Early and medium term results of the sleeve valve-sparing procedure for aortic root ectasia.

BACKGROUND: The aim of this retrospective study was to evaluate our experience of using a simplified aortic valve sleeve procedure to treat aortic root ectasia and aneurysms with or without aortic regurgitation. In experienced hands, 2 aortic valve-sparing procedures, ie, Yacoub and David, have yielded excellent long-term results in the treatment of aortic root aneurysms, with or without aortic regurgitation. However, these techniques are demanding and not widely used. Recently, a new and simplified valve-sparing technique, named "sleeve procedure," has been proposed, and has yielded encouraging early results. METHODS: Ninety consecutive patients with aortic root aneurysms underwent sleeve procedures from October 2006 to October 2012. Follow-up data (clinical 100% complete and echocardiographic 93% complete) were acquired from our outpatient clinic or from the referring cardiologist. RESULTS: The mean age of the patients was 61.5 ± 12.5 years, 79% were male, 16 (18%) had a bicuspid valve, 3 had Marfan syndrome, and 2 had aortic dissection. Over a mean clinical follow-up of 34 ± 19 months, 2 patients died from noncardiac causes and 1 was reoperated on for the recurrence of aortic regurgitation. On follow-up echocardiography after a mean of 18 ± 9 months, aortic regurgitation was absent/negligible, mild or moderate in 62%, 37%, and 1% of patients, respectively, and the diameters of the annulus, Valsalva sinuses, and sinotubular junction were 27.3 + 2.2, 37.0 + 3.4, and 30.6 + 3.1 mm, respectively. CONCLUSIONS: Our encouraging early and medium term results suggest that the sleeve procedure is a safe and effective aortic valve-sparing technique for the treatment of aortic root ectasia and aneurysm. However, longer follow-up is needed in order to draw definitive conclusions.

Hemodynamic comparison between Trifecta and Freestyle valves implanted in small aortic roots. One-year echocardiographic results from a prospective randomized study.

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement in patients with a small aortic root may be associated to high residual gradients. In such patients, both stentless valves and aortic annulus enlargement can reduce these residual gradients. Several studies have reported that Trifecta valves yield very good hemodynamic results. The aim of the present study was to compare the hemodynamic performance of Trifecta vs. Freestyle valves at one year in patients with an aortic annulus ≤ 2.3 cm. METHODS: Between September 2011 and September 2013, 40 patients with a native aortic annulus diameter ≤ 2.3 cm and average age of 81 ± 4 years, were randomized to receive either a St-Jude Trifecta stented prosthesis (20 patients) or a Medtronic Freestyle stentless prosthesis (20 patients). RESULTS: No differences between Trifecta and Freestyle were found at one year in mean gradient s: 6.1 ± 3 mmHg and 6.6 ± 3 mmHg (p = 0.796); effective ori fice area: 1.82 ± 0.3 mmHg and 1.76 ± 0.4 mmHg (p = 0.676) or regression of left ventricular mass: - 25% ± 14 vs. -19% ± 16 (p = 0.204), respectively. Only moderate patient -pro sthesis mismatch was found, which affected 3 patient s in each group. CONCLUSION: At one year both stentless and stented prostheses yielded comparable hemodynamic results. These data suggest that Trifecta implantation is a valid means of avoiding patient -prosthesis mismatch in aortic valve replacement in elderly patients with a small native aortic annulus.

Treatment of mediastinitis by ventrofil plates without sternal rewiring.

Mediastinitis is a serious complication of cardiac surgical procedures, with high rates of morbidity and mortality. We describe a new simple surgical technique to treat deep sternal infection based on the removal of all wires and deep sutures, and reapproximation of the sternum with four external plates without rewiring. Fourteen patients were treated with this technique. No complications related to the procedure occurred, the infection was successfully treated in all patients, and only 1 patient underwent vacuum treatment to obtain healing of the wound.

Early hemodynamic evaluation of Trifecta and Freestyle bioprostheses in patients with a small aortic root: preliminary results from a prospective randomized study.

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement (AVR) in patients with a small aortic root is often associated with some degree of obstruction and residual gradients. Stentless valves display better hemodynamic performance than stented valves, and might be ideal in patients with a small aortic annulus. A new stented bioprosthesis, the Trifecta valve, has recently become available and has yielded interesting early results. The study aim was to compare the hemodynamic performance of the Trifecta valve with that of the Freestyle valve in patients with an aortic annulus ≤ 2.3 cm. METHODS: Between September 2011 and September 2013, a total of 40 patients with pure aortic stenosis and native aortic annulus diameter ≤ 2.3 cm was randomized to receive either a St. Jude Medical Trifecta stented prosthesis (n = 20) or a Medtronic Freestyle stentless prosthesis (n = 20). Hemodynamics results were compared between the two groups on discharge from hospital. RESULTS: The Trifecta valve showed slightly better hemodynamics, with peak gradients of 11 ± 5 mmHg and 17 ± 9 mmHg (p = 0.009), and mean gradients of 5.5 ± 3 mmHg and 7.5 ± 4 mmHg (p = 0.06) for the Trifecta and Freestyle valves, respectively. The average indexed effective orifice area (EOAi) was 1.14 ± 0.23 cm2/m2 and 1.09 ± 0.20 cm2/m2 (p = 0.520) for the Trifecta and Freestyle, respectively. Patient-prosthesis mismatch (PPM) occurred in two patients of the Freestyle group, and in three patients of the Trifecta group. CONCLUSION: In the present study, the stentless and stented prostheses each yielded comparable and excellent early hemodynamics results. The data obtained suggest that Trifecta valve implantation is a valid means of avoiding PPM after AVR in patients with a small native aortic annulus.

Adjunctive devices in primary or rescue PCI: a meta-analysis of randomized trials.

OBJECTIVES: To overview and summarize the results emerging from the studies on adjunctive devices (AD) with theoretical anti-embolic properties in patients with ST-elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary interventions (PCI). BACKGROUND: A series of small-to-medium size randomized studies have compared different AD with standard PCI (SP) in the setting of STEMI. The reported results are conflicting. METHODS: Eighteen prospective randomized studies on 3180 STEMI patients comparing AD with SP were identified and entered the meta-analysis. Pre-specified angiographic, electrocardiographic (absence of ST-segment resolution, STR) and early (up to 30 days) clinical end-points were assessed. RESULTS: AD were associated with lower rates of angiographically evident distal embolization: OR (95% CI): 0.54 (0.37-0.81). Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity among studies and an overall trend toward better results with AD: OR (95% CI) 0.76 (95% CI 0.51-1.12) for TIMI<3, 0.53 (0.37-0.76) for myocardial blush grade (MBG)<3, 0.60 (0.45-0.78) for absence of STR. Subgroup analysis according to the type of AD for the end-point of no STR showed concordant absence of benefit in studies testing distal protection devices, positive results being confined to the studies using thrombectomy devices (OR 0.46, 95% CI 0.32-0.66). However, the possibility of a "small study" bias within thrombectomy studies cannot be discharged (significant heterogeneity and positive Egger's test). Early major adverse cardiac events were not different between AD and SP. CONCLUSIONS: AD use may be associated with reduced rate of angiographic distal embolization, and improved MBG 3 and STR rates. However, efficacy might vary with the type of device employed. Moreover, early clinical outcome is not modified suggesting that further, larger, studies are needed to assess the clinical impact of AD. CONDENSED ABSTRACT: We conducted a meta-analysis of 18 prospective randomized trials comparing adjunctive devices (AD) with standard PCI in the setting of STEMI. The use of AD was associated with lower rates of (angiographically evident) distal embolization. Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity and an overall trend toward better results with AD. Subgroup analysis suggested that different types of device may have different effects. Early major adverse cardiac events were similar between AD and SP.

Rationale for intracoronary administration of abciximab.

The present review aims to describe the pharmacological aspects as well as the available clinical data supporting the choice of intracoronary route of administration for abciximab, an antiplatelet drug used in patients with acute coronary syndromes undergoing percutaneous coronary interventions (PCI). Abciximab is a glycoprotein (GP) IIb/IIIa receptor antagonist which determines a potent inhibition of platelet aggregation and thrombus formation. These properties seem to prevent not only thrombus formation but also to promote (at higher drug concentration) lysis of fresh thrombus. Moreover, differently from the other GP IIb/IIIa inhibitors, abciximab also binds to the vitronectin receptor on endothelial, smooth muscle, and inflammatory cells and to an activated conformation of the aMb2 receptor on leukocytes. Such cross-reactivity raises the possibility that clinical benefits derived from its use may not be exclusively due to its anti-thrombotic effect, but may also be related to the suppression of inflammatory pathways involving platelets, white blood cells, and the vascular endothelium. On such basis, the local administration of abciximab at the site of coronary thrombosis may enhance, by increasing its local concentration, the binding to both platelet and endothelium receptors. The results of several angiographic studies assessing the effect of intracoronary abciximab administration support on clinical grounds its adoption in patients with fresh coronary thrombosis. Indeed, better post-angioplasty coronary flow, greater degree of myocardial salvage and a better left ventricular function recovery have been achieved as compared to the intravenous, systemic, administration of drug's bolus. Condensed Abstract Several studies have highlighted the benefits of abciximab, a potent antiplatelet agent, in patients with acute coronary syndromes undergoing percutaneous coronary interventions. Moreover, differently from the other glycoprotein IIb/IIIa receptor antagonists, abciximab also has non-IIb/IIIa-related properties raising the possibility that clinical benefits derived from its use may not be exclusively due to its anti-thrombotic effect, but may also be related to the suppression of inflammatory pathways. Several angiographic studies in patients with fresh coronary thrombosis and recent clinical studies in patients with acute coronary syndromes undergoing mechanical revascularization support the hypothesis that local administration of abciximab at the site of the culprit coronary artery may facilitate both the de-thrombotic and the non-GP IIb/IIIa-dependent properties of the drug. On such basis, the present review aims to describe the pharmacological aspects as well as the available clinical data supporting the choice of intracoronary route of administration for abciximab.

A pilot study with a new, rapid-exchange, thrombus-aspirating device in patients with thrombus-containing lesions: the Diver C.E. study.

BACKGROUND: In patients with acute coronary syndromes (ACS), distal embolization of thrombotic material is more likely to play a key role in the pathogenesis of myocardial no-reflow during percutaneous coronary intervention (PCI). Thus, interventional techniques able to reduce thrombus burden at the culprit vessel might improve final myocardial reperfusion. OBJECTIVE: To evaluate a new rapid-exchange thrombus-aspirating catheter, the Diver C.E., in patients with thrombotic coronary lesions undergoing PCI. METHODS: Fifty patients with acute myocardial infarction (n = 44) or with non-ST-elevation ACS and angiographic evidence of coronary thrombus (n = 6) undergoing urgent PCI were prospectively enrolled. The Diver C.E. was used to aspirate coronary thrombus from the culprit lesion after placement of the guidewire. Adjunctive balloon inflations and stent implantation were used to achieve good angiographic result. Angiographic coronary flow (by means of TIMI score and corrected TIMI frame count, cTFC), thrombus score (TS), and myocardial perfusion (by means of postintervention myocardial blush grade, MBG) were assessed in all patients. RESULTS: The device could be successfully employed in 96% of the cases (48/50) and yielded significant (P < 0.0001) acute reduction in thrombus burden (TS: predevice 3.5 +/- 0.8, postdevice 2.5 +/- 0.9) and improvement in coronary flow (TIMI grade: predevice 1.0 +/- 0.9, postdevice 2.0 +/- 0.9; CTFC predevice 71 +/- 31, postdevice 39 +/- 26). Final TIMI grade 0-1 was observed in one patient only (2%). A significant (P = 0.02) correlation was found between preintervention TS and efficacy of thrombus aspiration. A more pronounced acute reduction of thrombus burden after thrombus aspiration (TS reduction > or = 2) was associated with a better postintervention angiographic myocardial perfusion (MBG 2.3 +/- 0.9 vs 1.7 +/- 0.8; P = 0.05). CONCLUSIONS: This new, easy-to-use, device is able to reduce thrombus burden and to improve coronary flow in patients with thrombus-containing lesions. The improvement in myocardial perfusion associated to greater thrombus removal highlights the importance of thrombus aspiration in the management of thrombus-burdened coronary lesions.

Angiographic evaluation of the effect of intracoronary abciximab administration in patients undergoing urgent PCI.

BACKGROUND: Recent data suggest that the intracoronary (i.c.) administration of a systemic bolus dose of abciximab during PCI may increase the efficacy of this antiplatelet drug. However, the effect of i.c. abciximab on coronary angiographic flow has been not clarified. METHODS: We studied 37 consecutive patients with acute coronary syndromes (ACS) who underwent successful urgent PCI on the target vessel and were treated by an i.c. abciximab bolus (0.25 mg/kg) prior to the first balloon inflation (Group IC), and 37 matched controls who were treated by intravenous (i.v.) abciximab bolus at the same dose (Group IV). Corrected TIMI frame count (CTFC) in the culprit and in a non-culprit coronary artery branch was assessed before treatment, immediately after intracoronary administration of abciximab bolus and at the end of the procedure. RESULTS: After administration of abciximab, CTFC significantly decreased from 48+37 to 33+30 (P=0.001) in the culprit vessel while in the non-culprit vessel it remained unchanged (16+7 pre-treatment and 16+7 post-treatment, P=0.68). Final CTFC was 12+4 in Group IC and 14+5 in Group IV (P=0.069). Post-treatment mean peak of the cardiac enzymes showed a trend toward reduction in Group IC compared with Group IV. CONCLUSIONS: The i.c. administration of abciximab bolus acutely decreases CTFC through culprit vessels of patients with ACS undergoing urgent PCI. Further studies evaluating the potential clinical benefits associated with i.c. abciximab administration are warranted.

Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial.

OBJECTIVES: The aim of this study was to evaluate the use of a new manual thrombus-aspirating device in unselected patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing urgent percutaneous coronary intervention (PCI). BACKGROUND: Failure to achieve myocardial reperfusion often occurs during PCI in patients with STEMI. The use of thrombus-aspirating devices might improve myocardial reperfusion by reducing distal embolization. METHODS: We prospectively randomized before coronary angiography 100 consecutive patients with STEMI to either standard PCI or PCI with manual thrombus-aspiration. Primary end points of the study were post-procedural rates of myocardial blush grade (MBG) > or =2 and ST-segment resolution (STR) > or =70%. Analyses were planned by intention to treat. RESULTS: Ninety-nine patients entered the analyses. The rates of post-procedural MBG > or =2 and STR > or =70% were, respectively, 68.0% and 44.9% in the thrombus-aspiration group compared with 58.0% and 36.7% in the standard PCI group: odds ratio (OR) 2.6 (95% confidence interval [CI] 1.2 to 5.9), p = 0.020, and 2.4 (95% CI 1.1 to 5.3), p = 0.034, respectively. Moreover, the rate of patients achieving both the angiographic and electrocardiographic (ECG) criteria of optimal reperfusion was significantly higher in the thrombus-aspiration group compared with standard PCI: 46.0% versus 24.5%, OR 2.6 (95% CI 1.1 to 6.2), p = 0.025. In multivariate analysis, randomization to thrombus-aspiration was a significant independent predictor of achievement of MBG > or =2 and STR > or =70% (p = 0.013). CONCLUSIONS: This prospective randomized study shows that manual thrombus-aspiration in unselected patients with STEMI undergoing primary or rescue PCI is clinically feasible and results in better angiographic and ECG myocardial reperfusion rates compared with those achieved by standard PCI.

G20210A prothrombin gene variant and clinical outcome in patients with a first acute coronary syndrome.

BACKGROUND AND OBJECTIVES: The prognostic value of the G20210A prothrombin gene polymorphism in patients with a first acute coronary syndrome has not been previously assessed. We conducted a prospective study to investigate this issue. DESIGN AND METHODS: Genotyping at the 20210 prothrombin gene locus was performed in 162 patients with a first episode of myocardial infarction (MI) or unstable angina (UA) occurring before 65 years of age. Patients were stratified according to cardiovascular risk factors and to treatment strategy. The subsequent two-year relative risk (RR) of adverse events (death, MI and UA) was adjusted for possible confounders and analyzed according to genotype, risk factor category, and treatment allocation. RESULTS: In the entire study population, the prothrombin variant did not significantly increase the two-year risk of events: the adjusted RR for GA vs GG carriers was 1.82 (95% CI 0.68-4.89). However, in the absence of traditional cardiovascular risk factors the risk of events was consistently higher: among the 46 patients without hypertension, diabetes and hypercholesterolemia, GA vs GG carriership was associated with an adjusted RR at two years of 5.64 (95% CI 1.07-29.84). The gene variant also enhanced the risk of events among the 98 patients who did not undergo myocardial revascularization procedures (RR for GA vs GG: 2.89, 95% CI 1.04-8.00), but not among those who did. INTERPRETATION AND CONCLUSIONS: The present prospective study suggests that heterozygosity for the G20210A prothrombin polymorphism adversely affects prognosis after a first acute coronary syndrome in the subgroup of patients without metabolic risk factors and in those not treated by revascularization procedures.