The role of intra-vascular imaging in patients undergoing intravascular lithotripsy: Insights from the COIL registry.

BACKGROUND: The role of intra-coronary imaging in patients with stent failure undergoing intravascular lithotripsy (IVL) is unclear. We aimed to assess clinical outcomes in patients undergoing IVL treatment for stent failure stratified according to the use of intra-coronary imaging and lesion complexity. METHODS: This is a pre-specified subgroup analysis of patients who were included in the coronary intravascular lithotripsy in patients with stent failure (COIL) registry (international multi-centre study assessing IVL treatment for stent failure in 6 European centres). A complex lesion was defined if IVL treatment was used in the left main, true bifurcation, long lesion, or coupled with athero-ablative therapy. The primary endpoint was the composite of cardiac death, spontaneous myocardial infarction, or target vessel revascularization (TVR) at 12 months. RESULTS: There were 102 patients analyzed, of whom 27 (26%) patients had complex anatomy. The use of intra-coronary imaging following IVL in stent failure was more frequent in patients with complex versus Noncomplex anatomy (56% vs. 31%, p = 0.022). IVL treatment was effective in both groups, however, patients with complex anatomy had worse clinical outcomes (30% vs. 11%, p = 0.02), driven by a higher rate of TVR (26% vs. 8%, p = 0.017). In the complex group, patients who underwent intracoronary imaging post intervention had lower event rate compared to those without imaging (13% vs. 50%, p = 0.038). CONCLUSIONS: In patients undergoing IVL treatment for stent failure with complex coronary anatomy, the use of intra-coronary imaging was associated with fewer adverse events compared to angiography guided intervention.

Emergency treatment of iatrogenic coronary perforation by transcatheter embolization with gelatin sponge particles-Description of technique.

Coronary artery perforation (CAP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI) that requires prompt diagnosis and effective treatment. Importantly, dynamic advances in interventional cardiology reflected by the increasing percentage of more challenging PCIs performed in more complex lesions have resulted in significant changes in CAPs pattern. Herein, we describe a technique and present a case report of CAP that occurred during percutaneous recanalization of the occluded restenotic right coronary artery (RCA) successfully treated with transcatheter embolization using gelatin sponge particles prepared on-site. The patient underwent coronary angiography with a subsequent attempt to open chronically occluded RCA. During the procedure, a guidewire was inadvertently positioned outside the arterial bed resulting in type III CAP. After unsuccessful prolonged balloon inflations as well as an anticoagulation reversal, embolization of the RCA with gelatin sponge particles as an ultima ratio treatment was performed. Sponge particles were prepared on-site by the operator, by cutting gelatin sponge used for wound healing. The procedure resulted in a total occlusion of the RCA and significant clinical improvement. The patient did not require pericardiocentesis and was discharged from the hospital after 10 days of an uneventful postprocedural course. The described technique is an easy and effective method of guidewire-related CAPs treatment in whom stent grafts cannot be implanted. Noteworthy, the technique can be applied in most cath labs as it utilizes a widely available gelatin sponge and does not require any specific expertise.

Comparison of Baseline Heart Rate Variability in Stable Ischemic Heart Disease Patients with and without Stroke in Long-Term Observation.

GOAL: Decreased heart rate variability (HRV) has predictive value in postinfarction as well as in ischemic stroke patients. However, it is unknown if ischemic heart disease (IHD) patients who are at high risk of stroke have different HRV profile. The goal of this study was to compare baseline HRV (traditional and novel indices) in stable IHD patients with and without stroke in long-term observation. METHODS: A total of 139 consecutive patients with stable IHD scheduled for coronary angiography were enrolled. Five-minute electrocardiogram readings were taken. Traditional and novel HRV measures were calculated. After 70.06 ± 4.297 months of follow-up, baseline HRV indices in patients who had had a stroke were compared with indices in patients without the aforementioned cerebrovascular event. RESULTS: During follow-up, 6 patients developed stroke. Compared to patients without such a cerebrovascular event, these patients with stroke had lower values for the following HRV indices: de Hann long-term irregularity (30,521 ± 32,767 versus 46,678 ± 25,328; P < .05), Yeh interval index (.0207 ± .0208 versus .0326 ± .0157; P < .05), Organ BAND (3.0563 ± 3.328 versus 4.515 ± 2.276; P < .05), Dalton standard deviation (SD) (17,887 ± 17,636 versus 29,859 ± 16,478; P < .05), Zugaib short-term variability (.004 ± .00416 versus .00622 ± .00418; P < .05), Zugaib long-term variability (.0161 ± .0151 versus .0247 ± .0115; P < .05), standard deviation of all NN intervals (8,954 ± 8,812 versus 16,724 ± 11,594; P < .05), total power (2,616 ± 4,855 versus 4,678 ± 4,653; P < .05), w2 (.71 ± .338 versus 1.719 ± 1.08; P < .05), w3 (1.399 ± .924 versus 2.552 ± 1.609; P < .05), and w4 (1.367 ± 1.705 versus 2.824 ± 2.027; P < .05). No significant differences in other analyzed indices were observed. CONCLUSIONS: Patients with IHD and stroke in long-term observation have different baseline profiles of HRV indices. Further investigations are needed to assess the usefulness of HRV analysis in stroke risk assessment.

The Usefulness of Intravascular Ultrasound and Optical Coherence Tomography in Patients Treated with Rotational Atherectomy: An Analysis Based on a Large National Registry.

BACKGROUND: Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been shown to improve the clinical outcomes of percutaneous coronary interventions (PCIs) in selected subsets of patients. AIM: The aim was to investigate whether the use of OCT or IVUS during a PCI with rotational atherectomy (RA-PCI) will increase the odds for successful revascularization, defined as thrombolysis in myocardial infarction (TIMI) 3 flow. METHODS: Data were obtained from the national registry of PCIs (ORPKI) maintained by the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The dataset includes PCIs spanning from January 2014 to December 2021. RESULTS: A total of 6522 RA-PCIs were analyzed, out of which 708 (10.9%) were guided by IVUS and 86 (1.3%) by OCT. The postprocedural TIMI 3 flow was achieved significantly more often in RA-PCIs guided by intravascular imaging (98.7% vs. 96.6%, p < 0.0001). Multivariable analysis revealed that using IVUS and OCT was independently associated with an increased chance of achieving postprocedural TIMI 3 flow by 67% (odds ratio (OR), 1.67; 95% confidence interval (CI): 1.40-1.99; p < 0.0001) and 66% (OR, 1.66; 95% CI: 1.09-2.54; p = 0.02), respectively. Other factors associated with successful revascularization were as follows: previous PCI (OR, 1.72; p < 0.0001) and coronary artery bypass grafting (OR, 1.09; p = 0.002), hypertension (OR, 1.14; p < 0.0001), fractional flow reserve assessment during angiogram (OR, 1.47; p < 0.0001), bifurcation PCI (OR, 3.06; p < 0.0001), and stent implantation (OR, 19.6, p < 0.0001). CONCLUSIONS: PCIs with rotational atherectomy guided by intravascular imaging modalities (IVUS or OCT) are associated with a higher procedural success rate compared to angio-guided procedures.

Rotational Atherectomy Versus Intravascular Lithotripsy for Calcified In-Stent Restenosis: A Single-Center Study With 1-Year Follow-Up.

Although rotational atherectomy (RA) and intravascular lithotripsy (IVL) have been proved to be effective for calcified de novo coronary lesions, their use in patients with in-stent restenosis (ISR) is still controversial. No comparison of these techniques in patients with ISR has been published so far. We sought to evaluate safety and feasibility of RA and IVL in patients with calcified ISR. Furthermore, we aimed to compare in-hospital and 1-year clinical outcomes between both groups. This is a retrospective single-center study evaluating patients with calcified ISR treated with RA (between 2012 and 2021) and IVL (between 2019 and 2021). Inhospital and 1-year clinical outcomes were compared between IVL and RA patients. In total, 28 patients with ISR who underwent RA were compared with 24 ISR subjects after IVL. The procedural success rate was 100% in both the groups. Quantitative coronary analysis demonstrated a similar degree of stenosis prior (66.4 ± 11.4 vs 68.8 ± 19.7, p = nonsignificant [NS]), and after the procedure (21.5 ± 20.5 vs 22.8 ± 12.1, p = NS) with no difference in acute luminal gain (1.34 ± 0.60 vs 1.38 ± 0.59, p = NS). There was one in-hospital major adverse cardiovascular event in the RA group. At 1-year follow-up, no difference was observed with respect to major adverse cardiovascular event rate (14.3% vs 16.7%, p = NS) and target vessel revascularization (7.1% vs 12.5%, p = NS). In conclusion, RA and IVL are safe and feasible techniques for calcified ISR yielding comparable results at 1-year follow-up. Further clinical studies are warranted to confirm our findings and shed more light on patient and lesion characteristics associated with the best outcomes.

Transcatheter targeted myocardial restoration using hydrogel-based cell-free compound: Toward an adoptable clinical protocol.

Background: There is a need for a targeted, comprehensive, minimally invasive myocardial restoration treatment aimed at patients with chronic postinfarction heart failure that can provide a sustained effect and be conveniently adopted with transcatheter techniques. Here we evaluated the effectiveness of a platelet-rich plasma hydrogel-based, cell-free therapeutic compound delivered with the aid of a 3-dimensional electromechanical mapping and catheter-based technique (NOGA) in a porcine translational model. Methods: We assessed the feasibility of targeted, minimally invasive transcatheter NOGA-guided injections of the therapeutic compound in myocardial infarction (MI) survivors at 8 weeks post-MI. Results: Animals undergoing NOGA-guided hydrogel injections at 8 weeks post-MI demonstrated a significant improvement of the selected left ventricular parameters at a 12-week follow-up. Compared to nonintervention, the hydrogel-based therapy provided significant improvements in end-diastolic volume (-11.0% ± 11.1% vs 6.3% ± 15.2%; P = .008) and ejection fraction (-9.1% ± 16% vs 12.7% ± 18.6%; P = .009). In the slice closest to the apex, significant differences in scar area were observed; the treatment group demonstrated a smaller mean scar area in the infarcted zone compared with the control group (47.1% ± 7.0% vs 59% ± 8.2%;  P = .013) and a smaller mean scar area in the border zone compared with the saline group (31.4% ± 8.3% vs 42.6% ± 9.0%; P = .016). Conclusions: The study implies a translational potential of the hydrogel-based therapy and should trigger clinical trials focused on establishing a restoration therapy that can be integrated into a clinical protocol.

Clinical outcomes of coronary intravascular lithotripsy in patients with stent failure (COIL registry).

BACKGROUND: Intravascular lithotripsy (IVL) has been demonstrated to be an effective treatment of calcified de novo coronary lesions. Safety data on the use of IVL within stented segments are lacking. We sought to evaluate the safety, feasibility, and long-term outcomes of IVL in patients with stent failure. METHODS: This was a retrospective multi-centre registry that included consecutive patients with stent failure who had undergone IVL treatment. The primary efficacy endpoint was procedural success defined as residual stenosis <30% (determined by quantitative coronary angiography analysis) in patients who survived hospital admission without in-hospital adverse events. Major adverse cardiovascular events (MACE) were defined as the composite endpoints of cardiovascular death, spontaneous myocardial infarction, and target vessel revascularisation at one-year follow up. RESULTS: 102 patients were included in this study. Mean age was 73 ± 9 years and 81% were male. The duration from previous stent implantation and IVL treatment was 24 (interquartile range 7-76) months, of which 10.8% received IVL for acute under-expanded stent. IVL treatment allowed significant improvement in both minimal lumen diameter (1.14 ± 0.60 to 2.53 ± 0.59, P < 0.001) and degree of stenosis (66.8 ± 19.9 to 20.3 ± 11.3%, P < 0.001). The rate of procedural success was 78.4% (80/102 of patients). The one-year MACE was 15.7%. Ostial disease (HR 5.16; 95% CI 1.19 to 22.33; P = 0.028) and lesion length (HR 1.05; 95% CI 1.01 to 1.10; P = 0.010) were independently associated with one-year MACE. CONCLUSIONS: In patients with stent failure, IVL is a safe and feasible treatment for this high-risk group.

Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial.

BACKGROUND: It is unclear whether more effective forms of thrombus removal than current aspiration catheters would lead to improved outcomes. We sought to evaluate the prognostic role of residual thrombus burden (rTB), after manual thrombectomy, in patients undergoing primary percutaneous coronary intervention with routine manual thrombectomy in the TOTAL trial (Thrombectomy Versus PCI Alone). METHODS: This is a single-arm analysis of patients from the TOTAL trial who underwent routine manual aspiration thrombectomy. The rTB was quantified by an angiographic core laboratory using the Thrombolysis in Myocardial Infarction criteria and validated using existing optical coherent tomography data. Large rTB was defined as grade ≥3. The primary outcome was death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or new or worsening heart failure within 180 days. RESULTS: Of 5033 patients randomized to routine thrombectomy, 2869 patients had quantifiable rTB (1014 [35%] had large rTB). Patients with large rTB were more likely to have hypertension, previous percutaneous coronary intervention, myocardial infarction, or Killip class III on presentation but less likely to have Killip class I. The primary outcome occurred more frequently in patients with large rTB, even after adjustment for known risk predictors (8.6% versus 4.6%; adjusted hazard ratio, 1.83 [95% CI, 1.34-2.48]). These patients also had a higher risk of cardiovascular death (adjusted hazard ratio, 1.83 [95% CI, 1.13-2.95]), cardiogenic shock (adjusted hazard ratio, 2.02 [95% CI, 1.08-3.76]), and heart failure (adjusted hazard ratio, 1.74 [95% CI, 1.02-2.96]) but not myocardial infarction or stroke. CONCLUSIONS: Large rTB is a common finding in primary percutaneous coronary intervention and is associated with increased risk of adverse cardiovascular outcomes, including cardiovascular death. Future technologies offering better thrombus removal than current devices may decrease or even eliminate the risk associated with rTB. This, potentially, can turn into a strategic option to be studied in clinical trials. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01149044.

Colchicine in Patients with Coronary Artery Disease with or Without Diabetes Mellitus: A Meta-analysis of Randomized Clinical Trials.

BACKGROUND AND OBJECTIVES: Whether the anti-inflammatory drug colchicine has a differential treatment effect according to diabetes mellitus status in patients with coronary artery disease has never been studied. Therefore, the aim of the present meta-analysis was to evaluate whether the use of colchicine in patients with coronary artery disease with diabetes was associated with a higher magnitude of benefits compared to patients with coronary artery disease without diabetes. METHODS: Electronic databases were searched through June 2020 to identify randomized clinical trials using colchicine in patients with coronary artery disease. Studies using blood biomarkers, such as troponin or high-sensitive C-reactive protein, as well as angiographic endpoints were excluded. The primary endpoint was major cardiovascular events as defined by the included studies. RESULTS: In total, 11,594 patients from four randomized trials were included of whom 2278 (19.6%) had diabetes and 5540 (47.8%) presented with acute coronary syndrome. Colchicine was associated with almost twice the absolute risk reduction in patients with diabetes {absolute risk difference (ARD) - 3.94 [95% confidence interval (CI) - 1.28 to - 6.6], p = 0.004} compared with those without diabetes [ARD - 2.32 (95% CI - 1.32 to - 3.31), p < 0.001]. The magnitude of ARD between colchicine and placebo was significantly larger in patients with diabetes compared with patients without diabetes [ARD 1.62 (95% CI 1.43-1.81), p < 0.001]. When the analysis was restricted to patients presenting with acute coronary syndrome, the differential treatment effect of colchicine was more pronounced in patients with diabetes [ARD - 0.05 (95% CI - 0.08 to - 0.01), p = 0.02] compared with those without diabetes [ARD - 0.01 (95% CI - 0.02 to 0), p = 0.11]. CONCLUSIONS: This meta-analysis underscores the heightened inflammatory risk associated with diabetes and highlights the need to target inflammatory pathways in these individuals irrespective of glucose-lowering drugs.

Colchicine for the prevention of ischemic stroke: An updated meta-analysis of randomized clinical trials.

BACKGROUND: Inflammation is increasingly recognized as a target to reduce residual cardiovascular risk. Colchicine is an anti-inflammatory drug that was associated with improved cardiovascular outcomes. However, its effect on stroke reduction was not consistent across studies. Therefore, the aim of this study-level meta-analysis was to evaluate the influence of colchicine on stroke in patients with coronary artery disease (CAD). METHODS: Electronic databases were searched through October 2020, to identify randomized controlled trials using colchicine in patients with CAD. The incidence of clinical endpoints such as stroke, death, myocardial infarction (MI), study-defined major adverse cardiovascular events (MACE), and atrial fibrillation (AF) was compared between colchicine and placebo groups. RESULTS: A total number of 11,594 (5,806 in the colchicine arm) patients from 4 eligible studies were included in the final analysis. Stroke incidence was lower in the colchicine arm compared to placebo (rate ratio [RR] 0.48 [95% confidence interval [CI], 0.29-0.78], P = 0.003) whereby no significant difference was observed in the incidence of AF (odds ratio [OR] 0.86 [95% CI, 0.69-1.06], P = 0.16). Furthermore, a significant effect of colchicine on MACE [RR 0.65 (95% CI, 0.51-0.83), P = 0.0006] and MI (RR 0.65 (95% CI, 0.54-0.95], P = 0.02) was detected, with no influence on all-cause mortality (RR 1.04 [95% CI, 0.61-1.78], P = 0.88). CONCLUSIONS: This meta-analysis confirms a significant influence of colchicine on stroke in CAD patients. Despite its neutral effect on AF occurrence, other mechanisms related to plaque stabilization are plausible. The concept seems to be supported by contemporaneous MI reduction and posits that anti-inflammatory properties of colchicine may translate into a reduction of stroke risk.

Transcatheter treatment of functional mitral valve regurgitation.

Functional mitral regurgitation is a clinical entity with increasing prevalence and significant impact on morbidity and mortality. Because of the unsatisfactory results of medical therapy and high perioperative risk resulting in low referral/high denial rates for surgical treatment, benefits of which still remain controversial, novel minimally invasive transcatheter techniques are under development. Herein, in the present review, we discuss the recent progress in the emerging field of catheter-based techniques for functional mitral regurgitation.

Meta-Analysis of Intensive Lipid-Lowering Therapy in Patients With Polyvascular Disease.

Background Polyvascular atherosclerotic disease is associated with an increased risk of future cardiovascular events. Intensive lipid-lowering therapy (ILT) may mitigate this risk. The aims of this study-level meta-analysis were to examine the effects of ILT in patients with polyvascular disease and whether baseline low-density lipoprotein cholesterol (LDL-C) may determine the level of benefit. Methods and Results Electronic databases were searched through January 2020 to identify randomized controlled trials of treatments targeting upregulation of LDL-C receptors (ie, statins, ezetimibe, and PCSK9 [proprotein convertase subtilisin-kexin type 9] inhibitors). The primary end point was major adverse vascular events as defined by the included studies. A total of 94 362 patients (14 821 [18.6%] with polyvascular disease) from 7 studies were included. In patients with monovascular disease, ILT was associated with a 13% reduction in the primary end point (rate ratio [RR] 0.87; 95% CI, 0.81-0.93 [P=0.0002]) (absolute RR, 1.8%) compared with less ILT, while patients with polyvascular disease had 15% relative RR (0.85; 95% CI, 0.80-0.90 [P<0.00001]) (absolute RR, 6.5%) (P=0.66 for interaction). When factoring LDL-C, unlike patients with monovascular disease, the relative benefits of ILT, compared with less ILT, in patients with polyvascular disease were comparable with LDL-C >100 mg/dL (RR, 0.85; 95% CI, 0.80-0.90 [P<0.00001]) and LDL-C <100 mg/dL (RR, 0.88; 95% CI, 0.81-0.96 [P=0.003]) (P=0.23 for interaction). Conclusions Patients with polyvascular disease experienced comparable benefits to those with monovascular disease in response to ILT. The benefits of ILT in patients with polyvascular disease were not dependent on baseline LDL-C, challenging the approach of using LDL-C as a prerequisite to commence ILT for this high-risk subgroup.

Targeted Myocardial Restoration with Injectable Hydrogels-In Search of The Holy Grail in Regenerating Damaged Heart Tissue.

A 3-dimensional, robust, and sustained myocardial restoration by means of tissue engineering remains an experimental approach. Prolific protocols have been developed and tested in small and large animals, but, as clinical cardiac surgeons, we have not arrived at the privilege of utilizing any of them in our clinical practice. The question arises as to why this is. The heart is a unique organ, anatomically and functionally. It is not an easy target to replicate with current techniques, or even to support in its viability and function. Currently, available therapies fail to reverse the loss of functional cardiac tissue, the fundamental pathology remains unaddressed, and heart transplantation is an ultima ratio treatment option. Owing to the equivocal results of cell-based therapies, several strategies have been pursued to overcome the limitations of the current treatment options. Preclinical data, as well as first-in-human studies, conducted to-date have provided important insights into the understanding of injection-based approaches for myocardial restoration. In light of the available data, injectable biomaterials suitable for transcatheter delivery appear to have the highest translational potential. This article presents a current state-of-the-literature review in the field of hydrogel-based myocardial restoration therapy.

Automated Fastener vs Hand-tied Knots in Heart Valve Surgery: A Systematic Review and Meta-analysis.

BACKGROUND: Although several studies revealed that the Cor-knot automated fastener (LSI Solutions, Victor, NY) reduces aortic cross-clamp and cardiopulmonary bypass times, the influence of the device on postoperative morbidity and mortality still needs to be evaluated. The aim of this study was to verify the hypothesis that the use of the Cor-knot device for heart valve surgery reduces aortic cross-clamp and cardiopulmonary bypass times, and this time saving translates into reduced morbidity and mortality. METHODS: Retrospective cohort studies and randomized controlled trials reporting on the use of the automated fastener vs hand-tied knots were reviewed. The following end points were compared: aortic cross-clamp and cardiopulmonary bypass times, postoperative valvular regurgitation, postoperative ejection fraction, prolonged ventilator support, renal failure, and mortality. RESULTS: Eight studies reporting data on 942 patients were included in the final analysis. The Cor-knot device was associated with shorter cardiopulmonary bypass (mean difference [MD], -11.74; 95% confidence interval [CI], -14.54 to -8.93; P < .00001) and aortic cross-clamp times (MD, -14.36; 95% CI, -19.63 to -9.09; P < .00001) in minimally invasive heart valve procedures. Overall, lower rates of postoperative valvular regurgitation (risk ratio [RR], 0.40; 95% CI, 0.26 to 0.62; P < .0001) and prolonged ventilator support (RR, 0.29; 95% CI, 0.13 to 0.65; P = .003) were observed. No difference was observed in postoperative atrial fibrillation, ejection fraction, renal failure, and mortality. CONCLUSIONS: The use of the Cor-knot device in heart valve surgery reduced aortic cross-clamp and cardiopulmonary bypass times. Furthermore, as compared with hand-tie methods, the automated fastener may lead to decreased rates of prolonged ventilator support and valvular regurgitation while being noninferior in terms of other postoperative outcomes and mortality.

A Novel Minimally Invasive Technique of Temporary Caval Occlusion for Right Heart Surgery.

Right heart surgery is challenging in the minimally invasive cardiac surgery setting, particularly in terms of caval isolation procedures in patients with enlarged and pressurized atria. We describe a novel minimally invasive caval occlusion technique with the use of a balloon catheter designed for temporary large vessel occlusion. A patient with a large ostium secundum atrial septal defect and significant shunt flow underwent a successful minimally invasive closure of the pathological connection between atria with a bovine pericardial patch. The utilized occlusion technique provided excellent visibility of the surgical site and may facilitate minimally invasive procedures in various clinical scenarios.