Clinical and neurocognitive outcomes after transcatheter aortic valve implantation (TAVI) with cerebral protection: initial experience with a novel dual-filter device in Southeast Asia.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. A novel dual-filter system to reduce cerebral embolism during TAVI recently became available. We aimed to assess the feasibility, safety, and clinical and neurocognitive outcomes of TAVI with cerebral protection in Asian patients. METHODS: 40 consecutive patients undergoing TAVI with cerebral protection were enrolled. All procedures were performed via femoral access using the self-expanding Evolut R/PRO or Portico, or the balloon-expandable SAPIEN 3 bioprostheses. Baseline characteristics, procedural and clinical outcomes were recorded. Cognition was assessed at baseline and 30 days using the abbreviated mental test (AMT). RESULTS: The mean age of the patients (75% male) was 76.4 ± 8.4 years. TAVI was uncomplicated in all patients. The filter device was successfully deployed in 38 (95.0%) patients without safety issues. There was no stroke or death at 30 days, and the survival rate at nine months was 95.0%. There was no overall cognitive change (baseline vs. 30-day AMT: 9.2 ± 1.1 vs. 9.0 ± 1.5, p = 0.12), and only 1 (2.5%) patient developed impaired cognition at 30 days. Patients with a decreased AMT score at 30 days were significantly older than those without (82.1 ± 4.5 vs. 74.4 ± 7.7 years, p = 0.019). All patients with decreased AMT scores were aged ≥ 76 years. CONCLUSION: In this early Asian experience of TAVI under cerebral protection, the filter device was successfully deployed in 95% of patients, with 100% procedural success. There were no filter-related complications and no stroke or mortality at 30 days. Overall cognition was preserved, although increased age was associated with a decline in AMT score.

Drug-Coated Balloons: A Safe and Effective Alternative to Drug-Eluting Stents in Small Vessel Coronary Artery Disease.

BACKGROUND: Drug-coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug-eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year. METHODS: We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB-only angioplasty was performed in 172 patients, whereas 163 patients were treated with second-generation DES. RESULTS: DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES-treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1-year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601). CONCLUSIONS: In this high-risk cohort of patients, DCB-only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES-treated patients, but had the added benefit of a shorter DAPT regime.

Safety and Feasibility of Renal Sympathetic Denervation in Patients With Insufficient Renal Artery Length.

Insufficient renal artery length for renal sympathetic denervation (RDN) is defined as having a main renal artery shorter than 20 mm in length. Such an anatomy is considered a contraindication for most of the currently available endovascular RDN devices. The concern stems from the need to distribute the ablation points to effect circumferential ablation causing sympathetic denervation, without the risk of injuring the renal artery. We postulate that if the requisite ablation points could be distributed between large caliber renal branches and the short main renal artery, RDN is likely feasible and safe. We demonstrate this with 2 cases using 2 different RDN devices and detail the technical feasibility.

Drug coated balloon angioplasty in elderly patients with small vessel coronary disease.

BACKGROUND: Coronary angioplasty in advanced age is associated with higher rate of comorbidities and complications. Drug coated balloon only angioplasty (DCBA) has emerged as an alternative to treat small vessel coronary disease (SVCD), of reference vessel diameters <2.8 mm, with shorter duration of dual antiplatelet (DAPT). This is the first study to assess the DCBA efficacy in an elderly population with SVCD. METHODS AND RESULTS: We performed a prospective study of 447 patients (334 patients aged <75 and 113 patients aged ⩾75 years old) acquired from the SeQuent Please Small Vessel 'Paclitaxel-Coated Balloon Only' registry. In the older age group, more patients have hypertension (89% versus 77%; p = 0.006), renal insufficiency (21% versus 6%; p < 0.001), atrial fibrillation (17% versus 7%; p = 0.001), and calcified lesions (33% versus 20%; p = 0.006). At 30 days, there was one myocardial infarction requiring target lesion revascularization (TLR) in the younger group. No major adverse cardiac event (MACE) was observed in the older group. At 9 months, the MACE rate in the younger group was 4.2% and 6.1% in the older group (p = 0.453), with TLR rates at 3.9% and 3.0% (p = 0.704) respectively. There was no cardiac death observed. CONCLUSION: DBCA in the elderly with SVCD is as safe and effective compared with younger patients despite more complex anatomy and comorbidities.

Preliminary experience with drug-coated balloon angioplasty in primary percutaneous coronary intervention.

We evaluated the clinical feasibility of using drug-coated balloon (DCB) angioplasty in patients undergoing primary percutaneous coronary intervention (PPCI). Between January 2010 to September 2014, 89 ST-elevation myocardial infarction patients (83% male, mean age 59 ± 14 years) with a total of 89 coronary lesions were treated with DCB during PPCI. Clinical outcomes are reported at 30 d follow-up. Left anterior descending artery was the most common target vessel for PCI (37%). Twenty-eight percent of the patients had underlying diabetes mellitus. Mean left ventricular ejection fraction was 44% ± 11%. DCB-only PCI was the predominant approach (96%) with the remaining 4% of patients receiving bail-out stenting. Thrombolysis in Myocardial Infarction (TIMI) 3 flow was successfully restored in 98% of patients. An average of 1.2 ± 0.5 DCB were used per patient, with mean DCB diameter of 2.6 ± 0.5 mm and average length of 23.2 ± 10.2 mm. At 30-d follow-up, there were 4 deaths (4.5%). No patients experienced abrupt closure of the infarct-related artery and there was no reported target-lesion failure. Our preliminary experience showed that DCB angioplasty in PPCI was feasible and associated with a high rate of TIMI 3 flow and low 30-d ischaemic event.

Subacute bioresorbable vascular scaffold thrombosis: a report of 2 cases.

Drug-eluting bioresorbable vascular scaffold (BVS) is a revolutionary treatment option for obstructive coronary artery disease in percutaneous coronary intervention. It restores blood flow to the myocardium but unlike permanent metallic stent, BVS dissolves in the body within 2 years. This allows the coronary vessel to regain its normal function and motion. The clinical efficacy and safety of BVS in the first-in-human trials have been reported with low major adverse cardiac event rates observed at short- and long-term follow-up. The incidence of BVS scaffold thrombosis (ST) in these studies was 0 %. There is limited data on the incidence of BVS ST in the real world. We report 2 cases of subacute ST involving BVS in our real-world practice and discuss on the possible mechanisms of these thrombotic episodes (with insights from intracoronary imaging studies).

Renal function and anaemia in acute myocardial infarction.

BACKGROUND: Impaired renal function and anaemia are common among patients with acute myocardial infarction (AMI). While both conditions are known independent risk factors for increased mortality, their interaction as risk factors for increased mortality in AMI is unclear. METHODS: We studied 5395 subjects hospitalized for AMI between January 2000 and December 2005. An estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m(2) was defined as impaired GFR and GFR ≥ 60 mL/min/1.73 m(2) was defined as preserved GFR. Anaemia was defined as <13 g/dL (males) and <12 g/dL (females). The odds ratio (OR) for one-year mortality and its 95% confidence interval (CI) were calculated by logistic regression. RESULTS: We identified 758 (14%) patients with impaired GFR and anaemia, 1105 (20.5%) patients with impaired GFR without anaemia, 465 (8.6%) patients with preserved GFR and anaemia, and 3012 (55.8%) patients with preserved GFR without anaemia; one-year mortality rates were 56.5%, 41.8%, 31.8% and 10.3% respectively in these 4 groups. Among patients with impaired GFR, anaemia was associated with an adjusted OR of 1.47 (95% CI=1.17-1.85) for one-year mortality, while among patients with preserved GFR, anaemia was associated with a higher adjusted OR of 2.07 (95% CI=1.54-2.76) for one-year mortality, interaction P<0.001. CONCLUSION: The combination of impaired GFR and anaemia confers greater than five-fold increased risk of mortality after AMI. The differential effect of anaemia among patients with impaired and preserved GFR on mortality suggests that in patients with preserved GFR anaemia confers a greater relative hazard than in patients with impaired renal function.

Clinical Efficacy and Safety of SeQuent Please Paclitaxel-Eluting Balloon in a Real-World Single-Center Registry of South-East Asian Patients.

BACKGROUND: Drug eluting balloon (DEB) is a new therapeutic option for treatment of obstructive coronary lesions in percutaneous coronary intervention (PCI). There is limited data on the safety and efficacy of DEB in Asian patients in contemporary clinical registries. We evaluated the clinical efficacy and safety of SeQuent Please paclitaxel-eluting balloon in our cohort of South-East Asian patients in real world clinical practice. METHODS: Between January 2010 to November 2012, 320 patients (76% male, mean age 61.3 ± 11.2 years) with a total of 337 coronary lesions were treated with SeQuent Please drug-eluting balloon (DEB). The primary endpoint was major adverse cardiac events (MACE) ie a composite of cardiovascular death, target vessel related myocardial infarction (MI) and target lesion revascularization (TLR) at 9 months follow-up. RESULTS: The majority of patients presented with acute coronary syndrome (76%).The most common indication for the use of DEB was small vessel disease (54%) followed by instent restenosis (21%), bifurcation lesions (6%) and others (19%). An average of 1.23 ± 0.5 DEB were used per patient, with mean DEB diameter of 2.6 ± 0.6 mm and average total length of 24.0 ± 11.1 mm.At 9 months follow-up, 5.3% of patients developed MACE. MACE was mainly driven by TLR(4%) followed by target vessel related myocardial infarction (2.6%) and cardiovascular death (1%). CONCLUSION: SeQuent Please DEB was a safe and effective treatment modality in our cohort of South-East Asian patients with a low incidence of MACE observed at 9 months follow-up.

Deliverability of integrity coronary stents in severely tortuous coronary arteries: a preliminary experience.

BACKGROUND: Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCIs) and >90% of these failures are due to vessel tortuosity and/or calcification. Stent performance of the newly launched Integrity coronary stent has markedly improved due to its novel manufacturing process utilizing continuous sinusoid technology. We sought to evaluate the deliverability of Integrity coronary stents in severely tortuous coronary lesions in real-world clinical practice. METHODS: From January to August 2011, a total of 35 patients (25 males; mean age, 60.7 ± 11.4 years) with obstructive coronary artery disease involving severely tortuous coronary vessels underwent PCI with Integrity coronary stents. RESULTS: The most common target vessel for PCI was left circumflex artery (54.3%) followed by right coronary artery (42.8%) and left anterior descending (2.9%), with 37.1% of lesions located distally. Mean stent diameter was 3.04 ± 0.51 mm and mean stent length was 20.5 ± 6.6 mm. Acute procedural success was achieved in 33 patients (94%) using conventional PCI techniques. Predilatation was performed in 31 patients (89%) and buddy wires were used in 12 patients (34.3%). For the 2 cases (6%) in which stent delivery failed, Heartrail catheters were used as a bailout to facilitate stent delivery. There were no peri- or postprocedural adverse events. CONCLUSION: This early experience with Integrity coronary stent in severely tortuous coronary arteries yielded a promising result in terms of stent deliverability. It could potentially shorten PCI procedural time in this technically challenging subgroup of patients.

Clinical outcomes of intracoronary eptifibatide bolus only versus intracoronary bolus and intravenous infusion of eptifibatide in primary percutaneous coronary intervention.

Intracoronary bolus of eptifibatide during percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has been shown to result in higher local platelet glycoprotein IIb/IIIa receptor occupancy with improved microvascular perfusion. It is unclear whether intracoronary administration of eptifibatide in a larger patient population results in favourable clinical outcomes. We evaluated the safety and efficacy of two regimens of intracoronary eptifibatide (bolus only versus bolus followed by intravenous infusion) in patients undergoing primary PCI for ST-elevation MI. They were divided into two groups: Group A (n=67) who received fixed-dose intracoronary eptifibatide bolus only and Group B (n=88) who received intracoronary bolus and continuous intravenous infusion of eptifibatide for 18 h. The preliminary findings from our registry showed that both regimens were associated with good angiographic outcomes, few bleeding events and low in-hospital major adverse cardiac events. A large prospective randomized, multi-centre trial is needed to confirm our observation.

Good visibility of TITAN-2 coronary stents demonstrable on cardiac computer tomographic angiography: a report of 2 cases.

Numerous studies have sought to assess stent patency by cardiac computer tomographic angiography (CCTA) in comparison with invasive coronary angiography in patients who had undergone percutaneous coronary stenting. Even with newer generation scanners, CCTA has been of limited value in the assessment of the revascularized patient. The main reason being blooming artifact from metallic stents often obscures stent luminal dimension, making the stented segment unassessable. We report on a novel finding of good visibility of TITAN-2 coronary stents demonstrable on CCTA for 2 patients and discuss the possible mechanism and potential implications of this observation.

Successful percutaneous coronary intervention of 2 cases of complex coronary lesions facilitated by use of 0.010-inch guidewire and compatible balloon catheters.

We describe 2 cases of complex coronary lesions in which the conventional 0.014-inch balloon catheters failed to cross a chronic subtotal occlusion and also failed to adequately predilate a calcified coronary lesion. The novel use of a 0.010-inch guidewire and compatible balloon catheters in both cases allowed us to perform the percutaneous coronary intervention (PCI) successfully, and we highlight the usefulness of these new devices as important adjunctive tools in PCI. (J Interven Cardiol 2011;24:315-319).