Sutureless Aortic Valve Replacement Through Lateral Mini-Thoracotomy　- Feasibility and Effectiveness.

BACKGROUND: Minimally invasive sutureless aortic valve replacement with the Perceval bioprosthetic heart valve (MISUAVR) is commonly performed through a right anterior thoracotomy (AT). However, a lateral thoracotomy (LT) may be superior as it does not require rib and right internal thoracic artery (RITA) cutting.Methods and Results: In total, 38 MISUAVRs performed from May 2019 to approximately August 2021 were retrospectively reviewed; 21 through LT (Group L), and 17 through AT (Group A). In Group L, the skin incision was made on the right anterior axillary line and third intercostal space, and in group A, on the right anterior chest and second or third intercostal space. All other surgical techniques were the same. Age, body surface area, EuroSCORE II, and ejection fraction were similar between the patients. Cardiopulmonary bypass (L: 82±19 vs. A: 93±28 min, P=0.19) and cross-clamp times (L: 57±13, vs. A: 64±23 min, P=0.19) were similar. Rib and/or RITA cutting were required in 94.6% of patients in group A and in none of group L (P<0.001). Surgical visualization score was better in group L (L: 1.19±0.40 vs. A: 1.94±0.69, P<0.01). Total amount of intraoperative bleeding was lower in group L (L: 623±141 vs. A: 838±316 mL, P<0.01). Duration of hospital stay was similar (P=0.30). CONCLUSIONS: MISUAVR through LT has multiple advantages over AT.

A rescue transcatheter solution for early sutureless basal ring infolding.

We report the case of an 83-year-old woman treated with a "rescue" valve-in-valve transcatheter aortic valve implantation because of an early basal ring partial collapse of a sutureless valve, probably due to septal hypertrophy.

Hypo-attenuated leaflet thickening after Perceval sutureless bioprosthesis implantation.

Modern multi-slice computed tomography (CT) has increased the detection of hypo-attenuated leaflet thickening (HALT). Furthermore, HALT's impact on transcatheter or surgical biological aortic valve (AV) prostheses has attracted attention. However, few reports on HALT in sutureless bioprostheses exist. Herein, we report a case of early structural valve deterioration due to HALT after AV replacement (AVR) with a Perceval bioprosthesis, which improved after anticoagulation therapy. A 79-year-old man admitted to our hospital with paroxysmal atrial fibrillation (PAF) during hemodialysis was also diagnosed with AV stenosis and, coronary artery disease, and PAF. He underwent AVR, coronary artery bypass grafting, and left atrial appendage resection. Although the postoperative course was uneventful with dual antiplatelet therapy, postoperative enhanced CT revealed HALT with reduced leaflet motion, and echocardiography showed an increased transvalvular pressure gradient. After using warfarin with target prothrombin time-international normalized ratio of 2-2.5 and/or heparin with target activated partial thromboplastin time of 45-60 s, the HALT disappeared with an improved transvalvular pressure gradient without any thromboembolic events.

Hypo-attenuated leaflet thickening and reduced leaflet motion after the implantation of the Perceval S sutureless bioprosthesis.

Hypo-attenuated leaflet thickening (HALT) is gaining attention as a relatively common issue after surgical or transcatheter aortic valve replacement (AVR). However, only a few reports have described HALT in sutureless bioprosthesis, which has emerged as a promising tool with excellent hemodynamics and enhanced implantability. We herein report a 75-year-old woman who underwent quintuple coronary artery bypass grafting and sutureless AVR with a Perceval S bioprosthesis (LivaNova PLC, London, UK). Despite an uneventful perioperative course, her recovery was slow with persistent pleural effusion. Echocardiography revealed an increased transvalvular pressure gradient, and HALT was confirmed by computed tomography. The patient received aggressive anticoagulation therapy with resolution of the HALT and made an uneventful recovery. Current guidelines provide no specific recommendations for peri-procedural antithrombotic therapy for sutureless AVR. However, HALT is not rare after sutureless AVR and can lead to significant clinical consequences. In this case, aggressive anticoagulation therapy with systemic heparinization was effective as HALT treatment following early post-sutureless AVR. Further investigation is required to determine the optimal antithrombotic strategy for sutureless AVR.

Extended hockey stick aortotomy for Perceval valve implantation: How to reshape the aortic root.

The Perceval valve is a true sutureless aortic bioprosthesis. Overall, excellent performances have been demonstrated in terms of hemodynamic outcomes, safety, and versatility of use; furthermore, as a sutureless valve option, it has shown to reduce the surgical burden, shortening the operative times, and simplifying minimally invasive procedures. Since the valve has got a high frame profile, the recommended implantation technique requires a high and transverse aortotomy. In case of unplanned Perceval valve implantation, when an extended aortotomy is required, we have come up with a simple technique to reshape the aortic root before the valve is delivered in place: symmetry is pivotal to prevent folding issues and to improve the annular sealing. Although we discuss an out-of-recommendation use, in our experience that technique has shown to be safe and effective.

Sutureless aortic valve replacement with concomitant aortic arch reconstruction.

Sutureless aortic valve replacement (AVR) offers an alternative approach to the standard AVR in aortic valve disease. We herein report a case of an 82-year-old woman with severe aortic insufficiency and a persistent type 1 endoleak following a thoracic endovascular aortic repair, who underwent successful combined aortic arch reconstruction and sutureless AVR. The bioprosthesis, Perceval (LivaNova PLC, London, UK), a self-anchoring, self-expanding, sutureless valve, which can be implanted in selected patients with aortic insufficiency was used. Although the patient was frail and at a high risk of open-heart surgery, she had an uneventful postoperative course. Hence, Perceval may be a useful option for combined aortic arch reconstruction and aortic valve surgery in high-risk elderly patients.

Attempt at off-label balloon valvuloplasty post-dilation for intuity sutureless valve.

Alternatives to traditional aortic valve replacement now form part of the valve surgeon's armamentarium. Sutureless valves offer decreased bypass and crossclamp times, excellent maneuverability, and promising outcomes. We present a case of a sutureless aortic valve replacement for a late failed David procedure, complicated by postoperative development of severe paravalvular regurgitation. We attempted off-label balloon post-dilation to improve expansion of the valve, however paravalvular regurgitation persisted. The patient underwent subsequent aortic valve replacement using a mechanical valve and experienced no further paravalvular leak.

Aortic valve replacement with sutureless Perceval S valve: A case report of aortic root homograft failure in the setting of Streptococcus constellatus endocarditis.

BACKGROUND: Surgery for failed homograft aortic root replacement with extensive calcification in the setting of endocarditis alone is very challenging. CASE SUMMARY: We report the case of redo aortic valve replacement and mitral valve replacement, in a 39 years old presenting with a rare Streptococcus constellatus endocarditis of a previously implanted homograft root and native mitral valve, where conventional valve replacement proved nonfeasible. S. constellatus had caused severe tissue destruction and the extensive calcification in the homograft prevented conventional valve replacement with sutures. In this case, a sutureless valve provided a useful alternative surgical strategy. DISCUSSION: We consider heavily calcified failed homografts to be a good indication for sutureless (rapid deployment) valves.

Hospital cost savings and other advantages of sutureless vs stented aortic valves for intermediate-risk elderly patients.

PURPOSE: To evaluate and compare the clinical outcomes and hospital costs of using sutureless aortic valves vs conventional stented aortic valves. METHODS: Between 2007 and 2011, 52 elderly patients undergoing aortic valve replacement for aortic stenosis in our center had a sutureless valve inserted. From among 180 patients who had a stented valve inserted during the same period, 52 patients were matched to the sutureless group, based on age, gender, and operation type. We compared clinical outcomes and hospital costs between the two groups. RESULTS: The sutureless group had a higher Euroscore (logistic Euroscore I) risk (12.8 vs 9.7; p = 0.02), with significantly shorter aortic cross-clamp (ACC) time (p < 0.01), cardiopulmonary bypass (CPB) time (p < 0.01), intensive care unit stay (p < 0.01), intubation time (p < 0.01), and overall hospital stay (p = 0.05). The sutureless group also revealed a significant hospital cost saving of approximately 8200€ (p = 0.01). CONCLUSIONS: The clinical and hemodynamic outcomes of using the sutureless bioprosthesis were excellent. The reduced ACC and CPB times had a favorable effect on the duration of intubation and intensive care stay, resulting not only in faster recovery and discharge home, but also in a significant hospital cost reduction.

Utilizing a sutureless valve for prosthetic valve endocarditis after aortic root replacement.

BACKGROUND: Reoperation following aortic root replacement is associated with significantly high operative mortality. Etiologies related to infection are known to increase the operative mortality rate more than other etiologies. In such a clinical setting, a sutureless valve could lower the operative mortality by shortening the cardiac arrest and the operative time. CASE PRESENTATION: A 61-year-old male underwent emergent aortic root and total arch replacement with an open stent graft for acute type-A aortic dissection. A bioprosthetic valve was employed for aortic root replacement using the double-sewing ring technique. A fungal infection by Candida parapsilosis was postoperatively detected and improved with intravenous antifungal drug administration. However, he developed congestive heart failure one year later, and the blood cultures turned positive repeatedly for Candida parapsilosis. The prosthetic valve infection was suspected upon identifying vegetation on the bioprosthetic valve through transthoracic echocardiography. The computed tomography scan and operative findings confirmed that the infection was localized on the prosthetic valve. Consequently, the infected valve was removed without a vascular conduit, and a sutureless valve was implanted. The postoperative course was uneventful, without any evidence of recurrent fungal infection, and the patient was discharged on postoperative day 28. CONCLUSIONS: Deploying a sutureless valve can facilitate a more straightforward and minimally invasive redo procedure. Preoperative computed tomography can predict the valve size, which is the key to implanting a sutureless valve successfully after the modified Bentall procedure.

Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

Background: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use. Methods: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years. Results: The mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm2, respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. Conclusions: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

Perceval ViV-TAVR: Perception Is Not Always Reality.

Valve-in-valve transcatheter aortic valve replacement for failed Perceval sutureless valves has been shown to be safe and feasible. However, it is technically challenging and warrants understanding of potential risks and complications. We present a case of successful valve-in-valve implantation complicated by inadvertent wire passage outside of the Perceval frame.

Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study.

BACKGROUND: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve. METHODS: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. RESULTS: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported. CONCLUSIONS: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS. TRIAL REGISTRATION: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).

Thrombocytopenia after Aortic Valve Replacement Using Sutureless Valves.

Background: Sutureless valves are widely used in aortic valve replacement surgery, with Perceval valves and Intuity valves being particularly prominent. However, concerns have been raised about postoperative thrombocytopenia with Perceval valves (Corcym, UK). We conducted a comparative analysis with the Intuity valve (Edwards Lifesciences, USA), and assessed how thrombocytopenia affected patient and transfusion outcomes. Methods: Among 595 patients who underwent aortic valve replacement from June 2016 to March 2023, sutureless valves were used in 53 (Perceval: n=23; Intuity: n=30). Platelet counts were monitored during hospitalization and outpatient visits. Daily platelet count changes were compared between groups, and the results from patients who underwent procedures using Carpentier Edwards Perimount Magna valves were used as a reference group. Results: Compared to the Intuity group, the Perceval group showed a significantly higher amount of platelet transfusion (5.48±1.64 packs vs. 0.60±0.44 packs, p=0.008). During the postoperative period, severe thrombocytopenia (<50,000/µL) was significantly more prevalent in the Perceval group (56.5%, n=13) than in the Intuity group (6.7%, n=2). After initial postoperative depletion, daily platelet counts increased, with significant differences observed in the extent of improvement between the Perceval and Intuity groups (p<0.001). However, there was no significant difference in early mortality or the incidence of neurological complications between the 2 groups. Conclusion: The severity of postoperative thrombocytopenia differed significantly between the Perceval and Intuity valves. The Perceval group showed a significantly higher prevalence of severe thrombocytopenia and higher platelet transfusion volumes. However, thrombocytopenia gradually recovered during the postoperative period in both groups, and the early outcomes were similar in both groups.

Thrombocytopenia after sutureless and standard stented aortic valve replacement: a retrospective analysis of risk factors, clinical course, and early outcome.

OBJECTIVES: Thrombocytopenia following Perceval aortic valve replacement has been described previously with variable outcome. Studies have lacked a robust analysis of platelet fluctuation and factors affecting it. We aimed to statistically describe the trend in thrombocyte variability as compared with conventional aortic valve replacement, and to assess predictors as well as impact on associated outcomes. METHODS: One hundred consecutive patients with first-time Perceval were retrospectively compared to 219 patients after Perimount Magna Ease valve replacement. The primary outcome was the serial thrombocyte count on day 0-6. Generalized estimating equations were used to analyse the data using fixed-effect models: for the effect of the post-operative day on platelet count, and random-effect models estimating both time-variant (platelets) and time in-variant variables (valve type, age, LV function, pre-op platelet level). RESULTS: Perceval patients were older (72 ± 1 vs 68 ± 1 years, p < 0.01) with higher NYHA status (3(2-3) vs 2(1-2), p < 0.001). Mean platelet count in the sutureless group was lowest on day 2 (91.9 ± 31.6 vs 121.7 ± 53.8 × 103 µl-1), and lower on day 4 (97.9 ± 44) and 6 (110.6 ± 61) compared to the conventional group (157.2 ± 60 and 181.7 ± 79) but did not result in a higher number of transfusions, bleeding or longer hospital stay (p > 0.05). Reduced platelet count was a strong predictor of red cell transfusion in the conventional (p = 0.016), but not in the sutureless group (p = 0.457). Age (Coef -1.025, 95%CI-1.649--0.401, p < 0.001) and CPB-time (Coef 0.186, 95%CI-0.371--0.001, p = 0.048) were predictors for lower platelet levels. CONCLUSION: Considering the older patient profile treated with Perceval, postoperative thrombocytopenia does not impact on outcome in terms of transfusions, complications or hospital stay.

Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial.

BACKGROUND: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicylic acid should be considered for the first 3 months. Hypo-attenuated leaflet thickening on cardiac computed tomography has been associated with latent bioprosthetic valve thrombosis and may be prevented with anticoagulation. We hypothesize that anticoagulation with apixaban is superior to single antiplatelet therapy with acetylsalicylic acid in reducing hypo-attenuated leaflet thickening of bioprosthetic aortic valve prostheses. METHODS: In this prospective, open-label, randomized trial, patients undergoing isolated aortic valve replacement surgery with rapid deployment bioprosthetic valves will be randomized. The treatment group will receive 5 mg of apixaban twice a day for the first 3 months and 100 mg of acetylsalicylic acid thereafter. The control group will be administered 100 mg of acetylsalicylic acid once a day, indefinitely. After the 3-month treatment period, a contrast-enhanced electrocardiogram-gated cardiac computed tomography will be performed to identify hypo-attenuated leaflet thickening of the bioprosthetic valve. The primary objective of the study is to assess the impact of apixaban on the prevention of hypo-attenuated leaflet thickening at 3 months. The secondary and exploratory endpoints will be clinical outcomes and safety profiles of the two strategies. DISCUSSION: Antithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenuated leaflet thickening after surgical aortic valve replacement with rapid deployment bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov NCT06184113. Registered on December 28, 2023.

Totally endoscopic concomitant aortic and mitral valve surgery in junctional epidermolysis bullosa: a case report.

BACKGROUND: Junctional epidermolysis bullosa is a rare skin and mucosal disorder characterized by blister formation in response to minor trauma and extracutaneous manifestations. There have been no reports of cardiac surgery and prognostication in patients with epidermolysis bullosa due to skin and mucosal fragility. CASE PRESENTATION: A 55-year-old man presented with congenital junctional epidermolysis bullosa, hypertension, and vasospastic angina. He complained of dyspnea on exertion, and transthoracic echocardiography revealed severe aortic valve regurgitation, moderate aortic valve stenosis (tricuspid valve), and severe mitral valve regurgitation. Considering that the skin condition in the right chest wall was relatively healthy, the right thoracotomy approach was preferred and totally endoscopic concomitant mitral valve repair and aortic valve replacement were performed using a sutureless bioprosthetic valve (Perceval™ (Corcym, Group, Milan, Italy)). Polyurethane and silicon dressing foams were used to protect the skin at the site of contact with the bag valve mask, arterial pressure catheter, intravenous catheter, and the tracheal intubation tube. Vertical mattress sutures were used for the skin sutures. The postoperative course was uneventful, and the patient was discharged nine days after the operation. There was no indication for reoperation until three years follow-up period. CONCLUSIONS: The totally endoscopic concomitant aortic and mitral valve surgery using Perceval™ prosthesis can be performed safely in patients with junctional epidermolysis bullosa by adequate protection of the skin and mucosa.

Conventional vs. Sutureless Aortic Valve Bioprosthesis: Is Faster Better?

Purpose: The benefits of sutureless compared to conventional aortic valve prosthesis replacement remain controversial. Supposed advantages of sutureless aortic valve replacement include shortened cross-clamp and implantation time, as well as improved overall safety and good post-operative performance. We aimed to compare the early outcomes and performance of sutureless aortic valve replacement (su-AVR) with the sutureless Perceval (Corcym, Milan, Italy) vs. the conventional AVR with a conventional counterpart, in this case, the Labcor Dokimos Plus (LDP) aortic bioprosthesis. Methods: We compared two types of aortic valve prostheses, the sutureless (Corcym, Milan, Italy) and the conventional valve Labcor Dokimos Plus (LDP), implanted between August 2014 and May 2019 in our Department of Cardiac Surgery at RWTH Aachen University Hospital. Data were collected from 141 patients who received the Perceval (Corcym, Milan, Italy) and 138 who received the Labcor Dokimos Plus (LDP) aortic bioprosthesis. After matching the two groups considering STS mortality risk and pre-operative LDH levels, 201 patients were included in our final study cohort. Seventy-one patients (17 from the Perceval group and 54 from the Dokimos group) were excluded due to the lack of complete data, particularly standardized echocardiographic data (n = 71). Primary endpoints were 30-day mortality, length of hospital stay, and pacemaker implantation. Secondary endpoints were echocardiographic parameters, major adverse cardiovascular events, and prosthesis failure (grade II aortic regurgitation, paravalvular leak with reintervention). Results: Bypass and cross-clamp time proved to be shorter in the Perceval group, while hospital stays were longer. The faster implantation had no effect on the 30-day mortality primary endpoint. Transvalvular gradients were significantly higher in the Perceval group, in addition to a smaller effective orifice area. The LDH values were remarkably higher post-operatively in the Perceval group. Conclusions: Regarding the clinical outcomes, Perceval was equivalent and not superior to the Dokimus bioprosthesis. The suitability of a Perceval prosthesis implantation must be determined on a case-by-case basis and reserved for elderly patients with increased comorbidity.