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  1. Leschke M, Waliszewski M, Pons M, Champin S, Nait Saidi L, Mok Heang T, et al.
    Catheter Cardiovasc Interv, 2016 Sep;88(3):358-66.
    PMID: 26650913 DOI: 10.1002/ccd.26261
    OBJECTIVES: This observational study assessed the 9-month clinical outcomes in an « all comers » population with a focus on patients with atrial fibrillation (AF) after thin strut bare metal stenting.

    BACKGROUND: Drug eluting stent (DES) implantation is the treatment of choice for coronary artery disease (CAD) leaving only marginal indications for the use of bare metal stents (BMS). However, selected treatment populations with DES contraindications such as patients who cannot sustain 6-12 months of dual antiplatelet therapy (DAPT) remain candidates for BMS implantations.

    METHODS: Thin strut bare metal stenting in a priori defined subgroups were investigated in a non-randomized, international, multicenter «all comers» observational study. Primary endpoint was the 9-month TLR rate whereas secondary endpoints included the 9-month MACE and procedural success rates.

    RESULTS: A total of 783 patients of whom 98 patients had AF underwent BMS implantation. Patient age was 70.4 ± 12.8 years. Cardiovascular risk factors in the overall population were male gender (78.2%, 612/783), diabetes (25.2%, 197/783), hypertension (64.1%, 502/783), cardiogenic shock (4.9%, 38/783) and end stage renal disease (4.9%, 38/783). In-hospital MACE was 4.1% (30/783) in the overall population. The 9-month TLR rate was 4.5% (29/645) in the non-AF group and 3.3% (3/90) in the AF group (P = 0.613). At 9 months, the MACE rate in the AF-group and non-AF group was not significantly different either (10.7%, 69/645 vs. 6.7%, 6/90; P = 0.237). Accumulated stroke rates were 0.3% (2/645) in the non-AF subgroup at baseline and 1.1% (1/90) in the AF subgroup (P = 0.264).

    CONCLUSION: Bare metal stenting in AF patients delivered acceptably low TLR and MACE rates while having the benefit of a significantly shorter DAPT duration in a DES dominated clinical practice. © 2015 Wiley Periodicals, Inc.

  2. Tay E, Muda N, Yap J, Muller DW, Santoso T, Walters DL, et al.
    Catheter Cardiovasc Interv, 2016 Jun;87(7):E275-81.
    PMID: 26508564 DOI: 10.1002/ccd.26289
    OBJECTIVES: The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR).

    INTRODUCTION: Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well.

    METHODS: The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMR patients treated with the MitraClip.

    RESULTS: A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMR patients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR.

    CONCLUSIONS: The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class. © 2015 Wiley Periodicals, Inc.

  3. Abdelbasit MA, Alwi M, Kandavello G, Che Mood M, Samion H, Hijazi ZM
    Catheter Cardiovasc Interv, 2015 Jul;86(1):94-9.
    PMID: 25675888 DOI: 10.1002/ccd.25878
    OBJECTIVES: To evaluate the feasibility, safety, and efficacy of the Occlutech® PDA occluder for closure of patent ductus arteriosus (PDA).

    BACKGROUND: The Occlutech® PDA occluder is novel, self-shaping Nitinol wire device with PET (polyethylene terephthalate) patches integrated into the shank of the device to assure a better obturation of the ductus. The Occlutech® PDA occluder has undergone two design modifications.

    METHODS: A prospective, non-randomized pilot study was started in November 2011. Thirty-three patients were included until April 2013. Patients weighing <6 kg or those with associated cardiac anomalies that required surgery were excluded. All patients were followed up by transthoracic echocardiography at 24 hr, 30 days, 90 days, 180 days, and 360 days after implantation. Residual shunt, left pulmonary artery (LPA) and descending aortic velocities were among the parameters assessed. All occluders were delivered via 6-8 F long sheaths and PDA closures were performed following standard techniques.

    RESULTS: Thirty three patients (20 female/13 male), with a median age of 2 years (6 month to 38 years), and median weight of 9.3 kg (6-69.2 kg) were included. The narrowest median PDA diameter was 3mm (1.8-5.8 mm). All the 33 patients were closed successfully using Occlutech ductal occluder, 16 patients (48.4%) had immediate and complete closure on angiography. Within 24 hr, color Doppler revealed complete closure in 27patients (81.8%), 32patients (97%) at 30 days, and in 100% of patients at 90 days. All patients with a large PDA had immediate residual shunt which was closed at the 90-day follow-up. There was no device embolization, hemolysis, or obstruction to the LPA or descending aorta.

    CONCLUSION: The new Occlutech® PDA is safe and effective. In patients with a large PDA complete closure tended to take longer time.

  4. Alwi M
    Catheter Cardiovasc Interv, 2006 May;67(5):679-86.
    PMID: 16572430
    Pulmonary atresia with intact ventricular septum (PAIVS) is a disease with remarkable morphologic variability, affecting not only the pulmonary valve but also the tricuspid valve, the RV cavity and coronary arteries. With advances in interventional techniques and congenital heart surgery, the management of PAIVS continues to evolve. This review is an attempt at providing a practical approach to the management of this disease. The basis of our approach is morphologic classification as derived from echocardiography and angiography. Group A, patients with good sized RV and membranous atresia, the primary procedure at presentation is radiofrequency (RF) valvotomy. Often it is the only procedure required in this group with the most favourable outcome. Patients with severely hypoplastic RV (Group C) are managed along the lines of hearts with single ventricle physiology. The treatment at presentation is patent ductus arteriosus (PDA) stenting with balloon atrial septostomy or conventional modified Blalock Taussig (BT) shunt. Bidirectional Glenn shunt may be done 6-12 months later followed by Fontan completion after a suitable interval. Patients in Group B, the intermediate group, are those with borderline RV size, usually with attenuated trabecular component but well developed infundibulum. The treatment at presentation is RF valvotomy and PDA stenting +/- balloon atrial septostomy. Surgical re-interventions are not uncommonly required viz. bidirectional Glenn shunt when the RV fails to grow adequately (11/2 - ventricle repair) and right ventricular outflow tract (RVOT) reconstruction for subvalvar obstruction or small pulmonary annulus. Catheter based interventions viz. repeat balloon dilatation or device closure of patent foramen ovale (PFO) may also be required in some patients.
  5. Abdul Aziz B, Alwi M
    Catheter Cardiovasc Interv, 1999 Oct;48(2):191-3.
    PMID: 10506777
    We report a case of a 14-month-old-infant with severe congenital mitral stenosis who presented with pulmonary oedema, acute renal failure and haemodynamic instability. Balloon dilatation was successfully performed under fluoroscopic and transesophageal echocardiographic guidance. Cathet. Cardiovasc. Intervent. 48:191-193, 1999.
  6. Campos CM, Caixeta A, Franken M, Bartorelli AL, Whitbourn RJ, Wu CJ, et al.
    Catheter Cardiovasc Interv, 2018 02 15;91(3):387-395.
    PMID: 28471086 DOI: 10.1002/ccd.27109
    OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon.

    METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR).

    RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups.

    CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.

  7. Krackhardt F, Rosli MA, Leschke M, Schneider A, Sperling C, Heang TM, et al.
    Catheter Cardiovasc Interv, 2018 06;91(7):1221-1228.
    PMID: 28944613 DOI: 10.1002/ccd.27306
    OBJECTIVE: The objective of this study was to compare the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug eluting stent (PF-SES) to its uncoated bare-metal stent (BMS) platform of identical stent architecture.

    BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES).

    METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months.

    RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388).

    CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).

  8. Montefusco A, D'Ascenzo F, Gili S, Smolka G, Chieffo A, Baumbach A, et al.
    Catheter Cardiovasc Interv, 2019 02 01;93(2):208-215.
    PMID: 30298593 DOI: 10.1002/ccd.27809
    OBJECTIVES: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).

    BACKGROUND: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.

    METHODS: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.

    RESULTS: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.

    CONCLUSION: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

  9. Rosenberg M, Waliszewski M, Chin K, Ahmad WAW, Caramanno G, Milazzo D, et al.
    Catheter Cardiovasc Interv, 2019 02 01;93(2):181-188.
    PMID: 30280482 DOI: 10.1002/ccd.27724
    OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions.

    BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited.

    METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months.

    RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates.

    CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.

  10. Haude M, Lee SWL, Worthley SG, Silber S, Verheye S, Rosli MA, et al.
    PMID: 31489742 DOI: 10.1002/ccd.28483
    OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.

    BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.

    METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.

    RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.

    CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

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