Device-specific outcomes with endografts for thoracic aortic aneurysms

For the endovascular therapy of abdominal aortic aneurysm an increasing number of publications deal with the subject of device-related outcome and aneurysm sac behaviour. The present study was designed to investigate whether, and to what extent, aneurysm sac behaviour of thoracic aortic aneurysms and perioperative outcome is influenced by the different types of stent grafts. Bibliographic search and analysis was performed. A systematic MEDLINE search on thoracic aortic aneurysms produced a total of 2,884 references with abstracts between 1990 and 2004. Restricted by using the additional terms of 'descending' and 'stent graft' the result condensed to 152 papers. Each reference was analyzed according to predetermined criteria. The majority of articles were published in the English language. Two publications summarized the results of nation-wide or continental registers of endoluminally treated patients with descending aortic dissections or thoracic aortic disease. Several series were partial and/or updated reports from the same authors and/or on the same patients. A total of 48 centres reported about the endovascular treatment of more than 3,000 patients with pathological thoracic aortic entities (Approximately 1,650 degenerative thoracic aortic aneurysms, Approximately 1,000 aortic dissections, Approximately 400 miscellaneous aortic pathologies). The heterogeneity among the series precluded any relevant comparison. Only 4 centres have presented study groups of more than 100 treated patients, but 3 series contained several treated aortic pathologies. Without a differentiation to the underlying pathology, the bibliographic research documented a rate of technical success in a range of 76% to 100%. Summarizing the data of par-procedural and in-hospital mortality the bibliographic research documented a mortality rate of 6.8% for all reported procedures. The rate of paraplegia for all procedures was 1.7%. In conclusion the presented bibliographic search and analysis demonstrated the technical feasibility of the endoluminal stent grafting of a great variety of thoracic aortic pathologies. The short-term results are promising, but data of mid-term results are rare and long-term results are missing. Moreover, the question about the influence of different types of stent grafts on the outcome can not be answered.     

Midterm outcomes of AFX2 endografts used in combination with aortic cuffs

ObjectiveType III endoleaks after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with the Endologix unibody endograft remain a major concern, despite fabric, system, and instructional updates. The purpose of this study was to examine real-world outcomes of repairing AAAs using the current version of the AFX2 main body in combination with an aortic cuff, specifically focusing on type III endoleaks and morphological changes of the endograft.MethodsWe recruited facilities in Japan that used AFX2 combined with an aortic cuff for at least five cases between April 2017 and March 2018. A total of 175 cases in 24 facilities were analyzed. Patients’ background information, including anatomic factors, operative findings, device component variations, and midterm outcomes at 3 years after the EVAR were collected. The data on computed tomography scans from cases registered as types I and III endoleaks and migration from each institute were sent to our department for verification.ResultsThe mean patient age was 74.6 ± 8.1 years, and 48 cases (27%) were saccular aneurysms. The mean fusiform and saccular AAA diameters were 50.5 ± 5.8 mm and 43.5 ± 8.9 mm, respectively. No in-hospital deaths occurred. Data at 3 years, including computed tomography images, of 128 cases were analyzed. Overall survival, freedom from aneurysm-related mortality, and freedom from reintervention rates at 3 years were 85.8%, 99.3%, and 87.3%, respectively. There were three, one, and three cases of types I, IIIa, and IIIb endoleaks without sac dilatations, respectively. Among five migration cases, one case of aortic cuff migration presented as a type Ia endoleak, and four cases demonstrated sideways displacement, one of which presented as a type IIIa endoleak. The sac regression and enlargement rates at 3 years were 41.4% and 20.5% in the fusiform group and 44.2% and 16.7% in the saccular group, respectively. The proximal neck diameter slightly increased from 20.8 ± 2.7 mm before the EVAR to 22.2 ± 4.6 mm after the repair.ConclusionsMidterm outcomes of the AFX2 used in combination with an aortic cuff were acceptable, considering the rates of types I and III endoleaks. However, there were cases of sideways displacement that could cause future type IIIa endoleaks. When the AFX2 is used in combination with an aortic cuff, close surveillance for endograft deformations and subsequent adverse events, including type III endoleaks, is needed.     

A systematic review of infected descending thoracic aortic grafts and endografts

ObjectiveThe objective of this study was to collect and critically analyze the current evidence on the modalities and results of treatment of descending thoracic aortic surgical graft (SG) and endograft (EG) infection, which represents a rare but dramatic complication after both surgical and endovascular aortic repair.MethodsA comprehensive electronic health database search (PubMed/MEDLINE, Scopus, Google Scholar, and the Cochrane Library) identified all articles that were published up to October 2017 reporting on thoracic aortic SG or EG infection. Observational studies, multicenter reports, single-center series and case reports, case-control studies, and guidelines were considered eligible if reporting specific results of treatment of descending thoracic aortic SG or EG infection. Comparisons of patients presenting with SG or EG infection and between invasive and conservative treatment were performed. Odds ratio (OR) meta-analyses were run when comparative data were available.ResultsForty-three studies reporting on 233 patients with infected SG (49) or EG (184) were included. Four were multicenter studies including 107 patients, all with EG infection, associated with a fistula in 91% of cases, with a reported overall survival at 2 years of 16% to 39%. The remaining 39 single-center studies included 49 patients with SG infection and 77 with EG infection. Association with aortoesophageal fistula was significantly more common with EG (60% vs 31%; P = .01). In addition, time interval from index procedure to infection was significantly shorter with EG (17 ± 21 months vs 32 ± 61 months; P = .03). Meta-analysis showed a trend of increased 1-year mortality in patients with SG infection compared with EG infection (pooled OR, 3.6; 95% confidence interval, 0.9-14.7; P = .073). Surgical management with infected graft explantation was associated with a trend toward lower 1-year mortality compared with graft preservation (pooled OR, 0.3; 95% confidence interval, 0.1-1.0; P = .056).ConclusionsThoracic aortic EG infection is likely to occur more frequently in association with aortoesophageal fistulas and in a shorter time compared with SG infection. Survival is poor in both groups, especially in patients with SG infection. Surgical treatment with graft explantation seems to be the preferable choice in fit patients.     

Durability of renal artery stents in patients with transrenal abdominal aortic endografts

OBJECTIVE: The management of renal artery stenosis in patients with abdominal aortic aneurysms continues to be complex and technically challenging despite advances in endovascular therapy. There is growing concern about the durability of renal artery stents in the setting of transrenal abdominal aortic endografts. This study reports a single-center experience of renal artery stenting with transrenal abdominal aortic endografts for patients with renal artery stenosis. METHODS: All patients undergoing endovascular abdominal aortic aneurysm repair preceded or followed by renal artery stent placement between January 1999 and December 2005 were retrospectively reviewed from a prospectively gathered endovascular database. Patients were surveyed after renal stent procedures with multidetector computed tomography angiography or duplex sonography. The surveillance data were analyzed for primary patency of the renal artery stent at 6 months, incidence of complications, need for secondary interventions, and changes in creatinine clearance (CrCl). RESULTS: Sixty-two renal artery stents were placed in 56 patients (44 men, 12 women) with a mean age of 77.3 years (range, 61 to 94 years). Forty-one were placed before the endograft procedure, eight were placed during the endograft procedure, and 13 were placed postoperatively. There were no major or minor complications related to the renal artery stent procedures. Transrenal aortic endografts were used in 44 of the 56 patients, and 12 had devices with infrarenal fixation. The mean follow-up was 18.5 months (range, 1 to 73 months). The 6-month primary patency, which could be evaluated for 51 renal artery stents, was 97.4% (37/38) in patients with transrenal fixation and 84.6% (11/13) in patients with infrarenal fixation. The overall rate of in-stent restenosis was 8.5% (4/47) in the transrenal fixation group and 20.0% (3/15) in the infrarenal fixation group. The overall occlusion rate was 2.1% (1/47) in the transrenal fixation group and 0% (0/15) in infrarenal fixation group. Five (83.3%) of six patients underwent successful treatment of in-stent restenosis with placement of a new stent in all five cases. CrCl decreased in the total group by 4.2 +/- 11.8 mL/min, by 4.7 +/- 12.0 mL/min in patients with transrenal fixation, and by 2.2 +/- 11.0 mL/min in patients with infrarenal fixation. CONCLUSION: The presence of a transrenal aortic endograft did not affect the outcome of the renal artery revascularization procedure in this cohort. Renal artery stenting in the presence of transrenal abdominal aortic endografts appears to be a safe procedure without adverse effect on renal artery stent patency or renal function.     

Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms

ObjectiveThere is paucity of data on the durability of physician modified endografts (PMEGs) for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) despite widespread use. The aim of this study was to evaluate and compare the early and long-term outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for CAAAs and TAAAs using PMEGs.MethodsWe reviewed clinical data and outcomes of patients treated by FB-EVAR using PMEGs for CAAAs (defined as short-neck infrarenal, juxtarenal, and pararenal AAAs) and TAAAs between 2007 and 2019. All patients were treated by a dedicated team with extensive manufactured device experience. Endpoints included 30-day mortality and major adverse events, patient survival and freedom from aortic-related mortality (ARM), freedom from secondary intervention, target artery (TA) patency, and freedom from TA endoleak and TA instability.ResultsOf 645 patients undergoing FB-EVAR, 156 patients (24%) treated with PMEG (121 males; mean age, 75 ± 8 years) were included. There were 89 CAAAs, 33 extent IV TAAAs and 34 extent I to III TAAAs. A total of 452 renal-mesenteric targets (3.1 ± 1.0 vessels/patient) were incorporated. Patients with TAAAs had significantly (P < .05) larger aneurysms (73 ± 11 vs 68 ± 14 mm), more TAs incorporated (3.4 ± 0.9 vs 2.8 ± 1.0), and more often had previous aortic repair (54% vs 27%). Technical success was higher in patients treated for CAAAs (99% vs 91%; P = .04). Thirty-day and/or in-hospital mortality was 5.7% and was significantly lower for CAAAs compared with TAAAs (2% vs 10%; P = .04), with three of nine early mortalities (33%) among patients treated emergently. After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative complications and three late deaths (1.9%) from rupture. At 5 years, patient survival was 41%. Patients treated for CAAAs had higher 5-year freedom from ARM (P = .016), TA instability (P = .05), TA endoleak (P = .01), and TA secondary interventions (P = .05) with a higher, but non-significant, freedom from sac enlargement ≥5 mm (P = .11). Primary and secondary TA patency was 91% ± 2% and 99% ± 1%, respectively. Sac regression ≥5 mm occurred in 67 patients (43%) and was associated with increased survival (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80) compared with those without sac regression.ConclusionsFB-EVAR using PMEGs was performed with acceptable long-term outcomes. Overall patient survival was low due to significant underlying comorbidities. Patients treated for CAAAs had higher freedom from ARM, TA instability, TA endoleak, TA secondary interventions, and a trend towards higher freedom from sac enlargement compared with patients treated for TAAAs. Sac regression was associated with improved patient survival.     

Surgical mortality in patients with infected aortic aneurysms

BACKGROUND: Mortality in patients with infected aortic aneurysms remains high. A number of patient- and infection-specific risk factors for death have been proposed, but none is consistently predictive of poor outcomes. The purpose of this study was to examine the possible contribution of infection-related risk factors and the systemic inflammatory response syndrome (SIRS) to outcomes of patients with infected aortic aneurysms. STUDY DESIGN: Ten patients with infected aortic aneurysms presenting to our institution over a recent 6-year period were studied. Collected data included aneurysm location, culture results, preoperative indicators of SIRS, operative details, and outcomes. RESULTS: Common presenting symptoms included abdominal or back pain and fevers. Aneurysms involved the thoracoabdominal aorta in four patients, the suprarenal aorta in one, the juxtarenal aorta in one, and the infrarenal aorta in four. Seven patients met criteria for SIRS. Repairs included in situ replacement of the infected aneurysm using rifampin-soaked, gel-impregnated Dacron in four patients with thoracoabdominal aneurysms and using autogenous superficial femoral-popliteal vein in five patients with infrarenal aneurysms. Four patients died of sepsis, and six patients survived to discharge after a mean of 23 +/- 12 days in the hospital, followed by extensive rehabilitation. The combination of SIRS and suprarenal extension was present in all four patients who died. CONCLUSIONS: Although rare, infected aortic aneurysms are associated with marked morbidity and mortality. Sepsis is the leading cause of death. A combination of host- and infection-specific variables may be more predictive of outcomes than any single risk factor. Prolonged hospitalization and extended rehabilitation are frequently required in survivors, but longterm outlook is good after successful treatment.     

Exclusion of complex aortic aneurysm with chimney endovascular aortic repair is applicable in a minority of patients treated with fenestrated endografts

OBJECTIVESThe Medtronic Endurant II stent graft has recently received Conformité Européenne (CE) approval for the use in chimney endovascular aortic repair (ChEVAR) for the treatment for juxtarenal aortic aneurysms. The aim of this study was to assess the percentage of patients treated by fenestrated endovascular repair who would have been alternatively suitable for the treatment by the CE approved Medtronic ChEVAR. Open in a separate windowMETHODSPreoperative computed tomography scans of 100 patients who underwent fenestrated endovascular aortic repair (FEVAR) between April 2013 and February 2017 were retrospectively assessed for the applicability of the ChEVAR technique according to the Medtronic instructions for use. Eligibility criteria included an aortic neck diameter of 19–30 mm, a minimum infrarenal neck length of 2 mm, a total proximal sealing zone of at least 15 mm, thrombus in the aortic neck in ˂25% of the circumference, and maximum aortic angulations of 60° in the infrarenal, 45° in the suprarenal segment and ˂45° above the superior mesenteric artery.RESULTSAccording to CE-approved inclusion criteria, 19 individuals (19%) would have been eligible for ChEVAR. In 81 patients, at least 1 measure was found outside instructions for use: (i) excluding factor was detected in 26 patients, (ii) incongruous measures in 28 patients and in 27 patients, 3–5 measures were outside the instructions for use. The most frequently identified excluding factor was an insufficient infrarenal neck at ˂2 mm length (n = 63; 63%).CONCLUSIONSPatients with juxta- or pararenal aneurysm treated by FEVAR are in 19% of the cases alternatively suitable for the treatment by ChEVAR within CE-approved instructions for use. While ChEVAR is suitable in many emergency cases, FEVAR offers a broader applicability in an elective setting.     

Physician-modified endografts for urgent and emergent aortic pathology

Symptomatic or ruptured thoracoabdominal aortic aneurysms (TAAA) carry a high morbidity and mortality. Modern fenestrated and/or branched endovascular devices (B/FEVAR) have improved the immediate peri-operative mortality of TAAA and have increased the number of people that can undergo repair - in those who might otherwise be prohibitively high risk for surgery. Most modern B/FEVAR are custom made devices that require 6-12 weeks to assemble and ship to the site of implantation. Thus, patients who require more urgent repair due to symptomatic or ruptured aneurysms may not have access to this potentially life saving technology. Physician-modified endografts (PMEGs), or traditional endografts that have been back-table modified to have fenestrations or branches, have partially fixed this problem as they can be constructed in less than an hour and can provide similar results to modern custom made devices. Here we review the existing data behind the use of PMEGs in urgent and emergent aortic pathology and summarize a case describing one methodology for PMEG construction that has been standardized at our institution.     

Psoas abscess in patients with an infected aortic aneurysm

BACKGROUND: Psoas abscess is an uncommon disease, and its presenting features are usually nonspecific. Infected aortic aneurysms could be complicated by psoas abscess. METHODS: A retrospective chart review was conducted to examine the incidence, clinical presentations, microbiology, and outcomes of psoas abscess in patients with an infected aortic aneurysm. RESULTS: Between 1996 and 2007, 40 patients (32 men) with an infected infrarenal aortic aneurysm were treated in our hospital. Their median age was 71 years (range, 38 to 88 years). In 38 patients a blood or tissue culture had a positive result. The most common responsible pathogen was Salmonella spp in 29 patients (76%), followed by Staphylococcus aureus in 3 (8%), Escherichia coli in 2 (5%), Klebsiella pneumoniae in 3 (8%), and Mycobacterium tuberculosis in 1 (3%). One patient underwent endovascular repair but died. In-situ graft replacement was done in 32 patients. Persistent or recurrent infection occurred in seven (22%) of 32 operated on patients. The mortality rate was 86%, and the overall aneurysm-related mortality rate of in situ graft replacement was 22% (7/32). In eight (20%) of the 40 patients, aortic infection was complicated by psoas abscess. Infection complicated by psoas abscess was present in seven of 32 operated patients. It was associated with higher incidence of emergency operation, hospital mortality, prosthetic graft infection, and aneurysm-related mortality than infection without abscess. CONCLUSION: Psoas abscess was common in patients with infected infrarenal aortic aneurysm. Salmonella spp was the most common pathogen. Psoas abscess was associated with a high mortality rate, emergency operation, and persistent infection.     

Surgical treatment of abdominal aortic aneurysms associated with aortic valve incompetence: strategies and outcomes

BACKGROUND: The exact incidence of associated aortic valve incompetence (AVI) and abdominal aortic aneurysm (AAA) in the general population is not known. In recent years, we have observed this association with increasing frequency. This observation is probably due to the extensive preoperative screening of the cardiac and vascular status of patients who are candidates for surgical procedures. The choice of the optimal surgical strategy is needed to achieve low operative morbidity and mortality. The present study reviews our experience with a subset of patients suffering the association of AVI and large AAA. Surgical strategy, clinical management and outcome are presented.METHODS: Between January 1982 and May 2000, 76 patients with the association of AAA and AVI have been evaluated in our institution. Forty-four patients have been treated for both AAA and aortic valve (AV) regurgitation. These patients have been divided into three groups on the basis of the surgical strategy adopted. Group 1: combined procedure (16 patients); group 2: AAA repair prior to AV surgery (nine patients); group 3: AV surgery prior to aneurysm repair (19 patients).RESULTS: Hospital mortality was 4.5% (two patients); overall mortality was 6.8% (three patients).CONCLUSIONS: In patients with AAA and AVI, an accurate and complete preoperative evaluation is essential. Surgical strategy should be individualized on the basis of the cardiac preoperative status.     

Conformational changes associated with proximal seal zone failure in abdominal aortic endografts

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become a popular treatment for abdominal aortic aneurysm (AAA). This study examines conformational changes in the infrarenal aortas of patients in whom proximal seal zone failures (PSF) developed after EVAR. METHODS: All 189 patients with aortic endograft underwent routine post-EVAR computed tomographic scan surveillance. Patients identified with proximal type I endoleaks, type III endoleaks, or proximal component separation without demonstrable endoleak underwent three-dimensional reconstruction of the computed tomographic scans from which measurements of the migration, length, volume, and angulation of the infrarenal aorta were made. RESULTS: Five patients (3%) had PSF develop, four of whom had aortic extender cuffs. Although changes in the AAA volume and aortic neck angle were slight or variable, the mean AAA length increased 34 mm and the mean aortic body angulation increased 17 degrees (P =.03 and.01, respectively). Lengthening and migration caused proximal component separation in four patients, with concomitant migration in two patients. Two patients underwent endovascular repair, two patients needed explantation of the endograft, and one patient awaits endovascular repair. Proximal component separation and type III endoleak recurred in one patient and were repaired with a custom-fitted graft. CONCLUSION: PSF of aortic endografts is associated with proximal angulation and lengthening of the infrarenal aorta. These findings reinforce the importance of proper initial deployment to minimize the need for aortic extender cuffs, which pose a risk of late endoleak development.     

Early graft thrombosis after endovascular aortic aneurysm repair with aortouni-iliac endografts

Endovascular repair of aortic aneurysm has become a viable treatment option in selected patients. However, despite the minimally invasive nature ot this treatment a significant incidence of vascular complications has been reported. Here, we report two cases of acute limbs ischemia due to endograft thrombosis in patients treated with aortouni-iliac devices and we review the etiologic factors related with these events and the treatment options. We suggest that the presence of atherosclerotic plaques within the outflow arteries and coexistent infrainguinal arterial occlusive disease (poor runoff) is an underestimated factor in the risk of graft thrombosis, especially in patients treated with aortouni-iliac devices and we advocate the use in the early follow-up surveillance after endovascular repair of aortic aneurysm of noninvasive test such duplex scanning, segmental pressures and ankle-brachial indices to asses the presence or progress of coexistent occlusive disease. We also suggest that some adverse outcomes ascribed to device failure might be more properly charged to inappropriate patient selection.     

Hybrid repair of aortic arch aneurysms: a totally extrathoracic approach with branched endografts in two patients

Of all of the aortic segments, the aortic arch is the last frontier for endovascular treatment. The main difficulty for arch repair is the lack of an appropriate proximal landing zone of at least 2 to 3 cm required for endograft sealing and anchoring to diminish the risk of endoleaks or migration. We used branched endografts to treat two cases of aortic aneurysms that required complete arch endografting, with successful aneurysm exclusion.     

Partial and complete explantation of aortic endografts in the modern era

ObjectiveDespite the progressive advancement of devices for endovascular aortic repair (EVAR), endografts continue to fail, requiring explant. We present a single-institutional experience of EVAR explants, characterizing modern failure modes, presentation, and outcomes for partial and complete EVAR explantation.MethodsA retrospective analysis was performed of all EVARs explanted at an urban quaternary center from 2001 to 2020, with one infected endograft excluded. Patient and graft characteristics, indications, and perioperative and long-term outcomes were analyzed. Partial versus complete explants were performed per surgeon discretion without a predefined protocol. This process was informed by patient risk factors; asymptomatic, symptomatic, or ruptured aneurysm presentation; and anatomical or intraoperative factors, including endoleak type.ResultsFrom 2001 to 2020, 52 explants met the inclusion and exclusion criteria. More than one-half (57.7%) were explants of EVAR devices placed at outside institutions, designated nonindex explants. Most patients were male (86.5%), the median age was 74 years (interquartile range, 70-78 years). More than one-half (61.5%) were performed in the second decade of the study period. The most commonly explanted grafts were Gore Excluder (n = 9 grafts), Cook Zenith (n = 8), Endologix AFX (n = 7), Medtronic Endurant (n = 5), and Medtronic Talent (n = 5). Most grafts (78.8%) were explanted for neck degeneration or sac expansion. Five were explanted for initial seal failure, five for symptomatic expansion, and seven for rupture. The median implant duration was 4.2 years, although ranging widely (interquartile range, 2.6-5.1 years), but similar between index and nonindex explants (4.2 years vs 4.1 years). Partial explantation was performed in 61.5%, with implant duration slightly lower, 3.2 years versus 4.4 years for complete explants. Partial explantation was more frequent in index explants (68.2% vs 56.7%). The median length of stay was 8 days. The median intensive care unit length of stay was 3 days, without significant differences in nonindex explants (4 days vs 3 days) and partial explants (4 days vs 3 days). Thirty-day mortality occurred in two nonindex explants (one partial and one complete explant). Thirty-day readmission was similar between partial and complete explants (9.7% vs 5.0%), without accounting for nonindex readmissions. Long-term survival was comparable between partial and complete explants in Cox regression (hazard ratio, 2.45; 95% confidence interval, 0.79-7.56; P = .12).ConclusionsExplants of EVAR devices have increased over time at our institution. Partial explant was performed in more than one-half of cases, per operating surgeon discretion, demonstrating higher blood loss, more frequent acute kidney injury, and longer intensive care unit stays, however with comparable short-term mortality and long-term survival.     

Mid-term outcomes of rapid deployment aortic prostheses in patients with small aortic annulus

 Open in a separate windowOBJECTIVESThe Edwards Intuity valve is a rapid deployment aortic prosthesis that favours less invasive approaches. However, evidence about the clinical behaviour of their smaller sizes is scarce. Herein, we studied haemodynamic behaviours and clinical outcomes of small Intuity prostheses (19–21 mm) in comparison to larger Intuity prostheses (>21 mm).METHODSThis is an observational study including patients implanted with an Edwards Intuity rapid deployment aortic prosthesis. Patients with prosthesis sizes 19–21 and >21 mm were included. Baseline and perioperative variables, as well as adverse events during the follow-up were recorded and compared between groups.RESULTSA total of 122 patients (37% female, mean age 75 ± 4.5 years) were included, of whom 54 (45%) were implanted with a small prosthesis and 68 (55%) with a prosthesis >21 mm. There were no significant differences between patients with small Intuity prostheses and patients with larger prostheses regarding in-hospital mortality (2% vs 4%, P = 0.43) or mortality during the follow-up (3.41 vs 2.45 per 100 patients-years; P = 0.58). Survival in the small Intuity valve group was 95% at 1 year and 83% at 6 years, whereas in the larger Intuity valve group was 96% at 1 year and 78% at 6 years. The presence of a small prosthesis did not influence mid-term survival (log-rank P-value = 0.62).CONCLUSIONSThis study showed good clinical performance of Intuity aortic prostheses with appropriate mid-term survival in patients with the small aortic annulus. Thus, the Edwards Intuity rapid deployment aortic prosthesis may be considered as a potential option in patients with the small aortic annulus.