Surgical Bioprosthetic Aortic Valve Replacement Research Articles

Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves

The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been rapidly expanding as an alternative treatment to redo surgical aortic valve replacement (SAVR) for failed bioprosthetic valves despite limited long-term data. To assess mortality and morbidity in patients undergoing intervention for failed bioprosthetic SAVR. This was a retrospective population-based cohort analysis conducted between January 1, 2015, and December 31, 2020, with a median (IQR) follow-up time of 2.3 (1.1-4.0) years. A total of 1771 patients with a history of bioprosthetic SAVR who underwent ViV-TAVR or redo SAVR in California, New York, and New Jersey were included. Data were obtained from the California Department of Health Care Access and Information, the New York Statewide Planning and Research Cooperative System, and the New Jersey Discharge Data Collection System. Exclusion criteria included undergoing TAVR or redo SAVR within 5 years from initial SAVR, as well as infective endocarditis, concomitant surgical procedures, and out-of-state residency. Propensity matching yielded 375 patient pairs. Data were analyzed from January to December 2023. ViV-TAVR vs redo SAVR. The primary outcome was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization, reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis. From 2015 through 2020, the proportion of patients undergoing ViV-TAVR vs redo SAVR increased from 159 of 451 (35.3%) to 498 or 797 (62.5%). Of 1771 participants, 653 (36.9%) were female, and the mean (SD) age was 74.4 (11.3) years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV-TAVR group had lower periprocedural rates of major bleeding (2.4% vs 5.1%; P = .05), acute kidney failure (1.3% vs 7.2%; P < .001), and new pacemaker implantations (3.5% vs 10.9%; P < .001). The 5-year all-cause mortality rate was 23.4% (95% CI, 15.7-34.1) in the ViV-TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22). There were no differences in 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis. Compared with redo SAVR, ViV-TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years' follow-up. However, ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization. These findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.

Early thrombus formation including hypo-attenuated leaflet thrombosis after surgical bioprosthetic aortic valve replacement.

To assess the occurrence, predictors, and outcomes of hypo-attenuated leaflet thickening (HALT) and thrombus outside the prosthetic valve following surgical aortic valve replacement. A total of 118 patients underwent surgical aortic valve replacement with bioprosthetic valves between July 2020 and June 2022. Sixty-two (52.5%) patients, which is a fairly high number of patients, underwent cardiac computed tomography and transthoracic echocardiography one week after surgery. Patients were divided into two groups, those with HALT (n = 14) and those without HALT (n = 48). Of the 62 patients who underwent cardiac computed tomography, HALT was observed in 14 (22.5%) patients during the very early postoperative phase. Reduced leaflet motion was observed in two of the 14 patients. The low-attenuation areas were located outside the prosthetic valve in 10 cases (71.4%) in the HALT group and in 14 cases (29.2%) in the non-HALT group. More than 50% of patients (57.1%) with HALT and 79.2% without HALT were administered warfarin. Neither in-hospital deaths nor postoperative thromboembolic events were observed during hospitalization. No patient had a mean pressure gradient > 20mmHg in either group. HALT was observed in one-fifth of the cases after surgical aortic valve replacement during the very early postoperative phase in an institution wherein administration of continuous heparin infusion after surgery is a standard practice. HALT did not affect the early prognosis or incidence of cerebral infarction.

Abstract 16826: A Rare Case of an Emergent Third Valve in Valve Intervention

Introduction: Bioprosthetic valves are prone to structural degeneration due to an average lifetime of 10-15 years. Valve in Valve (VIV) TAVR has become an alternative to the high-risk surgical patients as the growing number of successful bioprosthetic valve placements and the deteriorations over time. Emergent VIV intervention effectiveness with prior multiple artificial valves is less studied. Hypothesis: We report a case of a 54-year-old male presenting with obstructive shock with history of substance abuse and bicuspid aortic valve status post bioprosthetic aortic valve with aortic root repair at age of 15(1983), aortic stenosis requiring repeat surgical bioprosthetic Aortic Valve Replacement (SAVR) (25 mm) at age 42(2011). Recalcitrant cardiogenic shock despite vasopressor. Emergent Heart catheterization showed mild coronary artery disease (CAD) and severe cardiomyopathy, Left Ventricle ejection Fraction 15-20%. Aortic valve Gradient was 80 mmHg. Transesophageal Echocardiography (TEE) ruled out endocarditis. Impella CP and Swan-Ganz catheter were placed for hemodynamic support and monitoring. Methods: The Heart Team approach was followed. Patient was at high risk of mortality and operative complications with redo sternotomy. He subsequently underwent valve in valve TAVR with self-expanding 26 mm valve. Prior surgical valve did not require fracturing post implantation. Results: Post Trans Aortic Valve Replacement (TAVR) the mean gradient on echocardiogram decreased to 10 mmHg and LVEF recovered to 55-60%. The patient was successfully weaned off Vaso-pressors and eventually discharged home. Conclusion: Most common cause of transcatheter bioprosthetic valve failure is stenosis from calcification and thrombosis. VIV TAVR in recent studies has proven to be safe with favorable outcomes. Our patient had already undergone two surgical valve interventions, presented with critical bioprosthetic valve stenosis requiring salvage TAVR for cardiogenic shock. After the Heart team approach, TAVR was opted as a more favorable option for the patient. Although, the life of a bioprosthetic valve results in multiple interventions but overall valve in Valve technique has been proven to provide expected results in emergent high-risk patients.

Porcine or Bovine Tissue Valves: Which are Better for Surgical Aortic Valve Replacement?

Summary The choice between mechanical and bioprosthetic aortic valve implants is affected by relatively clear criteria. However, the choice between porcine or pericardial valve is more complex regarding bioprosthetic devices. We aimed to elucidate any hemodynamic and clinical difference between two widely used bioprosthetic valves: the Sorin Mitroflow bovine pericardial valve and the St. Jude Medical Epic Supra porcine valve. We retrospectively studied 71 consecutive patients separated into two groups based on the valve they received. Clinical outcomes included patient survival and hemodynamic performance of the implanted prostheses. Patients were assessed at one and five years postoperatively. Mean transprosthetic pressure gradients were used as a marker of hemodynamic performance. The Mitroflow valve exhibited lesser mean transvalvular gradients than the Epic valve for all labelled sizes at one and five years postoperatively. The 5-year survival was equal between groups. Both prostheses demonstrated a small but significant increase in mean pressure gradients in the fifth year. Most patients enjoyed significant clinical improvement as assessed by NYHA functional class. Both bioprostheses performed very well with excellent hemodynamic parameters. The pericardial valves are a safe and appropriate choice for surgical bioprosthetic aortic valve replacement.

Impact of reintervention after index aortic valve replacement on the risk of subsequent mortality

ObjectivesThe use of bioprosthetic aortic valve replacement (AVR) is inherently associated with a risk of structural valve degeneration (SVD) and the need for aortic valve (AV) reintervention. We sought to evaluate whether AV reintervention, in the form of repeat surgical AVR (SAVR) or valve-in-valve transcatheter aortic valve replacement (ViV-TAVR), negatively affects patients’ subsequent long-term survival after index SAVR. MethodsWe identified patients who had undergone bioprosthetic SAVR from 2002 to 2017 at our institution. Median longitudinal follow-up after index SAVR was 7.3 years (10.9 years for those with and 7.2 years for those without AV reintervention), and median follow-up after AV reintervention was 1.9 years. Cox regression analyses using AV reintervention (re-SAVR and ViV-TAVR) as a time-varying covariate were used to determine the impact of reintervention on subsequent survival. ResultsOf 4167 patients who underwent index SAVR, 139 (3.3%) required AV reintervention for SVD, with re-SAVR being performed in 65 and ViV-TAVR in 74. Median age at the index SAVR was 73 years (interquartile range, 64-79 years), and 2541 (61%) were male. Overall, there were total of 1171 mortalities observed, of which 13 occurred after re-SAVR and 9 after ViV-TAVR. AV reintervention was associated with a greater risk of subsequent mortality compared with those patients who did not require AV reintervention (hazard ratio, 2.53; 95% confidence interval, 1.64-3.88, P < .001). This increased risk of subsequent mortality was more pronounced for those who received their index AVR when <65 years of age (hazard ratio, 5.60; 95% confidence interval, 2.57-12.22, P < .001) versus those ≥65 years (2.06, 1.21-3.52, P = .008). Direct comparison of survival between those who underwent re-SAVR versus ViV-TAVR showed 5-year survival to be comparable (re-SAVR: 74% vs ViV-TAVR: 80%, P = .67). ConclusionsAmong patients receiving bioprosthetic AVR, an AV reintervention for SVD is associated with an increased risk of subsequent mortality, regardless of re-SAVR or ViV-TAVR, and this risk is greater among younger patients. These findings should be balanced with individual preferences at index AVR in the context of patients’ lifetime management of aortic stenosis.

Redo Surgical Aortic Valve Replacement After Prior Transcatheter Versus Surgical Aortic Valve Replacement

BackgroundAortic stenosis treatment should consider risks and benefits for lifetime management. Although the feasibility of redo transcatheter aortic valve replacement (TAVR) remains unclear, concerns are emerging regarding reoperation after TAVR. ObjectivesThe authors sought to define comparative risk of surgical aortic valve replacement (SAVR) after prior TAVR or SAVR. MethodsData on patients undergoing bioprosthetic SAVR after TAVR and/or SAVR were extracted from the Society of Thoracic Surgeons Database (2011-2021). Overall and isolated SAVR cohorts were analyzed. The primary outcome was operative mortality. Risk adjustment using hierarchical logistic regression as well as propensity score matching for isolated SAVR cases were performed. ResultsOf 31,106 SAVR patients, 1,126 had prior TAVR (TAVR-SAVR), 674 had prior SAVR and TAVR (SAVR-TAVR-SAVR), and 29,306 had prior SAVR (SAVR-SAVR). Yearly rates of TAVR-SAVR and SAVR-TAVR-SAVR increased over time, whereas SAVR-SAVR was stable. The TAVR-SAVR patients were older, with higher acuity, and with greater comorbidities than other cohorts. The unadjusted operative mortality was highest in the TAVR-SAVR group (17% vs 12% vs 9%, respectively; P < 0.001). Compared with SAVR-SAVR, risk-adjusted operative mortality was significantly higher for TAVR-SAVR (OR: 1.53; P = 0.004), but not SAVR-TAVR-SAVR (OR: 1.02; P = 0.927). After propensity score matching, operative mortality of isolated SAVR was 1.74 times higher for TAVR-SAVR than SAVR-SAVR patients (P = 0.020). ConclusionsThe number of post-TAVR reoperations is increasing and represent a high-risk population. Yet even in isolated SAVR cases, SAVR after TAVR is independently associated with increased risk of mortality. Patients with life expectancy beyond a TAVR valve and unsuitable anatomy for redo-TAVR should consider a SAVR-first approach.

Effect of Prosthesis-Patient Mismatch on Long-Term Clinical Outcomes After Bioprosthetic Aortic Valve Replacement

BackgroundProsthesis-patient mismatch (PPM) is common following surgical aortic valve replacement (SAVR). ObjectivesThe purpose of this study was to quantify the impact of PPM on all-cause mortality, heart failure hospitalization, and reintervention following bioprosthetic SAVR. MethodsThis observational nationwide cohort study from SWEDEHEART (Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies) and other national registers included all patients who underwent primary bioprosthetic SAVR in Sweden from 2003 to 2018. PPM was defined according to the Valve Academic Research Consortium 3 criteria. Outcomes were all-cause mortality, heart failure hospitalization, and aortic valve reintervention. Regression standardization was used to account for intergroup differences and to estimate cumulative incidence differences. ResultsWe included 16,423 patients (no PPM: 7,377 [45%]; moderate PPM: 8,502 [52%]; and severe PPM: 544 [3%]). After regression standardization, the cumulative incidence of all-cause mortality at 10 years was 43% (95% CI: 24%-44%) in the no PPM group compared with 45% (95% CI: 43%-46%) and 48% (95% CI: 44%-51%) in the moderate and severe PPM groups, respectively. The survival difference at 10 years was 4.6% (95% CI: 0.7%-8.5%) and 1.7% (95% CI: 0.1%-3.3%) in no vs severe PPM and no vs moderate PPM, respectively. The difference in heart failure hospitalization at 10 years was 6.0% (95% CI: 2.2%-9.7%) in severe vs no PPM. There was no difference in aortic valve reintervention in patients with or without PPM. ConclusionsIncreasing grades of PPM were associated with long-term mortality, and severe PPM was associated with increased heart failure. Moderate PPM was common, but the clinical significance may be negligible because the absolute risk differences in clinical outcomes were small.

Developing Hemodynamic Valve Deterioration and Mortality in Aortic Valve Replacement

BackgroundAs life span increases, in patients having a bioprosthetic valve, the development of hemodynamic valve deterioration (HVD) is an important concern. We evaluated the association of developing HVD to survival in patients undergoing surgical aortic valve replacement (SAVR). MethodsThe individuals undergoing isolated SAVR and serial echocardiography exams (interval >30 d) were included in this study. HVD was defined as mean pressure gradient ≥ 20 mmHg, mean pressure gradient ≥10 mmHg higher than in the baseline exam, or more than moderate regurgitation on Doppler echocardiography (moderate and severe grade). A time-dependent Cox proportional hazard model was used for this study. ResultsA total of 631 patients were included. The mean age was 71.8 ± 6.1 y old (female: 53.6%). HVD was found in 259 patients (41%) during echocardiographic follow-up (mean 3.3 ± 3.0 y). Patient-prosthetic mismatch was found in 174 patients. One hundred and twenty-six patients died during follow-up (median 62.1 mo, interquartile range 31.1-96.8). The development of HVD was an independent risk factor for death during follow-up (P = 0.038, hazard ratio 1.46, 95% confidential interval: 1.02-2.08). ConclusionsHVD was common after bioprosthetic SAVR during mid-term follow-up. Developing HVD, including moderate and severe grades, was associated with a poor survival rate compared with patients without HVD.

Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center.

Bioprosthetic surgical aortic valve replacement (SAVR) is increasingly adopted in younger patients. We aimed to analyze mid-term follow-up data after SAVR to assess the performance of the prosthesis. Data were collected from a single-center series of 154 patients, who underwent SAVR with a bioprosthetic heart valve with the RESILIA tissue at our Heart Centre in Siegburg. All procedural and midterm patient outcomes were documented. Patients had a mean age of 56.8 ± 9.9 years, 35.7% were female, and the mean logistic European system for cardiac operative risk evaluation (EuroSCORE) was 3.4 ± 3.6%. Diabetes (12.3%), atrial fibrillation (10.4%), and chronic obstructive pulmonary disease (COPD) (5.8%) were common comorbidities. The mean surgery duration was 163.8 ± 73.4 min, with the 23 mm (34.4%) and 25 mm (33.8%) heart valves being most frequently implanted. At 3-year follow-up, mean pressure gradient was 13.9 ± 5.9 mmHg, peak gradient was 23.6 ± 7.7 mmHg, and effective orifice area (EOA) was 1.9 ± 0.4 cm². No patient died during the operation, 3 (2.1%) patients within 30 days, and 4 (2.7%) thereafter with an overall mortality of n = 7. Of the surviving patients, 97.8% were in New York Heart Association (NYHA) class I/II and none had structural valve deterioration (SVD). Results of our single-center study indicate favorable procedural outcomes. The safety outcomes confirm preliminary earlier results of this novel bioprosthesis but include more patients and a longer midterm follow-up.

IMPROVED OUTCOMES FOLLOWING THE ROSS PROCEDURE COMPARED WITH BIOPROSTHETIC AORTIC VALVE REPLACEMENT

IMPROVED OUTCOMES FOLLOWING THE ROSS PROCEDURE COMPARED WITH BIOPROSTHETIC AORTIC VALVE REPLACEMENT

Outcomes of surgical bioprosthetic aortic valve replacement for aortic insufficiency

BackgroundResults and durability of aortic valve replacement in aortic stenosis are well known, but no study has focused on the results of aortic valve replacement in aortic insufficiency. AimThe aim of this retrospective study was to describe our mid-term outcomes after aortic valve replacement for aortic insufficiency. MethodsAll consecutive adult patients who underwent bioprosthetic aortic valve replacement for aortic insufficiency at two European centres (in France and Germany) between May 2005 and December 2020 were analysed. ResultsDuring the study period, 289 patients were included. Mean age was 56.9±12.5 years. Overall operative mortality was 1.5%, and the 10-year survival estimate rate was 75.0%, which was significantly lower than in the age- and sex-matched general population, with a standardized mortality ratio of 2.88 (95% confidence interval 1.96–4.08; P<0001). Freedom from aortic valve-related death was 87.6%, and from aortic valve-related reoperation was 87.4%. No patient aged>60 years was reoperated on during follow-up. Freedom from severe structural valve deterioration at 10 years was 73.3%, and freedom from moderate structural valve deterioration at 10 years was 50.3%. Freedom from major adverse valve-related events at 10 years was 69.7%. ConclusionsAlthough bioprosthetic aortic valve replacement for aortic insufficiency shows good early results, 10-year mortality and major adverse valve-related event rates in young patients may be a concern, with a reduction in life expectancy compared with the general population.

Effects of short-term oral anticoagulation following surgical bioprosthetic aortic valve replacement

Short-term oral anticoagulation (OAC) is recommended for patients after surgical bioprosthetic aortic valve replacement (bAVR); however, the potential benefits remain controversial. This study evaluated the effects of short-term OAC following bAVR. From 2010 to 2017, total 450 patients who underwent bAVR were enrolled. The outcomes of patients who did (OAC group) and who did not receive OAC (without-OAC group) after bAVR were compared. Propensity-score matching (PSM) was used to adjust for potential confounders, and a 1:1 matched cohort was formed. The main outcomes were all-cause mortality and bioprosthetic valve dysfunction (BVD). A total of 175 (39%) patients received OAC after bAVR. The median follow-up period was 2.9 years, the median duration of OAC use was 4 months; 162 pairs of patients were identified after the PSM. There was no significant difference in the prevalence of 1-year embolism/ischemic stroke between the OAC and without-OAC group in PSM cohort (0.62% vs. 1.89% for embolism, p=0.623; 0 vs. 1.23% for ischemic stroke, p=0.499). The prevalence of 1-year intracranial hemorrhage (ICH) between OAC and without-OAC group was also comparable (0.62% vs. 0.62%, p=1). The OAC group had a lower all-cause mortality (adjusted hazard ratio (aHR):0.488, 95% confidence interval (CI): 0.259-0.919). There was also a trend for reduced BVD in the OAC group (aHR: 0.661, 95% CI: 0.339-1.290). Our study demonstrated that short-term OAC use after bAVR was associated with lower all-cause mortality. The prevalence of 1-year embolism/ischemic stroke/ICH were comparable despite of OAC use.

A retrospective study on the trends in surgical aortic valve replacement outcomes in the post-transcatheter aortic valve replacement era.

Background and AimsTranscatheter aortic valve replacement (TAVR) is the mainstay of treatment of inoperable and severe high‐risk aortic stenosis and is noninferior to surgical aortic valve replacement (SAVR) for low‐risk and intermediate‐risk patients as well. We aim to compare the valve size, area, and transaortic mean gradients in SAVR patients before and after the implementation of TAVR since being approved by the Food and Drug Administration in 2011.MethodsPatients who underwent a bioprosthetic SAVR placement were divided into two groups based on the date of procedure: the early pre‐TAVR implementation group (years 2011–2012) and the contemporary post‐TAVR group (years 2019–2020). The primary endpoint was the mean gradient across the aortic valve within 16 months of surgery. The secondary endpoints included the difference in valve size and various aortic valve echocardiographic variables.ResultsOne hundred and thirty patients had their valves replaced in the years 2011–2012 and 134 in the years 2019–2020. The early group had a significantly higher mean gradient (median of 13 mmHg [interquartile range, IQR: 9.3–18] vs. 10 mmHg [IQR: 7.5–13.1], p = 0.001) and a smaller median effective orifice area index (0.8 cm2/m2 [IQR: 0.6–1] vs. 1.1 cm2/m2 [IQR: 0.8–1.3], p < 0.001). The median valve size was significantly smaller in the early group (median of 21 mm [IQR: 21–23] vs. 23 mm [IQR: 22.5–25], p < 0.001).ConclusionIn the contemporary era, surgical patients receive larger valves which translates into lower mean gradients, larger valve area, and lower rates of patient‐prosthesis mismatch than in previous years before the routine introduction of TAVR.

Contemporary trends and in-hospital outcomes of mechanical and bioprosthetic surgical aortic valve replacement in the United States.

The choice between a mechanical versus a bioprosthetic valve in aortic valve replacement (AVR) is based on life expectancy, bleeding risk and comorbidities, since bioprosthetic AVR (bAVR) are associated with a more rapid structural deterioration compared to mechanical AVR (mAVR). The impact of widespread transcatheter valve replacements, on the decision to use bAVR versus mAVR, in the contemporary era and subsequent outcomes remain to be determined. The National Inpatient database (2009-2018) was used to study trends in admissions for bAVR and mAVR and in-hospital mortality and outcomes over time. Survey estimation commands were used to determine weighted national estimates. There were 700,896 ± 18,285 inpatient visits for AVR with 70.1% (95% CI 69.2%-71.1%) and 29.9% (95% CI 28.9%-30.8%) visits for bAVR and mAVR, respectively. Those undergoing bAVR were significantly older (bAVR [69.8 years] vs. mAVR [62.7 years] p < .001]. The rates of mAVR decreased across all age groups during the study period (ptrend < .001), including patients ≤50 years (ptrend < .001). In-hospital mortality for mAVR recipients was higher, both after multivariable adjustment (OR 1.35 95% CI 1.26-1.45 p < .001) and propensity matching (mean difference 0.846% ± 0.19%). In the contemporary era, the utilization of mAVR has decreased across all age groups, including those younger than 50 years old. Although mAVR recipients were healthier with less comorbidities, inpatient mortality was higher after mAVR compared to bAVR. In addition to understanding causes for higher in-hospital mortality after mAVR, future research should focus on developing transcatheter valve replacement friendly bAVR.

Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients Aged ≤65 and >65 Years

BackgroundImplantation of a bioprosthetic valve is a reasonable choice for patients aged > 65 years. For middle-aged patients there is less certainty about whether a mechanical or bioprosthetic valve is best. MethodsThe Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial is evaluating the safety and efficacy of the Avalus bioprosthesis (Medtronic). We evaluated clinical and echocardiographic outcomes through 5 years of follow-up, stratified by age ≤ 65 and >65 years. ResultsTwo hundred seventy-one patients (24.2%) were ≤65 years old and 847 (75.8%) >65 years old. Most patients in both groups were men (217 [80.1%] vs 623 [73.6%], respectively; P = .031). Younger patients had a lower Society of Thoracic Surgeons risk of mortality (1.1% ± 0.9% vs 2.2% ± 1.4%, P < .001), better baseline New York Heart Association class (P = .004), and fewer comorbidities than older patients. At 5 years mortality was lower among younger than older patients (5.3% vs 14.0%, P < .001) and no cases of structural valve deterioration occurred in either group. Effective orifice area was similar between age groups (P = .11), and mean gradient was 13.9 ± 5.4 vs 12.0 ± 4.1 mm Hg (P < .001). Multivariable linear regression identified several parameters associated with mean aortic gradient at 5 years, including baseline age and mean aortic gradient, discharge stroke volume index and EOA, and implanted valve size. Ninety-five percent of patients were in New York Heart Association class I/II through 5 years in both age groups (P = .85). ConclusionsFindings from this analysis demonstrate satisfactory safety, hemodynamic performance, and durability of the Avalus bioprosthesis through a 5-year follow-up in patients aged ≤ 65 and >65 years.

Long-term durability after surgical aortic valve replacement with the Trifecta and the Intuity valve-a comparative analysis.

Long-term durability of surgical bio-prostheses is a key factor, especially in the era of transcatheter aortic valve replacement. We compared the incidence of structural valve deterioration (SVD) between patients undergoing surgical aortic valve replacement (SAVR) with the Trifecta (Abbott Laboratories, Abbott Park, IL, USA) or the Intuity valve (Edwards Lifesciences, Irvine, CA, USA). Between April 2010 and May 2020, 1118 patients underwent SAVR with the Trifecta (n = 346) and the Intuity (n = 772) valve at a single centre. A total of 1070 patients (Trifecta n = 298, Intuity n = 772) were analysed after the exclusion of patients with pure regurgitation and endocarditis. Retro- and prospective echocardiographic and clinical follow-up was performed. Cox proportional hazards regression models were performed to identify prognostic factors for SVD, aortic re-interventions and mortality. With 27 cases (Trifecta n = 23, Intuity n = 4) of SVD observed, cumulative incidence of SVD was significantly higher in the Trifecta cohort (P < 0.001). Implantation of a Trifecta valve [hazard ratio (HR) 11.20; 95% confidence interval 3.79-33.09], log-transformed preoperative creatinine (HR 2.47; 1.37-4.44) and sex (male HR 0.42; 0.19-0.92) emerged as prognostic factors of SVD. A significantly higher cumulative incidence of re-interventions was observed in the Trifecta cohort (P = 0.004) and valve type was an independent time-varying risk factor (HR at 12 months 2.78; 95% confidence interval 1.42-5.45). Overall, no significant differences in all-cause mortality were observed between the groups (log-rank test: P = 0.052). SVD was significantly more frequent in patients receiving a Trifecta valve and its implantation was an independent risk factor for the occurrence of SVD and aortic valve re-interventions. This comparative analysis of 2 low-gradient bioprosthesis put the long-term durability of the Trifecta valve in question and need to be taken into consideration when performing bioprosthetic SAVR.

Durability of bioprosthetic surgical aortic valve replacement: valve reintervention is only the tip of the iceberg.

Durability of bioprosthetic surgical aortic valve replacement: valve reintervention is only the tip of the iceberg.

Does the availability of transcatheter aortic valve replacement impact inpatient outcomes after surgical aortic valve replacement? Analysis of the national inpatient sample

Abstract Background With the introduction of transcatheter aortic valve replacement (TAVR), the treatment of aortic stenosis (AS) has experienced a paradigm shift, altering patient selection for surgical aortic valve replacement (SAVR) over the past decade. What remains to be determined is the impact of a hospital's ability to offer TAVR, in the contemporary era, on inpatient outcomes following SAVR. Purpose The goal of this study was to assess inpatient mortality and the use of mechanical aortic valve replacement (mAVR) in patients undergoing SAVR at TAVR versus non-TAVR centers in the United States. Methods The National Inpatient Sample (2011–18), a probability sample of inpatient visits in the United States, was used to study trends in admissions for SAVR at TAVR and non-TAVR centers; in-hospital mortality was trended over time. Survey estimation commands were used to determine weighted national estimates. Results There were 559,365 inpatient visits for SAVR with 75.2% (95% CI 74.2%-76.2%) and 24.7% (95% CI 23.8%-25.8%) receiving bioprosthetic SAVR (bAVR) and mAVR, respectively at TAVR centers and 64.5% (95% CI 63.3%-65.6%) and 35.5% (95% CI 34.4%-36.7%) receiving bAVR and mAVR, respectively at non-TAVR centers. SAVR recipients at non-TAVR centers were older when compared to recipients at TAVR centers (68.3±0.09 vs 66.9±0.11 years p&amp;lt;0.001). Heart failure, cardiac arrhythmias, peripheral vascular disorders, complicated hypertension and diabetes, renal failure and liver disease were more common in patients undergoing SAVR at TAVR-centers. During the study period, both crude (OR = 0.78 95% CI 0.73–0.83) and adjusted (OR = 0.79 95% CI 0.73–0.86) inpatient mortality was lower amongst SAVR recipients at TAVR centers. The utilization rates of mAVR at both TAVR and non-TAVR centers decreased over time amongst all age groups (p trend &amp;lt;0.001). Conclusions Patients undergoing SAVR at TAVR centers were younger and had more co-morbidities compared to patients undergoing SAVR at non-TAVR centers. Although patients undergoing SAVR at TAVR centers had significantly more co-morbidities, inpatient mortality was lower at TAVR centers compared to non-TAVR centers. Further research is needed to determine whether the impact of a multidisciplinary cardiac approach resulted in significant differences in patient selection for SAVR, due to the availability of TAVR, influencing patient outcomes. Funding Acknowledgement Type of funding sources: None.

Native Aortic Valve Disease Progression and Bioprosthetic Valve Degeneration in Patients With Transcatheter Aortic Valve Implantation.

Major uncertainties remain regarding disease activity within the retained native aortic valve, and regarding bioprosthetic valve durability, after transcatheter aortic valve implantation (TAVI). We aimed to assess native aortic valve disease activity and bioprosthetic valve durability in patients with TAVI in comparison with subjects with bioprosthetic surgical aortic valve replacement (SAVR). In a multicenter cross-sectional observational cohort study, patients with TAVI or bioprosthetic SAVR underwent baseline echocardiography, computed tomography angiography, and 18F-sodium fluoride (18F-NaF) positron emission tomography. Participants (n=47) were imaged once with 18F-NaF positron emission tomography/computed tomography either at 1 month (n=9, 19%), 2 years (n=22, 47%), or 5 years (16, 34%) after valve implantation. Patients subsequently underwent serial echocardiography to assess for changes in valve hemodynamic performance (change in peak aortic velocity) and evidence of structural valve dysfunction. Comparisons were made with matched patients with bioprosthetic SAVR (n=51) who had undergone the same imaging protocol. In patients with TAVI, native aortic valves demonstrated 18F-NaF uptake around the outside of the bioprostheses that showed a modest correlation with the time from TAVI (r=0.36, P=0.023). 18F-NaF uptake in the bioprosthetic leaflets was comparable between the SAVR and TAVI groups (target-to-background ratio, 1.3 [1.2-1.7] versus 1.3 [1.2-1.5], respectively; P=0.27). The frequencies of imaging evidence of bioprosthetic valve degeneration at baseline were similar on echocardiography (6% versus 8%, respectively; P=0.78), computed tomography (15% versus 14%, respectively; P=0.87), and positron emission tomography (15% versus 29%, respectively; P=0.09). Baseline 18F-NaF uptake was associated with a subsequent change in peak aortic velocity for both TAVI (r=0.7, P<0.001) and SAVR (r=0.7, P<0.001). On multivariable analysis, 18F-NaF uptake was the only predictor of peak velocity progression (P<0.001). In patients with TAVI, native aortic valves demonstrate evidence of ongoing active disease. Across imaging modalities, TAVI degeneration is of similar magnitude to bioprosthetic SAVR, suggesting comparable midterm durability. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02304276.

Reintervention rates following bioprosthetic surgical aortic valve replacement—a Danish Nationwide Cohort Study

Updated European guidelines recommend annual echocardiographic evaluation after bioprosthetic surgical aortic valve replacement (bio-SAVR). Given the increased demand on health care resources, only clinically relevant controls can be prioritized. We therefore aimed to explore reintervention rates following bio-SAVR. From the nationwide Danish Register of Surgical Procedures, we identified all patients ≥40 years with isolated bio-SAVR ± concomitant coronary artery bypass graft surgery (CABG) during 2000-2016. In 90-day reintervention-free survivors, we assessed aortic valve reintervention rates (primary outcome) and all-cause mortality rates (secondary outcome) at 1, 3 and 5 years with total follow-up until 31 December 2017 and further estimated annual theoretical echocardiographic control visits. In 10 518 patients with bio-SAVR (+CABG 39.7%), we observed low reintervention rates at 1, 3 and 5 years, but with high rates of all-cause mortality; i.e. 5-year reintervention rate of 3.7/1000 person-years (≤1.5%) and 5-year mortality rate of 21.7/1000 person-years. Accounting for the competing risk of death, 5-year rates were inversely related to age group and remained relatively low across all age categories but increased gradually in the long term. A significant proportion of reinterventions were presumed due to infectious endocarditis (48% at 3 years, 37% at 5 years). With annual transthoracic echocardiography, the theoretical ratio of echocardiographies per reintervention in the first 5 years was 248, and 425 when endocarditis events were excluded. Reintervention rates within the first 5 years following bio-SAVR were relatively rare, and with a substantial number due to endocarditis.