Parachute Device Research Articles

EP News: Case Reports

Stereotactic body radiation therapy (SBRT) is increasingly being used in patients with refractory ventricular tachycardia (VT) to medical or ablation therapy or in patients not candidates for either. However, therapy for this application is relatively new. Consequently, how to optimally deliver the therapy and the mechanisms underlying the acute and chronic electrophysiological implications are being determined. Hayase et al (https://doi.org/10.1016/j.hrcr.2021.10.006) shared a case of a 78-year-old man with ischemic cardiomyopathy (ejection fraction 10%–15%), apical aneurysm, endocardial parachute device, and recurrent VT despite multiple endocardial ablation procedures.

Long-term prognosis analysis of PARACHUTE device implantation in patients with ischemic heart failure: a single-center experience of Chinese patients

BackgroundHeart failure (HF) is one of the leading causes of mortality and morbidity. The PARACHUTE device is designed to partition for left ventricular (LV) apical aneurysm post extensive anterior myocardial infarction (MI). However, the long-term prognosis of the PARACHUTE device post-implantation is unclear.MethodsFrom November 2015 to April 2017, six subjects with New York Heart Association Classes II, III and IV ischemic HF, LV ejection fraction between (LVEF) 15 and 40%; and LV anterior apical aneurysm were enrolled in our center. The cumulative event rates for MI, hospitalization, and mortality were documented. Further assessment of LVEF, LV end-diastolic diameter (LVEDD), and estimated pulmonary artery pressure were determined by echocardiography core laboratory. For quantitative data comparison, paired t-test was employed.ResultsDevice implantation was successful in all six enrolled subjects, and acute device association adverse events were not observed. At 4.6 ± 1.7 years follow-up, major adverse cardiac events (MACEs) were found in 50% patients, and the survival rate was 86.7%. We observed that the LVEF was significantly elevated after deployment (46.00 ± 6.00% vs. 35.83 ± 1.47%, P = 0.009). Besides, the LVEDD elevated after MI (51.17 ± 3.71 vs. 62.83 ± 3.25, P < 0.001) was revealed, but the device sustained preserved LVEDD after implantation.ConclusionThe PARACHUTE device is an alternative therapy for patients with severe LV maladaptive remodeling. However, the device seems to increase the HF ratio.Trial registrationNCT02240940

Structural Interventions and Potential Unforeseen Limits on Access to Ventricular Tachycardia Substrates.

Percutaneous structural interventions are increasingly performed and potentially risk future access for ablation of ventricular tachycardia (VT). The Parachute device (investigational device, Cardiokinetix, Inc., Menlo Park, California) was designed to reconfigure left ventricular volume and

Heart Failure Interventions Targeting Impaired Left Ventricles in Structural Heart Disease

Interventional techniques have been developed for a wide spectrum of mechanisms of heart failure (HF), especially in valvular heart disease and cardiomyopathies (ischaemic cardiomyopathy and hypertrophic cardiomyopathy). In this article, we review recent reports on catheter interventions to treat patients with HF. Direct modification using the Parachute device and the REVIVENT-TC device for patients with impaired left ventricle with large infarct scars improves geometry and haemodynamic efficiency, resulting in a reduction of HF symptoms. Interatrial shunt therapy improves symptoms and quality of life in HF patients. Uniquely, left ventricular outflow tract obstruction has also been targeted in patients with transcatheter mitral valve implantation. For advanced stage HF patients with prohibitively high surgical risk, emerging transcatheter interventions make it possible to modify life-limiting symptoms. Further results on HF interventions are expected from ongoing clinical trials.

P4887Acute hemodynamic and echocardiographic effects of percutaneous ventricular restoration therapy using the Parachute device in patients with severe ischemic cardiomyopathy: a single center experience

P4887Acute hemodynamic and echocardiographic effects of percutaneous ventricular restoration therapy using the Parachute device in patients with severe ischemic cardiomyopathy: a single center experience

Improvements in Left Ventricular Diastolic Mechanics After Parachute Device Implantation in Patients With Ischemia Heart Failure: A Cardiac Computerized Tomographic Study

BackgroundPercutaneous ventricular restoration therapy with the use of a left ventricle (LV)–partitioning Parachute device has emerged as a clinical treatment option for LV apical aneurysm after extensive anterior myocardial infarction (AMI). We assessed changes of diastolic mechanics and functional improvements following LV Parachute device implantation by means of cardiac computerized tomography (CCT). Methods and ResultsCCT data were obtained from 28 patients before and after LV Parachute device implantation. Diastolic functional indices were determined by means of quantitative CCT assessment: 1) transmitral velocities in early (E) and late (A) diastole and ratio (E/A); 2) early diastolic mitral septal tissue velocity (Ea) and E/Ea; and 3) vortex formation time (VFT). Functional improvements were assessed with the use of New York Heart Association (NYHA) functional classification. Among the study patients, there were no significant differences in all transmitral velocities and E/A, though there was significantly increased Ea, reduced E/Ea, and greater VFT 6 months after LV Parachute device implantation. Finally, the improvement of diastolic functional indices after Parachute treatment correlated with observed clinical functional alterations (Δ E/Ea and Δ NYHA functional class:, r = 0.563; P = .002; Δ VFT and Δ NYHA functional class: r = −0.507; P = .006). ConclusionsLV Parachute device implantation therapy in heart failure caused by AMI and LV apical aneurysm formation showed improvements in several diastolic functional mechanics according to CCT-based measures.

Percutaneous Ventricular Restoration Using the Parachute Device: The Parachute III Pressure-Volume Loop Sub-study

ABSTRACTBackground: Left ventricular (LV) dilatation and remodeling following acute myocardial infarction increases wall stress, ventricular volumes and leads to heart failure (HF), which is associated with a high mortality. Percutaneous ventricular restoration (pVR) therapy reduces LV volumes leading to a more effective ejection. This study investigated the hemodynamic effects of LV volume reduction from pVR on LV performance and its interaction with the arterial system.Methods: Ten patients with symptomatic ischemic HF of New York Heart Association (NYHA) classes II to IV with LV antero-apical wall motion abnormalities underwent Parachute implantation. Pressure-volume loops were recorded immediately pre- and post-pVR implantation and at 6-month follow up.Results: Parachute implantation significantly reduced end-diastolic volume index (from 112 ± 39 mL to 100 ± 41 mL; p < 0.05), with a greater relative reduction in end-systolic volume index (from 66 ± 33 mL to 56 ± 32 mL; p < 0.05) with an overall 7% increase in ejection fraction (from 38 ± 11 to 46 ± 14%; p < 0.05). Furthermore, there was an observed reduction in dyssynchrony index (from 20 ± 4 to 14 ± 6%; p < 0.05) and enhanced contractile function (Ees) immediately post-procedure, sustained at 6-months (from 0.92 ± 0.27 mmHg/mL to 1.37 ± 0.52 mmHg/mL, p < 0.05).Conclusion: This present study confirms positive hemodynamic effects of LV volume reduction using the Parachute percutaneous ventricular restoration device. The Parachute device improved synchronous contraction and enhanced ventricular-arterial interaction likely due to LV reverse remodeling.

Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study.

Background:The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI.Methods:Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison.Results:A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating improvement at 3 months.Conclusion:The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients.Trial Registration:ClinicalTrials.gov, NCT02240940; https://clinicaltrials.gov/ct2/show/NCT02240940.

Evaluating the quality of implantation of percutaneous ventricular restoration device (Parachute®) by cardiac computed tomography.

The Parachute is a novel percutaneously implanted ventricular partitioning device (VPD) that has emerged as a safe and feasible treatment option for patients with heart failure following anterior wall myocardial infarction. VPD efficacy is likely dependent on optimal device placement, but to date there are no published data examining the effect of device positioning on patient outcomes. We retrospectively identified 32 patients successfully implanted with the Parachute device, all of whom underwent cardiac computed tomography (CCT) at baseline and after 6 months of follow-up. Patients were divided into two groups based on self-reported improvement in New York Heart Association (NYHA) functional class: "not improved NYHA" (n = 12) and "improved NYHA" (n = 20). There were significant differences between both groups with regard to device positioning on follow-up CCT. Compared to patients with "improved NYHA," patients with "not improved NYHA" had longer distances from device foot to left ventricular apex (8.0 ± 4.9 vs. 2.9 ± 4.6 mm; P = 0.01), and higher lateral angles (18.0 ± 14 vs. 9.1 ± 6.8 degrees; P = 0.02), respectively. There was no significant difference between the two groups in landing zone (45.4 ± 7. vs. 45.1 ± 6.9 mm; P = 0.92) and inferior angle (14.0 ± 11.9 vs. 14.3 ± 10.1 degrees; P = 0.95). There was a numerically larger malapposition area in the "not improved NYHA" group (5.1 ± 4.5 vs. 3.2 ± 2.2 cm2; P = 0.12). Quality of Parachute implant impacted clinical outcome, these findings should be applied prospectively in helping operators to achieve optimal implant. © 2016 Wiley Periodicals, Inc.

Left ventricular partitioning in systolic heart failure subjects: addressing a mechanistic void with current therapies.

ICD patients with narrow QRS, CRT non-responders, and functional MR patients all have one mechanistic failure mode that is left untreated - the scar left behind following an MI. ICDs, CRTs, and MitraClip implantation are all well-proven therapies, but the Parachute device may address the mechanistic void that remains after each of these therapies has been used and may further improve patients' outcomes. A pooled analysis of 134 subjects was conducted using the first three clinical trials which included subjects with symptomatic ischaemic HF with LV wall motion abnormalities secondary to MI, and an LV ejection fraction less than 40%. The two-year cumulative mortality rate was 12.9%, with 8.7% in the first year and an increment of 4.2% in the second, which is a 53% reduction as compared to the first year. There is a significant proportion of patients with ischaemic heart failure being excluded from cardiac rhythm management (CRT, etc.), leaving a large treatment gap until mechanical support devices (LVAD) or heart transplantation in progressive heart failure are indicated. Along with other heart failure devices, Parachute may be a useful treatment modality, addressing a mechanistic void in the treatment of this disease. Current data support improvements in haemodynamics, functional capacity, six-minute walk distance, quality of life and a promising decline in mortality two years after Parachute implantation.

Novel device-based interventional strategies for advanced heart failure.

While heart failure is one of the leading causes of mortality and morbidity, our tools to provide ultimate treatment solutions are still limited. Recent developments in new devices are designed to fill this therapeutic gap. The scope of this review is to focus on two particular targets, namely (1) left ventricular geometric restoration and (2) atrial depressurization. (1) Reduction of the wall stress by shrinking the ventricular cavity has been traditionally attempted surgically. Recently, the Parachute device (CardioKinetix Inc., Menlo Park, CA, USA) has been introduced to restore ventricular geometry and cardiac mechanics. The intervention aims to partition distal dysfunctional segments that are non-contributory to the ventricular mechanics and forward cardiac output. (2) Diastolic heart failure is characterized by abnormal relaxation and chamber stiffness. The main therapeutic goal achieved should be the reduction of afterload and diastolic pressure load. Recently, new catheter-based approaches were proposed to reduce left atrial pressure and ventricular decompression: the InterAtrial Shunt Device (IASD™) (Corvia Medical Inc., Tewksbury, MA, USA) and the V-Wave Shunt (V-Wave Ltd, Or Akiva, Israel). Both are designed to create a controlled atrial septal defect in symptomatic patients with heart failure. While the assist devices are aimed at end-stage heart failure, emerging device-based percutaneous or minimal invasive techniques comprise a wide spectrum of innovative concepts that target ventricular remodeling, cardiac contractility or neuro-humoral modulation. The clinical adoption is in the early stages of the initial feasibility and safety studies, and clinical evidence needs to be gathered in appropriately designed clinical trials.

Deployed but not irretrievable: A novel surgical off-pump technique for parachute device extraction

Deployed but not irretrievable: A novel surgical off-pump technique for parachute device extraction

Percutaneous ventricular restoration (PVR) therapy using the Parachute device in 100 subjects with ischaemic dilated heart failure: one-year primary endpoint results of PARACHUTE III, a European trial.

This prospective, non-randomised, observational study conducted in Europe was designed in order to assess the long-term safety and efficacy of the Parachute device in ischaemic heart failure subjects as a result of left ventricle remodelling after anterior wall myocardial infarction. One hundred subjects with New York Heart Association Class II-IV ischaemic heart failure (HF), ejection fraction (EF) between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularised were enrolled. The primary safety endpoint was procedural- or device-related major adverse cardiac cerebral events (MACCE). The secondary safety endpoint was the composite of mortality and morbidity. Secondary efficacy endpoints included haemodynamic measurements determined by echocardiography, LV volume indices, and assessment of functional improvement measured by a standardised six-minute walk test. Of the 100 subjects enrolled, device implantation was successful in 97 (97%) subjects. The one-year rates of the primary and secondary safety endpoints were 7% and 32.3%, respectively. The secondary endpoints, LV volume reduction (p<0.0001) and six-minute walk distance improvement (p<0.01), were achieved. The favourable outcomes observed in this high-risk population provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for HF subjects.

Transcatheter Structural Heart Interventions for the Treatment of Chronic Heart Failure.

Heart failure (HF) is a major cause of mortality and morbidity in developed countries.1 In the past 2 decades, improvements in drug therapy and the widespread use of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices has improved the prognosis of HF patients.2 However, morbidity and mortality rates remain high, with an estimated 5-year mortality rate exceeding 50% coupled with significant rehospitalization rates. Several transcatheter implantable devices have recently emerged in an attempt to improve the prognosis and quality of life of such patients. We reviewed the current literature on interventional chronic HF. The review focus on the description of the devices and main procedural characteristics, patient eligibility, procedural results, and clinical outcomes associated with such devices. This article will focus only on mechanical transcatheter structural heart interventions for treating chronic HF. Devices used for percutaneously delivering biological therapies and interventions for acute HF fall beyond the scope of this article. Several surgical and device-based therapies have emerged in an attempt to reverse LV remodeling by restoring normal LV architecture and reducing LV volumes and wall stress. Among these surgical therapies, the most commonly used is the endoventricular circular patch plasty or Dor procedure, which consists of excluding the akinetic septal and apical ventricular regions by performing aneurysm resection with the insertion of a circular pericardial patch. Although this procedure showed promising results in multicenter registries,3 the only randomized trial—Surgical Treatment for Ischemic Heart Failure (STICH)—failed to demonstrate differences in the composite end point of death and rehospitalization for cardiac causes between surgical ventricular restoration+coronary artery bypass graft versus coronary artery bypass graft alone.4 However, some subgroups, experienced significant benefits with surgical ventricular restoration.5,6 In this regard, the parachute device (Cardiokinetix, Inc, Menlo Park, CA) emerged as a percutaneous device with the purpose of …

EYE ON CHINA

WuXi PharmaTech acquires NextCODE Health to create global leader in genomic medicine. CardioKinetix completes enrollment in Chinese trial of first-of-its-kind parachute device for treatment of heart failure. Hua Medicine raises $25 million in Series B financing to start Phase 2 trials. BCI forms partnership with CBIA. Greener nylon production could cut costs and pollution. Innovent Biologics, Inc. completes $100 million Series C financing funds to advance novel biologic pipeline and internal operations. PerkinElmer opens new medical laboratory in Suzhou, China. 3SBio acquires Sirton Pharmaceuticals SpA.

Three-dimensional analysis for the evaluation of left ventricular aneurysm and pseudo-aneurysm after myocardial infarction

Myocardial Infarction (MI) is an ischemic heart disease representing one of the main causes of death for acute cardiac pathologies. Two important consequences of MI are left ventricular (LV) aneurysm and pseudo-aneurysm. The aim of the present study is to highlight anatomical and functional changes in LV undergoing post-ischemic remodeling by means of three dimensional-Magnetic Resonance Imaging (MRI) and three dimensional-Computed Tomography (CT), which are useful techniques for the diagnosis and evaluation of accurate clinical and surgical approaches. In this way the surgeon can evaluate pro and counter of the classical approach or the parachute implant with possible promotion of mininvasive surgery [1]. Although to date MI consequences can be assessed with bidimensional technique (e.g. echocardiography and ventriculography), we want to suggest the use of three dimensional Direct Volume Rendering (DVR), which is a direct technique for visualizing primitive volumes without any intermediate conversion of the volume data to surface presentation [2]. DVR allows to better discriminate between aneurysm and pseudoaneurysm and to do a better evaluation of inclusion and exclusion criteria for the implant of a parachute device.

New evidence for favourable effects on haemodynamics and ventricular performance after Parachute(®) implantation in humans.

The Parachute(®) Ventricular Partitioning Device offers an additional strategy for heart failure patients with exclusion of the infarcted wall to decrease left ventricular volumes, myocardial work, and wall stress. The aim of the present study was to evaluate if Parachute implantation might influence acute haemodynamic and functional performance in patients with left ventricular aneurysm after anteroapical infarction. Sixteen patients underwent a Parachute device implantation. Invasive right and left heart haemodynamic assessments as well as left ventricular analysis for evaluating left ventricle end-diastolic and end-systolic volumes, and regional ventricular function were analysed. After implantation a significant increase in stroke volume (+25.4%, P = 0.0005), stroke volume index (+26.5%, P = 0.0005), cardiac output (+25.8%, P < 0.0001) and cardiac index (+25.9%, P < 0.0001) was found. In addition to an increase in mean aortic (P = 0.0050) and pulmonary pressure (P = 0.0347), there were significant increases in stroke work index (P = 0.0003), left (P = 0.0015) and right (P = 0.0024) ventricular stroke work index as well as left and right cardiac work index (both P = 0.0001), while the remaining haemodynamic parameters remained unchanged. Left ventricular analysis showed an acute reduction of the left ventricular end-diastolic volume (-18.0%, P < 0.0001) and left ventricular end-systolic volume (-26.3%, P < 0.0001) and an increase in ejection fraction from 22.9 to 30.6% (+38.4%, P < 0.0001). Most interestingly, the basal wall segments displayed an increased contribution to the left ventricular ejection fraction with increased wall motion in nearly all segments (except the apex region). The data demonstrate the acute haemodynamic efficacy of Parachute device implantation. The implantation of the device displays immediate significant left ventricular volume reduction leading to an acute improved right and left cardiac function, proving the concept of left ventricular partitioning.

Computed tomographic analysis of left ventricular volumes and function after implantation of the Parachute® endoventricular partitioning device.

Preliminary clinical experience with a percutaneous endoventricular partitioning device (Parachute®, CardioKinetix Inc., Menlo Park, CA, USA) suggests that it ameliorates global LV dysfunction and heart failure symptoms in selected patients who have suffered previous anterior myocardial infarction. Less is known of its effect on regional LV function. To gain insight into device effect on regional LV function by analysis of cardiac computed tomographic (CT) images obtained before and after device implantation. Comparative analysis of pre and 6 months post-implantation contrast-enhanced CT images from 6 subjects enrolled in the phase 1 Parachute clinical trials, including regional LV volume and systolic excursion, as well as device motion. After implantation, a significant reduction in volume of the "dynamic" LV compartment (that which was not excluded by the device) was accompanied by a significant reduction in dykinetic motion and a trend toward an improved ejection fraction. Penetration of contrast into the excluded compartment was still present at 6 months, however the apical motion was significantly less dyskinetic in 3 subjects and unchanged in the other 3. Overall device surface motion was inward in systole, a significant improvement relative to the overall dyskinetic LV apex pre-implantation. Device motion was spatially heterogeneous, which appeared to be dependent on the motility of the myocardium that anchored its individual splines. Our data suggest that the Parachute device acts as a functional impediment to flow and stretch, effectively depressurizing the apical segment.

Patient-specific finite element modeling of the Cardiokinetix Parachute(®) device: effects on left ventricular wall stress and function.

The Parachute(®) (Cardiokinetix, Inc., Menlo Park, California) is a catheter-based device intended to reverse left ventricular (LV) remodeling after antero-apical myocardial infarction. When deployed, the device partitions the LV into upper and lower chambers. To simulate its mechanical effects, we created a finite element LV model based on computed tomography (CT) images from a patient before and 6 months after Parachute(®) implantation. Acute mechanical effects were determined by in silico device implantation (VIRTUAL-Parachute). Chronic effects of the device were determined by adjusting the diastolic and systolic material parameters to better match the 6-month post-implantation CT data and LV pressure data at end-diastole (ED) (POST-OP). Regional myofiber stress and pump function were calculated in each case. The principal finding is that VIRTUAL-Parachute was associated with a 61.2 % reduction in the lower chamber myofiber stress at ED. The POST-OP model was associated with a decrease in LV diastolic stiffness and a larger reduction in myofiber stress at the upper (27.1%) and lower chamber (78.4%) at ED. Myofiber stress at end-systole and stroke volume was little changed in the POST-OP case. These results suggest that the primary mechanism of Parachute(®) is a reduction in ED myofiber stress, which may reverse eccentric post-infarct LV hypertrophy.

Interventions for failing vessels, valves, and now … ventricles: The Parachute device

Interventions for failing vessels, valves, and now … ventricles: The Parachute device