Unprotected left main coronary artery stenting Correlates of midterm survival and impact of patient selection

AbstractOBJECTIVESThe study served to present the in-hospital and six-month clinical outcome and also the long-term survival data of a consecutive series of patients undergoing stenting for unprotected left main coronary artery (LMCA) disease.BACKGROUNDRevascularization with coronary bypass surgery has been generally recommended for treatment of left main coronary stenosis. Improvements in angioplasty and coronary stent techniques and equipment may result in the wider applicability of a percutaneous approach.METHODSA total of 92 consecutive patients underwent unprotected LMCA stenting between March 1994 and December 1998. For the initial 39 patients (group I) angioplasty was performed only when surgical revascularization was contraindicated. The remaining 53 patients (group II) also included patients in whom surgery was feasible. Patients were followed for 7.3 ± 5.8 months (median 239 days; range 49 to 1,477 days).RESULTSCompared to group I, group II patients had higher left ventricular ejection fraction (60 ± 12% vs. 51 ± 16%, p < 0.01), less severe LMCA stenosis (68 ± 12% vs. 80 ± 10%, p < 0.001), lower surgical risk score (13 ± 7 vs. 20 ± 7, p < 0.001), and had angioplasty more often performed via the radial approach (88% vs. 23%, p < 0.001) with smaller guiding catheters (6F: 49% vs. 15%; 8F: 2% vs. 77%, p < 0.001). The procedural success rate was 100%. In-hospital mortality was 4% (4 deaths, 3 cardiac). During follow-up there were six deaths, 13 patients required repeat percutaneous transluminal coronary angioplasty (4 LMCA), and two required coronary artery bypass graft surgery. Estimated survival (±SEE) was 89 ± 6.3% at 500 days and 85 ± 12% at 1,000 days post-stenting. Overall mortality was 3.8% in group II and 20.5% in group I (p < 0.02).CONCLUSIONSCoronary stenting can be performed safely in high-risk individuals with acceptable intermediate-term outcome. It may be feasible to broaden the application of this technique in selected patients needing revascularization for left main coronary disease

TCT-613 A Prospective Randomized Multi-Center Trial to Assess the Everolimus-Eluting Stent System (Promus Element) for Coronary Revascularization in a Population of Unrestricted Patients

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Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

Abstract Objectives The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL). Background The clinical outcomes of IVL to opt..

901-21 Percutaneous Vascular Surgery: Suture Mediated Percutaneous Closure of Femoral Artery Access Site Following Coronary Intervention

A new device (prostarTm, Perclose, Inc.) was developed to close femoral artery access sites percutaneously following coronary interventions in fully anticoagulated patients. The catheter deploys four needles with two pairs of sutures around the hole of femoral artery access sites. The sutures are then tied to close the arteriotomy site mechanically to achieve immediate hemostasis. As a pilot phase, the device was tested in six centers. The device was used immediately following coronary intervention in 91 access sites. Despite an average ACT at the time of the procedure of &gt;300 seconds, immediate complete hemostasis was achieved in 82 sites (90%). The devices were not appropriately positioned in 8 cases and procedures were aborted followed by reinsertion of a sheath or manual compression. Two patients (2.2%) required surgical repair of the femoral artery; one with device mechanical failure and one with bleeding from the initial puncture site in the posterior wall despite successful closure of the sheath site in the front wall. There were no AV fistulae or pseudoaneurysms requiring surgery and no infection, distal embolism or need for blood transfusion.In conclusion, this pilot study suggests that this suture mediated closure device appears to provide safe and effective hemostasis at the femoral access site in fully anticoagulated patients following coronary interventions

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's repor

The Disrupt CAD II Study

BACKGROUND: The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions. METHODS: The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events. RESULTS: Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length. CONCLUSIONS: In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949