A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study.

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.

Ultrasound-Guided Intermediate Cervical Plexus Block for Transcarotid Transcatheter Aortic Valve Replacement.

OBJECTIVE: To report the authors' initial experience of transcarotid transcatheter aortic valve replacement (TAVR) managed with ultrasound-guided intermediate cervical plexus block. DESIGN: A single-center prospective study. SETTING: A teaching hospital in Paris, France. PARTICIPANTS: All consecutive patients undergoing a transcarotid TAVR were included. INTERVENTIONS: The ultrasound-guided intermediate cervical plexus block was performed in 28 of 31 patients. In 3 patients, the procedure was scheduled under general anesthesia: 2 because of failure of previous transfemoral procedures under local anesthesia, and 1 for an emergency procedure in a pulmonary edema context. MEASUREMENTS AND MAIN RESULTS: Anesthesia and all perioperative parameters were recorded, as well as any complications after the procedure. Twenty-eight patients were managed with intermediate cervical plexus block and light sedation without any anesthesia-related complication. No conversion to general anesthesia was required. The use of vasopressor was only required in 11% of the patients. In 2 patients, a loss of consciousness after the common carotid artery cross-clamping test occurred, leading to the use of a temporary femoral-carotid shunt; no other change in consciousness was recorded during the procedure. CONCLUSIONS: Ultrasound-guided intermediate cervical plexus block appeared to be an alternative anesthetic technique for carotid TAVR, providing adequate surgical conditions, continuous neurologic monitoring, and arterial pressure stability.

Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography.

BACKGROUND: The pathomechanisms underlying very late stent thrombosis (VLST) after implantation of drug-eluting stents (DES) are incompletely understood. Using optical coherence tomography, we investigated potential causes of this adverse event. METHODS AND RESULTS: Between August 2010 and December 2014, 64 patients were investigated at the time point of VLST as part of an international optical coherence tomography registry. Optical coherence tomography pullbacks were performed after restoration of flow and analyzed at 0.4 mm. A total of 38 early- and 20 newer-generation drug-eluting stents were suitable for analysis. VLST occurred at a median of 4.7 years (interquartile range, 3.1-7.5 years). An underlying putative cause by optical coherence tomography was identified in 98% of cases. The most frequent findings were strut malapposition (34.5%), neoatherosclerosis (27.6%), uncovered struts (12.1%), and stent underexpansion (6.9%). Uncovered and malapposed struts were more frequent in thrombosed compared with nonthrombosed regions (ratio of percentages, 8.26; 95% confidence interval, 6.82-10.04; P<0.001 and 13.03; 95% confidence interval, 10.13-16.93; P<0.001, respectively). The maximal length of malapposed or uncovered struts (3.40 mm; 95% confidence interval, 2.55-4.25; versus 1.29 mm; 95% confidence interval, 0.81-1.77; P<0.001), but not the maximal or average axial malapposition distance, was greater in thrombosed compared with nonthrombosed segments. The associations of both uncovered and malapposed struts with thrombus were consistent among early- and newer-generation drug-eluting stents. CONCLUSIONS: The leading associated findings in VLST patients in descending order were malapposition, neoatherosclerosis, uncovered struts, and stent underexpansion without differences between patients treated with early- and new-generation drug-eluting stents. The longitudinal extension of malapposed and uncovered stent was the most important correlate of thrombus formation in VLST.

Diagnostic performance of deep learning to exclude coronary stenosis on CT angiography in TAVI patients.

We evaluated the diagnostic performance of a deep-learning model (DLM) (CorEx®, Spimed-AI, Paris, France) designed to automatically detect > 50% coronary stenosis on coronary computed tomography angiography (CCTA) images. We studied inter-observer variability as an additional aim. CCTA images obtained before transcatheter aortic valve implantation (TAVI) were assessed by two radiologists and the DLM, and the results were compared to those of invasive coronary angiography (ICA) used as the reference standard. 165 consecutive patients underwent both CCTA and ICA as part of their TAVI work-up. We excluded the 42 (25.5%) patients with a history of stenting or bypass grafting and the 23 (13.9%) patients with low-quality images. We retrospectively subjected the CCTA images from the remaining 100 patients to evaluation by the DLM and compared the DLM and ICA results. All 25 patients with > 50% stenosis by ICA also had > 50% stenosis by DLM evaluation of CCTA: thus, the DLM had 100% sensitivity and 100% negative predictive value. False-positive DLM results were common, yielding a positive predictive value of only 39% (95% CI, 27-51%). Two radiologists with 3 and 25 years' experience, respectively, performed similarly to the DLM in evaluating the CCTA images; thus, accuracy did not differ significantly between each reader and the DLM (p = 0.625 and p = 0.375, respectively). The DLM had 100% negative predictive value for > 50% stenosis and performed similarly to experienced radiologists. This tool may hold promise for identifying the up to one-third of patients who do not require ICA before TAVI.

[Invasive and non-invasive imaging analysis for calcified coronary artery lesions]. / Imagerie invasive et non invasive des lésions coronaires calcifiées.

Coronary calcifications are frequently identified within coronary lesions as their incidence increases with age and cardiovascular risk factors. Their location can be superficial or deep, according to different pathological process. In all cases, the presence of calcifications within the vascular wall predicts poor clinical prognosis and unfavorable evolution after percutaneous revascularization. Coronary calcifications can be analyzed by angiography, CT or intracoronary imaging (IVUS or OCT) with variable accuracies. Angiography is the most frequently used method but is not very sensitive (sensitivity close to 50%) and insufficient for their precise quantification. The CT scan is a more effective non-invasive method leading to an accurate analysis of the lesion before coronary angiography. IVUS and OCT have an excellent spatial resolution and are the most sensitive methods for the identification (present in nearly 75-80% of lesions) and quantification of calcifications. These intracoronary imaging techniques offer interesting perspectives for identification of the highest-risk lesions, PCI procedures planning (including the choice of an optimal dedicated plaque preparation devices), the monitoring of their execution and the evaluation of the immediate post-stenting results.

Transcatheter Mitral Valve-In-Valve Implantation: An Option for Failed Bioprosthetic Mitral Valve Stenosis During Pregnancy.

A pregnant woman presented with symptomatic bioprosthetic mitral valve stenosis. We discuss the difficulties of decision making in this particular situation where two lives are at stake, the fetus's and the mother's, questioning whether transcatheter mitral valve-in-valve implantation can be an effective and safe option for this challenging condition. (Level of Difficulty: Advanced.).

Transcatheter Aortic Valve Replacement for Severe Aortic Regurgitation With Acute Refractory Cardiogenic Shock.

From January 2013 to January 2017, 686 consecutive patients were referred to our centre for transcatheter aortic valve replacement, including 5 subjects with severe aortic regurgitation and acute refractory cardiogenic shock. These patients were contraindicated for surgical treatment by the heart team because of high surgical risk (median logistic EuroSCORE: 74.6/Society of Thoracic Surgeons score: 37.9). The success rate of valve implantation was 100% through transfemoral access with self-expandable devices. The observed 30-day mortality rate was 20%. Hence, the transcatheter aortic valve replacement procedure might represent a successful and life-saving intervention for treatment of patients with severe aortic regurgitation who present with acute refractory cardiogenic shock.

Delayed Stenting for ST-Elevation Acute Myocardial Infarction in Daily Practice: A Single-Centre Experience.

BACKGROUND: The minimalist immediate mechanical intervention (MIMI) strategy aims to restore normal anterograde flow in the culprit artery (by using manual thrombectomy or small-sized balloon predilation) and to defer potential stent implantation. This study evaluated the applicability and midterm clinical results of the MIMI strategy for ST-elevation myocardial infarction (STEMI) management. METHODS: This observational study included consecutive patients admitted for ongoing STEMI (<24 hours' evolution) at 1 institution between June 2010 and June 2013. Revascularization was performed at the physician's discretion. We compared retrospectively "intentional immediate stenting" (standard technique) and "intentional delayed stenting" (MIMI technique). RESULTS: Twenty percent of the 279 included patients were treated with the MIMI strategy. These patients were significantly younger and were more frequently men and smokers compared with patients who underwent the standard procedure. The rate of acute reocclusion of the culprit artery related to STEMI in the MIMI group was 1.8%. Drug-eluting stents were used more frequently in the MIMI group (52% vs 27% in the standard group; P < 0.001). The culprit lesion was stented less frequently in the patients treated with MIMI compared with patients in the other group (28.5% vs 9%; P < 0.001). The 1-year actuarial survival free from major adverse cardiovascular events was higher in the MIMI group than in the standard group (96.3% ± 1.8% vs 83.8% ± 2.5%; P = 0.01). CONCLUSIONS: The MIMI strategy can be applied in selected patients with STEMI. In our centre, this strategy is associated with less systematic culprit lesion stenting and more implantation of drug-eluting stents. However, this needs to be evaluated further in a randomized trial.

Myocardial Fractional Flow Reserve Measurement Using Contrast Media as a First-Line Assessment of Coronary Lesions in Current Practice.

BACKGROUND: Fractional flow reserve (FFR) measurement requires adenosine injection. However, adenosine can induce conductive and rhythmic complications, or be contraindicated in some patients. Contrast-induced hyperemia could provide a simple first-line method (contrast-enhanced FFR; cFFR) to assess coronary lesions. In this study we evaluated the accuracy of cFFR to predict lesion significance. METHODS: This prospective study included 104 patients with 138 coronary lesions. Each stenosis was evaluated using resting distal coronary pressure to aortic pressure ratio (Pd/Pa) measurements using intracoronary iodixanol (cFFR) and adenosine (FFR) injection. An FFR value ≤ 0.8 defined a significant lesion. RESULTS: Dose-ranging analysis (n = 12 lesions) showed that 10 mL iodixanol was required to obtain the lowest cFFR value. Intermeasurement reproducibility of cFFR (n = 18 lesions) showed limited variability and small mean estimated bias (0.001 ± 0.014). Values of cFFR and FFR were highly correlated in a first series of n = 36 lesions (r = 0.9; P < 0.001). Receiver-operating characteristic curve analysis showed an excellent accuracy of cFFR cutoff value of ≤ 0.85 in predicting FFR value ≤ 0.80 (area under the curve, 0.94; 95% confidence interval, 0.90-0.98; sensitivity, 95%; specificity, 73%). This threshold was then tested prospectively in an independent cohort of n = 72 lesions. A cFFR value ≤ 0.85 correctly identified hemodynamically significant lesions with a sensitivity of 100%, specificity of 78%, positive predictive value of 78%, and negative predictive value of 100%. CONCLUSIONS: cFFR is reproducible and can be achieved with usual volumes of contrast. A cFFR threshold value of 0.85 provides excellent sensitivity and negative predictive value in coronary artery stenosis.

Feasibility limits of transradial primary percutaneous coronary intervention in acute myocardial infarction in the real life (TRAP-AMI).

BACKGROUND: There is growing evidence that transradial (TRI) as compared to transfemoral (TFI) percutaneous coronary intervention (PCI) is associated with improved clinical outcome driven by less hemorrhagic complications, in particular in STEMI patients receiving aggressive antithrombotic treatment. Feasibility rate of TRI in STEMI patients has not yet been evaluated. METHODS/RESULTS: Four-hundred seventy-five consecutive STEMI patients (<12h) without cardiogenic shock were prospectively screened for this all-comer single-centre registry between January 2008 and August 2010. Nine patients were excluded for a priori ineligibility for TRI (forearm shunt for dialysis, prior TRI failure). In the 466 patients enrolled, the operator's opinion about ease of radial puncture was assessed in 4 categories, based on radial pulse quality. Operators were advised not to attempt TRI if ease of puncture was judged "probably difficult/impossible". In case of puncture failure the operator switched immediately to TFI. The mean age of patients was 61 ± 14 (range 27-94) years. Seventy-three percent were men, 17% had diabetes. Nine percent had previous PCI. Glycoprotein inhibitors were used in 70%, and thrombectomy was performed in 70% of patients. PCI was performed using 6F and 5F guiding catheters. Procedural success rate was 98.2% (TIMI flow ≥ 2). In 4.1% (n=19) of patients the operator judged ease of radial puncture "probably difficult/impossible" and no TRI attempt was performed (primary TFI). In the 447 patients with TRI attempt, TRI failure requiring switch to TFI (secondary TFI) was necessary in 22 patients (4.7% of total) following radial puncture failure (n=15), dissection of the radial artery (n=1), prohibitive tortuosities or stenosis of the upper limb axis (n=2), or non-selective position or lack of stability of the guiding catheter (n=2). After the start of the angioplasty procedure, switch from TR to TF was not necessary in any patient. In total, the overall feasibility rate of TRI was 91.2%. Independent predictors of final TFI were age ≥ 80 years (adjusted OR: 2.37; 95% CI:1.05-5.34, p=0.037), body weight<60 kg (adjusted OR: 2.84; 95% CI:1.22-6.59, p=0.015); and previous PCI (adjusted OR: 3.42; 95% CI:1.40-8.37, p=0.007); female gender was borderline significant (adjusted OR:2.10; 95% CI:0.97-4.54, p=0.059). CONCLUSION: In STEMI patients without cardiogenic shock and without a priori indication for TFI, PCI can be performed via the radial artery in more than 90% of cases with high procedural success rate. Operator's judgement of eligibility for TRI based on radial pulse quality is predictive of successful TRI in 95% of cases. TR failure is significantly more common in the elderly and in patients with low body weight.