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  • Editorial: Super High-Pressure Balloons: Where Do They Fit in the Calcium Toolbox?

    Advanced age and an increasing frequency of diabetes mellitus, systemic hypertension and chronic kidney disease contribute to an increasing prevalence and severity of vascular calcification  . Calcified plaque negatively impacts clinical and angiographic outcomes following percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation by inhibiting stent delivery, disrupting polymer and drug delivery/distribution and by causing stent malapposition and under-expansion  . Stent under-expansion is a significant predictor of restenosis and thrombosis  . Indeed, the presence of severe lesion calcification is a significant independent predictor of all-cause mortality, target lesion revascularization, myocardial infarction and stent thrombosis through 10-year follow-up after PCI and this hazard is not mitigated by new generation DES  . Multiple technologies including high pressure, noncompliant, modified (cutting or scoring) balloons, atheroablative technologies (laser, rotational [RA] or orbital atherectomy [OA]) and more recently, intravascular lithotripsy (IVL) have been developed to modify calcified plaque, facilitate PCI success, optimize stent implantation and improve clinical outcomes. Atheroablative technologies have been limited by wire bias in effect as well as procedural complications including complex dissection, slow-flow/no-reflow and vessel perforation  . Further, high pressure balloon dilation of severely calcified plaque results in asymmetric force distribution disproportionately directed toward the non-calcified vessel wall with the consequent risk of dissection and/or rupture. Historically, there has been need for super high-pressure balloons to facilitate and optimize coronary stent implantation. In this context, the 0PN super-high pressure rapid exchange, twin layered non-compliant (NC) balloon (SIS Medical, Switzerland) was developed. This balloon has a hypo-tube shaft, inflated balloon diameters of 1.5 to 4.5 mm, lengths of 10, 15 or 20 mm and a rated burst pressure (RBP) of 35 atm. In the current Journal, Senguttuvan et al., describe their single Center “real world” experience with this balloon in 71 patients (133 target lesions) undergoing PCI of calcified coronary stenoses  . The authors conclude that the 0PN balloon is “safe and effective in treating calcified coronary lesions” and they provide specific algorithms for OPN use during either lesion pre- or post-dilation in the process of stent implantation. Both the conclusions and recommendations must be viewed from the following perspectives: 1. The analysis is post-hoc, retrospective without a prospectively defined algorithm for OPN use. Although consent was obtained retrospectively and those patients “who did not provide consent were excluded”, the number and clinical or angiographic profiles of excluded patients are not presented, and selection bias remains possible 2. The definition of severe calcification was site determined angiographically without independent core lab adjudication 3. The decision to use OPN was at operator discretion with 29 % of patients having pre-dilation only, 63 % post-dilation only and 8 % both pre- and post-dilation. Thus, the rationale for OPN use as well as subsequent angiographic and clinical outcomes are confounded by the arbitrary decision for OPN use as well as the frequent inclusion of RA, NC or cutting balloons and IVL to a variable degree 4. The primary endpoint of procedural success includes “>90% stent expansion” by visual angiographic determination without intravascular imaging adjudication. “Stent expansion” cannot be measured using this technique 5. The study is underpowered from which to draw any conclusions regarding OPN safety or efficacy. Indeed, in context of 3 complex dissections requiring additional stents, 3 coronary perforations, 1 longitudinal stent deformation related to OPN crossing and failure of OPN delivery with subsequent stent thrombosis complicating an under-expanded stent observed among only 71 patients, conclusions regarding safety and effectiveness are limited 6. Finally, and most importantly, the authors describe a novel OPN failure mode distinct from balloon rupture (which occurred uneventfully in 3 patients); hypo-tube rupture at a site proximal to the wire exit port which occurred at >35 atm (RBP) pressures. Hypo-tube rupture was observed in 4 cases and was complicated by difficulty in balloon deflation. This potentially serious complication requires better characterization.

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