Abstract 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.
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.
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.
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%).
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.
Freedom SOLO: Premature failures or technical flaws during implantation? Repossini, Alberto, MD; Bisleri, Gianluigi, MD
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
08/2015, Letnik:
150, Številka:
2
Journal Article
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.
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.
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 ± 3.0% vs G2 = 66.0 ± 3.1%; p < .001) and cardiac mortality (general population: G1 = 90.8 ± 2.1% vs G2 = 84.2 ± 1.9%, p = .043; diabetics:G1 = 84.7 ± 2.1 vs G2: 79.3 ± 3.4; p = .035) as well as occurrence of MACCEs (general population:G1 = 80.1 ± 3.2% vs G2 = 70.8 ± 2.9%; p > .001; diabetics:G1 = 77 ± 6 vs G2 = 53 ± 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).
Long-term survival following total arterial CABG is remarkably improved compared to conventional grafting with vein grafts especially in diabetic patients.
•Total arterial revascularization has at long-term lower incidence of cardiac adverse events.•Radial artery represents a valid option as graft for total arterial revascularization strategy.•In diabetic, SVG were identified as an independent predictor for mortality and incidence of MACCES.
Hybrid Approach for Lead Extraction
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.
Background
Cor triatriatum is a rare congenital heart disease representing the 0.4% of all congenital cardiac anomalies. To date, no specific genetic alteration has been associated to cor ...triatriatum. The left-sided presentation (cor triatriatum sinister (CTS)) generally consists in a fibromuscular membrane that divides the left atrium into two chambers, therefore generating a varying grade of flow obstruction depending on the shape, location, and membrane fenestration size. Cor triatriatum sinister can be isolated or associated to other congenital heart defects such as ostium secundum atrial septal defect, patent foramen ovale or abnormal pulmonary veins drainage.
Case presentation
Our case is a 63-year-old woman who was diagnosed with a non-restrictive membrane during a hospitalization for acute heart failure. In the following 6 months, she started to become symptomatic. However, the onset of symptoms was more likely related to mitral valve regurgitation worsening and previously unknown coronary artery disease, rather than to CTS. She underwent bi-atrial surgical ablation (Cox Maze IV procedure) for atrial fibrillation (AF), surgical resection of interatrial membrane with mitral annuloplasty, and myocardial revascularization.
Conclusion
The onset and severity of symptoms in patients with CTS mostly depend on membrane fenestration size, grade of stenosis generated and pulmonary veins drainage site. However, some cases may remain asymptomatic until adulthood; the degree of pulmonary hypertension and congestive heart failure is determined by the presence of additional cardiac anomalies and the fibromuscular membrane fenestration. In some cases, CTS may remain asymptomatic, thus the diagnosis can be incidental.
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.
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).
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).
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.
Abstract 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.
This systematic review examined the clinical and hemodynamic performance of the stentless Freedom SOLO (Sorin Group, Milan, Italy) aortic bioprosthesis. The occurrence of postoperative ...thrombocytopenia was also analyzed. The Freedom SOLO is safe to use in everyday practice, with short cross-clamp times, and postoperative pacemaker implantation is notably lower. Valvular gradients are low and remain stable during short-term follow-up. Thrombocytopenia is more severe than in other aortic prostheses; however, this is without clinical consequences. Within a few years, the 15-year follow-up of this bioprosthesis will be known, which will be key to evaluating its long-term durability.
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.