Search

Objective: This study aimed to compare hemodynamic performances and clinical outcomes of patients with small aortic annulus (SAA) who underwent aortic valve replacement by means of sutureless aortic valve replacement (SUAVR) or transcatheter aortic valve implantation (TAVI)., Methods: From 2015 to 2020, 622 consecutive patients with SAA underwent either SUAVR or TAVI. Through a 1:1 propensity score matching analysis, two homogeneous groups of 146 patients were formed. Primary endpoint: all cause-death at 36 months. Secondary endpoints: incidence of moderate to severe patient-prosthesis mismatch (PPM) and incidence of major adverse cardiovascular and cerebrovascular events (MACCEs)., Results: All-cause death at three years was higher in the TAVI group (SUAVR 12.2% vs. TAVI 21.0%, P=0.058). Perioperatively, comparable hemodynamic performances were recorded in terms of indexed effective orifice area (SUAVR 1.12 ± 0.23 cm2/m2 vs. TAVI 1.17 ± 0.28 cm2/m2, P=0.265), mean transvalvular gradients (SUAVR 12.9 ± 5.3 mmHg vs. TAVI 12.2 ± 6.2 mmHg, P=0.332), and moderate-to-severe PPM (SUAVR 4.1% vs. TAVI 8.9%, P=0.096). TAVI group showed a higher cumulative incidence of MACCEs at 36 months (SUAVR 18.1% vs. TAVI 32.6%, P<0.001). Pacemaker implantation (PMI) and perivalvular leak ≥ 2 were significantly higher in TAVI group and identified as independent predictors of mortality (PMI: hazard ratio [HR] 3.05, 95% confidence interval [CI] 1.34-6.94, P=0.008; PPM: HR 2.72, 95% CI 1.25-5.94, P=0.012)., Conclusion: In patients with SAA, SUAVR and TAVI showed comparable hemodynamic performances. Moreover, all-cause death and incidence of MACCEs at follow-up were significantly higher in TAVI group.

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., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: Sutureless valves became an alternative to standard bioprostheses, allowing surgeons to significantly reduce cross-clamping and extracorporeal circulation times, with a potential positive impact on major postoperative complications. The aim of this European multicentre study was to evaluate the safety and efficacy of sutureless valves in patients with an intermediate-risk profile undergoing aortic valve replacement (AVR)., Methods: We investigated early and mid-term outcomes of 518 elderly patients with aortic stenosis at intermediate-risk profile (mean STS Score 6.1 ± 2%) undergoing AVR with sutureless aortic valve. Primary endpoints were 30-day mortality and freedom from all-cause death at follow-up. The secondary endpoint was survival freedom from MACCEs [all-cause death, stroke/transitory ischemic attack (TIA), bleeding, myocardial infarction, aortic regurgitation Grade II, endocarditis, reintervention and pacemaker implant; VARC 1--2 criteria]., Results: Sutureless valve implantation was successfully performed in 508 patients, with a procedural success rate of 98.1% (508/518) as per VARC criteria. Concomitant myocardial revascularization [coronary artery bypass grafting (CABG)] was performed in 74 out of 518 patients (14.3%). In-hospital mortality was 1.9% (10/518). Postoperative complications included revision for bleeding (23/518; 4.4%), prolonged intubation more than 48h (4/518; 0.7%), acute renal failure (14/518; 2.7%), stroke/TIA (11/518; 2.1%), pacemaker implantation (26/518; 5.1%) and aortic regurgitation more than Grade II (7/518; 1.4%). At 48-month follow-up, Kaplan-Meier overall survival and freedom from MACCEs in patients receiving isolated AVR were 83.7% [95% confidence interval (95% CI): 81.1-86.3] and 78.4% (95% CI: 75.5-81.4), respectively, while in patients with concomitant CABG, Kaplan-Meier overall survival and freedom from MACCEs were 82.3% (95% CI: 73.3-91.3) and 79.1% (95% CI: 69.9-88.3), respectively., Conclusion: The use of sutureless aortic valves in elderly patients with an intermediate-risk profile provided excellent early and mid-term outcomes, providing a reliable tool in patients undergoing surgical AVR in this specific subset of population. These preliminary data need to be investigated with a TAVI control-group in further studies., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

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., Competing Interests: Repossini, MD, Fischlein, MD, Grubitsch, MD, and Muneretto, MD, are consultant for Livanova Company. Santarpino, MD, is a consultant for Sorin Italia., (Georg Thieme Verlag KG Stuttgart · New York.)

Surgical aortic valve replacement (SAVR) is highly effective and can be achieved with relatively low risk in patients with severe aortic stenosis. Bioprostheses have been used most frequently during the past 60 years. However, the function of biological valves usually declines after 10-15 years from implant when structural valve degeneration occurs often mandating a reoperation once valve dysfunction becomes haemodynamically significant. Known for many years by surgeons and cardiologists taking care of patients with SAVR, the issue of postimplant structural valve degeneration has been recently highlighted also in patients with transcatheter aortic valve implant (TAVI). There is growing concern that TAVI valves exhibit structural valve degeneration due to inherent challenges of the deployment mode. The impact on postimplant degeneration of TAVI valves compared to SAVR has still to be understood and defined. Based on the ongoing process of expanding TAVI indications, several potential shortcomings and caveats, learned during the last 60 years of SAVR experience, should be taken into consideration to refine this technique.

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.

The PARTNER group recently published a comparison between the latest generation SAPIEN 3 transcatheter aortic valve implantation (TAVI) system (Edwards Lifesciences, Irvine, CA, USA) and surgical aortic valve replacement (SAVR) in intermediate-risk patients, apparently demonstrating superiority of the TAVI and suggesting that TAVI might be the preferred treatment method in this risk class of patients. Nonetheless, assessment of the non-randomized methodology used in this comparison reveals challenges that should be addressed in order to elucidate the validity of the results. The study by Thourani and colleagues showed several major methodological concerns: suboptimal methods in propensity score analysis with evident misspecification of the propensity scores (PS; no adjustment for the most significantly different covariates: left ventricular ejection fraction, moderate-severe mitral regurgitation and associated procedures); use of PS quintiles rather than matching; inference on not-adjusted Kaplan-Meier curves, although the authors correctly claimed for the need of balancing score adjusting for confounding factors in order to have unbiased estimates of the treatment effect; evidence of poor fit; lack of data on valve-related death.These methodological flaws invalidate direct comparison between treatments and cannot support authors' conclusions that TAVI with SAPIEN 3 in intermediate-risk patients is superior to surgery and might be the preferred treatment alternative to surgery., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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 cm 2 for FS and 1.83 ± 0.3 cm 2 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., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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  ±  164.8 vs. G2 = 57.1  ±  39.3  mg/l, P = 0.04), interleukin-6 (G1 = 11.8  ± 12.5 vs. G2 = 26.5  ±  24.9  pg/ml, P = 0.02) and tumour necrosis factor-alpha (G1 = 29  ±  28.7 vs. G2 = 45.5  ±  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.

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., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Although the use of transcatheter aortic valve replacement (TAVR) has recently become an attractive strategy in extremely high-risk patients undergoing aortic valve replacement (AVR), the most appropriate treatment option in patients with an intermediate- to high-risk profile with conventional surgery (sAVR), TAVR or novel options, such as sutureless valves, has been widely debated., Methods: One hundred and sixty-three consecutive patients with intermediate to high risk were prospectively enrolled and selected to undergo sAVR (Group 1: G1, n = 55), sutureless valve implantation (Group 2: G2, n = 53) or TAVR (Group 3: G3, n = 55) following a multidisciplinary evaluation including frailty, anatomy and degree of atherosclerotic disease of the aorta/peripheral vessels. The mean logistic EuroSCORE (G1 = 21.3 ± 12.7 vs G2 = 16 ± 11.7 vs G3 = 20.4 ± 12.7, P = 0.06) and preoperative demographics, such as age, gender and left ventricular ejection fraction, were similar: of note, chronic obstructive pulmonary disease was more frequent in TAVI patients (G1 = 27.2% vs G2 = 15.1% vs G3 = 47%; P <0.01). The Perceval S sutureless valve was used in Group 2, whereas TAVR was performed with a Corevalve prosthesis., Results: Post-procedural pacemaker implantation (G1 = 1.8% vs G2 = 2% vs G3 = 25.5%, P <0.001) and peripheral vascular complications (G1 = 0% vs G2 = 0% vs G3 = 14.5%, P <0.001) occurred more frequently in patients undergoing TAVR. Hospital mortality was similar among the groups (G1 = 0% vs G2 = 0% vs G3 = 1.8%, P = NS). At the 24-month follow-up, overall survival free from major adverse cardiac and cerebrovascular events and prosthetic regurgitation was better in patients who had undergone sAVR and sutureless valves than those who had undergone TAVR (G1 = 95.2 ± 3.3% vs G2 = 91.6 ± 3.8% vs G3 = 70.5 ± 7.6%; P = 0.015)., Conclusions: This preliminary study suggests that the use of TAVR in patients with an intermediate- to high-risk profile is associated with a higher rate of perioperative complications and decreased survival at the 24-month follow-up compared with the use of conventional surgery or sutureless valves., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

The aim of the study was to investigate the multi-factorial phenomenon of possible postoperative thrombocytopenia after aortic valve replacement (AVR) with the freedom SOLO (FS) bioprosthesis. A total of 254 patients underwent AVR with FS bioprosthesis in two cardiac surgery institutes. Platelet counts were measured preoperatively, immediately postoperatively and daily until the 11th day postoperatively. A multivariate generalized estimating equation model was applied to identify prognostic factors for whether or not patients postoperative platelet counts indicated no thrombocytopenia (platelet count >150 10(3)/mm(3)) versus at least mild thrombocytopenia (≤150 10(3)/mm(3)). Preoperatively, 11.2% of patients showed thrombocytopenia. The preoperative platelet count averaged 233.0 ± 83.2 10(3)/mm(3). The postoperative mean of platelet counts decreased daily reaching a minimum mean of 88.4 ± 58.8 10(3)/mm(3) 3 days after surgery and then started to increase, with the Day 11 postoperative mean of 173.3 ± 51.8 10(3)/mm(3). Compared with patients with no preoperative thrombocytopenia, patients with preoperative thrombocytopenia had an 8.69 increased odds of being in the group with postoperative platelet count <150 10(3)/mm(3). No major haemorrhagic or thromboembolic event was reported during hospitalization. This study shows that thrombocytopenia after the FS bioprosthesis replacement is a transient postoperative phenomenon, largely resolved within a few days after surgery, with no clinical consequences and haemodynamic dysfunction.

We report a case of a quadricuspid aortic valve associated with severe aortic regurgitation and left ventricular systolic dysfunction.

Background and Aim of the Study: Heart valve surgery in high-risk patients is associated with considerable morbidity and mortality. Epidural anesthesia without mechanical ventilation has been proposed to reduce invasiveness. An analysis was conducted in very high-risk heart valve patients of mid-term survival free from complications, and patient satisfaction of regional anesthesia use, without mechanical ventilation., Methods: A prospective follow up study was conducted in 50 patients (24 females, 26 males; mean age 74 +/- 10 years; range: 43-89 years) who underwent heart valve surgery with epidural anesthesia without endotracheal intubation. Preoperatively, all patients were in NYHA class III or IV; eight patients (16%) had undergone a previous cardiac procedure. The median Additive and Logistic EuroSCORE were 14.5 and 52%, respectively. Twenty-seven patients underwent aortic valve replacement, 10 mitral valve replacement, 10 mitral valve repair, two double valve replacement, and one patient ascending aorta replacement. Associated surgical procedures included coronary artery bypass grafting in 12 patients (24%), ascending aorta replacement in three (6%), and left ventricle reshaping in two (4%). Radiofrequency ablation to treat chronic atrial fibrillation (AF) was performed in 15 patients (30%). All patients were prospectively followed up, and a six-month quality of life assessment was performed in all survivors., Results: Procedures were performed without mechanical ventilation in completely awake and conscious patients. There were two in-hospital and two long-term deaths (8%). Three patients had had previous cardiac surgery (two double valve replacements, two complex mitral valve surgery). Among survivors, 34 (71%) had an uneventful postoperative outcome, except for AF in nine cases. Eight patients required revision for bleeding; two of these were redo cases. The most consistent postoperative complication was acute renal failure in 16 patients, five of whom had previous chronic renal failure. Three patients required mechanical ventilatory support, and none had a cerebrovascular accident. Patients were discharged home after a mean of 10 +/- 5 days (including ICU stay; median 9 h). At follow up, all patients were in NYHA class I/II, and all survivors expressed their satisfaction with epidural anesthesia., Conclusion: Heart valve surgery while on cardiopulmonary bypass is feasible and safe using epidural anesthesia. By maintaining autonomic ventilation, a low mid-term morbidity and mortality was observed in patients in whom there was an unacceptable operative risk.

Objective: Hemodynamic and clinical performances of 21-mm and 23-mm St Jude Medical Hemodynamic Plus aortic valves (St Jude Medical, Inc, St Paul, Minn) were compared with those of 21-mm and 23-mm St Jude Medical standard cuff aortic valves in the first such multicenter, prospective, randomized study. Hemodynamic Plus valves are mechanical, bileaflet prostheses suitable for the small aortic anulus., Methods: Patients with 21-mm and 23-mm anulus diameters were randomized to receive either a Hemodynamic Plus or a standard cuff valve. Postoperatively and at 6 months after the operation, patients underwent 2-dimensional Doppler echocardiography. Ejection fraction, cardiac output, peak gradient, mean gradient, effective orifice area, effective area index, and performance index were calculated. Postoperative and 6-month echocardiographic measurements and their variations across observation times were analyzed statistically., Results: Of the 140 patients enrolled, 5 died at operation and 1 died of aortic dissection during the follow-up period. Eight patients were lost to follow-up. A total of 125 patients completed the study. In 1 patient a sewing cuff escaped intraoperatively. At 6 months the 21-mm and 23-mm Hemodynamic Plus valves showed significantly lower peak gradients and mean gradients than those of the 21-mm and 23-mm standard cuff valves. The 21-mm Hemodynamic Plus valves had gradients similar to those of the 23-mm Hemodynamic Plus valves. The effective orifice area did not differ significantly between the Hemodynamic Plus and standard cuff valves at either measurement. No valve mismatch was found in the 4 groups of patients. A more enhanced decrease of peak gradients and mean gradients and a more enhanced increase of effective orifice areas, effective area indices, and performance indices were found across observation times for patients with Hemodynamic Plus valves compared with those with standard cuff valves., Conclusions: Clinical hemodynamic performances of 21-mm and 23-mm St Jude Medical Hemodynamic Plus valves correspond closely with those of standard cuff valves, and gradients are substantially better than those of standard cuff valves of the same diameter. Therefore, use of this valve may minimize the need for aortic anulus enlargement. Early follow-up results with the Hemodynamic Plus valves were excellent, although more time is required to confirm this outcome.