Impact of completeness of revascularization in complex coronary artery disease as measured with the SYNTAX revascularization index: An SEEDS Substudy.

OBJECTIVES: We sought to study whether the level of completeness of revascularization as measured by the SYNTAX revascularization index (SRI) independently predicts adverse ischemic events after percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DES). BACKGROUND: The SRI quantifies the proportion of revascularized myocardium. It has been shown to independently predict adverse ischemic events after PCI with first-generation DES. METHODS: Among 1,900 patients enrolled in a registry to evaluate safety and effectiveness of everolimus drug-eluting stent (SEEDS) for coronary revascularization, the SRI was calculated and available for 1,851 patients. The patients were stratified into three groups according to the degree of revascularization (SRI = 100% [complete revascularization], SRI = 50 to <100%, and SRI <50%). Two-year mortality and major adverse cardiac events (MACE) were compared between the groups. RESULTS: The SRI ranged from 4-100%, with a mean of 85.4%. Complete revascularization was achieved in 1,190 patients, while the SRI was 50% to <100% in 472 patients and <50% in 189 patients. Two-year mortality and MACE rates were higher in patients with lower SRI. ROC analysis showed an optimal SRI cutoff of 85% for predicting the 2-year mortality risk. An SRI ≥85% was associated with a similar risk of death to complete revascularization. The SRI independently predicted 2-year mortality and MACE. CONCLUSIONS: The SRI predicts mortality and adverse ischemic events in patients with complex CAD who underwent contemporary PCI with second-generation DES. Revascularizing ≥85% of the CAD burden was associated with a good prognosis and should be considered as a reasonable goal. © 2017 Wiley Periodicals, Inc.

Risk stratification of patients undergoing medical therapy after coronary angiography.

AIM: We sought to investigate the prognostic impact of the SYNTAX (Synergy between PCI with TAXUS and Cardiac Surgery) score (SS) on 1-year clinical outcomes in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) undergoing medical therapy only. METHODS AND RESULTS: Among the 13 819 patients enrolled in the ACUITY trial and undergoing coronary angiogram, 4491 patients were treated with medical therapy as the initial strategy. Of those, baseline SS and complete angiographic analysis were available in 1275 patients. Patients were divided in four groups based on the presence or absence of coronary artery disease (CAD) and subsequently, among patients with CAD, by SS. Major adverse cardiac events (MACE) and its individual components (death, myocardial infarction, and unplanned revascularization) were compared between groups. Among the 1275 patients, the mean SS was 3.5 ± 7.0 (range 0-45). SYNTAX score was 0 in 842 patients, >0 and ≤5 in 170, >5 and ≤11 in 119, and >11 in 144 patients. The 1-year rates of MACE were higher in patients with CAD and higher SS. By multivariable analysis, the SS was a strong predictor of all adverse ischaemic events, including mortality. By receiver operator characteristic analysis, an SS cut-off of 8 showed the best prognostic accuracy for death and MACE. CONCLUSION: In patients with NSTE ACS undergoing medical therapy, the SS, especially when >8, was shown to be a strong predictor of 1-year MACE, including mortality. This finding has important clinical implications for risk stratification of patients with NSTE ACS undergoing medical therapy after an initial angiogram.

Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight from the ORBIT II trial.

OBJECTIVES: We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type. BACKGROUND: The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions. METHODS: ORBIT II was a single-arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30-day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first-generation drug-eluting stent [DES], or second-generation DES). The 2-year MACE rate and its components were compared between groups. RESULTS: In the ORBIT II study cohort, 2-year rates of MACE, cardiac death, and target vessel revascularization were 19.4%, 4.3%, and 8.1%, respectively. Two year data were available in 419 of 443 patients (94.6%) with median follow up time of 25.1 months. Stent-type data were available in 435 of the 443 patients (98.2%). Six patients received stents of more than one type and were excluded from the stent type comparisons. Among the 429 patients included in the stent comparison analyses, 43 patients (10.0%) received BMS, 74 (17.2%) received first-generation DES, and 312 (72.7%) received second-generation DES. The 1 and 2-year target lesion revascularization rates were lower among patients receiving first-generation (1.4% and 6.3%) and second-generation (3.9% and 5.0%) DES compared to patients receiving BMS (15.3% and 15.3%), respectively (1 year: P = 0.007; 2 year: P = 0.047). Higher diameter stenosis and the use of BMS were independently associated with the occurrence of MACE and TVR at 2 years. CONCLUSIONS: OAS remained safe and effective for patients with de novo, severely calcified lesions at 2 years in the ORBIT II study. Adverse ischemic events were significantly higher with BMS compared with DES. © 2016 Wiley Periodicals, Inc.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.

OBJECTIVES: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. BACKGROUND: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). METHODS: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. RESULTS: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). CONCLUSIONS: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.

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.

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.

Left atrial unloading with an 8 mm septal cutting balloon to treat postcapillary pulmonary hypertension: a case report.

We report the case of a 58-year-old female with severe postcapillary pulmonary hypertension (averaged mean pulmonary arterial pressure was 49 mmHg, pulmonary arterial wedge pressure 29 mmHg, and right atrial pressure 8 mmHg) due to heart failure with preserved ejection fraction. A left-to-right atrial shunt was created using an 8 mm cutting balloon, under transesophageal echocardiography guidance. Both pulmonary arterial and wedge pressure dramatically decreased after the procedure. Symptoms immediately improved and benefits were sustained at 6 months of follow-up. This case suggests that iatrogenic septal defect using a cutting balloon could be an option to treat symptomatic postcapillary pulmonary hypertension.

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.

Evaluation of length of stay after transfemoral transcatheter aortic valve implantation with SAPIEN 3 prosthesis: A French multicentre prospective observational trial.

BACKGROUND: Complications decrease after transfemoral transcatheter aortic valve implantation (TAVI), and early discharge is feasible and safe in selected populations. AIMS: To evaluate length of stay (LOS) and reasons for prolonged hospitalisation after transfemoral TAVI in unselected patients. METHODS: Patients with severe aortic stenosis, who had transfemoral TAVI with the SAPIEN 3 prosthesis using exclusively local anaesthesia, were prospectively and consecutively included at five French high-volume centres. LOS was calculated from TAVI procedure to discharge. Reasons for prolonged hospitalisation (i.e.>3 days) were evaluated. RESULTS: Between 2017 and 2018, 293 patients were included, with a mean age of 82.4±6.5 years and a mean logistic EuroSCORE of 13.7±9.0%. The in-hospital mortality rate was 1.4%. The median LOS was 5 (3-7) days, and varied considerably between centres (from 2 to 7 days). Sixty-four (21.8%) patients were discharged within 3 days after transfemoral TAVI. Reported reasons for prolonged hospitalisation were complications in 62.2%, loss of autonomy in 3.1%, discharge refusal in 2.2% and logistical reasons in 0.9%. In 31.6% of cases, the investigators reported no apparent reasons. CONCLUSIONS: The results of our study suggest that LOS after transfemoral TAVI, using the SAPIEN 3 prosthesis and a minimalist approach, varies considerably between centres. In almost a third of cases, hospitalisation was prolonged without any apparent reason. Efforts should be made to educate centres to reduce LOS.

Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition.

AIMS: Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions. METHODS AND RESULTS: All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively. CONCLUSIONS: Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.

Classification for Assessing the Quality of Diagnostic Coronary Angiography.

Coronary angiography remains the gold standard for diagnosing obstructive coronary artery disease. However, no standardized, objective, and quantitative classification to assess the quality of coronary angiography exists. In the present report, we sought to establish a novel standardized quantitative classification for the quality of coronary angiography, taking into consideration two main parameters: coronary contrast filling and coronary sinus contrast reflux. Intraobserver and interobserver reproducibility performed among 70 angiograms and 9 readers demonstrated excellent and substantial reproducibility, respectively. The proposed classification may be useful in daily practice, clinician training, and clinical trials.

Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to assess the incidence, prognostic impact, and predictive factors of readmission for congestive heart failure (CHF) in patients with severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is indicated in patients with severe symptomatic aortic stenosis in whom surgery is considered high risk or is contraindicated. Readmission for CHF after TAVR remains a challenge, and data on prognostic and predictive factors are lacking. METHODS: All patients who underwent TAVR from January 2010 to December 2014 were included. Follow-up was achieved for at least 1 year and included clinical and echocardiographic data. Readmission for CHF was analyzed retrospectively. RESULTS: This study included 546 patients, 534 (97.8%) of whom were implanted with balloon-expandable valves preferentially via the transfemoral approach in 87.8% of cases. After 1 year, 285 patients (52.2%) had been readmitted at least once, 132 (24.1%) for CHF. Patients readmitted for CHF had an increased risk for death (p < 0.0001) and cardiac death (p < 0.0001) compared with those not readmitted for CHF. On multivariate analysis, aortic mean gradient (hazard ratio [HR]: 0.88; 95% confidence interval [CI]: 0.79 to 0.99; p = 0.03), post-procedural blood transfusion (HR: 2.27; 95% CI: 1.13 to 5.56; p = 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; p < 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; p = 0.02) were independently associated with CHF readmission at 1 year. CONCLUSIONS: Readmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Low gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF.

Aortic Valve Annular Sizing: Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography.

BACKGROUND: Appropriate valve sizing is critical in aortic valve replacement. We hypothesized that direct intraoperative valve sizing results in smaller aortic annular diameters compared with sizing based on systolic-phase multidetector computerized tomographic (MDCT) imaging. METHODS AND RESULTS: We retrospectively analyzed 78 patients undergoing surgical aortic valve replacement for severe aortic stenosis between 2012 and 2014 at our institution. Preoperative MDCT measurements of the aortic annulus served as basis for assignment to a theoretical surgical valve size, which was then (1) compared to the implanted valve size and (2) to a theoretical transcatheter aortic valve replacement valve size. To quantify the resulting differences, geometric orifice areas (GOA) were calculated. MDCT-based sizing produced the same valve size for n=34 patients (group CT-same), a larger valve with a 25% increased GOA in n=32 patients (group CT-Lg) and a smaller GOA by 22% in n=12 patients (group CT-Sm). On the basis of MDCT measurements, 41% of valves implanted were undersized. The comparison of intraoperative implanted to a theoretical transcatheter aortic valve replacement valve size resulted in GOAs 25% larger for patients in group CT-same, 40.6% larger in group CT-Lg and 14.6% larger in group CT-Sm. CONCLUSIONS: Preoperative MDCT measurements differ substantially from direct intraoperative assessment of the aortic annulus. Implanted surgical aortic valve replacement valves were smaller relative to MDCT-based sizing in 41% of patients, and the potential GOA was between 25% and 40.6% larger if patients had undergone transcatheter aortic valve replacement.

Practical determination of aortic valve calcium volume score on contrast-enhanced computed tomography prior to transcatheter aortic valve replacement and impact on paravalvular regurgitation: Elucidating optimal threshold cutoffs.

BACKGROUND: The threshold for the optimal computed tomography (CT) number in Hounsfield Units (HU) to quantify aortic valvular calcium on contrast-enhanced scans has not been standardized. Our aim was to find the most accurate threshold to predict paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). METHODS: 104 patients who underwent TAVR with the CoreValve prosthesis were studied retrospectively. Luminal attenuation (LA) in HU was measured at the level of the aortic annulus. Calcium volume score for the aortic valvular complex was measured using 6 threshold cutoffs (650 HU, 850 HU, LA × 1.25, LA × 1.5, LA+50, LA+100). Receiver-operating characteristic (ROC) analysis was performed to assess the predictive value for > mild PVR (n = 16). Multivariable analysis was performed to determine the accuracy to predict > mild PVR after adjustment for depth and perimeter oversizing. RESULTS: ROC analysis showed lower area under the curve (AUC) values for fixed threshold cutoffs (650 or 850 HU) compared to thresholds relative to LA. The LA+100 threshold had the highest AUC (0.81), and AUC was higher than all studied protocols, other than the LA x 1.25 and LA + 50 protocols, where the difference approached statistical significance (p = 0.05, and 0.068, respectively). Multivariable analysis showed calcium volume determined by the LAx1.25, LAx1.5, LA+50, and LA+ 100 HU protocols to independently predict PVR. CONCLUSIONS: Calcium volume scoring thresholds which are relative to LA are more predictive of PVR post-TAVR than those which use fixed cutoffs. A threshold of LA+100 HU had the highest predictive value.

[Emergency percutaneous valvuloplasty: Which patients, which results?] / La valvuloplastie percutanée en urgence : quels patients, quels résultats ?

Balloon aortic valvuloplasty is a relatively simple procedure with a low rate of complications despite patients' frailty. Urgent balloon aortic valvuloplasty is especially useful in patients with temporary contra-indication to TAVI or in case of difficult clinical scenario. It allows for a functional improvement for up to 6 months. This period should be used to bridge the patient to TAVI or surgical aortic valve replacement, stand-alone aortic valvuloplasty being without mid-term survival benefit.