Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.

BACKGROUND: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. OBJECTIVES: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. RESULTS: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. CONCLUSIONS: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).

Update on advanced interventional neuromodulatory approaches to lower blood pressure.

Herein, we review interventional peripheral neuromodulatory approaches to reduce blood pressure (BP), specifically focusing on catheter-based renal denervation (RDN), as well as the latest data from recent clinical trials underpinning its clinical use. Given the apparent failure of established lifestyle measures and pharmacologic BP-lowering approaches to improve hypertension (HTN) control rates, the past decade has seen remarkable scientific efforts to explore the utility of interventional strategies for BP management. Experimental studies and human clinical trials have demonstrated the crucial role of the sympathetic nervous system in the development and mainenance of HTN - consequently, most recent interventional technologies aimed primarily at modulating neural pathways. Advanced approaches that were rigorously tested in human studies include RDN, endovascular baroreflex amplification, baroreflex activation therapy and cardiac neuromodulation stimulation.Amongst these, RDN is by far the most established technology. With recent robust evidence from clinical trials and real-world data showing the safety and efficacy of both ultrasound and radiofrequency-based approaches, a recent clinical consensus statement of the European Society of Cardiology Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions concludes that RDN represents an ancillary therapeutic option in patients with uncontrolled resistant HTN confirmed by ambulatory blood pressure measurement and in spite of attention to lifestyle changes and optimised pharmacological treatment. Furthermore, RDN could alos be considered for patienst unlikley to adhere to or tolerate long-term antihypertensive drug treatment. Very recent data indicate long-term safety and efficacy up to 10 years. Appropriate implementation of RDN into clinical practice is now warranted.For all other interventions additional data from adequately designed human studies are required to establish their safety and clinical utility for potential future use in routine practice.

Percutaneous extraction of a malpositioned subclavian arterial pacing lead using the retained wire technique and a vascular closure device: a case report.

Background: Inadvertent lead malposition (ILM) in the left ventricle (LV) via the subclavian artery is a rare complication during the insertion of cardiac implantable electronic devices (CIED). If not identified, there is a risk of systemic thromboembolism. Transarterial pacing lead extraction often requires surgical removal and carries high risks of bleeding and thromboembolism, but percutaneous extraction has also been previously described. Case summary: A 71-year-old female presented with left homonymous hemianopia on Day 1 post-insertion of a dual-chamber permanent pacemaker (PPM). A computed tomography (CT) angiogram of the brain and aortic arch revealed an acute occlusion of a branch of the right posterior circulating artery (PCA) and a malpositioned pacing lead in the left subclavian artery. Urgent percutaneous removal of the transarterial lead using the retained wire technique was successfully performed. Discussion: Inadvertent lead malposition in the arterial system is rare and often requires lead extraction due to systemic thromboembolic complications. The retained wire technique has been previously described for percutaneous transvenous lead extraction and exchange, but to our knowledge, we are the first to report utilizing this technique for transarterial lead extraction. Using a case report, we highlight the utility, safety, and effectiveness of the retained wire technique in extracting a malposition lead in the subclavian artery and LV.

Early Australian experience with intravascular lithotripsy treatment of severe calcific coronary stenosis: IVL in acute/chronic coronary syndromes.

Aims: Calcified coronary stenoses are a serious impediment to optimal stent expansion and can lead to stent failure and catastrophic adverse outcomes. We hereby present early Australian experience with intravascular lithotripsy for the treatment of calcific lesions in acute and chronic coronary syndromes. Methods and results: This was a single-centre retrospective study of all patients treated with intravascular lithotripsy (IVL) between October 2019 and June 2021. Patient demographics, procedural variables, and treatment safety/efficacy outcomes were evaluated. During this period, there were 40 patients and 41 coronary lesions with IVL-assisted percutaneous coronary intervention (PCI) (70% male; mean age 72.8±9.5 years). Indications for PCI were acute coronary syndromes in 25 patients (62.5%), and stable angina in 15 patients (37.5%). Upfront IVL usage occurred in 5% of cases with the rest being bailout procedures due to suboptimal initial balloon predilatation or stent underexpansion. Angiographic success (<20% residual stenosis) occurred in 37 cases (92.5%), with mean residual stenosis of 8.25%±8.5%. Two patients experienced procedural complications (5%). Conclusions: IVL appears to be a safe and effective modality in modifying coronary calcium to achieve optimal stent expansion in real-world practice. This device obviates the need for more complex lesion preparation strategies such as rotational or orbital atherectomy.

Interventional Approaches for Loin Pain Hematuria Syndrome and Kidney-Related Pain Syndromes.

PURPOSE OF REVIEW: Loin pain hematuria syndrome (LPHS) frequently presents with severe chronic pain that poses a clinical challenge. Current treatment approaches are mostly empirical and include a wide range of therapeutic strategies such as physical therapy, local and systemic analgesia, interventional and surgical approaches usually flanked by psycho-behavioral therapy, and other strategies. LPHS often impacts negatively on quality of life particularly in patients who are refractory to treatment. RECENT FINDINGS: With recent advances in catheter-based treatment approaches and better understanding of the pathophysiology of LPHS, intraluminal renal denervation (RDN) has been proposed as a valuable treatment option for kidney-related pain syndromes. The present review provides a brief overview of the clinical challenges associated with LPHS, highlights recent insights into its underlying mechanisms, and summarizes currently available data on the use of RDN in the context of LPHS and kidney-related pain syndromes. Renal denervation via various approaches including surgical and catheter-based techniques has shown promise in alleviating kidney-related pain syndromes. Randomized controlled trials are now required to better define its role in the management of these conditions.

Difficult Retrieval of a Broken Catheter From a Total Implantable Venous Access Device.

A broken TIVAD catheter segment was discovered lodged within the right ventricle of a man presenting with chest pain. The catheter removal is detailed.

First-in-Man Experience with a Novel Catheter-Based Renal Denervation System of Ultrasonic Ablation in Patients with Resistant Hypertension.

PURPOSE: To report results of renal denervation (RDN) with the first catheter-based, non-balloon occlusion ultrasonic system in patients with resistant hypertension. MATERIALS AND METHODS: In a multicenter, single-arm trial, 39 patients with resistant hypertension (defined as uncontrolled hypertension while taking ≥ 3 antihypertensive medications) were treated. The cohort consisted of 4 groups: severe resistant hypertension (office systolic blood pressure [OSBP] ≥ 160 mm Hg) treated with a unidirectional catheter (group 1; n = 14); severe resistant hypertension treated with a multidirectional catheter (group 2; n = 18); moderate resistant hypertension (OSBP 140-159 mm Hg) treated with a multidirectional catheter (group 3; n = 5); and recurrent severe resistant hypertension, after an initial response to RF RDN (group 4; n = 2). Blood pressure monitoring was performed for 6 months. RESULTS: Severe adverse events were not noted immediately after the procedure or during follow-up. Treatment time was longer with unidirectional than with multidirectional catheters (36.7 min ± 9.6 vs 11.9 min ± 5.8; P < .001). Mean reductions in office blood pressure (systolic/diastolic) at 1, 3, and 6 months were -26.1/-9.6 mm Hg, -28.0/-9.9 mm Hg, and -30.6/-14.1 mm Hg (P < .01 for all). Per-group analysis showed significant OSBP reduction for groups 1 and 2. Patients with isolated systolic hypertension had a significantly smaller reduction in OSBP after 6 months compared with patients with combined systolic/diastolic hypertension (-16.2 mm Hg ± 18.5 vs -9.9 mm Hg ± 33.4; P < .005). CONCLUSIONS: Use of the RDN system was feasible and safe in this phase I study. Significant blood pressure reductions were observed over 6 months, although less in patients with isolated systolic hypertension.

Sympathetic Response and Outcomes Following Renal Denervation in Patients With Chronic Heart Failure: 12-Month Outcomes From the Symplicity HF Feasibility Study.

BACKGROUND: Heart failure (HF) is associated with chronic sympathetic activation. Renal denervation (RDN) aims to reduce sympathetic activity by ablating the renal sympathetic nerves. We investigated the effect of RDN in patients with chronic HF and concurrent renal dysfunction in a prospective, multicenter, single-arm feasibility study. METHODS AND RESULTS: Thirty-nine patients with chronic systolic HF (left ventricular ejection fraction [LVEF] <40%, New York Heart Association class II-III,) and renal impairment (estimated glomerular filtration rate [eGFR; assessed with the use of the Modification of Diet in Renal Disease equation] < 75 mL • min-1 • 1.73 m-2) on stable medical therapy were enrolled. Mean age was 65 ± 11 years; 62% had ischemic HF. The average number of ablations per patient was 13 ± 3. No protocol-defined safety events were associated with the procedure. One subject experienced a renal artery occlusion that was possibly related to the denervation procedure. Statistically significant reductions in N-terminal pro-B-type natriuretic peptide (NT-proBNP; 1530 ± 1228 vs 1428 ± 1844 ng/mL; P = .006) and 120-minute glucose tolerance test (11.2 ± 5.1 vs 9.9 ± 3.6; P = .026) were seen at 12 months, but there was no significant change in LVEF (28 ± 9% vs 29 ± 11%; P= .536), 6-minute walk test (384 ± 96 vs 391 ± 97 m; P= .584), or eGFR (52.6 ± 15.3 vs 52.3 ± 18.5 mL • min-1 • 1.73 m-2; P= .700). CONCLUSIONS: RDN was associated with reductions in NT-proBNP and 120-minute glucose tolerance test in HF patients 12 months after RDN treatment. There was no deterioration in other indices of cardiac and renal function in this small feasibility study.

First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study.

OBJECTIVES: This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease. BACKGROUND: Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. METHODS: The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data. RESULTS: Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred. CONCLUSIONS: At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).

First-in-human evaluation of a novel polymer-free drug-filled stent: angiographic, IVUS, OCT, and clinical outcomes from the RevElution study

OBJECTIVES:This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.BACKGROUND:Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.METHODS:The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data...

Effect of non-surgical periodontal therapy on superoxide dismutase levels in gingival tissues of chronic periodontitis patients: a clinical and spectophotometric analysis.

BACKGROUND: Superoxide dismutase (SOD), an antioxidant acting against superoxide (oxygen radical, O(2)(∙-)), it is released in inflammatory pathways and causes connective tissue breakdown. Increased SOD activity in inflamed gingiva may indicate increased O(2)(∙-) radical generation by neutrophils and other inflammatory cells at the diseased site. The aim of the study was to evaluate the effects of non-surgical periodontal therapy (NSPT) on SOD levels in gingival tissues of chronic periodontitis patients. METHODS: Forty subjects: 20 periodontally healthy (Control) and 20 chronic periodontitis (Test); age range 24-55 years were recruited. Gingival tissue samples were collected by excising the inner lining of the periodontal pocket at baseline (prior to non-surgical periodontal therapy) and 2 months post therapy. In controls, tissue samples were obtained immediately after tooth extraction scheduled for orthodontic reasons. Clinical parameters included probing depth, clinical attachment level, gingival index, bleeding index, plaque index. SOD activities were assessed spectrophotometrically at baseline and 2 months post NSPT, results were analysed statistically. RESULTS: At baseline, patients with chronic periodontitis had higher mean SOD activity (2.73 ± 1.36) than the control subjects (1.12 ± 1.13) with p=0.00003 (p< 0.05). At 2 months post NSPT median SOD level (1.00) had come close to median SOD value of control group (0.85); p=0.99 (p> 0.05). The resolution of inflammation with successful NSPT resulted in decreased SOD levels as in control group. Clinical parameters in patients with chronic periodontitis showed a significant improvement 2 months post NSPT (p< 0.05). CONCLUSION: Non-surgical periodontal therapy significantly improves the clinical parameters and restores previously increased SOD levels to normal in chronic periodontitis patients.

Transcatheter renal artery sympathetic denervation for resistant hypertension: an old paradigm revisited.

Resistant hypertension, defined as the failure to achieve target blood pressure despite concurrent use of 3 antihypertensive agents of different classes, is estimated to affect 20-30% of hypertensive patients. These patients are vulnerable to cardiovascular, cerebrovascular and renal complications. There is ample evidence that sympathetic nervous system hyperactivity contributes to the initiation, maintenance and progression of hypertension. The renal sympathetic nervous system, in particular, has been identified as a major culprit for the development and progression of hypertension, heart failure and chronic kidney disease in both preclinical and human studies. Traditional surgical sympathectomy proposed in 1940s was halted due to unacceptable operative risk and the emergence of anti-hypertensive medications. Recently, catheter-based renal sympathetic denervation by radiofrequency ablation has shown encouraging intermediate-term results with minimal complications in patients with resistant hypertension. This review summarizes the patho-physiological role of the renal sympathetic nervous system and the potential application of renal denervation therapy for the treatment of resistant hypertension.

Left main coronary artery stenting prior to surgical repair of a type a aortic dissection.

Type A aortic dissection (TAAD) can be complicated by myocardial ischemia due to extension of the dissection into coronary artery or by extrinsic compression of a coronary artery by the false lumen. We present the successful surgical management of a hemodynamically unstable patient with acute aortic dissection with ongoing myocardial ischemia by stenting the left main system prior to the surgical repair of TAAD.

Percutaneous closure after inadvertent subclavian artery cannulation.

Accidental insertion of an arterial sheath is an uncommon but potentially serious complication of jugular venous catheterization. When the subclavian artery is inadvertently cannulated, sheath removal can be complicated by significant hemorrhage due to its incompressible location. We report a case of inadvertent insertion of an 8 French sheath into the subclavian artery, which was successfully removed and the puncture site sealed with a collagen-based vascular closure device (Angio-Seal STS Plus). This averted an otherwise emergent open surgical procedure to remove the sheath and repair the subclavian artery in a high-risk patient.

Anomalous right coronary artery angioplasty complicated by intramural hematoma in the ascending aorta.

An iatrogenic intramural hematoma (IMH) localized in the ascending aorta is a rare and potentially life-threatening complication following percutaneous coronary intervention (PCI). We describe the case of an ascending aortic IMH after the PCI of an anomalous right coronary artery. Early extension of the hematoma was observed during transesophageal echocardiography; the patient underwent successful surgical repair.