Effectively managing CRM device leads, lead failure and infection were highly discussed topics at the recent Heart Rhythm Society annual meeting in Denver. More than 35 sessions were dedicated to the topic. A day-long Lead Management Summit with a dozen and a half sessions by world-renowned experts focused on practical advice for physicians, administrators and patients. One central message prevailed: Successful lead management begins with careful implantation planning.
“The history of lead development runs hand in hand with lead failure,” said Andrew Epstein, MD, of the University of Pennsylvania. "Almost as long as we’ve had leads, we’ve had registries to manage them safely and efficiently, dating back to 1974. And despite the lessons learned from lead failures, they persist.”
|Lead Placement/Replacement: Achieving a Low Complication Rate|
– Neil F. Strathmore, MBBS, FHRS, CCDS, Royal Melbourne (Australia) Hospital
“We can’t think this way: Put it in and let the next person worry about taking it out if there is a problem,” said Charles J. Love, MD, FHRS, CCDS, of Ohio State University. “[Instead think] how do we prevent the need for lead extraction?”
Citing 10-year ICD failure rates of 20 percent and the dangers of death and infection from lead extraction, Epstein urged physicians to always be mindful of the consequences of lead extraction. Vigilance also is key in monitoring leads over time as failures are not often sudden; there’s an increase in peaks and change can occur very gradually. Remote monitoring is the best tool for watching performance over time. Physicians also should heed vendor advisories but “avoid the dark side of advisories and risk over reaction…and the significant number of major complications that can come with lead extraction… [in favor of] stepping back a bit to decide how do I want to reach this decision [for and with each patient],” Epstein shared.
Overall, Epstein and others stressed that all leads have a finite life expectancy. The goal of zero failure rate is unattainable; resolution is in how failures are managed. The cardiology community needs to watch performance of implanted leads and closely assess trends. “We need post-marketing surveillance, not the absence of approval of new technology by acquiring long-term follow-ups before approval,” he said. Physicians play a key role in vigilance, too—having a “huge responsibility” as they always need to return explanted hardware to the vendor and communicate problems. And when in need, reference the well-defined FDA and CMS processes and standards for issuing and managing recalls.
By the numbers
|Complications for Implantable Cardiac Devices|
– Klug D, Balde M, Pavin D, et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators. Circulation. 2007;116:1349-9
Approximately 400,000 patients receive ICDs every year in the U.S., and more than 3 million patients in the U.S. currently have ICDs. (Circulation 2011;123:e378-380) The number of devices implanted continues to increase while the population receiving them is often sicker. Studies show these factors can lead to additional complications for implant, lead management and extraction when necessary, noted Jeffrey A. Brinker, MD, of Johns Hopkins Hospital.
Performance data abound about successes and failures. The Danish Pacemaker Registry (1997-2008; 28,860 patients), for one, estimates that about 5.4 percent of patients have some kind of complication within three months of implantation, while 3.6 percent have lead complications, according to Neil F. Strathmore, MBBS, FHRS, CCDS, Royal Melbourne (Australia) Hospital. Figures from other studies and registries show acute and early lead dysfunctions, including displacement, occurring in 2.1 to 2.5 percent of patients. Bleeding complications are rare (0.4 percent) but most often are brought on by heparin bridging (2 percent) and dual antiplatelet therapy (1.9 percent).
Infection rates among cardiac rhythm management device implants are a more common concern, with one 2010 U.S. study by Voigt et al. in PACE showing infection rates rising faster (57 percent than CIED implantation rates (12 percent)—“possibly due to sicker patients and more complex procedures,” said Maria Grazia Bongiorni, MD, of the University Hospital of Pisa (Italy). Reported infection rates range from 1.2 to 2.4 percent, with ICDs more frequent.
Overall, we’ve seen a 3.1 fold increase in hospitalization rate for cardiac device infection (CDI), Bongiorni noted. Mortality rates run about 41 percent for patients with endocarditis and cardiac devices treated medically vs. 18 percent in those managed with combined medical and surgical therapies. Data show low-volume centers have higher complications, especially infections, and patients with co-morbidities who are sicker and more fragile are more prone to infections.
Prognosis is worse with endocarditis compared with pocket infection. The mean time from first implantation to infection is 2 to 4 years, Bongiorni said. In cases of cardiac device-related infections (CDRI) endocarditis, she recommends transvenous lead removal with antibiotic therapy for at least two weeks, TTE, TEE (ICE), negative BS and vegetations absent or less than 1.5 to 2 cm.
And what are the odds of developing a cardiovascular implantable electronic device (CIED) infection? About 15 percent with early re-intervention; 7.57 percent for CRT-D vs. ICD/PM; 5.41 percent with less than two leads in place; 3.67 percent for device replacement/revision; and 2.46 percent for a temporary pacing wire. For patients on corticosteroids, about 13.9 percent get an infection, while for those using oral anticoagulants it is about 2.82 percent. Among the patients at highest risk of infection are those in renal failure (17.97 percent), with a fever less than 24 hours after implantation (5.83 percent), renal insufficiency (5.46 percent), congestive heart failure (2.57 percent) and males (2.23 percent).
|Lead Extraction Risks|
✓ Rupture of SVC
– Gemma Pelargonio, MD, Catholic University, Istituto Di Cardiologia, Rome
Similarly, the LExICON retrospective study examining survival after extraction showed an all-cause hospital morality rate of 1.86 percent, endocarditis in 4.3 percent, endocarditis and diabetes 7.9 percent and endocarditis and creatinine more than two at 12.4 percent.
Infection rates are rising, Bongiorni notes, and can present as a pocket infection or endovascular infection. Staphylococcus spp. accounts for the majority of cases, with an increase rate of methicillin resistance. “Complete removal of all hardware along with antibiotic therapy is required to treat CIED infection,” she noted. “Morbidity and mortality is significant with CIED infection despite optimal management. Prevention of CIED infections remains the best choice.”
American Heart Association guidelines (2010), which the Heart Rhythm Society also endorses, recommend “a primary surgical approach to lead removal in patients with CIED infection should be limited to patients who have significant retained hardware after attempts at percutaneous removal…[and] in patients with lead vegetations less than 2 cm in diameter” due to concerns with the risk of pulmonary embolism with percutaneous lead extraction. But the recommendations continue to endorse percutaneous removal “in patients with large vegetations” with decisions being “individualized and based on a patient’s clinical parameters and the extractor’s evaluation.”
Patient at the center of care
✓ Lead problems < 2.5%
– Neil F. Strathmore, MBBS, FHRS, CCDS, Royal Melbourne (Australia) Hospital
Overall, prospective planning for a good implant and the possibility of a future extraction can facilitate a more rapid and safe operation and may reduce the need for counter-traction and cutting sheaths, according to Love. “Lessons learned from why leads fail, dislodge, become infected or are difficult to extract can lead to lead choices and implant techniques that reduce the need for subsequent lead extraction.”
With all the statistics provided, charts and research shared, and advice and warnings offered, the central person in lead management, the patient, was not forgotten. Speakers reiterated over and over that decisions in lead placement, lead management and lead removal are made one patient and one lead at a time. “People need to care very much about replacements,” Strathmore said, “All patients I see with lead extraction are a more challenging group. Sit down with the patient and discuss the risks first.”
|Study Highlights: Heart Rhythm Society Annual Meeting: Denver|
VA Data: Durata, Riata ST Optim Leads High Performing at 5-years
A VA team led by Edmund Keung, MD, of the San Francisco VA Medical Center, analyzed data from the VA National Cardiac Device Surveillance Program (NCDSP) database and the electronic Computerized Patient Record System (CPRS). Among the study group of 2,990 patients, four-year survival for Durata and Riata ST Optim leads was 98.8 percent and 98.1 percent at five years. The St. Jude Medical OPTIMUM/SCORE/SJ4 Post-approval Study showed four-year survival of 99.6 percent and five-year survival of 99.4 percent (Feb. 28,2013 –Freedom from all-cause mechanical failure; 11,005 patients). Data from the Medtronic System Longevity Study on the Quattro 6947 lead show four-year survival of 98.6 percent and five-year at 98.2 percent (CRDM PPR eSource, March 12, 2013; including four lead dislodgements; 2,715 patients).
Durata, Sprint Quattro and EndoTak Reliance ICD Leads Show Good Outcomes
A total of 3,206 SQ leads, 10,988 Riata ST Optim and Durata (OPT) leads and 578 Endotak Reliance G (REL) leads were enrolled in the registries. The survival probabilities of SQ, OPT and REL leads at the longest implant durations with at least 50 active leads were 95.6 percent (nine years), 98.4 percent (5.25 years) and 99.7 percent (3.17 years), respectively. The five-year survival probability for SQ leads was 97.8 percent while for OPT leads it was 98.4 percent; data were only available out to 38 months for REL leads, according to the study.
UPMC: Survival Curves of Recalled Leads Diverge from Non-recalled Leads at 2 years
A total of 5,159 patients (1012 Quattro, 611 Fidelis, 549 Riata, 805 Durata, 2,182 Reliance) were included, with follow-up of 3.7 years. Survival of the Durata lead (0.3 percent annual failure rate) was significantly better than Riata silicone leads (1.7 percent annual failure rate)(p < 0.0001). Survival was similar between the Durata lead (0.3 percent annual failure rate) and the Sprint Quattro lead (0.3 percent annual failure rate) (p = 0.94). Overall survival of all leads was 89.3 percent at five years and 87.2 percent at 10 years. Survival curves of ICD leads on FDA recall (Riata and Fidelis) diverged at approximately two years, even when only failure-free survival was considered.
Independent Study Shows Low Failure Rates in Durata, Optim ICD Leads
Median follow-up to date in the study is three years, with some 64 percent of the leads remaining under active follow-up. To date, the all-cause mechanical failure rate in the combined analysis is 0.35 percent, with a 0.22 percent conductor fracture rate, an insulation abrasion rate of 0.07 percent, and no cases of externalized conductors. The group who reviewed the data will continue to monitor and report on the SJM registries over the next five years.