Compliant vs noncompliant balloon catheters

Compliant vs noncompliant balloon catheters

Compliant balloon will increase in diameter as the pressure in the indeflator increases, as the name implies. They are made of polyurethane or silicone and can be inflated up to several times the nominal size. Compliant balloon is used when there is a need for the expanded balloon to fully conform to the vessel lumen or occlude it.

On the other hand, noncompliant balloons are high pressure balloons made of polyester or nylon. They can exert high pressure to expand up to a specific diameter, but not significantly beyond that. They can be used to crack calcified lesions and expand stents.

Then there is the concept of semi-compliant balloons, which are typically used for predilatation of lesions prior to stent implantation. While the increase in diameter of a noncompliant balloon is only up to 110% of the nominal size, increase in diameter of semi-compliant balloon can be up to about 130% of the nominal size. This is in sharp contrast to the maximum diameter of a compliant balloon which can increase even 800%!

An early study evaluated over thousand PTCA procedures using noncompliant balloons made of polyethylene terephthalate, semi-compliant balloons made of polyethylene and compliant balloons made of polyolefin copolymer. In that study, acute occlusion, myocardial infarction, emergency bypass surgery and death were low and unaffected by balloon material [1].

A study of 104 patients in 2020 compared predilatation using noncompliant balloon at high pressure with conventional semi-compliant balloons. Predilatation pressure was higher in the noncompliant group with mean of 24 atmospheres vs mean of 14 atmospheres in case of semi-compliant balloons. Need for post dilatation and post dilatation pressures were similar in both groups. Similar pressures with mean of 23 atmospheres were used for postdilatation with noncompliant balloons in both groups [2].

The authors of the study concluded that in simple coronary lesions, predilatation and postdilatation with noncompliant balloons at high pressures appeared to result in better scaffold and stent expansion. They noted that using only semi-compliant balloon for predilatation might lead to inadequate stent expansion and post dilatation with noncompliant balloon might only partially correct this. They also mentioned that predilatation and postdilatation using noncompliant balloons at high pressure is safe [2].

The concept of semi-compliant balloons is not redistricted to coronary angioplasty. It applies to endovascular procedures in general, including transcatheter aortic valve implantation. In that scenario, one study found that balloon compliance did not affect procedural mortality, device success or rate of paravalvular leakage. But they found lower rates of post dilatation and conversion to open surgery with semi-compliant balloons compared to noncompliant balloons [3].

References

1. Bach RG, Kern MJ, Aguirre FV, Donohue TJ, Bell C, Penick D. Effects of percutaneous transluminal coronary angioplasty balloon compliance on angiographic and clinical outcomes. Am J Cardiol. 1993 Oct 15;72(12):904-7. doi: 10.1016/0002-9149(93)91104-p. PMID: 8213547.
2. Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. PMID: 32076567; PMCID: PMC6999685.
3. Mach M, Szalkiewicz P, Poschner T, Hasan W, Andreas M, Winkler B, Hasimbegovic E, Steinkellner T, Strouhal A, Adlbrecht C, Delle-Karth G, Grabenwöger M. The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY). Eur J Clin Invest. 2021 Sep;51(9):e13570. doi: 10.1111/eci.13570. Epub 2021 May 6. PMID: 33954997; PMCID: PMC8459263.