The Characteristics and Outcomes of Native Aortic Valve Thrombosis: A Systematic Review.

BACKGROUND: There is a lack of knowledge in the current medical literature about native aortic valve thrombosis. OBJECTIVES: The aim of this systematic review was to summarize the characteristics, presentations, underlying etiologies, and outcomes of native aortic valve thrombosis and to present a meta-analysis of the best available data. METHODS: The authors performed a literature search, identified published cases of patients with native aortic valve thrombosis, and pooled the data in this meta-analysis. The statistical analysis included calculations of the prevalence of the various presentations, underlying etiologies, aortic cusp involvement, as well as choices of diagnostic testing. They calculated the sensitivities of the various diagnostic testing as well as in-hospital mortality event rates and the univariate ORs of the risk factors for poor outcomes. RESULTS: The search strategy and screening process yielded 74 cases of native aortic valve thrombosis, which are included in this meta-analysis. The data revealed that the most common presentation was myocardial infarction in 36%, and the most common underlying etiology was hypercoagulable state in 30%. In-hospital clinical deterioration after presentation including recurrent embolism occurred in ∼38%, and in-hospital mortality rate was ∼20%. CONCLUSIONS: Native aortic valve thrombosis is clinically relevant, especially in patients presenting with embolic events. Awareness about native aortic valve or root thrombosis as well as its underlying etiologies, diagnostic work-up, and management is essential, because this condition can be associated with poor outcomes.

Technical Modifications That Might Improve Long-term Outcomes of the Ross Procedure in Children.

BACKGROUND: Failure of the pulmonary valve autograft (PVA) after the Ross procedure (RP) has discouraged its widespread use and has led to modifications or alternatives to the procedure. We sought to analyze whether certain technical modifications could improve results of the RP in children. METHODS: Sixty-nine patients (median age, 12 years; range, 0.25-17.9) underwent the RP between January 1996 and December 2018. A concomitant Konno procedure was performed on 20 of 69 patients (29%). Prior interventions included balloon valvuloplasty in 30 (44%) and/or surgical valvuloplasty in 39 (57%). Technical modifications included using the native aortic root for external annuloplasty, implanting the autograft using uniplanar horizontal sutures through the aortic wall, normalizing the sinotubular junction, and wrapping the native root remnant around the PVA. RESULTS: Operative mortality was 1 of 69 patients (1.5%), with no late deaths. No patient had neoaortic valvar stenosis and 7 of 68 (10%) had mild regurgitation on discharge echocardiogram. At latest follow-up (median, 9.4 years; range, 0.4-21.3) there was no significant change in Z scores of annulus, sinus, or sinotubular junction diameters when compared with those at discharge. Three patients (4.4%) required late autograft replacement, 2 PVA repair, and 2 resection of a pseudoaneurysm. Actuarial freedom from PVA replacement was 87% at 20 years. Freedom from right ventricular outflow tract catheter reintervention or reoperation was 83% and 80%, respectively. CONCLUSIONS: Technical modifications of the RP used in this cohort might successfully prolong the life of the PVA without compromising its growth, an important advantage in pediatric patients.

Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.

AIMS: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. METHODS AND RESULTS: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. CONCLUSIONS: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.

Early and Two-year Outcomes after Sutureless and Conventional Aortic Valve Replacement: a Nationwide Population-based Study.

BACKGROUND: We compared early and 2-year clinical outcomes of sutureless aortic valve replacement (SAVR) with conventional aortic valve replacement (CAVR) in a nationwide study based on claims data. METHODS: From December 2016 to November 2018, 3,173 patients underwent bioprosthetic aortic valve replacements. SAVR and CAVR were performed in 641 and 2,532 patients, respectively. Propensity score-matched analysis was performed in 640 patient pairs. RESULTS: Operative mortality rate was 2.8% without significant differences between the SAVR (3.4%) and CAVR (2.3%) groups (P = 0.324). There were no significant differences in postoperative morbidities between the groups except for permanent pacemaker (PPM) implantation. PPM implantation rate was significantly higher in the SAVR (3.8%) than in the CAVR group (0.9%) (P < 0.001). One- and two-year overall survival was 89.1% and 87.5%, respectively, without significant differences between the groups (SAVR group vs. CAVR grouP = 89.9% and 90.5% vs. 87.2% and 88.7%, respectively; P = 0.475). There were no significant differences in the cumulative incidence of cardiac death, stroke, aortic valve reoperation and infective endocarditis between the groups. Cumulative PPM implantation incidence at 6 months in the CAVR was 1.1%, and no patient required PPM implantation after 6 months. In the SAVR, the cumulative PPM implantation incidence at 0.5, one, and two years was 3.9%, 5.0% and 5.6%, respectively. The cumulative PPM implantation rate was higher in the SAVR group than in the CAVR group (P < 0.001). CONCLUSION: Early and 2-year clinical outcomes between SAVR and CAVR were not different except for a high rate of permanent pacemaker implantation in the SAVR group.

Congenital aortic and truncal valve reconstruction using the Ozaki technique: Short-term clinical results.

OBJECTIVES: Aortic valve reconstruction (AVRec) with neocuspidization or the Ozaki procedure with complete cusp replacement for aortic valve disease has excellent mid-term results in adults. Limited results of AVRec in pediatric patients have been reported. We report our early outcomes of the Ozaki procedure for congenital aortic and truncal valve disease. METHODS: A retrospective analysis was performed on all 57 patients with congenital aortic and truncal valve disease who had a 3-leaflet Ozaki procedure at a single institution from August 2015 to February 2019. Outcome measures included mortality, surgical or catheter-based reinterventions, and echocardiographic measurements. RESULTS: Twenty-four patients had aortic regurgitation (AR), 6 had aortic stenosis (AS), and 27 patients had AS/AR. Two patients had quadricuspid valves, 26 had tricuspid, 20 had bicuspid, and 9 had unicusp aortic valves. Four patients had truncus arteriosus. Thirty-four patients had previous aortic valve repairs and 5 had replacements. Preoperative echocardiography mean annular diameter was 20.90 ± 4.98 cm and peak gradient for patients with AS/AR was 53.62 ± 22.20 mm Hg. Autologous, Photofix, and CardioCel bovine pericardia were used in 20, 35, and 2 patients. Eight patients required aortic root enlargement and 20 had sinus enlargement. Fifty-one patients had concomitant procedures. Median intensive care unit and hospital length of stay were 1.87 and 6.38 days. There were no hospital mortalities or early conversions to valve replacement. At discharge, 98% of patients had mild or less regurgitation and peak aortic gradient was 16.9 ± 9.5 mm Hg. Two patients underwent aortic valve replacement. At median follow-up of 8.1 months, 96% and 91% of patients had less than moderate regurgitation and stenosis, respectively. CONCLUSIONS: The AVRec procedure has acceptable short-term results and should be considered for valve reconstruction in pediatric patients with congenital aortic and truncal valve disease. Longer-term follow-up is necessary to determine the optimal patch material and late valve function and continued annular growth.

The impact of surgical aortic valve replacement on quality of life-a multicenter study.

OBJECTIVES: To explore the effect of surgical aortic valve replacement on quality of life and the variance with age, particularly in patients at risk of deterioration. METHODS: In an observational, multicenter, cohort study of routinely collected health data, patients undergoing and electively operated between January 2011 and January 2015 with pre- and postoperative quality of life data were included. Patients were classified into 3 age groups: <65, 65-79, and ≥80 years. Quality of life was measured at baseline and at 1-year follow-up using the Short-Form Health Survey-12 or SF-36. We defined a >5-point difference as a minimal clinically important difference. Multivariable linear regression analysis, with adjustment for confounders, was used to evaluate the association between age and quality of life. RESULTS: In 899 patients, mean physical health increased from 55 to 66 and mental health from 60 to 66. A minimal clinically important decreased physical health was observed in 12% of patients aged <65 years, 16% of patients aged 65-79 years, and 22% of patients aged ≥80 years (P = .023). A decreased mental health was observed in 15% of patients aged <65 years, 22% of patients aged 65-79 years, and 24% aged ≥80 years (P = .030). Older age and a greater physical and mental score at baseline were associated with a decreased physical and mental quality of life (P < .001). CONCLUSIONS: Patients surviving surgical aortic valve replacement on average improve in physical and mental quality of life; nonetheless, with increasing age patients are at higher risk of experiencing a deterioration.

Intermediate-Term Outcomes After Aortic Valve Replacement With the Medtronic 3F Stentless Prosthesis.

BACKGROUND: This study evaluated the early and intermediate-term clinical and hemodynamic results after implant of the Medtronic 3F (Minneapolis, MN) stentless aortic valve. METHODS: Between March 2007 and August 2015, 226 consecutive patients affected by aortic valve disease received a 3F valve at our unit by a single surgeon. The valve in 30 patients was included in a tubular prosthesis for a Bentall procedure. Size ranged between 21 and 29, age at operation was 74.17 ± 8.58 years, mean logistic European System for Cardiac Operative Risk Evaluation was 9.73 ± 6.00, and 51.3% of patients received a concomitant procedure. For isolated valve replacement, mean extracorporeal circulation time was 92 ± 17 minutes, and cross-clamp time was 73 ± 11 minutes. Follow-up was 100% complete and was a mean of 63 ± 2.4 months (range, 6-138 months). Primary end points were early and late mortality, freedom from endocarditis, freedom from structural valve deterioration, and freedom from valve-related reoperation. RESULTS: Early mortality after isolated aortic valve replacement was 1.7%. Of the 59 (25.3%) late overall deaths, 15 (6.6%) were cardiac-related, and survival rate was 93% at 10 years. At follow-up, 97% of patients were in New York Heart Association class I or II. Actuarial freedom from reoperation due to structural deterioration was 100% at 5 years and 96% at 10 years. Freedom from endocarditis at 10 years was 97%. Mean aortic pressure gradient measured by echocardiography was 11.5 mm Hg at hospital discharge and 10.4 mm Hg at the last follow-up. CONCLUSIONS: The 3F valve is a user-friendly third-generation stentless aortic prosthesis with proven durability and remarkable hemodynamic performance preserved over time. The 3F is particularly useful in cases of expected patient/prosthesis mismatch.

Analysis of risk factors for perioperative death in patients undergoing aortic valve replacement using biological valves.

BACKGROUND: Aortic valve disease has become one of the important factors affecting human health. Aortic valve disease is a progressive disease, if not actively treated, the prognosis is poor. Aortic valve replacement (AVR) surgery is an important treatment for aortic valve disease. At present, the AVR surgery using biological valve accounts for about 40% of the total number of AVR surgery. There are still more perioperative deaths in China due to the large number of AVR patients using biological valves. The objective of this study is to explore measures to reduce perioperative mortality of patients after AVR surgery with biological valves. METHODS: The clinical data of patients undergoing AVR surgery with biological valves in Affiliated Hospital of Qingdao University from November 15, 2020 to December 31, 2022 were reviewed and analyzed. Patients were divided into death group and survival group according to their perioperative survival. Risk factors that may influence perioperative mortality were analyzed and compared between the 2 groups. DISCUSSION: This study was a retrospective analysis of risk factors that may influence perioperative mortality in patients undergoing AVR surgery using biological valves. The conclusions of this study can be used to guide clinical decisions-making and relevant guidelines-developing for perioperative treatment of patients undergoing AVR surgery using biological valves.

Ross Procedures in Children With Previous Aortic Valve Surgery.

BACKGROUND: The Ross procedure in children is performed either as a primary operation, or a secondary operation after initial aortic valve surgery. OBJECTIVES: The study aimed to determine whether the outcomes of primary and secondary Ross procedure are similar. METHODS: All patients who underwent Ross procedure between 1995 and 2018 were included in the study. Outcomes were compared between those who had primary Ross procedure and those who had secondary Ross procedure, after aortic valve surgery. Propensity score matching for baseline characteristics and risk factors for death and reoperation was performed. RESULTS: Of 140 Ross procedures, 51.4% (n = 72 of 140) were primary operations, while 48.6% (n = 68 of 140) were secondary operations. Patients undergoing primary Ross procedure tended to be older (median age 8.6 years vs. 7.0 years; p = 0.10) and have a higher weight (28.9 kg vs. 19.4 kg; p = 0.07). There were no significant differences in survival or freedom from reoperation in the unmatched cohort. Propensity score matching resulted in 50 well-matched pairs. In the matched cohort, survival at 10 years was 90.0% (95% confidence interval [CI]: 77.5% to 95.7%) in the primary Ross group, compared with 96.8% (95% CI: 79.2% to 99.5%) in the secondary Ross group (p = 0.04). Freedom from autograft reoperation at 10 years was 82% (95% CI: 64.1% to 91.5%) in the primary Ross group, compared with 97.0% (95% CI: 80.4% to 99.6%) in the secondary Ross group (p = 0.03). CONCLUSIONS: Secondary Ross procedure performed after initial aortic valve surgery achieves superior long-term survival and freedom from autograft reoperation compared with primary Ross procedure. A strategy of initial aortic valve repair followed by delayed Ross procedure may provide better long-term survival and freedom from autograft reoperation.