Kissing Balloon-Stent Technique for Simple Bifurcation Lesions.

Background: Coronary bifurcation lesions are commonly encountered during coronary angiography. The management of bifurcation lesions remains challenging, with various bifurcation techniques being available and outcomes varying depending on the Medina classification and operator experience. Methods: We present a short case series and the outcomes of a new bifurcation technique for the management of simple Medina '0,0,1' and '0,0,1' bifurcation lesions using the kissing balloon-stent technique (kissing BS). Results: We retrospectively identified 8 patients who underwent bifurcation stenting using the kissing Balloon-Stent technique, along with their clinical and angiographic follow-up outcomes. We also describe the benefits and limitations of the technique, delineate the potential mechanisms of target lesion failure, and outline appropriate patient selection. Conclusions: Kissing Balloon-Stent technique is a simple single stent technique that is safe and feasible in select patients with Medina '0,0,1' and '0,0,1' bifurcation lesions.

Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results from the TARGET BP I Randomized Clinical Trial.

BACKGROUND: Renal denervation (RDN) has demonstrated clinically relevant reductions in blood pressure among individuals with uncontrolled hypertension despite lifestyle intervention and medications. The safety and effectiveness of alcohol-mediated RDN has not been formally studied in this indication. METHODS: TARGET BP I is a prospective, international, sham-controlled, randomized, patient- and assessor-blinded trial investigating the safety and efficacy of alcohol-mediated RDN. Patients with office systolic blood pressure (SBP) ≥150 and ≤180 mmHg, office diastolic BP ≥90 mmHg and mean 24-hour ambulatory SBP ≥135 and ≤170 mmHg, despite prescription of 2-5 antihypertensive medications were enrolled. The primary endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 3 months post procedure. Secondary endpoints include mean between-group differences in office and ambulatory BP at additional time points. RESULTS: Among 301 patients randomized 1:1 to RDN or sham control, RDN was associated with a significant reduction in 24-hour ambulatory SBP at 3 months (mean ± standard deviation -10.0 ± 14.2 mmHg versus -6.8 ± 12.1 mmHg, treatment difference -3.2 mmHg, 95% confidence interval [CI] -6.3, 0.0 mmHg; P=0.0487). Subgroup analysis of the primary endpoint revealed no significant interaction across predefined subgroups. At 3 months, the mean change in office SBP was -12.7 ± 18.3 mmHg and -9.7 ± 17.3 mmHg (difference, -3.0, 95% CI -7.0, 1.0; P=0.173), for RDN and sham, respectively. No significant differences in ambulatory or office diastolic BP were observed. Adverse safety events through 6 months were uncommon with 1 instance of accessory renal artery dissection in the RDN group (0.7%). No significant between-group differences in medication changes or patient adherence were identified. CONCLUSIONS: Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory systolic BP compared with sham control. No significant differences between groups in office BP or 6-month major adverse events were observed.

Guide extension catheters: Review of technology and future directions.

Although Percutaneous Coronary Intervention (PCI) has revolutionized the management of CAD, the deliverability of devices including balloons, specialty balloons, stents, atherectomy catheters, thrombectomy devices, and intravascular lithotripsy devices has become a common challenge faced by interventional cardiologists. Guide Extension Catheters (GECs) have been developed and are now widely used to create improved backup support to allow the advancement of interventional equipment required for the PCI. Improved lesion preparation, plaque modification (e.g., with atherectomy), and Guide Extension Catheters (GEC), also called as Mother-Child Technique, has proven critical to procedural success in complex cases. In this review, we discuss the role and limitations of current guide extension devices, with a brief discussion of next-generation GEC.

Radial artery pseudoaneurysm rupture after cardiac catheterization.

A 73-year-old man with history significant for paroxysmal atrial fibrillation on apixaban underwent percutaneous coronary intervention (PCI) of the left anterior descending artery via transradial access. The patient was discharged on clopidogrel, atorvastatin, carvedilol, isosorbide mononitrate, losartan, and apixaban.

Real world single center experience with saphenous vein grafts interventions: should filters be filtered out?

BACKGROUND: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) can be challenging due to no reflow phenomenon from distal embolization of debris and microvascular vasoconstriction, resulting in myocardial injury post-procedure. Guidelines promote the use of distal embolic protection devices (EPD) to protect the distal arterial bed during SVG PCI. However, this approach has shown less-than-optimal results in many studies. We report our data using the Borgess protocol [prophylactic intracoronary (IC) nicardipine injection and direct stenting], as an alternative to EPDs in a large series of SVG interventions. METHODS: This is a retrospective, cohort study of our single center experience with SVG interventions between 2017 and 2021. The primary outcome of the study was major adverse cardiovascular events (MACE) [a composite of death, emergent coronary artery bypass graft surgery (CABG), myocardial infarction (MI), and target vessel revascularization (TVR)] at 30 days post-procedure. RESULTS: There were 424 consecutive SVG interventions performed during the study period, and 76% of cases presented with acute coronary syndrome. Full adherence to the Borgess protocol was observed in 36% of cases; IC nicardipine was utilized in 72% of cases. MACE rate was 3.5% at 30 days driven primarily by MI (2.6%). CONCLUSION: The Borgess protocol approach to vein graft interventions proved good outcomes when compared to SVG PCI in randomized trials utilizing EPDs. Our study is limited by the retrospective nature and single center experience.

Shock and Awe: Successful Revascularization with Intravascular Lithotripsy in Recurrent ST-Elevation Myocardial Infarction Secondary to Stent Under-Expansion.

We report a case of recurrent ST-segment elevation myocardial infarction (STEMI) due to a previously implanted under-expanded stent with in-stent thrombosis refractory to traditional interventional techniques. We underscore the utility of bail-out shockwave intravascular lithotripsy to tackle previously under-expanded stents in this acute setting.

Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications.

BACKGROUND: Ultrasound and radiofrequency renal denervation (RDN) have been shown to safely lower blood pressure (BP) in hypertension. AIMS: The TARGET BP OFF-MED trial investigated the efficacy and safety of alcohol-mediated renal denervation (RDN) in the absence of antihypertensive medications. METHODS: This randomised, blinded, sham-controlled trial was conducted in 25 centres in Europe and the USA. Patients with a 24-hour systolic BP of 135-170 mmHg, an office systolic BP 140-180 mmHg and diastolic BP ≥90 mmHg on 0-2 antihypertensive medications were enrolled. The primary efficacy endpoint was the change in mean 24-hour systolic BP at 8 weeks. Safety endpoints included major adverse events up to 30 days. RESULTS: A total of 106 patients were randomised; the baseline mean office BP following medication washout was 159.4/100.4±10.9/7.0 mmHg (RDN) and 160.1/98.3±11.0/6.1 mmHg (sham), respectively. At 8 weeks post-procedure, the mean (±standard deviation) 24-hour systolic BP change was â2.9±7.4 mmHg (p=0.009) versus â1.4±8.6 mmHg (p=0.25) in the RDN and sham groups, respectively (mean between-group difference: 1.5 mmHg; p=0.27). There were no differences in safety events between groups. After 12 months of blinded follow-up, with medication escalation, patients achieved similar office systolic BP (RDN: 147.9±18.5 mmHg; sham: 147.8±15.1 mmHg; p=0.68) with a significantly lower medication burden in the RDN group (mean daily defined dose: 1.5±1.5 vs 2.3±1.7; p=0.017). CONCLUSIONS: In this trial, alcohol-mediated RDN was delivered safely but was not associated with significant BP differences between groups. Medication burden was lower in the RDN group up to 12 months.

The Potential Role of Renal Denervation in the Management of Heart Failure.

Sympathetic nervous system activation in patients with heart failure is one of the main pathophysiologic mechanisms associated with the worse outcomes. Pharmacotherapies targeting neurohormonal activation have been at the center of heart failure management. Despite the advancement of therapies and the available treatments, heart failure continues to have an overall poor prognosis. Renal denervation was originally developed to lower systemic blood pressure in patients with poorly controlled hypertension, by modulating sympathetic outflow. However, more recently, multiple studies have investigated the effect of renal denervation in heart failure patients with both preserved (HFpEF) and reduced ejection fractions (HFrEF). This paper provides an overview of the potential effect of renal denervation in altering the various pathophysiologic, sympathetically mediated pathways that contribute to heart failure, and reviews the literature that supports its future use in those patients.

Intracoronary Lithotripsy Use for In-Stent Restenosis, Including Multilayer ISR.

INTRODUCTION: Intravascular lithotripsy (IVL) has been well characterized as a safe and effective method for plaque modification in the treatment of de-novo, calcific coronary artery disease. In-stent restenosis (ISR) remains a major challenge in coronary revascularization, especially "multilayer" ISR. The use of IVL in ISR remains off-label and has been described in case reports and small case series. We report the single-center experience using IVL for the treatment of ISR, including multilayer ISR. MATERIALS AND METHODS: This was a retrospective single-center study. All intracoronary percutaneous interventions requiring lithotripsy use, between May 2021 and December 2021, were reviewed. We selected only the cases involving IVL use for the treatment of in-stent restenosis. Baseline characteristics of patients were obtained from chart review. Procedural details and outcomes were obtained from reports and from a detailed review of procedural images. RESULTS: A total of 13 ISR lesions were treated with IVL, of which 5 were in cases of multilayer ISR. Procedural success was observed in 11 lesions. Three patients had recurrent angina during a mean follow-up of 133 days. None of the patients had hard outcomes of myocardial infarction or cardiac death during the follow-up period. CONCLUSION: IVL is feasible and safe for ISR treatment including multilayer ISR. IVL is associated with good immediate procedural success, and a low rate of short-term adverse outcomes.

Impact of drug adherence on blood pressure response to alcohol-mediated renal denervation.

PURPOSE: While poor drug adherence is frequent in patients with resistant hypertension, detailed analyses of the impact of drug adherence on the success of renal denervation are scarce. We report drug adherence at baseline, changes in drug adherence, and the influence of these parameters on blood pressure changes at 6 and 12 months in patients treated with alcohol-mediated renal denervation as part of the Peregrine study. MATERIALS AND METHODS: Urinary detection of antihypertensive drugs was performed using high-performance liquid chromatography-tandem mass spectrometry. Full adherence, partial adherence, and complete non-adherence were defined as 0, 1, or ≥2 drugs not detected, respectively. RESULTS: Renal denervation was performed in 45 patients with uncontrolled hypertension on ≥3 antihypertensive medications (62% men, age 55 ± 10 years). At baseline, the proportion of fully, partially, and non-adherent patients was 62% (n = 28), 16% (n = 7), and 22% (n = 10), respectively. At 6 months, adherence improved by 21% (n = 9), remained unchanged at 49% (n = 21), and worsened by 30% (n = 13). Mean 24-h systolic blood pressure decreased by 10 ± 13, 10 ± 4, and 14 ± 19 mmHg in fully, partially, and non-adherent patients (p = 0.77), and by 14 ± 14, 8 ± 11, and 14 ± 18 mmHg in patients who improved, maintained, or decreased adherence, respectively (p = 0.35). The results at 12 months were similar. CONCLUSION: About 40% of patients with apparently treatment-resistant hypertension were not fully adherent at baseline, and adherence decreased further in 30%. Nevertheless, mean blood pressure changes after renal denervation were similar irrespective of drug adherence. Our results suggest that such patients may benefit from alcohol-mediated renal denervation, irrespective of drug adherence. These findings are hypothesis-generating and need to be confirmed in ongoing sham-controlled trials.

Managing coronary artery perforation after percutaneous coronary intervention.

INTRODUCTION: Coronary artery perforation is a serious complication during percutaneous coronary intervention that results in significant increase in morbidity and mortality. In this article, we provide a state-of-the-art overview of the contemporary management of coronary perforation and the possible scenarios that operators may run into during percutaneous coronary interventions. AREA COVERED: Coronary perforation during percutaneous coronary intervention. Literature search was performed using PubMed and Google Scholar to identify the most recently published articles covering this topic. EXPERT OPINION: As part of this review, we also provide an expert commentary discussing the nuances in the recognition and management of coronary artery perforation, in addition to future directions, and improvements in technology that could make the management of coronary perforation safer and more effective.

Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location.

OBJECTIVES: The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months. BACKGROUND: The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied. METHODS: The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension. RESULTS: No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference). CONCLUSION: In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months.

Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension.

[Figure: see text].

Unusual Gastric Contrast Extravasation After Coronary Angiography.

A 79-year-old woman presented with new-onset heart failure. She had pleural effusion, pericardial effusion, and an ejection fraction of 35% on echocardiogram. Her coronary angiogram revealed mild coronary artery disease (CAD). However, initially unexplained extravasation of the contrast was also seen in the cranial view during angiogram. The decision was made to medically manage CAD, but she remained tachycardic, with borderline low blood pressure. After a series of complications and tests, clearance of contrast from the stomach was confirmed. This represents an unusual case in which fluoroscopy revealed active gastric bleeding with contrast extravasation during coronary angiography.

Catheter-based alcohol-mediated renal denervation for the treatment of uncontrolled hypertension: design of two sham-controlled, randomized, blinded trials in the absence (TARGET BP OFF-MED) and presence (TARGET BP I) of antihypertensive medications.

BACKGROUND: Arterial hypertension is a common and life-threatening condition and poses a large global health burden. Device-based treatments have been developed as adjunctive or alternative therapy, to be used with or without antihypertensive medication for treating uncontrolled hypertension. The safety and feasibility of chemical renal denervation (RDN) using the Peregrine Catheter and alcohol were demonstrated in a first-in-man and open-label clinical trials, prompting the initiation of the ongoing TARGET BP OFF-MED and TARGET BP I trials. DESIGN: The TARGET BP trials are randomized, blinded, sham-controlled trials designed to assess the safety and efficacy of alcohol-mediated RDN for the treatment of uncontrolled hypertension in the absence of antihypertensive medications (TARGET BP OFF-MED) or in addition to prescribed antihypertensive medications (TARGET BP I). Subjects with confirmed uncontrolled hypertension and suitable renal artery anatomy are randomized (1:1) to receive either RDN using the Peregrine Kit with alcohol (0.6 mL per renal artery) infused through the Peregrine Catheter or diagnostic renal angiography only (sham procedure). TARGET BP OFF-MED completed enrollment and randomized 96 subjects. TARGET BP I will randomize approximately 300 subjects and will transition to an open-label safety cohort of approximately 300 subjects receiving RDN once the primary efficacy endpoint of the Randomized Controlled Trial (RCT) cohort has been met. Primary endpoints are change in mean 24-hour ambulatory systolic blood pressure from baseline to 8 weeks (TARGET BP OFF-MED) and 3 months (TARGET BP I) post-procedure. CONCLUSION: The TARGET BP trials are the first large-scale, international, randomized trials aimed to investigate the safety and BP lowering efficacy of a novel RDN method, with perivascular alcohol delivery using the Peregrine Kit.

Novel device-based therapies to improve outcome in ST-segment elevation myocardial infarction.

Primary percutaneous coronary intervention (PPCI) has dramatically changed the outcome of patients with ST-elevation myocardial infarction (STEMI). However, despite improvements in interventional technology, registry data show little recent change in the prognosis of patients who survive STEMI, with a significant incidence of cardiogenic shock, heart failure, and cardiac death. Despite a technically successful PPCI procedure, a variable proportion of patients experience suboptimal myocardial reperfusion. Large infarct size and coronary microvascular injury, as the consequence of ischaemia-reperfusion injury and distal embolization of atherothrombotic debris, account for suboptimal long-term prognosis of STEMI patients. In order to address this unmet therapeutic need, a broad-range of device-based treatments has been developed. These device-based therapies can be categorized according to the pathophysiological pathways they target: (i) techniques to prevent distal atherothrombotic embolization, (ii) techniques to prevent or mitigate ischaemia/reperfusion injury, and (iii) techniques to enhance coronary microvascular function/integrity. This review is an overview of these novel technologies with a focus on their pathophysiological background, procedural details, available evidence, and with a critical perspective about their potential future implementation in the clinical care of STEMI patients.

Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine™ Infusion Catheter.

Renal sympathetic denervation using conventional non-irrigated radiofrequency catheters has potential technical shortcomings, including limited penetration depth and incomplete circumferential nerve damage, potentially impacting therapeutic efficacy. Against this background, second generation multi-electrode, radiofrequency and ultrasound renal denervation systems have been developed to provide more consistent circumferential nerve ablation. Irrigated catheters may allow deeper penetration while minimizing arterial injury. In this context, catheter-based chemical denervation, with selective infusion of alcohol, a potent neurolytic agent, into the perivascular space, may minimize endothelial, intimal and medial injury while providing circumferential neurolysis. Animal studies demonstrate pronounced renal norepinephrine level reductions and consistent renal nerve injury after perivascular alcohol infusion using the Peregrine Catheter. Early clinical studies demonstrated significant blood pressure reductions and a reasonable safety profile. Randomized sham-controlled trials (NCT03503773, NCT02910414) are underway to examine whether the aforementioned theoretical advantages of alcohol-medicated denervation with the Peregrine System™ Kit translate into clinical benefits.

A Next-Generation Guide Extension System for Percutaneous Coronary Intervention.

BACKGROUND: Guide catheter extension is an integral part of percutaneous coronary intervention (PCI). First generation guide catheter extension devices are monorail, blunt ended tubular structures with limitations. The CrossLiner™ is a next generation guide extension "system" intended to allow safe, deep, coronary intubation. METHODS: The CrossLiner was tested in a head-to-head study with the GuideLiner™ and GuideZilla™ in a porcine coronary model, with stenting. Data were collected from 8 coronary vessels from four animals, to evaluate the ability to deeply intubate the vessel with the guide extension. RESULTS: The CrossLiner crossed distally and through a distal stented segment in 8/8 vessels, while the first-generation devices were stuck proximal to the stent (n=2/8) or at the stent edge (n=4/8), or passed partially into the deployed stent with difficulty (2/8) vessels (p < 0.0002 for deliverability). The average depth of guide extension delivery/ "intubation" was 12.9±3.6 cm for the CrossLiner and 5.6±1.1 cm for the first-generation guide extension (p < 0.001). CONCLUSIONS: The CrossLiner is a next generation guide extension system that may offer advantages over first generation devices. Further clinical evaluation will be required to assess the role of this new device in PCI.