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Biomedical subjects

I Gallo

Publications and source records attributed to I Gallo.

At least 37 records · Page 2Linked to original sources
PubMed1986

Comparative study of primary tissue valve failure between Ionescu-Shiley pericardial and Hancock porcine valves in the aortic position.

From August 1977 to June 1981, 221 patients received a Hancock porcine valve and 133 an Ionescu-Shiley bovine (I-S) pericardial valve as aortic valve substitutes. No special selection or randomization was used and no patient with either of these types of valves was excluded. Preoperative data show no differences between the groups influencing the appearance of primary tissue failure. Hospital survivors were followed until June 1984 and those with an uneventful history at least 36 months. Patients who died late postoperatively or who underwent reoperation for causes other than primary dysfunction were considered at risk until death or reoperation. Primary tissue failure occurred in 8 patients in the I-S group from 36 to 70 months postoperatively and in 6 patients of the Hancock group from 24 to 83 months. Linearized rates of primary failure were 0.61 valves per 100 patient-years for the Hancock and 1.70 valves per 100 patient-years for the I-S group. Mean age of patients with failing valves was 38 years (range 25 to 55) for Hancock valves and 39 years (range 15 to 62) for I-S valves. Actuarial analysis shows a lower rate of primary dysfunction in the Hancock group since the fourth year, which is statistically significant in the sixth and seventh years (96.5 +/- 1.5% vs 79.6 +/- 7.6% in the sixth year and 93.1 +/- 3.6 vs 79.6 +/- 7.6% in the seventh year). Microscopically, calcium and collagen degeneration were consistently associated and present on failing bioprostheses.(ABSTRACT TRUNCATED AT 250 WORDS)

Actuarial Analysis↗
PubMed1986

Primary tissue valve degeneration in glutaraldehyde-preserved porcine bioprostheses: Hancock I versus Carpentier-Edwards at 4- to 7-years' follow-up.

In the 32-month period between April, 1978, and December, 1980, 292 patients, divided into two equal groups, received a glutaraldehyde porcine bioprosthesis--either Hancock or Carpentier-Edwards (CE)--as mitral valve substitute. Every patient receiving a mitral porcine xenograft during that time was included in the study. The type of bioprosthesis was always selected by the surgeon and not randomly. Preoperative clinical characteristics, associated surgical procedures, valve implantation sizes, and follow-up data showed no relevant differences between the two groups. There were three instances of primary tissue failure in the Hancock group and six in the CE (linearized rates of 0.49 and 0.97 events percentage of patient/years, respectively). Mean duration of explanted valves and microscopic findings were similar in both groups. Primary tissue failure was more frequent in patients under 40 years of age in both groups, although differences were not statistically significant. A marginally significant trend toward greater incidence of tissue failure in patients of 40 years of age and older was seen in the CE group when compared with the Hancock group. Actuarial survival of the bioprostheses free from primary tissue failure was 6.5 years of 95 +/- 3% (mean +/- standard error) for Hancock and 84 +/- 9% for CE (p = NS). No significant difference in terms of durability has been found between the two most popular glutaraldehyde porcine bioprostheses, although the behavior of the CE in patients older than 40 years should be reassessed in a study with a larger number of patients and a longer follow-up period.

Adolescent↗
PubMed1986

Comparative study of calcification in the T6-treated and standard Hancock-I porcine xenografts: experimental study in weanling sheep.

We compared the morphological findings in 15 young sheep in which standard Hancock-I cardiac bioprostheses (7 animals) and T6-processed Hancock-I (8 animals) were implanted in the tricuspid position. The animals were sacrificed at intervals from 8 to 47 weeks after valve replacement. No valvular infection was detected. Six of the 7 untreated valves and 5 of the 8 T6-processed valves in the tricuspid position showed calcific deposits in the radiographic examination. Roentgenograms from all specimens showed a fairly uneven distribution of the mineralization sites with the commissures being the structure most frequently involved. Calcium in the aortic wall was more frequent in the T6-processed group while right coronary leaflet involvement more frequent in the control group. Histologic evaluation confirmed the above data and showed a fibrotic reaction with granulomatous degeneration of the muscular shelf in all valves. Comparison of linear regression lines of the evolution of tissue calcium content with time showed no statistically significant difference between the 2 groups. Under the conditions of this study, the T6-treatment does not reduce the extent of calcification in the Hancock-I porcine xenograft after implantation in the tricuspid position in young sheep.

Animals↗
PubMed1986

Six- to ten-year follow-up of patients with the Hancock cardiac bioprosthesis. Incidence of primary tissue valve failure.

From June, 1974, through June, 1978, 547 porcine xenografts (299 mitral, 239 aortic, eight tricuspid, and one pulmonary) were inserted in 459 selected patients who survived the operation and were considered at risk for primary tissue valve failure. Ninety-two instances of primary tissue valve degeneration occurred in 82 of the 459 patients. In patients operated on 10 years ago, 28% of the valves implanted in the mitral position (5/18) and 33% in the aortic position (4/12) failed. These percentages decreased to 24% (21/89) and 26% (15/57) for those implanted in 1975, 15% (13/85) and 16% (9/57) for those implanted in 1976, 13% (9/71) and 15% (12/82) for 1977, and 8% (3/36) and 3% (1/31) for 1978. None of the tricuspid or pulmonary valves have failed. The rate of valve survival without primary degeneration was 70% +/- 6% for the mitral and 69% +/- 7% for the aortic prostheses at 10 years of follow-up. Of the 10 valves implanted in patients younger than 20 years of age, 40% of the mitral and 60% of the aortic valves failed. This rate is 26% for mitral and 42% for aortic for the 21 to 30 year group, 20% and 19% for 31 to 40 years, 9% and 13% for 41 to 50 years, 20% and 6% for 51 to 60 years, and 11% and 0% for 61 to 70 years. The average interval between placement and explantation or death was 74 months (range 10 to 112) for valves in the mitral position and 78 months (range 13 to 117) for valves in the aortic position. We believe these current data should have some bearing of practical import not only when comparing different types of bioprostheses but especially when recommending the appropriate valve replacement for the individual patient.

Adolescent↗
PubMed1985

Early clinical results with the Xenomedica porcine bioprosthesis.

All patients undergoing heart valve replacement with a glutaraldehyde-preserved Xenomedica xenograft from June 1983 through November 1983, were reviewed. This analysis included 75 patients: 37 having undergone aortic valve replacement, 23 mitral valve replacement, and 15 mitral and aortic valve replacement. Of 70 patients discharged from the hospital, there were 5 late deaths, which represents an incidence of 1.06% per patient-year. Twenty-six patients were recatheterized between 3 and 6 months postoperatively. The mean mitral valve orifice area was 1.57 +/- 0.37 cm2. The average mitral valve gradient was 9.8 +/- 2.9 mmHg. No differences in hemodynamic behavior were found between standard and composite mitral prostheses. The average aortic valve peak systolic gradient was 11 +/- 6 mmHg. Fourteen out of the 34 mitral (41%) and 5 out of 52 aortic (9.6%) prostheses have some degree of incompetence. We have discontinued the use of this cardiac bioprosthesis due to the frequent appearance of incompetence in mitral valves, and high transvalvular gradients in mitral prostheses.

Adult↗
PubMed1985

Four- to seven-year follow-up of patients undergoing Carpentier-Edwards porcine heart valve replacement.

From April 1978 through December 1980, 216 Carpentier porcine xenografts (144 mitral, and 72 aortic) were inserted in 189 patients (117 mitral, 45 aortic, and 27 mitral and aortic). The hospital mortality was 8.5% (10/117) for mitral patients, 6.6% (3/45) for aortic, and 3.8% (1/27) for mitral and aortic. Of 175 patients discharged from the hospital, there were 16 late deaths, which represents an incidence of 1.9% per patient-year (10/107) for mitral, 0.9% per patient-year (2/42) for aortic, and 3.4% per patient-year (4/26) for mitral and aortic, patients. There were 13 thromboembolic events in 10 patients. This represents a linearized incidence of 2.3%, and 0.5% per patient-year for mitral and aortic patients, respectively. One of the accidents was fatal, and 3 of the 10 patients were on a regimen of anticoagulation at the time of embolism. Seven instances of valve endocarditis occurred in 4 mitral, 1 aortic, and 2 mitral and aortic patients (5 mitral, 2 aortic, and 2 mitral and aortic). This represents a linearized incidence of primary tissue failure of 0.96%, 0.96% and 1.7% per patient-year for mitral, aortic, and mitral and aortic patients, respectively.

Actuarial Analysis↗
PubMed1985

Late clinical results with the use of heterologous pericardium for closure of the pericardial cavity.

In a limited series of 87 patients, the pericardial cavity was closed with a patch of heterologous glutaraldehyde-preserved pericardium. Five specimens have become available for macroscopic and microscopic study, with a postimplant time ranging between 1.5 and 59 months. The patches maintained their initial structure, but the reaction over the epicardial area facing the graft greatly impeded the recognition of the coronary vessels.

Bioprosthesis↗
PubMed1985

Incidence of primary tissue valve failure with the Ionescu-Shiley pericardial valve. Preliminary results.

This report provides retrospective follow-up data on 88 patients who received an Ionescu-Shiley bovine pericardial valve in the aortic position between August, 1977, and June. 1980. Seven instances of primary tissue degeneration occurred in seven of the 65 patients followed up until June, 1984. Cumulative duration of follow-up was 335.5 patient-years. The linearized incidence of primary tissue failure was 2.08% per patient-year. The actuarial rate of freedom from valve failure for patients with an Ionescu-Shiley valve in aortic position was 79% +/- 8% at 7 years of follow-up. This series shows a higher incidence of primary tissue failure with this prosthesis than with the glutaraldehyde-preserved porcine xenograft in the aortic position at 7 years' follow-up.

Adolescent↗
PubMed1984

Degeneration in porcine bioprosthetic cardiac valves: incidence of primary tissue failures among 938 bioprostheses at risk.

From June 1974 through December 1980, 938 porcine xenografts were inserted in 794 selected patients who survived surgery and who were considered at risk for primary tissue valve failure. Sixty-three instances of primary tissue valve degeneration occurred in 59 of the 794 patients. In patients operated on 9 years ago, 29% of the valves implanted in the mitral position (5 of 17) and 27% in the aortic position (3 of 11) failed. These percentages decreased to 18% (14 of 80) and 20% (11 of 54) for those implanted in 1975, 8% (6 of 73) and 14% (7 of 51) for those implanted in 1976, 9% (6 of 68) and 5% (4 of 76) for 1977, and 4% (3 of 79) and 3% (2 of 63) for 1978. The average interval between valve placement and explantation or death was 56 months (range 10 to 98) for valves in the mitral position and 68 months (range 12 to 92) for valves in the aortic position. The rate of valve survival without degeneration was 98 +/- 1% at 4 years, 96 +/- 2% at 5 years, 90 +/- 3% at 6 years, 87 +/- 4% at 7 years and 76 +/- 7% at 8 and 9 years. Until 1978, 4 valves failed, 8 failed in 1979 to 1980, 12 in 1981, 25 in 1982, and 14 have already failed from January to May 1983. Our figures show a progressive increase in valve degeneration with the passing of time. No leveling of this failure rate has so far been observed.

Adolescent↗
PubMed1984

Isolated mitral valve replacement with the Hancock porcine bioprosthesis in rheumatic heart disease: analysis of 213 operative survivors followed up 4.5 to 8.5 years.

An analysis is presented of 236 patients aged greater than or equal to 20 years who underwent isolated mitral valve replacement for rheumatic heart disease with a glutaraldehyde Hancock bioprosthesis from June 1974 through June 1978. Of 213 patients discharged from the hospital, 3 were lost to follow-up study and are excluded from the analysis. The range of follow-up of the surviving patients was 54 to 102 months. There were 17 late deaths, an incidence of 1.3% per patient-year. The actuarial probability of survival of all patients at 102 months, excluding hospital mortality, is 88 +/- 6%. There were 24 thromboembolic events in 22 patients (1.8% per patient-year); none was fatal, and 3 patients were receiving coagulant therapy at the time. The probability of freedom from thromboembolism at 8.5 years is 84 +/- 9%. Primary tissue failure occurred in 17 patients (1.3% per patient-year). Average duration of the explanted valves was 70 months (range 55 to 90). Reoperation was undertaken in the 17 patients 2 days to 63 months (mean 9 months) after the appearance of a new murmur and 2 days to 23 months (average 4 months) after the onset of worsening symptoms. The probability of being free from primary tissue valve failure at 8.5 years of follow-up is 87 +/- 7%. Currently, 14 patients have valve dysfunction on the basis of the appearance of a new murmur 20 to 89 months after operation (average 5.2 years).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1983

Clinical experience with the Carpentier-Edwards porcine bioprosthesis: short-term results (from 2 to 4.5 years).

All patients undergoing a heart valve replacement with a glutaraldehyde Carpentier-Edwards xenograft from April 1978 through December 1980 were reviewed. This analysis included 189 patients: 117 having a mitral valve replacement (MVR), 45 having an aortic valve replacement (AVR), and 27 having mitral and aortic valve replacements (MAVR). Out of 174 patients discharged from the hospital, one was lost to follow-up and is excluded from the analysis. There were 11 late deaths, which represent an incidence of 1.89% per patient-year for the MVR (6/106), 0.83% per patient-year for the AVR (1/41), and 5.83% per patient-year for the MAVR (4/26). There were 6 instances of infective endocarditis (4 MVR, 2 MAVR), which represent a linearized incidence o 1.26% and 2.91% per patient-year for the MVR and MAVR respectively. All were successfully treated with medication. There were 10 thromboembolic events in 7 patients (6 MVR had 9 events and 1 AVR had 1 event). This represents a linearized incidence of 2.84% and 0.83% per patient-year for MVR and AVR, respectively. Primary tissue failure was observed in 3 patients (2 MVR, 1 MAVR), who required reoperation for explantation of the mitral valves. This represents an overall linearized incidence of mitral failures of 0.78% per patient-year. The probability of being free from primary tissue failure is 95.9 +/- 4.9% for all mitral prostheses at 4.5 years of follow-up. These current results indicate that the Carpentier-Edwards porcine xenograft valve can be considered as a valid alternative for heart valve replacement.

Adolescent↗
PubMed1983

Experimental atrioventricular bioprosthetic valve insertion: a simple and successful technique.

Animal testing has become mandatory for the development of new prosthetic heart valves. It is very expensive. Low mortality and morbidity are essential in controlling costs. A simple technique for atrioventricular valve replacement in dogs and sheep that includes normothermic cardiopulmonary bypass, the maintenance of a beating heart and the avoidance of excision of the natural valve is described. Results have been excellent.

Animals↗
PubMed1983

Five- to eight-year follow-up of patients with the Hancock cardiac bioprosthesis.

All patients undergoing a heart valve replacement with a glutaraldehyde-preserved Hancock xenograft from June, 1974, through June, 1977, were reviewed. This analysis included 403 patients: 202 having mitral valve replacement (MVR), 131 having aortic valve replacement (AVR), and 70 having mitral and aortic valve replacement (M/AVR). The hospital mortality was 9.9% (40/403): 10.8% (22/202) for MVR, 4.5% (6/131) for AVR, and 17.1% (12/70) for M/AVR. Of 363 patients discharged from the hospital, six were lost to follow-up at 24 and 37 months and they are excluded from the figures. There were 41 late deaths, which represents an incidence of 1.47% per patient-year for MVR (16/177), 1.95% per patient-year for AVR (14/122), and 3.35% per patient-year for the M/AVR (11/58). There were 37 thromboembolic events in 32 patients. This represents a linearized incidence of 1.93%, 0.97%, and 2.74% per patient-year for MVR, AVR, and M/AVR, respectively. None of the accidents was fatal, and four of the 32 patients were on a regimen of controlled anticoagulation at the time of embolism. Primary tissue failure was observed in 34 patients (231 MVR, eight AVR, and five MAVR). The probability of being free from primary tissue failure at 8 years is 85.3% +/- 3.7% for MVR, 85% +/- 11.6% for AVR, and 81% +/- 8.9% for M/AVR. These current results indicate that the Hancock xenograft valve can be considered as a valid alternative in heart valve replacement.

Adolescent↗
PubMed1981

Coronary arteriography and atrial thrombosis in mitral valve disease.

The arteriographic findings of neovascularity and fistula formation from the coronary arteries to the left atrium have occasionally been reported in association with atrial thrombosis in patients with mitral valve disease. To establish the diagnostic value of these findings, the preoperative coronary angiograms of 507 patients who underwent open mitral valve surgery were reviewed. Atrial thrombosis was present in 76 patients (14.9 percent). In the 30 patients with angiographic neovascularity and fistula formation, the thrombi were always observed to arise from the circumflex coronary artery. None of these 30 patients had atherosclerotic coronary lesions. In 25 of these patients an atrial thrombus was found at operation. These coronary arteriographic findings, in this selected group of patients, had a predictive accuracy of 83.3 percent, a specificity of 98.8 percent and a sensitivity of 32.8 percent for the diagnosis of the presence of thrombus in the left atrium. No relation was found between these signs and the size and histologic age of the thrombi examined.

Adult↗
PubMed1980

Conservative operation for mitral insufficiency: critical analysis supported by postoperative hemodynamic studies of 72 patients.

From May, 1974, through December, 1978, 255 mitral annuloplasties have been performed at our institution. Forty-three Carpentier rings and 212 flexible rings were used. Simultaneously, 307 patients with predominant insufficiency were treated with a Hancock bioprosthesis. A critical analysis of the flexible ring group versus the Hancock group is presented: The average ages were 41.3 versus 43.3 years. Preoperatively, 55% versus 60% were in Functional Class III and 9.6 versus 25.4% were in Class IV. The valve lesion was caused by rheumatic disease in 91.2% versus 93.9%. A multiple valve operation was required by 51% versus 60%. There was a significant difference in the operative mortality rates (1.8% versus 11.4%). This difference was maintained for each preoperative functional class and for the isolated and multiple valve groups. There was no significant difference in the late mortality rates (1.4% versus 3.7%). The total actuarial survival rates were of 96.4% and 81% (maximum follow-up times 4.0 and 4.5 years). The incidence of embolism was 2.4% and 4.1% per patient-year, with both groups being subjected to the same anticoagulation policy. The incidence of dysfunctions was equal (3.9% per patient-year). Postoperative hemodynamic evaluation of 72 patients having annuloplasty and 129 patients having Hancock valve replacement showed basal mean transmitral gradients of 10.98 +/- 3.6 and 9.66 +/- 2.73 mm Hg. The average effective orifice areas were 1.93 +/- 0.74 and 2.25 +/- 0.46 cm2. While the bioprosthesis behaves hemodynamically like a flow-related variable orifice, the reconstructed valve orifice is dependent upon its preoperative anatomy. In conclusion, the comparison of flexible ring annuloplasty and Hancock valve replacement for mitral valve disease shows a lower operative mortality for the former and comparable medium-term postoperative course. Since both techniques have a limited durability, longer follow-up periods will soon resolve this controversial issue.

Adolescent↗
PubMed1978

Intraoperative assessment of mitral valve function.

Clinical, echocardiographic, hemodynamic, and angiographic data can usually assess the preoperative status of the mitral valve quite accurately. However, there is need for an intraoperative method to observe the dynamic function of the mitral valve, particularly after an open commissurotomy, or to determine the efficacy of a valvoplasty. Our experience with more than 250 mitral annuloplasties has led to the development of a safe method for direct observation of the mitral closure mechanism using the left ventricular vent and a slight modification of the usual cardiopulmonary circuit.

Animals↗