Nonsurgical Strategies to Reduce Mortality in Patients Undergoing Cardiac Surgery: An Updated Consensus Process.

OBJECTIVE: A careful choice of perioperative care strategies is pivotal to improve survival in cardiac surgery. However, there is no general agreement or particular attention to which nonsurgical interventions can reduce mortality in this setting. The authors sought to address this issue with a consensus-based approach. DESIGN: A systematic review of the literature followed by a consensus-based voting process. SETTING: A web-based international consensus conference. PARTICIPANTS: More than 400 physicians from 52 countries participated in this web-based consensus conference. INTERVENTIONS: The authors identified all studies published in peer-reviewed journals that reported on interventions with a statistically significant effect on mortality in the setting of cardiac surgery through a systematic Medline/PubMed search and contacts with experts. These studies were discussed during a consensus meeting and those considered eligible for inclusion in this study were voted on by clinicians worldwide. MEASUREMENTS AND MAIN RESULTS: Eleven interventions finally were selected: 10 were shown to reduce mortality (aspirin, glycemic control, high-volume surgeons, prophylactic intra-aortic balloon pump, levosimendan, leuko-depleted red blood cells transfusion, noninvasive ventilation, tranexamic acid, vacuum-assisted closure, and volatile agents), whereas 1 (aprotinin) increased mortality. A significant difference in the percentages of agreement among different countries and a variable gap between agreement and clinical practice were found for most of the interventions. CONCLUSIONS: This updated consensus process identified 11 nonsurgical interventions with possible survival implications for patients undergoing cardiac surgery. This list of interventions may help cardiac anesthesiologists and intensivists worldwide in their daily clinical practice and can contribute to direct future research in the field.

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR-taVi procedures for severe Aortic steNosis Treatment) study. SETTING: Multicenter study, including Italian hospitals performing TAVR interventions. PARTICIPANTS: One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. INTERVENTIONS: Transfemoral TAVR under general or local anesthesia. MEASUREMENTS AND MAIN RESULTS: A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). CONCLUSIONS: Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

A comparison of the femoral and radial crossover techniques for vascular access management in transcatheter aortic valve implantation: the Milan experience.

OBJECTIVE: To compare radial and femoral crossover techniques (CT) for vascular access management in transcatheter aortic valve implantation (TAVI). BACKGROUND: Femoral crossover for controlled angiography and balloon inflation of the therapeutic access site to facilitate safe vascular closure is beneficial but technically challenging in patients with complex femoral anatomy. An alternative approach should be available. METHODS: Between June 2011 and March 2012, 41 transfemoral TAVI patients receiving the femoral CT were compared to 46 transfemoral TAVI patients receiving the radial CT. Outcomes were 30-day valve academic research consortium (VARC) endpoints. RESULTS: Patients undergoing the radial CT received higher median contrast volumes (150 interquartile range [IQR]: 105-180 vs. 111 IQR: 90-139 ml; P = 0.025) but procedural radiation dose and fluoroscopy times were comparable. Thirty day all cause and cardiovascular death were similar between radial and femoral CT groups (respectively 2.4% vs. 7.9%, P = 0.258 and 0% vs. 7.9%, P = 0.063). There were no differences in major vascular complications (4.3% vs. 7.3%, P = 0.553), life threatening or major bleeding events (respectively 9.1% vs. 19.5%, P = 0.168 and 13.6% vs. 22%, P = 0.315). CONCLUSION: In TAVI cases with unfavorable contralateral femoral anatomy, radial CT for vascular access management is a reasonable alternative to the femoral CT.

Anticoagulation for critically ill cardiac surgery patients: is primary bivalirudin the next step?

OBJECTIVE: Anticoagulation with unfractionated heparin (UFH) in critically ill cardiac surgery patients has several limitations, including the risk of heparin-induced thrombocytopenia. The use of a direct thrombin inhibitor, such as bivalirudin, might either treat this complication or completely eliminate it. The aim of the present study was to analyze the use of bivalirudin in this setting, as either a secondary drug switching from heparin or as the primary anticoagulant, and to evaluate clinical outcomes. DESIGN: Propensity-matching retrospective analysis. SETTING: A cardiac surgery intensive care unit. PARTICIPANTS: One hundred propensity-matched patients who received heparin or bivalirudin. INTERVENTIONS: Bivalirudin was administered as a first-line or second-line drug after heparin discontinuation in case of thrombocytopenia and suspicion of heparin-induced thrombocytopenia. Twenty-six patients (52%) received bivalirudin as a primary anticoagulant, while 24 patients (48%) received bivalirudin after switching from heparin. MEASUREMENTS AND MAIN RESULTS: Bivalirudin treatment was associated with a reduction of major bleeding (p=0.05) compared with the control group. Interestingly, in an intention-to-treat analysis, patients receiving primary bivalirudin showed significant reductions in minor bleeding (p=0.04), and mortality (p=0.01) compared with the secondary bivalirudin group and, similarly, compared with the rest of the study population (UFH and secondary bivalirudin patients, p=0.01 and p=0.05, respectively). Predictors of hospital mortality by multivariate analysis included urgent admission (odds ratio [OR]=2.7; 95 confidence interval [CI], 1.03-7.2; p=0.04), ;septic shock (OR=8.0; 95 CI, 2.26-28.7; p<0.005) and primary therapy with UFH (OR=19.2; 95 CI, 2.2-163.9; p=0.007). CONCLUSIONS: Novel anticoagulant strategies might play a crucial role in critically ill cardiac surgery patients. In a propensity-matched population, results of the present study showed that primary bivalirudin anticoagulation may reduce bleeding complications and mortality.

A "modified crossover technique" for vascular access management in high-risk patients undergoing transfemoral transcatheter aortic valve implantation.

OBJECTIVES: To describe results from our "modified crossover technique" for vascular access management during transcatheter aortic valve implantation (TAVI). BACKGROUND: Vascular access management remains a major cause of complications following TAVI due to the large bore sheaths required. METHODS: All suitable patients undergoing TAVI in our center, between June and August 2011, underwent our "modified crossover technique," which enables the passage of a balloon through left radial access and inflation in the proximal iliac to allow percutaneous closure in a clean field. RESULTS: In total, 15 patients were included: the logistic EuroSCORE was 19.7 ± 12.1% and STS score 5.7 ± 5.6%. The mean therapeutic femoral access site diameter was 8.1 ± 1.0 mm. Ten (66.7%) patients received Edwards SAPIEN™ XT (two using the new E-sheath) and five (33.3%) patients a Medtronic CoreValve ReValving System® device. The "modified crossover technique" was used successfully in all patients. There were three vascular complications occurring at the therapeutic access site: one rupture of the external iliac artery, one Prostar failure, and one pseudoaneurysm of the right common femoral artery. All complications were successfully treated percutaneously with covered stent implantation via access from the contralateral femoral artery. In view of the balloon inflation from the left radial artery, the complications could be treated in a clean field with minimal blood loss. CONCLUSIONS: Our "modified crossover technique" using the left radial artery as the diagnostic site for balloon inflation appears a helpful adjunct in managing TAVI vascular access sites.

Thoracic epidural anesthesia improves early outcome in patients undergoing cardiac surgery for mitral regurgitation: a propensity-matched study.

OBJECTIVE: There are no large studies that investigate the effect of thoracic epidural anesthesia (TEA) combined with general anesthesia (GA) in patients undergoing valvular surgery. The authors hypothesized that TEA might improve clinically relevant endpoints in patients with primary mitral regurgitation. DESIGN: Propensity-matched study. SETTING: Cardiac surgery. PARTICIPANTS: Patients scheduled for mitral valve repair or replacement were studied. INTERVENTIONS: A propensity model was constructed to match 33 patients receiving TEA combined with GA with 33 patients receiving standard GA alone. MEASUREMENTS AND MAIN RESULTS: Overall, the TEA group suffered fewer adverse events than the GA group: 10 (30%) v 23 (10%) with p = 0.002. In particular, the TEA group had a lower incidence of pulmonary events, 6 (18%) v 15 (45%) with p = 0.02, and of cardiac events, 8 (24%) v 16 (49%) with p = 0.04. Median (interquartile) time on mechanical ventilation was reduced in the TEA group, 11 (9-15) v 17 (12-36) with p = 0.007. CONCLUSIONS: This propensity-matched study suggested that TEA might be advantageous in patients undergoing surgery for mitral regurgitation.

Bivalirudin versus heparin as an anticoagulant during extracorporeal membrane oxygenation: a case-control study.

OBJECTIVE: Heparin-based anticoagulation for patients undergoing extracorporeal membrane oxygenation has many limitations, including a high risk of heparin-induced thrombocytopenia. However, little experience with other anticoagulants in these patients has been described. The aim of this study was to compare bivalirudin-based anticoagulation with heparin-based protocols in a population of patients treated with venovenous or venoarterial extracorporeal membrane oxygenation. DESIGN: In this case-control study, 10 patients received bivalirudin (cases) and 10 heparin (controls). The target activated partial thromboplastin time (aPTT) was 45 to 60 seconds. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: aPTT variations >20% of the previous value were much more frequent in patients treated with heparin than in patients receiving bivalirudin (52 v 24, p < 0.001). The number of corrections of the anticoagulant dose was higher in the heparin group compared with the bivalirudin group (58 v 51), although it did not reach statistical significance. Bleeding, thromboembolic complications, extracorporeal membrane oxygenation (ECMO) support duration, mortality, and the number of episodes of aPTT >80 seconds were not different between the 2 groups. A further analysis was performed in the bivalirudin group according to the presence of acute renal failure requiring continuous venovenous hemofiltration. The median bivalirudin dose in patients with or without hemofiltration was 0.041 (0.028-0.05) mg/kg/h and 0.028 (0-0.041) mg/kg/h, respectively (p = 0.2). CONCLUSIONS: Bivalirudin-based anticoagulation may represent a new method of anticoagulation for reducing thromboembolic and bleeding complications, which still jeopardize the application of extracorporeal membrane oxygenation. Moreover, bivalirudin is free from the risk of heparin-induced thrombocytopenia. Higher doses of bivalirudin may be needed in patients undergoing hemofiltration.

Meta-Analysis of Glucocorticoids for Covid-19 Patients Not Receiving Oxygen.

BACKGROUND: Glucocorticoids reduce mortality in hospitalized patients with severe and critical coronavirus disease 2019 (Covid-19), although a possible harm was documented in patients with Covid-19 not requiring oxygen. METHODS: We searched Embase, BioMed Central, medRxiv, bioRxiv, PubMed, and the Cochrane Central Register of Controlled Trials for any randomized trial or matched study ever performed on adult patients with Covid-19 not receiving oxygen therapy treated with intravenous or oral glucocorticoids versus any comparator (standard therapy or placebo); there were no restrictions on dose or time of administration. The primary end point was all-cause mortality at the longest available follow-up. RESULTS: Five randomized trials and one propensity-matched study involving 6634 hospitalized patients not on oxygen were finally included (3704 received glucocorticoids and 2930 received standard treatment). The overall mortality of patients treated with glucocorticoids was significantly higher than the mortality of patients in the control group (509 of 3704 [14%] in the glucocorticoid group vs. 294 of 2930 [10%] in the control group; odds ratio, 1.56 [95% confidence interval, 1.27 to 1.92], with three articles reporting mortality events and contributing to the combined odds ratio; P<0.001; number needed to harm=27). CONCLUSIONS: Glucocorticoid use likely increases mortality in hospitalized patients with Covid-19 not receiving oxygen, with a number needed to harm of 27. (PROSPERO number CRD42022342996.)

Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study.

BACKGROUND: Limited real-world data comparing outcomes after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with aortic stenosis are available. METHODS: We identified 182 consecutive patients who underwent TAVR via the transfemoral (TF) route (November 2007-February 2011) and 111 moderate-to-high-risk historical case controls undergoing SAVR (August 2003-July 2008). Using propensity score matching based on clinical characteristics and surgical risk scores, we compared clinical outcomes in 111 matched patients. Valve Academic Research Consortium definitions were applied for end point adjudication. RESULTS: Baseline clinical characteristics, in particular Logistic European System for Cardiac Operative Risk Evaluation (23.2 ± 15.1 vs 24.4 ± 13.4) and Society of Thoracic Surgeons score (4.6 ± 2.3 vs 4.6 ± 2.6), were well matched between groups. Transfemoral TAVR was associated with more vascular complications (33.3% vs 0.9%, P < .001). On the other hand, acute kidney injury was more frequent after SAVR (8.1% vs 26.1%, P < .001). The rates of all-cause mortality in both TF-TAVR and SAVR groups was1.8% at 30 days (P = 1.00) and 6.4% and 8.1%, respectively, at 1 year (P = .80). At 1 year, the rate of cerebrovascular events was similar in the 2 groups (4.6% vs 9.1%, P = .19). CONCLUSIONS: In this real-world cohort of intermediate-surgical-risk patients with aortic stenosis, TF-TAVR and SAVR were associated with similar mortality rates during follow-up but with a different spectrum of periprocedural complications. Furthermore, the survival rate after TF-TAVR in this group of elderly patients with intermediate Society of Thoracic Surgeons score was encouraging.

Milrinone and mortality in adult cardiac surgery: a meta-analysis.

OBJECTIVE: The authors conducted a review of randomized studies to show whether there are any increases or decreases in survival when using milrinone in patients undergoing cardiac surgery. DESIGN: A meta-analysis. SETTING: Hospitals. PARTICIPANTS: Five hundred eighteen patients from 13 randomized trials. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: BioMedCentral, PubMed EMBASE, the Cochrane central register of clinical trials, and conference proceedings were searched for randomized trials that compared milrinone versus placebo or any other control in the setting of cardiac surgery that reported data on mortality. Overall analysis showed that milrinone increased perioperative mortality (13/249 [5.2%] in the milrinone group v 6/269 [2.2%] in the control arm, odds ratio [OR] = 2.67 [1.05-6.79], p for effect = 0.04, p for heterogeneity = 0.23, I(2) = 25% with 518 patients and 13 studies included). Subanalyses confirmed increased mortality with milrinone (9/84 deaths [10.7%] v 3/105 deaths [2.9%] with other drugs as control, OR = 4.19 [1.27-13.84], p = 0.02) with 189 patients and 5 studies included) but did not confirm a difference in mortality (4/165 [2.4%] in the milrinone group v 3/164 [1.8%] with placebo or nothing as control, OR = 1.27 [0.28-5.84], p = 0.76 with 329 patients and 8 studies included). CONCLUSIONS: This analysis suggests that milrinone might increase mortality in adult patients undergoing cardiac surgery. The effect was seen only in patients having an active inotropic drug for comparison and not in the placebo subgroup. Therefore, the question remains whether milrinone increased mortality or if the control inotropic drugs were more protective.

Fenoldopam and acute renal failure in cardiac surgery: a meta-analysis of randomized placebo-controlled trials.

OBJECTIVE: Because at present no pharmacologic prevention or treatment of acute kidney injury seems to be available, the authors updated a meta-analysis to investigate the effects of fenoldopam in reducing acute kidney injury in patients undergoing cardiac surgery, focusing on randomized placebo-controlled studies only. DESIGN: A meta-analysis of randomized, placebo-controlled trials. SETTING: Hospitals. PARTICIPANTS: A total of 440 patients from 6 studies were included in the analysis. INTERVENTIONS: None. The ability of fenoldopam to reduce acute kidney injury in the perioperative period when compared with placebo was investigated. MEASUREMENTS AND MAIN RESULTS: Google Scholar and PubMed were searched (updated January 1, 2012). Authors and external experts were contacted. Pooled estimates showed that fenoldopam consistently and significantly reduced the risk of acute kidney injury (odds ratio [OR] = 0.41; 95% confidence interval [CI], 0.23-0.74; p = 0.003), with a higher rate of hypotensive episodes and/or use of vasopressors (30/109 [27.5%] v 21/112 [18.8%]; OR = 2.09; 95% CI, 0.98-4.47; p = 0.06) and no effect on renal replacement therapy, survival, and length of intensive care unit or hospital stay. CONCLUSIONS: This analysis suggests that fenoldopam reduces acute kidney injury in patients undergoing cardiac surgery. Because the number of the enrolled patients was small and there was no effect on renal replacement therapy or survival, a large, multicenter, and appropriately powered trial is needed to confirm these promising results.

Anesthetic management of transcatheter aortic valve implantation with transaxillary approach.

OBJECTIVE: To describe the anesthetic management of transcatheter aortic valve implantation (TAVI) with the transaxillary approach. DESIGN: An observational cohort study. SETTING: Two university hospitals. PARTICIPANTS: Twenty-two patients with severe aortic stenosis (± regurgitation) at high risk for surgical valve replacement, with contraindications for transfemoral TAVI (81 ± 4.9 years; logistic EuroSCORE, 27% ± 16.9%). INTERVENTION: General anesthesia or local anesthesia plus sedation followed by postoperative care. MEASUREMENTS AND MAIN RESULTS: Local anesthesia plus sedation and general anesthesia were used in 14 and 8 patients, respectively. Two patients undergoing local anesthesia were monitored with transesophageal echocardiography and supported with noninvasive mask ventilation during the procedure. Main complications included hemodynamic instability requiring inotropes (2 patients), severe postimplant aortic regurgitation requiring immediate second valve-in-valve implantation (1 patient), valve embolization requiring open-valve surgery (1 patient), subclavian artery dissection compromising the flow to a mammary artery graft (1 patient), ascending aortic dissection (1 patient), stroke (2 patients), and atrioventricular block requiring pacemaker implantation (3 patients). Four patients experienced an increased (baseline value × 1.5) postoperative serum creatinine. Five patients required red blood cell tranfusions (2 units). Intensive care unit stay and hospital stay were 6 (4-23) hours and 8 (8-9) days, respectively. All patients were alive 30 days after the procedure. The 6-month mortality was 9%. CONCLUSIONS: Transaxillary TAVI is feasible in high-risk patients with aortic stenosis and peripheral vasculopathy. Nevertheless, severe procedural complications are possible, and anesthesiologists should be prepared to assist in the management of these conditions.

Intrathecal lactate concentration and spinal cord injury in thoracoabdominal aortic surgery.

OBJECTIVE: The aim of this study was to evaluate the role of lactate as an early predictor of spinal cord injury during thoracoabdominal aortic aneurysm repair. DESIGN: Observational study. SETTING: University hospital. PARTICIPANTS: Sixteen consecutive patients (10 men and 6 women) scheduled to undergo thoracoabdominal aortic aneurysm repair were enrolled in the study. All patients were affected by atherosclerotic aneurysmal pathology. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: During surgery, the authors simultaneously withdrew samples of cerebrospinal fluid and arterial blood to evaluate pO(2), pCO(2), pH, and lactate concentration. Samples were collected at 5 fixed times during and after surgery: T1 (before aortic cross-clamping), T2 (15 minutes after clamping), T3 (just before unclamping), T4 (end of surgery), and T5 (4 hours after the end of surgery). Lactate levels in cerebrospinal fluid rose consistently during aortic cross-clamping (T1 = 1.89 mmol/L, T2 = 2.21 mmol/L, T3 = 2.88 mmol/L, T4 = 3.655 mmol/L, and T5 = 3.16 mmol/L). Lactate concentrations in the cerebrospinal fluid were significantly higher in the 4 patients who developed neurologic injury, even at T1 (before surgery), than in those who did not end in spinal cord injury with the 4 highest values belonging to the 4 patients who later developed spinal cord injury. CONCLUSIONS: This study has the potential to elucidate the time course of early lactate level elevation during thoracoabdominal aortic aneurysm repair and its clinical use in predicting the development of postoperative spinal cord injury.

Noninvasive Ventilatory Support of Patients with COVID-19 outside the Intensive Care Units (WARd-COVID).

Rationale: Treatment with noninvasive ventilation (NIV) in coronavirus disease (COVID-19) is frequent. Shortage of intensive care unit (ICU) beds led clinicians to deliver NIV also outside ICUs. Data about the use of NIV in COVID-19 is limited.Objectives: To describe the prevalence and clinical characteristics of patients with COVID-19 treated with NIV outside the ICUs. To investigate the factors associated with NIV failure (need for intubation or death).Methods: In this prospective, single-day observational study, we enrolled adult patients with COVID-19 who were treated with NIV outside the ICU from 31 hospitals in Lombardy, Italy.Results: We collected data on demographic and clinical characteristics, ventilatory management, and patient outcomes. Of 8,753 patients with COVID-19 present in the hospitals on the study day, 909 (10%) were receiving NIV outside the ICU. A majority of patients (778/909; 85%) patients were treated with continuous positive airway pressure (CPAP), which was delivered by helmet in 617 (68%) patients. NIV failed in 300 patients (37.6%), whereas 498 (62.4%) patients were discharged alive without intubation. Overall mortality was 25%. NIV failure occurred in 152/284 (53%) patients with an arterial oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio <150 mm Hg. Higher C-reactive protein and lower PaO2/FiO2 and platelet counts were independently associated with increased risk of NIV failure.Conclusions: The use of NIV outside the ICUs was common in COVID-19, with a predominant use of helmet CPAP, with a rate of success >60% and close to 75% in full-treatment patients. C-reactive protein, PaO2/FiO2, and platelet counts were independently associated with increased risk of NIV failure.Clinical trial registered with ClinicalTrials.gov (NCT04382235).

Non-invasive ventilation-aided transoesophageal echocardiography in high-risk patients: a pilot study.

AIMS: Transoesophageal echocardiography (TEE) may require patient sedation, eventually leading to respiratory depression, a risky condition in severe cardiac disease. Non-invasive ventilation (NIV) has been applied during diagnostic manoeuvres, but its use during TEE has not been reported. We describe NIV-aided continuous TEE monitoring under sedation in the supine position in three consecutive orthopnoeic patients with severe aortic valve stenosis: two of them underwent percutaneous aortic valve implantation, and one underwent aortic valvuloplasty. METHODS AND RESULTS: The TEE probe was passed through a hole performed with a surgical cutter in an NIV face-mask. Pulsoximetry, heart rate, arterial blood pressure, respiratory rate, arterial blood gases, patients' comfort, and patient's sedation were monitored throughout the procedure. Percutaneous aortic valve implantation procedures lasted almost 2 h, while the valvuloplasty procedure lasted 70 min. Non-invasive ventilation and continuous TEE were performed throughout the procedures without technical problems or respiratory or haemodynamic complications, and all patients felt always comfortable. CONCLUSION: Non-invasive ventilation through a modified face-mask allowed to perform continuous TEE examination and to avoid tracheal intubation and general anaesthesia in three high-risk patients undergoing beating heart treatment of aortic valve stenosis.

Anesthetic management of percutaneous aortic valve implantation: focus on challenges encountered and proposed solutions.

OBJECTIVE: To describe 6 months of experience in the anesthetic management of percutaneous aortic valve implantation. DESIGN: An observational, cohort study. SETTING: A university hospital. PARTICIPANTS: Eighteen high-risk patients with relative contraindications to surgical valve replacement (78 +/- 8.7 years, logistic EuroSCORE 26 +/- 19.1). INTERVENTION: An Edwards/Sapien Aortic Bioprosthesis (Edwards Lifesciences LLC, Irvine, CA) was implanted in patients with severe symptomatic aortic stenosis who underwent percutaneous retrograde aortic valve implantation without cardiopulmonary bypass. The procedure was performed using general anesthesia (15 patients) or sedation (3 patients). MEASUREMENTS AND MAIN RESULTS: The valve was successfully implanted in all patients. One patient had prolonged ventricular fibrillation that required advanced cardiopulmonary resuscitation, endotracheal intubation, and placement of an intra-aortic balloon pump. Six patients had vascular access site complications managed either percutaneously or surgically. Five patients were extubated in the catheterization laboratory. All patients were transferred to the intensive care unit for monitoring, and all but one were discharged to an intermediate care unit within 24 hours. Early postoperative complications included acute renal failure (1 patient), arrhythmias (1 atrial fibrillation and 1 transient heart block), and stroke (1 patient). One patient died 58 days after the procedure for noncardiac reasons. CONCLUSIONS: Transcatheter aortic valve implantation is possible in selected high-risk patients. Anesthesiologists must be aware of current technology in order to have an active role in patient selection, to develop monitoring and standards of care in the cardiac catheterization laboratory, and to plan postoperative management.

Spinal analgesia in cardiac surgery: a meta-analysis of randomized controlled trials.

OBJECTIVE: Controversial results exist on the effects of spinal analgesia in cardiac surgery. The authors conducted a review of randomized studies to show whether there are any advantages in clinically relevant outcomes using spinal analgesia in patients undergoing cardiac surgery. DESIGN: Meta-analysis. SETTING: Multiple hospitals. PARTICIPANTS: A total of 1,106 patients from 25 randomized trials. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULT: PubMed, BioMedCentral, CENTRAL, EMBASE, Cochrane Central Register of Controlled Trials, and conference proceedings were searched (updated January 2009) for randomized trials that compared general anesthesia with an anesthetic plan including spinal analgesia in cardiac surgery. Four independent reviewers performed data extraction, with divergences resolved by consensus. A total of 1,106 patients from 25 randomized studies were included in the analysis. Overall analysis showed that there were no differences in terms of mortality (2/562 [0.4%] in the spinal group v 2/514 [0.4%] in the control arm [risk difference (RD) = 0.00 [-0.02, +0.02], p = 1.0), perioperative myocardial infarction (9/421 [2.1%] in the spinal group v 11/407 [2.7%] in the control arm [RD = 0.00, -(0.03, +0.02), p = 0.77), and the length of hospital stay (WMD = -0.28 days [-0.68, -0.13], p = 0.18, with 419 included patients). CONCLUSIONS: This analysis indicated that spinal analgesia does not improve clinically relevant outcomes in patients undergoing cardiac surgery, discouraging further randomized controlled trials on this topic even if changes in techniques, devices, and drugs could modify the outlook of the comparison between spinal and standard anesthesia in this setting.

Early and Midterm Outcome of Propensity-Matched Intermediate-Risk Patients Aged ≥80 Years With Aortic Stenosis Undergoing Surgical or Transcatheter Aortic Valve Replacement (from the Italian Multicenter OBSERVANT Study).

The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p <0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p <0.0001), and paravalvular leak (8.9% vs 2.4%; p <0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p <0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality.