Late clinical and echocardiographic results with the Magna Ease© pericardial aortic bioprosthesis.

OBJECTIVES: The population of candidates to surgical aortic valve replacement (SAVR) is evolving. The Perimount Magna Ease© bioprosthesis has been introduced relatively recently in the practice. We aimed at evaluating its long-term results. METHODS: This article describes a single-centre cohort of 1016 consecutive SAVRs with the Magna Ease© valve (2008-2014), consisting of an all-comers population. We performed a prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Valve-related events were as follows: structural valve deterioration (SVD; according to modified definition criteria), nonstructural valve dysfunction, patient-prosthesis mismatch (PPM). RESULTS: Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. A total of 974 patients entered the follow-up; 564 were alive at the last follow-up (median duration: 9.8 years) (up to 13.4 years). New York Heart Association class was I or II in 92.1%. Overall survival at 10 years was 56.8 ± 1.8%. Freedom from SVD at 10 was 96.5 ± 0.8% (Kaplan-Meier) and 97.4 ± 0.6% (competing risks) (28 SVD events after 6.9 ± 3.3 years). There were 15 reinterventions for SVD (redo-SAVR and Transcatheter Aortic Valve Implantation (TAVI)); 10-year freedom from reintervention was 97.8 ± 0.6%. Moderate and severe PPM occurred in 26.8% and 5.4%, respectively, without association with late mortality (P = 0.12 for moderate and P = 0.70 for severe PPM). Freedom from valve-related mortality was 97.8 ± 0.5% at 10 years. CONCLUSIONS: In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-day outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy >10-12 years.

Assessment of Thoracic Endovascular Aortic Repair Using Relay Proximal Scallop: Results of a French Prospective Multicentre Study.

OBJECTIVE: A proximal scallop design allows aortic arch repair without complex endovascular manipulation in the aortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. METHODS: A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. RESULTS: Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. CONCLUSION: One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.

Porcine bioprostheses for surgical aortic valve replacement: very long-term performance of a third-generation device.

AIMS: We aimed at investigating the long-term durability of the Epic bioprosthesis for surgical aortic valve replacement (SAVR) in a single-centre series of 888 implantations (2001-2018), expanding previous evaluations with shorter follow-up. METHODS: We retrieved prospectively collected in-hospital data and performed a systematic follow-up focusing on valve-related events (SVD, structural valve deterioration; PPM, patient-prosthesis mismatch; reoperation) (competing risks, CIF and Kaplan--Meier methods). We distinguished between SVD (permanent changes in valve function due to evolutive structural deterioration, ≥10 mmHg average gradient vs. reference echocardiography) and PPM. RESULTS: Average age at SAVR was 75.4 ±â€Š7 years; 855 (96.3%) bioprostheses entered the follow-up and 396 (46.4%) were alive at last assessment. Follow-up was 99.9% complete, median duration was 7.7 years (entire cohort) and 9.9 years (survivors). At 10 years, overall survival was 50% ±â€Š1.9, freedom from SVD was 99.4% ±â€Š0.3 (competing risks) (seven SVD events after 8.1 ±â€Š4.3 years). Freedom from SVD at 15 years was 98.4% ±â€Š0.8 (competing risks). Prevalence of severe PPM was higher in 19 mm (6.5%) and 21 mm (10.2%) size cohorts. PPM (severe or moderate/severe) had no significant impact on overall survival (log-rank P = 0.27 and P = 0.21, respectively). Freedom from any reintervention (reoperation or TAVI Valve-in-Valve) for SVD at 10 years was 99.4% ±â€Š0.3 (competing risks); freedom from any valve-related reintervention was 97.4% ±â€Š0.6 (competing risks). CONCLUSION: The Epic bioprosthesis for SAVR is limited by nonnegligible rates of PPM, which have nonetheless no impact on late survival. This device shows excellent durability and low rates of adverse valve-related events.

Assessment of shape-based features ability to predict the ascending aortic aneurysm growth.

The current guidelines for the ascending aortic aneurysm (AsAA) treatment recommend surgery mainly according to the maximum diameter assessment. This criterion has already proven to be often inefficient in identifying patients at high risk of aneurysm growth and rupture. In this study, we propose a method to compute a set of local shape features that, in addition to the maximum diameter D, are intended to improve the classification performances for the ascending aortic aneurysm growth risk assessment. Apart from D, these are the ratio DCR between D and the length of the ascending aorta centerline, the ratio EILR between the length of the external and the internal lines and the tortuosity T. 50 patients with two 3D acquisitions at least 6 months apart were segmented and the growth rate (GR) with the shape features related to the first exam computed. The correlation between them has been investigated. After, the dataset was divided into two classes according to the growth rate value. We used six different classifiers with input data exclusively from the first exam to predict the class to which each patient belonged. A first classification was performed using only D and a second with all the shape features together. The performances have been evaluated by computing accuracy, sensitivity, specificity, area under the receiver operating characteristic curve (AUROC) and positive (negative) likelihood ratio LHR+ (LHR-). A positive correlation was observed between growth rate and DCR (r = 0.511, p = 1.3e-4) and between GR and EILR (r = 0.472, p = 2.7e-4). Overall, the classifiers based on the four metrics outperformed the same ones based only on D. Among the diameter-based classifiers, k-nearest neighbours (KNN) reported the best accuracy (86%), sensitivity (55.6%), AUROC (0.74), LHR+ (7.62) and LHR- (0.48). Concerning the classifiers based on the four shape features, we obtained the best accuracy (94%), sensitivity (66.7%), specificity (100%), AUROC (0.94), LHR+ (+∞) and LHR- (0.33) with support vector machine (SVM). This demonstrates how automatic shape features detection combined with risk classification criteria could be crucial in planning the follow-up of patients with ascending aortic aneurysm and in predicting the possible dangerous progression of the disease.

Predictive value of the TRI-SCORE for in-hospital mortality after redo isolated tricuspid valve surgery.

OBJECTIVES: The TRI-SCORE reliably predicts in-hospital mortality after isolated tricuspid valve surgery (ITVS) on native valve but has not been tested in the setting of redo interventions. We aimed to evaluate the predictive value of the TRI-SCORE for in-hospital mortality in patients with redo ITVS and to compare its accuracy with conventional surgical risk scores. METHODS: Using a mandatory administrative database, we identified all consecutive adult patients who underwent a redo ITVS at 12 French tertiary centres between 2007 and 2017. Baseline characteristics and outcomes were collected from chart review and surgical scores were calculated. RESULTS: We identified 70 patients who underwent a redo ITVS (54±15 years, 63% female). Prior intervention was a tricuspid valve repair in 51% and a replacement in 49%, and was combined with another surgery in 41%. A tricuspid valve replacement was performed in all patients for the redo surgery. Overall, in-hospital mortality and major postoperative complication rates were 10% and 34%, respectively. The TRI-SCORE was the only surgical risk score associated with in-hospital mortality (p=0.005). The area under the receiver operating characteristic curve for the TRI-SCORE was 0.83, much higher than for the logistic EuroSCORE (0.58) or EuroSCORE II (0.61). The TRI-SCORE was also associated with major postoperative complication rates and survival free of readmissions for heart failure. CONCLUSION: Redo ITVS was rarely performed and was associated with an overall high in-hospital mortality and morbidity, but hiding important individual disparities. The TRI-SCORE accurately predicted in-hospital mortality after redo ITVS and may guide clinical decision-making process (www.tri-score.com).

Risk of Bias in Randomized Clinical Trials Comparing Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis.

Importance: Recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines highlighted some concerns about the randomized clinical trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. Quantification of these biases has not been previously performed. Objective: To assess whether randomization protects RCTs comparing TAVI and SAVR from biases other than nonrandom allocation. Data Sources: A systematic review of the literature between January 1, 2007, and June 6, 2022, on MEDLINE, Embase, and Cochrane Central Register of Controlled Trials was performed. Specialist websites were also checked for unpublished data. Study Selection: The study included RCTs with random allocation to TAVI or SAVR with a maximum 5-year follow-up. Data Extraction and Synthesis: Data extraction was performed by 2 independent investigators following the PRISMA guidelines. A random-effects meta-analysis was used for quantifying pooled rates and differential rates between treatments of deviation from random assigned treatment (DAT), loss to follow-up, and receipt of additional treatments. Main Outcomes and Measures: The primary outcomes were the proportion of DAT, loss to follow-up, and patients who were provided additional treatments and myocardial revascularization, together with their ratio between treatments. The measures were the pooled overall proportion of the primary outcomes and the risk ratio (RR) in the TAVI vs SAVR groups. Results: The search identified 8 eligible trials including 8849 participants randomly assigned to undergo TAVI (n = 4458) or SAVR (n = 4391). The pooled proportion of DAT among the sample was 4.2% (95% CI, 3.0%-5.6%), favoring TAVI (pooled RR vs SAVR, 0.16; 95% CI, 0.08-0.36; P < .001). The pooled proportion of loss to follow-up was 4.8% (95% CI, 2.7%-7.3%). Meta-regression showed a significant association between the proportion of participants lost to follow-up and follow-up time (slope, 0.042; 95% CI, 0.017-0.066; P < .001). There was an imbalance of loss to follow-up favoring TAVI (RR, 0.39; 95% CI, 0.28-0.55; P < .001). The pooled proportion of patients who had additional procedures was 10.4% (95% CI, 4.4%-18.5%): 4.6% (95% CI, 1.5%-9.3%) in the TAVI group and 16.5% (95% CI, 7.5%-28.1%) in the SAVR group (RR, 0.27; 95% CI, 0.15-0.50; P < .001). The imbalance between groups also favored TAVI for additional myocardial revascularization (RR, 0.40; 95% CI, 0.24-0.68; P < .001). Conclusions and Relevance: This study suggests that, in RCTs comparing TAVI vs SAVR, there are substantial proportions of DAT, loss to follow-up, and additional procedures together with systematic selective imbalance in the same direction characterized by significantly lower proportions of patients undergoing TAVI that might affect internal validity.

AORTLANTIC: French registry of aortic valve-sparing root replacement, preliminary multicentre results from western France.

OBJECTIVES: Aortic root aneurysms often affect younger patients in whom valve-sparing surgery is challenging. Among current techniques, aortic valve-sparing root replacement described by Tirone David has shown encouraging results. The AORTLANTIC registry was instituted for a multicentre long-term evaluation of this procedure. The current initial study evaluates the hospital outcomes of the procedure. METHODS: This is a retrospective study of patients operated between 1 January 2004 and 31 December 2020 in 6 hospitals in western France. All study data were recorded in the national digital database of the French Society of Cardiac Surgery: EPICARD. RESULTS: A total of 524 consecutive patients with a mean age of 53 (15.1) years underwent surgery. 13% (n = 68) of patients presented with acute aortic dissection, 16.5% (n = 86) had associated connective tissue pathology and 7.3% (n = 37) had bicuspid aortic valves. Preoperative aortic regurgitation (AR) ≥2/4 was present in 65.3% (n = 341) of patients. Aortic valvuloplasty was required in 18.6% (n = 95) of patients. At discharge, 92.8% (n = 461) of patients had no or 1/4 AR. The stroke rate was 1.9% (n = 10). Intra-hospital mortality was 1.9% (n = 10). CONCLUSIONS: The AORTLANTIC registry includes 6 centres in western France with >500 patients. Despite numerous complex cases (acute aortic dissections, bicuspid aortic valves, preoperative AR), aortic valve-sparing root replacement has a low intra-hospital mortality. The initial encouraging results of this multicentre study warrant further long-term evaluation by future studies.

TRI-SCORE: a new risk score for in-hospital mortality prediction after isolated tricuspid valve surgery.

AIMS: Isolated tricuspid valve surgery (ITVS) is considered to be a high-risk procedure, but in-hospital mortality is markedly variable. This study sought to develop a dedicated risk score model to predict the outcome of patients after ITVS for severe tricuspid regurgitation (TR). METHODS AND RESULTS: All consecutive adult patients who underwent ITVS for severe non-congenital TR at 12 French centres between 2007 and 2017 were included. We identified 466 patients (60 ± 16 years, 49% female, functional TR in 49%). In-hospital mortality rate was 10%. We derived and internally validated a scoring system to predict in-hospital mortality using multivariable logistic regression and bootstrapping with 1000 re-samples. The final risk score ranged from 0 to 12 points and included eight parameters: age ≥70 years, New York Heart Association Class III-IV, right-sided heart failure signs, daily dose of furosemide ≥125 mg, glomerular filtration rate <30 mL/min, elevated bilirubin, left ventricular ejection fraction <60%, and moderate/severe right ventricular dysfunction. Tricuspid regurgitation mechanism was not an independent predictor of outcome. Observed and predicted in-hospital mortality rates increased from 0% to 60% and from 1% to 65%, respectively, as the score increased from 0 up to ≥9 points. Apparent and bias-corrected areas under the receiver operating characteristic curves were 0.81 and 0.75, respectively, much higher than the logistic EuroSCORE (0.67) or EuroSCORE II (0.63). CONCLUSION: We propose TRI-SCORE as a dedicated risk score model based on eight easy to ascertain parameters to inform patients and physicians regarding the risk of ITVS and guide the clinical decision-making process of patients with severe TR, especially as transcatheter therapies are emerging (www.tri-score.com).

Durability of Mitral Valve Replacement With a Third-generation Bioprosthesis.

BACKGROUND: Our aim was to evaluate the durability of a third-generation porcine bioprosthesis (Epic porcine xenograft; Abbott Cardiovascular Inc, St Paul, MN) in the mitral position, according to patients' age at surgery. METHODS: Four hundred eighty-two mitral valve replacements using the Epic valve at a single center were included (2009-2018). Perioperative and early postoperative data were prospectively collected. A systematic follow-up was performed (99% complete, 1609.5 patient-years; average, 3.8 ± 2.5). Standardized definitions of valve-related events were adopted. Mean patient age at mitral valve replacement was 68.1 ± 10.4 years. RESULTS: Operative mortality was 9.3%. There were 5 early valve-related reoperations, mainly due to recurrent infectious endocarditis. Global survival at 8.8 years was 69.5% ± 5%. Nine structural valve deterioration (SVD) events occurred during follow-up (3 receiving reoperations, 4 transcatheter mitral valve replacement valve-in-valve, and 2 medical treatment only). The freedom from SVD at 5 and 10 years was 97.4% ± 1.2% and 89.6% ± 4.4% (actuarial) and 97.8% ± 1% and 91.9% ± 3.3%, respectively (competing risks). After stratification into subgroups by age at surgery (≤59 years, 50.8%; 60-69, 32.8%; ≥70, 16.4%) there was no significant intergroup difference in freedom from SVD (log-rank P = .24). The overall freedom from any reintervention for SVD at 10 years was 90.5% ± 4.4% (actuarial) and 92.7% ± 3.3% (competing risks), with no intergroup difference (log-rank P = .14). The freedom from any valve-related complication at 8.4 years was 83.2% ± 4.5% (actuarial). CONCLUSIONS: The Epic bioprosthesis shows good durability at 5 to 10 years in the mitral position.

A rare case of Neuhauser syndrome associated with a Kommerell diverticulum.

Neuhauser syndrome is a rare vascular anomaly characterized by the esophagus and trachea circling via the ligamentum arteriosum and right aortic arch. Kommerell's diverticulum have the same characteristic by an outpouch at the onset of an aberrant left subclavian artery worsening this compression. The association between these pathologies is very rare and the operative strategy is unclear. We describe a case with the association with a computed tomography scanner aortic reconstruction and a repair's operative strategy.

Does Hypothermic Circulatory Arrest for Aortic Surgery Trigger Near-Death Experience? Incidence of Near-Death Experiences after Aortic Surgeries Performed under Hypothermic Circulatory Arrest.

BACKGROUND: Understanding near-death experiences (NDE) could provide a new insight into the analysis of human consciousness and the neurocognitive processes happening upon the approach of death. With a temporary interruption of systemic perfusion, aortic surgery under hypothermic circulatory arrest (HCA) may be the only available model of reversible clinical death. We present, herein, the results of an observational study designed to assess the incidence of NDE after aortic surgery. METHODS: We performed a prospective study including consecutive patients who underwent thoracic aortic surgery between July 2018 and September 2019 at our institution. Procedures without HCA were included to constitute a control group. The primary outcome was the incidence of NDE assessed with the Greyson NDE scale during the immediate postoperative course, via a standardized interview of the patients in the surgical ward. RESULTS: One hundred and one patients were included. Twenty-one patients (20.8%) underwent nonelective interventions for aortic dissection. Ninety-one patients had hemiarch replacement (90.1%). Sixty-seven (66.3%) interventions were performed with HCA, with an average circulatory arrest duration of 26.9 ± 25.5 minutes, and a mean body temperature of 23.7 ± 3.8°C. None of the patients reported any recollection from their period of unconsciousness. There was no NDE experiencer in the study cohort. CONCLUSION: Several confounding factors regarding anesthesia, or NDE evaluation, might have impaired the chance of NDE recollections, and might have contributed to this negative result. Whether HCA may trigger NDE remains unknown.

Early and long-term results of hypothermic circulatory arrest in aortic surgery: a 20-year single-centre experience.

AIMS: The aim of this study was to document the postoperative outcomes of patients who underwent hypothermic circulatory arrest (HCA), the evolution of HCA management over time and to identify the risks factor for early mortality and postoperative stroke. METHODS: Four hundred and twenty-four patients who underwent aortic surgery with HCA at our institution between January 1995 and June 2016 were consecutively included. RESULTS: The main indications were degenerative aneurysm (254; 59.9%) and acute type A aortic dissection (146; 34.4%). Interventions were performed under deep (18.4 ±â€Š0.9°C; n = 350; 82.5%) or moderate (23.9 ±â€Š1.9°C; n = 74; 17.5%) hypothermia. Antegrade cerebral perfusion (ACP) was employed in 86 (20.3%) cases. The use of moderate hypothermia significantly increased from 2011, to become the preferred strategy in 2016. The in-hospital mortality was 12.5% and the postoperative stroke rate was 7.1%. Kaplan--Meier 5-year survival was 65.7%. Nonelective timing [odds ratio (OR) 4.05; P < 0.001], stroke (OR 3.77' P = 0.032), renal failure (OR 2.49; P = 0.023), redo surgery (2.42; P = 0.049) and CPB time (OR 1.05; P = 0.03) were independent risk factors for in-hospital mortality in multivariate analysis. Femoral cannulation was the only independent risk factor for stroke (OR 3.97; P = 0.002). The level of hypothermia and the use of ACP were not associated with either in-hospital mortality or postoperative stroke. CONCLUSION: HCA might be widely considered to achieve a radical treatment of the aortic disease, provided that hypothermia is maintained below the 24°C safety threshold and ACP is used for HCA exceeding 30 min, to ensure optimal brain, spinal cord and visceral organs protection.

Adult cardiac surgery during COVID-19 lockdown: Impact on activity and outcomes in a high-volume centre.

BACKGROUND: The coronavirus disease 2019 (COVID-19) outbreak had a direct impact on adult cardiac surgery activity, which systematically necessitates a postoperative stay in intensive care. AIM: To study the effect of the COVID-19 lockdown on cardiac surgery activity and outcomes, by making a comparison with the corresponding period in 2019. METHODS: This prospective observational cohort study compared adult cardiac surgery activity in our high-volume referral university hospital from 9 March to 10 May 2020 versus 9 March to 10 May 2019. Data were collected in our local certified database and a national database sponsored by the French society of thoracic and cardiovascular surgery. The primary study endpoints were operative mortality and postoperative complications. RESULTS: With 105 interventions in 2020, our activity dropped by 57% compared with the same period in 2019. Patients were at higher risk, with a significantly higher EuroSCORE II score (3.8±4.5% vs. 2.0±1.8%; P<0.001) and higher rates of active endocarditis (7.6% vs. 2.9%; P=0.047) and recent myocardial infarction (9.5% vs. 0%; P<0.001). The weight and priority of the interventions were significantly different in 2020 (P=0.019 and P<0.001, respectively). The rate of acute aortic syndromes was also significantly higher in 2020 (P<0.001). Operative mortality was higher during the lockdown period (5.7% vs. 1.7%; P=0.038). The postoperative course was more complicated in 2020, with more postoperative bleeding (P=0.003), mechanical circulatory support (P=0.032) and prolonged mechanical ventilation (P=0.005). Only two patients (1.8%) developed a positive status for severe acute respiratory syndrome coronavirus 2 after discharge. CONCLUSIONS: Adult cardiac surgery was heavily affected by the COVID-19 lockdown. A further modulation plan is necessary to improve outcomes and reduce postponed operations to decrease operative mortality and morbidity.

Endovascular Repair of a Dacron Pseudoaneurysm in an Ascending-to-Descending Aortic Bypass.

In the setting of postcoarctation aortic repair, Dacron graft dilatation and late aneurysms are not uncommon. Reintervention usually involves redo open surgery and replacement of the aneurysmal graft or the pseudoaneurysmal suture line. The present case describes the endovascular repair of a Dacron anastomotic false aneurysm in an extra-anatomic ascending-to-descending aortic bypass, 19 years after surgical correction of aortic recoarctation.

Isolated tricuspid valve surgery: impact of aetiology and clinical presentation on outcomes.

AIMS: The aim of this study was to identify determinants of in-hospital and mid-term outcomes after isolated tricuspid valve surgery (ITVS) and more specifically the impact of tricuspid regurgitation (TR) mechanism and clinical presentation. METHODS AND RESULTS: Among 5661 consecutive adult patients who underwent a tricuspid valve (TV) surgery at 12 French tertiary centres in 2007-2017 collected from a mandatory administrative database, we identified 466 patients (8% of all tricuspid surgeries) who underwent an ITVS. Most patients presented with advanced disease [47% in New York Heart Association (NYHA) III/IV, 57% with right-sided heart failure (HF) signs]. Tricuspid regurgitation was functional in 49% (22% with prior left-sided heart valve surgery and 27% isolated) and organic in 51% (infective endocarditis in 31% and other causes in 20%). In-hospital mortality and major complications rates were 10% and 31%, respectively. Rates of survival and survival free of HF readmission were 75% and 62% at 5 years. Patients with functional TR incurred a worse in-hospital mortality than those with organic TR (14% vs. 6%, P = 0.004), but presentation was more severe. Independent determinants of outcomes were NYHA Class III/IV [odd ratios (OR) = 2.7 (1.2-6.1), P = 0.01], moderate/severe right ventricular dysfunction [OR = 2.6 (1.2-5.8), P = 0.02], lower prothrombin time [OR = 0.98 (0.96-0.99), P = 0.008], and with borderline statistical significance, right-sided HF signs [OR = 2.4 (0.9-6.5), P = 0.06] while TR mechanism was not [OR = 0.7 (0.3-1.8), P = 0.88]. CONCLUSION: Isolated TV surgery was associated with high mortality and morbidity, both in hospital and during follow-up, predicted by the severity of the presentation but not by TR mechanism. Our results suggest that TV intervention should be performed earlier in the course of the disease.

Long-term follow-up of the Shelhigh™ superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience.

BACKGROUND: The Shelhigh™ SuperStentless (Shelhigh, INC., Union, NJ, USA) is a stentless aortic valve bioprosthesis and aortic root valved conduit. In 2007, this device was recalled by FDA due to malfunction, and subsequently reintegrated by BioIntegral Surgical™ Few data are available over late durability of this device. We performed a long-term follow-up of Shelhigh™ devices implanted at our center. METHODS: Between 2002 and 2007, 44 patients underwent aortic valve replacement with a Shelhigh™ device (40 aortic valve bioprosthesis and 4 valved conduit). We performed a clinical and echocardiographic follow-up (9.2 years±4.3). Standardized definitions of valve-related events were adopted. RESULTS: At discharge, maximum and mean aortic gradients averaged 36.1±11.3 and 21.0±6.8 mmHg, respectively. The 30-days mortality was 2.3%. Over the follow-up period, 29 patients died (65.9%); 2 deaths were valve related. Overall survival at 1, 5 and 10 years was 97.7%, 85.8% and 54% respectively. At last echocardiography, average transvalvular gradients had remained globally stable in the population (33.6±12 and 20.4±10.5 mmHg). Eight (19%) structural valve deterioration (SVD) events were reported. Two (5%) non-structural valve dysfunction (NSVD) events occurred (periprosthetic leak). Two (5%) infectious endocarditis events and two (5%) valve thromboses were also deplored. Three (7%) patients required re-operation (2 due to SVD and 1 due to endocarditis). CONCLUSIONS: The immediate hemodynamic performance of the Shelhigh™ aortic bioprostheses was unexpectedly suboptimal. Despite this, hemodynamic performance remained stable over time. Patients survival at follow-up was satisfactory, however, continued surveillance is necessary.

Early and late outcomes of aortic surgery under hypothermic circulatory arrest in the elderly: a single center study.

BACKGROUND: With the progressive aging of the population, aortic surgeons are caring for an increasing number of elderly patients. The objective of this study was to analyze early and late outcomes of aortic surgery with hypothermic circulatory arrest in patients aged 70 and above at our institution. METHODS: We performed a retrospective cohort study including every patient aged 70 years or older who underwent aortic surgery with hypothermic circulatory arrest between January 1995 and June 2016 at our institution. Operative results were compared with the contemporary younger counterparts aged <70 years. In-hospital mortality and postoperative stroke were primary outcomes of interest. The main secondary outcomes included acute renal failure, reoperation for bleeding, and spinal cord injury. RESULTS: In the study population, the in-hospital mortality was 16.8% (21/125). Ten (8.0%) patients presented postoperative stroke, and 6 had temporary neurologic disturbance (4.8%). Spinal cord injury occurred in 1 (0.8%) patient. For elective interventions and type A aortic dissections, the in-hospital mortality and stroke rates were 4.6% (3/65) and 7.7% (5/65), 26.8% (11/41) and 12.2% (5/41), respectively. The proportion of non-elective interventions, including type A aortic dissection, and the type of neuroprotective strategy were similar in septuagenarians and younger patients. Patients aged ≥70 had significant shorter cardiopulmonary bypass, myocardial ischemia, and circulatory arrest durations, compared to their younger counterparts. The in-hospital mortality of septuagenarians and younger patients were similar for elective surgery (4.6% vs. 4.7%, P=0.900) and aortic dissections (26.8% vs. 15.1%, P=0.107). There was no statistically significant difference between the two age groups regarding postoperative stroke, spinal cord injury, renal failure requiring dialysis or reintervention for bleeding. Estimated 1-, 3-, and 5-year survival was 78.0%, 70.6%, and 65.7%, respectively. The 5-year survival for elective surgery was 74.9% and 56.0% for non-elective procedures. CONCLUSIONS: Aortic surgery with circulatory arrest in the elderly demonstrated favorable early and late results when compared with younger individuals, with an acceptable operative risk even under emergency conditions, and should not be denied only because of the chronological age of the patients.

Comparison of the Transarterial and Transthoracic Approaches in Nontransfemoral Transcatheter Aortic Valve Implantation.

Transfemoral approach stands as the reference access-route for transcatheter aortic valve implantation (TAVI). Nonetheless, alternatives approaches are still needed in a significant proportion of patients. This study aimed at comparing outcomes between transthoracic-approach (transapical or transaortic) and transarterial-approach (transcarotid or subclavian) TAVI. Data from 191 consecutive patients who underwent surgical-approach TAVI from May 2009 to September 2017 were analyzed. Patients were allocated in 2 groups according to the approach. The primary end point was the 30-day composite of death of any cause, need for open surgery, tamponade, stroke, major or life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary obstruction, or major vascular complications. During the study period, 104 patients underwent transthoracic TAVI (transapical: 60.6%, transaortic: 39.4%) whereas 87 patients underwent transarterial TAVI (subclavian: 83.9%, transcarotid: 16.1%). Logistic EuroSCORE I tended to be higher in transthoracic-TAVI recipients. In-hospital and 30-day composite end point rates were 25.0% and 11.5% (p = 0.025), and 26.0% and 14.9% (p = 0.075) for the transthoracic and transarterial cohorts, respectively. Propensity score-adjusted logistic regression demonstrated no significant detrimental association between the 30-day composite end point and transthoracic access (odds ratio 2.12 95% confidence interval 0.70 to 6.42; p = 0.18). Transarterial TAVI was associated with a shorter length of stay (median: 6 vs 7 days, p <0.001). TAVI approach was not an independent predictor of midterm mortality. In conclusion, nontransfemoral transarterial-approach TAVI is safe, feasible, and associated with comparable rates of major perioperative complications, and midterm mortality compared with transthoracic-approach TAVI.

Late surgical explantation of a transcatheter heart valve in a patient with a porcelain aorta.

Structural valve deterioration is a well-studied phenomenon in bioprosthetic heart valves. Conversely, structural valve deterioration after transcatheter aortic valve implantation is not as well-elucidated. Therefore, late surgical explantation after transcatheter aortic valve implantation is an infrequent procedure, and thus, surgical findings and management of such cases remain unclear, particularly in patients previously labelled as 'inoperable' or at 'high risk'. Herein, we report the case of a late surgical explantation of a transcatheter heart valve (THV) 7 years after its implantation in a patient with a porcelain aorta and periprosthetic regurgitation.