Valve-related Mortality Research Articles

Comparison of Long-Term Performance of Porcine versus Pericardial Bioprostheses.

The long-term comparative results between porcine and pericardial bioprostheses for surgical aortic valve replacement (SAVR) is debated. Scarce information exists concerning direct comparative evaluation among contemporary devices. We compared late and very late results in a single center series (N=3,983 cases). From a prospectively collected database we included 3,983 recipients of two current porcine bioprostheses (porcine group) or one current pericardial bioprosthesis (pericardial group). We evaluated the long-term freedom from SVD (Structural Valve Deterioration) with both Kaplan-Meier and competing risks methods (primary endpoint). We distinguished between SVD and patient-prosthesis mismatch (PPM). Secondary endpoints were late survival, freedom from valve-related mortality, freedom from reoperation for SVD, freedom from NSVD (Nonstructural Valve Dysfunction) and freedom from endocarditis. Median follow-up was 10.4 years (99.7% complete, 32,219 patient/years). Overall survival was significantly lower in the porcine group (p=0.002), related to baseline intergroup differences. At ten years, Kaplan-Meier freedom from SVD was significantly better in the porcine group (98.0%±0.3 vs. 96.3%±0.8) (p=0.003). Competing risks freedom from SVD at ten years was 98.6%±0.2 and 97.2%±0.6 (porcine and pericardial group, respectively) (p=0.001). The porcine group displayed higher rate of PPM. Despite augmented risk of PPM compared to pericardial valves, in this series porcine bioprostheses seem to perform better concerning protection from late (>10 years) SVD. On the other hand, PPM may negatively impact the survival beyond 10 years follow-up. These elements need to be considered for valve choice and surgical strategy in SAVR candidates according to their life expectancy and clinical context.

Prosthetic Valve Fate in Patients With Continuous-Flow Left Ventricular Assist Devices.

Prosthetic valve-related morbidity and mortality in patients with left ventricular assist devices (LVADs) remain unclear. We retrospectively reviewed patients who received a HeartMate II or 3 LVAD at our center between April 2004 and December 2022. Patients with a valve prosthesis in any position were included. Of the 726 LVAD recipients, 74 (10.2%) underwent valve replacement before (n = 37, 50.0%), concomitantly with (n = 32, 43.2%), or after (n = 6, 8.1%) LVAD insertion. Prosthetic valves were implanted in the aortic (n = 32), mitral (n = 23), and tricuspid (n = 26) positions. Mechanical valves were present in eight (three aortic, five mitral) patients. At a median follow-up of 1.97 years post-VAD (interquartile range [IQR]: 0.56-4.58 years), there was one valve-related death due to severe aortic bioprosthetic insufficiency. Five of 28 (17.9%) patients with an aortic bioprosthesis had evidence of dysfunction on follow-up echocardiography. Median time to first sign of aortic bioprosthetic valve dysfunction was 1 (IQR: 0.6-5.1) year from time of LVAD with the prosthesis in place and 10.8 (IQR: 9.5-12.6) years from date of initial valve insertion. Prosthetic valve-related mortality or reinterventions are uncommon in patients with LVADs; however, bioprosthetic aortic valve dysfunction can develop less than 1 year after LVAD implantation.

Long-Term Performance of Mechanical and Biological Prostheses in Young Rheumatics aged below 45 years undergoing Combined Mitral and Aortic Valve Replacements: A Propensity-Matched Study

Background and Aim: We compared 23-year composites of valve-related reoperation, morbidity, and mortality following combined mitral and aortic mechanical and bioprostheses in young rheumatics aged <45years. Methods: Retrospective comparative analysis of valve-related reoperations and survival data were performed from 498 consecutive propensity matched patients undergoing either bioprosthetic MVR (Group I, n=249) or mechanical MVR (Group II, n=249) between 1998 and 2022. Results: The median age was 33 (IQR: 27-40) and 33 (IQR: 28-39) years for Group I and II respectively. The median follow-up was 134 months (IQR: 99.5-178.5) with 5281.8 patient-years data in both biological and mechanical arm. Bioprosthetic arm exhibited lesser cumulative mortality (3.6% vs 4.8%, SMD= -0.18, p=0.01). Hazard regression for mortality included (HR, 95% CI) included preoperative CHF on inotropes and ventilator 9.84 (4.54, 18.64), p<0.001, renal failure requiring peritoneal/hemodialysis 11.64, (6.57, 20.64), p<0.001, atrial fibrillation 3.83 (1.63, 8.98), p<0.002, reoperation for thrombosed mechanical and degenerated bioprostheses 5.38, (3.09, 9.35), p<0.001, previous operation 3.53, (1.93, 6.45), p<0.001, poor left ventricular function 4.25, (2.29, 7.88), p<0.001, prolonged aortic clamp time 3.84, (2.19, 6.78), p<0.001, and prolonged CPB time 2.69, (1.84, 8.68), p<0.001. Propensity score matching did not exhibit any difference in reoperation between two groups (Group I vs Group II: 13.6% vs 17.6%, SMD= -0.110, p=0.21). At a median follow-up of 134 months (IQR: 99.5-178.5) months, actuarial survival was 92.3%±0.02% (group I vs 96.6%+0.01%) and there was no difference between the groups (p=0.90). Conclusions: Bioprostheses are an acceptable alternative to mechanical prostheses in young rheumatics aged <45 years undergoing mitral and aortic valve replacements unwilling for mechanical valve, redo surgeries, life-long anticoagulation, and those desirous of pregnancy.

Ross procedure or mechanical aortic valve, which is the best lifetime option for an 18-year-old? A decision analysis

Objective(s)Identifying the optimal solution for young adults requiring aortic valve replacement (AVR) is challenging, given the variety of options and their lifetime complication risks, impacts on quality of life, and costs. Decision analytic techniques make comparisons incorporating these measures. We evaluated lifetime valve-related outcomes of mechanical aortic valve replacement (mAVR) versus the Ross procedure (Ross) using decision tree microsimulations modeling. MethodsTransition probabilities, utilities, and costs derived from published reports were entered into a Markov model decision tree to explore progression between health states for hypothetical 18-year-old patients. In total, 20,000 Monte Carlo microsimulations were performed to model mortality, quality-adjusted-life-years (QALYs), and health care costs. The incremental cost-effectiveness ratio (ICER) was calculated. Sensitivity analyses was performed to identify transition probabilities at which the preferred strategy switched from baseline. ResultsFrom modeling, average 20-year mortality was 16.3% and 23.2% for Ross and mAVR, respectively. Average 20-year freedom from stroke and major bleeding was 98.6% and 94.6% for Ross, and 90.0% and 82.2% for mAVR, respectively. Average individual lifetime (60 postoperative years) utility (28.3 vs 23.5 QALYs) and cost ($54,233 vs $507,240) favored Ross over mAVR. The average ICER demonstrated that each QALY would cost $95,345 more for mAVR. Sensitivity analysis revealed late annual probabilities of autograft/left ventricular outflow tract disease and homograft/right ventricular outflow tract disease after Ross, and late death after mAVR, to be important ICER determinants. ConclusionsOur modeling suggests that Ross is preferred to mAVR, with superior freedom from valve-related morbidity and mortality, and improved cost-utility for young adults requiring aortic valve surgery.

Major Adverse Cardiac and Cerebrovascular Events in Patients Undergoing Simultaneous Heart Surgery and Carotid Endarterectomy.

Patients with simultaneous relevant internal carotid artery stenosis and coronary artery heart or valve disease represent a high-risk collective with respect to cerebral or cardiovascular severe events when undergoing surgery. There exist several concepts regarding the timing and modality of carotid revascularization, which are controversially discussed in patients with heart disease. More data regarding outcome predictors and measures are needed to gain a better understanding of the best treatment option of the discussed patient collective. This single-center study retrospectively analyzed n = 111 patients undergoing heart surgery with coronary artery bypass grafting or heart-valve surgery and concomitant carotid surgery due to significant internal carotid artery stenosis. In order to do so, patients were divided into two groups with respect to postoperative major adverse cardiac and cerebrovascular events (MACCE) with thirty-day all-cause mortality, valve related mortality, myocardial infarction, stroke and transitory ischemic attack. Preoperative patient's characteristic in the no-MACCE and MACCE group were mainly balanced, other than higher rates of chronic obstructive pulmonary disease, chronic kidney disease, instable angina pectoris and prior transitory ischemic attack in the MACCE cohort. The analysis of intraoperative characteristics revealed a higher number of intra-aortic balloon pump implantation, which is in line for a higher number of postoperative supports. Besides MACCE, patients suffered significantly more often from postoperative bleeding events and re-thoracotomy, cardiopulmonary reanimation, new onset postoperative dialysis and prolonged intensive care unit stay related complications. Within the reported patient population suffering from MACCE after a simultaneous carotid endarterectomy and heart surgery, a preoperative history of transitory ischemic attack and kidney disease might account for worse outcomes, as severe events were not only neurologically driven but also associated with postoperative cardiovascular complications following heart surgical procedures.

Two innovative aortic bioprostheses evaluated in the real-world setting. First results from a two-center study.

The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability. In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance. From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm2 vs. 1.4 cm2 (P=0.4) and 0.8 vs. 0.7 cm2/m2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m2 for the Inspiris and AVALUS groups, respectively, (R2-adjusted =0.14; P<0.01). INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.

Long-term evaluation of TTK Chitra™ heart valve prosthesis — a retrospective-prospective cohort study

PurposeThe TTK Chitra™ heart valve has more than 1,40,000 implantations so far, but no long-term data has been published. This study aims to provide long-term results of the valve.MethodologyA cohort of 476 patients with implantations from January 2006 to December 2018 were followed up prospectively consisting of 104 aortic valve replacement (AVR), 87 double valve replacement (DVR), and 285 mitral valve replacement (MVR) patients. Total follow-up was 4079 patient-years (py) (AVR = 983, MVR = 2392, DVR = 704), being 96% complete.ResultsThe results showed that actuarial survival at 15 years was 82.3% for AVR, 60.7% for MVR, and 52.2% for DVR. Freedom from all valve-related mortality and morbidity at 15 years was 73.8%, 64.8%, and 61.9% for AVR, MVR, and DVR, respectively. There was one instance of structural failure of valve disc leading to severe valvar regurgitation. Valve thrombosis incidence was 1 in AVR (0.1%/py), 6 in MVR (0.25%/py), and 1 in DVR (0.14%/py). Thrombo-embolic episodes occurred in 50 patients (AVR = 7 patients at 0.7%/py; MVR = 36 patients at 1.5%/py; DVR = 7 patients at 0.99%/py) and major hemorrhage (bleeding) in 24 patients (AVR = 0.61%/py; MVR = 0.5%/py; and DVR = 0.85%/py). The linearized rates of adverse events in this study were found to be lower than earlier published results.ConclusionThe results highlight the continued safety and performance of the TTK Chitra™ heart valve (TTKCHV) in the long term at 15 years.

Mitral valve surgery after failed MitraClip-Operation for the inoperable?

Percutaneous edge-to-edge mitral valve repair technique (MitraClip) is a widely used treatment for mitral regurgitation (MR) in patients assessed with high surgical risk or inoperability. Only limited experiences with this highest-risk patient population exist. Procedural failure for MitraClip or recurrent MR is a strong predictor of 1-year mortality. Open mitral valve surgery constitutes the last bailout for patients within this cohort. This retrospective single-center cohort study analyzed 17 mitral valve surgery patients after failed MitraClip. We, therefore, analyzed a high-risk patient population (EuroSCOREII = 10 ± 2.0) with persistent mitral valve regurgitation, which was mainly caused by detachment or dislocation of the MitraClip. Symptomatic patients with failed MitraClip need a convenient operation (mean time to mitral valve surgery = 23 ± 44 days). The patient's collective showed many complex reoperations with the need for concomitant surgery. Considering the high-risk patient population, we showed an average 30-day all-cause mortality (18%, n = 3) accompanied by typical postoperative complications related to prolonged mechanical ventilation (44 ± 48 h) and ICU stay (11 ± 11 days), reflecting high-risk patients. Further, excellent valve-related outcomes were shown regarding adverse cardiac events (valve-related mortality 6%, n = 1) and postoperative echocardiographic results (moderate or severe paravalvular leak 6%, n = 1). Failure of MitraClip represents a challenging situation limited by high-risk profiles of patients and limits the possibility of surgical valve repair, shown by a high rate of mitral valve replacement (94%, n = 16). Secondary surgery was associated with moderate 30-day and postdischarge outcomes. Therefore, a careful evaluation of patients undergoing MitraClip is of paramount importance.

Pulmonary Valve Designs and Innovation

Reconstruction of the right ventricular outflow tract and replacement of pulmonary valves in pediatric patients have been ongoing challenges, especially given the lack of a durable prosthesis that is adjustable to the patient’s growth needs and is free of infection risks. Preliminary Results With a Novel Expanded Polytetrafluoroethylene-based Pulmonary Valved ConduitThe Annals of Thoracic SurgeryVol. 114Issue 6PreviewA novel polymeric pulmonary valved conduit, resistant to calcification and structural valve deterioration, may provide a more durable therapy option for the pediatric population by preventing loss of right ventricular function and increasing freedom from valve-related reintervention and mortality. Full-Text PDF

Preliminary Results With a Novel Expanded Polytetrafluoroethylene-based Pulmonary Valved Conduit

BackgroundA novel polymeric pulmonary valved conduit, resistant to calcification and structural valve deterioration, may provide a more durable therapy option for the pediatric population by preventing loss of right ventricular function and increasing freedom from valve-related reintervention and mortality. MethodsThis was a prospective, multicenter, single-arm study evaluating safety and performance of an investigational novel expanded polytetrafluoroethylene–based valve. Patients met study inclusion/exclusion criteria, had a signed informed consent, had pre- and postoperative evaluation via transthoracic echocardiography, and 6-month cardiac magnetic resonance imaging. ResultsSeventeen patients were enrolled from 3 sites. Median age was 12 years (range, 6-17 years) with 52.9% male. Body surface area ranged from 0.82 to 1.57 m2. There has been no mortality and 100% freedom from device related reinterventions. Baseline compared with 6-month cardiac magnetic resonance imaging (in 11 of 16 patients with available data) suggests favorable right ventricular remodeling (right ventricular end-diastolic volume, 123 ± 37 to 94 ± 25 mL/m2) with no significant change in ejection fraction. Through current follow-up, no patient has a right ventricular outflow tract gradient >20 mm Hg (mean, 11.2 ± 4.3 mm Hg). No evidence of worsening valvular insufficiency was observed throughout postoperative serial transthoracic echocardiogram evaluations. No pulmonary regurgitation above baseline (≤ mild) was observed. No patient developed endocarditis. No thrombus or calcification was identified. ConclusionsThis preliminary evaluation of a novel expanded polytetrafluoroethylene–based valved conduit suggests promising valve function with no thromboembolic or infectious complications, no valve related reinterventions, no valve-related adverse events or unexpected findings, improved right ventricular volumes, and encouraging hemodynamic performance through current follow-up.

Considerations for prostheses choice in multiple valve surgery

ObjectivesThe prosthesis type for multiple valve surgery (replacement of two or more diseased native or prosthetic valves, replacement of two diseased valves with repair/reconstruction of a third, or replacement of a single diseased valve with repair/reconstruction of a second valve) remains inadequately evaluated. The clinical performance of multiple valve surgery with bioprostheses (BP) and mechanical prostheses (MP) was assessed to compare patient survival and composites of valve-related complications.MethodsBetween 1975 and 2000, 1245 patients had multiple valve surgery (BP 785, mean age 62.0 ± 14.7 years; and MP 460, mean age 56.9 ± 12.9 years). There were 1712 procedures performed [BP 969(56.6%) and MP 743(43.4%). Concomitant coronary artery bypass (conCABG) was BP 206(21.3%) and MP 105(14.1%) (p = 0.0002). The cumulative follow-up was BP 5131 years and MP 3364 years. Independent predictors were determined for mortality, valve-related complications and composites of complications.ResultsUnadjusted patient survival at 12 years was BP 52.1 ± 2.1% and MP 54.8 ± 4.6% (p = 0.1127), while the age adjusted survival was BP 48.7 ± 2.3% and MP 54.4 ± 5.0%. The predictors of overall mortality were age [Hazard Ratio (HR) 1.051, p < 0.0001], previous valve (HR 1.366, p = 0.028) and conCABG (HR 1.27, p = 0.021). The actual freedom from valve-related mortality at 12 years was BP 85.6 ± 1.6% and MP 91.0 ± 1.6% (actuarial p = 0.0167). The predictors of valve-related mortality were valve type (BP > MP) (2.61, p = 0.001), age (HR 1.032, p = 0.0005) and previous valve (HR 12.61, p < 0.0001). The actual freedom from valve-related reoperation at 12 years was BP 60.8 ± 1.9% and MP85.6 ± 2.1% (actuarial p < 0.001). The predictors of valve-related reoperation were valve type (MP > BP) (HR 0.32, p < 0.0001), age (HR 0.99, p = 0.0001) and previous valve (HR 1.38, p = 0.008)ConclusionsOverall survival (age adjusted) is differentiated by valve type over 10 and 12 years and valve-related mortality and valve-related reoperation favours the use of mechanical prostheses, overall for multiple valve surgery.

Midterm outcomes of aortic root surgery in patients with Marfan syndrome: A prospective, multicenter, comparative study

ObjectiveThe objective of this study was to compare midterm outcomes of aortic valve-replacing root replacement (AVR) and aortic valve-sparing root replacement (AVS) operations in patients with Marfan syndrome. MethodsPatients who met strict Ghent diagnostic criteria for Marfan syndrome and who underwent either AVR or AVS between March 1, 2005 and December 31, 2010 were enrolled in a 3-year follow-up prospective, multicenter, international registry study; the study was subsequently amended to include 20-year follow-up. Enrollees were followed clinically and echocardiographically. ResultsOf the 316 patients enrolled, 77 underwent AVR and 239 underwent AVS; 214 gave reconsent for 20-year follow-up. The median clinical follow-up time for surviving patients was 64 months (interquartile range, 42-66 months). Survival rates for the AVR and AVS groups were similar at 88.2% ± 4.4% and 95.0% ± 1.5%, respectively (P = .1). Propensity score-adjusted competing risk modeling showed associations between AVS and higher cumulative incidences of major adverse valve-related events, valve-related morbidity, combined structural valve deterioration and nonstructural valve dysfunction, and aortic regurgitation ≥2+ (all P < .01). No differences were found for reintervention (P = .7), bleeding (P = .2), embolism (P = .3), or valve-related mortality (P = .8). ConclusionsFive years postoperatively, major adverse valve-related events and valve-related morbidity were more frequent after AVS than after AVR procedures, primarily because of more frequent aortic valve dysfunction. No between-group differences were found in rates of survival, valve-related mortality, reintervention on the aortic valve, or bleeding. We plan to follow this homogenous cohort for 20 years after aortic root replacement.

Performance of Mechanical and Biological Mitral Prostheses in Young Rheumatics Aged Below 45 Years

Background and Aim: We compared 22-year composites of valve-related reoperation, morbidity, and mortality following mitral mechanical and bioprostheses in young rheumatics aged &lt;45years. Methods: Retrospective comparative analysis of valve-related reoperations and survival data were performed from 466 consecutive propensity matched patients undergoing either bioprosthetic MVR (Group I, n=233) or mechanical MVR (Group II, n=233) between 1998 and 2019. Results: The median age was 33 (IQR: 27-40) and 34 (IQR: 28-39) years for Group I and II respectively. The mean follow-up was 3278.9 patient-years in the biological arm and 3384.4 patient-years in mechanical arm. Bioprosthetic arm exhibited lesser cumulative mortality (4.5% vs 9.9%, SMD= -0.04, p=0.65). Hazard regression for mortality included (HR, 95% CI) preoperative congestive heart failure (CHF) 11.44 (8.44, 624.9), p&lt;0.0001; renal failure 19.51 (8.04, 47.35), p&lt;0.0001; previous operation 6.84 (2.48, 18.84), p&lt;0.0001; atrial fibrillation (AF) 7.64 (1.02, 57.13), p=0.006; LA clot 61.94 (8.28, 463.08), p&lt;0.0001; giant LA &gt;65 mm 7.87 (2.62, 23.56), p&lt;0.0001; poor left ventricular (LV) function 0.94 (0.92, 0.97), p&lt;0.0001; and prolonged aortic clamp time 1.07 (1.04, 1.11), p&lt;0.0001). Propensity matching did not exhibit any difference in reoperations between bioprostheses and mechanical prostheses (18.8% vs 13.3%, SMD= -0.152, p=0.1). At a median follow-up of 136 (IQR: 76-197) months, actuarial survival was 90.32%±0.02% (p=0.09) and there was no difference between the groups (p=0.09). Conclusions: Bioprostheses are an acceptable alternative to mechanical prostheses in young rheumatics aged &lt;45 years unwilling for mechanical valve, redo surgeries, life-long anticoagulation, and those desirous of pregnancy.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement \u2013 rationale and design of the international IMPACT registry

BackgroundDegenerative aortic valve disease accounts for 10–20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research.MethodsThe IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation.DiscussionIMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses.Trial registrationClinicalTrials.gov identifier: NCT04053088.

Long-term Performance of Epic and PERIMOUNT Mitral Bioprostheses in Young Rheumatics

Objective: We compared the long-term cossmposites of valve-related reoperation, morbidity and mortality following two types of mitral bioprostheses in young rheumatics aged &lt;45 years. Methods: Retrospective comparative analysis of structural valve-related reoperations, and survival data were performed on 260 propensity matched patients, undergoing bioprosthetic MVR between 2000 and 2019, using Epic (Group I, n=130) or PERIMOUNT bioprostheses (Group II, n=130). Results: The median age was 34.5 (IQR: 28-39) and 34 (IQR: 29-40) years for group I and II respectively. Hazard regression for mortality included HR (95% CI) preoperative congestive heart failure (CHF) 4.70 (1.76-12.56), p=0.002; renal failure 66.91 (12.88-347.59), p&lt;0.0001; low left ventricular ejection fraction &lt;0.25, 3.76 (1.72-7.27), p=0.004; and valve-related reoperations 3.82 (1.81-9.56), p=0.001. Although the structural valve degeneration (SVD)-related reoperations were more among the perimount group, propensity score matching did not exhibit any difference between the groups [8.5% (Group I) vs 14.6% (Group II), SMD -0.23, p=0.5]. At a median follow-up of 134 (IQR: 99.5-178.5) months, actuarial survival was 96.36%±0.01% (93.11-98.10), and there was no difference in survival between the groups (Log rank p=0.70). Conclusions: Both Epic and PERIMOUNT mitral bioprostheses provide similar long-term clinical outcomes and are an appealing alternative to mechanical prosthesis in younger rheumatics.

Long-term Clinical and Echocardiographic Outcomes in Young and Middle-aged Adults Undergoing the Ross Procedure

There is no ideal valve substitute for young adults requiring aortic valve replacement. Multicenter data supporting use of the Ross procedure with respect to long-term postoperative valve-related mortality and reintervention, as well as function of the autograft and pulmonary homograft, are needed. To determine the long-term clinical and echocardiographic outcomes in young and middle-aged patients undergoing the Ross procedure. A retrospective multicenter international cohort study with a median follow-up period of 9.2 years was conducted in 5 experienced centers regularly performing the Ross procedure. Consecutive patients aged 18 to 65 years were included by each center between 1991 and 2018. Survival and autograft-related and homograft-related reintervention. Serial echocardiographic measurements of valve function were analyzed using mixed-effects modeling. During the study period, 1431 patients (74.3% men; n = 1063) were operated on at a median age of 48.5 years (mean [SD], 47.7 [9.5]; range, 18.1-65; interquartile range, 42.7-54.0). Implantation techniques were root inclusion in 355 (24.9%), root replacement in 485 (34.0%), and subcoronary implantation in 587 (41.1%). Right ventricular outflow tract reconstruction was performed with homografts in 98.6% (n = 1189) and bioprostheses in 1.4% (n = 17). Ten patients (0.7%) died before discharge. Median follow-up was 9.2 years (13 015 total patient-years). Survival after 10 and 15 years was 95.1% (95% CI, 93.8%-96.5%) and 88.5% (95% CI, 85.9%-91.1%), respectively. Freedom from autograft and homograft reintervention after 15 years was 92.0% and 97.2%, respectively. Late events were autograft endocarditis in 14 patients (0.11% per patient-year), homograft endocarditis in 11 patients (0.08% per patient-year), and stroke in 37 patients (0.3% per patient-year). Given its excellent short-term and long-term outcome in young and middle-aged adults in this study, the Ross procedure should be considered in young and middle-aged adults who require aortic valve replacement. Patients should be referred to an experienced center with a program dedicated to the Ross procedure.

Abstract 14086: Early Results of a Novel EPTFE-based Pulmonary Valved Conduit in a Pediatric Patient Population

Introduction: This prospective, multicenter, single-arm, early feasibility study evaluates the safety and performance of an investigational ePTFE-based valve for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract. A novel polymeric pulmonary valved conduit, resistant to calcification and structural valve deterioration, may provide a more durable therapy option for the pediatric population by preventing loss of right ventricular function and increased freedom from valve-related reintervention and mortality. Methods: The primary endpoints at 6 months adjudicated by an independent Clinical Events Committee are valve-related mortality and device-related reintervention. The investigational device is a valved conduit comprised of ePTFE with stretch technology and a flexible tri-leaflet polymeric valve made of an advanced proprietary composite material, which can be tailored to length requirements of the anatomy. All enrolled patients met study inclusion/exclusion criteria and had a signed informed consent form. All patients had pre- and postoperative evaluation via transthoracic echocardiography (TTE). Aspirin was administered for a minimum of three months post procedure and, per institutional protocols, four patients were on temporary Coumadin. Results: Of the 17 patients enrolled from three sites, 52.9% were male. Ages ranged from 6 to 17 years (mean 11.5 ± 3.7). BSA ranged from 0.82 to 1.57 m 2 . At six months follow up, 100% of subjects successfully met the primary endpoint of freedom from valve-related mortality and device-related reintervention. No patient exhibited an RVOT gradient &gt; 20 mmHg. No patients had pulmonary regurgitation above baseline (≤ mild) observed through six months. Throughout postoperative serial TTE evaluation at discharge, 1, 3, and 6 months, no evidence of worsening valvular insufficiency was observed. No patient developed endocarditis and TTE detected no clinically significant thrombus formation. Conclusions: These preliminary data of a novel Pulmonary Valve Conduit suggest improved pulmonic and right ventricular function based on TTE measurements, no unexpected findings, no valve-related adverse events and encouraging hemodynamic performance through 6 months.

Root repair with aortic ring annuloplasty using the standard approach.

Standardization of aortic valve repair techniques with use of a calibrated annuloplasty have led to improved long-term outcomes in dystrophic aortic insufficiency. It can also improve dissemination of techniques and rates of aortic valve repair. Dystrophic aortic insufficiency can be found in three aortic phenotypes: dilated aortic root, dilated ascending aorta and isolated aortic insufficiency. The aortic annulus is invariably dilated above 25 mm in the vast majority of cases of aortic insufficiency, regardless of whether the aorta is dilated or not. A dilated annulus is a risk factor for late failure of aortic valve repair if not addressed at the time of surgery. We perform a calibrated annuloplasty at both sub- and supra-valvular levels in order to restore the ratio of sinotubular junction and annulus. Current evidence shows aortic valve repair reduces valve-related mortality compared to prosthetic valve replacement, with an improved quality of life.

Additional cusp reconstruction does not compromise valve durability and mid-term survival after the David procedure: results from 449 patients.

The aim of this study was to evaluate whether additional cusp interventions and valve types affect aortic valve-related reoperation and mortality rates after the David procedure. Between 1997 and 2018, a total of 449 patients {372 males; mean age 54.2 [standard deviation (SD) 15.2] years, range: 12.7-79.9 years} underwent elective valve-sparing aortic root replacement (David procedure) for aortic regurgitation and were prospectively followed up clinically and echocardiographically. The follow-up was 94% complete. Cumulative follow-up time was 2268 patient-years [mean follow-up time 5.1 (4.3 SD) years]. Thirty-day mortality was 2.2% (n = 10). Late (>30 days) survival did not differ from that of the age- and gender-matched general population. Freedom from reoperation in patients without additional cusp reconstruction was 94% [95% confidence interval (CI) 91-98] and 92% (95% CI 88-97) at 5 and 10 years, respectively, which was not significantly different (P = 1) for patients who did require additional cusp reconstruction 98% (95% CI 95-100) and 89% (95% CI 81-99). In patients with tricuspid aortic valves (n = 338), freedom from reoperation was 96% (95% CI 94-99) and 93% (95% CI 88-97) at 5 and 10 years, respectively. Patients with bicuspid aortic valves (n = 111) had a freedom from reoperation of 94% (95% CI 89-99) at 5 years and 88% (95% CI 79-98) at 10 years (P = 0.021 for the comparison to tricuspid aortic valve). Overall, 23 patients (5%; 1%/patient-year) required reoperation with a mean interval of 4.5 (4.8 SD) months. The David procedure revealed low mid-term reoperation risk and excellent survival independent of adjunctive cusp interventions/valve morphology and is comparable with that of the age- and gender-matched general population.

Aortic Valve Repair for Aortic Insufficiency or Dilatation: Technical Evolution and Long-term Outcomes

Aortic valve repair (AVR) is an attractive alternative to valve replacement for the treatment of aortic valve insufficiency. Here we report on the midterm outcomes after AVR for aortic valve insufficiency with an emphasis on durability of repair. Between 1996 and 2017, 560 consecutive patients (mean age, 57 ± 16 years) underwent various AVR procedures on tricuspid (n= 415, 74%) and bicuspid (n= 145, 26%) aortic valves. In 313 patients (56%) the David procedure was performed, whereas in 247 patients (44%) cusp repair without aortic root procedure was conducted. Concomitant procedures were coronary artery bypass grafting in 82 patients (15%) and mitral valve repair in 47 patients (8%). Clinical and echocardiographic follow-up was complete in 97% of patients. Mean follow-up was 6.3 ± 4.6 years. Thirty-day mortality was 1.4% (n= 8). Late mortality was observed in 132 patients with cardiovascular events accounting for mortality in 13 patients: Survival at 10 years was 70%. Reoperation on the aortic valve was performed on 39 patients for recurrent insufficiency, isolated in 25, or combined with valve stenosis in 5 patients; endocarditis accounted for reoperation in 9 patients (0.2% per patient-year). Freedom from reoperation was 88% at 10 years. Cumulative linearized incidence of all valve-related complications was 2% per patient per year. AVR for insufficiency is a durable procedure with low valve-related morbidity and mortality in the midterm.