Incidence Of Valve-related Complications Research Articles

The David procedure after the Ross operation: case series

Pulmonary autograft in the aortic position provides high survival rate and quality of life for patients, low incidence of valve-related complications, and excellent hemodynamic characteristics both in the early and long-term period. However, in some patients in the long-term period, pulmonary autograft may dilate, which in turn is one of the reasons for reoperations. In patients who require surgery for annuloaortic ectasia with aortic valve (AV) regurgitation or aortic root aneurysm (or both) with normal AV leaflets, David procedure is considered.Aim. To analyze results of David procedure after a prior Ross operation.Material and methods. From April 2009 to December 2020, 212 Ross operations were performed on patients 18 years of age and older. The median age of the operated patients was 34 (27-45) years. In the long-term period, 10 (4,7%) patients required a second AV operation and 7 (3,3%) of them required another intervention on the ascending aorta due to aortic dilatation. Four out of 10 patients underwent David procedure. The follow-up period for patients after David procedure ranged from 2 to 84 months.Results. The age of patients ranged from 23 to 45 years. Three patients had hypertension. The follow-up period from Ross's operation to David's one was 26 to 140 months. All patients had enlarged aortic annulus from 27 to 30 mm. The duration of myocardial ischemia ranged from 87 to 142 minutes, while the duration of artificial circulation — from 119 to 165 minutes. The graft diameter was 30 mm in two patients and 32 mm in the remaining ones. The length of stay in intensive care unit ranged from 16 to 23 hours. In the early postoperative period, no one had following postoperative complications: acute renal failure requiring hemodialysis, perioperative myocardial injury, stroke, sternal infection, respiratory failure requiring mechanical ventilation for ≥24 hours, resternotomy for bleeding and tamponade. In addition, there were no in hospital deaths. All patients had no aortic regurgitation at the time of discharge. All patients are alive and there were no reoperations. In one patient, in the long-term period, there was a mild aortic regurgitation, while in three patients — there is no regurgitation.Conclusion. The presented case series show that David procedure can be performed safely and effectively in a significant number of patients requiring a second autograft surgery due to neosinus dilatation. In the medium term, the David procedure has shown good outcomes in these patients with 100% survival and no aortic regurgitation and reoperation.

Valve-Sparing Root Replacement Provides Excellent Midterm Outcomes for Bicuspid Valve Aortopathy

Standard therapy for aortic root dilation in the setting of bicuspid aortic valves remains use of a composite valve conduit. The long-term durability of valve-sparing root replacement (VSRR) in bicuspid aortopathy is presently unclear. In this study, the midterm results of performing VSRR in the setting of a bicuspid valve was analyzed. A single institutional database identified 280 patients who underwent VSRR from 2005 to 2016. Outcomes were analyzed in 60 consecutive patients undergoing a VSRR in the setting of a bicuspid aortic valve with aortic insufficiency (AI). Patients were followed prospectively and had annual echocardiograms. The average age in this series was 42 ± 11 years. Eighty percent were men and 33% had New York Heart Association class III to IV symptoms. More than 2+ AI was present in 42% of patients preoperatively. The incidence of operative death, stroke, and renal failure was 0%. Mean follow-up was 39 ± 30 months. At latest follow-up, 62% of patients had zero AI and 87% of patients had <1+ AI. At 5 years, freedom from >2+ AI was 97% and freedom from AVR was 96%. Preoperative AI was not found to be a significant risk factor for postoperative >2+ AI (p= 0.61) or AVR (p= 0.61). VSRR can be safely and effectively performed in young patients with bicuspid valve anatomy regardless of degree of preoperative AI. Valve function is durable and the incidence of valve-related complications is low. VSRR is an attractive and potentially superior option to conventional root replacement in appropriately selected patients with bicuspid aortopathy.

Bicuspid aortic valve repair in the setting of severe aortic insufficiency.

Bicuspid aortic valve (BAV) is a common cardiac anomaly that affects 0.5-2% of adults. Valve sparing root replacement (VSRR) in bicuspid aortopathy is gaining popularity. We discuss the technical aspects of the procedure as well as the mid- to long-term results of performing VSRR in the setting of a bicuspid valve. A single institutional database identified 280 patients who underwent VSRR from 2005-2016. Outcomes were analyzed in 60 consecutive patients undergoing a VSRR in the setting of a BAV with aortic regurgitation (AR). Patients were followed prospectively and had annual echocardiograms. The average age in this series was 42±11 years. Moderate or more AR was present in 50% of patients preoperatively. The incidence of operative death, stroke, and renal failure was 0%. Mean follow-up was 39±30 months. At latest follow-up, 62% of patients had zero AR and 87% of patients had <1+ AR. At 9 years, freedom from >2+ AR was 97% and freedom from aortic valve repair (AVR) was 96%. VSRR can be safely and effectively performed in young patients with bicuspid valve anatomy regardless of degree of pre-operative AR. Valve function is durable and the incidence of valve-related complications is low. VSRR is an attractive and potentially superior option to conventional root replacement in appropriately selected patients with bicuspid aortopathy.

Multicenter Analysis of Clinical Follow-Ups in Patients with a Star GK Cardiac Valve Replacement for More than One Year

Star GK valves were widely used in China, and we studied the clinical follow-up results of patients with Star GK valve implants for more than one year. Clinical data were collected from those patients who had Star GK valve implants for over one year. Patients were divided into three groups: (1) AVR group: received aortic valve replacement surgery. Based on the valve model this group was further sub-divided into two groups: 21A group, and 23A group; (2) MVR group: received mitral valve replacement surgery. Based on the valve model this group was further sub-divided into three groups: 25M group, 27M group, and 29M group; (3) DVR group: received combined replacement surgeries including AVR + MVR. According to postoperative follow-up time these patients were divided into two groups: 1-year group and 3-year group. Follow-up data were collected by telephone, outpatient visits, or correspondence. Clinical data were aggregated by professional data scientists to conduct independent analyses. 959 patients were included in the study following Star GK valve implant. Follow-up after 1 year found that thrombosis occurred in 4 cases, hemorrhage in 15 cases, left heart failure in 13 cases, paravalvular leakage in 5 cases, and death due to cardiac causes in 2 cases. The long-term efficacy of Star GK valve implants was satisfactory with low incidence of valve-related complications, and following Star GK valve implant, valve and blood were highly compatible and blood component damage was minor. Very low incidence rate of thrombosis was observed following Star GK valve implant, however, attention should be paid to adjust the anticoagulation intensity.

Midterm Results of David V Valve-Sparing Aortic Root Replacement in Acute Type A Aortic Dissection

The David V valve-sparing aortic root replacement (David V) has been shown to provide excellent long-term valve function and low rates of valve-related complications in the elective treatment of aortic root aneurysms. The safety and durability of the David V in the repair of acute type A aortic dissection (type A) are currently unclear. In this study, the midterm results of David V in the setting of type A aortic dissection were analyzed. From 2005 to 2013, 350 patients underwent surgical repair of type A aortic dissection. Outcomes were analyzed in 43 consecutive patients who received a David V during repair of type A aortic dissection. Patients were followed with annual postoperative echocardiograms. Follow-up was 85% complete, with a mean duration of 40 ± 31 months. The mean age of these patients was 46 ± 10 years. There were two operative deaths (4.7%), and 93% of patients required a hemiarch replacement (n= 32) or a total arch replacement (n= 8) using hypothermic circulatory arrest. Cusp repairs were performed in 6 (14%) patients; 51% of patients had 3+ or greater preoperative aortic insufficiency (AI), 83% of patients left the operatingroom with zero AI, and the remainder had 1+ AI or less. No patient in the follow-up period developed endocarditis or required aortic valve replacement. At midterm follow-up, freedom from 2+ AI was 94%, and freedom from aortic valve replacement was 100%. The David V can be performed with lowmorbidity and mortality in young patients presenting with type A aortic dissection who require aortic root replacement. At midterm follow-up, valve function is durable, and the incidence of valve-related complications is low.

Effect of preoperative symptoms on outcomes after valve repair for degenerative aortic insufficiency

This study evaluated the effect of preoperative symptoms on long-term survival and valve reintervention in patients undergoing aortic valve repair (AVr) for severe degenerative aortic insufficiency (AI). Between March 1996 and June 2010, 274 patients underwent AVr for severe AI. Seventy-seven were performed in asymptomatic patients (Group I) and 197 were performed in symptomatic (Group II). Patients in Group I were younger (43.9 ± 15.0 vs 54.1 ± 15.5 years; P < 0.001) with a higher proportion of bicuspid valves (n = 40, 51.9% vs n = 68, 30.4%; P = 0.008). Group II had more patients with impaired left ventricular (LV; n = 36, 18.3% vs n = 5, 6.4%; P = 0.013). The mean follow-ups for Group I and Group II were 43.0 ± 34.0 and 61.3 ± 39.5 months, respectively. There was no in-hospital mortality. Overall, leaflet repair and reimplantation were higher in Group I (P = < 0.001 and P = 0.002, respectively), whereas subcommissural annuloplasty for tricuspid AV was higher in Group II (P = 0.002). Leaflet shaving and plication were performed in more patients in Group I (P = 0.002 for both). There was no difference in early complications, but during follow-up atrial fibrillation was more frequent in Group II (P = 0.03). There were 10 late cardiac deaths, all in Group II (P = 0.04). Overall, 10-year cardiac survival was better in Group I (100 vs 77.3 ± 8.6%) but not significant (P = 0.1). At 10 years, freedom from ≥ AI2+ was 63.2 ± 8.1 vs 56.4 ± 4.5% (P = 0.4), and freedom from AV reintervention was 81.8 ± 7.1 vs 89.0 ± 2.8% (P = 0.36), in Groups I and II, respectively. In the whole cohort, 10-year freedom from AV reintervention was greater in patients with an end-diastolic diameter of <60 mm (90.0 ± 7.6 vs 76.3 ± 5.5%; P = 0.003). Multivariate analysis identified increasing age as the only independent predictor of overall survival (P = 0.03). The incidence of valve-related complications was similar. In asymptomatic patients with severe degenerative AI, AVr is associated with excellent long-term outcomes, while symptoms are associated with reduced long-term survival. In dilated LV, freedom from reoperation is lower. If feasible, early AVr is recommended in experienced centres.

ACS Book Review.

Historically, the treatment of aortic regurgitation has undergone several changes. First attempts at repair were undertaken in the 1950s. At that time understanding of normal valve and root anatomy and physiology was limited by the lack of imaging techniques; consequently, the results of repair were unpredictable and suboptimal. Valve replacement, initially with mechanical and later with biologic prostheses, has revolutionized treatment of aortic regurgitation by making it reproducible. Replacement with a pulmonary autograft was developed as an option for young individuals who could not or would not take long-term anticoagulation. In the past 2 decades increasing evidence has been collected that prostheses are associated with a significant incidence of valve-related complications. Patients have become more educated and expect surgical options that address their specific needs; quality of life rather than mere life expectancy has increased in importance. In the past 20 years better imaging techniques and improved understanding of normal aortic valve anatomy and function have resulted in the development of repair techniques that today allow repair in many instances of aortic regurgitation, either with or without aortic dilatation. Aortic valve repair is evolving similar to mitral repair 30 years ago, and repair has been shown to result in fewer valve-related complications that would be expected from aortic valve replacement. The possibility of reconstruction has raised new questions regarding preoperative imaging, forced surgeons to change their approaches to aortic valve disease, and raise questions over traditional criteria in decision making for surgery. Treatment of aortic regurgitation has thus become the subject of interdisciplinary efforts similar to other areas of heart valve disease. Current textbooks have difficulty in keeping track with the dynamic changes. They often provide information with an isolated focus on pathology, cardiology, or surgery, rather than integrated knowledge of all involved specialties. In addition, aortic valve repair is not yet widely established and there is uncertainty regarding its options and limitations as well as exact the techniques that can be applied. This book tries to accommodate both traditional knowledge and recent developments (1). A group of internationally-renowned authors from a variety of specialties have made a collaborative effort to provide a state-of-the-art overview of all aspects of the disease. Anatomy, pathology, cardiological aspects and current guidelines are presented by European leaders in their fields. Surgical techniques and results are likewise summarized by an international team of individuals with a strong track record in their respective areas. The topics are presented precisely, comprehensively, and with the facility of quick reference in mind. Detailed description of surgical techniques and their long-term results allows cardiologists to judge their relative importance. Surgeons can use the technical descriptions before choosing or performing specific reconstructive operations. As such, this book is unique and can be a reference to all health care professionals seeking information on the latest developments. Aortic Regurgitation

Twelve years of experience with the ATS mechanical heart valve prostheses

The ATS Open Pivot mechanical heart valve has been implanted routinely at our institution since 1999. The objective of this study is to retrospectively analyze our 12-year clinical results with ATS prostheses. ATS Open Pivot mechanical valves were implanted in 268 adult patients between May 1999 and August 2010. We selected 259 subjects who could be adequately followed (follow-up rate 96.6%). Aortic valve replacement was performed in 157 patients, mitral valve replacement (MVR) in 71, and double (aortic and mitral) valve replacements (DVR) in 31. Mean age at the time of implant was 58.8±10.6years. The gender ratio was 128 males/131 females. Mean follow-up was 4.4±7.8years, and the cumulative follow-up was 1144 patient-years (pt-yr). Early death within 30days after the operation occurred in 5 (2.5%) patients. Late death occurred in 27 patients including valve-related deaths in 13. The 10-year survival rate after the operation was 82.7±2.9%. The rate of freedom from valve-related death was 92.2±2.2%. The incidence of valve-related complications was 2.19%/pt-yr. Of these, the incidence of thromboembolic events and that of bleeding complications were 1.22 and that 0.87%/pt-yr. The incidence of valve thrombosis was 0.09%/pt-yr. No structural valve deterioration was observed in any of the three operative procedure groups. Our 12-year experience with aortic and MVR using the ATS mechanical heart valve demonstrated low incidences of thromboembolic events, bleeding complications, and valve thrombosis.

Aortic Valve Repair—Current Status, Indications, and Outcomes

Aortic valve repair is a new development with old roots. In the past 20 years, marked progress has been made in understanding the normal anatomy of the aortic valve and the interrelation between cusps and root. Aortic dilatation is the single most frequent pathogenetic factor in aortic regurgitation, accompanied by cusp pathology, that is, prolapse or congenital anomaly in most industrialized countries. Frequently, aortic and cusp pathology coexist. Different operative techniques have been established for correction of aortic and cusp pathology. Experience has shown that the combined application of repair procedures will lead to good results if normal valve and cusp configuration is achieved. Some congenital anomalies may require design alteration of the aortic valve. Low-operative mortality rates have been reported consistently. When adequate repair durability is achieved, the incidence of valve-related complications is lower than what has been reported for valve replacement. Aortic valve repair is currently in transition from surgical improvisation to a reproducible operation and an option for many patients with aortic regurgitation. Current research focuses on some special aspects, such as stabilization of the basal ring, ideal material and technique for cusp replacement, and more objective information on ideal valve configuration.

Twenty-Year Experience With the St. Jude Medical Biocor Bioprosthesis in the Aortic Position

The purpose of this study was to evaluate the long-term performance of the St. Jude Medical Biocor stented porcine prosthesis in the aortic position. From January 1985 to December 1996, 455 patients admitted for aortic valve replacement were consecutively enrolled in this study. The mean age was 72.5 +/- 9 years, 18 patients (3.5%) had had previous cardiac surgery, and coronary artery bypass grafting was performed in 171 patients (37.6%). Follow-up was complete in 99.6%; up to 21 years were covered. Actuarial event-free rates are given as mean +/- standard error and adverse events were classified according to the guidelines for reporting morbidity and mortality after cardiac valvular operations. Cumulative follow-up time was 3,321 patient-years with a mean follow-up of 8.2 years. The actuarial survival rate after 20 years was 9.4% +/- 2.8%. The actuarial rates for freedom from structural valve deterioration were 93.1% +/- 1.7% at 10 years, 88.4% +/- 3.5% at 15 years, and 70.3% +/- 10.9% at 20 years. The actuarial rates for freedom from reoperation due to structural valve deterioration were 91.9% +/- 1.6% at 10 years, 90.6% +/- 2.1% at 15 years, and 86.5% +/- 4.5% at 20 years. This study presents one of the largest series of St. Jude Medical Biocor aortic valves in the world. Results indicate an age-dependent risk of structural valve degeneration beginning as soon as 7 years postoperatively for patients below the age of 65 years, but show a low overall incidence of valve-related complications and excellent durability.

The CarboMedics prosthetic heart valve: experience with 180 implants

At Jichi Medical School Hospital, three types of mechanical prosthetic valves (CarboMedics, Omnicarbon, Bicarbon) were used without randomization from 1991 to 2000. A retrospective study of valve replacements done between June 1991 and November 2000 utilizing 180 CarboMedics valves in 145 patients who had not previously undergone prosthetic valve replacement or aortic root and/or arch replacement was conducted to evaluate midterm patient outcomes to assess the future continuous use of CarboMedics valves. Women made up 47.6% of the patients and the mean age was 57.5 years (range 12-80 years). Preoperative New York Heart Association functional class was III or IV in 92.4% (134/145) of patients. Mean follow-up of 4.5 years (range 0-10.0 years) was 95.9% complete, with a total of 628 patient-years (PY). Early (within 30 postoperative days) mortality was 5.5% (8 of 145): 3 from hemorrhage, 3 from nonvalve-related heart failure, 1 from infection, and 1 from arrhythmia. There were 16 late deaths (2.54%/PY): 1 from hemorrhage, 4 from unknown causes/sudden death, 4 from nonvalve-related heart failure, and 7 from other noncardiac causes. A total of 121 patients (83.0%) were alive at the last follow-up, done in November 2000. The linearized death rate was 3.82%/year (including 1.11%/year for valve-related deaths). Linearized death rates from various causes were: bleeding, 0.96%/year; thromboembolism, 1.11%/year; thrombosis, 0.39%/year; perivalvular leak, 0.96%/year; endocarditis, 0%/year; hemolysis, 0%/year; and reoperation, 0.63%/year. No structural valve failure was observed. Comparative early mortality rates of valve replacement without aortic root replacement or arch replacement, excluding repeat valve replacement operations, in our institute, were 3.5% (12/307) for all valve types used contemporaneously, 2.6% (2/76) for Omnicarbon valves, and 2.3% (2/86) for Bicarbon valves. Although the CarboMedics valve had a rather high mortality rate of 5.5% (8/145) compared with the total early mortality rate of 3.5%, the low incidence of valve-related complications might support the continued use of the CarboMedics valve for valve replacement.

LONG TERM EFFECTS OF 19MM-SIZE BILEAFLET AORTIC VALVE PROSTHESIS

OBJECTIVES. 19mm-size aortic prostheses still raises concerns about long term effects of residual transprosthetic gradient, left ventricular mass, and patient's activity. We reviewed our experience with SJM 19 mm standard® and 17 mm supra-annular (SJM-HP® and Solin Bicarbon®) aortic valve prostheses for small aortic annulus. METHOD. Forty-six patients (2 men and 44 women, age 71 ± 8 years) operated on between April 1990 and August 2002 were enrolled in this study. The mean body surface area was 1.40±0.12 m2. Clinical late assessment was performed to evaluate the incidence of valve related complications, residual transprosthetic gradient, left ventricular mass index (LVMI), and NYHA functional class. Postoperative echocardiography was performed to evaluate hemodynamic performance of the prostheses. Follow up was 1 to 12.7 (mean 7.5) years. RESULTS. There was no hospital mortality (0%). Actuarial survival rates at 5 and 10 years were 97.4±2.5% and 97.4±2.5%. Actuarial freedom from valve-related events rates at 5 and 10 years were 89.4±5.9% and 89.4%. Late postoperative peak gradient was 24±12mmHg. LVMI was significantly reduced in late phase (preope vs. late, 189±49 vs. 138±57g/m2, p=0.004). NYHA functional class was significantly improved in late period. CONCLUSIONS. Although 19 mm size aortic valve prosthesis remains small transprosthetic pressure gradient, LVMI was significantly reduced and patients' activity was satisfactory maintained in late period.

Biological versus mechanical aortic valve replacement in children

Background. Aortic valve replacement in children remains challenging because of constraints imposed by available prosthetic devices. Potential risks of anticoagulation with mechanical valves and degeneration of other biological substitutes have kindled interest in the Ross procedure. This study outlines the evolution of our 27-year experience with prosthetic devices.Methods. Ninety-nine patients who underwent aortic valve replacement (January 1973 through September 2000) were included in this study. Procedures included implantation of pulmonary autograft (PA) (n = 42), aortic homograft (AH) (n = 3), mechanical valves (MV) (n = 41), and xenograft tissue valves (XG) (n = 13).Results. The mean follow-up times were: 3.8 ± 1.3 years for PA, 3.5 ± 1.5 years for AH, 7.7 ± 4.7 years for MV, and 8.4 ± 4.8 years for XG. There were no significant differences in perioperative outcomes among the groups (p ≤ 0.05) or early deaths (2 each in the MV, AH, and PA groups). The incidence of valve-related complications and reoperations was high in the MV (n = 5), XG (n = 7), and AH (n = 1) groups as compared with the PA group (n = 3, p < 0.01). Early and late mortality for the series was 8.6% (n = 8). Overall, the reoperation rate was 20.7% (n = 18): 15.2% (5 of 33) MV, 70% (7 of 10) XG, 50% (1 of 2) AH, and 11.9% (5 of 42) for PA. The actuarial survival rate was 87.8% and 100% at 10 years for MV and XG, and 95.2% and 6.6% at 7 years for PA and AH.Conclusions. Aortic valve replacement in children can be performed with acceptable mortality and good long-term results. The Ross procedure, although more complicated, has the advantage of not requiring anticoagulation therapy, can be performed in all age groups, possesses inherent growth potential, and exhibits the most normal left ventricular outflow tract hemodynamics.

Standard 19mm St Jude aortic valves in patients with body surface less than 1.7m2

Although new models of bileaflet valves with improved orifice have been devised, aortic valve replacement with 19mm prostheses still raises concerns about long term effects of residual transprosthetic gradient. We reviewed our experience with 19 mm standard model St Jude prostheses in 68 patients operated on between January 1983 and December 1995. Clinical late assessment was performed to evaluate the incidence of valve related complications. Postoperative echocardiography was performed to evaluate hemodynamic performance of the prostheses. Mean body surface area was 1.66+/-0.14 m2. Late postoperative peak gradient was 53.85+/-7.16 mmHg; mean gradient was 34.80+/-5.55 mmHg; effective orifice area was 1.93+/-0.05 cm2. Thirteen-year actuarial survival has been 90.89+/-0.6%; thirteen-year freedom from embolism 89.41+/-0.7% and freedom from hemorrhage 98.25+/-0.02%. No case of prosthetic endocarditis, thrombosis, or reoperation was observed during follow-up.

Aortic valve replacement for end-stage aortic valve disease.

To evaluate the outcome of surgical intervention for end-stage aortic valve disease, we carried out a retrospective, longitudinal survey of 85 patients (65 males, 20 females; mean age 53 period. All the patients presented in New York Heart Association (NYHA) class IV in cardiac failure (3 had cardiogenic shock and 27 had bacterial endocarditis). In-hospital mortality was 9.4% (8/85) overall. Those with endocarditis had a significantly higher mortality, 6/27 (22%) vs 2/58 (3.4%), p < 0.01. In-hospital mortality was not significantly increased in those with renal failure, reoperation, simultaneous coronary artery surgery, age > 65 years nor was it related to the predominance of aortic regurgitation or stenosis. After a mean follow-up period of 5.9 years (range 0 to 12.5 years), the overall actuarial survival was 82% and 74% at 5 and 10 years respectively. For 66 late survivors, the NYHA status improved to class I in 51, to II in 10, to III in 4 patients, and one patient remained in class IV. The incidence of paraprosthetic leak, reoperation, thromboembolism, anticoagulant-related haemorrhage, and endocarditis were respectively 0.8, 0.8, 1.6, 1.4, and 0.2 per 100 patient-years. Aortic valve replacement in the patient with end-stage aortic valve disease is a high-risk procedure, the risk being higher in the presence of endocarditis. The favourable long-term survival, long-term improvement in functional class and the relatively low incidence of valve-related complications justify surgical intervention in such patients, who would otherwise have a very poor prognosis.

Twelve-Year Comparison of a Bjork–Shiley Mechanical Heart Valve with Porcine Bioprostheses

Patients undergoing heart-valve replacement may receive a mechanical prosthesis, necessitating lifelong anticoagulant treatment, or a porcine bioprosthesis, which involves no absolute need for anticoagulants. We carried out a randomized, prospective trial to compare the durability of the Bjork-Shiley mechanical prosthesis (spherical tilting-disk model) and the incidence of valve-related complications with those variables in the Hancock and the Carpentier-Edwards porcine prostheses. The mitral valve was replaced in 261 patients, the aortic valve in 211, and both in 61; the survivors have been followed up for a mean of 12 years. We found a trend toward improved actuarial survival after 12 years with the Bjork-Shiley prosthesis, but this trend was not statistically significant (group with Bjork-Shiley valve vs. group with porcine valve [mean +/- SE], 51.5 +/- 3.2 vs. 44.4 +/- 3.2 percent; P = 0.08). There was no significant difference in the actuarial incidence of reoperation after 5 years, but after 12 years significantly more patients with a porcine prosthesis had undergone reoperation (8.5 +/- 2.0 vs. 37.1 +/- 4.1 percent, P less than 0.001). An analysis combining death and reoperation as end points for an actuarial assessment of survival with the original prosthesis intact confirmed that the patients with Bjork-Shiley Shiley prostheses had improved survival (48.6 +/- 3.2 vs. 30.0 +/- 3.0 percent after 12 years, P less than 0.001). Bleeding requiring hospitalization or blood transfusion was significantly more frequent in the patients with Bjork-Shiley prostheses (18.6 +/- 3.2 vs. 7.1 +/- 2.3 percent after 12 years, P less than 0.01). There was no significant difference after 12 years in the actuarial occurrence of embolism (Bjork-Shiley vs. porcine, 21.1 +/- 3.1 vs. 26.4 +/- 3.5 percent) or endocarditis (3.7 +/- 1.4 vs 4.6 +/- 1.6 percent). Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting-disk prosthesis than among patients with porcine bioprostheses, but use of the Bjork-Shiley valve carries an attendant increased risk of bleeding associated with the need for anticoagulant treatment.

Cardiac valve replacement with glutaraldehyde preserved aortic allografts

From September 1984 to December 1988, 144 patients underwent cardiac valve replacement using glutaraldehyde preserved stent mounted aortic allografts. The mean age was 21.4 years (54.9% were 15 years old or younger). The mitral valve was replaced in 125 patients, the aortic valve in 7, the pulmonary valve in 3, the tricuspid in 1, the mitral and tricuspid in 1, and the aortic and mitral in 7. Hospital mortality was 2.8% (4 patients). Total follow-up was 396.3 patient-years and the mean follow-up was 2.8 years per patient. The 5-year actuarial survival was 73.8% +/- 11.9%. The 4-year actuarial survival for patients aged 15 or younger was 81.4% +/- 7.1%. The overall mortality was 2.8% +/- 0.8%/per patient-year. The incidence of valve-related complications was 4.8% +/- 1.1%/per patient-year, and the calcification rate was 3.0% +/- 0.9%/per patient-year and was the main complication reported in 12 patients, all under the age of 15 years. It occurred 14-47 months after implantation (mean 32.7 months). Five-year actuarial freedom from valve dysfunction due to calcification was 82.6% +/- 5.0% and for patients aged 15 or younger was 69.9% +/- 8.8%. The incidence of reoperation was 3.3% +/- 0.9%/per patient-year. These initial results demonstrate a 5-year actuarial freedom from primary valve failure due to fibrocalcification superior to the results obtained with xenobioprostheses in the paediatric age group.

Late Results of Aortic Valve Replacement with Bjork Shiley Prostheses: A Comparison of Standard Aortic Valve Prosthesis with Reversed Mitral Valve Prosthesis Implanted in Aortic Position

Between 1976 and 1983, 435 patients underwent aortic valve replacement (AVR) with Bjork Shiley prostheses. Standard aortic Bjork Shiley prostheses (ABP) were used in 150 patients (Group I) and a reversed mitral Bjork Shiley prostheses in 285 (MBP in 250 and MBC in 35) patients (Group II). There was no significant difference in the number of the patients with valve calcification or the size of aortic root in the 2 groups. There was no significant difference in the early mortality in these two groups. The total follow up period in Group I was 912 years and 2130 years in Group II. The incidence of major aseptic prosthetic dehiscence and valve occlusion with tissue ingrowth were higher in Group I than in Group II. Reversed Bjork Shiley mitral valve prosthesis was successfully used in aortic position with reduced incidence of valve related complications.

Six month postoperative hemodynamics of the Hancock heterograft and the Björk-Shiley prosthesis: Results of a Veterans Administration Cooperative prospective randomized trial

In a Veterans Administration Cooperative Study involving 13 medical centers, 575 patients undergoing single valve replacement were prospectively randomized to receive either the standard Björk-Shiley prosthesis or the Hancock porcine heterograft (with a modified orifice for sizes 23 and smaller). The hemodynamic data in the 268 patients who underwent cardiac catheterization an average of 6 months (range 3 to 12) postoperatively are reported. Statistical analyses were performed on valve sizes 23, 25 and 27 in the aortic position, and 29, 31 and 33 in the mitral position.A wide variation was observed in mean pressure gradient and calculated orifice area in both valve types within all sizes in both the aortic and the mitral positions. In the aortic position, the Björk-Shiley prosthesis tended to have a lower pressure gradient and larger calculated orifice area than the Hancock heterograft, but the differences in gradient between the two valve types were significant only in the larger-sized valves. The difference in calculated area between the two valve types was not significant within each valve size. In the mitral position, there were no differences in gradient and calculated orifice area between the two types of prostheses.The postoperative cardiac index, regurgitant volume, pulmonary artery systolic and mean pressures, left ventricular end-diastolic pressure, left ventricular ejection fraction and left ventricular end-diastolic volume index did not differ in patients receiving the Björk-Shiley prosthesis from values in patients receiving the Hancock heterograft. Hence, the overall hemodynamic performance of both types of valves is remarkably similar. The choice between these two prostheses should, therefore, be governed not by the hemodynamic performance, but by other factors such as valve durability, risk of anticoagulation and incidence of valve-related complications.

Prediction of long-term complications associated with aortic valve prostheses. A 10-17 year follow-up.

Long-term complications following implantation of aortic valve prosthesis were assessed in 139 patients who had survived greater than 30 postoperative days (maximum follow-up 17 years). Most of the prostheses were Starr-Edwards valves (38 silastic ball, SESB, and 96 cloth-covered, SECC). All patients received maintenance coumarin. The rate of thromboembolic complications was 1.6/100 patient-years, without difference between SESB and SECC valves although there were no episodes with SESB from 6 years postoperatively. The overall rate of valve-related complications (VRC)--thromboembolism, hemorrhage, endocarditis, re-replacement, etc.--was 4.2/100 patient-years. High preoperative cardiothoracic index (CTI) significantly increased the incidence of VRC. Preoperative NYHA class III-IV and high CTI similarly influenced the rate of serious VRC (= VRC excluding extremity emboli, epistaxis and subcutaneous bleeding). The valve-and-heart-related morbidity (= VRC including myocardial infarction and pacemaker requirement) was also influenced by preoperative CTI. The long-term complications thus were not exclusively attributable to the prosthesis, but also to preoperative patient-related data.