Cath: Melody Valve in Contegra Graft - Animal Study

Circulation. 2010;122:A19333

Abstract 19333: Transcatheter Delivery of Melody Valves (MelV) Larger Than Contegra Conduit (CC)

Core 3. Genetics, Genomics and Congenital CV Disorders Session Title: Cardiac Catheterization and Electrophysiology in the Young

Prakul Chanthong; Luis Quinonez; Patty Boylen; Jon Timinsky; James Y Coe

UNIVERSITY ALBERTA HOSPITAL, Edmonton, Canada; Medtronic Canada, Missisauga, Canada; UNIVERSITY ALBERTA HOSPITAL, Edmonton, Canada

Transcatheter replacement of pulmonary valves is used in failed right ventricular to pulmonary artery (RV-PA) homografts (H) or prosthetic valves (PV). The former calcify and the latter have metal rings ± struts, both providing secure landing spots for MelV. The MelV expansion is limited by the H or PV size, and H may rupture if expanded beyond its original diameter. CCs often do not calcify, yet may become aneurysmal with increased intraluminal pressure. We tested the hypothesis that transcatheter MelV replacement is possible in a hypertensive, supported CC. Under general anesthesia, supported 18 mm CCs were placed as descending aortic jump grafts via a left thoracotomy in sheep (n=6). After a recovery period, 22 mm MelVs (n=4) were delivered via a carotid artery into the CCs. 56-82 (mean 72) days after aortic placement, the 18 mm CC dilated to 36-37 mm under systemic pressure, while the ring diameter remained at 18 mm. Deploying the MelV at 22 mm expanded the CC rings to 22 mm. without CC rupture. Transcatheter Melody valve replacement into the Contegra conduits is feasible. The Melody valve will expand the rings of the Contegra conduit to the largest valve diameter.

Author Disclosures: P. Chanthong, None; L. Quinonez, None; P. Boylen, Medtronic, Modest, Employment; J. Timinsky, None; J.Y. Coe, Medtronic, Modest, Consultant/Advisory Board; NuMed, Modest,Consultant/Advisory Board.

General Cardiology: Heart Failure, Hyponatremia, Mortality

CIRCHEARTFAILURE.111.961011Published online before print June 14, 2011,

Impact of Change in Serum Sodium Concentration on Mortality in Patients Hospitalized with Heart Failure and Hyponatremia

1. Vinay D. Madan,
2. Eric Novak and
3. Michael W. Rich*

Abstract

Background—Hyponatremia is a common electrolyte abnormality among patients hospitalized with heart failure and it is a marker for increased short-term and long-term mortality. However, little is known about the time-course of hyponatremia and whether changes in serum sodium levels impact clinical outcomes.

Methods and Results—322 patients hospitalized with decompensated heart failure and serum sodium <135 mmol/L were evaluated. Following hospital discharge, the first sodium value obtained within a 60-270 day period was recorded, and patients were classified into 3 groups based on whether the serum sodium value increased (≥2 mmol/L), decreased (≤2 mmol/L), or remained unchanged (±1 mmol/L) relative to the baseline value. Kaplan-Meier survival curves were constructed to illustrate mortality as a function of change in sodium concentration over time, and a Cox-proportional hazards model was constructed to determine if change in serum sodium concentration predicted mortality after adjusting for relevant covariates. The mean age of the population was 66 years, 45% were women, and 55% were Caucasian. The mean baseline sodium level was 131 mmol/L and the mean ejection fraction was 32.5%. 222 patients (68.9%) exhibited an increase in sodium during follow-up; in 57 patients (17.7%) the level was unchanged and in 43 patients (13.4%) there was a decrease in sodium level. During a median follow-up of 610 days, there was a strong positive association between change in sodium level and survival (p for trend <0.001); i.e., increased sodium was associated with decreased mortality. In multivariable analysis, change in sodium concentration and higher blood urea nitrogen were the strongest predictors of mortality (both p<0.0001).

Conclusions—Among patients hospitalized with heart failure and hyponatremia, change in serum sodium concentration over time is a strong predictor of long-term survival.

Heart Failure: Serum Marker (Follistatin-like 1)

• CIRCHEARTFAILURE.110.960625Published online before print May 27, 2011
• Original Article

Follistatin-like 1 in Chronic Systolic Heart Failure: A Marker of Left Ventricular Remodeling

1. Ali El-Armouche1,
2. Noriyuki Ouchi2,
3. Komei Tanaka2,
4. Gheorghe Doros3,
5. Katrin Wittköpper1,
6. Thomas Schulze4,
7. Thomas Eschenhagen5,
8. Kenneth Walsh2 and
9. Flora Sam2*

Abstract

Background—Follistatin-like 1 (FSTL1) is an extracellular glycoprotein that is found in human serum. Recent work suggests that FSTL1 is secreted in response to ischemic injuries and that its overexpression is protective in the heart and vasculature.

Methods and Results—Here, we examined serum FSTL1 levels in patients with chronic heart failure with left ventricular (LV) ejection fraction <40% (n=86). The distribution of the sample, from these chronic heart failure patients, was separated into three tertiles of low, medium and high FSTL1 levels. Serum FSTL1 levels were increased 56% above age- and gender-matched, healthy controls. Diabetes mellitus, brain natriuretic peptide level, left atrial size, LV posterior wall thickness, LV end-diastolic diameter and LV mass were significant determinants of FSTL1 serum levels by bivariate analysis. After controlling for significant covariates, FSTL1 levels predicted LV hypertrophy (as measured by LV mass index) by multivariate linear regression analysis (P<0.001). Unadjusted survival analysis demonstrated increased mortality in patients with increasing FSTL1 levels (P=0.09). After adjusting for significant parameters, patients with increased FSTL1 remained at the highest risk of death [hazard ratio (95% confidence limits) 1.028, (0.98 and 1.78)]; (P=0.26). To determine whether elevated FSTL1 may be derived from the myocardium, FSTL1 protein expression was measured in samples from explanted, failing (n=18) and non-failing human hearts (n=7). LV failing hearts showed 2.5-fold higher FSTL1 protein levels than non-failing control hearts (P<0.05).

Conclusions—Elevated serum FSTL1 in human heart failure patients was associated with LV hypertrophy. Further studies on the role of FSTL1 as a biomarker in chronic systolic heart failure are warranted.

QT interval - normal values during recovery from exercise

CIRCEP.110.961094
Published online before print May 23, 2011

The QT and Corrected QT Interval in Recovery After Exercise in Children

Wouter Rudolph Berger, Robert M. Gow, Suleman Kamberi, Michael Cheung, Katherine Rose Smith and Andrew Mark Davis

Background—Prolongation of the QT interval after exercise can be used to help diagnose Long QT syndrome, especially when the resting QT interval is borderline. The aim of this study was to determine the normal ranges for QT/QTc in the recovery phase after exercise in children.

Methods and Results—Ninety-four volunteer boys and girls aged 8 to less than 17 years, without any history of heart disease underwent exercise testing and had 12 lead ECGS performed in the supine position for 10 minutes of recovery. The QT was measured using a standardized tangent method with the baseline defined as the Q to Q line. The recovery QT was maximally short at 1 minute of recovery in 93/94 individuals, then lengthened and stabilized at 4 to 5 minutes recovery. The recovery QT lengthens as HR decreases in an approximately linear fashion with a mean increase of 15 milliseconds per 10 beat decrease in heart rate. The 98th percentiles for the QTc using the Bazett formula during minutes 4 to 6 in recovery were from 482 msec to 491 msec. There was excellent intra-observer and inter-observer reliability with intra-class correlation coefficients of 0.95 and 0.88 respectively.

Conclusions—There is substantial individual variability of the normal repolarization process in the post-exercise recovery period in children. The study provides a reference for normal responses for similar populations using a specific measurement protocol that can be easily applied.

Coffee consumption and Blood pressure

ASH - American Society of Hypertension 2011

Coffee Okay for Well-Managed Hypertensives


By Todd Neale, Staff Writer, MedPage Today
Published: May 23, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

In a meta-analysis of five trials, consuming 200 to 300 milligrams of caffeine -- the amount found in one-and-a-half to two cups of coffee -- produced a mean increase in blood pressure of 8.1/5.6 mm Hg, according to Esther Lopez-Garcia, PhD, of Autonoma University of Madrid.

The effect was observed within the first hour and sustained for up to three hours, she reported at the American Society of Hypertension meeting here.

Although meta-analyses of studies looking at the longer-term effects could not be conducted because of methodological differences, the bulk of the evidence pointed to a lack of an effect from coffee and caffeine intake on blood pressure and cardiovascular risk.

The association between coffee drinking and blood pressure has been well studied in normotensive individuals, with consistent findings of an acute increase in blood pressure after intake but no long-term risk of becoming hypertensive or having a cardiovascular event, according to Lopez-Garcia.

Some studies have even tied coffee drinking to a lower stroke risk, including a Swedish cohort study and an analysis of the Nurses' Health Study.

However, the relationship has not been studied as thoroughly in hypertensive individuals, in whom even a slight increase in blood pressure might be harmful.

In addition, Lopez-Garcia said that it is unknown whether coffee might reduce the effect of antihypertensive drug treatment and whether hypertensive individuals are able to develop a tolerance to caffeine like their normotensive counterparts.

Thus, she said, evidence is insufficient to guide medical advice regarding coffee and caffeine consumption in hypertensive individuals.

To explore the issue, Lopez-Garcia and her colleagues reviewed the literature and performed meta-analyses when possible.

In the meta-analysis of trials examining the acute effect of coffee and caffeine consumption, blood pressure was increased in the first three hours after intake, regardless of the duration of caffeine abstinence before the trial started and of the use of antihypertensive drugs.

Four other studies examined the longer-term effects of interventions involving coffee or caffeine intake. The two studies comparing coffee versus decaffeinated coffee found no longer-term effect on blood pressure up to eight weeks after the intervention.

Of two studies comparing coffee with a caffeine-free diet, however, one demonstrated a significant increase in systolic blood pressure in the coffee group (mean change 5.2 mm Hg). That came with an intervention consisting of drinking five cups of coffee a day.

There is not enough evidence to draw firm conclusions, Lopez-Garcia said, but the bulk of the evidence suggests that there is no longer-term effect on blood pressure from drinking coffee or caffeinated beverages.

A meta-analysis also was not possible for the five cohort studies -- with durations ranging from four to 25 years -- examining the relationship between habitual consumption of coffee and caffeinated beverages and cardiovascular risk.

Three studies found no association between habitual caffeine intake and risk of cardiovascular mortality.

Of two studies using stroke as an endpoint, one found a doubling in the risk (RR for the consumption of 20 ounces of coffee per day 2.1, 95% CI 1.2 to 3.7). The other failed to show a significant association.

Overall, the findings suggest that the relationship between coffee and caffeine consumption and blood pressure is similar in hypertensive and normotensive individuals, Lopez-Garcia said.

She said that one of the clinical implications of the findings is that the consumption of coffee or caffeinated beverages may alter blood pressure measurements in routine check-ups.

The findings also show that in hypertensive patients with well-controlled blood pressure, it may be safe to consume coffee, she added, but "for patients with uncontrolled blood pressure, moderation in coffee consumption is suggested."

The study was funded in part by an FIS research grant. Lopez-Garcia was supported by a Ramón y Cajal contract, and one of her co-authors was supported by a MAEC-AECID fellowship.

Lopez-Garcia reported that she had no conflicts of interest.

Bioabsorbable Stents: From EuroPCR 2011

EuroPCR: Novel Metal Stent Does Disappearing Act

By Crystal Phend, Senior Staff Writer, MedPage TodayPublished: May 19, 2011

Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine andDorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner


PARIS -- A novel drug-eluting stent may do away with the permanent metal jacket, according to early results with a bioabsorbable metal scaffold.The paclitaxel-eluting magnesium alloy stent degrades away after about nine months to a soft hydroxyapatite absorbed by the body, Michael Haude, MD, of Städtische Kliniken Neuss Lukaskrankenhaus in Neuss, Germany, and colleagues reported.First-in-man results suggested a 9.1% target lesion failure rate -- two revascularizations -- and 0.68 mm late lumen loss at six months in a small, 22-patient study Haude presented here at the European Society of Cardiology's EuroPCR meeting."We feel that we are on the right direction," Haude told MedPage Today at a press conference.

Bioabsorbable polymer scaffold stents have been developed as well, but a metal backbone holds clear advantages for conforming to the vessel, Haude explained.
"It is really adapting to the vessel size, and, of course, you can overstress it, you can dilate it, which is not to that extent possible with most of the polymers that are on the market," he said at the session.

While the novel technology still needs to prove itself against conventional drug-eluting stents, there would likely be advantages for treating younger patients in earlier stages of coronary artery disease, he suggested.

These patients with decades of life expectancy "obviously don't want to have a permanent scaffold stent within their arteries for the rest of their life," Haude told attendees.
The researchers tweaked the design of the stent, adding a bioabsorbable paclitaxel-eluting polymer coating and extending the scaffold degradation time, then tested it in 46 patients with de novo coronary artery stenosis in the BIOSOLVE-I study.

The 22 patient cohort with clinical follow-up at six months showed 100% procedural and technical successes. No deaths, heart attacks, or scaffold thrombosis were seen, though two patients required clinically driven target lesion revascularization by six months due to angina.
The in-scaffold late lumen loss was 0.68 mm at six months, which was a 37% improvement over results with the prior bare metal version of the stent. The 9.1% target lesion revascularization rate was a 62% improvement over results with the prior version.

The second cohort, which will have a 12-month follow-up, should provide additional information on long-term safety and efficacy of the new scaffold, Haude noted.

By comparison, first-in-man trials with conventional stents had reported late lumen loss of 0.10 with the Xience V stent, 0.09 mm with Cypher, and 0.12 mm with Endeavor, as Martial Hamon, MD, of the University Hospital of Caen in Normandy, France, noted in a separate presentation at the session.

Also for comparison purposes, at six months the late lumen loss was 0.44 mm and the restenosis rate was 11.5% for the first-in-man trial of an everolimus-eluting polymer bioabsorbable coronary stent.

The study was sponsored by Biotronik.
Haude reported research contracts with Biotronik, OrbusNeich, Cordis, Medtronic, Cardiac Dimensions, and Volcano as well as consulting for Biotronik and OrbusNeich.
Hamon reported consulting for Biotronik.

Primary source: European Association of Percutaneous Cardiovascular InterventionsSource reference:Haude M, et al "BIOSOLVE-I safety and clinical performance of the first drug-eluting absorbable metal scaffold" EuroPCR 2011.

Surgery: TAPVR - Primary Sutureless Repair Results

The Journal of Thoracic and Cardiovascular Surgery Volume 141, Issue 6, June 2011, Pages 1346-1354

Congenital heart disease

Primary sutureless repair for “simple” total anomalous pulmonary venous connection: Midterm results in a single institution

Bobby Yanagawa MD, PhDa, Abdullah A. Alghamdi MD, MSca, Andreea Dragulescu MDb, Nicola Viola MDa, Osman O. Al-Radi MDa, Luc L. Mertens MD, PhDb, John G. Coles MDa, Christopher A. Caldarone MDa and Glen S. Van Arsdell MDa, ,

Objective
We have previously reported the use of an atriopericardial or “sutureless” repair for surgical management of postoperative pulmonary vein stenosis. The potential of avoiding geometric distortion of pulmonary venous suture lines and preventing post-repair pulmonary vein stenosis encouraged us to extend the use of this technique for primary “simple” total anomalous pulmonary venous connection repair.

Methods
Between January 1997 and July 2009, 57 consecutive patients (median age, 15 days; median weight, 3.4 kg) underwent sutureless or conventional total anomalous pulmonary venous connection repair.

Results
Types of total anomalous pulmonary venous connection included supracardiac in 31 patients (54%), cardiac in 15 patients (26%), and infracardiac in 11 patients (19%). Median follow-up time was 2.9 years. Preoperative mean pulmonary vein score, a composite measure of stenosis in all 4 pulmonary veins, was 0.3/0–12, and vertical vein obstruction was found in 35 patients (61.4%). A primary sutureless repair was carried out in 21 patients (36.8%; supracardiac, n = 12; cardiac, n = 4; infracardiac, n = 5). The sutureless repair group had proportionally greater high-risk infracardiac total anomalous pulmonary venous connection (24% vs 16%, P = .05). Primary outcomes of death or reoperation for pulmonary vein stenosis and postoperative pulmonary vein scores (0.2 ± 0.7 vs 0.7 ± 1.7, P = .26) were not different between the techniques.

Conclusions
The sutureless repair group had proportionally more infracardiac total anomalous pulmonary venous connection and a higher rate of decline in postoperative right ventricular systolic pressure. Despite increased preoperative risk, no difference was observed in primary outcomes of death and reoperation in the conventional repair group.