Del Nido cardioplegia in adult cardiac surgery: Clinical outcomes in a single center all-comer study.

INTRODUCTION: The use of Del Nido Cardioplegia (DNC) has been extended in the latest years from pediatrics to adult cardiac surgery with encouraging results. We sought to investigate clinical and biochemical outcomes in adult patients who underwent cardiac surgery with different degrees of complexity who received DNC for myocardial protection. METHODS: Data on one-thousand patients were retrospectively collected from 2020 to 2022. The only exclusion criteria was off-pump adult cardiac surgery. Surgical procedures weight was categorized according EuroSCORE II in six groups: Single-CABG(G1), isolated non-CABG(mitral) (G2), isolated non-CABG(aortic) (G3), isolated non-CABG(any) (G4), 2-procedures(G5), 3/more-procedures(G6). Primary endpoint was to identify a binomial correlation between hs-TnT/CK-MB and the cross-clamp time (X-Clamp). A secondary endpoint was the comparison between the treatment groups of the vasoactive-inotropic score (VIS) and the need of mechanical circulatory support (MCS). RESULTS: A linear correlation was identified between hs-TnT and X-clamp in the overall population (rho:0.447, p< .001) and in the treatment groups (G1:rho=0.357, p< .001/G2:rho=0.455, p< .001/G3:rho=0.307, p= .001/G4:rho=0.165, p= .257/G5:rho=0.157, p= .031/G6:rho=0.226, p= .015). Similarly, a linear correlation between CK-MB and X-clamp in the overall population (rho=0.457, p< .001) and treatment group (G1:rho=0.282, p< .001/G2:rho=0.287, p= .025/G3:rho=0.211, p= .009/G4:rho=0.0878, p= .548/G5:rho=0.309, p< .001/G6: rho=0.212, p= .024) was identified. As regard for the secondary endpoint, no differences were reported between the treatment groups in terms of VIS and MCS (VIS G1:7; G2:4; G3:7; G4:7, G5:5.5, G6:6, p-value= .691) (MCS G1: 4.5%; G2:4.8%; G3:3.3%; G4:3.1%; G5:1.4%; G6:5.3%; p-value= .372). CONCLUSIONS: Del Nido Cardioplegia is a safe and useful tool in adult cardiac surgery allowing operators to achieve a stable and durable cardioplegic arrest. Despite accounting with different types of surgery, the six subgroups of our study population showed similar perioperative results.

Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study.

OBJECTIVE: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

A multicentre roadmap to restart elective cardiac surgery after COVID-19 peak in an Italian epicenter.

BACKGROUND: During the Italian Phase-2 of the coronavirus pandemic, it was possible to restart elective surgeries. Because hospitals were still burdened with coronavirus disease 2019 (COVID-19) patients, it was focal to design a separate "clean path" for the surgical candidates and determine the possible effects of major surgery on previously infected patients. METHODS: From May to July 2020 (postpandemic peak), 259 consecutive patients were scheduled for elective cardiac surgery in three different centers. Our original roadmap with four screening steps included: a short item questionnaire (STEP-1), nasopharyngeal swab (NP) (STEP-2), computed tomography (CT)-scan using COVID-19 reporting and data system (CO-RADS) scoring (STEP-3), and final NP swab before discharge (STEP-4). RESULTS: Two patients (0.8%) resulted positive at STEP-2: one patient was discharged home for quarantine, the other performed a CT-scan (CO-RADS: <2), and underwent surgery for unstable angina. Chest-CT was positive in 6.3% (15/237) with mean CO-RADS of 2.93 ± 0.8. Mild-moderate lung inflammation (CO-RADS: 2-4) did not delay surgery. Perioperative mortality was 1.15% (3/259), and cumulative incidence of pulmonary complications was 14.6%. At multivariable analysis, only age and cardiopulmonary bypass (CPB) time were independently related to pulmonary complications composite outcome (age >75 years: odds ratio [OR]: 2.6; 95% confidence interval [CI]: 1.25-5.57; p = 0.011; CPB >90 min. OR: 4.3; 95% CI: 1.84-10.16; p = 0.001). At 30 days, no periprocedural contagion and rehospitalization for COVID-19 infections were reported. CONCLUSIONS: Our structured roadmap supports the safe restarting of an elective cardiac surgery list after a peak of a still ongoing COVID-19 pandemic in an epicenter area. Mild to moderate CT residuals of coronavirus pneumonia do not justify elective cardiac surgery procrastination.

Surgical treatment of mediastinitis: The vertical bolstered Donati stitch.

Deep sternal wound infection is a major complication of cardiac surgery, with a low incidence but with catastrophic consequences in terms of morbidity, mortality, and health-care costs. Negative pressure wound therapy and appropriately timed sternal revision, with or without muscle flap mobilization, can improve the outcomes. This video tutorial illustrates the technical aspects of the surgical treatment of mediastinitis with the Robicsek method for sternal closure and an original wound closure technique, very effective and much simpler than the pectoral muscle flap technique.

MIDCAB Tips and tricks for a successful procedure.

Minimally invasive direct coronary artery bypass (MIDCAB) for a left internal mammary artery on left anterior descending (LIMA-LAD) graft, is a safe and relatively less traumatic surgical technique. Adoption in some centers has been slow because of perceived technical difficulty, but it should be considered a first-choice therapy for patients with isolated proximal LAD lesions or multi-vessel disease, and as a component of a hybrid revascularization strategy.  Results in our institute, where we have been using MIDCAB for more than 20 years, confirm both its short- and long-term efficacy. This video tutorial demonstrates the technical aspects of the procedure.

Long-Term Outcome of Total Arterial Myocardial Revascularization Versus Conventional Coronary Artery Bypass in Diabetic and Non-Diabetic Patients: A Propensity-Match Analysis.

OBJECTIVE: Despite the improved survival in patients with multi-vessel coronary disease compared to conventional myocardial revascularization associated with the use of multiple arterial grafting for myocardial revascularization, it has been adopted in the minority of centers. We sought to evaluate the long-term outcome of patients with and without diabetes undergoing total arterial versus conventional myocardial revascularization. METHODS: Among 1000 consecutive patients undergoing CABG, we performed a propensity-match analysis to compare patients with multi-vessel disease receiving total arterial (G1 = 618 pts) versus conventional myocardial revascularization (LIMA-LAD plus vein grafts, G2 = 382 pts). The primary end-point was survival free from all-cause and cardiac-related mortality, while the secondary end-point was the occurrence of major cardiac and cerebrovascular accidents. RESULTS: Hospital mortality was similar (G1: 0 pts. vs G2: 1 pts., 0.3%, p = .91). At a median follow-up of 101 months (range 11-185 months), total arterial grafting was associated with significantly improved survival free from overall (G1 = 76.5 ±â€¯3.0% vs G2 = 66.0 ±â€¯3.1%; p < .001) and cardiac mortality (general population: G1 = 90.8 ±â€¯2.1% vs G2 = 84.2 ±â€¯1.9%, p = .043; diabetics:G1 = 84.7 ±â€¯2.1 vs G2: 79.3 ±â€¯3.4; p = .035) as well as occurrence of MACCEs (general population:G1 = 80.1 ±â€¯3.2% vs G2 = 70.8 ±â€¯2.9%; p > .001; diabetics:G1 = 77 ±â€¯6 vs G2 = 53 ±â€¯5.8; p < .001). Cox regression analysis identified diabetes (HR = 1.94, CI 95% = 1.12-2.93; p < .001) and the use of veins (HR = 1.81, CI 95% = 1.32-2.65; p < .001) as independent predictors for all-cause mortality; among diabetics, vein grafts was the strongest predictor of MACCEs (HR = 2.41, CI 95% = 1.27-4.59; p = .007) and cardiac mortality (HR = 3.24, CI 95% = 1.69-6.23; p < .001). CONCLUSIONS: Long-term survival following total arterial CABG is remarkably improved compared to conventional grafting with vein grafts especially in diabetic patients.

Minimally invasive coronary artery bypass: Twenty-year experience.

OBJECTIVE: Minimally invasive direct coronary artery bypass for the left thoracic artery on the left anterior descending artery is a safe and less traumatic surgical technique. We retrospectively evaluated long-term outcomes in a large series of patients undergoing minimally invasive direct coronary artery bypass. METHODS: From 1997 to 2016, 1060 patients underwent minimally invasive direct coronary artery bypass: 646 patients (61%) with isolated proximal left anterior descending disease and 414 patients (39%) with multivessel disease as a part of hybrid coronary revascularization or in association with medical therapy. Long-term follow-up, major cardiac and cerebral adverse events, and freedom from angina were analyzed. RESULTS: Mean age of patients was 71 ± 12.5 years, and median European System for Cardiac Operative Risk Evaluation II was 3.2% (interquartile range, 0.6%-7.8%). Postoperative death occurred in 9 patients (0.8%), and perioperative stroke occurred in 3 patients (0.3%). An angiogram or computed tomography scan was performed and was available in patients within 10 years of follow-up (n = 696), demonstrating a 96.8% graft patency rate. At 13.9 ± 5.6 years of follow-up, no surgical reintervention was performed for left thoracic artery on left anterior descending artery graft failure, but 14 patients underwent left anterior descending or left thoracic artery on left anterior descending artery percutaneous coronary intervention. Kaplan-Meier survival curve shows 87.1% at 5 years (95% confidence interval, 81-92.5), 84.3% at 10 years (95% confidence interval, 77.1-91.4), and 79.8% at 15 years (95% confidence interval, 72.2-87.3). Survival freedom from major adverse events was 87.0% (95% confidence interval, 85.9-88.1) at 5 years and 70.5% (95% confidence interval, 66.4-74.6) at 15 years. CONCLUSIONS: Minimally invasive direct coronary artery bypass can be safely performed with low postoperative mortality and morbidity with excellent short- and long-term survival and freedom from major adverse events and angina with a reduced surgical invasiveness.

Long-term follow-up of total arterial versus conventional and hybrid myocardial revascularization: A propensity score matched analysis.

PURPOSE: To evaluate the impact of the revascularization technique (by means of conventional, total arterial or hybrid myocardial revascularization) in patients with multivessel coronary artery disease. METHODS: A propensity-score analysis of patients undergoing myocardial revascularization from 1998 to 2012 was performed based on the surgical technique utilized, either total arterial (Group1, G1,n°â€¯= 89), conventional CABG(LIMA on LAD plus veins, Group2, G2,n°â€¯= 89), or hybrid revascularization (LIMA on LAD plus PTCA on non-LAD vessels, Group3, G3, n°â€¯= 89). Primary end-points were overall survival and cardiac-related death while secondary composite end-point was survival freedom from major adverse cardiac and cerebrovascular events (MACCEs) defined as myocardial infarction, cardiac death, stroke and repeated target vessel revascularization. RESULTS: Study population was mostly affected by double-vessels disease (G1 = 2.35 vs G2 = 2.3 vs G3 = 2.4, p = 0.14) with a preserved LV function(G1 = 48% vs G2 = 49% vs G3 = 50%, p = 0.12). Hospital mortality was 0% in all groups. At a mean follow-up of 6 ±â€¯2 years overall survival was significantly better in patients receiving total arterial myocardial revascularization (G1 = 90.4 ±â€¯3.5% vs G2 = 82.3 ±â€¯4.2% vs G3 = 82.1 ±â€¯5.9%, p = 0.049) as well as freedom from MACCEs (G1 = 95.2 ±â€¯2.4% vs G2 = 86.5 ±â€¯4% vs G3 = 68 ±â€¯6.9%, p = 0.001) while survival free from cardiac-related death was similar(G1 = 97.7 ±â€¯1.6% vs G2 = 95.1 ±â€¯2.4% vs G3 = 89.5 ±â€¯5.4%, p = 0.08). Conversely, at 10 years follow-up only freedom from MACCEs was significantly better in patients of Group 1(G1 = 78.9 ±â€¯8.6% vs G2 = 72.4 ±â€¯5.7% vs G3 = 52 ±â€¯8.7%, p < 0.001). CONCLUSIONS: Total arterial revascularization provides improved outcomes at mid and long term follow-up compared with conventional or hybrid revascularization. The latter technique is particularly associated with a significantly higher incidence of late myocardial infarction and repeat revascularization.

Is the Freedom SOLO Stentless Bioprosthesis a Useful Tool for Patients with Aortic Endocarditis and Aortic Annular Destruction?

BACKGROUND: The Freedom SOLO (FS) stentless bovine-pericardial prosthesis with a supra-annular implantation technique can be a viable option for patients with endocarditic annular destruction. We assessed early- and long-term outcomes following the use of this prosthesis in extensive aortic valve endocarditis. METHODS: From 2006 to 2016, 59 patients with extensive aortic endocarditis underwent aortic valve replacement (AVR) with FS (cumulative follow-up 263 patients-years) in three European centers; all patients presented annular tissue infection, while 54.3% of patients had annular abscess. RESULTS: Mean age was 66 ± 11 years and mean EuroSCORE I was 30.3% (standard deviation: 24.1%). In our series, 30.5% of patients had prosthetic valve endocarditis. Early mortality was 15.2% (nine patients). Estimated overall survival at 5 and 10 years was 68.9% (95% confidence interval [CI]: 62.8-75.0%) and 59.1% (95% CI: 66.8-81.2%), respectively. At 10-year survival, freedom from valve-related death was 83.7% (95% CI: 80.9-86.5%). No structural valve deterioration was reported in this series. Five patients (8.5%) had recurrent endocarditis during follow-up and two of them underwent reoperation. Survival freedom from reoperation and endocarditis at 10-year follow-up was 88.0% (CI: 80.4-95.6%) and 86.7% (CI: 80.5-92.9%), respectively. CONCLUSION: FS stentless bioprosthesis is a valuable and simple option to achieve AVR in patients with extensive aortic annulus endocarditis. Although in this group of complex patients, early mortality remains considerably high, late survival outcomes are comparable to the more technically demanding homografts and conventional stentless bioprostheses, with low rates of endocarditis recurrence.

Stentless sutureless and transcatheter valves: a comparison of the hemodynamic performance of different prostheses concept.

BACKGROUND: Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. A new concept of surgical sutureless (SU) bioprosthesis has been developed in the last decade. In this multi-institutional study we sought to compare hemodynamics of different bioprosthesis concept as transcatheter (TAVR), Livanova Perceval S sutureless valve and Freedom Solo Stentless (FS) valve in patients undergoing aortic valve replacement (sAVR). METHODS: From 2010 to 2016, 478 patients underwent sAVR with FS, 518 Perceval S and 367 patients underwent TAVR. After a propensity matched analysis 185 patients in each group were selected. Thirty-day postoperative clinical and echocardiographic parameters were evaluated. Echocardiographic hemodynamic data were also collected at 12 and 24 months. RESULTS: Mean prosthesis diameter was 23.8±1.3 mm for FS, 23.2±2.1 mm for Perceval S and 25.1±2.6 mm for TAVR. In-hospital mortality was 2.0% for FS, 1.9% for Perceval, 5.8% for TAVR (P=0.02). Postoperative FS peak gradients were 15.6±9.1 mmHg (mean 7.6±5.4 mmHg); SU gradients were 18.7±9.1 mmHg (mean 10.9±5.4 mmHg), TAVR peak gradients were 14.7±9.1 mmHg (mean 6.1±5.4 mmHg) P=0.018 (P<0.001). Postoperative effective orifice area (EOA) was 1.94±0.7 cm² for FS, 1.6±0.7 cm² for SU and 1.97±0.7cm² for TAVR (P<0.001). There was no prostheses-patient-mismatch (PPM) in FS group, while 4 cases and 2 cases are reported in SU and TAVR respectively. Postoperative grade 2-3 paravalvular leak (PVL) was present in 4.3% for TAVR and 0.5% in SU valves and no cases in FS. Postoperative permanent pacemaker implant rate was 11.9% for TAVR (1.0%) in FS group and 5.4% in SU valves (P<0.001). CONCLUSIONS: SU patients demonstrated post-operative excellent hemodynamic performance with smaller EROA and higher gradients compared to FS and TAVR. TAVR demonstrated higher mortality and pacemaker rates. Further studies are warrented to validate TAVR indications in this subset of patients.

European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial.

OBJECTIVES: The HISTORIC-AF trial is a prospective, multicentre, single-arm study designed to evaluate the outcomes of a staged endoscopic and transcatheter ablation in patients with stand-alone, persistent or long-standing persistent atrial fibrillation (AF). METHODS: From 2012 to 2015, 100 consecutive patients were enrolled and underwent thoracoscopic left atrial epicardial isolation ('box lesion') followed by transcatheter ablation in case of AF recurrency. The safety end point was the composite outcome of freedom from major adverse events at 30-days, while efficacy end points were: (i) primary: freedom from AF and stable sinus rhythm following isolated thoracospic ablation >60% and (ii) secondary: freedom from AF and stable sinus rhythm >80% following hybrid ablation (as per HRS criteria). RESULTS: No death occurred and surgical thoracoscopic procedure was successfully completed in all patients. Survival free from major adverse events at 30 days was 94%: there were 3 permanent pacemaker implants, 2 episodes of stroke and 1 revision for bleeding. At discharge, 87% of patients were in sinus rhythm. A staged transcatheter ablation was carried out in all patients with AF recurrences at the end of 3 months blanking period (17% of patients). At 12-months follow-up, a stable restoration of sinus rhythm was achieved in 75% and 88% of patients following isolated thoracoscopic ablation and hybrid ablation, respectively. CONCLUSIONS: The HISTORIC-AF trial showed that thoracoscopic isolated surgical ablation reached both the safety and the efficacy end points. Hybrid ablation steadily improved rhythm outcomes and may be considered in the future as the treatment of choice for patients with persistent and long-standing persistent AF. CLINICALTRIALS.GOV IDENTIFIER: NCT01622907.

Hybrid Minimally Invasive Approach for Transvenous Lead Extraction: A Feasible Technique in High-Risk Patients.

INTRODUCTION: Despite the overall safety, transvenous lead extraction (TLE) remains a challenging procedure with inherent risks, where surgery can still be required in elective cases. In this study, we report our experience with a minimally invasive "hybrid" approach, defined as a procedure performed by an electrophysiologist with the support of a cardiac surgeon in the same operative session. METHODS AND RESULTS: We reported 12 cases of planned hybrid lead extraction; minithoracotomy and thoracoscopy were performed on 10 (83%) and 2 (17%) patients, respectively. A total of 25 leads out of 27 (median lead age 19 years) were successfully extracted with laser, mechanical or combined transvenous sheath. In 3 patients, the direct monitoring of vascular and myocardial integrity allowed for prompt treatment of potential vascular injury during the lead extraction maneuvers. Mean in-hospital stay was 4 ± 2 days. There were no major intraoperative complications and no deaths occurred after 30 days' follow-up. CONCLUSION: The hybrid approach, with minithoracotomy or thoracoscopy, is feasible and it might increase the safety in the most challenging TLE procedures: the minimally invasive surgical intervention allows for continuous monitoring of the critical cardiac structures and prompt treatment of potential complications.

Improved Outcomes of Total Arterial Myocardial Revascularization in Elderly Patients at Long-Term Follow-Up: A Propensity-Matched Analysis.

BACKGROUND: Despite the proven advantages of total arterial grafting in patients undergoing coronary artery bypass operation, its benefits in the elderly population at long-term follow-up have been widely debated to date. METHODS: Among 988 consecutive patients scheduled to undergo coronary artery bypass grafting operation, we performed a propensity-matched analysis in a population with double and triple vessel disease and older than 70 years and compared patients receiving total arterial grafting (G1; n = 315 patients) with conventional myocardial revascularization (left internal mammary artery on left anterior descending coronary artery plus saphenous vein grafts; G2; n = 201 patients). Two groups of 175 patients were obtained after matching. Primary end points were overall survival and survival free from cardiac-related mortality, whereas secondary end point was the occurrence of major adverse cardiovascular and cerebrovascular events (MACCEs; cardiac death, myocardial infarction, repeated revascularization on grafted vessels, stroke). RESULTS: Preoperative and intraoperative patients' characteristics were similar among the groups, as well the incidence of hospital mortality (none in both groups). At a median follow-up time of 89 months, total arterial grafting was associated with significantly improved actuarial overall survival (G1: 67.5% ± 4.6%, G2: 57.0% ± 4.4%, p = 0.029), survival free from cardiac-related mortality (G1: 86.9% ± 3.4%, G2: 75.9 ± 4.0%, p = 0.02), and occurrence of MACCEs (G1: 78.8 ± 3.9%, G2: 65.5% ± 4.4%, p = 0.017). Multivariate Cox regression analysis depicted conventional myocardial revascularization as an independent predictor of cardiac-related mortality (hazard ratio [HR] 2.5, 95% confidence interval [CI]: 1.3 to 4.8, p = 0.005) and MACCEs (HR 2.1, 95% CI: 1.2 to 3.4, p = 0.005). CONCLUSIONS: Total arterial myocardial revascularization in elderly patients is associated with a reduced late incidence of cardiac-related mortality and major cerebral and cardiovascular events compared with the use of saphenous grafts, thereby providing improved long-term benefits also in this specific subset of patients.

Early hemodynamics and clinical outcomes of isolated aortic valve replacement with stentless or transcatheter valve in intermediate-risk patients.

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 cm2 for FS and 1.83 ± 0.3 cm2 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.

Pericardial Stentless Valve for Aortic Valve Replacement: Long-Term Results.

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.

Separation of mediastinal shed blood during aortic valve surgery elicits a reduced inflammatory response.

AIMS: The detrimental effects of inflammation following cardiopulmonary bypass (CPB) could negatively affect the postoperative outcome in a specific subset of high-risk patients. We therefore investigated the impact of a CPB circuit (Admiral, Eurosets, Italy) that allows separation of intracavitary and mediastinal blood on the release of biochemical markers and clinical outcome when compared with a conventional circuit. METHODS: Thirty patients undergoing aortic valve surgery were prospectively enrolled and assigned to Admiral group (Group 1, G1, n = 15) or conventional CPB group (Group 2, G2, n = 15). The Admiral oxygenator allows for a separate collection of mediastinal blood processed through a cell-saver before retransfusion. Clinical data and biochemical parameters were measured preoperatively, during CPB and at different time-points postoperatively. RESULTS: Preoperative demographics, intraoperative data (as CPB and aortic cross-clamping time) and perioperative complications did not differ between groups. Inflammatory response was significantly decreased in G1, as assessed by means of D-dimer (G1 = 1332.3  ±  953.9 vs. G2 = 2791.9  ±  1740.7  ng/ml, P = 0.02), C-reactive protein (G1 = 169.1  ±â€Š 164.8 vs. G2 = 57.1  ±  39.3  mg/l, P = 0.04), interleukin-6 (G1 = 11.8  ± 12.5 vs. G2 = 26.5  ±â€Š 24.9  pg/ml, P = 0.02) and tumour necrosis factor-alpha (G1 = 29  ±â€Š 28.7 vs. G2 = 45.5  ±â€Š 23.6 pg/ml, P = 0.03). CONCLUSION: Although no considerable difference was detected in terms of perioperative outcomes, the Admiral oxygenator did result in a significant reduction of inflammatory markers during the early postoperative course.

A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.

BACKGROUND: The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. METHODS: Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. RESULTS: At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year. CONCLUSIONS: At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience.

A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in "real-world" patients with aortic stenosis and intermediate- to high-risk profile.

OBJECTIVE: We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. METHODS: Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. RESULTS: Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly better in patients undergoing surgical aortic valve replacement and sutureless valve implantation than in patients undergoing transcatheter aortic valve replacement (surgical aortic valve replacement = 92.6% ± 2.3% vs sutureless = 96% ± 1.8% vs transcatheter aortic valve replacement = 77.1% ± 4.2%; P < .001). Multivariate Cox regression analysis identified transcatheter aortic valve replacement as an independent risk factor for overall mortality hazard ratio (hazard ratio, 2.5; confidence interval, 1.1-4.2; P = .018). CONCLUSIONS: The use of transcatheter aortic valve replacement in patients with an intermediate- to high-risk profile was associated with a significantly higher incidence of perioperative complications and decreased survival at short- and mid-term when compared with conventional surgery and sutureless valve implantation.

Chest Blunt Trauma: An Uncommon Cause of Aortic Stentless Bioprosthesis Dysfunction.

Acute leaflet rupture occurred in a Freedom Solo (Sorin Group, Milan, Italy) pericardial stentless aortic bioprosthesis after chest blunt trauma 8 years after valve replacement. Intraoperative findings revealed an acute tear of the right cusp at the level of the structural suture line. Pericardial leaflets were not degenerated at histologic analysis. Reoperation was easy, with simple removal of the prosthetic cusps, and a sutureless Perceval (Sorin Group) bioprosthesis was successfully implanted. This is the first reported case of an acute rupture of a stentless aortic bioprosthesis after a chest blunt trauma and the first histologic analysis of an 8-year-old Freedom Solo.