Long-Term Results After Aortic Valve Replacement with Last-Generation Stentless Prostheses.

INTRODUCTION: The purpose of this study was to evaluate the long-term clinical and hemodynamic results in patients affected by severe aortic valve disease after aortic valve replacement with third-generation stentless aortic prostheses (3F® stentless equine pericardial [Medtronic plc, Minneapolis Minnesota] and Pericarbon Freedom™ stentless bovine pericardial [LivaNova plc, London, United Kingdom]) and to analyze the benefits and the drawbacks associated to their use. MATERIALS AND METHODS: Between June, 2003 and Sept, 2015 a cohort of 548 consecutive patients affected by aortic valve disease received an aortic valve replacement using a last-generation stentless pericardial aortic prosthesis at our unit. Respectively, 322 patients received a Pericarbon Freedom™ and 226 received a 3F® aortic valve. Size ranged between 19 and 29, with prevalence of 23 and 25 devices. Mean age at operation was 71± 11 years, 57% of patients were males, the mean logistic EuroScore was 8.9 ± 7.2 and 44.2% received concomitant procedures. The mean extracorporeal circulation (ECC) time was 119.2 ± 40.6. The mean cross clamp time was 90.5' ± 21.4'. In 30 patients, the aortic prosthesis was included in a Dacron tube straight graft for a Bentall operation. RESULTS: Early/in-hospital mortality was 2.55% (14 cases) for the entire cohort. In patients receiving isolated aortic valve replacement (AVR), it was 0.91% (5 cases). Follow up ranged between six months and 12 years (median follow-up time: 6.77 years). During follow up, 137 patients died of all causes (25%), of whom 32 patients died of cardiac causes (5.8%). Cardiac survival probability was 91% at 12 years. All surviving patients were in NYHA class I at last follow up. Actuarial freedom from structural valve deterioration was 86% at 12 years. Freedom from endocarditis was 95% at 12 years. Freedom from a valve-related reoperation at 12 years follow up was 95%. Mean residual transprosthetic gradient at 12 years was 10.3 ± 4.8MmHg. CONCLUSIONS: Last-generation stentless pericardial valves offer excellent hemodynamics and adequate durability and freedom from structural deterioration at 12 years follow up. The implantation technique of a stentless valve is a little more demanding when compared to a stented valve, but it can be easily reproduced after minimal training. Incidence of endocarditis and thromboembolic events is low and comparable to stented pericardial valves. Young and active patients, and patients with large BSA where a patient-prosthesis mismatch may be anticipated are, in our opinion, ideal candidates to receive these kinds of valves.

Mid-term outcomes of stentless Bio-Bentall vs. David Reimplantation for aortic root replacement.

OBJECTIVE: To compare the early and midterm clinical outcomes of patients undergoing two different surgical procedures (stentless biological Bentall [SBB] vs. valve-sparing David Reimplantation [VSDR]) for aortic root dilatation, with or without concomitant aortic valve pathology. METHODS: A population of 106 patients underwent aortic root replacement from 2004 to 2015 at our unit. Mean age at operation was 63.1 ± 10 years. The patients were retrospectively assigned to 2 groups according to surgical procedure. David operation was carried out in 52 patients (group A-VSDR) and stentless biological Bentall in 54 patients (group B-SBB). Preoperative characteristics were similar in the 2 cohorts, except for age and EuroSCORE. Mean follow-up time was 7.09 years (0.26-14.50 years), and 96% complete. Patients were evaluated and analyzed for intra-operative results and long-term clinical outcomes. RESULTS: Intraoperative mortality was 0% in both groups. Overall survival probability at 11 years was 91.8% in group A and 73.8% in group B (p = .004). Cardiac mortality at 11 years was similar in the 2 groups (p = .116). Freedom from structural valve deterioration at 11 years was 88.8% (VSDR) and 90.6% (SBB) [p = .689]. Freedom from reoperation at 11 years did not differ between the groups (83.6% VSDR vs. 98.5% SBB, p = .574). Freedom from major adverse cardiac and cerebrovascular events at 11 years was 76.7% (VSDR) versus 80.1% (SBB) (p = .542). Mean gradient at last follow-up was lower in VSDR group (8.13 vs. 11.70 mmHg, p < .001). CONCLUSIONS: David reimplantation and stentless biological Bentall procedures achieve excellent and comparable results at midterm follow-up. David operations provide superior hemodynamic performance preserved over time and may be preferred in younger, active patients.

Surgical Options for Physiological Treatment of Aortic Root Dilatation Either Isolated or Associated with Aortic Valve Disease.

Patients affected by severe aortic root pathology require an operation to replace the dilated aortic root and repair or replace the aortic valve, which is very frequently involved in the disease. Among the surgical options available for aortic root replacement, the Bentall operation and the David aortic valve reimplantation procedure are the most commonly used by surgeons. This article provides an overview of the Bio-Bentall and David operations. It illustrates their surgical details and discusses the correct indications for both procedures to achieve excellent long-term outcomes. Finally, the authors present their experience with the physiologic treatment of aortic root pathology by using stentless Bio-conduits and David reimplantation in a cohort of patients with long-term follow-up. A comparative analysis of early and late results along with an evaluation of possible benefits and drawbacks related to each technique concluded that both procedures were effective in correcting the aortic root pathology, and the results were adequate and stable over time. Since hemodynamic performance was more improved after the David operation, it should be preferred, whenever feasible, in younger and active patients.

Surgical Treatment of Ischemic Dilative Cardiomyopathy by Ventricular Restoration.

Patients with symptomatic post-ischemic dilative myocardiopathy of the left ventricle require, in selected cases, an operation to reshape and reduce the volume of the left ventricular chamber, in addition to surgical myocardial revascularization and mitral valve repair, with the aim of prolonging survival, improving the quality of life and minimizing the need for re-hospitalizations related to recurrent heart failure. This procedure is called surgical ventricular restoration (SVR), and is a useful tool for the treatment of heart failure patients as an alternative to heart transplant. This article provides an overview of surgical ventricular restoration for the treatment of dilative ischemic myocardiopathy. It illustrates several surgical options, describes the operative details, and discusses the correct indications for the procedure. Finally, an interesting protocol for one-step cell therapy during SVR is proposed, as an innovative treatment for heart failure patients.

Incremental prognostic value of echocardiography of left ventricular remodeling and diastolic function in STICH trial.

AIMS: We sought to determine which echocardiographic markers of left ventricular (LV) remodeling and diastolic dysfunction can contribute as incremental and independent prognostic information in addition to current clinical risk markers of ischemic LV systolic dysfunction in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. METHODS AND RESULTS: The cohort consisted of 1511 of 2136 patients in STICH for whom baseline transmitral Doppler (E/A ratio) could be measured by an echocardiographic core laboratory blinded to treatment and outcomes, and prognostic value of echocardiographic variables was determined by a Cox regression model. E/A ratio was the most significant predictor of mortality amongst diastolic variables with lowest mortality for E/A closest 0.8, although mortality was consistently low for E/A 0.6 to 1.0. Mortality increased for E/A < 0.6 and > 1.0 up to approximately 2.3, beyond which there was no further increase in risk. Larger LV end-systolic volume index (LVESVI) and E/A < 0.6 and > 1.0 had incremental negative effects on mortality when added to a clinical multivariable model, where creatinine, LVESVI, age, and E/A ratio accounted for 74% of the prognostic information for predicting risk. LVESVI and E/A ratio were stronger predictors of prognosis than New York Heart Association functional class, anemia, diabetes, history of atrial fibrillation, and stroke. CONCLUSIONS: Echocardiographic markers of advanced LV remodeling and diastolic dysfunction added incremental prognostic value to current clinical risk markers. LVESVI and E/A ratio outperformed other markers and should be considered as standard in assessing risks in ischemic heart failure. E/A closest to 0.8 was the most optimal filling pattern.

Long-term follow-up after Bentall operation using a stentless Shelhigh NR-2000 bio-conduit.

BACKGROUND: To analyze the long-term results after Bentall operation using the stentless Shelhigh No-React (NR)-2000 bio-root prosthesis. MATERIAL: From 2004 to 2008, 26 consecutive, nonselected patients (mean age at surgery: 67 ± 9 years) underwent a Bentall operation using a stentless Shelhigh valved conduit at our institution. Mean preoperative Logistic-EuroSCORE was 17.1 ± 12.9. The mean size of the aortic root was 53.2 ± 5 mm. The mean preoperative ejection fraction was 55 ± 7.4%. Three patients had a bicuspid valve. One patient with acute endocarditis and one patient with type A aortic dissection were operated on an emergency. Three patients (11.54%) had a previous cardiac operation. The Button-Bentall technique was used in all cases. Seven patients (26.92%) received an associated procedure. The mean size of the implanted prosthesis was 26.1 ± 2.2. Follow-up ranged between 6 and 174 months (mean 93.4 ± 59.1 months). Primary endpoints consisted of early and late mortality, freedom from acute endocarditis, freedom from structural valve deterioration, and freedom from valve-related-reoperation. RESULTS: Two patients died in hospital, while 10 patients died during follow-up time, of which three for cardiac causes (12.5%). Overall survival probability was 52.9% at 15 years. Freedom from acute endocarditis was 95.7% at 5 and 15 years. Freedom from severe aortic incompetence due to structural deterioration was 100% at 5 and 10 years, 90.9% at 15 years. The mean aortic gradient at follow-up was 11.4 ± 5 mm Hg. Freedom from valve-related reoperation was 100% at 5 and 10 years, 90.9% at 15 years. CONCLUSIONS: In our experience, Bentall's operation using the Shelhigh NR-2000 stentless bio-conduit provided satisfactory early and long-term results. However, our findings are not consistent with unfavorable long-term outcomes following the implantation of this device reported by other authors.

Outcomes of a New-Generation Stentless Aortic Valve: A Single-Center Experience with 251 Consecutive Implants.

BACKGROUND: The study aim was to investigate the hemodynamic behavior over time and ease of implant and durability of the Sorin Pericarbon Freedom (SPF)® stentless pericardial aortic xenograft. METHODS: Between March 2003 and April 2010, a total of 251 consecutive, non-selected patients (mean age 70.1 years; range: 17-89 years; 17.1% aged >80 years) received a SPF bioprosthesis as an aortic valve substitute at the authors' institution. All implantations were performed by a single surgeon using a classical, double-line, subcoronary implant technique. Of these patients. 108 (43%) underwent a concomitant procedure. The mean logistic EuroSCORE was 8.3. Patients were followed for complications and hemodynamic evaluation. Echocardiographic controls and clinical data were obtained at discharge, and at six months' and eight years' follow up. RESULTS: The in-hospital/30-day mortality was 1.2% for the entire group, but 0% for patients with isolated valve replacement. A total of 27 deaths had occurred at the time of the last follow up (22 were due to non-cardiac causes). At follow up (mean 3.7 years; range: 0-7.8 years), 91.1% of survivors were in NYHA classes I or II. Freedom from reoperation and from structural valve deterioration was 96.0% and 96.8%, respectively, at 7.8 years. The mean pressure gradient of the series (measured using echocardiography) was 10.3 ± 4.5 mmHg at discharge, and 8.3 ± 4.5mmHg at the time of the last follow up. The mean effective orifice area was 1.85 ± 0.70 cm2 for the entire series, and there was an absence of prosthesis-patient mismatch in 90% of patients. CONCLUSIONS: The study results confirmed the favourable hemodynamic behavior, low risk of implantation and acceptable durability of the pericardial stentless SPF aortic prosthesis. The data also endorsed use of the SPF as an aortic valve substitute, even in a young and active population, and particularly in the presence of a small aortic annulus. The accuracy of implantation remains a crucial factor for durability and subsequent satisfactory hemodynamic performance. A longer follow up would provide further information with regards to complications and durability of the SPF prosthesis.

Left coronary ostium isolation and aortic valve dysplasia in a young boy: a case report.

Congenital anomalies of the aortic valve represent a common malformation. Infrequently, a dysplastic aortic valve leaflet causes a severe coronary artery anomaly. Here, the case is reported of a malformed aortic valve in which the left rudimentary cusp occluded the left coronary ostium. At surgery the left coronary ostium was completely freed from the anomalous valvular tissue, a Konno operation was performed, and a 19 mm St. Jude Medical mechanical prosthesis was implanted. To date, very few reports have made of this rare malformation; moreover, to the present authors' knowledge this is the only case to have been treated.

Outcomes after surgical ventricular restoration for ischemic cardiomyopathy.

OBJECTIVE: The study objective was to evaluate the short- and long-term outcomes of patients with ischemic cardiomyopathy after surgical ventricular restoration and to identify risk factors related to poor results. METHODS: Between August 2002 and April 2016, 62 patients affected by ischemic cardiomyopathy underwent surgical left ventricular restoration at our unit. Patients' mean age at operation was 63 years (39-79 years). Mean ejection fraction was 29.6%. The Surgical Treatment for Ischemic Heart Failure trial criteria have been used as indications for surgery. Fifty-seven patients (91%) received surgical myocardial revascularization. Mitral valve repair was performed in 39 patients (63%). The surgical technique consisted of the classic Dor operation or a different approach reducing the equatorial diameter of the left ventricle and avoiding the use of a patch. The data were analyzed retrospectively for perioperative results and short- and long-term clinical outcomes. RESULTS: One patient died of noncardiac causes within 30 days (1.6%). All-cause death occurred in 36 patients (58%) during follow-up (0.6-14.7 years; median follow-up time, 7.02 years), of whom 15 died of cardiac causes. Age, need for preoperative intra-aortic balloon pump, reduction less than 35% of postoperative left ventricular end-diastolic and end-systolic volumes, type of surgical technique, and ejection fraction less than 25% were identified as risk factors for late cardiac mortality. Perioperative levosimendan administration and presence of preoperative moderate to severe mitral regurgitation influenced early and intermediate-term outcomes, but no statistical relevance on long-term results was demonstrated. CONCLUSIONS: Patients with ischemic dilative cardiomyopathy have favorable short- and long-term outcomes after ventricular restoration. Age, preoperative ejection fraction less than 25%, inadequate left ventricular surgical reverse remodeling, and type of surgical technique negatively affect long-term survival.

Intermediate-Term Outcomes After Aortic Valve Replacement With the Medtronic 3F Stentless Prosthesis.

BACKGROUND: This study evaluated the early and intermediate-term clinical and hemodynamic results after implant of the Medtronic 3F (Minneapolis, MN) stentless aortic valve. METHODS: Between March 2007 and August 2015, 226 consecutive patients affected by aortic valve disease received a 3F valve at our unit by a single surgeon. The valve in 30 patients was included in a tubular prosthesis for a Bentall procedure. Size ranged between 21 and 29, age at operation was 74.17 ± 8.58 years, mean logistic European System for Cardiac Operative Risk Evaluation was 9.73 ± 6.00, and 51.3% of patients received a concomitant procedure. For isolated valve replacement, mean extracorporeal circulation time was 92 ± 17 minutes, and cross-clamp time was 73 ± 11 minutes. Follow-up was 100% complete and was a mean of 63 ± 2.4 months (range, 6-138 months). Primary end points were early and late mortality, freedom from endocarditis, freedom from structural valve deterioration, and freedom from valve-related reoperation. RESULTS: Early mortality after isolated aortic valve replacement was 1.7%. Of the 59 (25.3%) late overall deaths, 15 (6.6%) were cardiac-related, and survival rate was 93% at 10 years. At follow-up, 97% of patients were in New York Heart Association class I or II. Actuarial freedom from reoperation due to structural deterioration was 100% at 5 years and 96% at 10 years. Freedom from endocarditis at 10 years was 97%. Mean aortic pressure gradient measured by echocardiography was 11.5 mm Hg at hospital discharge and 10.4 mm Hg at the last follow-up. CONCLUSIONS: The 3F valve is a user-friendly third-generation stentless aortic prosthesis with proven durability and remarkable hemodynamic performance preserved over time. The 3F is particularly useful in cases of expected patient/prosthesis mismatch.

A case of primary cardiac angiosarcoma: extensive right atrial wall reconstruction with autologous pericardium.

Primary cardiac angiosarcoma is a rare and aggressive tumor. Diagnosis is usually late because of the rarity of the lesion and the nonspecific clinical symptoms. We report the case of a 48-year-old man affected by angiosarcoma of the right atrium who presented with subacute cardiac tamponade. Extensive resection of the atrial wall infiltrated by the tumor, followed by autologous pericardial free atrial wall reconstruction, was successfully carried out. In spite of the optimal early outcome, the patient died 15 months later because of multiple osteal metastases.

Outcome at 26 Years After Repair of Fallot's Tetralogy With Absent Left Pulmonary Artery.

We report long-term outcome after two-stage, "one lung repair" in a four-year-old boy with tetralogy of Fallot and congenital absence of the left pulmonary artery. The operation was carried out two years after a palliative aortopulmonary central shunt and was uneventful. Twenty-six years later, the patient is in excellent clinical condition, with normal peripheral oxygen saturation. A recent radionuclide lung scan and cardiac magnetic resonance imaging show the pulmonary flow entirely directed into the right lung. In selected cases, the long-term prognosis of patients with tetralogy of Fallot and true absence of left pulmonary artery after "one lung repair" may be excellent.

Successful Reoperation in 3 Cases of Failed Sorin Freedom Stentless Aortic Valve Using the LivaNova Perceval Sutureless Prosthesis.

Reoperations for deteriorated stentless bioprostheses are quite challenging procedures. Calcification of the aortic annulus and of the subcoronary root makes often impossible the removal of the failed valve, living a complex Bentall operation or a high-risk transcatheter aortic valve implantation valve-in-valve procedure as the only options, particularly in cases of small-size prostheses. The Perceval sutureless prosthesis (LivaNova PLC, London, UK) can be a valid alternative for failed stentless valve replacement. We report our experience with 3 complex cases of degenerated Sorin Pericarbon Freedom prosthesis treated successfully by means of Perceval sutureless implantation and demonstrating the reproducibility and the safety of this surgical approach.

Stentless Pericarbon Freedom Versus Stented Perimount Aortic Bioprosthesis: Propensity-Matched Long-Term Follow-Up.

OBJECTIVE: Stentless aortic valves have shown superior hemodynamic performance and faster left ventricular mass regression compared to stented bioprostheses. Yet, controversies exist concerning the durability of stentless valves. This case-matched study compared short- and long-term clinical outcomes of stentless LivaNova-Sorin Pericarbon Freedom™ (SPF) and stented Carpentier-Edwards Perimount (CEP) aortic prostheses. METHODS: From 2003 through 2006, 134 consecutive patients received aortic valve replacement with SPF at our institution. This cohort was matched, according to 20 preoperative clinical parameters, with a control group of 390 patients who received CEP prosthesis during the same time. The resulting 55 + 55 matched patients were analyzed for perioperative results and long-term clinical outcomes. RESULTS: Early mortality was 0% for both groups. Lower transvalvular gradients were found in the SPF group (10.6 ± 2.9 versus 15.7 ± 3.1 mmHg, P < 0.001). Overall late mortality (mean follow-up: 10.03 years) was similar for both groups (50.1% versus 42.8%, P = 0.96). Freedom from structural valve degeneration (SVD) at 13 years was similar for both groups (SPF = 92.3%, CEP = 73.9%, P = 0.06). Freedom from aortic valve reinterventions did not differ (SPF = 92.3%, CEP = 93.5%, P = 0.55). Gradients at 13-year follow-up remained significantly lower in SPF group (10.0 ± 4.5 versus 16.2 ± 9.5 mmHg, P < 0.001). Incidence of acute bacterial endocarditis (ABE) and major adverse cardiovascular and cerebrovascular events (MACCE) was similar. CONCLUSIONS: SPF and CEP demonstrated comparable long-term outcomes related to late mortality, SVD, aortic valve reinterventions, and incidence of ABE and MACCE. Superior hemodynamic performance of SPF over time can make this valve a suitable choice in patients with small aortic root and large body surface area.

Cell therapy and left ventricular restoration for ischemic cardiomyopathy: long-term results of a perspective, randomized study.

BACKGROUND: Aim of this study is to verify the potential advantages and benefits of bone-marrow derived autologous stem cells implantation associated to surgical left ventricular restoration (SVR), to report a new modality of cell delivery to myocardium, and to identify possible side effects of this procedure. METHODS: Between March 2007 and March 2013, 30 patients affected by ischemic dilative cardiomyopathy who received a SVR operation were enrolled in the study. The population was divided in two groups:16 patients were randomly assigned to receive stem cells therapy in addition to SVR (groupA), 14 patients received a placebo (group B). The two groups were homogeneous in respect of age, gender, preoperative NYHA class, mitral incompetence and left ventricular sizes and volumes. The patients were evaluated by echo and pet-scan before surgery and at 6 months follow-up, and by echo at subsequent follow-up. RESULTS: Overall 30 days-in hospital mortality was 0 for the entire cohort. At last follow-up ejection fraction increased from 25.3% before surgery to 36.3% in group A, and from 31.8% to 45.6% in group B. Reduction of LVEDD was 6% in group A, 9% in group B. ESLVV and EDLVD decreased more significantly in patients receiving stem cells (55% vs. 35%). Late cardiac mortality at 9 years follow-up was similar in the two groups of patients. No early or late adverse reaction nor cases of infections were observed. CONCLUSIONS: Patients affected by ischemic cardiomyopathy have a favourable outcome after SVR. A higher reduction of LVEDV and LVESV assessed by CT-Scan evaluation in patients receiving cell therapy, when compared to control group, encourages the evolution and refinement of myocardial regenerative therapy added to SVR.

Aortopulmonary window and anomalous origin of the right coronary artery from the pulmonary artery: long-term result after Takeuchi-type repair.

We describe the case of a 2-month-old infant with the rare association of aortopulmonary window and anomalous origin of the right coronary artery from the pulmonary artery. The diagnosis was made by angiography and surgical repair was carried on employing the Takeuchi procedure. The angiographic control obtained 5 years after the operation showed an optimal surgical result. The latest echocardiographic follow-up, 24 years after the repair, has been fully satisfactory.

Long-term outcomes using the stentless LivaNova-Sorin Pericarbon Freedom™ valve after aortic valve replacement.

OBJECTIVES: Information on the long-term safety, efficacy and durability of third-generation stentless aortic valves is lacking. METHODS: In this single-centre, single-surgeon retrospective observational study, between 2003 and 2015, consecutive, non-selected aortic valve replacement (AVR) patients were implanted with the LivaNova-Sorin Pericarbon Freedom™, a third-generation stentless aortic xenograft. Changes in clinical and echocardiographic parameters were examined, as were mortality, structural valve deterioration and reoperation, according to age at 5, 10 and 14 years. RESULTS: The mean logistic EuroSCORE was 8.5% in 22 AVR patients (mean age 68.3 years; range 15-89 years). Many patients [n = 139 (43%)] underwent a concomitant procedure. Before AVR, 68.0% of patients were in New York Heart Association (NYHA) Class I or II, and at discharge, mean gradient was 10.0 ± 4.3 mmHg. Follow-up lasted up to 8.9 ± 2.8 years. At the last follow-up, 95.6% of patients were in New York Heart Association Class I or II, the mean gradient was 8.0 ± 3.5 mmHg (P < 0.001) and reduction in interventricular septum thickness and improvement of ejection fraction were significant (both P < 0.001). Early 30-day in-hospital mortality was 1.6% overall and 0% in the AVR-only population. Overall survival probability was 99.9%, 87.9% and 82.7% at 5, 10 and 14 years. Freedom from structural valve deterioration at 14 years was 67.5%, 88.9% and 68.2% in AVR patients overall, in those aged >70 years and in those aged 60-70 years, respectively. Freedom from reoperation at 14 years was 70.3%, 88.3% and 78.0% in the corresponding groups. CONCLUSIONS: Sorin Pericarbon Freedom is a valuable aortic bioprosthesis with favourable haemodynamics, particularly in smaller annuli, and durability similar to that of stented valves, which make Sorin Pericarbon Freedom a useful option in AVR.