The Mitris RESILIA Valve: New Skin for a Proven Design.

By incorporating the best features of the Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve (Edwards Lifesciences Corporation, Irvine, California) and INSPIRIS RESILIA tissue (Edwards Lifesciences Corporation, Irvine, California), the mitris valve inherits the advantages of the remarkable hemodynamic performance of the former and the durability of the latter. In this paper, we will summarize the process that led to the creation of this new valve and report on the first implant's feasibility and first impression. The mitris valve has an overall implantability profile, overlapping the previous generation with no added challenges, but compared to the PERIMOUNT Magna Mitral Ease valve, the mitris valve boasts a more pliable saddle-shaped sewing cuff that is specifically tailored to fit the complex structure of the mitral valve with a lower stent height. This could be particularly beneficial in the context of double-valve replacement, as it may prevent any disturbance to the bioprosthesis located in the aortic position in small annulus. This could also prevent some rare but unpleasant complications such as left ventricle outflow obstruction or rupture of the atrioventricular sulcus. In addition, it could allow for better adherence to the saddle-shaped annulus of the mitral valve with the possibility of less stress (and therefore fibrosis) on the valve tissue, while further reducing the degeneration time. Furthermore, thanks to the possibility of being temporarily adjusted inwards, it is possible to ensure greater implantability compared to the previous generation of Magna Edwards mitral valves. Thanks to INSPIRIS technology, which prevents the generation of free aldehydes that promote oxidation and calcification of pericardial tissue, it is possible to assume that the durability will probably also improve. This reinforces the trustworthiness of the mitris valve.

The New Era of Three-Dimensional Annuloplasty Devices for Mitral Valve Repair: Rationale and First Experiences.

Annuloplasty should always accompany mitral valve repair in order to achieve proper annular remodeling and stabilization. Numerous types of annuloplasty rings-that differ from rigid to semi-rigid and flexible devices, from complete to partial, and from flat to saddle-shaped rings-are clinically available. A deeper understanding of mitral valve function, in conjunction with several recent studies, suggest it is advisable to prefer annuloplasty rings that mimic the physiological mitral annulus shape and three-dimensional (3D) dynamic changes in order to reduce haemodynamic stress on valve components and optimize leaflet coaptation, perhaps improving valve repair durability too. This paper aims to focus on 3D annuloplasty rings, with dynamic features: MEMO 3D™ and MEMO 4D™ (Sorin Medical, New York, New York), as well as Physio Flex (Edwards Lifesciences, Irvine, California).

Ablation of persistent atrial fibrillation based on atrial electrogram duration map: methodology and clinical outcomes from the AEDUM pilot study.

BACKGROUND: Catheter ablation of persistent atrial fibrillation (PsAF) represents a challenge for the electrophysiologist and there are still divergences regarding the best ablative approach to adopt. Create a new map of the duration of atrial bipolar electrograms (Atrial Electrogram DUration Map, AEDUM) to recognize a functional substrate during sinus rhythm and guide a patient-tailored ablative strategy for PsAF. METHODS: Forty PsAF subjects were assigned in a 1:1 ratio to either for PVI alone (Group B1) or PVI+AEDUM areas ablation (Group B2). A cohort of 15 patients without AF history undergoing left-sided accessory pathway ablation was used as a control group (Group A). In all patients, voltage and AEDUM maps were created during sinus rhythm. The minimum follow-up was 12 months, with rhythm monitoring via 48-h ECG Holter or by implantable cardiac device. RESULTS: Electrogram (EGM) duration was higher in Group B than in Group A (49±16.2ms vs 34.2±3.8ms; p-value<0.001). In Group B the mean cumulative AEDUM area was 21.8±8.2cm2; no difference between the two subgroups was observed (22.3±9.1cm2 vs 21.2±7.2cm2; p-value=0.45). The overall bipolar voltage recorded inside the AEDUM areas was lower than in the remaining atrial areas [median: 1.30mV (IQR: 0.71-2.38mV) vs 1.54mV (IQR: 0.79-2.97mV); p-value: <0.001)]. Low voltage areas (<0.5mV) were recorded in three (7.5%) patients in Group B. During the follow-up [median 511 days (376-845days)] patients who underwent PVI-only experienced more AF recurrence than those receiving a tailored approach (65% vs 35%; p-value= 0.04). CONCLUSIONS: All PsAF patients exhibited AEDUM areas. An ablation approach targeting these areas resulted in a more effective strategy compared with PVI only.

Aortic Annuloplasty: Focus on the Use of an External Teflon Ring.

Aortic annuloplasty has been clearly demonstrated to have a protective influence in aortic valve repair. Over the past 20 years, different annuloplasty concepts have been proposed by different groups. However, the most appropriate approach to enable long-term annular stability remains highly controversial. The aim of this article is to give a general overview of all types of aortic annuloplasty, particularly focusing on the use of an external Teflon ring, as proposed by our group. In this technique, external root dissection is performed in the same fashion as for reimplantation; the only difference is that it is necessary to go below the coronary ostia take-off. A series of pledgeted sutures (usually between 6 and 9 sutures) are placed at the level of the virtual basal ring. The external ring is made using a Teflon strip with a length of 8 to 9 cm, to reduce the annulus to a diameter of between 21 and 23 mm. The sub-annular sutures are then passed at the appropriate level through the Teflon strip and the strip is parachuted outside the aortic root base, passing under the coronary ostia. The two ends of the Teflon strip are tied at the level of the non-coronary sinus. Aortic annuloplasty is a crucial step to improve valve competence and stabilization. While several techniques offer good mid- to long-term results, annuloplasty with an external Teflon ring appears to be a simple and effective alternative to guarantee stable root diameters. Longer follow-up studies are needed to confirm the mid- to long-term results.

Mitral repair of myxomatous valves with simple annuloplasty: a follow-up up to 12 years.

OBJECTIVES: Diffuse myxomatous mitral valve degeneration (DMD) represents a challenge in the reparative mitral valve surgery. A subgroup of patients with symmetrical DMD can be effectively treated with a simple band-annuloplasty with good early and mid-term results. Here, we evaluate the long-term outcomes in terms of freedom from reoperation, recurrence of moderate or severe mitral regurgitation (MR) and overall survival. METHODS: Between April 2006 and December 2020, patients with DMD causing severe MR and the echocardiographic features of symmetrical bileaflet prolapse, central regurgitant jet(s), annular dilation and no chordal ruptures were treated using a simple annuloplasty with a semi-rigid band. These patients were prospectively collected and retrospectively analysed. RESULTS: Seventy-five patients were enrolled. The mean clinical follow-up time was 104 [standard deviation (SD): 43] months, and echocardiographic follow-up time was 95 (SD: 43) months. The mean age was 54 (SD: 15) years, and 56% were females. Long-term overall survival was 98.2% [standard error (SE): 1.8], 93.7% (SE: 4.7) and 93.7% (SE: 4.7) at 4, 8 and 12 years, respectively. The freedom from reoperation was 100% at 4 and 8 years and 94.1% (SE: 5.7) at 12 years. The freedom from recurrent moderate or severe MR was 98.3% (SE: 1.7), 98.3% (SE: 1.7) and 92.8% (SE: 5.5) at 4, 8 and 12 years, respectively. CONCLUSIONS: Mitral repair with the simple band-annuloplasty for the treatment of MR due to symmetrical DMD seems to be stable and effective in the long term.

Biological Valves Impervious to Calcification: Is this Holy Grail a Cup Ready to Drink?

An indefinitely lasting bioprosthesis that does not require anticoagulation treatment is the holy grail of substitutive heart surgery. However, this goal is not yet in sight with the present state of technology. Over the past few years, tremendous advances have been achieved regarding tissue anticalcification processes, hemodynamic performance and future-proofing by ensuring compatibility with transcatheter valve-in-valve procedures. The Inspiris Resilia valve (Edwards Lifesciences, Irvine, CA) was designed to incorporate all of these enhancements. It is now leaving the experimental phase and is being tested in the real world. We present here a comprehensive review of the evolution of biological prostheses, details of new anticalcification technologies, and early results of published studies as well as the experience at the European Hospital (Rome, Italy), the site of the first European implant and a leading center in various protocols. In our two years of experience with the Inspiris Resilia, there have been no cases of structural valve deterioration, endocarditis, detachment or periprocedural complication, and gradients seem to be superior to those with the previous generation of Edwards valves. While longer-term experience is clearly needed, the results thus far are encouraging.

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.

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.

Kinetics of serum procalcitonin in patients with acute mesenteric ischemia and bowel infarction after cardiac surgery.

BACKGROUND: The present study reported perioperative changes in PCT levels occurring in cardiac patients with acute mesenteric ischemia (AMI) undergoing laparotomy. The aim of this study was to demonstrate that PCT kinetics may confirm the presence of AMI after cardiac surgery, distinguishing between bowel infarction and diffuse ischemia. METHODS: PCT values from adult patients undergoing laparotomy for AMI after elective or urgent cardiac surgery (January 2010-December 2019) were determined at the ICU admission after cardiac surgery, 24 hours later and at the onset of clinical symptoms. Patients affected by diffuse intestinal ischemia with no need for bowel resection were allocated to Group A (N. 8), patients presented with intestinal necrosis requiring small or large bowel resection were allocated to Group B (N. 12). RESULTS: At the beginning of the abdominal symptoms, PCT levels increased in both groups, compared to those immediately after cardiac surgery. The PCT increasing resulted much more evident in patients presenting with intestinal necrosis in Group B (20.65 ng/mL [IQR8.47-34.5] vs. 4.31 ng/mL [IQR 8.47-34.5], P<0.05), rather than in those with diffuse ischemia in Group A (13.25 ng/mL [IQR 5.97-27.65] vs. 10.4 ng/mL [IQR 3.68-14.05], P=0.260). This trend was confirmed in the subgroup of patients undergoing CVVHD and in patients who experience AMI recurrence. CONCLUSIONS: Increasing PCT values after cardiac surgery are proportional to the severity of wall ischemia and high levels of PCT are predictive of intestinal necrosis. Routine PCT monitoring after cardiac surgery should be considered extremely useful in suggesting the possibility of abdominal complications, alerting medical staff to the need of prompt treatment.

Towards a better comprehension of acute mesenteric ischemia after cardiac surgery. An analysis of 33 patients.

BACKGROUND: Acute mesenteric ischemia (AMI) after cardiac surgery is a rare but serious complication associated to high mortality. The time of onset is the key point to correctly evaluate the clinical scenarios. METHODS: Data from adult patients who underwent laparotomy for AMI after elective or urgent cardiac surgery were reviewed (January 2005 - December 2019) to report their anatomoclinical features in relationship to time of onset. Early events (within 48 hours) were allocated to Group 1, whereas late onsets were allocated to Group 2. RESULTS: The incidence of risk factors for non occlusive mesenteric ischemia was higher in Group 1 (chronic renal failure 80% vs 38.8%, P <0.05, use of inotropes 60% vs 5.5%, P <0.01, early oligo-anuria requiring CRRT 80% vs 16.6%, P <0.01, prolonged ventilation 46.6% vs 5.5%, P <0.05), where a significative occurrence of postoperative de novo atrial fibrillation was noted in Group 2 (55% vs 5.5%, P <0.01). The number of patients who required bowel resection was proportionally higher in the Group 2. CONCLUSIONS: Two well distinct categories of AMI after cardiac surgery can be classified. The first consists of patients with well-known risk factors developing ischemia as a result of severe visceral hypoperfusion The second consists of patients with low comorbidity who experience late AMI as a consequence of "trigger events", mainly de novo atrial fibrillation. This classification may be useful to better alert the medical staff to the possibility of bowel ischemia at any time after cardiac surgery, promoting early diagnosis and treatment. KEY WORDS: Mesenteric ischemia, Cardiovascular pathology.

Optimized Use of the "Skirt" of the Valsalva Graft for the Completion Bentall Procedure.

This report discusses the case of a patient with an aortic root aneurysm who had previously undergone aortic valve replacement with a large mechanical prosthesis that proved to be normally functioning at the time of reoperation. This report describes a technique of replacing the aortic root while retaining the existing aortic valve, similar to the completion Bentall procedure, using a 32-mm Valsalva graft by suturing the skirted portion of the graft to the sewing ring of the mechanical valve. The ability of the skirt to increase its diameter is the key to this approach.

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.

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.

External Stents for Vein Grafts in Coronary Artery Bypass Grafting: Targeting Intimal Hyperplasia.

INTRODUCTION: Progressive saphenous vein graft (SVG) failure remains a key limitation to the long-term success of coronary artery bypass grafting (CABG). SVG disease after the first year is dominated by intimal hyperplasia, which predisposes the SVG to thrombosis and accelerated atherosclerosis. The objective of this study was to review and summarize the latest experimental and clinical data on the use of mechanical external stents for vein grafts. METHODS: In January 2020, the PubMed database was searched using the terms "external stent", "CABG", "saphenous vein graft" and "intimal hyperplasia". The results were reviewed and only randomized experimental and clinical studies that analyzed the effect of external stenting on venous intimal hyperplasia were included in the analysis, together with studies that investigated the clinical benefit of external stenting. RESULTS: Eight experimental and four clinical trials met the search criteria. Controlled trials in different large animal models concluded that external stenting significantly reduced intimal hyperplasia 3-6 months post implantation, and reduced both thrombosis rates and the development of lumen irregularities. Data from randomized controlled trials with a follow-up period of 1-4.5 years supported the pre-clinical findings and demonstrated that external stents significantly reduced vein graft disease. CONCLUSION: Strong evidence indicates that supporting the vein with external stents is safe and leads to clear advantages at both the anatomical and cellular levels. With the further accumulation of consistent positive results, external stenting of SVG may become the standard of care in future CABG.

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.

The fate of small-size pericardial heart valve prostheses in an older patient population.

BACKGROUND: Structural valve deterioration (SVD) is the Achilles' heel of bioprostheses. Its correlation with younger age is well known. In recent years we exclusively reserved use of small-size Mitroflow valve prostheses (LivaNova, London, United Kingdom) to an older patient population with small aortic annuli. This study aimed to assess the incidence of SVD and its effect on patient survival and need for reoperation. MATERIALS AND METHODS: Two hundred five patients (aged 75.9 ± 5.3 years; range, 62-92 years) underwent aortic valve replacement with a 19-mm or 21-mm Mitroflow valve prosthesis between 2005 and 2011. The great majority was female (n = 170; 83%). In half of patients it was an isolated procedure. All valve prostheses were implanted in a supra-annular position using pledgeted sutures. A 19-mm valve was implanted in 93 patients (45.3%), whereas in 112 patients (54.6%) a 21-mm valve was used. RESULTS: Twenty-three patients (11.2%) were diagnosed with early SVD by echocardiography. Average time from surgery to diagnosis of SVD was 64.3 ± 26.8 months. Ten patients needed a reoperation for SVD. Average time from surgery to a second operation was 45.7 ± 35.7 months. Overall survival was 64.5% and 42.3% at 5 and 9 years, respectively. Cumulative freedom from SVD at 5 and 9 years was 94.8% ± 1.6% and 77.4% ± 5.4%, respectively. In 4 patients death was linked to the presence of SVD. There were no differences in mortality, reoperation, or SVD between the 2 Mitroflow valve sizes. CONCLUSIONS: Small-size Mitroflow pericardial valve prostheses have shown a worrisome incidence of SVD even in patients aged >70 years. Based on this experience we have discontinued their use.

Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery.

OBJECTIVE: Hemostasis is a critical component of all surgical procedures and especially cardiac surgery. In addition to traditional means, topical hemostatic agents have been reported to be extremely effective in terminating bleeding during cardiac procedures. We compared a hemostatic matrix sealant agent (HEMOPATCH Baxter Healthcare Corporation, Deerfield, IL) with alternative topical hemostatic treatment in patients undergoing ascending aorta surgery with moderate bleeding. MATERIALS AND METHODS: Following sample size calculation, in a prospective randomized study design, 85 patients were treated with HEMOPATCH matrix sealant and 85 patients received alternative treatment (dry or wet gauze compression or similar [control group]). The primary outcome measure was the percentage of patients with successful hemostasis within three minutes of HEMOPATCH or traditional treatment application. Other study outcome measures were postoperative blood loss and the rate of transfusion of blood products. RESULTS: A statistically higher rate of successful hemostasis within three minutes was observed in the HEMOPATCH group (97.6% [83/85] vs. 65.8% [56/85] in the control group; p< 0.001). The percentages of patients with postoperative bleeding and the rate of transfusion were lower in the HEMOPATCH group than in the control group. CONCLUSIONS: The use of HEMOPATCH is effective in terminating bleeding in patients undergoing ascending aorta cardiac procedures. Fewer patients treated with HEMOPATCH required blood transfusion. The cost-utility profile of HEMOPATCH should be addressed in dedicated trials.

Long-term results of the valve reimplantation technique using a graft with sinuses.

OBJECTIVE: Aortic valve reimplantation is the most commonly used technique to spare the aortic valve. Long-term results data are scarce and available only with the use of standard straight graft. We examined the long-term results of reimplantation of the aortic valve using a graft incorporating sinuses of Valsalva. METHODS: From May 2000 to December 2014, 124 patients had an aortic valve reimplanted into a graft with sinuses of Valsalva. The mean age was 53 ± 13 years and the majority were men (87%). Marfan syndrome was present in 21 patients (17%) and 12% had a bicuspid valve. Patients were prospectively followed by means of transthoracic echocardiography. The mean follow-up was 63 ± 52 months. RESULTS: Overall survival at 5, 10, and 13 years was 94.4% ± 2.2%, 90.5% ± 4.4%, and 81.4% ± 7.3%, respectively. Six patients required reoperation within a time frame of 6 to 96 months. None of the patients died at reoperation. Freedom from reoperation was 95.4% ± 2.3% at 5 years and 90.1% ± 4.3% at 10 and 13 years. All patients who needed reoperation had surgery during the first 5 years. Three patients had residual aortic insufficiency >2. Considering also all patients who underwent reoperation because of aortic insufficiency, freedom from moderate to severe residual aortic insufficiency was 94.1% ± 2.6% at 5 years, and 87.1% ± 4.7% at 10 and 13 years. CONCLUSIONS: The majority of patients who had their valve reimplanted in a graft with sinuses continue to perform well after 10 years.

Mitral repair with the sole use of a semi-rigid band in a sub-population of patients with Barlow's disease: a 4-year follow-up with stress echocardiography.

OBJECTIVES: Surgical treatment of Barlow's disease is usually demanding. In a sub-population of Barlow patients with bileaflets prolapse and central regurgitant jet, we performed mitral repair using only a semi-rigid annuloplasty band. Stress echocardiography follow-up was evaluated. METHODS: Of a total of 350 consecutive patients with mitral prolapse, 69 had anatomical features of Barlow's disease. Of these, 40 with multiple large central jets without chordal rupture were repaired only using an annuloplasty band, and these constituted the study group. An echocardiographic study of the acute change in valvular and ventricular morphology before and after surgery was carried out. Patients were evaluated at discharge and after a mean follow-up of 4.7 ± 3.2 years by stress echocardiography. RESULTS: No death or reoperation occurred. Acute echocardiographic study revealed that mitral annuloplasty led to a significant migration of the leaflets towards the apex of the left ventricle. Coaptation length increased dramatically from 2.7 ± 0.8 to 11.3 ± 2.7 mm and a reduction in annular diameters and leaflet length was observed. The left ventricle was elongated (72.8 ± 6.9 vs 63.2 ± 8.1 mm) and the distance from the papillary muscle tip to the mitral annulus increased (anterior 30 ± 3.9 vs 20.3 ± 4.8 mm, posterior 29.7 ± 4.3 vs 20.8 ± 5.6 mm). At discharge, residual mitral regurgitation was mild in 1 case and trivial in 3. The results were confirmed at stress echocardiography follow-up with normal valve function at peak exercise. CONCLUSIONS: In patients with severe mitral regurgitation due to Barlow's disease with multiple central jet and without chordal rupture, mitral annuloplasty is effective in restoring mitral valve function owing to profound changes in mitral valve and left ventricle geometry. At follow-up, stress echocardiography confirms the results and the stability of the repair.

A single dose of erythropoietin reduces perioperative transfusions in cardiac surgery: results of a prospective single-blind randomized controlled trial.

BACKGROUND: We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). STUDY DESIGN AND METHODS: Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. RESULTS: A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; p<0.0005). After baseline Hb was controlled for, there was no difference in the incidence of aRBCt between HRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; p<0.0005). The distribution of number of units transfused was shifted toward fewer units in HRE (p<0.0005). The all-cause mortality at 45 days was 3.00% (HRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). CONCLUSION: In anemic patients (Hb<13 g/dL), a single high dose of HRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events.