The third generation Carpentier-Edwards bioprosthesis: early results.

The current status of valve replacement was reviewed by analyzing six groups of 100 consecutive patients, each receiving the standard Carpentier-Edwards bioprosthesis, the Starr-Edwards valve or the Björk-Shiley valve in the mitral or aortic position and operated on by the same surgeons in the same institution during an identical time frame. Data were evaluated for valve failure, reoperation, thromboembolism and valve-related deaths. Long-term results up to 9 years showed the superiority of bioprostheses over mechanical valves in terms of valve-related deaths and thromboembolic and anticoagulant complications for a similar rate of valve failure. Persistent drawbacks associated with valvular bioprostheses, namely, transvalvular gradients, limited durability and tissue calcification in young patients, led to continual improvements in valve design and preservation techniques and the development of the third generation Carpentier-Edwards bioprosthesis: the supraanular porcine valve and pericardial valve. The supraanular porcine valve was designed with the aim of decreasing the transvalvular gradient, decreasing turbulence, increasing longevity and decreasing calcification. The pericardial valve was designed with the aim of improving hemodynamics in small-sized orifices, improving mounting techniques to avoid fixation sutures at the commissures, achieving a flexible stent and improving preservation. Between July 1980 and October 1984, there were 391 supraanular porcine and 61 pericardial valves implanted. The supraanular valves were used for three purposes: isolated aortic, isolated mitral and mitral valve replacement associated with tricuspid anuloplasty. The pericardial valves were used for isolated aortic valve replacement. Short-term results (1 to 4 years) are presented concerning the clinical use of these third generation bioprostheses.

Extensive calcification of the mitral valve anulus: pathology and surgical management.

Extensive calcification of the mitral valve anulus is a pathologic entity frequently associated with degenerative valvular disease. The calcification process remains localized to the anulus in 77% of the cases. It may extend, however, to the underlying myocardium. Whenever an operation is necessary for an associated valve insufficiency, the question arises whether it is preferable to repair or to replace the valve and how to manage the calcification. In the first part of this paper the pathology of this disease is studied, and in the discussion a mechanism is proposed to explain the development of the process of calcification. In the second part, a new operation is described, which comprises the temporary detachment of the leaflets, en bloc resection of the calcium deposit, annular reconstruction, and valve repair. For patients in whom the calcification extends to the myocardium a "sliding atrioplasty" of the left atrium is described, which allows the area of exposed muscular fibers to be covered. Between 1986 and 1994, among 68 patients with extensive calcification of the anulus and severe mitral valve insufficiency, 67 benefited from these repair techniques. Ages ranged from 18 to 82 years (mean 62 years). Thirty-two patients had a billowing mitral valve (Barlow), 27 a fibroelastic deficiency, and two Marfan's disease. The calcification involved more than one third of the anulus in 88% of the patients, the posterior anulus in 10.5%, and the whole anulus in 1.5%. The calcification process extended to the myocardial wall in 12% of the patients and to the papillary muscles in 4.5%. In the group of 67 valve repairs, there were two hospital deaths (2.9%), no instances of anulus dehiscence, and no early reoperations. The follow-up period extended from 4 months to 8 years (mean 3 years 8 months). There were two late deaths, 2 and 17 months after the operations, for an actuarial survival of 93% at 7 years. Late reoperation (6 to 62 months) was necessary in four patients (6.4%) for residual mitral valve incompetence (n=2), hemolysis (n=1), or endocarditis (n=1). In one of these patients a new repair was possible, whereas the three other patients required a valve replacement. All patients but one survived the reoperation. Actuarial freedom from reoperation was 87% at 7 years. All 60 patients with valve repair were reviewed for this study by clinical examination and echocardiography. All but one were in functional class I or II. There was no incompetence or trivial residual mitral valve incompetence in 55 patients and moderate incompetence in five. Two thromboembolic events have been recorded for a linearized rate of 1%/pt-yr. This study shows that complete anulus decalcification and valve repair can be done safely in patients with mitral valve insufficiency and extensive calcification of the anulus, even when the calcification process deeply involves the myocardium. It also demonstrates that an initially good result remained stable up to 7 years.

Dynamic cardiomyoplasty at seven years.

Since January 1985, the date of the first dynamic cardiomyoplasty, until April 1992, 52 patients with end-stage heart disease were operated on in our institution. Mean preoperative New York Heart Association functional class was 3.3 and ventricular ejection fraction 16% +/- 3%. Associated procedures in 23 patients comprised ventricular aneurysm resection (10), valve surgery (9), coronary artery bypass (8), and tumor resection (3). Thirty-eight patients had a ventricular reinforcement, 13 a ventricular substitution, and 1 an atrial reinforcement using the left latissimus dorsi muscle. Preassist mortality rate before full latissimus dorsi muscle stimulation was 7 of 13 patients (54%) in the 1985 to 1987 period and 5 of 39 (12%) in the 1988 to 1992 period. The causes of death were heart failure (4), multiorgan failure (4), septicemia (2), ventricular fibrillation (1), and sudden death (1). Multivariate analysis of factors influencing hospital mortality showed that age, cardiac suture technique, associated surgical procedures, biventricular heart failure, and hemodynamic instability plus inotropic drug support were predictors of unfavorable outcome. All patients were followed up for from 2 months to 7 years (mean 21 months). Postassist mortality rate was 8 of 40 (20%). Causes of death included heart failure (5), ventricular fibrillation (1), myocardial infarction (1), and gastric bleeding (1). Preoperative risk factors influencing long-term mortality were permanent New York Heart Association functional class IV, biventricular heart failure, atrial fibrillation, cardiothoracic ratio greater than 60%, and ejection fraction less than 15%. Actuarial survival at 7 years was 70.4% (preassist mortality excluded). Surviving patients were in a mean New York Heart Association functional class of 1.8 (preoperatively 3.3, p < 0.05). The average ejection fractions (rest/stress) were 25%/28% at 1 year, 26%/30% at 2 years, and 23%/28% at 3 years. Average cardiothoracic ratios were 57% +/- 3% at 1 year, 56% +/- 2% at 2 years, and 57% +/- 2.5% at 3 years. Catheterization obtained in 20 patients showed no significant changes at rest in capillary wedge pressure, pulmonary artery pressure, and diastolic left ventricular pressure when compared with preoperative pressures. Average ejection fractions increased from 24% to 30.6%. Maximal oxygen consumption increased from 12.8 +/- 3.5 to 18.6 +/- 4 ml/min per kilogram. The number of rehospitalizations resulting from congestive heart failure was reduced to 0.4 hospitalizations per patient per year (preoperatively 2.4, p < 0.05). In 62% of the patients, pharmacologic therapy was diminished after the operation. Three patients required orthotopic heart transplantation 6 months, 4 years, and 5 years after cardiomyoplasty.

Valve extension with glutaraldehyde-preserved autologous pericardium. Results in mitral valve repair.

Preliminary experimental studies in our laboratory have shown that autologous pericardium treated with glutaraldehyde prevents late deterioration and calcification of the tissue. For this reason, glutaraldehyde-treated autologous pericardium has been used in a series of 64 patients who underwent operations for leaflet extension of the mitral valve between 1980 and 1989. Ages ranged from 2.5 to 60 years (mean 19 +/- 15). The causes of mitral valve insufficiency were rheumatic fever (69%), bacterial endocarditis (17%), congenital (8%), endomyocardial fibrosis (4.5%), and trauma (1.5%). The autologous tissue was fixed in a 0.62% glutaraldehyde solution for 15 minutes and rinsed in saline for an additional 15 minutes. Patching techniques varied depending on the site and the extent of the lesion. Associated mitral valve repair techniques (Carpentier's techniques) were mandatory in all patients. The period of follow-up extended from 6 months to 9 years (mean 3.1 +/- 2.5 years). There were no operative deaths in this series, and there was one late death (2%). In the six patients (12%) who underwent reoperation, there has been no case of calcification of the pericardial patch. Postoperative mitral valve function was assessed by bidimensional color Doppler echocardiographic techniques. Mitral valve insufficiency was trivial or absent in 80% of the patients. This experience permits us to conclude that leaflet extension is a simple and safe technique in valve reconstruction, allowing repair of mitral valves that otherwise would need to be replaced. It permits use of an adult-size prosthetic ring in children. Glutaraldehyde-treated autologous pericardium is the material of choice for this type of repair.

Reconstructive surgery of mitral valve incompetence: ten-year appraisal.

Between January, 1969, and January, 1978, 551 patients with mitral incompetence were treated by a system of reconstructive techniques. Mitral valve incompetence was classified into three types according to leaflet pliability; type I normal leaflet motion, 150 cases; type II, leaflet prolapse, 213 cases; and type III, restricted leaflet motion, 188 cases. Associated tricuspid valvular disease was present in 174 cases (31.5%) and was treated by prosthetic ring annuloplasty. The operative mortality rate was 4.2% (16/377) in the mitral group and 14% (25/174) in the mitral-tricuspid group. Follow-up data are available in 341 patients from 1 year to 10 years (average 4 1/2 years). The late mortality rate was 7% (24/341). Actuarial curves including hospital mortality rate show an 82% survival rate at 9 years in the mitral group and a 79% rate in the mitral-tricuspid group. Thirty-seven patients (11%) underwent reoperation mainly for residual (17) or recurrent (16) mitral incompetence. Thromboembolism occurred in 12 patients for an embolic rate of 0.6% per patient-year, even though 48% were not given anticoagulants. Acorrding to the New York Heart Association (N.Y.H.A.) classification, 76% (207/270) of the patients were in Class I, 19% (51/270) were in Class II, 4% (10/270) were in Class III, and 0.7% were in Class IV (2/270). Results of postoperative catheterization and angiocardiography are available in 52 patients. Comparison between the various groups shows that the best results were obtained in type II mitral incompetence, followed by type I and type III mitral incompetence. This experience demonstrates that predictable and stable long-term results have been achieved by techniques of valvular reconstruction with a low incidence of thromboembolism. Reproducibility of the techniques is a limiting factor which can be overcome by adequate training and progressive experience. Patient selection is based on the valvular disease rather than age, physical condition, or cause of valvular disease.

Valve repair with Carpentier techniques. The second decade.

Among 206 consecutive patients having undergone mitral valve repair with a prosthetic ring between 1972 and 1979 in our institution, the 195 patients (94.5%) who survived the operation were studied to assess the long-term function of this method of repair. Patients' ages ranged from 18 to 79 years (mean age 48.7 years). Mitral valve insufficiency was due to degenerative disease in 113 patients (58%), rheumatic disease in 74 (38%), ischemia and other causes in eight patients (4%). A total of 188 patients (9.7%) were in New York Heart Association class III or IV preoperatively and 94 (48%) had atrial fibrillation. The patients were divided into three functional groups: type I (normal leaflet motion), 35 patients (18%); type II (leaflet prolapse), 147 patients (75%); and type III (restricted leaflet motion), 13 patients (7%). The techniques included prosthetic ring annuloplasty (185 patients), leaflet resection (158 patients), chordal shortening (89 patients), leaflet mobilization (10 patients) and papillary muscle reimplantation (2 patients). Long-term follow-up was available in 189 patients (96.8%), for a rate of 2316 patients per year. The 15-year actuarial and valve-related survival rates were 72.4% and 82.8%, respectively. At 15 years, 93.9% of the patients were free from thromboembolism, 96.6% free from endocarditis, 95.6% free from anticoagulant-related hemorrhage, and 87.38% free from reoperation. Actuarial rate of freedom from reoperation was higher in the group with degenerative disease (92.7%) than in the group with rheumatic disease (76.12%). Among the 157 survivors, 117 (74%) were in New York Heart Association class I and class II and 105 (66%) were in sinus rhythm. Doppler echocardiographic studies showed normal ventricular contractility in 134 patients (84.5%), absence of mitral regurgitation in 112 (74%), trivial regurgitation in 27 (17%), and significant regurgitation in 4 patients (2.5%).

Endoscopic coronary artery bypass grafting with the aid of robotic assisted instruments.

OBJECTIVE: The development of endoscopic coronary artery bypass grafting has been limited because of poor visualization and increased technical difficulties in carrying out operations through ports. We investigated whether the use of robotic assisted instruments could minimize these difficulties. METHODS: After a period of technical development and training on cadavers (n = 8) with the Intuitive Surgical system (Intuitive Surgical, Inc, Mountain View, Calif), the first clinical application in coronary artery surgery was performed in 4 male patients (mean age 59 +/- 6 years) with the indication of grafting the left internal thoracic artery to the left anterior descending coronary artery. Robotic assisted 3-dimensional endoscopes and instruments were introduced into the left side of the chest through 3 intercostal ports. The Heartport system (Heartport, Inc, Redwood City, Calif) was used for arresting the heart during the anastomosis. RESULTS: In 2 patients, the harvesting of the left internal thoracic artery was completed endoscopically with robotic assisted instruments and the anastomosis to the left anterior descending artery was performed through a minithoracotomy with conventional instruments. In 2 other patients, the entire operation was completed endoscopically with robotic assisted instruments. Early postoperative coronary angiography demonstrated the patency of the grafts in all cases. At 6-month follow-up, all patients were free of symptoms. CONCLUSIONS: Robotic assisted instruments make endoscopic coronary bypass possible and open a new era in minimally invasive surgery.

New surgical approach to aortic dissection: flow reversal and thromboexclusion.

With the aim of decreasing the complications and mortality associated with the current techniques for aortic dissections, we have developed an operation which consists of bypassing the dissected aorta and creating flow reversal in the dissected segment. Seven patients with either acute (five) or chronic aortic dissections (two) were operated upon successfully, with no early or late deaths. Three transient postoperative complications were encountered: low cardiac output, hemiparesis, and renal insufficiency. Postoperative arteriography was performed in five patients and demonstrated exclusion of the dissected lesions by thrombosis following flow reversal in the descending aorta. Follow-up is available from 2 to 28 months (average 13 months), with no long-term complications.

A new reconstructive operation for Ebstein's anomaly of the tricuspid valve.

Ebstein's anomaly is a complex malformation involving the tricuspid valve and the right ventricle. Various surgical techniques, either repair or replacement of the abnormal tricuspid valve, have been used with variable results. In an attempt to enlarge the indications of conservative procedures, we developed a technique of repair that comprises the reconstruction of a normally shaped right ventricle and the repositioning of the tricuspid valve at the normal level. In a series of 14 patients operated on between January 1980 and December 1986 in our institution, only one patient with an associated atrioventricular septal defect required a tricuspid valve replacement. All of the other patients, regardless of the complexity of the tricuspid malformation, were able to benefit from this conservative technique. There were two hospital deaths and no late deaths in this series. All surviving patients displayed a marked improvement over their preoperative status with regard to functional class (92% are in class I or II) and rhythm disturbances. Echocardiographic and Doppler studies demonstrated a normal shape of the right ventricle and good tricuspid valve function in all the patients but one.

Congenital malformations of the mitral valve in children. Pathology and surgical treatment.

A systematic study of congenital mitral valve malformations was undertaken on a surgical basis in an attempt to develop techniques of valvular reconstruction adapted to the various lesions. Forty-seven children between the ages of 4 months and 12 years (average 6 years, 4 months) have been operated upon between January, 1970, and March, 1976. Valvular lesions were classified into four group: Group I, mitral insufficiency owing to valvular lesions: Group II mitral insufficiency with subvalvular lesions; Group III, mitral insufficiency and stenosis; Group IV, stenosis. Associated lesions (ventricular or atrial septal defects, coarctation, or aortic valve stenosis) were present in 31 patients (65 per cent) and were corrected during the same operation. Valve reconsruction was possible in 38 patients whereas valve replacement was necessary in 9 patients. In the valve repair group there were three operative deaths (8 per cent), no late deaths, one reoperation for residual ventricular septal defect, and one myocardial infarction. In the valve replacement group of 9 patients, there were three operative deaths, three late deaths, and one case of repeated embolization. Thirty-one of 38 patients in the valve repair group were classified into Functional Class I after the operation (86 per cent), 2 were in Class II, and one in Class III. Minimal or moderate regurgitation and cardiomegaly persisted in the majority of the patients. Pulmonary artery pressure significantly decreased, however, as demonstrated by postoperative catheterization in 17 patients.

Conservative management of the prolapsed mitral valve.

Prolapsed leaflet is the result of ruptured chordae, elongated chordae, or ruptured papillary muscle. Various techniques adapted to each of these lesions were developed, and repair of 213 prolapsed mitral valves was performed between 1969 and 1977. There were 109 patients with ruptured chordae treated by quadrangular resection of the prolapsed leaflet; 103 patients with elongated chordae were treated by either a "sliding plasty" of the papillary muscle or a "shortening plasty" of the chordae; and 1 patient with ruptured papillary muscle was treated by reimplantation. The great majority of patients had an associated annular dilatation or deformation requiring the use of a Carpentier ring to remodel the annulus and reinforce the repair. The operative mortality was 4% and the late mortality, 3%. There were 6 reoperations, 3 of which occurred within 1 year. Thromboembolic complications occurred in only 1 patient (0.5%), even though the majority of patients received no anticoagulation treatment. Actuarial curves demonstrated a 91% survival at 8 years.

Carpentier-Edwards pericardial bioprosthesis in aortic position: long-term follow-up 1980 to 1994.

Aortic valve replacement with Carpentier-Edwards pericardial bioprosthesis was associated with excellent midterm clinical results. Long-term evaluation, however, remained to be determined. We reviewed the first 124 patients who underwent aortic valve replacement with a Carpentier-Edwards bioprosthesis at the Hôpital Broussais between 1980 and 1985. There were 67 males (54%) and 57 females (46%). The mean age at operation was 65 years (range, 18-83 years). The operative mortality (30 days) was 4%. All but 2 patients were followed up for an average of 7.7 years and a total of 973 patient years. There were 45 late deaths (4.7%/patient-year) of which 16 were valve-related (1.7%/patient-year). The actuarial survival rate was 49.9% at 12 years. The actuarial rate for freedom from valve-related mortality was 78.3% at 12 years. There were 7 thromboembolic events in 5 patients and 3 anticoagulation-related hemorrhages. Freedom from structural valve deterioration was 100% at 12 years and 83.3% at 13 years. We conclude that implantation of Carpentier-Edwards pericardial bioprosthesis in aortic position is associated with an excellent long-term clinical outcome. It is believed that the improved results of this valve result from the following original features: fully flexible stent, distensible struts, infrastent tissue mounting, optimal tissue orientation, and improved preservation.

The "physio-ring": an advanced concept in mitral valve annuloplasty.

BACKGROUND: A new annuloplasty ring has been developed with the aim of adding flexibility to the remodeling annuloplasty concept. Here we report its clinical use with special emphasis on segmental valve analysis and valve sizing. METHODS: From October 1992 through June 1994, 137 patients aged 4 to 76 years (mean age, 49.1 years) were operated on. The main causes of mitral valve insufficiency were degenerative, 90; bacterial endocarditis, 15; and rheumatic, 13. The indication for operation was based on the severity of the mitral valve insufficiency (90 patients were in grade III or IV) rather than on functional class (60 patients were in class III or IV). At echocardiography 6 patients had normal leaflet motion (type I), 119 leaflet prolapse (type II), and 12 restricted leaflet motion (type III). Surgical repair was carried out using Carpentier techniques of valve reconstruction. In 3 patients, inadequate ring sizing was responsible for systolic anterior motion of the anterior leaflet diagnosed by intraoperative echo. The valve was replaced in 2 patients. There were three hospital deaths, no late deaths, one reoperation for recurrent mitral valve insufficiency due to chordal rupture 1 month after repair, one reoperation for atrial thrombus formation 5 months after repair, one anticoagulant-related hemorrhage, and one thromboembolic episode. RESULTS: Mid-term follow-up between 6 and 18 months was available in 94 patients. Echocardiography showed trivial or no regurgitation in 93.2% of the patients and minimal regurgitation in 6.8%. The average transmitral diastolic gradient was 3.55 +/- 1.93 mm Hg. Left ventricular end-systolic diameter and volume decreased postoperatively, demonstrating an improved left ventricular function. CONCLUSIONS: This preliminary experience has provided promising results and allowed us to define the indications of the Physio-Ring versus the classic ring. It has also shown that valve sizing and proper ring selection are of primary importance.

A 10-year comparison of mitral valve replacement with Carpentier-Edwards and Hancock porcine bioprostheses.

Two hundred fifty-three patients who underwent isolated mitral valve replacement with a porcine bioprosthesis had long-term evaluation. One hundred forty-seven patients received a Carpentier-Edwards porcine bioprosthesis and 106, a Hancock valve. There were no significant differences in preoperative clinical characteristics between the two groups. Cumulative follow-up was 1,375 patient-years. At 10 years, 93% +/- 2.5% of the patients in the Carpentier-Edwards group and 85% +/- 7.8% of those in the Hancock group were free from valve-related death (not significant), and 95% +/- 2% and 91% +/- 3.8%, respectively, were free from thromboembolism (not significant). At 10 years, 65% +/- 7.2% of the patients in the Carpentier-Edwards group and 66% +/- 7.2% of those in the Hancock group were free from structural valve deterioration (not significant), and 64% +/- 6% and 59% +/- 7.3%, respectively, were free from reoperation (not significant). We conclude that the first generation of Carpentier-Edwards and Hancock prostheses produce comparable long-term results in the mitral position.

Heparin-induced thrombocytopenia and thrombosis following open heart surgery.

We recently observed five cases of early thrombus formation in patients undergoing anticoagulation with subcutaneous heparin following open heart surgery. The reasons prompting surgery were as follows: one mitral valve replacement, one double valve replacement, one mitral valve reconstruction, one aortic valve replacement associated with coronary bypass. In all cases, intravenous heparin was begun on the day of surgery and replaced by subcutaneous (SC) heparin on postoperative day 1. Acute thrombocytopenia was observed between the 6th and 11th postoperative day. This was interpreted as denoting an idiosyncratic reaction to heparin which was replaced by low molecular weight heparin (LMWH) in two cases and by acenocoumarol in the other cases. Massive thrombosis of the aortic valve resulted in the death of one patient. Thrombosis of the left atrium occurred in three patients (two of whom had a transient ischemic attack (TIA)). One patient had aorto-iliac thrombosis. Successful reoperation was carried out in four of the five patients. Although heparin-induced thrombocytopenia and thrombosis [HITT] is a rare complication of heparin therapy, serial platelet count monitoring and in vitro platelet aggregation tests are mandatory in the diagnosis of this syndrome. Discontinuation of heparin is indicated as soon as the syndrome is recognized and the institution of aspirin is recommended if the thromboembolic complication requires reoperation and reexposure to heparin.

Surgery for aortic dissection: 53 operated cases with 32 in the acute phase.

53 cases of aortic dissections were operated on between 1961 and 1975 in the Service of Cardiovascular Surgery at the Broussais Hospital, Paris (Prof. Ch. Dubost). The present study deals with 32 cases operated on in the acute phase. 31 originated in the ascending aorta and 1 in the descending aorta. Operative mortality was 50% (16/32), 4 patients died immediately following sternotomy. Operation consisted in replacement of the ascending aorta for the majority of type I and II dissections. When aortic insufficiency was present, a simple resuspension procedure was effective in 50% of cases. The authors prefer early operative intervention in type I and II dissections and medical treatment in type III dissections.