Clinical experience with the 3F stentless aortic bioprosthesis: one-year follow up.

BACKGROUND AND AIM OF THE STUDY: The 3F equine aortic bioprosthesis is a new stentless valve which is currently undergoing evaluation in a multicenter clinical trial and is considered to have superior hemodynamic performance. Herein is reported the authors' initial experience with the 3F valve, focusing on the hemodynamic performance of the device. METHODS: Between March 2002 and October 2003, 35 patients (age range 61-86 years) underwent aortic valve replacement with the 3F valve implanted in the subcoronary position. Evaluation of valve hemodynamic performance was assessed at discharge (postoperative day 5 +/- 2), at 3-6 months, and at 11-14 months' follow up by means of transthoracic echocardiography. The mean preoperative transvalvular pressure gradient was 63 +/- 14 mmHg. Before surgery, all patients were in NYHA class III or IV, despite aggressive medical treatment. Five patients underwent concomitant coronary artery bypass grafting. RESULTS: The implanted valve sizes ranged from 21 to 29 mm. There were no operative deaths and no major perioperative complications. After 12 months, mean pressure gradients for the 23-, 25-, 27- and 29-mm valves were 13, 13, 12 and 9 mmHg, respectively. Mean systolic pressure gradients and NYHA class were improved significantly after surgery. Mild signs of hemolysis and minimal central regurgitation were detected in some patients, but were of no clinical importance. Valve dysfunction or mechanical failure did not occur during the follow up period. CONCLUSION: Because of its flexible structure, the 3F aortic bioprosthesis is simple to implant, and no major adverse effects have been associated with such valve implantation at the authors' center. Transprosthetic gradients appeared to regress at 6-12 months' follow up. The durability of the device is yet to be established in ongoing long-term trials.

Impact of implantation technique on hemodynamic results of the Pericarbon Freedom stentless valve.

BACKGROUND: The Pericarbon Freedom stentless valve has shown excellent hemodynamic results in the midterm course. However, there is no information as to whether a continuous or interrupted suture technique at the inflow site has an impact on postoperative hemodynamics. METHODS: 139 patients were enrolled in a non-randomized, prospective matched trial. An interrupted suture line technique was used in 68 patients and a continuous suture line technique was used in 71 at the inflow site. Isolated valve replacement was performed in 70.4% of the continuous and 67.6% of the interrupted suture group. Pre- and postoperative hemodynamics and one-year follow-up were obtained by echocardiography and expressed as mean and peak gradients and grade of regurgitation. RESULTS: No significant difference between continuous and interrupted suture techniques were noted with respect to mean (11.8 +/- 6.3 vs. 12.5 +/- 6.2 mm Hg, p = 0.251) and peak gradients (21.0 +/- 9.6 vs. 22.0 +/- 10.9 mm Hg, p = 0.292) as well as to the degree of regurgitation. Bypass and cross-clamping times decreased by 22.4 and 20.6 minutes, respectively, with the use of the continuous suture technique. One year follow-up showed a further, significant decrease of mean and peak gradients. CONCLUSIONS: The Pericarbon Freedom stentless valve appears to offer excellent postoperative performance. The suture line technique at the inflow site does not result in any hemodynamic differences.

[Evaluation of passive cardiomyoplasty using left- and right-ventricular volume measurements by EBCT and MRI in patients with chronic congestive heart failure]. / Evaluierung der passiven Kardiomyoplastie mittels links- und rechtsventrikulärer EBCT- und MRT-Volumetrie bei Patienten mit chronischer Herzinsuffizienz.

PURPOSE: To evaluate the efficacy of passive cardiomyoplasty with the determination of biventricular volumes, global systolic function as well as left-ventricular muscle mass. MATERIALS AND METHODS: In 19 patients with congestive heart failure of idiopathic or ischemic origin, a polyester mesh-graft was implanted around both ventricles for stabilization and functional support. Before and three months after surgery, 15 patients underwent EBCT and 4 patients with impaired renal function underwent MRI, for the evaluation of the volume and ejection fraction of both ventricles. RESULTS: EBCT demonstrated a decrease from 385 to 310 ml in LV-EDV, from 312 to 242 ml in LV-ESV, from 209 to 160 ml in RV-EDV and from 149 to 87 ml in RV-ESV, and an increase from 20 to 26% in LV-EF and from 37 to 50% in RV-EF as well as a reduction of LV-MM from 300 to 274 g (p < 0.05 each). Similar results were obtained by MRI. CONCLUSION: Following passive cardiomyoplasty, EBCT and MRI revealed an improvement of the global systolic function as well as a reduction of biventricular volumes and left-ventricular muscle mass.

Passive containment and reverse remodeling by a novel textile cardiac support device.

BACKGROUND: Progressive remodeling and dilation of cardiac chambers is responsible in part for myocardial dysfunction in chronic heart failure. Preclinical studies with suitable animal models indicate that a passive cardiac constraint device can promote reverse remodeling, with improvement in cardiac function. We hypothesize that such a device could provide benefit for stable heart failure patients in New York Heart Association (NYHA) class II and III. METHODS AND RESULTS: From April 1999 to March 2000, 27 patients received Acorn's Cardiac Support Device (CSD) during an initial safety/feasibility study. In 11 patients, the only surgical measure was CSD placement. Most patients suffered from idiopathic cardiomyopathy; 4 were in NYHA class II, one was in class II/III, and 6 were in class III. All were stable on intensive medical treatment. The CSD, a textile polyester device, was fitted snugly around the heart during surgery. All patients survived surgery and recovered smoothly. Three months after surgery, 56% of patients were in NYHA class I, 33% were in class II, and 11% were in class II/III. Echocardiography showed an improvement in left ventricular ejection fraction from an average of 22% to 28% and 33% at 3 and 6 months, respectively. Simultaneously, the left ventricular end-diastolic dimension decreased from 74 mm to 68 mm and 65 mm, respectively. Mitral valve regurgitation (on a scale of 0 to 4+) decreased from 1.3 to 0.7 by 3 months. Quality-of-life indices correlated with the apparent reversal of ventricular remodeling. Preoperative cardiac medications remained virtually unchanged after implant. CONCLUSIONS: In the short- and intermediate-term, CSD implantation seems to ameliorate symptoms and improve cardiac and functional performance in heart failure patients. Worldwide randomized trials are currently underway.

[Indications, technique and initial results of passive cardiomyoplasty]. / Indikationen, Technik und erste Ergebnisse der passiven Kardiomyoplastie.

The cardiac support device (CSD, Acorn Cardiovasc. Inc.), a knitted polyester tissue, is surgically placed over the ventricles to prevent further dilatation of the heart. The aim of this study was to evaluate the feasibility and safety of CSD implantation in patients with advanced heart failure from cardiomyopathy of either idiopathic or ischemic origin. From April 1999, 23 patients received the CSD. In 8 patients the CSD implantation was the only surgical measure; in 12 patients a concomitant mitral valve repair was performed. In three more patients, the CSD implantation was combined with other surgical procedures. The CSD was placed while on bypass with the heart beating, attached to the AV groove and tailored anteriorly to snugly fit the ventricles. There were no intraoperative deaths or complications. Two patients died early postoperatively (4 d, 21 d); 1 late death occurred (44 d postop). The deaths were not considered to be device related. There were no CSD-related adverse events. Six months postoperatively all patients improved by at least one NYHA class. Echocardiography at 6 months revealed an increase in LVEF; the LVEDD decreased accordingly. Mitral valve regurgitation improved in all patients. These findings indicate that the CSD is safe, and improves heart failure symptoms and left ventricular function. Additional studies have to confirm these results.

Safety and feasibility of a cardiac support device.

The Cardiac Support Device (CSD), a preformed-knitted polyester device surgically placed over the cardiac ventricles, prevents left ventricular (LV) remodeling and improves LV ejection fraction (EF) in dogs with heart failure (HF). This study was designed to examine the safety of the CSD in patients with advanced HF. As of December 31, 1999, the CSD was implanted into 22 patients with myocardial disease. Ten patients had concomitant mitral valve repair, two patients had valve replacement (one patient aortic and one patient mitral), one patient had LV assist device (LVAD) placement, and eight patients received only the CSD. The CSD was placed while on bypass with the heart beating, attached to the epicardium groove, and tailored anteriorly to snugly fit the ventricles. There were no intraoperative deaths or complications. Two patients died early from non-CSD-related causes 4 and 23 days postoperatively; one late death occurred. Of the remaining 19 patients, none had any CSD-related adverse events during an average 3.5 +/- 0.4 month follow-up. All patients had completed 3-month follow-up. No patients had evidence of constrictive and/or restrictive physiology. Mitral valve regurgitation (MVR) improved in all patients. [table: see text] Initial findings indicate that the CSD is safe and improves heart failure symptoms and LV function. Additional studies and longer follow-up are needed to confirm these results.