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.
Objectives Electrophysiologic and surgical procedures to treat stand-alone atrial fibrillation (AF) have recently evolved, but disappointing results in patients with long-standing persistent (LSP) AF ...have challenged the durability of these procedures. Methods Lone AF patients (n = 36) with either LSP-AF (n = 28) or persistent AF (n = 8) were prospectively enrolled in the study and consecutively treated by thoracoscopic ablation followed by electrophysiologic evaluation 30 days afterward. Mean left atrial dimension was 50.3 ± 5.5 mm, and average AF duration was 72.8 months (range, 7-240 months). The thoracoscopic procedure was a right monolateral approach to create a box lesion using a temperature-controlled radiofrequency device with suction adherence. A continuous rhythm monitoring device was implanted at the end of the operation. Results Thoracoscopic ablation was successfully completed without morbidity or mortality and without any intensive care unit stay. Intraoperative exit and entrance block was achieved in 100% and 88.8% (32/36) of patients, respectively. At 33 ± 2 days after the operation, an electrophysiologic study confirmed entry–exit block in 83.3% (30/36) whereas pulmonary vein reconnections were observed in 16.7% (6/36) of patients. Additional transcatheter lesions were performed in 61.1% (22/36) of patients. At a mean follow-up of 30 months (range, 1-58 months), 91.6% (33/36) of patients are in sinus rhythm with 77.7% (28/36) of these patients off antiarrhythmic drugs and 88.8% (32/36) free of warfarin. Long-term incidence of left atrial flutter was 0%. Conclusions The combination of a surgical box lesion and transcatheter ablation in a hybrid approach provided excellent durable clinical outcomes in patients with LSP-AF.
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.
Background Despite the popularity of less invasive approaches for conduits procurement in coronary artery bypass graft surgery, concerns have been raised about the potential detrimental effects of ...the endoscopic technique when compared with the conventional “open” technique. Methods Among 470 patients undergoing coronary surgery with the use of a radial artery conduit, a propensity score analysis was performed among those patients assigned either to an open technique (n = 82) or to an endoscopic approach (n = 82). Endoscopic harvesting was performed with a nonsealed system. The primary endpoint was cardiac-related mortality, and secondary endpoint was survival free from major cardiac and cerebrovascular adverse events. Moreover, hand and forearm sensory discomfort and forearm wound healing were also assessed. Results No conversion to the open technique occurred in patients undergoing endoscopic harvesting. No patients in either group showed hand ischemia; wound infection occurred only in the open group (open 7.3% versus endoscopic 0%, p = 0.007). Wound healing (Hollander scale) was considerably better in the endoscopic group (open 3.3, endoscopic 4.7; p < 0.001) as well as paresthesia at the latest follow-up (open 19.5% versus endoscopic 3.6%, p < 0.001). Pain (visual analog scale score) was significantly reduced with the endoscopic technique (open 3.2, endoscopic 1.2; p = 0.003). At 5 years of follow-up, freedom from cardiac-related mortality (open 96.3% ± 2.1% versus endoscopic 98.1% ± 1.8%; p = 0.448) as well as survival free from major cardiac and cerebrovascular adverse events (open 93.9% ± 2.6% versus endoscopic 93% ± 3.4%; p = 0.996) were similar among the groups. Conclusions Endoscopic radial artery harvesting allows for incremental benefits in the short term in terms of improved cosmesis and reduced wound and neurologic complications, without yielding detrimental effects in terms of graft-related events at 5 years of follow-up.
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.
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.
Background Hybrid coronary revascularization, meaning, left mammary artery on left anterior descending artery combined with non–left anterior descending artery percutaneous coronary intervention ...stenting, is considered a viable alternative to conventional coronary artery bypass graft surgery or to multivessel percutaneous coronary intervention, to perform a functionally complete revascularization. Methods One hundred consecutive patients underwent hybrid coronary revascularization. Coronary risk was assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score. Long-term outcomes, major adverse cardiac and cerebrovascular events (MACCE) rate, and repeated target vessels revascularization (TVR) rate were evaluated. Results Mean age was 66.3 ± 12.0 years. Mean SYNTAX score was 28.22 ± 7. Mean European System for Cardiac Operative Risk Evaluation II score was 4.05 ± 1.83. Percutaneous coronary intervention was performed in all patients (n = 100), in 75% of cases before and in 25% of cases after surgery (interval, 2.2 ± 1.3 months). No in-hospital mortality was reported. At follow-up, 1 cardiac death of acute MI occurred. At 3.5 ± 1.3 years follow-up, overall population freedom from MACCE rate was 82.6% (95% confidence interval CI: 79.5% to 85.7%) and the freedom from TVR rate was 86.1% (95% CI: 82.9% to 89.3%). MACCE and TVR rates were higher in patients with intermediate and high coronary risk than in patients with SYNTAX score of 22 or less, although not statistically significant ( p > 0.05). Cox regression analysis showed a significant increment of risk for TVR on overall population in patients with diabetes mellitus (OR 2.4, 95% CI 1.3-3.5, p = 0.03) and in patients with non–left anterior descending artery stented lesions (OR 4.5, with 95% CI 2.8-6.2, p = 0.02). Conclusions Hybrid coronary revascularization is a viable option to perform a minimally invasive, functionally complete revascularization in high-risk patients for conventional revascularization, with better results when performed on patients with a SYNTAX score of 22 or less.
Degeneration of a surgically implanted valve bioprosthesis may occur in elderly, frail patients with an extremely high risk to undergo redo cardiac surgery. Transapical or fully percutaneous ...transseptal approaches have been described in order to treat degenerated aortic and mitral bioprosthesis. We performed the first-in-man successful mitral transcatheter valve delivery with a valve-in-valve technique through an innovative route; ie, a video-assisted endoscopic direct access to the left atrium, in an 82-year-old patient who previously underwent surgical replacement of the mitral valve and with a prohibitive surgical risk.
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.