Initial clinical experience with VersaCross transseptal system for transcatheter mitral valve repair.

OBJECTIVES: The aim of this study is to describe the initial experience with versacross transseptal (TS) system for transseptal puncture for the transcatheter mitral valve repair using the MitraClip device. BACKGROUND: Transeptal puncture is a key step in transcatheter mitral valve repair (MVR) and the use of the VersaCross system comprised of a sheath, a dilator and a radiofrequency wire has not been previously described. METHODS: Prospective single center study of consecutive patients undergoing transcatheter mitral valve repair with the MitraClip device were included. Targeted TS puncture was performed under transesophageal echocardiographic (TEE) guidance. Baseline demographics, procedural characteristics, and major adverse procedural events were collected. RESULTS: Twenty-five consecutive patients underwent transseptal puncture using the VersaCross TS system. Transseptal puncture was successful in 100% of patients. The mean time for TS puncture was 3 3 ± 1.6 min with no major adverse procedural events. The mean time from insertion of the VersaCross system to insertion of the MitraClip guide catheter was 3.8 ± 3.0 minutes. CONCLUSION: The VersaCross TS system was successful in all patients for MitraClip procedure with no adverse procedural events and may be associated with increased procedural efficiency.

Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial.

BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

Malnutrition and Mortality in Frail and Non-Frail Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be determined. METHODS: The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. RESULTS: There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01-1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001-1.12). CONCLUSIONS: Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.

Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.

BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.

Long-term outcomes of bioresorbable vascular scaffold in ST-elevation myocardial infarction.

BACKGROUND: Bioresorbable vascular scaffolds (BVS) implantation in selected patients with stable angina has been demonstrated feasible and safe. However, limited data are currently available on long-term outcomes after BVS implantation for ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess the safety, efficacy and long-term results of BVS implantation in STEMI patients. METHODS: Retrospective review of all STEMI patients treated with the Absorb® BVS (Abbott Vascular, Santa Clara, CA) or conventional drug eluting stent (DES) between 1 April 2013 and 30 March 2014. Primary outcomes were procedural success, device thrombosis and device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization. The study included 54 BVS patients and 121 DES patients. RESULTS: Patients were slightly younger in the BVS group (60 vs. 63 years old, p = .03). Other baseline characteristics were comparable between the two groups. Procedural success was achieved in all patients. Median follow-up was 901 days and 849 days for BVS and DES patients, respectively (p = .01). The cumulative incidence of DOCE was not significantly different between the BVS and DES groups (7.5% vs. 9.1%, hazard ratio [HR]: 0.74 [95% confidence interval (CI): 0.26-2.2], p = NS). Rate of probable/definite device thrombosis were not statistically different between both groups (3.7% vs. 3.3%, p = NS). CONCLUSIONS: The results of this single-centre retrospective study, one of the first assessing long-term safety and efficacy of BVS in STEMI, seems reassuring with similar long-term results as compared with patients treated with conventional DES.

From tricuspid to double orifice Morphology: Percutaneous tricuspid regurgitation repair with the MitraClip device in congenitally corrected-transposition of great arteries.

Edge to edge transcatheter mitral valve repair with MitraClip (Abbott Vascular, Menlo Park, CA) is increasing for high-risk surgical patients with significant mitral regurgitation. Patients with congenitally corrected transposition of the great arteries (CCTGA) presenting with tricuspid valve regurgitation of a systemic right ventricle may represent particularly challenging candidates for MitraClip given their anatomy. We report the case of a 67-year-old gentleman with CCTGA and severe tricuspid regurgitation who was referred for MitraClip implantation after heart team consensus. Successful implantation of one clip was performed, achieving a significant reduction of the regurgitation. Similarly, favorable findings were confirmed at 6 months, 1 and 2 years follow-up and the patient had no recurrent heart failure admissions after 2-year follow-up. We describe the technical considerations and the importance of 3D-transoesophageal echocardiography for performing the MitraClip of a trileaflet systemic atrioventricular valve. © 2016 Wiley Periodicals, Inc.

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.

Effect of valve design and anticoagulation strategy on 30-day clinical outcomes in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial.

BACKGROUND: Selection of valve type and procedural anticoagulant may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial. METHODS: BRAVO-3 was a randomized multicenter trial including 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin versus UFH. Selection of valve type was at the discretion of the operator but randomization was stratified according to valve type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis. RESULTS: Of the trial cohort, 63.9% were treated with BE valves (n = 251 bivalirudin vs. n = 249 UFH) and 36.1% with non-BE valves (n = 140 bivalirudin vs. n = 142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were nonsignificant differences between the two valve types for adjusted risk of all-cause death (HR 2.07, 95% CI 0.91-4.70, P = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, P = 0.062) with non-BE compared with BE valves, but all other outcomes were similar. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared with UFH in non-BE TAVR (P-interaction = 0.039). CONCLUSIONS: Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, adjusted risk of clinical outcomes was similar with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR.

Efficacy of a balloon-expandable vascular access system in transfemoral TAVI patients.

BACKGROUND: Vascular complications (VC) are a serious and frequent complication of transfemoral transcatheter aortic valve implantation (TAVI) and result in increased morbidity and mortality. It has been suggested that newly developed vascular sheaths may increase the ability to perform transfemoral TAVI in patients with normal and access-limiting peripheral artery disease (PAD) and reduce vascular complications. AIMS: We sought to assess the safety and efficacy of the 19 French (F) SoloPath balloon-expandable transfemoral vascular access system in patients who underwent transfemoral TAVI at our center between 2011 and 2014. METHODS AND RESULTS: Single-center retrospective study of 90 patients who underwent transfemoral TAVI with the use of the SoloPath sheath. Patients were categorized into two groups according to a sheath to femoral artery ratio (SFAR) of less than or equal to 1.05, or greater than 1.05. Overall, the incidence of major bleeding complications was low, 4.4%. No significant differences were found in technical or procedural success rates (100% in both groups and 100% vs. 91.3; P = 0.09; respectively), total vascular complications (20.8 vs. 21.7; P = 0.92) or total bleeding complications (20.8 vs. 30.4; P = 0.36 between those with SFAR greater or less than 1.05. CONCLUSIONS: The use of the SoloPath balloon-expandable sheath is feasible and safe even in patients with SFAR > 1.05, showing no increased vascular or bleeding complications compared to patients with larger vascular access. © 2016 Wiley Periodicals, Inc.

Impact of left ventricular function on clinical outcomes of functional mitral regurgitation patients undergoing transcatheter mitral valve repair.

OBJECTIVES: To evaluate the impact of baseline left ventricular (LV) function on the clinical outcomes of patients with functional mitral regurgitation (FMR) treated with MitraClip. BACKGROUND: It is unknown whether patients with significant FMR and severe LV dysfunction benefit from MitraClip. METHODS: A cohort of 77 patients with significant FMR undergoing MitraClip procedure between December 2010 and January 2015 was categorized by baseline LV ejection fraction (LVEF) into tertiles: LVEF <27% (n = 27), LVEF 27-37% (n = 25), and LVEF >37% (n = 25). We sought to evaluate the impact of LVEF on all-cause mortality at follow-up. RESULTS: There were no significant differences in baseline comorbidities, medical treatment and MR severity among tertiles of LVEF. Overall procedural success was 94%, with no differences among groups (LVEF <27%: 89%; LVEF 27-37%: 100%; LVEF >37%: 92%; P = 0.25). Median follow-up was 372 days (interquartile range: 128-627 days). MR severity improved in all three groups, as compared to baseline. There were no differences in the prevalence of MR ≤2+ on follow-up (P = 0.40). Mortality was highest in patients with LVEF <27% (41%), as compared with LVEF 27-37% (16%) and LVEF >37% (4%), P = 0.004. Patient who died had a lower baseline LVEF compared to those who survived (24.8 ± 7.7% versus 35.5 ± 13.7%, P < 0.001). An LVEF <27% was an independent predictor of mortality after adjusting for procedural success: hazard ratio 3.4 (95% CI: 1.1 to 10.0; P = 0.030). CONCLUSIONS: MitraClip is effective in FMR patients regardless of the severity of LV dysfunction. However, low baseline LVEF is associated with increased mortality, despite procedural success. © 2016 Wiley Periodicals, Inc.

Impact of coronary artery disease on left ventricular ejection fraction recovery following transcatheter aortic valve implantation.

OBJECTIVES: The objective of the present study was to assess if the presence and severity of CAD is associated with decreased LVEF recovery after TAVI. BACKGROUND: Coronary artery disease (CAD) and low left ventricular ejection fraction (LVEF) are common findings in patients undergoing transcatheter aortic valve implantation (TAVI). The impact of CAD on LVEF recovery after TAVI has not been specifically evaluated. METHODS: All patients with LVEF≤50% who underwent TAVI between March 2006 and May 2012 were included in the study. The presence and severity of coronary artery disease was measured using the Duke Myocardial Jeopardy Score (DMJS). A DMJS = 0 corresponds to patients without CAD or complete revascularization and a DMJS > 0 to those with incomplete revascularization. LVEF recovery was assessed by transthoracic echocardiography, measuring the change in LVEF from baseline to 3-months post-TAVI. Myocardial viability was evaluated in a subgroup of patients using cardiac magnetic resonance (CMR) imaging pre-TAVI. RESULTS: Fifty-six patients were included in the study. Twenty-eight patients (50%) had a DMJS > 0. At 3 months, patients with incomplete revascularization (DMJS > 0) demonstrated less LVEF recovery post-TAVI (2.0 ± 9.2% versus 11.7 ± 8.9% if DMJS = 0; P = 0.001). On multivariate analysis, DMJS and presence of significant delayed-enhancement were found to be independent predictors of LVEF recovery. Patients with incomplete revascularization exhibited a worse prognosis with higher mortality at 30-days (22.2% versus 0% if DMJS = 0; P = 0.010) and 1-year (25.9% versus 3.5% if DMJS = 0; P = 0.019). CONCLUSIONS: The present study demonstrates an independent association between incomplete revascularization and decreased LVEF recovery in patients with left ventricular dysfunction undergoing TAVI for severe aortic stenosis.

Functional Mitral Regurgitation: Transcatheter Therapy.

Mitral regurgitation (MR) is one of the most prevalent types of valvular heart disease and is expected to increase in the next decade. Transcatheter therapies for MR are constantly being developed and studied for use in this population. In this review, the author describes the phenotypes of functional or secondary mitral regurgitation, discusses the potential therapeutic targets for transcatheter intervention, and reviews the results of such technology in the literature.

Transcatheter Edge-to-Edge Repair for Acute Papillary Muscle Rupture After Transvenous Lead Extraction in a d-TGA.

We present a case of a patient known for dextrotransposition of the great arteries corrected with a Mustard procedure, in whom severe mitral valve regurgitation secondary to transvenous lead extraction was successfully repaired with transcatheter edge-to-edge repair using the TriClip device (Abbott Vascular).

Clinical considerations and challenges in TAV-in-TAV procedures.

Transcatheter aortic valve replacement (TAVR) has emerged as a viable treatment for aortic valve disease, including low-risk patients. However, as TAVR usage increases, concerns about long-term durability and the potential for addition interventions have arisen. Transcatheter aortic valve (TAV)-in-TAV procedures have shown promise in selected patients in numerous registries, offering a less morbid alternative to TAVR explantation. In this review, the authors aimed to comprehensively review the experience surrounding TAV-in-TAV, summarize available data, discuss pre-procedural planning, highlight associated challenges, emphasize the importance of coronary obstruction assessment and provide insights into the future of this technique.

Sensor-guided transcatheter aortic valve replacement.

OBJECTIVES: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population. METHODS: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure. RESULTS: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires. CONCLUSIONS: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.

Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial.

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

Canadian Cardiovascular Society 2023 Guidelines on the Fitness to Drive.

Cardiovascular conditions are among the most frequent causes of impairment to drive, because they might induce unpredictable mental state alterations via diverse mechanisms like myocardial ischemia, cardiac arrhythmias, and vascular dysfunction. Accordingly, health professionals are often asked to assess patients' fitness to drive (FTD). The Canadian Cardiovascular Society previously published FTD guidelines in 2003-2004; herein, we present updated FTD guidelines. Because there are no randomized trials on FTD, observational studies were used to estimate the risk of driving impairment in each situation, and recommendations made on the basis of Canadian Cardiovascular Society Risk of Harm formula. More restrictive recommendations were made for commercial drivers, who spend longer average times behind the wheel, use larger vehicles, and might transport a larger number of passengers. We provide guidance for individuals with: (1) active coronary artery disease; (2) various forms of valvular heart disease; (3) heart failure, heart transplant, and left ventricular assist device situations; (4) arrhythmia syndromes; (5) implantable devices; (6) syncope history; and (7) congenital heart disease. We suggest appropriate waiting times after cardiac interventions or acute illnesses before driving resumption. When short-term driving cessation is recommended, recommendations are on the basis of expert consensus rather than the Risk of Harm formula because risk elevation is expected to be transient. These recommendations, although not a substitute for clinical judgement or governmental regulations, provide specialists, primary care providers, and allied health professionals with a comprehensive list of a wide range of cardiac conditions, with guidance provided on the basis of the level of risk of impairment, along with recommendations about ability to drive and the suggested duration of restrictions.

First experience with the new GORE Septal Occluder for the closure of multiple atrial septal defects.

Transcatheter closure of an atrial septal defect (ASD) is considered the standard of care for most of the patients with secundum ASD. The existence of multiple or fenestrated ASD may constitute a challenge to achieve a satisfactory result. Data on the usage of multiple devices for closing multiple defects are limited. The GORE Septal Occluder (GSO) represents a new generation of transcatheter ASD occluders with a design that provides superior conformability, apposition, and closure performance compared with the previous GORE HELEX device. The present case report describes the first clinical experience with the implantation of two GSO devices in a patient with multiple ASDs and fenestrated septum.