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.

[Quality of life after transcatheter aortic valve implantation: a Comprehensive literature review and critical appraisal]. / La qualità di vita dopo impianto transcatetere di valvola aortica: revisione e valutazione critica della letteratura.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a very effective treatment option for patients with severe aortic stenosis who are either not suitable candidates or at high risk for surgical aortic valve replacement (AVR). Patients undergoing TAVI are often very elderly and their clinical status is burdened with multiple comorbidities, therefore evaluation of quality of life (QoL) might be challenging. We sought to provide an overview of available data on QoL changes after TAVI and critical insights on the instruments used to detect these changes. METHODS: This analysis focuses on studies that evaluated QoL after TAVI with standardized questionnaires. Out of 706 items identified through literature search, 23 studies were included in the final review: 2 randomized controlled trials (one comparing QoL pre- vs post-TAVI, one TAVI vs AVR vs medical therapy) and 21 observational studies (19 studies comparing QoL pre- and post-TAVI and 2 studies TAVI vs AVR). The instruments used in all studies were not specific for TAVI patients. RESULTS: Most studies reported a significant improvement in QoL after TAVI, greater for physical aspects compared with psychological components, which persisted at mid and long-term follow-up. A short-term benefit was found for transfemoral TAVI patients as compared with transapical TAVI and AVR; however, these differences tended to disappear over time. CONCLUSIONS: The study highlights an improvement in QoL after TAVI that persists over time. As different instruments resulted to be more sensitive to detect different aspects, multidimensional assessments - capable of combining disease-specific and disease-non-specific measures - should foster clinical research in order to have a more complete picture of QoL of TAVI patients.

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.

Medium term outcomes of transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). METHODS: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). RESULTS: Mean age was 81.0±6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6%±16.3%, 9.4%±11.0%, and 10.6%±8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7%±1.5%, 76.1%±1.9%, and 67.6%±3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p=0.04) but 3-year survival was not different (p=0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p=0.22). At discharge, peak and mean transprosthetic gradients were 21.0±10.3 mm Hg and 10.2±4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. CONCLUSIONS: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

[Transcatheter aortic valve implantation in bicuspid aortic valve: never say never]. / Valvola bicuspide e impianto di valvola aortica transcatetere: mai dire mai.

Transcatheter aortic valve implantation (TAVI) is an emerging alternative technique that has shown promise in the treatment of severe aortic stenosis in patient populations at high risk with conventional surgery. The presence of a bicuspid aortic valve (BAV) has been considered an exclusion criterion for TAVI, because of the presumed risk for poor seating or paravalvular regurgitation due to severe distortion of the native valve leaflets. For this reason, BAV disease has generally been an exclusion criterion in major trials of TAVI and there is little clinical experience available. We report a case of transcatheter valve replacement in a poor surgical candidate with BAV stenosis using a new 29 mm Edwards Sapien prosthesis.

Aortic valve replacement: reliability of EuroSCORE in predicting early outcomes.

EuroSCORE algorithms were developed to predict perioperative mortality in cardiac surgery. This study was designed to evaluate the reliability of EuroSCORE algorithms and to analyze the predicting role of the scoring system's factors on patients that undergo isolate AVR. 339 patients underwent aortic valve replacement. Data collection was prospective and the logistic and additive EuroSCORE algorithms were calculated according to published guidelines. The observed-over-expected mortality ratio was 0.096. In the ROC curve analysis, the asymptotic significance was greater than 0.05. On multivariate analysis, only critical preoperative state remained significant independent predictor of in-hospital mortality (Odds Ratio 1.6, CI 1.2-2.1). These outcomes suggest that EuroSCORE models may fail in predicting hospital mortality in subsets of cardiac surgery patients and dedicated risk models for isolate aortic valvular surgery may be useful to provide more precise estimates of hospital mortality.

[Cardiac surgery in octogenarians: a six-year follow-up with a multidimensional intervention]. / Vantaggi di un approccio multidimensionale personalizzato al paziente anziano sottoposto a chirurgia cardiaca: risultati a breve e lungo termine su 193 pazienti.

BACKGROUND: Elderly subjects frequently experience a decline in function following hospitalization and surgery. Specific changes in the provision of acute hospital care can improve the ability of acutely ill older patients to perform activities of daily living at the time of discharge and the quality of life. The aim of this study was to investigate outcomes of older (age > or =80 years) cardiac surgery patients managed with multicomponent intervention. METHODS: Between 1998 and 2004, we studied records of 193 octogenarian patients who underwent cardiac surgery and were treated with a multicomponent intervention that included: specially designed environment, patient-centered care, planning for patient discharge at home, and an interdisciplinary approach that incorporates in- and out-of-hospital health professionals. RESULTS: Mean follow-up was 26.4 months and 100% complete. Mean age of patients was 82.3 +/- 2 years. Eighty-nine patients had myocardial revascularization (CABG), 40 aortic valve replacement (AVR), 34 AVR + CABG, 8 mitral valve replacement (MVR), 11 MVR + CABG and 11 other interventions. Rates of hospital death, major complications and prolonged stay (> 14 days) were as follows: CABG 4 (4.4%), 3 (3.3%), 6 (6.4%); AVR 1 (2.5%), 3 (7.5%), 2 (5%); AVR + CABG 1 (2.9%), 2 (5.8%), 4 (11.7%); MVR 0 (0%), 0 (0%), 1 (12.5%); MVR + CABG 2 (18.1%), 2 (18.1%), 3 (27.2%). Multivariate predictors of hospital deaths were NYHA class, cardiopulmonary bypass and cross-clamping time, urgent procedure and ischemic mitral valve procedures. The actuarial 6-year survival was as follows: CABG 91%,AVR 92.5%, AVR + CABG 88.2%, MVR + CABG 81.8%. Total survival rate, free from rehospitalization and redo surgery, was 89.7, 69.8 and 99% respectively. Multivariate predictors of late death were urgent procedure and ischemic mitral valve procedures. At follow-up NYHA classification had improved a median of two classes. Global patients' satisfaction was excellent in 76.7% of survivors; 95.7% were autonomous, 40.5% live at home, 64% had a light-moderate physical activity, and 70% of patients had good social relationships and quality of life. Medical therapy was reduced in 29.3% and level of anxiety improved in 76%. CONCLUSIONS: An interdisciplinary approach and multicomponent intervention with an appropriate postoperative care, provides beneficial effects on outcome in geriatric cardiac surgery patients.