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Published on: February 28, 2012
Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent
Marius Hornung1, Stefan C Bertog, Jennifer Franke
1CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany.
Insights
The Amplatzer device demonstrated a significantly lower rate of recurrent neurological events after patent foramen ovale (PFO) closure compared to CardioSEAL-STARflex and Helex devices in patients with cryptogenic stroke.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Medical Devices
Background:
- Patent foramen ovale (PFO) closure is a debated strategy for secondary stroke prevention.
- Long-term comparative data on different PFO closure devices are limited.
Purpose of the Study:
- To prospectively compare procedural complications and long-term outcomes of three different PFO closure devices.
- To evaluate the efficacy of Amplatzer, CardioSEAL-STARflex, and Helex occluders in patients with cryptogenic stroke.
Main Methods:
- A randomized trial involving 660 patients with cryptogenic stroke.
- Patients were assigned to one of three closure devices: Amplatzer, CardioSEAL-STARflex, or Helex.
- The primary endpoint was recurrent cerebral ischemia, neurological death, or paradoxical embolism within 5 years.
Main Results:
- All device implantations were technically successful (100%).
- The Amplatzer group showed a significantly lower rate of recurrent neurological events (1.4%) compared to CardioSEAL-STARflex (6%) and Helex (4%).
- Device-related thrombus formation was more frequent with CardioSEAL-STARflex and Helex than with Amplatzer.
Conclusions:
- Procedural complications and long-term neurological event rates are low across all devices.
- The Amplatzer device offers a superior safety and efficacy profile for PFO closure in cryptogenic stroke patients.
- Findings impact the interpretation of trials comparing PFO closure with medical management.
Aims:
Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure devices.
Methods And Results:
Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions (n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and device embolization in three patients (all Helex group). Thrombus formation on the device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events (P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death).
Conclusion:
Although procedural complications and long-term neurological event rates are low regardless of the device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.
