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The stent-like IASD is deployed into a small hole made in the atrial septum and allows the left atrium to decompress at rest and during physical activity .
The open-label REDUCE LAP-HF trial tested the IASD in 64 patients with NYHA class II to IV HF , LVEF ≥ 40 %, and elevated PCWP ( ≥ 15 mm Hg at rest or ≥ 25 mm Hg during supine bicycle exercise ).
Previously reported 6-month outcomes showed good initial safety and an indication of efficacy , with 52 % of patients having a reduction in PCWP at rest , 58 % a reducing during exertion , and 39 % showing both . Mean exercise PCWP was lower at 6 months than at baseline , even though mean exercise duration was increased ( p = 0.03 ).
Building on these promising 6-month findings , the 12-month data showed sustained clinical efficacy . At 1-year post-procedure , median NYHA class had improved from III to II ( p < 0.001 ), and there was a 15-point improvement seen in the Minnesota Living with Heart Failure score ( p < 0.001 ). Additionally , the 30-meter improvement in 6-minute walk distance seen at 6 months was increased to 33 meters at 1 year .
Echocardiography showed no change in ejection fraction , but a small decrease in the left ventricular end-diastolic volume index ( p < 0.001 ) and a small increase in the right ventricular end-diastolic volume index ( p < 0.001 ). Invasive hemodynamic studies demonstrated a sustained reduction in the workload indexed PCWP ( p < 0.01 ).
At 1 year , there were 3 deaths ( 4.7 %) and one fatal stroke ( 1.5 %), with sustained evidence of left-to-right shunt flow in all patients , and no device-related complications . Device patency was confirmed by echocardiography or oximetry in 54 subjects .
“ This is an important trial because no pharmacological trial to date has demonstrated any significant reduction in mortality in this disease ,” said the scheduled discussant Nancy K . Sweitzer , MD , PhD , University of Arizona , Tucson . If benefits are confirmed in larger randomized trials , the IASD could have “ an enormous impact ” on the treatment of HFpEF , she said .
One hurdle : confirm that the improvements seen are not a placebo effect . “ Anyone enrolled in a heart failure trial tends to get better ,” she noted .
In March 2016 , Corvia Medical received an investigational device exemption approval from the U . S . Food and Drug Administration for a multicenter study of the IASD . In May they gained CE Mark approval .
Kaye DM , et al . Circ Heart Fail 2016 Nov 16 . [ Epub ahead of print ]
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HeartMate LVAD Maintains MOMENTUM In a multicenter head-to-head comparison of the HeartMate II and the HeartMate 3 ( and yes , they have mixed Roman and English numerals ), the newest left ventricular assist device ( LVAD ) system performed well , reducing clotting-related complications and improving patient outcomes . Results from MOMENTUM 3 demonstrated that patients receiving the HeartMate 3 had an 86.2 % survival rate with freedom from disabling stroke and reoperation to repair or replace the device .
“ This trial showed marked improvement in outcomes that were driven by a reduction in a need for reoperation for pump malfunction or replacement of the HeartMate 3 pump compared to the currently available HeartMate 2 device ,” reported Mandeep R . Mehra , MD , from Brigham and Women ’ s Hospital , Boston , MA .
The HeartMate II ( HMII ) is a mechanical bearing axial continuous-flow pump and still the only device approved in the U . S . for both bridge-to-transplant ( BTT ) and destination therapy ( DT ) patients . Its use , however , has been limited by reports of major bleeding complications , along with issues of pump malfunction , principally due to pump thrombosis .
The investigational HeartMate 3 ( HM3 ) is a continuous-flow , fully magnetically levitated ( often referred to as “ maglev ”) blood pump designed with wide blood flow passages to reduce shear stress . The device is also frictionless due to the absence of mechanical bearings , and its fully magnetically levitated centrifugal flow incorporates rapid changes in rotor speed to create an artificial pulse .
The MOMENTUM 3 trial enrolled patients with New York Heart Association class IIIB and IV heart failure who were candidates for LVAD implantation , either as BTT or DT . A total of 294 patients were randomly assigned to receive either an HMII or HM3 LVAS .
At an AHA press conference , Dr . Mehra reported interim , pre-specified 6-month findings , which were simultaneously published in the New England Journal of Medicine ( Mehra MR , et al . A fully magnetically levitated circulatory pump for advanced heart failure . New Engl J Med . 2016 Nov 16 . [ Epub ahead of print ])
Survival at 6 months free of disabling stroke or reoperation to replace or remove the pump other than for myocardial recovery did not differ between the Heart- Mate 3 and the HeartMate II ( 86 % for HM3 and 77 % for HMII ; absolute difference , 9.4 % favoring HM3 ; superiority
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analysis : hazard ratio , 0.55 ; p = 0.037 ).
Reoperations were required in 1 % of HM3 recipient , compared with 18 % of HMII recipients ( p = 0.002 ). There were no reports of suspected or confirmed pump thrombosis in the HM3 recipients , compared to 10 % ( 14 events ) in the HMII recipients ( p < 0.0001 ).
There were no differences in rates of death at 180 days or disabling stroke , nor in rates of gastrointestinal bleeding , or hemorrhagic , ischemic , or all-type stroke .
“ We saw similar functional improvement in quality of life in patients treated with either the HeartMate 2 or the HeartMate 3 pump with no difference whatsoever in other adverse effects ,” said Dr . Mehra .
MOMENTUM 3 will enroll a total of 1,028 patients and follow them for 2 years . The HeartMate 3 is CE Mark approved and limited to investigational use in the United States . ■
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Regression to the Mean : Lessons on Trial Design and Reporting from SYMPLICITY HTN-3
Stuart J . Pocock , PhD , a Professor of Medical Statistics , London School of Hygiene and Tropical Medicine , UK , discusses his review paper in JACC .
Thinking Positively about Cognitive Changes Post- TAVR
Some patients experience mild cognitive changes post-TAVR , ranging from deleterious effects to a global improvement in cognitive status . Josep Rodés-Cabau , MD , Quebec Heart & Lung Institute , Laval University , discusses his paper from the JACC November 15 / 22 issue .
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Million Hearts Initiative Leads to New Risk Assessment Tool Lloyd-Jones DM , Huffman MD , Karmali KN , et al . Estimating Longitudinal Risks and Benefits From Cardiovascular Preventive Therapies Among Medicare Patients : The Million Hearts Longitudinal ASCVD Risk Assessment Tool . J Am Coll Cardiol . 2016 . URL : http :// content . onlinejacc . org / article . aspx ? articleid = 2578915 |
Study Raises Questions Regarding 30-day Readmission Metric for HF Pandey A , Golwala H , Xu H , et al . Association of 30-Day Readmission Metric for Heart Failure Under the Hospital Readmissions Reduction Program With Quality of Care and Outcomes . JCHF . 2016 ; 4:935-46 . |
CT Angiography : The ‘ Smoking Gun ’ for the Association of Secondhand Smoke and Atherosclerosis ? Yankelevitz DF , Cham MD , Hecht H , et al . The Association of Secondhand Tobacco Smoke and CT Angiography- Verified Coronary Atherosclerosis . J Am Coll Cardiol Img . 2016 . URL : http :// imaging . onlinejacc . org / article . aspx ? articleid = 2581850 |
Assessing the Safety of Early U . S . Commercial Application of Left Atrial Appendage Closure with the WATCHMAN Reddy VY , Gibson DN , Kar S , et al . Post-FDA Approval , Initial US Clinical Experience with Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation . J Am Coll Cardiol . 2016 ; doi : 10.1016 / j . jacc / 2016.10.019 |
Heather Gornik , MD , is Medical Director , Non- Invasive Vascular Lab at the Cleveland Clinic and Vice Chair of the PAD Guidelines Writing Committee . |