International experience with endovascular therapy of the ascending aorta with a dedicated endograft.

OBJECTIVE: The objective of this study was to evaluate the safety and feasibility of a novel stent graft specifically designed for treatment of the ascending aorta. METHODS: This was a multicenter, retrospective analysis of all consecutive patients treated with the dedicated Zenith Ascend TAA Endovascular Graft (William Cook Europe, Bjaeverskov, Denmark) for pathologic processes requiring stent grafting of the ascending aorta. The graft is short (6.5 cm), with a delivery system designed for transfemoral placement in the ascending aorta. RESULTS: In 10 patients (five men; age, 67 years; range, 26-90 years), the Zenith Ascend graft was implanted for the following indications: dissection (n = 5) and aneurysm (n = 4) of the ascending aorta and fixation of an intraprocedural dislocated aortic valve (n = 1). All patients were judged to be at high risk for open surgery (nine patients were classified as American Society of Anesthesiologists class 3 or class 4). A transfemoral approach was selected in eight cases and a transapical approach in two. All endografts were successfully deployed without intraoperative adverse events at the targeted landing zone. Clinical success in coverage of the lesions was achieved in all cases with the exception of an attempted treatment of an intraprocedural aortic valve implantation dissection that resulted in early mortality. The 30-day survival was 90%. Early neurologic events included one patient with stroke and paraplegia and one patient with a transient ischemic attack. One patient underwent early evacuation of a hemopericardium. There were two late reinterventions for persisting endoleaks. At a mean follow-up of 10 months (range, 1-36 months), three late deaths occurred, with one treatment related, as a result of graft infection. CONCLUSIONS: Despite the fact that in this first published series the graft was frequently used as a "rescue tool" outside its intended indication, treatment with the Zenith Ascend graft in this early experience appears to be safe and feasible for repair of ascending aorta pathologic processes in high-risk patients unsuitable for open repair.

Three-dimensional multidetector computed tomography versus conventional 2-dimensional transesophageal echocardiography for annular sizing in transcatheter aortic valve replacement: Influence on postprocedural paravalvular aortic regurgitation.

OBJECTIVES: In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with either multidetector computed tomography (MDCT) or conventional transesophageal echocardiography (TEE) on the incidence of postprocedural paravalvular aortic regurgitation (PAR) was evaluated. BACKGROUND: PAR remains a major limitation in TAVR. Appropriate selection of transcatheter heart valve (THV) size is crucial to prevent PAR. METHODS: Outcomes following TAVR with a balloon-expandable THV were compared in two retrospective cohorts identified according to whether THV size selection was based on TEE (study group 1, n = 80) or MDCT (study group 2, n = 58). RESULTS: The two study groups were comparable with regard to baseline clinical, risk score, and echocardiographic characteristics. The incidence of moderate/severe PAR was lower in study group 2 than in group 1, 8.6% versus 28.8% (P < 0.01). The difference between the THV nominal diameter and MDCT annular diameter was predictive of moderate/severe PAR (AUC 0.84; 95% CI: 0.72-0.92). Neither age, gender, body mass index, annular eccentricity index, aortic valve calcification nor the difference between the THV diameter and the TEE annular diameter predicted postprocedural PAR. Increased THV oversizing relative to the MDCT mean annular diameter was associated with reduced severity of PAR. No difference in perprocedural complications between two study groups was observed. CONCLUSION: MDCT-based annular sizing in TAVR significantly reduces postprocedural PAR, and THV oversizing appears pivotal in this aspect. Further delineation of the optimal degree of THV oversizing is needed.

Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system.

OBJECTIVES: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system. METHODS: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant. RESULTS: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively. CONCLUSIONS: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery. NAME AND REGISTRATION OF REGISTRY: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.

Surgical approach to a mycotic aneurysm of the pulmonary artery presenting with hemoptysis - A case report and a review of the literature.

INTRODUCTION: Mycotic aneurysms of the pulmonary arteries are very rare and have high mortality. Risk groups are intravenous drug users and patients with congenital heart disorders. The surgical approach varies due to a limited number of reported cases. PRESENTATION OF CASE: We present a case of a mycotic aneurysm of the right pulmonary artery in a 56-year old man presenting with recurrent pneumonias, weight loss and hemoptysis. DISCUSSION: There is often a diagnostic delay because of non-specific symptoms mimicking more common disorders. Treatment strategies include conservative management, surgery and endovascular treatment. CONCLUSION: This report demonstrates a rare case of aneurysm of the pulmonary artery presenting with hemoptysis. For rapidly progressing proximal aneurysms of the pulmonary arteries, the midline surgical approach is recommended.

One-year outcomes after rapid-deployment aortic valve replacement.

OBJECTIVE: The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). METHODS: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years. RESULTS: Between 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm2, and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm2/m2), and 28 of 287 patients (9.8%) exhibited severe prosthesis-patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively. CONCLUSIONS: These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting.

Aortic valve and left ventricular outflow tract calcium volume and distribution in transcatheter aortic valve replacement: Influence on the risk of significant paravalvular regurgitation.

OBJECTIVES: We sought to determine the impact of aortic root calcium on the risk of significant paravalvular regurgitation (sPAR) in transcatheter aortic valve replacement (TAVR). METHODS: In 302 consecutive patients from 3 centers, aortic root calcium was quantified volumetrically on pre-TAVR multidetector computed tomography (MDCT) in three regions: 1) the aortic valve region, 2) the overall left ventricular outflow tract (LVOT) and 3) the upper LVOT. Transcathether heart valve (THV) oversizing was calculated as (THV nominal area/MDCT annular area-1) × 100. The study endpoint sPAR was a composite of post-dilatation (PD) and PAR > mild. RESULTS: sPAR occurred in 15% (46/302) of patients. Upper LVOT calcium volume was more predictive of sPAR than overall LVOT calcium volume, with an area under the receiver operating curve (AUC) (95% confidence interval [CI]) of 0.80 (0.67-0.89) vs. 0.60 (0.51-0.70); p = 0.0001. The optimal cut-off calcium volume thresholds determined from receiver operating curves were 21 mm3 and 30 mm3 for upper LVOT and overall LVOT calcium, respectively. Upper LVOT calcium ≥ 21 mm3, but not overall LVOT calcium ≥ 30 mm3, independently predicted sPAR, odds ratio (95%CI): 9.5 (4.1-22.3) vs 1.6 (0.6-2.7). Upper LVOT calcium was more predictive of sPAR in patients with THV oversizing ≥ 13% compared to patients with THV oversizing <13%, AUC (95% CI): 0.83 (0.72-0.93) vs. 0.67 (0.51-0.74); p < 0.0001. CONCLUSIONS: Upper LVOT calcium predicts more-than-mild paravalvular regurgitation following TAVR or the need for postdilatation. Upper LVOT calcium is most predictive of paravalvular regurgitation in the event of THV oversizing ≥ 13%.

High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.

AIMS: Transcatheter valve-in-valve (VIV) implantation is usually discouraged in small surgical tissue valves. We report our first ten cases of fracturing small dysfunctional Mitroflow bioprostheses by high-pressure balloon dilatation to increase the internal diameter of the surgical valve before VIV (BF-VIV). METHODS AND RESULTS: BF-VIV was performed in 10 patients (mean age 84±4 years) with failing Mitroflow valves size 19 mm (n=3, threshold of fracture 15 atm) and 21 mm (n=7, threshold of fracture 13 atm). An Edwards SAPIEN 3 or XT 20 mm or 23 mm transcatheter valve was implanted inside the fractured Mitroflow bioprosthesis. The procedure improved aortic valve area (0.7±0.3 vs. 1.1±0.3 cm2, p=0.001), reduced peak aortic valve gradient (66±27 vs. 29±7 mmHg, p=0.002), resolved aortic regurgitation and improved patients' NYHA functional class (p=0.005). One patient had a minor stroke with complete resolution of symptoms and another patient required a pacemaker due to AV block. All patients were still alive at the end of follow-up (438±255 days). CONCLUSIONS: Initial experience with transcatheter BF-VIV suggests that this method is feasible and safe, and that it improves aortic valve haemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing Mitroflow bioprostheses.

Durability after aortic valve replacement with the Mitroflow versus the Perimount pericardial bioprosthesis: a single-centre experience in 2393 patients.

OBJECTIVES: This study compares the durability and risk of reoperation in patients undergoing aortic valve replacement (AVR) with either a Mitroflow or a Carpentier-Edwards (CE) pericardial bioprosthesis. Since AVR with bioprosthetic valves has increased progressively in recent years as compared to mechanical valves, especially in patients aged 60-70 years, there has been renewed interest in the long-term durability of current pericardial bioprostheses. METHODS: We compared 440 AVR with Mitroflow valves with 1953 AVR with CE pericardial valves implanted from 1999 to 2014 with regard to reoperation, reoperation for structural valve deterioration (SVD) and all-cause mortality. RESULTS: Ten-year freedom from explant of any cause was higher for CE Perimount (98 ± 0.7%) than for Mitroflow (95 ± 1.4%, P < 0.01). Reasons for explant for CE Perimount were SVD (n = 2), endocarditis (n = 8) and paraprosthetic leak (n = 10). The reasons for explant for Mitroflow were SVD (n = 11), endocarditis (n = 3) SVD and pericarditis (n = 1) and paraprosthetic leak (n = 2). Ten-year freedom from explant due to SVD was higher for CE Perimount (100%) than for Mitroflow (96%) (P < 0.01). In small aortic annuli (bioprosthesis size 19-21 mm), freedom from SVD at 10 years for CE Perimount and Mitroflow was 100 versus 96%, respectively. By multivariate analysis, it was found that bioprosthesis size was not a risk factor for SVD. The choice of valve type could not be demonstrated to influence long-term survival. CONCLUSIONS: The Mitroflow pericardial bioprosthesis provides less than optimal mid- and long-term durability compared with the CE Perimount pericardial valve, especially for small aortic diameter implants (19 and 21 mm). This study hereby confirms the existence of a real risk of valvular deterioration of the Mitroflow valve that might compromise the prognosis of the patients.

Transcatheter aortic valve implantation in a young heart transplant recipient crossing the traditional boundaries.

Transcatheter aortic valve implantation (TAVI) is an established therapeutic alternative to surgical aortic valve replacement (SAVR) in high-risk or inoperable patients with symptomatic aortic valve stenosis. Hitherto, TAVI is not recommended in young and low-intermediate risk patients. However, TAVI may also serve as an alternative to SAVR in selected young patients, e.g., patients who have previously undergone multiple cardiac surgery procedures. We report a case of trans-femoral TAVI in a 25-year-old heart transplant (HTx) recipient with prior surgery for congenital heart disease.

Prosthetic valve endocarditis after transcatheter aortic valve implantation-diagnostic and surgical considerations.

Prosthetic valve endocarditis (PVE) after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) is a potential life threatening complication. Better understanding of the incidence, predictors, clinical presentation, diagnostic measures, complications and management of PVE may help improve TAVI long-term outcome. We report a case of TAVI-PVE in an 80-year-old high risk patient in whom SAVR was successfully performed. We have reviewed literature regarding TAVI-PVE.

Transcatheter Aortic Valve Thrombosis: Incidence, Predisposing Factors, and Clinical Implications.

BACKGROUND: There are limited data on the incidence, clinical implications, and predisposing factors of transcatheter heart valve (THV) thrombosis following transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors assessed the incidence, potential predictors, and clinical implications of THV thrombosis as determined by contrast-enhanced multidetector computed tomography (MDCT) after TAVR. METHODS: Among 460 consecutive patients who underwent TAVR with the Edwards Sapien XT or Sapien 3 (Edwards Lifesciences, Irvine, California) THV, 405 (88%) underwent MDCT in addition to transthoracic and transesophageal echocardiography 1 to 3 months post-TAVR. MDCT scans were evaluated for hypoattenuated leaflet thickening that indicated THV thrombosis. RESULTS: MDCT verified THV thrombosis in 28 of 405 (7%) patients. A total of 23 patients had subclinical THV thrombosis, whereas 5 (18%) patients experienced clinically overt obstructive THV thrombosis. THV thrombosis risk did not differ among different generations of THVs (8% vs. 6%; p = 0.42). The risk of THV thrombosis in patients who did not receive warfarin was higher compared with patients who received warfarin (10.7% vs. 1.8%; risk ratio [RR]: 6.09; 95% confidence interval [CI]: 1.86 to 19.84). A larger THV was associated with an increased risk of THV thrombosis (p = 0.03). In multivariable analysis, a 29-mm THV (RR: 2.89; 95% CI: 1.44 to 5.80) and no post-TAVR warfarin treatment (RR: 5.46; 95% CI: 1.68 to 17.7) independently predicted THV thrombosis. Treatment with warfarin effectively reverted THV thrombosis and normalized THV function in 85% of patients as documented by follow-up transesophageal echocardiography and MDCT. CONCLUSIONS: Incidence of THV thrombosis in this large study was 7%. A larger THV size may predispose to THV thrombosis, whereas treatment with warfarin appears to have a protective effect. Although often subclinical, THV thrombosis may have important clinical implications.

Aortic aneurysms and trans-apical endovascular repair in high risk heart transplant recipient, one year follow up.

Aortic aneurysms cause major morbidities and mortalities. Operative intervention in ascending aneurysms and dissections is the treatment of choice although there is the risk of major complications because of technical difficulties, late diagnoses, affected hemodynamic and organ mal perfusion. Improved survival of heart transplant (HTx) recipients, acceptance of older donors with co morbidities and advances in HTx give rise to new pathological challenges in the cardiovascular field. Only a few articles have been reported about cardiac and aorta surgery in HTx recipients. Endovascular treatment for aortic pathology in zone 0 is an emerging treatment option. We report the first trans-apical endovascular ascending aorta repair (EVAR) in a 26-year-old HTx recipient, with the history of mediastinitis and lack of femoral access. She had an uneventful operative and post-operative EVAR course.

Transcatheter mitral valve implantation via transapical approach: an early experience.

OBJECTIVES: As many as 50% of patients with severe symptomatic mitral valve regurgitation are denied surgical valve replacement or repair due to high operative risk. We describe an early series of cases of transcatheter implantation with a CardiAQ™ mitral valve via a transapical approach. METHODS: Three consecutive patients with an Society of Thoracic Surgeons (STS) mortality score of >22% were selected for transcatheter mitral valve implantation (TMVI) on compassionate grounds. All patients were elderly, had severe mitral regurgitation (MR), were in Class IV heart failure and deemed unsuitable for the MitraClip. Two of the patients had functional MR in the setting of ischaemic cardiomyopathy with left ventricular ejection fraction (LVEF) <40%, deemed while the remaining patient had chordal rupture with extensive anterior leaflet flail (preserved LVEF). Comorbidities included previous coronary artery bypass surgery (n = 2), severe pulmonary hypertension (n = 1) and moderate to severe chronic renal failure (n = 3). A CardiAQ mitral valve was implanted using fluoroscopy and transoesophageal (TEE) guidance via a standard transapical approach. RESULTS: Accurate prosthesis positioning and deployment with immediate elimination of the MR was achieved in all 3 cases. Two patients made full clinical recovery and were discharged home. Post-procedural TEE performed on Days 1, 30 and 60 days showed good valve function, stable valve position and minimal LVOT gradient. One patient expired on the postoperative day 9 due to pneumonia. CONCLUSIONS: TMVI using the CardiAQ™ device via a transapical approach is feasible and effective.

Effect of hemostatic material on sternal healing after cardiac surgery.

BACKGROUND: Postoperative sternal infection and dehiscence cause increased morbidity, mortality, and socioeconomic costs as well as patient discomfort and pain. Some predisposing factors have been uncovered but others remain uninvestigated. Among these are the influence of topical hemostatic agents such as bone wax (BW) and Ostene (Ceremed Inc, Los Angeles, CA) a new, water-soluble polymer wax (WSW). The object of this study was to investigate the impact of topical hemostatic agents on sternal healing in patients. METHODS: In total, 50 patients subjected to elective cardiac surgery and requiring intraoperative hemostatic treatment were randomized to 1 of 2 treatment groups: BW or WSW. Twenty-five patients without need for sternal hemostasis constituted a control group. The doctors analyzing the endpoints were blinded to the treatment. Radiologic bone healing was assessed by a radiologist using computed tomography at 3 and 6 months postoperatively. Quality of life and bodily pain was assessed by questionnaires (Short Form-36 and Visual Analogue Scale). RESULTS: No patients displayed complete radiologic healing at 3 months. Bone healing (evaluated semi-quantitatively at a score from 0 to 10) was significantly impaired in the BW group compared with both the control and WSW groups at both 3 and 6 months postoperatively (p < 0.0001). Radiologic bone healing was positively correlated with physical functioning score (Short Form-36) (p < 0.001). Pain scores were generally low (<1) at both 3 and 6 months with no significant difference between study groups. CONCLUSIONS: The results from this study suggest that WSW provides a useful alternative to BW when topic hemostasis on the sternum is required.

[Successful prehospital diagnosis secures fast and correct treatment of acute aorta dissection]. / Vellykket lægelig præhospitalsvisitation sikrer hurtig og korrekt behandling af akut aortadissektion.

Time from symptom onset to final treatment is crucial for survival. We present a case where prehospital diagnosis by the emergency physician in the ambulance was followed by a telemedicine conference and data transfer to the hospital. This was combined with bypassing of the emergency room and direct transfer to the thoracic surgical theatre, and time to treatment was reduced considerably. Obtaining a prehospital diagnosis in time-dependent life-threatening disease as basement for supportive treatment and transfer directly to treatment is very important.

Left ventricular global systolic longitudinal deformation and prognosis 1 year after femoral and apical transcatheter aortic valve implantation.

BACKGROUND: Aortic valve replacement is the recommended therapy for patients with severe aortic stenosis who have symptoms or decreased left ventricular (LV) function. Transcatheter aortic valve implantation (TAVI) is a treatment alternative in surgically high-risk or inoperable patients with severe aortic stenosis. The objective of this study was to analyze LV function assessed by global LV longitudinal systolic strain (GLS) and relation to prognosis in patients with severe aortic stenosis treated with femoral or apical TAVI. METHODS: Two-dimensional echocardiography was performed before and 1 year after TAVI. Ejection fraction (EF) was retrospectively measured using the biplane Simpson's method, and GLS was obtained as an average of 16 segments in the three standard apical views by speckle-tracking. GE Vivid 7 and Vivid 9 machines were used for echocardiography, and speckle-tracking analysis was performed using EchoPAC PC '08 version 7.0.1. RESULTS: The total population consisted of 100 TAVI patients. Eighty-one patients survived to 1-year follow-up, with a mean age of 81 ± 7 years (range, 64-93 years) and a mean European System for Cardiac Operative Risk Evaluation score of 9.6 ± 2.7. Nineteen patients died before 1-year follow-up (12 women), with a mean age of 82 ± 7 years (range, 66-92 years) and a mean European System for Cardiac Operative Risk Evaluation score of 10.5 ± 2.8. No differences were found between the 19 patients who died before follow-up and the 81 patients who survived to 1-year follow-up. GLS was increased significantly 1 year after TAVI. In 34 patients with EFs > 50%, GLS increased from -15.3 ± 3.4 to -17.1 ± 3.6 (P = .04). In these patients, the mean EF increased numerically from 57.9 ± 5.3% to 60 ± 7.7% (P = .19). In 74 patients with EFs ≤ 50%, mean GLS and EF improved significantly from -10 ± 2.8 to -13.8 ± 3.8 (P < .0001) and 39 ± 9.4% to 52 ± 12.5% (P < .0001), respectively. The 1-year gain in EF was the same after femoral TAVI (9.7 ± 10.1%) and after apical TAVI (8 ± 10.8%) (P = .52). Furthermore, GLS did not differ significantly after femoral and apical TAVI (-3.8 ± 3.3 and -2.6 ± 3.7, respectively, P = .21). There was no difference in causes of death according to approach. In the total population (n = 100), 35 deaths occurred, 19 before 1-year follow-up and 16 afterward. The median follow-up time was 30 months. Twenty-five patients (71%) died from cardiac causes. Overall 1-year mortality was 19%, and overall 2-year mortality was 28%. In the patients who died, the median survival time in the apical group was 28.5 ± 15.4 months, compared with 31.6 ± 19 months in the femoral group (P = .47). There was no impact on prognosis according to high (≥47.5%) versus low (<47.5%) baseline EF or high (≥11.95%) versus low (<11.95%) baseline GLS. However, the magnitude of changes in GLS seemed to have a prognostic impact. CONCLUSIONS: LV EF and longitudinal systolic deformation were improved in TAVI independent of technical approach using the Edwards SAPIEN valve prosthesis during 1-year follow-up. The mortality rate was comparable between technical approaches and independent of baseline LV function. However, patients with the greatest improvement in LV systolic longitudinal deformation after TAVI had a lower mortality rate.

A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial.

AIMS: In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients. METHODS AND RESULTS: The study was designed as a randomised controlled trial of a-TAVI (Edwards SAPIEN heart valve system; Edwards Lifesciences, Irvine, CA, USA) vs. SAVR. Operable patients with isolated aortic valve stenosis and an age ≥75 years were included. The primary endpoint was the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days. After advice from the Data Safety Monitoring Board, the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI group. The primary endpoint was met in five a-TAVI patients (two deaths, two strokes, and one case of renal failure requiring dialysis) vs. one stroke in the SAVR group (p=0.07). In the a-TAVI group, one patient was converted to SAVR because of an abnormally positioned heart, and four patients were re-operated with open heart surgery because of annulus rupture (n=1), severe paravalvular leakage (n=2), and blockage of the left coronary artery (n=1). In the SAVR group, one patient was converted to TAVI because of a large intra-thoracic goitre. CONCLUSIONS: Given the limitations of a small prematurely terminated study, our results suggest that a-TAVI in its present form may be associated with complications and device success rates in low-risk patients similar or even inferior to those found in high-risk patients with aortic valve stenosis. This will probably change in the near future with improved catheter based devices and better pre-procedural assessment.