St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry.

BACKGROUND: The Trifecta aortic bioprosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is a stented pericardial heart valve with excellent preliminary results. Aim of the study was to evaluate its early clinical and hemodynamic performances in a multicenter regional registry. METHODS: Between January 2011 and June 2012, 178 consecutive patients undergoing aortic valve replacement with the Trifecta bioprosthesis were prospectively enrolled at 9 Italian centers. Clinical and echocardiographic data were collectedat discharge, 6-months and at 1-year postoperatively. RESULTS: The average age was 75.4 ± 7.7 years,and 95 (53 %) were men. Indication for valve replacement included stenosis in 123 patients (69 %), mixed lesions in 25 (14 %), and regurgitation in 30 (17 %). Ninety-three (52 %) patients were in NYHA functional class III/ IV. Hospital mortality accounted for 5 (2.8 %) patients. No valve-related perioperative complications were encountered. Median follow-up was 20.5 months (range: 1-34). Early (≤6 months) complications included one thromboembolic event, one major bleeding, and 3 endocarditis (2 explants). Two late (>6 months) thromboembolic events and two endocarditis (1 explant) were registered. No valve thrombosis or structural deterioration were observed after discharge. At 30-months, freedom from all-cause mortality was 87 %, freedom from valve-related mortality 99.4 %, freedom from endocarditis 97.5 %, and freedom from valve explants 98 %. At 1-year, mean gradients ranged from 8 to 16 mmHg, and effective orifice area indexes from 1.0 to 1.2 cm(2)/m(2) for valve sizes from 19 to 27 mm, respectively. No patients had severe prosthesis-patient mismatch. CONCLUSIONS: Trifecta bioprosthesis provided favourable clinical and hemodynamic results over time.

[Acute coronary syndrome and cancer: which therapeutic option first?]. / Sindrome coronarica acuta e neoplasia: quale iter scegliere?

Cardiovascular disease and cancer are the leading causes of mortality worldwide. We report our experience in a cancer patient with acute coronary syndrome successfully treated by hybrid revascularization, i.e. off-pump coronary artery bypass grafting, followed by surgical removal of the tumor and percutaneous coronary intervention. The concomitant presence of cancer and acute coronary syndrome is not rare, ranging from 1.9% to 4.2%. Usually, the most life-threatening disease should be treated first, more frequently coronary artery disease. There are several therapeutic approaches to patients with cancer and coronary artery disease and cancer, including percutaneous coronary intervention, surgical treatment of cancer, or coronary artery bypass grafting. Each of these options should consider the severity of cardiac disease, the stage of malignancy and the clinical conditions of the patient.

Risk of stroke with percutaneous coronary intervention compared with on-pump and off-pump coronary artery bypass graft surgery: Evidence from a comprehensive network meta-analysis.

BACKGROUND: Although some trials have reported that on-pump coronary artery bypass graft (CABG) surgery may be associated with higher rates of stroke than percutaneous coronary intervention (PCI), whether stroke is more common after off-pump CABG compared with PCI is unknown. We therefore sought to determine whether off-pump CABG is associated with an increased risk of stroke compared with PCI by means of network meta-analysis. METHODS: Randomized controlled trials (RCTs) comparing CABG vs PCI were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. RESULTS: Eighty-three RCTs with 22,729 patients randomized to on-pump CABG (n = 10,957), off-pump CABG (n = 7,119), or PCI (n = 4,653) were analyzed. Thirty-day rates of stroke were significantly lower in patients treated with PCI compared with either off-pump CABG (odds ratio [OR]; 0.39, 95% CI, 0.19-0.83) or on-pump CABG (OR, 0.26; 95% CI, 0.12-0.47). Compared with on-pump CABG, off-pump CABG was associated with significantly lower 30-day risk of stroke (OR, 0.67; 95% CI, 0.41-0.95). However, in sensitivity analyses restricted to high-quality studies, studies with more than either 100 or 1,000 patients, or studies with protocol definition or adjudication of stroke by a clinical events committee, the precision of the point estimate for the 30-day risk of stroke between off-pump vs on-pump CABG was markedly reduced. CONCLUSIONS: Percutaneous coronary intervention is associated with lower 30-day rates of stroke than both off-pump and on-pump CABG. Further studies are required to determine whether the risk of stroke is reduced with off-pump CABG compared with on-pump CABG.

Type 2 diabetes mellitus is associated with faster degeneration of bioprosthetic valve: results from a propensity score-matched Italian multicenter study.

BACKGROUND: The present study was aimed at determining the impact of type 2 diabetes mellitus (DM) on postoperative bioprosthetic structural valve degeneration. METHODS AND RESULTS: Twelve Italian centers participated in the study. Patient data refer to bioprosthetic implantations performed from November 1988 to December 2009, which resulted in 6184 patients (mean age 71.3±5.4 years, 60.1% male) being enrolled. Of these patients, 1731 (27.9%) had type 2 DM. The propensity score-matching algorithm successfully matched 1113 patients with type 2 DM with the same number of no-DM patients. The postmatching standard differences were less than 0.1 for each of the covariates, and 64.2% of DM patients were matched. The early (30 days) mortality rate was 7.8% (n=87) versus 2.9% (n=33) in patients with or without type 2 DM (P<0.001), respectively. Seven-year freedom from valve deterioration was significantly lower in patients with DM (73.2% [95% confidence interval, 61.6-85.5] versus 95.4% [95% confidence interval, 83.9-100], P<0.001). In Cox regression models with robust SEs that accounted for the clustering of matched pairs, DM was the strongest predictor of structural valve degeneration (hazard ratio 2.39 [95% confidence interval 2.28-3.52]). When we allowed for interaction between type 2 DM and other key risk factors, DM remained a significant predictor beyond any potentially associated variable. CONCLUSIONS: Patients with type 2 DM undergoing bioprosthetic valve implantation are at high risk of early and long-term mortality, as well as of structural valve degeneration.

Early clinical experience and echocardiographic results with a new semirigid mitral annuloplasty ring: the Sorin Memo 3D.

BACKGROUND: The Sorin Memo 3D (Sorin Biomedica Cardio S.r.L., Saluggia, Italy) is a new, complete semirigid annuloplasty ring. Clinical use, outcomes, and echocardiographic results are reported as an evaluation of its safety and efficacy in the treatment of mitral valve regurgitation (MVR). METHODS: This device was assessed in 63 patients (63.5% men; mean age, 70.2 +/- 10.3 years) who underwent MVR operations between January 2007 and June 2008. Functional classification was normal leaflet motion (type I; 1.6%), leaflet prolapse (type II; 66.7%), and restricted leaflet motion (type III; 31.7%). Valve disease was degenerative (68.25%), ischemic (25.4%), and nonischemic dilated cardiomyopathy (6.35%). RESULTS: Early mortality (< or = 30 days) was 3.3% (2 patients). Late mortality (11.2 +/- 5.1 months) was 4.9% (3 patients). No deaths were device-related. Thromboembolic stroke occurred in 3.3% and endocarditis in 1.6%. Freedom from reoperation was 98.4%. At 6 months, MVR was grade 0/1 in 93.7% and grade 2+ in 6.4%. Left end-diastolic ventricular diameters decreased significantly from 59.3 +/- 6.9 mm preoperatively to 50.6 +/- 12.2 mm at 6 months, pulmonary arterial pressure decreased from 44.8 +/- 7.1 mm Hg to 38.4 +/- 5.5 mm Hg, and left ventricular ejection fraction increased significantly from 0.469 +/- 0.129 to 0.582 +/- 0.106. New York Heart Association functional class was I in 81% and II in 13.8%. CONCLUSIONS: Early results indicate the Sorin Memo 3D ring safely and effectively minimizes secondary MVR resulting from all causes and preserves mitral annular flexibility and function at follow-up.

Determination of pump flow rate during cardiopulmonary bypass in obese patients avoiding hemodilution.

BACKGROUND AND AIM: During cardiopulmonary bypass the pump flow is usually set on 2.4 L/min/m(2) of body surface area (BSA) to guarantee adequate tissue perfusion without differences for patient constitutional type. The present study attempts to evaluate the adequacy of pump flow rate in obese patients, considering the ideal weight instead of the real one, avoiding the overflow side effects and hemodilution. METHODS: Obese patients with body mass index (BMI) > 30 presented for cardiac surgery were randomized in two groups: in one the cardiopulmonary bypass was led traditionally, in the other, pump flow rate was calculated on ideal BMI of 25. RESULTS: Demographics, preoperative tests, and monitoring data were registered. Mortality at hospital discharge and 30 days after were analyzed. The pump flow rate between the groups was different (4.46 vs. 4.87; p = 0.004); there were no differences in organ perfusion (SvO(2); diuresis) and mortality, but the study group presented fewer complications and blood transfusions. CONCLUSIONS: The BSA is widely used as the biometric unit to normalize physiologic parameters included pump flow rate, but it is disputable if this practice is correct also in obese patients. The study group, in which pump flow rate was set on ideal BSA, presented no difference in diuresis and mixed venous saturation but fewer complications and fewer perioperative blood transfusions.

A comparison between coronary artery bypass grafting surgery and drug eluting stent for the treatment of unprotected left main coronary artery disease in elderly patients (aged > or =75 years).

AIMS: In this study, we compared the clinical outcomes of elderly patients with unprotected left main coronary artery (ULMCA) stenosis treated with either coronary artery bypass grafting (CABG) or drug-eluting stent (DES). METHODS AND RESULTS: From January 2003 to April 2006, 259 patients with ULMCA stenosis and age > or =75 years underwent coronary revascularization with either CABG or DES. One hundred and sixty-one patients were treated with CABG and 98 with DES. The cumulative unadjusted rates of 2-year mortality were 17% in CABG-treated patients and 18% in those treated with DES (P = 0.71). The adjusted rates of 2-year survival were 85% for CABG-treated patients and 87% for DES-treated patients (P = 0.74). The incidence of 2-year myocardial infarction was 6% in CABG-treated patients and 4% in DES-treated patients (P = 0.11). The incidence of target lesion revascularization (TLR) was 3% in CABG-treated patients and 25% in DES-treated patients (P < 0.0001). In the multivariable analysis, peripheral vascular disease, left ventricular ejection fraction and acute coronary syndrome were independent predictors of 2-year mortality. CONCLUSION: In this study, we could not demonstrate a difference in mortality between CABG-treated patients and those treated with DES. However, the rate of TLR was higher in the DES group.

Complete myocardial revascularization and sutureless technique for left ventricular free wall rupture: clinical and echocardiographic results.

Left ventricular free wall rupture (LVFWR) is one of the most dramatic complications of myocardial infarction. We present our mid-term clinical and echocardiographic results of LVFWR with patch and complete myocardial revascularization on viable tissue. From August 2000 to July 2005, 9 patients underwent surgery for LVFWR. Mean age was 68+/-S.D. 9.3 years. Mean interval time between AMI and LVFWR was 122.2+/-154.9 h. All patients presented for emergency surgery with cardiac tamponade at echocardiography. Three patients received IABP preoperatively. Eight had coronarography. Effective control of bleeding was achieved in all cases with a Teflon patch applied with Bioglue. Four patients had myocardial revascularization, all in ECC; two of them with cross-clamping. There was no operative death. Mean follow-up was 38.8+/-22.2 S.D. months. One further death occurred from myocardial infarction. All patients were in NYHA I-II. Survivors had follow-up transthoracic echocardiography: all patients had preserved left ventricular function with absence of restricted motion. There was no evidence of mitral regurgitation. Sutureless covering technique for LVFWR is related to excellent early and long-term clinical and echocardiographic results. Complete coronary artery bypass grafting improves long-term symptom-free survival. We have demonstrated that ECC and cross-clamping do not affect early survival.