CD&D

PARIS — A hospital reform law now in the French Senate that would removes surgeons from decision-making in French hospitals has sparked strong opposition and for the first time sent heads of prestigious medical centers into the streets in protest.

In a city where street demonstrations are as common as traffic jams, the sight of world leading physicians marching and chanting with nurses and unionized caregivers was not just unusual, it was a first.

At stake in the reform law Hospital, Patient, Health and Regions (HPST) is the power to decide which medical equipment to purchase, capital investments in the construction of new surgical centers and annual budgeting that determines the specialties and orientation for hundreds of hospital centers across all regions of France.

The law drafted by the Health Ministry was put on a new legislative fast track and approved by French Assembly in March.

With a majority in both houses, President Nicolas Sarkozy has every chance of pushing through the main points of HPST that would give new decision-making powers to a newly empowered CEO, or super-Boss, for public hospitals that will in turn serve as the hub for re-engineered regional healthcare clusters.

"No human endeavor can function without a leader," said Sarkozy, "I call it a 'boss.' I realize I am taking a risk saying that."

The law also spells out a series of rules and incentives for new Regional Health Authorities (ARS) to encourage general practitioners and specialists to move back into rural regions that are currently underserved.

To defuse opposition, the government separated these measures for restructuring France's healthcare administration from financing measures that are addressed in the Social Security Financing Law (LFSS 2010) and for capital investment in the plan, H pital 2012.

Yet HPST is charged with enough controversial proposals to have provoked widespread opposition from medical professionals who say they are being pushed out of decision-making, from regional authorities who see their powers being undermined, and from unions of nurses and caregivers who are threatened by the spirit of a law calling for a public hospital to be run like a private business.

"Do not fear reform," said Sarkozy, adding, "Who would tell me to keep the status quo for hospitals? No one."

Seizing upon an uproar among medical professionals, the Senate intends to modify the text, saying 'Non' to giving CEO status to hospital directors, and 'Yes' to returning doctors to hospital governance, according to former Prime Minister Jean-Pierre Raffarin, who is a leading member in the party of Sarkozy, the Union for a Presidential Majority.

In a televised interview, Raffarin clearly was enjoying the new powers of the French Senate, in which he played a key role winning in 2008, as he criticized the text approved by the Assembly as "too complex and not quite clear."

"We are not here to lie down to any text sent over from the Assembly," he said. "This is not a revolution, but it is showing something of a rebellious spirit," he said.

Despite its fast-track status, a prolonged stay in the Assembly and a detailed study ahead of debate in the Senate has given physicians an opportunity to gather their strength.

Angry that their counterproposals were not taken into consideration, the heads of the medical committees for France's leading hospitals in a press conference greeted the passage of the Bachelot law by the Assembly with a threat to quit their posts and suspend participation in hospital planning.

"Contrary to what is being said, the law is not going to expand the role of doctors in the operations of the hospital," said Alain Dest e, a neurologist with the Centre Hopitali re Universitaire (CHU) de Lille and president of the Conference of Presidents of the Medical Committees (CME; commission m dicale d' tablissement) for the CHUs.

The CME opposition was followed by another hostile reaction from 25 prominent physicians affiliated with French university hospitals, who jointly published a position papers asking the Senate to completely revise the text approved by the Assembly, and then joined the planned street demonstration on April 28.

At the same moment, the association of French hospital directors wrote to Sarkozy, sending the letter to the French press as well, asking him to resist such changes that would "empty all sense" in the reform law.

The hospital directors said in their letter that any change in the HPST text that limits their ability to be the ultimate decision-maker by forcing co-decisions or the imposition of doctors opinions on any final decision would only lead back to the current state of affairs and thwart the ability of the super-CEO proposed in the Bachelot law to wrestle with budget deficit.

Meanwhile, the French Hospital Federation (FHF) has fallen into line with the government, with Executive Director G rard Vincent saying, "There needs to be an orchestra leader, someone who can take decisions, and that is what is missing today."

Vincent said FHF favors this spirit in the reform law and supports the creation of regional health authorities, saying the challenge today is to "free up the energies in the departments so that a real wind of change will bring change to the current range of healthcare services and respond to the expectations of both medical professionals and patients."

Guillaume Sublet, head of economic intelligence and regulatory affairs with Nextep Consulting & Health Economics (Paris), predicts that despite the rebellious bravado of former Prime Minister Raffarin, the French Senate will ultimately have to vote with Sarkozy's position in mind.

"The president was very clear," said Sublet, who manages an online forum of interviews with leading players in the debate over the hospital reform.

"Medical practitioners may win some points about their importance," he said, "but we can expect that just as in the National Assembly, the core text will pass without significant modification and French hospitals will walk the president's line with a hospital chief executive leading a management inspired by the private enterprise model."

1st European use of EnSite Velocity

St. Jude Medical (SJM; St. Paul, Minnesota) reported European CE-mark approval and first use of its EnSite Velocity Cardiac Mapping System, which it said has been designed to help physicians "more efficiently diagnose and deliver therapy to treat abnormal heart rhythms."

SJM is featuring the EnSite Velocity System in its booth at this week's Heart Rhythm Society (Washington) scientific sessions in Boston.

The company said advancements in the EnSite Velocity System's design are focused on increasing procedural efficiency, from set-up and operation, to clinical application and use.

With new hardware and software, the system offers simple set-up and connections, an intuitive software interface and includes two key new capabilities: the OneMap tool and RealReview function.

The OneMap tool enables physicians to simultaneously create a detailed cardiac model and electrical map using multiple catheters and electrodes, allowing physicians to collect and display more relevant patient information in a shorter amount of time.

The RealReview function provides real-time, side-by-side views of the live procedure and previously recorded portions of the procedure, giving physicians a quick and easy comparison of events and results at different times throughout the procedure, without losing the ability to visualize and navigate catheters in real-time.

"The EnSite Velocity System allows me to efficiently collect anatomical and mapping data with whichever catheter I believe is most appropriate for the procedure. The system's versatility and catheter choice is important, providing me with enhanced control during the procedure," said Tony Chow, MD, of The Heart Hospital (London).

St. Jude said the system "maintains the strengths and clinical utility that have made the EnSite System the leading cardiac mapping system, while incorporating significant improvements into the design. Additionally, the EnSite Velocity System is an open platform, which means that it is compatible with essentially all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures.

"The EnSite Velocity System functions as though it were designed with the entire lab in mind; the simple setup and intuitive operation are incredibly helpful in supporting efficient procedural workflow," said Christopher Piorkowski, MD, of Herzzentrum Leipzig (Leipzig, Germany). "Because my practice has a fast-growing population of patients to serve, such efficiency gains benefit not only my patients but also other members of my team."

Jane Song, president of the St. Jude Medical Atrial Fibrillation Division, said, "As the next generation in cardiac navigation and visualization technology, the EnSite Velocity System is designed to integrate seamlessly with existing lab technology, while having built-in flexibility to allow for integration with future technologies."

St. Jude also reported CE-mark approval of its Promote Accel implantable cardiac resynchronization therapy defibrillator (CRT-D). The Promote Accel CRT-D automatically tailors treatment to individual patient needs by measuring the heart's reaction to therapy and ensuring that the heart is responding, providing the dual benefit of added safety for the patient and added efficiency for physicians.

The Promote Accel CRT-D family of products also features the QuickFlex m (micro) left ventricular lead and CPS Aim SL slittable inner catheter subselector designed to offer safer, more efficient implantation procedures and therapy delivery for patients with heart failure.

1st implants of Endotak Reliance 4-site lead

Boston Scientific (Natick, Massachusetts) reported receipt of the CE mark and the first human implants of the company's Endotak Reliance 4-Site defibrillation lead system. Defibrillation leads connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart and, when needed, deliver life-saving therapy.

The Endotak Reliance 4-Site lead system is designed to simplify the implant procedure by combining three terminals into one integrated connector, reducing the required implant area within the body. This system, combined with the new Teligen ICD and Cognis CRT-D, is designed to comply with the forthcoming international connector standard.

The new standard will permit product compatibility across manufacturers. The Company is working with physicians to launch the system in several phases with a focus on monitoring clinical performance through robust post-market analysis enhanced by the Latitude Patient Management system.

"We are pleased to announce CE mark and the first human implants of the Endotak Reliance 4-Site lead system," said Fred Colen, president, Boston Scientific Cardiac Rhythm Management. "This new system represents the next advance for the Endotak Reliance lead family, which has demonstrated reliability in more than 350,000 implants worldwide."

Boston Sci said this technology "allows the world's smallest, thinnest high-energy ICDs and CRT-Ds to become even smaller." It said the connector reduces the volume of Teligen and Cognis to 32 cc and 30 cc, respectively, while maintaining a thickness of less than 10 mm.

Some models of the Endotak Reliance 4-Site product line feature a proprietary Gore covering designed to prevent tissue ingrowth into the defibrillation coils, without compromising the electrical performance of the lead. The Endotak Reliance G model is the only defibrillation lead on the market to address tissue ingrowth using this approach. Preventing tissue ingrowth assists physicians with the long-term management of device patients. Although rare, lead removal is sometimes necessary. Studies have shown that the proprietary covering helps physicians perform this procedure more easily and effectively.

The implants were performed under the leadership of Oliver Przibille, MD, Cardioangiolisches Centrum Bethanien (Frankfurt, Germany); Hans-Joachim Trappe, MD, Marienhospital Herne Klinikum der Ruhr-Universitat Bochum (Herne, Germany); Johannes Heintze, MD, Herz und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen (Bad Oeynhausen, Germany); and Lieselot van Erven, MD, Leiden University Medical Center (Leiden, the Netherlands).

CE mark for TactiCath

Endosense (Geneva, Switzerland), a company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, reported receipt of the CE mark for its TactiCath system.

The first force-sensing ablation catheter, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium.

"The CE mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrythmias," said Eric Le Royer, president/CEO. "With its unique ability to measure contact force, we expect the TactiCath to have a major positive impact on the safety and efficacy of catheter ablation, while also standardizing ablation techniques and decreasing the learning curve."

The CE mark was granted based on select data submitted from Endosense's TOCCATA (TOuCh+ for CATheter Ablation) clinical study, which was performed by 17 investigators at eight European centers. During procedures on 42 enrolled SVT patients, the device was found to cause no serious adverse events, and the primary study endpoint was reached.

"The availability of the TactiCath marks an important advance in the field of catheter ablation," said Karl-Heinz Kuck, MD, of Asklepios Klinik St. Georg (Hamburg, Germany), an Endosense European scientific advisor and primary investigator of the TOCCATA trial. "The TactiCath is a critically important addition to our treatment armamentarium, as it will help to prevent perforation and identify sites of low contact force which may lead to re-conduction from the pulmonary veins in patients undergoing atrial fibrillation ablation."

Acute data from the TOCCATA study will be presented at the Heart Rhythm Society's 30^th annual scientific sessions in Boston next week.

Endosense said it plans to release the TactiCath system in Europe in the second half of 2009.

UK stroke care: 'shocking findings'

An editorial in The Lancet refers to a report by the Clinical Effectiveness and Evaluation Unit of the Royal College of Physicians (London), which found that as many as a quarter of stroke patients do not receive the best treatment in a specialist stroke unit.

The editorial says: "These are shocking findings. Stroke services in England, Wales, and Northern Ireland are offering not only unequal care, but also care that falls below the standards set out in the National Stroke Strategy." It adds, however, that the strategy has stimulated improvement in stroke care and things are better now than they were in 2006."

It concludes: "Despite almost two decades of research that has proven the benefits of stroke units, thrombolysis, and aspirin in reducing mortality and disability, stroke still lies in the shadow of its big sister, heart attack."