Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. METHODS: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. RESULTS: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. CONCLUSIONS: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes.

BACKGROUND: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited. OBJECTIVES: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned. METHODS: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm). RESULTS: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size. CONCLUSIONS: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies.

Balloon aortic valvuloplasty for severe aortic stenosis before urgent non-cardiac surgery.

BACKGROUND: Balloon aortic valvuloplasty (BAV) has been proposed as a therapeutic option in patients suffering from severe aortic stenosis (SAS) who need urgent non-cardiac surgery (NCS). Whether this strategy is better than medical therapy in this very specific population is unknown. AIMS: We aimed to evaluate the clinical benefit of an invasive strategy (IS) with preoperative BAV in patients with SAS requiring urgent NCS. METHODS: From 2011 to 2019, a registry conducted in two centres included 133 patients with SAS undergoing urgent NCS, of whom 93 underwent preoperative BAV (IS) and 40 a conservative strategy (CS) without BAV. All analyses were adjusted for confounding using inverse probability of treatment weighting (IPTW) (10 clinical and anatomical variables). RESULTS: The primary outcome was MACE at one-month follow-up after NCS including mortality, heart failure, and other cardiovascular outcomes. In patients managed conservatively, occurrence of MACE was 20.0% (n=8) and death was 10.0% (n=4) at 1 month. In patients undergoing BAV, the occurrence of MACE was 20.4% (n=19) and death was 5.4% (n=5) at 1 month. Among patients undergoing conservative management, all events were observed after NCS while, in patients undergoing BAV, 12.9% (n=12) had events between BAV and NCS including 3 deaths, and 7.5% (n=7) had events after NCS including 2 deaths. In IPTW propensity analyses, the incidence of the primary outcome (20.4% vs 20.0%; OR 0.93, 95% CI: 0.38-2.29) and three-month survival (89.2% vs 90.0%; IPTW-adjusted HR 0.90, 95% CI: 0.31-2.60) were similar in both groups. CONCLUSIONS: Patients with SAS managed conservatively before urgent NCS are at high risk of events. A systematic invasive strategy using BAV does not provide a significant improvement in clinical outcome.

Advanced image processing with fusion and calcification enhancement in transcatheter aortic valve implantation: impact on radiation exposure.

OBJECTIVES: Radiation exposure is a concern for both patients and operators during transcatheter aortic valve implantation (TAVI). Efforts to reduce radiation dose are warranted. We aimed at investigating if per-operative advanced image processing can reduce patient and operator irradiation use during TAVI. METHODS: We performed a prospective single-centre observational study comparing patient and operator radiation exposure using standard fluoroscopy (control group) or a novel technology of live advanced fluoroscopic image processing (test group) among consecutive patients undergoing TAVI between August 2015 and April 2016. Patient irradiation (dose-area product, effective dose and air kerma), contrast media volume and clinical outcomes were assessed. RESULTS: Among 152 elderly [median age (interquartile range): 83 (78-87)] patients (n = 76 per group) undergoing TAVI, baseline clinical characteristics were similar between the control and test groups, except for a higher median EuroSCORE II (2.8% vs 2.3%, P = 0.02) and higher rate of TAVI for failing surgical bioprosthesis (11.8% vs 2.6%, P = 0.03) in the control group. The dose-area product was reduced in the test group: mean reduction of -27.5 Gy × cm2 [95% confidence intervals (CIs): 15.9-39.1, P < 0.001]. Furthermore, effective dose [mean reduction -6.5 (95% CI: 5.9-7.2) mSv, P < 0.001] and air kerma [mean reduction -167.5 (95% CI 163.4-177.3) mGy, P < 0.001] were lower in the test group. Fluoroscopy time, contrast volume and clinical outcomes were similar. CONCLUSIONS: Patient radiation exposure was significantly reduced using a novel live advanced fluoroscopy image processing with calcification enhancement and fusion of the virtual aortic annulus without compromising patient safety.

Implantation of a Sapien XT aortic bioprosthesis through the left carotid artery.

Transcatheter aortic valve implantation (TAVI) is still under active investigation. When the femoral route is impossible for anatomic reasons, the transapical, transaxillary and direct aortic approaches have demonstrated their effectiveness. We report the successful implantation of a Sapien XT bioprosthesis with the NovaFlex catheter through a left carotid approach.

Poor agreement between light transmission aggregometry, Verify Now P2Y12 and vasodilatator-stimulated phosphoprotein for clopidogrel low-response assessment: a potential explanation of negative results of recent randomized trials.

Clopidogrel low response as assessed by several different biological tests correlates with poor prognosis after percutaneous coronary intervention (PCI). However, recent randomized clinical trials (RCT) testing the strategy of individual antiplatelet therapy tailoring based on one sole test have all shown negative results. Poor correlation between the different tests may explain the difficulties of patient selection and identification of "true poor responders" to clopidogrel. In this prospective study, clopidogrel response was assessed in 100 consecutive patients between 18 and 24 hours after a 600 mg clopidogrel loading dose using three different tests: light transmission aggregometry with 10 µmol ADP (LTA, results expressed as platelet aggregation percentage: PAP), Verify Now P2Y12 (VN, results expressed as P2Y12 reaction unit: PRU) and vasodilatator-stimulated phosphoprotein (VASP, results expressed as platelet reactivity index: PRI). Patients under chronic clopidogrel therapy were excluded. The mean PAP, PRU and PRI values were 38.6%, 176.1 PRU and 52.4%, respectively. When clopidogrel response was analyzed as continuous variable, there was a good correlation between the different tests: LTA/VN (R(2 )= 0.642, p < 0.001), LTA/VASP (R(2 )= 0.409, p < 0.001) and VN/VASP (R(2 )= 0.616, p < 0.001). However, when clopidogrel response was analyzed as pre-specified cut-off points to define patients as "poor or good responders" (according to the literature: 50% PAP for LTA, 235 PRU for VN and 50% PRI for VASP), only 47% of the patients were defined as "good" or "poor responders" by the three tests. Altogether, 33% of the patients were defined as "poor responders" by only one test, 20% by two tests and only 16% by the three tests. The correlation between the different tests is good when clopidogrel response is analyzed as continuous variable. Each individual is however rarely (less than 50%) defined as "poor or good responder" by all the three tests when pre-specified cut-off values are used. A sole test might not be sufficient to manage antiplatelet therapy in an individual patient and these results may explain the results of recent RCT showing the lack of benefit of systematic antiplatelet therapy monitoring strategy.

Impact of initial clinical presentation on clopidogrel low response.

BACKGROUND: Large interindividual variability exists in clopidogrel response. Clopidogrel low response correlates with poor prognosis after percutaneous coronary intervention. Some authors also suggest intraindividual variability over time. AIM: To assess the impact of initial clinical presentation on clopidogrel low response. METHODS: In this prospective study, clopidogrel response was assessed in 100 patients. Fifty patients presenting with acute coronary syndromes (ACS group) were compared with 50 patients with stable coronary artery disease matched 1:1 for age, sex, body mass index and diabetes (stable group). All patients were tested 18-24h after a 600 mg loading dose of clopidogrel using the VerifyNow-P2Y12 test (results expressed as platelet reaction units [PRUs]). Patients under chronic clopidogrel therapy or treated with glycoprotein IIb/IIIa inhibitors, bivalirudin or thrombolytics were excluded. RESULTS: Mean age was 61 ± 12 years in each group; 28% of patients in each group were diabetic; mean body mass index was 27.6 ± 5.6 kg/m(2) in the ACS group and 27.9 ± 5.9 kg/m(2) in the stable group (p=0.80). Mean PRU values were 197 ± 81 in the ACS group and 159 ± 94 in the stable group (p=0.03). By multivariable analysis, the ACS group was significantly associated with a higher PRU value (p=0.02). There were significantly more clopidogrel low responders (PRU value>230) in the ACS group (38% vs. 18%; p=0.04). CONCLUSION: Our study confirms that initial clinical presentation, especially ACS, is a strong predictor of clopidogrel low response; this suggests that the evolution of coronary artery disease for one patient influences the clopidogrel response over time. These results are in accordance with recent trials showing a benefit for more aggressive antiplatelet therapy in ACS patients.

Transcutaneous aortic valve implantation using the left carotid access: feasibility and early clinical outcomes.

BACKGROUND: In some patients, transfemoral, transaxillary, or transapical aortic valve implantation is not possible. Thus, carotid artery access may represent a safe alternative to those accesses, and even offers certain advantages. In this article, we describe aortic valve implantation using the left carotid arterial approach and report our initial experience. METHODS: Using a self-expandable nitinol based device (CoreValve ReValving system, Medtronic Ltd, Luxembourg), we exposed the left carotid artery through a small incision. Arterial puncture and initial 6F sheath introduction were achieved through a contraincision. The same implantation technique as for transaxillary implantation was used. Progressive artery dilatation was achieved using sheaths of increasing diameter. Rapid ventricular pacing was used to reduce cardiac output while performing a routine aortic balloon valvuloplasty. Only then, an 18F sheath was inserted into the carotid artery and pushed down into the ascending aorta. The patients were monitored using cerebral oxymetry to assess cerebral perfusion. RESULTS: Twelve consecutive patients, at high surgical risk, were implanted and studied prospectively. Transfemoral and subclavian catheterization were considered unfeasible or at risk of severe complications. Carotid arterial injury did not occur in any patient. A transient ischemic attack occurred in 1 patient, contralateral to the carotid access. There were no deaths in either intraprocedural or during the 30-day follow-up period. CONCLUSIONS: This initial experience suggests that left carotid transarterial aortic valve implantation, in selected high-risk patients, is feasible and safe with satisfactory short-term outcomes.

Transcutaneous aortic valve implantation using the axillary/subclavian access with patent left internal thoracic artery to left anterior descending artery: feasibility and early clinical outcomes.

OBJECTIVE: Both retrograde femoral and subclavian artery catheterization techniques have been described as the most common methods for the implantation of the Medtronic CoreValve percutaneous aortic valve (Medtronic Inc, Minneapolis, Minn). The subclavian artery has been shown to be a safe and effective alternative access route in patients with unfavorable femoral access. Of the patients who are identified as candidates for subclavian artery access, a subset possess a patent left internal thoracic artery to left anterior descending artery. This patent left internal thoracic artery presents an additional anatomic and clinical variable that must be taken into consideration to ensure procedural safety and efficacy. We describe the Medtronic CoreValve percutaneous aortic valve implantation using the subclavian arterial approach in patients with a patent left internal thoracic artery and report our study's findings. METHODS: The CoreValve percutaneous aortic valve is a self-expandable nitinol-based frame with a porcine pericardial valve. The subclavian access was created by a small infraclavicular surgical incision to expose the artery. Rapid ventricular pacing was used to reduce cardiac output to perform the balloon aortic valvuloplasty via a 12F sheath inserted into the subclavian artery. An 18F sheath was then inserted into the artery down into the ascending aorta and used for introduction of the delivery catheter and implantation of the percutaneous aortic valve. RESULTS: With the use of this method, 19 patients (76 ± 13 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications have received implants. Subclavian artery or left internal thoracic artery injury did not occur in any patient. Two deaths occurred. One patient died of right coronary artery occlusion during the procedure, and one patient died 48 hours after the procedure as the result of a tamponade after the temporary pacemaker wire ablation. CONCLUSIONS: This initial experience suggests that subclavian transarterial aortic valve implantation in patients with a patent left internal thoracic artery to left anterior descending artery is feasible and safe with satisfactory short-term outcomes.

Transcutaneous aortic valve implantation using the axillary/subclavian access: feasibility and early clinical outcomes.

OBJECTIVE: Retrograde transfemoral artery catheterization is the most common way of implanting a percutaneous aortic valve. But in some cases, this access cannot be used and the subclavian artery access may represent an alternative to the femoral route, even offering certain advantages. This article describes prosthetic aortic valve implantation using the subclavian arterial approach and reports the findings. METHODS: The valve prosthesis is a self-expandable, nitinol-based device (CoreValve; Medtronic Inc. Minneapolis, Minn). The axillary or subclavian artery was exposed with a small incision. Rapid ventricular pacing was used to reduce cardiac output while a routine aortic balloon valvuloplasty was performed. Then, an 18F sheath was inserted into the axillary artery down into the ascending aorta. By using this method, a prosthesis was implanted in 17 patients (aged 71±11 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications. RESULTS: Subclavian arterial injury did not occur in any patient. The postprocedural aortic valve area increased from 0.6±0.3 cm2 to 1.44±0.35 cm2. A transient ischemic attack occurred in 1 patient. Two patients experienced transitory brachial plexus deficit. There were no intraprocedural deaths. Two deaths occurred in the 30-day follow-up period. CONCLUSIONS: This initial experience suggests that subclavian transarterial aortic valve implantation, in selected high-risk patients, is feasible and safe with satisfactory short-term outcomes.

Hybrid revascularization, comprising coronary artery bypass graft with exclusive arterial conduits followed by early drug-eluting stent implantation, in multivessel coronary artery disease.

AIM: To assess the feasibility and safety of a hybrid myocardial revascularization strategy combining "exclusive arterial" conventional coronary artery bypass grafting (CABG) followed by early drug-eluting stent (DES) implantation in multivessel coronary artery disease (CAD). METHODS: Eighteen consecutive patients with multivessel CAD were enrolled prospectively. Within 48 hours of CABG using left internal mammary artery (IMA) to left anterior descending (LAD) coronary artery with or without right IMA to non-LAD vessel in an open chest approach, DESs were implanted systematically in an additional vessel after a clopidogrel 300-mg preloading dose. This group was compared with 18 matched patients who underwent standard CABG alone using left IMA to LAD and at least one additional graft. RESULTS: Baseline clinical characteristics were similar in both groups. There were 46 grafts in the CABG group and 28 in the hybrid group. In the hybrid group, 27.8% of patients were treated off-pump versus none in the CABG group; a median of 2 (interquartile range: 1-2) stents was implanted per patient. The hybrid procedure was associated with shorter durations of cardiopulmonary bypass (77 [67-100] min versus 97 [90-105] min, P=0.049). Major bleeding rates were higher in the CABG group, but the difference was not statistically significant (44.4% versus 11.1%, P=0.06). Re-intervention for bleeding was not needed in either group. One (5.6%) myocardial infarction occurred in hospital in each group following CABG. At 1 year, the cumulative rates of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) were similar (11.2% in hybrid group versus 5.6% in CABG group, P=0.99). One death occurred in the CABG group and one target vessel revascularization in the hybrid group. CONCLUSION: A hybrid revascularization strategy, combining conventional CABG with exclusive arterial conduits followed by early DES implantation, is feasible. One-year event rates compare favourably to those with traditional CABG alone.

High incidence of recurrent in stent thrombosis after successful treatment of a first in stent thrombosis.

OBJECTIVES: We attempted to investigate incidence and predictors of recurrent in stent thrombosis (IST) after successful treatment of a first IST. BACKGROUND: The occurrence of recurrent IST after successful treatment of a first IST may be a decisive factor for patient clinical outcome. However, incidence and predictors of recurrent IST are currently poorly described in the literature. METHODS: Between 2003 and 2005, 2,190 patients underwent a percutaneous coronary intervention in our center. During a median follow-up of 19.4 months, 49 patients (2.24%) presented a first definite IST. Patients presenting with a first IST were followed during an additional median period of 40 months. Their baseline characteristics were listed and cardiovascular events especially recurrent IST as defined by the Academic Research Consortium definition were systematically indexed. RESULTS: Altogether 39 (80%) patients were successfully treated with an effective reperfusion after percutaneous coronary intervention. Fourteen (36%) patients presented a recurrent IST and three presented multiple recurrent IST. The median occurrence time of recurrent IST was 5 days, range between 1 and 11 days. Multivariate analysis identified history of neoplasia (HR = 11.53, 95% CI 2.32-57.37, P = 0.003), residual diameter stenosis (HR = 1.15, 95% CI 1.02-1.29, P = 0.02), and residual dissection after treatment (HR = 8.78, 95% CI 1.85-41.62, P = 0.006), as independent predictors of recurrent IST. CONCLUSION: Recurrent IST is a frequent and early event after successful treatment of a first IST. Our results suggest that mechanical factors like residual dissection and residual diameter stenosis should be carefully tracked down. In addition, patients with multiple recurrent IST and the early time course of recurrent IST also suggest a potential role of inadequate antiplatelet therapy.

Acute coronary syndromes associated with thrombus in the sinus of valsalva and normal coronary arteriography: the pivotal role of transesophageal echocardiography in the intensive care unit.

We describe 4 patients with thrombus in nonaneurysmal sinus of Valsalva. The diagnosis was made with transesophageal echocardiography performed in the Intensive care unit, in the setting of acute coronary syndromes. Coronary arterlography showed normal coronary arteries in each patient. In 3 patients, conservative medical therapy resulted in full recovery. Two patients had previously undergone aortic valve surgery.

[Percutaneous coronary intervention in diabetic patients]. / La revascularisation myocardique du diabétique par angioplastie.

Diabetic patients represent one-quarter of all patients undergoing percutaneous coronary intervention (PCI). However, ten years ago a clinical alert recommended coronary artery bypass graft surgery for diabetic patients with multivessel disease. Diabetes is a risk factor for death, myocardial infarction and restenosis. The indications of PCI were re-evaluated after the advent of stenting and anti-GPIIbIIa drugs. In high-risk surgical populations such as those with acute coronary syndromes or prior Coronary Artery by pass Graft surgery-(CABG), PCI is a valuable alternative, even with bare metal stents. Stents eluting sirolimus or paclitaxel reduced the restenosis rate by about 80%, without modifying the risk of death or myocardial infarction. The first results of the EVASTENT study, a real-life study involving French patients treated with sirolimus-eluting stents, confirmed the increased rate of stent thrombosis in diabetic patients (2.5% vs 0.9%, p < 0.001). Drug eluting stent (DES) and abciximab give excellent results after PCI in diabetic patients with single-vessel disease. PCI is also promising for patients with multivessel disease but requires further evaluation in randomized trials. Secondary prevention is of paramount importance.