The impact of novel scoring balloon and cutting balloon after orbital atherectomy on severely calcified coronary lesion as assessed by optical coherence tomography.

BACKGROUND: Debulking devices are often followed by a scoring or cutting balloon in percutaneous coronary intervention (PCI) for severely calcified lesions. However, there are limited data on balloon preparation after orbital atherectomy (OA) assessed using optical coherence tomography (OCT). AIM: We aimed to compare the effects of a novel scoring and cutting balloon on calcified coronary lesions with OCT. METHODS: We retrospectively examined 38 patients (38 lesions) who underwent PCI with a scoring or a cutting balloon after OA. All patients underwent pre-PCI, preballooning, postballooning, and post-PCI OCT imaging. We divided the patients into novel scoring-balloon (group A: n = 22) and cutting-balloon (group B: n = 16) groups and compared the OCT findings, including minimum lumen area (MLA) and expansion ratio (MLA divided by mean reference lumen area). RESULTS: The mean patient age was 76.1 ± 8.7 years; 71.5% were male. There were no significant differences in patient background between both groups. Regarding procedural characteristics, the maximum balloon pressure was significantly higher in group A (median 23 atm, interquartile range [IQR] 18-24 vs. 12 atm [IQR: 10-12], p < 0.01). Although a calcium score of 4 was more frequently observed in group A (86.4% vs. 62.5%, p = 0.12), post-PCI MLA was comparable between both groups (3.95 mm2 [IQR: 3.27-4.41] vs. 3.43 mm2 [IQR: 2.90-4.82], p = 0.63). Furthermore, the expansion ratio was significantly greater in group A (0.83 ± 0.20 vs. 0.68 ± 0.14, p < 0.01). CONCLUSION: Despite a higher calcium score, a larger expansion ratio was achieved in patients with a novel scoring balloon than in those with a cutting balloon after OA.

Contrast-enhanced excimer laser stepwise approach during PCI for resistant coronary lesions.

BACKGROUND: The treatment of resistant coronary lesions (RCL) is a great challenge for interventional cardiologists. The excimer laser coronary atherectomy (ELCA) is a plaque modification tool based on a main mechanism of photomechanical effect leading to mechanical disruption of the plaque. Contrast dye injection during laser delivery has demonstrated to enhance its power. AIM: To evaluate the effectiveness and safety of the contrast-enhanced ELCA by a stepwise approach in the treatment of RCLs. METHODS: We retrospectively examined consecutive patients undergoing contrast-enhanced ELCA-assisted PCI between 2018 and 2021 at two Italian sites. RCLs were defined as novo or in-stent undilatable/uncrossable with conventional balloons (SC/NC balloon). The primary endpoint was ELCA technical success defined as the laser catheter crossing the entire length of the target lesion established by angiographic evidence of the catheter tip in the artery distal to the stenosis. RESULTS: We enrolled 114 patients who underwent contrast-enhanced ELCA-assisted PCI: 58% of the patients had acute coronary syndrome while the left anterior descending artery was the target vessel in 42.1% of cases. The target lesion was most commonly in-stent (56.2%). The 0.9 mm ELCA catheter tip was employed in 89.5% of cases. The most used frequency/fluency profile was 70/70 (39.5%). The use of contrast-enhanced ELCA was associated with high technical, procedural, and clinical success rates (97.4%, 93.7%, and 90.1%, respectively). CONCLUSIONS: The contrast-enhanced ELCA seems to be a safe and effective treatment option for the management of both de novo and in-stent-resistant coronary lesions.

Contemporary Trends and Outcomes of Intravascular Lithotripsy in Percutaneous Coronary Intervention: Insights From BMC2.

BACKGROUND: With an aging population and an increase in the comorbidity burden of patients undergoing percutaneous coronary intervention (PCI), the management of coronary calcification for optimal PCI is critical in contemporary practice. OBJECTIVES: This study sought to examine the trends and outcomes of coronary intravascular lithotripsy (IVL), rotational/orbital atherectomy, or both among patients who underwent PCI in Michigan. METHODS: We included all PCIs between January 1, 2021, and June 30, 2022, performed at 48 Michigan hospitals. Outcomes included in-hospital major adverse cardiac events (MACEs) and procedural success. RESULTS: IVL was used in 1,090 patients (2.57%), atherectomy was used in 1,743 (4.10%) patients, and both were used in 240 patients (0.57% of all PCIs). IVL use increased from 0.04% of PCI cases in January 2021 to 4.28% of cases in June 2022, ultimately exceeding the rate of atherectomy use. The rate of MACEs (4.3% vs 5.4%; P = 0.23) and procedural success (89.4% vs 89.1%; P = 0.88) were similar among patients treated with IVL compared with atherectomy, respectively. Only 15.6% of patients treated with IVL in contemporary practice were similar to the population enrolled in the pivotal IVL trials. Among such patients (n = 169), the rate of MACEs (0.0%) and procedural success (94.7%) were similar to the outcomes reported in the pivotal IVL trials. CONCLUSIONS: Since its introduction in February 2021, coronary IVL use has steadily increased, exceeding atherectomy use in Michigan by February 2022. Contemporary use of IVL and atherectomy is generally associated with high rates of procedural success and low rates of complications.

Current applications, procedural and 1-year outcomes of Rotatripsy for the treatment of calcified coronary lesions.

BACKGROUND: Intravascular lithotripsy (IVL) combined with rotational atherectomy (RA), known as Rotatripsy, is used to treat severe coronary artery calcification (CAC), though data on efficacy, midterm safety and use sequence is limited. We aimed to identify indicators for Rotatripsy use and to assess its safety and success rates, both acutely and at 1-year follow-up. METHODS: Patients undergoing Rotatripsy for severe CAC across six centers from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success [composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised Rotatripsy-related complications and MACE at 1-year follow-up. RESULTS: A total of 114 patients (75 ± 9 years, 78% male) underwent Rotatripsy for 120 lesions. In the majority of procedures RA was followed by IVL, mostly electively (n = 68, 57%) but also for balloon underexpansion (n = 37, 31%) and stent crossing failure (n = 1, 1%). Diverse and complex target lesions were addressed with an average SYNTAX score of 24.6 ± 13.0. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications included two (2%) coronary perforations, one (1%) coronary dissection and one (1%) burr entrapment. At 1-year follow-up(present in 77(67%) patients), MACE occurred in 7(9%) cases. CONCLUSIONS: Over a 1-year follow-up period, Rotatripsy was safe and effective, predominantly using RA electively before IVL.

Comparison of intravascular lithotripsy versus rotational atherectomy for the treatment of severe coronary artery calcification.

BACKGROUND: Calcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve. METHODS: We evaluated the baseline clinical, procedures characteristics and outcomes of patients with severe coronary artery calcification (CAC) who underwent coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA). RESULTS: Respectively 152 and 238 patients who underwent IVL and RA are enrolled from January 2023 to November 2023. Regarding demographic characteristics, the gender proportion, medical history of PCI and smoke history among groups reach statistical significance. Left anterior descending and right coronary artery were the main vessels treated in both groups. The 2.5 and 3.0 mm IVL balloons and 1.5 mm burr were the most commonly used. 99.3% cases were successfully implanted drug-eluting stents after IVL balloon pre-treatment, which was higher than in the group treated with RA. During hospitalization, there were no serious adverse events in the IVL group, but there were two adverse events in the RA group. Procedural complications were higher in the RA group than the IVL group (5.5% vs. 0.7%, P = 0.027). CONCLUSIONS: IVL appears to be safe and effective for the treatment of severe CAC lesions compared to RA.

An analysis of long-term clinical outcome following the use of excimer laser coronary atherectomy in a large UK PCI center.

BACKGROUND: Excimer laser atherectomy (ELCA) is an established adjunctive technique to facilitate acute success in percutaneous coronary intervention (PCI). Despite this there are a lack of contemporary outcome data, particulary longer-term, forpatients treated with ELCA PCI. AIMS: To evaluate the contemporary use ofELCA in PCI, the frequency of periprocedural complications and the longer-term outcomes associated with ELCA PCI. METHODS: This was a retrospective study that included all patients undergoing PCI (with or without ELCA) between April 2005 and May 2021. Relevant features from all cases were downloaded from the patient record and matched to hospital data on mortality on November 22, 2022. Kaplan Meier curves were used to compare mortality between the ELCA PCI and non-ELCA PCI cohorts with a landmark at 1 year. Multivariable Cox regression was performed to assess whether ELCA PCI was independently associated with long-term mortality. RESULT: There were 21,256 patients in this analysis, of which 448 (2.1%) were treated with ELCA PCI. ELCA PCI was associated with a higher frequency of any periprocedural complication. Median follow-up was 2812 days (IQR, 1577-4245 days) with higher mortality in ELCA PCI (38.2% vs. 29.0%, p < 0.001). However, on multivariable analysis, ELCA PCI was not independently associated with long-term mortality. The TVR frequency in ELCA PCI was 16.7% but TVR was significantly higher for cases of in-stent restenosis (ISR) (29.5%). CONCLUSION: Despite ELCA PCI being used in higher risk populations with complex coronary artery disease there was no long-term increased mortality associated with the use of this device. ELCA PCI for ISR is highly effective and safe although TVR in this cohort remains high in long-term follow-up.

Establishment and validation of a heart failure risk prediction model for elderly patients after coronary rotational atherectomy based on machine learning.

Objective: To develop and validate a heart failure risk prediction model for elderly patients after coronary rotational atherectomy based on machine learning methods. Methods: A retrospective cohort study was conducted to select 303 elderly patients with severe coronary calcification as the study subjects. According to the occurrence of postoperative heart failure, the study subjects were divided into the heart failure group (n = 53) and the non-heart failure group (n = 250). Retrospective collection of clinical data from the study subjects during hospitalization. After processing the missing values in the original data and addressing sample imbalance using Adaptive Synthetic Sampling (ADASYN) method, the final dataset consists of 502 samples: 250 negative samples (i.e., patients not suffering from heart failure) and 252 positive samples (i.e., patients with heart failure). According to a 7:3 ratio, the datasets of 502 patients were randomly divided into a training set (n = 351) and a validation set (n = 151). On the training set, logistic regression (LR), extreme gradient boosting (XGBoost), support vector machine (SVM), and lightweight gradient boosting machine (LightGBM) algorithms were used to construct heart failure risk prediction models; Evaluate model performance on the validation set by calculating the area under the receiver operating characteristic curve (ROC) curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, F1-score, and prediction accuracy. Result: A total of 17.49% of 303 patients occured postoperative heart failure. The AUC of LR, XGBoost, SVM, and LightGBM models in the training set were 0.872, 1.000, 0.699, and 1.000, respectively. After 10 fold cross validation, the AUC was 0.863, 0.972, 0.696, and 0.963 in the training set, respectively. Among them, XGBoost had the highest AUC and better predictive performance, while SVM models had the worst performance. The XGBoost model also showed good predictive performance in the validation set (AUC = 0.972, 95% CI [0.951-0.994]). The Shapley additive explanation (SHAP) method suggested that the six characteristic variables of blood cholesterol, serum creatinine, fasting blood glucose, age, triglyceride and NT-proBNP were important positive factors for the occurrence of heart failure, and LVEF was important negative factors for the occurrence of heart failure. Conclusion: The seven characteristic variables of blood cholesterol, blood creatinine, fasting blood glucose, NT-proBNP, age, triglyceride and LVEF are all important factors affecting the occurrence of heart failure. The prediction model of heart failure risk for elderly patients after CRA based on the XGBoost algorithm is superior to SVM, LightGBM and the traditional LR model. This model could be used to assist clinical decision-making and improve the adverse outcomes of patients after CRA.

Combined Rotational excimer lASER coronary atherectomy (RASER) in non-crossable, non-dilatable coronary artery disease: observations from a single center.

BACKGROUND: Balloon non-crossable stenoses represent a challenging subset of coronary artery disease (CAD). They are clinically associated with patients who are older, frailer, and with multi-morbidities, and angiographically with increased tortuosity and coronary artery calcification. Combined rotational (RA) excimer laser coronary atherectomy (ELCA), or RASER, may facilitate stent delivery and deployment in non-crossable, non-dilatable severely calcified lesions. In this study, we assessed preliminary safety and efficacy of the RASER hybrid technique. METHODS: RASER feasible percutaneous coronary intervention (PCI) procedures performed at a large tertiary hospital in the northeast of England were retrospectively analyzed from September 1, 2008, to February 28, 2022. Major endpoints were in-hospital death from any cause, as well as procedural and angiographic success, defined by stent delivery with less than 50% residual stenosis and without clinical or angiographic complications, respectively. RESULTS: From 74 unique cases, there were 28 RASER, 24 ELCA/RA, 16 balloon angioplasty ± stenting, and 6 medically treated patients. In-hospital mortality rate was 5.2%, including 1 ELCA- and 3 RASER-treated patients. Successful stent delivery was achieved in significantly more RASER-treated patients compared to ELCA/RA- or balloon-treated patients: 96.4% (27/28), 25% (6/24), and 31.3% (5/16) respectively (P less than .001). CONCLUSIONS: In our retrospective, single-center study, patients with CAD who were deemed appropriate for RASER PCI had a high peri-procedural mortality rate. In this context, adjunctive RASER therapy provides acceptable safety and efficacy as a bailout strategy, with at least 3 out of 5 patients achieving satisfactory procedural and angiographic results. Randomized controlled trials are needed to comprehensively compare the clinical outcomes of high-risk RASER PCI vs conservative medical therapy.

ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial.

BACKGROUND: The percutaneous treatment of calcified coronary lesions remains challenging and is associated with worse clinical outcomes. In addition, coronary artery calcification is associated with more frequent peri-procedural myocardial infarction. STUDY DESIGN AND OBJECTIVES: The ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions (SONAR) study is an investigator-initiated, prospective, randomized, international, multicenter, open label trial (NCT05208749) comparing a lesion preparation strategy with either shockwave intravascular lithotripsy (IVL) or rotational atherectomy (RA) before drug-eluting stent implantation in 170 patients with moderate to severe calcified coronary lesions. The primary endpoint is difference in the rate of peri-procedural myocardial infarction. Key secondary endpoints include rate of peri-procedural microvascular dysfunction, peri-procedural myocardial injury, descriptive study of IMR measurements in calcified lesions, technical and procedural success, interaction between OCT calcium score and primary endpoint, 30-day and 1-year major adverse clinical events. CONCLUSIONS: The SONAR trial is the first randomized controlled trial comparing the incidence of peri-procedural myocardial infarction between 2 contemporary calcium modification strategies (Shockwave IVL and RA) in patients with calcified coronary artery lesions. Furthermore, for the first time, the incidence of peri-procedural microvascular dysfunction after Shockwave IVL and RA will be evaluated and compared.

Orbital atherectomy safety and efficacy: A comparative analysis of ostial versus non-ostial calcified coronary lesions.

BACKGROUND: The safety and efficacy of coronary orbital atherectomy (OA) for treatment of ostial lesions are not yet fully established. We sought to evaluate (OA) treatment of severely calcified ostial and non-ostial lesions. METHODS: A retrospective analysis of subjects treated with OA for severely calcified ostial and non-ostial lesions, at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) from January 2014 to September 2020, was completed. Study baseline characteristics, lesion and vessel characteristics, procedural outcomes, and in-hospital major adverse cardiovascular events (MACE) were analyzed and compared. RESULTS: A total of 609 patients that underwent PCI with OA were identified. The majority of patients (81.9 %) had non-ostial lesions, while 16.6 % had ostial lesions (of which 2.8 % classified as aorto-ostial) and 1.5 % had unknown lesion anatomy. The mean age of the overall cohort was 74.0 ± 9.3 years, and 63.5 % were male. All patients received drug-eluting stent (DES) placement, and the overall freedom from MACE was 98.5 %, with no significant difference observed between the ostial and non-ostial groups. The freedom from cardiac death and MI was also similar between the two groups. There were low rates of bleeding complications and severe angiographic complications, and no persistent slow flow/no reflow was reported. CONCLUSIONS: This study demonstrated no significant differences in in-hospital MACE outcomes between patients with ostial versus non-ostial lesions, indicating that OA is a safe and effective treatment option for both lesion types, including those classified as aorto-ostial.

Halftime rotational atherectomy: a unique concept for diffuse long severely calcified lesions.

Rotational atherectomy (RA) is technically more difficult in a diffuse calcified lesion than in a focal calcified lesion. We hypothesized that taking a halftime can be another option for RA to the diffuse calcified lesions. Halftime was defined as at least one long break during RA, in which an operator pulled out the Rotablator system from the guide catheter before crossing the lesion. This study aimed to compare the complications between RA with and without halftime. We included 177 diffuse long severely calcified lesions (lesion lengths ≥ 30 mm) that required RA, and divided those lesions into a halftime group (n = 29) and a no-halftime group (n = 148). The primary outcome was periprocedural myocardial infarction (MI). The reference diameter was smaller in the halftime group than in the no-halftime group [1.82 (1.70-2.06) mm versus 2.17 (1.89-2.59) mm, p = 0.002]. The total run time was longer in the halftime group than in the non-halftime group [133.0 (102.0-223.0) seconds versus 71.5 (42.0-108.0) seconds, p < 0.001]. Although creatinine kinase (CK) and CK-myocardial band (MB) was significantly higher in the halftime group than in the no-halftime group [CK: 156 (97-308) U/L versus 99 (59-216) U/L, p = 0.021; CK-MB: 15 (8-24) U/L versus 5 (3-15) U/L, p < 0.001], periprocedural MI was not observed in the halftime group. In conclusion, periprocedural MI was not observed in RA with halftime. This preliminary study suggests that halftime RA may be a safe option for diffuse severely calcified lesions.

JETWING technique: Combination therapy of JETSTREAMⓇ and aggressive wire recanalization in calcified atheroma and dilatation technique for eccentric heavy calcified plaques using WINGMAN for insertion of protection wire.

Although endovascular treatment (EVT) has developed and still progressing, calcified lesions remain a big challenge to operators in obtaining good results. Whenever, the eccentric and calcified plaques or nodules are present, balloon dilatation may be difficult and vascular complications may frequently occur. We present a 73-year-old woman, with severe, eccentric, calcified lesion in the right superficial femoral artery (SFA). First, we performed the aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA) technique for the eccentric plaques. Then, we used a WingmanⓇ crossing catheter (ReFlow Medical, Inc.) to penetrate and pass through the calcifications and eventually exchanged to a ParachuteⓇ (Good Care, Inc.) filter wire. Finally, we performed rotational atherectomy using the JETSTREAMⓇ (Boston Scientific) rotational atherectomy device for debulking to obtain good lesion expansion and was able to avoid potential complications. Performing ARCADIA technique then using a Wingman catheter for inserting a filter wire before JETSTREAMⓇ atherectomy is safe and effective for heavily calcified, eccentric lesions. Further studies will be needed to validate the safety and efficacy of this approach.

Impact of atherothrombotic risk stratification in patients with heavily calcified lesions following rotational atherectomy.

BACKGROUND: Patients who undergo percutaneous coronary intervention (PCI) with rotational atherectomy (RA) are at high risk of adverse clinical outcomes, and there are few clinical risk stratification tools for these patients. METHODS: We conducted a study with 196 patients who underwent PCI with RA out of 7391 patients who underwent PCI using a multicenter, prospective cohort registry. Patients were divided into three groups according to the tertiles of the Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS 2°P): 65 patients in the T1 group (TRS 2°P < 3), 66 patients in the T2 group (TRS 2°P = 3), and 65 patients in the T3 group (TRS 2°P > 3). The primary endpoint was the cumulative 2-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiac death, acute coronary syndrome, and ischemic stroke. RESULTS: Cumulative 2-year MACCE occurred in 41 patients (24 %) during the follow-up period. The cumulative incidence of MACCE was significantly higher in the T3 group than in the T1 group (log-rank test, p = 0.02). Multivariate Cox analyses revealed that the T3 group was associated with an increased risk of MACCE compared to that of the T1 group (adjusted hazard ratio, 2.66; 95 % confidence interval, 1.04-6.77; p = 0.04). The addition of TRS 2°P to conventional risk factors, including male sex, number of diseased vessels, and low-density lipoprotein cholesterol levels, improved the net reclassification improvement (NRI) and integrated discrimination improvement (IDI) (NRI 0.39, p = 0.027; IDI 0.072, p < 0.001). CONCLUSIONS: Atherothrombotic risk stratification using TRS 2°P was useful in identifying high-risk patients with heavily calcified lesions following RA.