Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.

Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.

AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring.

OBJECTIVE: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF. METHODS: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes. RESULTS: To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076). CONCLUSION: The V-LAP left atrium monitoring system appears to be safe and accurate.

Adverse events and stroke prevention by interventional left atrial appendage occlusion in patients with low CHA2 DS2 -VASc score-results from the multicenter German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) is routinely performed in patients with nonvalvular atrial fibrillation and contraindications to standard anticoagulation. AIMS: We investigated its role in patients at low stroke risk, and compared the effectiveness and safety in patients with low versus high risk. METHODS: LAARGE is a prospective registry depicting the clinical reality of LAAO. LAAO was conducted with different standard commercial devices, and follow-up period was 1 year. Patients with started procedure and documented CHA2 DS2 -VASc score were selected from the whole database. RESULTS: A total of 638 patients from 38 centers were divided into CHA2 DS2 -VASc score ≤2, i.e., low-risk group (10.2%), and >2, i.e., high-risk group (89.8%). The latter had a pronounced cardiovascular risk profile and preceding strokes (0% vs. 23.9%; p < 0.001). Implantation success was consistently high (97.6%), frequencies of intrahospital major adverse cardiac and cerebrovascular events (0% vs. 0.5%) and other major complications (4.6% vs. 4.0%) were low (each p = not significant [NS]). Numerous moderate complications were also observed in the low-risk patients (12.3% vs. 9.4%; p = NS). Frequencies of nonfatal strokes (0% vs. 0.7%) and severe bleedings (0% vs. 0.7%) were low (each p = NS). In a specific analysis, patients at very high risk of stroke (i.e., CHA2 DS2 -VASc score >4) did not have increased rates of complications or nonfatal strokes in the first year after the procedure. CONCLUSIONS: Low-risk patients had no nonfatal strokes and major bleedings within 1 year after hospital discharge but had unexpectedly high rates of moderate procedural complications. The indication in these patients should be strictly defined based on an individual benefit-risk assessment.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

OBJECTIVES: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. BACKGROUND: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. METHODS: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. RESULTS: The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. CONCLUSIONS: Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

How a thrombectomy service can reduce hospital deficit: a cost-effectiveness study.

BACKGROUND: There is level 1 evidence for cerebral thrombectomy with thrombolysis in acute large vessel occlusion. Many hospitals are now contemplating setting up this life-saving service. For the hospital, however, the first treatment is associated with an initial high cost to cover the procedure. Whilst the health economic benefit of treating stroke is documented, this is the only study to date performing matched-pair, patient-level costing to determine treatment cost within the first hospital episode and up to 90 days post-event. METHODS: We conducted a retrospective coarsened exact matched-pair analysis of 50 acute stroke patients eligible for thrombectomy. RESULTS: Thrombectomy resulted in significantly more good outcomes (mRS 0-2) compared to matched controls (56% vs 8%, p = 0.001). More patients in the thrombectomy group could be discharged home (60% vs 28%), fewer were discharged to nursing homes (4% vs 16%), residential homes (0% vs 12%) or rehabilitation centres (8% vs 20%). Thrombectomy patients had fewer serious adverse events (n = 30 vs 86) and were, on average, discharged 36 days earlier. They required significantly fewer physiotherapy sessions (18.72 vs 46.49, p = 0.0009) resulting in a median reduction in total rehabilitation cost of £4982 (p = 0.0002) per patient. The total cost of additional investigations was £227 lower (p = 0.0369). Overall, the median cost without thrombectomy was £39,664 per case vs £22,444, resulting in median savings of £17,221 (p = 0.0489). CONCLUSIONS: Mechanical thrombectomy improved patient outcome, reduced length of hospitalisation and, even without procedural reimbursement, significantly reduced cost to the thrombectomy providing hospital.

Initial experiences of transapical beating-heart mitral valve repair with a novel artificial chordal implantation device.

BACKGROUND: Severe mitral regurgitation (MR) is associated with progressive heart failure and impairment of survival. Degenerative MR accounts for most MV repair surgeries. Conventional mitral valve repair surgery requires cardiopulmonary bypass and is associated with significant morbidity and risks. Transapical beating-heart mitral valve repair by artificial chordae implantation with transesophageal echocardiography (TEE) guidance has the potential to significantly reduce surgical morbidity. We report the first-in-human experience of degenerative MR repair using a novel artificial chordae implantation device (MitralstitchTM system). METHODS: Ten patients with severe MR underwent transapical artificial chordae implantation using MitralstitchTM system. The procedure was performed through a small left thoracotomy under general anesthesia and TEE guidance. Patients underwent transthoracic echocardiography and other assessments during the follow-up. RESULTS: All 10 patients with an average age of 63.7 ± 9.6 years successfully received transapical artificial chordae implantation. Their MR reduced from severe to none or trace in five patients, mild in five patients before discharge. Five patients received one artificial chordal implantation, four patients received two, and one patient received three and edge-to-edge repair by locking two of them. The safety and efficacy endpoint were achieved in all patients at 1-month follow-up. At 1-year follow-up, six patients had mild MR, three patients had moderate MR, one patient had recurrence of severe MR and underwent surgical repair. CONCLUSIONS: The results of this first-in-human study show safety and feasibility of transapical mitral valve repair using MitralStitch system. Patient selection and technical refinement are crucial to improve the outcomes.

Interdisciplinary management of acute ischaemic stroke: Current evidence training requirements for endovascular stroke treatment. Position Paper from the ESC Council on Stroke and the European Association for Percutaneous Cardiovascular Interventions with the support of the European Board of Neurointervention.

This ESC Council on Stroke/EAPCI/EBNI position paper summarizes recommendations for training of cardiologists in endovascular treatment of acute ischaemic stroke. Interventional cardiologists adequately trained to perform endovascular stroke interventions could complement stroke teams to provide the 24/7 on call duty and thus to increase timely access of stroke patients to endovascular treatment. The training requirements for interventional cardiologists to perform endovascular therapy are described in details and should be based on two main principles: (i) patient safety cannot be compromised, (ii) proper training of interventional cardiologists should be under supervision of and guaranteed by a qualified neurointerventionist and within the setting of a stroke team. Interdisciplinary cooperation based on common standards and professional consensus is the key to the quality improvement in stroke treatment.

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.

Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Gender-related outcomes in the German LAARGE Registry.

INTRODUCTION: Gender-based differences in atrial fibrillation have been identified, but limited data exist for patients undergoing left atrial appendage occluder (LAAO) implantation. This study reports gender-related periprocedural and 1-year outcomes of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). METHODS: LAARGE enrolled 641 patients who were scheduled for LAAO implantation from July 2014 to January 2016 in 38 hospitals in Germany. The data collected included demographics, clinical characteristics, details of implantation, and outcome. Efficacy and safety at 1-year follow-up were assessed by the occurrence of thrombembolic and bleeding events, as well as mortality. RESULTS: Of 638 patients undergoing LAAO implantation 38.9% were female and 61.1% male. Females were older (76.4 ± 8.2 [females] vs. 75.6 ± 7.7 [males], p = .042) and had a higher stroke risk (CHA2 DS2 -VASc score: 4.9 ± 1.5 vs. 4.3 ± 1.5, p < .001). In contrast, males suffered more often from coronary artery (33.1% vs. 53.8%, p < .001) and vascular disease (18.5% vs. 31.0%, p < .001). Technical success was high and similar for both genders (98.4% vs. 97.2%, p = .33). Severe periprocedural complications (6.9% vs. 3.1%, p = .032) occurred more often in females. At 1-year follow-up the rates of all-cause stroke (0.5% vs. 1.3%, p = .65) and severe bleeding (0.0% and 1.0%, p = .29) were low and comparable between the genders. Also, one-year all-cause mortality (9.2% vs. 13.1%, p = .14) did not differ significantly. CONCLUSION: LAARGE documented in this elderly patient population undergoing LAAO implantation a higher rate of severe periprocedural complications in females. At 1-year follow-up similar efficacy and safety outcomes were observed for both genders.

Acute stroke intervention for acute embolic procedural strokes performed by cardiologists.

Acute ischemic stroke is a feared complication during cardiovascular procedures associated with high morbidity and mortality if not immediately recognized and treated. We conducted a review of cases at our center where patients experienced an acute, procedure-related ischemic stroke and underwent immediate endovascular stroke treatment by the interventional cardiologists trained in acute endovascular stroke intervention. Baseline demographics, procedural and follow-up data were collected. Three patients were identified in whom the percutaneous procedure (peripheral arterial intervention, transapical NeoChord [NeoChord Inc, Minnesota, USA] implantation and transcatheter aortic valve implantation, respectively) was complicated by an acute embolic ischemic stroke. In all cases, cerebral vessel re-canalization was technically successful with thrombolysis in cerebral infarction (TICI) IIB/III flow. Follow-up computed tomography scans showed no infarct demarcation, oedema or intracranial hemorrhage. One patient survived with no neurological symptoms at 6-month follow-up whereas the two other patients died of unrelated intensive care complications and decompensated heart failure. We conclude that endovascular stroke treatment during cardiovascular interventions can be performed by interventional cardiologists with appropriate training. It offers the unique opportunity to treat cerebral embolization in a time-efficient manner, potentially improving morbidity and mortality of affected patients.

Contemporary use of balloon aortic valvuloplasty and evaluation of its success in different hemodynamic entities of severe aortic valve stenosis.

OBJECTIVES: To evaluate outcome assessment of percutaneous balloon aortic valvuloplasty (BAV) in different flow and gradient patterns of severe aortic stenosis (AS). BACKGROUND: The mean pressure gradient reduction after BAV is an often-used surrogate parameter to evaluate procedural success. The definition of a successful BAV has not been evaluated in different subgroups of severe AS, which were introduced in the latest guidelines on the management of patients with valvular heart disease. METHODS: In this observational study, consecutive patients from July 2009 to March 2018 undergoing BAV were divided into normal-flow high-gradient (NFHG), low-flow low-gradient (LFLG), and paradoxical low-flow low-gradient (pLFLG) AS. Baseline characteristics, hemodynamic, and clinical information were collected and compared. RESULTS: One-hundred-fifty-six patients were grouped into NFHG (n = 68, 43.5%), LFLG (n = 68, 43.5%), and pLFLG (n = 20, 12.8%) AS. Mean age of the study population was 81 years. Cardiogenic shock or refractory heart failure (46.8%) was the most common underlying reasons for BAV. Spearman correlation revealed that the mean pressure gradient reduction, determined by echocardiography, had a moderate correlation with the increase in the aortic valve area (AVA) in patients with NFHG AS (ρ: 0.529, p < .001) but showed no association in patients with LFLG (ρ: 0.017, p = .289) and pLFLG (ρ: 0.030, p = .889) AS. BAV as bridge to surgical or transcatheter aortic valve replacement was possible in 44.2% of patients, with no difference between groups (p = .070). CONCLUSION: The mean pressure gradient reduction might be an adequate surrogate parameter for BAV success in patients with NFHG AS but is not suitable for patients with other hemodynamic entities.

Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location.

OBJECTIVES: The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months. BACKGROUND: The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied. METHODS: The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension. RESULTS: No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference). CONCLUSION: In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months.

Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.

BACKGROUND: In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device. METHODS AND RESULTS: We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ± 1.7; HAS-BLED-Score 2.3 ± 1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42-111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p = .8). CONCLUSIONS: In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.

Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

BACKGROUND: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. AIMS: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. METHODS AND RESULTS: From August 2010 until July 2013, 799 patients (age 75.3 ±â€¯8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). CONCLUSIONS: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

Outcomes following endovascular therapy for acute stroke by interventional cardiologists.

OBJECTIVES: To summarize the outcomes of acute ischemic stroke (AIS) intervention by interventional cardiologists (IC) working on a stroke team. BACKGROUND: There is a geographic maldistribution of dedicated neuro-interventionalists (NI) to treat large vessel occlusion (LVO) AIS. METHODS: Results of 166 consecutive patients who received endovascular therapy (EVT) for AIS due to LVO by IC at three centers between 2009 and 2019 are reported. A modified Rankin score (mRs) of ≤ 2 at 90 days after EVT was used as the primary measurement of a good neurological outcome. Univariate logistic regression was used to evaluate predictors of the mRS > 2 and mortality. Those variables with significance of p < .2 from the univariate analysis were included in a multivariate analysis. RESULTS: All-cause mortality at 30 days was 22%. A favorable clinical outcome, mRS ≤ 2 at 90 days, was 49%. After multivariate analysis and controlling for confounders, a higher baseline NIHSS was predictive of 30-day mortality (OR 1.20 [95% CI 1.09-1.32] p < .001) and unfavorable clinical outcome (mRS > 2) at 90 days (OR 1.16 [95% CI 1.07-1.25] p < .001). CONCLUSION: Outcomes for carotid stent capable IC performing EVT for AIS are comparable to those achieved by NI physicians in major randomized clinical trials. Our data supports conducting a clinical trial of carotid stent capable IC working on multidisciplinary stroke teams to perform EVT for AIS due to LVO in communities and hospitals without timely access (<60 min by ground transport) to dedicated NI.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

OBJECTIVES: To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry. BACKGROUND: The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse. METHODS: In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year. RESULTS: Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02). CONCLUSIONS: TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.

Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN.

AIMS: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. METHODS AND RESULTS: A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. CONCLUSIONS: Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.

A collective European experience with left atrial appendage suture ligation using the LARIAT+ device.

AIMS: We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device. METHODS AND RESULTS: A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related. CONCLUSION: Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted.