Short summary

Aortic root disease is a condition, which is mainly treated surgically with aortic root replacement. Our primary outcome is to determine short- and longterm mortality and risk of re-operation, major adverse cardiac and cerebrovascular events (MACCE), acute kidney injury, and bleeding in patients, who are treated surgically for aortic root disease with valve-sparing aortic root replacement or composit root replacement (i.e. graft with an integrated mechanical or biological prosthetic valve).

Rationale

The incidence of thoracic aortic diseases (TAD) is generally increasing, and a Swedish study has reported an increase of 52% in men and 28% in women from 1987-2002. Aortic root disease (ARD) is a subgroup of TAD, which often manifest as dilatations of the aortic root with aortic regurgitation (AR) or as type A aortic dissections. ARDs have proven to be significantly malignant compared to the other subgroups of TADs. The Bentall procedure with its modification is the golden standard for treatment of ARD with associated AR and valve diseases (VD), which has demonstrated great short- and longterm outcomes. Aortic valve-sparing root replacement (AVSRR) procedures was later proposed by Yacoub et al. and David as alternative procedures in cases of ARD with morphologically normal valve leaflets. The Yacoub and David procedures preserve the root anatomy through remodeling and reimplantation, respectively, which maintain the true anatomical geometry of the leaflets, annulus, and sinuses of Valsava. Thus, physiological root hemodynamics with appropriate eddy currents is maintained.

The clinical advantage of AVSRR is the drawback of lifelong anticoagulation. Anticoagulation poses a significant risk of long-term stroke-related complications, which has been reported to be 12.9% within 7 years after Bentall-procedures with mechanical AVR. On the other hand, risk of reoperation after AVSRR due to limited durability of the spared valve has remained a major concern, although the risk of reoperation is low and can be carried out with excellent results regardless of the setting.

The indication for surgery with AVSRR is based on class I-evidence in patients with pliable non-calcified bicuspid/tricuspid aortic valve, irrespective of the severity of AR. This guideline-recommendation is limited to young patients and patients with Marfan Syndrome. Studies have since demonstrated, that AVSRR is safe and applicable in different age groups and settings with various etiologies of ARD and grades of AR. These studies have demonstrated excellent short-term and long-term outcomes concerning reoperation, all-cause mortality, and long-term major adverse cardiac and cerebrovascular events (MACCE).

Ongoing evaluation of surgical performance and clinical outcomes is therefore crucial and has contributed to transcend the barriers of surgery in cases, where surgery would be excluded earlier. AVSRR-procedures are therefore developed continuously with new techniques and supplementary imaging. The resulting advancements have improved patient-tailored surgical planning according to the functional anatomy of the ARD and AR. However, no definitive recommendations in favor of either proce-dure exists, mostly due to lack of high-quality clinical research from standardized data. Collection and evaluation of standardized patient- and procedure-related data is therefore needed to contribute to a better understanding of clinical outcomes after AVSRR.

The present guidelines recommend, that the choice of AVSRR in favour of other surgical modalities should be based upon the surgeon's experience, the patient's preferences, and careful preoperative assessment of the patient's anatomy and risk factors. Based on these statements, we aim to evaluate short-term and long-term outcomes of patients, who has undergone surgery for AVSRR at the departments of cardiothoracic surgery in Denmark between 2010-2022.

Description of the cohort

A population-based multicentre retrospective cohort study analysis including all patients of all ages, who underwent AVSRR in Denmark based on data from 2010 to 2022

Data and biological material

The data will be obtained in 2022 from The Western Danish Heart Registry (WDHR), The Danish Heart Registry (DHR), The National Danish Patient Registry, and the Program of clinical quality development of the Danish Regions. WDHR is a multi-centre prospective registry and is the most comprehensive registry regarding AVSRR in Denmark. DHR is the only database, which contains data from patients, who has undergone surgery at Copenhagen University Hospital.