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Percutaneous closure of paravalvar leaks (PVLs) was once only performed in extreme or non-surgical risk cases not suitable for redo-surgery with tissue or mechanical valves. This technique is now the treatment of choice with long term outcomes that are better than redo operations.123 As interventionalists become more familiar with using PVL devices, more off label device use has been reported in non-surgical cases involving complex native mitral valve regurgitation (NVMR). In this review, we appraise the literature regarding percutaneous treatment of paravalvar leaks and more recently esoteric off label use. We also describe two recent challenging cases where percutaneous devices were used to treat severe leaks that developed as a sequela of previous infective endocarditis. We also provide specific recommendations regarding periprocedural strategy and focus on the importance of device choice to provide an optimal outcome.

The present study assesses the clinical outcomes after left main coronary stenting, using clinical evaluation, angiography, and Fractional Flow Reserve (FFR). A prospective observational study was conducted on 72 patients undergoing left main coronary artery (LMCA) stenting, transthoracic echocardiography, coronary angiography, and percutaneous coronary intervention were done and FFR was recorded. At the end of 6 months, follow up check angiography, FFR study were performed. The stent was placed from LMCA to left anterior descending artery (LAD) artery among 45.83% of patients and 9.72% had from LMCA to Left circumflex artery. The mortality rate was 8.33%. The fractional flow reserve was 0.81 on an average ranging from 0.58 to 0.90. Relatively low incidence of major cardiac event was noted among patients with single vessel disease and ostial LMCA disease.

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.

Supplemental Digital Content is available in the text., Background: Physiological assessment with pressure wire pullback can characterize coronary artery disease (CAD) with a focal or diffuse pattern. However, the clinical relevance of this distinction is unknown. We use data from the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) to test if the pattern of CAD predicts the placebo-controlled efficacy of percutaneous coronary intervention (PCI) on stress echocardiography ischemia and symptom end points. Methods: One hundred sixty-four patients in ORBITA underwent blinded instantaneous wave-free ratio (iFR) pullback assessment before randomization. Focal disease was defined as a ≥0.03 iFR unit drop within 15 mm, rather than over a longer distance. Analyses were performed using regression modeling. Results: In the PCI arm (n=85), 48 were focal and 37 were diffuse. In the placebo arm (n=79), 35 were focal and 44 were diffuse. Focal stenoses were associated with significantly lower fractional flow reserve (FFR) and iFR values than diffusely diseased vessels (mean FFR and iFR, focal 0.60±0.15 and 0.65±0.24, diffuse 0.78±0.10 and 0.88±0.08, respectively, P

ObjectivesThe clinical impact of SARS-CoV-2 has varied across countries with varying cardiovascular manifestations. We review the cardiac presentations, in-hospital outcomes and development of cardiovascular complications in the initial cohort of SARS-CoV-2 positive patients at Imperial College Healthcare National Health Service Trust, UK.MethodsWe retrospectively analysed 498 COVID-19 positive adult admissions to our institute from 7 March to 7 April 2020. Patient data were collected for baseline demographics, comorbidities and in-hospital outcomes, especially relating to cardiovascular intervention.ResultsMean age was 67.4±16.1 years and 62.2% (n=310) were male. 64.1% (n=319) of our cohort had underlying cardiovascular disease (CVD) with 53.4% (n=266) having hypertension. 43.2%(n=215) developed acute myocardial injury. Mortality was significantly increased in those patients with myocardial injury (47.4% vs 18.4%, pConclusionHypertension, pre-existing CVD and acute myocardial injury were associated with increased in-hospital mortality in our cohort of COVID-19 patients. However, only a low number of patients required invasive cardiac intervention.

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

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 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.

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.

Background/Introduction The balloon expandable Edwards Sapien-S3 and Ultra, and the self-expanding Medtronic Evolut-Pro and Evolut-R 34mm represent the main volume of transcatheter aortic valve implantation (TAVI) procedures conducted worldwide. Purpose In the present study, we aim to compare the peri-procedural and one-year clinical outcomes between these last generation devices. Methods Consecutive patients from the ATLAS (Athens-Tokyo-London Aortic Stenosis) registry, who had undergone TAVI with either the S3/Ultra or Evolut-Pro/R 34mm device, in four centers were retrospectively studied. In-hospital procedural characteristics and outcomes were recorded and compared. Kaplan-Meier estimated 1-year all-cause mortality was compared between groups. Results In total, 692 patients (352pts treated with S3/Ultra and 340pts with Evolut-Pro/R34mm device) were included in the analysis. Baseline demographics (age, coronary artery disease risk factors, logistic Euroscore and aortic valve hemodynamics) were similar between the two groups. In terms of peri-procedural and short-term outcomes, patients treated with the Evolut-Pro/R34mm device had significantly lower peak (25.4±3.6mmHg for S3/Ultra vs 14.9±0.6mmHg for the self-expanding valves, p=0.002) and mean (10.7±0.3mmHg S3/Ultra vs 7.9±0.4mmHg Evolut PRO/R34, p Conversely, the S3 demonstrated significantly lower rates of at least moderate residual aortic regurgitation (AR) post-operatively (0.3% vs 4.8% for S3 and Evolut-Pro/R34mm respectively, p=0.001). Interestingly, the rate of new permanent pacemaker (PPM) required after the implantation in pacemaker-free patients on baseline, was higher for the S3/Ultra cohort compared to the self-expanding valve group (17.6% vs 11.7% respectively, p=0.054), however not reaching statistical significance yet. As expected, the need for balloon post dilatation of the implanted prosthesis was less among the S3/Ultra patients (5.5% vs 26.1%, p=0.001). One-year Kaplan-Meier estimated survival was similar between the two groups (85.9% for S3 vs. 90% for Evolut-Pro/R34mm, plog-rank=0.071). Hazard ratio for all-cause mortality (Pro/R34 vs. S3/Ultra) after adjustment for gender and previous MI was similar between the groups (HR=0.73; 95% CI 0.47 to 1.14, p=0.165). Conclusions Real life comparison of the last generation balloon expandable and self-expanding devices demonstrates similar 1-year all-cause mortality. The S3/Ultra platforms, as compared to the Evolut-Pro/R34mm, demonstrate less paravalvular leak, at the expense of higher transvalvular gradients. Long-term follow-up and future larger trials are required to establish any potential long-term difference in clinical outcomes and prognosis. Funding Acknowledgement Type of funding source: None

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.

Percutaneous coronary intervention relieves symptoms in patients with chronic ischemic heart disease resistant to optimal medical therapy and alters the natural history of acute coronary syndromes. However, adverse procedural outcomes may occur during the intervention. Knowledge of possible complications and their timely management are essential for the practicing cardiologist and can be life-saving for the patient. In this review, the authors summarize potential complications of percutaneous coronary intervention focusing on their practical management.

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.

Objectives The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. Background The coronary sinus Reducer is a novel device to aid in the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Methods Fifty patients with refractory angina and objective evidence of myocardial ischemia who were judged unsuitable for revascularization were treated with coronary sinus Reducer implantation at a single center between March 2015 and August 2016. Safety endpoints were procedural success and the absence of device-related adverse events. Efficacy endpoints, assessed at 4- and 12-month follow-up, were a reduction in Canadian Cardiovascular Society angina class, improvement in quality of life assessed using the Seattle Angina Questionnaire, improvement in exercise tolerance assessed using the 6-min walk test, and reduction in pharmacological antianginal therapy. Results Procedural success was achieved in all patients, with no device-related adverse effects during the procedure or at follow-up. Regarding the efficacy endpoint, 40 patients (80%) had at least 1 reduction in Canadian Cardiovascular Society class, and 20 patients (40%) had at least 2 class reductions, with a mean class reduction to 1.67 ± 0.83 vs. 2.98 ± 0.52 (p Conclusions In this real-world, single-center experience, implantation of the coronary sinus Reducer appeared safe and was associated with reduction in anginal symptoms and improvement in quality of life in patients with refractory angina who were not candidates for further revascularization.

A 70-year-old man presented as an emergency with acute pulmonary edema and hemodynamic compromise with a blood pressure of 60/38 mm Hg. His history included end-stage renal failure and rheumatic heart disease with tissue mitral valve replacement (27-mm Perimount Magma, Edwards Lifesciences, Irvine

BACKGROUND: A 68-year-old male, with a history of repeat percutaneous intervention for the treatment of severe calcific stenosis of the left circumflex artery and obtuse marginal branch bifurcation, presented with stable angina at a local hospital. He was found to have recurrent in-stent restenosis of this lesion and subsequently underwent a fifth reintervention; however, adequate balloon dilatation was not achievable in spite of non-compliant and cutting balloon use. In view of continuing symptoms despite optimal medical therapy, the patient was transferred to our hospital for further management. INVESTIGATION: Coronary angiography, intravascular ultrasound. DiAGNOSIS: Recurrent in-stent restenosis following prior repeat complex bifurcation stenting. MANAGEMENT: Rotational atherectomy of the multilayered stent struts, followed by successful balloon dilatation with a cutting balloon at high pressure, and treatment with a drug-coated balloon.

Transcatheter aortic valve implantation (TAVI) is now the treatment of choice for patients with symptomatic aortic stenosis who are inoperable or with high surgical risk. Data with regards to contemporary clinical practice and long-term outcomes are sparse. To evaluate temporal changes in TAVI practice and explore procedural and long-term clinical outcomes of patients in a contemporary "real-world" population, outcomes of 829 patients treated from November 2007 to May 2015, at the San Raffaele Scientific Institute, Milan, Italy, were retrospectively analyzed. Median follow-up was 568 days, with the longest follow-up of 2,677 days. Overall inhospital mortality was 3.5%. During the study period, there was a trend toward treating younger, lower risk patients. Overall mortality rates were 3.5% (30 days), 14% (1 year), 22% (2 years), 29% (3 years), 37% (4 years), 47% (5 years), 53% (6 years), and 72% (7 years). The survival probability at 5 years was significantly higher in patients treated through the transfemoral (TF) route compared to other vascular access sites (log rank p

Objectives In this study, a systematic analysis was conducted of phasic intracoronary pressure and flow velocity in patients with severe aortic stenosis (AS) and coronary artery disease, undergoing transcatheter aortic valve replacement (TAVR), to determine how AS affects: 1) phasic coronary flow; 2) hyperemic coronary flow; and 3) the most common clinically used indices of coronary stenosis severity, instantaneous wave-free ratio and fractional flow reserve. Background A significant proportion of patients with severe aortic stenosis (AS) have concomitant coronary artery disease. The effect of the valve on coronary pressure, flow, and the established invasive clinical indices of stenosis severity have not been studied. Methods Twenty-eight patients (30 lesions, 50.0% men, mean age 82.1 ± 6.5 years) with severe AS and coronary artery disease were included. Intracoronary pressure and flow assessments were performed at rest and during hyperemia immediately before and after TAVR. Results Flow during the wave-free period of diastole did not change post-TAVR (29.78 ± 14.9 cm/s vs. 30.81 ± 19.6 cm/s; p = 0.64). Whole-cycle hyperemic flow increased significantly post-TAVR (33.44 ± 13.4 cm/s pre-TAVR vs. 40.33 ± 17.4 cm/s post-TAVR; p = 0.006); this was secondary to significant increases in systolic hyperemic flow post-TAVR (27.67 ± 12.1 cm/s pre-TAVR vs. 34.15 ± 17.5 cm/s post-TAVR; p = 0.02). Instantaneous wave-free ratio values did not change post-TAVR (0.88 ± 0.09 pre-TAVR vs. 0.88 ± 0.09 post-TAVR; p = 0.73), whereas fractional flow reserve decreased significantly post-TAVR (0.87 ± 0.08 pre-TAVR vs. 0.85 ± 0.09 post-TAVR; p = 0.001). Conclusions Systolic and hyperemic coronary flow increased significantly post-TAVR; consequently, hyperemic indices that include systole underestimated coronary stenosis severity in patients with severe AS. Flow during the wave-free period of diastole did not change post-TAVR, suggesting that indices calculated during this period are not vulnerable to the confounding effect of the stenotic aortic valve., Graphical abstract

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is the first area of interventional cardiology where women are treated as often as men. In this analysis of the gender specific results of randomised controlled trials (RCTs) comparing TAVI with surgical aortic valve replacement (SAVR) we aimed to determine whether gender affects the survival comparison between TAVI and SAVR. We identified all RCTs comparing TAVI versus SAVR for severe AS and reporting 1 and/or 2year survival. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I 2 . Four RCTs met the criteria, totalling 3758 patients, 1706 women and 2052 men. Amongst females, TAVI recipients had a significantly lower mortality than SAVR recipients, at 1year (OR 0.68; 95%CI 0.50 to 0.94) and at 2years (OR 0.74; 95%CI 0.58 to 0.95). Amongst males there was no difference in mortality between TAVI and SAVR, at 1year (OR 1.09; 95%CI 0.86 to 1.39) or 2years (OR 1.05; 95%CI 0.85 to 1.3). The difference in treatment effect between genders was significant at both 1year (p interaction =0.02) and 2years (p interaction =0.04). In women TAVI has a 26 to 31% lower mortality odds than SAVR. In men, there is no difference in mortality between TAVI and SAVR.

Objectives The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for “long coronary lesions.” Background The present substudy derived from the GHOST-EU registry included 1,722 lesions in 1,468 consecutive patients, enrolled between November 2011 and September 2014 at 11 European centers. Methods The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm; 2) between 30 and 60 mm; and 3) longer than 60 mm. Primary device-oriented endpoint (target lesion failure [TLF]) was defined as a combination of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Results Patients with lesions ≥60 mm had more comorbidities and more complex lesion characteristics, including chronic total occlusions (37%), bifurcation lesions (40.3%), higher Syntax score (16.4 ± 7.8), and higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). The main target vessel was the left anterior coronary artery in all groups. Median follow-up was 384 (interquartile range: 359 to 459) days. One-year follow-up was completed in 70.3% of patients. TLF at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), whereas there were no significant differences between groups A and B. Finally, a numerically higher (but not statistically significant) number of scaffold thromboses were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29). Conclusions In a real-world setting, treatment of long coronary lesions with BVS ≥60 mm was associated with a higher TLF rate, driven by myocardial infarction and clinically driven target lesion revascularization.

Learning objectives Atherosclerosis is a chronic inflammatory process and both the innate and adaptive immune systems1 play central roles in its initiation and subsequent progression.2 Experimental models have demonstrated that the specific targeting of these biological processes can attenuate plaque formation and, in some instances, even induce regression of disease.3 As a consequence, there has been great interest in the development of clinical immune-modulatory (anti-inflammatory) agents. To date, the results of these endeavours have largely been disappointing. The recently published Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS)4 demonstrated that targeting a particular element of inflammation through inhibition of interleukin (IL)-1β in patients with coronary artery disease reduced occurrence of a composite cardiovascular end point. However, the effects size was modest in the population studied.5 Thus, while re-igniting interest in targeting elements of ‘inflammation’, CANTOS also emphasised that more precise characterisation of disease processes will be essential. This review will consider currently described roles for inflammatory processes in the pathogenesis of atherosclerosis, the use of biomarkers (and their limitations) to characterise these processes and emerging opportunities in the field, including novel therapeutics. In a current paradigm, atherogenesis is initiated by the deposition and retention of apolipoprotein B-containing lipoproteins into the subintimal space resulting from loss of endothelial integrity, in turn due to disrupted shear stress. Oxidative modification of these lipoproteins in combination with endothelial activation trigger both innate and adaptive immune responses. Following upregulation of a number of cell-adhesion molecules (intercellular adhesion molecule 1, P-selectin and vascular cell adhesion molecule 1 (VCAM-1)), circulating monocytes released from the bone marrow and spleen6 adhere and then …

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.

Introduction The incidence of stroke in young patients is increasing and is associated with significant morbidity, mortality and socioeconomic cost. Identifying potential underlying causes is central to their overall management to reduce recurrence and improve long-term outcomes. A proportion of these patients are found to have an underlying cardiac cause including atrial fibrillation (AF), patent foramen ovale (PFO) or an intracardiac source of embolus. This area has recently gained greater interest with evidence demonstrating a significant reduction in recurrent ischaemic events following PFO closure. The identification of these patients however, requires extensive investigation and has implications relating to cardiology resources. Outside of clinical trials the true incidence of these patients in a “real-world” population is poorly defined. Purpose The aim of this study was to determine the proportion of strokes attributable to cardiac causes in young patients presenting with ischaemic stroke. Methods The Sentinel Stroke National Audit Programme (SSNAP) database of a large UK stroke service was used to identify patients ≤55 years old presenting with stroke between 1/1/15 and 31/12/17. Clinical letters, imaging reports and laboratory reports were reviewed. Patients were then categorised by cause of stroke using the Trial of Acute Stroke Treatment (TOAST) criteria. Cardiac causes of stroke were defined as: AF, PFO and intracardiac source of embolus. Patients presenting with a haemorrhagic stroke or where an alternate diagnosis to stroke was more likely were excluded. Results During the study period, 206 patients were identified as having suffered a stroke. 35 patients were excluded resulting in a final study population of 171 patients (Figure). 24% (41/171) were identified as having a cardiac cause of stroke including 9.4% (16/171) PFO, 8.8% (15/171) intracardiac source of embolus and 5.8% (10/171) atrial fibrillation. 50.3% (86/171) were thought to have other causes: 24.6% (42/171) small vessel disease; 9.4% (16/171) large artery atherosclerosis; and 16.4% (28/171) other determined aetiology including 5.1% (8.8/171) with arterial dissection. 25.7% (44/171) presented with a stroke but with no clear underlying cause found. Causes of stroke in young patients Conclusion A high proportion (24%) of strokes in young patients were found to be likely secondary to a cardiac cause. With the significant benefit of intervention (medical or procedural) in this patient group, the resource provision allocated to this population does appear to be warranted and further demonstrates the importance of close interdisciplinary links between cardiologists and stroke physicians.

Background The Evolut PRO self-expanding transcatheter aortic valve has been designed to feature an outer pericardial wrap that aims to reduce paravalvular regurgitation (PVR) rates. Medium-term clinical outcomes, compared to its predecessor Evolut R, in a real-world setting, have not been investigated. The aim of the present study was to compare the two valves with regards to peri-procedural complications, early outcomes and mid-term survival. Methods Consecutive patients, undergoing TAVI with either the Evolut PRO or Evolut R device, from the multicenter ATLAS registry were retrospectively studied. Outcomes studied included periprocedural complications, PVR at discharge, need for new pacemaker implantation and Kaplan-Meier estimated 1-year all-cause mortality. Results Analysis included 673 patients (498 treated with Evolut R and 175 treated with Evolut PRO). At least moderate PVR was numerically lower amongst patients treated with Evolut PRO (7.4% vs 3.8% for Evolut R and Evolut PRO respectively, p = .108). Rates of new permanent pacemaker (PPM) implantation (21.1% vs. 11.9%, p = .023), and bail-out valve-in-valve (2.4% vs. 0%, p = .049) were significantly lower amongst the Evolut PRO group. No differences were demonstrated regarding bleeding, stroke or acute kidney injury. One-year Kaplan-Meier estimated survival was similar between groups (93% for Evolut R vs. 91.2% for Evolut PRO, plog-rank = 0.806). Conclusions The Evolut PRO self-expanding valve demonstrates similar mid-term survival rates and numerically, yet not significant, lower incidence of PVR compared to its predecessor. Interestingly this new generation valve is associated with a significantly reduced rate for new PPM implantation. Future studies are required to confirm this finding.

Background Very little is known about long-termvalvedurability aftertranscatheter aortic valve replacement(TAVR). Objectives This study sought to evaluate the incidence of structural valvedegeneration(SVD) 5 to 10 years post-procedure. Methods Demographic, procedural, and in-hospital outcome data on patients who underwent TAVR from 2007 to 2011 were obtained from the U.K.TAVI(United Kingdom Transcatheter Aortic Valve Implantation) registry. Patients in whom echocardiographic data were available both at baseline and≥5 years post-TAVR were included.HemodynamicSVD was determined according to European task force committeeguidelines. Results A total of 241 patients (79.3 ± 7.5 years ofage; 46% female) with paired post-procedure and late echocardiographicfollow-up(median 5.8 years, range 5 to 10 years) were included. A total of 149 patients (64%) were treated with a self-expandable valve and 80 (34.7%) with a balloon-expandable valve. Peakaortic valvegradientatfollow-upwas lower than post-procedure (17.1 vs. 19.1mmHg; p=0.002). More patients had none/trivialaortic regurgitation(AR) (47.5% vs. 33%), and fewer had mild AR (42.5% vs. 57%) at follow-up (p=0.02). There was 1 case (0.4%) of severe SVD 5.3 years afterimplantation(new severe AR). There were 21 cases (8.7%) of moderate SVD (mean 6.1 years post-implantation; range 4.9 to 8.6 years). Twelve of these (57%) were due to new AR and 9 (43%) torestenosis. Conclusions Long-term transcatheter aortic valve function is excellent. In the authors’ study, 91% of patients remained free of SVD between 5 and 10 years post-implantation. The incidence of severe SVD was&nbsp

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.

The Coronary Sinus (CS) Reducer (Neovasc Inc., Richmond, British Columbia, Canada) is a percutaneous device implanted in the CS to create a controlled narrowing of the lumen leading to an increase in coronary venous pressure, capillary and arteriolar dilatation, and restoration of the endocardial/

AIMS The aim of this multicentre study was to investigate the in-hospital and midterm outcomes of rotational atherectomy (RA) followed by metallic stent implantation. METHODS AND RESULTS Between 2002 and 2013, 1,176 de novo lesions with calcified coronary lesions treated by RA and metallic stent implantation at nine institutions were assessed. Patients with ST-segment elevation myocardial infarction (STEMI) within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis were excluded from the current analysis. In-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16.0% at one-year and 24.9% at two-year follow-up, both driven by target vessel revascularisation (13.5% at one year and 19.8% at two years). Multivariable analysis revealed that dialysis was an independent predictor for both in-hospital MACE (OR 2.33, 95% CI: 1.11-4.87, p=0.03) and follow-up MACE (HR 4.14, 95% CI: 2.87-5.96, p

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.

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°≦CA

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.

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.

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.

Aims Our aim was to assess the feasibility and results of a hybrid approach with a bioresorbable scaffold (BRS) plus a drug-coated balloon (DCB) for the treatment of diffuse coronary artery disease (CAD). Methods and results A retrospective analysis was performed on consecutive patients with diffuse de novo or in-stent restenosis treated with BRS implantation (larger proximal segment) and DCB inflation (smaller distal segment or bifurcation side branch). Endpoints were procedural success, then ischaemia-driven target lesion revascularisation (ID-TLR) and BRS/DCB segment thrombosis rates at follow-up. A total of 42 consecutive patients were treated with the hybrid strategy. Mean patient age was 62±1.02 years, while 12 (28.6%) patients were diabetics. Mean BRS and DCB length were 28.0±5.1 mm and 25.8±8.8 mm, respectively. Procedural success was obtained in all patients, but three (7.3%) patients required bail-out scaffolding for DCB-related dissection. At a median follow-up of 12 months (IQR: 6-18), there were no cases of cardiac death, target vessel myocardial infarction, or BRS/DCB segment thrombosis. ID-TLR occurred in two (4.7%) BRS-treated segments. Conclusions Our data in consecutive patients with diffuse CAD suggest that a hybrid strategy using BRS and DCB in different segments of the diseased vessel is feasible and associated with encouraging clinical outcomes.

Aims Our aim was to investigate one-year outcomes in patients treated with bioresorbable scaffolds (BRS) for "off-label" versus currently "established" indications. Methods and results Consecutive patients treated with BRS between May 2012 and September 2014 in two centres were retrospectively recruited. Patients who met inclusion criteria as defined by the ABSORB III study were allocated to the established indication group (ESTG; 21 patients with 35 lesions) and the remaining patients to the off-label group (OFLG; 168 patients with 225 lesions). Target vessel failure (TVF) and ischaemia-driven target lesion revascularisation (id-TLR) at one year were evaluated in both groups. Patients in the OFLG had a higher prevalence of diabetes mellitus and longer lesion length. Predilatation, post-dilatation and intracoronary imaging were conducted in the majority of patients. At one-year follow-up, TVF (0% vs. 7.8%, p=0.32) and id-TLR (0% vs. 4.5%, p=0.31) occurred only in the OFLG with no adverse events in the ESTG. Definite stent thrombosis occurred in two OFLG patients (1.3%). Conclusions In a real-world setting, the majority (88.9%) of patients were treated with BRS for off-label indications. Off-label use of BRS appears to be associated with an acceptable occurrence of outcomes considering the greater complexity of this patient group.

AIMS Meticulous lesion preparation prior to bioresorbable vascular scaffold (BVS) implantation has been strongly recommended. The aim of this study was to investigate if there was a benefit associated with scoring balloon use in lesion preparation in comparison to conventional balloons prior to implantation of a BVS. METHODS AND RESULTS Of the lesions treated with BVS between May 2012 and July 2014, 155 lesions in the conventional balloon group and 29 lesions in the scoring balloon group were included. Procedures without predilatation and those which utilised cutting balloon or rotational atherectomy devices were excluded. Complex (B2/C lesion: 76.1% vs. 93.1%; p=0.028), restenotic (5.2% vs. 17.2%; p=0.036) and calcified (36.1% vs. 79.3%; p

Significant unprotected left main stem (ULMS) disease is in approximately 5% to 7% of patients undergoing coronary angiography. Historically, coronary artery bypass grafting has been the gold standard treatment of these patients. With recent advances in stent technology, adjunctive pharmacotherapy, and operator experience, percutaneous coronary intervention (PCI) is increasingly regarded as a viable alternative treatment option, especially in patients with favorable coronary anatomy (low and intermediate SYNTAX (Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) scores). This article aims to discuss the evidence supporting PCI for ULMS disease, current guidelines, and technical aspects.

Objectives The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. Background An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. Methods We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Results Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. Conclusions BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc.

Background: Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation. Methods: Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2). Results: Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s −1 versus post-TAVI 3.04±1.6 mm Hg·cm·s −1 [ P =0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [ P =0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74. Conclusions: TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values

Background: The coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies. This study aims to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. Methods: One hundred forty-one consecutive patients were treated with CS Reducer implantation. The primary efficacy endpoint was reduction in angina symptoms from baseline as assessed by Canadian Cardiovascular Society (CCS) class status and Seattle Angina Questionnaire (SAQ) scores. The primary safety endpoint was successful Reducer device delivery and deployment in the absence of any device-related events. Results: Procedural success was achieved in 139 (98.6%) patients. Reducer implantation was not obtained in 2 (1.4%) patients because of unfavorable anatomy of the CS. There were no CS perforations, cardiac tamponade, peri-procedural death or myocardial infarction during a median follow-up of 14 months (range from 6- to 70-month). In patients undergoing Reducer implantation, mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Overall, 113 (81%) patients experienced at least 1 CCS improvement, and 63 (45%) patients at least 2 CCS-class improvement. All SAQ items improved significantly (p < 0.001 for all) and translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37 ± 0.97 vs 2.17 ± 0.95; p = 0.003). Conclusions: In a real-world multi-center experience, implantation of the CS Reducer appears safe, and efficacious in reducing symptoms of angina and improving quality of life.

While transcatheter aortic valve implantation (TAVI) is now the accepted treatment option of choice for patients presenting with severe symptomatic aortic stenosis who are deemed to be inoperable or of high surgical risk, there have been concerns regarding the risk of early valve failure and durability. One potential limitation is the occurrence of early post-TAVI thrombosis. Whilst the incidence of obstructive transcatheter heart valve (THV) thrombosis is

Aims Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure. Methods and results Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status. Conclusions For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.

OBJECTIVES We aimed to investigate procedural feasibility and outcomes associated with planned rotational atherectomy (RA) for severely calcified coronary lesions. BACKGROUND Limited data are available addressing the benefits of planned RA compared to provisional RA. METHODS Between 2002 and 2013, all patients with calcified lesions treated by RA were enrolled. Of these, patients treated with planned RA (358 patients) were compared to those treated with provisional RA (309 patients). RESULTS In-hospital major adverse cardiovascular events (MACE) were tended to be better in the planned RA group (unadjusted OR: 0.76; 95% CI: 0.44-1.31, P = 0.32, and adjusted OR: 0.59; 95% CI: 0.33-1.05, P = 0.07). The number of pre-dilation balloon catheters was significantly lower in the planned RA group (1.17 ± 0.60 vs. 1.47 ± 0.76, P

Objectives This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). Background The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. Methods The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). Results Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. Conclusions This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route.