Currently, the implantation of cardiac stimulation devices (CSDs) is associated with increased costs for three reasons:

1. Demographic Changes: An aging, more fragile population with increased comorbidities and expanding device indications has led to a rise in both primary and replacement CSD implants.

1. Device Complexity: The growing intricacy of devices, with multiple leads and therapies, has resulted in higher initial implant and replacement costs.

1. Infection Rates: An unexplained increase in infections, currently ranging from 3–7%, possibly linked to the above reasons. Additionally, the increase in implanting centers, some with limited experience or in a learning curve, may also be a factor. These infections are invariably associated with increased patient morbidity and mortality, leading to substantial healthcare costs due to prolonged hospital stays (often extended for systemic infections), antibiotic treatment, and the expense of materials used for both device removal and reimplantation.

CSD infections (CSDIs) can be categorized based on clinical manifestations into two types:

• Local Infections: Characterized by the absence of systemic symptoms (fever, shock, emboli, vegetations, or distant complications) and negative blood cultures. Symptoms are localized to the generator pocket, such as pain, inflammation, continuous discharge in the form of a fistula, or even generator and/or lead extrusion.

• Systemic Infections: Defined by the presence of systemic signs (fever, shock, emboli, distant complications like spondylitis), consistently positive blood cultures, and often (in approximately 70% of cases) vegetations on leads or right-sided cardiac chambers visualized via transesophageal echocardiography.

Therapeutic Approaches:

The therapeutic strategies currently used for managing CSDIs are primarily threefold:

1. Antibiotic Therapy Only

1. Local Surgery: Including pocket debridement, generator replacement in the same or contralateral pocket while maintaining the old leads.

1. Complete System Extraction: Typically preferred through transvenous lead extraction (TLE) as the first choice or open-heart surgery if TLE fails.

Currently, the preferred treatment for CSDIs is the complete system removal via TLE, using self-rotating mechanical sheaths or lasers. In experienced hands, TLE is a safe technique, but it can still have serious complications in up to 2–4% of cases, including tricuspid valve rupture, right ventricular rupture with cardiac tamponade, and even superior vena cava tears, which may require open-heart surgery (sternotomy) and even cardiopulmonary bypass (CPB). Therefore, it is essential that these procedures are performed in an environment equipped with comprehensive safety measures.

For systemic infections, the best treatment appears to be the removal of electrodes from the circulatory stream via TLE. In cases of very old leads and very fragile patients, a chronic suppressive treatment may be attempted.

In local infections, which are generally less aggressive without systemic repercussions, localized approaches, such as pocket debridement and generator replacement while maintaining the old leads, are frequently used. This approach is common in centers lacking TLE capability and even in those with TLE capability but limited experience. However, this can lead to an unacceptable rate of clinical failures and subsequent complications, resulting in increased patient mortality and healthcare costs.

Our conclusions are based on a study of 380 CSDIs, of which 233 were local infections (61.3%) and 147 systemic (38.7%), with costs analyzed based on the treatment strategy and patient mortality, both in-hospital and during follow-up. Notably, 126 (33.2%) cases were referred from other centers, where multiple failed local approaches were frequently attempted.

In patients treated with TLE for local infections, mortality was 2.5% (6 cases, with 4 related to TLE: 2 superior vena cava ruptures, 1 cardiac tamponade, and 1 ventricular arrhythmia). For systemic infections, mortality was higher, reaching 10.8%, primarily due to sepsis. Regarding costs, we found them to be very high, averaging €21,790 for local infections and €34,086 for systemic infections, with 46% of local and 74% of systemic infection costs stemming from hospital stays.

Comparing these figures with those from patients with local infections treated using other strategies, we found that:

The failure rate was 58.3% for antibiotic therapy alone and 74.6% for local pocket surgery. Among all untreated local infections, 48.5% developed into systemic infections, which later required TLE or even open-heart surgery when TLE failed. The mortality rate in this patient group was 3.1% (3 cases related to TLE).

The average cost of local approaches was €42,978 due to repeated procedures (re-implantations with new generators), which almost always resulted in a final TLE or even open-heart surgery once the infection evolved to a systemic level, making TLE impractical due to prior lead manipulation.

Conversely, initial TLE yielded a higher cure rate (83.7%) and a lower cost (€24,699).

For initial systemic infections, results were as follows:

High mortality (19.2%) with a cure rate of only 7.6% for those treated solely with antibiotics, contrasting with a cure rate of 86.6% and mortality of 7.7% in those treated with TLE, with no deaths related to the procedure.

Again, when comparing antibiotic-only therapy with TLE, the latter was associated with lower costs (€37,545 vs. €39,525).

Based on these findings, we affirm that TLE is the most effective and safest treatment for patients with CSDIs, whether local or systemic, with lower associated costs.

Another aspect we analyzed in this CSDI patient group was the costs and morbidity-mortality of reimplantation after extraction, performed either in a single-stage surgery (extraction and reimplantation in the same procedure) or in a two-stage surgery (reimplantation on a different day). In single-stage surgery, performed in 74% of cases, we found:

• Lower reinfection rates, all of which were local infections, with reinfection understood as infection of the new device by a different microorganism during the first year of follow-up (4% vs. 7%).

• Shorter hospital stays (11 vs. 28 days).

• Lower cost (€25,600 vs. €44,797).

There was no significant difference in late mortality concerning reimplantation timing.

In local infections, there were no significant differences between single- and two-stage surgeries. However, for systemic infections, single-stage surgery was significantly better in three analyzed parameters:

• Fewer hospitalization days (22 vs. 32 days).

• Fewer relapses, defined as infection by the same microorganism (1.3% vs. 3.5%).

• Fewer reinfections, where the infection is caused by a different microorganism (2.6% vs. 14.2%).

These results support the practice of single-stage extraction and replacement, which not only reduces hospital stay and patient discomfort (double operating room visits) but is also associated with (contrary to theoretical expectations) fewer reinfections or relapses in the new implant.

Finally, when analyzing patient age, we found that even in octogenarians, initial aggressive TLE approaches yielded excellent results, leading us to believe that age should not be an absolute contraindication for TLE.

In conclusion, our multidisciplinary team believes that:

• CSDIs are associated with increased patient morbidity and mortality and pose a significant financial burden on the healthcare system.

• Local infections, far from being a minor problem often addressed with local surgery (generator excision and reimplantation), frequently precede systemic infections, warranting aggressive initial treatment with complete system removal by TLE, proven as the most cost-effective and safest strategy, even for frail patients.

• Therefore, specialized reference centers in our country are desirable for managing this low-prevalence yet highly complex, multidisciplinary condition. Including this aspect within the National Health System’s Reference Centers, Services, and Units Network (CSUR) is an advancement that will facilitate easier referral of complex cases to reference centers for appropriate management. This will help concentrate high-level expertise in specific centers, ensuring quality, safe, and efficient healthcare, while providing equitable access to specialized services for all citizens when needed. 

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