Dataset Information

Rotate-on-Retract Procedural Automation for Robotic-Assisted Percutaneous Coronary Intervention: First Clinical Experience.

ABSTRACT: The advent of percutaneous coronary intervention (PCI) has dramatically changed the outlook for patients with cardiovascular disease. However, room for improvement and advancement remains in the safety, speed, and efficiency of manually guided PCI. In recent years, the CorPath robotic platform (Corindus Inc., Waltham, MA) has been approved to aid the interventionalist during PCI and other endovascular interventions. Favorable results in several clinical studies suggest that robotic-assisted PCI may further improve patient outcomes while also benefiting the interventionalist through reduced orthopedic strain and less exposure to ionizing radiation. In this report, we communicate our experience with the first-in-human use of a new, optional automation feature that has been added to the platform's guidance software. This "Rotate-on-Retract" feature is designed to facilitate faster and more precise maneuvering of the guidewire through tortuous vessels by automatically rotating the guidewire whenever it is retracted by the operator. This movement changes the tip's orientation in preparation for the next advancement. We evaluated this feature in a patient undergoing PCI to treat a severe (90% stenotic), long, diffuse, and calcified lesion of the proximal to mid LAD segments.

SUBMITTER: Al Nooryani A

PROVIDER: S-EPMC6317112 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Rotate-on-Retract Procedural Automation for Robotic-Assisted Percutaneous Coronary Intervention: First Clinical Experience.

Al Nooryani Arif A Aboushokka Wael W

Case reports in cardiology 20181220

The advent of percutaneous coronary intervention (PCI) has dramatically changed the outlook for patients with cardiovascular disease. However, room for improvement and advancement remains in the safety, speed, and efficiency of manually guided PCI. In recent years, the CorPath robotic platform (Corindus Inc., Waltham, MA) has been approved to aid the interventionalist during PCI and other endovascular interventions. Favorable results in several clinical studies suggest that robotic-assisted PCI ...[more]

PMID: 30671266

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Project description:BackgroundTwenty percent to 40% of patients are affected by angina after percutaneous coronary intervention (PCI), which is associated with anxiety, depression, impaired physical function, and reduced quality of life. Understanding patient and procedural factors associated with post-PCI angina may inform alternative approaches to treatment.MethodsTwo hundred thirty patients undergoing PCI completed the Seattle Angina Questionnaire (SAQ-7) and European quality of life-5 dimension-5 level (EQ-5D-5L) questionnaires at baseline and 3 months post-PCI. Patients received blinded intracoronary physiology assessments before and after stenting. A post hoc analysis was performed to compare clinical and procedural characteristics among patients with and without post-PCI angina (defined by follow-up SAQ-angina frequency score <100).ResultsEighty-eight of 230 patients (38.3%) reported angina 3 months post-PCI and had a higher incidence of active smoking, atrial fibrillation, and history of previous myocardial infarction or PCI. Compared with patients with no angina at follow-up, they had lower baseline SAQ summary scores (69.48±24.12 versus 50.20±22.59, P<0.001) and EQ-5D-5L health index scores (0.84±0.15 versus 0.69±0.22, P<0.001). Pre-PCI fractional flow reserve (FFR) was lower among patients who had no post-PCI angina (0.56±0.15 versus 0.62±0.13, P=0.003). Percentage change in FFR after PCI had a moderate correlation with angina frequency score at follow-up (r=0.36, P<0.0001). Patients with post-PCI angina had less improvement in FFR (43.1±33.5% versus 67.0±50.7%, P<0.001). There were no between-group differences in post-PCI FFR, coronary flow reserve, or corrected index of microcirculatory resistance. Patients with post-PCI angina had lower SAQ-summary scores (64.01±22 versus 95.16±8.72, P≤0.001) and EQ-5D-5L index scores (0.69±0.26 versus 0.91±0.17, P≤0.001) at follow-up.ConclusionsLarger improvements in FFR following PCI were associated with less angina and better quality of life at follow-up. In patients with stable symptoms, intracoronary physiology assessment can inform expectations of angina relief and quality of life improvement after stenting and thereby help to determine the appropriateness of PCI.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT03259815.

Project description:Background Despite the clinical benefits to intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI), most patients with coronary artery disease undergo angiography-guided PCI alone in the real-world setting. We sought to investigate the procedural characteristics of IVUS-guided PCI and their clinical outcomes, as compared with angiography-guided PCI. Methods and Results This was a cohort study using patient-level data from the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) and ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All-Comers Coronary Lesions) clinical trials. A total of 2848 patients with 3872 native coronary lesions were included and procedural characteristics assessed by quantitative coronary angiography (QCA) were compared between IVUS and angiography guidance. Stent-to-reference vessel diameter ratio (ie, QCA stent sizing) was greater (1.11±0.16 versus 1.07±0.14, P<0.001) and high-pressure postdilation was more frequently performed (83.7% versus 75.4%, P<0.001) with IVUS guidance, whereas residual stent edge dissections were more frequent in lesions treated with IVUS guidance (4.6% versus 0.7%, P<0.001). Given the dissection risk, optimal QCA stent sizing for IVUS guidance was a stent-to-QCA reference vessel diameter ratio ≥1.1 to <1.3. Among 1424 patients (1969 lesions) treated with angiography guidance, QCA stent sizing <1.0 was observed in 651 (33.1%) lesions, while QCA stent sizing ≥1.1 to <1.3 was observed in only 526 (26.7%) lesions. Under angiography guidance, patients with both QCA stent sizing ≥1.1 to <1.3 and high-pressure postdilation (235 of 1424, 16.5%) had a lower risk of 3-year target lesion failure compared with others (hazard ratio, 0.532; 95% CI, 0.293-0.966 [P=0.038]). Conclusions IVUS-guided PCI resulted in larger QCA-assessed stent sizing and more frequent postdilation with high-pressure inflations. These procedures may further improve long-term clinical outcomes in patients undergoing PCI without IVUS. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01308281 (IVUS-XPL); NCT02215915 (ULTIMATE).

Dataset Information

Rotate-on-Retract Procedural Automation for Robotic-Assisted Percutaneous Coronary Intervention: First Clinical Experience.

Publications

Rotate-on-Retract Procedural Automation for Robotic-Assisted Percutaneous Coronary Intervention: First Clinical Experience.

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