A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina.

BACKGROUND: Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina. RESULTS: A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group. CONCLUSIONS: Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).

Striatin plays a major role in angiotensin II-induced cardiomyocyte and cardiac hypertrophy in mice in vivo.

The three striatins (STRN, STRN3, STRN4) form the core of STRiatin-Interacting Phosphatase and Kinase (STRIPAK) complexes. These place protein phosphatase 2A (PP2A) in proximity to protein kinases thereby restraining kinase activity and regulating key cellular processes. Our aim was to establish if striatins play a significant role in cardiac remodelling associated with cardiac hypertrophy and heart failure. All striatins were expressed in control human hearts, with up-regulation of STRN and STRN3 in failing hearts. We used mice with global heterozygote gene deletion to assess the roles of STRN and STRN3 in cardiac remodelling induced by angiotensin II (AngII; 7 days). Using echocardiography, we detected no differences in baseline cardiac function or dimensions in STRN+/- or STRN3+/- male mice (8 weeks) compared with wild-type littermates. Heterozygous gene deletion did not affect cardiac function in mice treated with AngII, but the increase in left ventricle mass induced by AngII was inhibited in STRN+/- (but not STRN3+/-) mice. Histological staining indicated that cardiomyocyte hypertrophy was inhibited. To assess the role of STRN in cardiomyocytes, we converted the STRN knockout line for inducible cardiomyocyte-specific gene deletion. There was no effect of cardiomyocyte STRN knockout on cardiac function or dimensions, but the increase in left ventricle mass induced by AngII was inhibited. This resulted from inhibition of cardiomyocyte hypertrophy and cardiac fibrosis. The data indicate that cardiomyocyte striatin is required for early remodelling of the heart by AngII and identify the striatin-based STRIPAK system as a signalling paradigm in the development of pathological cardiac hypertrophy.

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

OBJECTIVE: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). BACKGROUND: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. RESULTS: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. CONCLUSIONS: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Adapting the role of handheld echocardiography during the COVID-19 pandemic: A practical guide.

The COVID-19 pandemic has altered our approach to inpatient echocardiography delivery. There is now a greater focus to address key clinical questions likely to make an immediate impact in management, particularly during the period of widespread infection. Handheld echocardiography (HHE) can be used as a first-line assessment tool, limiting scanning time and exposure to high viral load. This article describes a potential role for HHE during a pandemic. We propose a protocol with a reporting template for a focused core dataset necessary in delivering an acute echocardiography service in the setting of a highly contagious disease, minimising risk to the operator. We cover the scenarios typically encountered in the acute cardiology setting and how an expert trained echocardiography team can identify such pathologies using a limited imaging format and include cardiac presentations encountered in those patients acutely unwell with COVID-19.

Facilitating right-sided axillary artery access for transcatheter aortic valve replacement using the Edwards Sapien 3 and ultra valves: Technical considerations.

Trans-Axillary Transcatheter Aortic Valve Replacement (TAVR) has become established as the safest arterial approach when femoral arterial anatomy is unfavorable. Although a left sided axillary approach is generally preferred, patient specific factors may require use of the right axillary artery. In this case series we describe procedural modifications that are required to overcome the challenge of restricted space in the ascending aorta for in situ valve preparation of balloon-expandable valve systems when a right sided trans-Axillary approach is taken. These steps permit implantation of both the Edwards LifeSciences Sapien 3 and Ultra prostheses via the right trans-Axillary approach, allowing patients a greater range of valve options when this arterial route is required for TAVR.

Comparison of warfarin versus DOACs in patients with concomitant indication for oral anticoagulation undergoing TAVI; results from the ATLAS registry.

The optimal antithrombotic therapy for patients undergoing TAVI with concomitant indication for oral anticoagulation remains unclear. In this high-risk population group, there is a paucity of data with regards to the use of DOACs. In the present study we compared long-term clinical outcomes of TAVI patients requiring anticoagulation, treated with warfarin versus DOACs. Consecutive patients, who underwent TAVI with indication for oral anticoagulation from the multicenter ATLAS registry were studied and divided in two groups depending on the chosen anticoagulation regimen, warfarin vs. DOACs. 30-day survival, as well as estimated 1 and 2-year all-cause mortality were compared between groups. The secondary endpoint included in-hospital major or life-threatening bleeding. The study group included 217 patients (102 treated with warfarin; 115 treated with DOACs). Kaplan-Meier estimated survival was found to be statistically similar in the warfarin and DOAC groups (90.6% vs. 93.7% for 1-year and 84.5% vs. 88.5%, for 2-year survival, respectively, Plog-rank = 0.984). Adjusted hazard ratio for all cause mortality was similar between the two groups (HRwarfarin vs. DOAC = 1.15; 95% CI 0.33 to 4.04, p = 0.829). Propensity matching revealed similar results. At 30-days, all-cause mortality was found to be comparable between the two groups. With regards to BARC defined bleeding complications, major and life-threatening complications did not differ between the two anticoagulation groups (6% vs. 8% for warfarin and DOACs respectively, p = 0.857). DOACs seem to demonstrate a similar safety and efficacy profile compared to warfarin in TAVI patients with a concomitant indication for oral anticoagulation.

Percutaneous left atrial appendage occlusion with the Amulet device: The impact of device disc position upon periprocedural and long-term outcomes.

OBJECTIVE: To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes. BACKGROUND: The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain. METHODS: Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention. RESULTS: Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P = 0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P = 0.03). There were no differences in reposition attempts (P = 0.9) or long-term events (P = 0.57). CONCLUSIONS: Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure.

Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.

OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Differential Gene Expression in Macrophages From Human Atherosclerotic Plaques Shows Convergence on Pathways Implicated by Genome-Wide Association Study Risk Variants.

Objective- Plaque macrophages are intricately involved in atherogenesis and plaque destabilization. We sought to identify functional pathways in human plaque macrophages that are differentially regulated in respect of (1) plaque stability and (2) lipid content. We hypothesized that differentially regulated macrophage gene sets would relate to genome-wide association study variants associated with risk of acute complications of atherosclerosis. Approach and Results- Forty patients underwent carotid magnetic resonance imaging for lipid quantification before endarterectomy. Carotid plaque macrophages were procured by laser capture microdissection from (1) lipid core and (2) cap region, in 12 recently symptomatic and 12 asymptomatic carotid plaques. Applying gene set enrichment analysis, a number of gene sets were found to selectively upregulate in symptomatic plaque macrophages, which corresponded to 7 functional pathways: inflammation, lipid metabolism, hypoxic response, cell proliferation, apoptosis, antigen presentation, and cellular energetics. Predicted upstream regulators included IL-1ß, TNF-α, and NF-κB. In vivo lipid quantification by magnetic resonance imaging correlated most strongly with the upregulation of genes of the IFN/ STAT1 pathways. Cross-interrogation of gene set enrichment analysis and meta-analysis gene set enrichment of variant associations showed lipid metabolism pathways, driven by genes coding for APOE and ABCA1/G1 coincided with known risk-associated SNPs (single nucleotide polymorphisms) from genome-wide association studies. Conclusions- Macrophages from recently symptomatic carotid plaques show differential regulation of functional gene pathways. There were additional quantitative relationships between plaque lipid content and key gene sets. The data show a plausible mechanism by which known genome-wide association study risk variants for atherosclerotic complications could be linked to (1) a relevant cellular process, in (2) the key cell type of atherosclerosis, in (3) a human disease-relevant setting.

Paravalvular leak closure under intracardiac echocardiographic guidance.

OBJECTIVES: The objective of this study was to determine the safety and efficacy of intracardiac echocardiography (ICE) to guide percutaneous paravalvular leak (PVL) closure. BACKGROUND: PVL following surgical valve replacement occurs in 2%-15% of patients. Percutaneous treatment is an accepted management strategy in patients deemed to be too high risk for redo surgery. This is most commonly performed with transesophageal (TOE) guidance requiring general anesthesia that both potentially further increase the risk of intervention. ICE can be used to guide intervention, facilitating procedures to be performed under local anesthesia without esophageal intubation potentially making procedures shorter and safer and further enabling the treatment of patients that may have been turned down for intervention. METHODS: All patients that underwent ICE-guided percutaneous transcatheter PVL closure between 2006 and 2016 at the John Radcliffe Hospital, Oxford, United Kingdom were retrospectively analyzed. RESULTS: Twenty-one procedures were performed in 18 patients during the study period. Fourteen patients (77.8%) underwent successful ICE guided PVL closure. There were no ICE-related complications. Eleven patients (78.6%) reported symptomatic improvement of at least one New York Heart Association (NYHA) Class and the remaining 3 patients had no change. No patient demonstrated objective evidence of persistent hemolysis following successful closure. There was one death within 30 days of the procedure and 1 year survival was 71.4%. CONCLUSIONS: Percutaneous paravalvular leak closure guided by ICE without the requirement of general anesthesia is feasible, safe, and associated with acceptable procedural success rates.

A comparison of the fully repositionable and retrievable Boston Lotus and direct flow medical valves for the treatment of severe aortic stenosis: A single center experience.

BACKGROUND: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. OBJECTIVES: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices. METHODS AND RESULTS: 175 patients with severe aortic stenosis underwent transfemoral TAVI with the Lotus (n = 60) and DFM (n = 115) valve. Baseline clinical characteristics did not differ between the two groups. All devices were successfully implanted, with one case of valve embolization in the Lotus group. Device success (95 vs. 98.2%, P = 0.89), VARC-defined combined safety (90 vs. 93%, P = 0.48), and clinical efficacy (86.7 vs. 90.4%, P = 0.65) rates at 30-days were similar between Lotus and DFM groups. There was no severe PVL; one patient in both Lotus and DFM group developed moderate PVL after the procedure. The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3 vs. 11.2%, P < 0.001) and a lower mean aortic gradient (9.4 ± 5 vs. 12.3 ± 5, P < 0.001) at 30-days as compared with the DFM valve. CONCLUSIONS: In this single-center, retrospective analysis, both Lotus and DFM devices demonstrated excellent device success, safety and efficacy at 30-day follow-up. The DFM valve was associated with minimally higher transvalvular gradients but lower new pacemaker implantation rates when compared to the Lotus valve.

Expansion in calcific lesions and overall clinical outcomes following bioresorbable scaffold implantation optimized with intravascular ultrasound.

OBJECTIVES: This study aimed to investigate clinical outcomes following bioresorbable scaffold (BRS) optimized with intravascular ultrasound (IVUS), and furthermore expansion of BRS in calcific lesions. BACKGROUND: Although IVUS use has contributed to improved clinical outcomes with metallic stent implantation, it is unclear if this is also true with regards to BRS, especially in calcified lesions. METHODS: Between May 2012 and April 2015, 291 lesions in 198 patients were treated with BRS with IVUS use. We evaluated overall clinical outcomes at 1-year and investigated the expansion and eccentricity index of BRS amongst quadrants categorized by calcium arc (CA) every 90-degrees. RESULTS: The rates of major adverse cardiac events were 5.4% (at 6 months) and 10.7% (at 12 months). TLR was observed in 3.1% at 6-month and 7.5% at 12-month follow up. Although there was a significant difference among quadrants regarding to eccentricity of calcium (0°â‰¦CA < 90°: 0.82 ± 0.09, 90°â‰¦CA < 180°: 0.75 ± 0.12, 180°â‰¦CA < 270°: 0.78 ± 0.11, and 270°â‰¦CA≦360°: 0.79 ± 0.09, ANOVA P = 0.002), the BRS expansion index [minimal scaffold area (MSA) divided by BRS area expanded at a nominal pressure] was comparable between quadrants. CONCLUSIONS: The use of IVUS to optimize BRS implantation results in favorable clinical outcomes even for complex lesions. Although eccentric calcium distribution resulted in asymmetric expansion of BRS, the final MSA was comparable irrespective of calcium distribution. © 2016 Wiley Periodicals, Inc.

Long-term outcomes following mini-crush versus culotte stenting for the treatment of unprotected left main disease: Insights from the milan and New-Tokyo (MITO) registry.

OBJECTIVES: This study aimed to investigate the long-term outcomes following mini-crush versus culotte stenting with drug-eluting stents (DES) for the treatment of unprotected left main coronary artery (LMCA) disease. BACKGROUND: Both mini-crush and culotte stenting are considered efficacious treatment options when a planned 2-stent strategy is deemed necessary for unprotected LMCA disease. However, there are limited data available with regard to the long-term clinical outcomes of each strategy in this setting. METHODS: Between July 2002 and November 2013, 225 patients were identified. 135 patients were treated with the mini-crush technique, and 90 patients with culotte stenting. The median follow-up period was 1,263 (IQR 820-1,847) days. RESULTS: The mini-crush group had worse lesion and procedural characteristics when compared to the culotte group. There were no significant differences in major adverse cardiac events (MACE) at 5 years (mini-crush 36.0% vs. culotte 41.4%, P = 0.57). Myocardial infarction (MI) and definite stent thrombosis (ST) occurred significantly higher (MI; 0 vs. 11.3%, log-rank P = 0.003, and definite ST; 0 vs. 6.3%, log-rank P = 0.02, respectively) in the culotte group. Cox regression analysis indicated that full stent coverage of the LMCA and SYNTAX score were independent predictors for MACE. CONCLUSIONS: The incidence of MACE and overall TLR were comparable between groups. However, the rates of MI and definite ST were significantly higher in the culotte group. Full stent coverage of the LMCA may reduce the incidence of MACE when a two-stent strategy is used for the treatment of unprotected LMCA disease. © 2016 Wiley Periodicals, Inc.

Left atrial appendage closure: A single center experience and comparison of two contemporary devices.

OBJECTIVES: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population. BACKGROUND: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared. METHODS: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed. RESULTS: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices. CONCLUSIONS: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc.

Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry.

OBJECTIVES: The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions. BACKGROUND: BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions. METHODS: Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated. RESULTS: True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191-419) days. The Kaplan-Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78-12.3; P = 0.002 and HR 3.37; 95% CI: 1.38-8.26; P = 0.008, respectively). CONCLUSIONS: BVS use for coronary bifurcation lesions in an "all-comer" population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels.

OBJECTIVES: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. BACKGROUND: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. METHODS: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. CONCLUSIONS: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc.

Modified contrast microinjection technique to facilitate chronic total occlusion recanalization.

OBJECTIVES: To assess the efficacy and safety of the modified contrast microinjection technique to facilitate chronic total occlusion recanalization. BACKGROUND: The success rate of chronic total occlusion percutaneous coronary intervention (CTO-PCI) does not exceed 90% even in the most experienced centres. We have previously demonstrated that a large volume of contrast injected into the subintimal space can facilitate recanalization but is limited by a risk of serious complication. The aim of this study was to assess the application, efficacy and safety of a modified contrast microinjection technique that utilizes the injection of a much smaller volume of contrast in CTO-PCI. METHODS: A retrospective analysis of patients in whom the modified microinjection technique was utilised in patients undergoing CTO-PCI at five tertiary centres was conducted. RESULTS: Of 1,192 patients who underwent CTO-PCI, the microinjection technique was used in 59 patients (4.7%). The majority of CTOs treated were in the right coronary artery (79.7%), were of high complexity and 35.6% of lesions had a least one previously failed PCI attempt. The modified microinjection technique was used for more than one indication in 7 (11.9%) of patients. The success rate was 81.4%. There were no procedural complications related to the use of the reported modified microinjection. CONCLUSION: Initial experience with the modified microinjection demonstrates that it can be performed safely, is reproducible, and is broadly applicable. Whilst not required for all CTO procedures it can be a helpful adjunctive tool to increase the likelihood of success especially in complex, or refractory cases, without compromising the safety of the procedure. © 2015 Wiley Periodicals, Inc.

Predictors of restenosis following contemporary subintimal tracking and reentry technique: The importance of final TIMI flow grade.

OBJECTIVES: To identify predictors of restenosis after recanalization of chronic total occlusions (CTOs) with the Subintimal Tracking And Reentry (STAR) technique. BACKGROUND: STAR is associated with high rates of restenosis but the associated factors are not clear. Understanding the underlying mechanisms may be important to improve STAR outcomes and possibly other contemporary CTO recanalization techniques utilizing extensive subintimal dissection and stenting. METHODS: We retrospectively analyzed 211 lesions that underwent a STAR procedure (between 2002 and 2013) with a final Thrombolysis in Myocardial Infarction (TIMI) flow grade 2 or 3. One-hundred and nineteen lesions that received drug eluting stents (DES) and underwent follow-up angiography were included in the final analysis. RESULTS: Of the 119 lesions treated with DES following STAR, 75 restenoses were observed (63.0%). Utilizing multivariate analysis, TIMI flow grade in the recanalized artery following stent implantation at the end of the index procedure was the only independent predictor of restenosis. CONCLUSIONS: Following recanalization of a CTO with STAR, final TIMI flow predicted future restenosis or reocclusion. As a bailout technique, STAR resulted in a high acute success rate with good safety and acceptable long-term results. When poor flow is observed following recanalization, and prior to stent implantation, a two-step strategy whereby a second procedure is performed at an interval to maximize coronary flow at the end of the procedure may be considered with the goal to reduce the risk of future restenosis or total vessel occlusion following STAR.

Percutaneous Transcatheter Treatment for Tricuspid Bioprosthesis Failure.

OBJECTIVES: To report procedural and 30-day outcomes following percutaneous transcatheter valve-in-valve (VIV) implantation for tricuspid bioprosthesis failure, with a new generation balloon-expandable transcatheter aortic valve implantation prosthesis. BACKGROUND: Severe tricuspid regurgitation is associated with a reduction in survival and increased morbidity. Many patients previously treated with tricuspid valve replacement require further intervention due to bioprosthesis failure. Surgical redo is the "gold standard" treatment however this is technically challenging and associated with significant risk. Percutaneous VIV intervention that is now well established in the management of aortic and mitral bioprosthesis failure may therefore be an alternative treatment option. METHODS: The study population consisted of all patients that underwent percutaneous transcatheter tricuspid VIV implantation for tricuspid bioprosthesis failure at the San Raffaele Scientific Institute, Milan, Italy. RESULTS: Five patients underwent successful transfemoral transcatheter tricuspid VIV implantation for bioprosthetic failure. One patient suffered acute kidney injury that was successfully medically managed. The remaining patients suffered no complications prior to hospital discharge. During 30-day follow-up, all patients reported a significant improvement in their functional status with normal valve function. Additionally, we observed an improvement in renal function (eGFR baseline 62.0 ± 16.5 vs. follow-up 70.2 ± 23.1 ml/min/m2 , P = 0.12) and improved hepatic congestion: bilirubin (1.47 ± 0.8 vs. 1.01 ± 0.7 mg/DL, P = 0.12), alanine aminotransferase (31.0 ± 11.1 vs. 23.2 ± 5.1 U/L, P = 0.11) and aspartate aminotransferase (35.8 ± 6.3 vs. 29.8 ± 13.6 U/L, P = 0.12). CONCLUSIONS: Transfemoral, transcatheter VIV treatment with a new generation balloon expandable devices appears to be a safe and efficacious treatment option for tricuspid bioprosthesis failure. © 2016 Wiley Periodicals, Inc.

Clinical outcomes following target lesion revascularization for bioresorbable scaffold failure.

OBJECTIVES: To investigate clinical outcomes following target lesion revascularization (TLR) for bioresorbable scaffold (BRS) failure in a real world population. BACKGROUND: BRS has become a new option in percutaneous coronary intervention, and may be potentially advantages because of the absence of a permanent metallic cage and the possibility for restoration of vasomotion and endothelial function. However, the requirement for TLR following BRS has been reported, but data on outcomes following reintervention are currently lacking. METHODS: Eighteen patients (20 lesions) who underwent TLR for BRS failure were identified at two high-volume centers in Milan, Italy. Clinical outcomes including all cause death, myocardial infarction, and repeat TLR after TLR for BRS failure were examined. RESULTS: The type of scaffold failure at TLR was classified into focal pattern in 15 lesions, diffuse pattern in two lesions, restenosis at side branch ostium in one lesion and scaffold thrombosis in two lesions. TLR was treated with plain old balloon angioplasty (POBA) in two lesions, with drug-coating balloon in three lesions, drug eluting stent implantation in 11 lesions, further BRS implantation in four lesions. During the followup (median: 345 days after TLR), one sudden death and three repeat TLRs were observed. CONCLUSION: In our series, we observed an adverse event rate of 20% of during the followup period following TLR for BRS failure. The optimal treatment option for these patients remains to be determined.