Initial clinical experience with the GORE® CARDIOFORM ASD occluder for transcatheter atrial septal defect closure.

OBJECTIVES: To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). BACKGROUND: Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium METHODS: Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. RESULTS: Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0-30 days). Follow-up echocardiography (median of 119 days [IQR: 92-146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135-239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. CONCLUSIONS: In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.

Experience with the Atrium Advanta covered stent for aortic obstruction.

INTRODUCTION: We sought to assess the efficacy, safety and clinical outcomes of the Advanta V12™ covered stent in management of coarctation of the aorta (CoA). MATERIALS AND METHODS: Stent functionality was assessed by review of angiographic imaging, clinical data at admission, discharge and at the last clinic visit, stent configuration on chest roentgenogram, radiation exposure, and complications. RESULTS: Between October 2009 and February 2012, 17 patients underwent stent implantation. There were 9-12, 2-14, and 6-16 mm diameter stents deployed. Balloon angioplasty after implantation was required in 2 patients. Mean percent recoil in the middle of the stent for the 12, 14, and 16 mm implants was 14%, 24%, and 24%, respectively. There was improvement in CoA diameter from 6.6 ± 3.2 to 11.5 ± 1.7 mm (P<0.0001) and a reduction in the peak pressure gradient from 23.1 ± 10.1 to 0.8 ± 3.3 mmHg (P<0.0001). No patient had a symptomatic complication. Left arm cuff blood pressure fell 24 hours after implantation and left arm to leg blood pressure gradient fell to <20 mmHg in all (P<0.0001). Follow-up was a median 242 days and at the last clinic visit there were no statistically different findings from discharge. Five children (33%) required antihypertensive medications but 3 were off medication at latest follow-up. Three patients (18%) required reintervention. CONCLUSION: The implantation of the Advanta™ V12 stent for the treatment of CoA is safe and effective in the early term. However, further study is required to determine longer-term stent efficacy.

Association Between Sarcopenia and Adverse Events Following Transcatheter Aortic Valve Implantation.

BACKGROUND: Sarcopenia, the age-related loss of skeletal muscle mass/function, has been identified as a marker of frailty. We examined the association between sarcopenia and adverse events following transcatheter aortic valve implantation (TAVI). METHODS: A retrospective cohort study was conducted at Toronto General Hospital. All patients who underwent TAVI in the time period 2007-2017 with preoperative computed tomography were included. Skeletal muscle index (SMI) was calculated radiographically using psoas muscle area at the L3 vertebral level, divided by height. Various measures of sarcopenia, including mean SMI, SMI below the sex-specific median, and SMI in the lowest sex-specific quartile were calculated. The primary outcome was postoperative adverse events, defined as a composite of in-hospital mortality and morbidity including cardiovascular, pulmonary, neurologic, access-related, and gastrointestinal complications. Univariate and multivariate logistic regression were performed to determine the association between sarcopenia and adverse events. RESULTS: A total of 468 patients (mean age: 80.7 years) were included. Baseline comorbidity burden was high, particularly congestive heart failure (93.4%). Postoperative adverse events occurred in 62 patients (13.2%). Univariate logistic regression demonstrated that postoperative adverse events were correlated with mean SMI (odds ratio [OR] 0.81, 95% confidence interal [CI] 0.66-0.97), events were less than the SMI (OR 2.16, 95% CI 1.24-3.84), and SMI in the sex-specific lowest quartile (OR 2.34, 95% CI 1.33-4.07). On multivariate analysis, SMI in the sex-specific lowest quartile was an independent predictor of adverse events (OR 2.53, 95% CI 1.41-4.50). CONCLUSIONS: Sarcopenia defined by radiologic psoas muscle measurements was independently associated with in-hospital mortality and morbidity following TAVI.

CONTEXTE: La sarcopénie, soit la perte de masse et de fonction des muscles squelettiques liée à l'âge, a été identifiée comme un marqueur de fragilité. Nous avons examiné l'association entre la sarcopénie et les événements indésirables suivant l'implantation valvulaire aortique par cathéter (IVAC). MÉTHODOLOGIE: Une étude de cohorte rétrospective a été menée au Toronto General Hospital. Tous les patients ayant subi une IVAC avec tomodensitométrie préopératoire au cours de la période 2007-2017 ont été inclus. L'indice de masse musculaire squelettique (IMMS) a été calculé par radiographie en utilisant la surface du psoas au niveau de la vertèbre L3, divisée par la taille. Diverses mesures de la sarcopénie, y compris l'IMMS moyen, l'IMMS sous la médiane selon le sexe et l'IMMS dans le quartile inférieur selon le sexe, ont été calculées. Le critère d'évaluation principal était les événements indésirables postopératoires, définis comme un critère composite comprenant la mortalité et la morbidité à l'hôpital, notamment les complications cardiovasculaires, pulmonaires, neurologiques, gastro-intestinales et liées à l'accès vasculaire. Des régressions logistiques univariée et multivariée ont été effectuées pour déterminer l'association entre la sarcopénie et les événements indésirables. RÉSULTATS: Un total de 468 patients (âge moyen : 80,7 ans) ont été inclus. Le fardeau de comorbidité au départ était élevé, en particulier pour ce qui est de l'insuffisance cardiaque congestive (93,4 %). Des événements indésirables postopératoires sont survenus chez 62 patients (13,2 %). La régression logistique univariée a montré que les événements indésirables postopératoires étaient en corrélation avec un IMMS moyen (rapport des cotes [RC] : 0,81, intervalle de confiance [IC] à 95 % : 0,66 à 0,97), un IMMS sous la médiane selon le sexe (RC : 2,16; IC à 95 % : 1,24 à 3,84) et un IMMS dans le quartile inférieur selon le sexe (RC : 2,34; IC à 95 % : 1,33 à 4,07). Lors de l'analyse multivariée, un IMMS situé dans le quartile inférieur selon le sexe était un prédicteur indépendant d'événements indésirables (RC : 2,53; IC à 95 % : 1,41 à 4,50). CONCLUSIONS: La sarcopénie définie par les mesures radiologiques du psoas était indépendamment associée à la mortalité et à la morbidité à l'hôpital à la suite d'une IVAC.

The sPLA2 Inhibition to Decrease Enzyme Release after Percutaneous Coronary Intervention (SPIDER-PCI) trial.

BACKGROUND: Secretory phospholipase A(2) (sPLA(2)) may play a role in myonecrosis after elective percutaneous coronary intervention (PCI). Inhibition of this enzyme may have a beneficial effect. The central hypothesis of this study was that treatment with varespladib, a small-molecule inhibitor of sPLA(2) would reduce postprocedural release of cardiac biomarkers after elective percutaneous coronary intervention. METHODS AND RESULTS: Between October 2007 and June 2009, 144 stable patients were randomized in a phase II trial to receive varespladib 500 mg PO BID or placebo 3 to 5 days before and for 5 days after elective percutaneous coronary intervention. The primary end point was elevation of troponin I or creatine kinase-MB above the upper limit of normal at 6 to 8 or 18 to 24 hours after percutaneous coronary intervention. Mean age was 63±10 and 64±10 years, with 38% and 42% with diabetes mellitus and 29% and 28% with prior myocardial infarction for the varespladib and placebo groups, respectively. The primary end point occurred in 75% of varespladib and 63% of placebo patients (P=0.14). Troponin I 3 times the upper limit of normal was observed in 57% and 50% (P=0.39) and creatine kinase-MB 2 times the upper limit of normal in 14% and 3% (P=0.018). Median (first and third quartiles) change in high-sensitivity C-reactive protein in these 2 groups was 0.65 mg/L (-0.18 and 1.48) and 0.70 mg/L (0.00 and 1.50) at 18 to 24 hours (P=0.81) and 0.20 mg/L (-0.70 and 1.40) and 0.60 mg/L (-0.12 and 1.72) at 3 to 5 days (P=0.23), whereas change in sPLA(2) activity at 3 to 5 days in a subset was -2.85 ng/ml (-3.40 and -1.85) and 0.25 ng/ml (-0.20 and 0.85) (P<0.001). CONCLUSIONS: Inhibition of sPLA(2) by varespladib administered for 3 to 5 days before the procedure does not reduce periprocedural myonecrosis associated with elective percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00533039.

Transcatheter aortic valve implantation for high risk patients with severe aortic stenosis using the Edwards Sapien balloon-expandable bioprosthesis: a single centre study with immediate and medium-term outcomes.

BACKGROUND: Transcatheter aortic valve implantation (TCAVI) is an emerging alternative therapy to open-heart surgery in high-risk patients with symptomatic aortic stenosis. METHODS: Between January 2007 and May 2009, 46 patients underwent TCAVI with the 23 mm or 26 mm Edwards Sapien bioprosthesis via either the transapical (TA-AVI) or transfemoral (TF-AVI) approach. All patients had an estimated operative mortality risk of >15%. RESULTS: A total of 46 patients (30 TA-AVI, 16 TF-AVI) with a mean aortic valve area (AVA) of 0.63 +/- 0.2 cm(2) and mean gradient of 54 +/- 16 mm Hg were treated. Predicted operative mortality was 25.3% by logistic Euroscore and 8.7% by Society of Thoracic Surgeons risk score. Procedural success was 93% in the TA-AVI group and 88% in the TF-AVI group. There was one intraprocedural death in the TA-AVI group. Overall 30-day mortality was 6.5% (2-TA-AVI, 1-TF-AVI). Four patients (9.5%) died from noncardiac causes after 30 days. Successful TCAVI was associated with a significant increase in AVA from 0.6 +/- 0.1 cm(2) to 1.6 +/- 0.6 cm(2) in the TA-AVI group and 0.6 +/- 0.1 cm(2) to 1.4 +/- 0.2 cm(2) in the TF-AVI group at a mean follow up of 7.4 +/- 4.4 and 8.3 +/- 5.0 months, respectively. At discharge, there was significant improvement in AVA (P < 0.0001), transaortic mean gradient (P < 0.0001), and mitral regurgitation (P = 0.01). At medium term follow up, the valve area was maintained and there was significant improvement in NYHA class in both groups (P < 0.0001). CONCLUSION: At medium term follow-up, both transcatheter approaches demonstrated good valve durability with no cardiac-related mortality post hospital discharge.

Clinical Outcomes After Percutaneous Patent Ductus Arteriosus Closure in Adults.

BACKGROUND: There is little published data regarding percutaneous patent ductus arteriosus (PDA) closure in adults. We aim to describe the outcomes of adult patients undergoing PDA closure at a single tertiary referral centre. METHODS: All adults who underwent device PDA closure at our centre from 2001 to 2017 were identified and enrolled in the study. Available clinical data and imaging data were reviewed. RESULTS: At total of 141 patients were identified, with a mean age of 43 ± 15 years. Left ventricular dilation was present in 27% and pulmonary hypertension in 36% of the patients. Most ducts (74%) were of type A morphology. Mean ductal diameter at the pulmonary artery end was 4.1 ± 1.9 mm and mean length was 10.0 ± 4.7 mm. Wire passage from the pulmonary artery was achieved in 79%. Procedural success rate was 100%, and an Amplatzer duct occluder was deployed in all successful cases (ADO1 device in 97%). There was a small residual shunt in 6% at the time of closure, and only 2 patients had a residual leak on echocardiography at a median 3 months' follow-up. No major complications occurred. CONCLUSIONS: Transcatheter PDA closure with the use of an Amplatzer duct occluder is very effective in adults across all duct morphologies and associated with a very low complication rate.

Periprocedural Outcomes of Fluoroscopy-Guided Patent Foramen Ovale Closure With Selective Use of Intracardiac Echocardiography.

BACKGROUND: Recent randomized trials have confirmed the role of patent foramen ovale (PFO) closure in the secondary prevention of cryptogenic stroke. Guidelines have suggested a central role for intraprocedural imaging using intracardiac echocardiography (ICE). However, this modality may not be required to achieve safe and effective closure. We aimed to examine the periprocedural outcomes of PFO closure retrospectively, using fluoroscopic guidance in patients with cryptogenic stroke, with provisional ICE guidance driven by anatomic and procedural factors. METHODS: A retrospective chart review of consecutive patients who underwent PFO closure in a single centre using the Amplatzer PFO occluder (AGA Medical Corporation, Plymouth, Minnesota) for cryptogenic stroke was conducted. Outcomes analyzed included procedural data, periprocedural complications, length of stay, and factors contributing to the use of intraprocedural imaging. RESULTS: Between 2006 and 2017, 467 patients underwent PFO closure for cryptogenic stroke with the Amplatzer PFO occluder; 381 patients underwent closure with fluoroscopy alone, and 86 with ICE and fluoroscopic guidance. Periprocedural arrhythmic complications occurred in 1.3% in the fluoroscopy group and 1.2% in the ICE group (P = 1.000). Vascular complications occurred in 0.5% in the fluoroscopy group and 2.3% (P = 0.323) in the ICE group. One device embolized requiring surgical intervention. There was no in-hospital mortality or stroke. Same-day discharge occurred in 97.6% of patients. CONCLUSION: Our single-centre experience suggests that PFO closure can be safely conducted under fluoroscopic guidance alone with provisional adjunctive ICE use limited to specific anatomic situations.

Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study.

BACKGROUND: The Harmony transcatheter pulmonary valve (TPV) was designed for treatment of postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts. METHODS: The Native TPV EFS (Early Feasibility Study) is a prospective, multicenter, nonrandomized feasibility study. Three-year outcomes are reported. RESULTS: Of 20 implanted patients, 17 completed 3-year follow-up (maximum: 4.1 years). There were no deaths and 2 early explants. One patient did not complete the 3-year visit. In patients with available 3-year echocardiographic data, 1 had a mild paravalvular leak and the rest had none/trace; 1 patient had mild pulmonary valve regurgitation and the remainder had none/trace. The 3-year mean right ventricular outflow tract echocardiographic gradient was 15.7±5.5 mm Hg. Radiographically, no late frame fractures or erosions were identified. At 2 years, 2 patients presented with an increased echocardiographic outflow gradient (1 mixed lesion with moderate/severe pulmonary valve regurgitation). Computed tomography scans identified neointimal tissue ingrowth within the stent frame in both patients, and they were treated successfully with a transcatheter valve-in-valve procedure (Melody TPV). Additional follow-up computed tomography scans performed at 3.2±0.5 years after implant were obtained in 16 patients and revealed luminal tissue thickening at the inflow and outflow portion of the frame with no significant alteration of the valve housing. CONCLUSIONS: Three-year results from the Native TPV EFS revealed stable Harmony TPV device position, good valve function in most, and the absence of moderate/severe paravalvular leak and significant late frame fractures. Two patients developed significant neointimal proliferation requiring valve-in-valve treatment, while all others had no clinically significant right ventricular outflow tract obstruction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01762124.

Impact of renal insufficiency on angiographic, procedural, and in-hospital outcomes following percutaneous coronary intervention.

Patients with chronic renal insufficiency (RI) have higher in-hospital mortality and major adverse cardiac event (MACE) rates after percutaneous coronary intervention (PCI). The mechanisms of this adverse course are not well understood. It was hypothesized that this worse outcome may be caused by inadequate PCI results secondary to more complex coronary anatomy in patients with RI. Baseline, procedural, and outcome variables of all PCI cases at the University Health Network are entered prospectively in the PCI Registry. All PCI cases between April 1, 2000, and October 31, 2005, excluding patients in shock, who had preprocedural creatinine clearance (CrCl) measured were included in this study (n = 10,821 of 11,023 patients). Moderate RI (CrCl <60 ml/min) was evaluated as an independent predictor of procedural outcomes, death, and MACE (defined as death, myocardial infarction, abrupt closure, or coronary artery bypass grafting). Moderate RI (CrCl <60 ml/min) independently predicted the procedural outcomes of worse residual stenosis >20% (p = 0.03), number of undeliverable stents (p = 0.003), and smallest stent diameter (p <0.001). Worst residual stenosis >20% and any undeliverable stent were significantly associated with in-hospital MACEs (odds ratio [OR] 3.97, 95% confidence interval [CI] 3.0 to 5.3, p <0.001 and OR 1.89, 95% CI 1.2 to 2.9, p = 0.002) and mortality (OR 3.82, 95% CI 2.2 to 6.7, p <0.001 and OR 3.0, 95% CI 1.6 to 5.9, p = 0.002). These risks were independent of all other measured variables. In conclusion, moderate to severe RI was a strong predictor of worse procedural results during PCI, which, in turn, were independent predictors of in-hospital MACE and mortality and independent contributors to the higher risk of in-hospital adverse events observed after PCI in patients with RI.

The ultimate proof of paradoxical embolism and a percutaneous solution.

Central venous catheters (CVCs) and ports are frequently used for the administration of total parenteral nutrition, antibiotics, and chemotherapeutic agents. Their use may be associated with serious complications, such as venous thrombosis, embolization, and catheter rupture. Catheter fragments most commonly embolize to the right atrium, right ventricle, and pulmonary artery (Surov et al., Angiology 2008;59:90-97). We report the first case of a CVC that embolized across a patent foramen ovale (PFO) into the left atrium in a 72-year-old female who presented with symptoms of a transient ischemic attack (TIA). Treatment consisted of retrieving the embolized portacath, which had lodged in the right upper pulmonary vein followed by percutaneous PFO closure.

Left Atrial Phasic Function and Its Association With Atrial Fibrillation in Patients After Transcatheter Aortic Valve Implantation.

BACKGROUND: Left atrial (LA) size is a marker of prognosis in severe aortic stenosis (AS). The aims of this retrospective study were to assess the impact of transcatheter aortic valve implantation (TAVI) on the recovery of LA phasic function and to assess the relationship between LA function and new-onset atrial fibrillation (NAF) after TAVI. METHODS: In this retrospective cohort study, LA function was measured using biplane volumes and 2-dimensional (2D) speckle tracking echocardiography (STE) in 52 patients (median age, 81 years) with severe AS before TAVI and at midterm follow-up. Twenty healthy individuals ≥ 75 years were used as controls. RESULTS: Before TAVI, the 3 phasic volumetric emptying fractions and all STE-derived parameters of LA function were significantly reduced. At 5 ± 3 months after TAVI, there was an improvement in LA reservoir and contractile function. However, LA phasic volumes and emptying fractions showed minimal changes. Fourteen patients had NAF in the early postprocedural period after TAVI. These patients experienced longer hospitalization (11 days vs 6 days; P = 0.002). By bivariable logistic regression analysis, the use of a transapical approach and the LA early diastolic strain rate (SR) before TAVI were significantly associated with NAF immediately after TAVI. CONCLUSIONS: Severe AS is associated with LA dysfunction. Intrinsic LA compliance and LA contractile properties by STE improved at midterm follow-up after TAVI. Preprocedural LA early diastolic SR may predict the development of NAF after TAVI pending confirmation by larger prospective evaluations.

Harmony Feasibility Trial: Acute and Short-Term Outcomes With a Self-Expanding Transcatheter Pulmonary Valve.

OBJECTIVES: This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance. BACKGROUND: The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement. METHODS: Three sites participated in this first Food and Drug Administration-approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported. RESULTS: Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg). CONCLUSIONS: In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.

Patient Selection Process for the Harmony Transcatheter Pulmonary Valve Early Feasibility Study.

This early feasibility study was designed to obtain in vivo data to confirm assumptions on device loading conditions of the Medtronic Harmony transcatheter pulmonary valve (TPV). Secondary objectives included procedural feasibility, safety, and valve performance. The Harmony TPV was developed for nonsurgical pulmonary valve replacement in non-right ventricle-pulmonary artery conduit patients. The Native Outflow Tract TPV Research Clinical Study was the first study approved under the Food and Drug Administration Early Feasibility Study guidance. Enrollment required that patient anatomy be precisely matched to the single-size Harmony TPV implant, necessitating a rigorous selection process. The study was nonrandomized, prospective, and performed at 3 sites. All patients met standard indications for surgical pulmonary valve replacement. The goal of the screening committee was to match the candidate anatomy to predetermined engineering criteria thought to be predictive of secure Harmony TPV implantation for the single-size device under study. A majority of the screening committee was required to recommend a patient as eligible for implant. A total of 270 patients underwent prescreening cardiac magnetic resonance imaging, 66 were enrolled and received a computed tomography scan (24%), 21 met criteria for implant and were catheterized (8%), and 20 underwent implant. Nineteen of 20 met criteria for implant success. In conclusion, the Medtronic Harmony TPV represents an emerging therapeutic option for patients with complex postoperative right ventricular outflow tract failure. The initial clinical evaluation of this technology was unique, and the highly variable anatomy of this population required careful screening to ensure acceptable device fit.

Impact of Prosthesis-Patient Mismatch on Left Ventricular Myocardial Mechanics After Transcatheter Aortic Valve Replacement.

BACKGROUND: The aim of this study was to compare left ventricular (LV) remodeling using myocardial strain between patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) with and without prosthesis-patient mismatch (PPM). METHODS AND RESULTS: In a retrospective study, speckle-tracking echocardiography was used to measure global longitudinal strain (GLS) and strain rate (GLSR), circumferential strain, and rotation before and at mid-term follow-up post-TAVR. Moderate and severe PPM were defined as an effective orifice area ≤0.85 and <0.65 cm(2)/m(2), respectively. A total of 102 patients (median age, 83 years [77-88]) with severe AS were included. At 6±3 months post-TAVR, moderate and severe PPM were found in 32 (31%) and 9 (9%) patients. Patients without PPM had a significant regression in LV mass (from 134±41 to 119±38 g/m(2); P=0.001) at follow-up whereas those with PPM did not. There was a significant improvement in LV GLS (-12.8±4.0 to -14.3±4.3%; P=0.01), GLSR (-0.61±0.20 to -0.73±0.25 second(-1); P<0.001), and early diastolic strain rate (0.52±0.20 to 0.64±0.20 second(-1); P<0.001) in patients without PPM, but not in those with PPM. After adjustment for pre-TAVR ejection fraction and post-TAVR aortic regurgitation, patients without PPM had greater improvement in LV longitudinal strain parameters compared to those with PPM. After a median follow-up of 46.1 months (interquartile range, 35.4-60.8), there was no difference in survival between patients with and without PPM. CONCLUSIONS: TAVR was associated with an incidence of PPM of 40%. Greater reverse LV remodeling using myocardial strain was evident in patients without PPM compared to PPM. Presence of PPM was not associated with mortality.

Transcatheter Pulmonary Valve Replacement With the Edwards Sapien System: The Toronto Experience.

OBJECTIVES: This study sought to review the outcomes for the Sapien and Sapien XT valves (Edwards Lifesciences, Irvine, California) for percutaneous pulmonary valve implantation (PPVI). BACKGROUND: PPVI has emerged as a viable alternative to surgery in patients with right ventricular (RV) outflow tract dysfunction. Limited data are available for the Sapien and Sapien XT valves in this setting. METHODS: Retrospective analysis was performed for all patients to have undergone PPVI using the Edwards Sapien system at a large quaternary center. RESULTS: Twenty-five patients (70% male, mean age 34 ± 8.9 years) were identified. Primary underlying diagnosis was tetralogy of Fallot (n = 15), Ross procedure (n = 5), and other (n = 5). RV outflow tract characteristics included: biological valve (n = 16) and homograft (n = 9). Technical success was 96%. One patient required elective surgical pulmonary valve replacement for a high residual gradient. Pre-stenting was performed in all cases (52% covered stents). Valve sizes were 23 mm (n = 8), 26 mm (n = 15), and 29 mm (n = 2). Procedural hemodynamics revealed a decrease in the mean RV-to-systemic pressure ratio from 0.64 to 0.36 (p < 0.001) and RV-to-pulmonary artery (PA) gradient from 39 to 9 mm Hg (p < 0.001). No patient had clinically significant pulmonary regurgitation (PR). At a mean follow-up of 3.5 ± 2.1 years (range 0.3 to 7.2 years), there were no deaths. One patient required reintervention (no PR evident immediately post-procedure but severe valvular PR at 1 year requiring a valve-in-valve procedure). There were no episodes of endocarditis and no stent fractures. There was preserved valve function during follow-up with no change in RV-to-PA gradient nor PR severity. CONCLUSIONS: The Edwards Sapien system is a viable and durable option for PPVI in this single-center study.

Long-term outcome of unprotected left main stenting: a Canadian tertiary care experience.

BACKGROUND: Coronary stenting is increasingly used to treat unprotected left main disease in selected patients. However, there is a paucity of data on the long-term outcome of these patients in a Canadian context outside of clinical trials. METHODS: We retrospectively reviewed all provincially-insured patients undergoing left main coronary stenting at a large tertiary referral centre from 2000-2011. Pre-procedural angiograms were reviewed to identify the location of left main disease, and extent of concomitant coronary disease quantified by calculating Synergy Between Percutaneous Coronary Intervention With TAXUS Drug-Eluting Stent and Cardiac Surgery (SYNTAX) scores for each patient. In-hospital death and major adverse cardiac event (MACE) rates were evaluated as were long-term death and MACE rates obtained via linkage of our institutional registry with the Ontario health claims database. RESULTS: Two hundred twenty-one patients underwent unprotected left main stenting with 29 (13.1%) in-hospital death and 34 (15.4%) a MACE. At an average follow-up of 3.1 ± 2.8 years, 109 patients (49.3%) died and 151 (68.3%) experienced a MACE. Higher SYNTAX tertile and use of bare metal rather than drug-eluting stents was associated with increased rates of in-hospital and long-term death. CONCLUSIONS: This study reports, to our knowledge, the largest Canadian cohort of unprotected left main stenting over more than a decade. Coronary stenting was associated with acceptable in-hospital event rates, but poor long-term outcomes, reflecting the higher-risk population traditionally selected for this procedure.

Recovery of left ventricular mechanics after transcatheter aortic valve implantation: effects of baseline ventricular function and postprocedural aortic regurgitation.

BACKGROUND: Impaired left ventricular (LV) myocardial deformation is associated with adverse outcome in patients with severe aortic stenosis (AS). The aim of this retrospective study was to assess the impact of transcatheter aortic valve implantation (TAVI) on the recovery of myocardial mechanics and the influence of postprocedural aortic regurgitation (AR). METHODS: Speckle-tracking echocardiography was used to assess multidirectional myocardial deformation (longitudinal and circumferential strain) and rotational mechanics (apical rotation and twist) before and at midterm follow-up after TAVI. Predictors of myocardial recovery, defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline, were examined. RESULTS: Sixty-four patients (median age, 83 years; interquartile range, 77-86 years) with severe AS and high surgical risk (mean European System for Cardiac Operative Risk Evaluation score, 20 ± 13%) were evaluated. Overall, LV longitudinal deformation was impaired at baseline compared with controls. At 5 ± 3 months after TAVI, LV longitudinal deformation had significantly improved only in the group of patients with baseline LV ejection fractions (LVEF) ≤ 55%: global longitudinal strain from -9.7 ± 3.7% to -11.8 ± 3.2% (P = .05), longitudinal strain rate from -0.44 ± 0.14 sec(-1) to -0.57 ± 0.16 sec(-1) (P = .001), and early diastolic strain rate from 0.38 ± 0.17 sec(-1) to 0.49 ± 0.18 sec(-1) (P = .01). In patients with normal LVEFs, LV twist was supraphysiologic at baseline and normalized after TAVI (from 16.1 ± 6.9° to 11.9 ± 6.2°, P = .004). In patients with baseline LVEFs ≤ 55%, circumferential deformation was impaired before TAVI and improved after TAVI. Baseline LVEF (odds ratio, 0.56 per 10% increment; P = .02) and global longitudinal strain (odds ratio, 0.65 per absolute 1% increment; P < .001) were significant predictors of myocardial recovery. LV mass, volumes, and longitudinal strain failed to favorably remodel in patients with post-TAVI important AR (defined as new mild post-TAVI AR or moderate or severe post-TAVI AR [either preexisting or new AR]). CONCLUSIONS: TAVI restores LV function toward more physiologic myocardial mechanics in both normal- and depressed-LVEF groups. Patients with lower systolic function derive the most benefit in terms of longitudinal reverse remodeling. Postprocedural AR adversely affects LV structural and functional remodeling.

Association between drug-eluting stent type and clinical outcomes in patients with chronic kidney disease undergoing percutaneous coronary intervention.

BACKGROUND: The comparative efficacy of first- vs second-generation drug-eluting stents (DESs) in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) is unknown. METHODS: A retrospective analysis of consecutive patients undergoing PCI at a tertiary PCI center from 2007-2011 was performed, with linkage to administrative databases for long-term outcomes. CKD was defined as creatinine clearance (CrCl) < 60 mL/min. Propensity matching by multivariable scoring method and Kaplan-Meier analyses were performed. RESULTS: Of 6481 patients with available CrCl values undergoing a first PCI during the study period, 1658 (25%) had CKD. First- and second-generation DESs were implanted in 320 (19.3%) and 128 (7.7%) patients with CKD, respectively. At 2 years, no significant differences were observed between first-generation (n = 126) and second-generation (n = 126) propensity-matched DES cohorts for the outcomes of death (19% vs 16%; P = 0.51), repeat revascularization (10% vs 10%; P = 1.00), and major adverse cardiovascular and cerebrovascular events (MACCE) (36% vs 37%; P = 0.90). The 2-year Kaplan-Meier survival was also similar (P = 0.77). In patients with CKD, second-generation DES type was not an independent predictor for death (P = 0.49) or MACCE (P = 1.00). CONCLUSIONS: Although the use of first- and second-generation DESs was associated with similar 2-year safety and efficacy in patients with CKD, our results cannot rule out a beneficial effect of second- vs first-generation DESs owing to small sample size. Future studies with larger numbers of patients with CKD are needed to identify optimal stent types, which may improve long-term clinical outcomes.

Complex Interventions in the Adult with Congenital Heart Disease: Percutaneous Solutions for Venous Baffles, Coronary Artery Fistulas, and Ruptured Sinus of Valsalva Aneurysms.

We describe 3 distinct ACHD lesions amenable to percutaneous repair: (1) venous baffle obstruction in transposition of the great arteries, (2) coronary artery fistulas, and (3) ruptured sinus of Valsalva aneurysms. For each entity, we chronicle the typical clinical scenario and indications for intervention to supplement the technical approach and potential pitfalls with treatment.

Clinical characteristics of coronary artery disease in adults with congenital heart defects.

BACKGROUND: There are now more adults with congenital heart disease than children. This aging cohort is at risk for acquired heart diseases such as coronary artery disease (CAD). The purpose of the study was to examine the clinical features of the CAD in adults with congenital heart disease. METHODS: A retrospective chart review was performed. The clinical characteristics of adults with congenital heart disease and angiographically confirmed atherosclerotic CAD were examined. RESULTS: One hundred and forty-one adults with CAD (69% male) were identified from a total of 12,124 patients (1%) seen in our congenital cardiac clinic. The most common cardiac diagnoses were atrial septal defect, bicuspid aortic valve disease, tetralogy of Fallot and coarctation of the aorta. We identified 7 adults with Eisenmenger physiology and CAD. The mean age of diagnosis of CAD was 56 ±13years. Twenty patients had premature CAD (14%) presenting before age 40years. Traditional risk factors of patients with CAD were common and were present in the majority (82%) of patients. While many adults had symptoms of angina or myocardial infarction, a significant proportion (38%) were asymptomatic. The age at diagnosis in patients with coarctation of the aorta was younger than other subgroups (48±13years). Seventy-seven percent (109/141) underwent percutaneous or surgical coronary interventions. CONCLUSION: Atherosclerotic coronary artery disease may coexist with congenital heart disease. Coronary artery disease in adults with congenital heart disease typically occurs later in adulthood and in patients with traditional cardiovascular risk factors. This study highlights the need for cardiovascular risk factor screening and therapy when indicated.