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.

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.

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.

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.

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.

Off-Pump Coronary Artery Bypass Grafting and Stroke-Exploratory Analysis of the GOPCABE Trial and Methodological Considerations.

BACKGROUND: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke. METHODS: In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke. RESULTS: There was no significant difference in the rate of stroke within 30 days after surgery between both groups (off-pump: 2.2%; on-pump: 2.7%; odds ratio [OR]: 0.83 [0.5-1.38]; p = 0.47). Within the off-pump group, different degrees of aortic manipulation did not lead to significant different stroke rates (tangential clamping: 2.3%; OR 0.86 [0.46-1.60]; clampless device: 1.8%; OR 0.67 [0.26-1.75]; no aortic manipulation: 2.4%; OR 0.88 [0.37-2.14]). An aggregate analysis including more than 10,000 patients out of the four recent major trials also yielded comparable stroke rates for on- and off-pump CABG (off-pump: 1.4%; on-pump: 1.7%; OR 0.87 [0.64-1.20]). CONCLUSION: Within recent prospective randomized multicenter trials off-pump CABG did not result in lower stroke rates. The possible intrinsic benefit of off-pump CABG may be offset by the complexity of the operative therapy as well as the multiple pathomechanisms involved in perioperative stroke.

Hematocrit and impact of transfusion in patients receiving extracorporeal life support.

INTRODUCTION: Increasing the hematocrit is considered to increase oxygen delivery to the patient, especially when hypoxic conditions exist and the patient may become more stable. The aim of this study was to evaluate the relationship between hematocrit and hospital mortality via subgroup analyses of trauma and non-trauma patients. METHODS: The hospital length of stay (LOS) and LOS in the intensive care unit (ICU) and hospital after extracorporeal life support (ECLS) treatment of 81 patients were analyzed and compared. In-hospital survival until extracorporeal membrane oxygen (ECMO) weaning and hospital discharge were defined as the clinical outcome. RESULTS: Significantly increased mortality, with a relative risk of 1.73 with a 95% confidence interval of 1.134 to 2.639, was identified in the group with an hematocrit greater than 31%. However, no significant differences in relative risk (95% confidence interval) of death for each group were found among groups with an hematocrit less than or equal to 25%, 26-28% and 29-31%. Additionally, no significant relationship between survival and median hematocrit level was observed at a significance level of 0.413 and an Exp (B) of 1.089 at a 95% confidence interval of 0.878 to 1.373 in binary logistic regression analysis; a model was established with a -2 log likelihood of 40.687 for the entire group of patients. Moreover, a significant increase in mortality was observed as the average number of transfusions per day in the hospital increased (significance level 0.024, Exp (B) 4.378, 95% confidence interval for Exp (B) 1.212 to 15.810). CONCLUSION: Because a variety of factors influence therapy, the indication for transfusion should be re-evaluated and adapted repeatedly on a case-by-case basis. Further studies are needed to demonstrate whether an acceptable outcome from ECLS device therapy can also be achieved with a low hematocrit and a restrictive indication for transfusion.

Outcome measures of extracorporeal life support (ECLS) in trauma patients versus patients without trauma: a 7-year single-center retrospective cohort study.

This single-center retrospective study included a total of 99 extracorporeal life support (ECLS) cannulated patients assigned to a traumatic extracorporeal life-support cohort (TECLS) or a non-traumatic extracorporeal life-support cohort (NTECLS). Forty-nine TECLS patients and 50 NTECLS patients were compared. The TECLS patients were significantly younger [49.9 years 16.6-86.2 vs. 57.1 (21.4-78.6); p = 0.007] and had lower body mass indices (BMIs) [27.7 kg/m2 (20-37) vs. 32.5 (19-88.5); p = 0.001] than the NTECLS patients. The intensive care unit (ICU) survival rate [n = 34 (69.4%) vs. n = 13 (26%); p ≤ 0.001] and the hospital survival rate [n = 32 (65.3%) vs. n = 13 (26%); p ≤ 0.001] were significantly higher for the TECLS cohort than for the NTECLS cohort. The lengths of stay (LOSs) in the ICU [24 days (4.8-71.1) vs. 11.3 (0-88.6); p = 0.001] and in the hospital [46.6 days (2.9-197.6) vs. 21 (0.1-213.8); p = 0.001] were significantly longer for the TECLS patients than for the NTECLS patients.

Veno-venous ECMO as a safe bridge to recovery in a patient with severe peripartum cardiomyopathy - learning from errors.

Peripartum cardiomyopathy (PPCM) is a rare disorder of unknown etiology and pathogenesis. The most important tool for diagnostic confirmation is transthoracic echocardiography. The recommended management of PPCM in pregnancy is summarized by the European Society of Cardiology Heart Failure Guidelines. Few data exist on the treatment of patients with fulminant PPCM and the need for extracorporeal membrane oxygenation (ECMO) in this context. We report on a young multiparous woman with cardiogenic shock caused by severe PPCM who was successfully, but atypically, supported with veno-venous ECMO as a bridge to recovery immediately after the birth of her third child.

Annular rupture leading to fatal complications in an elderly patient with calcified aortic and mitral annulus undergoing transapical aortic valve implantation.

This case illustrates the awareness that must be taken of the high morphological risk due to the calcifications of both, the aortic and mitral annulus in elderly patients when performing transapical aortic valve implantation. In an 86-year-old, multimorbid woman (logistic EuroSCORE = 27%) with symptomatic aortic stenosis (annular diameter = 23.4 mm) and severe mitral annular calcification, the implantation of a 26-mm Edwards SAPIEN (Edwards Lifesciences, Irvine, California, United States) valve in aortic position was primary successful, with no paravalvular leakage, valve instability, or coronary malperfusion. Second, a persisting transmural bleeding led to hypovolemic shock, which could not be stabilized even after going on cardiopulmonary bypass, and the patient died in the operation room. The autopsy showed a subvalvular ventricular rupture due to a transmural perforation of the calcified fibrotic annulus during valvuloplasty.

Transapical minimally invasive aortic valve implantation and conventional aortic valve replacement in octogenarians.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has been developed to minimize the operative trauma in high-risk patients. Patient selection for TAVI is still subject to debate and octogenarians are often regarded as high-risk patients. METHODS: In this single-center study, data of 169 octogenarians who received conventional AVR (90) or TAVI (79) have been analyzed retrospectively according to the endpoint definitions of the Valve Academic Research Consortium to answer the following questions: (a) Should patients due to their age of 80 years or older be considered as high risk? (b) Is the EuroSCORE a suitable tool for estimating mortality after AVR or TAVI in octogenarians? (c) Is TAVI the procedure of choice for octogenarians? RESULTS: TAVI patients showed higher comorbid conditions concerning an existing renal dysfunction (31 vs. 56%, p = 0.001), peripheral vascular disease (6 vs. 30%, p < 0.001), diabetes (19% vs. 49%, p < 0.001), a decreased ejection fraction (LVEF < 30%: 2 vs. 13%, p < 0.05), and pulmonary hypertension (23 vs. 48%; p < 0.005) with an increase of the perioperative risk represented by logistic EuroSCORE (AVR 11% ± 1.27 vs. TAVI 38% ± 1.35; p < 0.0005) and STS Score (7% ± 0.52 vs. 14% ± 0.56; p < 0.0005). All-cause and cardiovascular-cause in-hospital or 30-day mortality was 5.6% (n = 5) and 3.4% (n = 3) in the AVR cohort and 8.8% (n = 7) and 7.6% (n = 6) in TAVI-patients (p = 0.55; p = 0.31), respectively. The overall combined safety endpoint at 30 days was 22.2% (n = 20) in AVR patients and 29.1% (n = 23) with regard to the TAVI group (p = 38). Analysis of cerebrovascular complications, vascular complications, and pacemaker revealed no significant differences. In the AVR group, actuarial survival at 6 months and 1 and 2 years was 89, 78, and 74%, respectively. Data of the TAVI patients are only available for a follow-up of 6 months and revealed a survival of 85%. CONCLUSION: AVR and TAVI in octogenarians show comparable results, but the analyzed cohorts differ significantly in their risk profile. The results indicate an overrated perioperative mortality using the EuroSCORE but on the other hand logistic EuroSCORE represents articulately the different risk profile of the two groups. For this reason, we consider the EuroSCORE still to be a useful tool for preoperative risk assessment. Moreover, octogenarians cannot per se be considered as "true high risk" patients. Differentiated clinical judgment is most important for reasonable decision making.

Transapical aortic valve implantation: experiences and survival analysis up to three years.

BACKGROUND: We determined our 30-day results after transapical aortic valve implantation (TA-AVI) according to Valve Academic Research Consortium criteria, analyzed midterm outcome, and summarize our institutional learning experience. METHODS: From February 2008 to July 2011, 150 high-risk patients underwent TA-AVI. Endpoints of this retrospective analysis were safety as indicated by morbidity and 30-day mortality and midterm survival with a follow-up period up to 3.4 years (mean follow-up 14.1 months). In addition we analyzed our institutional learning curve by comparing the outcome of our first 50 patients (group 1) to the following 100 patients (group 2). RESULTS: Procedural success was 98% (147 patients). All-cause and cardiovascular cause 30-day mortality was 11.3% (n = 17) and 7.3% (n = 11), respectively. The cumulative survival rates were 78.7% at one year, 62.8% at two years, and 50.8% at three years. As compared to group 1, there was a significantly reduced incidence of relevant bleeding complications (0% vs. 14%[n = 7]; p < 0.001) and a reduced incidence of acute kidney injury (35%[n = 35] versus 56% (n = 28); p < 0.05) in group 2, resulting in a combined safety endpoint at 30 days of 22% in group 2 versus 40% in group 1 (p < 0.05). One-year mortality (group 2, n = 20 [20%] versus group 1, n = 10 [20%]; p = 1) and midterm survival (p = 0.998; Hazard ratio 1.001; 95% CI 0.5141 to 1.949) did not differ significantly. CONCLUSIONS: Although the incidence of technical complications decreased significantly over time, 30-day and midterm mortality were unaltered, most likely due to patients' comorbidities. The development of more accurate risk scores may improve future outcome.

Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system.

OBJECTIVES: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system. METHODS: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant. RESULTS: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively. CONCLUSIONS: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery. NAME AND REGISTRATION OF REGISTRY: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.

Thrombocytopenia after implantation of the Perceval S aortic bioprosthesis.

OBJECTIVE: The Perceval S bioprosthesis (LivaNova PLC, London, United Kingdom) is based on the Freedom Solo aortic bioprosthesis (LivaNova PLC), which has been reported to be associated with perioperative thrombocytopenia. We compared platelet counts after aortic valve replacement with the Perceval S with those with other aortic valve bioprostheses. METHODS: A total of 87 patients receiving aortic valve replacement were included in this retrospective study; 25 patients received the Perceval S, 23 patients received the Labcor TLPB-A (Labcor, Belo Horizonte, Brazil), and 39 patients received the Hancock II bioprosthesis (Medtronic, Minneapolis, Minn). Thrombocyte count was corrected for hematocrit. Multivariable analyses were performed to assess the potential effect of other variables. RESULTS: Preoperatively, there were no differences in platelet counts comparing the Perceval S group (median 200/nl, interquartile range, 157-252) and the control group (Labcor: median 213/nl, interquartile range, 160-246, Hancock: median 227/nl, interquartile range, 183-280, P = .23). Postoperatively, there was significant evidence that the minimum platelet count (median, Perceval: 47, interquartile range, 38-66; Labcor: 76, interquartile range, 61-110; Hancock: 78, interquartile range, 61-111/nl; P = .001), both absolute and corrected, was lower for the Perceval S, even after allowing for other variables. The significant difference in absolute platelet counts persisted until discharge or death. However, there were no significant differences regarding blood loss, transfusion requirements, or rates of reoperation for bleeding. CONCLUSIONS: After aortic valve replacement, platelet counts in patients with the Perceval S decrease more severely compared with other bioprostheses, but in our small study we found no evidence of a detrimental clinical effect of this phenomenon. Future studies have to confirm our findings and investigate a cause for this phenomenon.

Effect of body mass index on the outcome of surgical patients receiving extracorporeal devices (VV ECMO, pECLA) for respiratory failure.

INTRODUCTION: To determine whether obese surgical patients are at a significant disadvantage in terms of outcomes after extracorporeal device (ECD) support, such as veno-venous extracorporeal membrane oxygenation (VV ECMO) or pumpless extracorporeal lung assist (pECLA), for respiratory failure, the relationship between body mass index (BMI) and hospital outcomes was analyzed. METHODS: This retrospective study included data on patients who were supported with an ECD between January 1, 2008 and December 31, 2014. The analysis included 89 patients (74 male). RESULTS: The median BMI was 30 kg/m2 (19-88.5). The median duration of the ECD support was 9.0 days, with a maximum of 37.1 days. The median LOS (length of stay) in the intensive care unit (ICU) was 21 days (range 0.06-197.6). The median hospital LOS was 34.9 days (range 0.1-213.8). VV ECMO was performed 72 times, and pECLA was performed 18 times. The number of patients successfully weaned off the ECD was 54 (60.6%). Survival at the discharge from the hospital was 48.3%. CONCLUSIONS: 54 (60.6%) patients were successfully weaned off the ECD; 43 (48.3%) patients survived and were discharged from the hospital. The analysis of correlations between BMI and outcomes of surgical patients treated with ECD showed no association between BMI and mortality. Complications (especially oxygenator clotting) were not more frequent in obese and extremely obese patients. We hypothesized that patients with higher or morbid BMIs would have increased mortality after ECD support. A BMI of 30.66 kg/m2 corresponded to the desired sensitivity and specificity to predict mortality. This finding applied only to the study group. Treatment with ECD in obese patients presents unique challenges, including percutaneous cannulation and increased staff requirements. However, based on these data, obesity should not be an exclusion criterion for ECD therapy.

The Effects of Propofol and Isoflurane Sedation on the Outcomes of Surgical Patients Receiving Extracorporeal Membrane Oxygenation.

This article resurrects a historical technique using a new technology by describing the results of a retrospective, observational, single-center study that investigated the effects of propofol compared with isoflurane sedation on patient outcomes after extracorporeal membrane oxygenation (ECMO). No differences in patient outcomes were observed between the propofol and isoflurane groups. Nevertheless, the results of this study might improve our understanding of the effects of sedation on patient outcomes after ECMO and provide insight into the effects of spontaneous breathing during ECMO.

Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries.

OBJECTIVES: The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.

Infections and Extracorporeal Membrane Oxygenation: Incidence, Therapy, and Outcome.

The objective is to assess the influence of infections and the microbiological spectrum on the general outcome of patients undergoing therapy with extracorporeal devices (ECDs), extracorporeal membrane oxygenation, extracorporeal life support, and pumpless extracorporeal lung assist. We performed a single-center, retrospective analysis of 99 patients receiving ECD. Infections requiring ECD, nosocomial infections occurring during treatment, the use of guideline-based antiinfective therapies, and patient outcomes were described and statistically analyzed. We analyzed 88 patients-survivors and nonsurvivors-and subdivided the infections into primary and nosocomial infections. The median patient age was 54.0 years, 85.2% were men, and 45 (51.1%) survived. Surviving ECD patients had a higher risk of nosocomial infection because of their prolonged hospital stay. Our results indicated that early, focused, antiinfective therapy was important to avoid severe infection complications. Infections causing sepsis and multiorgan dysfunction were negatively associated with outcome and successful weaning of ECD. The percentages and types of pathogens in the ECD cohort did not differ from the general colonization of intensive care units. Because a significant correlation between pathogens, infections, and outcome was not detected, we recommend focusing on clinical parameters to decide whether patients will benefit from ECD support.

Optimal temperature for selective cerebral perfusion.

OBJECTIVE: Although combinations of hypothermic circulatory arrest and antegrade selective cerebral perfusion are used for cerebral protection during arch surgery, there is no consensus regarding the optimal temperature during selective cerebral perfusion. This study explored the effect of different temperatures during selective cerebral perfusion on cerebral metabolism and neurologic outcome. METHODS: In this blinded study, 40 pigs (19-21 kg) were randomized into 4 groups after 30 minutes of hypothermic circulatory arrest at 20 degrees C. During a 60-minute interval of selective cerebral perfusion, with flow regulated to maintain a perfusion pressure of 50 mm Hg, pigs were perfused at 10 degrees C, 15 degrees C, 20 degrees C, and 25 degrees C. Fluorescent microspheres enabled calculation of cerebral blood flow during perfusion and recovery. Hemodynamics, intracranial pressure, cerebrovascular resistance, and oxygen consumption were also monitored. Behavioral scores were obtained for 7 days after surgery. RESULTS: Cerebral blood flow decreased significantly ( P < .002) during cooling in all groups: it was significantly higher throughout selective cerebral perfusion in the 20 degrees C to 25 degrees C versus the 10 degrees C to 15 degrees C group ( P = .0001) and remained higher during recovery ( P = .0001). Oxygen consumption decreased significantly with cooling ( P = .0001), remained low during perfusion, and rebounded with rewarming but was significantly lower at 10 degrees C to 15 degrees C than at 20 degrees C to 25 degrees C throughout selective cerebral perfusion ( P = .003) and after CPB was discontinued ( P = .001). Postoperative behavioral scores were significantly better after selective cerebral perfusion at 10 degrees C to 15 degrees C than at 20 degrees C to 25 degrees C ( P = .001). CONCLUSIONS: This study suggests that selective cerebral perfusion at 10 degrees C to 15 degrees C provides better cerebral protection than selective cerebral perfusion at 20 degrees C to 25 degrees C, even though oxygen consumption remains low for hours after selective cerebral perfusion at 10 degrees C to 15 degrees C. Prompt return of metabolism to baseline levels after hypothermic circulatory arrest/selective cerebral perfusion does not necessarily predict superior behavioral outcome.