Dmitriy S. Sulimov

Long-term clinical outcome of rotational atherectomy followed by drug-eluting stent implantation in complex calcified coronary lesions

To assess long‐term outcome after rotational atherectomy (RA) is followed by drug‐eluting stent (DES) implantation in complex calcified coronary lesions.

Stuck rotablator: the nightmare of rotational atherectomy.

AIMS Rotational atherectomy (RA) is frequently performed to modify complex fibrocalcific coronary lesions with high procedural success. A stuck rotablator is a rare but life-threatening complication. However, its description remains sporadic and it has never been systematically analysed. The aim of this analysis is to present our experience and summarise the available literature about stuck rotablator, and to identify risk factors and possible management strategies for this complication. METHODS AND RESULTS We analysed our experience of 442 RA procedures and identified four cases of stuck rotablator. Two of these cases were rotablations in freshly implanted stents. All cases were managed percutaneously. We further analysed the available literature and identified a total of 11 reports with 14 cases of a stuck rotablator burr; seven were managed surgically and seven with endovascular approaches. Based on our experience and the literature review we developed an algorithm to guide operators while managing this complication. CONCLUSIONS Entrapment of a rotablation burr is a rare but very serious complication of RA. Operators performing RA should be aware of this risk and be prepared to manage it adequately. In our experience, the risk seems to be higher when rotablating freshly implanted underexpanded stents.

Longitudinal Deformation of Contemporary Coronary Stents: An Integrated Analysis of Clinical Experience and Observations from the Bench

OBJECTIVE  To report clinical experience with longitudinal stent deformation (LSD) and observations from the bench. BACKGROUND  LSD was recently reported with thin-strut coronary stents. Whether it is related to a particular stent or constitutes a class-effect remains debatable. METHODS After 2 cases of LSD were reported, information was sent to operators to warn of this event and identify possible cases. All cases were reviewed to ensure LSD had occurred. Simultaneously, bench testing was conducted to identify the susceptibility of stents to longitudinal compression and whether LSD detection is influenced by fluoroscopic stent visibility. RESULTS  Between July 2010 and November 2011, 2,705 coronary interventions were performed with 4,588 stents (Promus Element = 41.6%, Xience Prime = 24.4%). Six patients with LSD were identified, all with Promus Element (0.31%). Wire bias was a predisposing factor in 4 cases. All patients were treated with postdilatation and/or additional stenting. No adverse events occurred (mean 5.8 months). In bench testing, LSD occured in all examined stents, but at different levels of applied force (weight). Most shortening at 50 g was observed with Promus Element (38.9%), as was the best visibility of LSD on x-ray images. With postdilatation all stents showed some re-elongation. CONCLUSION In our practice LSD was a rare observation only seen with the Promus Element stent. When subjected to longitudinal compression in a bench test all contemporary stents can be compressed. Compression of Promus Element occurs at a lower force, but it is the only stent where deformations are detected with x ray. Postdilatation can partially improve LSD.

Comparison of Bailout and Planned Rotational Atherectomy for Heavily Calcified Coronary Lesions: A Single-Center Experience

OBJECTIVES The aim of this study was to compare outcomes of bailout and planned rotational atherectomy (RA) in the treatment of calcified coronary lesions. BACKGROUND Current guidelines recommend RA as a bailout procedure for calcified or fibrotic lesions that cannot be adequately dilated before stenting. Nonetheless, planned RA is sometimes performed in certain challenging anatomies. METHODS Data of patients treated with RA between 2002 and 2014 at a single-center registry were retrospectively analyzed. The bailout RA group included patients where RA was employed after failure of balloon dilatation or stent delivery. Planned RA included patients where RA was employed electively without previous device failure. RESULTS The study comprised 204 patients (221 lesions) and 308 patients (338 lesions) treated with bailout or planned RA, respectively. Angiographic success was achieved in the majority of cases, but was lower in the bailout RA group (93.7% vs. 97.6%, P = 0.02). Coronary dissections occurred more frequently in the bailout RA group (8.6% vs. 4.4%, P = 0.04), mean contrast amount was higher (279 ± 135 mL vs. 202 ± 92 mL, P < 0.001), and fluoroscopy time and procedural duration were longer in that group (32 min [IQR 21-51] vs. 18 min [IQR 14-28], P < 0.001 and 111 ± 50 min vs. 76 ± 35 min, P < 0.001, respectively). In-hospital death and myocardial infarction were not significantly different between the groups (2.9% vs. 1.3%, P = 0.21 and 6.9% vs. 4.2%, P = 0.19). In-hospital major adverse cardiac events (MACE) were higher in the bailout RA group (10.3% vs. 5.5%, P = 0.04). The 2-year estimated rates of MACE (25.2% vs. 28.7%, log rank P = 0.52) and its components death, myocardial infarction, and target vessel revascularization were not significantly different between the groups. Equivalence of 2-year MACE rates was also seen in all examined subgroups. CONCLUSION Shortened procedural duration and reduction of coronary dissections were observed with planned RA for selected lesions. However, this strategy does not affect long-term clinical outcomes.

Relationship between peri-strut low intensity areas and vascular healing response after everolimus-eluting bioresorbable scaffold implantation: An optical coherence tomography study

BACKGROUND Peri-strut low intensity areas (PLIA) surrounding metallic coronary stent struts on optical coherence tomography (OCT) images have been histologically related to delayed healing and inflammation, and have been associated with neointimal proliferation. The relationship between PLIA and vascular healing response after bioresorbable scaffold (BRS) implantation remains unclear. METHODS This study includes 38 consecutive patients (50 scaffolds) evaluated using OCT 12 months after BRS implantation. Mean and percent neointimal area were quantified. A PLIA was defined as a peri-strut region with an homogenous lower intensity appearance than the surrounding tissue on OCT images without significant signal attenuation. Cross sections were scored as follows: score 0, no PLIA; score 1, <1 quadrant; score 2, ≥1 but <2 quadrants; score 3, ≥2 quadrants but <3 quadrants; and score 4, ≥3 quadrants. Scaffolds were divided into two groups (PLIA+ and PLIA-) based on the presence or absence of any PLIA in the scaffold segment. RESULTS The frequency of any PLIA within the scaffold segment was 70.0%. The median PLIA score per scaffold was 0.51 (interquartile range 0-1.07). Using both scaffold- and frame-level analysis, a significant positive correlation was observed between PLIA score and both mean and percent neointimal area. Mean and percent neointimal area were significantly higher in the PLIA+ group than in the PLIA- group (1.95±0.65mm2 vs. 1.51±0.27mm2, p<0.01 and 24.0±7.0% vs. 17.4±3.6%, p<0.01, respectively). CONCLUSION The presence and extent of PLIA on OCT imaging after BRS implantation appears to be significantly associated with neointimal formation.

High-speed rotational atherectomy of the left main coronary artery: a single-center experience in 50 high-risk patients

BACKGROUND Certain patients with complex calcified left main (LM) disease have a prohibitive risk for bypass surgery. Rotational atherectomy (RA) prior to stent implantation is an option for this subset of patients. OBJECTIVE To analyze acute and long-term results of RA in the LM location. METHODS We present a single-center analysis of RA in severe LM disease applied in patients with high surgical risk. RESULTS RA was performed in the LM location in 50 consecutive patients with a mean age of 73years. In 30% of the patients clinical presentation was an acute coronary syndrome, and 42% had diabetes. LM bifurcation was involved in 80% of the cases, 36% had a Medina class 1.1.1 lesion, and 38% of RA procedures were performed as bailout. In 38% of patients the left main was protected. Median logistic EuroSCORE was 12.4% (interquartile range, IQR, 5.24-36.11%) and mean SYNTAX Score was 28.6±8.2. The median burr size was 1.5mm and a two-stent strategy was required in 58% of interventions. Drug-eluting stents were implanted in 86% of procedures. Angiographic success rate was 96%, and in-hospital major adverse cardiac event rate was 10%. Survival free of cardiac death at 12 and 24months was 87.6% and 78.4%. Target lesion revascularization rates (TLR) were 13.3% and 18.8%, respectively. Cardiac deaths were significantly higher in patients with acute coronary syndromes compared with patients with stable angina (cardiac death free survival was 72.7% and 94% at 12months, p=0.01). The TLR rate was numerically higher in diabetic patients (21.1% vs. 7.7% at one year, p=0.18). CONCLUSION Acute and long-term outcomes after LM rotational atherectomy are satisfactory, considering the high procedure- and patient-related risks.

Impact of femoral artery puncture using digital subtraction angiography and road mapping on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation.

AIMS The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. METHODS AND RESULTS This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p<0.001, respectively) associated with the more frequent implantation of the 29 mm Edwards SAPIEN XT valve in the RM group (43.8% vs. 7%, respectively, p<0.001). Despite the latter finding, both major vascular complications and major bleeding at 30 days were significantly lower in the RM group compared to the control group (4.3% vs. 11.8%, p=0.01, and 14.4% vs. 25.6%, p=0.01). An analysis limited to access site-related complications also revealed lower events in the road map group but did not reach statistical significance (8.1% vs. 13.8%, p=0.1). Other forms of vascular and bleeding complications as well as all-cause mortality were comparable in both groups. CONCLUSIONS A modified femoral artery puncture technique using DSA and road mapping was associated with a reduction in major vascular and bleeding complications after transfemoral TAVI, and provides a simple and effective strategy for potentially improving patient outcomes.

Fractional Flow Reserve in Acute Myocardial Infarction: A Guide for Non-Culprit Lesions?

In patients presenting with ST-segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the optimal therapy for non-culprit lesions is still a matter of debate. While guidelines discourage a concomitant treatment of infarct- and non-infarct-related arteries, recent studies document advantages of a complete (preventive) revascularization during primary percutaneous coronary intervention. Such an approach, however, may result in overtreatment, because angiography does not provide robust information about the functional severity of MVD. Fractional flow reserve (FFR) measurements can be a valuable guide for non-culprit lesions in acute myocardial infarction, but so far, only the reliability and safety of FFR measurements have been established in this setting. The clinical implications of an FFR-guided treatment strategy in STEMI patients with MVD are currently being tested in a large randomized trial.

High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions: The Randomized PREPARE-CALC Trial

Background: Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined. Methods and Results: We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3–39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group (P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups. Conclusions: Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02502851.

The fate of incomplete scaffold apposition of everolimus-eluting bioresorble scaffolds: A serial optical coherence tomography analysis

BACKGROUND Incomplete stent apposition (ISA) can be divided into acute and late forms. Late ISA may be due to persistent ISA or late-acquired ISA (LAISA). This study evaluated the natural course of ISA after bioresorbable vascular scaffold (BRS) implantation using optical coherence tomography (OCT). METHODS Thirty-two patients (45 BRS) were assessed immediately after BRS implantation and 1 year thereafter using OCT. Acute ISA identified after BRS implantation but absent at follow-up was defined as resolved; otherwise, it was considered persistent. LAISA was defined as newly developed ISA that was identified at follow-up despite complete apposition immediately after BRS implantation. Intra-BRS fibrin-like material (IBF) was identified as an irregular intraluminal mass. ISA percentage was expressed as follows: (number of ISA/total number of BRS struts)×100. RESULTS Among 45 BRS and 15,894 analyzed BRS struts, 34 and 882 had acute ISA post-procedure, respectively. At follow-up, 92 of 15,364 analyzed struts exhibited late ISA (64 persistent ISA and 28 LAISA). In 15 of 28 struts with LAISA, LAISA occurred at the sites adjacent to post-interventional dissection. Uncovered struts were more frequently observed in late ISA compared to apposed struts (3.7±4.8 vs. 0.58±2.2%, p=0.09). IBF was significantly more common in BRS with late ISA (62.5 vs. 8.1%, p=0.02). Receiver-operating characteristic curve analysis identified a cut-off value of 280μm for acute ISA distance predicting persistent ISA. CONCLUSION Resolution of acute ISA after BRS is common. The occurrence of LAISA may be infrequent and may be a nidus of stent thrombosis.