The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate the early results, hemodynamics and left ventricular remodeling after aortic valve replacement (AVR) with the Freedom SOLO valve, a bovine pericardial valve bioprosthesis, using a single running suture line in a supra-annular position. METHODS: Between July 2004 and September 2006, a total of 256 patients (116 males; 140 females; mean age 74.5 +/- 6.4 years; range: 41-89 years) who underwent AVR with the Freedom SOLO valve in nine European institutions were enrolled in the study. The indications for AVR were stenosis in 182 patients, regurgitation in 15, and combined in 57. Preoperatively, 37%, 59% and 4% of the patients were in NYHA classes I-II, III, and IV, respectively. Concomitant procedures were performed in 91 patients (36%). A patient subgroup underwent echocardiography preoperatively (n=192), and at one (n=194) and 12 (n=165) months postoperatively. RESULTS: The early mortality was 2.3% (n=6). There were 18 late deaths (6.2%/pt-yr). After 12 months, 82% of the patients were in NYHA class I-II. Linearized rates were 0.69%/pt-yr for bleeding, 0.34%/pt-yr for thromboembolism, 0.0%/pt-yr for structural degeneration and thrombosis, 1.37%/pt-yr for paravalvular leak, and 2.06%/pt-yr for endocarditis. Five patients required reoperation. Twelve-month transprosthetic regurgitation was graded as absent in 92% of cases. The mean gradient was 42.3 +/- 20.2 mmHg preoperatively, 6.5 +/- 3.8 mmHg at one month, and 6.7 +/- 4.1 mmHg at 12 months. The effective orifice area was improved from 0.78 +/- 0.35 cm2 preoperatively to 1.90 +/- 0.56 cm2 at one month and 1.89 +/- 0.56 cm2 at 12 months. The left ventricular mass was decreased by 23%, from 217.8 +/- 77.2 g/m2 preoperatively to 167.4 +/- 68.2 g/m2 at one year. The mean left ventricular ejection fraction was 65.5 +/- 14.2% preoperatively, and 64.5 +/- 12.5% and 66.0 +/- 10.6% at one month and at 12 months, respectively. CONCLUSION: The data obtained suggest that the Freedom SOLO stentless bioprosthesis shows excellent early clinical and hemodynamic results, resulting in a significant regression of left ventricular hypertrophy and improvement in left ventricular systolic function.

Covered perforated aortocoronary saphenous vein graft aneurysm.

We report a case of a 75-year-old man suffering from a covered perforated aneurysm of a saphenous bypass graft to the right coronary artery (RCA) constructed 22 years ago. Additional complete revascularization had been performed in 2001. A thoracic computed tomography scan for evaluation of fever of unknown origin had revealed a huge hematoma in front of the right heart. Coronary angiography showed open bypasses but an irregular-shaped aneurysm of the venous graft to the RCA right before the distal anastomosis. Occurrence of a new right-sided pleural effusion led to the emergent operation since rupture of the aneurysm and drainage into the pleura was likely. A massive precordial hematoma was found and the existence of the perforated aneurysm could be confirmed. After institution of cardiopulmonary bypass the graft was resected. Since the patient had a functioning bypass to the RIVP, there was no need for additional revascularization. The patient underwent an uneventful postoperative course.

Surgical ablation of atrial fibrillation in patients with congestive heart failure.

BACKGROUND: Congestive heart failure (CHF) and atrial fibrillation (AF), both of which cause morbidity and mortality, are mutually promoting diseases. We aimed to evaluate surgical AF ablation in CHF. METHODS AND RESULTS: Among 212 patients (age 69 +/- 8.8 years, 87% with persistent AF) undergoing concomitant left atrial (LA) ablation, 79 (37.3%) presented CHF (n = 62 with a left ventricular ejection fraction [LVEF] 0.31-0.45, n = 17 with an LVEF < or = 0.30). Patients with CHF were similar to controls regarding AF duration (61 +/- 65.1 months vs. 54 +/- 67.2 months, not significant [NS]), LA diameter (49 +/- 7.5 mm vs. 50 +/- 9.2 mm, NS), and heart rate (78 +/- 18.4 min(-1) vs. 81 +/- 21.3 min(-1), NS), but they required more circulatory support (17.7% vs. 1.5%, P < .001) and a longer intensive care unit stay (6 +/- 9.5 days vs. 4 +/- 10.5 days, P = .032). At follow-up after 13 +/- 7.3 months, 42 patients (66%) with CHF and 81 controls (74%, NS) were in sinus rhythm (SR) (55% and 64% without antiarrhythmic drugs, respectively, NS). Univariate and logistic regression analysis revealed that AF duration and LA diameter predicted rhythm outcome but not CHF. In patients with an LVEF of 0.30 or less, SR conversion significantly improved LVEF, New York Heart Association class, and Minnesota Living with Heart Failure score. Kaplan-Meier estimates suggested superior survival of patients with stable SR (100% vs. 73%, log-rank P < .05). CONCLUSIONS: If patients presenting with CHF and AF require cardiac surgery, concomitant AF ablation should be considered, especially if left ventricular function is severely impaired.

The Freedom SOLO valve: superior hemodynamic results with a new stentless pericardial valve for aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: The new Freedom SOLO aortic valve, as a modification of the Pericarbon Freedom stentless valve, requires only one suture line. The study aim was to compare both prostheses with regard to surgical convenience and early postoperative hemodynamics. METHODS: In this case-matched study, 90 patients underwent primary elective isolated or combined aortic valve replacement (AVR) between 2001 and 2004. The Freedom SOLO valve was implanted in 30 patients using a supra-annular, subcoronary technique with one continuous subcoronary suture line (group FS). For comparison, the Pericarbon Freedom valve was implanted in 30 patients using an interrupted suture (group PFI), and in 30 patients using a continuous suture line at the inflow site (group PFC). Patient hemodynamics at discharge were investigated by monitoring echocardiographic peak and mean gradients, and regurgitation. RESULTS: The mean extracorporeal circulation time (75.5+/-22.7 min in FS; 83.7+/-21.0 min in PFC versus 110.9+/-31.4 min in PFI) and cross-clamp time (56.0+/-18.6 min in FS; 62.2+/-16.2 min in PFC versus 87.7 +/-25.4 min in PFI) were significantly shorter with the continuous implantation techniques. Hemodynamics were most favorable for the Freedom SOLO valve as compared to either implantation technique of the Pericarbon Freedom valve (mean gradient 7.4+/-4.6 mmHg in FS versus 10.6+/-6.0 mmHg in PFC and 11.0+/-5.7 mmHg in PFI). There were no paravalvular leakages or transvalvular regurgitations. CONCLUSION: The Freedom SOLO stentless valve is easy to implant and demonstrates superior early postoperative hemodynamics. Due to the reduced cross-clamp time, it also offers an attractive option in isolated and combined AVR.

Avoiding early partial valve thrombosis of the Pericarbon Freedom stentless valve.

Pericardial stentless valve prostheses have shown excellent results in aortic valve replacement. However, due to flexibility of the prosthetic material, immobilization and subsequent partial valve thrombosis may occur in case of non-symmetric sinuses of Valsalva. This report details an implantation technique designed to prevent stress on the non-coronary cusp of pericardial stentless prostheses, thereby avoiding this problem.

Ablation of atrial fibrillation in valvular heart surgery: are results determined by underlying valve disease?

BACKGROUND AND AIM OF THE STUDY: Although, in recent years, atrial fibrillation (AF) ablation has become an effective concomitant procedure in cardiac surgery, it is unclear whether the outcome of the procedure is determined by the underlying valve disease. METHODS: Between 2003 and 2005, 191 patients (100 females, 91 males; mean age 70+/-8.7 years) underwent concomitant left atrial (LA) ablation. Among these patients, those with permanent AF (pAF) and mitral (MVD; n = 64), aortic (AVD; n = 37), and combined valve disease (CVD; n = 23) were prospectively studied after three, six and 12 months, and annually thereafter. The predictive values of preoperative variables for postoperative AF were examined. RESULTS: AVD patients were older than MVD patients (74 +/-7.8 versus 66+/-8.6 years; p <0.001), and presented smaller atria (48+/- 5.7 versus 53+/-8.0 mm; p <0.05), but CVD patients were similar to MVD patients in terms of these parameters (age 70+/-9.3 years, LA diameter 54+/-9.6 mm). Ablation caused no injury or death in any of the patients. Within 30 days after surgery, three (4.7%), three (8.1%) and two (8.7%) of the MVD, AVD and CVD patients, respectively, had died (6.4% overall mortality). The sinus rhythm (SR) conversion rate was 76.8, 63.3 and 58.8% (p = NS) after a mean follow up (FU) of 10+/-4.0, 9+/-4.2 and 10+/-3.9 months (p = NS) in the MVD, AVD and CVD groups, respectively. FU was 97% complete. During FU, four (6.6%), two (5.9%) and four (19.0%) MVD, AVD and CVD patients died, respectively. Univariate analysis demonstrated a shorter AF duration (42+/-49.0 versus 85+/-67.2 months; p <0.05) and smaller LA diameter (50+/-8.1 versus 55+/-9.2 mm; p <0.05) in patients with SR versus non-SR. Multivariate analysis revealed AF duration (Odds ratio (OR) 1.01, 95% CI 1.00-1.02, p <0.05) and LA diameter (OR 1.08, 95% CI 1.01-1.15, p <0.05) as independent predictors of SR conversion. Overall, 86% of patients with two or less years' duration of pAF were in SR at FU. CONCLUSION: AF duration and LA diameter, but not the type of valve disease, predict SR conversion after concomitant ablation of pAF in valvular heart surgery.

Operative technique and early hemodynamic results with the Freedom Solo valve.

BACKGROUND AND AIM OF THE STUDY: Stentless aortic valve prostheses usually require two separate suture lines. The Freedom Solo valve (Sorin Group, Saluggia, Italy), by using a minimized implantation technique, requires only a single running suture line of 4-0 polypropylene. Herein are reported the surgical experience and early hemodynamic results obtained with this new valve. METHODS: Following annular decalcification, the Freedom Solo prosthesis was implanted in the supraannular aortic position in the sinuses of Valsalva of 82 patients (52 females, 30 males; mean age 76.6 +/- 7.0 years). Echocardiography was performed to monitor gradients and regurgitation. RESULTS: The logistic EuroSCORE was 12.8 +/- 9.9. Isolated aortic valve replacement was performed in 48 patients; concomitant procedures included coronary artery bypass grafting, mitral procedures, subvalvular myectomy, and atrial ablation. The mean valve size implanted was 26.4 +/- 2.1 mm, and cross-clamp time was 39.0 +/- 7.0 min in primary isolated valve replacement. Non-valve-related 30-day mortality was 3.6%. At discharge, hemodynamic parameters were favorable, with low peak (16.2 +/- 8.0 mmHg) and mean (8.3 +/- 4.5 mmHg) gradients, and without paravalvular leakage and only minimal regurgitation (grade < I degrees) in 10 patients. CONCLUSION: Supraannular implantation of the Freedom Solo stentless valve is safe and reliable, using a single suture line. The valve provides excellent hemodynamics at hospital discharge, without paravalvular leakage. The reduced cross-clamp time represents an attractive surgical alternative in elderly patients.

[Customer satisfaction with a quality management system according to DIN EN ISO 9001:2000: Increase in the satisfaction of cooperating clinics]. / Kundenzufriedenheit unter einem Qualitätsmanagementsystem nach din en iso 9001:2000: Steigerung der Zufrieden- heit zuweisender Arzte.

The evaluation of customers' satisfaction is elementary for any quality management system. In our university cardiac surgery unit that has been certified according to DIN EN ISO 9001:2000 the influence of repeated evaluation of the referring physicians' satisfaction conducted in the course of three consecutive years on structures and processes in the scope of the quality management system was examined. Customers' satisfaction with the possibility of access to the department could be increased by targeted interventions. Further interventions in the field of documentation led to a measurable increase in satisfaction with postoperative communication. Repeated annual evaluation of the satisfaction of referring physicians has proved to be a valuable tool in the process of continuous quality improvement.

Aortic valve replacement with new-generation stentless pericardial valves: short-term clinical and hemodynamic results.

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement (AVR) with stentless bioprostheses offers superior hemodynamics. In order to overcome the disadvantages of older, stentless valves, a new generation of pericardial stentless prostheses has been developed. Herein, the hemodynamic and clinical results of these substitutes have been evaluated. METHODS: Between March 2002 and May 2004, 85 patients (59 females, 26 males; mean age 73.6 +/- 6.1 years) who underwent AVR received either a bovine (Sorin Pericarbon Freedom; SPF; n = 50) or an equine (3F Aortic Bioprosthesis; 3F; n = 35) pericardial stentless valve. Patients were followed up prospectively at six months after surgery by clinical and echocardiographic examination. The mean follow up period was 5.6 +/- 0.8 months, and was 96.4% complete. RESULTS: Mortality was 2.4% at 30 days (two SPF patients; one died at reoperation for suspected valve thrombosis and one was a non-valve-related death) and 2.5% at follow up (two SPF patients; both nonvalve-related). Neither structural valve failure nor endocarditis were observed. Preoperatively, there were no differences in baseline data, functional status and hemodynamics between SPF and 3F patients. The aortic cross-clamp time was similar in both groups (51.7 +/- 11.2 min for SPF; 51.6 +/- 8.2 min for 3F). NYHA functional status improvement was similar in each group (1.8 +/- 0.5 for SPF; 1.7 +/- 0.6 for 3F). The mean transaortic pressure gradient (deltapmean) was reduced in all patients during follow up. With SPF, a lower deltapmean was found for smaller aortic roots (indexed annular diameter (IAD) < 14 mm/m2) as well as in larger (IAD > 14 mm/m2) aortic roots: 8.0 +/- 4.5 mmHg versus 13.2 +/- 7.2 mmHg (p < 0.05) and 6.8 +/- 3.0 mmHg versus 12.8 +/- 4.8 mmHg (p < 0.05), respectively. CONCLUSION: New-generation pericardial stentless aortic valves are very pliable, which facilitates their implantation. Clinical and hemodynamic results with these prostheses are promising. The SPF prosthesis demonstrates excellent performance, and may be superior when implanted in small aortic roots.

Hemodynamic characteristics of the Matrix P decellularized xenograft for pulmonary valve replacement during the Ross operation.

BACKGROUND AND AIM OF THE STUDY: Aortic valve disease can be treated successfully by means of the Ross operation. Alternatives to pulmonary valve replacement with homografts are needed. The study aim was to demonstrate the performance of a decellularized porcine xenograft valve (Matrix P) in adult patients after the Ross operation. METHODS: Between July 2002 and May 2004, a total of 50 Ross operations was performed with the Matrix P for pulmonary valve replacement. Operative results and postoperative hemodynamics were evaluated. RESULTS: The median patient age was 46 years (range: 17-70 years). Among patients, 36% underwent additional procedures, most often repair of aneurysms of the ascending aorta or coronary artery bypass grafts. One patient died from septic multiorgan failure on postoperative day 36. One reoperation on the Matrix P and one reoperation on the aortic valve were necessary; both reoperations were uneventful. Postoperative echocardiography demonstrated low transvalvular gradients that did not tend to increase over time. CONCLUSION: In contrast to homografts and other xenografts the Matrix P decellularized xenograft showed, postoperatively, no rise in right ventricular-pulmonary artery pressure gradients. Indeed, the valve was seen to behave similarly to a physiologically normal valve in a healthy subject.