Atrial Shunt Research Articles

Non-adjustable gravitational valves or adjustable valves in the treatment of hydrocephalus after aneurysmal subarachnoid hemorrhage patients?

PurposeHydrocephalus requiring permanent CSF shunting after aneurysmal subarachnoid hemorrhage (aSAH) is frequent. It is unknown which type of valve is optimal. This study evaluates if the revision rate of gravitational differential pressure valves (G-DPVs, GAV® system (B Braun)) (G-DPV) is comparable to adjustable pressure valves (Codman Medos Hakim) (APV) in the treatment of post-aSAH hydrocephalus.MethodsThe use of a gravitational differential pressure valve is placed in direct comparison with an adjustable pressure valve system. A retrospective chart review is performed to compare the revision rates for the two valve systems.ResultsWithin the registry from Radboud University Medical Center, 641 patients with a SAH could be identified from 1 January 2013 until 1 January 2019, whereas at the Heinrich Heine University, 617 patients were identified, totaling 1258 patients who suffered from aSAH. At Radboud University Medical Center, a gravitational differential pressure valve is used, whereas at the Heinrich Heine University, an adjustable pressure valve system is used. One hundred sixty-six (13%) patients required permanent ventricular peritoneal or atrial shunting. Shunt dysfunction occurred in 36 patients: 13 patients of the 53 (25%) of the gravitational shunt cohort, and in 23 of the 113 (20%) patients with an adjustable shunt (p = 0.54). Revision was performed at a mean time of 3.2 months after implantation with the gravitational system and 8.2 months with the adjustable shunt system. Combined rates of over- and underdrainage leading to revision were 7.5% (4/53) for the gravitational and 3.5% (4/113) for the adjustable valve system (p = 0 .27).ConclusionThe current study does not show a benefit of a gravitational pressure valve (GAV® system) over an adjustable pressure valve (CODMAN ® HAKIM®) in the treatment of post-aSAH hydrocephalus. The overall need for revision is high and warrants further improvements in care.

The short-term efficacy of adventitial inversion with graft eversion anastomosis for the reconstruction of the aortic sinus in the root treatment of aortic dissection.

BackgroundThe surgical approaches for a mildly affected aortic sinus (AS) are varied and controversial. Here, the AS was reconstructed using the extended adventitial inversion with graft eversion anastomosis technique before its perioperative and short-term efficacy was compared with that of the vascular grafts that wrap the aortic wall and the right atrial shunt technique, providing a new basis for surgical management strategies.MethodA total of 101 patients with mildly affected AS were enrolled in the clinical trial. The extended adventitial inversion suture and the graft eversion anastomosis technique was performed in group A. Aorta wrapping and the right atrial shunt technique were performed in group B. The primary endpoints were reoperation-related events and fatal events related to the aorta, while the secondary endpoints were the duration of surgery and structural changes in the aortic root. Cardiac ultrasound and aortic computed tomography angiography examinations were performed before surgery, 2 weeks after surgery, and 1 year after surgery.ResultsCompared to group B (n = 56), group A (n = 36) had a significantly shorter duration of surgery (the time from skin incision to skin closure) and a reduced time from shutdown to skin closure (P < 0.05). Cardiovascular ultrasound examinations performed at follow-up 12 months after surgery and 2 weeks after surgery revealed a significant increase in the diameter of the aortic sinotubular junction (STJ) of group B (n = 50) (P < 0.05). The extended adventitial inversion suture and the graft eversion anastomosis technique (n = 33) performed better than Aorta wrapping and the right atrial shunt technique in terms of persistence of the false lumen closure effect, anastomotic leakage, and reduction in aortic valve (P < 0.05), and there was a significant difference between the two groups in terms of the incidence of events related to reoperation (P < 0.05).ConclusionCompared with the aorta wrapping and the right atrial shunt technique, the extended adventitial inversion suture and the graft eversion anastomosis technique allow shortening of the operation time and preventing near-term dilation of the STJ, with improved safety and an improved short-term surgical effect.

Correction to: Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure.

Correction to: Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure.

Development of Innovative Biomaterials and Devices for the Treatment of Cardiovascular Diseases.

Cardiovascular diseases have become the leading cause of death worldwide. The increasing burden of cardiovascular diseases has become a major public health problem and how to carry out efficient and reliable treatment of cardiovascular diseases has become an urgent global problem to be solved. Recently, implantable biomaterials and devices, especially minimally invasive interventional ones, such as vascular stents, artificial heart valves, bioprosthetic cardiac occluders, artificial graft cardiac patches, atrial shunts, and injectable hydrogels against heart failure, have become the most effective means in the treatment of cardiovascular diseases. Herein, an overview of the challenges and research frontier of innovative biomaterials and devices for the treatment of cardiovascular diseases is provided, and their future development directions are discussed.

One-Year Results of Occlutech’s Atrial Flow Regulator for Left Atrial Shunting in Symptomatic Heart Failure: The Prelieve Study

One-Year Results of Occlutech’s Atrial Flow Regulator for Left Atrial Shunting in Symptomatic Heart Failure: The Prelieve Study

PO-657-07 SPONTANEOUS RESTORATION OF SINUS RHYTHM AFTER INTER ATRIAL SHUNT PLACEMENT IN A PATIENT WITH LONGSTANDING PERSISTENT ATRIAL FIBRILLATION

Left atrial (LA) pressure overload is an important mediator of atrial remodeling and stretch-induced atrial fibrillation (AF). Mechanoelectrical alterations promote atrial myocyte hypertrophy, fibrosis, and potassium gene expression with resultant proarrhythmic spatiotemporal changes in atrial action potential. Increased LA pressure is known to predict incidence and recurrence of AF. An Inter Atrial Shunt Device (IASD) is an experimental treatment for heart failure with preserved ejection fraction (HFpEF), used to reduce LA pressure and improve HF symptoms.

Amplatzer Patent Foramen Ovale Occluder Device-Related Complications.

Patent foramen ovale (PFO) is a standard variant that is present in 25% of the whole adult population. In a certain population, PFO can lead to cerebrovascular accidents. Mechanism of cerebrovascular accidents can be by paradoxical embolization from the right circulation or in situ thrombosis. Diagnosis of a PFO-responsible cerebrovascular accident is based on a thorough work-up to exclude other possible etiologies and detect PFO on trans-thoracic or trans-esophageal echocardiography with bubble study and/or Doppler. Over the last few years, multiple studies have supported that percutaneous PFO closure is superior to medical therapy in the secondary prevention of cerebrovascular accidents. However, numerous adverse events have been linked to PFO closure devices in general compared to medical therapy as new-onset atrial fibrillation, residual shunt, device-related thrombus, bleeding, deep vein thrombosis, pulmonary embolism, and inter-atrial septal erosions. Amplatzer device is one of the PFO occluder devices approved by the FDA. Device-related adverse events have been addressed by comparing the Amplatzer device with other PFO occluder devices. Based on the new data, we expect to see more complications related to PFO closure in the coming few years. We reviewed different studies that looked at the PFO closure-related complications and the trials comparing adverse events in the Amplatzer PFO occluder device compared to other devices. Amplatzer PFO occluder device is either superior or non-statistically different from other PFO occluder devices related to new-onset atrial fibrillation and residual shunt. More studies are needed to address the other less common adverse events. Since many of the device-related complications appear many years after device placement, a long-term follow-up is recommended.

Gerbode defect or left ventricular to right atrial shunt. Case report and literature review

Gerbode defect or left ventricular to right atrial shunt. Case report and literature review

Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure.

In REDUCE LAP-HF II (A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure), implantation of an atrial shunt device did not provide overall clinical benefit for patients with heart failure with preserved or mildly reduced ejection fraction. However, prespecified analyses identified differences in response in subgroups defined by pulmonary artery systolic pressure during submaximal exercise, right atrial volume, and sex. Shunt implantation reduces left atrial pressures but increases pulmonary blood flow, which may be poorly tolerated in patients with pulmonary vascular disease (PVD). On the basis of these results, we hypothesized that patients with latent PVD, defined as elevated pulmonary vascular resistance during exercise, might be harmed by shunt implantation, and conversely that patients without PVD might benefit. REDUCE LAP-HF II enrolled 626 patients with heart failure, ejection fraction ≥40%, exercise pulmonary capillary wedge pressure ≥25 mm Hg, and resting pulmonary vascular resistance <3.5 Wood units who were randomized 1:1 to atrial shunt device or sham control. The primary outcome-a hierarchical composite of cardiovascular death, nonfatal ischemic stroke, recurrent HF events, and change in health status-was analyzed using the win ratio. Latent PVD was defined as pulmonary vascular resistance ≥1.74 Wood units (highest tertile) at peak exercise, measured before randomization. Compared with patients without PVD (n=382), those with latent PVD (n=188) were older, had more atrial fibrillation and right heart dysfunction, and were more likely to have elevated left atrial pressure at rest. Shunt treatment was associated with worse outcomes in patients with PVD (win ratio, 0.60 [95% CI, 0.42, 0.86]; P=0.005) and signal of clinical benefit in patients without PVD (win ratio, 1.31 [95% CI, 1.02, 1.68]; P=0.038). Patients with larger right atrial volumes and men had worse outcomes with the device and both groups were more likely to have pacemakers, heart failure with mildly reduced ejection fraction, and increased left atrial volume. For patients without latent PVD or pacemaker (n=313; 50% of randomized patients), shunt treatment resulted in more robust signal of clinical benefit (win ratio, 1.51 [95% CI, 1.14, 2.00]; P=0.004). In patients with heart failure with preserved or mildly reduced ejection fraction, the presence of latent PVD uncovered by invasive hemodynamic exercise testing identifies patients who may worsen with atrial shunt therapy, whereas those without latent PVD may benefit.

Staged left ventricular recruitment facilitated by Sano conduit upsizing

Staged left ventricular recruitment facilitated by Sano conduit upsizing

Presumed congenital Gerbode defect in an American Domestic Shorthair cat

A five-month-old, intact female Domestic Shorthair cat presented to the Kansas State Veterinary Health Center for evaluation of a murmur and exercise intolerance. Physical exam revealed a grade V/VI right, parasternal, holosystolic murmur. On echocardiogram, there was an abnormality in the membranous interventricular septum and tricuspid valve, allowing blood to shunt from the left ventricle to the right atrium. This lesion is consistent with an infravalvular Gerbode defect. The Gerbode defect is a rare, left ventricle-to-right atrial shunt that can be congenital or acquired, and in cats, has only been reported once. At the time of submission, the patient is alive and is maintaining a good quality of life.

Indication and Technique of Ventriculo:Atrial Shunt for Normal Pressure Hydrocephalus

The type of shunt surgery with the best outcome and lowest complication rate has not been established. Ventriculo-atrial(V-A)shunts have almost been abandoned as the first choice of surgery. However, the V-A shunt has many advantages; the operative site is narrower than in other types of shunt surgery, and intra-atrial pressure is lower than intra-abdominal pressure, which may guarantee constant cerebrospinal fluid flow and less malfunction. Since this procedure has been neglected, devices of V-A shunt are scarce. Furthermore, the technique to insert an atrial catheter into the jugular vein is not commonly performed by general neurosurgeons. Herein, we introduce a simple method of V-A shunt for general neurosurgeons.

RESIDUAL ATRIAL SEPTAL DEFECT AFTER PERCUTANEOUS CLOSURE: WHAT THERAPEUTIC ATTITUDE FOR THIS RARE COMPLICATION

Residual atrial septal defect (ASD) is a rare complication after percutaneous closure of an ostium secundum atrial defect in eligible patients. Cardiac imaging, mainly transthoracic and transesophageal echocardiography is essential to establish the diagnosis. Surgical closure is the therapeutic strategy of choice. We present the case of a 54-year-old woman who presented with a residual left-to-right atrial shunt four years after percutaneous closure of an ASD ostium secundum.

Clinical study on the treatment of chronic heart failure with a novel D-shant atrium shunt device.

BackgroundAtrial septal shunt devices might improve hospitalizations and also prognosis in heart failure with increased pulmonary pressures due to left heart diseases. In recent years, atrial shunt devices have been used for the treatment of chronic heart failure, but there remains a lack of clinical experience. This study aimed to analyse the therapeutic effect of a novel type of atrial shunt on chronic heart failure.Methods and resultsFrom May 2020 to September 2020, six patients who were diagnosed with chronic heart failure and completed percutaneous D‐shant atrium shunt device implantation in the Department of Cardiovascular Surgery, Union Hospital, were retrospectively included. The shunt location was evaluated by echocardiography and digital subtraction angiography. Heart function was evaluated by New York Heart Association functional class. Echocardiography was used to measure the diameter of the new chamber and ventricle, and to evaluate the degree of mitral and tricuspid regurgitation. Before operation and 6 months after operation, left atrial end‐diastolic volume, right atrial end‐diastolic volume, left ventricular end‐diastolic volume, and right ventricular end‐diastolic volume were measured by magnetic resonance imaging. Left ventricular ejection fractions and right ventricular ejection fractions were calculated. Haemodynamic indexes of right heart catheterization and clinical cardiac function indexes were collected and compared before and 6 months after shunt implantation. All six patients completed percutaneous shunt device implantation. Echocardiography and digital subtraction angiography showed that the shunt device was correctly positioned and unobstructed in all patients. Echocardiography revealed that the left ventricular diameter decreased significantly from 6.40 ± 0.57 mm to 5.03 ± 0.73 mm (P < 0.05). There was an obvious decrease in mitral regurgitation. Magnetic resonance imaging showed a reduction in the volume of the left ventricle (182.00 ± 27.02 mL vs. 125.75 ± 16.11 mL, P < 0.05). Cardiac catheter examination showed the mean left atrium pressure or pulmonary capillary wedge pressure decreased postoperatively (31.83 ± 11.55 vs. 18.00 ± 5.51 mmHg, P < 0.05). There was also obvious improvement in clinical indicators of cardiac function at 6 months after implantation.ConclusionsThis novel D‐shant atrium shunt device revealed maintained good function, no dislodgement and no paradoxical emboli. After implantation, functional mitral regurgitation in all patients with heart failure with reduced ejection fraction improved.

Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial

Placement of an interatrial shunt device reduces pulmonary capillary wedge pressure during exercise in patients with heart failure and preserved or mildly reduced ejection fraction. We aimed to investigate whether an interatrial shunt can reduce heart failure events or improve health status in these patients. In this randomised, international, blinded, sham-controlled trial performed at 89 health-care centres, we included patients (aged ≥40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg. Patients were randomly assigned (1:1) to receive either a shunt device or sham procedure. Patients and outcome assessors were masked to randomisation. The primary endpoint was a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months. Pre-specified subgroup analyses were conducted for the heart failure event endpoint. Analysis of the primary endpoint, all other efficacy endpoints, and safety endpoints was conducted in the modified intention-to-treat population, defined as all patients randomly allocated to receive treatment, excluding those found to be ineligible after randomisation and therefore not treated. This study is registered with ClinicalTrials.gov, NCT03088033. Between May 25, 2017, and July 24, 2020, 1072 participants were enrolled, of whom 626 were randomly assigned to either the atrial shunt device (n=314) or sham procedure (n=312). There were no differences between groups in the primary composite endpoint (win ratio 1·0 [95% CI 0·8-1·2]; p=0·85) or in the individual components of the primary endpoint. The prespecified subgroups demonstrating a differential effect of atrial shunt device treatment on heart failure events were pulmonary artery systolic pressure at 20W of exercise (pinteraction=0·002 [>70 mm Hg associated with worse outcomes]), right atrial volume index (pinteraction=0·012 [≥29·7 mL/m2, worse outcomes]), and sex (pinteraction=0·02 [men, worse outcomes]). There were no differences in the composite safety endpoint between the two groups (n=116 [38%] for shunt device vs n=97 [31%] for sham procedure; p=0·11). Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%. Corvia Medical.

CRT-600.05 One-Year Results of Occlutech’s Atrial Flow Regulator for Left Atrial Shunting in Symptomatic Heart Failure: The Prelieve Study

CRT-600.05 One-Year Results of Occlutech’s Atrial Flow Regulator for Left Atrial Shunting in Symptomatic Heart Failure: The Prelieve Study

Long-Term Outcome after Closure of an Atrial Shunt in Patients Aged 60 Years or Older with Ischemic Stroke: A Nationwide, Registry-Based, Case-Control Study

Long-Term Outcome after Closure of an Atrial Shunt in Patients Aged 60 Years or Older with Ischemic Stroke: A Nationwide, Registry-Based, Case-Control Study

759 Platypnoea orthodeoxia syndrome following middle-lower bilobectomy: a case report

Abstract Aims PlatypneaOrthodeoxiasyndrome (POS) is a rare clinical condition characterized by dyspnoea and arterial desaturation, typically occurring in orthostatism and vanishing in a supine position. The real pathophysiologic triggers are still not completely understood. Methods and results In January 2021, a 76-year-old female patient was admitted to our department for the management of a large mass in the right lung (69 × 54 × 76 cm). Pre-operative Computed Tomography (CT)-scan showed a lesion of the right lower lobe, with suspected infiltration of posterior costal pleura and bronchoscopy revealed distal occlusion of intermedious bronchus. Surgical treatment was planned: extrapleural lower bilobectomy with the removal of the VI rib to reduce intracavity space was performed, using postero-lateral thoracotomy approach. On the third post-operative day, an acute neurologic deficit with left-sided paralysis, associated with desaturation and hypotension, occurred during a new attempt to mobilize the patient. Nonetheless the patient showed complete resolution of symptoms in supine position. A new similar episode of severe desaturation (SO2 80%) was observed in the 7th post-operative day. Arterial blood gas test showed PO2 37 mmHg; PCO2 27 mmHg; SO2 80.3%, pH 7.61, tHb 12.4 g/dl; O2Hb 78.4%. CT pulmonary angiography excluded a suspicious of pulmonary embolism. A right to left atrial shunt was suspected. Contrast-enhanced transcranial Doppler ultrasound showed microembolic signals in the basal cerebral arteries. Transoesophageal echocardiography was performed, confirming an interatrial septum with an exuberant hyperdynamic movement and showing an abundant passage of contrast from the right atrium to the left, even without the Valsalva manoeuvre, compatible with an important patent foramen ovale (PFO). Patient was referred to the cardiac Catheterization Laboratory for percutaneous closure of PFO. The device was successfully placed via right femoral venous catheter access and on transesophageal echocardiogram guidance. The procedure was performed without any complications. The implanted device was noted to be in a stable position with trivial residual inter-atrial shunting immediately after the procedure. The day after implantation, positional discomfort improved remarkably and the patient was able to stand-up with no symptoms, maintaining normal saturation (SaO2 100%). The patient was discharged and sent home on the third post-implantation day. The 4 month follow-up examination showed a good andstable condition. Conclusions Platypnoea Orthodeoxia Syndrome after lobectomy is a rare cause of postoperative dyspnoea/hypoxia.It is the result of right-to-left shunt via interatrial communication. Mediastinal relocation, stretching of the atrial septum are among the functional elements necessary for the clinical manifestations. It is essential to have a high index of suspicion to detect POS in patient with dyspnoea given the subtle and positional nature of the symptoms. Physicians should always consider POS in patients with unexplained dyspnoea; hence the treatment modalities could alleviate symptoms and be potentially curative.

Abstract 11058: Pooled Analysis of Six Randomized Trials Comparing Device Closure of Patent Foramen Ovale After Stroke to Medical Treatment: Overall Effects and Patient Selection Using a Causal Classification System

Introduction: Patent foramen ovale (PFO)-associated strokes account for ~10% of ischemic strokes in adults aged 18-60. Despite overall beneficial effects of device closure on stroke recurrence risk, the best treatment option for any individual patient is often unclear. Methods: We pooled individual participant-level data from all 6 RCTs comparing PFO closure with percutaneous devices plus medical therapy vs medical therapy alone. The primary outcome was recurrent ischemic stroke. We used Cox proportional hazards models to estimate adjusted HRs, with study-specific baseline hazards and a fixed treatment effect. Pre-specified primary subgroup analyses used the Risk of Paradoxical Embolism (RoPE) Score (a 10 point score with higher scores reflecting younger age and absence of vascular risk factors) and the PFO-Associated Stroke Causal Likelihood (PASCAL) algorithm, a classification system that combines the RoPE Score with presence/absence of high risk PFO features (either atrial septal aneurysm or large-sized shunt) to group patients into 3 causal relatedness categories: Unlikely (RoPE&lt; 7 and no high risk PFO feature); Possible (either RoPE &gt; 7 or any high risk PFO feature); or Probable (both RoPE &gt; 7 and any high risk PFO feature). The protocol was registered at PROSPERO. Results: A total of 121 recurrent strokes occurred in 3740 patients over median follow up of 57 months (IQR 24-64). The annualized incidence of stroke was lower with device vs medical therapy: 0.47% (0.34-0.65) vs 1.09% (0.87-1.36); adjusted HR 0.41 (0.27-0.60), p &lt; 0.001. The main results were robust to alternative analytic approaches. The primary subgroup analyses (Figure) showed statistically significant and clinically important interaction effects. Discussion: PFO closure reduces recurrent ischemic stroke in a robust manner. However, patients with neither a RoPE Score &gt; 7 or a high risk PFO feature (i.e. PASCAL Unlikely) do not appear to benefit, even in the well-selected trial population.

Abstract 10753: Exercise-Induced ECG Changes Predict Adverse Outcomes in Pulmonary Hypertension

Introduction: Cardiopulmonary exercise testing (CPET) is an important tool in assessing the functional status of patients with pulmonary hypertension (PH). During CPET, ECG is used as marker of exercise induced ischemia. We hypothesize that ECG changes with exercise may be an early indicator of clinical worsening in PH and could predict adverse outcomes. Methods: Clinical, hemodynamic, and CPET data of 101 PH patients who underwent CPET between 2013 and 2019 were included. ECGs were analyzed for ST depressions and T wave inversions during the earliest CPET in this time frame, along with coincident hemodynamic data. These data were correlated to adverse outcomes, including shunt creation (atrial septostomy or POTTs shunt), lung transplantation, and death. Results: Median age was 19 y (7-40 y, IQR 12-26), 68% were female, and median follow up time was 3 y (1-8 y, IQR 1-5). Sixteen patients had an adverse outcome (8 shunt creation, 4 lung transplant, 7 death). Twenty-two patients demonstrated significant ST/T wave changes with exercise, 18 ST depressions and 9 T wave inversions. Multivariate regression, including pulmonary arterial pressure, revealed exercise induced ST/T wave changes to be an independent predictor of procedure-free survival (without lung transplantation or shunt creation) (hazard ratio 11.10, p=.006). Only 21% with ST/T wave changes demonstrated procedure-free survival vs 85% without. Conclusions: ST/T wave changes on exercise ECG are significantly associated with adverse outcomes in PH on a medium term follow up study. These ECG changes with exercise can be used as early indicators of clinical worsening in PH and predictors of adverse outcomes.