Clinical outcomes of single- versus two-stent PCI technique in severely calcified true bifurcation lesions after rotational atherectomy.

BACKGROUND: Severely calcified coronary bifurcations complicate percutaneous coronary interventions (PCI) and often necessitate dedicated lesion preparation. We compared the outcomes of single- versus two-stent techniques for treating heavily calcified true bifurcation lesions following rotational atherectomy (RA). METHODS: Among patients receiving RA for severely calcified true bifurcations at a single center, 59 were treated with a single stent, and another 59 received two stents. We analyzed in-hospital adverse outcomes and 1-year rates of the bifurcation-oriented composite endpoint (BOCE), defined as cardiac death, target bifurcation myocardial infarction (TB-MI), or target bifurcation revascularization (TBR). RESULTS: The single-stent arm was associated with more in-hospital adverse outcomes (adj. OR, 6.13; 95% CI, 1.34-28.0; p = 0.019), driven by higher peri-procedural MI rates (18.6% vs. 5.1%, p = 0.043) and more side branch compromise (13.6% vs. 0%, p = 0.006). After 1 year, both techniques had comparable 1-year BOCE (adj. HR, 0.38; 95% CI, 0.12-1.23; p = 0.106). We observed a significant interaction between the treatment technique and the presence of LM bifurcation (p interaction = 0.012), favoring single-stent technique in patients with non-LM bifurcations (HR 0.14, 95% CI 0.03-0.68; p = 0.015). Notably, the single-stent technique had lower rates of TBR (2% vs. 15%, p log-rank = 0.026) after 1 year. CONCLUSION: Patients with severely calcified true bifurcation lesions, treated with RA followed by a single stent implantation, had more in-hospital adverse outcomes compared to those treated with two stents. However, the superior outcomes of the two-stent technique did not translate into improved long-term results. In fact, the two-stent technique was even associated with higher rates of revascularization after 1 year.

[Optical coherence tomography imaging for the evaluation and treatment of calcified coronary artery disease]. / Uso della tomografia a coerenza ottica nella valutazione e nel trattamento della malattia coronarica calcifica.

Coronary calcific disease represents one of the main challenges for the interventional cardiologist, for whom optimal lesion preparation and percutaneous coronary intervention optimization are paramount for correct management. In this perspective, intravascular imaging using optical coherence tomography (OCT) is becoming an increasingly indispensable tool. This work aims to provide a detailed overview of the complexity of calcified lesions, first analyzing their various morphologies and their clinical impact: spotty calcium seems to be more present in plaques at higher risk of destabilization, while diffuse calcification is typical of stable coronary stenosis; the eruptive calcific nodule is one of the three culprit lesion phenotypes responsible for acute coronary syndromes.In the second part of this review, the available technologies for the treatment of calcified lesions are described, with the aid of illustrative OCT images. Intravascular lithotripsy causes fractures at various levels of the calcified plaque, both circumferentially and longitudinally, with an improvement in vessel compliance; atherectomy acts by modifying the composition of the plaque with selective action on the hard calcific component. OCT, providing a comprehensive overview of lesion characteristics, can guide in the selection of the most appropriate therapeutic strategy, while also offering important information on the effectiveness of the chosen treatment.

Development and Validation of Artificial Intelligence-Based Algorithms for Predicting the Segments Debulked by Rotational Atherectomy Using Intravascular Ultrasound Images.

We develop and evaluate an artificial intelligence (AI)-based algorithm that uses pre-rotation atherectomy (RA) intravascular ultrasound (IVUS) images to automatically predict regions debulked by RA. A total of 2106 IVUS cross-sections from 60 patients with de novo severely calcified coronary lesions who underwent IVUS-guided RA were consecutively collected. The 2 identical IVUS images of pre- and post-RA were merged, and the orientations of the debulked segments identified in the merged images were marked on the outer circle of each IVUS image. The AI model was developed based on ResNet (deep residual learning for image recognition). The architecture connected 36 fully connected layers, each corresponding to 1 of the 36 orientations segmented every 10°, to a single feature extractor. In each cross-sectional analysis, our AI model achieved an average sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 81%, 72%, 46%, 90%, and 75%, respectively. In conclusion, the AI-based algorithm can use information from pre-RA IVUS images to accurately predict regions debulked by RA and will assist interventional cardiologists in determining the treatment strategies for severely calcified coronary lesions.

Impact of Periprocedural Myocardial Injury on Long-Term Outcomes After Percutaneous Coronary Intervention Requiring Atherectomy.

The prognostic implications of cardiac troponin elevation after percutaneous coronary intervention (PCI) with atherectomy have not been established. The aim of this study was to investigate the incidence of periprocedural myocardial injury (PMI) and its association with cardiovascular events in patients with severely calcified lesions who underwent PCI with atherectomy. The study analyzed 346 patients (377 lesions) who underwent PCI with atherectomy between January 2018 and December 2021. Peak post-PCI high-sensitivity cardiac troponin (hs-cTn) was measured. The primary outcome was target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target lesion revascularization. A lesion-based analysis was conducted to assess the association of PMI with TLF up to 5 years after PCI. Increase of hs-cTn was seen with 362 lesions (96%), and significant PMI, defined as hs-cTn increase ≥70 × upper reference limit, was seen with 83 lesions (22%). Significant PMI was associated with a significantly greater risk of TLF (adjusted hazard ratio 1.93, 95% confidence interval 1.12 to 3.30, p = 0.017), primarily driven by an increased risk of cardiovascular death (adjusted hazard ratio 5.29, 95% confidence interval 1.46 to 19.16, p = 0.011). In conclusion, hs-cTn increase was frequently observed in patients who underwent PCI with atherectomy, and significant PMI was associated with an increased risk of TLF and cardiovascular death.

Gender Differences in the Short and Long-Term Outcomes Following Rotational Atherectomy: A Meta-Analysis.

Rotational atherectomy (RA) is used to address complex calcified coronary lesions but data regarding the association between gender and outcomes of patients who underwent RA remain uncertain. We aimed to investigate the short- and long-term outcomes of patients who underwent RA based on gender. A systematic literature search was performed in PubMed, Embase, and Cochrane databases from its inception until August 2023 for relevant studies. Endpoints were pooled using the DerSimonian and Laird random-effects model as odd ratios (OR) with 95% confidence intervals (CIs). A total of 7 studies with 8,490 patients (2,565 women and 5,925 men) who underwent RA were included in the study. In terms of periprocedural outcomes, women had a higher risk of in-hospital mortality (OR 2.00, 95% CI 1.08 to 3.68, p = 0.03), coronary dissection (OR 1.80, 95% CI 1.05 to 3.10, p = 0.03), coronary perforation (OR 1.96, 95% CI 1.19 to 3.23, p = 0.01), and stroke (OR 4.22, 95% CI 1.06 to 16.82, p = 0.04) than men. There were no significant differences between women and men in terms of major adverse cardiovascular events (OR 1.43, 95% CI 0.69 to 2.94, p = 0.33), myocardial infarction (OR 1.35, 95% CI 0.87 to 2.08, p = 0.18), bleeding (OR 1.71, 95% CI 0.88 to 3.30, p = 0.11), and cardiac tamponade (OR 2.30, 95% CI 0.45 to 11.68, p = 0.32). Over a follow-up period of 3 years, the results of meta-analysis showed that women had a higher risk of all-cause mortality (OR 1.45, 95% CI 1.19 to 1.77, p <0.001), long-term major adverse cardiovascular events (OR 1.38, 95% CI 1.10 to 1.74, p = 0.01), and long-term stroke (OR 3.41, 95% CI 1.63 to 7.17, p <0.001). The risk of long-term myocardial infarction was found to be similar between both genders (OR 1.45, 95% CI 0.95 to 2.22, p = 0.09). In conclusion, female gender is associated with adverse periprocedural and long-term outcome after RA. Women consistently demonstrated higher risk of in-hospital mortality, coronary dissection, coronary perforation, and stroke in the periprocedural period. Long-term follow-up further highlighted a heightened risk for women in terms of all-cause mortality and stroke.

Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial.

BACKGROUND: In the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies. METHODS: PREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years. RESULTS: At 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60-2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08-0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04-0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98-42.6, p < 0.001). CONCLUSION: In patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov . Unique identifier: NCT02502851.

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.

Comparison of intravascular lithotripsy and rotational atherectomy for the treatment of heavily calcified coronary lesions: the STIFF ( S tenoses with calcificaTIon treated with angioplasty e FF ected with dedicated interventional tools) study.

BACKGROUND: Percutaneous coronary interventions in heavily calcified coronary lesions are associated with technical difficulties and the worse prognosis. Lesion preparation is important to reduce complications and improve outcomes. The aim of this study is to compare the results of rotational atherectomy (RA) and intravascular lithotripsy (IVL) at achieving optimal stent implantation using intravascular ultrasound criteria. METHODS: Retrospective, single-center study comparing patients with heavily calcified coronary lesions that underwent percutaneous coronary interventions using RA or IVL. RESULTS IN TOTAL: 25 patients (13 in the RA group and 12 in the IVL group) were included. Reference vessel diameter was similar between the groups [2.59 (2.51-3.63) mm in the RA group vs. 2.79 (2.59-3.16) mm in the IVL group; P = 0.89], as were minimal lumen area [1.02 (0.80-1.23) mm vs. 1.40 (1.01-1.40) mm; P = 0.43] and diameter stenosis [60.4% (52.3-72.3) vs. 56.1% (47.8-61.3); P = 0.56). The final minimal lumen area was significantly larger in the IVL group [7.6 mm 2 (5.8-8.6) vs. 5.4 mm 2 (4.5-6.2); P = 0.01] as were lumen area gain [4.1 mm 2 (2.6-5.9) vs. 2.3 mm 2 (1.4-3.6); P = 0.01] and final stent volume [491.2 mm 3 (372.2-729.8) vs. 326.2 mm 3 (257.1-435.4); P = 0.03]. In the RA group, 69.2% of the patients achieved the preestablished intravascular ultrasound-based criteria for successful stent implantation, vs. 100% of the patients in the IVL group ( P = 0.04). CONCLUSION: Patients in the IVL group achieved the Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation trial criteria of successful stent implantation more frequently than those treated with RA.

Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial.

BACKGROUND: Percutaneous coronary intervention (PCI) of calcified lesions remains challenging for interventionalists. AIMS: We aimed to investigate whether combining rotational atherectomy (RA) with cutting balloon angioplasty (RA+CBA) results in more optimal stent expansion compared with RA followed by non-compliant balloon angioplasty (RA+NCBA). METHODS: ROTA-CUT is a prospective, multicentre, randomised trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomised 1:1 to either RA+CBA or RA+NCBA. The primary endpoint was the minimum stent area on intravascular ultrasound (IVUS). Secondary endpoints included minimum lumen area and stent expansion assessed by IVUS and acute lumen gain, final residual diameter stenosis and minimum lumen diameter assessed by angiography. Clinical endpoints were obtained at 30 days. RESULTS: The mean age was 71.1±9.4 years, and 22% were women. The procedural details of RA were similar between groups, as were procedure duration and contrast use. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm2 vs 6.9±1.8 mm2; p=0.685). Furthermore, there were no significant differences regarding the other IVUS and angiographic endpoints. Procedural complications were rare, and 30-day clinical events included 2 myocardial infarctions and 1 target vessel revascularisation in the RA+CBA group and 1 myocardial infarction in the RA+NCBA group. CONCLUSIONS: Combining RA with CBA resulted in a similar minimum stent area compared with RA followed by NCBA in patients undergoing PCI of moderately or severely calcified lesions. RA followed by CBA was safe with rare procedural complications and few clinical adverse events at 30 days.

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.

Technical aspects of entrapped coronary guidewire retrieval using rotational atherectomy device: A case series.

BACKGROUND: This article highlights four unique cases where rotational atherectomy (RA Rotapro, Boston Scientific) was used to cut and retrieve an entrapped coronary guidewire with parts extending into the aorta We discuss the technique and step by step approach to the retrieval procedure. CASE SUMMARY: Three of four cases described a guide wire entrapment in the right coronary artery (RCA), and one in the left anterior descending artery via retrograde route. In all cases the guide wire was intact within the intracoronary segment. In Case 1, the guide wire (Runthrough; Terumo) was entrapped in an acute marginal branch during chronic total occlusion (CTO) percutaneous coronary intervention. In Case 2, a whisper wire (Abbott) was entrapped during re-wiring of the right posterolateral branch through stent struts, the traction on the wire caused severe malformation of distal and proximal stents requiring second staged procedure to complete revascularization of the RCA CTO. In Case 3, a Runthrough wire was entrapped between two layers of stents and fractured at the proximal point with filaments extending into descending aorta. And in Case 4, a Pilot 200 (Abbott) wire was entrapped retrograde in the subintimal space via saphenous vein graft connection by tying a knot at the distal tip of the wire. In all four cases RA was used to successfully cut and remove the entrapped guide wires. DISCUSSION: Rotablation technique appears to be a safe and effective strategy for the management of entrapped coronary guidewire when conventional strategies fail.

In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.

BACKGROUND: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI). METHODS: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed. RESULTS: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001). CONCLUSIONS: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality.

Subexpansión de stent tratado con balón de Shockwave / Use of a Shockwave balloon to treat insufficient stent expansion

La calcificación coronaria afecta negativamente los resultados de las intervenciones coronarias al impedir el cruce, lograr una buena aposición y expansión del stent; puede alterar el polímero y la cinética de liberación del fármaco. La subexpansión del stent se asocia a trombosis posterior del stent y/o necesidad de nueva revascularización de la lesión. Existen distintas técnicas para modificar el calcio de las arterias coronarias como los balones no complacientes (BNC), balones modificadores de placa y tecnologías de ateroablación como la aterectomia rotacional, orbital y láser. Todas con complicaciones y limitaciones. La litotripsia intracoronaria es una tecnología nueva, que mediante la emisión de ondas de choque acústicas es capaz de fracturar el calcio coronario profundo mejorando la distensibilidad de la arteria coronaria, lo que permite una adecuada expansión del stent. En esta oportunidad presentamos el caso de un stent subexpandido debido a una lesión muy calcificada de la arteria coronaria derecha (ACD) tratada con un catéter de Shockwave IVL (Shockwave Medical, Santa Clara, California).

Coronary calcification negatively affects the results of coronary interventions by preventing crossing, achieving good apposition and expansion of the stent; it may alter the polymer and the kinetics of drug release. Stent underexpansion is associated with subsequent stent thrombosis and/or the need for new revascularization of the lesion. There are different techniques to modify the calcium of the coronary arteries such as non-compliant balloons (NCB), plaque-modifying balloons and atheroablation technologies such as rotational, orbital and laser atherectomy. All with complications and limitations. Intracoronary lithotripsy is a new technology that, through the emission of acoustic shock waves, is capable of fracturing deep coronary calcium, improving compliance of the coronary artery, which allows adequate expansion of the stent. On this occasion, we present the case of an underexpanded stent due to a highly calcified lesion of the right coronary artery (RCA) treated with a Shockwave IVL catheter (Shockwave Medical, Santa Clara, California).

Burr entrapment in a percutaneous coronary intervention during rotational atherectomy: An experience with 3195 cases.

OBJECTIVES: Burr entrapment is a potentially life-threatening complication of rotational atherectomy (RA). However, owing to its infrequency, there have been no major reports on burr entrapment. This study aimed to evaluate the incidence, treatment, and outcomes of burr entrapment. METHODS: This multicenter retrospective study analyzed patients who had undergone percutaneous coronary interventions (PCIs) and were treated by RA between May 2013 and March 2022. RESULTS: Of the 22 640 PCI procedures, RA was performed in 3195 patients (14.1%), among whom burr entrapment occurred in 22 patients (0.69%). The mean patient age was 78 ± 8.7 years; 64% were male, and 32% were on dialysis. The entrapped burr size was 1.7 ± 0.2 mm, and the burr/artery ratio was 0.6 ± 0.1. In 20 patients (91%), the burr was extracted by strong manual pullback. The other patients underwent balloon angioplasty at the site of the entrapped burr, which might have provided space for successful burr withdrawal. Major adverse cardiac events occurred in 23% of patients. Tamponade requiring pericardiocentesis occurred in two patients (9%). No patients required emergency surgery or suffered an in-hospital death. CONCLUSIONS: Burr entrapment occurred in 0.69% of patients who had undergone RA. Most burrs were extracted by a strong manual pullback. None required emergency surgery, and there were no in-hospital deaths. The results provide a treatment approach and prognosis for burr stuck in the use of RA.