Prosthetic Valve Failure Research Articles

Recent outcomes of surgical redo aortic valve replacement in prosthetic valve failure.

As redo surgical aortic valve replacement(AVR) is relatively high risk, valve-in-valve transcatheter AVR has emerged as an alternative for failed prostheses. However, the majority of studies are outdated. This study assessed the current clinical outcomes of redo AVR. This study enrolled 324 patients who underwent redo AVR due to prosthetic valve failure from 2010 to 2021 in four tertiary centers. The primary outcome was operative mortality. The secondary outcomes were overall survival, cardiac death, and aortic valve-related events. Logistic regression analysis, clustered Cox proportional hazards models, and competing risk analysis were used to evaluate the independent risk factors. Redo AVR was performed in 242 patients without endocarditis and 82 patients with endocarditis. Overall operative mortality was 4.6% (15 deaths). Excluding patients with endocarditis, the operative mortality of redo AVR decreased to 2.5%. Multivariate analyses demonstrated that endocarditis (HR 3.990, P=0.014), longer cardiopulmonary bypass time (HR 1.006, P=0.037) and lower left ventricular ejection fraction (LVEF) (HR 0.956, P=0.034) were risk factors of operative mortality. Endocarditis and lower LVEF were independent predictors of overall survival. The relatively high risk of redo AVR was due to reoperation for prosthetic valve endocarditis. The outcomes of redo AVR for non-endocarditis are excellent. Our findings suggest that patients without endocarditis, especially with acceptable LVEF, can be treated safely with redo AVR.

Long-term outcome of transcatheter repair of paravalvular leak post surgical mitral valve replacement

Objective: To explore the long-term clinical efficacy of transcatheter repair of mitral paravalvular leak (PVL) post surgical mitral valve replacement. Methods: This study is a retrospective study. Patients who completed transcatheter repair of paravalvular leak after surgical mitral valve replacement at Shanghai Chest Hospital, Shanghai Jiaotong University School of Medicine from March 2010 to December 2018 were included. Technical success was defined as the occluder being stably implanted in the paravalvular leak site without affecting the function of the mitral valve and surrounding tissues; and there were no intervention-related complications, such as new hemolysis or aggravated hemolysis, and echocardiography confirmed mitral paravalvular regurgitation reduced by more than 1 grade. Patients were followed up at 30 days, 1, and 3 years after the intervention. The main endpoints were all-cause death and re-surgery due to interventional failure or serious complications. The occurrence of occluder-mediated hemolysis and chronic renal insufficiency was recorded, and patients were monitored with echocardiography during follow up. Results: A total of 75 patients were included, aged (54.3±22.9) years old, and 38 patients were males. All patients had decreased cardiac function and/or hemolysis before intervention. Procedural success was achieved in 54 patients (72.0%). Incidence of device-mediated hemolysis was 18.7% (14/75). During the follow-up period, all-cause death occurred in 7 patients (9.3%), and 3 were cardiac deaths.The 3-year event-free survival rate was 81.3% (61/75). The need for cardiac surgery was 9.3% (7/75): 3 cases due to severe device-mediated hemolysis, 2 cases due to prosthetic valve failure and 2 cases due to moderate to severe residual regurgitation. The echocardiography follow-up results showed that the position of the occluder was stable, there was no impact on the artificial valve function and surrounding structures, and the residual regurgitation was stable without progressive increase in event-free patients. Compared with pre-intervention, the left ventricular end systolic diameter ((33.9±7.4)mm vs. (38.3±8.9) mm, P=0.036), end diastolic diameter ((53.7±8.3) mm vs. (58.4±9.1) mm, P=0.045) and left atrial diameter (59.3 (44.5, 90.7) mm vs. 64.3 (44.8, 96.6) mm, P=0.049) were significantly reduced, pulmonary artery systolic pressure was also significantly decreased ((36.5±15.8) mmHg vs. (46.3±14.9) mmHg, P=0.022, 1 mmHg=0.133 kPa). There was no significant difference between 3 years and 1 year after transcatheter repair of mitral paravalvular leak post surgical mitral valve replacement (all P>0.05). Conclusion: Transcatheter repair of mitral paravalvular leak post surgical mitral valve replacement is an effective treatment option in selective patients.

Mechanical vs Bioprosthetic Aortic Valve Replacement in Patients on Dialysis: Long-term Outcomes

BackgroundUsing the Japan National Clinical Database and additional data, this study is an analysis of long-term survival of dialysis-dependent patients who underwent aortic valve replacement (AVR). MethodsDialysis-dependent patients who underwent de novo AVR between 2010 and 2012 and who were registered in the database were included. Concomitant aortic surgery and transcatheter aortic valve replacement were excluded. Additional data on the underlying kidney disease, the duration of dialysis, and clinical outcomes were registered between October 29, 2019, and August 30, 2020. The primary outcome was all-cause mortality. The secondary outcomes were cerebral infarction, cerebral bleeding, gastrointestinal bleeding, and prosthetic valve failure. ResultsAfter propensity score matching, 1016 cases (508 each in the bioprosthetic and mechanical valve groups) were matched. The median follow-up period was 3.29 years (interquartile range [IQR], 0.59 years, 6.25 years). The median survival time was 5.38 years (IQR, 1.20 and 9.26 years) in the mechanical valve group and 4.98 years (IQR, 1.69 and 9.62 years) in the bioprosthetic valve group. The Cox regression model showed no significant difference in long-term survival between the groups (mechanical valve: hazard ratio [HR], 0.895; 95% CI, 0.719-1.113; P = .318). The incidences of cerebral infarction and prosthetic valve failure requiring admission were similar between the groups. Cerebral bleeding (HR, 2.143; 95% CI, 1.125-4.080; P = .002) and gastrointestinal bleeding (HR, 2.071; 95% CI, 1.243-3.451; P = .0005) were more frequent in the mechanical valve group. ConclusionsLong-term survival of dialysis-dependent patients was similar regardless of whether mechanical valves or bioprosthetic valves were implanted. The incidences of cerebral and gastrointestinal bleeding were 2-fold higher in the mechanical valve group.

Pulmonary Valve Replacement in Repaired Tetralogy of Fallot: Midterm Impact on Biventricular Response and Adverse Clinical Outcomes.

Background:Pulmonary regurgitation (PR), though well tolerated for short term in patients with repaired tetralogy of Fallot (rTOF), could lead to right ventricular (RV) dysfunction, arrhythmias, and sudden cardiac death. Pulmonary valve replacement (PVR), considered as the gold-standard treatment for PR, is performed to mitigate these late effects. In this study, we aimed to evaluate the midterm outcomes and predictors of adverse clinical outcomes (ACO).MethodsFrom May 2014 to December 2017, 42 patients with rTOF undergoing surgical or transcatheter PVR in our department were retrospectively included. Cardiovascular magnetic resonance was performed before PVR (pre-PVR), early after PVR (early post-PVR), and midterm after PVR (midterm post-PVR). Medical history and individual data were collected from medical records. ACO included all-cause death, new-onset arrhythmia, prosthetic valve failure, and repeat PVR.ResultsThe median follow-up duration was 4.7 years. PVR was performed at a median age of 21.6 years. There was no early or late death. Freedom from ACO at 3 and 5 years was 88.1 ± 5% and 58.2 ± 9%, respectively. RV end-diastolic volume index (RVEDVI) and end-systolic volume index (RVESVI) significantly reduced early after PVR and further decreased by midterm follow-up (pre-PVR vs. early post-PVR vs. midterm post-PVR: RVEDVI, 155.2 ± 34.7 vs. 103.8 ± 31.2 vs. 95.1 ± 28.6 ml/m2, p < 0.001; RVESVI, 102.9 ± 28.5 vs. 65.4 ± 28.2 vs. 57.7 ± 23.4 ml/m2, p < 0.001). Multivariable analysis revealed that the occurrence of ACO was significantly increased in patients with lower left ventricular end-systolic volume index.ConclusionsA significant reduction of RV volume occurred early after PVR, followed by a further improvement of biventricular function by midterm follow-up. The midterm freedom from ACO was favorable.

Contemporary Etiologies, Outcomes, and Novel Risk Score for Isolated Tricuspid Regurgitation

ObjectivesThe authors report etiologies and outcomes and devise a risk model in a large contemporary cohort of patients with isolated tricuspid regurgitation (TR). BackgroundIsolated TR is a challenging clinical entity with heterogeneous etiology and often poor outcomes, with a paucity of recent research regarding the epidemiology of isolated TR. MethodsConsecutive patients with isolated TR graded at least moderate to severe on echocardiography from January 2004 to December 2018 (n = 9,045, mean age 70.4 ± 15.4 years, 60.3% women) were studied. TR etiologies were individually adjudicated as secondary or primary, with subcategories. All-cause death during follow-up was the primary endpoint, with associations between etiology and outcomes analyzed and a risk model created. ResultsPrimary and secondary TR etiologies were present in 470 (5.2%) and 8,575 (94.8%) patients, respectively. The main secondary etiologies were left heart disease in 4,664 (54.4%), atrial functional in 2,086 (24.3%), and pulmonary disease in 1,454 (17.0%), and the main primary etiologies were endocarditis in 222 (47.2%), degenerative or prolapse in 86 (18.3%), and prosthetic valve failure in 79 (16.8%). There were 3,987 deaths (44.0%) over a mean follow-up period of 2.6 ± 3.3 years. In unadjusted analyses, patients with secondary TR had worse survival than those with primary TR (HR: 1.56; 95% CI: 1.32-1.85), but this result was not statistically significant in multivariable analysis. The authors devised and internally validated a risk score for predicting 1-year mortality in these patients. ConclusionsSecondary TR constituted 95% of isolated significant TR and conferred worse survival than primary TR in unadjusted but not adjusted analyses. The present novel risk score stratifies the risk for 1-year death and may influence decision making for management in these high-risk patients.

APROTININ USE IN CARDIAC SURGERY IN A TERTIARY CENTRE IN IRELAND: CASE NUMBERS, INDICATIONS & COMPARISON TO TRANEXAMIC ACID

Introduction Aprotinin is a serine protease inhibitor which is used in cardiac surgery as an anti-fibrinolytic agent to minimise patient bleeding. It was withdrawn from the European market in 2008 due to potential increased mortality when compared to tranexamic acid. Aprotinin was subsequently re-introduced in 2012 with narrow licencing indications, specifically isolated coronary artery bypass graft surgery in high risk patients. Minimisation of intra-operative blood loss plays an important role in patient outcomes, especially in decreasing the need for transfusion which carries its own mortality risks(3,. Tranexamic acid is utilised in the majority of cardiac surgery cases throughout Europe. We looked to quantify and determine indications for aprotinin usage in an Irish tertiary cardiac centre and compare findings to tranexamic acid. Methods Retrospective study of aprotinin usage in cardiac surgery in an Irish tertiary centre over a 3 year period to determine number of cases and indications. Data collection involved operative notes, patient records, pharmacy dispensing accounts. Aprotinin dosage intra-operatively was per the full or half Hammersmith protocol. A cohort which had undergone comparable cardiac surgery procedures with tranexamic acid as the anti-fibrinolytic agent were also studied. Results From 2018-2021, 21 cardiac surgeries were carried out using aprotinin as the sole anti-fibrinolytic agent to minimise patient bleeding in a high risk cohort. For the same time period, to provide scale, 737 cardiac surgeries were carried out using tranexamic acid. Each of the cases which utilised aprotinin represents an emergent, life-threatening operation. The emergency cases comprised: repair of Stanford type A aortic dissection (8, 38%); aortic valve replacement (7, 33.3%); mitral valve replacement (3, 14.3%); tricuspid valve replacement (1, 4.8%); mediastinal revision for cardiac tamponade (1, 4.8%). Valve replacements were complicated by: acute infective endocarditis, aortic root abscess, haematoma, failure of pre-existing prosthetic valves. 1 case utilised aprotinin as per the licenced indication: isolated CABG in patient with high bleeding risk. An ST-elevated myocardial infarction necessitated the emergency CABG procedure in this case. Discussion In summation, 95% of aprotinin usage for cardiac surgery in an Irish tertiary centre falls outside the remit of the licenced indication. Given similar findings in a number of European institutes(5), is it time to re-assess the existing guidelines on aprotinin use, with view to expansion of the licenced indications?

BALLOON VALVULOPLASTY FOR EARLY BIOPROSTHETIC AORTIC VALVE STENOSIS IN SEPTUAGENARIAN - A RAY OF HOPE

Calcic aortic stenosis (AS) remains a major cause of mortality and morbidity in the aging population . Surgical AV Replacement (SAVR) and Transfemoral Aortic Valve Implantation (TAVI) are available treatment options. With improvements in long term patient survival after AVR and increases in overall longevity, more patients are now seen with Prosthetic Aortic Valve failure. The management of patients with stenotic aortic bioprostheses is usually surgical. However, a proportion of such patients are unt for such procedures. The technique of aortic balloon valvuloplasty as an alternative treatment strategy for such patients is explored. We report a case of seventy-three-year-old male with prosthetic aortic valve stenosis treated with balloon valvuloplasty with promising intermediate term outcome and describe the growing valve in valve procedure. Hence this case is reported to enhance our knowledge and potentiate literature regarding the management strategy of prosthetic aortic valve stenosis in old age.

Tricuspid Valve Repair at Pulmonary Valve Replacement in Repaired Tetralogy of Fallot.

Pulmonary valve replacement (PVR) is often performed in patients with repaired tetralogy of Fallot (TOF). Concomitant tricuspid valvuloplasty (TVP) in those with tricuspid regurgitation (TR) at the time of PVR is still controversial. We retrospectively reviewed clinical records of patients who underwent PVR between 2001 and 2012. We analyzed the impact of concomitant TVP on the tricuspid valve function and right ventricle function and size in mid-term. 119 patients with mild to moderate TR at the time of PVR were enrolled. 33 patients underwent concomitant TVP (TVP group) and 86 patients underwent PVR alone (no-TVP group). There was a significant reduction of TR (p < 0.001) and right ventricular end-diastolic volume index (RVEDVi) (p < 0.001). However, in patients who showed prosthetic pulmonary valve (PV) failure at the last follow-up, there was no significant decrease in TR regardless of concomitant TVP. In the patients with preserved prosthetic PV function, TR was significantly improved (p < 0.001 in both groups). The multivariable analysis showed that significant risk factors for recurrence of significant TR were preoperative moderate TR and prosthetic PV failure. After PVR in repaired TOF patients, there was an improvement in the degree of TR and the RVEDVi. Concomitant TVP at the time of PVR may not be able to prevent the recurrence of TR when prosthetic PV failure occurs; however, it may effectively preserve tricuspid valve function until that time.

Tricuspid Valve Replacement: Mechanical or Biological Prostheses? A Systematic Review and Meta-Analysis.

Tricuspid valve replacement (TVR) is seldom performed in cardiac valve surgery, and there currently are no clinical guidelines as to which type of prostheses is better in tricuspid valve position. This meta-analysis was performed to compare the results of mechanical and biological prostheses for TVR. We searched the Pubmed, Cochrane, and Embase clinical trial databases to collect all related studies published from January 1, 2000 to July 31, 2020. A random-effects model was used to evaluate the odds ratios (OR) and its 95% confidence intervals (CI) of time-to-event related effects of the surgical procedures; every study's quality was evaluated by the Newcastle-Ottawa Scale (NOS). A total of 13 retrospective studies, including 1453 patients were analyzed. There were no statistically differences between mechanical and biological prostheses with respect to prosthetic valve failure [OR = 0.84, 95% CI(0.54, 1.28), P = .41], bleeding [OR = 0.84, 95% CI(0.54,1.28), P = .41], reoperation [OR = 1.02, 95% CI(0.58,1.78), P = .95], early mortality [OR = 1.35, 95% CI(0.82,2.25), P = .24] and long-time survival [OR = 1.09, 95% CI(0.70, 1.69), P = .70], but a significant difference can be seen in mechanical prostheses with a higher risk of thrombosis [OR = 0.17, 95% CI(0.05, 0.60), P = .006, I2 = 0%]. In tricuspid valve position, mechanical valve prostheses have a higher risk of thrombosis than biological prostheses, but no statistical differences between mechanical and biological prostheses with respect to prosthetic valve failure, bleeding, reoperation, early mortality, and long-term survival. The valve disease and patient's age and risk factors are the most important considerations in the decision-making process. The more specific conclusion needs to be further proved by large-sample, multi-center, randomized, double-blind and control trials.

Valve-in-Valve Transcatheter Implantation Versus Redo Surgical Aortic Valve Replacement

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) for a failing prosthesis is an appealing alternative to redo surgical AVR. We utilized data from the US National Inpatient Sample for the period 2012 to 2016 to identify hospitalizations for either ViV-TAVI or redo-SAVR. The primary outcomes of interest were in-hospital adverse events composite outcome (comprising of mortality, myocardial infarction, stroke, or acute kidney injury) and all-cause mortality. We used propensity score matching to adjust for the baseline differences between ViV-TAVI and redo-SAVR cohorts. Survey techniques were employed to compare the 2 groups. Over 5 years, there has been a considerable increase in both interventions for prosthetic aortic valve failure, with significantly higher utilization of ViV-TAVI compared to redo-SAVR (p <0.01). Out of the 3,305 hospitalizations for prosthetic aortic valve failure, 1,420 in matched pairs underwent either ViV-TAVI (n = 710) or redo-SAVR (n = 710). ViV-TAVI was associated with lower in-hospital composite adverse outcomes (14.1% vs 25.4%, p = 0.018), and numerically lower but statistically insignificant mortality (<1.0% vs 5.2%; p = 0.06). ViV-TAVI was associated with a decreased length of hospitalization (mean 6.6 vs 9.7 days; p <0.01). In the matched cohort, postoperative bleeding and transfusions were significantly lower for ViV-TAVI compared with redo-SAVR (17.6% vs 31.0% and 12% vs 31% respectively, p <0.01 for both). Acute kidney injury, sepsis, permanent pacemaker implantation, and vascular complications, although numerically better, did not differ between 2 strategies. In conclusion, ViV-TAVI is associated with lower in-hospital MACE rates and reduced length of hospitalization compared with redo-SAVR.

Long-term durability of bioprosthetic valves in pulmonary position: Pericardial versus porcine valves

ObjectivesThe long-term durability of the 2 most commonly used types of bioprosthetic valves in the pulmonic position, the porcine and pericardial valves, is unclear. We compared the long-term durability of the pericardial (Carpentier-Edwards PERIMOUNT [CE]) and porcine (Hancock II) valves in the pulmonic position in patients with congenital cardiac anomalies. MethodsWe retrospectively reviewed the medical records of 258 cases (248 patients) of pulmonary valve implantation or replacement using CE (129 cases, group CE) or porcine (129 cases, group H) valves from 2 institutions between 2001 and 2009. ResultsThe patients' age at pulmonary valve implantation was 14.9 ± 8.7 years. No significant differences in perioperative characteristics were observed between groups CE and H. Follow-up data were complete in 219 cases (84.9%) and the median follow-up duration was 10.5 (interquartile range, 8.4∼13.0) years. Ten mortalities (3.9%) occurred. Sixty-four patients underwent reoperation for pulmonary valve replacement due to prosthetic valve failure; 10 of these 64 patients underwent reoperation during the study period. Patients in group CE were significantly more likely to undergo reoperation (hazard ratio, 2.17; confidence interval, 1.26-3.72; P = .005) than patients in group H. Patients in group CE showed had a greater prosthetic valve dysfunction (moderate-to-severe pulmonary regurgitation or pulmonary stenosis with ≥3.5 m/s peak velocity through the prosthetic pulmonary valve) rate (hazard ratio, 1.83; confidence interval, 1.07-3.14; P = .027) than patients in group H. ConclusionsCompared with the pericardial valve, the porcine valve had long-term advantages in terms of reduced reoperation rate and prosthetic valve dysfunction in the pulmonic position in patients with congenital cardiac anomalies.

P3698Long-term durability of transcatheter aortic valve prostheses: results of a center

Abstract The durability of transcatheter heart valves and long-term clinical outcomes are unknown. The aim of this study was to evaluate clinical and hemodynamic outcomes between 5 to 9 years after Transcatheter Aortic Valve Implantation (TAVI). Methods Between April 2008 and December 2012, 305 patients underwent TAVI for the treatment of severe symptomatic aortic stenosis with the auto-expandable prosthesis. Results The mean age, logistic EuroSCORE and STS score were 79.3±6.5 years, 19.4±12% and 6.6±4% respectively. Mean aortic valve gradient decreased from 48.7±15 mm Hg to 8.9±4.3 mmHg after TAVI, to 11.1±9 mm Hg at 4 years, and 22.7±12 mmHg at 5 years (p for post-TAVI trend 0.03). Mean aortic valve area increased from 0.63±0.16 cm2 to 1.57±0.3cm2 after TAVI to 1.48±0.2 at 4 years and 0.97±0.3 cm2 at 5 years (p for post-TAVI trend 0.01). Mean left ventricular ejection fraction increased from 61.1±15% to 65.5±11% after TAVI, to 58.2±17% at 4 years and 60.7±8% at 5 years (p for post-TAVI trend 0.001). Late mortality after a mean of 4.15±2.4 years 58% and in only 34.1% patients was cardiovascular mortality. Survival rates at 1 to 9 years were at 87.5%, 79%, 73.1%, 65.6%, 55.4%, 48.2%, 41.9%, 37.3% and 35.1% respectively. At 5 years, 3 patients had severe prosthetic valve dysfunction (severe stenosis and moderate transvalvular regurgitation). Median survival time after TAVI was 6 years (95% confidence interval [CI]: 5.89 to 6.28), and the risk of death was significantly increased in patients with frailty (adjusted hazard ratio [HR]: 1.864; 95% CI: 1.204 to 2.886), p=0.001, Charlson index [HR= 1.243 (95% CI 1.148–1.346), p&lt;0.001], and left ventricular ejection fraction [HR= 1.012; (95% CI 1.001–1.024)p=0.044]. Conclusions Our study demonstrated favorable long-term outcomes after TAVI. Signs of prosthetic valve failure were observed in 0.97% of patients

Pulmonary versus aortic pressure behavior of a bovine pericardial valve

BackgroundThe Carpentier Edwards Perimount Magna Ease aortic valvular prosthesis (Edwards Lifesciences, Irvine, Calif) has been among the most frequently and successfully used tissue prosthetic cardiac valves. Furthermore, this prosthesis has been used off-label in the pulmonary position. Until now, there has been a paucity of data regarding the functioning of tissue prosthetic valves under pulmonary conditions. MethodsUsing a pulse duplicator, hydrodynamic characteristics of a 21-mm and 25-mm Magna Ease valve were evaluated. Among parameters evaluated were leakage orifice area, closing time (ie, time required to close), and leakage duration. This procedure was performed under different pulmonic pressure conditions (15/5 mm Hg, 28/11 mm Hg, 73/32 mm Hg) and normal aortic pressure (120/80 mm Hg) as a reference. Moving images were obtained using a Phantom MIRO M320S high-speed camera (Vision Research Inc, Wayne, NJ) at 600 frames per second and used to analyze valve area in closed position. ResultsUnder normal pulmonic conditions (28/11 mm Hg) the leakage orifice area was 0.020 ± 0.012 mm2 for the 21-mm valve and 0.054 ± 0.041 mm2 for the 25-mm valve (P = .03). Hydrodynamic characteristics of the valves differed between pulmonary and aortic testing condition. Valve closing volumes were significantly lower under pulmonary hypotension and normal pulmonary conditions than under normal aortic conditions (P < .05). ConclusionsUnder normal pulmonary pressure conditions, the hydrodynamic characteristics of Magna Ease valves are significantly different compared with aortic conditions. Further research is needed to determine whether these results are associated with prosthetic valve failure.

Tissue Valve Degeneration and Mechanical Valve Failure.

The management of valvular heart disease has been dramatically influenced by recent evolutions in biomedical technology and surgical practice. With an aging population worldwide and accompanying increase in the prevalence of surgical valve disease, an understanding of prosthetic valve behavior and durability is essential for proper patient selection and management. This report offers an overview of the definitions, mechanisms, management, and clinical impact of structural valve degeneration and failure. Published literature has employed variable definitions and outcome measures, complicating our understanding of bioprosthetic valve behavior and function. The pathophysiology leading to structural valve degeneration is multifactorial and involves mechanical, hematologic, and immunologic elements. Technological advancements have resulted in improved valve performance and new strategies to mitigate the risks of degeneration. While mechanical valves have demonstrated negligible durability concerns, the benefits of bioprosthetic valves must be weighed against their potential for structural degeneration and subsequent reintervention. Valve selection should involve patient-specific deliberation, and guidelines have been established to help guide risk reduction strategies. Surgical valve replacement remains the standard of care for prosthetic valve failure, but emerging technology offers the potential to slow the development of structural degeneration and transcatheter valve-in-valve options are being increasingly explored.

Abstract 17390: Pre-Operative Right Ventricular Outflow Tract and Pulmonary Artery Geometry Predicts Pulmonary Valve Replacement Outcomes in Patients With Tetralogy of Fallot

Introduction: Patients with Tetralogy of Fallot who had pulmonary valve replacement (PVR) are at risk for prosthetic valve failure that requires repeated valve replacement. Hypothesis: We hypothesize that the pre-operative geometry of the right ventricular outflow tract (RVOT) and the central pulmonary arteries is a predictor of future prosthetic valve dysfunction. Methods: In a retrospective study, using pre-operative cardiac MRI, we measured morphologic parameters including bifurcation angles, length, major and minor diameters, area, and circumference in various locations along the RVOT, pulmonary trunk (PT) and branch pulmonary arteries (BPAs) in 48 patients with Tetralogy of Fallot before they underwent PVR. Physiologic data was collected from their imaging reports (age, weight, height, body surface area (BSA), ventricular volumes and ejection fractions, valvular regurgitant fractions). All measurements were normalized by the patients’ BSA. Post-operative pulmonary valve function was assessed using Echocardiograms performed at an average of 5.5 years after the surgery. Valve dysfunction was defined as pulmonary regurgitation and/or pulmonary stenosis of at least moderate intensity. All geometric and physiologic parameters were compared between the group of patients who developed pulmonary valve dysfunction and those who did not, using a two-tailed Student t-test. Results: Patients who developed valve dysfunction had (1) greater RVOT circumference (p=0.038), (2) a more acute bifurcation angle between the PT and the Left Pulmonary Artery (p=0.016), and (3) smaller cross-sectional area at the distal BPAs (p=0.031, p=0.026). Conclusions: A dilated RVOT leading to flow vortices may increase the shear stress experienced by the valve, a sharp bifurcation angle disrupts flow patterns, adding dynamic load to the valve, and stenosis in the distal BPAs lead to increased resistance and an increased volume load to the valve - all promoting valve degeneration. Our findings are consistent with physiologic expectations and will be further explored using computational fluid dynamic simulations to elucidate how the parameters identified impact the hemodynamics around the pulmonary valve. A deeper understanding of the hemodynamic implications may ultimately reduce the incidence of valve degeneration by helping surgeons identify patients who are at high risk for valve dysfunction and guiding them to reconstruct the RVOT in specific configurations.

Mid-term outcomes of mechanical pulmonary valve replacement: a single-institutional experience of 396 patients

Previous small-sized studies have demonstrated the safety and efficacy of mechanical pulmonary valve replacement (mPVR) in patients with congenital heart disease; however, the predictors of major complications and reoperation remained unclear. In a retrospective study, we reported the mid-term outcomes of a large-scaled series of patients, 396 patients, with congenital heart diseases who underwent mPVR in a single institution. The patients' mean age at mPVR was 24.3 ± 9years (4-58years). Most patients (84.3%) underwent tetralogy of Fallot total correction. The median of follow-up was 36months (24-49months). Prosthetic valve malfunction caused by thrombosis or pannus formation developed in 12.1% of patients during follow-up period. Reoperation was performed in 7 cases with pannus formation and 6 cases with mechanical valve thrombosis. Freedom from reoperation at 1, 5, and 10years was 99%, 97%, and 96%, respectively. Neither early nor mid-term mortalities were detected. Cox regression models showed that male gender and smaller valve size increased the risk of prosthetic valve failure. The age at mPVR, interval between congenital heart defect repair and mPVR, and concomitant procedures predicted reoperation. In multivariate analysis, younger age and the interval between first operation and mPVR predicted reoperation either. The success rate of mPVR is excellent in mid-term follow-up. Younger age, longer interval between the repair of congenital defect and mPVR, and cooperation increased reoperation risk. However, strict adherence to life-long anticoagulation regimen and patient selection are of great importance for the implementation of mPVR.

The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer\xae) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial

BackgroundAnemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion.Methods/designIn this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days.DiscussionsFrom our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.Trial registrationClinicalTrials.gov, Identifier: NCT02862665. Registered on August 2016.

Surgical Aortic Valve Replacement Following Early Sapien-XT Valve Failure: A First

Early degeneration of prosthetic aortic valve in transcatheter aortic valve replacement (TAVR) is a rare complication. We report the case of a 75-year-old woman who presented with severe calcific stenosis of Edwards SAPIEN-XT valve implanted only 4 years previously. She is a Jehovah's Witness and has background of Sjogren's syndrome with secondary cryoglobulinaemic vasculitis. She was not a suitable candidate for valve-in-valve TAVR in view of early prosthetic valve failure by calcification. She underwent surgical explantation of the Sapiens XT valve and mechanical aortic valve replacement. To our knowledge, this is the first time that early TAVR valve degeneration and failure of an Edwards SAPIEN-XT valve was reported which required surgical replacement with a mechanical valve.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Allografts in aortic position: Insights from a 27-year, single-center prospective study

ObjectiveOver the past decades, the indication for allograft implantation in aortic position has evolved. The purpose of this study is to report long-term survival, allograft durability, and potential risk factors. MethodsBetween 1987 and 2010, 353 patients underwent aortic valve replacements via allograft (92 subcoronary, 261 root replacement; 98% aortic allografts). Patient characteristics, survival, valve durability, and valve-related events were analyzed. Patients also were followed with standardized echocardiography. A joint modeling approach was used to detect the effect of (echocardiographic) variables on mortality and reoperation hazard. ResultsMean age was 45 years (range, 1 month to 84 years); 71% were males. The etiology was endocarditis in 32% (active 22%), congenital 31%, degenerative 9%, aneurysm/dissection 12%, rheumatic 6%, and prosthetic valve failure 10%. Hospital mortality was 5.9% (n = 21). During follow-up (mean 12 years, range, 0-24; 99% complete), 113 patients died. Twenty-year cumulative survival was 41% (95% confidence interval, 32-50). Valve-related reoperations occurred in 117 patients: 100 structural valve deterioration, 9 nonstructural valve deterioration, and 8 endocarditis. Competing-risk analysis predicted that at 20 years 31% died, and 30% were alive without reoperation. Younger patient age was associated with increased reoperation. During follow-up left ventricular dilatation and severe aortic regurgitation were associated with mortality (P = .006 and .005, respectively), and grade 3 or greater aortic regurgitation during follow-up was associated with risk of reoperation (P = .001). ConclusionsAfter almost 3 decades of experience with allografts in aortic position, the indication for use has become selective, mainly because of progressive structural valve deterioration over time. In case of complex aortic root pathology and active endocarditis allografts may still be useful.