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

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

Impact of post-procedural hyperglycemia on acute kidney injury after transcatheter aortic valve implantation.

BACKGROUND: Post-operative hyperglycemia, in individuals with and without diabetes, has been identified as a predictor of acute kidney injury (AKI) in patients following cardiac surgery. Whether or not this is also true for patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. OBJECTIVES: To evaluate whether post-procedural glucose levels are associated with AKI after TAVI. METHODS AND RESULTS: A total of 422 consecutive patients undergoing transfemoral TAVI were included in the analysis. For each patient, plasma glucose levels were assessed at hospital admission, 4h after the procedure and daily during hospitalization. Post-procedural hyperglycemia was defined as 2 consecutive blood glucose readings ≥150mg/dL in the 72-hour period following TAVI. AKI was defined according to the VARC consensus report regarding standardized endpoint definitions. Overall, 137 (32.5%) patients developed post-procedural hyperglycemia and 138 (33%) patients developed AKI. Hyperglycemia was associated with a 2-fold higher incidence of AKI than in patients without hyperglycemia (48% vs. 25%, p<0.001). In-hospital mortality was higher in patients with hyperglycemia than in those without hyperglycemia (9.6% vs. 1.8%, p<0.001). In-hospital mortality rate was also higher in patients who developed AKI (12.7% vs. 2.7%, p<0.001). Patients with acute hyperglycemia that developed AKI had the highest in-hospital and long-term mortality rate (15% and 38%). Post-procedural hyperglycemia was an independent predictor of AKI. CONCLUSIONS: Post-procedural hyperglycemia is associated with a higher incidence of AKI and mortality after TAVI. Randomized controlled trials are needed to determine whether meticulous post-procedural glycemic control following TAVI impacts upon clinical outcomes.

A case of an occlusive right coronary artery dissection after stent implantation: dilemmas and challenges.

A 53-year-old man with stable angina had a staged percutaneous coronary intervention to a critical focal stenosis of the mid-segment of the right coronary artery (RCA). Two hours after successful RCA stent implantation, the patient re-presented with inferior ST elevation secondary to acute dissection originating at the distal edge of the stent, causing subtotal occlusion of the distal RCA. The patient had TIMI-2 flow in the posterolateral branch and occlusion of the posterior descending artery. This case describes the procedural challenges the operators were faced with and successful use of the "rescue STAR" technique as a last resort.

Cardiac surgery for patients with heart failure due to structural heart disease in Uganda: access to surgery and outcomes.

OBJECTIVE: Few data are available on heart failure (HF) in sub-Saharan Africa. We aimed to provide a current picture of HF aetiologies in urban Uganda, access to heart surgery, and outcomes. METHODS: We prospectively collected clinical and echocardiographic data from 272 consecutive patients referred for suspected heart disease to a tertiary hospital in Kampala during seven non-governmental organisation (NGO) missions from 2009 to 2013. We focused the analysis on 140 patients who fulfilled standardised criteria of HF by echocardiography. RESULTS: Rheumatic heart disease (RHD) was the leading cause of HF in 44 (31%) patients. Among the 50 children included (age ≤ 16 years), congenital heart disease (CHD) was the first cause of HF (30 patients, 60%), followed by RHD (16 patients, 32%). RHD was the main cause of HF (30%) among the 90 adults. All 85 patients with RHD and CHD presented with an indication for heart surgery, of which 74 patients were deemed fit for intervention. Surgery was scheduled in 38 patients with RHD [86%, median age 19 years (IQR: 12-31)] and in 36 patients with CHD [88%, median age 4 years (IQR 1-5)]. Twenty-seven candidates (32%) were operated on after a median waiting time of 10 months (IQR 6-21). Sixteen (19%) had died after a median of 38 months (IQR 5-52); 19 (22%) were lost to follow up. CONCLUSION: RHD still represents the leading cause of HF in Uganda, in spite of cost-efficient prevention strategies. The majority of surgical candidates, albeit young, do not have access to treatment and present high mortality rates.

A comparison of the femoral and radial crossover techniques for vascular access management in transcatheter aortic valve implantation: the Milan experience.

OBJECTIVE: To compare radial and femoral crossover techniques (CT) for vascular access management in transcatheter aortic valve implantation (TAVI). BACKGROUND: Femoral crossover for controlled angiography and balloon inflation of the therapeutic access site to facilitate safe vascular closure is beneficial but technically challenging in patients with complex femoral anatomy. An alternative approach should be available. METHODS: Between June 2011 and March 2012, 41 transfemoral TAVI patients receiving the femoral CT were compared to 46 transfemoral TAVI patients receiving the radial CT. Outcomes were 30-day valve academic research consortium (VARC) endpoints. RESULTS: Patients undergoing the radial CT received higher median contrast volumes (150 interquartile range [IQR]: 105-180 vs. 111 IQR: 90-139 ml; P = 0.025) but procedural radiation dose and fluoroscopy times were comparable. Thirty day all cause and cardiovascular death were similar between radial and femoral CT groups (respectively 2.4% vs. 7.9%, P = 0.258 and 0% vs. 7.9%, P = 0.063). There were no differences in major vascular complications (4.3% vs. 7.3%, P = 0.553), life threatening or major bleeding events (respectively 9.1% vs. 19.5%, P = 0.168 and 13.6% vs. 22%, P = 0.315). CONCLUSION: In TAVI cases with unfavorable contralateral femoral anatomy, radial CT for vascular access management is a reasonable alternative to the femoral CT.

Comparison of first- and second-generation drug-eluting stents in saphenous vein grafts used as aorto-coronary conduits.

Saphenous vein grafts (SVGs) are prone to an aggressive atherosclerotic process, and the efficacy of drug-eluting stents (DES) in treating this is still debated. In recent years, second-generation DES have been increasingly used in SVG intervention. The main objective of this study was to compare midterm clinical outcomes between first- and second-generation DES in SVGs because data regarding the use of second-generation DES in SVG are lacking. Patients treated with first-generation DES (127 patients with 143 lesions) and those treated with second-generation DES (84 patients with 100 lesions) were included in the study. Major adverse cardiac events, defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization, as well as target vessel revascularization and target lesion revascularization separately, were evaluated at 30-day, 12-month, and 18-month follow-up. Baseline characteristics were similar between the 2 groups. Older grafts were treated with second-generation DES (11.6 ± 5.3 vs 14.3 ± 6.0 years, p = 0.001). Stent length was longer in the first-generation group (34.1 ± 25.1 vs 30.5 ± 19.4 mm, p = 0.006), and maximum balloon diameter was smaller in the second-generation group (3.42 ± 0.42 vs 3.30 ± 0.41 mm, p = 0.003). Embolic protection device use was higher in the second-generation DES group (55.2% vs 72.0%, p = 0.012). At 18-month follow-up, rates of major adverse cardiac events, target vessel revascularization, and target lesion revascularization for the first- and second-generation groups were 24.4% versus 20.2% (p = 0.479), 18.1% versus 14.2% (p = 0.465), and 15.0% versus 10.7% (p = 0.373), respectively. In conclusion, second-generation DES are at least comparable with first-generation DES with regard to clinical outcomes at midterm follow-up.

Clinical outcome and quality of life in octogenarians following transcatheter aortic valve implantation (TAVI) for symptomatic aortic stenosis.

OBJECTIVE: TAVI is the alternative option in pts with AS deemed ineligible for surgery. Although mortality and morbidity are measures to assess the effectiveness of treatments, quality of life (QOL) should be an additional target. We assessed clinical outcome and QOL in octogenarians following TAVI. DESIGN: All octogenarians with a risk profile considered by the Heart Team to be unacceptable for surgery entered in this registry. QOL was assessed by questionnaires concerning physical and psychic performance. PATIENTS: A hundred forty-five octogenarians (age: 84.7 ± 3.4 years; male: 48.3%) underwent TAVI for AS (97.2%) or isolated AR (2.8%). NYHA class: 2.8 ± 0.6; Logistic EuroScore: 26.1 ± 16.7; STS score: 9.2 ± 7.7.Echocardiographic assessments included AVA (0.77 ± 0.21 cm2), mean/peak gradients (54.5 ± 12.2/88 ± 19.5 mm Hg), LVEF (21%=EF ≤ 40%), sPAP (43.1 ± 11.6 mmHg). INTERVENTIONS: All pts underwent successful TAVI using Edward-SAPIEN valve (71.2%) or Medtronic CoreValve (28.8%). MAIN OUTCOME MEASURES: Rates of mortality at 30 days, 6 months and 1 year were 2.8%, 11.2% and 17.5%. RESULTS: At 16-month follow up, 85.5% survived showing improved NYHA class (2.8 ± 0.6 vs 1.5 ± 0.7; p<0.001), decreased sPAP (43.1 ± 11.6 mm Hg vs 37.1 ± 7.7 mm Hg; p<0.001) and increased LVEF in those with EF ≤ 40% (34.9 ± 6% vs 43.5 ± 14.4%; p=0.006). Concerning QOL, 49% walked unassisted, 79% (39.5% among pts ≥ 85 years) reported self-awareness improvement; QOL was reported as "good" in 58% (31.4% among pts ≥ 85 years), "acceptable according to age" in 34% (16% among pts ≥ 85 years) and "bad" in 8%. CONCLUSION: TAVI procedures improve clinical outcome and subjective health-related QOL in very elderly patients with symptomatic AS.

Percutaneous valve replacement in a young adult for radiation-induced aortic stenosis.

A 46-year-old woman known with relapsing Hodgkin's lymphoma diagnosed at age 5, treated with repeated cycles of radiotherapy and chemotherapy, presented with severe symptomatic radiation-induced aortic stenosis. She also had other late sequelae of radiotherapy including thyroid cancer, mediastinal fribrosis and left pulmonary fibrosis with severe restrictive lung disease and a newly diagnosed renal carcinoma. Due to the prohibitively high surgical risk and need for urgent treatment, she underwent successful transcatheter aortic valve replacement with transfemoral implantation of a 23 mm Edwards SAPIEN-XT prosthesis, which was performed without valvuloplasty of the noncalcified fibrotic valve. The final result was excellent with reduction of the transaortic gradient and no residual aortic regurgitation.

Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience.

AIMS: Reoperation for bioprosthetic heart valve failure is associated with significant morbidity and mortality, particularly in high-risk patients. Transcatheter valve-in-valve (VIV) implantation may offer a less invasive alternative. The aim of this study was to report our initial experience with transcatheter VIV implantation to treat degenerated tissue valves. METHODS AND RESULTS: VIV implantation with the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifesciences Inc, Irvine, CA, USA) was performed in 18 high-risk patients (STS 8.2±5.2%; logistic EuroSCORE 37.4±20.8%) with symptomatic bioprosthetic failure (17 aortic, one mitral). Valve Academic Research Consortium (VARC) definitions were applied for endpoint adjudication. Transfemoral access was the preferred vascular approach (16 patients, with the mitral VIV delivered anterogradely through the femoral vein; one transaxillary and one transapical). The majority (83%) of procedures were performed under local anaesthesia and sedation. Device success was achieved in all but one patient who had a final transaortic gradient ≥20mmHg. Acute kidney injury occurred in three patients (Stage 3 in 1), life-threatening or major bleeding in four patients, while major vascular complications occurred in one patient. Permanent pacemaker implantation was required in two patients. There were no deaths or neurological events at 30-day follow-up. At a median follow-up of 11 months (interquartile range 6-16), the mortality rate was 5.6% and all patients were in NYHA class II or lower. CONCLUSIONS: Transcatheter implantation of the Edwards THV within a degenerated aortic bioprosthesis, performed predominantly via the transfemoral route, is feasible and associated with good periprocedural and clinical outcomes in high-risk surgical patients.

Clinical and angiographic outcomes after percutaneous recanalization of chronic total saphenous vein graft occlusion using modern techniques.

Poor long-term outcomes after percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) of saphenous vein grafts (SVGs) have been reported. However, limited data are available evaluating the use of modern techniques in this group. The aim of the present study was to assess the efficacy and long-term outcomes of PCI in SVG CTO with the routine use of embolic protection devices and drug-eluting stents. A retrospective cohort analysis was conducted of all consecutive patients undergoing PCI to SVG CTO from May 2002 to July 2009 at 2 centers. The indication for PCI was the presence of angina or silent ischemia with evidence of inducible ischemia after functional testing in the territory supplied by the SVG, despite optimal medical therapy. We identified 34 patients with SVG CTO. Of the 34 patients, 23 (68%) underwent successful SVG recanalization with stent implantation. An embolic protection device was used in 78% and 95% of stents implanted were drug-eluting stents. No in-hospital major adverse cardiac events occurred in the successful PCI group; one myocardial infarction occurred in the unsuccessful group. At follow-up (median 18.0 months, interquartile range 10.4 to 48.3), 1 case of myocardial infarction had occurred in the successful group. The in-stent restenosis rate was 68% (n = 13), of which 77% were focal, with target vessel revascularization in 61%. In conclusion, despite the relatively low procedural success rates, the clinical outcomes after successful PCI to SVG CTO with modern techniques were favorable. The repeat revascularization rates were high; however, graft patency was achievable in most after reintervention.