Objectives Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue. Methods This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory. Results Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years. Conclusions The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue. Clinical trial registration number NCT01651052.

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis.

Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement with RESILIA Tissue.

Objectives We sought to provide further evidence on the safety and efficacy of aortic valve neocuspidization (AVNeo) using autologous pericardium in adult patients with aortic valve disease by reporting clinical and echocardiographic results from the first UK experience and performing a meta-analytic comparison with other biological valve substitutes Methods We reported clinical and echocardiographic outcomes of 55 patients (mean age 58 ± 15 years) undergoing AVNeo with autologous pericardium in 2 UK centres from 2018 to 2020 These results were included in a meta-analytic comparison between series on AVNeo (7 studies, 1205 patients, mean weighted follow-up 36 years) versus Trifecta (10 studies, 8705 patients, 38 years), Magna Ease (3 studies, 3137 patients, 41 years), Freedom Solo (4 studies, 1869 patients, 44 years), Freestyle (4 studies, 4307 patients, 7 years), Mitroflow (4 studies, 4760 patients, 41 years) and autograft aortic valve (7 papers, 3839 patients, 91 years) Results In the present series no patients required intraoperative conversion After mean follow-up of 125 ± 09 months, 3 patients presented with endocarditis and 1 required reintervention The remaining patients had absent or mild aortic valve insufficiency with very low peak and mean transvalvular gradients (16 ± 37 and 9 ± 22 mmHg, respectively) Meta-analytic estimates showed non-significant difference between AVNeo and all but Magna Ease valves with regards to structural valve degeneration, reintervention and endocarditis When compared Magna Ease valve, AVNeo and other valve substitutes showed an excess of valve-related events Conclusions AVNeo is safe, associated with excellent haemodynamic profile Its midterm risk of valve-related events is comparable to most biological valve substitutes Magna Ease is potentially the best biological choice as far as risk of reintervention is concerned

Aortic valve neocuspidization with autologous pericardium in adult patients: UK experience and meta-analytic comparison with other aortic valve substitutes.

Cusp tear is an increasingly described mode of failure of the Trifecta aortic bioprosthesis. Acute aortic regurgitation after implantation of a Trifecta in absence of endocarditis should suggest a cusp tear and be promptly treated with redo surgery.

Early surgical aortic bioprosthesis failure caused by cusp tear: A word of caution

OBJECTIVES Long-term durability of surgical bio-prostheses is a key factor, especially in the era of transcatheter aortic valve replacement. We compared the incidence of structural valve deterioration (SVD) between patients undergoing surgical aortic valve replacement (SAVR) with the Trifecta (Abbott Laboratories, Abbott Park, IL, USA) or the Intuity valve (Edwards Lifesciences, Irvine, CA, USA). METHODS Between April 2010 and May 2020, 1118 patients underwent SAVR with the Trifecta (n = 346) and the Intuity (n = 772) valve at a single centre. A total of 1070 patients (Trifecta n = 298, Intuity n = 772) were analysed after the exclusion of patients with pure regurgitation and endocarditis. Retro- and prospective echocardiographic and clinical follow-up was performed. Cox proportional hazards regression models were performed to identify prognostic factors for SVD, aortic re-interventions and mortality. RESULTS With 27 cases (Trifecta n = 23, Intuity n = 4) of SVD observed, cumulative incidence of SVD was significantly higher in the Trifecta cohort (P < 0.001). Implantation of a Trifecta valve [hazard ratio (HR) 11.20; 95% confidence interval 3.79-33.09], log-transformed preoperative creatinine (HR 2.47; 1.37-4.44) and sex (male HR 0.42; 0.19-0.92) emerged as prognostic factors of SVD. A significantly higher cumulative incidence of re-interventions was observed in the Trifecta cohort (P = 0.004) and valve type was an independent time-varying risk factor (HR at 12 months 2.78; 95% confidence interval 1.42-5.45). Overall, no significant differences in all-cause mortality were observed between the groups (log-rank test: P = 0.052). CONCLUSIONS SVD was significantly more frequent in patients receiving a Trifecta valve and its implantation was an independent risk factor for the occurrence of SVD and aortic valve re-interventions. This comparative analysis of 2 low-gradient bioprosthesis put the long-term durability of the Trifecta valve in question and need to be taken into consideration when performing bioprosthetic SAVR.

Long-term durability after surgical aortic valve replacement with the Trifecta and the Intuity valve-a comparative analysis.

Durability and clinical experience using a bovine pericardial prosthetic aortic valve.

Durable mechanical circulatory support (MCS) systems are established therapy option in patients with end-stage heart failure, with increasing importance during the last years due to donor organ shortage. Left ventricular assist devices (LVADs) are traditionally implanted through median sternotomy (MS). However, improvement in the pump designs during the last years led to evolvement of new surgical approaches that aim to reduce the invasiveness of the procedure. Numerous reports and studies have shown the viability and possible advantages of less-invasive approach compared to the sternotomy approach. The less invasive implant strategies for LVADs, while vague in definition, are characterized by minimizing surgical trauma and if possible, cardio-pulmonary bypass related complications. Usually it involves minimizing or completely avoiding sternal trauma, avoiding heart luxation while simultaneously leaving the major part of pericardium intact. There is no consensus between the centers regarding the ideal approach for LVAD implantation. Some centers, like our center, perform by default VAD implantation using less invasive approach in almost all patients and some centers use only sternotomy approach. The aim of this review article is to shed light on the currently available less invasive options of LVAD implantation, with particular focus on the centrifugal pumps, and their possible advantages compared to traditional sternotomy approach.

/pdf/minimally-invasive-ventricular-assist-device-implantation-ci7803pwgz.pdf

Minimally invasive ventricular assist device implantation.

Less-invasive ventricular assist device implantation: A multicenter study

OBJECTIVE The clinical consequences of alternative outflow cannula positioning in patients undergoing left ventricular assist device implantation are unknown. We evaluated clinical outcomes in patients who underwent implantation with the outflow cannula implanted from the right side into the ascending aorta versus the left side of the pericardium. METHODS Fifty consecutive patients with terminal left heart failure underwent implantation using the Medtronic Heartware Ventricular Assist Device at Toronto General Hospital. Patients were divided between left and right outflow cannula positioning during implantation where anastomosis occurred in the ascending aorta. Propensity score matching using exact matching on the following pre-specified covariates: Interagency Registry for Mechanically Assisted Circulatory Support score, previous cardiac surgery, and preoperative inotrope use. RESULTS Fifty consecutive patients (25 left implantation and 25 right implantation) were included in the unmatched cohort and 45 patients (25 left implantation and 20 right implantation) were included in the matched cohort. No significant differences in baseline demographics. Pump thrombosis occurred in 10% (n = 2) receiving right-sided implantation and 8% (n = 2) with left implantation (p = 1.00). Postoperative stroke occurred in 10% (2/20) with right implantation and 16% (4/25) with left implantation (p = .88). No difference in 1-year mortality between right 20% (5/25) and left 25% (5/20) implantation (p = .97). CONCLUSION No observed difference in mortality when adjusting for competing risk of heart transplantation. There was also no difference in stroke, pump thrombosis, driveline infection. Larger studies are required to confirm these findings. These preliminary data support the use of left-sided anastomoses to facilitate subsequent re-entry during heart transplantation.

Khalil Jawad

Papers

Durability and clinical experience using a bovine pericardial prosthetic aortic valve.

Minimally invasive ventricular assist device implantation.

Less-invasive ventricular assist device implantation: A multicenter study

Outflow cannula position for left ventricular assist device: A propensity score-matched study.