Showing papers in "Circulation-cardiovascular Interventions in 2021"

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation

Abstract: Background: The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with publis...

Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis.

Abstract: Background: Ultrasonic flow ratio (UFR) is a novel method for fast computation of fractional flow reserve (FFR) from intravascular ultrasound images. The objective of this study is to evaluate the ...

Primary Results of the EVOLVE Short DAPT Study: Evaluation of 3-Month Dual Antiplatelet Therapy in High Bleeding Risk Patients Treated With a Bioabsorbable Polymer-Coated Everolimus-Eluting Stent.

Abstract: Background Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is associated with increased bleeding, despite a reduced incidence of ischemic events. The SYNERGY everolimus-eluting stent is a thin-strut platinum-chromium stent that elutes everolimus from a thin abluminal layer of bioabsorbable polymer. These design elements may facilitate rapid endothelialization and enable shorter-duration DAPT. Methods EVOLVE Short DAPT prospectively evaluated the safety of 3-month DAPT in high bleeding risk patients treated with the SYNERGY everolimus-eluting stent, enrolling 2009 patients at 110 global sites. Patients with acute myocardial infarction or complex lesions were excluded. After percutaneous coronary intervention, patients were required to take DAPT (aspirin+P2Y12 inhibitor) for 3 months, except those on chronic anticoagulation in whom aspirin was optional. Patients free of events (stroke, myocardial infarction, revascularization, and stent thrombosis) who discontinued P2Y12 inhibitor at 3 months, but continued aspirin, and had at least 1 year of follow-up or an end point event were included in the primary analysis. Two powered coprimary end points were (1) death/myocardial infarction compared with a historical control and (2) study stent-related definite/probable stent thrombosis compared to a performance goal. Results The analysis population consisted of 1487 patients. The adjusted rate of death/myocardial infarction between 3 and 15 months was 5.6% among patients receiving 3-month DAPT versus 5.7% patients in the 12-month DAPT control (propensity adjusted difference=-0.12%; 97.5% upper bound=1.63% which was less than the prespecified margin of 2.52; Pnon-inferiority=0.0016). The rate of study stent-related stent thrombosis between 3-15 months was 0.2% in the 3-month DAPT group (97.5% upper bound=0.63%; P=0.0005 for comparison to 1% performance goal). Conclusions Favorable rates of ischemic outcomes were observed among selected high bleeding risk patients undergoing percutaneous coronary intervention with the SYNERGY everolimus-eluting stent who tolerated 3 months of P2Y12 inhibitor and then discontinued it, supporting the safety of abbreviated DAPT with this stent platform. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02605447.

Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry.

Abstract: Background Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach. Methods One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome. Results DRT was detected after a median of 93 days (interquartile range, 54–161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA2DS2-VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P=0.29; mortality: 31.3% versus 13.1%, P=0.05). Conclusions A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, incomplete DRT resolution appeared to identify patients at even higher risk. Optimal DRT diagnostic criteria and treatment regimens are warranted.

Impact of Poststenting Fractional Flow Reserve on Long-Term Clinical Outcomes: The FFR-SEARCH Study

Abstract: Supplemental Digital Content is available in the text. Background: Fractional flow reserve (FFR)-guided treatment has been demonstrated to improve percutaneous coronary intervention (PCI) results. However, little is known on the long-term impact of low post-PCI FFR. Methods: This is a large prospective all comers study evaluating the impact of post-PCI FFR on clinical outcomes. All patients undergoing successful PCI were eligible for enrollment. FFR measurements were performed immediately after PCI when the operator considered the angiographic result acceptable and final. No further action was undertaken based on the post-PCI result. Suboptimal post-PCI FFR was defined as FFR<0.90. The primary end point was major adverse cardiac events, a composite of cardiac death, any myocardial infarction, or any revascularization at 2-year follow-up. Secondary end points were target vessel revascularizations and stent thrombosis and the separate components of the primary end point. Results: A total of 1000 patients were enrolled. Post-PCI FFR was successfully measured in 1165 vessels from 959 patients. A poststenting FFR<0.90 was observed in 440 vessels (37.8%). A total of 399 patients had at least 1 vessel with FFR<0.90 post-PCI. At 2-year follow-up, a patient level analysis showed no association between post-PCI FFR and major adverse cardiac event (hazard ratio [HR], 1.08 [95% CI, 0.73–1.60], P=0.707), cardiac death (HR, 1.55 [95% CI, 0.72–3.36], P=0.261), any myocardial infarction (HR, 1.53 [95% CI, 0.78–3.02], P=0.217). A vessel level analysis showed a higher rate of target vessel revascularization (HR, 1.91 [95% CI, 1.06–3.44], P=0.030) and a tendency toward higher rate of stent thrombosis (HR, 2.89 [95% CI, 0.88–9.48], P=0.081) with final post-PCI FFR<0.90. Conclusions: Suboptimal post-PCI FFR has only a moderate impact on major adverse cardiac event but coronary arteries with a post-PCI FFR<0.90 have a higher rate of target vessel revascularization.

Calcific Plaque Modification by Acoustic Shock Waves: Intravascular Lithotripsy in Coronary Interventions

Abstract: Constituting a significant proportion of lesions treated with transcatheter interventions in the coronary arteries, moderate-to-severe calcification portends lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared with noncalcific plaques. Adapted from the lithotripsy technology for treatment of nephrolithiasis, intravascular lithotripsy is a new technique for treatment of severely calcific lesions that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. Herein, we summarize the physics and characteristics of the currently available intravascular lithotripsy system (Shockwave Medical, Santa Clara, CA), the clinical data on intravascular lithotripsy use in the coronary arteries, and future directions for adoption of the technique in percutaneous coronary intervention.

Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial.

Abstract: Background Atrial fibrillation (AF), mitral regurgitation (MR), and left ventricular (LV) ejection fraction have a complex interplay. We evaluated the role of AF in patients with heart failure and moderate-to-severe or severe secondary MR enrolled in the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and its impact on mechanisms and outcomes with the MitraClip. Methods Patients in the COAPT trial were stratified by the presence (n=327) or absence (n=287) of a history of AF and by assignment to treatment group. Clinical, echocardiographic, and outcome measures were assessed. The primary outcome was the composite rate of death or heart failure hospitalization at 24 months. Results Patients with history of AF were older and more often male. They had a higher LV ejection fraction, larger left atrial volumes and mitral valve orifice areas, smaller LV volumes, and similar MR severity. Patients with AF compared with those without a history of AF had a higher unadjusted (hazard ratio [HR], 1.32 [95% CI, 1.06-1.64], P=0.01) and adjusted (HR, 1.30 [1.03-1.64], P=0.03) 2-year rate of the primary outcome. Treatment with the MitraClip compared with guideline-directed medical therapy alone reduced death or heart failure hospitalization in both those with (HR, 0.61 [0.46-0.82]) and without (HR, 0.46 [0.33-0.66]) a history of AF (Pint=0.18). Treatment with the MitraClip was associated with a lower risk of stroke in patients with a history of AF (HR, 0.18 [0.04-0.86]) but not in those without a history of AF (HR, 1.64 [0.58-4.62]; Pint=0.02). Conclusions In the COAPT trial, patients with a history of AF had larger left atrial and mitral valve orifice areas with higher LV ejection fraction and smaller LV volumes, suggesting an atrial mechanism contribution to functional MR. Despite the worse prognosis of heart failure patients with a history of AF, MR reduction with the MitraClip still afforded substantial clinical benefits. Treatment with MitraClip was associated with a lower risk of stroke in patients with a history of AF. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.

BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction.

Abstract: Background Coronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement. Transcatheter electrosurgical aortic leaflet laceration (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary end points of 30-day success and safety have been reported previously. Methods The BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. End points at 1 year included death, stroke, and myocardial infarction. Source data was independently verified and end points independently adjudicated. Results Thirty subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30 days and 1 year, there were no additional strokes, no myocardial infarction, and 2 deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%), but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. Fourteen (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire scores improved from baseline to 30 days and were maintained at 1 year. Conclusions In these subjects with multiple comorbidities and restrictive anatomy that underwent transcatheter aortic valve replacement, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission. These results are reassuring for patients and physicians who wish to avoid the long-term complications related to snorkel stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381989.

Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients

Abstract: Background: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear. Methods: In this randomized open-label study, low-risk patients undergoing transfemoral ...

Time Delay, Infarct Size, and Microvascular Obstruction After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction.

Abstract: Background: Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segmen...

Feasibility and Validity of Computed Tomography-Derived Fractional Flow Reserve in Patients With Severe Aortic Stenosis: The CAST-FFR Study.

Abstract: Background: Coronary artery disease is common in patients with severe aortic stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) is a clinically used modality for assessing coron...

Safety and Feasibility of Same-Day Discharge After Left Atrial Appendage Closure With the WATCHMAN Device.

Abstract: Background: As the use of left atrial appendage closure (LAAC) becomes more widespread, improvements in resource utilization and cost-effectiveness are necessary. Currently, there are limited data ...

Efficacy and Safety of Percutaneous Pulmonary Artery Subtotal Occlusion and Chronic Total Occlusion Intervention in Chronic Thromboembolic Pulmonary Hypertension.

Abstract: Background Balloon pulmonary angioplasty (BPA) is an emerging percutaneous therapy for patients with inoperable chronic thromboembolic pulmonary hypertension, and patients with mean pulmonary artery pressure ≤30 mm Hg have an excellent survival. Common vascular lesion types are ring-like stenoses (type A), web lesions (type B), subtotal occlusions (type C), chronic total occlusions (CTOs; type D), and tortuous lesions (type E). Occlusive lesions (ie, subtotal occlusions and CTOs) are the most challenging. Risk and benefit of pulmonary occlusive lesion intervention in chronic thromboembolic pulmonary hypertension has not been studied. We evaluated the impact of percutaneous pulmonary artery subtotal occlusion and CTO intervention on BPA treatment response. Methods One hundred twenty patients underwent 712 BPA procedures between April 2014 and October 2019 at the Medical University of Vienna. Clinical features and hemodynamics were assessed at baseline and 6 to 12 months after the last BPA session. Results A total of 2542 lesions were targeted: 720 occlusions (28.3%; 352 CTOs and 368 subtotal occlusions) and 1822 nonocclusion lesions (71.7%). Complications occurred in 6.0% of all procedures (severe complications in 0.4% of all procedures). The overall success rate for recanalization of occlusions was 81% (subtotal occlusions [type C lesions], 98%; CTOs [type D lesions], 50%). Number of successfully treated lesions of any type (β, -0.86 [-1.19 to -0.53]; P Conclusions The number of successfully treated vascular lesions predicts treatment response to BPA. The number of successfully recanalized occlusions (particularly CTOs) appears to have the strongest impact on change in mean pulmonary artery pressure, highlighting the importance of advanced BPA technique.

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Abstract: Background: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determin...

Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality.

Abstract: BACKGROUND The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score. METHODS All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: 8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR. RESULTS Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non–high risk, the findings remained consistent. CONCLUSIONS In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.

Colchicine to Prevent Periprocedural Myocardial Injury in Percutaneous Coronary Intervention: The COPE-PCI Pilot Trial

Abstract: BACKGROUND Periprocedural myocardial infarction and injury (PM-injury) are the most common complications of percutaneous coronary intervention (PCI) and are associated with future adverse cardiac events. Inflammation plays a pivotal role in the development of PM-injury. In this randomized pilot trial, we assessed the effect of an anti-inflammatory medication colchicine on periprocedural myocardial injury. METHODS Patients undergoing PCI for stable angina or non–ST-segment–elevation myocardial infarction were randomized to oral colchicine (1 mg followed by 0.5 mg 1 hour later) or placebo, 6 to 24 hours preprocedure. Blood samples were taken immediately pre- and 24-hours post-PCI. The primary outcome, periprocedural myocardial infarction, was defined by an increase in post-PCI troponin >5×99th% upper reference limit when the pre-PCI troponin was normal, or >20% increase in post-PCI troponin when the pre-PCI troponin was raised, including supporting evidence of new myocardial ischemia. Major PM-injury was defined as per periprocedural myocardial infarction without supporting evidence of new myocardial ischemia. Minor PM-injury was defined by post-PCI troponin increase >99th% upper reference limit but ≤5×99th% upper reference limit. RESULTS A total of 196 patients met inclusion criteria and were randomized. One hundred twenty-one patients were excluded (no PCI, unstable troponin before PCI, or poor-quality measurements) leaving a study population of 75 patients. Thirty-six patients were randomized to colchicine and 39 to placebo preprocedure. Forty-four presented with non–ST-segment–elevation myocardial infarction and 31 with stable angina. High-sensitive (hs) troponin-I pre-PCI was similar between treatment groups (colchicine: 79 ng/L [4–1336] versus placebo: 35 [5–448], P=0.42). Absolute change in hs-troponin-I (calculated as 24-hour post-PCI minus pre-PCI measurements) was significantly lower in the colchicine group: 59 (1–221) versus placebo: 166 (53–530), P=0.02. No patients developed periprocedural myocardial infarction in either group. Significantly fewer patients developed major PM-injury: 11 (31%) versus 21 (54%), P=0.04 or minor PM-injury: 21 (58%) versus 33 (85%), P=0.01, if given colchicine pre-PCI. CONCLUSIONS In this randomized pilot trial, colchicine given 6 to 24 hours pre-PCI reduces periprocedural myocardial injury.

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis.

Abstract: Background Transradial access (TRA) has emerged as the preferred vascular access site for coronary angiography and percutaneous coronary intervention. This systematic review and meta-analysis was performed to evaluate 30-day all-cause mortality comparing TRA with transfemoral access for percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction. Methods We performed a systematic literature search and meta-analysis of randomized controlled studies published from inception until January 7, 2020, in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science Core Collection. Preferred Reported Items for Systematic Reviews and Meta-Analyses guidelines were used for abstracting data. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included myocardial infarction, major bleeding, stroke, and access site complications. Results A total of 14 studies representing 11 707 patients (5802 patients with TRA; 5905 patients with transfemoral access) were included in this systematic review. All-cause mortality (N=8 studies) was significantly reduced in the TRA group with an overall risk ratio (RR) of 0.72 (95% CI, 0.56-0.92) in the pooled analysis. Major bleeding (N=12 studies; RR, 0.60 [95% CI, 0.45-0.80]) and access site complications (N=9 studies; RR, 0.40 [95% CI, 0.30-0.53]) were significantly higher in the transfemoral access group. There was no statistical difference in reinfarction (N=10 studies; RR, 0.96 [95% CI, 0.75-1.25]) or stroke (N=8 studies; RR, 1.47 [95% CI, 0.87-2.50]). Conclusions TRA is associated with lower 30-day mortality, major bleeding, and access site complications when compared with transfemoral access in ST-segment-elevation myocardial infarction patients who undergo percutaneous coronary intervention. Registration URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: 127955.

Transcatheter Mitral Valve Implantation: Current Status and Future Perspectives.

Abstract: Mitral transcatheter therapies represent the treatment of choice for all patients deemed unsuitable for cardiac surgery. So far, the largest clinical experience has been limited to percutaneous repair techniques. However, given the complexity and heterogeneity of mitral valve anatomy and pathology, transcatheter mitral valve implantation will widen the mitral valve therapies horizon, toward a patient-tailored approach. Current data about transcatheter mitral valve implantation is still limited and, although some data are promising, there are still some issues to be addressed. This review provides a comprehensive insight into the available devices and describes potential advantages and limitations of transcatheter mitral valve implantation.

Transcatheter Treatment of Secondary Tricuspid Regurgitation With Direct Annuloplasty: Results From a Multicenter Real-World Experience

Abstract: Background Treatment options for secondary tricuspid regurgitation (TR) remain limited. Early real-world data of a new percutaneous direct annuloplasty system for tricuspid repair were examined. Methods The first 60 patients treated with the Cardioband tricuspid valve repair system at 4 centers were included in this retrospective study. The primary efficacy end point was technical success with reduction of TR ≥2 grades at discharge. Combined primary safety end point was major adverse events (death, myocardial infarction, cardiothoracic surgery, and stroke) at 30 days. Results Median patient age was 76 years (73-82), median EuroScore II was 3.9% (2.2-8.1), heart failure with preserved ejection fraction was present in 78%, and 81.7% were in the New York Heart Association class III/IV. Massive or torrential TR was found in 51.7%, and severe TR in 48.3%. The primary efficacy end point was achieved in 45%, while 60.3% of patients had less-than-severe TR at discharge. Vena contracta was reduced by 47% from 12.9±4.8 to 7.0±3.4 mm (P Conclusions This first real-world experience suggests that transcatheter treatment of advanced secondary TR using direct annuloplasty is feasible and reasonably safe early in the learning curve, with significant symptomatic benefit. Further studies are warranted to provide data on long-term outcome and patient prognosis.

Indirect Impact of the COVID-19 Pandemic on Activity and Outcomes of Transcatheter and Surgical Treatment of Aortic Stenosis in England.

Abstract: Background: Aortic stenosis requires timely treatment with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). This study aimed to investigate the indirect impact of coronavirus disease 2019 (COVID-19) on national SAVR and TAVR activity and outcomes. Methods: The UK TAVR Registry and the National Adult Cardiac Surgery Audit were used to identify all TAVR and SAVR procedures in England, between January 2017 and November 2020. The number of isolated aortic valve replacement (AVR), AVR+coronary artery bypass graft surgery, AVR+other surgery, and TAVR procedures per month was calculated. Separate negative binomial regression models were fit to monthly procedural counts, with functions of time as covariates, to estimate the expected change in activity during COVID-19. Results: We included 15 142 TAVR cases, 13 357 isolated AVR cases, 8550 AVR+coronary artery bypass graft cases, and 6773 AVR+other cases. Before March 2020 (UK lockdown), monthly TAVR activity was rising, with a slight decrease in the SAVR activity during 2019. We observed a rapid and significant drop in TAVR and SAVR activity during the COVID-19 pandemic, especially for elective cases. Cumulatively, over the period March to November 2020, we estimated an expected 4989 (95% CI, 4020–5959) cases of aortic stenosis who have not received treatment. Conclusions: This study has demonstrated a significant decrease in TAVR and SAVR activity in England following the COVID-19 outbreak. This situation should be monitored closely, to ensure that monthly activity rapidly returns to expected levels. There is potential for significant backlog in the near-to-medium term and potential for increased mortality in this population.

Optical Coherence Tomography Assessment in Patients Treated With Rotational Atherectomy Versus Modified Balloons: PREPARE-CALC OCT.

Abstract: Background Percutaneous intervention of calcified coronary lesions often requires lesion preparation with either balloon dilatation or atherectomy. We sought to evaluate the impact of lesion preparation strategy on stent expansion following preparation of severely calcified coronary lesions with modified (cutting/scoring) balloons (MB) versus rotational atherectomy (RA) and to evaluate the impact of calcium burden as assessed by optical coherence tomography (OCT) on acute stent performance. Methods In the PREPARE-CALC trial (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions), 200 patients with severely calcified coronary lesions were randomly assigned to receive either lesion preparation with MB or RA. In 122 patients, OCT was performed before lesion preparation and at the end of the procedure. The principal end point of this OCT sub-analysis was stent expansion as assessed by OCT. The key secondary end points included stent asymmetry and eccentricity. Results The maximal calcific arc (257.5±96.7° versus 248.7±82.1°, P=0.59), thickness (1.34±0.29 versus 1.32±0.27 mm, P=0.76), and length of calcification (21.1±9.7 versus 24.0±10.9 mm, P=0.12) did not differ between the MB versus RA group. Lesion preparation with MB versus RA lead to comparable stent expansion (73.5±13.3% versus 73.1±12.2%, respectively, P=0.85). The use of RA did not have a significant impact on stent asymmetry or eccentricity compared with the use of MB. Length of calcified plaque appeared to be increased in patients with stent underexpansion, while thickness of calcified plaque was increased in patients with stent asymmetry. Target lesion revascularization at 9 months was 3.3% when MB was used and 1.6% when RA was performed (P=0.62). Conclusions In this OCT sub-analysis from the PREPARE-CALC trial, calcified plaque length was increased in patients with stent underexpansion, while its thickness was higher in patients with stent asymmetry, with no impact of the lesion preparation strategy. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02502851.

Long-Term Outcomes of the Coarctation of the Aorta Stent Trials

Abstract: BACKGROUND Long-term outcome data of stent-implantation for coarctation of the aorta are limited. We report up to 5 years of postimplant follow-up in patients enrolled into the COAST (Coarctation of the Aorta Stent Trial) and the COAST II trial (Covered Cheatham-Platinum Stents for Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta), evaluating the bare and Covered Cheatham-Platinum Stents for the treatment of coarctation of the aorta and associated aortic wall injury. METHODS Data was prospectively collected during the 2 multi-center studies, enrolling 248 patients (COAST: n=121, COAST II: n=127). Late follow-up data (48–60 month) was compared with immediate (1 month) and early (12 months) follow-up. RESULTS There was a notable decrease in the use of antihypertensive medication, from 53% at immediate, to 42% at early, and 29% at late follow-up. The cumulative incidence of stent fractures was 0% immediately, 2.9% at early, and 24.4% at late follow-up. Independent predictors for stent fractures at late follow-up were age <18 years, male sex, minimum stent diameter ≥12 mm, and use of bare metal stent. The cumulative incidence of reintervention was 1.6% at immediate, 5.1% at early, and 21.3% at late follow-up. Independent predictors for reinterventions at late follow-up were age <18 years, post implantation systolic arm-leg blood pressure gradient ≥10 mm Hg, minimum stent diameter at implantation <12 mm, and initial coarctation minimum diameter <6 mm. There were 13 patients with aortic aneurysms, with a cumulative incidence of 6.3% at late follow-up. CONCLUSIONS Coarctation stenting is effective at maintaining obstruction relief up to 60 months postimplant with reduction in the number of patients requiring antihypertensive medication. However, an increase in-stent fractures and reinterventions were observed between medium and long-term follow-up. Covered stents appear to confer some protection from the development of stent fractures but do not provide complete protection from late aneurysm formation. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00552812 and NCT01278303.

First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.

Abstract: Background: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombol...

Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease: Insights From the AFIRE Trial.

Abstract: Background: Early bleeding after percutaneous coronary intervention is associated with increased risk of death and myocardial infarction; however, the association between bleeding and subsequent ma...

Calcium Modification Techniques in Complex Percutaneous Coronary Intervention

Abstract: Percutaneous coronary intervention is the most common mode of revascularization and is increasingly undertaken in high-risk subsets, including the elderly. The presence of coronary artery calcification is increasingly observed and significantly limits technical success. The mechanisms for this are multi-factorial, including increased arterial wall stiffness and impaired delivery of devices, leading to suboptimal stent delivery, deployment, and expansion which are harbingers for increased risk of in-stent restenosis and stent thrombosis. Although conventional balloon pretreatment techniques aim to mitigate this risk by modifying the lesion before stent placement, many lesions remain resistant to conventional strategies, due to the severity of calcification. There have been several substantial technological advancements in calcium modification methods in recent years, which have allowed improved procedural success with low periprocedural complication rates. This review will summarize the current adjunctive modification technologies that can be employed to improve technical outcomes in percutaneous coronary intervention in calcific disease and the evidence supporting these tools.