CardioSource WorldNews - Page 21

More Simultaneous Publications from AHA . 16
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 ]
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
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 . ■
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 .

More Simultaneous Publications from AHA . 16

New Guidelines on Managing Lower Extremity PAD
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 .
ACC . org / CSWN CardioSource WorldNews
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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] 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. 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