Minimally Invasive versus Conventional Aortic Root Surgery: Results of an Intermediate-Volume Center.

BACKGROUND: We evaluate the outcome of aortic root surgery via an upper J: -shaped mini-sternotomy (MS) versus full sternotomy (FS) in an intermediate-volume center. METHODS: Between November 2011 and February 2019, 94 consecutive patients underwent aortic root surgery: 62 (66%) patients were operated via a J: -shaped MS (group A) and 32 (34%) patients via FS (group B). The primary endpoints were mortality, major adverse cardiac and cerebral events (MACCE), and reoperation in a 2-year follow-up. The secondary endpoints were perioperative complications and patient's satisfaction with the procedural results. RESULTS: Valve sparing root replacement (David procedure) was performed in 13 (21%) of the MS and 7 (22%) of the FS patients. The Bentall procedure in MS versus FS was 49 (79%) versus 25 (78%), respectively. Both groups presented similar mean operation, cardiopulmonary bypass, and cross-clamp times. Postoperative bleeding was 534 ± 300 and 755 ± 402 mL (p = 0.01) in MS and FS, respectively, erythrocyte concentrate substitution was 3 ± 3 and 5.3 ± 4.8 (p = 0.018) in MS and FS, respectively, and pneumonia rates were 0 and 9.4% (p = 0.03) in MS and FS, respectively. The 30-day mortality was 0% in both groups, whereas MACCE was 1.6 and 3% (p = 0.45) in MS and FS, respectively. After 2 years, the mortality and MACCE were 4.6 and 9.5% (p = 0.11) and 4.6 and 0% (p = 0.66) in MS and FS, respectively. The number of patients who were satisfied with the surgical cosmetic results in groups A and B was 53 (85.4%) and 26 (81%), respectively. CONCLUSION: Aortic root surgery via MS is a safe alternative to FS even in an intermediate-volume center. It offers a shorter recovery time and similar midterm results.

Nucleated red blood cells are a predictor of mortality in patients under extracorporeal membrane oxygenation.

BACKGROUND: The presence of Nucleated Red Blood Cells (NRBCs) in critically ill patients is associated with higher mortality and poor prognosis. Although patients on extracorporeal support such as veno-venous or veno-arterial extracorporeal membrane oxygenation (VV/VA-ECMO) are severely ill, NRBCs have rarely been investigated regarding their predictive value so far. METHODS: As part of a retrospective study, we examined all cardiothoracic surgery patients from July 2019 to September 2020 who received ECMO treatment during their inpatient stay. The aim of this study was to investigate the occurrence of NRBCs during ECMO support in terms of their predictive value for mortality. RESULTS: In total 30 patients (age at admission: 62.7 ± 14.3 year; 26 male; ECMO duration: 8.5 ± 5.1 days; ICU duration: 18.0 ± 14.5 days) were included. 16 patients (53.3%) died during their inpatient stay. There were no significant differences in demographic characteristics between VA- or VV- ECMO patients. NRBCs occurred in all patients while under ECMO support. NRBC value was significant higher in those who died (2299.6 ± 4356.6 µl) compared to the surviving patients (133.6 ± 218.8 µl, p < 0.001). Univariate analysis found that patients with a cutoff value of ≥ 270 NRBCs/µl during ECMO support were 39 times more likely to die (OR 39.0, 95% CI 1.5-997.5, p < 0.001). 12 out of 13 patients (92.3%) with ≥ 270 NRBCs/µl died. The area under the curve (AUC) of the receiver operating characteristic curve was 0.85 (95% CI 0.69-0.96) with a sensitivity of 75.0% and a specificity of 92.9%. CONCLUSION: NRBCs appear to be an accurate biomarker for mortality in patients with ECMO support. They may be helpful in deciding if therapy becomes futile. Trial registration DRKS00023626 (December 20th 2020).

Statin loading before coronary artery bypass grafting: a randomized trial.

AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.

Early-Term Results of Rapid-Deployment Aortic Valve Replacement versus Standard Bioprosthesis Implantation Combined with Coronary Artery Bypass Grafting.

OBJECTIVES: Aortic stenosis is highly prevalent among patients with concomitant coronary artery disease. Surgical aortic valve replacement with coronary artery bypass grafting is usually the treatment of choice for patients with severe aortic stenosis and significant coronary disease. The aim of this study was to evaluate the outcome and hemodynamic results of the implantation of rapid-deployment valves (Rapid-Deployment Edwards Intuity Valve System [RDAVR]) versus conventional sutured valves (CSAVR) in combined surgery. METHODS: Between January 2012 and January 2017, 120 patients underwent replacement via RDAVR and 133 patients underwent replacement using CSAVR with concomitant coronary bypass grafting. Clinical and echocardiographic data were compared. RESULTS: The mean age was 76 ± 7 for RDAVR patients and 74 ± 6 years for CSAVR patients (p = 0.054); 48% in the RDAVR group were female versus 17% in the CSAVR group (p <0.002). Other characteristics such as diabetes mellitus, body-mass index, chronic obstructive pulmonary disease, nicotine consumption, and extracardiac arteriopathy were similar. Coronary three-vessel disease was more common in the RDAVR group (42.5 vs. 27.8%, p = 0.017). Both mean EuroSCORE II (6.6 ± 5.4 vs. 4.3 ± 3.0, p = 0.001) and STS score (5.4 ± 4.4 vs. 3.4 ± 2.4, p = 0.001) were significantly higher in the RDAVR group. Mean cross-clamp time (82 ± 25 vs. 100 ± 30 minutes, p < 0.001) and cardiopulmonary bypass time (119 ± 38 vs. 147 ± 53 minutes, p < 0.001) were shorter with RDAVR. The mean number of bypass grafts, length of hospital and ICU stays, and mechanical ventilation time were not statistically significant different. Hospital mortality was 2.5% for RDAVR and 9.7% for CSAVR (p = 0.019). There was a similar rate of stroke (5.8 vs. 6.0%, p = 0.990) and postoperative delirium (14.1 vs. 15.8%, p = 0.728). Mean gradients were 8.2 ± 4.1 mm Hg in the RDAVR group vs. 11.3 ± 4.6 mm Hg in the CSAVR group (p = 0.001) at discharge. CONCLUSION: RDAVR combined with coronary artery bypass grafting (CABG) can be performed extremely safely. Cross-clamp and cardiopulmonary bypass times can be significantly reduced with rapid deployment aortic valve system in the scenario of combined CABG. RDAVR resulted in lower gradients than CSAVR in patients implanted with prostheses of the same size.

Modified transapical-transcatheter aortic valve implantation.

Background and Aim: Some transcatheter aortic valve implantation (TAVI) candidates present with ubiquitary arterial disease with massive calcification burden and stenoses in the whole arterial tree and cannot undergo any transvascular TAVI-approach. Moreover, a history of previous coronary surgery including LIMA-LITA in situ bypass grafting, previous carotid surgery or stenosis/occlusions, a concomitant porcelain aorta, Leriche syndrome, diverse other aortic diseases, arterial occlusions, or a chronic dialysis with arteriovenous shunt are common in such patients with end-stage peripheral artery disease, making even a minimal artery access impossible. For patients without arterial access or at very high risk for artery injury, we modified the transapical-TAVI method to ensure artery-no-touch-technique. We employed this technique in six patients without procedural and in-hospital complications. Relevance for Patients: A high-grade aortic stenosis is a serious disease. Untreated patients exhibit poor survival. Only surgery or TAVI is valid therapy concept for treatment. However, some patients can undergo neither surgery nor TAVI, because of an extensive surgical risk or inoperability, whereas at the same time, no arterial approaches are available due to extensive, end-stage panarteriopathy. For these high-specific patients, our modified, artery-no-touch-TA-TAVI is an appropriate method and can be safely used.

Long-term Follow up after Transfemoral Transcatheter Aortic Valve Implantation in Lower Risk Patients Using the Balloon-Expandable Bioprosthesis: Gender-Dependent Outcomes.

INTRODUCTION: Long-term data on gender-related outcomes after transfemoral transcatheter aortic valve implantation (TF-TAVI) using newer generations heart valves in lower-risk patients are sparse. We aimed to evaluate gender-dependent long-term outcomes after TF-TAVI in lower-risk patients using the third-generation balloon expandable bioprosthesis. METHODS: Data of 103 patients undergoing TF-TAVI using the third-generation balloon expandable bioprosthesis were analyzed. We conducted up to six years follow up and performed comparison on gender basis: men (45 patients; 82 ± 4.7 years; STS Score 3.7 ± 1.6%) vs. women (58 patients; 83.2 ± 4.5 years; STS Score 3.6 ± 1.8%). The mean follow-up time was 30 months. RESULTS: Cardiovascular risk factors at baseline were similar, without significant differences between men and women. The 30-day mortality was 4.4% in men vs. 3.4% in women (P = 0.745). The 30-day stroke was 4.4% in men vs. 1.7% in women (P = 0.582). The major vascular injury rate and the pacemaker rate was 2.3% vs. 10.7% (P = 0.134) and 19.5% vs. 18.9% (P = 1) in men vs. women, respectively. There was a significant difference of mean long-term survival: men, 42.1 months [95%CI: 33.154-51.101] vs. women, 57.3 months [95%CI: 50.618-64.159], P = 0.015. CONCLUSION: Although considerably more prone to procedural complications, women had a significantly long-term survival benefit after TF-TAVI in lower-risk patients despite similar baseline characteristics.

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.

Transapical-transcatheter aortic valve implantation in patients without transvascular options: Modified transapical approach.

OBJECTIVES: Outcomes in patients with iliofemoral and concomitant iliofemoral-remote arteriopathies who cannot undergo transfemoral or other alternative transvascular approaches have not been studied so far. This study aimed to evaluate the early and midterm outcomes after transapical (TA)-transcatheter aortic valve implantation (TAVI) in patients with femoral and femoral-remote arteriopathies who cannot undergo transvascular approaches. METHODS: Multimorbid patients with severe aortic stenosis and distinct panarteriopathy underwent TA-TAVI treatment between January 2012 and January 2021 at the authors' institution. Second- and third-generation self- and balloon-expanding valves were used. For patients without arterial access, TA-TAVI was modified to the artery-no-touch technique. RESULTS: Seventy-two consecutive elderly patients (78.2 ± 6.9 years; 73% male) were included in the study. The Society of Thoracic Surgery-Predicted Risk of Mortality score was 7 ± 5%. No procedural deaths or conversion to conventional surgery was registered. The 30-day and midterm mortality rates were 5% and 28%, respectively. The median time of freedom from a composite of death and cardiocerebral adverse events was 34.3 months (95% confidence interval: 17.6-51.1). The rate of moderate/severe paravalvular leakage was 0%. The pacemaker rate was 11%. CONCLUSIONS: TA-TAVI is a safe method with low-rate procedural complications and shows good early and midterm outcomes in patients with extensive panarteriopathy for whom transfemoral and other alternative transvascular approaches are contraindicated or at high interventional risk. The modified artery-no-touch TA-TAVI method is safe and feasible for selected patients with no other possible arterial approach.

Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial.

BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [ΔSOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for ΔSOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, ΔSOFA, did not differ between the hemoadsorption and the control group (1.79±3.75 and 1.93±3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1ß and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03266302.

Efficacy of Auricular Acupuncture and Lavender Oil Aromatherapy in Reducing Preinterventional Anxiety in Cardiovascular Patients: A Randomized Single-Blind Placebo-Controlled Trial.

Introduction: Auricular acupuncture at the "relaxation point" and lavender oil aromatherapy can reduce preoperative anxiety associated with increased mortality and morbidity. Data on the effect of combined auricular acupuncture and lavender oil aromatherapy in patients undergoing cardiovascular interventions with the use of local anesthesia or under conscious sedation are sparse. The authors sought to evaluate the efficacy of auricular acupuncture and lavender oil aromatherapy in reducing preinterventional anxiety in cardiovascular patients. Materials and Methods: Data of 80 consecutive patients undergoing diagnostic coronary angiography (n = 56) with or without percutaneous coronary intervention (n = 9) and right heart catheterization (n = 6), transcatheter aortic valve replacement (n = 17) and percutaneous mitral valve repair (MitraClip; n = 2) were analyzed. Patients were prospectively randomized to receive either preinterventional auricular acupuncture and lavender oil (Lavandula angustifolia) aromatherapy (verum group, n = 39) or combined sham auricular acupuncture and placebo oil aromatherapy (placebo group, n = 41). For the verum group bilateral auricular acupuncture was performed at the "relaxation point." State anxiety and blood pressure were assessed before and at 30 min after acupuncture and presternal oil application. State anxiety was defined as primary outcome measure and assessed using the Spielberger State Anxiety Inventory (STAI) for Adults form Y6. Intervention-specific anxiety was assessed by a 10-point numerical rating scale, and perceived treatment success by a single dichotomous question. Clinical blood pressure was further assessed. Results: After the intervention, the verum group had significantly decreased anxiety on the STAI compared with the placebo group (Δ = -4.18; 95% confidence interval = -8.31 to -0.05; p = 0.047). Significantly more patients reported subjective treatment success in the verum group (87.2%) than in the placebo group (65.9%, p = 0.035). No significant differences were observed regarding intervention-specific anxiety and blood pressure between the two groups. No serious adverse events occurred in any group. Conclusions: Combined auricular acupuncture and lavender oil aromatherapy can decrease preinterventional anxiety in cardiovascular patients and requires further investigation. German Clinical Trials Register (registration no. DRKS00023686).

Early Results after Aortic Valve Replacement Using Last Generation Bioprosthetic Aortic Valve.

INTRODUCTION: Few data are available about the newest generation surgical bioprosthesis. We aimed to evaluate early clinical and hemodynamic outcomes after using the INSPIRIS RESILIA aortic valve (Edwards Lifesciences, Irvine, California, USA). METHODS: Between July 2018 and April 2021, 80 patients underwent aortic valve replacement receiving the INSPIRIS RESILIA aortic valve at our institution. Primary outcomes were the composite of early mortality, stroke, and myocardial infarction. Secondary outcomes were hemodynamic performances of the valve, paravalvular leakage, and new pacemaker implantation. RESULTS: The mean age of the study population was 60.6 ± 8.3 years. The mean Society of Thoracic Surgery-Predicted Risk of Mortality score was 2.9 ± 1.7%. In 43.7% of the patients, concomitant surgery was performed. The in-hospital mortality, all-stroke, and myocardial infarction rates were 2.5%, 1.2%, and 1.2%, respectively. No valve was explanted and no redo was performed. The mean postoperative trans-prosthetic gradient at discharge was 10.2 ± 4.1 mm Hg. There was no need for new pacemaker implantation. We registered only two cases with minimal (trace) paravalvular leakage. CONCLUSION: The use of the INSPIRIS RESILIA aortic valve in a young, low-risk population is safe and associated with very good early clinical and hemodynamic outcomes.

Surgical Resection of Very Small Multiple Papillary Fibroelastomas of the Aortic Valve.

Papillary fibroelastomas (PFEs) in multiple presentations on the aortic valve surface are extremely rare tumors that can cause sudden major cardio-cerebral adverse events. The treatment of these tumors varies from conservative care strategy to curative surgical resection. The bigger the tumor size, the bigger seems the tendency toward surgical treatment concepts. Here, we present the case of a completely healthy young woman who suffered sudden myocardial infarction and occlusion of the circumflex artery caused by very small multiple PFEs of the aortic valve. The patient underwent cardiac surgery for resection at our institution. The surgical approach appears to be recommended as a solitary reasonable treatment option once multiple PFEs have been detected.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

Impact of diverse aortic pathologies on outcomes after transapical transcatheter aortic valve replacement.

OBJECTIVES: Some patients who undergo transcatheter aortic valve replacement (TAVR) have a concomitant diverse aortic pathologies (AP). They are usually considered high-risk candidates for the procedure and require further assessment to determine the best vascular approach. The impact of these AP on TAVR is not well known as the information is scarce. We aimed to evaluate midterm clinical impact of different AP after transapical (TA)-TAVR. METHODS: Twenty patients with atherosclerotic/occluding aortic diseases (A/OAD) (porcelain aorta, Leriche Syndrome, penetrating aortic ulcer, and aortic thrombus), 24 patients with aortic morphologic diseases (AMD) (thoracic/abdominal aortic aneurysms, aortic kinking, aortic type B dissection, aortic elongation/tortuosity, and previous aortic intervention), and 11 patients with combined aortic diseases (CAD) underwent TA-TAVR treatment between January 2011 and November 2019 at our center. We conducted up to 5-years clinical follow-up. RESULTS: All patients were classified in the heart team as a high interventional risk. The 30-day mortality and stroke were 5% and 10% in the A/OAD, 8.3% and 0% in the AMD, and 0% and 0% in the CAD, respectively. The median time of freedom from a composite of death and cardio-cerebral adverse events was 22.1 months [95% confidence interval [CI]: 9.9-34.3] in A/OAD versus 34.3 months [95% CI: 15.6-53] in AMD versus 17 months [95% CI: 0-39.4] in CAD; p = .525. We registered neither procedural aortic injury nor aortic syndrome at follow-up. The moderate/severe paravalvular leakage rates were 5%, 0% and 0% in the A/OAD, AMD and CAD, respectively. CONCLUSION: Independent of underlying AP, the TA-TAVR is a safe method and shows very promising early and midterm outcomes in patients with various AP.

Transapical transcatheter aortic valve implantation in patients with aortic diseases.

OBJECTIVES: Patients scheduled for transcatheter aortic valve implantation (TAVI) treatment frequently present with concomitant aortic diseases, in which case they are usually considered to be at high interventional risk and, in particular, unable to undergo the transfemoral TAVI approach. Since the establishment of the 'transfemoral first' strategy for TAVI, there has been an evidence gap with regard to the outcomes of such patients. We aimed to evaluate the mid-term outcomes after transapical TAVI in patients with diverse aortic diseases. METHODS: Fifty-five consecutive elderly patients (78.4 years; standard deviation: 8.6 years) at intermediate surgical risk with severe aortic stenosis and aortic diseases (porcelain aorta 36%, ascending aneurysm 15%, descending aneurysm 26%, type-B dissection 4%, aortic thrombus 7%, Leriche syndrome 4%, aortic kinking 11%, aortic ulcer 2%, previous aortic operation 20%, aortic elongation/tortuosity 4%) underwent transapical TAVI treatment between January 2011 and November 2019 at our institution. We used the second-and third-generation self- and balloon-expanding valves. The follow-up time was 92.6 patient-years. RESULTS: The Society of Thoracic Surgery-Predicted Risk of Mortality score was 7% (standard deviation: 4%). The 30-day mortality and all-stroke rates were 6% and 4%, respectively. The median survival time was 24.9 months (95% confidence interval 17.6-32.3). The median time of freedom from a composite of death and cardio-cerebral adverse events was 24.3 months (95% confidence interval 11.9-36.8). The rate of moderate/severe paravalvular leakage was 2%. The pacemaker rate was 10%. No early or late aortic syndrome occurred. CONCLUSIONS: Transapical TAVI is a safe method and shows very promising early and mid-term outcomes, without early/late aortic syndrome, in patients with aortic diseases for whom transfemoral TAVI as the first-line transcatheter method might be contraindicated or not feasible.

Transcatheter aortic valve replacement using the SAPIEN 3 valve versus surgical aortic valve replacement using the rapid deployment INTUITY valve: Midterm outcomes.

OBJECTIVES: Little data have been published on the midterm effect of transapical/transfemoral-transcatheter aortic valve replacement (TA-/TF-TAVR) using the Edwards SAPIEN 3 valve (S3). We aimed to compare the outcomes after TA-/TF-TAVR utilizing the S3 (TA-/TF-S3) valve with those after surgical aortic valve replacement utilizing the rapid deployment Edwards INTUITY valve (RD-SAVR). METHODS: Between March 2012 and April 2018, 122 patients with aortic stenosis underwent TA-S3, 77 patients underwent TF-S3 and 182 patients underwent RD-SAVR through partial sternotomy at our institution. We conducted clinical and echocardiographic midterm follow-ups. The primary outcomes of the study were the incidence of new pacemakers permanent pacemaker implantation (PPI), the occurrence of paravalvular leakage (PVL) and the hemodynamic performance of the valves. RESULTS: All study groups were at intermediate surgical risk. The 30-day all-cause mortality and stroke rates in the TA-S3, TF-S3, and RD-SAVR groups were 4.1% and 1.6%, 3.9% and 2.6%, and 3.8% and 2.2%, respectively. The RD-SAVR group had significantly smaller PVL and PPI rates than did the TA-/TF-S3 group (p < .0001). At the discharge, the one-year postprocedure mean gradients were 9 ± 5.1/10 ± 4.5 mmHg, 11 ± 4.1/12 ± 3.8 mmHg, and 10.1 ± 4.3/10.4 ± 2.6 mmHg in the TA-S3, TF-S3, and RD-SAVR groups, respectively. Midterm valve thrombosis, Re-TAVR/SVAR were low and similar among the study groups, whereas endocarditis was higher in the TAVR group. CONCLUSION: RD-SAVR was superior to TA-/TF-S3 in the PVL and PPI rates. We observed similar early outcomes and valve hemodynamics. The endocarditis was higher in the TAVR group.

Transapical-transcatheter aortic valve implantation using the Edwards SAPIEN 3 valve.

BACKGROUND: Scarcely any data has been published on the mid-term effect of transapical-transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 valve (S3; Edwards Lifesciences Corp., Irvine, CA, USA). We present mid-term clinical and echocardiographic outcomes after TA-TAVI utilizing S3. METHODS: Between 02/2014-06/2017, 122 elderly patients with severe aortic stenosis underwent TA-TAVI utilizing S3 at our institution. We conducted clinical and echocardiographic follow-up. The mean follow-up was 15 months. All end-point-related outcomes were adjudicated according to Valve Academic Research Consortium-2 definitions. RESULTS: The STS-score of the entire cohort was 6.26±4.6. More than one-third of the patients exhibited severe peripheral artery disease. The 30-d all-cause mortality, all-stroke rate, and myocardial infarction of the entire cohort were 4.1%, 1.6%, and 0.8% respectively. Median survival time of the entire cohort was 35 months. The cumulative mid-term myocardial infarction and stroke rate was 2.6% and 3.5%, respectively. The postoperative moderate/severe paravalvular leakage occurred in 1.6% of cases. At discharge, one-year and two-year postprocedure peak/mean gradients were 16.6±8.3/ 9±5.1 mmHg, 18±6.9/ 10±4.5 mmHg, and 22.2±5.4/ 12.8±4.6 mmHg, respectively. The rate of new pacemaker cases was 14.1%. Acute kidney injury network 2/3 appears, as an independent predictor of mortality. CONCLUSIONS: We observed very promising early and mid-term clinical outcomes with a high degree of device success and good hemodynamic performance after TA-TAVI using the S3 in the intermediate risk patient profile.

Single-Center Outcomes with Rapid Deployment Aortic Valve Replacement.

OBJECTIVES: Rapid-deployment valves can reduce procedural times and may facilitate minimally invasive surgery. In our institution, more than 500 patients underwent rapid deployment aortic valve replacement (AVR). METHODS: A total of 510 patients underwent rapid deployment AVR between March 2012 and September 2017, of whom 270 patients underwent isolated AVR and 240 underwent AVR with concomitant procedures. The cumulative follow-up time was 1,444 patient-years, the median follow-up time 2.8 years, respectively RESULTS: An early all-cause mortality of 3.5% (n = 18) was seen with a cumulative survival of 91.9 ± 2.2% after 12 months. Mean cross-clamp times were 37 ± 19 minutes for isolated AVR and 93 ± 29 minutes for AVR with concomitant procedures. The rate of new pacemaker implantation was 7.8% (n = 40). No case of structural degeneration occurred in the follow-up. Three (0.6%) cases of endocarditis were registered. CONCLUSIONS: Rapid deployment AVR can be performed safely with low complication rates and good hemodynamic results. Therefore, the relevance in aortic valve surgery can be stressed.

Oversized versus Non-oversized Prosthesis: Midterm Outcomes after Transcatheter Aortic Valve Replacement Using SAPIEN 3 Valve.

BACKGROUND: A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical-transcatheter aortic valve replacement (TA-TAVR). METHODS: Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort. RESULTS: The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality. CONCLUSION: Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.