Nurse-led sedation for transfemoral transcatheter aortic valve implantation seems safe for a selected patient population.

Transcatheter aortic valve implantation (TAVI) has become a high-volume procedure with increasing demands on hospital resources. Local anaesthesia with sedation supervised by an anaesthesiology team is the current standard of care. We aimed to describe our experience with a simplified, nurse-led sedation (NLS) protocol. This study enrolled 128 consecutive patients who underwent transfemoral TAVI with self-expandable Evolut R prosthesis between November 2019 and April 2021. Operators selected 50% of patients for NLS based on the clinical expectation of lower risk of procedural difficulties. Nurse-led sedation protocol demanded only mild to moderate levels of sedation. The clinical outcomes were determined from the local TAVI registry and the national mortality database. Baseline patient characteristics were similar in the NLS (n = 64) and anaesthesiologist-led sedation (ALS) (n = 64) groups except higher prevalence of diabetes mellitus (48.4% vs. 31.3%, P = 0.035) and peripheral vascular disease (20.3% vs. 7.8%, P = 0.036) in the ALS group. There was a trend for the larger prostheses used in the ALS group (P = 0.058). The procedural results did not differ, and coronary care team backup was rarely needed in the NLS group (6% of patients). The in-hospital outcomes were identical from both clinical and echocardiography perspectives, and 30-day mortality was low in both groups (1.5%). For the NLS group, preparation in the catheterization laboratory was quicker by 6.4 min (P = 0.01), and intensive care unit stay was shorter (2.03 vs. 3.48 days, P = 0.001). In conclusion, the NLS for the selected transfemoral TAVI population seems safe.

Optical coherence tomography-guided primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients: a pilot study.

BACKGROUND: The objective of our study was to assess whether optical coherence tomography (OCT) guidance could guide intervention to avoid balloon angioplasty and stenting during primary percutaneous coronary intervention. METHODS: One hundred patients with ST-segment elevation myocardial infarction and thrombus-containing lesion were enrolled in this study. Thrombus aspiration was performed in all cases followed by an OCT study. After thrombectomy, no stent was implanted in residual significant stenosis (> 50%) if examination using OCT suggested that the occlusion was mostly thrombotic, provided that the patient was symptom-free and the Thrombolysis in Myocardial Infarction (TIMI) flow was ≥ 2. All patients managed only using thrombectomy underwent 1-week and 9-month angiography and OCT. Patients with significant lesion or those in whom thrombectomy failed to re-establish flow underwent standard treatment. RESULTS: Based on the OCT information, 20 patients (20%) were treated only with aspiration even in the presence of angiographically detected "high-grade stenosis." Angiogram and OCT performed at 1 week and 9 months showed a "normal vessel" without significant stenosis in all 20 cases. There were no cases of major adverse cardiovascular event (including death, myocardial infarction, and target lesion revascularization) during the in-hospital period or at the 12-month follow-up. CONCLUSIONS: The results of our pilot study suggest that ST segment elevation myocardial infarction patients with TIMI 2/3 flow in the angiogram and without significant coronary narrowing using OCT examination (even in the presence of angiographically detected "high-grade stenosis"), in whom thrombus aspiration is performed in addition to optimal medical therapy might benefit only from thrombus aspiration without plain old balloon angioplasty/stenting during primary percutaneous coronary intervention. Validation of these preliminary data in larger randomized studies is warranted.

Randomized comparison of endothelial progenitor cells capture stent versus cobalt-chromium stent for treatment of ST-elevation myocardial infarction. Six-month clinical, angiographic, and IVUS follow-up.

PURPOSE: The aim of this trial was to assess the feasibility and safety of endothelial progenitor cells capture (EPC) stent in the treatment of acute ST-elevation myocardial infarction (STEMI) when compared with cobalt-chromium stents (CoCr). METHODS: Between July 2006 and May 2008, 100 patients with single vessel disease undergoing primary PCI for STEMI were randomly assigned to receive either EPC stent (N = 50) or CoCr stent (N = 50). High-pressure stent implantation was carried out in both groups. Dual antiplatelet treatment was administered for 30 days in both groups. All patients underwent 6-month clinical, angiographic, and IVUS follow-up. RESULTS: The rate of major adverse cardiovascular events (MACEs) at 30 days was comparable in both groups. At 6-month follow-up, the rates of MACEs and TLR in the EPC stent group when compared with CoCr stent were 24% vs.10%; P = 0.06 and 14% vs. 4%; P = 0.08, respectively. There were three cases (6%) of stent thrombosis (ST) in the EPC stent group versus none in CoCr group. CONCLUSION: The use of EPC capture stents in the setting of STEMI is feasible and safe in terms of 30-days outcome. However, at the 6-month follow-up, we found a trend of higher rates of MACE and TLR in the EPC stent capture group compared to CoCr stents. The study does not support the use of EPC capture stents with short duration dual antiplatelet therapy in patients with STEMI. Future randomized studies with large sample sizes would be necessary to demonstrate the safety of such approach. © 2010 Wiley-Liss, Inc.

Long-term health outcome and mortality evaluation after invasive coronary treatment using drug eluting stents with or without the IVUS guidance. Randomized control trial. HOME DES IVUS.

OBJECTIVE: To assess the role of the intravascular ultrasound (IVUS) during implantation of drug-eluting stents (DES) on long-term outcome in patients with complex coronary artery disease and high clinical risk profile with special attention to the development of late stent thrombosis (LST). METHODS: Two hundred and ten patients were randomly assigned to receive DES either with (N = 105) or without (N = 105) the IVUS guidance. Dual antiplatelet treatment was administered for 6 months in all patients. At 18-month follow-up, the rates of major adverse cardiac events (MACEs) (death, myocardial infarction, and reintervention) were assessed in both groups with special attention to possible LST. Stent thrombosis was classified according to Academic Research Consortium (ARC). RESULTS: At the 18-month follow-up, there was no significant difference between both groups regarding MACE (11% vs. 12%; P = NS). Stent thrombosis has occurred in four patients (3.8%) in the group with and in 6 patients (5.7%; P = NS) in the group without the IVUS guidance. CONCLUSIONS: In our randomized trial we failed to demonstrate the superiority of the IVUS guidance during DES implantation over standard high-pressure postdilatation. However we confirmed worrisome results concerning DES thrombosis after discontinuation of dual antiplatelet-treatment with documented stent thrombosis related events in almost 5% of patients with 50% of mortality in this high-risk clinical scenario.

Treatment of bifurcation lesions using dedicated bifurcation stents versus classic bare-metal stents. Randomized, controlled trial with 12-month angiographic follow up.

BACKGROUND: The aim of this study was to compare the use of classic bare- metal stents with dedicated bifurcation bare-metal stents in patients who were not eligible for drug-eluting stents (DES) implantation. METHODS: Sixty patients with bifurcation stenosis were randomly assigned to received either a dedicated bifurcation or a bare-metal stent (n = 30) or classic bare-metal stent (n = 30) with stenting of the parent vessel and angioplasty/or provisional stenting of the side branch. Fifty-nine patients underwent 12-month clinical and angiographic follow up unless this was performed earlier due to symptoms. Dual antiplatelet treatment was administered for 1 month. Acute success as well as the long-term clinical and angiographic outcome have been assessed in both groups. RESULTS: Baseline demographic, angiographic and procedure-related characteristics were well balanced in both groups. The use of dedicated stents was associated either with reduced procedure or fluoroscopy time (34 +/- 9 minutes vs. 46 +/- 20 minutes; p = 0.004 and 9 +/- 6 minutes vs. 15 +/- 9 minutes; p = 0.003, respectively) and lesser contrast volume (168 +/- 86 milliliters vs. 199 +/- 103 ml; p = 0.02). At the 12-month follow up, no statistically significant difference was found between both groups regarding major adverse cardiovascular events (MACE) (13.7 vs. 13.3%; p = 0.9). CONCLUSIONS: In our study we failed to demonstrate the superiority of a dedicated stent versus classic a bare-metal stent for the treatment of bifurcation lesions regarding MACE in patients who were not eligible for DES implantation. However, the use of dedicated stents may be preferable due to reduced procedure and fluoroscopy time and lesser contrast volume.

The lack of endothelization after drug-eluting stent implantation as a cause of fatal late stent thrombosis.

The authors present a fatal case of late thrombosis of paclitaxel-eluting stent implanted in the left main stem occurring 6 months after the procedure and 3 weeks after the cessation of clopidogrel. An autopsy has shown the lack of endothelization of deployed stent.

"Head-to-head comparison between sirolimus-eluting and paclitaxel-eluting stents in patients with complex coronary artery disease: an intravascular ultrasound study".

BACKGROUND: The aim of this study was to assess neointimal hyperplasia following sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) implantation in a patients with complex coronary disease. METHOD: Between January to December 2004, 70 patients were enrolled in this study (SES = 37; PES = 33. The primary objective was to assess the efficacy of SES and PES on neointimal proliferation inhibition in patients with complex coronary lesions by volumetric 3D intravascular ultrasound (IVUS) assessment at six-month follow-up. RESULTS: Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. All procedures as well as hospitalisation were uneventful. The percentage of B2/C lesions in our study was > 90% in both groups. The IVUS-assessed in-stent mean neointimal hyperplasia volume was significantly lower in lesions treated with SES compared to PES (4.1 +/- 11 mm3 vs. 17.4 +/- 23 mm3, p < 0.002) at 6 month follow-up. No difference in both MACE (3.0 versus 6.0%, p = NS) and restenosis (5.4 versus 9.1%, p = NS) were found. The in-segment late loss at six month was 0.26 mm in the SES and 0.48 mm in the PES group (p = NS). CONCLUSIONS: The present study showed reduced neointimal proliferation after sirolimuseluting as compared to paclitaxel-eluting stents in patients with complex coronary artery disease. Both SES and PES were associated with low rate of angiographic restenosis or major adverse cardiovascular events.