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Background/Objectives: Lower extremity amputations (LEAs) are a burdensome complication of peripheral artery disease (PAD) and/or arterial embolism and thrombosis (AET). We assessed the trends in PAD- and/or AET-related LEAs in Romania. Methods: This retrospective study (2015-2019) analyzed data on minor and major LEAs in hospitalized patients recorded in the National School for Public Health, Management, and Health Education database. The absolute numbers and incidences of LEAs were analyzed by diagnosis type, year, age, sex, and amputation level. Results: Of 38,590 vascular disease-related amputations recorded nationwide, 36,162 were in PAD and 2428 in AET patients. The average LEA incidence in the general population was 34.73 (minimum: 31.96 in 2015; maximum: 36.57 in 2019). The average incidence of major amputations, amputations above the knee, hip amputations, amputations below the knee, and minor amputations was 16.21 (15.62 in 2015; 16.84 in 2018), 13.76 (13.33 in 2015; 14.28 in 2018), 0.29 (0.22 in 2017; 0.35 in 2019), 2.15 (2.00 in 2015; 2.28 in 2019), and 18.52 (16.34 in 2015; 20.12 in 2019), respectively. Yearly PAD- and/or AET-related amputations were significantly higher in men versus women. The overall number of LEAs increased with age, particularly in patients ≥ 70 years. The increase in the total number of amputations was mainly due to a constant rise in minor amputations for both groups, regardless of gender. Conclusions: PAD- and/or AET-related LEAs in Romania increased from 2015 to 2019, with men having a greater incidence than women. Raising awareness and effective management strategies are needed to prevent LEAs.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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OBJECTIVES: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on acute and elective thoracic and abdominal aortic procedures. METHODS: Forty departments shared their data on acute and elective thoracic and abdominal aortic procedures between January and May 2020 and January and May 2019 in Europe, Asia and the USA. Admission rates as well as delay from onset of symptoms to referral were compared. RESULTS: No differences in the number of acute thoracic and abdominal aortic procedures were observed between 2020 and the reference period in 2019 [incidence rates ratio (IRR): 0.96, confidence interval (CI) 0.89-1.04; P = 0.39]. Also, no difference in the time interval from acute onset of symptoms to referral was recorded (<12 h 32% vs > 12 h 68% in 2020, < 12 h 34% vs > 12 h 66% in 2019 P = 0.29). Conversely, a decline of 35% in elective procedures was seen (IRR: 0.81, CI 0.76-0.87; P < 0.001) with substantial differences between countries and the most pronounced decline in Italy (-40%, P < 0.001). Interestingly, in Switzerland, an increase in the number of elective cases was observed (+35%, P = 0.02). CONCLUSIONS: There was no change in the number of acute thoracic and abdominal aortic cases and procedures during the initial wave of the COVID-19 pandemic, whereas the case load of elective operations and procedures decreased significantly. Patients with acute aortic syndromes presented despite COVID-19 and were managed according to current guidelines. Further analysis is required to prove that deferral of elective cases had no impact on premature mortality.

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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.

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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.

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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.

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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.

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BACKGROUND: Current recommendations for valve size selection are based on multidimensional annular measurements, yet the overlap between two different transcatheter heart valve (THV) sizes remains. We sought to evaluate whether undersizing but overfilling eliminates the gray zones of valve sizing. METHODS: Data of 246 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable bioprosthesis with either conventional sizing and nominal filling (group 1 (NF-TAVR), n = 154) or undersizing but overfilling under a Less Is More (LIM)-Principle (group 2 (LIM-TAVR), n = 92) were compared. Paravalvular leakage (PVL) was graded angiographically and quantitatively using invasive hemodynamics. RESULTS: Annulus rupture (AR) occurred only in group 1 (n = 3). Due to AR adequate evaluation of PVL was possible in 152 patients of group 1. More than mild PVL was found in 13 (8.6%) patients of group 1 and 1 (1.1%) patient of group 2 (p = 0.019). Postdilatation was performed in 31 (20.1%) patients of group 1 and 6 patients (6.5%) of group 2 (p = 0.003). For patients with borderline annulus size in group 1 (n = 35, 22.7%) valve size selection was left to the physicians choice resulting in selection of the larger prosthesis in 10 (28.6%). In group 2 all patients with borderline annulus (n = 36, 39.1%) received the smaller prosthesis (LIM-TAVR). The postprocedural mean transvalvular pressure gradient was significantly higher in the NF-TAVR-group (11.7 ± 4 vs. 10.1 ± 3.6 mmHg, p = 0.005). CONCLUSION: LIM-TAVR eliminates the gray zones of sizing and associated PVL, can improve THV-performance, reduce incidence of annular rupture and simplify the procedure especially in borderline cases.