Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons.

OBJECTIVES: Despite the introduction of improved drug eluting stents (DES), the rate of repeat revascularization procedures following percutaneous coronary interventions (PCI) in coronary chronic total occlusions (CTO) remains high. By leaving vessels uncaged and limiting length of stented segments, drug-coated balloons (DCB) represent an appealing alternative to DES for CTO-PCI. Since data supporting the use of DCBs in CTO-PCI is scarce, we compared the outcomes of patients undergoing CTO-PCI involving DCBs vs DES only. METHODS: From 2 prospective registries, outcomes of patients undergoing CTO-PCI involving DCBs and those undergoing PCI with DES only were compared. Outcomes included major adverse cardiac and cerebrovascular events (MACCE) and cardiovascular death (CV-death). RESULTS: Overall, 157 patients were studied; 112 (71%) underwent CTO-PCI involving DCBs and 45 (29%) were treated with DES only. Mean J-CTO score was 1.84 ± 0.7. Most CTO-lesions involved the right coronary artery, 88 (56%), and 26 (17%) cases were in-stent occlusions. In the DCB group, 46 (41%) lesions were treated with DCBs alone. Mean lengths of the stented segments in the DCB vs DES cohorts were 59 ± 28 mm vs 87 ± 37 mm (P less than .001), respectively. After 12 months, the MACCE rate was higher in the DES only vs DCB group (26% vs 11%, P=.03). Length of the stented segment was an independent predictor for MACCE (HR 1.15 [95% CI, 1.05-1.26] per 10-mm stent length). CONCLUSIONS: Revascularization of CTO lesions involving DCBs appears safe and potentially lowers MACCE rates compared to treatment with DES alone. Importantly, using DCBs for CTO treatment may reduce total stent length, which determines PCI outcomes.

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

Background: There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions. Methods: Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated. Results: From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed. Conclusions: Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry.

BACKGROUND: Calcified lesions often lead to difficulty achieving optimal stent expansion. OPN non-compliant (NC) is a twin layer balloon with high rated burst pressure that may modify calcium effectively. METHODS: Retrospective, multicenter registry in patients undergoing optical coherence tomography (OCT) guided intervention with OPN NC. Superficial calcification with > 180o arc and > 0.5 mm thickness, and/or nodular calcification with > 90o arc were included. OCT was performed in all cases before and after OPN NC, and after intervention. Primary efficacy endpoints were frequency of expansion (EXP) ≥80 % of the mean reference lumen area and mean final EXP by OCT, and secondary endpoints were calcium fractures (CF), and EXP ≥90 %. RESULTS: 50 cases were included; 25 (50 %) superficial, and 25 (50 %) nodular. Calcium score of 4 in 42 (84 %) cases and 3 in 8 (16 %). OPN NC was used alone, or after other devices if further modification was needed, NC in 27 (54 %), cutting in 29 (58 %), scoring in 1 (2 %), IVL in 2 (4 %); or if non-crossable lesion, rotablation in 5 (10 %) cases. EXP ≥80 % was achieved in 40 (80 %) cases with mean final EXP post intervention of 85.7 % ± 8.9. CF were documented in 49 (98 %) cases; multiple in 37 (74 %). There were 1 flow limiting dissection requiring stent deployment and 3 non-cardiovascular related deaths in 6 months follow-up. No records of perforation, no-reflow or other major adverse events. CONCLUSION: Among patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications.

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon.

BACKGROUND: Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions. METHODS: Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization. RESULTS: From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a "DCB only" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed. CONCLUSIONS: In complex coronary lesions, a "DCB only" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

Etiology and device therapy in complete atrioventricular block in pediatric and young adult population: Contemporary review and new perspectives.

Complete atrioventricular block (CAVB) is a total dissociation between the atrial and ventricular activity, in the absence of atrioventricular conduction. Several diseases may result in CAVB in the pediatric and young-adult population. Permanent right ventricular (RV) pacing is required in permanent CAVB, when the cause is neither transient nor reversible. Continuous RV apical pacing has been associated with unfavorable outcomes in several studies due to the associated ventricular dyssynchrony. This study aims to summarize the current literature regarding CAVB in the pediatric and young adult population and to explore future treatment perspectives.