HRS, APHRS, and LAHRS publish new clinical practice guideline on cardiac physiologic pacing

Today, the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Latin American Heart Rhythm Society (LAHRS) released a new clinical practice guideline on cardiac physiologic pacing (CPP) strategies to restore ventricular synchrony and improve cardiac performance. The 2023 HRS/APHRS/LAHRS Guideline on Cardiac Physiologic Pacing for the Avoidance and Mitigation of Heart Failure is intended to provide guidance to clinical cardiac electrophysiologists, cardiologists, and other clinicians on the use of CPP, which includes cardiac resynchronization therapy and conduction system pacing, in patients with indications for pacemakers or heart failure. The guideline appears in Heart Rhythm, published by Elsevier.

Heart failure is a leading cause of morbidity and mortality and is responsible for significant healthcare costs. Cardiac resynchronization therapy has been shown to reduce heart failure symptoms and improve heart function and survival rates in select patients.

Over the past few years, new data have emerged on the optimization of pacing techniques and new pacing-related therapies to improve survival in patients with heart failure. With recent advances in technology, conduction system pacing has emerged as a potential alternative to traditional pacing and cardiac resynchronization therapy.

The field of physiologic pacing has undergone significant expansion and these technological advancements gave rise to questions regarding patient selection, indications, and follow-up procedures. We hope that this guideline answers those questions and provides evidence-based practical guidance on pacing practices in patients with heart failure.

Mina K. Chung, MD, FHRS, from the Cleveland Clinic and Chair of the guideline

Throughout the guideline, the authors emphasize the importance of shared decision-making between providers and patients when considering treatment with a CPP device. These discussions should account for the patient's values, preferences, and care goals, while considering the potential advantages and risks associated with the pacing therapy. In addition, the authors acknowledge there remain critical gaps in our current understanding within the field and highlight novel directions for future research.

"More randomized trials and long-term data are required, specifically around clinical outcomes from conduction system pacing," said Kristen K. Patton, MD, FHRS, from the University of Washington and Vice-Chair of the guideline. "We've identified several areas for future study, and we hope this document will serve as a valuable guide for researchers and industry partners involved in the advancement of these devices and procedures."

This guideline is the outcome of an international collaboration among renowned experts in the fields of electrophysiology, cardiology, pediatric electrophysiology and cardiology, as well as biostatistics and epidemiology. The writing committee actively involved a patient partner in the development process to ensure that the recommendations prioritize delivering the best possible patient care aligned with patients' desires, requirements, and preferences. The HRS-led guideline was developed in partnership with and endorsed by APHRS and LAHRS, and in collaboration with and endorsed by the American College of Cardiology, the American Heart Association, the Heart Failure Society of America, the International Society for Holter and Noninvasive Electrocardiology, and the Pediatric and Congenital Electrophysiology Society.

The guideline is jointly published in Heart Rhythm and the Journal of Arrhythmia. Its release will coincide with a session at Heart Rhythm 2023 in New Orleans-a premier event gathering heart rhythm professionals from around the world to advance the field of electrophysiology and improve patient outcomes through the exchange of groundbreaking science, innovative technologies, and life-saving therapies.

Source:

Journal reference:

Chung, M. K., et al. (2023) 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. doi.org/10.1016/j.hrthm.2023.03.1538.

Medical office buildings, a senior living facility and other central Pa. medical projects

A senior living community is planned in South Middleton Township, outside of Carlisle in Cumberland County.

In Lancaster County, WellSpan is building a 34,000-square-foot surgery center in Lancaster.

Over in York County, York College of Pennsylvania has announced it will construct a human performance and neuromuscular control laboratory with financial assistance from UPMC in Central Pa.

These are just a few of the many healthcare development projects underway in central Pa. Here’s our latest list of medical-related plans, openings, and moves in the region.

PennLive publishes a list of medical-related projects in central Pa. several times during the year. The last list was published on April 3.

Cal’s Hope

Cal’s Hope, a nonprofit working to address mental health issues and suicide prevention, has opened a new office at 502 N. Baltimore Ave.

Life care community

Weathervane Capital Partners plans to construct a 77-bed senior living community near Spring Garden Street.

UPMC/HACC Medical Assisting Certificate Program

The University of Pittsburgh Medical Center and HACC have announced a partnership to support area residents who want to pursue careers as medical assistants. Prospective students can enroll in HACC’s new two-semester Medical Assisting Certificate Program that will begin on Aug. 28.

Penn State Health Lancaster Medical Center cardiac catheterization laboratories

Two cardiac catheterization laboratories have opened at Penn State Health Lancaster Medical Center. The cardiac catheterization laboratories as well as preparatory and post-procedure rooms and storage areas take up approximately 15,000 square feet of space on the hospital’s second floor. Cardiac catheterization laboratories are equipped with imaging technology to allow cardiology specialists to perform a range of diagnostic tests as well as stent procedures to treat conditions such as blockages or irregular heartbeat.

Penn Medicine Lancaster General Health Physicians Orthopaedics

Westphal Orthopedics has joined Penn Medicine Lancaster General Health Physicians. The practice, now named Penn Medicine Lancaster General Health Physicians Orthopaedics, specializes in orthopedic care, particularly joint replacement and sports medicine surgery. The primary office is located at the LG Health Suburban Pavilion, 2106 Harrisburg Pike, Suite 116. The practice has approximately 30 employees and includes three orthopedic surgeons — doctors Thomas Westphal, Brian Brislin and Carl Becker— as well three physician assistants, an in-house physical therapy team, and administrative and clinical support staff. Information: 717-393-1900.

WellSpan Health surgery center

WellSpan held a groundbreaking ceremony for a 34,000-square-foot surgery center to be constructed in the CityGate Corporate Center at 35 Erick Road. The two-story building that will house the surgery center is expected to open in the summer of 2024. The center will also be the home to numerous WellSpan specialty practices.

WellSpan Health outpatient endoscopy center

WellSpan has announced that construction is underway on an outpatient endoscopy center, which is expected to open in the spring of 2024 at 4150 Barrett Blvd.

WellSpan Health EMS

Northeastern Area EMS and WellSpan EMS have announced a new service agreement. Equipment and other assets of Northeastern Area EMS transitioned ownership to WellSpan EMS. Nine employees from Northeastern Area EMS are now employees at WellSpan. The employees will continue to work out of the facility at 10 Devco Drive.

York College of Pennsylvania human performance and neuromuscular control laboratory

York College of Pennsylvania has announced it will construct a human performance and neuromuscular control laboratory thanks UPMC in Central Pa. The Human Performance and Neuromuscular Control Laboratory will be part of the Dr. Donald E. And Lois J. Myers School of Nursing and Health Professions. The school said the lab will provide students with a hands-on learning experience.

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The effect of sibutramine prescribing in routine clinical practice on cardiovascular outcomes: a cohort study in the United Kingdom

A cohort study using prospectively collected routine primary care data from the UK Clinical Practice Research Datalink (CPRD).

CPRD contains anonymized healthcare records for ~14 million patients registered at over 660 general practice (GP) surgeries in the United Kingdom.10 This represents nearly 10% of the UK population.11 The database began in 1987 and continuously records information relating to each consultation. It contains sociodemographic data, prescribed medication records and Read Codes (searchable clinical terms) relating to diagnoses (made in primary and secondary care), signs and symptoms, and procedures and clinical investigations.12, 13, 14 CPRD has been shown to be largely representative of the United Kingdom in terms of GP surgery size and geographical distribution. Individuals registered in the database are representative in terms of age and sex.15

The cohort was drawn from CPRD starting from the date which the GP data was defined as being of suitable research quality16 and ending at the start of June 2013. Patients were included if they: were aged over 18 years old, were prescribed either sibutramine or orlistat, were recorded as having BMI ⩾27 kg m−2 (in line with NICE guidance for prescribing weight loss medication), had at least 12 months registration before their first prescription (to identify incident rather than prevalent users) and the data quality in their record had met minimum agreed standards for use in research.16 A subgroup analysis was completed on patients that before their first prescription of weight loss medication had a Read code consistent with a history of cardiovascular disease (not including acute MI or CVE) such as coronary artery disease, transient ischemic attack, or peripheral arterial occlusive disease, or T2D with at least one other cardiovascular risk factor (hypertension, dyslipidaemia, current smoking or diabetic nephropathy).

Patients were defined as exposed during the time they received their first continuous period of sibutramine prescribing; from the date of the first prescription to the date of the last prescription, plus the prescription length (expected end of treatment date), plus 60 days (to account for possible delayed side effects of treatment). The comparison group were patients prescribed orlistat, with the exposure period defined in the same manner. Patients were censored at the earliest of: event date, death date, bariatric surgery date or end of first constant prescribing period.

The decision to define patients as exposed 60 days following final dose of sibutramine was made because the postulated mechanism for causing MI or CVE is via acute changes in heart rate, blood pressure and QT interval.17 This approach should, therefore, produce an overestimate of the risk of sibutramine.

The primary outcome of interest was time to first MI or CVE (MI/CVE). If a patient had multiple codes representing acute MI or CVE on multiple dates in their record the event was recorded as occurring on the date of first entry of that code. A secondary outcome was all-cause mortality; death was ascertained from patients’ medical records and the date of death defined as the earliest of any records indicating that death had occurred.

Other covariates were examined as possible confounders: age, sex, BMI, year of index prescribing of weight loss drug, smoking status, alcohol consumption, comorbidities (history of coronary heart disease, cerebrovascular disease (CVD), peripheral vascular disease, any other atheroma, T2D and hypertension) and co-prescribing (oral anti-glycaemic medication, insulin and statin).

BMI, comorbidities and co-prescribing information was taken from the most proximate entry in the notes before the start of weight loss medication prescribing. Smoking and alcohol history were from the most proximate entry either before or after the start of prescribing. Patients with missing information on smoking and/or alcohol consumption were compared with those with complete data. A complete case analysis was performed as we found no evidence that missingness was associated with the outcome.18

Assuming a baseline 7% annual event rate,3 a two-sided type I error rate of 0.05, and power set at 90%, to detect a 10% difference in HR between orlistat and sibutramine would require a sample size of 19 000 patients prescribed sibutramine and 58 000 patients prescribed orlistat (with a 1:3 exposed to unexposed ratio). A preliminary analysis revealed 23 927 (23.70%) were exposed to sibutramine and 77 047 to orlistat. Given these numbers and the predicted number of events, there should be ample power to explore the main hypothesis.

A multivariable Cox model was constructed to assess the association between sibutramine and both outcomes (MI/CVE, all-cause mortality) controlled for all other covariates considered, and adjusted for clustering within GP surgeries. Wald tests were used to calculate P-values for multivariable models. These results were compared with a propensity score (PS) analysis. A PS is a measure of the probability that a patient will receive a particular treatment and is calculated from the observed risk factors for the outcome and for receiving the treatment.19 This approach is, therefore, one possible solution to the problem of confounding by indication in observational studies. Covariates were included in the PS if they did not introduce multicollinearity in the logistic regression model predicting treatment allocation. The PS was included in a Cox regression model as a continuous variable.

Two subgroups were defined a priori based on the analysis of SCOUT; patients with pre-existing cardiovascular disease (7761 individuals) and patients with T2D plus at least one other cardiovascular risk factor (that is, hypertension, statin use and current smoking) (15 455 individuals). Effect modification because of possible interaction between sibutramine prescribing and existing cardiovascular disease or T2D plus other cardiac risk factors was examined using the PS-adjusted model.

If there were differences between subgroups these were presented as number needed to harm. Number needed to harm was calculated from the estimated survivor function generated from the PS-adjusted Cox regression model.20

Assumption of proportional hazards was checked by producing Aalen plots and testing whether HRs varied over different intervals of time. A number of sensitivity analyses were completed (1) PS 1:1 matching, rather than using the score directly in the regression model; (2) censoring all patients prescribed orlistat at the date of sibutramine withdrawal (2010); and (3) assuming that the possible delayed effects of sibutramine lasted 15 days after the final dose, rather than 60 days. All analysis was carried out using Stata version 13.21

Ethical approval for this study was obtained from the London School of Hygiene and Tropical Medicine Ethics Committee and scientific approval was gained from the Independent Scientific Advisory Committee for Medicines and Healthcare products Regulatory Agency.