Arrhythmia

Pacemaker and Implantable Cardioverter Defibrillator Implants

Initial Implantation Complications: Pacemaker and Implantable Cardioverter Defibrillator

2020, N = 773

In 2020, Cleveland Clinic performed 426 pacemaker and 347 implantable cardioverter defibrillator (ICD) implants, for a total of 773 procedures with low rates of complications. The device-related infection rate within 90 days of implant was 0.3%. The overall complication rate for these implanted device procedures was 3.1%.ᵃ There were no procedure-related deaths.

ComplicationsNPercent
Device-related infection within 90 days of implant20.3
Overall major complication rate243.1

Source: EP Database

ᵃInitial implant: No prior device had been implanted (includes all devices for bradycardia and tachycardia); excludes special devices such as laptop and loop recorders. Percentage totals were rounded.

The overall major complication rate is inclusive of lead dislodgements, device-related infections, and pericardial effusions with percutaneous interventions.

Lead Extraction Procedure: Volume, Success, and In-Hospital Mortality

2016 – 2020

Electrophysiologists at Cleveland Clinic perform a high number of lead extractions. Many of these patients have complex conditions that result in referral to Cleveland Clinic physicians. Leads may need removal because of malfunction, blocked blood vessels, or infection. In most cases, the leads can be removed without opening the chest or heart. A multidisciplinary approach is utilized to minimize the risk of this procedure.

A total of 881 lead extraction procedures were performed to remove 1632 leads at Cleveland Clinic from 2016 through 2020. The overall clinical success rateᵃ was 96.8%. In-hospital mortalityᵇ was 0.45% vs the benchmark¹ of 1.2%.

Source: EP Database

ᵃClinical success is defined as removal of all targeted leads and lead material from the vascular space or retention of a small portion of the lead (< 4 cm) that does not negatively impact the outcome goals of the procedure.

ᵇIn-hospital mortality was calculated by dividing the total number of in-hospital deaths (N = 4) by the total number of lead extraction procedures (N = 881).

Device Clinic Evaluations: Volume

2020, N = 70,258

Cleveland Clinic was the first hospital in the country to integrate a patient database for pacemaker and implantable cardioverter defibrillator follow-up with electronic medical records. This innovative approach to follow-up allows staff to keep track of patients’ health conditions regardless of the patient's location. Remote monitoring is also associated with increased longevity and decreased need for in-person follow-up.

The Miller Family Heart, Vascular & Thoracic Institute uses the MyChart® function in Epic, Cleveland Clinic’s electronic medical record system, to quickly notify patients of their device status.

Evaluation TypeN
Pacemaker evaluations28,804
ICD evaluations32,922
Implantable loop recorders8532

ICD = implantable cardioverter defibrillator

Source: Device Clinic Volume Files

Secondary Implantation Complications: Pacemaker and Implantable Cardioverter Defibrillator

2020, N = 433

In 2020, Cleveland Clinic doctors performed 433 secondary pacemaker and implantable cardioverter defibrillator (ICD) implants. The complication rates for all procedures were below the benchmark rates.

Procedure TypeNumber of ProceduresMajor Complication
N (%)
Benchmark (%)²
ICD with lead addition732 (2.7)17.4
ICD without lead addition1940 (0)5.8
Pacemaker with lead addition541 (1.9)5.9
Pacemaker without lead addition1120 (0)2.3

ICD = implantable cardioverter defibrillator

Source: EP Database

References
  1. Kusumoto FM, Schoenfeld, MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551.
  2. Poole JE, Gleva MJ, Mela T, et al.; REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010 Oct 19;122(16):1553-1561.