Preprocedural assessment of coronary artery disease in patients undergoing transcatheter aortic valve implantation: Rationale and design of the EASE-IT CT registry.

BACKGROUND: Invasive coronary angiography (ICA) is the standard for pre-procedural assessment of coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI). However, it requires hospitalization and can be associated with complications. Computed tomography angiography (CTA) may be a viable alternative to rule out prognostically relevant CAD. METHODS: The EASE-IT CT Registry is an investigator-initiated, prospective, observational, multicentre pilot registry involving patients aged ≥75 years with severe aortic stenosis (AS) intended to implant a transcatheter heart valve (THV) of the SAPIEN family. A total of 150 patients will be recruited from four sites in Germany and Austria. The registry will consist of two prospective cohorts: the investigational CTA-only cohort and the CTA + ICA control cohort. The CTA-only cohort will enrol 100 patients in whom significant (≥50%) left main (LM) and/or proximal left anterior descending artery (LAD) stenosis are ruled out on CTA. The CTA + ICA control cohort will enrol 50 patients who have undergone both CTA and ICA before TAVI and in whom ≥50% LM/proximal LAD stenosis has been ruled out by CTA. Three composite endpoints will be assessed at 3 months post-TAVI: CAD-specific endpoints, VARC-3-defined device success and early safety. CONCLUSION: The EASE-IT CT Registry evaluates whether TAVI can be carried out safely without performing ICA if prognostically relevant CAD of the LM/proximal LAD is ruled out with CTA. If so, the omission of ICA would help streamline the pre-procedural workup of TAVI patients.

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).

Urgent Endovascular Aortic Repair Requiring Coverage of the Left Subclavian Artery.

BACKGROUND: Evaluation of the optimal left subclavian artery (LSA) management during thoracic endovascular aortic repair (TEVAR) involving the distal aortic arch in an urgent setting. METHODS: A total of 52 patients with acute aortic syndromes underwent TEVAR (March 2017 to May 2021) requiring proximal landing in the distal aortic arch. Decision for partial or complete LSA ostial endograft coverage, with or without additional bypassing, was made depending upon the aortic pathology and vascular anatomy. We focused on the patency of the circle of Willis and the unilateral dominance of one carotid or a vertebral artery: 35% underwent complete (complete LSA group) and 17% partial LSA coverage (partial LSA group), whereas in 48% the LSA was reached only by the bare springs of the endograft (control group). A total of 22% of the complete LSA group underwent LSA bypass before TEVAR, whereas 11% underwent cerebrospinal fluid drainage. Endpoints were 30-day and 1-year mortality, stroke, spinal cord ischemia (SCI), and malperfusion. RESULTS: Technical success was achieved in 96%. The endograft length was 171 ± 34 (complete LSA group) versus 151 ± 22 (partial LSA group) versus 181 ± 52 mm (control group), covering 6 ± 2 versus 5 ± 1 versus 7 ± 2 intercostal arteries. The 30-day mortality, stroke and SCI rates did not differ. One patient with arm malperfusion underwent LSA bypass post-TEVAR. After 1 year, aortic interventions occurred in 6 (complete LSA group) versus 22 (partial LSA group) versus 13% (control group). One-year mortality (0 vs. 0 vs. 8%), stroke (6 vs. 0 vs. 4%), and SCI (0 vs. 0 vs. 4%) were similar between groups. CONCLUSION: With an adequate analysis of vascular anatomy, coverage of the LSA for TEVAR is safe and may offer results similar to TEVAR starting distal to the LSA.

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.

Outcomes in Patients with Left Bundle Branch Block after Rapid Deployment Aortic Valve Replacement.

OBJECTIVES: Increased rates of postoperative left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) frequently occur after implantation of rapid deployment valves. The impact of LBBB on follow-up outcomes remains controversial. So far, no data regarding long-term outcomes exist. AIM: The aim of this study was to analyze the impact of LBBB on postoperative outcomes after rapid deployment aortic valve replacement (RDAVR). METHODS: A total of 620 consecutive patients without preexisting LBBB or PPI who underwent rapid deployment AVR between March 2012 and September 2019 were included. New-onset LBBB was defined as any new LBBB that persisted at hospital discharge. The median follow-up time for clinical data was 1.7 years post-RDAVR. RESULTS: At discharge, new-onset LBBB was seen in 109 patients (17.5%). There were no differences between the LBBB groups and no-LBBB groups regarding baseline characteristics. At a median follow-up of 1.7 years, no difference was found between LBBB groups and no-LBBB groups concerning all-cause mortality (12.8 vs. 11.7%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.74-1.53; p = 0.54). Nevertheless, new-onset LBBB was associated with significant higher pacemaker implantation rates at follow-up (10.1 vs. 6.3%; HR: 3.58; 95% CI: 1.89-6.81 p < 0.001). CONCLUSION: After a median follow-up of 1.7 years, new-onset LBBB was not associated with increased mortality. Nevertheless, higher pacemaker implantation rates were observed in patients with new-onset LBBB after RDAVR.

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.

Long-Term Outcomes After Transfemoral-Transcatheter Aortic Valve Implantation in Very Old Patients Using the Balloon-Expandable Bioprosthesis.

Transcatheter aortic valve implantation (TAVI) can be safely performed in old patients. Increasing longevity raises often the question whether TAVI can be still useful for patients beyond a certain age limit. Data on long-term outcomes of elderly patients after TAVI are sparse. We sought to assess the impact of very advanced age on long-term outcomes after transfemoral (TF)-TAVI. Data of 103 patients undergoing TF-TAVI with the balloon-expandable bioprosthesis between May/2014 and May/2019 were analyzed. We divided the cohort into two age groups: ≥85 years (group1: n = 37; 87.5 ± 2.6 years; STS-Score 3.9 ± 1.4) versus < 85 years (group2: n = 66; 80 ± 3.1 years; STS-Score 3.4 ± 1.8). We conducted up to 6 years clinical follow-up. Overall mortality at 30 days was 3.8% without significant differences between the two age groups. Incidence of major vascular injury (8.6 vs. 6.3%, p = .695) and stroke (2.8 vs. 3%, p = 1) was not significantly different between group 1 and 2, respectively. More than mild paravalvular leakage was found in 1 patient (group 1). The mean long-term survival probability was 51.3 months [95% CI: 42.234-60.430] in group 1 versus 49.5 months [95% CI: 42.155-56.972] in group2 (p = .921). Long-term outcomes of very old patients after TF-TAVI show a similar treatment benefit compared to the younger patients.

Use of On-Site Digital Subtraction Angiography for Left Subclavian Artery Management During Hybrid Aortic Arch Repair in DeBakey I Dissection.

PURPOSE: A hybrid aortic repair using the frozen elephant trunk (FET) technique with an open distal anastomosis in zone 2 and debranching of the left subclavian artery (LSA) has been demonstrated to be favorable and safe. Although a transposition of the LSA reduces the risk of cerebellar or medullar ischemia, this may be challenging in difficult LSA anatomies. CASE REPORT: We present the case of a 61-year old patient with DeBakey I aortic dissection, treated with FET in moderate hypothermic circulatory arrest (26°C) and selective cerebral perfusion using a Thoraflex-Hybrid (Vascutek Terumo) prosthesis anchored in zone 2, with overstenting of the LSA orifice and no additional LSA debranching. Sufficient perfusion of the LSA was proved intraoperatively using LSA backflow analysis during selective cerebral perfusion in combination with on-site digital subtraction angiography (ARTIS Pheno syngo software). No neurologic dysfunction or ischemia occurred in the postoperative course. An angiographic computed tomography revealed physiologic LSA perfusion, with subsequent thrombotic occlusion of the false lumen in the proximal descending aorta after 7 days. CONCLUSION: Using an angiography-guided management in patients with complex DeBakey I dissection and difficult anatomy may simplify a proximalization of the distal anastomosis in zone 2 for FET, even without an additional LSA debranching.

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).

Transcatheter Aortic Valve Implantation in Patients Who Cannot Undergo Transfemoral Access.

INTRODUCTION: Though transfemoral (TF) access has emerged as a gold standard access for patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI), there has been no study that has characterized patients who cannot undergo TF access in detail. We aim to evaluate the contraindications for TF access, their incidence, classify them, and provide the outcomes of patients who failed to be TF candidates. METHODS: From 925 patients who underwent TAVI between February 2014 and May 2020 at our heart center, 130 patients failed to be TF candidates and underwent transapical-transcatheter aortic valve implantation (TA-TAVI). In this study, we included all those patients who failed to be TF candidates and underwent TA-TAVI using the third-generation balloon expandable valve (Edwards SAPIEN 3 valve [S3]) (116 patients; STS score 6.07 ± 4.4; age 79.4 ± 7). RESULTS: The incidence of patients unsuitable for TF access at our heart center was 14%. We classified this TAVI population into absolute contraindication for TF access n = 84 (72.5%) and increased interventional risk for TF access n = 32 (27.5%). After TA-TAVI of this specific population using S3, the in-hospital mortality and stroke were 1.7 and 1.7%, respectively. The vascular injury rate was 1.7%. We registered no paravalvular leakage ≥2. The pacemaker rate was 7.4%. The mean transvalvular pressure gradient was 8.7 mm Hg. CONCLUSION: The incidence of patients who cannot undergo TF access or who are at high interventional risk is considerably high. TA-TAVI, supported with sufficient interventional experience and appropriate valve system, represents an excellent alternative for patients with distinct vasculopathy.

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.

Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study.

BACKGROUND: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. METHODS AND RESULTS: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe). CONCLUSIONS: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.

Incidence and Impact of Routine Inflammatory Parameters on Outcome after Transcatheter Aortic Valve Replacement.

BACKGROUND: Previous research reported adverse clinical outcomes in association with systemic inflammation (SI) after transcatheter aortic valve replacement (TAVR). However, data characterizing the impact of SI, as reflected by postprocedural routine inflammatory parameters (pRIP), on clinical outcome of patients undergoing TAVR are sparse. OBJECTIVES: In light of this, the present work aimed to analyze incidence and clinical significance of pRIP after transapical (TA) and transfemoral (TF)-TAVR. METHODS AND RESULTS: Data of 81 high-risk consecutive patients undergoing TAVR in our center from 2017 to 2018 were analyzed in a retrospective manner. 40 out of 81 patients (49, 4%) were treated via TF access (group A) and 41 patients via TA access (group B). Incidence, cause, and amplitude of pRIP were analyzed in relation to pre- and peri-interventional data. Assessment of outcomes was conducted according to the valve academic research consortium (VARC-2). Postprocedural C-reactive protein (pCRP) and leucocytes (pL) were significantly increased in patients undergoing TA-TAVR (group B) vs. TF-TAVR (group A; 12.1 ± 9.7 vs. 22.1 ± 7.9 mg/dl, p < 0.001 and 12.8 ± 4.0 vs. 14.2 ± 3.8/nl, p = 0.002); however, there was no significant difference regarding incidence of postprocedural fever (pF) ≥38.0°C (12.5% vs. 22%, p = 0.37). Furthermore, we observed a vast (though insignificant) trend towards a longer fever duration in group B vs. group A (9.9 ± 14.9 vs. 3.2 ± 5.9 hours, p = 0.06). Further analysis identified pCRP >30 mg/dl (hazard ratio (HR) 3.15, confidence interval (CI) 1.22-8.14, p = 0.018) and European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE I (ES)) >20% (HR 2.95, CI 1.17-7.47, p = 0.02) as predictors of mortality; in this context, we also discovered a marginally significant trend for pL > 14/nl (HR 2.44, CI 0.97-6.14, p = 0.05). Multivariate analysis by use of the fisher`s exact test revealed a significant association between pCRP >30 mg/dl and ES >20% (p < 0.001). CONCLUSION: pRIP are significantly increased in patients undergoing TA-TAVR. pCRP >30 mg/dl, ES>20%, and pL > 14/nl are hallmark of adverse prognosis and require further investigation.