Two innovative aortic bioprostheses evaluated in the real-world setting. First results from a two-center study.

BACKGROUND: The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability. METHODS: In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance. RESULTS: From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm2 vs. 1.4 cm2 (P=0.4) and 0.8 vs. 0.7 cm2/m2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m2 for the Inspiris and AVALUS groups, respectively, (R2-adjusted =0.14; P<0.01). CONCLUSIONS: INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.

Evaluation of an Innovative Device for Mitral Valve Regurgitation: Experimental Acute In Vivo Results.

Objective: Currently, mitral prosthetic rings are intended only to reshape the annulus. We present in vivo results of an innovative device characterized by an intraventricular segment designed to enable artificial chordae implantation and simplify leaflets and subvalvular apparatus correction. Methods: Eight sheep were employed. The first 4 underwent solely device implantation. In the last 4, primary chordae of the anterior leaflet (A2) were torn to induce severe mitral regurgitation. The severed chordae were replaced by 2 pairs of 5-0 Gore-Tex artificial chordae previously measured and anchored to the device bridge. Ease of device and chordae implantation were evaluated, and postprocedural valve competence was verified by postoperative echocardiogram. Results: The procedure was completed in all 8 sheep. In the 4 sheep with induced severe mitral regurgitation, repair could be achieved by means of artificial chordae implantation. Length of the 2 chordae implanted was 21.6 ± 2 mm and 22 ± 3 mm, respectively. The time required to suture the artificial chordae was 2.5 ± 1.2 min. Postoperative echocardiograms showed normal left ventricular ejection fraction and free motion of the mitral leaflets. Mitral regurgitation was absent in 5 cases and trivial in 3. The transvalvular peak pressure gradient was 9.5 ± 6 mm Hg, and mean gradient was 3.7 ± 4 mm Hg. Postprocedural evaluation of the heart and mitral valve showed no damage to the left ventricle wall, valve leaflets, chordae, and papillary muscles. Conclusions: In vivo tests confirm safety of the device, ease of chordal length estimation prior to implantation, short operative time, and no negative impact of the device on mitral leaflet motion, function, and structure.

Bleeding Complications in Patients With Perioperative COVID-19 Infection Undergoing Cardiac Surgery: A Single-Center Matched Case-Control Study.

OBJECTIVE: Previous studies reported a poor outcome in patients with coronavirus 2019 (COVID-19) undergoing cardiac surgery. Complications most frequently described were respiratory failure, renal failure, and thromboembolic events. In their recent experience, the authors observed a very high incidence of bleeding complications. The purpose of the study was to investigate a possible significant correlation between perioperative COVID-19 infection and hemorrhagic complications compared to non-COVID-19 patients. DESIGN: Single-center, observational, retrospective, matched case-control (1:2) study involving patients who underwent open-heart cardiac surgery from February 2020 and March 2021 with positive perioperative diagnosis of COVID-19 infection, matched with patients without COVID-19 infection. SETTING: Cardiac surgery unit and intensive care unit of a university tertiary center in a metropolitan area. PARTICIPANTS: In the study period, 773 patients underwent cardiac surgery on cardiopulmonary bypass (CPB). Among them, 23 consecutive patients had perioperative diagnosis of COVID-19 infection (study group). These patients were compared with 46 corresponding controls (control group) that matched for age, sex, body mass index, and Society of Thoracic Surgeons score. INTERVENTIONS: Open-heart cardiac surgery on CPB. MEASUREMENTS AND MAIN RESULTS: In the study group, 2 patients (9%) died in the intensive care unit from severe respiratory failure, shock, and multiple organ failure. In the study group, patients showed a significantly higher incidence of bleeding complications (48% v 2%, p = 0.0001) and cases of surgical reexploration for bleeding (35% v 2%, p = 0.0001), a higher incidence of severe postoperative thrombocytopenia (39% v 6%, p = 0.0007), and a higher need of blood components transfusions (74% v 30%, p = 0.0006). Chest tubes blood loss and surgical hemostasis time were markedly prolonged (p = 0.02 and p = 0.003, respectively). CONCLUSIONS: A worrisome increased risk of early and late bleeding complications in COVID-19 patients was observed, and it should be considered when assessing the operative risk. CPB-related inflammatory reaction could exacerbate the deleterious effect of COVID-19 on the coagulation system and likely deviate it toward a hemorrhagic pattern.

Single pulmonary valve cusp agenesis first detected by computed tomography reconstruction.

We present the case, with tomographic three-dimensional reconstructions, of an adult patient affected by congenital absence of one pulmonary valve cusp with completely normal morphology of the other two cusps.

Influence of cardiopulmonary bypass set-up and management on clinical outcomes after minimally invasive aortic valve surgery.

INTRODUCTION: Minimally invasive aortic valve replacement (MIAVR) requires changes in cannulation strategy and cardiopulmonary bypass (CPB) management when compared to the conventional approach (CAVR). We aimed at evaluating if these differences could influence perfusion-related quality parameters and impair postoperative outcomes. METHODS: Overall, 339 consecutive patients underwent MIAVR or CAVR between 2014 and 2020 and were analyzed retrospectively. To account for baseline differences, a propensity-matching analysis was performed, obtaining two groups of 97 patients each. RESULTS: MIAVR group had longer CPB time [107 (95-120) vs 95 (86-105) min, p = .003] than CAVR group. Of note, average pump flow rate index [2.4 (2.2-2.5) vs 2.7 (2.4-2.8) l/min/m2, p = .004] was lower in the MIAVR group. Mean arterial pressure was 73 = 9 mmHg vs 62 = 11 mmHg for the MIAVR and CAVR group, respectively (p < .001). Cell-salvaged blood was most commonly used in the MIAVR group (25.8% vs 11.3%, p = .02). Finally, CPB temperature was 32.8°C (32.1-34.8) for MIAVR group vs 34.9°C (33.2-36.1) for the CAVR group (p = .02). Postoperative complications were similar between groups. CONCLUSIONS: In conclusion, despite differences in CPB parameters in patients undergoing CAVR and MIAVR, the incidences of adverse outcomes were similar. However, compared to CAVR, MIAVR was associated with shorter durations of mechanical ventilation and hospital stay as well as less transfusion of blood products.

Heart Valve Critical Pathway and Heart Valve Clinic: Novel Benchmarks for Modern Management of Valvular Heart Disease.

The growing burden of valvular heart disease in Western countries represents a challenge for the daily clinical practice, especially in the light of the ever-increasing number of therapeutic options. The Euro Heart Survey showed that, among elderly subjects with severe, symptomatic valve dysfunction, surgery is denied for 33% of patients with aortic stenosis and for 50% of patients with mitral regurgitation. Current management (from diagnosis to follow-up) is often fragmented in multiple-sometimes unnecessary-steps. Such a "patchy" approach may translate into a suboptimal management, especially in the geriatric population. New healthcare models exist that can coordinate care, reduce fragmentation, limit costs and, ultimately, improve outcomes: the clinical pathways.

Late results after mitral valve replacement with Mosaic bioprosthesis in patients aged 65 years or younger.

OBJECTIVES: Although in younger patients indications for biological prosthesis implantation in mitral valve replacement remain controversial, recently bioprostheses use increased considerably. We present late results obtained with the Medtronic Mosaic bioprosthesis in patients aged 65 years or younger. METHODS: Between 2007 and 2017, 67 mitral Mosaic bioprostheses were implanted in patients aged 65 years or younger (58.5 ± 6.4 years). Follow-up extended up to 13 years. Survival, freedom from structural valve degeneration, endocarditis, thromboembolic events and reoperation were considered as main clinical end points evaluated at 1, 5 and 10 years. RESULTS: The mean follow-up was 4.7 ± 2.8 years. Overall mortality rate was 12%. At 1, 5 and 10 years, survival was 94 ± 3%, 89 ± 4% and 77 ± 9%, respectively. Freedom from structural valve degeneration was 100%, 94 ± 4% and 71 ± 21%. Freedom from endocarditis was 95 ± 3%, 90 ± 6% and 84 ± 8%. Freedom from thromboembolic events was 94 ± 3%, 90 ± 5% and 90 ± 5%. Freedom from reoperation was 94 ± 3%, 87 ± 5% and 65 ± 19%. CONCLUSIONS: Mosaic bioprosthesis appears a valid mitral valve substitute even when employed in ≤65-year-old patients.

Minimally Invasive Aortic Valve Surgery in Octogenarians: Reliable Option or Fallback Solution?

OBJECTIVE: Aortic valve disease is more and more common in western countries. While percutaneous approaches should be preferred in older adults, previous reports have shown good outcomes after surgery. Moreover, advantages of minimally invasive approaches may be valuable for octogenarians. We sought to compare outcomes of conventional aortic valve replacement (CAVR) versus minimally invasive aortic valve replacement (MIAVR) in octogenarians. METHODS: We retrospectively collected data of 75 consecutive octogenarians who underwent primary, elective, isolated aortic valve surgery through conventional approach (41 patients, group CAVR) or partial upper sternotomy (34 patients, group MIAVR). RESULTS: Mean age was 81.9 ± 0.9 and 82.3 ± 1.1 years in CAVR and MIAVR patients, respectively (P = 0.09). MIAVR patients had lower 24-hour chest drain output (353.4 ± 207.1 vs 501.7 ± 229.9 mL, P < 0.01), shorter mechanical ventilation (9.6 ± 2.4 vs 11.3 ± 2.3 hours, P < 0.01), lower need for blood transfusions (35.3% vs 63.4%, P = 0.02), and shorter hospital stay (6.8 ± 1.6 vs 8.3 ± 4.3 days, P < 0.01). Thirty-day mortality was zero in both groups. Survival at 1, 3, and 5 years was 89.9%, 80%, and 47%, respectively, in the CAVR group, and 93.2%, 82.4%, and 61.8% in the MIAVR group, with no statistically significant differences (log-rank test, P = 0.35). CONCLUSIONS: Aortic valve surgery in older patients provided excellent results, as long as appropriate candidates were selected. MIAVR was associated with shorter mechanical ventilation, reduced blood transfusions, and reduced hospitalization length, without affecting perioperative complications or mid-term survival.

Total Surgical Plication of Left Ventricular Aneurysm Using the BioVentrix Revivent Myocardial Anchoring System.

Surgical ventricular reconstruction (SVR) is the therapy of choice for patients with left ventricular dilatation, apical and anterolateral transmural scar, and low ejection fraction. STICH trial did not show that SVR led to improved survival but several observational studies did. However, because of the considerable operative risk, open heart surgery is considered risky in debilitated patients and clinical results are controversial. Alternative less invasive strategies for left ventricular aneurysm repair have been proposed. We present a case of a left ventricular aneurysm repair using the less invasive ventricular enhancement technique (LIVE) with the Revivent TC system (BioVentrix Inc., San Ramon, CA) in a totally surgical approach, instead of a hybrid interventional-surgical one, as previously described.

The "Heart Valve Clinic" Pathway for the Management of Frail Patients With Valvular Heart Disease: From "One for All" to "All for One".

Valvular heart disease (VHD) is frequently diagnosed in old patients with clinical evidence of heart failure. This elderly population typically presents a high prevalence of frailty and comorbidities, which are associated with increased operative risk for surgical and percutaneous procedures. Recently, the Euro Heart Survey reported a clear gap between treatment guidelines and their application in the "real world". A more realistic approach to the treatment of older VHD patients treatment, mostly if associated with heart failure, is advocated. A multidisciplinary approach, as obtained with the Heart Valve Clinic methodology (intended to put the patient in the "center" of the scene and the specialists "around him"), has been applied in a group of 79 patients, aged >70 years, with symptomatic VHD, divided in 2 groups according to their frailty status (58 robust and 21 frail). No in-hospital mortality and no difference in late mortality and complications were observed. Infections were more frequent (14.3 vs. 1.7 %; P = 0.02) in frail patients. In patients with postoperative complications, serum levels of interleukin 6 (67.6 vs. 49.6; P = 0.01) and of CAF (C-terminal agrin fragment) as sarcopenia marker (67.9 vs. 62.0; P = 0.04) were higher than that in uncomplicated patients. This study was designed to determine the outcomes of the multidimensional geriatric assessment in the management of older patients with heart failure eligible for heart valve surgery. Geriatric assessment and measurement of inflammatory and sarcopenia markers may represent valid tools for a more realistic evaluation of elderly patients with VHD.

Aortic Valve Replacement in Elderly Patients With Small Aortic Annulus: Results With Three Different Bioprostheses.

OBJECTIVES: Aortic valve replacement (AVR) in patients with small aortic annulus (diameter ≤21 mm) is considered a challenging scenario because of technical aspects and the high risk of patient-prosthesis mismatch (PPM). The choice of the appropriate prosthesis is crucial, and at the moment, an ideal device has yet to be identified. We compare clinical and hemodynamic results after AVR with three bioprostheses with different design and characteristics. METHODS: We retrospectively evaluated 76 consecutive patients from two cardiac surgery centers who underwent AVR (Trifecta = 24; Edwards INTUITY Elite valve system = 26, and Perceval = 26) for severe aortic stenosis between 2013 and 2017. Patients selected were older than 75 years and with an annulus diameter ≤21 mm at preoperative echocardiogram. Reinterventions and combined procedures were excluded. Minimally invasive AVR was performed in 44 (57.8%) patients. Telephonic interview was obtained at 2.9 ± 0.5 years and echocardiographic follow-up at 2.2 ± 0.8 years. RESULTS: Clinical outcome was similar in the three groups. At follow-up, Trifecta patients presented significantly higher peak and mean transprosthetic pressure gradients ( P = 0.04 and 0.01). Effective orifice area and left ventricular mass regression were comparable, although an advantage was observed in Perceval patients without reaching the statistical significance. Incidence of moderate ( P = 0.2) and severe PPM ( P = 0.7) was comparable. CONCLUSIONS: Despite higher postoperative pressure gradients observed with the Trifecta valve, all three prostheses (Trifecta, Edwards INTUITY Elite, and Perceval) have proven to be reliable when implanted in small aortic annuli, with good clinical outcome and favorable left ventricular mass regression.

Acute heart failure related to a large left atrial myxoma.

An association between atrial myxoma and left ventricular failure is rarely described, is not completely understood, and may have multiple etiologies. We present a 49-year-old man with no history of cardiovascular disease who was admitted to our hospital with pulmonary edema. He was in atrial fibrillation with rapid ventricular response. Echocardiography showed a 10.5-cm left atrial myxoma, which had been asymptomatic until the onset of congestive heart failure in the presence of severe left ventricular systolic dysfunction. Left ventricular inflow obstruction associated with the giant atrial mass could not be the only cause for acute heart failure.