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PubMed2005

Complications of supra-annular mitral valve placement in infants.

Two infants underwent supra-annular placement of prosthetic mitral valves. The objective of this strategy was to insert a larger valve and delay replacement. This approach was initially successful but by two and three years later the patients developed impairment of cardiac function. The prosthesis decreased the volume and compliance of the left atrium causing high left atrial and pulmonary venous pressures. The "ventricularised" atrium below the prosthesis dilated. In neither case was it possible to delay second valve replacement.

Female↗
PubMed2002

Severe hemolysis due to cloth wear 23 years after aortic valve replacement on a Starr-Edwards ball valve model 2320.

Despite iron substitution therapy, a patient developed severe hemolytic anemia 23 yr after insertion of a cloth-covered Starr-Edwards model 2320 aortic valve prosthesis. The prosthesis showed no sign of significant dysfunction. Upon removal, it showed extensive cloth wear on the inner surface of all three struts; one strut was completely denuded of its cloth covering. Hemolysis immediately resolved after replacement with a St Jude aortic prosthesis.

Anemia, Hemolytic↗
PubMed2003

Long-term results of reoperative mitral valve surgery in patients with rheumatic disease.

BACKGROUND: Reoperative (redo) mitral valve surgery is still a continuing challenge to surgeons. The aim of this study was to detect the factors that affect late mortality or morbidity after redo mitral valve surgery in patients with rheumatic disease. METHODS: Between May 1983 and February 2003, 92 patients who underwent redo mitral valve surgery for rheumatic disease were enrolled. Risk factors influencing survival or cardiac events were investigated with univariate analysis and a Cox model. RESULTS: Operative mortality rate was 4.2%. Kaplan-Meier actuarial analysis demonstrated an 84.7% 5-year, a 69.5% 10-year, and a 65.9% 15-year survival. Multivariate analysis demonstrated that age at surgery and preoperative New York Heart Association (NYHA) class were found to be independent predictors of late deaths, and that higher age, advanced NYHA class, and previous mitral valve replacement were independent predictors of cardiac events. CONCLUSIONS: Redo mitral valve surgery can be achieved with low early mortality. However, long-term results of redo mitral surgery are not necessarily satisfactory in patients with preoperative advanced NYHA class or with a previous mechanical heart valve, and especially in 60 years or older age.

Actuarial Analysis↗
PubMed2001

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.

Adolescent↗
PubMed2006

[Diastolic heart failure in patients with aortic valve disease].

From March 2002 to August 2005, 53 patients with age between 30 and 86 underwent surgical treatment for aortic valve disease. Preoperative diastolic heart failure was observed in 15 cases (28.3%). Operative procedures consisted of aortic valve replacement (AVR) in 42 cases [AVR and mitral valve replacement (MVR) in 3], aortic valve plasty (AVP) in 2, and aortic root replacement in 4. Concomitant procedures included maze procedure in 2 cases, coronary artery bypass grafting (CABG) in 6, mitral valve surgery in 15, and tricuspid valve annuloplasty (TAP) in 8. There were 7 cases for patient-prosthesis mismatch (PPM) [13.2%]. There were 2 hospital deaths (both were low-output syndrome). Among the surgical survivors, there were 2 late cardiac-related complications (all cases were cardiac failure). There was no recurrence or re-operation. Although all cases had severe diastolic failure, their systolic function was almost normal. Our study suggested that in patients with aortic valve disease, not PPM but diastolic heart failure correlated strongly with postoperative event and survival.

Aged↗
PubMed2006

Eleven-year single-center experience with the ATS Open Pivot Bileaflet heart valve.

BACKGROUND: The ATS Open Pivot Heart Valve was first introduced in 1992 and has been implanted routinely at our institution since 1993. Valve selection was based on surgeon preference. The objective of this study is to retrospectively analyze our 11-year clinical results with ATS prostheses. METHODS: Between January 1993 and December 2003, 601 ATS valves (393 aortic valve replacement [AVR], 168 mitral valve replacement [MVR], 20 aortic plus mitral valve replacement [DVR]) were implanted in 581 patients (377 male, 204 female; mean age, 63.7 years; range 18 to 89). Preoperatively, 47 (8%) were New York Heart Association class I, 212 (36.5%) were class II, 267 (46%) were class III, and 55 (9.5%) were class IV. Preoperative comorbidities were coronary artery disease, 167 (29%); diabetes mellitus, 72 (12%); cerebrovascular disease, 2 (0.3%); endocarditis, 53 (9%); and atrial fibrillation, 115 (20%). RESULTS: Follow-up is 99% complete. Data represent 2,500 cumulative patient-years. Mean follow-up is 4.3 +/- 2.6 years (range, 0.1 to 11.6). Overall hospital mortality is as follows: AVR, 3.8% (15 patients); MVR, 1.8% (3 patients); DVR, 10% (2 patients). Structural valve failure was not encountered. Overall survival at 10 years is AVR, 84.7% +/- 3.1%, AVR plus coronary artery bypass, 67.5% +/- 8.2%; MVR, 59.8% +/- 7.1%, MVR plus coronary artery bypass, 39% +/- 27.8%; and DVR, 74.3% +/- 10%. Freedom from valve-related death at 10 years is AVR, 99.2%; MVR, 94.6%; and DVR, 100%. Linearized rates for postoperative complications are paravalvular leak, 0.6% per patient-year; valve thrombosis, 0.04% per patient-year; thromboembolism, 1.1% per patient-year; major bleeding, 0.5% per patient-year; and de novo prosthesis endocarditis, 0.1% per patient-year. Postoperative mortality risk was significantly elevated by diabetes (p < 0.01), but not by other comorbidities. CONCLUSIONS: Our 11-year experience demonstrates low rates of adverse events and valve-related complications with the ATS Open Pivot heart valve.

Adolescent↗
PubMed1998

Long-term results of mitral-aortic valve operations.

OBJECTIVE: We analyzed the long-term morbidity and mortality of our experience with combined mitral-aortic surgery, as well as their determinants. METHODS: Among 2109 consecutive patients undergoing valve operations, 200 had mitral-aortic valve procedures with at least implantation of a mechanical prosthesis: 163 of 200 (81.5%) patients had double valve replacement and 37 of 200 (18.5%) had mitral valve repair and aortic valve replacement. All mechanical valves were bileaflet prostheses. Preoperatively, 171 of 200 (85.5%) patients were in New York Heart Association class III-IV. Event-free survivals were determined by means of the Kaplan-Meier method and determinants of survivals with the Cox proportional hazards model (p < 0.05) entering 39 preoperative and perioperative factors. Follow-up was complete for 96% of the patients (192/200). RESULTS: Overall survivals at 5, 10, and 15 years were 88.5% +/- 0.55%, 73.5% +/- 4%, and 53.3% +/- 8.9%, and rates of freedom from valve-related mortality were 92.9% +/- 1.5%, 85.8% +/- 3.5%, and 85.8% +/- 3.5%. The rates of freedom from permanent valve-related impairment were 91.5% +/- 1.7%, 85.4% +/- 3.5%, and 79.3% +/- 6.7%, and those from all valve-related mortality and morbidity were 74.1% +/- 2.3%, 53.8% +/- 5%, and 49% +/- 5.6%. At last follow-up, 90% (139/154) of the survivors were in New York Heart Association class I-II. Left ventricular ejection fraction less than 50%, age older than 70 years, and preoperative ventricular arrhythmias were independent risk factors for valve-related late deaths. Diabetes, ejection fraction less than 50%, and coronary artery disease were independent determinants of all valve-related events. CONCLUSIONS: Functional results of survivors of combined mitral-aortic surgery are excellent. However long-term valve-related morbidity and mortality are substantial. In the patient population studied, the predictors are determined by patient-related factors, mainly myocardial factors, but not by valve-related factors.

Adolescent↗
PubMed2001

[Long-term results of the surgical treatment in acute aortic valve endocarditis].

Late results after surgery for acute infectious aortic endocarditis using allografts are compared with those achieved with bioprostheses or mechanical heart valves. Cryopreserved allografts were used in 74 (22%) and prosthetic heart valve in 262 out of 336 (78%) patients presenting acute aortic endocarditis. Prosthetic (p = 0.001) and destructive endocarditis (p = 0.001) were more frequent in patients receiving allografts. Mean follow-up time was 6.6 +/- 4 years (range, 3 to 28 years). The 30-day-mortality was 19% for allograft patients and 6% for those receiving prosthetic heart valves (p = 0.002). Early reoperation, postoperative renal failure and sepsis did not differ between groups. After 20 years, actuarial survival was 60% for mechanical heart valves, 44% for bioprosthesis and 38% for allografts (p = 0.003), reoperation was unnecessary in 52% of mechanical heart valves and 10% of bioprostheses and allografts (p = 0.0007). Acute infection at the time of operation (p = 0.0001), redo surgery (p = 0.0006), staphylococci (p = 0.0003), older age (p = 0.004) and mitral valve involvement (p = 0.004) were risk factors for late death, irrespective of preoperative antibiotic treatment and type of prosthesis used. A longer bypass and aortic cross-clamp time predicted early (p = 0.0001) and late survival (p = 0.0001), independently. Destructive aortic endocarditis has a poor long-term outcome irrespective of the use of allografts. Acute infection at the time of surgery predicted early and late death; however, surgery is indicated prior to secondary involvement of the mitral valve. The duration of preoperative antibiotic treatment did not affect outcome. A thorough surgical technique directly influences early and late survival.

Acute Disease↗
PubMed2004

Complications of prosthetic heart valves.

Treatment of native valvular heart disease has resulted in an increasing number of patients with prosthetic valves. Although an improvement over the diseased native valve removed at surgery, prosthetic valves have suboptimal hemodynamics; mechanical valves require anticoagulation and tissue valves wear out over time. Serious complications of prosthetic valves occur at a rate of about 2% to 3% per patient-year. Complications include thromboembolism, prosthesis-patient mismatch, structural valve dysfunction, endocarditis, and hemolysis. Prosthetic valve endocarditis is a lethal disease with mortality rates of 50% to 80% even with appropriate therapy. Echocardiography now provides detailed information on valve function and hemodynamics, allowing early detection of complications. Many of these complications can be prevented by choosing the optimal valve at the time of surgery, rigorous control of anticoagulation and adherence to established anticoagulation guidelines, dental hygiene and endocarditis prophylaxis, and periodic echocardiographic monitoring by a cardiologist.

Anemia, Hemolytic↗
PubMed2005

Does the type of prosthesis influence the incidence of permanent pacemaker implantation following isolated aortic valve replacement.

BACKGROUND: The incidence of conduction disorders requiring permanent pacing (PPM) in patients operated on for aortic valve replacement (AVR) has been reported to be 5.7%. However, perioperative risk predictors for PPM following AVR are not well characterized and debate exists regarding selection of the prosthesis-type most likely to minimize this incidence. The aim of the study was to assess whether the type of the prosthesis used influences the prevalence of PPM following aortic valve replacement. METHODS: A total of 782 consecutive patients with predominant aortic stenosis accepted for isolated non-emergent AVR were studied over a 3 year period; of which 305 patients (Group A) received mechanical prostheses, 335 received stented tissue prostheses (Group B), and the remaining 142 received stentless tissue valves (Group C). A stepwise logistic regression analysis was used to identify the independent predictors for PPM and statistical significance was accepted at a level of P < .05. RESULTS: Univariate and multivariate analyses showed a significant relationship between the preoperative factors (poor ejection fraction < 35%; P < .001), left atrial enlargement (LAE; P < .001) and left bundle branch block (LBBB; P < .001), the perioperative variables (bypass time > 100 minutes with x-clamp time > 70 minutes; P < .001) and the incidence of PPM. CONCLUSIONS: The proposed predictive model correlated highly with actual pacemaker use, suggesting that the requirement for PPM results from either operative trauma or increased ischemic burden and the incidence of PPM is independent of prosthesis-type implanted.

Adult↗
PubMed2005

Reoperation for a Starr-Edwards aortic prosthetic valve 33 years after initial implantation.

A 40-year-old woman admitted with heart failure had undergone aortic valve replacement with a Model 2310 Starr-Edwards valve due to aortic regurgitation 33 years previously. She had been followed up for several years, but discontinued follow-up and medication (including Warfarin) for the past 25 years. Echocardiography demonstrated marked dilatation and thickening of the left ventricle, and the peak pressure gradient of the prosthesis was measured as 87.9 mmHg. Under the diagnosis of chronic aortic valve prosthesis-patient mismatch with subsequent severe left ventricular dysfunction, the Starr-Edwards valve was explanted and replaced with a 23 mm St. Jude Medical prosthetic valve. The removed valve showed minimal cloth wear except for a small part of the strut. The postoperative echocardiography demonstrated recovering of left ventricular function. To our best knowledge, this case presents the longest duration for a surgically explanted Starr-Edwards aortic prosthetic valve in Japan.

Adult↗
PubMed1996

Early experience with the Sorin bileaflet prosthetic valve.

Between 1.6.1991 and 31.5.1995, 62 patients underwent heart valve replacement with Sorin Bicarbon bileaflet prosthetic valve, age 16-83 years (mean 60.5). The valve disease was rheumatic in 37 cases, degenerative in 17, congenital in 4 and miscellaneous etiologies in the other 4. The valve lesion was AS in 24 patients, AR in 5, AR+MS in 2, MS in 13, MR+MS in 6, MR in 6, tricuspid prosthetic stenosis in 1, A+M disease in 3, and a clotted prosthetic valve (Sorin disc) in 1. CAD was present in 14 patients (23%) and AF in 19 (31%). 11 had moderate pulmonary hypertension and 4 severe. Preoperatively 6 patients were in FC II, 40 in FC III and 16 in FC IV. Operative procedures included AVR 18, AVR+CABG 13, AVR+T annuloplasty 1, AVR and open M valvotomy 1, MVR 7, MVR+T annuloplasty 7, MVR+AVR (Medtronic) 1, MVR+AVR 1, TVR, prosthetic valve replacement 1, and MVR+CABG 1. Hospital mortality was 3 (4.8%) -- one due to ruptured A-V groove and two due to LoCO. Postoperative complications: LoCO necessitating IABP -- 3 patient; 3 transient CVA and 1 CVA with hemiplegia. One patient had aortic prosthetic valve endocarditis 18 months following the operation necessitating reoperation. Other cases were treated for positive blood cultures. One patient had CVA after anticoagulant were discontinued. 28 patients are in FC I, 22 in H, 4 in III and 1 in IV. 4 patients are lost to follow-up. These data suggest that the Sorin Bicarbon Prosthetic valve can be safely and effectively used for heart valve replacement.

Aortic Valve↗
PubMed2006

Patient-prosthesis mismatch: the Japanese experience.

The concept of patient-prosthesis mismatch (PPM) was defined as existing "when the effective prosthetic valve area, after insertion into the patient, is less than that of a normal valve". However, based on the correlation between the mean transvalvular pressure gradient and the corrected effective orifice area (EOA), PPM is currently defined as an EOA corrected by a body surface area (BSA) of 65 years old, while supra-annular implantation of a bioprosthesis was done in patients >or=65 years old with a small aortic annulus. We discuss our present strategy after the introduction of a new high performance prosthesis, since the EOAs are dramatically increased.

Adolescent↗
PubMed2000

Porcine versus pericardial bioprostheses: eleven-year follow up of a prospective randomized trial.

BACKGROUND AND AIM OF THE STUDY: There is renewed interest in the pericardial heart valve as an alternative to the porcine bioprosthesis. The long-term results of a randomized trial comparing a second-generation pericardial valve against a well-tested porcine bioprosthesis are presented. Seven-year follow up has been reported previously. Production of the Bioflo pericardial prosthesis used in this trial was discontinued due to fears related to bovine spongiform encephalopathy. METHODS: Between February 1987 and March 1990, 170 patients undergoing aortic (AVR) or mitral (MVR) valve replacement were assigned randomly to receive either the Bioflo pericardial bioprosthesis or the Carpentier-Edwards (CE) supra-annular porcine bioprosthesis. Eighty-five patients received 93 Bioflo valves (46 AVR, 31 MVR, eight AVR+MVR), and the remaining 85 received 99 CE valves (48 AVR, 23 MVR, 14 AVR+MVR). Mean patient age was 61.0 years (range: 38-77 years) for the Bioflo group and 62.1 years (range: 41-77 years) for the CE group. Current follow up is 100% complete and totals 1,391 patient-years; mean +/- SD follow up was 8.2 +/- 3.4 years (maximum 12.2 years). RESULTS: The operative mortality rate was 4.12%. There were 70 patients still at risk at 11 years (31 Bioflo, 39 CE); of these, 91.4% were in NYHA classes I/II. No significant difference in survival or valve-related complications was seen between the groups. Mean (+/- SEM) survival at 11 years was 41.4 +/- 6.8% in the Bioflo group and 55.3 +/- 6.8% in the CE group (p = 0.15). There were 16 valve-related deaths (nine in the Bioflo group, seven in the CE group). At 11 years, freedom from valve-related mortality was 89.5 +/- 3.9% for the Bioflo group and 91.0 +/- 3.5% for the CE group (p = 0.4). Valve position had no impact on survival. At 11 years, freedom from structural valve deterioration was 83.9 +/- 5.4% and 87.5 +/- 4.2% in the Bioflo and CE groups, respectively (p = 0.9). CONCLUSION: Over the 11-year period of follow up, clinical performance of the Bioflo pericardial valve was comparable with that of the Carpentier-Edwards supra-annular porcine bioprosthesis. No difference was apparent between the two valve types when implanted in either the aortic or the mitral position.

Animals↗
PubMed2003

Leaflet escape in a new bileaflet mechanical valve: TRI technologies.

BACKGROUND: Leaflet escape is a mode of structural valve failure for mechanical prostheses. This complication previously has been reported for both monoleaflet and bileaflet valve models. We report 2 leaflet escape occurrences observed in 2 patients who underwent valve replacement with a TRI Technologies valve prosthesis. METHODS AND RESULTS: At the University of Padua, between November 2000 and February 2002, 36 TRI Technologies valve prostheses (26 aortic and 10 mitral) were implanted in 34 patients (12 women and 22 men) with a mean age of 59.9+/-10.3 years (range, 30 to 75 years). There were 5 deaths: 3 in hospital, 1 early after discharge, and 1 late. Two patients experienced a catastrophic prosthetic leaflet escape; the first patient was a 52-year-old man who died 10 days after aortic valve and ascending aorta replacement, and the second was a 58-year-old man who underwent a successful emergency reoperation 20 months after mitral valve replacement. Examination of the explanted prostheses showed in both cases a leaflet escape caused by a leaflet's pivoting system fracture. Prophylactic replacement was then successfully accomplished so far in 12 patients, without evidence of structural valve failure in any of them. Among other significant postoperative complications, we observed 3 major thromboembolisms, 1 hemorrhage, and 1 paravalvular leak. CONCLUSIONS: These catastrophes prompted us to interrupt the implantation program, and they cast a shadow on the durability of the TRI Technologies valve prosthesis because of its high risk of structural failure.

Adult↗
PubMed1998

Medtronic Hall versus St. Jude Medical mechanical aortic valve: downstream turbulences with respect to rotation in pigs.

BACKGROUND AND AIMS OF THE STUDY: Turbulences downstream of mechanical aortic valves are known to contribute to most valve-related complications such as thrombosis, embolization or damage to blood components. In vitro studies have demonstrated the impact of the orientation of prostheses on transvalvular energy loss. This study evaluates the influence of valve orientation on turbulences in the supravalvular aorta in pigs. METHODS: A rotation device which could carry a Medtronic Hall (MH) or St. Jude Medical (SJM) aortic valve prosthesis (23 mm) was constructed and implanted into four healthy pigs. Turbulence measurements using pulsed Doppler ultrasonography were carried out 3 cm downstream of the valve, while the prostheses were rotated in 45 degrees steps. Reynold's normal stress values (RNS) were calculated as key markers for turbulent stresses. RESULTS: Turbulences downstream of MH and SJM valves demonstrated a significant change with rotation. The MH valve showed minimum RNSmean values with orientation of the large orifice to the right posterior aortic wall, which is the area of highest velocities during ejection. With this orientation, aortic flow almost complied with physiologic conditions. Increase of turbulence was observed with any other position. The SJM valve revealed significant turbulent flow at any orientation. Minimum RNSmean values were also measured with one orifice facing the right posterior wall of the aorta. CONCLUSION: With optimum orientation (major orifice facing the right posterior aortic wall) the MH valve matches the aortic flow pattern to near-normal physiology. The flow patterns of the SJM valve are less susceptible to rotation, but cannot attain the optimum RNS values of the MH prosthesis.

Animals↗
PubMed2006

Transapical approach for sutureless stent-fixed aortic valve implantation: experimental results.

OBJECTIVE: Percutaneous aortic valve implantation has been performed in patients with severe aortic stenosis judged as nonsurgical candidates. We evaluated a facilitated transapical antegrade approach for potential use in surgical high-risk patients. METHODS: A pericardial xenograft fixed within a 23-mm stent (Cribier-Edwards aortic prosthesis, Edwards Inc., Irvine, CA, USA) was implanted using a transapical approach in fifteen 35-45 kg pigs. A limited or a full sternotomy was used to transapically introduce a crimped valve through a 24-F sheath. Deployments were performed on the beating heart either with ventricular unloading using femoro-femoral cardiopulmonary bypass (CPB) or rapid ventricular pacing (RVP), all under fluoroscopic and echocardiographic visualization. RESULTS: All valves were successfully deployed at the target site with acceptable visualization of the noncalcified annulus. Valve migration occurred in six procedures (three distal and three retrograde) secondary to inadequate reduction of ventricular output, unfavorable annular anatomy, excessive crimping of the valve, and dislodgement by the delivery balloon. Exact positioning of the valve into the target area was confirmed by autopsy at the end of the procedures. Paravalvular leak was noted in five implants. CONCLUSIONS: The transapical approach provides a safe, accurate, and effective route for facilitated antegrade delivery of a stent-fixed valve. Advanced stent design will lead to better stability of the implant and may minimize the risk of paravalvular leakage in future. Identifying the appropriate population for human feasibility trials remains a challenge.

Animals↗