Patient survival with defibrillators in real-world matches trial expectations

Washington, January 2 (ANI): In a new study, researchers assessed the survival of patients receiving defibrillators, which are commonly used to prevent sudden cardiac death.

The researchers found that patients who received an implantable heart defibrillator in everyday practice had survival benefits on par with those who received the same devices in carefully controlled clinical trials.

Led by the Duke Clinical Research Institute and published Jan. 2, 2013, in the Journal of the American Medical Association, the study used data from a large national Medicare registry.

Because clinical trial participants tend to receive more meticulous care while also being healthier than patients seen in clinical practice, the actual benefits of new drugs and medical devices can be less positive than initially reported.

Not so for the defibrillators, at least when comparing patients with similar characteristics in both the clinical trials and real-world practice.

"Many people question how the results of clinical trials apply to patients in routine practice," lead author Sana M. Al-Khatib from the Duke Clinical Research Institute said.

"We showed that patients in real-world practice who receive a defibrillator but who are most likely not monitored at the same level provided in clinical trials have similar survival outcomes compared to patients who received a defibrillator in the clinical trials," Al-Khatib said.

Implantable cardioverter-defibrillators (ICDs) have been lifesavers for people with a history of cardiac arrest or heart failure. The devices, small electrical units implanted in the chest with wires that lead into the heart, send an electronic pulse when the heart stops beating to reestablish a normal rhythm.

To monitor treatment patterns, effectiveness and safety of ICDs among Medicare patients, the Centers for Medicare and Medicaid Services mandated that data on all Medicare patients receiving a primary prevention ICD be entered into a national registry.

In response to this mandate, a national ICD Registry has been collecting data from hospitals performing implantations since 2005. The Duke-led research group used data from that registry to compare more than 5,300 real-world patients against more than 1,500 patients who had enrolled in two large clinical trials of ICD devices.

Al-Khatib said the patients who were included in the analysis were selected to closely resemble the patients who participated in the clinical trials, with much older and sicker patients in the registry excluded. Both groups - study participants who received an ICD and ordinary recipients - had similar two-year and three-year survival rates.

Ordinary recipients had better survival than patients in the clinical trial who did not receive an ICD. These findings were true for Medicare and non-Medicare patients.

By comparing similar populations, the researchers were able to address the concern that outcomes reported in clinical trials are overly optimistic because patients receive extraordinary care.

"We know from previous studies that many patients in real-world clinical settings don't receive the follow-up care that is recommended after the device is implanted," Al-Khatib said.

She said doctors who participate in clinical trials also tend to be highly skilled specialists who do hundreds of the implantation surgeries, while physicians in ordinary practice may be less proficient. Studies have shown that patients have more complications when their doctors have less experience with a procedure.

Al-Khatib said the study had a limitation that could warrant additional examination. By eliminating Medicare patients who were appreciably older and sicker than those who enrolled in the clinical trials, the researchers were unable to determine how all patients seen in real-world practice compare to study participants.

"That is in an issue, and the only way to get at that is to randomly assign such patients to either receive an ICD or not in a clinical trial," Al-Khatib said.

"Even without those data, however, our study gives patients and their health care providers reassurance that what we have been doing in clinical practice has been helpful, and is improving patient outcomes. Our findings support the continued use of this life saving therapy in clinical practice," she added.

The study has been recently published in the Journal of the American Medical Association. (ANI)

Matches

MORE TOP STORIES TODAY

Bangalore vs Mumbai: A battle of the big-hitters

Bangalore vs Mumbai: A battle of the big-hitters

Preview — Given the firepower in both line-ups, Dubai crowd may see another high-scorer More »

Delhi look for first points against confident Kolkata

Delhi look for first points against confident Kolkata

Preview — The threat of Sunil Narine looms large again. More »

Glenn Maxwell carves his parallel universe

Glenn Maxwell carves his parallel universe

Glenn Maxwell seems to project an icy disdain when at the crease. Match situations rarely faze him and the bubble in which he plays excludes everyone … More »

[REWIND] The world record that nearly wasn't

[REWIND] The world record that nearly wasn't

Twenty years ago this week, Brian Lara became Test cricket's highest scorer, but he almost didn't make it. More »

BCCI is not anybody’s property — Dalmiya

BCCI is not anybody’s property — Dalmiya

Dalmiya feels that Srinivasan’s ‘power hungry’ attitude isn’t helping matters. More »

It's getting increasingly tough for bowlers: Ajmal

It's getting increasingly tough for bowlers: Ajmal

The 36-year-old believes the T20 format and rule changes in 50-over matches have made a real difference. More »

Moores set for England recall

Moores set for England recall

The 51-year-old will succeed Andy Flower, who stepped down after five years in charge following the 5-0 Ashes defeat in Australia in January. More »

Rajasthan edge low-scoring thriller

Rajasthan edge low-scoring thriller

The bowlers restricted Hyderabad to 133 for 6 before Rahane and Binny took Rajasthan over the line. More »

KP ridicules idea of day-night Tests

KP ridicules idea of day-night Tests

Kevin Pietersen has ridiculed the idea of day-night Test cricket, saying the game would be so different to proper Test cricket that we will need a whole… More »

BCCI members want independent probe

BCCI members want independent probe

The board members are realising after the Supreme Court's observations that something has to be done — IS Bindra More »

Maxwell blitz takes Punjab home

Maxwell blitz takes Punjab home

The Kings XI batsman blasted a 43-ball 95 to help his team pull off a massive chase against Chennai Super Kings. More »

'BCCI lacks leaders to take on Srini'

'BCCI lacks leaders to take on Srini'

Two former BCCI presidents, Shashank Manohar and Jagmohan Dalmiya, have reacted strongly to the news of the BCCI calling an emergent meeting on Sunday… More »

Yuvraj tees off to Sharjah's delight

Yuvraj tees off to Sharjah's delight

Yuvraj Singh was hardly convincing to begin with against Delhi, but a big dose of crowd support and a helping of poor bowling meant he had the opportunity… More »

Stressed Trott stands down again

Stressed Trott stands down again

The England and Wales Cricket Board (ECB) on Friday confirmed that batsman Jonathan Trott is to take another break from all cricket with immediate eff… More »

PCB starts another coach hunt

PCB starts another coach hunt

The PCB has decided to not extend the contracts of head coach Moin Khan, fielding coach Shoaib Mohammad and batting consultant Zaheer Abbas, and has invited… More »

Fiery star Stokes bids to curb his temper

Fiery star Stokes bids to curb his temper

England all-rounder Ben Stokes admits he must keep his anger under control if he is to end his international exile. More »

Bangalore's arsenal blazes to victory

Bangalore's arsenal blazes to victory

Yuvraj Singh was back to his best in his first match for Royal Challengers Bangalore. More »

Pakistan cricketers face probe

Pakistan cricketers face probe

Pakistani cricket authorities have launched an investigation after a number of current international stars played in exhibition matches in the United States… More »

BCCI to meet before next court hearing

BCCI to meet before next court hearing

The BCCI will hold an emergent working committee meeting on April 20 to discuss the future course of action with regard to the Supreme Court hearing concerning… More »

Gavaskar wants a clean IPL

Gavaskar wants a clean IPL

"Integrity is non-negotiable..." says the BCCI's interim chief ahead of Season 7 of the tainted league. More »

Time for Chennai to enter familiar cocoon

Time for Chennai to enter familiar cocoon

Chennai have an emphatic 8-3 lead in the head-to-head with Punjab, with one game tied More »

Kallis, Narine star in KKR win

Kallis, Narine star in KKR win

An all-round display saw Knight Riders thump Mumbai Indians by 41 runs in the IPL-7 opener. More »

'Yak' Kallis still on top of his game

'Yak' Kallis still on top of his game

The 38-year-old South African veteran turned it on for Kolkata Knight RIders in the opening match of IPL-7. More »

Rajasthan and Hyderabad face-off

Rajasthan and Hyderabad face-off

A quality that defines Rajasthan and Hyderabad is consistency. Rajasthan was one among two teams to enjoy complete dominance at home last season. Hyderabad… More »