Long-term outcomes of concomitant transcatheter aortic valve implantation and percutaneous coronary intervention.

BACKGROUND: The safety of concomitant percutaneous coronary intervention (PCI) during transcatheter aortic valve implantation (TAVI) setting is still highly debated. This study aimed to assess the safety and the effectiveness of TAVI and PCI performed in the same session compared with TAVI alone. METHODS: Patients with severe aortic stenosis and coronary artery disease (CAD) (N.=786) who underwent TAVI from June 2007 to April 2021 were divided into two groups: patients who underwent TAVI alone (N.=633) and patients treated with TAVI and concomitant PCI (N.=153). The propensity-score matching adjustment was used to account for baseline confounding variables. RESULTS: A total of 302 TAVI with CAD patients (151 matched pairs), undergoing either isolated TAVI or TAVI+PCI were compared. In-hospital death (6% vs. 4%; P=0.427), stroke (2% vs. 0.7%; P=0.314), myocardial infarction (MI) (0% vs. 0.7%; P=0.317), major and life-threatening bleeding (14.6% vs. 15.9%; P=0.749), and acute kidney injury (9.3% vs. 10.6%; P=0.700) were similar for both groups. At 3 years, the rates of all-cause death (25.2% vs. 19.2%; P=0.615), the composite endpoints of all-cause death and MI (27.2% vs. 21.2%; P=0.699) and all-cause death, MI, and stroke (28.5% vs. 22.5%; P=0.739) were also comparable between the two groups. Achieving complete coronary revascularization in the TAVI setting did not impact on long-term mortality (P=0.257). CONCLUSIONS: In patients with severe aortic stenosis and CAD, concomitant TAVI and PCI was as safe and effective as TAVI alone up to 3-year follow-up.

Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.

OBJECTIVES: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). METHODS: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019). RESULTS: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.

Sutureless and rapid deployment versus sutured aortic valve replacement: a propensity-matched comparison from the Sutureless and Rapid Deployment International Registry.

OBJECTIVES: To compare procedural and in-hospital outcomes of patients undergoing sutureless (Perceval, Livanova PLC, London, UK) and rapid deployment (Intuity Elite, Edwards Lifesciences, Irvine, CA, USA) aortic valve replacement (group 1) versus sutured aortic valve replacement (group 2). METHODS: Patients receiving isolated aortic valve replacement between 2014 and 2020 were analysed using data from the Sutureless and Rapid Deployment International Registry. Patients in group 1 and group 2 were propensity-score matched in a 1:1 ratio. RESULTS: A total of 7708 patients were included in the study. After matching, 2 groups of 2643 each were created. Patients in group 1 were more likely to undergo minimally invasive approaches and were associated with shorter operative times when compared with group 2. Overall in-hospital mortality was similar between groups. While an increased risk of stroke was observed in group 1 in the first study period (2014-2016; relative risk 3.76, P < 0.001), no difference was found in more recent year period (relative risk 1.66, P = 0.08; P for heterogeneity 0.003). Group 1 was associated with reduced rates of postoperative low cardiac output syndrome, atrial fibrillation and mild aortic regurgitation. New pacemaker implant was three-fold higher in group 1. CONCLUSIONS: Our findings showed significant differences in procedural and clinical outcomes between the study groups. These results suggest that sutureless and rapid deployment aortic valve replacement should be considered as part of a comprehensive valve programme. The knowledge of the respective post-aortic valve replacement benefits for different valve technologies may result in patient-tailored valve selection with improved clinical outcomes.

[Evolution of transcatheter aortic valve implantation from a high-volume Italian center: report of 2058 procedures over 15-year experience]. / Evoluzione dell'impianto transcatetere di valvola aortica in un centro italiano ad alto volume: report di 2058 procedure in 15 anni di esperienza.

BACKGROUND: To assess the longitudinal changes in transcatheter aortic valve implantation (TAVI) practice and patients' outcomes in a high-volume Italian center. METHODS: We analyzed all patients undergoing TAVI at our Institution from June 2007 to August 2021. We stratified the overall population considering four time periods according to procedural advancements and changes in clinical practice: period 1 (2007-2009, n=107) vs period 2 (2010-2014, n=449) vs period 3 (2015-2019, n=864) vs period 4 (2019-2021, n=638). Baseline and procedural characteristics, and in-hospital outcomes among the four groups were compared. RESULTS: A total of 2058 patients underwent TAVI receiving all the available devices. Patients had a median age of 82 years (78-85) with no differences among time periods. A stepwise reduction of median Society of Thoracic Surgeons mortality risk score (3.7 [2.8-5.3] vs 3.6 [2.6-5.4] vs 3.6 [2.5-5.5] vs 3.3 [2.2-4.9]; p=0.01) was observed. In-hospital all-cause-death (7.5% vs 5.1% vs 2.9% vs 3.0%; p<0.05), major stroke (4.7% vs 0.7% vs 1.0% vs 0.8%; p<0.05), major vascular complications (17.8% vs 8.7% vs 10.5% vs 5.8%; p<0.05) and permanent pacemaker implantation (23.4% vs 12.0% vs 8.7% vs 8.8%; p<0.05) rates significantly lowered over time. Device success markedly improved (80.4% vs 87.1% vs 95.0% vs 96.3%; p<0.05) with significant improvement of paravalvular regurgitation after TAVI (moderate-to-severe 16.8% vs 8.1% vs 0.7% vs 0.2%; mild 61.4% vs 38.2% vs 38.5% vs 25.6%; p<0.05). CONCLUSIONS: All-cause death and in-hospital outcomes of patients undergoing TAVI significantly improved accordingly to technical advancements and changes in clinical practice over 15-year experience.

Review of Contemporary Invasive Treatment Approaches and Critical Appraisal of Guidelines on Hypertrophic Obstructive Cardiomyopathy: State-of-the-Art Review.

BACKGROUND: Hypertrophic obstructive cardiomyopathy (HOCM) is a heterogeneous disease with different clinical presentations, albeit producing similar dismal long-term outcomes if left untreated. Several approaches are available for the treatment of HOCM; e.g., alcohol septal ablation (ASA) and surgical myectomy (SM). The objectives of the current review were to (1) discuss the place of the standard invasive treatment modalities (ASA and SM) for HOCM; (2) summarize and compare novel techniques for the management of HOCM; (3) analyze current guidelines addressing HOCM management; and (4) offer suggestions for the treatment of complex HOCM presentations. METHODS: We searched the literature and attempted to gather the most relevant and impactful available evidence on ASA, SM, and other invasive means of treatment of HOCM. The literature search yielded thousands of results, and 103 significant publications were ultimately included. RESULTS: We critically analyzed available guidelines and provided context in the setting of patient selection for standard and novel treatment modalities. This review offers the most comprehensive analysis to-date of available invasive treatments for HOCM. These include the standard treatments, SM and ASA, as well as novel treatments such as dual-chamber pacing and radiofrequency catheter ablation. We also account for complex pathoanatomic presentations and current guidelines to offer suggestions for tailored care of patients with HOCM. Finally, we consider promising future therapies for HOCM. CONCLUSIONS: HOCM is a heterogeneous disease associated with poor outcomes if left untreated. Several strategies for treatment of HOCM are available but patient selection for the procedure is crucial.

Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses.

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients' survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45-70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14-23 mm Hg) and 10 mmHg (IQR: 8-13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91-1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3-96.7%); 90.7% (88.3-93.1%); 86.4% (82.6-90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04-1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002-1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.

Sutureless Versus Rapid Deployment Aortic Valve Replacement: Results From a Multicenter Registry.

BACKGROUND: This study compared clinical and hemodynamic in-hospital outcomes of patients undergoing sutureless vs rapid deployment aortic valve replacement (SURD-AVR) in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: We examined 4695 patients who underwent isolated or combined SURD-AVR. The "sutureless" Perceval valve (LivaNova PLC, London, United Kingdom) was used in 3133 patients and the "rapid deployment" Intuity (Edwards Lifesciences, Irvine, CA) in 1562. Potential confounding factors were addressed by the use of propensity score matching. After matching, 2 well-balanced cohorts of 823 pairs (isolated SURD-AVR) and 467 pairs (combined SURD-AVR) were created. RESULTS: Patients who received Perceval and Intuity valves showed similar in-hospital mortality and rate of major postoperative complications. Perceval was associated shorter cross-clamp and cardiopulmonary bypass times. In the isolated SURD-AVR group, patients receiving Perceval were more likely to undergo anterior right thoracotomy incision. Postoperative transvalvular gradients were significantly lower for the Intuity valve compared with those of the Perceval valve, either in isolated and combined SURD-AVR. The Intuity valve was associated with a lower rate of postoperative mild aortic regurgitation. CONCLUSIONS: Our results confirm the safety and efficacy of SURD-AVR regardless of the valve type. The Perceval valve was associated with reduced operative times and increased anterior right thoracotomy incision. The Intuity valve showed superior hemodynamic outcomes and a lower incidence of postoperative mild aortic regurgitation.

Minimally Invasive vs Conventional Aortic Valve Replacement With Rapid-Deployment Bioprostheses.

BACKGROUND: The aim of this multicenter retrospective study was to compare early and midterm clinical and hemodynamic results of aortic valve replacement with rapid-deployment bioprostheses performed through conventional full-sternotomy vs mini-sternotomy. METHODS: Data from the Italian multicenter registry of aortic valve replacement with rapid-deployment bioprostheses (INTU-ITA registry) were analyzed. Patients were divided into 2 groups: full sternotomy (FS) and ministernotomy (MS). Primary endpoint was the comparison of early and midterm mortality. Secondary endpoints were: comparison of intraoperative variables, complications, and hemodynamic performance. A propensity score weighting approach was used for data analysis. RESULTS: A total of 1057 patients were analyzed: 435 (41.2%) and 622 (58.8%) in group FS and MS, respectively. Thirty-day mortality was 1.6% and 0.6% in FS and MS groups, respectively (P = .074). cardiopulmonary bypass time was 78.5 minutes and 83 minutes in FS and MS groups, respectively (P = .414). In the overall cohort, the incidence of intraoperative complications and of device success was 3.8% (40 patients) and 95.9% (1014 patients), respectively, with no significant differences between groups. Survival at 1, 3, and 5 years was 94.1%, 98.1%, 88.5% and 91.8%, 85.2%, and 84.8% in FS and MS groups, respectively (P = .412). The 2 groups showed similar postoperative gradients (median mean gradient, FS: 10.0 mm Hg, MS: 11.0 mm Hg; P = .170) and also similar incidence of patient-prosthesis mismatch (FS: 7%, MS: 6.4%, P = .647). CONCLUSIONS: According to our data, rapid-deployment bioprostheses allow the performance of minimally invasive aortic valve replacement with similar surgical times and similar clinical and hemodynamic outcomes to conventional surgery and should be considered the first choice in these procedures.

Sutureless and rapid deployment implantation in bicuspid aortic valve: results from the sutureless and rapid-deployment aortic valve replacement international registry.

BACKGROUND: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR). METHODS: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve. RESULTS: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively. CONCLUSIONS: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome.

Minimally invasive access type related to outcomes of sutureless and rapid deployment valves.

OBJECTIVES: Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART). METHODS: We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group). RESULTS: Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2 and 9.2 min; P < 0.001). Patients undergoing FS had a higher rate of acute kidney injury (5.6% vs 2.8%; P = 0.012). Direct comparison of MS and ART revealed longer mean cross-clamp and CPB times (12 and 16.7 min) in the ART group (P < 0.001). The postoperative outcome revealed a higher stroke rate (3.2% vs 1.2%; P = 0.043) as well as a longer postoperative intensive care unit [2 (1-3) vs 1 (1-3) days; P = 0.009] and hospital stay [11 (8-16) vs 8 (7-12) days; P < 0.001] in the MS group than in the ART group. CONCLUSIONS: According to this non-randomized international registry, FS resulted in a higher rate of acute kidney injury. The ART access showed a lower stroke rate than MS and a shorter hospital stay than all other accesses. All these findings may be related to underlying patient risk factors.

Failure to achieve a satisfactory cardiac outcome after isolated coronary surgery in low-risk patients.

OBJECTIVES: This study aims to investigate the incidence and determinants of major early adverse events in low-risk patients undergoing isolated coronary artery bypass grafting (CABG). METHODS: The multicentre E-CABG registry included 7352 consecutive patients who underwent isolated CABG from January 2015 to December 2016. Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of <2% and without any major comorbidity were the subjects of the present analysis. RESULTS: Out of 2397 low-risk patients, 11 (0.46%) died during the index hospitalization or within 30 days from surgery. Five deaths were cardiac related, 4 of which were secondary to technical failures. We estimated that 8 out of 11 deaths were potentially preventable. Logistic regression model identified porcelain aorta [odds ratio (OR) 34.3, 95% confidence interval (CI) 1.3-346.3] and E-CABG bleeding grades 2-3 (OR 30.2, 95% CI 8.3-112.9) as independent predictors of hospital death. CONCLUSIONS: Mortality and major complications, although infrequently, do occur even in low-risk patients undergoing CABG. Identification of modifiable causes of postoperative adverse events may be useful to develop preventative strategies to improve the quality of care of patients undergoing cardiac surgery. CLINICAL TRIAL REGISTRATION: NCT02319083 (https://clinicaltrials.gov/ct2/show/NCT02319083).

Current trends of sutureless and rapid deployment valves: an 11-year experience from the Sutureless and Rapid Deployment International Registry.

OBJECTIVES: Current evidence on sutureless and rapid deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions. METHODS: Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086). RESULTS: Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%). CONCLUSIONS: The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.

[Long-term clinical and echocardiographic follow-up of the edge-to-edge technique for surgical mitral valve repair]. / Follow-up clinico ed ecocardiografico a lungo termine dopo riparazione valvolare mitralica con tecnica "edge-to-edge".

BACKGROUND: To evaluate the long-term clinical and echocardiographic performance of mitral valve repair with the edge-to-edge technique. METHODS: In-hospital results, actuarial freedom from all-cause mortality, cumulative incidence of cardiovascular mortality, recurrent mitral regurgitation ≥3+ and reoperation on the mitral valve were assessed in 180 consecutive patients undergoing mitral repair with the edge-to-edge technique for degenerative or functional regurgitation. Exercise echocardiography was performed in 24 patients to assess valve hemodynamics in the long-term follow-up. RESULTS: The edge-to-edge repair was applied as a first strategy in 157 patients (87.2%) or as a bail-out procedure in 23 patients (12.8%). At discharge, mitral regurgitation grade was absent in 152 patients (84.4%) and trivial in 28 patients (15.6%). Mean gradient was 2.8 ± 0.6 mmHg and effective orifice area was 2.9 ± 0.4 cm2. After a median follow-up of 6.5 (interquartile range 3.5-10.2) years, 93.6% patients were in NYHA functional class I-II. Actuarial survival at 15 years was 89.2 ± 2.7%, whereas the cumulative incidence of cardiovascular mortality was 7.0%, of recurrent mitral regurgitation ≥3+ 12.6% and of reoperation on the mitral valve 3.2%. Exercise stress echocardiography revealed a significant increase of functional area (3.1 ± 0.3 vs 4.0 ± 0.6 cm2, p<0.001) and mean gradients (2.7 ± 0.4 vs 4.6 ± 1.2 mmHg, p<0.001). CONCLUSIONS: The edge-to-edge technique effectively corrects degenerative and functional mitral regurgitation and represents a valid bail-out procedure in case other approaches failed to achieve adequate intraoperative valve competence. Long-term results are sustained up to 15 years, with significant improvement in functional status. Despite an altered geometry, the occurrence of iatrogenic mitral stenosis is avoided even at high workload conditions.

Minimally Invasive Redo Aortic Valve Replacement: Results From a Multicentric Registry (SURD-IR).

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Surgical aortic valve replacement with new-generation bioprostheses: Sutureless versus rapid-deployment.

OBJECTIVES: The aim of this retrospective multicenter study was to compare early clinical and hemodynamic outcomes of Perceval-S sutureless (Livanova, London, United Kingdom) and Intuity rapid-deployment (Edwards Lifesciences, Irvine, Calif) bioprostheses. METHODS: Data from patients who underwent isolated or combined aortic valve replacement with Perceval-S and with Intuity bioprostheses at 18 cardiac surgical institutions were analyzed. Propensity matching was performed to identify similar patient cohorts. RESULTS: We included 911 patients from March 2011 until May 2017. Perceval-S and Intuity valves were implanted in 349 (38.3%) and in 562 (61.7%) patients, respectively. Propensity score identified 117 matched pairs. In the matched cohort, device success was 99.1% and 100% in Perceval-S and Intuity group, respectively (P = 1.000). Thirty-day Valve Academic Research Consortium mortality occurred in 2 (1.7%) and 4 (3.4%) patients in the Perceval-S and in Intuity group, respectively (P = .6834). The rate of postoperative new permanent pacemaker implantation was 6% (7 patients) and 6.8% (8 patients) in the Perceval-S and in Intuity group, respectively (P = .7896). Perceval-S valve implantation requires significantly shorter aortic crossclamp and cardiopulmonary bypass times than Intuity valve implantation (aortic crossclamp time for isolated, 52 ± 14 minutes vs 62 ± 24 minutes; P < .0001). Peak transaortic gradients were 22.4 ± 8.1 mm Hg and 19.6 ± 6.7 mm Hg (P = .0144), whereas mean gradients were 11.8 ± 4.7 mm Hg and 10.5 ± 3.9 mm Hg (P = .0388) in the Perceval-S and Intuity groups, respectively. CONCLUSIONS: Sutureless Perceval-S and rapid-deployment Intuity bioprostheses provide good and similar early clinical and hemodynamic outcomes. Perceval-S valve implantation requires shorter crossclamp and cardiopulmonary bypass times, whereas Intuity valve implantation provides lower transaortic peak and mean gradients.

Minimally invasive aortic valve replacement with sutureless and rapid deployment valves: a report from an international registry (Sutureless and Rapid Deployment International Registry)†.

OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. The aim of this study was to assess clinical characteristics and in-hospital results of patients receiving SURD-AVR through less invasive approaches in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: Of the 1935 patients who received primary isolated SURD-AVR between 2009 and 2018, a total of 1418 (73.3%) underwent MI interventions and were included in this analysis. SURD-AVR was performed using upper ministernotomy in 56.4% (n = 800) of cases and anterior right thoracotomy in 43.6% (n = 618). Perceval S was implanted in 1011 (71.3%) patients and Edwards Intuity or Intuity Elite in 407 (28.7%) patients. RESULTS: Overall in-hospital mortality and stroke rates were 1.7% and 2%, respectively. A definitive pacemaker implantation was reported in 9% of cases and significantly decreased over the observational period, from 20.6% to 5.6% (P = 0.002). The Perceval valve was associated with shorter operative times and was more frequently implanted in patients receiving anterior right thoracotomy incision. The Intuity valve was preferred in younger patients and revealed superior postoperative haemodynamic results. CONCLUSIONS: SURD-AVR was largely performed through less invasive approaches and can be considered as a primary indication in MI surgery. In the SURD-IR cohort, MI SURD-AVR using both Perceval and Intuity valves appeared a safe and reproducible procedure associated with promising early results.

Operative outcome of patients at low, intermediate, high and 'very high' surgical risk undergoing isolated aortic valve replacement with sutureless and rapid deployment prostheses: results of the SURD-IR registry.

OBJECTIVES: The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, rapid deployment aortic valve replacement. METHODS: From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE <5; n = 500), intermediate (EuroSCORE 5-10; n = 901), high (EuroSCORE 11-20; n = 500) and very high (EuroSCORE >20; n = 156) preoperative risk. RESULTS: Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories. CONCLUSIONS: Surgical aortic valve replacement using sutureless, rapid deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.

Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA).

BACKGROUND: Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation. METHODS: Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis. RESULTS: A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 ± 7 mm Hg and 11 ± 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% ± 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality. CONCLUSIONS: Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR): early results from 3343 patients.

OBJECTIVES: The Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR) was established by a consortium of 18 research centres-the International Valvular Surgery Study Group (IVSSG)-to overcome limitations of the literature and provide adequately powered evidence on sutureless and rapid-deployment aortic valves replacement (SURD-AVR). METHODS: Data from 3343 patients undergoing SURD-AVR over a 10-year period (2007-2017) were collected in the registry. The mean age of the patients was 76.8 ± 6.7 years, with 36.4% being 80 years or older. The average logistic EuroSCORE was 11.3 ± 9.7%. RESULTS: Isolated SURD-AVR was performed in 70.7% (n = 2362) of patients using full sternotomy (35.3%) or less invasive approaches (64.8%). Overall hospital mortality was 2.1%, being 1.4% in patients who had isolated SURD-AVR and 3.5% in those who had concomitant procedures (P < 0.001). When considering baseline risk profile, mortality rate was 0.8% and 1.9% in low risk (logistic EuroSCORE <10%) isolated SURD-AVR and combined SURD-AVR, respectively, and 2.2% and 3.7% in higher risk patients (logistic EuroSCORE ≥10%). Postoperative neurological complications included stroke (2.8%) and transient ischaemic attack (1.1%). New atrioventricular block requiring pacemaker occurred in 10.4% of the patients. The rate of pacemaker implantation significantly decreased over time [from 17.2% (2007-2008) to 5.4% (2016); P = 0.02]. CONCLUSIONS: Our findings showed that SURD-AVR is a safe and effective alternative to conventional aortic valve replacement and is associated with excellent clinical outcomes. Further adequately powered statistical analyses from the retrospective and prospective SURD-IR will allow for the development of high-quality evidence-based clinical guidelines for SURD-AVR.

Early Outcome of Bilateral Versus Single Internal Mammary Artery Grafting in the Elderly.

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.