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Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P =.5336). TM-ViV patients were older (74.73 vs 72.2 years; P =.0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P =.0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P =.1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P <.0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P <.0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P =.0011), 30-day (OR, 3.76; P =.0180), and midterm mortality (OR, 4.30; P =.0378), irrespective of group. In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups. [ABSTRACT FROM AUTHOR]

Recent randomized controlled trials showed comparable short-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate and low-risk patients. However, independent studies comparing transcatheter aortic valve implantation results versus surgical aortic valve replacement at 5 years showed worsening outcomes in patients treated with transcatheter aortic valve implantation. The aim of this study was to analyze mid- to long-term outcomes of patients with isolated aortic stenosis and an intermediate-risk profile who underwent aortic valve replacement using a sutureless valve versus transcatheter aortic valve implantation. This retrospective multi-institutional European study investigated 2,123 consecutive patients with isolated aortic stenosis at intermediate risk profile treated with sutureless aortic valve replacement (824 patients) or transcatheter aortic valve implantation (1,299 patients) from 2013 to 2020. After 1:1 propensity score matching, 2 balanced groups of 517 patients were obtained. Primary endpoints were as follows: 30 days, late all-cause, and cardiac-related mortality. Secondary endpoints included major adverse cardiocerebrovascular events (all-cause death, stroke/transient ischemic attack, endocarditis, reoperation, permanent pacemaker implantation, and paravalvular leak grade ≥2). Median follow-up was 4.3 years (interquartile range 1.1–7.4 years). Primary endpoints were as follows—30-day mortality sutureless aortic valve replacement: 2.13% versus transcatheter aortic valve implantation: 4.64% (P =.026), all-cause mortality sutureless aortic valve replacement: 36.7% ± 7.8% vs transcatheter aortic valve implantation: 41.8% ± 8.2% (P =.023), and cardiac-related mortality sutureless aortic valve replacement: 10.2% ± 2.8% vs transcatheter aortic valve implantation: 19.2% ± 3.5%;(P =.00043) at follow-up. Secondary endpoints were as follows—major adverse cardiocerebrovascular events in the sutureless aortic valve replacement group: 47.2% ± 9.0% versus transcatheter aortic valve implantation: 57.3% ± 7.5% (P <.001). In particular, the incidence of permanent pacemaker implantation (sutureless aortic valve replacement: 6.38% versus transcatheter aortic valve implantation: 11.8% [ P =.002]) and paravalvular leak ≥2 (sutureless aortic valve replacement: 0.97% versus transcatheter aortic valve implantation: 4.84% [ P =.001]) was significantly higher in transcatheter aortic valve implantation group. At Multivariable Cox regression analysis, paravalvular leak ≥2 (hazard ratio: 1.63%; 95% confidence interval: 1.06–2.53, P =.042) and permanent pacemaker implantation (hazard ratio: 1.49%; 95% confidence interval: 1.02–2.20, P =.039) were identified as predictors of mortality. Sutureless aortic valve replacement showed a significantly lower incidence of all-cause mortality, cardiac-related death, permanent pacemaker implantation, and paravalvular leak than transcatheter aortic valve implantation. Moreover, permanent pacemaker implantation and paravalvular leak negatively affected survival in patients treated for isolated aortic stenosis. [ABSTRACT FROM AUTHOR]

To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes. Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 definition for bioprosthetic valve failure was applied. A Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2% were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3% (range, 2.1%-6.2%), and 33.4% had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9% vs 1.9% for small and 55.1% vs 19.5% for medium; P <.001). The mean aortic valve gradients decreased significantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient–prosthesis mismatch (with an effective orifice area/m2 of >0.8). Significant LV mass regression was documented regardless valve sizes, plateaued at -9.1% at 5 years. Freedom from SVD and reintervention were 95.2% and 96.3%, respectively, at 5 years and were independent of implanted valve size (P =.22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8% at 5 years. The Perceval valve demonstrated low and stable mean gradients, significant LV mass regression, and low SVD and reintervention rates across all valve sizes. [Display omitted] [ABSTRACT FROM AUTHOR]

Left ventricular free-wall rupture (LVFWR) is an uncommon but serious mechanical complication of acute myocardial infarction. Surgical repair, though challenging, is the only definitive treatment. Given the rarity of this condition, however, results after surgery are still not well established. The aim of this study was to review a multicenter experience with the surgical management of post-infarction LVFWR and analyze the associated early outcomes. Using the CAUTION (Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study) database, we identified 140 patients who were surgically treated for post–acute myocardial infarction LVFWR in 15 different centers from 2001 to 2018. The main outcome measured was operative mortality. Multivariate analysis was carried out by constructing a logistic regression model to identify predictors of postoperative mortality. The mean age of patients was 69.4 years. The oozing type of LVFWR was observed in 79 patients (56.4%), and the blowout type in 61 (43.6%). Sutured repair was used in the 61.4% of cases. The operative mortality rate was 36.4%. Low cardiac output syndrome was the main cause of perioperative death. Myocardial rerupture after surgery occurred in 10 patients (7.1%). Multivariable analysis revealed that preoperative left ventricular ejection fraction (P <.001), cardiac arrest at presentation (P =.011), female sex (P =.044), and the need for preoperative extracorporeal life support (P =.003) were independent predictors for operative mortality. Surgical repair of post-infarction LVFWR carries a high operative mortality. Female sex, preoperative left ventricular ejection fraction, cardiac arrest, and extracorporeal life support are predictors of early mortality. [ABSTRACT FROM AUTHOR]

Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P <.0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program. [ABSTRACT FROM AUTHOR]

Reoperation for aortic valve replacement can be challenging and is usually associated with an increased risk for complications and mortality. The study aim was to report the results of a multicenter cohort of patients who underwent minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis. From 2007 to 2018 data from 3651 patients were retrospectively collected from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry. Of them, 63 patients who had previously undergone cardiac surgery represented the study population. In-hospital clinical and echocardiographic outcomes were recorded. Mean age of the selected 63 patients was 75.3 ± 7.8 years and logistic EuroSCORE 10.1. Surgery was performed by ministernotomy in 43 patients (68.3%) and by anterior right thoracotomy in 20 (31.7%); 31 patients (49.2%) received the Perceval valve (Livanova PLC, London, UK) and 32 (50.8%) the Intuity valve (Edwards Lifesciences, Irvine, CA). Mean cross-clamp time was 57.8 ± 23.2 minutes and cardiopulmonary bypass time 95.0 ± 34.3 minutes. Neither conversion to full sternotomy nor in-hospital deaths occurred. Postoperative events were ischemic cerebral events in 3 patients (4.8%), need for pacemaker implantation in 2 (3.6%), bleeding requiring reoperation in 5 (8.9%), and dialysis in 1 (1.6%). Median intensive care unit stay was 1 day, and median length of hospital stay was 10 days. On echocardiographic evaluation 1 patient showed a significant postoperative aortic regurgitation. Minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis is a safe and feasible treatment strategy, resulting in fast recovery and improved postoperative outcome with no mortality and an acceptable complication rate. [ABSTRACT FROM AUTHOR]

Aortic valve calcification is supposed to be a possible cause of embolic stroke or subclinical valve thrombosis after transcatheter aortic valve replacement (TAVR). We aimed to assess the role of aortic valve calcification in the occurrence of in-hospital clinical complications and survival after TAVR. We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent TAVR on the native aortic valve in our center. Calcium volume was calculated for each aortic cusp, above and below the aortic annulus. Outcomes were recorded according to VARC-2 criteria. Overall, 581 patients were included in the study (SapienXT = 192; Sapien3 = 228; CoreValve/EvolutR = 45; Engager = 5; Acurate = 111). Median survival was 4.98 years (interquartile range 4.41–5.54). Logistic regression identified calcium load beneath the right coronary cusp in left ventricular outflow tract (LVOT) as significantly associated with stroke (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.03–1.3; p = 0.0019) and in-hospital mortality (OR 1.1; 95% CI 1.004–1.2; p = 0.04), whereas total calcium volume of the LVOT was associated with both in-hospital and 30 day-mortality (OR 1.2; 95% CI 1.01–1.4; p = 0.03, and OR 1.2; 95% CI 1.02–1.43; p = 0.029, respectively). Cox regression identified total calcium of LVOT (hazard ratio [HR] 1.18; 95% CI 1.02–1.38; p = 0.026), male sex (HR 1.88; 95% CI 1.06–3.32; p = 0.031), baseline creatinine clearance (HR 0.96; 95% CI 0.93–0.98; p < 0.001), and baseline severe aortic regurgitation (HR 7.48; 95% CI 2.76–20.26; p < 0.001) as risk factors associated with lower survival. LVOT calcification is associated with increased risk of peri-procedural stroke and mortality as well as shorter long-term survival. [ABSTRACT FROM AUTHOR]

Several studies reported high rates of postoperative permanent pacemaker (PPM) implantation, which has been described as the "Achilles' heel" of sutureless aortic valve replacement (AVR). From July 2010 to December 2017, 3,158 patients with symptomatic, severe aortic valve stenosis were referred to the Department of Cardiac Surgery (Klinikum Nürnberg - Paraclesus Medical University, Nuremberg, Germany), and 512 received a Perceval sutureless bioprosthesis (LivaNova PLC, London, United Kingdom). Thirty-nine patients who had been discharged with concomitant PPM implantation were reevaluated. After a cumulative follow-up of 1,534 months (100% complete, median 50 months, interquartile range 30 months, maximum 76 months, minimum 3 months), a total of 22 patients were still pacemaker dependent. Kaplan-Meier analysis showed pacemaker-dependent rhythm in 92.0%, 80.0%, 49.4%, and 32.3% of patients at 1, 2, 4, and 5 years, respectively. At Cox regression analysis, pressure during valve deployment (hazard ratio, 79.41; p = 0.0003) and "late-onset" atrioventricular block were found to be independent predictors of sinus rhythm restoration (hazard ratio, 0.16; p = 0.0061). Log-rank test showed significantly lower pacemaker dependency rates in patients with "low-pressure" prosthesis implantation (p < 0.0001). This study shows that several technical measures, including appropriate annulus decalcification, precise positioning of guiding sutures, release of traction sutures applied to the valve commissures, and ballooning with reduced pressure, all reduce the rate of PPM implantation after sutureless AVR. Furthermore, a high proportion of patients were found to be no longer pacemaker dependent at follow-up. [ABSTRACT FROM AUTHOR]

Background Bilateral internal mammary artery (BIMA) grafting is increasingly used in elderly patients without evidence of its risks or benefits compared with single internal mammary artery (SIMA) grafting. Methods In all, 2,899 patients aged 70 years or older (855 [29.5%] underwent BIMA grafting) operated on from January 2015 to December 2016 and included in the prospective multicenter Outcome After Coronary Artery Bypass Grafting (E-CABG) study were considered in this analysis. Results One-to-one propensity matching resulted in 804 pairs with similar preoperative risk profile. Propensity score matched analysis showed that BIMA grafting was associated with a nonstatistically significant increased risk of inhospital death (2.7% versus 1.6%, p = 0.117). The BIMA grafting cohort had a significantly increased risk of any sternal wound infection (7.7% versus 5.1%, p = 0.031) as well as higher risk of deep sternal wound infection/mediastinitis (4.0% versus 2.2%, p = 0.048). The BIMA grafting cohort required more frequently extracorporeal membrane oxygenation (1.0% versus 0.1%, p = 0.02), and the intensive care unit stay (mean 3.6 versus 2.6 days, p < 0.001) and inhospital stay (mean 11.3 versus 10.0 days, p < 0.001) were significantly longer compared with the SIMA grafting cohort. Test for interaction showed that urgent operation in patients undergoing BIMA grafting was associated with higher risk of inhospital death (5.6% versus 1.3%, p = 0.009). Conclusions Bilateral internal mammary artery grafting in elderly patients seems to be associated with a worse early outcome compared with SIMA grafting, particularly in patients undergoing urgent operation. Until more conclusive results are gathered, BIMA grafting should be reserved only for elderly patients with stable coronary artery disease, without significant baseline comorbidities and with long life expectancy. [ABSTRACT FROM AUTHOR]

The sutureless Perceval aortic valve (Sorin Group, Saluggia, Italy) is a device increasingly used in many European cardiac surgery centers. Since the first reports evaluating implantation feasibility and valve safety in humans in 2007, an increasing amount of data have become available, including premarketing clinical results and experience in particular conditions. Overall, excellent performances have been demonstrated in hemodynamic outcomes, safety, and versatility of use. However, several questions remain unanswered, especially regarding long-term durability, risk for endocarditis, and the need for postoperative pacemaker implantation. In this article, the most important studies published until now in the literature will be described, providing a state-of-the-art overview of current knowledge as well as future directions and indications for the use of the Perceval valve based on preliminary results of ongoing studies. [ABSTRACT FROM AUTHOR]

Background The Freedom Solo (FS) bovine pericardial valve (Sorin Group, Milan, Italy) is a stentless bioprosthesis that was introduced in 2004 and approved by the United States Food and Drug Administration in 2014. No long-term follow-up series are available to date. We report the multicenter experience of 4 European institutions that began implanting FS extensively from its introduction, providing the largest series with long-term follow-up. Methods From 2004 to 2009, 565 patients (242 women [42.8%]; mean age, 74.6 ± 8.3 years) underwent isolated (n = 350) or combined (n = 215) aortic valve replacement with the FS. Mean follow-up, including clinical and strict echocardiographic evaluation, was 6.9 ± 3.7 years (maximum, 11.8 years; cumulative 2,965 patient-years). Primary end point was freedom from structural valve deterioration (SVD), and secondary end points were freedom from reoperation and overall survival. Results Mean logistic European System for Cardiac Operative Risk Evaluation I was 10.3% ± 6.7%. Overall 30-day mortality was 3.7%, and no deaths were valve related. There was no severe prostheses-patient mismatch, and moderate prostheses-patient mismatch occurred only in 1 patient (0.17%). Twenty-eight patients (5.2%) underwent reoperation (20 surgical replacements, 8 transcatheter aortic valve-in-valve replacements) due to endocarditis in 9, blunt trauma in 1, and SVD in 18. SVD was reported in 5 other patients alive at time of censoring. Freedom from SVD and reoperation was 90.8% (95% confidence interval, 89.1% to 92.5%) and 87.3% (95% confidence interval, 85.6% to 89.0%), respectively, at 10 years of follow-up, and the overall actuarial survival was 56.4% (95% confidence interval, 53.3% to 59.5%). Conclusions The FS valve provided excellent long-term durability and hemodynamic performance in this large, multicenter European experience. Moreover, the FS, given the low rate of SVD, along with a simple implantability, proved to be a reliable bioprosthesis in the aortic position as a valid alternative to stented bioprostheses. [ABSTRACT FROM AUTHOR]

Background: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial. Ticagrelor, an oral, reversibly binding and direct-acting P2Y12 receptor antagonist, provides a rapid, competent, and consistent platelet inhibition and has shown beneficial results compared with clopidogrel in the subset of patients undergoing bypass surgery in a large previous trial.Hypothesis: Ticagrelor is superior to ASA for the prevention of major cardiovascular events within 1 year after CABG.Study Design: The TiCAB trial (NCT01755520) is a multicenter, phase III, double-blind, double-dummy, randomized trial comparing ticagrelor with ASA for the prevention of major cardiovascular events within 12 months after CABG. Patients undergoing CABG will be randomized in a 1:1 fashion to either ticagrelor 90 mg twice daily or ASA 100 mg once daily. The study medication will be started within 24 hours after surgery and maintained for 12 months. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, and repeat revascularization at 12 months after CABG. The sample size is based on an expected event rate of 13% of the primary end point within the first 12 months after randomization in the control group, a 2-sided α level of .0492 (to preserve the overall significance level of .05 after planned interim analysis), a power of 0.80%, 2-sided testing, and an expected relative risk of 0.775 in the active group compared with the control group and a dropout rate of 2%. According to power calculations based on a superiority design for ticagrelor, it is estimated that 3,850 patients should be enrolled.Summary: There is clinical equipoise on the issue of optimal platelet inhibition after CABG. The TiCAB trial will provide a pivotal comparison of the efficacy and safety of ticagrelor compared with ASA after CABG. [ABSTRACT FROM AUTHOR]

Prone positioning is a therapeutic maneuver to improve arterial oxygenation in patients with acute lung injury that is not implemented in most centers performing adult cardiac surgery. The aim of this study was to review our experience with prone positioning to assess the effects of this maneuver in patients with postoperative acute respiratory failure. From 2010-2014, 127 adult patients with postoperative acute respiratory failure were treated with prone positioning in addition to specific therapy. Univariate and multivariate logistic regression analyses were performed to identify independent risk factors associated with in-hospital mortality. In-hospital mortality was 22.8% (n = 29). No significant differences were observed in preoperative risk factors between patients who survived (S) and those who died (D), except for age (62.7 ± 11.2 vs 70.2 ± 11.3; P = 0.007-at multivariate analysis P = 0.03, odds ratio [OR] = 1.1/year). Preproning values of PaO2/FiO2 were significantly different between groups (D vs S: 115 ± 46 vs 150 ± 56; P = 0.006), but only preproning FiO2 remained highly significant at multivariate analysis (D vs S: 0.82 ± 0.18 vs 0.67 ± 0.16; P = 0.001, OR = 1.07; with FiO2 > 0.75 vs < 75, OR = 19.6). D showed a higher improvement of PaO2/FiO2 immediately after prone positioning (207 ± 100 vs 219 ± 90, P = 0.56; within-group analysis between preproning and 1 hour after proning: S-P = 0.49, D-P = 0.019; at 12 hours: 286 ± 123 vs 240 ± 120, P = 0.06; within-group analysis between 1 hour and 12 hours after proning: S-P = 0.15; D-P = 0.17; between groups-P = 0.05). D had higher peak WBC count (26 ± 9.8 vs 17.7 ± 5.9×103/mL; P = 0.0001) and a higher rate of low output syndrome (15 vs 9 patients-51.7% vs 9.2%; P = 0.0001). At multivariate analysis, white blood cell count: P = 0.005, OR = 1.11/103 white blood cell; low output syndrome: P = 0.0002, OR = 20.5. In conclusion, our results show that prone positioning, if performed early, is a safe and effective adjunct measure for patients with postoperative acute hypoxemic respiratory failure of noncardiogenic origin. [ABSTRACT FROM AUTHOR]

The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance. Despite the advanced age of the study population, with an intermediate risk profile, mortality and morbidity rates at 5 years compare with those reported in both arms of recent trials that have compared transcatheter and surgical valves in similar risk populations. CAVALIER , Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark; DSMB , Data Safety Monitoring Board; CEC , Clinical Event Committee; Echo , echocardiography; SD , standard deviation; STS , Society of Thoracic Surgeons; CI , confidence interval; AVR , aortic valve replacement. [Display omitted] [ABSTRACT FROM AUTHOR]

Background Annular stabilization is important during bicuspid aortic valve (BAV) repair to obtain the best long-term results. This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose. Methods Under regulatory supervision (NCT02071849), a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients. Three patients had Sievers type 0 valves, 11 had Sievers type 1, and 2 had Sievers type 2. Thirteen patients had left-/right-coronary cusp fusion, 1 had right-/noncoronary cusp fusion, and 2 had both. Moderate to severe aortic insufficiency (AI) was present in 13 of 16 patients, and 3 had mild AI with aortic aneurysms. Ascending aortic aneurysms, root aneurysms, or both were replaced in 7 of 16 patients. The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissural posts positioned opposite on the circumference. The ring was implanted into the annulus beneath the valve, and then leaflet repair was performed. Results Immediate postrepair echocardiograms showed grade 0 residual AI in all patients, with good cusp mobility and effective height, and satisfactory gradients. There were no in-hospital or late mortalities. Two patients experienced leaflet tears from long annular suture tails, requiring late valve replacement. After implementation of a lateral suture fixation technique, no more failures occurred. At a mean follow-up time of 9 months, the remaining 14 patients were in New York Heart Association class I, with predominant grade 0 AI. Conclusions As a technique for BAV repair, internal ring annuloplasty produces major annular remodeling and stabilization. Annular reduction and reshaping to a 50/50% symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation. Geometric ring annuloplasty could have useful applications in BAV repair. [ABSTRACT FROM AUTHOR]

Background The aim of this study was to analyze early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) with the sutureless Perceval bioprosthesis (Sorin Biomedica Cardio Srl, Salluggia, Italy) performed through ministernotomy compared with full sternotomy. Methods This was a study of 267 consecutive patients who underwent isolated AVR with the sutureless Perceval bioprosthesis between 2007 and 2014 at 6 European centers. Of these, 189 (70.8%) were performed through ministernotomy and 78 through a full sternotomy. Propensity score matching was used to reduce selection bias. Results In the overall cohort of ministernotomy and full sternotomy patients, in-hospital mortality was 1.1% and 2.6% and 2-year survival was 92% and 91%, respectively. Propensity score matching resulted in 56 pairs with similar characteristics and operative risk. Aortic cross-clamp (44 minutes in both groups, p = 0.931) and cardiopulmonary bypass time (69 vs 74 minutes, p = 0.363) did not differ between the groups. Apart from higher values in the ministernotomy group for postoperative peak gradients (28.1 vs 23.3 mm Hg, p = 0.026) and mean aortic valve gradients (15.2 vs 11.7 mm Hg, p = 0.011), early postoperative outcomes did not differ in the propensity-matched cohort. There were no differences in the in-hospital mortality rate or 2-year survival between the groups. Conclusions AVR with the sutureless Perceval bioprosthesis through a ministernotomy was a safe and reproducible procedure that was not associated with prolonged aortic cross-clamp or cardiopulmonary bypass time compared with a full sternotomy. Early postoperative outcomes and 2-year survival were comparable between patients undergoing ministernotomy and full sternotomy. [ABSTRACT FROM AUTHOR]

Objective: The aim of our study was to evaluate the early outcomes and 1-year survival of patients undergoing minimally invasive aortic valve replacement with the Perceval S sutureless valve for severe aortic stenosis. Methods: From March 2010 to March 2013, 281 high-risk patients underwent minimally invasive aortic valve replacement with the Perceval S sutureless valve through either right anterior minithoracotomy (n = 164) or upper ministernotomy (n = 117) at 2 cardiac centers. Results: The overall in-hospital mortality was 0.7% (2 patients). The overall median cardiopulmonary bypass and crossclamp time was 81 minutes (interquartile range, 68-98) and 48 minutes (interquartile range, 37-60), respectively. Postoperative stroke occurred in 5 patients (1.8%). The incidence of paravalvular leak greater than 1 of 4 and atrioventricular block requiring pacemaker implantation was 1.8% (5 patients) and 4.2% (12 patients), respectively. No migration occurred, and the mean postoperative gradient was 13 ± 4 mm Hg. At a median follow-up of 8 months (interquartile range, 4-14), the overall survival was 90%. Conclusions: Minimally invasive aortic valve replacement with the Perceval S sutureless valve in high-risk patients is a safe and reproducible procedure associated with excellent hemodynamic results, postoperative outcomes, and 1-year survival. [ABSTRACT FROM AUTHOR]

Background Refining leaflet reconstruction has become a primary issue in aortic valve repair. This descriptive analysis reviews leaflet pathology, repair techniques, and early results in a prospective regulatory trial of aortic valve repair. Methods Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency (AI). The mean age was 63 ± 13 years, and 69% of the patients were male. Ascending aortic/root replacement was required in 62%. As a first step, ring annuloplasty was performed, and then leaflet repair included leaflet plication for prolapse, nodular unfolding, double pericardial patching of commissural defects or holes, complete pericardial leaflet replacement, leaflet extension, and Gore-Tex reinforcement. Leaflet techniques and causes of adverse outcomes were evaluated. Results The follow-up time was 2-years maximal and 0.9 years mean, with a survival of 97%. Eighty percent of patients required repair of leaflet defects: leaflet prolapse (52/65–80%), ruptured commissures (6/65–9%), leaflet holes (4/65–6%), and nodular retraction (6/65–9%). The average preoperative AI grade of 2.9 ± 0.8 fell to 0.7 ± 0.7 ( p < 0.0001). Three patients (4.6%) required interval valve replacement because of (1) suture untying, (2) iatrogenic leaflet tear, or (3) diphtheroid endocarditis. Five other patients experienced grade 2 or grade 3 AI: probable suture untying in 1 patient, ineffective leaflet extensions in 2 patients, and unsuccessful Gore-Tex reinforcements in 2 patients. Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well. Conclusions Leaflet defects are common in patients with moderate to severe AI. Leaflet plication, nodular unfolding, and double pericardial patching performed well. Gore-Tex and leaflet extension seemed less satisfactory. Standardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy). Methods This is a retrospective analysis of 314 patients (mean age, 77.9 ± 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% ± 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers. Results The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 ± 20 minutes (isolated procedure, 39 ± 15 minutes; concomitant coronary surgery, 52 ± 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2% (1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively (P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively. Conclusions The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis. [ABSTRACT FROM AUTHOR]

Background Sutureless aortic valve prostheses have the potential of shortening ischemic time. However, whether shorter operative times may also result in improved patient outcomes and have an effect on hospital costs remains to be established. Methods From March 2010 to April 2013, 566 patients underwent aortic valve replacement with bioprostheses; of these, 166 received a sutureless valve, and 400 received a stented valve. Redo and associated procedures were included. A propensity-score analysis was used to create two groups (sutureless and stented) with 82 matched pairs with comparable preoperative characteristics. Hospital outcome, follow-up, and health care resource consumption were compared. Results There were 3 hospital deaths in the stented group and 2 in the sutureless group (p = 0.65). Aortic cross-clamp, cardiopulmonary bypass, and operation times were significantly shorter in the sutureless group (p < 0.001). Patients in the sutureless group required blood transfusion less frequently (1.2 ± 1.3 vs 2.5 ± 3.7 units, p = 0.005), with a similar need for reexploration for bleeding (2 vs 5, p = 0.221). The sutureless group had a shorter intensive care unit stay (2.0 ± 1.2 vs 2.8 ± 1.3 days, p < 0.001), hospital stay (10.9 ± 2.7 vs 12.4 ± 4.4 days, p = 0.001) and intubation time (9.5 ± 4.6 vs 16.6 ± 6.4 hours, p < 0.001), and a lower incidence of postoperative atrial fibrillation (p = 0.015), pleura effusions (p = 0.024), and respiratory insufficiency (p = 0.016). Pacemaker implantation and occurrence of neurologic events were similar between groups (p > 0.05). A lower rate of postoperative complications resulted in reduced resource consumption in the sutureless group for diagnostics (€2,153 vs €1,387), operating room (€5,879 vs €5,527), and hospital stay (€9,873 vs €6,584), with a total cost saving of approximately 25% (€17,905 vs €13,498). Conclusions A shorter procedural time in the sutureless group is associated with better clinical outcomes and reduced hospital costs. [ABSTRACT FROM AUTHOR]

Objective: This propensity-matched study compared clinical and echocardiographic outcomes between patients undergoing transcatheter aortic valve implantation (TAVI) and sutureless aortic valve replacement. Methods: From January 2010 to March 2012, 122 patients (age 79.4 ± 5.3 years, logistic euroSCORE 12% ± 8.4%) underwent minimally invasive sutureless aortic valve replacement, and 122 (age 84.6 ± 6.2 years, logistic euroSCORE 20.9% ± 2.5%) underwent TAVI. After propensity matching, 37 matched pairs were available for analysis. Results: Preoperative characteristics and risk scores of matched groups were comparable. In-hospital mortalities were 0% in the sutureless group and 8.1% (n = 3) in the TAVI group (P = .24). Permanent pacemaker implantation was required in 4 patients in the sutureless group and 1 patient in the TAVI group (10.8% vs 2.7%; P = .18). A neurologic event was recorded in 2 patients of each group. Predischarge echocardiographic data showed higher paravalvular leak rate in the TAVI group (13.5% vs 0%; P = .027). At mean follow-up of 18.9 ± 10.1 months, overall cumulative survival was 91.9% and significantly differed between groups (sutureless 97.3% vs TAVI 86.5%; P = .015). In the TAVI group, a significant difference in mortality was observed between patients with (n = 20) and without (n = 17) paravalvular leak (25% vs 0%; P = .036). Conclusions: Combining the advantage of standard diseased valve removal with shorter procedural times, minimally invasive sutureless aortic valve replacement may be the first-line treatment for high-risk patients considered in the “gray zone” between TAVI and conventional surgery. [Copyright &y& Elsevier]

Background: Octogenarians undergoing surgical aortic valve replacement (AVR) after prior cardiac surgery are expected to be at high risk of adverse events. This finding has recently popularized transcatheter AVR in this cohort. Methods: This multicenter study includes 744 patients (99 were 80 years or older) who underwent surgical AVR after prior cardiac surgery. The outcome of octogenarians was compared with younger patients in the entire cohort and in a propensity score–matched population. Results: Octogenarians and younger patients had similar immediate outcome (in-hospital mortality, 3.0% versus 5.9%; p = 0.34; stroke, 5.1% versus 6.7%; p = 0.66; dialysis, 9.1% versus 6.5%; p = 0.34), as confirmed also in 84 propensity score–matched pairs. Octogenarians and younger patients had similar late survival (5-year survival, 83.1% versus 78.0%; p = 0.68; propensity score–adjusted relative risk [RR], 0.23; 95% confidence interval [CI], 0.59 to 1.88). Octogenarians and younger patients had similar freedom from heart failure episodes (at 5 years, 84.5% versus 89.2%; p = 0.311; propensity score–adjusted RR, 1.37; 95% CI, 0.62 to 3.04) and from reoperation (at 5 years, 94.9% versus 97.9%; p = 0.51; propensity score–adjusted RR, 1.93; 95% CI, 0.35 to 10.56). However, octogenarians had poorer freedom from late stroke (at 5 years, 89.8% versus 97.5%; p = 0.016; propensity score–adjusted RR, 6.137; 95% CI, 1.776 to 21.208) and peripheral thromboembolism (at 5 years, 90.0% versus 98.2%; p = 0.003; propensity score–adjusted RR, 4.00; 95% CI, 1.07 to 15.00). Conclusions: Octogenarians undergoing surgical AVR after prior cardiac surgery have similar immediate postoperative outcome as younger patients, and their 5-year outcome is excellent. These data suggest that indications to undergo transcatheter AVR should not rely only on coexistence of advanced age and history of prior cardiac surgery. [Copyright &y& Elsevier]

Background. Sutureless aortic valve prostheses have the potential of shortening surgical time. However, whether shorter operative times may also result in improved patient outcomes remains to be established. Methods. One hundred patients underwent minimally invasive isolated aortic valve replacement. Of these, 50 patients received a Perceval (Sorin Group, Saluggia, Italy) bioprosthesis (group P) and 50 patients received a non-Perceval valve (group NP). Results. The group P patients were older (77.5 ± 5.3 versus 71.7 ± 10 years, p = 0.001) and at higher risk (logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE] 9.9 ± 6.5 versus 4.3 ± 1, p = 0.001) than group NP patients. One implant failure occurred in group P (p = 0.5), and conversion to full sternotomy was necessary in 1 patient from each group. Aortic cross-clamp and cardiopulmonary bypass times were 39.4% and 34% shorter in group P (both p < 0.001). Within 30 days, a total of 5 patients died (2 in group P and 3 in group NP, p = 0.5). No significant differences were observed between groups in postoperative arrhythmias and need for pacemaker implantation (p = 0.3 and p = 0.5, respectively). Despite the higher surgical risk, group P patients less frequently required blood transfusion (1.1 ± 1.1 units versus 2.3 ± 2.8 units, p = 0.007), and had a shorter intensive care unit stay (1.9 ± 0.7 versus 2.8 ± 1.9 days, p = 0.002) and a shorter intubation time (9.2 + 3.6 hours versus 15 + 13.8 hours, p = 0.01). Group NP patients had a mean prosthesis size significantly smaller than for group P (23 ± 2 mm versus 23.9 ± 1.1 mm, p = 0.01). The Perceval valve provided comparable hemodynamic performance to that of non-Perceval valves (mean gradient 8.4 ± 6 mm Hg versus 10 ± 4.9 mm Hg, p = 0.24). Conclusions. Sutureless implantation of the Perceval valve is associated with shorter cross-clamp and cardiopulmonary bypass times, resulting in improved clinical outcome. In addition, it compares favorably with conventional valves in terms of mortality and outcome variables. [ABSTRACT FROM AUTHOR]

Background: Sutureless aortic bioprostheses bear the potential of easy implantation, reduced ischemic time, and surgical trauma in aortic valve replacement. We herein show our clinical and echocardiographic results after a 1-year experience with a new sutureless bioprosthesis. Methods: The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center. Results: The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a “J” sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10. ± 7.5%, mean aortic cross-clamp time was 43.8 ± 20.8 minutes (36 ± 12.7 minutes for isolated procedures). Mean implantation time was 8 ± 3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5 ± 4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0 ± 0.6. Mean transprosthetic gradients were 13.4 ± 2.8, 12.6 ± 2.3, and 10.8 ± 1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively. Conclusions: The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time. [ABSTRACT FROM AUTHOR]

This multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation. From 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation). After matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P =.024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P =.032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P =.010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P <.001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P =.006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P =.002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P =.022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P =.010). Sutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort. [ABSTRACT FROM AUTHOR]

The HAART 300 (BioStable Science and Engineering, Austin, TX) is a rigid, elliptical device introduced to facilitate aortic valve repair providing annular stabilization in the setting of aortic regurgitation. Percutaneous strategies have been described for patients with dysfunctional biological prostheses or recurrence insufficiency after mitral ring annuloplasty. This report shows the feasibility of aortic valve-in-ring transcatheter aortic valve replacement (TAVR). The sufficient ring stability to support the implanted TAVR-prosthesis and the fact that the elliptical shape of the HAART-ring did not result in a problem concerning paravalvular leakage were important for the success of this procedure. [ABSTRACT FROM AUTHOR]

Abstract Objective To assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation in a large single-center cohort, including measurement of aortic valve calcification using a reproducible method. Methods We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent transcatheter aortic valve implantation in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve, left ventricular outflow tract, and device landing zone. Results Overall, 539 patients were included in the study who had experience with 4 prothesis types (SapienXT [Edwards Lifesciences, Irvine, Calif] [n = 192], Sapien3 [Edwards Lifesciences] [n = 206], CoreValve EvolutR [Medtronic, Minneapolis, Minn] [n = 44], and Acurate [Symetis, Ecublens, Switzerland] [n = 97]). Median calcium volume in the device landing zone was 757 mm3, with no significant differences among the 4 prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8% (95% confidence interval [CI], 12.8%-19.1%). On multivariate logistic regression, device landing zone calcification (P =.00006; odds ratio for an increase of 100 mm3, 1.08; 95% CI, 1.04-1.13) and use of the CoreValve (P =.0028; odds ratio, 4.1; 95% CI, 1.6-10 with SapienXT as reference) prosthesis were found to be associated with mild or greater PVL. In contrast, degree of oversizing (P =.002; odds ratio, 0.97; 95% CI, 0.95-0.99), and use of Sapien3 (P =.00005; odds ratio, 0.23; 95% CI, 0.11-0.47 with SapienXT as reference) were associated with a lower incidence of mild or greater PVL. Conclusions Aortic calcification volume in the device landing zone is associated with residual PVL after transcatheter aortic valve implantation. When taking calcification into account, the balloon-expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL. [ABSTRACT FROM AUTHOR]

Objective Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. The aim of the current multi-institutional study was to compare hemodynamics of transcatheter (TAVR) and the Freedom SOLO Stentless (FS) valve in an intermediate risk population undergoing surgical aortic valve replacement. Methods From 2010 to 2014, 420 consecutive patients underwent isolated surgical aortic valve replacement with FS and 375 patients underwent TAVR. Only patients with intermediate operative risk (Society of Thoracic Surgeons score 4-10) and small aortic annulus (≤23 mm) were included. After a propensity matched analysis 142 patients in each group were selected. Thirty-day postoperative clinical and echocardiographic parameters were evaluated. Results Mean prosthesis diameter was 22.2 ± 0.9 mm for FS and 22.4 ± 1.0 mm for TAVR. In-hospital mortality was 2.1% for FS and 6.3% for TAVR ( P = .02). Postoperative FS peak gradients were 19.1 ± 9.6 mm Hg (mean 10.8 ± 5.9 mm Hg); TAVR peak gradients were 20.2 ± 9.5 mm Hg (mean 10.7 ± 6.9 mm Hg) P = .57 ( P = .88). Postoperative effective orifice area was 1.93 ± 0.52 cm 2 for FS and 1.83 ± 0.3 cm 2 for TAVR ( P = .65). There was no prostheses-patient mismatch in either group. Postoperative grade 2-3 paravalvular leak was present in 3.5% for TAVR and 0.7% for FS. Postoperative permanent pacemaker implant rate was 12% for TAVR and only 1 case (0.7%) in the FS group ( P < .001). Conclusions In patients with small aortic annulus and intermediate risk, both FS and TAVR demonstrated similar excellent hemodynamic performance. TAVR demonstrated greater mortality and rates of pacemaker insertion. Further studies are warranted to validate TAVR indications in this subset of patients. [ABSTRACT FROM AUTHOR]