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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes after transcatheter aortic valve replacement in older patients.

BACKGROUND: The prevalence of aortic valve stenosis is increasing due to the continuously growing geriatric population. Data on procedural success and mortality of very old patients are sparse, raising the question of when this population may be deemed as "too old even for transcatheter aortic valve replacement (TAVR)." We, therefore, sought to evaluate the influence of age on outcome after TAVR and the impact of direct implantation. METHODS: The data of 394 consecutive patients undergoing TF-TAVR were analyzed. Patients were divided into four age groups: ≤75 (group 1, n = 28), 76-80 (group 2, n = 107), 81-85 (group 3, n = 148), and >85 (group 4, n = 111) years. Direct implantation was performed when possible according to current recommendations. Survival was evaluated by Kaplan-Meier analysis. RESULTS: Mortality at 30 days and 1 year was not significantly different between the four age groups (3.6 vs. 6.7 vs. 5.4 vs. 2.7% and 7.6 vs. 17 vs. 14.5 vs. 13%m respectively, log-rank p = 0.59). Direct implantation without balloon aortic valvuloplasty was more frequently performed on patients aged >85 vs. ≤85 years (33.3 vs. 14.1%, p < 0.001). the incidence of procedural complications frequently associated with advanced age (stroke, vascular complications) was not significantly increased in group 4. CONCLUSION: Outcome after TF-TAVR is comparable among different age cohorts, even in very old patients. Direct implantation simplifies the procedure and could therefore play a role in reducing the incidence of peri-interventional complications in patients of advanced age.

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.

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.

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.

Intermediate Outcomes after Rapid Deployment Aortic Valve Replacement in Multiple Valve Surgery.

BACKGROUND: Multiple valve surgery is associated with significant higher operative risks. Reduced cross-clamp and cardiopulmonary bypass times in multiple valve surgery may potentially be beneficial as they can be considered independent risk factors for increased morbidity and mortality following cardiac surgery. We report first intermediate outcomes of the Edwards Intuity valve system (Edwards Lifesciences, Irvine, California, United States) in combined procedures METHODS: Fifty-eight patients underwent rapid deployment aortic valve replacement with concomitant mitral valve surgery between January 2014 and November 2017 in our institution. The valve was assessed echocardiographically after 12 months. The median follow-up was 1.7 years with a cumulative follow-up time of 115.3 patient years. RESULTS: The mean age was 73.5 ± 6.2 years and the mean logistic Euroscore was 11.6 ± 3.1%. Concomitant mitral valve repair was performed in 43 cases (74.1%), and mitral valve replacement in 15 cases (19.0%). The mean cross-clamp time was 93 ± 21 minutes along with a mean bypass time of 118 ± 24 minutes. All-cause mortality after 30 days was 8.6%. Overall actuarial survival at 1 year was 87.2 ± 4.5% and after 2 years 82.8 ± 5.3%, respectively. CONCLUSIONS: Rapid deployment aortic valve replacement in multiple valve surgery can be performed safely with good intermediate outcomes in elderly, high-risk patients.

Mid-Term Outcomes after Transapical and Transfemoral Transcatheter Aortic Valve Implantation for Aortic Stenosis and Porcelain Aorta with a Systematic Review of Transfemoral versus Transapical Approach.

BACKGROUND: We have aimed to analyze early and mid-term outcomes of patients undergoing transapical/transfemoral transcatheter aortic valve implantation (TA-/TF-TAVI) for aortic stenosis and porcelain aorta (PAo) in our institution. Additionally, we postulated that the TA approach may be associated with a more favorable neurological outcome than the TF approach; hence, a systematic literature review was conducted. METHODS: Between 2011 and 2017, 15 patients with PAo underwent TA-TAVI and 4 patients with PAo TF-TAVI at our institution. The assessment of PAo was done either intraoperatively after aborted sternotomy or via computed tomography for elective TAVI. We conducted mid-term follow-up. Furthermore, a systematic review was performed to compare the mortality and neurological outcomes of TF and TA-TAVI approaches. RESULTS: TA/TF-TAVIs were performed with 100% device success, without paravalvular leakage ≥ 2 and without procedural death. The 30-day mortality/stroke rates were 6.6%/0% in TA-TAVI and 0%/25% in TF-TAVI, respectively. The 6-month, 1-year, and 2-year survival rates were in TA/TF-TAVI 93%/75%, 82%/66.6%, and 50%/0%, respectively.The pooled results derived from the literature review were as follows: The prevalence of PAo in the TAVI population is 9.74%; the mean logistic EuroSCORE is 41.9% in TA-TAVI versus 16.2% in TF-TAVI; the mean 30-day mortality is 5.9% in TA-TAVI versus 6.3% in TF-TAVI, and the mean stroke is 0.8% in TA-TAVI versus 9% in TF-TAVI. CONCLUSION: TA-TAVI shows promising early and mid-term outcomes in patients with PAo. TF-TAVI performed in patients with PAo is likely to be associated with higher rates of stroke than TA-TAVI.