In-Hospital Complications, Mortality High With Lead Extractions for Device Infections

It would be reasonable to send the highest-risk patients to the most-experienced centers for extractions, Jeremy Ruskin says.

In-Hospital Complications, Mortality High With Lead Extractions for Device Infections

Patients who are undergoing transvenous lead extraction for a device-related infection have particularly high rates of complications and mortality during the initial hospital stay, new national US data show.

For extractions performed over a nearly 13-year period, the overall rate of in-hospital major complications was 10.4%, including a 4.1% rate of mortality.

Prior studies, which largely represent data from clinical trials and single centers, have provided rates of 2% to 4% for overall complications and 1% to 2% for mortality, according to senior author Jeremy Ruskin, MD (Massachusetts General Hospital, Boston).

Asked why rates are higher in the current study, Ruskin pointed to multiple factors. First, this new analysis includes an unselected sample of patients from centers with varying levels of operator and institutional experience with transvenous lead extraction, whereas prior studies were mostly conducted at experienced, high-volume hospitals. And second, the current analysis included only patients who underwent extractions for device-related infections, which are known to be associated with heightened risks of complications and mortality.

“The main purpose of the paper is simply to draw attention to the fact that in an unselected sample from a broad-based data set, the complication and mortality rates are higher than seen in clinical trials and single-center observations,” Ruskin told TCTMD.

The analysis, which was led by Seyed Mohammadreza Hosseini, MD, and Guy Rozen, MD (both Massachusetts General Hospital), was published online recently in JACC: Clinical Electrophysiology.

Nationwide Look

Worldwide, an estimated 10,000 to 15,000 leads from cardiac implantable electronic devices (CIEDs) are extracted each year, with device-related infection being the most common reason, according to the researchers.

To get an idea of the real-world incidence and predictors of in-hospital mortality associated with extractions secondary to infectious causes, they turned to the National (formerly Nationwide) Inpatient Sample. The analysis included data representing 59,082 patients who underwent transvenous lead extraction for device-related infections between January 2003 and September 2015. Patients were mostly older than 60 years (75%), white (76%), and male (70%); 80% had at least one comorbidity, most commonly hypertension.

The median length of stay was 8 days, and the median hospitalization cost per patient was $23,177. Taking all patients together, the aggregate cost of these extractions during the study period was nearly $1.8 billion.

More than one in every 10 patients had major complications during their hospital stay, with the incidence increasing over time. Complications included hemorrhage requiring transfusion in 2.2%, open cardiac surgery in 1.9%, pulmonary complications in 1.8%, pericardial injuries in 1.8%, and vascular complications in 0.5%.

Risk of in-hospital mortality remained relatively consistent over time. After accounting for potential confounders, the researchers identified several factors that were independently associated with dying in the hospital.

Factors Independently Tied to In-Hospital Mortality

 

Adjusted HR

95% CI

Weight Loss

4.02

3.13-5.17

Congestive Heart Failure

3.28

2.48-4.34

Pericardial Complications

2.87

1.79-4.61

Vascular Complications

2.82

1.26-6.28

Chronic Kidney Disease

2.09

1.70-2.56

Pulmonary Complications

2.06

1.25-3.40

Age 45 to 59 (vs < 45)

1.97

1.10-3.55

Age 60 to 74 (vs < 45)

2.09

1.17-3.72

Age 75 or Older (vs < 45)

2.31

1.28-4.17

 

Overall, 26.2% of patients received a new CIED during the same hospitalization, and most of the devices were permanent pacemakers (72.5%). Hospital stays were longer and costlier in patients implanted with a new CIED.

Extract at Experienced Centers

Commenting on the study for TCTMD, Ulrika Birgersdotter-Green, MD (UC San Diego Health, La Jolla, CA), said “what it highlights more than anything is the importance of treating device infections promptly and correctly. We often underdiagnose device infections and we also at times try against all odds [to treat] with more conservative management when really the only thing that is going to help that patient is to take the device system out, generator and leads.”

Importantly, lead extractions should be performed at centers equipped to handle them, she said. “When you take the leads out, we do know that that is a much more complex procedure than putting leads in, and that this is not a procedure that should be done by anyone in the hospital but rather a procedure that should be reserved for institutions with experience in these extractions who can do this safely and under the right circumstances.”

Most parts of the United States will have an experienced center nearby, but if there is not a close hospital with the right setup, transfer is the best option, Birgersdotter-Green said. “Taking these types of patients on when you don’t have the expertise or the setup is not the right thing for the patients.”

She stressed these are particularly sick individuals: “They’re sick because they have an infection, and they’re sick because they likely have comorbidities such as diabetes and end-stage renal disease, which often go hand in hand with infections. So right off the bat, you have a sick patient who is now facing a complex procedure and those . . . complex procedures should only be done at institutions that know how to do this.”

Ruskin said that even though this study did not provide information on the best strategies for reducing complications and mortality, it makes sense that extraction outcomes would be better at experienced centers.

“It would be reasonable to think about, if the option exists, referring the very highest-risk patients to high-volume operators at experienced, high-volume centers because we know their risks of complication and mortality are high,” he agreed, noting that the factors associated with in-hospital mortality in this study could be used to help in selecting those patients.

 

 

Disclosures
  • The study was conducted with support from Harvard Catalyst – The Harvard Clinical and Translational Science Center and financial contributions from Harvard University and its affiliated academic healthcare centers.
  • Rozen reports being a scientific advisory board member for Medtronic.
  • Ruskin reports being a consultant or scientific advisory board member for Acesion Pharma, Advanced Medical Education, Cala Health, Element Science, InCarda Therapeutics, InfoBionic, Janssen, Lantheus, NewPace Medical, and Medtronic; being a steering committee member for Pfizer; and holding equity or options in Portola, Element Science, NewPace, Gilead, and InfoBionic.
  • Hosseini and Birgersdotter-Green report no relevant conflicts of interest.

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