Low Incidence Of Valve-related Complications Research Articles

Valve-sparing aortic root replacement—for all patients?

BackgroundValve-sparing root replacement (VSRR) has been associated with good survival and low rates of valve-related complications (VRCs). Whether these advantages are present irrespective of patient comorbidity or age is unclear. The aim of this study was to analyze survival and frequency of VRCs in relation to patient comorbidity and age. MethodsBetween October 1995 and December 2021, 1156 patients with a bicuspid or tricuspid aortic valve were treated by root remodeling. The mean patient age was 53.3 ± 14 years, and 973 (84%) were male. The mean duration of follow-up was 6.7 ± 5.5 years (median, 5.9 years), and follow-up was 95% complete (7746 patient-years). We analyzed the population according to comorbidity and age at surgery. A discriminating cutoff for the effect of age was determined using receiver operating characteristic curve (ROC) analysis. ResultsMean survival at 15 years was 74.7 ± 2.5%. Deceased patients were older (mean, 65.3 ± 12 years vs 51.6 ± 14.1 years; P < .001) at the time of surgery and had more comorbidities (coronary artery disease [CAD], 28.4% vs 9.8%; P < .001). The sole significant adjusted predictor was age (P < .001). By ROC analysis (area under the curve, 0.780), the optimal cutoff for age was 61 years. Survival was 87.1 ± 2.8% at 15 years in patients age <61 years, compared to 55.3 ± 4.3% in patients age >61 years (P < .0001). Using competing risk analysis, VRC-free survival at 15 years was 66.8% at 15 years, including 76.7% in patients age <61 years and 52.4% in those age >61 years (P < .0001). ConclusionsVSRR is associated with a low incidence of VRC and excellent durability. Survival is decreased in the presence of comorbidities, mainly CAD, and patient age >61 years. Despite lower survival, freedom from VRC is good.

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.

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.

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

The aim of this study was to evaluate the long-term performance of the St. Jude Medical Biocor porcine stented bioprosthesis in the aortic position. From January 1985 to December 1996, 455 patients underwent aortic valve replacement with the St. Jude Medical Biocor prosthesis at the German Heart Center Munich. Mean age at time of operation was 72.5 ± 9 years. In all, 172 patients (37.8%) underwent concomitant coronary artery bypass grafting and 20 patients (4.4%) had had previous cardiac surgery. Event-free rates are given as mean ± SD. Adverse events were recorded according to the guidelines for reporting morbidity and mortality after cardiac valvular operations. Follow-up was complete in 93.4%. Mean follow-up time was 8.4 ± 5.6 years, with a total of 3,834 patient-years and a maximum of 27.4 years. Thirty patients were lost to follow-up after a mean of 9.2 ± 4.1 years. Overall survival rate at 10 and 15 years was 43.3% ± 2.4% and 19.2% ± 2.0%, respectively. Freedom from structural valve deterioration at 10 and 15 years was 92.1% ± 1.7% and 84.8% ± 3.0%, respectively. Freedom from valve-related reoperation at 10 and 15 years was 90.6 ± 1.7% and 86.3 ± 2.5%, respectively. Twenty-four patients needed reoperation for structural valve deterioration, 9 patients for endocarditis, 3 patients for paravalvular leakage, and 2 patients for aortic root aneurysm. At 15 years, freedom from major bleeding was 91.0% ± 2.0% and freedom from thromboembolism was 72.2% ± 2.8%. This study represents the longest follow-up for the St. Jude Medical Biocor prosthesis and shows an excellent durability with a low incidence of valve-related complications.

Fifteen-year experience with the Bicarbon heart valve prosthesis in a single center.

BackgroundThe purpose of this study was to evaluate retrospectively the clinical performance of the Bicarbon valve (Sorin Biomedica Cardio, Saluggia, Italy) implanted at our center in Japan.MethodsBetween January 1997 and December 2011, 415 patients in our institution were implanted with the Bicarbon valve. Nine of these recipients were excluded from the study because they had already undergone valve implantation and received a Bicarbon valve in a different position. The remaining patients were analyzed for evaluation of the postoperative clinical outcomes. Of the 406 patients (mean age 60.2 ± 11.7 years), 179 underwent aortic valve replacement (AVR), 149 mitral valve replacement (MVR), and 78 both aortic and mitral valve replacement (DVR).ResultsThere were 10 early deaths (2.5 %: 4 in the AVR group and 6 in the MVR group). Three hundred eighty-nine patients were followed up (95.8 % completeness of follow-up) with a mean follow-up of 6.6 ± 4.2 years overall (AVR 6.8 ± 4.2, MVR, 6.7 ± 4.4, and DVR 5.7 ± 3.4 years) and a cumulative follow-up of 2661 patient-years (1214, 1001, and 446 patient-years for AVR, MVR, and DVR, respectively). Ninety-nine patients died (3.7 % per patient-year: 22 valve-related and 77 valve-unrelated deaths). Survival at 10 years was 74.1 ± 4.0 % in the AVR group, 73.7 ± 4.2 % in the MVR group, and 61.0 ± 7.9 % in the DVR group. The linearized incidence of thromboembolic complications, bleeding complications, prosthetic valve endocarditis, paravalvular leaks, and sudden death in all patients was 0.5 %, 0.5 %, 0.2 %, 0.2 %, and 0.4 % per patient-year, respectively. The incidence of valve-related complications and reoperation was 1.6 % and 0.4 %, respectively. No other valve-related complications were observed.ConclusionsThe Bicarbon prosthetic heart valve has shown excellent clinical results and is associated with a low incidence of valve-related complications.

Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience

The Carpentier-Edwards pericardial valve was designed to minimize structural valve deterioration. Excellent durability and low incidence of valve-related complications have been reported. The objective of the present study was to analyze clinical results after 25 years of experience with this valve implanted in the aortic position. The effect of patient age at the time of surgery was also evaluated. This is a retrospective cohort study of 2,405 patients from November 1981 to March 2011. Primary outcomes of interest were survival and freedom from major adverse effects such as thromboembolic, endocarditis, and reoperation. Sixty percent were male, with a mean age of 71 ± 9 years old. Actuarial survival rates including early deaths averaged 78% ± 2%, 55% ± 2%, and 16 % ± 2% after 5, 10, and 20 years of follow-up, respectively. The freedom rate of valve reoperation for prosthesis dysfunction and all other causes averaged 98 % ± 0.2%, 96% ± 1%, and 67% ± 4% at 5, 10, and 20 years. Patients younger than 60 years of age had a 15-year survival averaging 54% ± 5% compared with patients aged between 60 and 70 years of age averaging 46% ± 3% and with patients older than 70 years of age averaging 28% ± 3% (p = 0.001). Survival at 5, 10, and 20 years for patients who had concomitant CABG [coronary artery bypass grafting] were 78% ± 1%, 55% ± 2%, and 9% ± 3% compared with no concomitant CABG (84% ± 1%, 62% ± 2%, and 22% ± 3% (p < 0.001)). Carpentier-Edwards pericardial valve implantation in the aortic position is secure and durable. The effects of age influence reoperation rate and survival as well as a concomitant coronary artery bypass procedure.

740 The Carpentier-Edwards Pericardial Valve: 30-Year Experience at the Montréal Heart Institute

The Carpentier-Edwards pericardial valve (Edwards Lifesciences, Irvine, CA, USA) has been in clinical use since 1980 in Canada. It was designed to minimize structural valve deterioration. Several studies have published clinical results with this pericardial valve to up to 20 years. Excellent durability especially in the aortic position in elderly patients and low incidence of valve-related complications has been reported. The objective of the present study is to analyse clinical results after 30 years of experience with this valve implanted in aortic position.

Mitral Valve Replacement Is a Viable Alternative to Mitral Valve Repair for Ischemic Mitral Regurgitation: A Case-Matched Study

Comparisons of mitral valve repair with mitral valve replacement for ischemic mitral regurgitation (IMR) have been limited by differences in preoperative and operative characteristics of patients undergoing these two types of surgical treatment. We performed a propensity-based, case-matched analysis to examine whether patients who undergo mitral valve repair and those who undergo mitral valve replacement for IMR have similar long-term outcomes. We compared 65 patients who underwent mitral valve replacement for IMR between 2001 and 2010 with 65 patients who underwent mitral repair during the same period on the basis of age, concomitant coronary bypass grafting, gender, left ventricular function, preoperative pulmonary hypertension, and urgency of operation. Mitral replacement involved preservation of the subvalvular apparatus. The mean study follow-up period was 2.5 ± 2.1 years. Two patients who underwent mitral valve repair died at 30 days postoperatively and three patients died after valve replacement. Late survival was the same in the two groups (p = 0.4). Recurrent mitral regurgitation (MR) (grade 2+ or higher) at late follow-up was observed in 15 patients (23%) after repair; however, only 1 patient (2%) had MR with a grade of more than 2+. Mitral valve repair was more commonly associated with recurrent MR (grade 2+ or higher) than was mitral valve replacement (p = 0.04). Patients in both groups had similar freedom from valve-related complications and similar left ventricular function at follow-up (both p > 0.2). Mitral valve replacement remains a viable option for the treatment of IMR. Although mitral valve repair effectively protects against persistent or recurrent moderate-to-severe MR, mitral valve replacement provides better freedom from mild-to-moderate MR in this population, with a low incidence of valve-related complications. Notably, there was no significant difference in left ventricular function between the valve-repair and valve-replacement groups at follow-up.

Aortic valve repair leads to a low incidence of valve-related complications

Aortic valve replacement for aortic regurgitation (AR) has been established as a standard treatment but implies prosthesis-related complications. Aortic valve repair is an alternative approach, but its mid- to long-term results still need to be defined. Over a 12-year period, 640 patients underwent aortic valve repair for regurgitation of a unicuspid (n=21), bicuspid (n=205), tricuspid (n=411) or quadricuspid (n=3) aortic valve. The mechanism of regurgitation involved prolapse (n=469) or retraction (n=20) of the cusps, and dilatation of the root (n=323) or combined pathologies. Treatment consisted of cusp repair (n=529), root repair (n=323) or a combination of both (n=208). The patients were followed clinically and echocardiographically; follow-up was complete in 98.5% (cumulative follow-up: 3035 patient years). Hospital mortality was 3.4% in the total patient cohort and 0.8% for isolated aortic valve repair. The incidences of thrombo-embolism (0.2% per patient per year) and endocarditis (0.16%per patient per year) were low. Freedom from re-operation at 5 and 10 years was 88% and 81% in bicuspid and 97% and 93% in tricuspid aortic valves (p=0.0013). At re-operation, 13 out of 36 valves could be re-repaired. Freedom from valve replacement was 95% and 90% in bicuspid and 97% and 94% in tricuspid aortic valves (p=0.36). Freedom from all valve-related complications at 10 years was 88%. Reconstructive surgery of the aortic valve is feasible with low mortality in many individuals with aortic regurgitation. Freedom from valve-related complications after valve repair seems superior compared to available data on standard aortic valve replacement.

Initial Experience with the Medtronic ADVANTAGE Valve Prosthesis in the Mitral Position - Clinical Outcome and Analysis of Complications

The Medtronic ADVANTAGE prosthetic heart valve is a bileaflet mechanical heart valve which has two main design modifications. The prosthesis has an enlarged central orifice to improve blood flow characteristics and an asymmetric butterfly pivot recess with expanded outflow component designed to enhance the blood flow washing through the pivot region. This report summarizes the initial experience with 55 patients who underwent isolated mitral valve replacement. We prospectively followed 55 patients undergoing mitral valve replacement with the Medtronic ADVANTAGE prosthesis in a single center study. All patients were operated on via a median sternotomy and a left atrial approach. The age of the patients at implant ranged from 42 years to 77 years with a mean of 61.8 years. Forty-five percent of the patients were male. Seventy-five percent of the patients were in NYHA functional class III or IV prior to valve replacement. The diameters of the implanted prostheses were as follows: 25 mm in 2 patients, 27 mm in 12 patients, 29 mm in 20 patients, and 31 mm in 21 patients. Coronary artery bypass grafting was performed with valve replacement in 16.4 % of patients and additional tricuspid repair in 10.9 %. After one year, 97.6 % and after two years 100 % of the included patients were in NYHA functional class I or II. All patients had Coumadin (warfarin) therapy postoperatively with a target INR range of 2.5 to 3.5, or 3.0 to 4.0. There were 4 thromboembolic events (7.3 %) in the early period and 2 late events (2.6 %). Episodes of valve thrombosis were not seen during the follow-up, which consisted of 76.5 patient years. The hemodynamic performance was favorable and within clinically acceptable ranges. The incidence of valve-related mortality and morbidity in this preliminary study was extremely low, indicating good clinical results comparable to those reported for other bileaflet valves. The ADVANTAGE valve is a safe and effective option for mitral valve replacement with a very low incidence of valve-related complications.

Clinical experience with the Bicarbon heart valve prosthesis

BacgroundWe have previously reported mid-term results of a study, which ended in January 2000, on the Bicarbon valve. The study concluded that the valve showed excellent clinical results, associated with a low incidence of valve-related complications. In the present study, the same patients were prospectively followed for an additional 5 years.MethodsForty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 ± 11.3 years. The mean follow-up was 6.1 ± 1.9 years with a cumulative follow-up of 616 patient-years.ResultsThere were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 21 late deaths (3.4%/patient-year: 5 valve related deaths and 16 valve unrelated deaths). Survival at 8 years was 75.2 ± 7.0% in the AVR group, 76.6 ± 6.2% in the MVR group, and 55.4 ± 16.1% in the DVR group. The linearized incidence of thrombo-embolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 0.65 ± 1.48%, 0.81 ± 1.69%, and 0.16 ± 0.54%/patient-year respectively. No other complications were observed.ConclusionThe Bicarbon prosthetic heart valve has shown excellent long-term clinical results, associated with a low incidence of valve-related complications.

GK-2 prosthetic heart valve: a 20-year clinical experience

The aim of this study is to analyze our 20-year clinical results with 413 GK-2 mechanical heart valves. 123 men and 204 women with a mean age of 38.62 +/- 10.14 years accepted cardiac valve replacements. Ninety-one percent had NYHA class III or IV heart function. The mitral position was in 205 patients, aortic position in 31 patients, aortic and mitral in 86 patients, and tricuspid position in 5. Altogether 296 mitral prosthetic valves and 117 aortic prosthetic valves were implanted. Follow-up is 91% and extended 0.5 to 19.6 years with cumulative 2440.7 patient-years. The early mortality was 3.36% (11/327). There were 24 late deaths (0.98% per patient-year). The actuarial probability of survival was 93.31% +/- 0.03% at 5 years, 89.59 +/- 2.1% at 10 years, 83.61% +/- 6.09% at 15 years. The linearized rate of thromboembolism was 0.29% pt-yr, the rate of bleeding event 0.49% pt-yr. In 91.98% of survivors NYHA functional performance have improved to class II or I. Early and long-term results in our hospital demonstrate that the GK-2 prosthetic heart valve exhibits excellent hemodynamic properties, mechanical durability and a low incidence of valve-related complications.

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.

Single-center experience with the bicarbon bileaflet prosthetic heart valve in Japan.

We analyzed midterm results using the Bicarbon valve in a single center. Forty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 +/- 11.3 years. The mean follow-up was 1.8 +/- 1.1 years with a cumulative follow-up of 188 patient-years. There were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 5 late deaths (2.7% per patient-year: 3 malignancy, 1 cerebral hemorrhage, 1 myocardial infarction). Survival at 3 years was 91 +/- 4% in the AVR group, 92 +/- 5% in the MVR group, and 66 +/- 23% in the DVR group. The linearized incidence of thromboembolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 1.06 +/- 2.34%, 1.60 +/- 2.53%, and 0.53 +/- 2.22% per patient-year, respectively. No other complications were observed. In conclusion, the Bicarbon prosthetic heart valve has shown excellent clinical results associated with a low incidence of valve-related complications.

Stentless bioprostheses in aortic root disease.

The availability of aortic homografts is steadily decreasing. In the meantime, stentless xenografts convey similar flow characteristics, and tissue preservation methods are improving durability. Initially, these valves were contraindicated in aortic roots with discrepancy between annulus and sinotubular junction or with extensive calcification or sepsis. With increasing experience stentless xenografts are now applied in a wide spectrum of aortic root disease. I reviewed our own experience with stentless aortic bioprosthesis for aortic valve replacement (AVR) and more taxing root problems. I used these valves in aortic aneurysm repair, acute Type A dissection, and for endocarditis with abcess formation. I studied valve hemodynamics, regression of left ventricular hypertrophy, and comparative survival with stented bioprostheses. Stentless bioprostheses convey hemodynamic and possibly survival benefit through a low incidence of valve-related complications. They provide a useful alternative to aortic homografts in endocarditis, Type A dissection, and aortic aneurysm surgery. Stentless bioprostheses are no longer confined to AVR alone. Experience supports the use of stentless bioprostheses where aortic homografts were previously applied. With availability in a wide range of sizes.

Intermediate-term results with 1,019 Carbomedics aortic valves

Background. A retrospective study was conducted to evaluate the intermediate-term outcome in patients with the Carbomedics aortic valve prosthesis. Methods. The study included 1,019 primary valve replacements between 1989 and 1997. Seventy-two percent of patients were men; mean (standard deviation) age was 61 (10) years. The preoperative New York Heart Association functional class was III or IV in 70% of patients. Follow-up at 9 years was 99.6% complete, comprising 2,730 patient-years (mean, 2.7 years). Results. Patient survival, including operative deaths, was 80% at 7 years. The linearized death rate was 2.9%/year. Statistically significant risk factors for mortality were diabetes, pure valve insufficiency, advanced age at operation, and advanced preoperative functional class. Linearized rates were thrombosis, 0.1%/year; thromboembolism, 1.0%/year; hemorrhage, 1.7%/year; endocarditis, 0.1%/year; paravalvular leak, 0.1%/year; reoperation, 0.1%/year; and all events, 3.0%/year. The 7-year estimates of freedom from complications were thrombosis, 99%; thromboembolism, 93%; hemorrhage, 89%; endocarditis, 99%; paravalvular leak, 99.7%; reoperation, 99%; and all events, 82%. No structural valve failure was observed. Conclusions. The low incidence of valve-related complications favors the continued use of the Carbomedics valve in the aortic position.

A single-center experience with 1,378 CarboMedics mechanical valve implants

Background. The CarboMedics bileaflet prosthetic heart valve was introduced in 1986. We first implanted it in March 1991. The purpose of this study was to analyze our clinical experience with this valve.Methods. Between March 1991 and December 1997, 1,378 valves were implanted in 1,247 patients, 705 men (56.5%) and 542 (43.5%) women with a mean age of 62 ± 11.9 years (± the standard deviation). Follow-up is 99% complete and totals 3,978 patient-years.Results. The early mortality rate was 4.4% (55/1,247). The survival rates at 1 year and 5 years were 91.8% ± 0.8% (± the standard error of mean) (n = 1,062) and 79.2% ± 1.4% (n = 281), respectively. Freedom from valve-related complications (linearized rate, 4.9% per patient-year) at 1 year and 5 years was 90.6% ± 0.8% (± the standard error of the mean) (n = 996) and 80.6% ± 1.4% (n = 243), respectively. Linearized rates for various complications were as follows: bleeding events, 1.73% per patient-year; embolic events, 1.76% per patient-year; operated valvular endocarditis, 0.18% per patient-year; valve thrombosis, 0.10% per patient year; and nonstructural dysfunction, 1.21% per patient-year. Freedom from reoperation at 1 year and 5 years was 98.6% ± 0.3% (± the standard error of the mean) (n = 1,070) and 97.7% ± 0.5% (n = 285), respectively.Conclusions. Midterm results demonstrate that the CarboMedics prosthetic heart valve exhibits a low incidence of valve-related complications.

Long-term results of the Carpentier-Edwards pericardial aortic valve: a 12-year follow-up

Background. Pericardial valves have excellent hemodynamic function; however, long-term durability is questionable. To determine the function of the Carpentier-Edwards pericardial valve in the aortic position, the results of 310 aortic valve replacements performed between 1982 and 1985 were analyzed. Mean age was 64.2 ± 10.8 years (range, 22 to 95 years); 190 (61.3%) were men. Isolated valve replacement was performed in 135 patients (43.5%). There were 18 hospital deaths (5.8%), none of them valve related. Methods. Follow-up of 292 survivors was 100% complete at a mean of 8.8 years; 2,556 patient-years of follow-up were analyzed. There were 150 late deaths (51.4%). Survival at 5, 10, and 12 years were 83% ± 2%, 47% ± 3%, and 34% ± 3%, respectively. The 12-year actuarial and actual freedom from thromboembolism was 87% ± 2% and 89% ± 2%, respectively. Freedom from hemorrhage was 91% ± 2% and 92% ± 2%; freedom from endocarditis was 93% ± 2% and 95% ± 1%; and freedom from structural deterioration was 82% ± 4% and 91% ± 2%, respectively. Results. Actuarial freedom from structural deterioration at 12 years was considerably higher for 153 hospital survivors 65 years or older, 93% (5 explants) compared to 76% (19 explants) for patients younger than 65 years, p = 0.03. Of 24 explanted valves for structural deterioration, leaflet calcification resulting in stenosis occurred in 20 (83%) and 4 were wear-related leaflet tears. Conclusions. We conclude that the Carpentier-Edwards pericardial valve has a low incidence of valve-related complications, that structural deterioration is infrequent and results from leaflet calcification, and that the low incidence of structural deterioration in patients 65 years or older makes this an increasingly appropriate option in this age group.

Clinical Evaluation of the Physio Annuloplasty Ring

Prospective evaluation of a selectively flexible annuloplasty ring was undertaken to assess its safety and efficacy. Between December 1992 and November 1996, 190 patients with mitral regurgitation underwent mitral valve repair using an annuloplasty ring (Carpentier-Edwards Physio; Baxter-Edwards CVS Laboratories; Irvine, Calif). Ninety-four were in New York Heart Association class I or II. Etiology was degenerative in 74% of the patients. Four patients died early for a hospital mortality of 2.1%, and one late death occurred. Two patients with systolic anterior motion required early valve replacement. Two transient episodes of hemiparesis occurred during the first postoperative month. There were no late thromboembolic complications, no late reoperation, and no endocarditis. Mean follow up of 23+/-13 months was complete in 99% of the patients. Seventy-seven patients (40.5%) have had Doppler echocardiography > 1 year after surgery: 61 (80%) of them have no residual regurgitation, 15 have grade 1+/4+ mitral regurgitation, while 1 has grade 2+/4+ insufficiency. Left ventricular end-diastolic volume index (mL/lm2) decreased from 107.4+/-35.5 preoperatively to 74.2+/-24.4 at last control (p<0.001). The physio annuloplasty ring provided reliable and stable results at medium-term follow-up with a very low incidence of valve-related complications.

Stentless Aortic Bioprostheses: Compelling Data From the Second International Symposium

Background. Stentless aortic xenografts are an important addition to the range of prosthetic valves. So far their use has been restricted to a limited number of study centers. This report summarizes the principal findings from the Second International Symposium on Stentless Bioprostheses. Attention is focused on the Toronto SPV and Freestyle valves recently approved by the United States Food and Drug Administration. Methods. Stentless xenografts are used predominantly in elderly patients with aortic stenosis. Implant techniques are more complex than for stented valves, as reflected by longer ischemic and cardiopulmonary bypass times. The valves have been subjected to detailed serial echocardiographic assessment and clinical follow-up. Results. The hemodynamic characteristics resemble those of the aortic homograft. There is a progressive increase in effective orifice area and decrease in transvalvular pressure gradients with time. Left ventricular mass index and wall thickness normalize between 6 and 12 months postoperatively. Left ventricular remodeling is accompanied by improved symptomatic status and a low incidence of valve-related complications. Limited comparative studies suggest important benefits over stented xenografts. Improved hemodynamics may translate into better bioprosthetic durability. Conclusions. Reproducible and reliable implant methods should be taught carefully, but the hemodynamic advantages are substantial. Stentless xenografts are ideal for the elderly patient with aortic stenosis.