Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study).

BACKGROUND: Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. METHODS: A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. RESULTS: After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. CONCLUSION: In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy　- J2T Multicenter Registry.

BACKGROUND: Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.Methods and Results:This multi-center registry assessed the characteristics and outcomes of patients treated by RA for calcified coronary lesions between 2004 and 2015. Among 1,090 registered patients, mean age was 70±10 years and 815 (75%) were male. Sixty percent of patients had diabetes mellitus and 27.7% were receiving hemodialysis. The procedure was successful in 96.2%. In-hospital death occurred in 33 patients (3.0%), and 14 patients (1.3%) developed definite/probable stent thrombosis. During the median follow-up period of 3.8 years, the incidence of major adverse cardiac events (MACE), defined as all-cause death, acute coronary syndrome, stent thrombosis, target vessel revascularization and stroke, was 46.7%. On multivariable Cox hazard analysis, hemodialysis (HR, 2.08; 95% CI: 1.53-2.86; P<0.0001) and age (HR, 1.03; 95% CI: 1.01-1.04; P<0.0001) were strong independent predictors of MACE. Conversely, statin treatment was associated with lower incidence of MACE (P=0.035). CONCLUSIONS: This study has provided the largest Japanese dataset for long-term follow-up of RA. Although RA in calcified lesions appears feasible with a high rate of procedural success, a high incidence of MACE was observed.

Outcomes of Orbital Atherectomy for the Treatment of Severely Calcified Coronary Artery Lesions.

Background Orbital atherectomy (OA) is used to prepare severely calcified coronary artery lesions before percutaneous coronary intervention (PCI). Intravascular ultrasound (IVUS) is used to determine the plaque volume and degree of stenosis within the arterial vessel. This study evaluated the safety and efficacy of OA for treating severely calcified coronary lesions and determined if IVUS impacted these outcomes. Methods We retrospectively collected data from a single center of patients with severe coronary artery calcification who underwent OA. The data on baseline characteristics and procedural and clinical outcomes were collected and analyzed. Results A total of 374 patients underwent OA. The mean age was 69 ± 12.7; 53.6% were Black, and 38% were female. Hypertension was present in 96% of the patients, followed by hyperlipidemia in 79.4%, diabetes mellitus in 53.7%, and chronic kidney disease (CKD) in 22.7%. More patients had presented with a non-ST-elevation myocardial infarction (NSTEMI) compared to ST-elevation myocardial infarction (STEMI) at 36.3% versus 4.3%, respectively. The radial artery was used in 35.4% of the cases, and the left anterior descending artery (LAD) was the most commonly treated vessel with OA at 61%, followed by the right coronary artery (RCA) at 30.7%. IVUS was utilized in 63.4% of cases. The most common complication of the procedure was perforation and dissection at an equal proportion of 1.3% among all patients. The no-reflow rate was 0.5%, and 0.5% developed post-procedural myocardial infarction (MI). The average length of stay was 4.7 days, while a marginal proportion, at 10.5%, had same-day discharge with no recorded complications. Conclusion In this analysis of patients with severely calcified coronary lesions, OA had low rates of major adverse cardiovascular events (MACE) and was considered a safe and effective treatment for complex coronary lesions.

Coronary orbital atherectomy using a five-French guiding catheter.

Recently, the efficacy was demonstrated of the Diamondback 360® Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, MN, USA) for treating calcified coronary lesions in percutaneous coronary intervention (PCI). The safety and feasibility of OAS application through a 5-Fr guiding catheter (GC) which is less invasive and reduces access site complications were validated. This sequential, retrospective, observational study was conducted in a single center from September 2018 to May 2020. The primary endpoint was a successful PCI with the OAS. Secondary endpoints were major adverse complications related to PCI with the OAS, including coronary dissection, perforation, side branch loss, need for an unexpected cardiac assist device, access site complications, and major adverse cardiac and cerebrovascular events. 33 PCIs in 30 patients (mean age 72 ± 11 years; male, 83.3%) were surveyed. All PCIs were successfully completed with OAS application through a 5-Fr GC. Coronary perforation after the OAS procedure occurred in one case (3.0%). Severe coronary dissection occurred in three cases (9.1%), and procedural myocardial infarction in two cases (6.1%). Regarding PCIs performed with the 5-Fr GC, the OAS is a safe and feasible strategy for calcified plaque modification.

Successful Off-Label Use of Rotational Atherectomy in ST-Segment Elevation Myocardial Infarction: A Case Report.

Rotational atherectomy (RA) in ST-segment elevation myocardial infarction (STEMI) is uncommon and its use in a thrombotic lesion is labelled a contraindication by its manufacturer due to the concern for further increase in platelet activation and aggregation by the spinning burr or distal embolization of the thrombotic material promoting no-reflow (NR). However, thrombus burden varies significantly in the STEMI setting and can be classified according to the thrombolysis in myocardial infarction (TIMI) thrombus grade (TG). This case demonstrates the successful off-label use of RA-assisted primary percutaneous coronary intervention to facilitate treatment of a heavily calcified ostial right coronary artery lesion with low thrombotic burden (TIMI TG 0) in an octogenarian STEMI patient. Atherectomy drug cocktails, intracoronary vasodilators, short burr runs and avoidance of rotating the burr at slower than minimum approved rotational speed contribute to atherectomy success and decrease the chances of NR.

Clinical Outcomes of Biodegradable versus Durable Polymer Drug Eluting Stents in Rotational Atherectomy: Results from ROCK Registry.

BACKGROUND: The aim of this study was to compare the clinical outcomes of biodegradable polymer (BP) versus durable polymer (DP) drug eluting stents (DES) in patients with calcified coronary lesions who underwent rotational atherectomy (RA) and percutaneous coronary intervention (PCI). METHODS: This study was based on a multicenter registry which enrolled patients with calcified coronary artery disease who received PCI using RA during between January 2010 and October 2019 from 9 tertiary centers in Korea. The primary outcome was 3-year all-cause mortality, and the secondary outcomes were cardiovascular death and target-lesion failure. RESULTS: A total of 540 patients who underwent PCI using RA were enrolled with a follow-up period of median 16.1 months. From this registry, 272 patients with PCI using DP-DES and 238 patients with BP-SGDES were selected for analysis. PCI with BP-DES was associated with decreased all-cause mortality after propensity score matching (HR 0.414, CI 0.174-0.988) and multivariate Cox regression analysis (HR 0.458, HR 0.224-0.940). BP-DES was also associated with decreased cardiovascular mortality, but there was no difference in TLF between the two groups. CONCLUSIONS: BP-DES were associated with favorable outcomes compared to DP-DES in patients undergoing PCI using RA for calcified coronary lesions.

Shockwave intravascular lithotripsy in the treatment of under-expanded coronary stent: Case Series.

Under-expanded coronary stent related to inadequate preparation of calcified lesion is associated with poor clinical outcomes.Off-label use of S-IVL to correct this clinical issue is effective and safe, probably more than other current techniques. However, this statement needs further evidence.

Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents.

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer-generation drug-eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target-lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P=0.003) and stent thrombosis rates (2.1% versus 0.2%; P<0.0001), whereas target-lesion revascularization was not different between the groups (5.0% versus 3.9%; P=0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89-2.08; P=0.148) but did for target-vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03-2.68; P=0.037). TLF rates were similar between bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent (12.6% versus 15.4%, P=0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable-polymer sirolimus-eluting stent showed lower TLF (7.5% versus 10.3%, P=0.045). Conclusions With newer-generation drug-eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target-vessel myocardial infarction was higher. The bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Rotatripsy: synergistic effects of complementary technologies: a case report.

BACKGROUND: Percutaneous coronary intervention (PCI) to calcified coronary lesions (CCLs) remains one of the most complex procedures. Latest modality to modify calcium, intravascular lithotripsy (IVL), has shown good safety and efficacy in preliminary research. However, it may be associated with acute complications, and as standalone therapy, is not sufficient for all CCLs. CASE SUMMARY: Eighty-two-year-old man, known case of coronary artery disease and multiple comorbidities, presented with worsening angina of 1 month duration. Coronary angiography revealed heavily calcified triple vessel disease with critical distal left main (LM) involvement. Owing to high surgical risk, he was offered intravascular ultrasound (IVUS) guided PCI with intra-aortic balloon support. While the diffuse, circumferential calcified lesions in LM and left anterior descending (LAD) artery were modified with rotablation (RA) followed by IVL with 3.5 and 3.0 mm balloons; ostial-proximal lesion in left circumflex (LCX) artery was treated with 3.0 mm IVL balloon as a standalone therapy. During second cycle of shockwave therapy in LCX, the 3.0 mm IVL balloon ruptured with type C dissection extending upto LM ostium which required emergent LM bifurcation stenting. We had a good angiographic result which was confirmed with IVUS. DISCUSSION: ntravascular lithotripsy and RA are complementary technologies in treating CCLs. Rotablation with a relatively small-sized burr is safe and can favourably modify superficial calcium which helps in smooth delivery of IVL balloon and ensures safe shockwave therapy, if required. Unselected upfront use of IVL without intravascular imaging may be associated with complications as described in this case.

The "RotaTripsy Plus" Approach in a Heavily Calcified Coronary Stenosis.

Percutaneous treatment of heavily calcified coronary stenoses is one the most demanding setting, due to the high risk of acute and long-term complications. Various dedicated devices are currently available and their combined use can be an option in these high-risk procedures. We hereby report a successful case of several combined debulking technologies for the treatment of a long, highly calcified coronary lesion.

"Rota-Tripsy": A Successful Combined Approach for the Treatment of a Long and Heavily Calcified Coronary Lesion.

Heavily calcified coronary lesions remain a technical challenge and an important cause of stent under-expansion and then failure. We hereby present a successful case of combined rotational atherectomy and intravascular lithotripsy for the treatment of an un-dilatable, heavily calcified coronary stenosis.

Additional debulking efficacy of low-speed rotational atherectomy after high-speed rotational atherectomy for calcified coronary lesion.

We aimed to evaluate the additional debulking efficacy of low-speed rotational atherectomy (RA) after high-speed RA by using intravascular imaging. A total of 22 severe calcified coronary lesions in 19 patients (age, 74 ± 10 years; 74% male) were retrospectively analyzed. All of these lesions underwent RA under optical coherence tomography (OCT) or optical frequency domain imaging (OFDI) guidance. At first, we performed high-speed RA with 220,000 rpm until the reduction of rotational speed disappeared; then, low-speed RA with 120,000 rpm using the same burr size was performed. OCT or OFDI was performed after both high-speed and low-speed RAs, and the minimum lumen area were compared. The initial and final burr sizes of high-speed RA were 1.5 (1.5-1.75) and 1.75 (1.5-2.0) mm, respectively. The number of sessions, total duration time, and maximum decreased rotational speed during high-speed RA were 11 ± 5 times, 113 ± 47 s, and 4000 (3000-5000) rpm, respectively. During low-speed RA, the number of sessions, total duration time, and maximum reduction of rotational speed were 3 ± 1 times, 32 ± 11 s, and 1000 (0-2000) rpm, respectively. The minimum lumen area was similar between after high-speed and after low-speed RA [2.61 ± 1.03 mm2 (after high-speed RA) vs. 2.65 ± 1.00 mm2 (after low-speed RA); P = 0.91]. Additional low-speed RA immediately after sufficient debulking by high-speed RA was not associated with increased lumen enlargement. There was no clinical efficacy of low-speed RA after high-speed RA.

Rotablation of Heavily Calcified Left Main Stenosis and Aortic Valve Valvuloplasty Under ECMO Cardiopulmonary Support.

High-risk coronary intervention involving the left main coronary artery represents an indication for mechanical circulatory support in hemodynamically unstable patients. Extracorporeal membrane oxygenation permits adequate hemodynamic stabilization and myocardial recovery from life-threatening pulmonary and cardiac failure. Our case report demonstrates the importance of choosing the correct method of hemodynamic support in different case scenarios. (Level of Difficulty: Advanced.).

Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study).

BACKGROUND: Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy. METHODS: Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR). RESULTS: Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9-3.6) years. The mean age of the patients was 72.3 ±â€¯8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74-155.5; p = 0.01, HR, 9.01; 95% CI, 1.34-62.5; p = 0.02). CONCLUSIONS: PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.

Orbital Atherectomy: A Comprehensive Review.

Successful percutaneous coronary intervention (PCI) can be challenging in the presence of heavily calcified lesions. Severely calcified lesions are associated with worse clinical outcomes. Recognition of calcification is important before stenting to ensure adequate stent expansion can be attained. Orbital atherectomy is a safe and effective method to ablate calcified plaque. Lesion preparation through plaque modification with orbital atherectomy before stent implantation can help to optimize the results of PCI in these complex lesions.

Coronary artery stent dislodgement and aortic dissection in a patient with a severely calcified lesion in the proximal right coronary artery.

In atherosclerosis progression, calcium deposition may have an impact on the natural history of coronary atherosclerosis, and the amount of calcium may affect the success rate of percutaneous coronary intervention (PCI). Coronary stent dislodgement does not commonly occur in the modern PCI era; however, it may lead to fatal death. If it occurs, retrieval of a dislodged stent can be performed either surgically or percutaneously using a variety of retrieval techniques, including inflating a catheter balloon distal to the undeployed stent, twirling 2 wires around the stent, a loop snare, or forceps. Here, we report a rare case that coronary artery stent dislodgement and aortic dissection simultaneously occurred during PCI for a severely calcified lesion in the proximal right coronary artery with shepherd's crook morphology. The situation was successfully rectified by using balloons to deploy the stent, as well as by applying an additional stent and minimizing the contrast used to treat aortic dissection. Learning objective: During percutaneous coronary intervention (PCI), stent dislodgement and aortic dissection are extremely rare, but life-threatening complications. In this rare case of simultaneous stent dislodgement in the coronary artery and aortic dissection during PCI for a severely calcified lesion in the right coronary artery with shepherd's crook morphology, the situation was successfully rectified by using balloons to retrieve and deploy the stent, as well as by applying an additional stent and minimizing the contrast used to treat aortic dissection.

Two-year outcome after treatment of severely calcified lesions with newer-generation drug-eluting stents in acute coronary syndromes: A patient-level pooled analysis from TWENTE and DUTCH PEERS.

BACKGROUND: Data on medium-term outcome of patients with acute coronary syndrome (ACS), treated with newer-generation durable polymer drug-eluting stents (DES) in severely calcified coronary lesions, are scarce. We aimed to assess the impact of severe coronary lesion calcification on clinical outcome of patients with ACS, treated with newer-generation DES. METHODS: The TWENTE and DUTCH PEERS randomized trials comprise 1779 ACS patients, who were categorized into patients with versus without severe target lesion calcification. We performed a patient-level pooled analysis to assess 2-year outcome, including target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS: Patients with severe target lesion calcification (n=340, 19.1%) were older (66.8±10.6 years vs. 62.8±11.5 years, p<0.001) and had more often diabetes (22.1% vs. 16.8%, p=0.02) and hypercholesterolemia (51.5% vs. 42.9%, p=0.005) than other patients (n=1439, 79.9%). In addition they showed a higher TVF rate (12.4% vs.7.0%, p=0.001), mainly related to a difference in TVR (6.8% vs. 3.3%, p=0.003). There was a borderline significant between-group difference in cardiac death (3.6% vs. 1.8%, p=0.05), but not in target vessel MI (3.8% vs.2.6%, p=0.23) and definite stent thrombosis (0.9% vs. 0.6%, p=0.71). Multivariate analysis demonstrated that severe lesion calcification was an independent risk factor of TVF (adjusted HR; 1.58, 95% CI: 1.23-2.03; p<0.001). CONCLUSIONS: In patients with ACS, treatment of severely calcified lesions with newer-generation DES was associated with an overall higher clinical event risk - related in particular to a higher TVR rate, while the risk of MI was low.