Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction: Results of the PercutAneous Ventricular RestorAtion in Chronic Heart failUre PaTiEnts Trial

Mazzaferri, Ernest L.; Gradinac, Siniša; Sagić, Dragan; Otašević, Petar; Hasan, Ayesha; Goff, Thomas L.; Sievert, Horst; Wunderlich, Nina; Nikolic, Serjan D.; Abraham, William T.

doi:10.1016/j.ahj.2012.02.013

Cited by 64 publications

(56 citation statements)

References 16 publications

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“…The Minnesota Living with Heart Failure and 6-minute walk test have been reported previously in the 12-month followup report. 6 Complementary data supporting the hemodynamic and functional improvements were collected on a subset of patients. Invasive pressure monitoring data were available in 10 subjects showing a 29% reduction in LV end-diastolic pressure at 6 months postprocedure (P<0.05).…”

Section: Hemodynamic and Functional Outcomesmentioning

confidence: 99%

Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

Costa

Mazzaferri

Sievert

et al. 2014

Circ: Heart Failure

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Background— Left ventricle remodeling after anterior wall myocardial infarction leads to increased left ventricle volumes, myocardial stress, and ultimately heart failure (HF). Treatment options are limited for these high-risk HF patients. A study was conducted to assess safety and feasibility of a percutaneous ventricular restoration therapy using the Parachute device in subjects with HF because of a cardiac ischemic event. Methods and Results— Thirty-nine subjects with New York Heart Association class II to IV ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled in a prospective, nonrandomized, multicenter investigation testing percutaneous ventricular restoration using the Parachute device. The safety primary end point was defined as successful procedure without device-related major adverse cardiac events during 6 months. Clinical and echocardiographic outcomes were obtained at 6, 12, 24, and 36 months post-treatment. Echocardiographic and end point data were adjudicated independently. Of the 39 subjects enrolled, device implantation was attempted in 34 and successful in 31 patients. Twenty-three subjects reached 3 years post-treatment with the device implanted. New York Heart Association symptom class was improved or maintained in 85% of subjects. Left ventricle end-diastolic volume index and end-systolic volume index were reduced from 128.4±22.1 and 94.9±22.3 mL/m 2 preimplant to 115.2±23.1 and 87.3±18.7 mL/m 2 at 3-year follow-up (end-diastolic volume index, P =0.0056; end-systolic volume index, P =0.4719). The cumulative incidence of HF hospitalization or death was 16.1%, 32.3%, and 38.7% at 12, 24, and 36 months, respectively. By 3-year follow-up, 2 (6.5%) of 31 patients with successful implant had died from cardiac reasons, with no cardiac deaths occurring past 6 months post-treatment. Conclusions— The first series of ischemic HF patients treated with percutaneous ventricular restoration using the Parachute device demonstrates feasibility and safety of the device ≤3 years post-treatment. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifiers: NCT00573560 (US patients) and NCT01286116 (EU patients).

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Section: Hemodynamic and Functional Outcomesmentioning

confidence: 99%

Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

Costa

Mazzaferri

Sievert

et al. 2014

Circ: Heart Failure

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“…The concept of percutaneous ventricular restoration (PVR) of the LV is based on the premise that a dedicated partitioning, compliant device delivered via a catheter-based approach may achieve LV volume reduction, geometric reconfiguration, and synchronised wall motion to achieve a more effective ejection while minimising the risk of a surgical approach 7 . Initial studies 8,9 in subjects with post-MI remodelling and symptoms of New York Heart Association (NYHA) Class II-IV HF demonstrated safety, feasibility, and favourable LV function as measured by LVESVi, LVEDVi, EF and LVEDP. Moreover, improved symptoms and functional status were confirmed after 12 months.…”

Section: Introductionmentioning

confidence: 99%

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

Thomas

Ca²,

Ince³

et al. 2015

EuroIntervention

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Aims: 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. Methods and results: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 anteriorapical 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. Conclusions: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. Clinical registration: www.clinicaltrials.gov numbers are NCT01297296 (PARACHUTE III) and NCT01286116 (cohort B subjects). KEYWORDS• ischaemic heart failure • left ventricle remodelling • structural heart

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“…Despite one incomplete device opening with subsequent percutaneous device removal, no device or catheter malfunctions were reported. Very few complications occurred (1 inadequately attached device migrated into the LV cavity and was removed surgically, 1 patient developed a non-device-related sepsis and the device did not open completely in one patient during the procedure as mentioned above) [7,8]. Our case demonstrates that implantation of the percutaneous ventricular partitioning device is safe and feasible under local anaesthesia by the transfemoral route.…”

Section: Discussionmentioning

confidence: 74%

Percutaneous left ventricular partitioning device for chronic heart failure

et al. 2012

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Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction: Results of the PercutAneous Ventricular RestorAtion in Chronic Heart failUre PaTiEnts Trial

Cited by 64 publications

References 16 publications

Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

Percutaneous Ventricular Restoration Using the Parachute Device in Patients With Ischemic Heart Failure

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

Percutaneous left ventricular partitioning device for chronic heart failure

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