Clinical and hemodynamic performance of the Freestyle aortic root bioprosthesis.

BACKGROUND: The objective of this study is to assess the clinical and hemodynamic performance of a stentless porcine bioprosthesis, the Freestyle aortic root bioprosthesis. METHODS: Consenting patients requiring isolated aortic valve or aortic root replacement received the Freestyle bioprosthesis. Clinical follow-up and echocardiographic data were obtained at discharge, 3 to 6 months, 1 year, and annually thereafter. RESULTS: Two hundred seventy-six patients received a Freestyle aortic root bioprosthesis between January 1993 and July 1997. The mean age was 67.7 years. Preoperatively, 86.3% were either New York Heart Association class III or IV. Two hundred thirty-eight patients underwent valve (subcoronary) replacement, 36 underwent aortic root replacement, and 2 underwent valve replacement using the root-inclusion technique. The early mortality was 5.4%, with 3.3% mortality for the subcoronary technique and 19.4% mortality for aortic root replacement. The mean gradient decreased significantly between discharge and the 3- to 6-month follow-up and stabilized thereafter. The effective orifice area increased significantly from discharge to 3 to 6 months' follow-up. At 3 years, 84.4% of the patients had either no or trivial regurgitation. CONCLUSIONS: The Freestyle bioprosthesis has good clinical performance and good short-term hemodynamic performance. The majority of the regurgitation identified is not clinically significant.

Hemodynamic features of the freestyle aortic bioprosthesis compared with stented bioprosthesis.

BACKGROUND: The Freestyle prosthesis is a new stentless aortic bioprosthesis. Anticipated benefits are improved hemodynamics and increased longevity. METHODS: Doppler echocardiograms were performed early and at 3 to 6 months, 1 year, and 2 years after operation in 157 patients (69 men, 88 women, aged 48 to 85 years) with this prosthesis, and results were compared with hemodynamic data in patients with Intact and Mosaic stented bioprostheses. RESULTS: Distinctive features of the prosthesis compared with stented prostheses are (1) an increase in effective orifice area (+0.15+/-0.26 cm2; p < 0.05) and a decrease in mean gradient (-3.5+/-4.0 mm Hg; p < 0.001) during the first 3 to 6 months postoperatively and stabilization thereafter; (2) a markedly lower mean gradient at 1 year after operation (average, 6+/-4 mm Hg) than in stented prostheses (Intact, 22+/-8 mm Hg; Mosaic, 12+/-6 mm Hg); (3) in contrast to stented prostheses, in vivo effective orifice areas much lower (-0.91+/-0.35 cm2) than those calculated in vitro; (4) as in stented prostheses, the indexed effective orifice area (cm2/m2) is the best predictor (r = 0.77 at 1 year) of the mean gradient after operation; and (5) similar incidence of aortic regurgitation (trivial or mild, 34% versus 29% in Intact). CONCLUSIONS: The hemodynamics of the Freestyle are very satisfactory and represent a marked improvement in comparison to stented prosthesis.

Technique and results of operative transluminal angioplasty in 81 consecutive patients.

Eighty-one consecutive patients with distal multivessel coronary artery disease underwent 93 attempts at operative transluminal angioplasty at the time of coronary bypass operation. Lesions chosen for angioplasty were those in coronary arteries that otherwise would not have been bypassed because of small size and/or inaccessible location; 53% involved the distal anterior descending artery. A guide wire-tipped catheter with a 2 mm balloon was found to be the more satisfactory of the two devices used. An operative "successful" dilatation was achieved with 75 lesions (81%). Eighteen "unsuccessful" dilatations occurred primarily because of inability to transverse the lesions with the catheter. Postoperative angiography was performed in 29 patients to study 31 lesions. In 20 of 28 "successfully" dilated lesions (71%), the stenoses were completely alleviated. Three lesions were found unimproved and in two lesions, the coronary arteries were occluded distally. Two bypass grafts, involving two lesions with extensive dilatation, were closed. Two patients had definite perioperative myocardial infarction, and there were no deaths in this series. Whereas calcification did not influence success, the length of the lesion was inversely proportional to a successful dilatation. Operative dilatation of short coronary distal lesions is safe, has a high percentage of success, and offers a larger distal runoff for coronary bypass grafts. Areas of normal coronary arteries should not be dilated. Careful attention to detail and proper selection of the lesions to be dilated are required. The technique should be used only to dilate arteries that otherwise would not accept a bypass graft.

Does operative transluminal angioplasty extend the limits of coronary artery bypass surgery? A preliminary report.

Distal coronary artery disease often reduces the feasibility and effectiveness of coronary bypass surgery to specific vessels. Operative transluminal angioplasty (OTA) is a valuable adjunct to coronary bypass surgery without significant sequelae. OTA should not be used to supplant coronary bypass; rather, if should be used to augment that procedure. We report our experience with 24 patients who underwent OTA. Twenty-nine lesions were dilated: 17 distal lesions in a primary coronary artery limiting runoff, six tandem lesions that would otherwise not warrant separate grafts, and six lesions in coronary branches and large enough to accept a bypass graft. Catheter dilatations were performed with 20-mm-long balloons inflated to an external diameter of 2-3 mm. Hand inflation monitored by direct vision for 10 second was used for dilatation. Severe stenosis prevented passage of the balloon across lesions in four cases. Stenoses in 25 lesions would not allow passage of a 0.5-1 mm probe before dilatation. After successful dilatation, passage of 1.5-2.0-mm probes was possible. Repeat cardiac catheterization was performed on eight patients 10 days to 4 months postoperatively. Seven patients improved, one did not improve, and there were no closures, extravasations or aneurysms. One hypercoagulable patient required reoperation for two early graft occlusions at 8 days. There were no perioperative infarctions or deaths.