Description
Deepthy Varghese, MSN, ACNP, FNP, Northside Hospital is joined by Aarti Dalal, DO, FHRS, CEPS-P, Vanderbilt University and Peter S. Fischbach, MA, MD, Emory University/Children's Healthcare of Atlanta to discuss the multicenter, single-arm trial evaluated the safety and efficacy of transplacental treatment for fetal supraventricular tachycardia (SVT) and atrial flutter (AFL). The treatment involved using digoxin, sotalol, and flecainide for singleton pregnancies from 22 to less than 37 weeks of gestation with sustained fetal SVT or AFL with heart rates of at least 180 beats per minute.Out of the 50 enrolled patients, fetal tachyarrhythmia resolved in 89.8% of cases overall, and in 75.0% of cases where fetal hydrops was present. Pre-term births occurred in 20.4% of patients. Maternal adverse events were observed in 78.0% of patients, with serious adverse events leading to discontinuation of treatment in 4 patients. Two fetal deaths occurred due to heart failure, and neonatal tachyarrhythmia was observed in 31.9% of neonates within 2 weeks after birth. In conclusion, the transplacental treatment protocol was effective and tolerable in 90% of patients, but serious adverse events were noted in fetuses, and tachyarrhythmias could recur in neonates within the first 2 weeks after birth.
Learning Objectives
- Understand the efficacy of transplacental treatment using digoxin, sotalol, and flecainide for fetal supraventricular tachycardia (SVT) and atrial flutter (AFL) in singleton pregnancies between 22 to less than 37 weeks of gestation.
- Identify the primary and secondary endpoints utilized in evaluating the safety and efficacy of the protocol-defined transplacental treatment, including resolution of fetal tachyarrhythmia, pre-term birth rates, neonatal arrhythmia occurrence, and adverse events.
- Recognize the potential risks associated with transplacental treatment, such as maternal adverse events, serious adverse events leading to treatment discontinuation, fetal deaths caused by heart failure, and the recurrence of tachyarrhythmias in neonates within the first 2 weeks after birth.
Article Authors and Podcast Contributors
Article Authors
Takekazu Miyoshi, Yasuki Maeno, Toshimitsu Hamasaki, Noboru Inamura, Satoshi Yasukochi, Motoyoshi Kawataki, Hitoshi Horigome, Hitoshi Yoda, Mio Taketazu, Masaki Nii, Akiko Hagiwara, Hitoshi Kato, Wataru Shimizu, Isao Shiraishi, Heima Sakaguchi, Keiko Ueda, Shinji Katsuragi, Haruko Yamamoto, Haruhiko Sago, Tomoaki Ikeda
Podcast Contributors
Deepthy Varghese, MSN, ACNP, FNP, Northside Hospital
Aarti Dalal, DO, FHRS, CEPS-P, Vanderbilt University
Peter S. Fischbach, MA, MD, Emory University/Children's Healthcare of Atlanta
Disclosure Policy
ACE Disclosure Policy
The Heart Rhythm Society is committed to the provision of Accredited Continuing Education (formerly known as Continuing Medical Education (CME)) that is balanced, objective, and evidence based. HRS adheres to the Standards for Integrity and Independence in Accredited Continuing Education of the Accreditation Council for Continuing Medical Education (ACCME) which require that those individuals in a position to control the content of an educational activity (including, but not limited to, planners, faculty, authors, committee members, content reviewers, editors, and staff) disclose all financial relationships with an ACCME-defined ineligible company* within the 24 months prior to the disclosure.
Any individual who refuses to disclose financial relationships is disqualified from participating in HRS ACE-certified activities. Owners and employees of ACCME-defined ineligible companies may have no role in the planning or implementation of ACE activities without a special written exemption from the HRS Chief Learning Officer that will be granted only in specific circumstances that meet ACCME requirements.
ACCME Definition:
*An ineligible company is one whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
Examples of such organizations include:
- Advertising, marketing, or communication firms whose clients are ineligible companies
- Bio-medical startups that have begun a governmental regulatory approval process
- Compounding pharmacies that manufacture proprietary compounds
- Device manufacturers or distributors
- Diagnostic labs that sell proprietary products
- Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
- Manufacturers of health-related wearable products
- Pharmaceutical companies or distributors
- Pharmacy benefit managers
- Reagent manufacturers or sellers
All relevant financial relationships have been mitigated.
Host Disclosure(s):
D. Varghese: Nothing to disclose
Contributor Disclosure(s):
A. Dalal: Honoraria, Speaking, and Consulting: Medtronic Inc.
P. Fischbach: Nothing to disclose
Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner):
S. Sailor: No relevant financial relationships with ineligible companies to disclose.
S. Colbert: No relevant financial relationships with ineligible companies to disclose.
ACE Statements
Accreditation Statement
The Heart Rhythm Society is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Physicians AMA Designation Statement
The Heart Rhythm Society designates this internet-enduring activity for a maximum of .25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ABIM Maintenance of Certification (MOC) Statement
Successful completion of this ACE activity, which includes participation in the evaluation component, enables the participant to earn up to .25 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of ACE credits claimed for the activity. It is the ACE activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.
Royal College of Physicians and Surgeons of Canada MOC Recognition Statement
Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “ACE in Support of MOC” program in Section 3 of the Royal College’s MOC Program.
Other Credit Available
A Credit Certificate (for physicians) or Certificate of Participation (for non-physicians) will be provided to individuals seeking credit from the following organizations which accept AMA PRA Category 1 Credit(s)™. Note that participants are advised to contact their certifying body for specific information regarding credit submissions:
· American Academy of Family Physicians (AAFP) (for elective credit)
· American Academy of Nurse Practitioners Certification Board (AANPCB)
· American Academy of Physician Assistants (AAPA)
· American Nurses Credentialing Center (ANCC)
· American Osteopathic Association (AOA) (for Category 2 credit)
· Committee on Accreditation of Continuing Medical Education (Canada)
· European Board for Accreditation in Cardiology (EBAC)
· European CME Credits (ECMEC)
· German Chambers of Physicians
· National Society of Genetic Counselors (for Category 2 credit)
· Oman Medical Specialty Board
· Qatar Council for Healthcare Practitioners
· Royal College of Physicians and Surgeons of Canada (RCPSC)