Clinical outcomes following predilation with a novel 1.25‐mm diameter angioplasty catheter

Kandzari, David E.; Zankar, Ahmad; Teirstein, Paul S.; Brilakis, Emmanouil S.; Banerjee, Subhash; Price, Matthew J.; Stinis, Curtiss T.; Hudson, Paul A.; Dahle, Thom G.; Eng, Marvin H.; Brown, Ryan Andrew; Ferguson, Andrew; Addo, Tayo; Popma, Jeffrey J.

doi:10.1002/ccd.22734

Cited by 7 publications

(17 citation statements)

References 11 publications

(13 reference statements)

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“…Four studies were conducted in Germany [21-24], two in Italy [25,26], and one each in Israel [27], Taiwan [28], the US [29] and Japan [30]. One study was performed in Italy and the UK [31].…”

Section: Resultsmentioning

confidence: 99%

“…A single-arm prospective cohort study design was used in three studies [21,28,29] and one study was a three-arm prospective cohort in design [24]. Three studies were retrospective cases series [31], one was a single-arm retrospective cohort [30], one a three-arm retrospective cohort [26] and one a case–control study [27].…”

Section: Resultsmentioning

confidence: 99%

“…Three studies were retrospective cases series [31], one was a single-arm retrospective cohort [30], one a three-arm retrospective cohort [26] and one a case–control study [27]. Four studies were multi-centred [21-23,29]. The two- or three-armed studies assessed the comparative effectiveness of PTCA catheters with comparable devices or procedures.…”

Section: Resultsmentioning

confidence: 99%

“…Patients with coronary total obstruction lesions were selected in another two studies [22,26], and patients with stable or unstable angina were included in two studies [23,25]. Two studies encompassed patients with single- or multi-vessel CAD [24,29], and the morbidities of a patient population undergoing PCI was not available in one study [27]. Sample sizes ranged from 21 [28] to 996 [24].…”

Section: Resultsmentioning

confidence: 99%

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Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review

et al. 2013

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BackgroundPost-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published.MethodsWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature.ResultsThis review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting.ConclusionsOur systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review

et al. 2013

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“…Initially, we advance a low-profile balloon (1.25 mm [3] or 1.5 mm in diameter) as far as possible into the lesion and inflate it at high pressure (>20 atm). This often ''cracks'' the proximal cap and allows successful crossing with the same or occasionally a new low-profile balloon.…”

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confidence: 99%

Crossing the “balloon uncrossable” chronic total occlusion: Tornus to the rescue

Brilakis

Banerjee

2011

Cathet Cardio Intervent

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The retrograde approach to coronary artery chronic total occlusions

Brilakis

Grantham

Thompson

et al. 2012

Cathet Cardio Intervent

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129

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Clinical outcomes following predilation with a novel 1.25‐mm diameter angioplasty catheter

Abstract: Percutaneous coronary revascularization involving a predilation strategy with a low profile, 1.25-mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective initial treatment for complex coronary anatomy.

Cited by 7 publications

References 11 publications

Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review

Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review

Crossing the “balloon uncrossable” chronic total occlusion: Tornus to the rescue

The retrograde approach to coronary artery chronic total occlusions

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