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.

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.

Sutureless Valves Reduce Hospital Costs Compared to Traditional Valves.

BACKGROUND: The study aim was to assess differences in clinical outcome, safety, and associated costs between sutureless and aortic isolated aortic valve replacement (AVR) with a standard bioprosthesis. METHODS: A retrospective comparative study was conducted to investigate 65 patients, each of whom had undergone isolated AVR with a traditional aortic valve (T) or a Perceval S sutureless aortic prosthesis (P) between January 2010 and December 2012. Cost data were drawn from the proprietary cost accounting system of the hospital, excluding acquisition costs of the devices. A linear regression model was used to estimate the mean total costs difference between groups. RESULTS: The mean cardiopulmonary bypass time and aortic cross-clamp times in the T and P groups were 80 ± 41 min and 58 ± 26 min versus 38 ± 16 min and 26 ± 10 min, respectively (p <0.0001). The mean intensive care unit and ward stays in both groups were 4.2 ± 5.9 and 11.9 ± 6.5 days versus 3.8 ± 4.7 and 10 ± 4.5 days, respectively (p = 0.68 and p = 0.05). The mean costs savings for group P compared to group T were €3,801 (p = 0.13), mainly driven by hospital stay costs. Savings between the P and T groups increased with age: €4,992 in patients aged 70-79 years and €9,326 in those aged 80+ years, and with risk (€4,296 for high-risk patients). CONCLUSIONS: Sutureless aortic valves present shorter procedural times and lower hospital costs compared to traditional valves, with higher cost savings at increased patient age and risk. Sutureless aortic valves seem to be cost-effective in patients undergoing AVR.

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.

The sutureless aortic valve at 1 year: A large multicenter cohort study.

OBJECTIVE: Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year. METHODS: From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%. RESULTS: One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up. CONCLUSIONS: The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.

Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial)†.

OBJECTIVES: The aim of the Cavalier trial was to evaluate the safety and performance of the Perceval sutureless aortic valve in patients undergoing aortic valve replacement (AVR). We report the 30-day clinical and haemodynamic outcomes from the largest study cohort with a sutureless valve. METHODS: From February 2010 to September 2013, 658 consecutive patients (mean age 77.8 years; 64.4% females; mean logistic EuroSCORE 10.2%) underwent AVR in 25 European Centres. Isolated AVRs were performed in 451 (68.5%) patients with a less invasive approach in 219 (33.3%) cases. Of the total, 40.0% were octogenarians. Congenital bicuspid aortic valve was considered an exclusion criterion. RESULTS: Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, the mean cross-clamp time and the cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, and with the less invasive approach 38.8 and 64.5 min, respectively. The 30-day overall and valve-related mortality rates were 3.7 and 0.5%, respectively. Valve explants, stroke and endocarditis occurred in 0.6, 2.1 and in 0.1% of cases, respectively. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg to 10.24 and 19.27 mmHg at discharge, respectively. The mean effective orifice area improved from 0.72 to 1.46 cm(2). CONCLUSIONS: The current 30-day results show that the Perceval valve is safe (favourable haemodynamic effect and low complication rate), and can be implanted with a fast and reproducible technique after a short learning period. Short cross-clamp and CPB times were achieved in both isolated and combined procedures. The Perceval valve represents a promising alternative to biological AVR, especially with a less invasive approach and in older patients.

Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel.

OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.

European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients.

OBJECTIVES: This report summarizes the 5-year clinical and haemodynamic data from three prospective, European multicentre trials with the Perceval sutureless aortic valve. METHODS: From April 2007 to August 2012, 731 consecutive patients (mean age: 78.5 years; 68.1% females; mean logistic EuroSCORE 10.9%) underwent AVR with the Perceval valve in 25 European centres. Isolated AVR was performed in 498 (68.1%) patients. A minimally invasive approach was performed in 189 (25.9%) cases. The cumulative follow-up was 729 patients-years. RESULTS: In isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 30.8 and 50.8 min in full sternotomy, and 37.6 and 64.4 min in the minimally invasive approach, respectively. Early cardiac-related deaths occurred in 1.9%. Overall survival rates at 1 and 5 years were 92.1 and 74.7%, respectively. Major paravalvular leak occurred in 1.4% and 1% at early and late follow-up, respectively. Significant improvement in clinical status was observed postoperatively in the majority of patients. Mean and peak gradients decreased from 42.9 and 74.0 mmHg preoperatively, to 7.8 and 16 mmHg at the 3-year follow-up. LV mass decreased from 254.5 to 177.4 g at 3 years. CONCLUSIONS: This European multicentre experience, with the largest cohort of patients with sutureless valves to date, shows excellent clinical and haemodynamic results that remain stable even up to the 5-year follow-up. Even in this elderly patient cohort with 40% octogenarians, both early and late mortality rates were very low. There were no valve migrations, structural valve degeneration or valve thrombosis in the follow-up. The sutureless technique is a promising alternative to biological aortic valve replacement.

Surgical Treatment of Cor Triatriatum Sinister in a Cat Under Cardiopulmonary Bypass.

OBJECTIVE: To report the surgical repair of cor triatriatum sinister (CTS) incorporating heart-beating cardiopulmonary bypass (CPB) in a cat. STUDY DESIGN: Clinical case report. ANIMAL: Fourteen-month-old, 5.9-kg male castrated Maine Coon cat. MATERIALS AND METHODS: The cat had a 3 month history of inappetance, weight loss, and recurrent pulmonary edema. CTS with severe systolic pulmonary arterial (SPA) hypertension (124 mm Hg) was diagnosed by 2D echocardiography, color flow and continuous wave Doppler modes, and left atrial and pulmonary angiography. Surgery was performed through a left intercostal thoracotomy. CPB was initiated and the heart was kept beating. The left atrial appendage was opened and the intra-atrial membrane was excised. RESULTS: After 48 hours, the cat was doing well. Reduced SPA pressure (52 mm Hg) with decreased right heart enlargement was observed on ultrasound examination and the cat was discharged 6 days after surgery with oral antibiotics for 10 days, aspirin, and furosemide. Four months after surgery, the cat presented with increased activity and weight gain and was completely asymptomatic. Transthoracic echocardiography showed a marked improvement of all echo-Doppler variables with disappearance of SPA hypertension (24 mm Hg). Four years after surgery, the cat was still doing well with no recurrence of clinical signs despite the lack of medical treatment. CONCLUSION: CTS in the cat may be successfully treated by surgery facilitated by use of CPB leading to early and long-term substantial improvement in clinical status and cardiac function. CTS can safely be repaired under CPB in cats.

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.

Five-year results of the pilot trial of a sutureless valve.

OBJECTIVE: A prospective trial was designed to evaluate the feasibility of the Perceval sutureless aortic valve. We report the 5-year clinical and hemodynamic outcome. METHODS: A total of 30 patients (mean age: 80.4 ± 3.8 years; mean logistic European System for Cardiac Operative Risk Evaluation [euroSCORE]: 13.2 ± 7.3) received the valve in 3 European centers, between April 2007 and February 2008. Cumulative follow-up was 92.67 patient-years, with a median of 4.2 years. Patients with a small annulus were selected because only sizes 21 and 23 mm (covering annuli diameters from 19 to 23 mm) were available at this early stage of the trial. In 37% of the patients, a 21-mm valve was used; 63% received a 23-mm valve; 14 patients had concomitant coronary artery bypass grafting. Clinical and hemodynamic follow-up evaluation were performed annually, including echocardiography. RESULTS: Procedural success was 100%. Cardiopulmonary bypass time and cross-clamp time in isolated aortic valve replacement were 46.4 ± 6.7 minutes and 29.3 ± 8.0 minutes, respectively. One patient died during the hospital stay. Postoperative complications included 1 patient with mediastinal bleeding, and 1 with atrioventricular block that led to pacemaker implantation. No stroke occurred in either the early or late period. At the last available follow-up, 22 patients were alive. The mean gradient was 9.3 mm Hg, with an effective orifice area of 1.7 cm(2) at 5 years. No dislodgement, structural valve deterioration, hemolysis, or valve thrombosis was reported. CONCLUSIONS: This study reports the first and longest experience with a truly sutureless valve, evaluating implantation feasibility and valve safety. Results from up to 5 years of follow up confirmed the performance and safety of this device, even in a medium- to high-risk patient population with a small aortic annulus.

Challenge for perceval: aortic valve replacement with small sutureless valves--a multicenter study.

BACKGROUND: There is controversy concerning the performance of small aortic prostheses (size < 21). These have been associated with morbidity and mortality after aortic valve replacement (AVR) due to their increased gradient. Sutureless technology is now available but the performance of the smallest of these prostheses needs to be assessed. METHODS: The registries of 4 European centers, including 276 consecutive patients (mean age 79.7 ± 5.2 years, 69.9% females), were reviewed in order to compare data on the smallest model of the Sorin-Perceval sutureless prosthesis (Sorin Group, Saluggia, Italy) compared with larger models. The small valve ("S" size) was inserted (S group) in 47 patients, while 229 patients had a larger one (labeled "M" and "L" by manufacturer, herein L group). Except for body surface area (1.60 ± 0.16 vs 1.78 ± 0.19 m(2), p < 0.001), there were no other relevant preoperative differences. The European system for cardiac operative risk evaluation log was 11.4 ± 6.1 versus 12.6 ± 9.6 (p = 0.28). RESULTS: Median sternotomy was the most frequent approach (S group 87.2% vs L group 79.5%, p = 0.31). The associated procedures were similar for both groups (31.9% vs 34.5%, p = 0.87). For isolated AVR, cardiopulmonary bypass and cross-clamp times were, respectively, 49.1 ± 16.0 and 30.7 ± 9.2 minutes (S group) versus 52.6 ± 23.1 and 32.3 ± 13.6 minutes (L group) (p = 0.33 and 0.45). Hospital mortality was nil (S group) versus 2.6% (L group) (p = 0.62). At discharge, the peak-pressure-gradients were 22.7 ± 7.9 and 20.9 ± 8.4 mm Hg (p = 0.24) while indexed effective orifice areas were 0.84 ± 0.16 and 0.86 ± 0.25 cm(2)/m(2) (p = 0.76). At follow-up (1.5 ± 1.3 years), echo data and survival did not differ (p = 0.17). CONCLUSIONS: This multicenter study confirms the safety, efficacy, and ease of insertion of Perceval valves in elderly patients with small annulus. The performance of the smaller prosthesis was satisfying and prosthesis size did not affect patient outcome.

Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials.

BACKGROUND: The Perceval (Sorin Group, Milan, Italy) is a self-anchoring sutureless aortic valve prosthesis. We report the short- to midterm results of combined aortic valve replacement (AVR) with concomitant procedures in elderly patients undergoing operation as part of 3 consecutive prospective multicenter European studies. METHODS: From April 2007 to February 2013, 243 patients (mean age, 79.7 ± 5.1 years; female patients, 61%; median EuroSCORE, 9%) underwent AVR with concomitant procedures. The concomitant procedures were coronary artery bypass grafting (CABG) (182 cases), septal myectomy (21 cases), CABG + other procedures (18 cases), and 22 other procedures. Primary and secondary end points included implant feasibility and safety (for mortality and morbidity) and efficacy (New York Heart Association [NYHA] class improvement and hemodynamic results) of the prosthesis at the different follow-up periods. Data were expressed as mean ± standard deviation. Kaplan-Meier analysis was performed for survival analysis. RESULTS: Mean aortic cross-clamp and extracorporeal circulation (ECC) times were 50.7 ± 22.8 minutes and 78.9 ± 32.3 minutes, respectively. Thirty-day mortality was 2.1%. Mean postoperative gradient and effective orifice area were 10.1 ± 4.7 mm Hg and 1.5 ± 0.4 cm(2) and 8.9 ± 5.6 mm Hg and 1.6 ± 0.4 cm(2), respectively, at 1 year. There were early explantations, 4 of which resulted from paravalvular leaks. One additional valve explantation resulted from aortic root bleeding, probably caused by excessively extensive decalcification. In the late period, there was 1 mild paravalvular leak and no intravalvular insufficiency. No migration, dislodgement, or degeneration of the valve occurred during follow-up. Median follow-up was 444 days. CONCLUSIONS: These trials confirm the safety and efficacy of the Perceval sutureless aortic valve, especially in elderly patients requiring AVR + concomitant procedures. In this patient group, sutureless valves may be advantageous compared to transcatheter valve implantations as concomitant procedures other than percutaneous coronary artery angioplasty are not always possible in the latter.

Leiomyosarcoma of the superior vena cava.

Leiomyosarcoma of the superior vena cava is a very rare tumor and only a few cases have been reported, with various techniques of vascular reconstruction. We describe a new case of leiomyosarcoma of the superior vena cava in a 61-year-old woman with extension to the brachiocephalic arterial trunk. Resection and vascular reconstruction were performed using, respectively, polytetrafluoroethylene and polyethylene terephtalate vascular grafts.

Interleukin-1 receptor-related protein ST2 and mitral valve repair outcome in patients with chronic degenerative mitral regurgitation.

BACKGROUND: ST2 is a member of the interleukin-1 receptor family that is markedly upregulated in cultured cardiomyocytes subjected to mechanical strain. Serum soluble ST2 (sST2) levels can be detected in patients with acute myocardial infarction and severe chronic heart failure. This study sought to assess for the first time the activation of the ST2 pathway in patients with severe chronic degenerative mitral regurgitation. MATERIALS AND METHODS: Serum sST2 levels were measured in 20 patients scheduled for mitral valve (MV) repair at baseline, at the end of the intervention, on postoperative day 1, at hospital discharge, and after 6 months. Patients also underwent measurement of N-terminal pro-brain natriuretic peptide and echocardiographic evaluation at each time point. RESULTS: At baseline, sST2 was detected in 10 (50%) patients (mean value, 60 ± 74 pg/mL; range, 0-234 pg/mL; median, 8 pg/mL). MV repair was performed successfully in all patients. Cardiac surgery with cardiopulmonary bypass was associated with a rapid and transient increase in sST2 levels. Patients with baseline higher versus lower sST2 levels (≥ 8 vs. < 8 pg/mL) had significantly higher levels of sST2 on postoperative day 1 (1,050 ± 593 vs. 440 ± 312 pg/mL; p = 0.009). At follow-up, patients with preoperative sST2 ≥ 8 pg/mL had significantly higher ejection fraction (EF) (64.7 ± 5.8 vs. 57.6 ± 5.9; p = 0.03) and lower left ventricular end-diastolic diameter (LVEDD) (50.6 ± 5.8 vs. 56 ± 4.2; p = 0.03) compared with patients with preoperative sST2 < 8 pg/mL. CONCLUSION: Preoperative ST2 activation, evidenced by the presence of serum sST2 levels, is present in half of the patients with chronic degenerative mitral regurgitation and is associated with higher levels of EF and lower levels of LVEDD after MV repair.

Aortic valve replacement with the perceval S bioprosthesis: single-center experience in 143 patients.

BACKGROUND AND AIM OF THE STUDY: Aortic stenosis (AS) is the most frequent heart valve disease in western countries, and its prevalence increases with age. Sutureless valves have recently become available that allow the surgical procedures to be shortened. The study aim was to assess clinical outcome after sutureless aortic valve replacement (SAVR) performed with the Perceval S bioprosthesis at the authors' institution. METHODS: Between June 2007 and November 2011, a total of 143 patients (78 females, 65 males; mean age 79.4 +/- 5.9 years) was prospectively enrolled and followed at the authors' center. The median preoperative logistic EuroSCORE was 12.04 +/- 10.7. Preoperatively, 58.8% of patients were in NYHA class III or IV, and the mean gradient and effective orifice area (EOA) were 38.8 +/- 17 mmHg and 0.76 +/- 0.24 cm2, respectively. Isolated SAVR was performed in 95 patients (66.4%), while associated procedures were necessary in 48 patients (33.6%). The follow up was 100% complete (mean 13.4 +/- 11.6 months; range: 0-5 years; total cumulative follow up 155 patient-years). RESULTS: The procedural success rate was 99.3%. The mean cross-clamp and cardiopulmonary bypass times were 32.0 +/- 14.9 min and 44.7 +/- 18.6 min, respectively. In-hospital mortality was 4.9% (n=7). Pacemaker implantation was required in seven patients (4.9%). Survival at five years was 85.5%. Reoperation was necessary in seven patients (4.9%); early reoperations were due to paravalvular leak (n = 3; 2.0%) and intra-prosthetic regurgitation (n=3; 2.0%). One late reoperation (at 29 months) was required, due to fibrous pannus overgrowth. One late endocarditis (0.7%) occurred at 26 months and was medically treated. No structural valve deterioration occurred during the follow up. At 12 months, 94.4% of survivors were in NYHA class I-II, and the mean pressure gradient and EOA were 9.0 +/- 3.4 mmHg and 1.60 +/- 0.3 cm2, respectively. CONCLUSION: The Perceval S valve appears to be a safe option for SAVR, though further follow up is needed to evaluate the long-term outcome with this bioprosthesis.

Sutureless Perceval aortic valve replacement in aortic homograft.

We report a case of aortic valve replacement with a sutureless valve in a degenerated aortic homograft. This technique allows rapid aortic valve replacement in a heavily calcified aortic root. It avoids the problems of postoperative prosthetic disinsertion frequently encountered after aortic valve replacement in a calcified annulus. It is particularly suitable in redo procedures for homograft degeneration. It avoids performing a redo Bentall operation with its known morbidity.

Leiomyosarcoma of the right inferior pulmonary vein: 2 years survival with multimodality therapy.

Primary leiomyosarcoma of the heart is an extremely rare and aggressive tumor. The authors report a case of a 29-year-old man with a leiomyosarcoma of the right inferior pulmonary vein who underwent surgery, chemotherapy, and radiotherapy. The patient experienced two local recurrences and he finally died 2 years after onset of symptoms because of multiple distal metastases.

Sutureless perceval aortic valve replacement: results of two European centers.

BACKGROUND: The Perceval S bioprosthesis (Sorin Biomedica Cardio Srl, Sallugia, Italy) is a self-expanding valve designed to preserve aortic sinuses and sinotubular junction. We report the midterm results of a prospective, multicenter clinical study evaluating the safety and efficacy of this stented bioprosthesis in patients undergoing aortic valve replacement with or without concomitant procedures. METHODS: From January 2007 to September 2011, a total of 208 high-risk patients (mean European system for cardiac operative risk evaluation: 8.7±5.3 years) received a Perceval bioprosthesis in 2 European centers. Median follow up was 10±20 months and 100% complete, and the total accumulated follow-up was 156 patient-years. Ten patients have reached a 4-year follow-up. Valve function was assessed in all patients. RESULTS: Valve implantation resulted in significant improvement of patients' symptoms. Mean preoperative and postoperative gradients were 48.6±18.6 mm Hg and 10.4±4.3 mm Hg, respectively, and preoperative and postoperative mean effective orifice areas were 0.7±0.2 and 1.4±0.4 cm2. Survival at 12 months was 87.1%, success of implantation was 95%, and freedom from reoperation was 96%. In hospital mortality was 2.4%. During follow-up, 9 patients (4%) required reoperation for paravalvular regurgitation; 7 early and 2 late reoperations. Mean cross-clamp time (CCT) and extracorporeal circulation time (ECT) were, respectively, 33±14 minutes and 54±24 minutes, including 45 patients who underwent surgery through ministernotomy. Concomitant coronary bypass was done in 48 patients with mean CCT 43±13 and ECT 68±25 minutes. CONCLUSIONS: Perceval sutureless is a safe bioprosthesis that can easily be implanted, including by a minimally invasive technique. It provides excellent hemodynamic with significant clinical improvement. Overall, these data confirm the safety and utility of the Perceval bioprosthesis aortic valve replacement for high-risk patients.

New sutureless aortic valve prosthesis: another tool in less invasive aortic valve replacement.

PURPOSE OF REVIEW: Sutureless aortic valve prosthesis is a new and promising tool for treatment of aortic valve stenosis. It could increase applicability of surgical aortic valve replacement in the elderly with severe comorbidities. RECENT FINDINGS: Three devices are currently available. The 3f Enable (ATS, Minneapolis, USA) and the Perceval S (Sorin, Saluggia, Italy) have a CE mark, whereas the Intuity (Edwards Lifesciences, Irvine, California) is still under investigation. We present the above valves, focusing on the Perceval S, which was used in our institution. Indications, contraindications, technical considerations and patient selection are described. The potential advantages of sutureless valve technology over conventional aortic and percutaneous valves are discussed. We emphasize new perspectives offered by sutureless valves in the aortic replacement field. SUMMARY: This new technology may offer improved results. Cost-effectiveness and fine-tuning of patient selection are two aspects that future investigation should address.