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.

Redo surgery for a type A aortic dissection in a pregnant woman with Marfan syndrome: a complex clinical case.

Aortic dissection during pregnancy is a very rare event in the general population but can be fatal to both the mother and the fetus. A rate of dissection as high as 10% was observed in pregnant patients affected by Marfan syndrome. Facing this kind of disease can represent a challenge for the involved physicians because of its rarity. Here we present the case of an aortic dissection in a pregnant woman with Marfan syndrome who previously underwent an open heart surgery for a mitral prolapse. The diagnosis and the treatment of this case, given the mid-term gestational age combined with an increased surgical risk due to the reintervention, required a particular effort by our team. A multidisciplinary approach to the management of this patient was the key to achieve a favorable outcome both for the mother and for the baby.

Surgical aortic valve replacement with new-generation bioprostheses: Sutureless versus rapid-deployment.

OBJECTIVES: The aim of this retrospective multicenter study was to compare early clinical and hemodynamic outcomes of Perceval-S sutureless (Livanova, London, United Kingdom) and Intuity rapid-deployment (Edwards Lifesciences, Irvine, Calif) bioprostheses. METHODS: Data from patients who underwent isolated or combined aortic valve replacement with Perceval-S and with Intuity bioprostheses at 18 cardiac surgical institutions were analyzed. Propensity matching was performed to identify similar patient cohorts. RESULTS: We included 911 patients from March 2011 until May 2017. Perceval-S and Intuity valves were implanted in 349 (38.3%) and in 562 (61.7%) patients, respectively. Propensity score identified 117 matched pairs. In the matched cohort, device success was 99.1% and 100% in Perceval-S and Intuity group, respectively (P = 1.000). Thirty-day Valve Academic Research Consortium mortality occurred in 2 (1.7%) and 4 (3.4%) patients in the Perceval-S and in Intuity group, respectively (P = .6834). The rate of postoperative new permanent pacemaker implantation was 6% (7 patients) and 6.8% (8 patients) in the Perceval-S and in Intuity group, respectively (P = .7896). Perceval-S valve implantation requires significantly shorter aortic crossclamp and cardiopulmonary bypass times than Intuity valve implantation (aortic crossclamp time for isolated, 52 ± 14 minutes vs 62 ± 24 minutes; P < .0001). Peak transaortic gradients were 22.4 ± 8.1 mm Hg and 19.6 ± 6.7 mm Hg (P = .0144), whereas mean gradients were 11.8 ± 4.7 mm Hg and 10.5 ± 3.9 mm Hg (P = .0388) in the Perceval-S and Intuity groups, respectively. CONCLUSIONS: Sutureless Perceval-S and rapid-deployment Intuity bioprostheses provide good and similar early clinical and hemodynamic outcomes. Perceval-S valve implantation requires shorter crossclamp and cardiopulmonary bypass times, whereas Intuity valve implantation provides lower transaortic peak and mean gradients.

Left atrial ball thrombus after edge-to-edge mitral valve repair.

A thrombus can develop in the left atrium during atrial fibrillation because the loss of contractile function leads to blood flow stasis. Anticoagulation therapy is indicated for prevention of systemic embolism, usually maintaining an international normalized ratio between 2 and 3. Rarely a massive thrombosis develops in the atrium resulting in a peduncolated ball valve thrombus or in a free-floating thrombus. These two conditions are characterized by variables in the physical findings. Such masses are hazardous and upon discovery surgical treatment, often in emergency, is mandatory. We present here the case of a patient who developed an unnoticed huge left atrial ball thrombus despite warfarin therapy after previous mitral valve surgery. .

[Transcatheter valve-in-valve implantation in a patient with a degenerative sutureless aortic bioprosthesis: case report and literature review]. / Impianto transcatetere di valvola aortica in paziente con bioprotesi aortica sutureless degenerata: descrizione di un caso e revisione della letteratura.

Sutureless aortic bioprostheses (SAB) provide shorter aortic cross-clamp time and cardiopulmonary bypass duration compared to conventional aortic valve replacement. Similarly to other bioprostheses, reintervention may become necessary in some cases because of long-term structural degeneration of the valve. Valve-in-valve (ViV) transcatheter aortic valve replacement may represent an effective and safe alternative to aortic valve replacement in patients with degenerated bioprostheses who carry a high risk for reintervention. We report the case of a self-expandable transcatheter ViV procedure in a degenerated SAB.

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches.

OBJECTIVE: To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. METHODS: A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. RESULTS: No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed tomographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. CONCLUSIONS: Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

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.

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.

Treating the patients in the 'grey-zone' with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement.

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.

Early clinical and haemodynamic results after aortic valve replacement with the Freedom SOLO bioprosthesis (experience of Italian multicenter study).

OBJECTIVES: The present study investigates early clinical and haemodynamic results with the Freedom SOLO bioprosthesis (FSB) for aortic valve replacement (AVR) in eight Italian institutions. METHODS: From 2004 to 2008, a total of 229 patients [139 females (60.7%); mean age 74 ± 8 years, left ventricular (LV) ejection fraction >40%] underwent AVR with FSB. One hundred and four patients underwent preoperatively, at 1-3 and at 12 months after AVR resting transthoracic echocardiography with the effective orifice area index (EOAi) assessment, peak and mean transvalvular pressure gradients and the LV mass index (LVMi) measurement. A subset of 34 patients underwent exercise stress echocardiography at a mean of 9.6 months after AVR. RESULTS: Post-operative mortality was 3.1%. At 1-3 months, FSB showed a significant increase in the EOAi (0.39 ± 0.17 to 1.04 ± 0.17 cm(2)/m(2); P < 0.0001), a reduction in the mean gradient (43.2 ± 16.9 to 4.3 ± 2.3 mmHg; P < 0.0001) and a significant regression of the LVMi (147.6 ± 30.5 to 121.6 ± 27.4 g/m(2); P < 0.0001). During exercise stress echocardiography, the mean aortic gradients increased from 4.4 ± 1.7 at rest to 7.0 ± 2.7 mmHg at peak stress (P < 0.001). The EOA increased from 1.74 ± 0.33 to 1.80 ± 0.36 cm(2) (P = 0.0291). Mean gradients at peak stress had better correlation with resting EOAi (r = -0.74; P < 0.001) than with the prosthesis size (r = 0.43; P = 0.01). CONCLUSIONS: The supra-annular implantation of FSB offers excellent haemodynamic performance both at rest and during exercise and is associated with the rapid regression of the LV.

Efficacy of antimicrobial activity of slow release silver nanoparticles dressing in post-cardiac surgery mediastinitis.

We report our preliminary experience in post-cardiac surgery mediastinitis using a recently introduced silver-releasing dressing claiming prompt antibacterial activity. Acticoat, a silver nanoparticles slow release dressing was used in four patients with documented post-cardiac surgery mediastinitis and persistently positive microbiological cultures despite vacuum-assisted closure (VAC) therapy. In all four patients negative cultures were obtained within a maximum of 72 h and patients were discharged within a maximum of 20 days.

Edge-to-edge mitral valve repair for isolated prolapse of the anterior leaflet caused by degenerative disease.

OBJECTIVE: The use of new techniques to correct mitral regurgitation due to prolapse of the anterior leaflet has been shown to expand the original surgical armamentarium and to improve postoperative outcome. We retrospectively analysed our experience with isolated prolapse of the anterior mitral leaflet repaired using the edge-to-edge technique. METHODS: From October 1986 to June 2004, 790 patients underwent mitral valve repair for mitral regurgitation at our institution. Isolated pathology of the anterior mitral leaflet, due to degenerative disease, was the cause of mitral regurgitation in 84 patients and, from 1991, 68 underwent edge-to-edge repair. RESULTS: There was no intraoperative death and one in-hospital death. Three patients died in the late follow-up period for a cumulative 13-year survival rate of 90 +/- 1.4%. No patient underwent early reoperation. Four patients underwent reoperation during the follow-up for a cumulative 13-year freedom from reoperation of 92.3 +/- 3.2%. At echocardiographic evaluation, mitral valve repair failure was associated with severe mitral regurgitation in four patients. Of the remaining 60 patients, 40 had no residual regurgitation, 18 had trivial residual regurgitation, and two had mild regurgitation. At follow-up, 49 patients are still in New York Heart Association (NYHA) class I, 14 in NYHA class II and only one in NYHA class III. CONCLUSIONS: Our study demonstrates that the 'edge-to-edge' technique is a reliable procedure to correct prolapsing leaflets. The addition of this technique to the surgical armamentarium has neutralized prolapse of the anterior leaflet as an incremental risk factor for reoperation.

The triple-orifice repair: a new technique for the treatment of mitral regurgitation in severe Barlow's disease.

We report a case of severe Barlow's disease with a very complex pathology, in which we applied the "edge-to-edge" technique, creating a triple-orifice mitral valve. Different techniques should be used to correct a similar valve defect; the combination of different surgical procedures and the valve pathology may influence the post-repair recurrence of regurgitation. We believe that it is better to perform a simple and reproducible repair than to carry on with combined complex procedures that could increase the risk of a suboptimal outcome.