Results of surgical aortic valve replacement and transapical transcatheter aortic valve replacement in patients with previous coronary artery bypass grafting.

OBJECTIVES: To evaluate the results of aortic valve replacement through sternotomic approach in redo scenarios (RAVR) vs transapical transcatheter aortic valve replacement (TAVR), in patients in the eighth decade of life or older already undergone previous coronary artery bypass grafting (CABG). METHODS: One hundred and twenty-six patients undergoing RAVR were compared with 113 patients undergoing TaTAVR in terms of 30-day mortality and Valve Academic Research Consortium-2 outcomes. The two groups were also analysed after propensity-matching. RESULTS: TaTAVR patients demonstrated a higher incidence of 30-day mortality (P = 0.03), stroke (P = 0.04), major bleeding (P = 0.03), worse 'early safety' (P = 0.04) and lower permanent pacemaker implantation (P = 0.03). TaTAVR had higher follow-up hazard in all-cause mortality [hazard ratio (HR) 3.15, 95% confidence interval (CI) 1.28-6.62; P < 0.01] and cardiovascular mortality (HR 1.66, 95% CI 1.02-4.88; P = 0.04). Propensity-matched patients showed comparable 30-day outcome in terms of survival, major morbidity and early safety, with only a lower incidence of transfusions after TaTAVR (10.7% vs RAVR: 57.1%; P < 0.01). A trend towards lower Acute Kidney Injury Network Classification 2/3 (3.6% vs RAVR 21.4%; P = 0.05) and towards a lower freedom from all-cause mortality at follow-up (TaTAVR: 44.3 ± 21.3% vs RAVR: 86.6 ± 9.3%; P = .08) was demonstrated after TaTAVR, although cardiovascular mortality was comparable (TaTAVR: 86.5 ± 9.7% vs RAVR: 95.2 ± 4.6%; P = 0.52). Follow-up freedom from stroke, acute heart failure, reintervention on AVR and thrombo-embolisms were comparable (P = NS). EuroSCORE II (P = 0.02), perioperative stroke (P = 0.01) and length of hospitalization (P = 0.02) were the determinants of all-cause mortality at follow-up, whereas perioperative stroke (P = 0.03) and length of hospitalization (P = 0.04) impacted cardiovascular mortality at follow-up. CONCLUSIONS: Reported differences in mortality and morbidity after TaTAVR and RAVR reflect differences in baseline risk profiles. Given the lower trend for renal complications, patients at higher perioperative renal risk might be better served by TaTAVR.

Aortic Valve Replacement in Redo-Scenarios: A Comparison Between Traditional Aortic Valve Replacement (TAVR) and Transapical-TAVR from Two Real-World Multicenter Registries.

BACKGROUND: The study aim was to compare the outcome of transapical transcatheter aortic valve replacement (TaTAVR) and traditional aortic valve replacement (AVR) in redo from two real-world registries. METHODS: The 30-day and follow up outcome of 462 patients enrolled in two multicenter redo registries, treated with redo-AVR (RAVR; n = 292 patients) or TaTAVR (n = 170 patients), were analyzed according to VARC-2 criteria, stratified also by propensity-matching analysis. RESULTS: TaTAVR-patients were older and sicker than RAVR patients, and reported a higher all-cause 30-day mortality (p <0.01), a higher risk for all-cause mortality (p = 0.006) and cardiovascular mortality (p = 0.05) at follow up, but similar 30-day cardiovascular mortality (p = 0.12). Prolonged intubation (p <0.01) and Acute Kidney Injury Network (AKIN) 2/3 p = 0.02) prevailed in RAVR. TaTAVR patients reported a higher level of major/life-threatening/disabling bleeding (p <0.01) and 'early safety-events' (ES) (p = 0.04). Thirty-day acute myocardial infarction (AMI), stroke, and follow up freedom from acute heart failure (AHF), from stroke and from reinterventions were similar (p = NS). The NYHA class was better after RAVR (p <0.01). The intermediate-to-high risk (Logistic EuroSCORE RAVR 17.1 ± 8.5; TaTAVR 16.0 ± 17.0) propensity-matched population demonstrated comparable 30-day and follow up all-cause and cardiovascular mortality, ES, AMI, stroke, prolonged intubation, follow up freedom from AHF, from stroke and from reinterventions and NYHA class. TaTAVR still reported lower levels of AKIN 2/3 (2.2% versus 15.6%, p = 0.03) and shorter hospitalization (9.5 ± 3.4 days versus 12.0 ± 7.0 days, p = 0.03). CONCLUSIONS: Outcome differences between RAVR and TaTAVR in redo-scenarios reflect methodological differences and different baseline risk profiles. Propensity-matched patients showed a better renal outcome after TaTAVR. *Drs. Onorati and D'Onofrio contributed equally to this article and should both be considered as first authors.

When does transapical aortic valve replacement become a futile procedure? An analysis from a national registry.

OBJECTIVES: Patient selection is crucial to achieve good outcomes and to avoid futile procedures in patients undergoing transcatheter aortic valve replacement. The aim of this multicenter retrospective study was to identify independent predictors of 1-year mortality in patients surviving after transapical transcatheter aortic valve replacement. METHODS: We analyzed data from the Italian registry of transapical transcatheter aortic valve replacement that includes patients undergoing operation in 21 centers from 2007 to 2012. Futility was defined as mortality within 1 year after transapical transcatheter aortic valve replacement in patients surviving at 30 days. Thirty-day survivors were divided in 2 groups: futility (group F) and nonfutility (group NF). Cox proportional hazard regression analysis was performed to identify independent predictors of futility. RESULTS: We analyzed data from 645 patients with survival of 30 days or more after transapical transcatheter aortic valve replacement. Groups F and NF included 60 patients (10.8%) and 585 patients (89.2%), respectively. Patients in group F were more likely to have insulin-dependent diabetes (15% vs 7.2%, P = .03), creatinine 2.0 mg/dL or greater or dialysis (18.3% vs 8.2%, P = .01), logistic European System for Cardiac Operative Risk Evaluation greater than 20% (66.7% vs 50.3%, P = .02), preoperative rhythm disorders (40% vs 25.3%, P = .03), critical preoperative state (8.3% vs 1.8%, P = .002), and left ventricular ejection fraction less than 30% (15% vs 2.9%, P < .001). The multivariate analysis identified the following as independent predictors of futility: insulin-dependent diabetes (odds ratio, 3.1; P = .003), creatinine 2.0 mg/dL or greater or dialysis (odds ratio, 2.52; P = .012), preoperative rhythm disorders (odds ratio, 1.88; P = .04), and left ventricular ejection fraction less than 30% (odds ratio, 4.34; P = .001). CONCLUSIONS: According to our data, among patients undergoing transapical transcatheter aortic valve replacement, those with insulin-dependent diabetes, advanced chronic kidney disease, rhythm disorders, and low left ventricular ejection fraction have a higher risk to undergo futile procedures.

Previous percutaneous coronary interventions increase mortality and morbidity after coronary surgery.

BACKGROUND: This multicenter study investigated the impact of previous percutaneous coronary interventions (PCI) on postoperative outcome and 5-year survival of subsequent coronary artery bypass grafting. METHODS: Among 7,855 patients who underwent isolated first-time coronary artery bypass grafting between January 2000 and December 2005, 6,834 (87%) had no previous PCI and 1,021 (13%) had previous PCI with stenting. Logistic multiple regression and propensity score analyses were used to assess the risk-adjusted impact of prior PCI on in-hospital mortality and major adverse cardiac events. The Cox regression model was used to assess the effect of prior PCI on 3-year and 5-year survival. RESULTS: After risk-adjusted multivariate analysis, age over 70 years, female sex, 3-vessel or 2-vessel plus left main coronary disease, multivessel PCI, ejection fraction 0.40 or less, diabetes mellitus, previous myocardial infarction, and chronic obstructive pulmonary disease were identified as independent predictors of both hospital mortality and major adverse cardiac events. After propensity score matching, conditional logistic regression analysis identified history of previous PCI as significantly associated with an increased risk for hospital mortality (odds ratio, 2.8; 95% confidence interval 1.4 to 4.8; p=0.003) and major adverse cardiac events (odds ratio 2.1; 95% confidence interval 1.2 to 3.6; p<0.001). Survival at 3 and 5 years was lower in patients with previous PCI compared with the no-PCI patients (97.4%±0.01% vs 96.5%±0.02% and 94.2%±0.03% vs 92.1%±0.05%; log-rank test: p=0.03). CONCLUSIONS: Our results provided further evidence that history of PCI before coronary artery bypass grafting increases risk of both operative death and perioperative complications, and decreases survival at 5 years follow-up.

Early clinical and haemodynamic results after aortic valve replacement with the Freedom SOLO bioprosthesis (experience of Italian multicenter study).

OBJECTIVES: The present study investigates early clinical and haemodynamic results with the Freedom SOLO bioprosthesis (FSB) for aortic valve replacement (AVR) in eight Italian institutions. METHODS: From 2004 to 2008, a total of 229 patients [139 females (60.7%); mean age 74 ± 8 years, left ventricular (LV) ejection fraction >40%] underwent AVR with FSB. One hundred and four patients underwent preoperatively, at 1-3 and at 12 months after AVR resting transthoracic echocardiography with the effective orifice area index (EOAi) assessment, peak and mean transvalvular pressure gradients and the LV mass index (LVMi) measurement. A subset of 34 patients underwent exercise stress echocardiography at a mean of 9.6 months after AVR. RESULTS: Post-operative mortality was 3.1%. At 1-3 months, FSB showed a significant increase in the EOAi (0.39 ± 0.17 to 1.04 ± 0.17 cm(2)/m(2); P < 0.0001), a reduction in the mean gradient (43.2 ± 16.9 to 4.3 ± 2.3 mmHg; P < 0.0001) and a significant regression of the LVMi (147.6 ± 30.5 to 121.6 ± 27.4 g/m(2); P < 0.0001). During exercise stress echocardiography, the mean aortic gradients increased from 4.4 ± 1.7 at rest to 7.0 ± 2.7 mmHg at peak stress (P < 0.001). The EOA increased from 1.74 ± 0.33 to 1.80 ± 0.36 cm(2) (P = 0.0291). Mean gradients at peak stress had better correlation with resting EOAi (r = -0.74; P < 0.001) than with the prosthesis size (r = 0.43; P = 0.01). CONCLUSIONS: The supra-annular implantation of FSB offers excellent haemodynamic performance both at rest and during exercise and is associated with the rapid regression of the LV.

Thoracic epidural anesthesia improves early outcomes in patients undergoing off-pump coronary artery bypass surgery: a prospective, randomized, controlled trial.

BACKGROUND: The aim of this two-center, open, randomized, controlled trial was to evaluate the impact of thoracic epidural anesthesia on early clinical outcomes in patients undergoing off-pump coronary artery bypass surgery. METHODS: Two hundred and twenty-six patients were randomized to either general anesthesia plus epidural (GAE) (n = 109) or general anesthesia only (GA) (n = 117). The primary outcome was length of postoperative hospital stay. Secondary outcomes were: arrhythmia, inotropic support, intubation time, perioperative myocardial infarction, neurologic events, intensive care stay, pain scores, and analgesia requirement. RESULTS: Baseline characteristics were similar in the two groups. One patient died in the GAE group. Median postoperative stay was significantly reduced in the GAE, compared with the GA, group (5 days, interquartile range [5-6] vs. 6 days, interquartile range [5-7], hazard ratio = 1.39, 95% CI [1.06-1.82]; P = 0.017). The incidence of arrhythmias and the median intubation time were both significantly lower in the GAE, compared with the GA, group (odds ratio = 0.41, 95% CI [0.22-0.78], P = 0.006 and hazard ratio = 1.73, 95% CI [1.31-2.27], P < 0.001, respectively). Patients in the GAE group were more likely to need vasoconstrictors intraoperatively than in the GA group (odds ratio = 2.50, 95% CI [1.22-5.12]; P = 0.012). The GAE, compared with GA, group reported significantly lower levels of impairment for all pain domains and reduced morphine usage (odds ratio = 0.07, 95% CI [0.03-0.17]; P < 0.001). CONCLUSION: In patients undergoing off-pump coronary artery bypass surgery, the addition of thoracic epidural to general anesthesia significantly reduces the incidence of postoperative arrhythmias and improves pain control and overall quality of recovery, allowing earlier extubation and hospital discharge.

Acute left main obstructions following TAVI.

AIMS: Transcatheter aortic valve implantation (TAVI) is becoming a safe and effective technique for treating symptomatic aortic valvular stenosis (AVS) as an alternative to surgery in very high-risk patients. A possible consequence of valve implantation is the obstruction of coronary ostia. METHODS AND RESULTS: Here we report five cases of angiographically confirmed left main (LM) obstruction, occurred immediately after balloon expandable aortic valve implantations at our institution. In four of these cases, LM obstruction was resolved with an emergency percutaneous coronary intervention (PCI). In the remaining case, obstruction transiently occurred only at the time of balloon valvuloplasty and did not required treatment. During this type of intervention, performing an aortography at the time of balloon valvuloplasty could help to identify patients at risk for coronary obstructions. CONCLUSIONS: These cases illustrate that obstruction of the coronary ostia following TAVI is a possible complication. As the use of TAVI becomes widespread, the operators should be aware of this dangerous complication in their case preparation should it arise.

Management of percutaneous aortic valve malposition with a transapical "valve-in-valve" technique.

Transcatheter aortic valve replacement is an emerging therapeutic alternative for patients with severe aortic valve stenosis and high surgical risk. The inability to reposition the current prosthesis is a limiting feature of these devices. Here we report on a case of a 74-year-old woman, in which a balloon expandable aortic valve malpositioning was treated with a second transapical transcatheter aortic valve implant.

A randomized trial of tranexamic acid in combination with cell salvage plus a meta-analysis of randomized trials evaluating tranexamic acid in off-pump coronary artery bypass grafting.

OBJECTIVES: We sought to evaluate the effectiveness of tranexamic acid in off-pump coronary artery bypass grafting surgery, either when used in combination with mechanical cell salvage or when used alone. METHODS: One hundred patients were randomized to either 2 g of tranexamic acid as an intravenous bolus before sternotomy or to placebo. Intraoperative and postoperative cell salvage was used in all patients. The primary end point was early postoperative blood loss (within 4 hours). To evaluate the efficacy of tranexamic acid in isolation, we also performed a meta-analysis of 4 randomized trials identified from a systematic literature search. The primary end point of the meta-analysis was red cell transfusion. RESULTS: In our randomized trial patients in the tranexamic acid group had a significant reduction in early postoperative blood loss, (median difference, 50 mL; 95% confidence interval, 15-100 mL; P < .01); however, there was no reduction in the frequency of blood component transfusion. Patients in the placebo group received a significantly larger volume of autotransfused red cells (median difference, 120 mL; 95% confidence interval, 0-220 mL; P = .02). The meta-analysis demonstrated a significant reduction in red cell transfusions in patients receiving tranexamic acid compared with those receiving placebo (risk ratio, 0.48; 95% confidence interval, 0.24-0.97; P = .041). There was also a reduction in the frequency of any allogeneic blood component transfusion, as well as a highly significant reduction in postoperative blood loss, in patients receiving tranexamic acid (P < .001). CONCLUSIONS: Tranexamic acid reduces blood loss and transfusion requirements in off-pump coronary artery bypass grafting surgery. A reduction in allogeneic blood transfusion was not evident in the presence of perioperative cell salvage. These data support the routine use of tranexamic acid in off-pump coronary artery bypass grafting surgery.