Reoperation of left heart valve bioprostheses according to age at implantation.

BACKGROUND: Evidence supporting the use of bioprostheses for heart valve replacement in young adults is accumulating. However, reoperation data, which may help guide clinical decision making in young patients, remains poorly defined in the literature. METHODS AND RESULTS: We examined the need for reoperation in 3975 patients who underwent first-time bioprosthetic aortic valve replacement (AVR) (n=3152) or mitral valve replacement (MVR) (n=823). There were 895 patients below the age of 60 years at bioprosthesis implant (AVR, n=636; MVR, n=259). The median interval to reoperation of contemporary, stented aortic bioprostheses was 7.74 years (95% CI 7.28 to 9.97 years) in patients less than 40 years, and 12.93 years (95% CI 11.10 to 15.76 years) in patients between 40 and 60 years of age. Multivariable risk factors associated with reoperation following bioprosthetic AVR include age (hazard ratio [HR] 0.94 per year, 95% CI 0.91 to 0.96, P<0.001) and concomitant coronary artery bypass grafting (HR 0.34, 95% CI 0.11 to 0.99, P=0.04). The median interval to reoperation of contemporary mitral bioprostheses was 8.11 years (95% CI 5.79 to 16.50 years) in patients less than 40 years, and 10.14 years (95% CI 8.64 to 11.14 years) in patients between 40 and 60 years of age. As for AVR, age (HR 0.96 per year, 95% CI 0.95 to 0.98, P<0.001) and concomitant coronary artery bypass grafting (HR 0.55, 95% CI 0.32 to 0.93, P=0.03) were associated with decreased reoperation risk following bioprosthetic MVR. CONCLUSIONS: These data constitute clinically relevant age-specific prognostic information regarding reoperation in young patients, who may wish to select a bioprosthesis at initial left heart valve replacement.

Very long-term survival implications of heart valve replacement with tissue versus mechanical prostheses in adults <60 years of age.

BACKGROUND: Several centers favor replacing a diseased native heart valve with a tissue rather than a mechanical prosthesis, even in younger adult patients. However, long-term data supporting this approach are lacking. We examined the survival implications of selecting a tissue versus a mechanical prosthesis at initial left-heart valve replacement in a cohort of adults <60 years of age who were followed for over 20 years. METHODS AND RESULTS: Comorbid and procedural data were available from 6554 patients who underwent valve replacement at our institution over the last 35 years. Of these, 1512 patients contributed follow-up data beyond 20 years, of whom 567 were adults <60 years of age at first left-heart valve operation (mean survivor follow-up, 24.0+/-3.1 years). Late outcomes were examined with Cox regression. Valve reoperation, often for prostheses that are no longer commercially available, occurred in 89% and 84% of patients by 20 years after tissue aortic and mitral valve replacement, respectively, and was associated with a mortality of 4.3%. There was no survival difference between patients implanted with a tissue versus a mechanical prosthesis at initial aortic valve replacement (hazard ratio 0.95; 95% CI: 0.7, 1.3; P=0.7). For mitral valve replacement patients, long-term survival was poorer than after aortic valve replacement (hazard ratio 1.4; 95% CI: 1.1, 1.8; P=0.003), but again no detrimental effect was associated with use of a tissue versus a mechanical prosthesis (hazard ratio 0.9; 95% CI 0.5, 1.4; P=0.5). CONCLUSIONS: In our experience, selecting a tissue prosthesis at initial operation in younger adults does not negatively impact survival into the third decade of follow-up, despite the risk of reoperation.

Using Clinical Questions Asked by Primary Care Providers Through eConsults to Inform Continuing Professional Development.

INTRODUCTION: Continuing professional development (CPD) offerings should address the educational needs of health care providers. Innovative programs, such as electronic consultations (eConsults), provide unique educational opportunities for practice-based needs assessment. The purpose of this study is to assess whether CPD offerings match the needs of physicians by coding and comparing session content to clinical questions asked through eConsults. METHODS: This study analyzes questions asked by primary care providers between July 2011 and January 2015 using a service that allows specialists to provide consultation over a secure web-based server. The content of these questions was compared with the CPD courses offered in the area in which these primary care providers are practicing over a similar period (2012-2014). The clinical questions were categorized by the content area. The percentage of questions asked about each content area was calculated for each of the 12 specialties consulted. CPD course offerings were categorized using the same list of content areas. Percentage of minutes dedicated to each content area was calculated for each specialty. The percentage of questions asked and the percentage of CPD course minutes for each content area were compared. RESULTS: There were numerous congruencies and discrepancies between the proportion of questions asked about a given content area and the CPD minutes dedicated to it. DISCUSSION: Traditional needs assessment may underestimate the need to address topics that are frequently the subject of eConsults. Planners should recognize eConsult questions as a valuable source of practice-associated challenges that can identify professional development needs of physicians.

Predictors of early neurocognitive deficits in low-risk patients undergoing on-pump coronary artery bypass surgery.

BACKGROUND: Postoperative cognitive deficits (POCDs) are a source of morbidity and occur frequently even in low-risk patients undergoing cardiac surgery. Predictors of neurocognitive deficits can identify potentially modifiable risk factors as well as high-risk patients in whom alternate revascularization strategies may be considered. METHODS AND RESULTS: 448 patients undergoing coronary surgery (coronary artery bypass graft [CABG]) underwent standardized preoperative and postoperative neurocognitive testing as part of 2 randomized trials evaluating the effects of mild hypothermia during coronary surgery. Prospectively collected data were used to identify univariate predictors of POCDs and multivariable logistic regression models were constructed. Models were bootstrapped 1000 times. POCDs occurred in 59% of patients. Significant univariate predictors included intraoperative normothermia, impaired left ventricular (LV) function, higher educational level, elevated serum creatinine and reduced creatinine clearance, prolonged intubation time, intensive care unit (ICU) stay, and hospital stay. Advanced age, presence of carotid disease, and cardiopulmonary bypass time were not associated with increased POCDs in this cohort. Multivariable modeling identified intraoperative normothermia (odds ratio [95% confidence interval] -1.15 [1.01, 1.31]), poor LV function (1.53 [1.02, 2.30]), and elevated preoperative creatinine (1.01 [1.00 to 1.03] for every 1 mmol/L increase), prolonged (>24 hours) ICU stay (1.88 [1.27 to 2.79]), and higher educational level (1.52 [1.01 to 2.28]) as independent predictors of POCD occurrence. CONCLUSIONS: Mild hypothermia, in the intraoperative and perioperative period, may be a protective strategy for the prevention of POCDs. Patients with elevated pre-operative creatinine and poor LV function carry a higher risk of POCDs and may benefit from revascularization strategies other than conventional on-pump CABG.

Surgical approach to cardiac papillary fibroelastomas.

The routine use of echocardiography has led to an increase in the diagnosis of cardiac papillary fibroelastomas. From 1990 to 2004, 10 cases of papillary fibroelastoma were observed, nine of which underwent successful surgical excision with valve repair or replacement and without major complications. One patient presented with an asynchronous lesion requiring repeat excision. Surgical excision of papillary fibroelastomas is safe and curative, and carries minimal morbidity. A review of the current literature suggests that symptomatic cardiac papillary fibroelastomas should be surgically removed, whereas asymptomatic lesions that are left-sided, large (larger than 1 cm) or mobile should be considered for surgical excision.

Mechanical versus bioprosthetic valve replacement in middle-aged patients.

OBJECTIVE: The current trend towards decreasing the age for selection of a tissue over a mechanical prosthesis has led to a dilemma for patients aged 50-65 years. This cohort study examines the long-term outcomes of mechanical versus bioprosthetic valves in middle-aged patients. METHODS: Patients (N = 659) aged between 50 and 65 years who had first-time aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed prospectively after surgery. The total follow-up was 3,402 patient-years (mean 5.1 +/- 4.1 years; maximum 18.3 years). Outcomes were examined with multivariate actuarial methods. A composite outcome of major adverse prosthesis-related events (MAPE) was defined as the occurrence of reoperation, endocarditis, major bleeding, or thromboembolism. RESULTS: Ten-year survival was 73.2 +/- 4.2% after mechanical AVR, 75.1 +/- 12.6% after bioprosthetic AVR, 74.1 +/- 4.6% after mechanical MVR, and 77.9 +/- 7.4% after bioprosthetic MVR (P=NS). Ten-year reoperation rates were 35.4% and 21.3% with aortic and mitral bioprostheses, respectively. Major bleeding occurred more often following mechanical MVR (hazard ratio [HR]: 3.3; 95% confidence interval [CI] 1.2, 9.0; P = 0.022), and the incidence of any thromboembolic event was more common after mechanical MVR (HR: 4.7; CI 1.4, 13.3; P = 0.01). Overall freedom from MAPE at 10 years was 70.2 +/- 4.1% for mechanical AVR patients, 41.0+/-30.3% for bioprosthetic AVR patients, 53.3 +/- 8.8% for mechanical MVR patients, and 61.2 +/- 9.2% for bioprosthetic MVR patients. Although a trend existed towards more MAPE amongst middle-age patients with tissue valves, multivariate analysis did not identify the presence of a bioprosthesis as an independent risk factor for MAPE (HR: 1.3; CI 0.9, 2.0; P = 0.22). CONCLUSIONS: In middle-aged patients, MAPE may occur more often in patients with bioprosthetic valves, but definitive conclusions necessitate the accumulation of additional follow-up. At present, these data do not support lowering the usual cutoff for implantation of a tissue valve below the age of 65.

Neuroendocrine profiling of humans receiving cardiac allografts.

BACKGROUND: Several studies have investigated changes in circulating hormones and markers of cardiac status after heart transplantation in humans. As a result, plasma levels of various hormones and autocoids have been associated with cardiac allograft rejection status. However, no clear associations can be defined given the highly contradictory nature of the available literature. METHODS: In this study of 69 consecutive heart transplant patients followed for >2 years we examine the relationship between neurohumors potentially related to allograft rejection and endomyocardial biopsy grade of rejection (according to the ISHLT) and hemodynamic status. Markers assessed include brain natriuretic peptide (BNP), amino-terminal pro-BNP (N-BNP), atrial natriuretic factor (ANF), adrenomedullin, interleukin-1beta, interleukin-6, tumor necrosis factor-alpha, troponin C and C-reactive protein. RESULTS: The highest plasma levels for most neurohumors were found shortly after surgery and showed a trend towards normalization with time. BNP and N-BNP were the only significantly elevated plasma analytes for patients with Grade 3 rejection as compared with other ISHLT grades. ANF plasma levels correlated with BNP and N-BNP in Grades 0 to 2, but not in Grade 3, suggesting that in this rejection grade the usual coordinated changes observed in BNP and ANF secretion no longer exist. Cardiac filling pressures were correlated with plasma BNP, N-BNP and ANF levels only for Grades 0 and 1. CONCLUSIONS: The timing of blood sampling after transplantation influences the level of the neurohumors measured, which may help explain the conflicting literature reports on the association between neurohumor levels and rejection grade. The significant increase in circulating levels of BNP and N-BNP observed in most cases of Grade 3 rejection occurred with no apparent relationship to post-transplantation time, which suggests a specific influence of acute rejection on BNP gene expression.

Surgical treatment of atrial fibrillation with diathermy: an in vitro study.

OBJECTIVE: The utilization of diathermy (electrocautery) as an energy source in the treatment of chronic atrial fibrillation has generated positive early clinical results. Although this technology is available and affordable, it has not been well studied for this indication. The objectives of this study were: (1) to characterize atrial lesions created by diathermy, (2) to determine relationships between power setting, tissue contact time, and lesion depth and (3) to histologically compare diathermy and unipolar radiofrequency lesions. METHODS: Fresh bovine atrial tissue samples were used to create endocardial lesions using a unipolar diathermy system with a blade tip. A total of 120 lesions were created at varying power settings and tissue contact times. Subendocardial temperatures were recorded. All lesions were examined grossly, then fixed, sectioned and evaluated histologically by a blinded pathologist. Comparisons were made with saline irrigated unipolar radiofrequency lesions. RESULTS: Gross examination revealed extensive tissue destruction of the endocardial surface at the point of contact. Histological examination showed minimal penetrance of the lesions beyond the destroyed tissue margin of the endocardium. This was corroborated by the finding of minimal thermal penetration beyond the endocardium and superficial myocardium. There was a linear relationship between the power setting (15-55 watts), depth of penetrance (2-15 mm) at varying contact times (1-5s/cm). CONCLUSIONS: In this in vitro model, lesions created by diathermy were not transmural, even with high power settings and prolonged contact times. At these settings, significant tissue destruction was observed that may predispose to atrial perforation without achieving penetration. Diathermy did not constitute an effective energy source in the creation of transmural lesions for atrial fibrillation ablation.

Long-term outcomes of valve replacement with modern prostheses in young adults.

OBJECTIVES: To examine the multiple impacts of valve replacement on the lives of young adults. METHODS: Patients (N=500) between age 18 and 50 who had aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed annually. Events, functional status, and quality of life were examined with regression models. RESULTS: Median follow-up was 7.1+/-5.3 years (maximum 26.7 years). Five, 10, and 15-year survival was 92.7+/-1.7, 88.3+/-2.4 and 80.1+/-4.7% after AVR, and 93.1+/-2.3, 79.5+/-4.3 and 71.5+/-5.4% after MVR, respectively. Survival decreased with concomitant coronary disease (hazard ratio (HR): 4.5) and preoperative LV grade (HR: 2.0/grade increase) in AVR patients, and with atrial fibrillation (HR: 5.5), coronary disease (HR: 5.7), preoperative left atrial diameter (HR: 3.0/cm increase) and NYHA class (HR: 2.1/class increase) in MVR patients. Despite reoperation, late survival was equivalent between bioprostheses and mechanical valves in both implant positions. The ten-year cumulative incidence of embolic stroke was 6.3+/-2.4% for mechanical AVR patients, 6.4+/-2.9% for bioprosthetic AVR patients, 12.7+/-3.9% for mechanical MVR patients, and 3.1+/-3.1% for bioprosthetic MVR patients. Atrial fibrillation (HR: 2.8) and smoking (HR: 4.0) were risk factors for stroke in MVR patients. In AVR patients, SF-12 physical scores, freedom from recurrent heart failure, and freedom from disability were significantly higher in bioprosthetic than mechanical valve patients. Career or income limitations were more often subjectively linked to a mechanical prosthesis in both implant positions. CONCLUSIONS: Late outcomes of modern prosthetic valves in young adults remain suboptimal. Bioprostheses deserve consideration in the aortic position, as mechanical valves are associated with lower physical capacity, a higher prevalence of disability, and poorer disease perception. Early surgical referral and atrial fibrillation surgery may improve survival after MVR.

Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves.

BACKGROUND: We examined factors associated with persistent or recurrent congestive heart failure after aortic valve replacement. METHODS: Patients who underwent aortic valve replacement with contemporary prostheses (n = 1563) were followed up with annual clinical assessment and echocardiography. The effect of demographic, comorbid, and valve-related variables on the composite outcome of New York Heart Association class III or IV symptoms or congestive heart failure death after surgery was evaluated with stratified log-rank tests, Cox proportional hazard models, and logistic regression. Factors associated with all-cause death were also examined. Prediction models were bootstrapped 1000 times. RESULTS: Total follow-up was 6768 patient-years (mean, 4.3 +/- 3.3 years; range, 60 days to 17.1 years). Freedom from congestive heart failure or congestive heart failure death was 98.6% +/- 0.3%, 88.6% +/- 1.0%, 73.9% +/- 2.3%, and 45.2% +/- 8.5% at 1, 5, 10, and 15 years, respectively. Age, preoperative New York Heart Association class, left ventricular grade, atrial fibrillation, coronary artery disease, smoking, and redo status predicted congestive heart failure after surgery (all P <.05). Larger prosthesis size and effective orifice area, both absolute and indexed for body surface area, were independently associated with freedom from congestive heart failure. Increased transprosthesis gradients were predicted by prosthesis-patient mismatch and were associated with congestive heart failure after surgery. Mismatch defined as an effective orifice area/body surface area of 0.80 cm(2)/m(2) or less was a significant predictor of congestive heart failure events after surgery, but mismatch defined as an effective orifice area/body surface area of 0.85 cm(2)/m(2) or less was not. Small prosthesis size and mismatch were not significantly associated with all-cause mortality. CONCLUSIONS: These analyses identify independent predictors of congestive heart failure symptoms and congestive heart failure death late after aortic valve replacement and indicate that prosthesis size has a significant effect on this cardiac end point, but not on overall survival after aortic valve replacement.

Long-term follow-up of Thoratec ventricular assist device bridge-to-recovery patients successfully removed from support after recovery of ventricular function.

BACKGROUND: In certain forms of severe heart failure there is sufficient improvement in cardiac function during ventricular assist device (VAD) support to allow removal of the device. However, it is critical to know whether there is sustained recovery of the heart and long-term patient survival if VAD bridging to recovery is to be considered over the option of transplantation. METHODS: To determine long-term outcome of survivors of VAD bridge-to-recovery procedures, we retrospectively evaluated 22 patients with non-ischemic heart failure successfully weaned from the Thoratec left ventricular assist device (LVAD) or biventricular assist device (BVAD) after recovery of ventricular function at 14 medical centers. All patients were in imminent risk of dying and were selected for VAD support using standard bridge-to-transplant requirements. There were 12 females and 10 males with an average age of 32 (range, 12-49). The etiologies were 12 with myocarditis, 7 with cardiomyopathies (4 post-partum [PPCM], 1 viral [VCM], and 2 idiopathic [IDCM]), and 3 with a combination of myocarditis and cardiomyopathy. BVADs were used in 13 patients and isolated LVADs in 9 patients, for an average duration of 57 days (range, 11-190 days), before return of ventricular function and successful weaning from the device. Post-VAD survival was compared with 43 VAD bridge-to-transplant patients with the same etiologies who underwent cardiac transplantation instead of device weaning. RESULTS: Nineteen of the 22 patients are currently alive. Three patients required heart transplantation, 1 within 1 day, 2 at 12 and 13 months post-weaning, and 2 died at 2.5 and 6 months. The remaining 17 patients are alive with their native hearts after an average of 3.2 years (range, 1.2-10 years). The actuarial survival of native hearts (transplant-free survival) post-VAD support is 86% at 1 year and 77% at 5 years, which was not significantly different (p = 0.94) from that of post-VAD transplanted patients, also at 86% and 77%, respectively. CONCLUSIONS: Long-term survival for bridge-to-recovery with VADs for acute cardiomyopathies and myocarditis is equivalent to that for cardiac transplantation. Recovery of the native heart, which can take weeks to months of VAD support, is the most desirable clinical outcome and should be actively sought, with transplantation used only after recovery of ventricular function has been ruled out.

Essential thrombocytosis causing a massive myocardial infarction.

Essential thrombocytosis (ET) is an uncommon myeloproliferative disorder. This disease may have both occlusive thrombotic as well as hemorrhagic complications throughout the body. We report a young man with severe thrombocytosis, clinically thought to be unknown ET, who had massive myocardial infarction requiring bypass surgery, ventricular assist device and ultimately cardiac transplantation. ET may have devastating cardiovascular consequences and should be considered as a rare cause of myocardial infarction in the young.

A strategy of hypothermic circulatory arrest for difficult heart transplant postventricular assist device.

Donor heart and ventricular assist device excision can be extremely difficult at the time of heart transplant. We present a strategy of hypothermic circulatory arrest established with ventricular assist device cannulas for difficult heart transplants. The device inlet or outlet cannulas already in place, or both, are used to complement the safe cannulation sites available. This approach permits controlled excision of the recipient heart and device, easy access to convert to standard ascending aorta and bicaval cannulation, and minimizes the donor graft anoxia time. Two case reports are presented.

Mechanical circulatory support for adolescent patients: the Ottawa Heart Institute experience.

BACKGROUND: Mechanical circulatory support devices may be used for patients with end-stage heart failure for bridging either to cardiac transplant or to recovery of the native heart. While less common in adolescents, fulminant heart failure may be rapidly fatal in these patients unless circulatory support can be instituted. OBJECTIVES: To assess the outcomes and the utility of mechanical circulatory assist devices for children. METHODS: A retrospective review of pediatric patients (18 years of age or younger) who underwent circulatory support at the Ottawa Heart Institute, Ottawa, Ontario, from 1992 to 2001 was performed using chart audits. RESULTS: Seven patients (four boys, three girls) with a mean age of 14.9 +/- 0.9 years were supported with Thoratec ventricular assist devices (n=6) or a CardioWest total artificial heart (n=1). Preoperatively, the cardiac index was 1.64 +/- 0.2 L/min/m2 on one or two inotropes with ejection fractions of 11 +/- 2.2%. Mean duration of circulatory support was 59.3 +/- 17.2 days with a hospital length of stay of 89.6 +/- 12.8 days. All seven patients underwent successful transplantation and were discharged home. CONCLUSIONS: Pediatric patients with fulminant heart failure may be bridged to cardiac transplant successfully with mechanical circulatory support devices.

Virtual anatomical three-dimensional fit trial for intra-thoracically implanted medical devices.

Our purpose is to develop a system that converts computed tomography (CT) scans into an interactive three-dimensional (3-D) model of the thoracic cavity. This study will allow for the preoperative determination of optimal anatomical fit of intra-thoracically implanted medical equipment such as circulatory support devices. From the radiology data bank, we consecutively selected 34 cardiac and 42 noncardiac patients who had CT scans of the chest. Anatomical structures of the electronic CT scans were manually extracted using software. These structures included the thoracic cage, lungs, heart, and the great vessels. The information was converted into a 3-D surface mesh model, which was imported into a 3-D viewer to acquire direct anatomical measurements. The thoracic cage and intra-thoracic organs were measured for data analysis. A methodology was successfully developed to convert a patient's thoracic CT scans into interactive 3-D models, permitting the collection of key anatomical measurements to assess intra-thoracic device fit feasibility. Extensive measurements of the reconstructed thoracic cavity were recorded in a database format and analyzed. This study demonstrated the feasibility of implementing a rapid preoperative screening method based on anatomical fit for the selection or rejection of patients who are candidates for an intra-thoracic mechanical device. This new method will allow for the virtual preoperative implantation of such devices within a patient's chest cavity.

In vivo evaluation of the biocompatibility of the totally implantable ventricular assist device (HeartSaver VAD).

A series of multicenter in vivo studies have been conducted to assess the biocompatibility and device performance of the HeartSaver VAD, a totally implantable pulsatile ventricular assist device (VAD). The experiments (n = 23) were conducted in calves with a mean weight of 101 (75-152) kg. Implants took place at four centers using two different surgical procedures of implantation (one with cardiopulmonary bypass and one without). Three anticoagulation regimens were used (one with continuous intravenous heparin, one with oral warfarin, and one with oral warfarin combined with antiplatelet clopidogrel therapy). Device function and biochemistry were monitored during the study, and organs and device analysis were conducted at explant. There were six nonsurvivors because of early surgical complications (during the first week of support). The postoperative courses in the remaining 17 (74%) calves were uneventful. Hemodynamic and biocompatibility indicators were monitored throughout the study. The mean duration of device support for those cases was 48 (13-92) days. Mean device flow was 7.15 (+/- 1.68) L/min. There were no deaths caused by infection; however, two animals developed endocarditis believed to be caused by the percutaneous instrumentation lines used for the study. No severe bleeding requiring reoperation occurred during the study. The mean plasma free hemoglobin was within normal limits at 6.8 +/- 2.6 mg/dl. Renal and hepatic functions were normal with a mean creatinine of 0.6 +/- 0.1 mg/dl and a mean aspartate aminotransferase of 68.7 +/- 42.6 mg/dl. Several device related improvements were identified and have now been implemented. Additional bovine implants with an optimized device are currently underway in preparation for human trials.

Sudden power loss in a HeartMate II left ventricular assist device due to intermittent pin contact with the battery: case report.

Left ventricular assist device technology has improved such that mechanical malfunction, particularly with newer generation continuous flow devices, is a relatively rare event. We present a case of sudden power loss in a HeartMate II caused by intermittent contact of the battery terminals after a clip was dropped with the battery inserted in it. The clip was replaced and the patient made a complete recovery. A new inspection and testing methodology, and amended approach to patient and caregiver training, designed to prevent future occurrences is described.

Postoperative lipid-lowering therapy and bioprosthesis structural valve deterioration: justification for a randomised trial?

OBJECTIVE: Bioprosthesis structural valve deterioration (SVD) is an incompletely understood process involving the accumulation of calcium and lipids. Whether this process could be delayed with lipid-lowering therapy (LLT) is currently unknown. The purpose of this observational study was to evaluate if an association exists between early LLT and a slowing of bioprosthesis SVD, with a view to designing a prospective trial. METHODS: We followed 1193 patients who underwent aortic valve replacement with contemporary bioprostheses between 1990 and 2006 (mean follow-up 4.5+/-3.1 years, maximum 17.3 years). Of these patients, 150 received LLT (including statins) early after surgery. Prosthetic valve haemodynamics on echocardiography and freedom from re-operation for SVD were compared between patients who did and did not receive postoperative LLT. RESULTS: After bioprosthetic implantation, the progression of peak and mean trans-prosthetic gradients during echocardiographic follow-up (mean 3.3 years) was equivalent between patients treated with and without LLT (peak increase: 0.9+/-7.7 vs 1.1+/-10.9 mmHg, LLT vs no LLT, P=0.87; mean increase: 0.8+/-4.1 vs 0.2+/-5.9 mmHg, LLT vs no LLT, P=0.38). The annualised linear rate of gradient progression following valve replacement was also similar between groups (peak increase per year: 2.0+/-12.1 vs 1.0+/-12.9 mmHg per year, LLT vs no LLT, P=0.52; mean increase per year: 0.5+/-2.2 vs 0.6+/-6.0 mmHg per year, LLT vs no LLT, P=0.94). The incidence of mild or greater aortic insufficiency on the most recent echocardiogram was comparable (16.3% vs 13.8%, LLT vs no LLT, P=0.44), and there was no difference in the 10-year freedom from re-operation for SVD between the two groups [98.9% (95% confidence interval (CI): 91.9%, 99.8%) vs 95.4% (95% CI 90.5%, 97.9%), LLT vs no LLT, P=0.72]. CONCLUSIONS: In this observational study, there was no association demonstrated between early postoperative LLT and a slowing of bioprosthesis SVD. With the excellent durability of bioprostheses in the current era, a prospective randomised trial of statin therapy to prevent bioprosthetic SVD does not appear to be justified, let alone feasible.

When a pack becomes a plug.

The authors present a case of a surgical wound that was inappropriately packed to the extent that a significant and major deterioration occurred in the expected healing by secondary intention. This is intended to alert surgeons to the fact that careful supervision is required of such seemingly simple and straightforward tasks as the topical treatment of open wounds by inexperienced caregivers.