Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial.

OBJECTIVE: To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: CAD is a common comorbidity among patients undergoing TAVR and studies provide conflicting data on its prognostic impact. METHODS: The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence or absence of history of CAD as well as periprocedural anticoagulation. The coprimary endpoints were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding) and major Bleeding Academic Research Consortium (BARC) bleeding ≥3b at 30 days postprocedure. RESULTS: Among 801 patients, 437 (54.6%) had history of CAD of whom 223 (51.0%) received bivalirudin. There were no significant differences in NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or BARC ≥ 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC ≥ 3b bleeding (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding). CONCLUSION: CAD was not associated with a higher short-term risk of NACE or major bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show any advantage over UFH in patients with and without CAD.

Impact of anemia on short-term outcomes after TAVR: A subgroup analysis from the BRAVO-3 randomized trial.

OBJECTIVES: To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. METHODS: The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dl in men and <12 g/dl in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (Bleeding Academic Research Consortium ≥3b) at 30 days. RESULTS: Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30 days between patients with and without anemia, irrespective of the type of anticoagulant used (pinteraction  = 0.71 for NACE, pinteraction  = 1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42-4.16, p = 0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16-2.59, p = 0.007) compared to non-anemic patients at 30 days. CONCLUSIONS: Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH.

Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: Results from the BRAVO-3 randomized trial.

OBJECTIVES: This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH). BACKGROUND: PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH. METHODS: BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE. RESULTS: The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days. CONCLUSIONS: Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications.

Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.

BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.

Cyclosporine before PCI in Patients with Acute Myocardial Infarction.

BACKGROUND: Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS: In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS: A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS: In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.).

Impact of pre-existing or new-onset atrial fibrillation on 30-day clinical outcomes following transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial.

BACKGROUND: Prior studies have suggested that patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are at higher risk for adverse cardiovascular events. Whether procedural bivalirudin compared with unfractionated heparin (UFH) has a beneficial effect on early outcomes in these patients is unknown. We examined for the effect of baseline or new-onset AF within 30 days of TAVR and explored for the effect of bivalirudin versus UFH by AF status, on 30-day outcomes from the BRAVO 3 trial. METHODS: The BRAVO-3 trial multicenter randomized trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin or UFH. We compared AF and no-AF groups and examined for 30-day Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic endpoints. Adjusted outcomes were analyzed using logistic regression methods. RESULTS: Of the study population, 41.4% (n = 332) patients had baseline or new-onset AF within 30 days of TAVR, whereas 58.6% (n = 470) had no AF. Patients with AF had greater prevalence of renal dysfunction, lower left ventricular ejection fraction, and higher euroSCORE I compared with their counterparts without AF. Among AF and no-AF patients, there were no significant baseline differences between bivalirudin and UFH groups. At 30 days the incidence of death (6.0 vs. 4.5%, P = 0.324) and stroke (3.9 vs. 2.6%, P = 0.274) was similar in AF vs. no-AF patients. However, new-onset AF (n = 38) was associated with significantly greater crude risk of 30-day stroke compared with no AF (HR 4.49, 95% CI 1.37-14.67). Regardless of AF status, there were no differences in 30-day death (P-int = 0.652) or stroke (P-int = 0.066) by anticoagulation type. CONCLUSIONS: Prior or new-onset AF is noted in more than one-third of patients undergoing transfemoral TAVR. Despite greater baseline comorbidities than non-AF patients, AF was not associated with significantly higher risk of adjusted 30-day outcomes. In the BRAVO 3 trial, early outcomes were similar regardless of anticoagulant strategy in each group.

Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial).

BACKGROUND: Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction (STEMI). The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention (PPCI) has been associated with a reduction of infarct size in STEMI patients. METHODS: CIRCUS is an international, prospective, multicenter, randomized, double-blinded, placebo-controlled trial. The study is designed to compare the efficacy and safety of cyclosporine versus placebo, in addition to revascularization by PPCI, in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow ≤1 in the culprit left anterior descending coronary artery. Patients are randomized in a 1:1 fashion to 2.5 mg/kg intravenous infusion of cyclosporine or matching placebo performed in the minutes preceding PCI. The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality, rehospitalization for heart failure or heart failure worsening during initial hospitalization, and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography. Secondary outcomes will be tested using a hierarchical sequence of left ventricular (LV) ejection fraction and absolute measurements of LV volumes. The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction. RESULTS: Recruitment lasted from April 2011 to February 2014. The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction. The 12-months results are expected to be available in 2015. CONCLUSIONS: The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up.

Balloon aortic valvuloplasty in the era of transcatheter aortic valve replacement: acute and long-term outcomes.

BACKGROUND: The use of balloon aortic valvuloplasty (BAV) has resurged since the development of transcatheter aortic valve replacement (TAVR). The aim of our study was to determine the procedural and long-term outcomes of patients treated by BAV in the early TAVR era. METHODS: From 2005 to 2008, 323 consecutive patients presenting with severe aortic stenosis were treated by BAV in our institution. RESULTS: Mean age and logistic EuroSCORE were 80.5 ± 9.9 years and 28.7% ± 12.5%, respectively. The effective orifice area increased from 0.68 ± 0.25 to 1.12 ± 0.39 cm(2) (P < .001) after BAV. Inhospital major complications occurred in 22 patients (6.8%), with a mortality rate of 2.5%. Eighty-five patients (26.3%) were bridged to surgical aortic valve replacement (SAVR, 9.6%) or TAVR (16.7%). Twenty-eight patients (8.7%) had at least 1 repeat BAV. Two hundred ten patients (65%) received only medical therapy post-BAV. Mean duration of follow-up was 20.7 ± 20.0 months. Kaplan-Meier analysis demonstrated that survival after single BAV was poor. Patients treated by BAV followed by SAVR or TAVR had the highest long-term survival rate (P < .001). Multivariable analysis revealed that logistic EuroSCORE, severe aortic regurgitation and stroke complications post-BAV, and medical therapy post-BAV were independent predictors of mortality. CONCLUSIONS: The results of our study suggest that BAV is an acceptable bridge to SAVR or TAVR in a very high-risk population not immediately suitable for definitive therapy. Balloon aortic valvuloplasty remains only a brief temporizing procedure with a poor long-term outcome without subsequent definitive therapy.

Expandable sheath for transfemoral transcatheter aortic valve replacement: procedural outcomes and complications.

AIMS: It is currently unknown whether the expandable sheath (e-sheath) for transfemoral Edwards transcatheter aortic valve replacement (TAVR) has a lower rate of access complications than the 18/19F fixed size sheath (f-sheath). Our aim was to compare the incidence of procedural complications when using f-sheath vs. e-sheath during TAVR. METHODS: We included 162 consecutive patients, implanted with the Edwards SAPIEN XT valve in our center. Access closure was obtained with the Prostar system in all cases. E-sheath was used in 80 patients (49%). RESULTS: Minimal ilio-femoral diameter was comparable in e-sheath and f-sheath groups: 6.7 (6.1-7.7) vs. 7 (6.2-8) mm, P = 0.25, as was the frequency of peripheral artery disease: 12.5% vs. 13.4%, P = 1.0. VARC major vascular complications rate was similar in the 2 groups: e-sheath 7 (8.8%) vs. f-sheath 6 (7.3%), P = 0.74, as was the incidence of minor vascular complications: 8 (10%) vs. 14 (17.1%), P = 0.19, life-threatening bleeding: 6 (7.5%) vs. 6 (7.3%), P = 0.96, major and minor bleeding and use of covered vascular stents: 9 (11%) vs. 6 (7.5%), P = 0.59. CONCLUSIONS: The e-sheath for TAVR with the Edwards valve did not show an advantage over the f-sheath in reducing vascular and bleeding complications.

Single-source dual-energy CT angiography with reduced iodine load in patients referred for aortoiliofemoral evaluation before transcatheter aortic valve implantation: impact on image quality and radiation dose.

OBJECTIVES: To compare image quality and radiation dose of pre-transcatheter aortic valve implantation (TAVI) aortoiliofemoral CT angiography (AICTA) provided by standard vs. dual-energy mode with reduced iodine load protocols. METHODS: One hundred and sixty-one patients underwent a two-step CTA protocol before TAVI including cardiac CTA with injection of 65 mL of iodinated contrast agent (ICA), immediately followed by AICTA. From this second acquisition, the following three different patient groups were identified: Group 1: 52 patients with standard AICTA (60 mL ICA, 100 kVp, mA automodulation); Group 2: 48 patients with dual-energy AICTA with 50 % iodine load reduction (30 mL ICA, fast kVp switching, 600 mA); Group 3: 61 patients with an identical protocol to Group 2, but exposed to 375 mA. The qualitative/subjective image quality (13-point score) and quantitative/objective image quality (contrast attenuation and image noise) were evaluated. The radiation dose was recorded. RESULTS: There was no significant difference in non-diagnostic images between the three protocols. Contrast attenuation, signal-to-noise ratio and contrast-to-noise ratio were significantly higher, whereas noise was significantly lower in the standard protocol (all P < 0.05). The radiation dose was lower in the dual-energy protocol at 375 mA (P < 0.05). CONCLUSIONS: Dual-energy AICTA before TAVI results in a reduction of iodine load while maintaining sufficient diagnostic information despite increased noise. KEY POINTS: • Dual-energy AICTA before TAVI results in a 50 % reduction of iodine load. •The reduction of iodine load maintains sufficient image quality despite increased noise. • Using 375 mA in dual-energy mode results in a reduction of radiation dose. • A high tube current setting (600 mA) should be used in overweight patients.

Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement.

BACKGROUND: Data on the long-term impact of prosthesis-patient mismatch (PPM) on outcomes after transcatheter aortic valve replacement (TAVR) remain sparse. We therefore aimed to investigate the incidence, predictive factors, and long-term prognostic impact of PPM on bioprosthesis durability and mortality. METHODS: This was a single-centre retrospective study including 2117 patients who underwent TAVR for aortic stenosis from 2002 to 2022. Moderate PPM was defined by indexed effective orifice area (iEOA) > 0.65 and ≤ 0.85 cm2/m2 (> 0.55 and ≤ 0.70 cm2/m2 if BMI ≥ 30 kg/m2) and severe PPM by an iEOA ≤ 0.65 cm2/m2 (≤ 0.55 cm2/m2 If BMI ≥ 30 kg/m2). RESULTS: There were 351 patients (16.6%) with PPM, including 39 patients (1.8%) with severe PPM and 312 patients (14.7%) with moderate PPM. The mean follow-up duration was 31.2 ± 26.5 months. Factors independently associated with the occurrence of PPM were body surface area (odds ratio [OR] 3.32, 95% confidence interval [CI] 1.32-8.35; P = 0.01), valve-in-valve TAVR (OR 6.12, 95% CI 2.29-16.08; P < 0.001), small annulus (OR 2.42, 95% CI 1.41-4.07; P = 0.001), and the use of a balloon-expandable valve (OR 4.17, 95% CI 2.17-8.33; P < 0.001). PPM was associated with increased risk of mortality (hazard ratio [HR] 1.3, 95% CI 1.1-1.5, P = 0.004) and valve thrombosis (HR 4.2, 95% CI 1.4-12.6, P = 0.01), and a trend towards increased risk of structural valve deterioration (HR 1.7, 95% CI 0.9-2.9; P = 0.08). CONCLUSIONS: The results of this study suggest that PPM has a negative long-term impact on outcomes after TAVR. These findings emphasise the importance of preventing PPM.

Phenotypic clustering of patients hospitalized in intensive cardiac care units: Insights from the ADDICT-ICCU study.

BACKGROUND: Intensive cardiac care units (ICCUs) were created to manage ventricular arrhythmias after acute coronary syndromes, but have diversified to include a more heterogeneous population, the characteristics of which are not well depicted by conventional methods. AIMS: To identify ICCU patient subgroups by phenotypic unsupervised clustering integrating clinical, biological, and echocardiographic data to reveal pathophysiological differences. METHODS: During 7-22 April 2021, we recruited all consecutive patients admitted to ICCUs in 39 centers. The primary outcome was in-hospital major adverse events (MAEs; death, resuscitated cardiac arrest or cardiogenic shock). A cluster analysis was performed using a Kamila algorithm. RESULTS: Of 1499 patients admitted to the ICCU (69.6% male, mean age 63.3±14.9 years), 67 (4.5%) experienced MAEs. Four phenogroups were identified: PG1 (n=535), typically patients with non-ST-segment elevation myocardial infarction; PG2 (n=444), younger smokers with ST-segment elevation myocardial infarction; PG3 (n=273), elderly patients with heart failure with preserved ejection fraction and conduction disturbances; PG4 (n=247), patients with acute heart failure with reduced ejection fraction. Compared to PG1, multivariable analysis revealed a higher risk of MAEs in PG2 (odds ratio [OR] 3.13, 95% confidence interval [CI] 1.16-10.0) and PG3 (OR 3.16, 95% CI 1.02-10.8), with the highest risk in PG4 (OR 20.5, 95% CI 8.7-60.8) (all P<0.05). CONCLUSIONS: Cluster analysis of clinical, biological, and echocardiographic variables identified four phenogroups of patients admitted to the ICCU that were associated with distinct prognostic profiles. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05063097.

TAPSE/sPAP prognostic value for In-Hospital Adverse Events in Patients Hospitalized for Acute Coronary Syndrome.

AIMS: Although several studies have shown that the right ventricular to pulmonary artery (RV-PA) coupling, assessed by the ratio between tricuspid annular plane systolic excursion and systolic pulmonary artery pressure (TAPSE/sPAP) using echocardiography, is strongly associated with cardiovascular events, its prognostic value is not established in acute coronary syndrome (ACS). We aimed to assess the in-hospital prognostic value of TAPSE/sPAP among patients hospitalized for ACS in a retrospective analysis from the prospective ADDICT-ICCU study. METHODS AND RESULTS: 481 consecutive patients hospitalized in intensive cardiac care unit (mean age 65±13 years, 73% of male, 46% STEMI) for ACS (either ST-elevation [STEMI] or non-ST-elevation [NSTEMI] myocardial infarction) with TAPSE/sPAP available were included in this prospective French multicentric study (39 centers). The primary outcome was in-hospital major adverse cardiovascular events (MACEs) defined as all-cause death, resuscitated cardiac arrest or cardiogenic shock and occurred in 33 (7%) patients. ROC-curve analysis identified 0.55 mm/mmHg as the best TAPSE/sPAP cut-off to predict in-hospital MACEs. TAPSE/sPAP <0.55 was associated with in-hospital MACEs, even after adjustment with comorbidities (OR:19.1, 95%CI[7.78-54.8]), clinical severity including left ventricular ejection fraction (OR:14.4, 95%CI[5.70-41.7]) and propensity-matched population analysis (OR:22.8, 95%CI[7.83-97.2], all p<0.001). After adjustment, TAPSE/sPAP <0.55 showed the best improvement in model discrimination and reclassification above traditional prognosticators (C-statistic improvement: 0.16; global chi-square improvement: 52.8; LR-test p<0.001) with similar results for both STEMI and NSTEMI subgroups. CONCLUSION: A low RV-PA coupling defined as TAPSE/sPAP ratio <0.55 was independently associated with in-hospital MACEs and provided incremental prognostic value over traditional prognosticators in patients hospitalized for ACS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05063097.

Patients with severe aortic stenosis and reduced ejection fraction: earlier recovery of left ventricular systolic function after transcatheter aortic valve implantation compared with surgical valve replacement.

BACKGROUND: Only 50% of patients with aortic stenosis (AS) and low ejection fraction (EF) improve their contractility after surgical aortic valve replacement (AVR). Long-term prognosis of these patients is strongly correlated to EF recovery after the surgery. The aim of this study was to compare the postoperative left ventricular function recovery in patients with severe AS and reduced EF after AVR and transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Twenty-one patients undergoing AVR for severe AS (<1 cm²) and reduced EF (<45%) were echocardiographically compared with 31 patients treated with TAVI by conventional and two-dimensional (2D) strain method. TAVI patients were older (83 ± 6 vs. 74 ± 13 years, P < 0.001), had more comorbidities (Euroscore 26 ± 15% vs. 16 ± 12%, P < 0.001) and no differences in ischemic heart disease (16.1% vs. 9.5%, P = 0.39). EF was similar in both groups at baseline. Aortic valve area significantly increased (P = 0.01) while pressure gradient decreased (P = 0.009) after both procedures but TAVI was associated with a better EF recovery compared with AVR at day 7. Regional function assessed by radial 2D strain increased in TAVI group but was transiently deteriorated in AVR patients (P < 0.05). Longitudinal as well as circumferential 2D strain progressively increased at follow-up in both groups (P < 0.05). EF was similar in both groups at 3-month follow-up. CONCLUSION: In patients with severe AS and reduced EF, TAVI is associated with faster and better recovery of LV function compared with AVR.

Transcatheter aortic valve implantation: The road to a minimalist "stent-like" procedure.

BACKGROUND: Since the first-in-man implantation of a transcatheter aortic stented valve in April 2002 in Rouen, the procedure has expanded worldwide. In our centre, all transfemoral procedures have been performed using local anaesthesia without transoesophageal echocardiographic monitoring. AIM: To report our experience of transfemoral arterial transcatheter aortic valve implantation (TAVI) over the last 2 decades, following the evolution of devices, practices and indications. METHODS: Between 2002 and 2021, 2097 consecutive patients had a TAVI procedure in our centre. Among them, 1780 underwent transfemoral arterial aortic valve implantation, and were subdivided into three groups according to the time period: before 2009; 2009-2014; and 2014-2021. RESULTS: Median age was 85 years, and remained unchanged over time. The mean logistic EuroSCORE gradually decreased over time (28% before 2009 vs 15% for 2009-2014 vs 11% since 2014; P<0.001). Predilatation was performed almost systematically before 2009 (93%), but was rarely performed in the last period (14%; P<0.001). Thirty-day all-cause mortality decreased over time, and was only 1.4% in 2021. Length of stay decreased considerably, with a median duration of only 2 days after the procedure, and>70% of patients were discharged home within 72hours. Similarly, procedural duration, X-ray time and contrast volume decreased over time. CONCLUSION: Transfemoral aortic valve implantation, performed as a minimalist "stent-like" procedure using only local anaesthesia, is feasible in the vast majority of patients, with excellent outcomes.

Incidence, Predictive Factors, and Prognostic Impact of Right Ventricular Dysfunction Before Transcatheter Aortic Valve Implantation.

Right ventricular dysfunction (RVD) is considered to be a late marker of aortic stenosis. However, there is a lack of consensus regarding the incidence, prognostic impact, and evolution of RVD in patients treated with transcatheter aortic valve implantation (TAVI). All patients treated with TAVI for severe aortic stenosis were included in a prospective single-center database. Patients who had a quantitative assessment of right ventricular (RV) function including tricuspid annular plane systolic excursion (TAPSE) and/or Doppler tissue imaging-derived tricuspid lateral annular systolic velocity (S' wave) measurements were eligible for this study. RVD was defined as TAPSE <17 mm or S' <9.5 cm/s if TAPSE was not available. Between 2014 and 2019, 503 patients with RV function assessment were included. The incidence of RVD before TAVI was 18.7%. Predictors of RVD were diabetes (p = 0.03), atrial fibrillation (p = 0.001), impaired left ventricular ejection fraction (p <0.0001), left ventricular dilatation (p = 0.007), and previous cardiac surgery (p = 0.002). Long-term survival was worse in patients with RVD before TAVI compared with those without RVD (hazard ratio 1.97, 95% confidence interval 1.1 to 3.4, p = 0.01). One year after TAVI, 58.7% of patients with baseline RVD had normal RV function and had similar outcomes as compared with those without RVD at baseline. In contrast, patients with persistent RVD had the worst prognosis. In conclusion, RVD is not rare and has a deleterious prognostic impact in patients treated with TAVI. Recovery of normal RV function is frequent after TAVI, whereas persistence of RVD is associated with poor outcomes.

Standardized Measurement of Femoral Artery Depth by Computed Tomography to Predict Vascular Complications After Transcatheter Aortic Valve Implantation.

Vascular complications (VCs) are difficult to predict and remain an important issue after transfemoral (TF) transcatheter aortic valve implantation (TAVI) although their incidence has decreased with size reduction of introducers. We aimed to evaluate a standardized measurement of femoral artery depth (FAD) using computed tomography (CT) to predict VCs after TAVI. We performed a retrospective study of 679 TF TAVI patients. We evaluated a standardized CT method to measure FAD immediately above the bifurcation. Sheath-to-femoral-artery ratio (SFAR), calcification, and tortuosity were also evaluated. VCs were defined by the Valve Academic Research Consortium (VARC)-2. Receiver operating characteristic (ROC) curves were used to predict major VCs and the need for a stent-graft. The median values of FAD and SFAR were 49.0 (36.2 to 66.7) mm and 0.95 (0.81 to 1.18), respectively. Major VCs occurred in 37 (5.4%) patients and a stent-graft was required in 49 (7.1%) patients. FAD predicted the need for a stent-graft [0.61 (0.51 to 0.70), p = 0.04] but not major VCs [0.52 (0.40 to 0.63), p = 0.76]. In contrast, SFAR did not predict the need for a stent-graft [0.53 (0.43 to 0.62), p = 0.61] but predicted major VCs [0.70 (0.58 to 0.81), p = 0.001]. Calcification and tortuosity predicted neither major VCs nor the need for a stent-graft. In conclusion, the results of our study suggest that CT measurements of FAD and SFAR provide additional information to predict major VCs and the need for a femoral stent-graft after TF TAVI.

Analysis of length of stay after transfemoral transcatheter aortic valve replacement: results from the FRANCE TAVI registry.

BACKGROUND: Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry. METHODS: TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the "very early" discharge group, patients with a LOS between 3 and 6 days constituted the "early" discharge group, and patients with a length of stay > 6 days constituted the "late" discharge group. RESULTS: The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66). CONCLUSIONS: LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.

Diagnostic and prognostic value of myocardial perfusion gated SPECT in orthotopic heart transplant recipients.

BACKGROUND: Cardiac allograft vasculopathy (CAV) limits long-term survival after heart transplantation. Diagnostic and prognostic value of gated single photon emission computed tomography (gated SPECT) has not been documented in this setting. METHODS AND RESULTS: We identified 110 consecutive heart transplant recipients (with transplantation >18 months) who underwent stress-rest gated SPECT and coronary angiography within 1 month, and were clinically monitored in a single heart transplantation center. Visual scoring of perfusion and wall motion images used a 16-segment model. Left ventricular function was automatically calculated. Coronary angiography was normal in 64 patients (58%) and abnormal in 46 (any CAV, 42%), of whom 19 had severe stenoses. Sensitivity and negative predictive (NPV) value were .63 and .75 for identification of any CAV, and .84 and .96 for severe CAV. Cox regression analysis showed that independent predictors of cardiac death and retransplantation were the presence of any angiographic CAV lesions (RR = 8.816, P = .043) and a stress perfusion defect >3 segments (RR = 5.607, P = .0053). A stress perfusion defect >3 segments predicted the need for late coronary revascularization >2 months (RR = 6.11, P = .0002). CONCLUSIONS: We conclude that perfusion gated SPECT is a useful noninvasive screening test and may be proposed to help identify heart transplant recipients with a high risk of poor clinical outcome. A normal gated SPECT was associated with a low risk of cardiac hard event and might alleviate the need for coronary angiography.

Is heparin plasma suitable for the determination of B-type natriuretic peptide on the Beckman-Coulter Access 2?

BACKGROUND: The use of heparin as an alternative to EDTA in the production of plasma samples is of particular interest for B-type natriuretic peptide (BNP) measurements. Lithium heparin is now widely used for the determination of biochemical parameters, including cardiac markers. The goal of this study was to determine the feasibility of measuring BNP using heparin plasma instead of EDTA plasma with the Access 2 system (Beckman-Coulter). METHODS: BNP was determined in heparin plasma and EDTA plasma from 24 patients within 1 h of blood collection. Additional measurements were performed with heparin plasma, every hour for the first 4 h, and then 8 h after the collection of blood that was stored at room temperature. RESULTS: At H(0), the observed BNP concentrations in heparin plasma were much higher (mean values 65% higher) than those in EDTA plasma. Using predetermined thresholds, this difference would lead to 30% discordance between samples in heparin and EDTA. BNP stability decreased over time in heparin plasma: immunoreactivity decreased approximately by 30% during the first 2 h and by 60% after 8 h. CONCLUSIONS: Heparin plasma does not seem to be a suitable alternative to EDTA plasma for measurement of BNP using the Access 2 system, even if measurements are performed immediately after blood sampling.