Mechanical aortic valve replacement in non-elderly adults: meta-analysis and microsimulation.

AIMS: To support decision-making regarding prosthetic valve selection in non-elderly adults, we aim to provide a detailed overview of outcome after contemporary mechanical aortic valve replacement (AVR). METHODS AND RESULTS: A systematic review was conducted for papers reporting clinical outcome after AVR with bileaflet mechanical valves with a mean patient age ≥18 and ≤55 years, published between 1 January 1995 and 31 December 2015. Through meta-analysis outcomes were pooled and entered into a microsimulation model to calculate (event-free) life expectancy and lifetime event risk. Twenty-nine publications, encompassing a total of 5728 patients with 32 515 patient-years of follow-up (pooled mean follow-up: 5.7 years), were included. Pooled mean age at surgery was 48.0 years. Pooled early mortality risk was 3.15% (95% confidence interval (CI):2.37-4.23), late mortality rate was 1.55%/year (95%CI:1.25-1.92); 38.7% of late deaths were valve-related. Pooled thromboembolism rate was 0.90%/year (95%CI:0.68-1.21), major bleeding 0.85%/year (95%CI:0.65-1.12), nonstructural valve dysfunction 0.39%/year (95%CI:0.21-0.76), endocarditis 0.41%/year (95%CI:0.29-0.57), valve thrombosis 0.14%/year (95%CI:0.08-0.25), structural valve deterioration 0.00%/year (zero events observed), and reintervention 0.51%/year (95%CI:0.37-0.71), mostly due to nonstructural valve dysfunction and endocarditis. For a 45-year-old, for example, this translated to an estimated life expectancy of 19 years (general population: 34 years) and lifetime risks of thromboembolism, bleeding and reintervention of 18%, 15%, and 10%, respectively. CONCLUSION: This study demonstrates that outcome after mechanical AVR in non-elderly adults is characterized by suboptimal survival and considerable lifetime risk of anticoagulation-related complications, but also reoperation. Non-elderly adult patients who are facing prosthetic valve selection are entitled to conveyance of evidence-based estimates of the risks and benefits of both mechanical and biological valve options in a shared decision-making process.

Long-term clinical outcome of the symmetry aortic connector system in off-pump coronary artery bypass grafting.

BACKGROUND: Several short-term and midterm follow-up studies of the Symmetry aortic connector system showed controversial results. The objective of the present study was assessing the long-term clinical outcome of patients operated with the Symmetry device and to compare the results with hand-sewn control patients. METHODS: A retrospective case-control study of 156 (46 cases, 110 controls) consecutive patients, that underwent off-pump coronary revascularization, between January 2001 and December 2004, was conducted. Study endpoints were all-cause mortality, coronary reintervention and postoperative stroke. RESULTS: There was no difference in survival between cases and controls (89.1 vs. 82.4%, p = 0.27) after 8 years of follow-up. No significant difference could be detected between cases and controls with respect to overall long-term coronary reintervention free survival (82.6 vs. 88.9%, p = 0.41) and freedom from coronary reintervention due to proximal vein graft failure (91.3 vs. 96.3%, p = 0.24). The use of Symmetry device could not be identified as independent risk-factor of coronary reintervention due to proximal vein graft failure (p = 0.25). Furthermore, postoperative stroke rates were comparable between cases and controls (0.0 vs. 0.9%, p = 1.00). CONCLUSION: This study suggests that the use of the Symmetry Bypass Connector was not associated with adverse outcome in terms of overall survival, long-term coronary reintervention free survival, freedom from reintervention due to proximal vein graft failure and postoperative stroke.

Autograft and pulmonary allograft performance in the second post-operative decade after the Ross procedure: insights from the Rotterdam Prospective Cohort Study.

AIMS: The objective of the present study was to report our ongoing prospective cohort of autograft recipients with up to 21 years of follow-up. METHODS AND RESULTS: All consecutive patients (n = 161), operated between 1988 and 2010, were analysed. Mixed-effects models were used to assess changes in echocardiographic measurements (n = 1023) over time in both the autograft and the pulmonary allograft. The mean patient age was 20.9 years (range 0.05-52.7)-66.5% were male. Early mortality was 2.5% (n = 4), and eight additional patients died during a mean follow-up of 11.6 ± 5.7 years (range 0-21.5). Patient survival was 90% [95% confidence interval (CI), 78-95] up to 18 years. During the follow-up, 57 patients required a re-intervention related to the Ross operation. Freedom from autograft reoperation and allograft re-intervention was 51% (95% CI 38-63) and 82% (95% CI 71-89) after 18 years, respectively. No major changes were observed over time in autograft gradient, and allograft gradient and regurgitation. An initial increase of sinotubular junction and aortic anulus diameter was observed in the first 5 years after surgery. The only factor associated with an increased autograft reoperation rate was pre-operative pure aortic regurgitation (AR) (hazard ratio 1.88; 95% CI 1.04-3.39; P= 0.037). CONCLUSION: We observed good late survival in patients undergoing autograft procedure without reinforcement techniques. However, over half of the autografts failed prior to the end of the second decade. The reoperation rate and the results of echocardiographic measurements over time underline the importance of careful monitoring especially in the second decade after the initial autograft operation and in particular in patients with pre-operative AR.

Survival comparison of the Ross procedure and mechanical valve replacement with optimal self-management anticoagulation therapy: propensity-matched cohort study.

BACKGROUND: It is suggested that in young adults the Ross procedure results in better late patient survival compared with mechanical prosthesis implantation. We performed a propensity score-matched study that assessed late survival in young adult patients after a Ross procedure versus that after mechanical aortic valve replacement with optimal self-management anticoagulation therapy. METHODS AND RESULTS: We selected 918 Ross patients and 406 mechanical valve patients 18 to 60 years of age without dissection, aneurysm, or mitral valve replacement who survived an elective procedure (1994 to 2008). With the use of propensity score matching, late survival was compared between the 2 groups. Two hundred fifty-three patients with a mechanical valve (mean follow-up, 6.3 years) could be propensity matched to a Ross patient (mean follow-up, 5.1 years). Mean age of the matched cohort was 47.3 years in the Ross procedure group and 48.0 years in the mechanical valve group (P=0.17); the ratio of male to female patients was 3.2 in the Ross procedure group and 2.7 in the mechanical valve group (P=0.46). Linearized all-cause mortality rate was 0.53% per patient-year in the Ross procedure group compared with 0.30% per patient-year in the mechanical valve group (matched hazard ratio, 1.86; 95% confidence interval, 0.58 to 5.91; P=0.32). Late survival was comparable to that of the general German population. CONCLUSIONS: In comparable patients, there is no late survival difference in the first postoperative decade between the Ross procedure and mechanical aortic valve implantation with optimal anticoagulation self-management. Survival in these selected young adult patients closely resembles that of the general population, possibly as a result of highly specialized anticoagulation self-management, better timing of surgery, and improved patient selection in recent years.

The risk of new onset heart failure associated with dopamine agonist use in Parkinson's disease.

The aim of present study was to investigate the risk of heart failure associated with dopamine agonist use in patients with Parkinson's disease. The data sources of this study were four different population-based, healthcare databases in United Kingdom, Italy and Netherlands. A case control study nested within a cohort of Parkinson's disease patients who were new users of either dopamine agonist or levodopa was conducted. Incident cases of heart failure were identified and validated, using Framingham criteria. Controls were matched to cases on age, gender and database. To estimate the risk of newly diagnosed heart failure with ergot and non-ergot derived dopamine agonists, as compared to levodopa, odds ratios and 95% confidence intervals were calculated through conditional logistic regression. In the cohort of 25,459 Parkinson's disease patients (11,151 new users of dopamine agonists, 14,308 new users of levodopa), 518 incident heart failure cases were identified during follow-up. Compared to levodopa, no increased risk of heart failure was found for ergot dopamine agonists (odds ratio: 1.03; 95% confidence interval: 0.69-1.55). Among non-ergot dopamine agonists, only pramipexole was associated with an increased risk of heart failure (odds ratio: 1.61; 95%confidence interval: 1.09-2.38), especially in the first three months of therapy (odds ratio: 3.06; 95% confidence interval: 1.74-5.39) and in patients aged 80 years and older (odds ratio: 3.30; 95% confidence interval: 1.62-7.13). The results of this study indicate that ergot dopamine agonist use in Parkinson's disease patients was not associated with an increased risk of newly diagnosed heart failure. Among non-ergot dopamine agonists, we observed a statistically significant association between pramipexole use and heart failure, especially during the first months of therapy and in very old patients.

Infective endocarditis in a tertiary referral hospital: long-term follow up.

BACKGROUND AND AIM OF THE STUDY: Infective endocarditis (IE) is associated with significant mortality and morbidity. The aim of the present study was to assess the long-term survival of patients with IE, and to assess objectively the mortality in these patients by comparing their survival with that of an age- and gender-matched sample of the general population. METHODS: A retrospective observational cohort study of adults with IE, as determined by the modified Duke criteria, was admitted to a tertiary referral center between January 1998 and December 2007. Cumulative survival was analyzed using the Kaplan-Meier method. The log-rank test was used to compare the different groups, and multivariate Cox proportional hazards regression analyses were carried out to identify predictors of long-term, all-cause mortality. RESULTS: A total of 191 consecutive patients with IE was evaluated (176 left-sided, 15 right-sided). Cardiac surgery was performed in 72% of cases, and the median follow up was 6.3 years. The cumulative long-term survival was 59% after 10 years of follow up, the main causes of death being congestive heart failure (28%) and different type of malignancy (17%). Age- and gender-matched survival in the general population was 98%, 92%, and 80% after follow up periods of one, five, and ten years, respectively. The main predictor of long-term mortality was cancer, while surgery had a positive effect on long-term survival. CONCLUSION: Despite diagnostic and therapeutic advances, IE is associated with a high long-term mortality. Compared to the general Dutch population, the survival of patients with IE was significantly lower. Even in the event of IE being cured, the survival of these patients may be diminished compared to that of the general population. Hence, a careful follow up of these patients is warranted.

Homograft durability after correction of pulmonary atresia and ventricular septal defect with or without systemic pulmonary collateral arteries.

Background: Pulmonary atresia and ventricular septal defect (PA-VSD), with or without systemic pulmonary collateral arteries (SPCAs), represents a complex anatomic and surgical spectrum of congenital heart disease. Currently, there is limited evidence on homograft durability after complete correction, which potentially could be affected by anatomic differences in pulmonary vasculature. Methods: This retrospective single-center study included all 69 consecutive PA-VSD patients (46 with SPCAs, 23 without SPCAs) operated on between 1978 and 2018. The primary interest was in homograft durability after complete repair. Longitudinal echocardiographic homograft function and right ventricular systolic pressure were analyzed with linear mixed-effects models. Results: The median duration of follow-up was 20 years. Of the 46 patients with SPCAs, 37 (80.4%) underwent biventricular correction at a median age of 2.7 years (interquartile range [IQR], 1.8-6.3 years). Two patients are currently awaiting unifocalization and correction. All 23 patients without SPCAs underwent successful complete correction at a median age of 1.6 years (IQR, 1.1-3.6 years). Freedom from any reintervention after 20 years was 15%. When a homograft was used during correction, freedom from homograft replacement after 20 years was comparable in the 2 groups (P = .925), at 32 ± 11% in the SPCA group and 32 ± 13% in the non-SPCA group. Indications for homograft replacement were isolated stenosis (n = 7; 46.7%), isolated regurgitation (n = 3; 20.0%), and mixed stenosis and regurgitation (n = 5; 33.3%) in the SPCA group and isolated stenosis (n = 8; 88.9%) and stenosis and regurgitation (n = 1; 11.1%) in the non-SPCA group. Peak homograft gradient was significantly (P = .0003) higher in patients without SPCA, with a comparable rate of progression in the 2 groups. However, the prevalence of severe pulmonary regurgitation (PR) was higher in patients with SPCAs, estimated at 35% at 10 years, compared with 15% in patients without SPCAs. Conclusions: Homografts used for right ventricular outflow tract reconstruction in patients with PA-VSD, either with or without SPCAs, have similar limited durability. Repeated reintervention is common, and careful follow-up with attention to severe PR is warranted.

Outcome after surgical repair of tetralogy of Fallot: A systematic review and meta-analysis.

INTRODUCTION: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease. Intracardiac correction was pioneered by Walton Lillehei in 1955 and has since then gone through major developments. The aim of this study was to provide a systematic literature review of published results on the long-term outcome of complete surgical correction of TOF. METHODS: MEDLINE, PubMed, Embase, Web of Science, Cochrane, and Google Scholar were systematically searched for literature published between January 2000 and July 2018. Pooled estimates with a random effects model after log-transformation were calculated for mortality and reintervention. Potential heterogeneity was assessed by subgroup analyses and meta-regression. RESULTS: A total of 143 papers of 137 distinct cohorts comprising 21,427 patients and total follow-up duration of 147,430 patient-years were included. Overall mean age at correction was 3.7 ± 5.6 years, but excluding papers exclusively focusing on correction in adults yielded a mean age of 0.5 ± 2.5 years at correction. Previous palliative shunts (107 studies), a transventricular approach (81 studies), and a transannular patch (124 studies) were used in 16% (range 0%-78%), 39% (range 0%-100%), and 49% (range 0%-100%) of the patients. respectively. In case a transannular patch was used, monocusp reconstruction was applied in 15% (range 0%-100%) (49 studies). The most common genetic abnormality was Down syndrome, with a pooled estimated prevalence of 4.6% (range 0%-12.3%). The pooled estimates of early and late mortality were 2.84% (95% confidence interval [CI], 2.34-3.45) and 0.42%/year (95% CI, 0.33-0.54), respectively. The pooled estimate of late cardiac mortality was 0.26%/year (95% CI, 0.21-0.34). Valve-related mortality and non-valve-related mortality had pooled estimates of 0.20%/year (95% CI, 0.15-0.26) and 0.17%/year (95% CI, 0.12-0.22), respectively. The pooled estimate of reintervention was 2.26%/year (95% CI, 1.86-2.75). CONCLUSIONS: TOF can be surgically corrected at a young age with low perioperative and long-term mortality. Life-long intensive follow-up and substantial reintervention rates characterize the clinical course.

Timing of pulmonary valve replacement in patients with corrected Fallot to prevent QRS prolongation.

OBJECTIVES: Timing of pulmonary valve replacement (PVR) remains one of the most heavily debated topics in congenital cardiac surgery. We aimed to analyse the temporal evolution of QRS duration before and after PVR. METHODS: We included 158 consecutive patients who underwent PVR after previous correction with transannular patch. All 3549 available serial standard 12-lead surface QRS measurements of 158 (100%) patients were analysed with linear mixed-effect modelling. RESULTS: PVR was performed at a mean age of 28.0 ± 10.7 years, 23.4 ± 8.4 years after correction. Hospital survival was 98.1%. A longer time interval between ToF correction and PVR (P < 0.001), and an older age at correction (P = 0.015) were predictive of progressive QRS prolongation after PVR. Women on average had a shorter QRS duration (P = 0.005) after PVR. The model predicted that in patients corrected early (model age 0.5 years), PVR within 17 years after correction leads to narrowing or stabilization of QRS width. PVR beyond 17 years was associated with prolongation of QRS duration. In a patient corrected late (model age 5 years), PVR has to be performed within 15 years after correction to prevent prolongation. Finally, a longer time period between correction and PVR was associated with an increased hazard of cardiac death (hazard ratio 1.097, 95% confidence interval 1.002-1.200). CONCLUSIONS: Prolongation of QRS duration after PVR was associated with a longer time between correction and PVR, older age at correction and male sex. Prevention of progressive QRS prolongation by earlier PVR can potentially reduce the hazard of adverse events after PVR.

Influence of pregnancy on long-term durability of allografts in right ventricular outflow tract.

BACKGROUND: There is very limited published evidence about the influence of pregnancy on allograft durability in right ventricular outflow tract position. We present the first study using mixed and joint modeling. METHODS: This retrospective study compared clinical and valve related outcomes of all consecutive female hospital survivors in their fertile life phase (18-50 years) based on pregnancy. Serial echocardiographic measurements of pulmonary gradient and regurgitation were analyzed for their association with valve replacement using joint models for longitudinal and time-to-event data. Occurrence of first pregnancy was included as a time-dependent intermediate event in both the longitudinal and survival analyses of the joint model to assess its impact on the hemodynamic and clinical outcome. RESULTS: In total, 196 consecutive women in their fertile life-phase with an allograft were included. Complete information of 176 (90%) allografts in 165 women was available, including 1395 echocardiograms. Of these women, 51 (30.9%) women had 84 completed pregnancies at an average age of 29.1 ± 3.9 (SD) years; 8.1 ± 6.1 years since allograft implantation. Tetralogy of Fallot was the most common diagnosis in both groups. After a mean follow-up of 15.2 years (range 0.1-30), 7 (13.7%) parous women underwent valve replacement versus 20 (17.5%) nulliparous women. During this follow-up, the mean allograft gradient in parous (24.2 mm Hg) and nulliparous (21.0 mm Hg) women was comparable (P = .225). A 1-mm Hg increase in pulmonary gradient increased the instantaneous risk of pulmonary valve replacement (PVR) by a ratio of 1.051 (P < .001), regardless of pregnancy. Similarly, development of moderate or severe regurgitation increased the risk of PVR (P = .038), regardless of pregnancy. Pregnancy was not associated with a change in the allograft gradient (P = .258), regurgitation grade (P = .774), or hazard of PVR (P = .796) during follow-up. CONCLUSIONS: Pregnancy is not associated with impaired allograft durability in women with good cardiac health.

Biatrial Versus Bicaval Orthotopic Heart Transplantation: A Systematic Review and Meta-Analysis.

BACKGROUND: Orthotopic heart transplantation (OHT) is the gold standard treatment in end-stage heart disease. Controversy remains whether bicaval OHT is superior to biatrial OHT in both early and late outcomes. This study aimed to provide an overview of the early and late outcomes in patients who underwent a bicaval or biatrial OHT. METHODS: A systematic literature search was performed for articles published before December 2017. Studies comparing adult patients undergoing biatrial OHT and bicaval OHT were included. Early outcomes were pooled in odds ratios and late outcomes were pooled in rate ratios. Late survival was visualized by a pooled Kaplan-Meier curve. RESULTS: A total of 36 publications were included in the meta-analysis, counting 3555 patients undergoing biatrial OHT and 3208 patients undergoing bicaval OHT. Early outcomes in mortality, tricuspid regurgitation, mitral regurgitation, and permanent pacemaker implantation differed significantly in favor of the bicaval OHT patients. Long-term survival was significantly better in patients undergoing bicaval vs biatrial OHT (hazard ratio, 1.32; 95% confidence interval, 1.1-1.6; P = .008). Also, late tricuspid regurgitation was less frequently seen in the bicaval OHT patients (rate ratio, 2.14; 95% CI, 1.17-3.94; P = .014). CONCLUSIONS: This systematic review with meta-analysis shows that bicaval OHT results in more favorable early and late outcomes for patients undergoing a bicaval OHT compared with a biatrial OHT. Therefore, bicaval OHT should be considered as preferable technique for OHT.

Long-term clinical outcome and echocardiographic function of homografts in the right ventricular outflow tract†.

OBJECTIVES: Although homografts are often the preferred valve conduits for right ventricular outflow tract (RVOT) reconstruction, data on long-term homograft-related outcomes, durability and impact on quality of life (QoL) are scarce. The aim of this study was therefore to describe the long-term homograft function, clinical outcomes and QoL after RVOT reconstruction. METHODS: We performed a single-centre retrospective analysis of all consecutive patients who underwent RVOT reconstruction with a homograft. Multiple subsequent allografts in the same patients were regarded as separate subjects. Valve-related events were analysed by Kaplan-Meier and Life Table methods. Serial echocardiographic measurements were analysed with mixed effects models. In addition, QoL was repeatedly assessed and compared with a matched general population. RESULTS: In total, 701 consecutive homografts were implanted in 604 patients [59.6% males, mean age at operation 19.5 ± 15.2 (standard deviation)]. Hospital mortality was 3.3%. After 25 years follow-up, survival and freedom from valve replacement were 84 ± 4% and 56 ± 6%, respectively. Freedom from valve replacement after 15 years for patients under 1 year of age was 28 ± 14% years, for those between 1 and 18 years, 59 ± 8%, and for those older than 18 years, 82 ± 5%. The peak gradient increased predominantly in the first postoperative decade in infants and paediatric patients from 19 to 54 mmHg. In adults, the average gradient increased from 9 to 31 mmHg after 14 years. Compared to a gender- and age-matched Dutch population, patients reported lower vitality and general health but less bodily pain. Patients, in whom QoL was repeatedly assessed, reported lower scores on physical functioning and vitality after a 5-year follow-up period. However, we found no differences in any of the subscales in patients who underwent valve replacement during the 5-year interval. CONCLUSIONS: Homografts are a durable valve alternative for RVOT reconstruction; in particular, adults show extensive freedom from valve replacement and report QoL comparable with healthy subjects. An online interactive application form created by our institution can be used to assess patient outcome after RVOT reconstruction with a homograft for different patient profiles.

Male-female differences in aortic valve and combined aortic valve/coronary surgery: a national cohort study in the Netherlands.

Objective: The outcome of female patients after adult cardiac surgery has been reported to be less favourable compared with the outcome of male patients. This study compares men with women with respect to patient and procedural characteristics and early mortality in a contemporary national cohort of patients who underwent aortic valve (AV) and combined aortic valve/coronary (CABG/AV) surgery. Methods: All patients who underwent AV (n=8717, 56% male) or a combined CABG/AV surgery (n=5867, 67% male) in the Netherlands between January 2007 and December 2011 were included. Results: In both groups, women were generally older than men (p<0.001) and presented with higher logistic EuroSCORES. In isolated AV surgery, men and women had comparable in-hospital mortality (OR 1.20, 95% CI 0.90 to 1.61; p=0.220). In concomitant CABG/AV surgery, in-hospital mortality was higher in women compared with men (OR 2.00, 95% CI 1.44 to 2.79; p<0.001). The area under the curve for logistic EuroSCORE 1 was systematically higher for men versus women in isolated AV surgery 0.82 (95% CI 0.78 to 0.86) vs 0.75 (95% CI 0.69 to 0.80) and in concomitant CABG/AV surgery 0.78 (95% CI 0.73 to 0.82) vs 0.69 (95% CI 0.63 to 0.74). Finally, (the weight of) risk factors associated with in-hospital mortality differed between men and women. Conclusions: There are substantial male-female differences in patient presentation and procedural aspects in isolated AV and concomitant CABG/AV surgery in the Netherlands. Further studies are necessary to explore the mechanisms underlying the observed differences. In addition, the observation that standard risk scores perform worse in women warrants exploration of male-female specific risk models for patients undergoing cardiac surgery.Brief title.

The Ross Procedure: A Systematic Review, Meta-Analysis, and Microsimulation.

BACKGROUND: To support decision-making in aortic valve replacement in children and adults, we provide a comprehensive overview of outcome after the Ross procedure. METHODS AND RESULTS: A systematic search was conducted for publications reporting clinical outcome after the Ross procedure, published between January 1, 2000, and November 22, 2017. Reported event rates and time-to-event data were pooled and entered into a microsimulation model to calculate life expectancy and lifetime event risk. Ninety-nine publications were included (13 129 patients; total follow-up: 93 408 patient-years, pooled mean follow-up: 7.9±5.3 years). Pooled mean age at surgery was 9.4±5.5 years for children and 41.9±11.4 for adults. For children and adults, respectively, pooled early mortality risk was 4.19% (95% CI, 3.21-5.46) and 2.01% (95% CI, 1.44-2.82), late mortality rate was 0.54%/y (95% CI, 0.42-0.70) and 0.59%/y (95% CI, 0.46-0.76), autograft reintervention 1.28%/y (95% CI, 0.99-1.66) and 0.83%/y (95% CI, 0.68-1.01), and right ventricular outflow tract reintervention 1.97%/y (95% CI, 1.64-2.36) and 0.47%/y (95% CI, 0.37-0.59). Pooled thromboembolism and bleeding rates were low and comparable to the general population. Lifetime risks of autograft and right ventricular outflow tract reintervention were, respectively, 94% and 100% for children and 49% and 19% for a 45-year-old. Estimated life expectancy after surgery was 59 years for children (general population: 64 years) and 30 years for a 45 years old (general population: 31 years). CONCLUSIONS: Through excellent survival and avoidance of the burden of anticoagulation, the Ross procedure provides a unique opportunity for patients whose preferences do not align with the outcome provided by mechanical valve replacement and for growing children who also benefit from autograft diameter increase along with somatic growth. On the downside, almost all pediatric and many adult Ross patients will require a reintervention in their lifetime.

Decellularized Versus Standard Pulmonary Allografts in the Ross Procedure: Propensity-Matched Analysis.

BACKGROUND: It is hypothesized that decellularization of allografts used for right ventricular outflow tract reconstruction may result in decreased valve deterioration. This study compared the durability of fresh decellularized pulmonary allografts with standard cryopreserved pulmonary allografts in patients undergoing the Ross procedure. METHODS: The Ross procedure was performed in 144 patients with decellularized allografts (DA) from 2005 to 2014 and in 619 with standard cryopreserved allografts (SCA) from 1990 to 2014. Propensity score matching was used to compare early and midterm clinical outcome and echocardiographic allograft function over time between the two groups. RESULTS: We matched 94 DA patients (79.3% male; median age, 34.0 years; mean follow-up, 2.4 ± 1.9 years) to 94 SCA patients (78.3% male; median age, 35.0 years; mean follow-up, 9.4 ± 4.2 years). There were no significant differences in baseline characteristics after matching. The matched DA vs SCA groups, respectively, were comparable in actuarial 5-year freedom from allograft dysfunction (85.6% [95% confidence interval {CI}, 53.9% to 96.2%] vs 93.3% [95% CI, 85.7% to 96.9%], p = 0.892), freedom from allograft reintervention (98.8% [95% CI, 91.7% to 99.8%] vs 95.5% [95% CI, 88.5% to 98.3%], p = 0.383), survival (95.3% [95% CI, 87.8% to 98.2%] vs 97.7% [95% CI, 91.3% to 99.4%], p = 0.323), and event-free survival (83.5% [95% CI, 70.6% to 91.1%] vs 84.5% [95% CI, 75.2% to 90.5%], p = 0.515). Longitudinal echocardiographic analyses showed a similarly modest increase in allograft gradient and regurgitation grades over time in both groups, although direct statistical comparison was not possible. CONCLUSIONS: Up to 5 years of follow-up, DA and SCA used for right ventricular outflow tract reconstruction in the Ross procedure are associated with comparably excellent clinical and hemodynamic outcome. Longer follow-up and dedicated echocardiographic studies will shed light on the long-term performance of DAs.

Outcomes of Pregnancy After Right Ventricular Outflow Tract Reconstruction With an Allograft Conduit.

BACKGROUND: There is no published evidence on pregnancy after right ventricular outflow tract (RVOT) reconstruction with an allograft. OBJECTIVES: The aim of this study was to describe pregnancy outcomes in women with allografts in the RVOT position. METHODS: A retrospective cohort study of consecutive female patients who received allografts in the RVOT position was conducted. All patients between 18 and 50 years of age were screened for cardiac, obstetric, and fetal outcomes of completed (≥20 weeks' gestation) pregnancies. RESULTS: In total, 196 women met the inclusion criteria, of whom 56 had 89 completed pregnancies. Information could be retrieved in 84 cases (94.4%). Mean maternal age was 29.6 ± 4.3 years, with 80 patients (95.2%) in New York Heart Association functional class I or II. The most common diagnosis was tetralogy of Fallot. All women survived pregnancy. There were 2 cases (2.4%) of heart failure (arrhythmic and diastolic dysfunction), 1 case (1.2%) of infection (chorioamnionitis), and 3 cases (3.6%) of pre-eclampsia. No other cardiac or obstetric events were reported. All children were born alive at a median gestational age of 38.4 weeks (interquartile range: 36.9 to 39.6 weeks), with a median birthweight of 2,930 g (interquartile range: 2,535 to 3,385 g). Seventeen (20.2%) were small for gestational age, and 20 (23.8%) were premature. Neonatal death was reported in 2 children (2.5%). Preconception pulmonary regurgitation was associated with an increased probability of pre-term labor (odds ratio: 2.610; 95% confidence interval: 1.318 to 5.172). Compared with the general Dutch population, pre-term delivery (25.0% vs. 7.4%, p < 0.001) and children small for gestational age (20.2% vs. 10.0%, p = 0.002) were more common. CONCLUSIONS: Women in good cardiac health after RVOT reconstruction with allografts can safely experience pregnancy and labor. The higher incidence of pre-term delivery and children small for gestational age warrants special attention.

Outcome after aortic valve replacement in children: A systematic review and meta-analysis.

OBJECTIVE: Despite an increasing interest in pediatric aortic valve repair, aortic valve replacement in children may be unavoidable. The evidence on outcome after pediatric aortic valve replacement is limited and usually reported in small case series. This systematic review and meta-analysis aims to provide an overview of reported outcome of pediatric patients after aortic valve replacement. METHODS: A systematic literature search for publications reporting outcome after pediatric aortic valve replacement published between January 1990 and May 2015 was conducted. Studies written in English with a study size of more than 30 patients were included. RESULTS: Thirty-four publications reporting on 42 cohorts were included in this review: 26 concerning the Ross procedure (n = 2409), 13 concerning mechanical prosthesis aortic valve replacement (n = 696), and 3 concerning homograft aortic valve replacement (n = 224). There were no studies on bioprostheses that met our inclusion criteria. The pooled mean patient age was 9.4 years, 12.8 years, and 8.9 years for Ross, mechanical prosthesis, and homograft recipients, respectively. Pooled mean follow-up was 6.6 years. The Ross procedure was associated with lower early (4.20%; 95% confidence interval [CI], 3.37-5.22 vs 7.34%; 95% CI, 5.21-10.34 vs 12.82%; 95% CI, 8.91-18.46) and late mortality (0.64%/y; 95% CI, 0.49-0.84 vs 1.23%/y; 95% CI, 0.85-1.79 vs 1.59%/y; 95% CI, 1.03-2.46) compared with mechanical prosthesis aortic valve replacement and homograft aortic valve replacement, respectively. No significantly different aortic valve reoperation rates were observed between the Ross procedure and mechanical prosthesis aortic valve replacement (1.60%/y; 95% CI, 1.27-2.02 vs 1.07%/y; 95% CI, 0.68-1.68, respectively), whereas homograft aortic valve replacement was associated with significantly higher aortic valve reoperation rates (5.44%/y; 95% CI, 4.24-6.98). The Ross procedure-associated right ventricular outflow tract reoperation rate was 1.91% per year (95% CI, 1.50-2.44). CONCLUSIONS: This systematic review illustrates that all currently available aortic valve substitutes are associated with suboptimal results in children, reflecting the urgent need for reliable and durable repair techniques and innovative replacement solutions for this challenging group of patients.

The Ross procedure using autologous support of the pulmonary autograft: techniques and late results.

OBJECTIVES: It is hypothesized that by performing radical aortic root manipulation and then autologous support for the pulmonary autograft in the Ross procedure, this will maintain aortic root size and should, in turn, lead to the demonstrated low incidence of late aortic regurgitation and need for reoperation on the aortic root and valve. METHODS: Aortic root size was measured echocardiographically both preoperatively and then at second yearly intervals in 322 consecutive patients who underwent a Ross operation between October 1992 and June 2013 with autologous support of the pulmonary autograft root using the patient's own aorta. This technique, a variant of the inclusion cylinder method, has been developed with the aim of minimizing prosthetic materials in the aortic root. RESULTS: Measures to reduce aortic root size included annulus reduction in 201 patients (62.4%) and reduction in aortic sinus or sinotubular junction in 159 patients (49.4%). Maximal aortic root diameter postoperatively at 5, 10, and 15 years was 34.0, 34.6, and 34.7 mm, respectively. Eleven reoperations were required during the study period for progressive aortic regurgitation (none for aortic root enlargement), with freedom from reoperation being 96% at both 15 years and 18 years. Preoperative pure aortic regurgitation, aortic annulus, and sinotubular junction enlargement were risk factors for reoperation. CONCLUSIONS: This inclusion method of pulmonary autograft implantation leads to minimal increases in aortic root size over time, with no reoperations for aortic root dilatation and a low requirement for aortic valve reoperation. The Ross procedure deserves to remain on the surgical menu for aortic valve replacement.