Treatment of Complex Two-Vessel Coronary Heart Disease with Single Left Internal Mammary Artery as T-Graft with Itself-A Retrospective Double Center Analysis of Short-Term Outcomes.

Background and Objectives: The strategy of revascularization may be constrained in patients with insufficient bypass grafts and with increased risk of wound healing disorders. Among those with complex left-sided double-vessel disease in whom a percutaneous coronary intervention (PCI), as well as the surgical procedure of minimally invasive coronary artery bypass grafting via left minithoracotomy (MICS CABG), is not a treatment option, CABG using the left internal mammary artery as a T-graft with itself may be an effective treatment strategy. Materials and Methods: We reviewed the data from patients treated in Cologne and Tuebingen from 2019 to 2022. We included 40 patients who received left internal mammary artery (LIMA) grafting, and additional T-graft with the LIMA itself. The objective was focused on intraoperative and short-term outcomes. Results: A total of 40 patients were treated with the LIMA-LIMA T-graft procedure with a Fowler score calculated at 20.1 ± 3.0. A total of 37.5% of all patients had lacking venous graft material due to prior vein stripping, and 21 patients presented severe vein varicosis. An overall of 2.6 ± 0.5 distal anastomoses (target vessels were left anterior descending, diagonal, intermediate branch, and/or left marginal ramus) were performed, partly sequentially. Mean flow of LIMA-Left anterior descending (LAD) anastomosis was 59.31 ± 11.04 mL/min with a mean PI of 1.21 ± 0.18. Mean flow of subsequent T-Graft accounted for 51.31 ± 3.81 mL/min with a mean PI of 1.39 ± 0.47. Median hospital stay was 6.2 (5.0; 7.5) days. No incidence of postoperative wound healing disorders was observed, and all patients were discharged. There was one 30-day readmission with a diagnosis of pericardial effusion (2.5%). There was no 30-day mortality within the cohort. Conclusions: Patients requiring surgical myocardial revascularization due to complex two-vessel coronary artery disease (CAD) can be easily managed with LIMA alone, despite an elevated Fowler score and a promising outcome. A prospective study needs to be conducted, as well as longer term surveillance, to substantiate and benchmark the long-term results, as well as the patency rates.

Transcatheter aortic valve replacement- management of patients with significant coronary artery disease undergoing aortic valve interventions: surgical compared to catheter-based approaches in hybrid procedures.

BACKGROUND: Coronary artery disease (CAD) is associated with poorer outcomes after aortic valve replacement (AVR). For high-risk patients with complex CAD, combined transcatheter aortic valve replacement (TAVR) plus off-pump/minimally-invasive coronary artery bypass (OPCAB/MIDCAB) has been proposed. METHODS: A prospective registry analysis was performed to compare the characteristics and outcomes of patients undergoing TAVR+OP/MIDCAB with those undergoing TAVR plus percutaneous coronary intervention (PCI) and surgical AVR plus coronary artery bypass grafting (CABG) between 2008 and 2015 at a single site in Germany. RESULTS: 464 patients underwent SAVR+CABG, 50 underwent TAVR+OP/MIDCAB, and 112 underwent TAVR+PCI. The mean ages (p < 0.001) and logistic EuroSCOREs (p < 0.001) were similarly higher in TAVR+OP/MIDCAB and TAVR+PCI patients compared to SAVR+CABG patients. Prior cardiac surgery was more common in TAVR+PCI than in TAVR+OP/MIDCAB and SAVR+CABG patients (p < 0.001). Procedural times were shortest (p < 0.001), creatine kinase (muscle brain) levels least elevated (p < 0.001), pericardial tamponade least common (p = 0.027), and length of hospital stay shortest (p = 0.011) in TAVR+PCI, followed by TAVR+OP/MIDCAB and SAVR+CABG patients. In-hospital mortality was highest for TAVR+OP/MIDCAB patients (18.0%) with comparable rates for TAVR+PCI and SAVR+CABG groups (9.0 and 6.9%; p = 0.009). Mortality by 12 months was more probable after TAVR+OP/MIDCAB (HR: 2.17, p = 0.002) and TAVR/PCI (HR: 1.63, p = 0.010) than after SAVR+CABG, with the same true of rehospitalisation (HR: 2.39, p = 0.003 and HR: 1.63, p = 0.033). CONCLUSIONS: TAVR+OP/MIDCAB patients share many characteristics with TAVR+PCI patients, with only slightly poorer long-term outcomes. In patients ineligible for SAVR+CABG and TAVR+PCI, hybrid interventions are reasonable second-line options.

Minimally Invasive versus Conventional LVAD-Implantation-An Analysis of the Literature.

This review aims to provide an overview on recent data to evaluate minimally invasive (MVAD) and conventional (CVAD) left ventricular assist device (LVAD) implantation. A comprehensive literature search of PubMed, Cochrane Library, and ClinicalTrials.gov was conducted up to April 2017. A total of 183 studies were identified; 13 studies met inclusion criteria. The review revealed a trend toward a lower rate of transfusion, and shorter time for cardiopulmonary bypass, as well as a lower 30-day mortality rate for MVAD. This review indicates that there are possible benefits of minimally invasive LVAD implantation, even though the state of literature is poor.

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

OBJECTIVES: We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. METHODS: The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. RESULTS: Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. CONCLUSIONS: The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.

Expanding Surgical Opportunities: Endoscopic Harvesting of the Vena Saphena Parva in Supine Position.

The small saphenous vein (SSV) has proved to be a valid graft option for coronary artery bypass grafting (CABG), if other grafts are absent or unsuitable. Beside the described open technique we herein present our approach to endoscopic harvesting in supine position in seven patients. Harvesting was successful in six patients. Mean skin-to-skin time was 29.8 minutes. There were no infections or neurological deficits and the intraoperatively measured graft flow was excellent according to mean flow and low pulsatility index. Therefore, endoscopic harvesting of the SSV extends surgical opportunities not only in CABG, but also in surgery of peripheral artery disease.

Conventional versus Transapical Aortic Valve Replacement: Is It Time for Shift in Indications?

Background The incidence of degenerative aortic valve diseases has increased along with the life expectancy of our population. Although conventional aortic valve replacement (AVR) is the gold standard for symptomatic aortic stenosis, transcatheter procedures have proven to be a valid therapeutic option in high-risk patients. The aim of this study was to compare these procedures in a high-risk cohort. Methods We retrospectively analyzed all symptomatic (dyspnea or angina) high-risk patients (logistic EuroSCORE ≥ 15%) fulfilling the transcatheter aortic valve implantation (TAVI) indications. Most of the AVR patients (n = 180) were operated on before the implementation of TAVI. All TAVI procedures (n = 127) were performed transapically (TA). After matching for age, logistic EuroSCORE, and left ventricular ejection fraction, 82 pairs of patients were evaluated. Results When comparing AVR with TA-TAVI, there was no difference between groups in survival after 1 year (Kaplan-Meier analysis, 81.1% [95% CI: 72.5-89.7%] vs. 75.8% [95% CI: 66.2-75.9%], Log tank p = 0.660) and the complication rates (n for AVR vs. TA-TAVI: stroke, 2 vs. 0, p = 0.580; acute renal insufficiency, 8 vs. 12, p = 0.340; atrial fibrillation, 24 vs. 26, p = 0.813; pacemaker implantation, 4 vs. 4, p > 0.999). In addition, quality of life did not differ between groups. Patients in the TA-TAVI group had lower mean valvular gradients postoperatively compared with the AVR group (14.6 ± 6.6 vs. 10.2 ± 4.9 mm Hg, p < 0.001). Conclusion For high-risk patients, the TAVI procedure is comparable with conventional AVR, but is not advantageous. These results do not support the expansion of TAVI to low- or intermediate-risk patients.

Two-year post-discharge costs of care among patients treated with transcatheter or surgical aortic valve replacement in Germany.

BACKGROUND: This study presents data on post-discharge costs of care among patients treated with transcatheter or surgical aortic valve replacement over a two year period. METHODS: Based on a prospective clinical trial, post-discharge utilization of health services and status of assistance were collected for 151 elderly patients via 2250 monthly telephone interviews, valued using standardized unit costs and analysed using two-part regression models. RESULTS: At month 1 post-discharge, total costs of care are substantially elevated (monthly mean: €3506.7) and then remain relatively stable over the following 23 months (monthly mean: €622.3). As expected, the majority of these costs are related to in-hospital care (~98% in month 1 post-discharge and ~72% in months 2-24). Patients that died during follow-up were associated with substantially higher cost estimates of in-hospital care than those surviving the two-year study period, while patients' age and other patient characteristics were of minor relevance. Estimated costs of outpatient care are lower at month 1 than during the rest of the study period, and not affected by the event of death during follow-up. The estimated costs of nursing care are, in contrast, much higher in year 2 than in year 1 and differ substantially by gender and type of procedure as well as by patients' age. Overall, these monthly cost estimates add up to €10,352 for the first and €7467.6 for the second year post-discharge. CONCLUSIONS: Substantial cost increases at month 1 post-discharge and in case of death during follow-up are the main findings of the study, which should be taken into account in future economic evaluations on the topic. Application of standardized unit costs in combination with monthly patient interviews allows for a far more precise estimate of the variability in post-discharge health service utilization in this group of patients than the ones given in previous studies. TRIAL REGISTRATION: German Clinical Trial Register Nr. DRKS00000797 .

Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement- a model-based longitudinal data analysis.

BACKGROUND: Quality of life (QoL) measurements reported in observational studies are often biased, since patients who failed to improve are more likely to be unable to respond due to death or impairment. In order to observe the development of QoL in patients close to death, we analyzed a set of monthly QoL measurements for a cohort of elderly patients treated for aortic valve stenosis (AS) with special consideration of the effect of distance to death. METHODS: QoL in 169 elderly patients (age ≥ 75 years), treated either with transcatheter aortic valve replacement (TAVR; n = 92), surgical aortic-valve replacement (n = 70), or drug-based therapy (n = 7), was evaluated using the standardized EQ-5D questionnaire. Over a two-year period, patients were consulted using monthly telephone interviews or outpatient visits, leading to a total of 2463 time points at which QoL values, New York Heart Association (NYHA) Functional Classification and their status of assistance were assessed. Furthermore, post-procedural clinical events and complications were monitored. Linear and ordered logistic regression analyses with random intercept were carried out, taking into account overall trends and distance to death. RESULTS: QoL measures decreased slightly over time, were temporarily impaired at month 1 after the initial episode of hospitalization and decreased substantially at the end of life with a measurable effect starting at the sixth from last follow-up (month) before death. Many clinical complications (bleeding complications, stroke, acute kidney injury) showed an impairment of QoL measurements, but the inclusion of lagged variables demonstrated medium term (three months) QoL impairments for access site bleeding only. All other complications are associated with event-related impairments that decreased dramatically at the second and third follow-up interviews (month) after event. CONCLUSIONS: Distance to death shows clear effects on QoL and should be taken into account when analyzing QoL measures in the elderly patients treated for aortic valve stenosis. TRIAL REGISTRATION: German Clinical Trial Register Nr. DRKS00000797.

In-hospital resource utilization in surgical and transcatheter aortic valve replacement.

BACKGROUND: Little is known about preoperative predictors of resource utilization in the treatment of high-risk patients with severe symptomatic aortic valve stenosis. We report results from the prospective, medical-economic "TAVI Calculation of Costs Trial". METHODS: In-hospital resource utilization was evaluated in 110 elderly patients (age ≥ 75 years) treated either with transfemoral (TF) or transapical (TA) transcatheter aortic valve implantation (TAVI, N = 83), or surgical aortic valve replacement (AVR, N = 27). Overall, 22 patient-specific baseline parameters were tested for within-group prediction of resource use. RESULTS: Baseline characteristics differed between groups and reflected the non-randomized, real-world allocation of treatment options. Overall procedural times were shortest for TAVI, intensive care unit (ICU) length of stay (LoS) was lowest for AVR. Length of total hospitalization since procedure (THsP) was lowest for TF-TAVI; 13.4 ± 11.4 days as compared to 15.7 ± 10.5 and 21.2 ± 15.4 days for AVR and TA-TAVI, respectively. For TAVI and AVR, EuroScore I remained the main predictor for prolonged THsP (p <0.01). Within the TAVI group, multivariate regression analyses showed that TA-TAVI was associated with a substantial increase in THsP (55 to 61 %, p <0.01). Additionally, preoperative aortic valve area (AVA) was identified as an independent predictor of prolonged THsP in TAVI patients, irrespective of risk scores (p <0.05). CONCLUSIONS: Our results demonstrate significant heterogeneity in patients baseline characteristics dependent on treatment and corresponding differences in resource utilization. Prolonged ThsP is not only predicted by risk scores but also by baseline AVA, which might be useful in stratifying TAVI patients. TRIAL REGISTRATION: German Clinical Trial Register Nr. DRKS00000797.

Minimally Invasive Mitral Valve Replacement and Transfemoral Aortic Valve Implantation.

The case is reported of a symptomatic elderly patient with severe mitral regurgitation, severe aortic valve stenosis, and coronary heart disease. The coronary artery disease had been interventionally treated four years previously with stent implantation into the right coronary artery. Published studies have shown that a combination of mitral and aortic valve surgery is associated with a significantly increased risk of mortality and morbidity, particularly in elderly patients. In the present patient, both valvular malformations were successfully treated with a single-step interdisciplinary approach, namely an initial surgical mitral valve replacement followed by transfemoral transcatheter aortic valve replacement.

Transcatheter Aortic Valve Implantation in Patients at Extremely High Risk of Perioperative Mortality.

BACKGROUND AND AIM OF THE STUDY: Transcatheter procedures are considered the therapy of choice for high-risk patients who are not eligible for surgical aortic valve replacement. Although its utility is debated, the logistic EuroSCORE I is still the most frequently used risk calculator for cardiac surgery in Europe, and was used in the present study to identify patients with an extremely high risk of predicted perioperative mortality. METHODS: This single-centre study included 319 consecutive patients who underwent transapical or transaortic transcatheter aortic valve implantation (TAVI) between September 2008 and December 2012. Combined hybrid procedures and transfemoral TAVI patients were excluded. Those patients predicted to have an excessively high risk of perioperative mortality (EuroSCORE >40%, n = 90) were compared to those with a lower calculated risk (EuroSCORE <40%, n = 229) with respect to perioperative complications, short-term-mortality and major adverse cardiac and cerebrovascular events. RESULTS: The 30-day mortality was 12.2% (n = 11) in the extremely high-risk group, and 6.6% (n = 15) in the lower-risk group (p = 0.08). There were no significant differences in the stroke rate (3.3% versus 0.4%, p = 0.07) or the incidence of acute kidney injury stage 3 (11.1% versus 5.2%, p = 0.32). The establishment of cardiopulmonary bypass (3.9% versus 11.1%, p = 0.02), conversion to sternotomy (1.3% versus 5.6%, p = 0.04), mean ventilation time (15.2 h versus 43.5 h, p = 0.007) and length of intensive care unit stay (2.9 days versus 6.8 days, p <0.001) were all significantly lower in the lower-risk group. CONCLUSION: The data acquired verified that TAVI is a safe procedure, even in patients with an extremely high predicted risk of perioperative mortality and major adverse cardiac and cerebrovascular events. Furthermore, the analysis substantiated the need for individualized risk evaluation.

Results and Quality of Life after Minimally Invasive Ross Procedure.

BACKGROUND AND AIM OF THE STUDY: Based on superior long-term results, an increasing interest in the Ross procedure for young adult patients can be observed. After the first publication of this challenging procedure through a minimally invasive access, this operation has become an alternative to conventional sternotomy at the authors' department. This analysis compares the results and quality of life of the conventional and the minimally invasive Ross procedures. METHODS: By April 2013, a total of 136 patients had undergone the Ross procedure at the authors' institution. Preoperative parameters did not differ between the conventional group (C-group; n = 58; mean age 49 years) and the minimally invasive group (M-group; n = 78; mean age 50 years). Only the aortic cross-clamp time was longer for the M-group (151 versus 140 min). RESULTS: One C-group patient died on the day of operation. Consecutively, survival was 99% for the follow up period of 1,093 ± 601 days. Valve-related reoperations were necessary for four patients. One C-group patient developed a distal pulmonary stenosis due to fibrotic scar tissue. Two M-group patients showed fistulas after early endocarditis, but the native valves could be preserved in these cases. One C-group patient with recurrent severe aortic regurgitation showed holes in two of three cusps. The SF-36 questionnaire detected better physical parameters (physical function, physical role function) for patients after minimally invasive access. CONCLUSION: The minimally invasive Ross procedure allows the same excellent clinical outcome as the conventional technique. However, the physical quality of life is better with the minimally invasive procedure, in addition to an improved cosmetic result.

Minimally invasive versus conventional extracorporeal circulation in minimally invasive cardiac valve surgery.

BACKGROUND: Minimally invasive extracorporeal circulation (MECC) technology was applied predominantly in coronary surgery. Data regarding the application of MECC in minimally invasive valve surgery are missing largely. PATIENTS AND METHODS: Patients undergoing isolated minimally invasive mitral or aortic valve procedures were allocated either to conventional extracorporeal circulation (CECC) group (n = 63) or MECC group (n = 105), and their prospectively generated data were analyzed. RESULTS: Demographic data were comparable between the groups regarding age (CECC vs. MECC: 71.0 ± 7.5 vs. 66.2 ± 10.1 years, p = 0.091) and logistic EuroSCORE I (6.2 ± 2.5 vs. 5.4 ± 3.0, p = 0.707). Hospital mortality was one patient in each group (1.6 vs. 1.0%, p = 0.688). The levels of leukocytes were lower in the MECC group (11.6 ± 3.2 vs. 9.4 ± 4.3 109/L, p = 0.040). Levels of platelets (137.2 ± 45.5 vs. 152.4 ± 50.3 109/L, p = 0.015) and hemoglobin (103.3 ± 11.3 vs. 107.3 ± 14.7 g/L, p = 0.017) were higher in the MECC group. Renal function was better preserved (creatinine: 1.1 ± 0.4 vs. 0.9 ± 0.2 mg/dL, p = 0.019). We were able to validate shorter time of postoperative ventilation (9.5 ± 15.1 vs. 6.3 ± 3.4 h, p = 0.054) as well as significantly shorter intensive care unit (ICU) stay (1.8 ± 1.3 vs. 1.2 ± 1.0 d, p = 0.005) for MECC patients. The course of C-reactive protein did not differ between the groups. CONCLUSION: We were able to prove the feasibility of MECC even in minimally invasive performed mitral and aortic valve procedures. In addition, the use of MECC provides decreased platelet consumption and less hemodilution. The use of MECC in these selected patients lead to a shorter ventilation time and ICU stay.

Transfemoral aortic valve implantation: bleeding events, related costs and outcomes.

Although less invasive then SAVR, TAVI is associated with a significant rate of access site and non-access site bleeding. These complications are major determinants of therapy outcome, however, the economic consequences are not well defined. The purpose of this study was to determine the relationship between bleeding, in-hospital resource utilization and costs among patients undergoing transfemoral aortic valve implantation (TF-AVI) at a representative university hospital in Germany. Between February 2010 and December 2011, we prospectively enrolled 60 consecutive patients undergoing TAVI using a 18F transfemoral approach at our institution. The relationship between overt bleeding (OVB), defined according to the definitions provided by the Valve Academic Research Consortium, in-hospital resource utilization and in-hospital costs was investigated. The mean age was 82 (±6) years, 53% were female and the mean EuroScore was 17.2% (±8, 7). Thirty-eight percent (23/60) of the patients had an OVB following TF-AVI procedure. In-hospital mortality was 8.7% in the OVB patients (2/23) and 2.7% among patients without any OVB (1/37; NOVB), which was not statistically significant (p = 0.3). The total length of stay (LOS) of patients with and without bleeding complication were 15.0 ± 6.4 and 10.4 ± 5.1 days, respectively (p < 0.01). Time spent on ICU in the OVB group was twice as long as compared to the NOVB group (120.5 ± 98.5 min vs. 63.6 ± 26.5 min, p < 0.01). Consequently, in-hospital costs were statistically significant higher in OVB patients (40.051 ± 9.293 vs. 33.625 ± 4.368, p < 0.01). Bleeding is associated with increased resource use and in-hospital costs among TF-AVI patients. Our data indicates that strategies reducing bleeding risk may have the potential to generate important in-hospital costs reductions in TF-AVI patients.

On- vs. Off-Pump CABG in Heart Failure Patients with Reduced Ejection Fraction (HFrEF): A Multicenter Analysis.

OBJECTIVE: This study aimed to compare postoperative outcomes and 30-day mortality in patients with reduced ejection fraction (<40%) who underwent isolated coronary artery bypass grafting (CABG) with (ONCAB) and without (OPCAB) the use of cardiopulmonary bypass. METHODS: data from four university hospitals in Germany, spanning from January 2017 to December 2021, were retrospectively analyzed. A total of 551 patients were included in the study, and various demographic, intraoperative, and postoperative data were compared. RESULTS: demographic parameters did not exhibit any differences. However, the OPCAB group displayed notably higher rates of preoperative renal insufficiency, urgent surgeries, and elevated EuroScore II and STS score. During surgery, the ONCAB group showed a significantly higher rate of complete revascularization, whereas the OPCAB group required fewer intraoperative transfusions. No disparities were observed in 30-day/in-hospital mortality for the entire cohort and the matched population between the two groups. Subsequent to surgery, the OPCAB group demonstrated significantly shorter mechanical ventilation times, reduced stays in the intensive care unit, and lower occurrences of ECLS therapy, acute kidney injury, delirium, and sepsis. CONCLUSIONS: the study's findings indicate that OPCAB surgery presents a safe and viable alternative, yielding improved postoperative outcomes in this specific patient population compared to ONCAB surgery. Despite comparable 30-day/in-hospital mortality rates, OPCAB patients enjoyed advantages such as decreased mechanical ventilation durations, shorter ICU stays, and reduced incidences of ECLS therapy, acute kidney injury, delirium, and sepsis. These results underscore the potential benefits of employing OPCAB as a treatment approach for patients with coronary heart disease and reduced ejection fraction.

Performance of the Edwards Sapien 3 Ultra Transcatheter Aortic Valve System in Patients With Aortic Stenosis and Annulus Diameter in Proximity to Valve Size.

OBJECTIVES: The new Sapien 3 Ultra (S3U) transcatheter heart valve (Edwards Lifesciences) was designed with the intention to improve paravalvular sealing. In patients with an annulus size in proximity to the prosthesis size, little or no oversizing of the transcatheter aortic valve implantation (TAVI) prosthesis may lead to paravalvular regurgitation. Thus, this study was designed to assess valve performance in such patients. METHODS: We retrospectively enrolled 30 consecutive patients with symptomatic high-grade aortic stenosis scheduled for transfemoral TAVI between October 2019 and May 2020. Comprehensive computed tomography angiography for TAVI planning included standard measurements and quantification of calcification of the aortic valve. All patients had an aortic annular size in proximity to the valve size (maximum <15%) and received an S3U valve. Before discharge, paravalvular leakage was assessed via transthoracic echocardiography with an operator blinded to the TAVI results. In addition, 30-day outcome was assessed. RESULTS: The S3U was implanted in all patients without any procedural complications. One patient received a 20 mm S3U valve, 18 received 23 mm S3U valves, and 11 received 26 mm S3U valves; the annular sizes were 19.7 mm, 22.9 ± 0.2 mm, and 25.8 ± 0.2 mm, respectively. Quantification of calcification of the aortic valve revealed significant calcifications with a median Agatston score of 2571 AU (interquartile range, 1685-3467 AU). Postprocedural transthoracic echocardiography showed an excellent result in all but 2 patients. In the latter, aortic insufficiency grade I was seen. Thirty-day survival was 96.7%. CONCLUSIONS: The new S3U valve shows excellent performance in patients with high-grade aortic stenosis and annular size in proximity to the valve size, even in presence of significant valvular calcification.

Prognostic implications of psoas muscle area in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: This study sought to assess the incremental prognostic value of the psoas muscle area in patients scheduled for transcatheter aortic valve implantation (TAVI). METHODS: A total of 1076 consecutive patients undergoing TAVI at 2 centres between 2010 and 2017 were prospectively included in this study. Computed tomography-derived cross-sectional area of the psoas muscle was measured at the superior border of the third (L3) and fourth (L4) lumbar vertebra and indexed to body surface area (PMAi) as well as stratified into tertiles. Multivariable logistic regression and Cox regression analyses were performed to investigate the value of PMAi as a predictor of 30-day and cumulative mortality. The incremental prognostic value of PMAi over the Society of Thoracic Surgeons (STS) score was assessed using a net reclassification analysis. RESULTS: The rate of 30-day mortality was 5.8% (n = 62). PMAi at the level of L3 [odds ratio 0.082, 95% confidence interval (CI) 0.011-0.589; P = 0.013] and L4 (odds ratio 0.049, 95% CI 0.005-0.536; P = 0.013) was independently associated with 30-day mortality. During a median follow-up of 435 days (interquartile range 139-904), 292 patients (27.1%) died. PMAi of L3 (hazard ratio 0.200, 95% CI 0.083-0.482; P < 0.001) and L4 (hazard ratio 0.083, 95% CI 0.029-0.235; P < 0.001) was independently associated with mortality during follow-up. The addition of PMAi to the STS score led to a net reclassification improvement for 30-day and cumulative mortality. CONCLUSIONS: PMAi emerged as a valuable outcome predictor in patients undergoing TAVI. The addition of PMAi to the established STS score led to an increase in its prognostic ability.

Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†.

OBJECTIVES: There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI. METHODS: The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization. RESULTS: Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75). CONCLUSIONS: Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT01991431.

Current Generation Balloon-Expandable Transcatheter Valve Positioning Strategies During Aortic Valve-in-Valve Procedures and Clinical Outcomes.

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.

EuroSCORE II and the STS score are more accurate in transapical than in transfemoral transcatheter aortic valve implantation.

OBJECTIVES: The European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and the Society of Thoracic Surgeons (STS) score are currently used to estimate periprocedural risk of death in patients undergoing transcatheter aortic valve implantation (TAVI). However, data regarding the predictive ability and usefulness of these scores for TAVI are controversial, especially for different access sites. METHODS: Between 2008 and 2016, 1192 consecutive patients undergoing TAVI [transfemoral (TF): n = 607 (51%); transapical (TA): n = 585 (49%)] at 2 centres were included. All-cause mortality was assessed at a median of 533 days (interquartile range 153-1036). The value of the EuroSCORE II and the STS score in terms of predicting 30-day and cumulative mortality according to access site was investigated. RESULTS: The mean age was 83 (interquartile range 79-86) years. Overall, the 30-day mortality rate was 7.6% (n = 90), and the cumulative all-cause mortality rate was 35.1% (n = 418). The EuroSCORE II and the STS score were significantly increased in non-survivors compared with survivors (P < 0.001). The EuroSCORE II and the STS score emerged as independent predictors of 30-day mortality [EuroSCORE II: odds ratio (OR) 1.039, 95% confidence interval (CI) 1.013-1.065; P = 0.003; STS score: OR 1.055, 95% CI 1.023-1.088; P = 0.001] and cumulative all-cause mortality [EuroSCORE II: hazard ratio (HR) 1.026, 95% CI 1.013-1.038; P < 0.001; STS score: HR 1.05, 95% CI 1.03-1.06; P < 0.001]. In contrast to TF TAVI, the EuroSCORE II (OR 1.038, 95% CI 1.009-1.068; P = 0.010) and the STS score (OR: 1.063, 95% CI 1.025-1.102; P = 0.001) were independent predictors of 30-day mortality and cumulative mortality (EuroSCORE II: HR 1.023, 95% CI 1.009-1.037; P = 0.001; STS score: HR 1.055, 95% CI 1.037-1.073; P < 0.001) in patients undergoing TA TAVI. CONCLUSIONS: The EuroSCORE II and the STS score were independent predictors of 30-day and cumulative mortality rates in patients undergoing TAVI. The EuroSCORE II and the STS score were associated with 30-day mortality and mortality during follow-up period only in TA TAVI.