study group (patency rate, 10 of 20 in the study group versus 18 of 20 in the control group; P=0.001). Use of venous graft was an independent predictor of failure in the study group, whereas hypercholesterolemia was associated with graft failure in both series. Conclusions—Venous grafts have an high incidence of failure among cases who previously developed in-stent restenosis, whereas the use of arterial conduits can improve the angiographic and clinical results. Arterial grafts should probably be the first surgical choice in this patient population.

Assessment of left atrial dimensions by cross sectional echocardiography in patients with mitral valve disease.

Left atrial dimensions were measured using cross sectional echocardiography in 37 patients with mitral valve disease and 30 normal subjects of similar ages. The anteroposterior (AP), superior-inferior (SI), and medial-lateral (ML) left atrial dimensions were determined at the end of ventricular systole using parasternal long and short axis and apical four chamber views (for SIa and MLa). To assess the reliability of these measurements cross sectional echocardiographic and angiographic left atrial volumes were compared in 19 patients with mitral valve disease, giving an excellent correlation. A moderate correlation was found between the anteroposterior dimension of the left atrium obtained using M mode echocardiography and that obtained using the parasternal short axis and long axis projections. In normal subjects a good correlation was found between SI and ML dimensions, while a lower correlation was found between SI and AP, and ML and AP dimensions. The SI dimension was the major axis of the left atrium and AP dimension the minor axis. In patients with mitral valve disease a good correlation was found between SI and ML dimensions, while SI and ML dimensions had a low correlation with AP dimensions. The AP dimension was the minor axis of the left atrium, while the SI and ML dimensions were not significantly different. All left atrial dimensions were significantly greater in patients with mitral valve disease than in normal subjects. Of 30 patients with at least one dimension increased, all three dimensions were abnormal in 16, two dimensions were increased in 10, and only one dimension was increased in four. AP, SI, and ML dimensions were abnormal in 25, 20, and 27 patients, respectively. Cross sectional echocardiography may provide a reliable estimate of left atrial dimensions. In patients with mitral valve disease a thorough examination of the left atrium using multiple cross sectional views is necessary to detect asymmetric left atrial enlargement and to measure the degree of left atrial dilatation.

Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study.

Objective We evaluated the acute and long-term results of the use of a new intracardiac microaxial pump, the Impella Recover LP 2.5, during elective high-risk percutaneous coronary interventions in a two-centre registry. Methods Ten consecutive patients with poor left ventricular function and multivessel or left main coronary artery disease were considered at high risk of haemodynamic compromise and underwent percutaneous coronary interventions with preintervention Impella implantation. Procedural complications, 30-day and 12-month clinical outcome were recorded. Left ventricular ejection fraction was assessed by echocardiography before procedure and after at least 6 months. Results The Impella was implanted before percutaneous coronary interventions by femoral approach and percutaneous coronary interventions were successfully performed (by contra lateral femoral or radial approach) in all cases. After percutaneous coronary intervention, Impella was removed in all patients, and haemostasis was obtained by prolonged manual compression or by double suture device preimplantation technique. No access-site complication was observed and no patient required transfusions. One patient died after Impella removal due to acute stent thrombosis. The other patients had an uncomplicated in-hospital course and were discharged within 5 days. At 1-year follow-up, no patient died nor suffered acute myocardial infarction, whereas two patients underwent re-percutaneous coronary intervention. Left ventricular ejection fraction at follow-up increased significantly in this study population (from 31 ± 7% to 41% ± 13%, P = 0.02). Conclusion Our results support the feasibility and safety of Impella-assisted percutaneous coronary intervention in high-risk patients. Prospective randomized trials are needed to test the clinical impact of such an innovative approach.

Comparison of outcomes (early and six- month) of direct stenting with conventional stenting (a meta-analysis of ten randomized trials).

Although direct stenting (DS) is increasingly used in clinical practice instead of stent implantation after predilatation (conventional stenting [CS]), its impact has not been scientifically proved. We therefore performed, using Mantel-Haenszel analysis, a meta-analysis of the published randomized studies comparing DS with CS. Furthermore, all the key procedural data were systematically sought out and pooled. Ten trials (2,650 coronary lesions, 2,576 patients) were identified and entered into the analysis. Adopted angiographic exclusion criteria were homogeneous. DS, compared with CS, was found to have a similar success rate (98.7% vs 98.9%) and no specific complications. Across the studies, the mean rate of crossover to predilatation in the DS arm was 5.9%. Overall, DS was associated with a 17% procedural time (95% confidence interval [CI] 14% to 20%), a 18% fluoroscopic time (95% CI 15% to 21%), a 11% contrast volume (95% CI 9% to 14%), and a 22% cost reduction (95% CI 16% to 28%). In the early postintervention period, DS was associated with a trend toward reduction of each of the major adverse events (MACEs) and with a significant reduction of myocardial infarction (MI) + death (odds ratio [OR] 0.57, 95% CI 0.35 to 0.95). However, at 6 months, the OR (95% CI) for death, MI, target lesion revascularization, and MACEs were 0.47 (0.19 to 1.27), 0.72 (0.45 to 1.25), 1.07 (0.77 to 1.46), and 0.82 (0.63 to 1.08), respectively. In the subgroup of studies providing quantitative angiographic data, all the parameters were found to be similar between the CS and DS groups. In conclusion, the present meta-analysis shows that DS compared with CS, in selected coronary lesions, is safe, optimizes equipment use, and may enhance the early results of coronary interventions while warranting similar late clinical outcomes.

Feasibility of complex coronary and peripheral interventions by trans-radial approach using large sheaths

Background: Trans‐radial approach (TRA) reduces vascular access‐site complications but has some technical limitations. Usually, TRA procedures are performed using 5 Fr or 6 Fr sheaths, whereas complex interventions requiring larger sheaths are approached by trans‐femoral access. Methods: During 4 years, at two Institutions with high TRA use, we have attempted to perform selected complex coronary or peripheral interventions by TRA using sheaths larger than 6 Fr. Clinical and procedural data were prospectively collected. Attempt to place a 7 Fr or 8 Fr sheath (according to the planned strategy of the procedure) was performed after 5–6 Fr sheath insertion, administration of intra‐arterial nitrates and radial artery angiography. Late (>3 months) patency of the radial artery was checked (by angiography in the case of repeated procedures or by palpation + reverse Allen test). Results: We collected 60 patients in which TRA large sheath insertion was attempted. The large sheath (87% 7 Fr, 13% 8 Fr) was successfully placed in all cases. Most of the procedures were complex coronary interventions (bifurcated or highly thrombotic or calcific chronic total occlusive lesions), whereas 8.3% were carotid interventions. Procedural success rate was 98.3% (1 failure to reopen a chronic total occlusion). No access‐site related complication occurred. In 57 (95%) patients, late radial artery patency was assessed and showed patency in 90% of the cases, the remaining patients having asymptomatic collateralized occlusion. Conclusions: In selected patients, complex percutaneous interventions requiring 7–8 Fr sheaths can be successfully performed by RA approach without access‐site clinical consequences.

Frequency domain optical coherence tomography to assess non-ostial left main coronary artery

AIMS The aim of this study was to assess the feasibility of unprotected non-ostial left main (LM) imaging by frequency domain optical coherence tomography (FD-OCT). METHODS AND RESULTS We conducted a retrospective analysis of OCT studies performed to image lesions located in the non-ostial LM. OCT studies were analysed off-line to detect the number of artefact frames in the different LM/bifurcation segments. OCT cross-sectional images were used to assess area measures. OCT longitudinal reconstructions were used to obtain the LM length. Standard quantitative coronary angiography (QCA) was used as the reference methodology. A total of 54 patients with non-ostial LM disease entered the study. The mean number of LM artefact frames was 8±10, corresponding to 19% of the total number of LM frames analysed. The percentages of artefact frames differed significantly according to the segment analysed: 43.3% proximal LM, 11.4% mid LM and 2.1% distal LM, 2.0% ostial left anterior descending artery and 0% ostial left circumflex artery (p<0.0001). All LM OCT measurements were significantly correlated with QCA measurements. CONCLUSIONS The results of the present study show that FD-OCT assessment of non-ostial LM disease is feasible and may provide high-quality imaging. OCT assessment of distal LM is more efficient than that of the proximal LM segment.