Coronary artery disease and reasonably incomplete coronary revascularization in high-risk patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the long-term impact of coronary artery disease (CAD) and heart team-guided incomplete coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Revascularization strategy of CAD diagnosed with routine coronary angiography before TAVI is uncertain. METHODS: Five hundred and forty consecutive TAVI patients were classified as having CAD or normal coronary arteries (no-CAD). Within the CAD group, patients were further classified as those with complete (CR) versus incomplete revascularization (IR). Revascularization strategy was guided by the Heart Team following an algorithm largely based on current guidelines. Main outcome of interest was the incidence of 5-year cardiovascular (CV) death. RESULTS: Prevalence of CAD was 53.9%. CAD patients showed significantly lower left ventricular ejection fraction (LVEF: 55.8 ± 13.4% CAD vs. 61.4% ± 12.1 no-CAD, p < .0001), lower gradients, and larger ventricular volumes in comparison with the no-CAD group. Within the CAD group, 138 patients (47.4%) received CR and 153 (52.6%) IR. In-hospital mortality was 3.9%, without significant difference between groups (4.0% no-CAD vs. 3.8% CAD, p = .88; 2.9% CR vs. 4.6% IR, p = .45). Median follow-up was 57.8 months. Five-year survival free from CV death was 79.6% in the CAD versus 77.9% in the no-CAD group (p = .98), and 84.3% in the CR versus 74.3% in the IR groups (p = .25). These results were confirmed excluding patients with previous revascularization. At multivariable analyses, presentation with acute coronary syndrome (ACS) was significantly associated with 5-year CV death. CONCLUSIONS: CAD is frequent in patients undergoing TAVI but portends an adverse prognosis only when presenting with ACS. Heart-team directed complete or reasonably incomplete revascularization was associated with comparable outcomes.

Vascular complications after balloon aortic valvuloplasty in recent years: Incidence and comparison of two hemostatic devices.

OBJECTIVES: To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). BACKGROUND: VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. METHODS: All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. RESULTS: A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. CONCLUSIONS: VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD.

Randomized comparison of balloon aortic valvuloplasty performed with or without rapid cardiac pacing: The pacing versus no pacing (PNP) study.

OBJECTIVES: To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). BACKGROUND: BAV technique is poorly standardized. METHODS: One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. RESULTS: There were 51 patients in the BAV group performed with RP, 49 in the BAV group without RP (noRP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1%, respectively (P = 0.16). Fewer people in the noRP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the noRP group compared to 20/51 in the RP (42.9% vs 39.2%; P = 0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ≥3 (8.2% noRP vs 13.7%; P = 0.53). The noRP group required fewer bailout temporary pacemakers (P = 0.048) and had a lower incidence of moderate/severe renal function worsening (4.1% vs 17.6%; P = 0.052). CONCLUSIONS: Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse.

Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study.

BACKGROUND: Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. METHODS AND RESULTS: An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. CONCLUSIONS: TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.

Incidence, treatment, and outcome of acute aortic valve regurgitation complicating percutaneous balloon aortic valvuloplasty.

OBJECTIVES: To evaluate the incidence, treatment, and outcomes of acute aortic regurgitation (ARR) complicating BAV. BACKGROUND: In the transcatheter aortic valve implantation (TAVI) era, there is an increase of percutaneous balloon aortic valvuloplasty (BAV) procedures with different indications. METHODS: From the prospective BAV registry of the University of Bologna, which has enrolled patients between the year 2000 and the present, we selected those who suffered intraprocedural AAR with overt hemodynamic instability. Worsening of baseline aortic insufficiency without hemodynamic collapse, treatment of degenerated biological valve prosthesis, and BAV performed within a planned TAVI procedure were excluded. The main endpoints were in-hospital and 30-day mortality. RESULTS: Out of 1517 BAVs, we identified 26 cases of AAR (1.7%). This complication occurred in 80.8% of cases after one or two balloon inflations. Mean transaortic gradient decreased from 50.6 ± 19.3 to 26.0 ± 14.4 mm Hg (p < 0.01). In 8(30.8%) patients, AAR spontaneously resolved within few minutes; in 18 cases, the operators had to perform a rescue maneuver to reposition a valve leaflet got stuck in the opening position (this maneuver was successful in 13/18 of the cases, 72.2%). Out of 5 persistent AAR, 3 were managed with emergency TAVI or surgery, while 2 were unresolved. In-hospital mortality was 15.4% (n = 4), whereas no more deaths occurred up to 30 days. CONCLUSIONS: AAR is a fearsome complication of BAV and portends a grim prognosis. In some cases, it can be resolved with appropriate technical maneuvers; in others, a rescue TAVI or surgical valve replacement may be necessary. © 2015 Wiley Periodicals, Inc.

Causes and timing of death during long-term follow-up after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an effective therapeutic option for patients with severe aortic stenosis at high risk for surgery. Identification of causes of death after TAVR may help improve patient selection and outcome. METHODS: We enrolled 874 consecutive patients who underwent TAVR at 3 centers using all approved bioprostheses and different access routes. Clinical outcomes during follow-up were defined according to the Valve Academic Research Consortium 2 definitions. Causes of deaths were carefully investigated. RESULTS: Mean logistic European System for Cardiac Operative Risk Evaluation was 23.5% ± 15.3%; Society of Thoracic Surgery score, 9.0% ± 8.2%. The Corevalve (Medtronic, Minneapolis, MN) was used in 41.3%; the Edwards Sapien (Edwards Lifesciences Inc., Irvine, CA) in 57.3%. Vascular access was transfemoral in 75.7%. In-hospital mortality was 5.0%. Cumulative mortality rates at 1 to 3 years were 12.4%, 23.4%, and 31.5%, respectively. Landmark analysis showed a significantly higher incidence of cardiovascular (CV) death in the first 6 months of follow-up and a significantly higher incidence of non-CV death thereafter. At Cox regression analysis, the independent predictors of in-hospital mortality were acute kidney injury grades 2 to 3 (hazard ratio [HR] 3.41) life-threatening bleeding (HR 4.26), major bleeding (HR 4.61), and myocardial infarction (HR 3.89). The independent predictors of postdischarge mortality were chronic obstructive pulmonary disease (HR 1.48), left ventricular ejection fraction at discharge (HR 0.98), and glomerular filtration rate <30 mL/min per 1.73 m(2) (HR 1.64). CONCLUSIONS: Around a third of patients treated with TAVR in daily practice die within the first 3 years of follow-up. Early mortality is predominantly CV, whereas late mortality is mainly non-CV, and it is often due to preexisting comorbidity.

Aortic balloon valvuloplasty outcome according to calcium distribution and valve geometry - The ABCD study.

BACKGROUND: There is little data on the outcome of balloon aortic valvuloplasty (BAV) in relation to valve dimensions and calcification patterns. The procedure is not standardized, particularly the choice of balloon size. METHODS: This retrospective multicenter study focused on BAV efficacy and safety by analyzing the relationship between balloon size, annulus geometry (i.e., diameters, perimeter, and area), and calcification patterns (total burden and calcium distribution over each individual leaflet). From March 2018 to March 2023, all consecutive patients who underwent clinically indicated BAV and ECG-gated multidetector computed tomography of the aorta were included, except those with a bicuspid valve. Calcium score was calculated on contrast-enhanced images based on a luminal attenuation threshold of +100 HU. RESULTS: One hundred and fifteen patients were included. Procedural success was 82.6 %. The balloon-to-annulus ratio (BAR) relative to diameter, perimeter, and area was higher in patients with successful BAV. Patients with unsuccessful BAV had a significantly higher aortic valve calcium burden. The complication rate was 4.3 % and there was no association with valve geometry or calcium burden. A trend towards a reduced complication rate was found as calcium asymmetry increased. BAR minimum annulus diameter was the best parameter in predicting procedural success, with a cut-off at 0.85. CONCLUSIONS: BAV efficacy is correlated directly with balloon size in relation to annulus dimension and inversely with total calcium burden. The minimum diameter of the valve may be adopted as a reference for balloon sizing.

Baseline white blood cell count is an independent predictor of long-term cardiovascular mortality in patients with non-ST-segment elevation acute coronary syndrome, but it does not improve the risk classification of the GRACE score.

OBJECTIVES: To investigate the prognostic significance of baseline white blood cell count (WBCc) in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and its additive predictive value beyond the Global Registry of Acute Coronary Events (GRACE) score. METHODS: We included 1,315 consecutive NSTE-ACS patients. Patients were divided in quartiles according to the WBCc (cells per 1 mm(3)) i.e. Q1 <6,850, Q2 = 6,850-8,539, Q3 = 8,540-10,857 and Q4 ≥10,858. The study end point was 3-year cardiovascular death (CVD). RESULTS: The median age of the study population was 76 years. Overall, 335 patients (25.5%) died with 211 of these (16%) suffering from CVD. Patients in Q4 showed a higher cumulative probability of CVD compared to patients in Q1-Q3. On multivariable analysis, patients in Q4 were at higher risk of CVD [hazard ratio (HR) = 1.47, 95% confidence interval (CI) 1.09-1.98, p = 0.011]. WBCc as a continuous variable was also independently associated with the study end point (HR = 1.043; 95% CI 1.02-1.07; p = 0.001). However, the incorporation of WBCc into the GRACE score did not improve either prediction of risk (C-index = 0.796 for GRACE score with or without WBCc) or classification of risk [relative integrated discrimination improvement = 0.0154, 95% CI) -0.029 to 0.0618; continuous net reclassification improvement = -0.0676, 95% CI -0.2149-0.0738). CONCLUSIONS: WBCc was an independent predictor of 3-year CVD in patients with NSTE-ACS. However, it did not add prognostic information beyond the GRACE score.

Is balloon aortic valvuloplasty safe in patients with significant aortic valve regurgitation?

OBJECTIVES: To assess safety and effectiveness of balloon aortic valvuloplasty (BAV) in patients with symptomatic severe aortic stenosis (AS) and significant aortic regurgitation. BACKGROUND: BAV is a palliative procedure that has possibly been underused in patients with symptomatic AS not suitable for surgical aortic valve replacement or transcatheter aortic valve implantation. Significant aortic regurgitation is commonly perceived as a contraindication to BAV. METHODS: Among 416 consecutive patients undergoing BAV at our Institution, 73 patients showed moderate or severe AR before the procedure. Demographics and baseline characteristics, as well as in-hospital clinical outcome, have been prospectively collected in a dedicated database. Transthoracic echocardiography was regularly performed in all patients undergoing BAV before the procedure and at hospital discharge. RESULTS: Patients had a high-risk profile, confirmed by advanced age (77.2 ± 11.8 years) and important comorbidity (logistic Euroscore 26.5 ± 16.3%). Advanced heart failure was present in 73.9%. Indication to BAV was cardiogenic shock in 9.6%, palliation in 31.5%, bridge in 58.9% of the patients. BAV was performed with standard retrograde approach. Aortic valve area increased from 0.62 ± 0.15 cm(2) at baseline to 0.83 ± 0.17 cm(2) before discharge (P < 0.001). The degree of AR was improved or unchanged in 65 patients (89%). In-hospital mortality was 6.9%, mainly limited to terminal patients. Symptomatic status at discharge was improved in all surviving patients. Acute AR occurred in seven patients; in five of them it was successfully resolved in the catheterization laboratory. CONCLUSIONS: When clinically indicated, BAV can be safely performed in patients with combined aortic stenosis and significant aortic regurgitation.

[Transcatheter closure of ventricular septal defect: how and when?] / Chiusura percutanea di difetto interventricolare post-infartuale: come e quando?

Ventricular septal defect (VSD) is a rare but clinically severe complication of acute myocardial infarction. Although cardiac surgery is the gold standard to correct post-infarction VSD, transcatheter closure represents an effective therapeutic alternative in selected cases. However, the correct timing for VSD correction is a matter of debate. Herein, we report the case of a patient who underwent transcatheter closure of post-infarction VSD, focusing the discussion on the pros and cons of an early VSD correction.

Long-term echocardiographic findings after TAVR: 5-year follow-up in 400 consecutive patients.

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.

Sex based analysis of the impact of red blood cell transfusion and vascular or bleeding complications related to TAVI - The TRITAVI-Women Study.

BACKGROUND: Women present specific risks for transcatheter aortic valve replacement (TAVI) but there are scarce sex-based analysis. The aim of this study was to explore the risk of vascular/bleeding complications in females vs. males that underwent TAVI and the impact of red blood cell (RBC) transfusion. METHODS: TRITAVI-Women is a retrospective analysis in 13 European institutions. Propensity score based on pairs of different sex was performed and global outcomes, vascular/bleeding risk factors were determined. Afterwards, the female population of the study was divided into two groups according to the need of RBC transfusion and the risk for mortality, AKI, MI, stroke at 30-days and at 1-year were compared as a combined endpoint (primary endpoint) and separately (secondary endpoints). RESULTS: The global study population included 5837 patients. Females presented more advanced NYHA class, chronic kidney disease, and baseline anemia. Vascular/bleeding complications and RBC transfusion were more common in women. However, 1-year mortality was lower for women in the matched cohort (8.1% vs.10.3%, p = 0.028). The need for RBC transfusion was an independent predictor of higher incidence of the primary endpoint at 30-day and 1-year. The main predictor of RBC transfusion in women was the presence of baseline anemia. CONCLUSIONS: Women present lower risk of mortality than men at 1-year follow up, but not at 30-day due to higher rates of vascular/bleeding complications. RBC transfusion was also more often required in women and was an independent predictor or poorer outcomes. The treatment of pre-existing anemia before TAVI might improve the short-term results in women.

Use of complementary and alternative therapies in outpatients with Parkinson's disease in Argentina.

We interviewed 300 patients (54.7% male; mean age was 65.8 ± 9.5) attending the Movement Disorders Clinic at the Buenos Aires University Hospital to determine the prevalence of CATs use and their association with demographic, social, or disease-specific characteristics among patients with Parkinson's disease (PD) in Buenos Aires, Argentina. We found that 25.7% of the PD patients interviewed (77/300) stated they had used CATs to improve their PD symptoms whereas 38.0% (114/300) had used some CATs without any relation to PD, at least once in life. At the moment of the interview, CATs prevalence use was 50.6% in the former group and 25.0% in the latter. The use of CATs was much more frequent among women and more common in the 50- to 69-year age group. Friends and neighbors of the patients had most frequently recommended these therapies. No major association was observed between CATs use and the duration of the disease, side of initial involvement, PD phenotype, or the Hoehn and Yahr staging. Acupuncture, homeopathy, yoga, and therapeutic massage were the most widely used therapies. After the initiation of conventional treatment the use of massage, yoga, and acupuncture in patients using CATs to improve PD significantly increased. Neurologists should be aware and inquire about the use of CATs to rule out potentially harmful effects.

Impact of the COVID-19 pandemic on coronary invasive procedures at two Italian high-volume referral centers.

AIMS: The purpose of this study was to verify the impact on the number and characteristics of coronary invasive procedures for acute coronary syndrome (ACS) of two hub centers with cardiac catheterization facilities, during the first month of lockdown following the COVID-19 pandemic. MATERIALS AND METHODS: Procedural data of ACS patients admitted between 10 March and 10 April 2020 were compared with those of the same period of 2019. RESULTS: We observed a 23.4% reduction in ACS admissions during 2020, with a decrease for both ST-elevation myocardial infarction (STEMI) (-5.6%) and non-ST-elevation myocardial infarction (-34.5%), albeit not statistically significant (P = 0.2). During the first 15 days of the examined periods, the reduction in ACS admissions reached 52.5% (-25% for STEMI and -70.3% for non-ST-elevation myocardial infarction, P = 0.04). Among STEMI patients, the rate of those with a time delay from symptoms onset longer than 180 min was significantly higher during the lockdown period (P = 0.01). Radiograph exposure (P = 0.01) was higher in STEMI patients treated in 2020 with a slightly higher amount of contrast medium (P = 0.1) and number of stents implanted (P = 0.1), whereas the number of treated vessels was reduced (P = 0.03). Percutaneous coronary intervention procedural success and in-hospital mortality were not different between the two groups and in STEMI patients (P NS for all). CONCLUSION: During the early phase, the COVID-19 outbreak was associated with a lower rate of admissions for ACS, with a substantial impact on the time delay presentation of STEMI patients, but apparently without affecting the in-hospital outcomes.

Routine minimalist transcatheter aortic valve implantation with local anesthesia only.

AIMS: Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support. METHODS: The routine transfemoral TAVR protocol adopted at our center includes a minimalist approach, local anesthesia alone with fully awake patient, anesthesiologist available on call but not in the room, and direct transfer to the cardiology ward after the procedure. All consecutive patients undergoing transfemoral TAVR between January 2015 and July 2018 were included. We assessed the rates of actual local anesthesia-only procedures, conversion to conscious sedation or general anesthesia and 30-day clinical outcomes. RESULTS: Among 321 patients, 6 received general anesthesia upfront and 315 (98.1%) local anesthesia only. Mean age of the local anesthesia group was 83.2 ±â€Š6.9 years, Society of Thoracic Surgery score 5.8 ±â€Š4.8%. A balloon-expandable valve was used in 65.7%. Four patients (1.3%) shifted to conscious sedation because of pain or anxiety; 6 patients (1.9%) shifted to general anesthesia because of procedural complications. Hence, local anesthesia alone was possible in 305 patients (96.8% of the intended cohort, 95% of all transfemoral procedures). At 30 days, in the intended local anesthesia group, mortality was 1.6%, stroke 0.6%, major vascular complications 2.6%. Median hospital stay was 4 days (IQR 3-7). CONCLUSION: Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.

Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry.

BACKGROUND: There is no consensus on the benefit of red blood cell (RBC) transfusion after transcatheter aortic valve replacement. METHODS: The multicenter Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry retrospectively included patients after transfemoral transcatheter aortic valve replacement; propensity score-matching identified pairs of patients with and without RBC transfusion. The primary end point was 30-day mortality; nonfatal myocardial infarction, cerebrovascular accident, and stage 2 to 3 acute kidney injury at 30 days were secondary end points. We repeated propensity score-matching according to the hemoglobin nadir, hemoglobin drop, and in the subgroup of uncomplicated patients, without major vascular complications or major bleeding. RESULTS: Among 2587 patients, RBC transfusion was administered in 421 cases (16%). The primary end point occurred in 104 (4.0%) patients, myocardial infarction in 9 (0.4%), cerebrovascular accident in 38 (1.5%), and acute kidney injury in 125 (4.8%) cases. In the 842 propensity-matched patients, RBC transfusion was associated with increased mortality (hazard ratio, 2.07 [95% CI, 1.06-4.05]; P=0.034) and acute kidney injury (hazard ratio, 4.35 [95% CI, 2.21-8.55]; P<0.001). Interaction testing between RBC transfusion and mortality was not statistically significant in the above-mentioned subgroups, and such association was not documented in the corresponding propensity score-matched cohorts. In the multivariable Cox proportional hazards regression model, major vascular complications (P=0.044), major bleeding (P=0.041), and RBC transfusion (P=0.048) were independent correlates of 30-day mortality. CONCLUSIONS: RBC transfusion correlates with increased mortality and acute kidney injury early after transcatheter aortic valve replacement and is an independent predictor of 30-day mortality, irrespective of periprocedural major bleeding and vascular complications. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03740425.

Surgical Risk Scores Applied to Transcatheter Aortic Valve Implantation: Friends or Foes? Short-Term and Long-Term Outcomes From a Single-Center Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgical aortic valve replacement for the treatment of symptomatic aortic stenosis. The EuroScore (ES) II, logistic EuroScore (log ES), and the Society of Thoracic Surgeons (STS) score are the most applied scores for surgical risk stratification. However, their predictive value for patients undergoing TAVI is still unclear. AIM: To evaluate the performance of STS, log ES and ES II as predictors of short-term and long-term mortality in patients undergoing TAVI. METHODS: Between February 2008 and October 2017, a total of 384 patients underwent transfemoral TAVI at our institution and constituted the study population. Patients were divided into three groups based on the class of risk (low, intermediate, and high) calculated by each score. In-hospital complications, 30-day outcomes, and 5-year outcomes were assessed. RESULTS: In-hospital mortality rate was 2.6% (n = 10). All scores over-estimated the risk of 30-day mortality, especially for the highest risk classes. At the end of follow-up (5 years), STS risk stratification was able to stratify all-cause and cardiovascular (CV) mortality (P<.01 and P=.02, respectively). Patients with intermediate ES II risk showed a lower survival rate (P=.04) while CV deaths did not differ between classes of risk. All-cause mortality and CV mortality curves did not diverge according to the patients' risk profiles derived from log ES. CONCLUSION: Conventional surgical risk scores are not appropriate to predict 30-day mortality in patients undergoing transfemoral TAVI. STS assessment was the only risk score able to stratify long-term all-cause and CV mortality.

Cognitive functions: evaluation and changes after transcatheter aortic valve implantation in elderly patients.

AIM: To assess the prevalence and postprocedural evolution of cognitive impairment (CI) in patients undergoing transcatheter aortic valve implantation. METHODS: 62 patients were enrolled. Mini Mental state examination (MMSE), verbal memory test (VMT), visual search test (VST) and phonemic verbal fluency (PVF) were used to evaluate the cognitive status. CI was considered when a pathological result of MMSE was confirmed by VMT, VST and PVF. RESULTS: A total of 26.2% patients had CI at baseline. MMSE, VMT, VST and PVF were pathologic in 39, 16.1, 8.1 and 22.6% of the patients, respectively. Overall, no significant differences in cognitive function in any dimension were observed from baseline up to 1-year follow-up. CONCLUSION: CI is frequent in patients undergoing transcatheter aortic valve implantation, though the procedure does not forge cognitive status.

Risk of Stroke in Patients with Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention versus Optimal Medical Therapy: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Stroke is a rare but serious adverse event associated with percutaneous coronary intervention (PCI). However, the relative risk of stroke between stable patients undergoing a direct PCI strategy and those undergoing an initial optimal medical therapy (OMT) strategy has not been established yet. This study sought to investigate if, in patients with stable coronary artery disease (SCAD), an initial strategy PCI is associated with a higher risk of stroke than a strategy based on OMT alone. METHODS: We performed a meta-analysis of 6 contemporary randomized control trials in which 5673 patients with SCAD were randomized to initial PCI or OMT. Only trials with stent utilization more than 50% were included. Study endpoint was the rate of stroke during follow up. RESULTS: Mean age of patients ranged from 60 to 65 years and stent utilization ranged from 72% to 100%. Rate of stroke was 2.0% at a weighted mean follow up of 55.3 months. On pooled analysis, the risk of stroke was similar between patients undergoing a PCI plus OMT and those receiving only OMT (2.2% vs. 1.8%, OR on fixed effect = 1.24 95%CI: 0.85-1.79). There was no heterogeneity among the studies (I2 = 0.0%, P = 0.15). On sensitivity analysis after removing each individual study the pooled effect estimate remains unchanged. CONCLUSIONS: In patients with SCAD an initial strategy based on a direct PCI is not associated with an increased risk of stroke during long-term follow up compared to an initial strategy based on OMT alone.

Balloon aortic valvuloplasty as a bridge-to-decision in high risk patients with aortic stenosis: a new paradigm for the heart team decision making.

BACKGROUND: Whilst the majority of the patients with severe aortic stenosis can be directly addressed to surgical aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), in some instances additional information may be needed to complete the diagnostic workout. We evaluated the role of balloon aortic valvuloplasty (BAV) as a bridge-to-decision (BTD) in selected high-risk patients. METHODS: Between 2007 and 2012, the heart team in our Institution required BTD BAV in 202 patients. Very low left ventricular ejection fraction, mitral regurgitation grade ≥ 3, frailty, hemodynamic instability, serious comorbidity, or a combination of these factors were the main drivers for this strategy. We evaluated how BAV influenced the final treatment strategy in the whole patient group and in each specific subgroup. RESULTS: Mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 23.5% ± 15.3%, age 81 ± 7 years. In-hospital mortality was 4.5%, cerebrovascular accident 1% and overall vascular complications 4% (0.5% major; 3.5% minor). Of the 193 patients with BTD BAV who survived and received a second heart team evaluation, 72.6% were finally deemed eligible for definitive treatment (25.4% for AVR; 47.2% for TAVI): 96.7% of patients with left ventricular ejection fraction recovery; 70.5% of patients with mitral regurgitation reduction; 75.7% of patients who underwent BAV in clinical hemodynamic instability; 69.2% of frail patients and 68% of patients who presented serious comorbidities. CONCLUSIONS: Balloon aortic valvuloplasty can be considered as bridge-to-decision in high-risk patients with severe aortic stenosis who cannot be immediate candidates for definitive transcatheter or surgical treatment.