Complications and Failure Modes of Polymer-Jacketed Guidewires; Insights From the MAUDE Database.

BACKGROUND: The modes of failure of coronary polymer-jacketed guidewires have received limited study. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports. RESULTS: The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection). CONCLUSIONS: The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires.

Outcomes With Drug-Coated Balloons vs. Drug-Eluting Stents in Small-Vessel Coronary Artery Disease.

BACKGROUND: The use of drug-coated balloons (DCBs) in small-vessel coronary artery disease (SVD) remains controversial. METHODS: We performed a meta-analysis of all randomized controlled trials (RCTs) reporting the outcomes of DCB vs. DES in de-novo SVD. We included a total of 5 RCTs (1459 patients), with (DCB n = 734 and DES n = 725). RESULTS: Over a median follow-up duration of 6 months, DCB was associated with smaller late lumen loss (LLL) compared with DES (mean difference -0.12 mm) (95% confidence intervals (CI) [-0.21, -0.03 mm], p = 0.01). Over a median follow-up of 12 months, both modalities had similar risk of major adverse cardiovascular events (MACE) (8.7% vs. 10.2%; odds ratio (OR): 0.94, 95% CI [0.49-1.79], p = 084), all-cause mortality (1.17% vs. 2.38%; OR: 0.53, 95% CI [0.16-1.75], p = 0.30), target lesion revascularization (TLR) (7.9% vs. 3.9%; OR: 1.26, 95% CI [0.51-3.14], p = 0.62), and target vessel revascularization (TVR) (8.2% vs. 7.8%; OR: 1.06, 95% CI [0.40-2.82], p = 0.91). DCBs were associated with lower risk of myocardial infarction (MI) compared with DES (1.55% vs. 3.31%; OR: 0.48, 95% CI [0.23-1.00], p = 0.05, I2 = 0%). CONCLUSION: PCI of SVD with DCBs is associated with smaller LLL, lower risk of MI, and similar risk of MACE, death, TLR, and TVR compared with DES over one year. DCB appears as an attractive alternative to DES in patients with de-novo SVD, but long-term clinical data are still needed.

Outcomes with Orbital and Rotational Atherectomy for Inpatient Percutaneous Coronary Intervention.

INTRODUCTION: Our objective was to describe the contemporary outcomes of orbital atherectomy (OA) vs. rotational atherectomy (RA) use for inpatient percutaneous coronary intervention (PCI) in the United States. Data on the use of OA vs. RA in contemporary inpatient PCI are limited. METHODS: We queried the Nationwide Readmission Database (NRD) from January to November for the years 2016-2017 to identify hospitalizations of patients who underwent PCI with atherectomy. We conducted a multivariate regression analysis to identify variables associated with in-hospital mortality. RESULTS: We included 77,040 records of patients who underwent inpatient PCI with atherectomy. Of those, 71,610 (93%) had RA, and 5430 (7%) had OA. There was no significant change in the trend of using OA or RA over 2016 and 2017. OA was less utilized in patients presenting with ST-segment elevation myocardial infarction (STEMI) (4.3% vs. 46.8%, p < 0.001). In our cohort, OA was associated with lower in-hospital mortality (3.1% vs. 5%, p < 0.001) and 30-day urgent readmission (< 0.01% vs. 0.2%, p = 0.009), but a higher risk of coronary perforation (1.7% vs. 0.6%, p < 0.001) and cardiac tamponade (1% vs. 0.3%, p < 0.001) and a higher cost of index hospitalization ($28,199 vs. $23,188, p < 0.001) compared with RA. CONCLUSION: RA remains the predominant atherectomy modality for inpatient PCI in the United States (93%). There was no change in the trend of use for either modality over the years 2016 and 2017. OA was noted to have a lower incidence of in-hospital death, but a higher risk of coronary perforation and a higher cost of index hospitalization for the overall unmatched cohorts.

Outcomes with Drug-Coated Balloons in Percutaneous Coronary Intervention in Diabetic Patients.

BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study. METHODS: We performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL). RESULTS: Three studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ±â€¯11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: -0.13 mm, 95% CI [-0.41, 0.14], p = 0.34) compared with DES. CONCLUSION: In diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.

Evaluation of YouTube as a reliable source for patient education on aortic valve stenosis.

BACKGROUND: Aortic stenosis (AS) is a prevalent disease in the elderly population and has been a public health concern for decades. YouTube is currently being used for obtaining healthcare related information. We evaluated the quality of information about AS on YouTube for patient education. METHODS: YouTube was queried for the search phrases "aortic valve stenosis", "aortic valve replacement", "transcatheter aortic valve replacement" and "TAVR". Videos were assessed for their reliability and content with two five-point scales. They were categorized into groups according to usefulness and uploader source. All videos were assessed for audience interaction. Videos were viewed and analyzed by 2 independent investigators. Conflicts were resolved by a third investigator. RESULTS: Search phrases yielded 69,300 videos, among which, 120 videos were evaluated and 85 videos were included in the final analysis. Of the 85 videos, only 45 videos (53%) were found to be useful while 40 videos (47%) were found to be non-useful. The majority (98%) of the useful videos were uploaded by professional sources. Overall, videos uploaded by non-professional sources had higher number of views (23,553 vs. 11,110, P≤0.001) despite of being less useful (14% vs. 67%, P<0.001) when compared to videos uploaded by professional sources. CONCLUSIONS: There is a potential to increase public awareness about aortic valve stenosis and the available treatment options by utilizing YouTube. Professional societies are encouraged to provide more useful material that can deliver comprehensive and reliable information in an entertaining and intuitive manner to the public.

Mesalamine-induced Myocarditis in a Young Athlete: Can He Run Again?

Mesalamine is often used in the treatment of inflammatory bowel disease (IBD). Mesalamine-induced cardiotoxicity has been reported in the literature and is a rare entity. The mechanism of cardiotoxicity remains unclear, however, it is believed to be due to a humoral-mediated hypersensitivity reaction. Patients with mesalamine-induced cardiotoxicity could present with a wide range of cardiovascular symptoms ranging from mild chest pain and shortness of breath (SOB) to cardiogenic shock secondary to left ventricular systolic dysfunction. Symptoms could be associated with elevation in cardiac biomarkers and electrocardiogram (EKG) changes including ST-segment or T-wave abnormalities. We report a case of mesalamine-induced myocarditis in a young athlete presenting with chest pain 10 days after mesalamine therapy was initiated for recently diagnosed Crohn's disease. Workup was significant for elevated cardiac biomarkers. The diagnosis was confirmed with cardiovascular magnetic resonance imaging (CMR). Immediate cessation of the medication resulted in resolution of symptomatology and normalization of cardiac biomarkers over a 48-hour period. Mesalamine-induced cardiotoxicity is a rare, yet serious side effect that necessitates medical community awareness. CMR is the confirmatory diagnostic modality of choice.