Does the Use of Sutureless Valve Provide Benefits to Asian Patients?
Article ID: CJ-21-0415
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Article ID: CJ-21-0415
Aortic valve stenosis is the most frequent valvular heart disease requiring surgical intervention,1,2 and the number of patients undergoing surgery for aortic valve replacement (AVR) in Japan is increasing annually2 (Figure) Although the age of patients requiring AVR is increasing, the short- and long-term outcomes after AVR are gradually improving owing to the advanced technology for stented bioprostheses,3 and the introduction of less invasive interventions, including minimally invasive cardiac surgery and transcatheter AVR (TAVR). The short- and mid-term outcomes for TAVR are comparable to those for surgical AVR, and the ongoing advances in technology render this approach also applicable to low-risk patients.4,5 However, surgical AVR remains the gold standard treatment for aortic valve stenosis in terms of reliable long-term durability, less paravalvular leakage and, particularly, lower rate of permanent pacemaker implantation (PMI).5
Nationwide analysis of isolated aortic valve replacement (AVR) using annual reports of the Japanese Association for Thoracic Surgery. The number of isolated AVR cases was approximately 10,000 in 2017. The hospital mortality rate was ≈3.0% and a bioprosthesis was implanted in 85% of the patients. The number of transcatheter AVR cases is not included.
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Use of the rapid-deployment sutureless aortic valve, represented by the Perceval bioprosthesis (LivaNova, Saluggia, Italy), is expected to facilitate surgical AVR in combined operations and reduce the surgical impact through a minimally invasive approach, thereby maintaining excellent short- and long-term outcomes. A recent multicenter, prospective, randomized trial (PERSIST-AVR), conducted in European countries demonstrated the noninferiority of this approach to stented valves with respect to the occurrence of major adverse cerebral and cardiovascular events at 1 year in patients undergoing AVR: notably, sutureless valves were associated with a higher incidence of PMI (11.3% vs. 3.6% respectively, at 1 year).6 Moreover, both a systematic review and meta-analysis performed in Western countries showed an unfavorable trend in PMI in patients undergoing sutureless valve replacement.7,8
Greason et al cautioned that PMI after AVR is associated with an increased risk of long-term mortality. Hence, the rate of PMI after AVR should be considered in new valve replacement paradigms, especially in younger and lower-risk patients.9 Therefore, the requirement for postoperative PMI is a major concern in sutureless valve implantation, particularly considering the smaller body size of Asian patients. If PMI in sutureless valve replacement occurs, the value of this approach is markedly reduced and not comparable to that of TAVR. Moreover, there is a clinical question raised regarding the usage of bulky valves in patients with smaller body sizes.
In this issue of the Journal, Kim et al10 attempt to address this question, with regard to reducing the incidence of PMI in consecutive Korean patients. Firstly, they demonstrate excellent short- and mid-term outcomes in 121 patients. Secondly, they modified the depth of the guiding suture placement (1 mm below the nadir of the annulus); this modification led to a marked reduction in the rate of PMI from 9.9% to 2.5% and did not result in paravalvular leakage. Shallow implantation of 1 mm provides the maximum implantation depth according to the size of the valve: 4.9 mm (S) valve, 5.2 mm (M), 5.5 mm (L), and 5.8 mm (XL). Of note, the reduction of conduction disturbance depends on the anatomy of the individual conduction system and the approach used for the decalcification/debridement of the aortic anulus. However, the investigators eventually demonstrate an acceptable incidence of PMI comparable to that associated with conventional bioprosthesis in Korean patients with small body size (mean body surface area: 1.63±0.19 m2).9 Furthermore, the researchers demonstrate excellent hemodynamic performance with a sufficient effective orifice area of 1.87 cm2/m2 at discharge without severe patient-prosthesis mismatch and significant reduction of the left ventricular mass index at the last follow-up. Multivariable analysis revealed that the presence of preoperative right bundle branch block and age >80 years were independent risk factors for postoperative PMI. Use of the new guiding suture technique was not a risk reduction factor. However, further large-scale studies are warranted to assess the efficacy of shallow implantation under proper selection of valve size.
Finally, all previous studies investigating sutureless valve replacement have shown that this method leads to shorter cardiopulmonary bypass and myocardial ischemic times.6–8 The reduced surgical invasiveness linked to this method may result in a lower incidence of postoperative atrial fibrillation and major cardiac and cerebrovascular adverse events, as well as better long-term patient survival. The current available evidence indicates sutureless valve replacement is practically feasible in Asian patients.
(1) Edwards Life Science, (2) Senko Medical Instrument Mfg. Co. Ltd.
K.O. is a member of Circulation Journal’s Editorial Team.
