A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.

BACKGROUND: The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. METHODS: Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. RESULTS: At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year. CONCLUSIONS: At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience.

Early clinical and haemodynamic results after aortic valve replacement with the Freedom SOLO bioprosthesis (experience of Italian multicenter study).

OBJECTIVES: The present study investigates early clinical and haemodynamic results with the Freedom SOLO bioprosthesis (FSB) for aortic valve replacement (AVR) in eight Italian institutions. METHODS: From 2004 to 2008, a total of 229 patients [139 females (60.7%); mean age 74 ± 8 years, left ventricular (LV) ejection fraction >40%] underwent AVR with FSB. One hundred and four patients underwent preoperatively, at 1-3 and at 12 months after AVR resting transthoracic echocardiography with the effective orifice area index (EOAi) assessment, peak and mean transvalvular pressure gradients and the LV mass index (LVMi) measurement. A subset of 34 patients underwent exercise stress echocardiography at a mean of 9.6 months after AVR. RESULTS: Post-operative mortality was 3.1%. At 1-3 months, FSB showed a significant increase in the EOAi (0.39 ± 0.17 to 1.04 ± 0.17 cm(2)/m(2); P < 0.0001), a reduction in the mean gradient (43.2 ± 16.9 to 4.3 ± 2.3 mmHg; P < 0.0001) and a significant regression of the LVMi (147.6 ± 30.5 to 121.6 ± 27.4 g/m(2); P < 0.0001). During exercise stress echocardiography, the mean aortic gradients increased from 4.4 ± 1.7 at rest to 7.0 ± 2.7 mmHg at peak stress (P < 0.001). The EOA increased from 1.74 ± 0.33 to 1.80 ± 0.36 cm(2) (P = 0.0291). Mean gradients at peak stress had better correlation with resting EOAi (r = -0.74; P < 0.001) than with the prosthesis size (r = 0.43; P = 0.01). CONCLUSIONS: The supra-annular implantation of FSB offers excellent haemodynamic performance both at rest and during exercise and is associated with the rapid regression of the LV.

The fate of Hancock II porcine valve recipients 25 years after implant.

OBJECTIVE: The Hancock II (HII) is a second-generation porcine bioprosthesis introduced into clinical use in 1982. This study aimed to evaluate very long-term outcomes for the HII valve in a large patient population. METHODS: Between May 1983 and November 1993, 517 consecutive patients (pts) (309 male, mean age: 64+/-9 years) underwent valve replacement (VR) surgery with HII, with 302 (58.4%) in the aortic VR (AVR) and 215 (41.6%) in the mitral VR (MVR) position, respectively. At implant, 106 pts (20.5%) were <60 years of age (G1), while 411 (79.5%) were > or =60 years of age (G2). The 25-year follow-up was complete for all pts at a median of 12 years (range: 0-25). RESULTS: Long-term death occurred in 208 AVR and in 165 MVR pts. Survival at 15 and 20 years was 39.5% and 23.3% in AVR pts and 39.0% and 15.8% in MVR pts. At 25 years the survival of MVR pts was 13.7% (four pts at risk). Late freedom from re-operation was 85.5% and 79.3% at 15 and 20 years in the AVR pts and 73.3% and 52.8% in the MVR pts, respectively. In the AVR population, 20-year freedom from re-operation was 52.2% in G1 pts and 86.8% in G2 pts (p<0.0001), while in the MVR population it was 41.4% in G1 pts and 61.9% in G2 pts (p=0.201), respectively. CONCLUSIONS: These results confirm the excellent long-term performance of the HII bioprosthesis.

High take-off of the right coronary artery with intramural course associated with the persistence of the left superior vena cava.

We describe the case of a coronary artery with an intra-aortic course (a rare coronary anomaly) associated with the persistence of the left superior vena cava. The first finding could represent an important surgical risk factor and should be recognized before cardiac surgery; the latter is not yet reported in the literature. A modified surgical technique is described.

Left atrial radiofrequency ablation during cardiac surgery in patients with atrial fibrillation.

INTRODUCTION: Intraoperative left atrial radiofrequency (RF) ablation recently has been suggested as an effective surgical treatment for atrial fibrillation (AF). The aim of this study was to verify the outcome of this technique in a controlled multicenter trial. METHODS AND RESULTS: One hundred three consecutive patients (39 men and 65 women; age 62 +/- 11 years) affected by AF underwent cardiac surgery and RF ablation in the left atrium (RF group). The control group consisted of 27 patients (6 men and 21 women; age 64 +/- 7 years) with AF who underwent cardiac surgery during the same period and refused RF ablation. Mitral valve disease was present in 89 (86%) and 25 (92%) patients, respectively (P = NS). RF endocardial ablation was performed in order to obtain isolation of both right and left pulmonary veins, a lesion connecting the previous lines, and a lesion connecting the line encircling the left veins to the mitral annulus. Upon discharge from the hospital, sinus rhythm was present in 65 patients (63%) versus 5 patients (18%) in the control group (P < 0.0001). Mean time of cardiopulmonary bypass was longer in the RF group (148 +/- 50 min vs 117 +/- 30 min, P = 0.013). The complication rate was similar in both groups, but RF ablation-related complications occurred in 4 RF group patients (3.9%). After a mean follow-up of 12.5 +/- 5 months (range 4-24), 83 (81%) of 102 RF group patients were in stable sinus rhythm versus 3 (11%) of 27 in the control group (P < 0.0001). The success rate was similar among the four surgical centers. Atrial contraction was present in 66 (79.5%) of 83 patients in the RF group in sinus rhythm. CONCLUSION: Endocardial RF left atrial compartmentalization during cardiac surgery is effective in restoring sinus rhythm in many patients. This technique is easy to perform and reproducible. Rare RF ablation-related complications can occur. During follow-up, sinus rhythm persistence is good, and biatrial contraction is preserved in most patients.