Catheter versus surgical approach for the management of concomitant aortic stenosis and coronary artery disease: An inverse probability treatment weighting analysis.

BACKGROUND: Two therapeutic strategies are available when aortic stenosis and coronary artery disease coexist: a transcatheter approach, with percutaneous coronary intervention followed by transcatheter aortic valve replacement; and a surgical approach, consisting of surgical aortic valve replacement combined with coronary artery bypass graft. AIM: We sought to compare the outcomes of these two strategies. METHODS: The study population consisted of 241 patients who benefited from aortic valve replacement and coronary revascularization (transcatheter, n=150; surgery, n=91). RESULTS: Patients in the transcatheter population were older (83.5 vs. 71.8years; P<0.001) and had a higher Logistic EuroSCORE (11.1% vs. 5.7%; P<0.001). At 30days postprocedure, patients who had surgery exhibited more life-threatening bleedings (12.1% vs 4.5%; P=0.034), acute kidney injury (12.1% vs. 1.3%; P<0.001) and atrial fibrillation (55.6% vs. 8.7%; P<0.001). After a median follow-up of 27months, the risk of major adverse cardiovascular or cerebrovascular events did not differ significantly between the two strategies (hazard ratio [HR] 1.41, 95% confidence interval [CI] 0.97-2.04; P=0.07), whereas estimated glomerular filtration rate<60mL/min (HR 2.22, 95% CI 1.58-3.12; P<0.001), peripheral artery disease (HR 2.00, 95% CI 1.37-2.91; P<0.001) and left ventricular ejection fraction<50% (HR 1.69, 95% CI 1.12-2.55; P=0.012) were associated with a negative prognosis. CONCLUSIONS: In our study, patients with aortic stenosis and coronary artery disease treated by catheter were older and had a higher co-morbidity burden than those treated by surgery. The surgical strategy was associated with a higher rate of 30-day complications, but long-term outcomes were similar between the two strategies.

Postoperative Quality of Life After Full-sternotomy and Ministernotomy Aortic Valve Replacement.

BACKGROUND: Few longitudinal data exist comparing quality of life (QoL) after full sternotomy (fs) aortic valve replacement (AVR) (fsAVR) with ministernotomy AVR (msAVR). METHODS: A total of 1844 consecutive patients undergoing AVR who were prospectively enrolled in a European multicenter registry were dichotomized according to surgical access. Nonparsimonious propensity score matching selected 187 pairs of patients who underwent fsAVR or msAVR with comparable baseline characteristics. Hospital outcome was compared in the 2 groups. QoL was assessed with the Short Form-36, further detailed in its Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. QoL was investigated at hospital admission, at discharge, and at 1 month, 6 months, and 1 year thereafter. RESULTS: There were 1654 patients undergoing fsAVR and 190 undergoing msAVR in the entire population. The fsAVR group showed a worse preoperative risk profile, a longer intensive care unit length of stay (59.7 hours vs 38.8 hours; p = .002), and a higher rate of life-threatening or disabling bleeding (4.1% vs 0%; P = .011); the msAVR group had a higher rate of early reintervention for failed index intervention (2.1% vs 0.5%; P = .001). QoL investigations showed better PCS and MCS at 1 month after fsAVR, but no temporal trend differences (PCS group-time P = .202; MCS group-time P = .141). Propensity-matched pairs showed comparable baseline characteristics and hospital outcomes (P = not significant for all end points) and comparable improvements of PCS and MCS over time, but no between-group differences over time (PCS group time P = .834; MCS group time P = .737). CONCLUSIONS: Patients with similar baseline profiles report comparable hospital outcomes and comparable improvements of physical and mental health, up to 1 year after surgery, with both fsAVR and msAVR. As for QoL, ministernotomy does not seem to offer any advantage compared with the traditional approach.

Transfemoral versus transcarotid access for transcatheter aortic valve replacement.

Objectives: To compare the outcomes after transcatheter aortic valve replacement (TAVR) through a transfemoral (TF) and transcarotid (TC) access at our institution. Methods: From January 2014 to January 2020, 62 TC-TAVR and 449 TF-TAVR were performed using 2 prosthesis devices (Edwards SAPIEN 3, n = 369; Medtronic Evolut R, n = 142). Propensity score matching was used to adjust for imbalance in the baseline characteristics of the study groups. Results: Propensity score matching provided 62 matched pairs with comparable operative risk (mean European System for Cardiac Operative Risk Evaluation II, TC-TAVR 7.6% vs TF-TAVR 6.6%, P = .17). Thirty-day mortality (4.8% vs 3.2%, P = 1.00) and 2-year mortality (11.3% vs 12.9%, P = .64) after TC-TAVR were comparable with TF-TAVR. Strokes were numerically more frequent after TC-TAVR compared with TF-TAVR (3.2% vs 0%, P = .23), but the difference did not reach statistical significance. TF-TAVR was associated with a significantly greater risk of permanent pacemaker implantation (29.0% vs 12.9%, P = .04) compared with TC-TAVR. Other complications were not frequent and were similarly distributed between the matched groups. Conclusions: TC access for TAVR was associated with satisfactory results compared to the femoral access. TC-TAVR could be considered a valid and safe alternative to TF-TAVR when femoral access is contraindicated.

Extracorporeal Membrane Oxygenation for Respiratory Failure Related to COVID-19: A Nationwide Cohort Study.

BACKGROUND: Despite expanding use, knowledge on extracorporeal membrane oxygenation support during the COVID-19 pandemic remains limited. The objective was to report characteristics, management, and outcomes of patients receiving extracorporeal membrane oxygenation with a diagnosis of COVID-19 in France and to identify pre-extracorporeal membrane oxygenation factors associated with in-hospital mortality. A hypothesis of similar mortality rates and risk factors for COVID-19 and non-COVID-19 patients on venovenous extracorporeal membrane oxygenation was made. METHODS: The Extracorporeal Membrane Oxygenation for Respiratory Failure and/or Heart failure related to Severe Acute Respiratory Syndrome-Coronavirus 2 (ECMOSARS) registry included COVID-19 patients supported by extracorporeal membrane oxygenation in France. This study analyzed patients included in this registry up to October 25, 2020, and supported by venovenous extracorporeal membrane oxygenation for respiratory failure with a minimum follow-up of 28 days after cannulation. The primary outcome was in-hospital mortality. Risk factors for in-hospital mortality were analyzed. RESULTS: Among 494 extracorporeal membrane oxygenation patients included in the registry, 429 were initially supported by venovenous extracorporeal membrane oxygenation and followed for at least 28 days. The median (interquartile range) age was 54 yr (46 to 60 yr), and 338 of 429 (79%) were men. Management before extracorporeal membrane oxygenation cannulation included prone positioning for 411 of 429 (96%), neuromuscular blockage for 419 of 427 (98%), and NO for 161 of 401 (40%). A total of 192 of 429 (45%) patients were cannulated by a mobile extracorporeal membrane oxygenation unit. In-hospital mortality was 219 of 429 (51%), with a median follow-up of 49 days (33 to 70 days). Among pre-extracorporeal membrane oxygenation modifiable exposure variables, neuromuscular blockage use (hazard ratio, 0.286; 95% CI, 0.101 to 0.81) and duration of ventilation (more than 7 days compared to less than 2 days; hazard ratio, 1.74; 95% CI, 1.07 to 2.83) were independently associated with in-hospital mortality. Both age (per 10-yr increase; hazard ratio, 1.27; 95% CI, 1.07 to 1.50) and total bilirubin at cannulation (6.0 mg/dl or more compared to less than 1.2 mg/dl; hazard ratio, 2.65; 95% CI, 1.09 to 6.5) were confounders significantly associated with in-hospital mortality. CONCLUSIONS: In-hospital mortality was higher than recently reported, but nearly half of the patients survived. A high proportion of patients were cannulated by a mobile extracorporeal membrane oxygenation unit. Several factors associated with mortality were identified. Venovenous extracorporeal membrane oxygenation support should be considered early within the first week of mechanical ventilation initiation.

Radiation Exposure During Transcatheter Aortic Valve Replacement: Impact of Arterial Approach and Prosthesis Type.

BACKGROUND: The impact of novel alternative access and valve type on radiation exposure during transcatheter aortic valve replacement (TAVR) has not yet been evaluated. This study sought to determine the impact of a transarterial approach and prosthesis type on physician and patient exposure to radiation during TAVR. METHODS: This was a prospective study including 140 consecutive patients undergoing TAVR by transfemoral (n = 102) or transcarotid (TC) (n = 38) access at 2 centers. Implanted valves were the self-expanding Evolut R/PRO system (Medtronic, Minneapolis, MN; n = 38) and the balloon-expandable SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA; n = 102). The primary endpoint was first operator radiation exposure. The secondary endpoint was patient radiation exposure. RESULTS: First operator radiation exposure was 4-fold greater during TC TAVR (P < .001). The use of a self-expanding valve was associated with a longer x-ray time (P = .015) and a 2-fold greater first operator radiation dose (P = .018). Patient radiation dose was not significantly affected by arterial approach (P = .055) or valve type (P = .095). After adjustment for potential confounders, the TC approach remained associated with a 174.8% (95% confidence interval, 80.6-318.3, P < .001) increase in first operator radiation dose, whereas the use of a self-expanding valve no longer influenced the first operator dose (P = .630). CONCLUSIONS: TC access and the use of a self-expanding valve were associated with a 4- and 2-fold greater first operator radiation exposure during TAVR procedures, respectively. Unlike the arterial approach, the effect of bioprosthesis type on radiation exposure was mainly related to x-ray time and was no longer significant after adjustment.

Obesity and Preoperative Anaemia as Independent Risk Factors for Sternal Wound Infection After Coronary Artery Bypass Graft Surgery with Pedicled (Non-Skeletonized) Internal Mammary Arteries: The Role of Thoracic Wall Ischemia?

PURPOSE: Obesity remains statistically associated with coronary artery disease, for which coronary artery bypass graft surgery (CABG) remains the standard of care. However, obesity is also associated with sternal wound infection (SWI) which is a severe complication of CABG despite advances in surgery and in infection prevention and control. Strategies to reduce the incidence of SWI are still being investigated, and we therefore conducted a retrospective study to revisit factors other than obesity associated with SWI after CABG. PATIENTS AND METHODS: Data were extracted from the medical records of 182 patients who underwent elective on-pump CABG using one or both pedicled internal mammary artery grafts in Reims University Hospital between May 2015 and May 2016. All preoperative or perioperative variables with a p value<0.10 in univariate analysis were entered into a stepwise logistic regression model. RESULTS: Among the 182 patients (145 male (79.6%), median age 68.0 [45.0-87.0] years), 138 (75.8%) underwent CABG using bilateral internal mammary artery grafts. Median BMI was 27.7 [18.7-50.5] kg/m2, and there were 51 (28.0%) and 79 (43.4%) patients with obesity and overweight, respectively. Twenty-three out of the 182 patients (12.6%) developed SWI. In-hospital mortality was not statistically different between patients with and without SWI but the median length of stay was (6.0 [2.0-38.0] versus 5.0[3.0-21.0] days in the intensive care unit, p=0.03, and 26.0 [9.0-134.0] versus 9.0 [7.0-51.0] days in hospital, p<0.0001). Obesity and preoperative anaemia were independently associated with SWI, as was the number of red blood cell (RBC) units transfused (OR 14.61 [2.64-80.75], OR 4.64 [1.61-13.34] and OR 1.27 [1.02-1.58], respectively). CONCLUSION: The independent association of SWI with the number of RBC units transfused and the existence of preoperative anaemia and obesity suggests a mechanism of thoracic wall ischemia in SWI after CABG, thus leaving insufficient perfusion of the thoracic wall in patients with obesity. Medical strategies are warranted to try to prevent this costly complication.

The frozen elephant trunk technique in an emergency: THORAFLEX French National Registry offers new insights.

OBJECTIVES: Our goal was to study the immediate outcome after an emergency frozen elephant trunk procedure with a Thoraflex™ Hybrid prosthesis (THP) in patients included in the EPI-Flex national registry and operated on in 21 French centres. METHODS: All patients operated on in France between April 2016 and April 2019 for acute aortic syndromes and who had an frozen elephant trunk procedure with a THP were included in the study. The main end point was in-hospital mortality. The secondary end point was neuromorbidity, including paraplegia. The evolution of the main end point was monitored using a variable life-adjusted display graph with cumulative sum derivatives in order to stop inclusions in case the observed mortality became out of range compared to an expected mortality between 15% and 20%. RESULTS: Enrolment ended on the scheduled date and included 109 patients. Most cases (54%) were performed at 3 centres, where more than 10 THP each were implanted (10-26). The observed mortality in the large-volume centres (22%) was comparable to that observed in the low-volume centres (20%). The individually risk-adjusted cumulative sum revealed that observed in-hospital mortality was statistically in line with that predicted by the log EuroSCORE. Analysis of the secondary end point revealed 8% cases of paraplegia, all of which appeared after treatment of the thoracic type A aortic dissection. CONCLUSIONS: In France, THP for emergency frozen elephant trunk surgery outside high-volume centres did not result in excessive in-hospital deaths. However, a word of caution must be expressed regarding the prevention of medullar ischaemia even in emergency aortic surgery.

Aortic Valve Replacement for Aortic Stenosis in Low-, Intermediate-, and High-Risk Patients: Preliminary Results From a Prospective Multicenter Registry.

OBJECTIVE: To evaluate current results of surgical aortic valve replacement (SAVR) ± coronary artery bypass grafting surgery. DESIGN: Independent, multicenter, prospective registry. SETTING: Tertiary university hospitals. PARTICIPANTS: The study comprised 1,192 consecutive patients, stratified as low-, intermediate-, and high-risk according to EuroSCORE II (<4, 4-9, >9, respectively). INTERVENTIONS: SAVR ± coronary artery bypass grafting surgery. MEASUREMENTS AND MAIN RESULTS: Thirty-day mortality and major morbidity, 2-year actuarial survival and freedom from stroke, and independent predictors of mortality in each risk category were assessed. These data were considered in light of published randomized controlled trials. Thirty-day mortality was 1.0%, 3.0% and 2.1% in the low-, intermediate-, and high-risk patients, with a 2-year actuarial survival of 98.6%, 93.8%, and 94.0%, respectively. Preoperative atrial fibrillation (odds ratio [OR] 8.3), minithoracotomy access (OR 5.8), postoperative dialysis (OR 3.4), type V acute myocardial infarction (OR 20.4), and moderate aortic regurgitation (OR 28.8) predicted 30-day mortality in the low-risk group. Preoperative dialysis (OR 18.3), critical state (OR 36.7), postoperative transfusions of plasma (OR 1.9 per unit transfused), and de-novo dialysis (OR 6.2) predicted 30-day mortality in the intermediate-risk group. Prior cardiac surgery (OR 18.1), postoperative extracorporeal membrane oxygenation (OR 9.8), and gastrointestinal complications (OR 17.2) predicted 30-day mortality in the high-risk group. Although baseline differences existed, low-risk patients demonstrated low 30-day mortality and 30-day to 12-month stroke in light of the PARTNER 3 and EVOLUT Low Risk trial results. Intermediate-risk patients demonstrated low 30-day to 2-year mortality, when the PARTNER 2 trial was considered, and low 30-day to 2-year stroke, when the PARTNER 2 and SURTAVI trials were considered. High-risk patients showed low 30-day to 2-year mortality in light of the results of the PARTNER 1 and CoreValve US trials. CONCLUSIONS: SAVR is still a safe and effective surgery for aortic stenosis regardless of risk category.

Comparison of clinical outcomes after transcarotid and transsubclavian versus transfemoral transcatheter aortic valve implantation: A propensity-matched analysis.

BACKGROUND: Transcarotid and trans-subclavian access routes are increasingly used as alternative approaches for transcatheter aortic valve implantation (TAVI) when transfemoral access is not suitable. However, concerns remain about the risk of periprocedural stroke and long-term outcomes following transcarotid/trans-subclavian TAVI. AIMS: The present study sought to compare early and long-term outcomes of transcarotid/trans-subclavian TAVI versus transfemoral TAVI after propensity-score matching. METHODS: The 260 patients who underwent TAVI through a transfemoral (n=220), transcarotid (n=32) or trans-subclavian (n=8) approach at our institution over a 4-year period were identified. A 1:1 matching based on propensity score was performed, and led to a study population of 80 patients (40 transfemoral and 40 transcarotid/trans-subclavian). Primary endpoints were early complications; secondary endpoints were long-term outcomes. RESULTS: There were no differences in the baseline characteristics of the two groups. At 30 days after TAVI there were no significant differences between transfemoral and transcarotid/trans-subclavian TAVI in terms of death rates (5% vs 5%, respectively; P=1.00) and stroke rates (5% vs 2.5%, respectively; P=1.00). After a median follow-up of 21 months, the risk of death (P=0.95), stroke (P=0.82) and myocardial infarction (P=0.16) did not differ between the two groups. CONCLUSIONS: After propensity-score matching, no significant differences in early and long-term outcomes were observed between transfemoral and transcarotid/trans-subclavian TAVI. These findings should encourage heart teams to consider a transcarotid or trans-subclavian approach when transfemoral access is unavailable.

Abdominal aorta tortuosity on computed tomography identifies patients at risk of complications during transfemoral transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement is now indicated in patients at intermediate surgical risk and will probably soon be indicated in patients at low surgical risk, for whom the occurrence of serious procedural complications is not acceptable. AIMS: We aimed to investigate whether simple arterial variables from computed tomography scanning can predict the occurrence of severe early complications in patients undergoing transfemoral TAVR. METHODS: All patients with symptomatic severe aortic stenosis treated by transfemoral transcatheter aortic valve replacement in our centre, and for whom computed tomography images were available, were included. An exhaustive analysis of preprocedural computed tomography scans was performed retrospectively, in search of arterial tortuosity and vascular calcifications. The primary endpoint was a composite 30-day safety endpoint. RESULTS: Overall, 175 patients were included. The primary endpoint was observed in 60 patients (35%). Abdominal aorta tortuosity was identified in 28 patients (16%) and was strongly associated with the occurrence of a complication (adjusted odds ratio 2.7, 95% confidence interval 1.1-6.6; P=0.03). There was no significant association between iliofemoral tortuosity or vascular calcification and the occurrence of complications. CONCLUSIONS: A tortuous abdominal aorta was found to be a predictor of the occurrence of a complication in patients undergoing transfemoral transcatheter aortic valve replacement. This computed tomography variable should therefore be taken into account when choosing the approach, especially for patients at intermediate and low surgical risk.

Negative Pressure versus Conventional Sternal Wound Dressing in Coronary Surgery Using Bilateral Internal Mammary Artery Grafts.

BACKGROUND: Sternal wound infection (SWI) is a major complication occurring often after coronary artery bypass grafting (CABG) using bilateral internal mammary artery (BIMA) grafts. The aim of this study is to assess whether such a risk may be reduced by using incision negative pressure wound therapy (INPWT). METHODS: Data on patients undergoing isolated CABG using BIMA grafts at the Reims University Hospital, France, from 2013 to 2016 without or with INPWT was prospectively collected.  Results: INPWT was used in 161 patients and conventional sterile wound dressing was used in 266 patients. Propensity score matching resulted in 128 pairs with similar characteristics. SWIs were similarly distributed between the conventional sterile wound dressing (10.9%) and the INPWT cohorts (10.2%) (P = 1.00). Patients treated with INPWT had a lower rate of deep SWI/mediastinitis than patients who had conventional sterile dressing (5.5% versus 10.2%, P = .210), but the difference did not reach statistical significance. Tests for interaction confirmed these findings in different patient subgroups. CONCLUSION: The routine use of INPWT may not significantly reduce the risk of SWI in patients undergoing BIMA grafting. In view of previous reports showing a benefit with the use of this method, a large randomized study is justified to assess the efficacy of INPWT in patients undergoing cardiac surgery.

Transcarotid Approach for Transcatheter Aortic Valve Replacement With the Sapien 3 Prosthesis: A Multicenter French Registry.

OBJECTIVES: This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device. BACKGROUND: The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device. METHODS: The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2). RESULTS: A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%. CONCLUSIONS: TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.

Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves.

BACKGROUND: Aortic valve replacement (AVR) in small aortic roots remains a surgical dilemma with a higher risk of patient-prosthesis mismatch (PPM). The Perimount Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We examined the early hemodynamic performance, the mid-term outcomes of the PMEAV, and the impact of PPM on outcome and functional class. METHODS: We performed a retrospective analysis of prospectively collected in-hospital data, and a prospective single-center follow-up of 849 patients who received a 19 to 23 mm PMEAV (2008-2014). Concomitant mitral or tricuspid replacement was the exclusion criterion. Early hemodynamic features were prospectively collected; mid-term follow-up was conducted according to current guidelines. RESULTS: Size of implanted prosthesis was 19 mm in 11.5% of patients, 21 mm in 36.9%, and 23 mm in 51.5%. Operative mortality was 4.5% (3.1% for isolated AVR). The rate of severe and moderate PPMs was significantly higher in the 19 mm group. Follow-up was 99.9% complete (3.7 ± 2 years). Actuarial freedom from structural valve deterioration (SVD) at 5 years was 99.1%. At stratified Kaplan-Meier's analysis, PPM and age <70 years were associated with SVD. PPM was not associated with worse functional status (New York Heart Association class) or mortality at follow-up. CONCLUSION: This series shows satisfactory clinical outcomes of the PMEAV implanted in small aortic annuli at mid-term follow-up. Although PPM may occur in smaller sizes, it has limited clinical impact, and it is not associated with mid-term mortality or worse functional class. Few SVD events are evidenced; nonetheless, limited follow-up duration and its methodology need to be considered.

Decision support system for the planning of minimally invasive aortic valve replacement surgery.

PURPOSE: Minimally invasive aortic valve replacement (MIAVR) procedures remain more complex and technically challenging compared to conventional full sternotomy surgery. This technique involves a restricted surgical field and a limited workspace, which is, at present, strictly reserved for the most experienced surgeons. The MIAVR clinical outcomes are strongly dependent on the appropriate choice of the thoracic incision. This work presents a decision support system to optimize, through an interactive visualization interface, the exposure of the target structure in a limited field of view. METHODS: Our approach is based on the computation of relevant anatomical measurements from preoperative CT images, and it takes into account the surgical guidelines in order to propose the surgical access that best fits the patient's morphology. RESULTS: The proposed planning system was applied and tested on 30 datasets from patients affected by severe aortic stenosis for validation purposes. We evaluated the accuracy of the automatic detections and the measurements calculated by the system with those chosen manually by the expert. CONCLUSIONS: In 87% of thirty cases, the surgical strategy proposed by the decision support system was correct. For the remaining cases, the graphical user interface (GUI) allowed the user to manually adjust the anatomical features.

Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).

INTRODUCTION: Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both 'sutured' and 'sutureless' valves) will provide a 'real-world' picture of available results of current surgical options and will help to clarify the 'grey zones' of current guidelines. METHODS AND ANALYSIS: European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing 'early' 30-day all-cause and cardiovascular mortality, as well as major morbidity, and 'late' cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results. ETHICS AND DISSEMINATION: The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship. TRIAL REGISTRATION NUMBER: NCT03143361; Pre-results.

Long-term follow-up of bioprosthetic aortic valve replacement in patients aged ≤60 years.

OBJECTIVE: To address the long-term durability of bioprostheses used for aortic valve replacement (AVR) in adult patients aged ≤60 years at the time of surgery. METHODS: Through a retrospective review of a prospectively collected database, we identified 416 bioprosthetic AVRs performed between 1977 and 2013. A prospective follow-up of valve-related and non-valve-related events was performed. RESULTS: Follow-up was 98.5% complete (2423.1 patient-years; average, 6 ± 5.5 years). At 15 years, overall survival was 62.1 ± 4.4%; freedom from valve-related death was 97.1 ± 1.6%. There were 68 SVD events (11.9 ± 28.8 years after surgery). Freedom from SVD at 15 years was 48.7 ± 5.5% for Kaplan-Meier analysis and 61.4 ± 4.3% for competing-risks analysis. After stratification into age subgroups (<40 years, ≥40 and <50 years, and ≥50 and ≤60 years), we observed no significant difference in freedom from SVD (P = .50). The average delay to SVD was not statistically different among subgroups (P = .30). There were 57 reoperations for SVD (11.8 ± 5.2 years after implantation). The 15 year freedom from reoperation for SVD was 55.4 ± 5.6% by Kaplan-Meier analysis and 67.1 ± 4.2% by competing-risks analysis. After stratification by age, freedom from reoperation for SVD was comparable (P = .13). Freedom from any valve-related complication or death was 42 ± 5% by Kaplan-Meier analysis and 54.4 ± 4.1% by competing-risks analysis. CONCLUSIONS: The lifetime risk of SVD is considerable in patients aged ≤60 years at the time of bioprosthesis implantation. Nonetheless, durability remains consistent during the first decade; additional data are required for the second decade. Patients' information is pivotal for valve choice (competing-risks method).

Elective frozen elephant trunk procedure using the E-Vita Open Plus prosthesis in 94 patients: a multicentre French registry.

OBJECTIVES: Our goal was to evaluate the operative outcomes of the frozen elephant trunk technique using the E-Vita Open Plus® hybrid prosthesis in chronic aortic arch diseases and report clinical and radiological outcomes at the 1-year follow-up. METHODS: As determined from a prospective multicentre registry, 94 patients underwent frozen elephant trunk procedures using the E-Vita Open Plus hybrid device for the treatment of chronic aortic conditions, including 50% chronic aortic dissections, 40% degenerative aneurysms and 10% miscellaneous indications. Fifty percent of the cases were reoperations. RESULTS: The perioperative mortality rate was 11.7%. Spinal cord ischaemia and stroke rates were 4% and 9.6%, respectively. The mean cardiopulmonary bypass time was 252 ± 97 min, cardiac ischaemia time was 152 ± 53 min and cerebral perfusion time was 82 ± 22 min. Concomitant procedures were observed in 15% of patients. Among the 83 surviving patients, the survival rate after the 1-year follow-up was 98%. Eleven percent of patients underwent endovascular completion, whereas 4% of patients required aortic reintervention at 1 year. CONCLUSIONS: The E-Vita Open Plus hybrid device confirms the favourable short- and mid-term outcomes offered by its predecessor in frozen elephant trunk procedures in patients with chronic aortic arch disease. Implantation of the E-Vita Open Plus is associated with good 1-year survival rates, good rates of favourable aortic remodelling in both chronic dissection and degenerative aneurysms and a reproducible technique in a multicentre registry. Continued follow-up is required due to the risk of evolution at the downstream aorta.