An analysis of long-term clinical outcome following the use of excimer laser coronary atherectomy in a large UK PCI center.

BACKGROUND: Excimer laser atherectomy (ELCA) is an established adjunctive technique to facilitate acute success in percutaneous coronary intervention (PCI). Despite this there are a lack of contemporary outcome data, particulary longer-term, forpatients treated with ELCA PCI. AIMS: To evaluate the contemporary use ofELCA in PCI, the frequency of periprocedural complications and the longer-term outcomes associated with ELCA PCI. METHODS: This was a retrospective study that included all patients undergoing PCI (with or without ELCA) between April 2005 and May 2021. Relevant features from all cases were downloaded from the patient record and matched to hospital data on mortality on November 22, 2022. Kaplan Meier curves were used to compare mortality between the ELCA PCI and non-ELCA PCI cohorts with a landmark at 1 year. Multivariable Cox regression was performed to assess whether ELCA PCI was independently associated with long-term mortality. RESULT: There were 21,256 patients in this analysis, of which 448 (2.1%) were treated with ELCA PCI. ELCA PCI was associated with a higher frequency of any periprocedural complication. Median follow-up was 2812 days (IQR, 1577-4245 days) with higher mortality in ELCA PCI (38.2% vs. 29.0%, p < 0.001). However, on multivariable analysis, ELCA PCI was not independently associated with long-term mortality. The TVR frequency in ELCA PCI was 16.7% but TVR was significantly higher for cases of in-stent restenosis (ISR) (29.5%). CONCLUSION: Despite ELCA PCI being used in higher risk populations with complex coronary artery disease there was no long-term increased mortality associated with the use of this device. ELCA PCI for ISR is highly effective and safe although TVR in this cohort remains high in long-term follow-up.

Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.

BACKGROUND: Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. METHODS: In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426. FINDINGS: Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. INTERPRETATION: Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. FUNDING: ReCor Medical.

Novel application of intravascular lithotripsy in stent under-expansion: A single-center experience.

INTRODUCTION: Stent under-expansion due to calcification is associated with a less durable result. The development of intravascular lithotripsy (IVL) has provided clinicians with a readily available, simple-to-use treatment option for coronary calcification, but the use of IVL within a previously stented segment is currently off-license. There are, however, developing data suggesting that the use of IVL can be an effective treatment option for patients with calcific stent under-expansion. METHOD: This was a single-center study of all patients treated with IVL for calcific stent under-expansion between January 2019 and June 2021. The impact of IVL on quantitative coronary angiography (QCA) stenosis and on the minimal stent area (MSA) derived from intracoronary imaging were recorded. The presence of periprocedural complications and adverse cardiovascular events was obtained from the clinical record during the study timeframe. RESULTS: Thirty-nine patients underwent IVL for calcific stent under-expansion during the study time frame with one patient treated with more than one lesion in the same session. In all lesions, there was an improvement in the QCA stenosis with 37 (92.5%) having a residual stenosis of ≤30%. The mean QCA stenosis pre-IVL was 68 ± 21% and following IVL the mean QCA was 18 ± 9% (p < 0.001). In all lesions, there was an improvement in the MSA, with 26 (92.9%) achieving an MSA of more than 4.5 mm2 . The mean MSA pre-IVL was 3.88 ± 1.51 mm2 and following IVL the mean MSA was 7.41 ± 2.34 mm2 (p < 0.001). There were no major procedural complications. Over a mean follow-up of 506 ± 277 days, one patient died from ventricular arrhythmia but there were no other major adverse cardiovascular events. CONCLUSION: This single-center study demonstrates that IVL is a safe and effective treatment for calcific stent under-expansion with good medium-term results.

Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial.

BACKGROUND: Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. METHODS: RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic-diastolic hypertension aged 18-75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. FINDINGS: Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (-8·5 mm Hg, SD 9·3) than with the sham procedure (-2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: -6·3 mm Hg, 95% CI -9·4 to -3·1, p=0·0001). No major adverse events were reported in either group. INTERPRETATION: Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic-diastolic hypertension in the absence of medications. FUNDING: ReCor Medical.

Feasibility and Efficacy of Herculink Elite ((TM)) Biliary Stent Implantation in Large Coronary Arteries (≥ 5 mm) and Venous Conduits: An Observational Study.

BACKGROUND AND OBJECTIVES: Percutaneous coronary intervention (PCI) in patients with lesions of large calibre coronary arteries (≥ 5 mm) and saphenous venous grafts (≥ 5 mm) can be challenging. There are no separate guidelines available to treat these vessels with PCI. Standard coronary stents of 4 mm diameter are used to treat these lesions conventionally but carry the risk of under deployment, distortion of stent architecture and future stent thrombosis even if they are subsequently expanded beyond 5 mm. METHODS AND RESULTS: Biliary stents (Herculink Elite™) provide a better alternative to standard coronary stents in these patients. These stents are of larger diameter (5-7 mm) and can be safely delivered over a 6 French sheath. In our case series, we demonstrate the use of intravascular ultrasound examination to confirm that biliary stents provide improved stent strut apposition within the coronary artery associated with extremely low repeat revascularisation rates. CONCLUSION: Our paper highlights that PCI of lesions in patients with large calibre coronary arteries can successfully be achieved using biliary stents.

Durability of blood pressure reduction after ultrasound renal denervation: three-year follow-up of the treatment arm of the randomised RADIANCE-HTN SOLO trial.

BACKGROUND: While the blood pressure (BP)-lowering effect of renal denervation (RDN) has been established, long-term durability is a key prerequisite for a broader clinical implementation. AIMS: Our aims were to assess the long-term durability of the office BP (OBP)-lowering efficacy, antihypertensive medication (AHM) use, and safety of ultrasound RDN (uRDN). METHODS: Four weeks after withdrawal of AHM, patients with untreated daytime ambulatory BP ≥135/85 mmHg and <170/105 mmHg were randomised to uRDN (n=74) or sham (n=72) in the RADIANCE-HTN SOLO trial. Initiation of AHM was encouraged for home BP >135/85 mmHg following primary endpoint ascertainment at 2 months. Patients and physicians were unblinded at 6 months.  Results: Fifty-one of 74 patients (age: 53.9±11 years; 67% men) originally randomised to uRDN completed the 36-month follow-up. Initial screening OBP upon study entry was 145/92±14/10 mmHg on a mean of 1.2 AHM (range: 0-2.0). Baseline OBP after AHM washout was 154/99±13/8 mmHg. At 36 months, patients were on an average of 1.3 AHM (range: 0-3.0) with 8 patients on no AHM. OBP decreased by 18/11±15/9 mmHg from baseline to 36 months (p<0.001 for both). Overall, OBP control (<140/90 mmHg) improved from 29.4% at screening to 45.1% at 36 months (p=0.059). For patients uncontrolled at screening (n=36), systolic OBP decreased by 10.8 mmHg (p<0.001) at 36 months on similar AHM (p=0.158). CONCLUSIONS: The safety and effectiveness of uRDN was durable to 36 months, with reduced OBP and improved OBP control despite a similar starting medication burden. No new uRDN-related long-term safety concerns were identified.

Renal Artery Variations in Patients With Mild-to-Moderate Hypertension From the RADIANCE-HTN SOLO Trial.

PURPOSE: To assess the variability of renal artery (RA) anatomy and presence of RA-pathology in patients with mild-to-moderate hypertension enrolled in the RADIANCE-HTN SOLO trial. BACKGROUND: RADIANCE-HTN SOLO was a multicenter, international, blinded, randomized, sham-controlled trial evaluating ultrasound-based endovascular renal denervation (RDN) in patients with mild-to-moderate hypertension while off antihypertensive medications. METHODS: Eligible subjects had pre-randomization renal CT- or MR- angiography (CTA, MRA) to confirm anatomic suitability and to define RA ablation sites. All images were sent for independent review for evaluation of RA anatomy and other vascular pathology. RESULTS: A total of 324 patients underwent RA imaging (282 CTA and 42 MRA). Of those, 178 had simple anatomy with a single left and single right RA with mean diameters of 5.4 ± 0.9 and 5.1 ± 0.8 mm and mean lengths of 40.0 ± 12.9 and 52.0 ± 13.1 mm, respectively. Twenty-seven patients (8.3%) had unilateral or bilateral dual RAs with mean diameters of 4.0 ± 0.9 mm on the left and 3.9 ± 0.9 mm on the right. Forty percent (129/324) of patients had at least 1 accessory RA, with mean accessory diameters of 2.4 ± 0.8 mm on the left and 2.3 ± 0.8 mm on the right. Twenty-eight patients (8.6%) had at least 1 short (<25 mm) main RA. Incidental findings included: 9 patients (2.8%) with atherosclerotic RA stenosis ≥30%, 9 patients (2.8%) with fibromuscular dysplasia of RA and 2 patients (0.6%) with kidney and adrenal gland tumors. CONCLUSIONS: Pre-procedure CTA or MRA imaging is a valuable aid in assessing RA anatomy prior to RDN because of variable RA anatomy. CTA or MRA may detect RA lesions, and renal or adrenal tumors which may need additional workup prior to consideration of RDN. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02649426.

Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation: Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial.

Importance: Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. Objectives: To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. Design, Setting, and Participants: This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. Interventions: uRDN vs sham procedure in conjunction with added medications to target BP control. Main Outcomes and Measures: Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. Results: A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of -2.4 [16.6] vs -7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups. Conclusions and Relevance: In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group. Trial Registration: ClinicalTrials.gov Identifier: NCT02649426.

The role of computed tomography coronary angiography in multi-vessel coronary vasospasm: a case report.

BACKGROUND: Coronary vasospasm can present like an acute coronary syndrome (ACS) with an intense vasoconstriction resulting in total or near-total occlusion of one or more of the coronary vessels. Definitive diagnosis can be made by intracoronary provocation testing. CASE SUMMARY: A 37-year-old Caucasian male and smoker was admitted with chest pain. Highly sensitive troponin-I was positive at 63 ng/L (99th percentile upper reference limit, <15 ng/L) with a repeat value of 45 ng/L three and a half hours later which was of clinical significance. Serial electrocardiography (ECG) showed no ischaemic changes. Coronary angiography revealed several distal and side branch stenoses; however, angiographic appearances were atypical of coronary plaque. A differential diagnosis of spontaneous coronary artery dissection was suspected although the patient was pain free during the procedure. Computed tomography coronary angiography (CTCA) demonstrated normal coronary arteries, confirmed on repeat invasive coronary angiography. Cold pressor testing was unsuccessful in reproducing vasospasm. Acute coronary syndrome treatment was discontinued, he received smoking cessation advice and Amlodipine 5 mg daily was started. He has experienced no further episodes of cardiac chest pain on follow-up consultation 7 months later. DISCUSSION: This is an unusual case of persistent, extensive coronary vasospasm in a patient without ongoing chest pain or ischaemic ECG changes. Intracoronary nitrates are usually effective at relieving coronary spasm. Cold pressor testing has poor sensitivity for diagnosing vasospasm when compared to intracoronary provocation testing using either acetylcholine or ergonovine. Multi-slice CTCA may help to discriminate coronary plaque from coronary vasospasm when there is diagnostic uncertainty.

12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation.

OBJECTIVES: This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months. BACKGROUND: The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported. METHODS: Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety. RESULTS: Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography. CONCLUSIONS: Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.

Joint UK societies' 2019 consensus statement on renal denervation.

Improved and durable control of hypertension is a global priority for healthcare providers and policymakers. There are several lifestyle measures that are proven to result in improved blood pressure (BP) control. Moreover, there is incontrovertible evidence from large scale randomised controlled trials (RCTs) that antihypertensive drugs lower BP safely and effectively in the long-term resulting in substantial reduction in cardiovascular morbidity and mortality. Importantly, however, evidence is accumulating to suggest that patients neither sustain long-term healthy behaviours nor adhere to lifelong drug treatment regimens and thus alternative measures to control hypertension warrant further investigation. Endovascular renal denervation (RDN) appears to hold some promise as a non-pharmacological approach to lowering BP and achieves renal sympathectomy using either radiofrequency energy or ultrasound-based approaches. This treatment modality has been evaluated in clinical trials in humans since 2009 but initial studies were compromised by being non-randomised, without sham control and small in size. Subsequently, clinical trial design and rigour of execution has been greatly improved resulting in recent sham-controlled RCTs that demonstrate short-term reduction in ambulatory BP without any significant safety concerns in both medication-naïve and medication-treated hypertensive patients. Despite this, the joint UK societies still feel that further evaluation of this therapy is warranted and that RDN should not be offered to patients outside of the context of clinical trials. This document reviews the updated evidence since our last consensus statement from 2014 and provides a research agenda for future clinical studies.

Renal artery sympathetic denervation: observations from the UK experience.

BACKGROUND: Renal denervation (RDN) may lower blood pressure (BP); however, it is unclear whether medication changes may be confounding results. Furthermore, limited data exist on pattern of ambulatory blood pressure (ABP) response-particularly in those prescribed aldosterone antagonists at the time of RDN. METHODS: We examined all patients treated with RDN for treatment-resistant hypertension in 18 UK centres. RESULTS: Results from 253 patients treated with five technologies are shown. Pre-procedural mean office BP (OBP) was 185/102 mmHg (SD 26/19; n = 253) and mean daytime ABP was 170/98 mmHg (SD 22/16; n = 186). Median number of antihypertensive drugs was 5.0: 96 % ACEi/ARB; 86 % thiazide/loop diuretic and 55 % aldosterone antagonist. OBP, available in 90 % at 11 months follow-up, was 163/93 mmHg (reduction of 22/9 mmHg). ABP, available in 70 % at 8.5 months follow-up, was 158/91 mmHg (fall of 12/7 mmHg). Mean drug changes post RDN were: 0.36 drugs added, 0.91 withdrawn. Dose changes appeared neutral. Quartile analysis by starting ABP showed mean reductions in systolic ABP after RDN of: 0.4; 6.5; 14.5 and 22.1 mmHg, respectively (p < 0.001 for trend). Use of aldosterone antagonist did not predict response (p > 0.2). CONCLUSION: In 253 patients treated with RDN, office BP fell by 22/9 mmHg. Ambulatory BP fell by 12/7 mmHg, though little response was seen in the lowermost quartile of starting blood pressure. Fall in BP was not explained by medication changes and aldosterone antagonist use did not affect response.

Heart rate dependency of pulse pressure amplification and arterial stiffness.

BACKGROUND: Pulse pressure and aortic pulse wave velocity, measures of arterial stiffness, are both important determinants of cardiovascular risk. However, assessment of peripheral pulse pressure does not always provide a reliable measure of changes in central pulse pressure or arterial stiffness. The aim of the present study was to assess the effect of acute changes in heart rate on arterial stiffness and on peripheral and central pulse pressure in healthy subjects. METHODS: Twenty subjects (age range, 20 to 72 years) were studied at cardiac catheterization. Pulse wave analysis was used to determine central pressure, augmentation index (AIx), a measure of systemic arterial stiffness, and aortic pulse wave velocity (PWV) during right atrial pacing (80 to 120 beats/min). RESULTS: Pulse pressure amplification increased during pacing due to a reduction in central pressure augmentation. AIx was significantly and inversely related to heart rate (r = -0.70, P < .001) due to an alteration in the relative timing of the reflected pressure wave, rather than a reduction in arterial stiffness, as PWV did not change. CONCLUSIONS: These data suggest that peripheral pulse pressure does not provide an accurate assessment of changes in central hemodynamics in relation to changes in heart rate, and that aortic stiffness is not affected by acute changes in heart rate.

The impact of routine and intravascular ultrasound-guided high-pressure postdilatation after drug-eluting stent deployment: the STent OPtimization (STOP) study.

OBJECTIVES: Drug-eluting stent (DES) implantations with low final cross-sectional area (CSA) are associated with adverse clinical outcomes. However, there is no guidance to facilitate optimal stent deployment (SD). The stent optimization (STOP) study was performed to assess DES routine postdilatation (PD) following implantation with intravascular ultrasound (IVUS) guidance. METHODS: Forty-eight patients were included in this single-center prospective study. All DESs were deployed at 16 atm for 20 seconds and underwent routine non-compliant balloon PD (minimum 20 atm for 10 seconds). IVUS performed after SD (blinded) and PD (unblinded) measured CSA at 4 stent reference points. Optimal deployment was defined as distal and proximal stent CSA ≥60% distal and proximal reference CSA; mid and minimum stent CSA ≥70% of distal reference CSA. All per-protocol criteria were required to define optimal SD. Suboptimally deployed DESs underwent further PD with IVUS guidance (IVPD). RESULTS: Fifty-two lesions were treated in 48 patients. CSA increased by 20% following PD. STOP criteria were only achieved in 21% of DESs after SD compared to 54% after PD. IVPD was performed in 20 DESs, which increased CSA by a further 21%. STOP criteria were eventually attained in 81% cases (P<.001 for all comparisons). CONCLUSION: DES deployment leads to suboptimal deployment, which can be optimized by routine PD. IVUS identifies DES implantations that benefit from further PD. Optimizing final DES-CSA may have longterm clinical benefits, although a randomized study is required.

Beyond the balloon: excimer coronary laser atherectomy used alone or in combination with rotational atherectomy in the treatment of chronic total occlusions, non-crossable and non-expansible coronary lesions.

AIMS: To establish success and complication rates of excimer laser coronary atherectomy (ELCA) in a contemporary series of patients with balloon failure during percutaneous coronary intervention (PCI) of both chronic total occlusions (CTO) and lesions with distal TIMI 3 flow. METHODS AND RESULTS: We identified 58 cases of balloon failure treated with ELCA±rotational atherectomy (RA) over four years, representing 0.84% of all PCI performed in our centre during this period. Balloon failures were classified according to: (i) mechanism of balloon failure; and (ii) whether this occurred in the context of treating a CTO. ELCA was performed following balloon failure using the CVX-300 Excimer Laser System and a 0.9 mm catheter with saline flush. For the entire cohort, procedure success was achieved in 91% (with ELCA successful: alone in 76.1%, after RA failure in 6.8% and in combination with RA for 8.6%). Only in one case did RA succeed where ELCA had failed. There were four procedure-related complications, including transient no-reflow, side branch occlusion and two coronary perforations, of which one was directly attributable to ELCA and led to subsequent mortality. CONCLUSIONS: ELCA provides safe and effective adjunctive therapy in contemporary PCI to treat lesions associated with balloon failure due to an inability either to cross the lesion or to expand a balloon sufficiently to permit stenting. ELCA was successful in the majority of these selected cases when used independently with further effectiveness achieved when combined with RA or after RA failure.

A novel strategy for managing clopidogrel-induced adverse skin reactions.

AIMS: We conducted a prospective observational study using a course of steroids and antihistamines to treat a cohort of patients who developed skin reactions to clopidogrel, to assess whether dual antiplatelet therapy could be continued in an outpatient setting. METHODS AND RESULTS: This study included 2,701 patients who underwent percutaneous coronary intervention (PCI) at our centre over a 23 month period. Patients with skin reactions to clopidogrel were identified and then commenced on five days oral prednisolone (30 mg/od) and chlorpheniramine (4 mg/tds) for seven days. A subsequent telephone survey was performed to evaluate a number of variables. The probability of the adverse reaction being secondary to clopidogrel was assessed using the Naranjo adverse drug reaction probability scale. Twenty (0.7%) patients were identified who developed adverse skin reactions to clopidogrel. There was complete resolution seen in the majority (89%) of patients within an average of 3.2 days following treatment. One patient had partial resolution, and one had no response to treatment, but both were able to continue clopidogrel. CONCLUSIONS: We propose a novel, safe and effective way of managing clopidogrel-induced skin reactions using a short course of prednisolone and chlorpheniramine, without stopping or substituting clopidogrel.

Brachial artery perforation repaired with percutaneous transfemoral covered stent deployment in a patient on abciximab.

Radial diagnostic angiography and percutaneous coronary intervention have been shown to be safe and feasible with fewer major complications in comparison with the femoral approach. Despite their safety profile, occasional vascular complications do still occur. We present a case of a brachial artery perforation treated successfully by the deployment of a covered stent designed for coronary intervention. We believe we are the first to describe this technique, which may provide an alternative to vascular surgery in such a situation.

Myocardial iron loading by magnetic resonance imaging T2* in good prognostic myelodysplastic syndrome patients on long-term blood transfusions.

Magnetic resonance imaging (MRI) was used to quantify myocardial iron loading by T2* in 11 transfusion-dependent good prognostic myelodysplastic syndrome (MDS) patients. Myocardial T2*, left ventricular function and hepatic T2* were measured simultaneously. Patients had been on transfusion therapy for 13-123 months and had serum ferritin levels of 1109-6148 microg/l at the time of study. Five patients had not commenced iron chelation and had been transfused with a median of 63 red cell units and had a median serum ferritin level of 1490 microg/l. Six patients were on iron chelation and had been transfused with a median of 112 red cell units and had a median serum ferritin level of 4809 mug/l. Hepatic iron overload was mild in two, moderate in seven and severe in two patients. The median liver iron concentration was 5.9 mg/g dry weight in chelated patients and 9.5 mg/g in non-chelated patients (P = 0.17; not significant). Myocardial T2* indicated absent iron loading in 10/11 patients (91%; 95% confidence interval 62-98%) and borderline-normal in one patient. Left ventricular function was normal in all patients. No correlation was observed between increasing serum ferritin levels, hepatic iron overload and myocardial T2*. A long latent period relative to hepatic iron loading appears to predate the development of myocardial iron loading in transfusion-dependent MDS patients.