Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial.

BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02). CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

Post-infarction ventricular septal defect: percutaneous or surgical management in the UK national registry.

AIMS: Post-infarction ventricular septal defect (PIVSD) is a mechanical complication of acute myocardial infarction (AMI) with a poor prognosis. Surgical repair is the mainstay of treatment, although percutaneous closure is increasingly undertaken. METHODS AND RESUTS: Patients treated with surgical or percutaneous repair of PIVSD (2010-2021) were identified at 16 UK centres. Case note review was undertaken. The primary outcome was long-term mortality. Patient groups were allocated based upon initial management (percutaneous or surgical). Three-hundred sixty-two patients received 416 procedures (131 percutaneous, 231 surgery). 16.1% of percutaneous patients subsequently had surgery. 7.8% of surgical patients subsequently had percutaneous treatment. Times from AMI to treatment were similar [percutaneous 9 (6-14) vs. surgical 9 (4-22) days, P = 0.18]. Surgical patients were more likely to have cardiogenic shock (62.8% vs. 51.9%, P = 0.044). Percutaneous patients were substantially older [72 (64-77) vs. 67 (61-73) years, P < 0.001] and more likely to be discussed in a heart team setting. There was no difference in long-term mortality between patients (61.1% vs. 53.7%, P = 0.17). In-hospital mortality was lower in the surgical group (55.0% vs. 44.2%, P = 0.048) with no difference in mortality after hospital discharge (P = 0.65). Cardiogenic shock [adjusted hazard ratio (aHR) 1.97 (95% confidence interval 1.37-2.84), P < 0.001), percutaneous approach [aHR 1.44 (1.01-2.05), P = 0.042], and number of vessels with coronary artery disease [aHR 1.22 (1.01-1.47), P = 0.043] were independently associated with long-term mortality. CONCLUSION: Surgical and percutaneous repair are viable options for management of PIVSD. There was no difference in post-discharge long-term mortality between patients, although in-hospital mortality was lower for surgery.

Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Getting the best from the Heart Team: guidance for cardiac multidisciplinary meetings.

The purpose of this document is to update the existing joint British Societies recommendations on multidisciplinary meetings (MDMs) published in 2015 to reflect changes in practice. We aim to provide guidance on the structure and function of MDMs which should be taking place in every cardiac surgical centre. Out of scope are MDMs that do not require the routine presence of a cardiac surgeon such as electrophysiology MDMs and those which are not provided in every centre, such as complex aortic surgery.

Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.

BACKGROUND: Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking. METHODS: In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed. RESULTS: A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group. CONCLUSIONS: In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).

Systemic inflammation and oxidative stress contribute to acute kidney injury after transcatheter aortic valve implantation.

BACKGROUND: Acute kidney injury (AKI) is a frequent complication of transcatheter aortic valve implantation (TAVI) and has been linked to preexisting comorbidities, peri-procedural hypotension, and systemic inflammation. The extent of systemic inflammation after TAVI is not fully understood. Our aim was to characterize the inflammatory response after TAVI and evaluate its contribution to the mechanism of post-procedural AKI. METHODS: One hundred and five consecutive patients undergoing TAVI at our institution were included. We analyzed the peri-procedural inflammatory and oxidative stress responses by measuring a range of biomarkers (including C-reactive protein [hsCRP], cytokine levels, and myeloperoxidase [MPO]), before TAVI and 6, 24, and 48 hours post-procedure. We correlated this with changes in renal function and patient and procedural characteristics. RESULTS: We observed a significant increase in plasma levels of pro-inflammatory cytokines (hsCRP, interleukin 6, tumor necrosis factor alpha receptors) and markers of oxidative stress (MPO) after TAVI. The inflammatory response was significantly greater after transapical (TA) TAVI compared to transfemoral (TF). This was associated with a higher incidence of AKI in the TA cohort compared to TF (44% vs. 8%, respectively, p < 0.0001). The incidence of AKI was significantly lower when N-acetylcysteine (NAC) was given peri-procedurally (12% vs. 38%, p < 0.005). In multivariate analysis, only the TA approach and no use of NAC before the procedure were independent predictors of AKI. CONCLUSIONS: TAVI creates a significant post-procedural inflammatory response, more so with the TA approach. Mechanisms of AKI after TAVI are complex. Inflammatory response, hypoperfusion, and oxidative stress may all play a part and are potential therapeutic targets to reduce/prevent AKI.

In-hospital stroke after transcatheter aortic valve implantation: A UK observational cohort analysis.

OBJECTIVES: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001). CONCLUSIONS: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve.

Prior Coronary Artery Bypass Graft Surgery and Outcome After Percutaneous Coronary Intervention: An Observational Study From the Pan-London Percutaneous Coronary Intervention Registry.

Background Limited information exists regarding procedural success and clinical outcomes in patients with previous coronary artery bypass grafting (CABG) undergoing percutaneous coronary intervention (PCI). We sought to compare outcomes in patients undergoing PCI with or without CABG. Methods and Results This was an observational cohort study of 123 780 consecutive PCI procedures from the Pan-London (UK) PCI registry from 2005 to 2015. The primary end point was all-cause mortality at a median follow-up of 3.0 years (interquartile range, 1.2-4.6 years). A total of 12 641(10.2%) patients had a history of previous CABG, of whom 29.3% (n=3703) underwent PCI to native vessels and 70.7% (n=8938) to bypass grafts. There were significant differences in the demographic, clinical, and procedural characteristics of these groups. The risk of mortality during follow-up was significantly higher in patients with prior CABG (23.2%; P=0.0005) compared with patients with no prior CABG (12.1%) and was seen for patients who underwent either native vessel (20.1%) or bypass graft PCI (24.2%; P<0.0001). However, after adjustment for baseline characteristics, there was no significant difference in outcomes seen between the groups when PCI was performed in native vessels in patients with previous CABG (hazard ratio [HR],1.02; 95%CI, 0.77-1.34; P=0.89), but a significantly higher mortality was seen among patients with PCI to bypass grafts (HR,1.33; 95% CI, 1.03-1.71; P=0.026). This was seen after multivariate adjustment and propensity matching. Conclusions Patients with prior CABG were older with greater comorbidities and more complex procedural characteristics, but after adjustment for these differences, the clinical outcomes were similar to the patients undergoing PCI without prior CABG. In these patients, native-vessel PCI was associated with better outcomes compared with the treatment of vein grafts.

Transcatheter Valve-in-Valve Therapy Using a Balloon Expanding Valve for Treatment of Aortic Paravalvular Leakage.

Aortic paravalvular leakage (PVL) is a recognised complication of surgically replaced valves which is often treated using vascular plugs. Whilst transcatheter valve-in-valve therapy has been increasingly used for failed surgical bioprostheses, it is not considered as a treatment option for aortic PVL. However, the newer design of transcatheter aortic valves has a fabric skirt to create a more effective seal around the annulus. To our best knowledge, for the first time, we report successful adoption of the valve-in-valve therapy for the treatment of PVL in surgical bioprosthetic aortic valves such that the fabric skirt is placed immediately below the regurgitant orifice resulting in significant reduction in the PVL.

Comparison of general anaesthesia and non-general anaesthesia approach in transfemoral transcatheter aortic valve implantation.

OBJECTIVE: Performing transfemoral transcatheter aortic valve implantation (TAVI) without general anaesthesia (GA) has been increasingly adopted. We sought to study the impact of GA and non-GA approaches on procedural outcome and 30-day and 1-year mortality in transfemoral TAVI. METHODS: The UK TAVI registry holds information for every TAVI procedure in the UK. We analysed the data for patients implanted during 2013-2014 using either an Edwards Sapien or a Medtronic CoreValve prosthesis. Propensity score-matching analysis was performed to adjust for confounding factors. RESULTS: 2243 patients were studied (aged 81.4±7.5 years, 1195 males). 1816 (81%) underwent TAVI with GA and 427 (19%) without GA. Transoesophageal echocardiography (TOE) was used in 92.3% of GA and 12.4% of non-GA cases (p<0.001). There was no significant difference in the rate of successful valve deployment (GA 97.2% vs non-GA 95.7%, p=0.104) and in the incidence of more than mild aortic regurgitation (AR) at the end of the procedure (GA 5.6% vs non-GA 7.0%, p=0.295). However, procedure time was longer (131±60 vs 121±60mins, p=0.002) and length of stay was greater (8.0±13.5 vs 5.7±5.5 days, p<0.001) for GA cases. 30-day and 1-year mortality rates did not differ between the GA and non-GA cases. After propensity matching, these results remained unchanged. A second propensity analysis (adjusted for mode of anaesthesia) did not show an association between use of TOE and rate of successful valve deployment or frequency of significant AR. Neither was TOE associated with a longer procedural time or greater length of stay. CONCLUSION: Procedure outcome, and 30-day and 1-year mortality are not influenced by mode of anaesthesia. However, GA is associated with longer procedure duration and greater length of stay.

Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE).

INTRODUCTION: Safety and efficacy data on patent foramen ovale (PFO) closure with the Occlutech Figulla Flex II device are lacking. We undertook a fully monitored prospective Registry on PFO closure using this device. METHODS: 100 patients undergoing PFO closure were enrolled into the OPPOSE Registry at 6 UK centres. The primary endpoint was PFO closure (grade 0 or 1 shunt) at 6-month BCTTE assessed by Corelab. Secondary endpoints included implantation success, complications, and atrial fibrillation during follow-up. RESULTS: 100 patients aged 43.8±11.5years, 53% male, were recruited. Indications for PFO closure included stroke (56%), TIA (29%) systemic embolism (4%) and MI (3%). Closure was undertaken under GA (44%) or LA (56%), with TOE (45%), ICE (31%), no imaging (20%) or TTE (3%). Balloon sizing was used in 98% of cases and showed a tunnel length of 7.3±3.6mm, primum-secundum separation of 7.0±2.9mm and basal inlet width of 8.5±3.5mm. Implantation was successful in all cases using 18mm (9%), 25mm (80%), 30mm (10%) and 35mm (1%) devices. 5 patients were lost to follow-up. 92 patients underwent six-month BCTTE. The primary endpoint of PFO closure (grade 0 or 1 shunt) at six months was 79.3%. One patient developed major bleeding (BARC 3b), one patient required vascular surgery, and in one patient device embolization was noted at six months and a larger device implanted. There was one case of new atrial fibrillation. CONCLUSIONS: This first prospective monitored data for the Occlutech Figulla Flex II device demonstrates good safety and efficacy data at implant and six-month follow-up.

Simultaneous Transseptal Para-Ring Leak Closure and Transcatheter Mitral Valve Implantation for the Treatment of Surgical Mitral Repair Failure.

Repeat cardiac surgery in patients with a previous sternotomy is associated with significant morbidity and mortality. While transcatheter aortic valve implantation in high risk surgical patients is now well established, experience with transcatheter mitral valve replacement is still at an early stage. Although many successful reports of transcatheter mitral valve replacements now exist, the predominant approach has been via a transapical approach. It is likely that, as with the evolution of favoured access routes for transcatheter aortic therapies, future directions for transcatheter mitral valves will focus on smaller delivery systems favouring the transvenous transseptal approach where possible. We present the first reported case of combined transseptal para-ring leak closure followed by transcatheter mitral valve implantation using a 12/5mm Amplatzer III vascular plug and a 29mm SAPIEN 3 valve.

Dynamic transcatheter mitral valve repair: a new concept to treat functional mitral regurgitation using an adjustable spacer.

We report the first-in-man implantation of the Mitra-Spacer. The device was implanted transapically. FMR was reduced to moderate. At two months, while in NYHA Class II, LVEF had improved, but FMR increased and 2 mL was added, reducing FMR to mild. Despite anticoagulation, thrombi developed around the device and the valve was replaced at eight months. The Mitra-Spacer successfully bridged this patient to surgery after LVEF had recovered.

Optimized Outcomes Using a Standardized Approach for the Treatment of Patients with Carcinoid Heart Disease.

BACKGROUND: Carcinoid heart disease (CHD) is common in patients with carcinoid syndrome (CS). Surgical treatment improves the poor prognosis of CHD, although the reported peri-operative mortality is high (∼17%). We attempted to improve outcomes by implementation of a protocol for the management of patients with CHD at a UK Neuroendocrine Centre of Excellence and report our experience. METHODS: All patients treated for CHD between 2008 and 2015 were included. Peri-operative treatment included surgical features such as invasive pulmonary valve (PV) inspection and preservation of the tricuspid subvalvular apparatus. RESULTS: A total of 11 patients were treated; the median age was 63 years (IQR: 56-70). Ten patients underwent both pulmonary valve replacement (PVR) and tricuspid valve replacement (TVR); 1 patient underwent isolated TVR. One patient had additional aortic valve replacement (AVR), another one coronary artery bypass grafting. Bioprostheses (BP) were used in all patients, stented for TVR and AVR, stentless for PVR. Invasive PV inspection caused unplanned PVR in 3 cases (27.3%). All patients were discharged home. One patient (9.1%), who had had previous TVR by another surgeon, had right heart failure (RHF) during follow-up. One death occurred due to progression of CS (day 346). The carcinoids' primary was resected in 5 patients (45.5%) 10 months (4.5-19.5) after cardiac surgery. CONCLUSION: Excellent results were achieved in patients with CHD. PV stenosis can be underestimated by echocardiography; therefore, intraoperative inspection is recommended. Right ventricular geometry should be respected to prevent RHF. BP should be used, as these patients are likely to undergo future non-cardiac surgeries.

Transcatheter valve-in-valve implantation versus redo surgical aortic valve replacement in patients with failed aortic bioprostheses.

OBJECTIVES: Transcatheter aortic valve-in-valve implantation (ViV) is a new treatment for failing bioprostheses (BP) in patients with high surgical risk. However, comparative data, using standard repeat surgical aortic valve replacement (redo-SAVR), are scarce. We compared outcomes after ViV with those after conventional redo-SAVR in two European centres with established interventional programmes. METHODS: In-hospital databases were retrospectively screened for patients ≥60 years, treated for failing aortic BP. Cases of infective endocarditis or combined procedures were excluded. End-points were adjudicated according to the Valve Academic Research Consortium (VARC-2) criteria. RESULTS: From 2002 to 2015, 130 patients were treated (ViV: n = 71, redo-SAVR: n = 59). Age and logistic EuroSCORE I scores were higher with ViV (78.6 ± 7.5 vs 72.9 ± 6.6 years, P < 0.01; 25.1 ± 18.9 vs 16.8 ± 9.3%, P < 0.01). The 30-day mortality rate was not significantly different (4.2 and 5.1%, respectively) (P = 1.0). Device success was achieved in 52.1% (ViV) and 91.5% (P < 0.01). No stroke was observed after ViV but in 3.4% after redo-SAVR (P = 0.2). Intensive care stay was longer after redo-SAVR (3.4 ± 2.9 vs 2.0 ± 1.8 days, P < 0.01). Mean transvalvular gradients were higher post-ViV (19.7 ± 7.7 vs12.2 ± 5.7 mmHg, P < 0.01), whereas the rate of permanent pacemaker implantation was lower (9.9 vs 25.4%, P < 0.01). Survival rates at 90 and180 days were 94.2 and 92.3% vs 92.8 and 92.8% (P = 0.87), respectively. CONCLUSIONS: Despite a higher risk profile in the ViV group, early mortality rates were not different compared with those of surgery. Although ViV resulted in elevated transvalvular gradients and therefore a lower rate of device success, mortality rates were similar to those with redo-SAVR. At present, both techniques serve as complementary approaches, and allow individualized patient care with excellent outcomes.

Inception of the 'endocarditis team' is associated with improved survival in patients with infective endocarditis who are managed medically: findings from a before-and-after study.

Objective: Despite improvements in its management, infective endocarditis (IE) is associated with poor survival. The aim of this study was to evaluate the impact of a multidisciplinary endocarditis team (ET), including a cardiologist, microbiologist and a cardiac surgeon, on the outcome of patients with acute IE according to medical or surgical treatment strategies. Methods: We conducted an observational before-and-after study of 196 consecutive patients with definite IE, who were treated at a tertiary reference centre between 2009 and 2015. The study was divided into two periods: period 1, before the formation of the ET (n=101), and period 2, after the formation of the ET (n=95). The role of the ET included regular multidisciplinary team meetings to confirm diagnosis, inform the type and duration of antibiotic therapy and recommend early surgery, when indicated, according to European guidelines. Results: The patient demographics and predisposing conditions for IE were comparable between the two study periods. In the time period following the introduction of the ET, there was a reduction in both the time to commencement of IE-specific antibiotic therapy (4.0±4.0 days vs 2.5±3.2 days; P=0.004) and the time from suspected IE to surgery (7.8±7.3 days vs 5.3±4.2 days; P=0.004). A 12-month Kaplan-Meier survival for patients managed medically was 42.9% in the pre-ET period and 66.7% in the post-ET period (P=0.03). The involvement of the ET was a significant independent predictor of 1-year survival in patients managed medically (HR 0.24, 95% CI 0.07 to 0.87; P=0.03). Conclusions: A standardised multidisciplinary team approach may lead to earlier diagnosis of IE, more appropriate individualised management strategies, expedited surgery, where indicated, and improved survival in those patients chosen for medical management, supporting the recent change in guidelines to recommend the use of a multidisciplinary team in the care of patients with IE.

Percutaneous Device Closure of Paravalvular Leak: Combined Experience From the United Kingdom and Ireland.

BACKGROUND: Paravalvular leak (PVL) occurs in 5% to 17% of patients following surgical valve replacement. Percutaneous device closure represents an alternative to repeat surgery. METHODS: All UK and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data were analyzed for association with death and major adverse cardiovascular events (MACE) at follow-up. RESULTS: Three hundred eight PVL closure procedures were attempted in 259 patients in 20 centers (2004-2015). Patient age was 67±13 years; 28% were female. The main indications for closure were heart failure (80%) and hemolysis (16%). Devices were successfully implanted in 91% of patients, via radial (7%), femoral arterial (52%), femoral venous (33%), and apical (7%) approaches. Nineteen percent of patients required repeat procedures. The target valve was mitral (44%), aortic (48%), both (2%), pulmonic (0.4%), or transcatheter aortic valve replacement (5%). Preprocedural leak was severe (61%), moderate (34%), or mild (5.7%) and was multiple in 37%. PVL improved postprocedure (P<0.001) and was none (33.3%), mild (41.4%), moderate (18.6%), or severe (6.7%) at last follow-up. Mean New York Heart Association class improved from 2.7±0.8 preprocedure to 1.6±0.8 (P<0.001) after a median follow-up of 110 (7-452) days. Hospital mortality was 2.9% (elective), 6.8% (in-hospital urgent), and 50% (emergency) (P<0.001). MACE during follow-up included death (16%), valve surgery (6%), late device embolization (0.4%), and new hemolysis requiring transfusion (1.6%). Mitral PVL was associated with higher MACE (hazard ratio [HR], 1.83; P=0.011). Factors independently associated with death were the degree of persisting leak (HR, 2.87; P=0.037), New York Heart Association class (HR, 2.00; P=0.015) at follow-up and baseline creatinine (HR, 8.19; P=0.001). The only factor independently associated with MACE was the degree of persisting leak at follow-up (HR, 3.01; P=0.002). CONCLUSION: Percutaneous closure of PVL is an effective procedure that improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.