Impact of balloon post-dilation on valve durability and long-term clinical outcomes after self-expanding transcatheter aortic valve implantation.

BACKGROUND: Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown. AIMS: To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI). METHODS: Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated. RESULTS: Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p = 0.557) and SVD (2.1% vs. 1.4%, p = 0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up. CONCLUSIONS: BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.

Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test.

AIMS: Permanent pacemaker implantation (PPM-I) remains nowadays the most important drawback of transcatheter aortic valve replacement (TAVR) procedure and the optimal strategy of delayed conduction disturbances (CDs) in these patients is unclear. The study aimed to validate an ambulatory electrocardiogram (ECG) monitoring through a 30 s spot ambulatory digital mobile ECG (AeECG), by using KardiaMobile-6L device in a 30-day period after TAVR procedure. METHODS AND RESULTS: Between March 2021 and February 2022, we consecutively enrolled all patients undergoing TAVR procedure, except pacemaker (PM) carriers. At discharge, all patients were provided of a KardiaMobile-6L device and a spot digital ECG (eECG) recording 1 month schedule. Clinical and follow-up data were collected, and eECG schedule compliance and recording quality were explored. Among 151 patients without pre-existing PM, 23 were excluded for pre-discharge PPM-I, 18 failed the KardiaMobile-6L training phase, and 10 refused the device. Delayed CDs with a Class I/IIa indication for PPM-I occurred in eight patients (median 6 days). Delayed PPM-I vs. non-delayed PPM-I patients were more likely to have longer PR and QRS intervals at discharge. PR interval at discharge was the only independent predictor for delayed PPM-I at multivariate analysis. The overall eECG schedule compliance was 96.5%. None clinical adverse events CDs related were documented using this new AeECG monitoring modality. CONCLUSION: A strategy of 30 s spot AeECG is safe and efficacious in delayed CDs monitoring after TAVR procedure with a very high eECG schedule level of compliance.

Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis.

AIMS: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). METHODS AND RESULTS: Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%). CONCLUSION: While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.

Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: Insights from the Italian Clinical Service Project.

AIMS: We aim at exploring whether severe chronic kidney disease (CKD) may modify the impact of acute kidney injury (AKI) post-transcatheter aortic valve implantation (TAVI) on early, mid, and long-term mortality. METHODS AND RESULTS: The analysis included 2,733 TAVI patients from the Italian Clinical Service Project. The population was stratified in four groups according to the presence of baseline severe CKD and postprocedural AKI. All-cause mortality was the primary end point. Postprocedural AKI is associated with an increased risk of early and mid-term mortality after TAVI regardless of baseline severe CKD. Preprocedural severe CKD is associated with an increased risk of long-term mortality after TAVI regardless of postprocedural AKI. No interaction between preprocedural severe CKD and postprocedural AKI was observed in predicting mortality at both 30-day (CKD: hazard ratio [HR] = 2.65, 95% confidence interval [CI] = 1.15-6.12; no-CKD: HR = 3.83, 95% CI = 2.23-6.58; Pint = .129) and 1-year (CKD: HR = 2.29, 95% CI = 1.37-3.82; no-CKD: HR = 2.47, 95% CI = 1.75-3.49; Pint = .386). Preprocedural severe CKD is an independent predictor of postprocedural AKI (HR = 2.17, 95% CI = 1.56-3.03; p < .001) as well as general anesthesia and access alternative to femoral. Among no-AKI patients, those with severe CKD at admission underwent kidney function recovery after TAVI (serum creatinine at baseline 2.24 ± 1.57 mg/dL and at 48-hr 1.80 ± 1.17 mg/dL; p = .003). CONCLUSIONS: Preprocedural severe CKD did not modify the impact of postprocedural AKI in predicting early and mid-term mortality after TAVI. Closely monitoring of serum creatinine and strategies to prevent AKI post-TAVI are needed also in patients without severe CKD at admission.

Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study.

OBJECTIVES: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population. BACKGROUND: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry. METHODS: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR. CONCLUSIONS: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.

Left ventricular stiffness predicts outcome in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

OBJECTIVES: Assessment of the prognostic role of left ventricular stiffness (LVS) in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS: We performed a complete two-dimensional transthoracic echocardiographic study before and after TAVI in patients with severe AS at high surgical risk. In order to assess LVS, we measured LV end-diastolic pressure (EDP) invasively during TAVI and LV end-diastolic volume (EDV) by means of echocardiography. We defined LVS as the EDV indexed by body surface area at an EDP of 20 mm Hg (EDVI20 ). Our aim was to assess the impact of LVS on one-year all-cause mortality after TAVI. RESULTS: One hundred sixty-six patients undergoing TAVI (64% female; mean age 82.7 ± 5.1 years) were enrolled. Seven patients died within the first 30 days after TAVI and 21 within 1 year. Overall follow-up duration was 580 ± 478 days. At multivariate analysis, independent predictors of 1-year all-cause mortality were moderate-to-severe paravalvular leak (PVL; HR 4.7, 95% confidence interval [CI] 1.9-11, P=.0003), female gender (HR 3.5, 95% CI 1.0-12, P=.045), and EDVI20 (HR 0.94, 95% CI 0.90-0.98, P=.015). In particular, patients with higher LVS (EDVI20 ≤48 mL/m2 ) had a 1-year mortality of 26.9% vs 7.4% in patients with lower LVS (EDVI20 >48 mL/m2 ; HR 4.2, 95% CI 1.6-10.6, P=.0007). Patients with higher LVS who developed moderate-to-severe PVL had the worst outcome (incremental chi-square test, P=.014). CONCLUSION: In patients with AS, an increased LVS has a negative prognostic impact. Development of significant PVL in patients with higher LVS had an incremental adverse effect.

Evolving Paradigms in Transcatheter Aortic Valve Replacement: Results from a High-Volume, Single Center Experience.

Given the expanding indications toward younger patients at lower surgical risk, transcatheter aortic valve replacement (TAVR) simplification and streamlining are gaining increasing importance. Patients who underwent TAVR from the year 2015 to 2020 were prospectively enrolled. The patients were divided in time tertiles according to the date of intervention. Data on preprocedural planning, including coronary computed tomography angiography (CCTA), procedures, and outcomes, were compared between the time tertiles. A total of 771 consecutive patients from a single institution were enrolled. We observed a trend toward the use of a fully percutaneous versus surgical approach for the index access, left radial artery versus contralateral femoral artery for the secondary access, and left ventricular pacing on the stiff guidewire versus right ventricular pacing. Immediate device success significantly increased, whereas the length of hospital stay decreased. Overall, approximately 60% of the total study population underwent CCTA instead of coronary angiography, with no adverse events. One-year survival rates significantly improved over time. A simplified TAVR approach was associated with better survival, whereas low baseline functional capacity, preexisting coronary artery disease, renal impairment, periprocedural blood transfusions, and paravalvular leak were related to worse outcomes. In conclusion, our study showed a constant tendency to procedure streamlining and improve procedural success and 1-year outcomes. A strategy based on CCTA allows sparing safely almost half of the preoperative invasive coronary angiography.

Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve.

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up.

Eight-Year Outcomes of Patients With Reduced Left Ventricular Ejection Fraction Who Underwent Transcatheter Aortic Valve Replacement With a Self-Expanding Bioprosthesis.

Data deriving from patients who underwent TAVR between 2007 and 2017 in 13 Italian centers were prospectively collected. Patients were stratified in those with normal LVEF and reduced LVEF. The latter was further classified according to ischemic or nonischemic etiology. The primary end point was a composite of all-cause death and rehospitalizations; the secondary end points were the isolated composers of the primary end point and cardiac death. Overall, 2,626 patients were included in the analysis: 68.1% with normal LVEF and 31.9% with reduced LVEF. At 8 years, reduced LVEF was significantly associated with the primary end point (adjusted hazard ratio 1.17, 95% confidence interval 1.06 to 1.29). Consistent findings were evident for the composite end point. No differences in these trends were found at the 30-day landmark analyses. Compared with nonischemic etiology, ischemic reduced LVEF was associated with an increased risk of cardiac death (adjusted hazard ratio 1.43, 95% confidence interval 1.02 to 2.02). In conclusion, patients with reduced LVEF who underwent TAVR are exposed to a progressively increased risk of death and rehospitalizations, even at very long-term follow-up.

Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study.

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

CharActeristics, sizing anD outcomes of stenotic, tapered, rapHe-type bicuspid aOrtic valves treated with trans-catheter device implantation: Insights the AD HOC registry.

BACKGROUND: Raphe-type bicuspid aortic valve (BAV) is a potential hostile scenario in trans-catheter aortic valve replacement (TAVR) due to pronounced calcium burden, possibly associated with tapered valve configuration. Trans-Catheter heart valve (THV) sizing strategy (annular vs. supra-annular) is controversial in this valve subtype. OBJECTIVES: To describe the phenotypical characteristics of severe, tapered, raphe-type, BAV stenosis undergoing TAVR and to explore safety and efficacy of modern-generation THVs, analysing the impact of annular and supra-annular sizing strategies on short- and mid-terms outcomes. METHODS: This is a retrospective, multicenter registry enrolling consecutive stenotic Sievers type 1 BAV treated with TAVR. Study population was divided into tapered and non-tapered configuration according to MSCT analysis. Matched comparison between annular and supra-annular sizing groups was performed in tapered population. RESULTS: From January 2016 to June 2023, 897 patients were enrolled. Of them, 696 patients displayed a tapered configuration. Of those, 510 received a THV according to annular sizing. After propensity score matching 186 matched pairs were selected. Technical success (96.2 % vs 94.1 %, OR 1.61 [0.61-4.24], p = 0.34), 30-day device success (83.6 % in both groups, OR 1.42 [0.78-2.57], p = 0.25) and 30-day early safety (71.8 % vs 70.5 %, OR 1.07 [0.68-1.68], p = 0.78) were similar between the annular and supra-annular sizing groups; a higher post-TAVR gradient was observed in supra-annular group, although it was only 2 mmHg mean. At mid-term follow-up, the rate of clinical efficacy was 84.7 %. CONCLUSIONS: TAVR with modern-generation devices is safe and effective for tapered raphe-type BAV, showing comparable results for annular and supra-annular sizing strategies.

A multiparametric clinical and echocardiographic score to risk stratify patients with chronic systolic heart failure: derivation and testing.

Although echo Doppler and biomarkers are the most common examinations performed worldwide in heart failure (HF), they are rarely considered in risk scores. In outpatients with chronic HF and left ventricular ejection fraction (LVEF) ≤45%, data on clinical status, echo Doppler variables, aminoterminal pro-type B natriuretic peptide (NT-proBNP), estimated glomerular filtration rate (eGFR), and drug therapies were combined to build up a multiparametric score. We randomly selected 250 patients to produce a derivation cohort and 388 patients were used as a testing cohort. Follow-up lasted 29 ± 23 months. The univariable predictors that entered into the multivariable Cox model were as follows: furosemide daily dose >25 mg, inability to tolerate angiotensin converting enzyme (ACE) inhibitors, inability to tolerate ß-blockers, age >75 years, New York Heart Association (NYHA) >2, eGFR<60 mL/min, NT-proBNP plasma levels above the median, tricuspid plane systolic excursion (TAPSE) ≤14 mm, LV end-diastolic volume index (LVEDVi) >96 mL/m(2) , moderate-to-severe mitral regurgitation (MR) and LVEF <30%. The scores of prognostic factors were obtained with the respective odds ratio divided by the lower odd ratio: 4 points for furosemide dose, 3 points for age, NT-proBNP, LVEDVi, TAPSE, 2 points for inability to tolerate ß-blockers, inability to tolerate ACE inhibitors, NYHA, eGFR<60 mL/min, moderate-to-severe MR, 1 point for LVEF. The multiparametric score predicted all-cause mortality either in the derivation cohort (68.4% sensitivity, 79.5% specificity, area under the curve [AUC] 78.7%) or in the testing cohort (73.7% sensitivity, 71.3% specificity, AUC 77.2%). All-cause mortality significantly increased with increasing score both in the derivation and in the testing cohort (P < 0.0001). In conclusion, this multiparametric score is able to predict mortality in chronic systolic HF.

Outcomes of Patients With Very Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation.

Symptoms of aortic stenosis (AS) are not proportional to its severity and patients with very severe AS (VSAS) remain asymptomatic for a long time. The appropriate time for intervention in patients with VSAS and the effects of transcatheter aortic valve implantation (TAVI) on left ventricular hypertrophy (LVH) remain debated. Our aim was to compare the procedural and 30-day outcomes of TAVI between patients with VSAS and patients with severe AS (SAS) and the changes in LVH. We selected patients with an aortic peak velocity ≥5 m/s (VSAS) and those with aortic peak velocity 4 to 5 m/s (SAS) treated with TAVI. Patients with reduced left ventricular ejection fraction (<45%) were excluded. The primary end point was the incidence of all-cause death at 30 days. The secondary end points included the 30-day incidence of cardiac death, cardiac rehospitalization, and stroke/transient ischemic attack and the changes in LVH from baseline to 30 days. A total of 102 patients in the VSAS group and 535 in the SAS group were included. Patients in the VSAS group had a thicker septal wall (p <0.001) and a higher Agaston score (p <0.001) and calcium volume (p = 0.007). No differences were observed regarding the primary and secondary clinical end points. However, patients with VSAS showed a significantly greater improvement in concentric LVH, although the prevalence of concentric LVH remained higher than in patients with SAS. TAVI in patients with VSAS showed similar procedural and clinical outcomes to patients with SAS and experienced a more pronounced improvement in the prevalence of concentric LVH.

Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry.

BACKGROUND: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. AIMS: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry. METHODS: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. RESULTS: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. CONCLUSIONS: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Heterotopic Transcatheter Tricuspid Valve Replacement in Severe Tricuspid Regurgitation and Refractory Right Heart Failure.

Torrential tricuspid regurgitation may lead to heart failure and poor survival and quality of life. Heterotopic transcatheter tricuspid replacement is increasingly offered to patients unsuitable for direct valve repair or replacement. We describe 1 patient treated by transcatheter implantation of 2 self-expanding valves in the venae cavae with a multimodality imaging approach. (Level of Difficulty: Advanced.).

Prognostic value of right ventricle to pulmonary artery coupling in transcatheter aortic valve implantation recipients.

AIMS: To investigate the impact of the right ventricle to pulmonary artery (RV-PA) coupling on the outcome of patients undergoing transcatheter aortic valve intervention (TAVI), and to describe changes in right ventricular function, pulmonary hypertension, and their ratio after TAVI. METHODS: Three hundred and seventy-seven patients from the Italian ClinicalService Project, who underwent TAVI between February 2011 and August 2020, were included. Tricuspid annular plane systolic excursion/pulmonary artery systolic pressure (TAPSE/PASP) ratio was retrospectively calculated as a surrogate of RV-PA coupling. The population was stratified according to TAPSE/PASP using a cut-off of 0.36 mm/mmHg derived from a receiving operating characteristic (ROC) curve. The primary end point was 6-month all-cause death. RESULTS: Compared with patients with a TAPSE/PASP ratio ≥0.36 mm/mmHg (81%), those with TAPSE/PASP ratio <0.36 mm/mmHg (19%) had more comorbidities and were more symptomatic.Moreover, they were more likely to receive general anesthesia and an old generation device. Device success was similar between the two groups. A TAPSE/PASP ratio <0.36 mm/mmHg was associated with a higher risk of all-cause death at 6-months (17.3% versus 5.3%; adjusted HR 2.66; P = 0.041). The prognostic impact of the TAPSE/PASP ratio was stronger than the impact of TAPSE and PASP as separate parameters and was independent of the surgical risk score. Both TAPSE, PASP, and their ratio improved from baseline to 1 month and 6 months after TAVI. CONCLUSIONS: A TAPSE/PASP ratio <0.36 mm/mmHg is strongly associated with an increased risk of mortality after TAVI. Providing a left ventricle unloading, TAVI is associated with improvement of both TAPSE, PASP, and their ratio.

Transcatheter aortic valve replacement with or without anesthesiologist: results from a high-volume single center.

AIMS: Local instead of general anesthesia has become the standard approach in many centers for transfemoral transcatheter aortic valve replacement (TAVR). New generation devices and an increase in operator skills had led to a drastic reduction in periprocedural complications, bringing in the adoption of a minimalist approach. In our study, we aimed to compare patients treated with TAVR under local anesthesia with or without the presence of an anesthesiologist on site (AOS). METHODS: We compare procedural aspects and results of patients treated with TAVR with an AOS against patients treated with TAVR with an anesthesiologist on call (AOC). From January 2019 to December 2020, all consecutive patients undergoing transfemoral TAVR with either the self-expandable Evolut (Medtronic, MN, USA) or balloon-expandable SAPIEN 3 (Edwards Lifesciences, CA, USA) were collected. RESULTS: Of 332 patients collected, 96 (29%) were treated with TAVR with AOS, while 236 (71%) were treated with TAVR with AOC. No differences in procedural time, fluoroscopy time and amount of contrast medium were observed. No procedural death and conversion to open-chest surgery was reported. The rate of stroke/transient ischemic attacks and major vascular complications was similar in the two groups. No patients in both groups required conversion to general anesthesia. Two patients (0.8%) in the AOC group required urgent intervention of the anesthesiologist. In the AOC group, there was a greater use of morphine (55.9% vs. 33.3%, P  = 0.008), but with a lower dose for each patient (2.0 vs. 2.8 mg, P  = 0.006). On the other hand, there was a lower use of other painkiller drugs (3.4% vs. 20.8%, P  = 0.001). No difference in inotropic drugs use was observed. CONCLUSION: In patients at low or intermediate risk undergoing transfemoral TAVR, a safe procedure can be performed under local anesthesia without the presence of an anesthesiologist in the catheterization laboratory.

Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients With Failing Bioprosthetic Aortic Valves: Mid-term Outcomes From the Italian CoreValve Clinical Service Project.

OBJECTIVES: We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project. BACKGROUND: Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking. METHODS: The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria. RESULTS: A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up. CONCLUSIONS: This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.

Predictors of early discharge after transcatheter aortic valve implantation: insight from the CoreValve ClinicalService.

AIMS: The aim of this study was to minimize the procedure, and reduce the length of hospital stay (LoS) is the future objective for transcatheter aortic valve replacement (TAVI).Aims of the study are to identify procedural and electrocardiographical predictors of fast-track discharge in patients who underwent TAVI. METHODS: Patients treated with TAVI included in the One Hospital ClinicalService project were categorized according to the LoS. 'Fast-Track' population, with a postprocedural LoS less than or equal to 3 days, was compared with the 'Slow-Track' population with a postprocedural LoS greater than 3 days. RESULTS: One thousand five hundred and one patients were collected. Despite single baseline characteristics being almost similar between the two groups, Slow-Track group showed a higher surgical risk (P < 0.001). Patients in the Slow-Track group were more frequently treated with general anaesthesia (P = 0.002) and less frequently predilated (P < 0.001) and received a lower amount of contrast media. No difference between Slow-Track and Fast-Track patients was observed at 30 days in death and in cardiovascular rehospitalization.In the multivariable analysis, STS score of at least 4% [odds ratio (OR): 1.64; P = 0.01], general anaesthesia (OR: 2.80; P = 0.03), predilation (OR: 0.45; P < 001), NYHA 3-4 at baseline (OR: 1.65; P = 0.01), AVB I/LBBB/RBBB onset (OR: 2.41; P < 0.001) and in-hospital new PM (OR: 2.63; P < 0.001) were independently associated with a higher probability of Slow-Track. CONCLUSION: Fast-Track patients were safely discharged home showing no difference in clinical outcomes after discharge up to 30 days compared with the Slow-Track group. The STS score, general anaesthesia, NYHA 3--4 at baseline, in-hospital onset of conduction disturbances and new PM implantation after TAVI turned out to be predictors of Slow-Track.

Bicuspid Valve Sizing for Transcatheter Aortic Valve Implantation: The Missing Link.

Transcatheter aortic valve implantation (TAVI) is a well-recognized and established therapy for severe aortic stenosis, with expanding indications toward younger patients with low surgical risk profile. As bicuspid aortic valve (BAV) affects ~1-2% of the population, it may be speculated that an increasing number of patients with degenerated BAV may eventually need TAVI during the course of the disease. On the other hand, BAV represents a challenge due to its peculiar anatomical features and the lack of consensus on the optimal sizing strategy. The aim of this paper is to review the peculiar aspects of BAV and to discuss and compare the currently available sizing methods. Special attention is given to the role of pre-procedural imaging, mostly with multislice computed tomography, and to the aspects that operators should evaluate in order to ensure an optimal procedural planning and avoid procedural-related complications.